Medicare and Medicaid Programs; CY 2025 Payment Policies under

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 401, 405, 410, 411, 414, 423, 424, 425, 427, 428, and 491

[CMS-1807-P]

RIN 0938-AV33

Medicare and Medicaid Programs; CY 2025 Payment Policies under the Physician Fee

Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared

Savings Program Requirements; Medicare Prescription Drug Inflation Rebate Program;

and Medicare Overpayments

AGENCY: Centers for Medicare & Medicaid Services (CMS), Health and Human Services

(HHS).

ACTION: Proposed rule.

SUMMARY: This major proposed rule addresses: changes to the physician fee schedule (PFS);

other changes to Medicare Part B payment policies to ensure that payment systems are updated

to reflect changes in medical practice, relative value of services, and changes in the statute;

codification of, and proposing policies for, the Medicare Prescription Drug Inflation Rebate

Program under the Inflation Reduction Act of 2022; updates to the Medicare Diabetes Prevention

Program expanded model; payment for dental services inextricably linked to specific covered

medical services; updates to drugs and biological products paid under Part B including

immunosuppressive drugs and clotting factors; Medicare Shared Savings Program requirements;

updates to the Quality Payment Program; Medicare coverage of opioid use disorder services

furnished by opioid treatment programs; updates to policies for Rural Health Clinics and

Federally Qualified Health Centers; electronic prescribing for controlled substances for a

covered Part D drug under a prescription drug plan or a Medicare Advantage Prescription Drug

(MA-PD) plan under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and

Treatment for Patients and Communities Act (SUPPORT Act); update to the Ambulance Fee

This document is scheduled to be published in the

Federal Register on 07/31/2024 and available online at

https://federalregister.gov/d/2024-14828, and on https://govinfo.gov

Schedule regulations; codification of the Inflation Reduction Act and Consolidated

Appropriations Act, 2023 provisions; updates to Clinical Laboratory Fee Schedule regulations;

updates to the diabetes payment structure and PHE flexibilities; expansion of colorectal cancer

screening and Hepatitis B vaccine coverage and payment; establishing payment for drugs

covered as additional preventive services; Medicare Parts A and B Overpayment Provisions of

the Affordable Care Act.

DATES: To be assured consideration, comments must be received at one of the addresses

provided below, no later than 5 p.m. on September 9, 2024.

ADDRESSES: In commenting, please refer to file code CMS-1807-P.

Comments, including mass comment submissions, must be submitted in one of the

following three ways (please choose only one of the ways listed):

1. Electronically. You may submit electronic comments on this regulation to

https://www.regulations.gov. Follow the “Submit a comment” instructions.

2. By regular mail. You may mail written comments to the following address ONLY:

Centers for Medicare & Medicaid Services,

Department of Health and Human Services,

Attention: CMS-1807-P,

P.O. Box 8016,

Baltimore, MD 21244-8016.

Please allow sufficient time for mailed comments to be received before the close of the comment

period.

3. By express or overnight mail. You may send written comments to the following

address ONLY:

Centers for Medicare & Medicaid Services,

Department of Health and Human Services,

Attention: CMS-1807-P,

Mail Stop C4-26-05,

7500 Security Boulevard,

Baltimore, MD 21244-1850.

FOR FURTHER INFORMATION CONTACT:

[email protected], for any issues not identified below. Please

indicate the specific issue in the subject line of the email.

Michael Soracoe, (410) 786-6312, Morgan Kitzmiller, (410) 786-1623, or

[email protected], for issues related to practice expense, work

RVUs, conversion factor, and PFS specialty-specific impacts.

Kris Corwin, (410) 786-8864, or [email protected], for

issues related to strategies for updates to practice expense data collection and methodology.

Hannah Ahn, (814) 769-0143, or [email protected], for

issues related to potentially misvalued services under the PFS.

Kris Corwin, (410) 786-8864, Patrick Sartini, (410) 786-9252, Mikayla Murphy, (667)

414-0093, or [email protected], for issues related to direct

supervision using two-way audio/video communication technology, telehealth, and other

services involving communications technology.

Tamika Brock, (312) 886-7904, or [email protected], for

issues related to teaching physician billing for services involving residents in teaching settings.

Sarah Leipnik, (410) 786-3933, Mikayla Murphy, (667) 414-0093, Regina Walker-Wren,

(410) 786-9160, or [email protected], for issues related to payment

for caregiver training services and addressing health-related social needs(community health

integration, principal illness navigation, and social determinants of health risk assessment).

Erick Carrera, (410) 786-8949, or [email protected], for

issues related to office/outpatient evaluation and management visit inherent complexity add-one.

Sarah Irie, (410) 786-1348, Emily Parris (667) 414-0418, or

[email protected], for issues related to payment for advanced

primary care management service.

Sarah Leipnik, (410) 786-3933, or [email protected], for

issues related to global surgery payment accuracy.

Pamela West, (410) 786-2302, for issues related to supervision of outpatient therapy

services in private practices, certification of therapy plans of care, and KX modifier threshold.

Lindsey Baldwin, (410) 786-1694, Regina Walker-Wren, (410) 786-9160, Erick Carrera,

(410) 786-8949, Mikayla Murphy, (667) 414-0093, or

[email protected], for issues related to advancing access to

behavioral health services.

Laura Ashbaugh, (410) 786-1113, and Erick Carrera, (410) 786-8949, Zehra Hussain,

(214) 767-4463, or [email protected], for issues related to dental

services inextricably linked to specific covered medical services.

Zehra Hussain, (214) 767-4463, or [email protected], for

issues related to payment of skin substitutes.

Laura Kennedy, (410) 786-3377, Adam Brooks, (202) 205-0671, Rachel Radzyner, (410)

786-8215, Rebecca Ray, (667) 414-0879, and Jae Ryu, (667) 414-0765 for issues related to

Drugs and Biological Products Paid Under Medicare Part B.

[email protected], for issues related to complex drug

administration.

Glenn McGuirk, (410) 786-5723, or [email protected] for issues related to

Clinical Laboratory Fee Schedule.

Lisa Parker, (410) 786-4949, or [email protected], for issues related to FQHC

payments.

Heidi Oumarou, (410) 786-7942, for issues related to the FQHC market basket.

Michele Franklin, (410) 786-9226, or [email protected], for issues related to RHC

payments.

Kianna Banks (410) 786-3498 and Cara Meyer (667) 290-9856, for issues related to

RHCs and FQHCs and Conditions for Certification or Coverage.

Colleen Barbero (667) 290-8794, for issues related to Medicare Diabetes Prevention

Program.

Ariana Pitcher, (667) 290- 8840, or [email protected], for issues related to

Medicare coverage of opioid use disorder treatment services furnished by opioid treatment

programs.

Sabrina Ahmed, (410) 786-7499, or [email protected], for issues

related to the Medicare Shared Savings Program (Shared Savings Program) Quality performance

standard and quality reporting requirements.

Janae James, (410) 786-0801, or [email protected], for issues related

to Shared Savings Program beneficiary assignment and benchmarking methodology.

Richard (Chase) Kendall, (410) 786-1000, or [email protected], for

issues related to reopening ACO payment determinations, and mitigating the impact of

significant, anomalous, and highly suspect billing activity on Shared Savings Program financial

calculations.

Lucy Bertocci, (410) 786-3776, or [email protected], for issues

related to Shared Savings Program prepaid shared savings, advance investment payments,

beneficiary notice and eligibility requirements.

Rachel Radzyner, (410) 786-8215, for issues related to payment for preventative services,

including preventive vaccine administration and drugs covered as additional preventive services.

Elisabeth Daniel, (667) 290-8793, for issues related to the Medicare Prescription Drug

Inflation Rebate Program.

Genevieve Kehoe, [email protected], or 1-844-711-2664 (Option

4) for issues related to the Request for Information: Building upon the MIPS Value Pathways

(MVPs) Framework to Improve Ambulatory Specialty Care.

Kimberly Long, (410) 786-5702, for issues related to expanding colorectal cancer

screening.

Rachel Katonak, (410) 786-8564, for issues related to expanding Hepatitis B vaccine

coverage.

Mei Zhang, (410) 786-7837, for issues related to requirement for electronic prescribing

for controlled substances for a covered Part D drug under a prescription drug plan or an MA-PD

plan (section 2003 of the SUPPORT Act).

Katie Parker, (410) 786-0537, for issues related to Parts A and B overpayment provisions

of the Affordable Care Act.

Amy Gruber, (410) 786-1542, for issues related to low titer O+ whole blood transfusion

therapy during ground ambulance transport.

Renee O’Neill, (410) 786-8821, or Sophia Sugumar, (410) 786-1648, for inquiries related

to Merit-based Incentive Payment System (MIPS) track of the Quality Payment Program.

Danielle Drayer, (516) 965-6630, for inquiries related to Alternative Payment Models

(APMs).

SUPPLEMENTARY INFORMATION:

Addenda Available Only Through the Internet on the CMS Website: The PFS Addenda

along with other supporting documents and tables referenced in this proposed rule are available

on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-

Payment/PhysicianFeeSched/index.html. Click on the link on the left side of the screen titled,

“PFS Federal Regulations Notices” for a chronological list of PFS Federal Register and other

related documents. For the CY 2025 PFS proposed rule, refer to item CMS-1807-P. Readers

with questions related to accessing any of the Addenda or other supporting documents referenced

in this proposed rule and posted on the CMS website identified above should contact

[email protected].

CPT (Current Procedural Terminology) Copyright Notice: Throughout this proposed

rule, we use CPT codes and descriptions to refer to a variety of services. We note that CPT

CPT is a registered trademark of the American Medical Association (AMA). Applicable Federal

Acquisition Regulations (FAR) and Defense Federal Acquisition Regulations (DFAR) apply.

I. Executive Summary

A. Purpose

This major annual rule proposes to revise payment policies under the Medicare PFS and

makes other policy changes, including proposals to implement certain provisions of the Further

Continuing Appropriations and Other Extensions Act of 2024 (Pub. L. 118-22, November 16,

2023), Consolidated Appropriations Act, 2023 (Pub. L. 117-328, September 29, 2022), Inflation

Reduction Act of 2022 (IRA) (Pub. L. 117-169, August 16, 2022), Consolidated Appropriations

Act, 2022 (Pub. L. 117-103, March 15, 2022), Consolidated Appropriations Act, 2021 (CAA,

2021) (Pub. L. 116-260, December 27, 2020), Bipartisan Budget Act of 2018 (BBA of 2018)

(Pub. L. 115-123, February 9, 2018) and the Substance Use-Disorder Prevention that Promotes

Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) (Pub. L.

115-271, October 24, 2018), related to Medicare Part B payment. In addition, this major

proposed rule includes proposals regarding other Medicare payment policies described in

sections III. and IV.

This rulemaking also proposes to codify policies previously established in guidance for

the Medicare Prescription Drug Inflation Rebate Program at new parts 427 and 428, including

clarifications to certain existing policies, consistent with sections 1847A(i) and 1860D-14B of

the Act. This rulemaking also proposes new policies for the Medicare Prescription Drug Inflation

Rebate Program, including removal of units of drugs subject to discarded drug refunds from the

Part B rebate amounts, exclusion of units for which a manufacturer provides a discount under the

340B Program from the Part D inflation rebate amount starting on January 1, 2026, the process

for reconciliation of a Part B or Part D rebate amount to incorporate certain revised information,

and procedures for imposing civil money penalties on manufacturers that do not pay Part B or

Part D inflation rebate amounts within a specified period of time.

This rulemaking proposes to update the Rural Health Clinic (RHC) and Federally

Qualified Health Clinic (FQHC) Conditions for Certification and Conditions for Coverage

(CfCs), respectively, by clarifying the requirements and intent of the program regarding the

provision of services. We also aim to ensure RHCs are provided flexibility in the services they

offer, including specialty and laboratory services.

This rulemaking also proposes to further advance Medicare’s overall value-based care

strategy of growth, alignment, and equity through the Medicare Shared Savings Program (Shared

Savings Program) and the Quality Payment Program. The structure of the programs enables us to

develop a set of tools for measuring and encouraging improvements in care, which may support a

shift to clinician payment over time into Advanced Alternative Payment Models (APMs) and

accountable care arrangements which reduce care fragmentation and unnecessary costs for

patients and the health system.

This rulemaking also proposes changes to Medicare regulations regarding requirements

for reporting and returning Parts A and B overpayments.

B. Summary of the Major Provisions

Please note, some sections of this proposed rule contain a request for information (RFI).

In accordance with the implementing regulations of the Paperwork Reduction Act of 1995

(PRA), specifically 5 CFR 1320.3(h)(4), these general solicitations are exempt from the PRA.

Facts or opinions submitted in response to general solicitations of comments from the public,

published in the Federal Register or other publications, regardless of the form or format thereof,

provided that no person is required to supply specific information pertaining to the commenter,

other than that necessary for self-identification, as a condition of the agency's full consideration,

are not generally considered information collections and therefore not subject to the PRA.

Respondents are encouraged to provide complete but concise responses. These RFIs are issued

solely for information and planning purposes; they do not constitute a Request for Proposal

(RFP), applications, proposal abstracts, or quotations. These RFIs do not commit the U.S.

Government to contract for any supplies or services or make a grant award. Further, CMS is not

seeking proposals through these RFIs and will not accept unsolicited proposals. Responders are

advised that the U.S. Government will not pay for any information or administrative costs

incurred in response to these RFIs; all costs associated with responding to these RFIs will be

solely at the interested party’s expense. Not responding to these RFIs does not preclude

participation in any future procurement, if conducted. It is the responsibility of the potential

responders to monitor these RFI announcements for additional information pertaining to these

requests. Please note that CMS will not respond to questions about the policy issues raised in

these RFIs. CMS may or may not choose to contact individual responders. Such communications

would only serve to further clarify written responses. Contractor support personnel may be used

to review RFI responses. Responses to this notice are not offers and cannot be accepted by the

U.S. Government to form a binding contract or issue a grant. Information obtained as a result of

these RFIs may be used by the U.S. Government for program planning on a non-attribution basis.

Respondents should not include any information that might be considered proprietary or

confidential. These RFIs should not be construed as a commitment or authorization to incur cost

for which reimbursement would be required or sought. All submissions become U.S.

Government property and will not be returned. CMS may publicly post the comments received,

or a summary thereof.

Section 1848 of the Social Security Act (the Act) requires us to establish payments under

the PFS, based on national uniform relative value units (RVUs) that account for the relative

resources used in furnishing a service. The statute requires that RVUs be established for three

categories of resources: work, practice expense (PE), and malpractice (MP) expense. In

addition, the statute requires that each year we establish, by regulation, the payment amounts for

physicians’ services paid under the PFS, including geographic adjustments to reflect the

variations in the costs of furnishing services in different geographic areas.

In this major proposed rule, we are proposing to establish RVUs for CY 2025 for the PFS

to ensure that our payment systems are updated to reflect changes in medical practice and the

relative value of services, as well as changes in the statute. This proposed rule also includes

discussions and provisions regarding several other Medicare Part B payment policies, Medicare

and Medicaid provider and supplier enrollment policies, and other policies regarding programs

administered by CMS.

Specifically, this proposed rule addresses:

● Background (section II.A.)

● Determination of PE RVUs (section II.B.)

● Potentially Misvalued Services Under the PFS (section II.C.)

● Payment for Medicare Telehealth Services Under Section 1834(m) of the Act (section

II.D.)

● Valuation of Specific Codes (section II.E.)

● Evaluation and Management (E/M) Visits (section II.F.)

● Enhanced Care Management (section II.G.)

● Supervision of Outpatient Therapy Services in Private Practices, Certification of

Therapy Plans of Care with a Physician or NPP Order, and KX Modifier Thresholds (section

II.H.)

● Advancing Access to Behavioral Health Services (section II.I.)

● Proposals on Medicare Parts A and B Payment for Dental Services Inextricably Linked

to Specific Covered Services (section II.J.)

● Payment for Skin Substitutes (section II.K.)

● Drugs and Biological Products Paid Under Medicare Part B (section III.A.)

● Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs)

(section III.B.)

● Rural Health Clinic (RHC) and Federally Qualified Health Center (FQHC) Conditions

for Certification and Conditions for Coverage (CfCs) (section III.C.)

● Clinical Laboratory Fee Schedule: Revised Data Reporting Period and Phase-in of

Payment Reductions (section III.D.)

● Medicare Diabetes Prevention Program (MDPP) (section III.E.)

● Modifications Related to Medicare Coverage for Opioid Use Disorder (OUD)

Treatment Services Furnished by Opioid Treatment Programs (OTPs ) (section III.F.)

● Medicare Shared Savings Program (section III.G.)

● Medicare Part B Payment for Preventive Services (§§ 410.10, 410.57, 410.64,

410.152) (section III.H.)

● Medicare Prescription Drug Inflation Rebate Program (section III.I.)

● Request for Information: Building upon the MIPS Value Pathways (MVPs)

Framework to Improve Ambulatory Specialty Care (section III.J.)

● Expand Colorectal Cancer Screening (section III.K.)

● Requirements for Electronic Prescribing for Controlled Substances for a Covered

Part D Drug under a Prescription Drug Plan or an MA-PD Plan (section III.L.)

● Expand Hepatitis B Vaccine Coverage (section III.M.)

● Low Titer O+ Whole Blood Transfusion Therapy During Ground Ambulance

Transport (section III.N.)

● Medicare Parts A and B Overpayment Provisions of the Affordable Care Act

(section III.O.)

● Updates to the Quality Payment Program (section IV.)

● Collection of Information Requirements (section V.)

● Response to Comments (section VI.)

● Regulatory Impact Analysis (section VII.)

C. Summary of Costs and Benefits

We have determined that this proposed rule is economically significant. We estimate the

CY 2025 PFS conversion factor to be 32.3562 which reflects a 0.05 percent positive budget

neutrality adjustment required under section 1848(c)(2)(B)(ii)(II) of the Act, the 0.00 percent

update adjustment factor specified under section 1848(d)(19) of the Act, and the removal of the

temporary 2.93 percent payment increase for services furnished from March 9, 2024, through

December 31, 2024, as provided in the CAA, 2024. For a detailed discussion of the economic

impacts, see section VII., Regulatory Impact Analysis, of this proposed rule.

II. Provisions of the Proposed Rule for the PFS

A. Background

In accordance with section 1848 of the Social Security Act (the Act), CMS has paid for

physicians’ services under the Medicare physician fee schedule (PFS) since January 1, 1992.

The PFS relies on national relative values that are established for work, practice expense (PE),

and malpractice (MP), which are adjusted for geographic cost variations. These values are

multiplied by a conversion factor (CF) to convert the relative value units (RVUs) into payment

rates. The concepts and methodology underlying the PFS were enacted as part of the Omnibus

Budget Reconciliation Act of 1989 (OBRA ’89) (Pub. L. 101-239, December 19, 1989), and the

Omnibus Budget Reconciliation Act of 1990 (OBRA ’90) (Pub. L. 101-508, November 5, 1990).

The final rule published in the November 25, 1991 Federal Register (56 FR 59502) set forth the

first fee schedule used for Medicare payment for physicians’ services.

We note that throughout this proposed rule, unless otherwise noted, the term

“practitioner” is used to describe both physicians and nonphysician practitioners (NPPs) who are

permitted to bill Medicare under the PFS for the services they furnish to Medicare beneficiaries.

B. Determination of PE RVUs

1. Overview

Practice expense (PE) is the portion of the resources used in furnishing a service that

reflects the general categories of physician and practitioner expenses, such as office rent and

personnel wages, but excluding malpractice (MP) expenses, as specified in section 1848(c)(1)(B)

of the Act. As required by section 1848(c)(2)(C)(ii) of the Act, we use a resource-based system

for determining PE RVUs for each physicians’ service. We develop PE RVUs by considering

the direct and indirect practice resources involved in furnishing each service. Direct expense

categories include clinical labor, medical supplies, and medical equipment. Indirect expenses

include administrative labor, office expense, and all other expenses. The sections that follow

provide more detailed information about the methodology for translating the resources involved

in furnishing each service into service specific PE RVUs. We refer readers to the CY 2010

Physician Fee Schedule (PFS) final rule with comment period (74 FR 61743 through 61748) for

a more detailed explanation of the PE methodology.

2. Practice Expense Methodology

a. Direct Practice Expense

We determine the direct PE for a specific service by adding the costs of the direct

resources (that is, the clinical staff, medical supplies, and medical equipment) typically involved

with furnishing that service. The costs of the resources are calculated using the refined direct PE

inputs assigned to each CPT code in our PE database, which are generally based on our review of

recommendations received from the American Medical Association (AMA) Relative Value Scale

Update Committee (RUC) and those provided in response to public comment periods. For a

detailed explanation of the direct PE methodology, including examples, we refer readers to the 5-

year review of work RVUs under the PFS and proposed changes to the PE methodology in the

CY 2007 PFS proposed rule (71 FR 37242) and the CY 2007 PFS final rule with comment

period (71 FR 69629).

b. Indirect Practice Expense per Hour Data

We use survey data on indirect PEs incurred per hour worked to develop the indirect

portion of the PE RVUs. Prior to CY 2010, we primarily used the PE/HR by specialty obtained

from the AMA’s Socioeconomic Monitoring System (SMS). The AMA administered a new

survey in CY 2007 and CY 2008, the Physician Practice Information Survey (PPIS). The PPIS is

a multispecialty, nationally representative, PE survey of physicians and NPPs paid under the PFS

using a survey instrument and methods highly consistent with those used for the SMS and the

supplemental surveys. The PPIS gathered information from 3,656 respondents across 51

physician specialty and health care professional groups. We believe the PPIS is the most

comprehensive source of PE survey information available. We used the PPIS data to update the

PE/HR data for the CY 2010 PFS for almost all of the Medicare-recognized specialties that

participated in the survey.

When we began using the PPIS data in CY 2010, we did not change the PE RVU

methodology or how the PE/HR data are used. We only updated the PE/HR data based on the

new survey. Furthermore, as we explained in the CY 2010 PFS final rule with comment period

(74 FR 61751), because of the magnitude of payment reductions for some specialties resulting

from the use of the PPIS data, we transitioned its use over a 4-year period from the previous PE

RVUs to the PE RVUs developed using the new PPIS data. As provided in the CY 2010 PFS

final rule with comment period (74 FR 61751), the transition to the PPIS data was complete for

CY 2013. Therefore, PE RVUs from CY 2013 forward are developed based entirely on the PPIS

data, except as noted in this section.

Section 1848(c)(2)(H)(i) of the Act requires us to use the medical oncology supplemental

survey data submitted in 2003 for oncology drug administration services. Therefore, the PE/HR

for medical oncology, hematology, and hematology/oncology reflects the continued use of these

supplemental survey data.

Supplemental survey data on independent labs from the College of American

Pathologists were implemented for payments beginning in CY 2005. Supplemental survey data

from the National Coalition of Quality Diagnostic Imaging Services (NCQDIS), representing

independent diagnostic testing facilities (IDTFs), were blended with supplementary survey data

from the American College of Radiology (ACR) and implemented for payments beginning in

CY 2007. Neither IDTFs nor independent labs participated in the PPIS. Therefore, we continue

to use the PE/HR that was developed from their supplemental survey data.

Consistent with our past practice, the previous indirect PE/HR values from the

supplemental surveys for these specialties were updated to CY 2006 using the Medicare

Economic Index (MEI) to put them on a comparable basis with the PPIS data.

We also do not use the PPIS data for reproductive endocrinology and spine surgery since

these specialties are not separately recognized by Medicare, nor do we have a method to blend

the PPIS data with Medicare-recognized specialty data.

Previously, we established PE/HR values for various specialties without SMS or

supplemental survey data by crosswalking them to other similar specialties to estimate a proxy

PE/HR. For specialties that were part of the PPIS for which we previously used a crosswalked

PE/HR, we instead used the PPIS based PE/HR. We use crosswalks for specialties that did not

participate in the PPIS. These crosswalks have been generally established through notice and

comment rulemaking and are available in the file titled “CY 2025 PFS proposed rule PE/HR” on

the CMS website under downloads for the CY 2025 PFS proposed rule at

https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-

Federal-Regulation-Notices.html.

For CY 2025, we have incorporated the available utilization data for two new specialties,

Marriage and Family Therapist (MFT) and Mental Health Counselor (MHC), which we

recognized effective January 1, 2024, in accordance with section 4121 of the CAA, 2023. We

are proposing to use proxy PE/HR values for these new specialties, as there are no PPIS data for

these specialties, by crosswalking the PE/HR as follows from specialties that furnish similar

services in the Medicare claims data:

● Marriage and Family Therapist (MFT) from Licensed Clinical Social Workers; and

● Mental Health Counselor (MHC) from Licensed Clinical Social Workers

These updates are reflected in the “CY 2025 PFS proposed rule PE/HR” file available on

the CMS website under the supporting data files for the CY 2025 PFS proposed rule at

https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-

Federal-Regulation-Notices.html.

c. Allocation of PE to Services

To establish PE RVUs for specific services, it is necessary to establish the direct and

indirect PE associated with each service.

(1) Direct Costs

The relative relationship between the direct cost portions of the PE RVUs for any two

services is determined by the relative relationship between the sum of the direct cost resources

(that is, the clinical staff, medical supplies, and medical equipment) typically involved with

furnishing each of the services. The costs of these resources are calculated from the refined

direct PE inputs in our PE database. For example, if one service has a direct cost sum of $400

from our PE database and another service has a direct cost sum of $200, the direct portion of the

PE RVUs of the first service would be twice as much as the direct portion of the PE RVUs for

the second service.

(2) Indirect Costs

We allocate the indirect costs at the code level based on the direct costs specifically

associated with a code and the greater of either the clinical labor costs or the work RVUs. We

also incorporate the survey data described earlier in the PE/HR discussion. The general

approach to developing the indirect portion of the PE RVUs is as follows:

● For a given service, we use the direct portion of the PE RVUs calculated as previously

described and the average percentage that direct costs represent of total costs (based on survey

data) across the specialties that furnish the service to determine an initial indirect allocator. That

is, the initial indirect allocator is calculated so that the direct costs equal the average percentage

of direct costs of those specialties furnishing the service. For example, if the direct portion of the

PE RVUs for a given service is 2.00 and direct costs, on average, represent 25 percent of total

costs for the specialties that furnish the service, the initial indirect allocator would be calculated

so that it equals 75 percent of the total PE RVUs. Thus, in this example, the initial indirect

allocator would equal 6.00, resulting in a total PE RVU of 8.00 (2.00 is 25 percent of 8.00 and

6.00 is 75 percent of 8.00).

● Next, we add the greater of the work RVUs or clinical labor portion of the direct

portion of the PE RVUs to this initial indirect allocator. In our example, if this service had a

work RVU of 4.00 and the clinical labor portion of the direct PE RVU was 1.50, we would add

4.00 (since the 4.00 work RVUs are greater than the 1.50 clinical labor portion) to the initial

indirect allocator of 6.00 to get an indirect allocator of 10.00. In the absence of any further use

of the survey data, the relative relationship between the indirect cost portions of the PE RVUs for

any two services would be determined by the relative relationship between these indirect cost

allocators. For example, if one service had an indirect cost allocator of 10.00 and another service

had an indirect cost allocator of 5.00, the indirect portion of the PE RVUs of the first service

would be twice as great as the indirect portion of the PE RVUs for the second service.

● Then, we incorporate the specialty specific indirect PE/HR data into the calculation.

In our example, if, based on the survey data, the average indirect cost of the specialties

furnishing the first service with an allocator of 10.00 was half of the average indirect cost of the

specialties furnishing the second service with an indirect allocator of 5.00, the indirect portion of

the PE RVUs of the first service would be equal to that of the second service.

(3) Facility and Nonfacility Costs

For procedures that can be furnished in a physician’s office, as well as in a facility

setting, where Medicare makes a separate payment to the facility for its costs in furnishing a

service, we establish two PE RVUs: facility and nonfacility. The methodology for calculating

PE RVUs is the same for both the facility and nonfacility RVUs but is applied independently to

yield two separate PE RVUs. In calculating the PE RVUs for services furnished in a facility, we

do not include resources that would generally not be provided by physicians when furnishing the

service. For this reason, the facility PE RVUs are generally lower than the nonfacility PE RVUs.

(4) Services with Technical Components and Professional Components

Diagnostic services are generally comprised of two components: a professional

component (PC); and a technical component (TC). The PC and TC may be furnished

independently or by different healthcare providers, or they may be furnished together as a global

service. When services have separately billable PC and TC components, the payment for the

global service equals the sum of the payment for the TC and PC. To achieve this, we use a

weighted average of the ratio of indirect to direct costs across all the specialties that furnish the

global service, TCs, and PCs; that is, we apply the same weighted average indirect percentage

factor to allocate indirect expenses to the global service, PCs, and TCs for a service. (The direct

PE RVUs for the TC and PC sum to the global.)

(5) PE RVU Methodology

For a more detailed description of the PE RVU methodology, we direct readers to the CY

2010 PFS final rule with comment period (74 FR 61745 through 61746). We also direct readers

to the file titled “Calculation of PE RVUs under Methodology for Selected Codes” which is

available on our website under downloads for the CY 2025 PFS proposed rule at

https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-

Federal-Regulation-Notices.html. This file contains a table that illustrates the calculation of PE

RVUs as described in this proposed rule for individual codes.

(a) Setup File

First, we create a setup file for the PE methodology. The setup file contains the direct

cost inputs, the utilization for each procedure code at the specialty and facility/nonfacility place

of service level, and the specialty specific PE/HR data calculated from the surveys.

(b) Calculate the Direct Cost PE RVUs

Sum the costs of each direct input.

Step 1: Sum the direct costs of the inputs for each service.

Step 2: Calculate the aggregate pool of direct PE costs for the current year. We set the

aggregate pool of PE costs equal to the product of the ratio of the current aggregate PE RVUs to

current aggregate work RVUs and the projected aggregate work RVUs.

Step 3: Calculate the aggregate pool of direct PE costs for use in ratesetting. This is the

product of the aggregate direct costs for all services from Step 1 and the utilization data for that

service.

Step 4: Using the results of Step 2 and Step 3, use the CF to calculate a direct PE scaling

adjustment to ensure that the aggregate pool of direct PE costs calculated in Step 3 does not vary

from the aggregate pool of direct PE costs for the current year. Apply the scaling adjustment to

the direct costs for each service (as calculated in Step 1).

Step 5: Convert the results of Step 4 to an RVU scale for each service. To do this, divide

the results of Step 4 by the CF. Note that the actual value of the CF used in this calculation does

not influence the final direct cost PE RVUs as long as the same CF is used in Step 4 and Step 5.

Different CFs would result in different direct PE scaling adjustments, but this has no effect on

the final direct cost PE RVUs since changes in the CFs and the associated direct scaling

adjustments offset one another.

Create indirect allocators.

Step 6: Based on the survey data, calculate direct and indirect PE percentages for each

physician specialty.

Step 7: Calculate direct and indirect PE percentages at the service level by taking a

weighted average of the results of Step 6 for the specialties that furnish the service. Note that for

services with TCs and PCs, the direct and indirect percentages for a given service do not vary by

the PC, TC, and global service.

We generally use an average of the three most recent years of available Medicare claims

data to determine the specialty mix assigned to each code. Codes with low Medicare service

volume require special attention since billing or enrollment irregularities for a given year can

result in significant changes in specialty mix assignment. We finalized a policy in the CY 2018

PFS final rule (82 FR 52982 through 59283) to use the most recent year of claims data to

determine which codes are low volume for the coming year (those that have fewer than 100

allowed services in the Medicare claims data). For codes that fall into this category, instead of

assigning a specialty mix based on the specialties of the practitioners reporting the services in the

claims data, we use the expected specialty that we identify on a list developed based on medical

review and input from expert interested parties. We display this list of expected specialty

assignments as part of the annual set of data files we make available as part of notice and

comment rulemaking and consider recommendations from the RUC and other interested parties

on changes to this list annually. Services for which the specialty is automatically assigned based

on previously finalized policies under our established methodology (for example, “always

therapy” services) are unaffected by the list of expected specialty assignments. We also finalized

in the CY 2018 PFS final rule (82 FR 52982 through 52983) a policy to apply these service-level

overrides for both PE and MP, rather than one or the other category.

Step 8: Calculate the service level allocators for the indirect PEs based on the

percentages calculated in Step 7. The indirect PEs are allocated based on the three components:

the direct PE RVUs; the clinical labor PE RVUs; and the work RVUs.

For most services the indirect allocator is: indirect PE percentage * (direct PE

RVUs/direct percentage) + work RVUs.

There are two situations where this formula is modified:

● If the service is a global service (that is, a service with global, professional, and

technical components), then the indirect PE allocator is: indirect percentage (direct PE

RVUs/direct percentage) + clinical labor PE RVUs + work RVUs.

● If the clinical labor PE RVUs exceed the work RVUs (and the service is not a global

service), then the indirect allocator is: indirect PE percentage (direct PE RVUs/direct percentage)

+ clinical labor PE RVUs.

(Note: For global services, the indirect PE allocator is based on both the work RVUs and

the clinical labor PE RVUs. We do this to recognize that, for the PC service, indirect PEs would

be allocated using the work RVUs, and for the TC service, indirect PEs would be allocated using

the direct PE RVUs and the clinical labor PE RVUs. This also allows the global component

RVUs to equal the sum of the PC and TC RVUs.)

For presentation purposes, in the examples in the download file titled “Calculation of PE

RVUs under Methodology for Selected Codes”, the formulas were divided into two parts for

each service.

● The first part does not vary by service and is the indirect percentage (direct PE

RVUs/direct percentage).

● The second part is either the work RVU, clinical labor PE RVU, or both depending on

whether the service is a global service and whether the clinical PE RVUs exceed the work RVUs

(as described earlier in this step).

Apply a scaling adjustment to the indirect allocators.

Step 9: Calculate the current aggregate pool of indirect PE RVUs by multiplying the

result of step 8 by the average indirect PE percentage from the survey data.

Step 10: Calculate an aggregate pool of indirect PE RVUs for all PFS services by adding

the product of the indirect PE allocators for a service from Step 8 and the utilization data for that

service.

Step 11: Using the results of Step 9 and Step 10, calculate an indirect PE adjustment so

that the aggregate indirect allocation does not exceed the available aggregate indirect PE RVUs

and apply it to indirect allocators calculated in Step 8.

Calculate the indirect practice cost index.

Step 12: Using the results of Step 11, calculate aggregate pools of specialty specific

adjusted indirect PE allocators for all PFS services for a specialty by adding the product of the

adjusted indirect PE allocator for each service and the utilization data for that service.

Step 13: Using the specialty specific indirect PE/HR data, calculate specialty specific

aggregate pools of indirect PE for all PFS services for that specialty by adding the product of the

indirect PE/HR for the specialty, the work time for the service, and the specialty’s utilization for

the service across all services furnished by the specialty.

Step 14: Using the results of Step 12 and Step 13, calculate the specialty specific indirect

PE scaling factors.

Step 15: Using the results of Step 14, calculate an indirect practice cost index at the

specialty level by dividing each specialty specific indirect scaling factor by the average indirect

scaling factor for the entire PFS.

Step 16: Calculate the indirect practice cost index at the service level to ensure the

capture of all indirect costs. Calculate a weighted average of the practice cost index values for

the specialties that furnish the service. (Note: For services with TCs and PCs, we calculate the

indirect practice cost index across the global service, PCs, and TCs. Under this method, the

indirect practice cost index for a given service (for example, echocardiogram) does not vary by

the PC, TC, and global service.)

Step 17: Apply the service level indirect practice cost index calculated in Step 16 to the

service level adjusted indirect allocators calculated in Step 11 to get the indirect PE RVUs.

(d) Calculate the Final PE RVUs

Step 18: Add the direct PE RVUs from Step 5 to the indirect PE RVUs from Step 17 and

apply the final PE budget neutrality (BN) adjustment. The final PE BN adjustment is calculated

by comparing the sum of steps 5 and 17 to the aggregate work RVUs scaled by the ratio of

current aggregate PE and work RVUs. This adjustment ensures that all PE RVUs in the PFS

account for the fact that certain specialties are excluded from the calculation of PE RVUs but

included in maintaining overall PFS BN. (See “Specialties excluded from ratesetting

calculation” later in this proposed rule.)

Step 19: Apply the phase-in of significant RVU reductions and its associated adjustment.

Section 1848(c)(7) of the Act specifies that for services that are not new or revised codes, if the

total RVUs for a service for a year would otherwise be decreased by an estimated 20 percent or

more as compared to the total RVUs for the previous year, the applicable adjustments in work,

PE, and MP RVUs shall be phased in over a 2-year period. In implementing the phase-in, we

consider a 19 percent reduction as the maximum 1-year reduction for any service not described

by a new or revised code. This approach limits the year one reduction for the service to the

maximum allowed amount (that is, 19 percent), and then phases in the remainder of the

reduction. To comply with section 1848(c)(7) of the Act, we adjust the PE RVUs to ensure that

the total RVUs for all services that are not new or revised codes decrease by no more than 19

percent, and then apply a relativity adjustment to ensure that the total pool of aggregate PE

RVUs remains relative to the pool of work and MP RVUs. For a more detailed description of

the methodology for the phase-in of significant RVU changes, we refer readers to the CY 2016

PFS final rule with comment period (80 FR 70927 through 70931).

(e) Setup File Information

● Specialties excluded from ratesetting calculation: To calculate the PE and MP RVUs,

we exclude certain specialties, such as NPPs paid at a percentage of the PFS and low volume

specialties, from the calculation. These specialties are included to calculate the BN adjustment.

They are displayed in Table 1.

TABLE 1: Specialties Excluded from Ratesetting Calculation

Specialty

Code

Specialty Description

Ambulatory surgical center

Nurse practitioner

Medical supply company with certified orthotist

Medical supply company with certified prosthetist

Medical supply company with certified prosthetist-orthotist

Medical supply company not included in 51, 52, or 53.

Individual certified orthotist

Individual certified prosthetist

Individual certified prosthetist-orthotist

Medical supply company with registered pharmacist

Ambulance service supplier, e.g., private ambulance companies, funeral homes, etc.

Public health or welfare agencies

Voluntary health or charitable agencies

Mass immunization roster biller

Radiation therapy centers

All other suppliers (e.g., drug and department stores)

Unknown supplier/provider specialty

Certified clinical nurse specialist

Optician

Physician assistant

Hospital

SNF

Intermediate care nursing facility

Nursing facility, other

HHA

Pharmacy

Medical supply company with respiratory therapist

Department store

Grocery store

Supplier of oxygen and/or oxygen related equipment (eff. 10/2/2007)

Pedorthic personnel

Medical supply company with pedorthic personnel

Rehabilitation Agency

Ocularist

Centralized Flu

Indirect Payment Procedure

Dentistry

● Crosswalk certain low volume physician specialties: Crosswalk the utilization of

certain specialties with relatively low PFS utilization to the associated specialties.

● Physical therapy utilization: Crosswalk the utilization associated with all physical

therapy services to the specialty of physical therapy.

● Identify professional and technical services not identified under the usual TC and 26

modifiers: Flag the services that are PC and TC services but do not use TC and 26 modifiers (for

example, electrocardiograms). This flag associates the PC and TC with the associated global

code for use in creating the indirect PE RVUs. For example, the professional service, CPT code

93010 (Electrocardiogram, routine ECG with at least 12 leads; interpretation and report only), is

associated with the global service, CPT code 93000 (Electrocardiogram, routine ECG with at

least 12 leads; with interpretation and report).

● Payment modifiers: Payment modifiers are accounted for in creating the file consistent

with the current payment policy as implemented in claims processing. For example, services

billed with the assistant at surgery modifier are paid 16 percent of the PFS amount for that

service; therefore, the utilization file is modified to only account for 16 percent of any service

that contains the assistant at surgery modifier. Similarly, for those services to which volume

adjustments are made to account for the payment modifiers, time adjustments are applied as well.

For time adjustments to surgical services, the intraoperative portion in the work time file is used;

where it is not present, the intraoperative percentage from the payment files used by contractors

to process Medicare claims is used instead. Where neither is available, we use the payment

adjustment ratio to adjust the time accordingly. Table 2 details the manner in which the

modifiers are applied.

TABLE 2: Application of Payment Modifiers to Utilization Files

Modifier

Description

Volume Adjustment

Time Adjustment

80,81,82

Assistant at Surgery

16%

Intraoperative portion

Assistant at Surgery –

Physician Assistant

14% (85% * 16%)

Intraoperative portion

50 or

LT and RT

Bilateral Surgery

150%

150% of work time

Multiple Procedure

50%

Intraoperative portion

Reduced Services

50%

Discontinued Procedure

50%

Intraoperative Care only

Preoperative + Intraoperative

Percentages on the payment files used

by Medicare contractors to process

Medicare claims

Preoperative + Intraoperative

portion

Postoperative Care only

Postoperative Percentage on the

payment files used by Medicare

contractors to process Medicare claims

Postoperative portion

Co-surgeons

62.5%

50%

Team Surgeons

33%

CO, CQ

Physical and Occupational

Therapy Assistant Services

88%

We also adjust volume and time that correspond to other payment rules, including special

multiple procedure endoscopy rules and multiple procedure payment reductions (MPPRs). We

note that section 1848(c)(2)(B)(v) of the Act exempts certain reduced payments for multiple

imaging procedures and multiple therapy services from the BN calculation under section

1848(c)(2)(B)(ii)(II) of the Act. These MPPRs are not included in the development of the

RVUs.

Beginning in CY 2022, section 1834(v)(1) of the Act required that we apply a 15 percent

payment reduction for outpatient occupational therapy services and outpatient physical therapy

services that are provided, in whole or in part, by a physical therapist assistant (PTA) or

occupational therapy assistant (OTA). Section 1834(v)(2)(A) of the Act required CMS to

establish modifiers to identify these services, which we did in the CY 2019 PFS final rule (83 FR

59654 through 59661), creating the CQ and CO payment modifiers for services provided in

whole or in part by PTAs and OTAs, respectively. These payment modifiers are required to be

used on claims for services with dates of service beginning January 1, 2020, as specified in the

CY 2020 PFS final rule (84 FR 62702 through 62708). We applied the 15 percent payment

reduction to therapy services provided by PTAs (using the CQ modifier) or OTAs (using the CO

modifier), as required by statute. Under sections 1834(k) and 1848 of the Act, payment is made

for outpatient therapy services at 80 percent of the lesser of the actual charge or applicable fee

schedule amount (the allowed charge). The remaining 20 percent is the beneficiary copayment.

For therapy services to which the new discount applies, payment will be made at 85 percent of

the 80 percent of allowed charges. Therefore, the volume discount factor for therapy services to

which the CQ and CO modifiers apply is: (0.20 + (0.80* 0.85), which equals 88 percent.

We note that for CY 2025, we are proposing mandatory use of the 54 and 55 modifiers

when practitioners furnishing global surgery procedures share in patient care and intend only to

furnish preoperative/intraoperative or postoperative portions of the total global procedure. If

finalized, this proposal will likely increase the number of claims subject to the adjustment

described in the discussion above. We discuss this proposal in section II.G. of this proposed

rule.

For anesthesia services, we do not apply adjustments to volume since we use the average

allowed charge when simulating RVUs; therefore, the RVUs as calculated already reflect the

payments as adjusted by modifiers, and no volume adjustments are necessary. However, a time

adjustment of 33 percent is made only for medical direction of two to four cases since that is the

only situation where a single practitioner is involved with multiple beneficiaries concurrently, so

that counting each service without regard to the overlap with other services would overstate the

amount of time spent by the practitioner furnishing these services.

● Work RVUs: The setup file contains the work RVUs from this proposed rule.

(6) Equipment Cost per Minute

The equipment cost per minute is calculated as:

(1/ (minutes per year * usage)) * price * ((interest rate/(1 (1/((1 + interest rate)^ life of

equipment)))) + maintenance)

Where:

minutes per year = maximum minutes per year if usage were continuous (that is,

usage=1); generally, 150,000 minutes.

usage = variable, see discussion below in this proposed rule.

price = price of the particular piece of equipment.

life of equipment = useful life of the particular piece of equipment.

maintenance = factor for maintenance; 0.05.

interest rate = variable, see discussion below in this proposed rule.

Usage: We currently use an equipment utilization rate assumption of 50 percent for most

equipment, with the exception of expensive diagnostic imaging equipment, for which we use a

90 percent assumption as required by section 1848(b)(4)(C) of the Act.

Useful Life: In the CY 2005 PFS final rule we stated that we updated the useful life for

equipment items primarily based on the AHA’s “Estimated Useful Lives of Depreciable Hospital

Assets” guidelines (69 FR 66246). The most recent edition of these guidelines was published in

2018. This reference material provides an estimated useful life for hundreds of different types of

equipment, the vast majority of which fall in the range of 5 to 10 years, and none of which are

lower than two years in duration. We believe that the updated editions of this reference material

remain the most accurate source for estimating the useful life of depreciable medical equipment.

In the CY 2021 PFS final rule, we finalized a proposal to treat equipment life durations of

less than 1 year as having a duration of 1 year for the purpose of our equipment price per minute

formula. In the rare cases where items are replaced every few months, we noted that we believe

it is more accurate to treat these items as disposable supplies with a fractional supply quantity as

opposed to equipment items with very short equipment life durations. For a more detailed

discussion of the methodology associated with very short equipment life durations, we refer

readers to the CY 2021 PFS final rule (85 FR 84482 through 84483).

● Maintenance: We finalized the 5 percent factor for annual maintenance in the CY

1998 PFS final rule with comment period (62 FR 33164). As we previously stated in the CY

2016 PFS final rule with comment period (80 FR 70897), we do not believe the annual

maintenance factor for all equipment is precisely 5 percent, and we concur that the current rate

likely understates the true cost of maintaining some equipment. We also noted that we believe it

likely overstates the maintenance costs for other equipment. When we solicited comments

regarding data sources containing equipment maintenance rates, commenters could not identify

an auditable, robust data source that CMS could use on a wide scale. We noted that we did not

believe voluntary submissions regarding the maintenance costs of individual equipment items

would be an appropriate methodology for determining costs. As a result, in the absence of

publicly available datasets regarding equipment maintenance costs or another systematic data

collection methodology for determining a different maintenance factor, we did not propose a

variable maintenance factor for equipment cost per minute pricing as we did not believe that we

have sufficient information at present. We noted that we would continue to investigate potential

avenues for determining equipment maintenance costs across a broad range of equipment items.

● Interest Rate: In the CY 2013 PFS final rule with comment period (77 FR 68902), we

updated the interest rates used in developing an equipment cost per minute calculation (see 77

FR 68902 for a thorough discussion of this issue). The interest rate was based on the Small

Business Administration (SBA) maximum interest rates for different categories of loan size

(equipment cost) and maturity (useful life). The Interest rates are listed in Table 3.

TABLE 3: SBA Maximum Interest Rates

Price

Useful Life

Interest Rate

<$25K

<7 Years

7.50%

$25K to $50K

<7 Years

6.50%

>$50K

<7 Years

5.50%

<$25K

7+ Years

8.00%

$25K to $50K

7+ Years

7.00%

>$50K

7+ Years

6.00%

We are not proposing any changes to the equipment interest rates for CY 2025.

3. Adjusting RVUs To Match the PE Share of the Medicare Economic Index (MEI)

In the past, we have stated that we believe that the MEI is the best measure available of

the relative weights of the three components in payments under the PFS—work, practice expense

(PE), and malpractice (MP). Accordingly, we believe that to ensure that the PFS payments

reflect the relative resources in each of these PFS components as required by section 1848(c)(3)

of the Act, the RVUs used in developing rates should reflect the same weights in each

component as the cost share weights in the Medicare Economic Index (MEI). In the past, we

have proposed (and subsequently finalized) to accomplish this by holding the work RVUs

constant and adjusting the PE RVUs, MP RVUs, and CF to produce the appropriate balance in

RVUs among the three PFS components and payment rates for individual services, that is, that

the total RVUs on the PFS are proportioned to approximately 51 percent work RVUs, 45 percent

PE RVUs, and 4 percent MP RVUs. As the MEI cost shares are updated, we would typically

propose to modify steps 3 and 10 to adjust the aggregate pools of PE costs (direct PE in step 3

and indirect PE in step 10) in proportion to the change in the PE share in the rebased and revised

MEI cost share weights, and to recalibrate the relativity adjustment that we apply in step 18 as

described in the CY 2023 PFS final rule (87 FR 69414 and 69415) and CY 2014 PFS final rule

(78 FR 74236 and 74237). The most recent recalibration was done for the CY 2014 RVUs.

In the CY 2014 PFS proposed rule (78 FR 43287 through 43288) and final rule (78 FR

74236 through 74237), we detailed the steps necessary to accomplish this result (see steps 3, 10,

and 18). The CY 2014 proposed and final adjustments were consistent with our longstanding

practice to make adjustments to match the RVUs for the PFS components with the MEI cost

share weights for the components, including the adjustments described in the CY 1999 PFS final

rule (63 FR 58829), CY 2004 PFS final rule (68 FR 63246 and 63247), and CY 2011 PFS final

rule (75 FR 73275).

In the CY 2023 PFS final rule (87 FR 69688 through 69711), we finalized to rebase and

revise the MEI to reflect more current market conditions faced by physicians in furnishing

physicians' services (referred to as the “2017-based MEI”). We also finalized a delay of the

adjustments to the PE pools in steps 3 and 10 and the recalibration of the relativity adjustment in

step 18 until the public had an opportunity to comment on the rebased and revised MEI (87 FR

69414 through 69416). Because we finalized significant methodological and data source

changes to the MEI in the CY 2023 PFS final rule and significant time has elapsed since the last

rebasing and revision of the MEI in CY 2014, we believed that delaying the implementation of

the finalized CY 2023 rebased and revised MEI was consistent with our efforts to balance

payment stability and predictability with incorporating new data through more routine updates.

We refer readers to the discussion of our comment solicitation in the CY 2023 PFS final rule (87

FR 69429 through 69432), where we reviewed our ongoing efforts to update data inputs for PE

to aid stability, transparency, efficiency, and data adequacy. We also solicited comment in the

CY 2023 PFS proposed rule on when and how to best incorporate the CY 2023 rebased and

revised MEI into PFS ratesetting, and whether it would be appropriate to consider a transition to

full implementation for potential future rulemaking. We presented the impacts of implementing

the rebased and revised MEI in PFS ratesetting through a 4-year transition and through full

immediate implementation, that is, with no transition period in the CY 2023 PFS proposed rule.

We also solicited comment on other implementation strategies for potential future rulemaking in

the CY 2023 PFS proposed rule. In the CY 2023 PFS final rule, we discussed that many

commenters supported our proposed delayed implementation, and many commenters expressed

concerns with the redistributive impacts of the implementation of the rebased and revised MEI in

PFS ratesetting. Many commenters also noted the AMA’s intent to collect practice cost data

from physician practices, which could be used to derive cost share weights for the MEI and RVU

shares.

In light of the AMA’s current data collection efforts and because the methodological and

data source changes to the MEI finalized in the CY 2023 PFS final rule would have significant

impacts on PFS payments, similar to our discussion of this topic in the CY 2024 PFS rulemaking

cycle (88 FR 78829 through 78831), we continue to believe that delaying the implementation of

the finalized 2017-based MEI cost share weights for the RVUs is consistent with our efforts to

balance payment stability and predictability with incorporating new data through more routine

updates. For these reasons, we did not propose to incorporate the 2017-based MEI in PFS

ratesetting for CY 2024. As we noted in the CY 2024 PFS final rule, many commenters on the

CY 2024 PFS proposed rule supported our continued delayed implementation of the 2017-based

MEI in PFS ratesetting (88 FR 78830). Most of these commenters urged us to pause

consideration of other sources for the MEI until the AMA’s efforts to collect practice cost data

from physician practices have concluded, although a few commenters recommended that we

implement the MEI for PFS ratesetting as soon as possible. We agree with the commenters that

it would be prudent, and avoid potential duplication of effort, to wait to consider other data

sources for the MEI while the AMA’s data collection activities are ongoing. As we discussed in

the CY 2024 PFS final rule, we continue to monitor the data available related to physician

services' input expenses, but we are not proposing to update the data underlying the MEI cost

weights at this time. Given our previously described policy goal to balance PFS payment

stability and predictability with incorporating new data through more routine updates to the MEI,

we are not proposing to incorporate the 2017-based MEI in PFS ratesetting for CY 2025. We

invite comments on this approach as well as any information on the timing of the AMA’s

practice cost data collection efforts and other sources of data we could consider for updating the

MEI.

4. Changes to Direct PE Inputs for Specific Services

This section focuses on specific PE inputs. The direct PE inputs are included in the CY

2025 direct PE input public use files, which are available on the CMS website under downloads

for the CY 2025 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-

Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.

a. Standardization of Clinical Labor Tasks

As we noted in the CY 2015 PFS final rule with comment period (79 FR 67640 through

67641), we continue to make improvements to the direct PE input database to provide the

number of clinical labor minutes assigned for each task for every code in the database instead of

only including the number of clinical labor minutes for the preservice, service, and post service

periods for each code. In addition to increasing the transparency of the information used to set

PE RVUs, this level of detail would allow us to compare clinical labor times for activities

associated with services across the PFS, which we believe is important to maintaining the

relativity of the direct PE inputs. This information would facilitate the identification of the usual

numbers of minutes for clinical labor tasks and the identification of exceptions to the usual

values. It would also allow for greater transparency and consistency in the assignment of

equipment minutes based on clinical labor times. Finally, we believe that the detailed

information can be useful in maintaining standard times for particular clinical labor tasks that can

be applied consistently to many codes as they are valued over several years, similar in principle

to physician preservice time packages. We believe that setting and maintaining such standards

would provide greater consistency among codes that share the same clinical labor tasks and

could improve the relativity of values among codes. For example, as medical practice and

technologies change over time, standards could be updated simultaneously for all codes with the

applicable clinical labor tasks instead of waiting for individual codes to be reviewed.

In the CY 2016 PFS final rule with comment period (80 FR 70901), we solicited

comments on the appropriate standard minutes for the clinical labor tasks associated with

services that use digital technology. After consideration of comments received, we finalized

standard times for clinical labor tasks associated with digital imaging at 2 minutes for

“Availability of prior images confirmed”, 2 minutes for “Patient clinical information and

questionnaire reviewed by technologist, order from physician confirmed and exam protocoled by

radiologist”, 2 minutes for “Review examination with interpreting MD”, and 1 minute for “Exam

documents scanned into PACS” and “Exam completed in RIS system to generate billing process

and to populate images into Radiologist work queue.” In the CY 2017 PFS final rule (81 FR

80184 through 80186), we finalized a policy to establish a range of appropriate standard minutes

for the clinical labor activity, “Technologist QCs images in PACS, checking for all images,

reformats, and dose page.” These standard minutes will be applied to new and revised codes that

make use of this clinical labor activity when they are reviewed by us for valuation. We finalized

a policy to establish 2 minutes as the standard for the simple case, 3 minutes as the standard for

the intermediate case, 4 minutes as the standard for the complex case, and 5 minutes as the

standard for the highly complex case. These values were based upon a review of the existing

minutes assigned for this clinical labor activity; we determined that 2 minutes is the duration for

most services and a small number of codes with more complex forms of digital imaging have

higher values. We also finalized standard times for a series of clinical labor tasks associated

with pathology services in the CY 2016 PFS final rule with comment period (80 FR 70902). We

do not believe these activities would be dependent on number of blocks or batch size, and we

believe that the finalized standard values accurately reflect the typical time it takes to perform

these clinical labor tasks.

In reviewing the RUC-recommended direct PE inputs for CY 2019, we noticed that the 3

minutes of clinical labor time traditionally assigned to the “Prepare room, equipment and

supplies” (CA013) clinical labor activity were split into 2 minutes for the “Prepare room,

equipment and supplies” activity and 1 minute for the “Confirm order, protocol exam” (CA014)

activity. We proposed to maintain the 3 minutes of clinical labor time for the “Prepare room,

equipment and supplies” activity and remove the clinical labor time for the “Confirm order,

protocol exam” activity wherever we observed this pattern in the RUC-recommended direct PE

inputs. Commenters explained in response that when the new version of the PE worksheet

introduced the activity codes for clinical labor, there was a need to translate old clinical labor

tasks into the new activity codes, and that a prior clinical labor task was split into two of the new

clinical labor activity codes: CA007 (Review patient clinical extant information and

questionnaire) in the preservice period, and CA014 (Confirm order, protocol exam) in the

service period. Commenters stated that the same clinical labor from the old PE worksheet was

now divided into the CA007 and CA014 activity codes, with a standard of 1 minute for each

activity. We agreed with commenters that we would finalize the RUC-recommended 2 minutes

of clinical labor time for the CA007 activity code and 1 minute for the CA014 activity code in

situations where this was the case. However, when reviewing the clinical labor for the reviewed

codes affected by this issue, we found that several of the codes did not include this old clinical

labor task, and we also noted that several of the reviewed codes that contained the CA014

clinical labor activity code did not contain any clinical labor for the CA007 activity. In these

situations, we believe that the three total minutes of clinical staff time would be more accurately

described by the CA013 “Prepare room, equipment and supplies” activity code, and we finalized

these clinical labor refinements. We direct readers to the discussion in the CY 2019 PFS final

rule (83 FR 59463 through 59464) for additional details.

Following the publication of the CY 2020 PFS proposed rule, one commenter expressed

concern with the published list of common refinements to equipment time. The commenter

stated that these refinements were the formulaic result of applying refinements to the clinical

labor time and did not constitute separate refinements; the commenter requested that CMS no

longer include these refinements in the table published each year. In the CY 2020 PFS final rule,

we agreed with the commenter that these equipment time refinements did not reflect errors in the

equipment recommendations or policy discrepancies with the RUC’s equipment time

recommendations. However, we believed it was important to publish the specific equipment

times that we were proposing (or finalizing in the case of the final rule) when they differed from

the recommended values due to the effect these changes can have on the direct costs associated

with equipment time. Therefore, we finalized the separation of the equipment time refinements

associated with changes in clinical labor into a separate table of refinements. We direct readers

to the discussion in the CY 2020 PFS final rule (84 FR 62584) for additional details.

Historically, the RUC has submitted a “PE worksheet” that details the recommended

direct PE inputs for our use in developing PE RVUs. The format of the PE worksheet has varied

over time, and among the medical specialties developing the recommendations. These variations

have made it difficult for the RUC’s development and our review of code values for individual

codes. Beginning with its recommendations for CY 2019, the RUC mandated the use of a new

PE worksheet for its recommendation development process that standardizes the clinical labor

tasks and assigns them a clinical labor activity code. We believe the RUC’s use of the new PE

worksheet in developing and submitting recommendations helps us simplify and standardize the

hundreds of clinical labor tasks currently listed in our direct PE database. As in previous

calendar years, to facilitate rulemaking for CY 2025, we are continuing to display two versions

of the Labor Task Detail public use file: one version with the old listing of clinical labor tasks

and one with the same tasks crosswalked to the new listing of clinical labor activity codes.

These lists are available on the CMS website under downloads for the CY 2025 PFS proposed

rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-

Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.

b. Updates to Prices for Existing Direct PE Inputs

In the CY 2011 PFS final rule with comment period (75 FR 73205), we finalized a

process to act on public requests to update equipment and supply price and equipment useful life

inputs through annual rulemaking, beginning with the CY 2012 PFS proposed rule. Beginning in

CY 2019 and continuing through CY 2022, we conducted a market-based supply and equipment

pricing update using information developed by our contractor, StrategyGen, which updated

pricing recommendations for approximately 1300 supplies and 750 equipment items currently

used as direct PE inputs. Given the potentially significant changes in payment that would occur,

in the CY 2019 PFS final rule, we finalized a policy to phase in our use of the new direct PE

input pricing over a 4-year period using a 25/75 percent (CY 2019), 50/50 percent (CY 2020),

75/25 percent (CY 2021), and 100/0 percent (CY 2022) split between new and old pricing. We

believed that implementing the proposed updated prices with a 4-year phase-in would improve

payment accuracy while maintaining stability and allowing interested parties to address potential

concerns about changes in payment for particular items. This 4-year transition period to update

supply and equipment pricing concluded in CY 2022; for a more detailed discussion, we refer

readers to the CY 2019 PFS final rule with comment period (83 FR 59473 through 59480).

For CY 2025, we are proposing to update the price of 17 supplies and one equipment

item in response to the public submission of invoices following the publication of the CY 2024

PFS final rule. The 18 supply and equipment items with proposed updated prices are listed in the

valuation of specific codes section of the preamble under Table 16, CY 2025 Invoices Received

for Existing Direct PE Inputs.

An interested party submitted 30 invoices to update pricing for the human amniotic

membrane allograft mounted on a non-absorbable self-retaining ring (SD248) supply. We

previously updated the price of this supply in the CY 2024 final rule (88 FR 78901) based on

averaging together the price of the Prokera Slim, Prokera Classic, and Prokera Plus devices. The

interested party submitted new invoices for all three of these devices which averaged to a new

price of $1149.00 which we are proposing for the SD248 supply. We are soliciting additional

comments from interested parties regarding the price of the SD248 supply as well as any

information as far as whether one of these three devices (the Prokera Slim, Prokera Classic, and

Prokera Plus) would be more typical than the other two for use as a supply in CPT code 65778.

In the case of the indocyanine green (25ml uou) (SL083) supply, we noticed that there

was a clear bimodal distribution of prices on the eight submitted invoices, clustered around

$91.00 and $141.67, respectively, with no pricing in between $100 and $140. We are proposing

the updated total average price of $125.11 based on the eight submitted invoices for the SL083

supply, however, we are soliciting comments on why there was such divergence in the pricing on

the submitted invoices, as well as whether these may represent pricing for two different supplies.

Regarding the Reaction buffer 10X (Ventana 950-300) (SL478) supply, we are proposing

to update the price from $0.037 to $0.045, which is less than the $0.075 contained on the invoice

submitted by interested parties. We were able to find this product readily available for purchase

online at a quantity of 10 liters for $453 or a price of $0.045. We do not believe that it would be

typical for providers to pay a higher price based on smaller unit quantities; therefore, we are

proposing to update the price of the SL478 supply but only to $0.045, which is the price to

purchase this supply online, as stated above.

Interested parties also alerted CMS to a technical correction for pricing the Atomizer tips

(disposable) (SL464) supply. We previously finalized a price of $2.66 for the SL464 supply,

which was included in the table of Invoices Received for Existing Direct PE Inputs in the CY

2018 final rule (82 FR 53162). However, due to a technical error, the updated pricing for the

SL464 supply was never implemented. We are proposing to make this correction for CY 2025;

the corrected price of $2.66 for the SL464 supply is included in Table 16.

We are not proposing to update the price of another ten supplies, which were the subject

of public submission of invoices. Our reasons for not proposing updates to these prices are

detailed below, and we are seeking additional information from interested parties for assistance

in pricing these supplies:

● Liposorber supplies: Tubing set (SC083), Plasma LDL adsorption column (SD186),

and Plasma separator (SD188): We received invoices for these three Liposorber supplies from

an interested party. However, it was unclear from the invoice submissions what the unit quantity

size is for each product. We require additional information regarding the unit size of each supply

included on these invoices to establish updated pricing, and therefore, we are not proposing

updates to the prices for these supplies. We are seeking additional comments regarding the

pricing of these supplies and whether the pricing has increased so dramatically, as it seems

unlikely that prices have tripled in the five years since we most recently updated the pricing for

these supplies.

● Congo Red kits (SA110): We received three invoices from interested parties requesting

an increase in the price of the SA110 supply from $6.80 to $18.78. However, we were able to

find Congo Red staining kits readily available online at a price of 100 for $410 or $4.10 per kit.

The unit size of these kits was also unclear, which made price comparisons with the submitted

invoices difficult. Based on the three invoices and the online price of 100 for $410 or $4.10 per

kit, we do not believe there is enough pricing data to support an increase in the price of the

SA110 supply from $6.80 to $18.78, and we are not proposing an increase in the price of this

supply.

● Gauze, non-sterile 4in x 4in (SG051): We received one invoice from interested parties

requesting an increase in the price of the SG051 supply from $0.03 to $0.04. However, the

submitted invoice price appeared to be for surgical gauze, not non-sterile gauze. We were able

to find the 4x4 non-sterile gauze readily available online at less than the invoice price. Based on

this information, we do not believe there is enough pricing data to support an increase in the

price of the SG051 supply from $0.03 to $0.04, and we are not proposing an increase in the price

of this supply.

● Permanent marking pen (SL477): We received one invoice from interested parties

requesting an increase in the price of the SL477 supply from $2.81 to $4.62. However, we found

black marking pens, such as Sharpies, widely available at unit prices around $2.00 when

purchased in larger quantities. Based on this information, we do not believe there is enough

pricing data to support an increase in the price of the SL477 supply from $2.81 to $4.62, and we

are not proposing an increase in the price of this supply.

● Hematoxylin II (Ventana 790-2208) (SL483): We received four invoices from

interested parties requesting an increase in the price of the SL483 supply from $0.780 to $2.722.

However, we were able to find hematoxylin II stains readily available online at cheaper prices,

such as $52.00 for 500 ml ($0.104 per ml). Based on this information, we do not believe there is

enough pricing data to support an increase in the price of the SL483 supply from $0.780 to

$2.722, and we are not proposing an increase in the price of this supply.

● Bluing reagent (Ventana 760-2037) (SL484): We received three invoices from

interested parties requesting an increase in the price of the SL484 supply from $4.247 to $6.130.

While researching the pricing of the SL484 supply, we were unable to determine the unit

quantity size on invoices, which made it difficult to evaluate if the requested price accurately

reflected market pricing. As best we could tell, the requested price increase to $6.130 was more

expensive than comparable online bluing reagents available for purchase. Based on this

information, we do not believe there is enough pricing data to support an increase in the price of

the SL484 supply from $4.247 to $6.130, and we are not proposing an increase in the price of

this supply.

● EZ Prep (10X) (Ventana 950-102) (SL481) and 250 Test Prep Kit # 78 (Ventana 786-

3034) (SL486): In each of these cases, we received invoices from interested parties requesting

substantial increases in the price of the associated supplies, from $0.034 to $0.509 for the SL481

supply and from $0.309 to $2.134 for the SL486 supply. We do not believe that it is reasonable

to expect that the typical market prices for these supplies have increased by 1400 percent and

600 percent, respectively, in the 5 years since we most recently updated the pricing for these

supplies. The limited pricing information we could find online for each product also failed to

support these drastic increases in pricing. Based on this information, we do not believe there is

enough pricing data to support the requested increases for the SL481 and SL486 supplies, and we

are not proposing increases to the prices for these supplies.

(1) Invoice Submission

We remind readers that we routinely accept public submissions of invoices as part of our

process for developing payment rates for new, revised, and potentially misvalued codes. Often,

these invoices are submitted in conjunction with the RUC-recommended values for the codes.

To be included in a given year’s proposed rule, we generally need to receive invoices by the

same February 10th deadline we noted for consideration of RUC recommendations. However,

we will consider invoices submitted as public comments during the comment period following

the publication of the PFS proposed rule and would consider any invoices received after

February 10th or outside of the public comment process as part of our established annual process

for requests to update supply and equipment prices. Interested parties are encouraged to submit

invoices with their public comments or, if outside the notice and comment rulemaking process,

via email at [email protected].

In recent years, we have noticed a growing number of invoice submissions for use in

updating supply and equipment pricing. Although we continue to believe in the importance of

using the most recent and accurate invoice data to reflect current market pricing, we do have

some concerns that the increased use of these submissions may distort relativity across the fee

schedule. Relying on voluntary invoice submissions to update pricing for a small subset of the

total number of supply and equipment items in our database, while leaving the overwhelming

majority of prices untouched, could be distorting pricing in favor of the most recent submissions.

We believe that it may be more efficient, and more accurate, to update supply and equipment

pricing in a more comprehensive fashion similar to the pricing update that took place from CY

2019 to CY 2022. For example, future updates to supply and equipment pricing could take place

in tandem with updates to clinical labor pricing after the current clinical labor update concludes

in CY 2025. We welcome public comments on this general topic of more comprehensive updates

to supply and equipment pricing, and we may consider comments we receive to inform future

rulemaking.

(2) Supply Pack Pricing Update

Interested parties previously notified CMS that they identified numerous discrepancies

between the aggregated cost of some supply packs and the individual item components contained

within. The interested parties indicated that CMS should rectify these mathematical errors as

soon as possible to ensure that the sum correctly matches the totals from the individual items,

and they recommended that we resolve these pricing discrepancies in the supply packs during

CY 2024 rulemaking. The AMA RUC convened a workgroup on this subject and submitted

recommendations to update pricing for a series of supply packs along with the RUC’s comment

letter for the CY 2024 rule cycle.

We appreciated the additional information and RUC workgroup recommendations

regarding discrepancies in the aggregated cost of some supply packs. However, due to the

projected significant cost revisions in the pricing of supply packs and because we did not

propose to address supply pack pricing in the CY 2024 proposed rule, we stated that this issue

would be better addressed in future rulemaking. For example, the cleaning and disinfecting

endoscope pack (SA042) is included as a supply input in more than 300 HCPCS codes, which

could have a sizable impact on the overall valuation of these services, and which was not

incorporated into the proposed RVUs published for the CY 2024 proposed rule. We stated that

interested parties would be better served if we comprehensively addressed this topic during

future rulemaking in which commenters could provide feedback in response to proposed pricing

updates (88 FR 78833 through 78834).

For CY 2025, we are proposing to implement the supply pack pricing update and

associated revisions as recommended by the RUC’s workgroup. We are proposing to update the

pricing of the “pack, cleaning and disinfecting, endoscope” (SA042) supply from $19.43 to

$31.29, to update the pricing of the “pack, drapes, cystoscopy” (SA045) supply from $17.33 to

$14.99, to update the pricing of the “pack, ocular photodynamic therapy” (SA049) supply from

$16.35 to $26.35, to update the pricing of the “pack, urology cystoscopy visit” (SA058) supply

from $113.70 to $37.63, and to update the pricing of the “pack, ophthalmology visit (w-

dilation)” (SA082) supply from $3.91 to $2.33. As recommended by the RUC workgroup, we

are also proposing to delete the “pack, drapes, laparotomy (chest-abdomen)” (SA046) supply

entirely. The proposed updated prices for these supply packs are listed in the valuation of

specific codes section of the preamble under Table 16, CY 2025 Invoices Received for Existing

Direct PE Inputs.

In accordance with the RUC workgroup’s recommendations, we are also proposing to

create eight new supply codes, including components contained within previously existing

supply packs. Aside from the SB056 supply, which is a replacement in several HCPCS codes for

the deleted SA046 supply pack, all of these new supplies are not included as standalone direct

PE inputs in any current HCPCS codes, as they are, again, components contained within

previously existing supply packs. We are proposing to add:

● The kit, ocular photodynamic therapy (PDT) (SA137) supply at a price of $26.00 as a

component of the SA049 supply pack;

● The Abdominal Drape Laparotomy Drape Sterile (100 in x 72 in x 124 in) (SB056)

supply at a price of $8.049 as a replacement for the SA046 supply pack;

● The drape, surgical, legging (SB057) supply at a price of $3.284 as a component of the

SA045 supply pack;

● The drape, surgical, split, impervious, absorbent (SB058) supply at a price of $8.424

as a component of the SA045 supply pack;

● The post-mydriatic spectacles (SB059) supply at a price of $0.328 as a component of

the SA082 supply pack;

● The y-adapter cap (SD367) supply at a price of $0.352 as a component of the SA049

supply pack;

● The ortho-phthalaldehyde 0.55% (eg, Cidex OPA) (SM030) supply at a price of

$0.554 as a component of the SA042 supply pack; and

● The ortho-phthalaldehyde test strips (SM031) supply at a price of $1.556 as a

component of the SA042 supply pack.

The proposed new supply pack component items are listed in the valuation of specific

codes section of the preamble under Table 17, CY 2025 New Invoices.

We are also proposing the following additional supply substitutions based on the

recommendations of the RUC workgroup. We are proposing to remove the deleted SA046

supply pack and replace it with the drape, sterile, fenestrated 16in x 29in (SB011) supply for

CPT codes 19020, 19101, 19110, 19112, 20101, and 20102. We are proposing to remove the

deleted SA046 supply pack and replace it with two supplies – the drape, sterile, three-quarter

sheet (SB014) and the drape, towel, sterile 18in x 26in (SB019) – for CPT codes 19000 and

60300. We are proposing to remove the deleted SA046 supply pack and replace it with two

supplies – the drape, towel, sterile 18in x 26in (SB019) and the newly created Abdominal Drape

Laparotomy Drape Sterile (100 in x 72 in x 124 in) (SB056) supply – for CPT codes 22510,

22511, 22513, and 22514. We are proposing to remove the deleted SA046 supply pack without

replacing it with anything for CPT code 22526; the RUC workgroup did not make a

recommendation on what to do with CPT code 27278, which also previously contained the

SA046 supply pack. Therefore, we are also proposing not to replace the SA046 supply pack with

any supplies for this code. The RUC workgroup also recommended removing the SA046 supply

pack from CPT code 64595 with no replacement; however, this code was recently reviewed at

the April 2022 RUC meeting and it no longer includes the SA046 supply.

The RUC workgroup also reviewed the issue of skin adhesives and identified several

generic alternatives to using the skin adhesive (Dermabond) (SG007) supply. The workgroup

stated that there are multiple skin adhesive products, at different price points, available that work

similarly to Dermabond and requested that generic alternatives be used overall in place of brand

names in the CMS direct PE database. The workgroup made a series of suggestions for CMS to

create new medical supply item codes to encompass the generic formulations of cyanoacrylate

skin adhesive in multidose form and single use sterile application.

We appreciate the recommendations from the RUC workgroup and concur that generic

alternatives be used in place of brand names, where appropriate, in the CMS direct PE database.

However, we have no pricing information or submitted invoices for the four generic formulations

of cyanoacrylate skin adhesive requested by the RUC workgroup (2-Octyl-cyanoacrylate, n-

Butyl-2-cyanoacrylate, Combined n-Butyl and 2-Octylcyanoacrylate, and Ethyl-2-

cyanoacrylate). Since these four potential new supplies have no pricing information and are not

currently included as direct PE inputs for any HCPCS codes, we have not added them to our

direct PE database for the CY 2025 proposed rule due to lack of available information.

c. Clinical Labor Pricing Update

Section 220(a) of the PAMA provides that the Secretary may collect or obtain

information from any eligible professional or any other source on the resources directly or

indirectly related to furnishing services for which payment is made under the PFS and that such

information may be used in the determination of relative values for services under the PFS. Such

information may include the time involved in furnishing services; the amounts, types, and prices

of PE inputs; overhead and accounting information for practices of physicians and other

suppliers, and any other elements that would improve the valuation of services under the PFS.

Beginning in CY 2019, we updated the supply and equipment prices used for PE as part

of a market-based pricing transition; CY 2022 was the final year of this 4-year transition. We

initiated a market research contract with StrategyGen to conduct an in-depth and robust market

research study to update the supply and equipment pricing for CY 2019, and we finalized a

policy in CY 2019 to phase in the new pricing over a period of 4 years. However, we did not

propose to update the clinical labor pricing, and the pricing for clinical labor has remained

unchanged during this pricing transition. Clinical labor rates were last updated for CY 2002

using Bureau of Labor Statistics (BLS) data and other supplementary sources where BLS data

were not available; we refer readers to the full discussion in the CY 2002 PFS final rule for

additional details (66 FR 55257 through 55262).

Interested parties raised concerns that the long delay since clinical labor pricing was last

updated created a significant disparity between CMS’ clinical wage data and the market average

for clinical labor. In recent years, several interested parties suggested that certain wage rates

were inadequate because they did not reflect current labor rate information. Some interested

parties also stated that updating the supply and equipment pricing without updating the clinical

labor pricing could create distortions in the allocation of direct PE. They argued that since the

pool of aggregated direct PE inputs is budget neutral, if these rates are not routinely updated,

clinical labor may become undervalued over time relative to equipment and supplies, especially

since the supply and equipment prices are in the process of being updated. There was

considerable interest among interested parties in updating the clinical labor rates, and when we

solicited comment on this topic in past rules, such as in the CY 2019 PFS final rule (83 FR

59480), interested parties supported the idea.

Therefore, we proposed to update the clinical labor pricing for CY 2022, in conjunction

with the final year of the supply and equipment pricing update (86 FR 39118 through 39123).

We believed updating the clinical labor pricing was important to maintain relativity with the

recent supply and equipment pricing updates. We proposed to use the methodology outlined in

the CY 2002 PFS final rule (66 FR 55257), which draws primarily from BLS wage data, to

calculate updated clinical labor pricing. As we stated in the CY 2002 PFS final rule, the BLS’

reputation for publishing valid estimates that are nationally representative led to the choice to use

the BLS data as the main source. We believe that the BLS wage data continues to be the most

accurate source to use as a basis for clinical labor pricing and this data will appropriately reflect

changes in clinical labor resource inputs for setting PE RVUs under the PFS. We used the most

current BLS survey data (2019) as the main source of wage data for our CY 2022 clinical labor

proposal.

We recognized that the BLS survey of wage data does not cover all the staff types

contained in our direct PE database. Therefore, we crosswalked or extrapolated the wages for

several staff types using supplementary data sources for verification whenever possible. In

situations where the price wages of clinical labor types were not referenced in the BLS data, we

used the national salary data from the Salary Expert, an online project of the Economic Research

Institute that surveys national and local salary ranges and averages for thousands of job titles

using mainly government sources. (A detailed explanation of the methodology used by Salary

Expert to estimate specific job salaries can be found at www.salaryexpert.com.) We previously

used Salary Expert information as the primary backup source of wage data during the last update

of clinical labor pricing in CY 2002. If we did not have direct BLS wage data available for a

clinical labor type, we used the wage data from Salary Expert as a reference for pricing, then

crosswalked these clinical labor types to a proxy BLS labor category rate that most closely

matched the reference wage data, similar to the crosswalks used in our PE/HR allocation. For

example, there is no direct BLS wage data for the Mammography Technologist (L043) clinical

labor type; we used the wage data from Salary Expert as a reference and identified the BLS wage

data for Respiratory Therapists as the best proxy category. We calculated rates for the “blend”

clinical labor categories by combining the rates for each labor type in the blend and then dividing

by the total number of labor types in the blend.

As in the CY 2002 clinical labor pricing update, the proposed cost per minute for each

clinical staff type was derived by dividing the average hourly wage rate by 60 to arrive at the per

minute cost. In cases where an hourly wage rate was not available for a clinical staff type, the

proposed cost per minute for the clinical staff type was derived by dividing the annual salary

(converted to 2021 dollars using the Medicare Economic Index) by 2080 (the number of hours in

a typical work year) to arrive at the hourly wage rate and then again by 60 to arrive at the per

minute cost. We ultimately finalized the use of median BLS wage data instead of mean BLS

wage data in response to comments in the CY 2022 PFS final rule. To account for the

employers’ cost of providing fringe benefits, such as sick leave, we finalized a benefits multiplier

of 1.296 based on a BLS release from June 17, 2021 (USDL-21-1094). As an example of this

process, for the Physical Therapy Aide (L023A) clinical labor type, the BLS data reflected a

median hourly wage rate of $12.98, which we multiplied by the 1.296 benefits modifier and then

divided by 60 minutes to arrive at the finalized per-minute rate of $0.28.

After considering the comments on our CY 2022 proposals, we agreed with commenters

that the use of a multi-year transition would help smooth out the changes in payment resulting

from the clinical labor pricing update, avoiding potentially disruptive changes in payment for

affected interested parties, and promoting payment stability from year-to-year. We believed it

would be appropriate to use a 4-year transition, as we have for several other broad-based updates

or methodological changes. While we recognized that using a 4-year transition to implement the

update means that we will continue to rely in part on outdated data for clinical labor pricing until

the change is fully completed in CY 2025, we agreed with the commenters that these significant

updates to PE valuation should be implemented in the same way, and for the same reasons, as for

other major updates to pricing such as the recent supply and equipment update. Therefore, we

finalized the clinical labor pricing update implementation over four years to transition from

current prices to the final updated prices in CY 2025. We finalized the implementation of this

pricing transition over 4 years, such that one-quarter of the difference between the current price

and the fully phased-in price is implemented for CY 2022, one-third of the difference between

the CY 2022 price and the final price is implemented for CY 2023, and one-half of the difference

between the CY 2023 price and the final price is implemented for CY 2024, with the new direct

PE prices fully implemented for CY 2025. (86 FR 65025) An example of the transition from the

current to the fully-implemented new pricing that we finalized in the CY 2022 PFS final rule is

provided in Table 4.

TABLE 4: Example of Clinical Labor Pricing Transition

Current Price

$1.00

Final Price

$2.00

Year 1 (CY 2022) Price

$1.25

1/4 difference between $1.00 and $2.00

Year 2 (CY 2023) Price

$1.50

1/3 difference between $1.25 and $2.00

Year 3 (CY 2024) Price

$1.75

1/2 difference between $1.50 and $2.00

Final (CY 2025) Price

$2.00

(1) CY 2023 Clinical Labor Pricing Updates

For CY 2023, we received information from one interested party regarding the pricing of

the Histotechnologist (L037B) clinical labor type. The interested party provided data from the

2019 Wage Survey of Medical Laboratories which supported an increase in the per-minute rate

from the $0.55 finalized in the CY 2022 PFS final rule to $0.64. This rate of $0.64 for the

L037B clinical labor type is a close match to the online salary data that we had for the

Histotechnologist and matches the $0.64 rate that we initially proposed for L037B in the CY

2022 PFS proposed rule. Based on the wage data provided by the commenter, we proposed this

$0.64 rate for the L037B clinical labor type for CY 2023; we also proposed a slight increase in

the pricing for the Lab Tech/Histotechnologist (L035A) clinical labor type from $0.55 to $0.60

as it is a blend of the wage rate for the Lab Technician (L033A) and Histotechnologist clinical

labor types. We also proposed the same increase to $0.60 for the Angio Technician (L041A)

clinical labor type, as we previously established a policy in the CY 2022 PFS final rule that the

pricing for the L041A clinical labor type would match the rate for the L035A clinical labor type

(86 FR 65032).

Based on comments received on the CY 2023 proposed rule, we finalized a change in the

descriptive text of the L041A clinical labor type from “Angio Technician” to “Vascular

Interventional Technologist”. We also finalized an update in the pricing of three clinical labor

types: from $0.60 to $0.84 for the Vascular Interventional Technologist (L041A), from $0.63 to

$0.79 for the Mammography Technologist (L043A), and from $0.76 to $0.78 for the CT

Technologist (L046A) based on submitted wage data from the 2022 Radiologic Technologist

Wage and Salary Survey (87 FR 69422 through 69425).

(2) CY 2024 Clinical Labor Pricing Updates

We did not receive new wage data or other additional information for use in clinical labor

pricing from interested parties prior to the publication of the CY 2024 PFS proposed rule.

Therefore, our proposed clinical labor pricing for CY 2024 was based on the clinical labor

pricing that we finalized in the CY 2023 PFS final rule, incremented an additional step for Year

3 of the update. Based on comments received on the CY 2024 proposed rule, we finalized an

update in the clinical labor pricing of the cytotechnologist (L045A) clinical labor type from

$0.76 to $0.85 based on submitted data from the 2021 American Society of Clinical Pathologists

(ASCP) Wage Survey of Medical Laboratories (88 FR 78838).

(3) CY 2025 Clinical Labor Pricing Update Proposals

We did not receive new wage data or other additional information for use in clinical labor

pricing from interested parties prior to the publication of the CY 2025 PFS proposed rule.

Therefore, our proposed clinical labor pricing for CY 2025 in Table 5 is based on the clinical

labor pricing that we finalized in the CY 2024 PFS final rule, incremented an additional step for

the final Year 4 of the update:

TABLE 5: Proposed CY 2025 Clinical Labor Pricing

Labor

Code

Labor Description

Source

CY 2021

Rate Per

Minute

Final Y4

Rate Per

Minute

Total %

Change

L023A

Physical Therapy Aide

BLS 31-2022

0.23

0.28

22%

L026A

Medical/Technical Assistant

BLS 31-9092

0.26

0.36

38%

L030A

Lab Tech/MTA

L033A, L026A

0.30

0.46

53%

L032B

EEG Technician

BLS 29-2098

0.32

0.44

38%

L033A

Lab Technician

BLS 29-2010

0.33

0.55

67%

L033B

Optician/COMT

BLS 29-2081, BLS 29-2057

0.33

0.39

18%

L035A

Lab Tech/Histotechnologist

L033A, L037B

0.35

0.60

70%

L037A

Electrodiagnostic Technologist

BLS 29-2098

0.37

0.44

19%

L037B

Histotechnologist

BLS 29-2010

0.37

0.64

73%

L037C

Orthoptist

BLS 29-1141

0.37

0.76

105%

L037D

RN/LPN/MTA

L051A, BLS 29-2061, L026A

0.37

0.54

46%

L037E

Child Life Specialist

BLS 21-1021

0.37

0.49

32%

L038A

COMT/COT/RN/CST

BLS 29-2057, BLS 29-2055,

L051A, BLS 19-4010

0.38

0.52

37%

L038B

Cardiovascular Technician

BLS 29-2031

0.38

0.60

58%

L038C

Medical Photographer

BLS 29-2050

0.38

L039A

Certified Retinal Angiographer

BLS 29-9000

0.39

0.52

33%

L039B

Physical Therapy Assistant

BLS 31-2021

0.39

0.61

56%

L039C

Psychometrist

BLS 21-1029

0.39

0.64

62%

L041A

Vascular Interventional Technologist

ASRT Wage Data

0.41

0.84

104%

L041B

Radiologic Technologist

BLS 29-2034

0.41

0.63

54%

L041C

Second Radiologic Technologist for

Vertebroplasty

BLS 29-2034

0.41

0.63

54%

L042A

RN/LPN

L051A, BLS 29-2061

0.42

0.63

50%

L042B

Respiratory Therapist

BLS 29-1126

0.42

0.64

52%

L043A

Mammography Technologist

ASRT Wage Data

0.43

0.79

84%

L045A

Cytotechnologist

BLS 29-9092

0.45

0.85

89%

L045B

Electron Microscopy Technologist

BLS 29-1124

0.45

0.89

98%

L045C

CORF social worker/psychologist

BLS 21-1022, BLS 19-3031

0.45

0.70

56%

L046A

CT Technologist*

ASRT Wage Data

0.46

0.78

70%

L047A

MRI Technologist

BLS 29-2035

0.47

0.76

62%

L047B

REEGT (Electroencephalographic

Tech)

BLS 29-2035

0.47

0.76

62%

L047C

RN/Respiratory Therapist

L051A, L042B

0.47

0.70

49%

L047D

RN/Registered Dietician

L051A, BLS 29-1031

0.47

0.70

49%

L049A

Nuclear Medicine Technologist

BLS 29-2033

0.62

0.81

32%

L050A

Cardiac Sonographer

BLS 29-2032

0.50

0.77

54%

L050B

Diagnostic Medical Sonographer

BLS 29-2032

0.50

0.77

54%

L050C

Radiation Therapist

BLS 29-1124

0.50

0.89

78%

L050D

Second Radiation Therapist for IMRT

BLS 29-1124

0.50

0.89

78%

L051A

BLS 29-1141

0.51

0.76

49%

L051B

RN/Diagnostic Medical Sonographer

L051A, BLS 29-2032

0.51

0.77

51%

L051C

RN/CORF

L051A

0.51

0.76

49%

L052A

Audiologist

BLS 29-1181

0.52

0.81

56%

L053A

RN/Speech Pathologist

L051A, L055A

0.53

0.79

49%

L054A

Vascular Technologist

BLS 19-1040

0.54

0.91

69%

L055A

Speech Pathologist

BLS 29-1127

0.55

0.82

49%

L056A

RN/OCN

BLS 29-2033

0.79

0.81

L057A

Genetics Counselor

BLS 29-9092

0.57

0.85

50%

L057B

Behavioral Health Care Manager

BLS 21-1018

0.57

L063A

Medical Dosimetrist

BLS 19-1040

0.63

0.91

44%

L107A

Medical Dosimetrist/Medical

Physicist

L063A, L152A

1.08

1.52

41%

L152A

Medical Physicist

AAPM Wage Data

1.52

2.14

41%

As was the case for the market-based supply and equipment pricing update, the clinical

labor rates will remain open for public comment during the 60-day comment period for this CY

2025 PFS proposed rule. We expect to set the updated clinical labor rates for CY 2025 in the

final rule. We updated the pricing of some clinical labor types in the CY 2022, CY 2023, and

CY 2024 PFS final rules in response to information provided by commenters. For the full

discussion of the clinical labor pricing update, we direct readers to the CY 2022 PFS final rule

(86 FR 65020 through 65037).

5. Development of Strategies for Updates to Practice Expense Data Collection and Methodology

a. Background

The AMA PPIS was first introduced in 2007 as a means to collect comprehensive and

reliable data on the direct and indirect PEs incurred by physicians (72 FR 66222). In considering

the use of PPIS data, the goal was to improve the accuracy and consistency of PE RVUs used in

the PFS. The data collection process included a stratified random sample of physicians across

various specialties, and the survey was administered between August 2007 and March 2008.

Data points from that period of time are integrated into PFS calculations today. In the CY 2009

PFS proposed rule (73 FR 38507 through 3850), we discussed the indirect PE methodology that

used data from the AMA's survey that predated the PPIS. In CY 2010 PFS rulemaking, we

announced our intent to incorporate the AMA PPIS data into the PFS ratesetting process, which

would first affect the PE RVU. In the CY 2010 PFS proposed rule, we outlined a 4-year

transition period, during which we would phase in the AMA PPIS data, replacing the existing PE

data sources (74 FR 33554). We also explained that our proposals intended to update survey

data only (74 FR 33530 through 33531). In our CY 2010 final rule, we finalized our proposal,

with minor adjustments based on public comments (74 FR 61749 through 61750). We

responded to the comments we received about the transition to using the PPIS to inform indirect

PE allocations (74 FR 61750). In the responses, we acknowledged concerns about potential gaps

in the data, which could impact the allocation of indirect PE for certain physician specialties and

suppliers, which are issues that remain important today. The CY 2010 PFS final rule explains

that section 212 of the Balanced Budget Refinement Act of 1999 (Pub. L. 106-113, November

29, 1999) (BBRA) directed the Secretary to establish a process under which we accept and use,

to the maximum extent practicable and consistent with sound data practices, data collected or

developed by entities and organizations to supplement the data we normally collect in

determining the PE component. BBRA required us to establish criteria for accepting

supplemental survey data. Since the supplemental surveys were specific to individual specialties

and not part of a comprehensive multispecialty survey, we had required that certain precision

levels be met in order to ensure that the supplemental data was sufficiently valid, and acceptable

for use in the development of the PE RVUs. At the time, our rationale included the assumption

that because the PPIS is a contemporaneous, consistently collected, and comprehensive

multispecialty survey, we do not believe similar precision requirements are necessary, and we

did not propose to establish them for the use of the PPIS data (74 FR 61742). We noted potential

gaps in the data, which could impact the allocation of indirect PE for certain physician and

suppliers. The CY 2010 final rule adopted the proposal, with minor adjustments based on public

comments, and explained that these minor adjustments were in part due to non-response bias that

results when the characteristics of survey respondents differ in meaningful ways, such as in the

mix of practices sizes, from the general population (74 FR 61749 through 61750).

Throughout the 4-year transition period, from CY 2010 to CY 2013, we gradually

incorporated the AMA PPIS data into the PFS rates, replacing the previous data sources. The

process involved addressing concerns and making adjustments as necessary, such as refining the

PFS ratesetting methodology in consideration of interested party feedback. For background on

the refinements that we considered after the transition began, we refer readers to discussions in

the CY 2011 through 2014 final rules (75 FR 73178 through 73179; 76 FR 73033 through

73034; 77 FR 98892; 78 FR 74272 through 74276).

In the CY 2011 PFS proposed rule, we requested comments on the methodology for

calculating indirect PE RVUs, explicitly seeking input on using survey data, allocation methods,

and potential improvements (75 FR 40050). In our CY 2011 PFS final rule, we addressed

comments regarding the methodology for indirect PE calculations, focusing on using survey

data, allocation methods, and potential improvements (75 FR 73178 through 73179). We

recognized some limitations of the current PFS ratesetting methodology but maintained that the

approach was the most appropriate at the time. In the CY 2012 PFS final rule, we responded to

comments related to indirect PE methodology, including concerns about allocating indirect PE to

specific services and using the AMA PPIS data for certain specialties (76 FR 73033 through

73034). We indicated that CMS would continue to review and refine the methodology and work

with interested parties to address their concerns. In the CY PFS 2014 final rule, we responded to

comments about fully implementing the AMA PPIS data. By 2014, the AMA PPIS data had

been fully integrated into the PFS, serving as the primary source for determining indirect PE

inputs (78 FR 74235). We continued to review data and the PE methodology annually,

considering interested party feedback and evaluating the need for updates or refinements to

ensure the accuracy and relevance of PE RVUs (79 FR 67548). In the years following the full

implementation of the AMA PPIS data, we further engaged with interested parties, thought

leaders and subject matter experts to improve our PE inputs' accuracy and reliability. For further

background, we refer readers to our discussions in final rules for CY 2016 through 2022 (80 FR

70892; 81 FR 80175; 82 FR 52980 through 52981; 83 FR 59455 through 59456; 84 FR 62572;

85 FR 84476 through 84478; 86 FR 62572).

In our CY 2023 PFS final rule, we issued an RFI to solicit public comment on strategies

to update PE data collection and methodology (87 FR 69429 through 69432). We solicited

comments on current and evolving trends in health care business arrangements, the use of

technology, or similar topics that might affect or factor into PE calculations. We reminded

readers that we have worked with interested parties and CMS contractors for years to study the

landscape and identify possible strategies to reshape the PE portion of physician payments. The

fundamental issues are clear but thought leaders and subject matter experts have advocated for

more than one tenable approach to updating our PE methodology.

As described in previous rulemaking, we have continued interest in developing a

roadmap for updates to our PE methodology that account for changes in the health care

landscape. Of various considerations necessary to form a roadmap for updates, we reiterate that

allocations of indirect PE continue to present a wide range of challenges and opportunities. As

discussed in multiple cycles of previous rulemaking, our PE methodology relies on AMA PPIS

data, which may represent the best aggregated available source of information at this time.

However, we acknowledge the limitations and challenges interested parties have raised about

using the current data for indirect PE allocations, which we have also examined in related

ongoing research. We noted in our CY 2023 and CY 2024 rules that there are several competing

concerns that CMS must take into account when considering updated data sources, which also

should support and enable ongoing refinements to our PE methodology.

b. Preparation for Incorporating Refreshed Data and Request for Information on Timing to

Effectuate Routine Updates

In the CY 2024 PFS proposed rule, we continued to encourage interested parties to

provide feedback and suggestions to CMS that give an evidentiary basis to shape optimal PE

data collection and methodological adjustments over time. Considering our ratesetting

methodology and prior experiences implementing new data, we issued a follow-up from the CY

2023 comment solicitation for general information. We solicited comments from interested

parties on strategies to incorporate information that could address known challenges we

experienced in implementing the initial AMA PPIS data. Our current methodology relies on the

AMA PPIS data, legislatively mandated supplemental data sources (for, example, we use

supplemental survey data collected in 2003, as required by section 1848(c)(2)(H)(i) of the Act to

set rates for oncology and hematology specialties), and in some cases crosswalks to allocate

indirect PE as necessary for certain specialties and provider types. We also sought to understand

whether, upon completion of the updated PPIS data collection effort by the AMA, contingencies

or alternatives may be necessary and available to address the lack of data availability or response

rates for a given specialty, set of specialties, or specific service suppliers who are paid under the

PFS.

In response to last year’s RFI, most commenters stated that CMS should defer significant

changes until the AMA PPIS results become available. For further background, refer to 88 FR

78841 to 78843. In responding to our RFI, the AMA RUC provided a set of responses, which

many other commenters repeated in their separate, individual comments. In summary, the AMA

RUC letter submission from CY 2024 suggested that CMS should not consider further changes

until PPIS data collection and analysis is complete. Overall, the AMA comments generally do

not support any change to the methodology and stated that CMS should wait to consider any

further changes until PPIS updates become available. Further, we noted that through its

contractor, Mathematica, the AMA secured an endorsement for the PPIS updates from each State

society, national medical specialty society, and others prior to fielding the survey (88 FR 78843).

Refer to the AMA’s summary of the PPIS, available at https://www.ama-

assn.org/system/files/physician-practice-information-survey-summary.pdf. The AMA expects

analysis, reporting, and documentation to complete by the end of CY 2024, and the AMA would

share data with CMS when results become available.

We believe the AMA’s approach may possibly mitigate nonresponse bias, which created

challenges using previous PPIS data. However, we remain uncertain about whether

endorsements prior to fielding the survey may inject other types of bias in the validity and

reliability of the information collected. We believe it remains important to reflect on the

challenges with our current methodology, and to continue to consider alternatives that improve

the stability and accuracy of our overall PE methodology. We reiterate our discussion

summarizing the responses to previous years’ RFIs in each of the CY 2023 and CY 2024 final

rules (refer to 87 FR 69429 through 69432 and 88 FR 78841 to 78843). We have started new

work under contract with the RAND Corporation to analyze and develop alternative methods for

measuring PE and related inputs for implementation of updates to payment under the PFS. We

continue to study possible alternatives, and would include analysis of updated PPIS data, as part

of our ongoing work. In the meantime, we request general information from the public on ways

that CMS may continue work to improve the stability and predictability of any future updates.

Specifically, we request feedback from interested parties regarding scheduled, recurring updates

to PE inputs for supply and equipment costs.

We believe that establishing a cycle of timing to update supply and equipment cost inputs

every 4 years may be one means of advancing shared goals of stability and predictability. CMS

would collect available data, including, but not limited to, submissions and independent third-

party data sources, and propose a phase-in period over the following 4 years. The phase-in

approach maps to our experience with previous updates. Additionally, we believe that more

frequent updates may have the unintended consequence of disproportionate effects of various

supplies and equipment that have newly updated costs.

Further, we seek feedback on possible mechanisms to establish a balance whereby our

methodology would account for inflation and deflation in supply and equipment costs. We

remain uncertain how economies of scale (meaning a general principle that cost per unit of

production decreases as the scale of production increases) should or should not factor into future

adjustments to our methodology. There remains a diversity of perspectives among interested

parties about such effects. We seek information about specific mechanisms that may be

appropriate, and in particular, approaches that would leverage verifiable and independent, third-

party data that is not managed or controlled by active market participants.

C. Potentially Misvalued Services Under the PFS

1. Background

Section 1848(c)(2)(B) of the Act directs the Secretary to conduct a periodic review, not

less often than every 5 years, of the relative value units (RVUs) established under the PFS.

Section 1848(c)(2)(K) of the Act requires the Secretary to periodically identify potentially

misvalued services using certain criteria and to review and make appropriate adjustments to the

relative values for those services. Section 1848(c)(2)(L) of the Act also requires the Secretary to

develop a process to validate the RVUs of certain potentially misvalued codes under the PFS,

using the same criteria used to identify potentially misvalued codes, and to make appropriate

adjustments.

As discussed in section II.E. of this proposed rule, under Valuation of Specific Codes,

each year we develop appropriate adjustments to the RVUs taking into account recommendations

provided by the American Medical Association (AMA) Resource-Based Relative Value Scale

(RBRVS) Update Committee (RUC), MedPAC, and other interested parties. For many years,

the RUC has provided us with recommendations on the appropriate relative values for new,

revised, and potentially misvalued PFS services. We review these recommendations on a code-

by-code basis and consider these recommendations in conjunction with analyses of other data,

such as claims data, to inform the decision-making process as authorized by statute. We may

also consider analyses of work time, work RVUs, or direct PE inputs using other data sources,

such as the Veterans Health Administration (VHA), National Surgical Quality Improvement

Program (NSQIP), the Society for Thoracic Surgeons (STS), and the Merit-based Incentive

Payment System (MIPS) data. In addition to considering the most recently available data, we

assess the results of physician surveys and specialty recommendations submitted to us by the

RUC for our review. We also consider information provided by other interested parties such as

from the general medical-related community and the public. We conduct a review to assess the

appropriate RVUs in the context of contemporary medical practice. We note that section

1848(c)(2)(A)(ii) of the Act authorizes the use of extrapolation and other techniques to determine

the RVUs for physicians' services for which specific data are not available and requires us to take

into account the results of consultations with organizations representing physicians who provide

the services. In accordance with section 1848(c) of the Act, we determine and make appropriate

adjustments to the RVUs.

In its March 2006 Report to the Congress (https://www.medpac.gov/document/report-to-

the-congress-2006-medicare-payment-policy/), MedPAC discussed the importance of

appropriately valuing physicians’ services, noting that misvalued services can distort the market

for physicians’ services, as well as for other health care services that physicians order, such as

hospital services. In that same report, MedPAC postulated that physicians’ services under the

PFS can become misvalued over time. MedPAC stated, “When a new service is added to the

physician fee schedule, it may be assigned a relatively high value because of the time, technical

skill, and psychological stress that are often required to furnish that service. Over time, the work

required for certain services would be expected to decline as physicians become more familiar

with the service and more efficient in furnishing it.” We believe services can also become

overvalued when PE costs decline. This can happen when the costs of equipment and supplies

fall, or when equipment is used more frequently than is estimated in the PE methodology,

reducing its cost per use. Likewise, services can become undervalued when physician work

increases, or PE costs rise.

As MedPAC noted in its March 2009 Report to Congress

(https://www.medpac.gov/docs/default-source/reports/march-2009-report-to-congress-medicare-

payment-policy.pdf), in the intervening years since MedPAC made the initial recommendations,

CMS and the RUC have taken several steps to improve the review process. Also, section

1848(c)(2)(K)(ii) of the Act augments our efforts by directing the Secretary to specifically

examine, as determined appropriate, potentially misvalued services in the following categories:

● Codes that have experienced the fastest growth.

● Codes that have experienced substantial changes in PE.

● Codes that describe new technologies or services within an appropriate time-period

(such as 3 years) after the relative values are initially established for such codes.

● Codes which are multiple codes that are frequently billed in conjunction with

furnishing a single service.

● Codes with low relative values, particularly those that are often billed multiple times

for a single treatment.

● Codes that have not been subject to review since implementation of the fee schedule.

● Codes that account for the majority of spending under the PFS.

● Codes for services that have experienced a substantial change in the hospital length of

stay or procedure time.

● Codes for which there may be a change in the typical site of service since the code was

last valued.

● Codes for which there is a significant difference in payment for the same service

between different sites of service.

● Codes for which there may be anomalies in relative values within a family of codes.

● Codes for services where there may be efficiencies when a service is furnished at the

same time as other services.

● Codes with high intraservice work per unit of time.

● Codes with high PE RVUs.

● Codes with high cost supplies.

● Codes as determined appropriate by the Secretary.

Section 1848(c)(2)(K)(iii) of the Act also specifies that the Secretary may use existing

processes to receive recommendations on the review and appropriate adjustment of potentially

misvalued services. In addition, the Secretary may conduct surveys, other data collection

activities, studies, or other analyses, as the Secretary determines to be appropriate, to facilitate

the review and appropriate adjustment of potentially misvalued services. This section also

authorizes the use of analytic contractors to identify and analyze potentially misvalued codes,

conduct surveys or collect data, and make recommendations on the review and appropriate

adjustment of potentially misvalued services. Additionally, this section provides that the

Secretary may coordinate the review and adjustment of any RVU with the periodic review

described in section 1848(c)(2)(B) of the Act. Section 1848(c)(2)(K)(iii)(V) of the Act specifies

that the Secretary may make appropriate coding revisions (including using current processes for

consideration of coding changes), which may involve consolidating individual services into

bundled codes for payment under the PFS.

2. Progress in Identifying and Reviewing Potentially Misvalued Codes

To fulfill our statutory mandate, we have identified and reviewed numerous potentially

misvalued codes as specified in section 1848(c)(2)(K)(ii) of the Act, and we intend to continue

our work examining potentially misvalued codes in these areas over the upcoming years. As part

of our current process, we identify potentially misvalued codes for review, and request

recommendations from the RUC and other public commenters on revised work RVUs and direct

PE inputs for those codes. The RUC, through its own processes, also identifies potentially

misvalued codes for review. Through our public nomination process for potentially misvalued

codes established in the CY 2012 PFS final rule with comment period (76 FR 73026, 73058

through 73059), other individuals and groups submit nominations for review of potentially

misvalued codes as well. Individuals and groups may submit codes for review under the

potentially misvalued codes initiative to CMS in one of two ways. Nominations may be

submitted to CMS via email or through postal mail. Email submissions should be sent to the

CMS e-mailbox at [email protected], with the phrase “Potentially

Misvalued Codes” and the referencing CPT code number(s) and/or the CPT descriptor(s) in the

subject line. Physical letters for nominations should be sent via the U.S. Postal Service to the

Centers for Medicare & Medicaid Services, Mail Stop: C4-01-26, 7500 Security Blvd,

Baltimore, Maryland 21244. Envelopes containing the nomination letters must be labeled

“Attention: Division of Practitioner Services, Potentially Misvalued Codes.” Nominations for

consideration in our next annual rule cycle should be received by our February 10th deadline.

Since CY 2009, as a part of the annual potentially misvalued code review and Five-Year Review

process, we have reviewed over 1,700 potentially misvalued codes to refine work RVUs and

direct PE inputs. We have assigned appropriate work RVUs and direct PE inputs for these

services as a result of these reviews. A more detailed discussion of the extensive prior reviews

of potentially misvalued codes is included in the CY 2012 PFS final rule with comment period

(76 FR 73052 through 73055). In the same CY 2012 PFS final rule with comment period, we

finalized our policy to consolidate the review of physician work and PE at the same time and

established a process for the annual public nomination of potentially misvalued services.

In the CY 2013 PFS final rule with comment period (77 FR 68892, 68896 through

68897), we built upon the work we began in CY 2009 to review potentially misvalued codes that

have not been reviewed since the implementation of the PFS (so-called “Harvard-valued

codes”

). In the CY 2019 PFS proposed rule (73 FR 38589), we requested recommendations

from the RUC to aid in our review of Harvard-valued codes that had not yet been reviewed,

focusing first on high-volume, low intensity codes. In the fourth Five-Year Review of Work

RVUs proposed rule (76 FR 32410, 32419), we requested recommendations from the RUC to aid

in our review of Harvard-valued codes with annual utilization of greater than 30,000 services. In

the CY 2013 PFS final rule with comment period, we identified specific Harvard-valued services

with annual allowed charges that total at least $10,000,000 as potentially misvalued. In addition

to the Harvard-valued codes, in the CY 2013 PFS final rule with comment period we finalized

for review a list of potentially misvalued codes that have stand-alone PE (codes with physician

work and no listed work time and codes with no physician work that have listed work time). We

The research team and panels of experts at the Harvard School of Public Health developed the original work RVUs

for most CPT codes, in a cooperative agreement with the Department of Health and Human Services (HHS).

Experts from both inside and outside the Federal Government obtained input from numerous physician specialty

groups. This input was incorporated into the initial PFS, which was implemented on January 1, 1992.

continue each year to consider and finalize a list of potentially misvalued codes that have or will

be reviewed and revised as appropriate in future rulemaking.

3. CY 2025 Identification and Review of Potentially Misvalued Services

In the CY 2012 PFS final rule with comment period (76 FR 73058), we finalized a

process for the public to nominate potentially misvalued codes. In the CY 2015 PFS final rule

with comment period (79 FR 67548, 67606 through 67608), we modified this process whereby

the public and interested parties may nominate potentially misvalued codes for review by

submitting the code with supporting documentation by February 10

of each year. Supporting

documentation for codes nominated for the annual review of potentially misvalued codes may

include the following:

● Documentation in peer reviewed medical literature or other reliable data that

demonstrate changes in physician work due to one or more of the following: technique,

knowledge and technology, patient population, site-of-service, length of hospital stay, and work

time.

● An anomalous relationship between the code being proposed for review and other

codes.

● Evidence that technology has changed physician work.

● Analysis of other data on time and effort measures, such as operating room logs or

national and other representative databases.

● Evidence that incorrect assumptions were made in the previous valuation of the

service, such as a misleading vignette, survey, or flawed crosswalk assumptions in a previous

evaluation.

● Prices for certain high cost supplies or other direct PE inputs that are used to determine

PE RVUs are inaccurate and do not reflect current information.

● Analyses of work time, work RVU, or direct PE inputs using other data sources (for

example, VA, NSQIP, the STS National Database, and the MIPS data).

● National surveys of work time and intensity from professional and management

societies and organizations, such as hospital associations.

We evaluate the supporting documentation submitted with the nominated codes and

assess whether the nominated codes appear to be potentially misvalued codes appropriate for

review under the annual process. In the following year’s PFS proposed rule, we publish the list

of nominated codes and indicate for each nominated code whether we agree with its inclusion as

a potentially misvalued code. The public has the opportunity to comment on these and all other

proposed potentially misvalued codes. In each year’s final rule, we finalize our list of potentially

misvalued codes.

a. Public Nominations

In each proposed rule, we seek nominations from the public and from interested parties of

codes that they believe we should consider as potentially misvalued. We receive public

nominations for potentially misvalued codes by February 10

and we display these nominations

on our public website, where we include the submitter’s name, their associated organization, and

the submitted studies for full transparency. We sometimes receive submissions for specific, PE-

related inputs for codes, and discuss these PE-related submissions, as necessary under the

Determination of PE RVUs section of the rule. We summarize below this year’s submissions

under the potentially misvalued code initiative. For CY 2025, we received 5 nominations

concerning various codes. The nominations are as follows:

1) CPT codes 22210, 22212, 22214, 22216

An interested party nominated CPT codes 22210 (Osteotomy of spine, posterior or

posterolateral approach, 1 vertebral segment; cervical) (090 day global code), 22212

(Osteotomy of spine, posterior or posterolateral approach, 1 vertebral segment; thoracic) (090

day global code), 22214 (Osteotomy of spine, posterior or posterolateral approach, 1 vertebral

segment; lumbar) (090 day global code), and 22216 (Osteotomy of spine, posterior or

posterolateral approach, 1 vertebral segment; each additional vertebral segment (List separately

in addition to primary procedure) (add-on ZZZ) as potentially misvalued for six reasons: (1)

incorrect global period; (2) incorrect inpatient days; (3) incorrect intraservice work description;

(4) overvalued intraservice times; (5) changed surgical practice; and (6) incorrect use of posterior

osteotomy codes. The posterior osteotomy codes were last valued by the RUC in 1995.

Currently, CPT code 22210 has a work RVU of 25.38, CPT code 22212 has a work RVU of

20.99, CPT code 22214 has a work RVU of 21.02, and CPT code 22216 has a work RVU of

6.03. CPT codes 22210, 22212, and 22214 have 7 inpatient days each, while CPT code 22216

has 0 inpatient days, and it is an add-on code.

First, the nominator stated that these posterior osteotomies are always performed as an

optional addition to a spinal fusion and should be valued as add-on services and not as 90-day

global services. We note that no references are provided to support the statement that the service

is always performed as an optional addition to a spinal fusion. Second, the nominator explained

that the average hospital stay for scoliosis fusion with osteotomy is 4 to 5 days according to the

current literature,

2,3,4

in contrast with the currently included 7 inpatient days. We note that the

majority of the medical literature submitted by the nominator presented outcome information on

adolescent patients, which may be different from the Medicare population. Furthermore, the

nominator stated that the intraservice work description for CPT code 22216 describes removal of

the pedicle, which is not a typical part of a Ponte/Schwab II osteotomy. Among the posterior

osteotomy codes, only CPT code 22216 had vignettes and we do not have information to decide

whether the code descriptor is correct. We believe this issue would benefit from further review

by the medical community and welcome comments and considerations, including from the AMA

CPT.

Halanski, Matthew Aaron, and Jeffrey A Cassidy. “Do multilevel Ponte osteotomies in thoracic idiopathic scoliosis

surgery improve curve correction and restore thoracic kyphosis?” Journal of spinal disorders & techniques vol. 26,5

(2013): 252-5. doi:10.1097/BSD.0b013e318241e3cf.

Floccari, Lorena V et al. “Ponte osteotomies in a matched series of large AIS curves increase surgical risk without

improving outcomes.” Spine deformity vol. 9,5 (2021): 1411-1418. doi:10.1007/s43390-021-00339-x.

Buckland, Aaron J et al. “Ponte Osteotomies Increase the Risk of Neuromonitoring Alerts in Adolescent Idiopathic

Scoliosis Correction Surgery.” Spine vol. 44,3 (2019): E175-E180. doi:10.1097/BRS.0000000000002784.

The nominator also asserted that intraservice times were too high, particularly for these

osteotomy services furnished with scoliosis fusion procedures. The nominator explained that a

typical scoliosis fusion would be billed with an intraservice time of up to 840 minutes for

pediatric scoliosis fusion and 915 minutes for adult cases. However, referencing current

literature, they observed that a typical scoliosis fusion in a child requires approximately 278

minutes (243-296 minutes),

2,3,5,6,7

which contrasts significantly with the durations indicated for

the current codes. The nominator provided no studies to support a typical scoliosis fusion time in

adults. Drawing from the literature, the nominators assert that intraservice times are overvalued

for these services and propose that these times should be adjusted to align more closely with

average and/or typical surgery times.

The nominator further asserted that this code family is potentially misvalued because

surgical practice for these procedures has evolved since 1995. Approximately 30 years ago,

osteotomies were infrequently performed and usually reserved for addressing completely

ankylosed or fused spinal segments.

However, according to the nominator, contemporary

surgical techniques often involve posterior osteotomies to release multiple stiff vertebral

segments, thereby enhancing coronal correction and reducing thoracic hypokyphosis. In addition

to changes in surgical techniques over time, there are notable shifts in the trends regarding the

utilization of osteotomies. For instance, between 2007 and 2015, the use of posterior osteotomies

Samdani, Amer F et al. “Do Ponte Osteotomies Enhance Correction in Adolescent Idiopathic Scoliosis? An

Analysis of 191 Lenke 1A and 1B Curves.” Spine deformity vol. 3,5 (2015): 483-488.

doi:10.1016/j.jspd.2015.03.002.

Pizones, Javier et al. “Ponte osteotomies to treat major thoracic adolescent idiopathic scoliosis curves allow more

effective corrective maneuvers.” European spine journal : official publication of the European Spine Society, the

European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society vol. 24,7

(2015): 1540-6. doi:10.1007/s00586-014-3749-1.

Feng, Jing et al. “Clinical and radiological outcomes of the multilevel Ponte osteotomy with posterior selective

segmental pedicle screw constructs to treat adolescent thoracic idiopathic scoliosis.” Journal of orthopaedic surgery

and research vol. 13,1 305. 29 Nov. 2018, doi:10.1186/s13018-018-1001-0.

Ponte, Alberto et al. “The True Ponte Osteotomy: By the One Who Developed It.” Spine deformity vol. 6,1 (2018):

2-11. doi:10.1016/j.jspd.2017.06.006.

in scoliosis cases nearly doubled, increasing from 17 percent to 35 percent.

Additionally, 73

percent of patients undergoing scoliosis surgery received posterior osteotomies.

This

information supports the nominator’s assertion that there have been notable changes in the

surgical practice for these codes over time.

Lastly, the nominator highlighted incorrect usage of posterior osteotomy codes. They

noted instances where facet/soft tissue releases, such as Schwab type I osteotomies, are

inaccurately reported with these codes. According to the nominator, isolated partial facetectomy

and soft tissue release are already included in spinal fusion procedures and should not be

separately billed with an osteotomy code. Additionally, CMS in reviewing data for these services

identified potential bundling of services within this code family. For instance, CPT code 22210 is

frequently billed alongside CPT code 22600 (Arthrodesis, posterior or posterolateral technique,

single interspace; cervical below C2 segment) (090-day global code), approximately 83 percent

of the time. This indicates a common billing pattern, suggesting potential for coding revisions,

including the consideration of consolidating individual services into bundled codes.

Overall, based on the six reasons provided by the nominator, along with the fact that

these codes were last valued almost 30 years ago, and given the identified billing practices, we

concur that CPT codes 22210, 22212, 22214, and 22216 are potentially misvalued. The

nominator suggested two options to address this concern: (1) developing add-on codes to

differentiate between the number of vertebral segments involved in the osteotomy procedure and

whether it occurs in the cervical, thoracic, or lumbar regions; and (2) removing the current

posterior osteotomy codes and incorporating osteotomies into new deformity fusion codes, both

with and without osteotomy. We are proposing to consider this code family as potentially

misvalued and we appreciate the detailed information submitted by the nominator with sufficient

Shaheen, Mohammed et al. “Complication risks and costs associated with Ponte osteotomies in surgical treatment

of adolescent idiopathic scoliosis: insights from a national database.” Spine deformity vol. 10,6 (2022): 1339-1348.

doi:10.1007/s43390-022-00534-4.

supporting evidence. We believe that this code family would benefit from a comprehensive

review by the RUC, and we welcome comments on a broader understanding of these codes.

Additionally, we seek input on current standard billing practices. For example, information on

whether the standard of practice has evolved over time, and if so, how it has evolved, could aid

in identifying potential coding issues related to this matter.

2) CPT code 27279

CPT code 27279 (Arthrodesis, sacroiliac joint, percutaneous or minimally invasive

(indirect visualization), with image guidance, includes obtaining bone graft when performed,

and placement of transfixing device) (090 day global code) has been re-nominated as potentially

misvalued based on the absence of separate direct PE inputs for this 090 day global code in the

nonfacility setting. Currently, CPT code 27279 is only priced under the PFS in the facility

setting, but the nominator is requesting that we establish separate direct PE inputs for this service

to value the service when performed in the nonfacility/office setting (for example, in an office-

based lab). The nominator stated that establishing payment for direct PE inputs in the

nonfacility/office setting would increase access to this service for Medicare patients.

We did not nominate CPT code 27279 as potentially misvalued in the CY 2024 PFS final

rule, mainly due to a lack of consensus on whether these services may be safely and effectively

furnished in the nonfacility/office setting. In this year’s submission, the nominator provided three

post-market surveillance publications and two independent reviews of minimally invasive

sacroiliac (SI) joint fusion procedures to support their assertion that this 90-day surgical service

could be safely and effectively furnished in the nonfacility/office setting. Based on the studies,

the nominator stated that the current medical literature provides evidence supporting the

conclusion that percutaneous or minimally invasive SI joint arthrodesis (CPT code 27279)

carries a complication rate that is acceptably low, comparable to other spinal procedures

commonly performed in the office-based lab (OBL). For instance, the risk of major

complications during lateral trans iliac (LTI) SI joint fusion (CPT code 27279) is lower than the

risks associated with other OBL procedures. These include the risk of iliac perforation during

angioplasty, the risk of death, myocardial infarction (MI), and stroke during diagnostic cardiac

catheterization. The nominator did not reference literature regarding the rates of major

complications for other OBL procedures in their submission.

Based on the information submitted we recognize the possibility that CPT code 27279

may be potentially misvalued, given the nominator’s assertion that its complication rate is

acceptably low based on the five studies they submitted. The results of the studies may suggest

that CPT code 27279 can be safely performed in the office-based lab setting, as asserted by the

nominator, with a relatively low complication rate. However, upon reviewing the submitted

information, we also note that these studies collectively report heterogeneous safety outcomes.

The large variabilities in safety outcomes reported in the studies, coupled with several unreported

outcomes, may indicate that we have little knowledge about the effect of the service on safety

outcomes, prompting the need for further investigation. Therefore, we are not proposing to

consider this code as potentially misvalued, and we are instead seeking comments and additional

studies from the broader medical community regarding whether this code should be priced under

the PFS for the non-facility/office setting.

3) CPT code 95800

An interested party re-nominated CPT code 95800 (Sleep study, unattended,

simultaneous recording; heart rate, oxygen saturation, respiratory analysis (e.g., by airflow or

peripheral arterial tone), and sleep time) to update practice expenses that were last reviewed in

2017. This code was nominated as potentially misvalued in the CY 2024 PFS proposed rule (88

FR 52283). For the CY 2024 final rule, we stated that we were unable to properly assess whether

CPT code 95800 is potentially misvalued based on the evidence submitted with the original

nominations and subsequent comments that CMS received (88 FR 78849–78850). This year, an

interested party re-nominated CPT code 59800 noting two significant changes: (1) in the

technologies available to perform home sleep apnea testing (HSAT) services; and (2) in clinical

practice that leads to the typical procedure reported with the CPT code 95800. According to the

nominator, the current practice utilizes disposable HSAT technology, such as the WatchPat One

device, more often than the reusable equipment currently included in the procedure’s direct

practice expense (PE) inputs.

To account for these changes, the nominator requested the deletion of three direct PE input

codes: (1) equipment code EQ335 (WatchPAT 200 Unit with strap, cables, charger, booklet, and

patient video); (2) equipment code EQ336 (Oximetry and Airflow Device); and (3) supply code

SD263 (WatchPAT pneumo-opt sleep probes), which are WatchPAT probes used with the

reusable WatchPAT unit. Instead, the nominator requested the addition of a supply code SD362

(the WatchPAT ONE device), a disposable HSAT technology, as a replacement. According to our

PE supply list, the combined price of the items that the nominator requested to delete (EQ335,

EQ336, and SD263) is $4.71 + $4.55 + $73.32 = $82.58, which is $15.62 less than the price of

the item that the nominator requested to add (SD362), priced at $98.20. The price of $98.20 is

mentioned in the nomination letter without an accompanying specific invoice. Last year, the

nominator submitted invoices, showing a price of $99.00 each (a case of 12 totaling $1,188.00)

for the WatchPat One Device (SD362) (see Table 6).

TABLE 6: Listing of Nominator’s Practice Expense items for addition or deletion to CPT

code 95800

Current

Equipment/Supply Code

Equipment/Supply

Description

Non-Facility/ Office

Equipment/Supply

PE Cost

Recommended

Equipment/

Supply Status

EQ335

WatchPAT 200 Unit with strap,

cables, charger, booklet and

patient video

$4.71

Delete

EQ336

Oximetry and Airflow Device

$4.55

Delete

SD263

WatchPAT pneumo-opt slp

probes (reusable)

$73.32

Delete

SD362

WatchPAT ONE device

(disposable)

$98.20

Add

The nominator asserted that testing trends have shifted away from traditional airflow-

based tests, with a noticeable rise in peripheral arterial tone (PAT)-based (non-airflow) tests. The

traditional airflow-based tests use the reusable supplies and equipment, whereas the PAT-based

non-airflow tests use the disposable HSAT device. While describing these changes in trends, the

nominator did not provide us with their internal data, thus we are unable to verify its validity.

The nominator also stated that disposable HSAT devices were used for nearly 50 percent of CPT

code 95800 services in 2023 and attributed the increased use of disposable devices to the

COVID-19 public health emergency (PHE). Furthermore, the nominator projected that over 50

percent of CPT code 95800 services will be furnished using disposable devices in 2024 and

2025. Explaining the patterns and predictions, the nominator concluded that the pandemic

significantly altered the delivery of HSAT services, with many sleep physicians transitioning to

single-use, disposable sleep tests as an alternative to the reusable testing equipment that is

shipped from patient-to-patient after post-use cleaning. The nominator believes that, going

forward, the typical procedure described by CPT code 95800 in CY 2024 and beyond will be

furnished using disposable HSAT devices rather than reusable equipment.

Since the COVID-19 PHE ended in 2023, we are still unclear as to whether the typical

procedure reported with CPT code 95800 involves the use of a reusable or disposable HSAT

device. Given that we only have access to the nominator’s summary of their internal data to

observe changes in usage trends, which may not be generalizable, we propose to maintain the

current direct PE supply and equipment inputs for CPT code 95800. While we are not currently

proposing to review CPT code 95800 as potentially misvalued for CY 2025, we seek public

comments on this nomination. In particular, we seek comments on whether the typical procedure

described by CPT code 95800 now involves the use of a disposable HSAT device rather than

reusable equipment.

4) CPT codes 10021, 10004, 10005, 10006

An interested party nominated the CPT code 10021 (Fine needle aspiration biopsy,

without imaging guidance; first lesion), CPT code 10004 (Fine needle aspiration biopsy, without

imaging guidance; each additional lesion), CPT code 10005 (Fine needle aspiration biopsy,

including ultrasound guidance; first lesion) and CPT code 10006 (Fine needle aspiration biopsy,

including ultrasound guidance; each additional lesion) as potentially misvalued. We note that

this code family has been nominated several times in recent years. We discussed our review of

these codes and our rationale for finalizing the current values extensively in the CY 2019 PFS

final rule (83 FR 59517), and CY 2021 PFS final rule (85 FR 84602). Furthermore, this code

family was nominated as potentially misvalued and discussed in the CY 2020 PFS final rule (84

FR 62625). For more information we encourage the interested parties to go to our previous PFS

final rules.

The nominator specifically requested that we revisit our work RVU decisions for these

codes, stating that the underpinnings of the reduction in work RVUs from the RUC-

recommended values were flawed. The nominator suggested that CMS should adopt the RUC-

recommended work RVUs. For CPT code 10021, the RUC recommended a work RVU of 1.20,

but we adopted a lower value of 1.03. Similarly, for CPT code 10005, the RUC recommended a

work RVU of 1.63, but we adopted 1.46. The nominator disagreed with these reductions from

the RUC-recommended values by CMS, raising particular concerns about our choice for the

RVU crosswalk for CPT code 36440 (Push blood transfusion, patient 2 years or younger).

According to the nominator, the CPT code we chose is not comparable to fine needle aspiration

in any respect other than service time. The nominator raised several points, including that CPT

code 36440 is rarely utilized and is almost never billed to Medicare because it pertains to a

pediatric procedure conducted on neonates, while CPT code 10021 is never performed on

neonates. They further asserted that the training and experience levels required to properly

perform these procedures differ significantly; neonatal transfusions can be conducted by less

experienced personnel, while performing a thyroid fine needle aspiration demands more

experience. Specifically, they argued that there is a notable difference in the work intensity

between the two procedures. The thyroid is closely positioned to vital structures such as the

carotid artery, jugular vein, lymphatic vessels, nerves, trachea, and esophagus. When sampling

thyroid nodules, they are often in proximity to the carotid artery, jugular vein, or both. According

to the nominator, even a slight deviation of 1-2 millimeters during the sampling procedure can

result in accidental puncture of these critical blood vessels or other nearby structures. Factors

such as respiratory movements, patient swallowing, or anxiety may cause the thyroid to move,

further increasing the risk during the procedure. In contrast, neonatal phlebotomy does not

require such measures. Also, the CPT code 36440 is designated as facility-only, meaning it does

not include any clinical staff pre-service time and has no associated practice expense inputs.

According to the nominator, fine needle aspiration is a very complex and high-risk procedure

that may require significant physician work and a higher level of clinical expertise to furnish the

service, which is very different from CPT code 36440. We appreciated the survey (N=74) results

that the nominator submitted to support their statements. The nominator-conducted survey, and

their survey questions aimed to gather information on the practitioners' experiences, opinions,

and practices related to fine needle aspiration procedures. However, no other references such as

peer reviewed medical literature or other nationally representative survey data were provided to

reinforce their argument.

The nominator further stated that thyroid fine needle aspiration should exclusively be

performed as an outpatient procedure and does not require hospitalization. The nominator

emphasized that the reduction in payment for the code family due to the reduction in work RVUs

from the RUC-recommended values has led endocrinologists in office-based practices, those

who are not affiliated with facilities, to discontinue furnishing this service. According to the

nominator, as a consequence of this payment decrease, patients are now being referred to

hospital-based radiology practices, despite the fact that thyroid fine needle aspiration should

ideally be conducted exclusively in nonfacility outpatient settings. The nominator asserted that

radiologists in hospital settings are often unfamiliar with the patient's medical history and risk

factors for suspected thyroid cancer. The nominator further noted that radiologists' training in

thyroid cancer primarily emphasizes imaging and procedures, rather than considering the

patient's overall health perspective. This result may further lead to an increase in medically

unnecessary procedures. Additionally, the nominator believes that the payment reduction for this

code family has the potential to diminish the specialist workforce trained to perform these

procedures, thereby presenting future challenges in patient care and access to specialized

services.

Overall, we appreciate the comprehensive information and level of detail provided by the

nominator. The nominator disagreed with the choice of crosswalk CPT code 36440 made by

CMS, emphasizing the differences in provider training, procedure risk, and patient population.

They noted the rarity of Medicare billing for this code. Additionally, they emphasized the

importance of outpatient thyroid fine needle aspiration being performed by endocrinologists. The

shift to facility settings, prompted by reduced work RVUs, could raise Medicare costs. This,

along with a potential decline in specialist workforce, may hinder patient access. However, in

discussing this group of codes, we must note that these codes have been recently reviewed

multiple times through the annual PFS rulemaking process. We would like to clarify once again

that we disagree with the nominator that this code family is potentially misvalued. We

acknowledge the possibility that there could be significant changes in the practice of delivering

services described by these codes that were not fully reflected in the current work RVU. In such

cases, it would be appropriate to refer the codes to the RUC to conduct a new survey to capture

these changes accurately. However, we note that these codes underwent thorough RUC survey

and review processes during the October 2017 and January 2018 RUC meetings. Based on these

considerations, we disagree with the assertion that this code family is potentially misvalued.

Nevertheless, we welcome comments on whether these codes should be re-reviewed in light of

the arguments made by the nominator.

5) Tympanostomy codes

CMS routinely interacts with interested parties, and in our most recent review, we have

observed several new devices that could be beneficial for populations but are not currently

included in our coding system. While there are variations in the described devices, they

commonly share the following descriptions. This device uses an innovative surgical technology

that combines the separate functions of creating a myringotomy (incision in the eardrum), and

positioning and placing a ventilation tube across the tympanic membrane. The new device is

intended to deliver a tympanostomy tube (also referred to as a ventilation tube) through the

tympanic membrane of the patient and is indicated to be used in office settings for pediatric

patients 6 months and older. This device allows the tympanostomy service to be furnished to

patients without general anesthesia and the service could therefore be performed in the office

setting.

Regarding the delivery of this service using innovative surgical technology, CMS

recognizes that CPT code 69433 (Tympanostomy (requiring insertion of ventilating tube), local

or topical anesthesia) (010-day global code) may serve as a sufficient base code, adequately

describing the majority of the surgeon’s work and facility resources. However, a practitioner

may incur additional resources, due to the higher expected intraservice work driven by both time

and intensity factors, especially when furnishing a service to a child, and the cost of the device

when using these devices as part of the performed procedure. While the existing CPT code

69433 is not age-specific, both the vignette and the RVU associated with this procedure are

established for adult patients who can respond to surgeon direction, and do not have risk of

movement during the procedure. We believe that potentially establishing additional coding and

payment for tympanostomy services may enable the provision of these services utilizing new

technologies to a broader patient population who may benefit from innovative surgical

technology. To improve the accuracy of the payment for these services, we are soliciting

comments on several alternatives that we are considering for adoption in the CY 2025 PFS final

rule or future rulemaking. First, we are seeking comment on whether to establish a new G code

that accounts for the work and practice expense for a procedure involving the positioning and

placement of a ventilation tube across the tympanic membrane using an innovative surgical

technology that combines the separate functions of creating a myringotomy (incision in the

eardrum). We could assign contractor pricing to this potential G code for generalizable

innovative tympanostomy tube delivery devices and/or systems falling under emerging

technology and services categories. Alternatively, we are seeking comment on whether we

should establish an add-on payment for the service using inputs from CPT code 69433 as a

crosswalk reference, plus direct costs from invoices for the surgical devices referenced above.

We are seeking comments regarding these potential approaches, particularly on whether there is

additional information we should consider if we were to establish additional coding and payment

for these services.

D. Payment for Medicare Telehealth Services Under Section 1834(m) of the Act

As discussed in prior rulemaking, several conditions must be met for Medicare to make

payment for telehealth services under the PFS. See further details and full discussion of the scope

of Medicare telehealth services in the CY 2018 PFS final rule (82 FR 53006), the CY 2021 PFS

final rule (85 FR 84502) and the CY 2024 PFS final rule (88 FR 78861 through 78866) and in 42

CFR 410.78 and 414.65. For a discussion of Telemedicine Evaluation and Management (E/M)

Services, we refer readers to section II.E.4.18 of this proposed rule.

1. Payment for Medicare Telehealth Services Under Section 1834(m) of the Act

a. Changes to the Medicare Telehealth Services List

In the CY 2003 PFS final rule with comment period (67 FR 79988), we established a

regulatory process for adding services to or deleting services from the Medicare Telehealth

Services List in accordance with section 1834(m)(4)(F)(ii) of the Act. This process provides the

public with an ongoing opportunity to submit requests for adding services, which are then

reviewed by us and assigned to categories established through notice and comment rulemaking.

Under the process we established beginning in CY 2003, we evaluated whether a service meets

the following criteria:

● Category 1: Services similar to professional consultations, office visits, and office

psychiatry services currently on the Medicare Telehealth Services List. In reviewing these

requests, we looked for similarities between the requested and existing telehealth services for the

roles of, and interactions among, the beneficiary, the physician (or other practitioner) at the

distant site, and, if necessary, the telepresenter, a practitioner who was present with the

beneficiary in the originating site. We also looked for similarities in the telecommunications

system used to deliver the service, for example, the use of interactive audio and video equipment.

● Category 2: Services that are not similar to those on the current Medicare Telehealth

Services List. Our review of these requests included assessing whether the service was accurately

described by the corresponding code when furnished via telehealth and whether using a

telecommunications system to furnish the service produces demonstrated clinical benefit to the

patient. Submitted evidence should have included both a description of relevant clinical studies

that demonstrated the service furnished by telehealth to a Medicare beneficiary improves the

diagnosis or treatment of an illness or injury or improves the functioning of a malformed body

part, including dates and findings, and a list and copies of published peer-reviewed articles

relevant to the service when furnished via telehealth. Our evidentiary standard of clinical benefit

did not include minor or incidental benefits. Some examples of other clinical benefits that we

considered include the following:

● Ability to diagnose a medical condition in a patient population without access to

clinically appropriate in-person diagnostic services.

● Treatment option for a patient population without access to clinically appropriate in-

person treatment options.

● Reduced rate of complications.

● Decreased rate of subsequent diagnostic or therapeutic interventions (for example, due

to reduced rate of recurrence of the disease process).

● Decreased number of future hospitalizations or physician visits.

● More rapid beneficial resolution of the disease process treatment.

● Decreased pain, bleeding, or other quantifiable signs or symptoms.

● Reduced recovery time.

In the CY 2021 PFS final rule (85 FR 84507), we created a third category of criteria for adding

services to the Medicare Telehealth Services List on a temporary basis following the end of the

PHE for the COVID-19 pandemic. This new category described services that were added to the

Medicare Telehealth Services List during the PHE, for which there was likely to be clinical

benefit when furnished via telehealth, but there was not yet sufficient evidence available to

consider the services for permanent addition under the Category 1 or Category 2 criteria.

Services added on a temporary, Category 3 basis ultimately needed to meet the criteria under

Category 1 or 2 in order to be permanently added to the Medicare Telehealth Services List. To

add specific services on a Category 3 basis, we would conduct a clinical assessment to identify

those services for which we could foresee a reasonable potential likelihood of clinical benefit

when furnished via telehealth.

In the CY 2024 PFS final rule (88 FR 78861 through 78866), we consolidated these three

categories and implemented a revised 5-step process for making additions, deletions, and

changes to the Medicare Telehealth Services List (5-step process), beginning for the CY 2025

Medicare Telehealth Services List. Rather than categorizing a service as “Category 1” or

“Category 2,” each service is now assigned a “permanent” or “provisional” status. As described

further below, a service is assigned a “provisional” status if there is not enough evidence to

demonstrate that the service is of clinical benefit, but there is enough evidence to suggest that

further study may demonstrate such benefit. The 5-step process review criteria are set forth in the

CY 2024 PFS final rule (88 FR 78861 through 78866), listed at

https://www.cms.gov/medicare/coverage/telehealth/criteria-request, and summarized below.

Consistent with the deadline for our receipt of code valuation recommendations from the

American Medical Association’s Relative Value Scale Update Committee (AMA RUC) and

other interested parties (83 FR 59491) and with the process set forth in prior calendar years, for

CY 2025, requests to add services to the Medicare Telehealth Services List must have been

submitted to and received by CMS by February 10, 2024. Each request to add a service to the

Medicare Telehealth Services List must have included any supporting documentation the

requester wishes us to consider as we review the request. Because we use the annual PFS

rulemaking process to make changes to the Medicare Telehealth Services List, requesters are

advised that any information submitted as part of a request is subject to public disclosure for this

purpose. For more information on submitting a request to add services to the Medicare

Telehealth Services List, including where to send these requests, and to view the current

Medicare Telehealth Service List, see our website at https://www.cms.gov/Medicare/Medicare-

General-Information/Telehealth/index.html.

Step 1. Determine whether the service is separately payable under the PFS.

When considering whether to add, remove, or change the status of a service on the

Medicare Telehealth Services List, we first determine whether the service, as described by the

individual HCPCS code, is separately payable under the PFS because, as further discussed in CY

2024 PFS final rule (88 FR 78861 through 78866), Medicare telehealth services are limited to

those services for which separate Medicare payments can be made under the PFS. Before

gathering evidence and preparing to submit a request to add a service to the Medicare Telehealth

Services List, the submitter should therefore first check the payment status for a given service

and ensure that the service (as identified by a HCPCS code), is a covered and separately payable

service under the PFS (as identified by payment status indicators A, C, T, or R on our public use

files).

Step 2. Determine whether the service is subject to the provisions of section 1834(m) of the Act.

If we determine at Step 1 that a service is separately payable under the PFS, we apply

Step 2 under which we determine whether the service at issue is subject to the provisions of

section 1834(m) of the Act. Section 1834(m) of the Act provides for payment to a physician (or

other practitioner) for a service furnished via an interactive telecommunications system,

notwithstanding that the furnishing practitioner and patient are not in the same location, at the

same amount that would have been paid if the service was furnished without the

telecommunications system. We have historically interpreted this to mean that only services that

are ordinarily furnished with the furnishing practitioner and patient in the same location can be

classified as a “telehealth service” for which payment can be made under section 1834(m) of the

Act. Given that there may be a range of services delivered using certain telecommunications

technology that, though they are separately payable under the PFS, do not fall within the

definition of telehealth service set forth in section 1834(m) of the Act, the aim of Step 2 is

therefore to determine whether the service at issue is, in whole or in part, inherently a face-to-

face service. Such services generally include services that do not require the presence of, or

involve interaction with, the patient (for example, remote interpretation of diagnostic imaging

tests, and certain care management services). Other examples include virtual check-ins, e-visits,

and remote patient monitoring services which involve the use of telecommunications technology

to facilitate interactions between the patient and practitioner, but do not serve as a substitute for

an in-person encounter, for example, to assess whether an in-person or telehealth visit is needed

or to transmit health information to the practitioner.

In determining whether a service is subject to the provisions of section 1834(m) of the

Act, we therefore review during this Step 2 whether one or more of the elements of the service,

as described by the particular HCPCS code at issue, ordinarily involve direct, face-to-face

interaction between the patient and practitioner such that the use of an interactive

telecommunications system to deliver the service would be a substitute for an in-person visit.

Step 3. Review the elements of the service as described by the HCPCS code and determine

whether each of them is capable of being furnished using an interactive telecommunications

system as defined in § 410.78(a)(3).

Step 3 is corollary to Step 2, and is used to determine whether one or more elements of a

service are capable of being delivered via an interactive telecommunication system as defined in

§ 410.78(a)(3). In Step 3, we consider whether one or more face-to-face component(s) of the

service, if furnished via audio-video communications technology, would be equivalent to the

service being furnished in-person, and we seek information from requesters to demonstrate

evidence of substantial clinical improvement in different beneficiary populations that may

benefit from the requested service when furnished via telehealth, including, for example, in rural

populations. The services are not equivalent when the clinical actions, or patient interaction,

would not be of similar content as an in-person visit, or could not be completed.

Step 4. Consider whether the service elements of the requested service map to the service

elements of a service on the list that has a permanent status described in previous final

rulemaking.

The purpose of Step 4 is to simplify and reduce the administrative burden of submission

and review. For Step 4, we review whether the service elements of a code that we are

considering for addition to, or removal from, the Medicare Telehealth Services List map to the

service elements of a service that is already on the list and is assigned permanent status. Any

code that satisfies this criterion would require no further analysis. If the service elements of a

code maps to the service elements of a code that is already included on the Medicare Telehealth

Services List and is assigned permanent basis, we will add the code to the Medicare Telehealth

Services List and assign it permanent status. While we have not previously found that the service

elements of a code we are considering for addition to the list map to the elements of a service

that was previously added to the list and assigned permanent basis, we believe that it is

appropriate to apply this step 4 analysis to compare the candidate service with any permanent

code that is on the list on a permanent basis. When Step 4 is met, further evidence review is not

necessary. We continue to Step 5 if Step 4 is not met.

Step 5. Consider whether there is evidence of clinical benefit analogous to the clinical benefit of

the in-person service when the patient, who is located at a telehealth originating site, receives a

service furnished by a physician or practitioner located at a distant site using an interactive

telecommunications system.

Similar to Steps 3, 4, and 5 above, the purpose of the proposed step 5 is to simplify and

reduce the administrative burden. Under Step 5, we review the evidence provided with a

submission to determine the clinical benefit of a service. We then compare the clinical benefit of

that service, when provided via telehealth, to the clinical benefit of the service if it were to be

furnished in person. If there is enough evidence to suggest that further study may demonstrate

that the service, when provided via telehealth, is of clinical benefit, CMS will assign the code a

‘‘provisional’’ status on the Medicare Telehealth Services List. Where the clinical benefit of a

service, when provided via telehealth, is clearly analogous to the clinical benefit of the service

when provided in person, CMS will assign the code ‘‘permanent’’ status on the Medicare

Telehealth Services List, even if the code’s service elements do not map to the service elements

of a service that already has permanent status. We reminded readers that our evidentiary standard

of demonstrated clinical benefit does not include minor or incidental benefits (81 FR 80194).

We review the evidence submitted by interested parties, and other evidence that CMS has on

hand. The evidence should indicate that the service can be safely delivered using two-way

interactive audio-video communications technology. Clinical practice guidelines, peer-reviewed

literature, and similar materials, should illustrate specifically how the methods and findings

within the material establish a foundation of support that each element of the defined, individual

service described by the existing face-to-face service code has been studied in the typical setting

of care, typical population of beneficiaries, and typical clinical scenarios that practitioners would

encounter when furnishing the service using only interactive, two-way audio-video

communications technology to complete the visit or encounter with Medicare beneficiaries.

General evidence may also answer the question of whether a certain beneficiary population

requiring care for a specific illness or injury may benefit from receiving a service via telehealth

versus receiving no service at all, but must establish that the service is a substitute for an

equivalent in-person service. Evidence should demonstrate how all elements described by the

individual service code can be met when two-way, interactive audio-video communications

technology is used as a complete substitute for any face-to-face interaction required between the

patient and practitioner that are described in the individual code descriptor. We further remind

readers that submissions reflecting practitioner services furnished to Medicare beneficiaries are

helpful in our considerations.

b. Requests to Add Services to the Medicare Telehealth Services List for CY 2025

We received several requests to permanently add various services to the Medicare

Telehealth Services List, effective for CY 2025. The requested services are listed in Table 7.

TABLE 7: CY 2025 Requests for Permanent Addition to the Medicare Telehealth Services

List

Category

HCPCS

Short Descriptor

Radiation

Treatment

Mgmt

77427

Radiation tx management x5

96130

Psycl tst eval phys/qhp 1st

96136

Psycl/nrpsyc tst phy/qhp 1st

Psych Testing

96137

Psycl/nrpsyc tst phy/qhp ea

G0422

Intens cardiac rehab w/exerc

Intensive

Cardiac Rehab

G0423

Intens cardiac rehab no exer

96112

Devel tst phys/qhp 1st hr

Developmental

Testing

96113

Devel tst phys/qhp ea addl

0591T

Hlth&wb coaching indiv 1st

0592T

Hlth&wb coaching indiv f-up

Health and Well

Being Coaching

0593T

Hlth&wb coaching group

94625

Phy/qhp op pulm rhb w/o mntr

Outpatient

Pulmonary

Rehab

94626

Phy/qhp op pulm rhb w/mntr

93797

Cardiac rehab

Cardiac Rehab

93798

Cardiac rehab/monitor

97550

Caregiver traing 1st 30 min

Caregiver

Training

97551

Caregiver traing ea addl 15

97161

Physical therapy evaluation, low complexity

97162

Physical therapy evaluation, moderate complexity

97163

Physical therapy evaluation, high complexity

97164

Physical therapy re-evaluation

97110

Therapeutic exercises, each 15 mins

97112

Neuromuscular re-education, each 15 mins

97116

Gait training, each 15 mins

97530

Therapeutic activities, each 15 mins

Physical

Therapy

97535

Self-care home management

97165

Ot eval low complex 30 min

97166

Ot eval mod complex 45 min

97167

Ot eval high complex 60 min

OT Evaluation

97168

Ot re-eval est plan care

92507

Speech/hearing therapy

92508

Speech/hearing therapy

92521

Evaluation of speech fluency

92522

Evaluate speech production

92523

Speech sound lang comprehen

92524

Behavral qualit analys voice

96105

Assessment of aphasia

92626

Eval aud funcj 1st hour

92627

Eval aud funcj ea addl 15

96125

Cognitive test by hc pro

97129

Ther ivntj 1st 15 min

Speech,

Language, and

Voice

Evaluation and

Treatment

97130

Ther ivntj ea addl 15 min

92607

Ex for speech device rx 1hr

92608

Ex for speech device rx addl

SGD Evaluation

and Treatment

92609

Use of speech device service

92526

Oral function therapy

Swallowing

Evaluation and

Treatment

92610

Evaluate swallowing function

92550

Tympanometry & reflex thresh

92552

Pure tone audiometry air

92553

Audiometry air & bone

92555

Speech threshold audiometry

Diagnostic

Audiologic

Testing

92556

Speech audiometry complete

Category

HCPCS

Short Descriptor

92557

Comprehensive hearing test

92563

Tone decay hearing test

92565

Stenger test pure tone

92567

Tympanometry

92568

Acoustic refl threshold tst

92570

Acoustic immitance testing

92587

Evoked auditory test limited

92588

Evoked auditory tst complete

92625

Tinnitus assessment

92626

Eval aud funcj 1st hour

92627

Eval aud funcj ea addl 15

92601

Cochlear implt f/up exam <7

92602

Reprogram cochlear implt <7

92603

Cochlear implt f/up exam 7/>

Diagnostic CI

Testing

92604

Reprogram cochlear implt 7/>

Many services were added to the Medicare Telehealth Services List on a temporary basis

as discussed in the March 31st COVID–19 interim final rule with comment period (IFC) (85 FR

19235 through 19237) for the PHE for Covid-19, and we subsequently retained these services on

a provisional basis. All of the received submissions were requests for addition on a permanent

basis. We believe that, rather than selectively adjudicating only those services for which we

received requests for potential permanent status, it would be appropriate to complete a

comprehensive analysis of all provisional codes currently on the Medicare Telehealth Services

List before determining which codes should be made permanent. We are therefore not making

determinations to recategorize provisional codes as permanent until such time as CMS can

complete a comprehensive analysis of all such provisional codes which we expect to address in

future rulemaking.

The following is a discussion of the requests received for addition of services to the

Medicare Telehealth Services List:

(1) Continuous Glucose Monitoring

We received a request to add CPT code 95251 (Ambulatory continuous glucose

monitoring of interstitial tissue fluid via a subcutaneous sensor for a minimum of 72 hours;

analysis, interpretation and report) to the Medicare Telehealth Services List and assign it

permanent status. This code is not on the Medicare Telehealth Services List, nor had it been

previously added and removed. The requester stated that the ability of the practitioner to interpret

continuous glucose monitoring data and communicate changes in the diabetes care plan to our

patients is enhanced by the availability of video visits, and the code should therefore be added to

the Medicare Telehealth Services List. This service does not meet the criteria described by Step 2

of the 5-step process: determination of whether the service is subject to the provisions of section

1834(m) of the Act. Section 1834(m) of the Act limits the definition of Medicare telehealth

services to those services that would ordinarily be furnished with the furnishing practitioner and

patient in the same location (88 78863). In other words, as stated above, for a service to be

considered a Medicare telehealth service subject to and payable under section 1834(m) of the

Act, the service must be so analogous to in-person care such that the telehealth service, as

defined in § 410.78, is essentially a substitute for a face-to-face encounter. We do not consider

this service a Medicare telehealth service because it is not an inherently face-to-face service; the

patient does not need to be present for the service to be furnished in its entirety. CPT code 95251

describes sensor placement and monitoring over a 72-hour period. We do not consider CPT code

95251 a telehealth service under section 1834(m) of the Act or our regulation at § 410.78.

Therefore, we are not proposing to add this service to the Medicare Telehealth Services List.

(2) Cardiovascular and Pulmonary Rehabilitation

We received requests to permanently add cardiovascular rehabilitation services (CPT

codes 93797 and 93798) and pulmonary rehabilitation services (CPT codes 94625 and 94626) to

the Medicare Telehealth Services List. These services are currently on the Medicare Telehealth

List and are assigned provisional status. We had originally added CPT codes 93797 and 93798

and HCPCS codes G0422 and G0423 on a temporary basis in the CY 2022 PFS final rule (FR 86

65054 through 65055). A requester cited studies that they say demonstrate that the availability of

these services via telehealth enhances access and patient equity. Another requester cited evidence

of improved outcomes for patients that had access to these services via telehealth. As explained

previously, we are not proposing to revise the status of codes from provisional to permanent in

this proposed rule because we intend to conduct a comprehensive review. While considering

these issues for future rulemaking, we are not proposing to assign CPT codes 93797 and 93798

or CPT codes 94625 and 94626 permanent status on the Medicare Telehealth Services List and

would instead maintain the services on the Medicare Telehealth Services List on a provisional

basis for CY 2025.

(3) Health and Well Being-Coaching

We received a request to add Health and Well-Being Coaching (CPT codes 0591T -

0593T) to the Medicare Telehealth Services List with permanent status. These services are

currently on the Medicare Telehealth Services List and are assigned a provisional status. We

originally added these codes on a provisional basis in the CY 2024 PFS final rule (FR 88 78859

and 78860). One requester stated that health and well-being coaching, including content

education, delivered in a telehealth modality is an evidence-based, cost-effective, sustainable,

and common sense approach to facilitating lifestyle/behavioral intervention and treating the

Medicare population with or at heightened risk for chronic diseases. As explained previously, we

are not proposing to revise the status of codes from provisional to permanent in this proposed

rule because we intend to conduct a comprehensive review. Therefore, we are not proposing to

assign them to the Medicare Telehealth Services List with permanent status.

(4) Psychological Testing and Developmental Testing

We received a request to add Psychological Testing and Developmental Testing (CPT

codes 96112, 96113, 96130, 96136, and 96137) to the Medicare Telehealth Services List on a

permanent basis. These services are currently on the Medicare Telehealth Services List and are

assigned provisional status. In the March 31, 2020 interim final rule with comment period (IFC–

1) (85 FR 19239), we originally added CPT codes 96130, 96136, and 96137 to the Medicare

Telehealth Services List for the duration of the PHE for COVID–19, and in the CY 2021 PFS

final rule (85 FR 85003), we stated we were retaining them on the list on a category 3 basis. In

the CY 2023 PFS final rule (87 FR 69460), we added CPT codes 96112 and 96113 on a

temporary basis.

As explained previously, we are not proposing to revise the status of codes from

provisional to permanent in this proposed rule because we intend to conduct a comprehensive

review. Therefore, we are not proposing to either remove these services from or to assign them

permanent status on the Medicare Telehealth Services List.

(5) Therapy/Audiology/Speech Language Pathology

We received multiple requests to add the Therapy services described by CPT codes

97110, 97112, 97116, 97161 through 97164, 97530 and 97535, 97165 through 97168, and

Audiology and Speech Language Pathology services CPT codes 92507, 92508, 92521 through

92524, 92526, 92607 through 92610, 96105 92626, 92627, 96125, 97129, 97130, 92607 through

92609 92550 through 92557, 92563, 92565 92567, 92568, 92570, 92587, 92588, 92601 through

92604, 92625 through 92627, and 92651 and 92652 to the Medicare Telehealth Services List on

a permanent basis stating that continuing Telehealth flexibilities for these services could lead to

reduced health care expenditures, increased patient access, and improved management of chronic

disease and quality of life. These services are currently available on the Medicare Telehealth

Services List and are assigned provisional status, and we refer readers to section II.D.1. for

further discussion of these services. In the CY 2023 PFS final rule (87 FR 69451), we originally

added CPT codes 90901, 97150, 97530, 97537, 97542, 97763, and 98960–98962 to the Medicare

Telehealth Services List on a Category 3 basis. As explained previously, we are not proposing to

revise the status of codes from provisional to permanent in this proposed rule because we intend

to conduct a comprehensive review. Therefore, we are not proposing to assign them permanent

status on the Medicare Telehealth Services List.

(6) Care Management

We received a request to permanently add General Behavioral Health Integration (CPT

code 99484) and Principal Care Management (CPT codes 99424 – 99427) to the Medicare

Telehealth Services List. These services are not on the Medicare Telehealth Services List, nor

have they been previously added and removed. These services do not meet the criteria described

by Step 2 of the 5-step process: determination of whether the service is subject to the provisions

of section 1834(m) of the Act. As stated above, the scope of section 1834(m) of the Act is

limited to services that would ordinarily be furnished with the furnishing practitioner and patient

in the same location (88 78863), and for a service to be considered a telehealth service subject to

and payable under section 1834(m) of the Act, the service must be so analogous to in-person care

such that the telehealth service, as defined in § 410.78, is essentially a substitute for a face-to-

face encounter. We do not consider these services to be Medicare telehealth services because

they are not inherently face-to-face services, and the patient need not be present for the services

to be furnished in its entirety. Therefore, we do not consider CPT codes 99484 and 99424 –

99427 to be telehealth services under section 1834(m) of the Act or our regulation at § 410.78.

Therefore, we are not proposing to add this service to the Medicare Telehealth Services List.

(7) Posterior Tibial Nerve Stimulation for Voiding Dysfunction

We received a request to permanently add Posterior tibial neurostimulation (CPT code

64566) to the Medicare Telehealth Services List. This code is not on the Medicare Telehealth

Services List, nor had it been previously added and removed. This service does not meet the

criteria for addition described by Step 3 of the 5-step process, namely the review the elements of

the service as described by the HCPCS code and determine whether each of them is capable of

being furnished using an interactive telecommunications system as defined in § 410.78(a)(3).

The requestor describes the services underlying CPT code 64566 as the continual or recurring

treatments over a period of time consisting of the remote monitoring of device utilization and

bladder diary for the generation of reports for review by the care provider. Based on our review,

this description does not align with the elements of the service as described by CPT code 64566.

CPT code 64566 describes a single treatment provided by a clinician who has direct contact with

the patient and inserts an electrode into the skin overlying the posterior tibial nerve. Upon

conclusion of the treatment, the clinician removes the electrode and examines and dresses the

puncture wound. Providing these services would require in-person interaction. We are therefore

not proposing to add the service to the Medicare Telehealth Services List because we do not

believe the service elements can be met in full using two-way audio-video telecommunications

technology.

(8) Radiation Treatment Management

We received requests to permanently add Radiation Treatment Management (CPT code

77427) to the Medicare Telehealth Services List. The code is currently on the Medicare

Telehealth List with provisional status. In the March 31, 2020 IFC (85 FR 9240), we originally

added CPT code 77427 on the Medicare Telehealth Services List for the duration of the PHE for

Covid-19. A requester stated that data collected during the PHE demonstrates that the telehealth

option is as safe as the in-person equivalent. We also received a request that we remove this code

from the Medicare Telehealth Services List, citing the importance of in-person physical

examination to ensure quality of care and stating that a telehealth modality presents patient safety

concerns such as those related to the ability of the practitioner to address side effects of radiation

therapy. Given the safety concerns raised by members of the practitioner community, we believe

this service may not be safely and effectively furnished, and therefore believe that such concerns

merit removing this item from the telehealth list We are therefore proposing to remove this code

from the Medicare Telehealth Services List, and we are soliciting comment on these quality of

care concerns.

(9) Home International Normalized Ratio (INR) Monitoring

We received a request to permanently add Home INR Monitoring (HCPCS code G0248)

to the Medicare Telehealth Services List. This service is not on the Medicare Telehealth Services

List, nor had it been previously added and removed. We are proposing to add HCPS code G0248

to the Medicare Telehealth Services List with provision status because our clinical analyses of

these services indicate that they can be furnished in full using two-way, audio and video

technology, and information provided by requesters indicates that there may be clinical benefit;

however, there is not yet sufficient evidence available to consider the services for permanent

status. This service as described by the HCPCS code describes face-to-face demonstration of use

and care of the INR monitor, obtaining at least one blood sample, provision of instructions for

reporting home INR test results, and documentation of patient’s ability to perform testing and

report results, and we believe each of these service elements the elements is capable of being

furnished using an interactive telecommunications system. Adding this service on a provisional

basis will allow additional time for the development of evidence of clinical benefit when this

service is furnished via telehealth for CMS to consider when evaluating this service for potential

permanent addition to the Medicare Telehealth Services List.

(10) Caregiver Training

We received a request to permanently add Caregiver Training services, as described by

HCPCS codes 97550 (Caregiver training in strategies and techniques to facilitate the patient’s

functional performance in the home or community (eg, activities of daily living [ADLs],

instrumental ADLs [iADLs], transfers, mobility, communication, swallowing, feeding, problem

solving, safety practices) (without the patient present), face to face; initial 30 minutes) and CPT

code 97551 (Caregiver training in strategies and techniques to facilitate the patient’s functional

performance in the home or community (eg, activities of daily living [ADLs], instrumental ADLs

[iADLs], transfers, mobility, communication, swallowing, feeding, problem solving, safety

practices) (without the patient present), face to face; each additional 15 minutes (List separately

in addition to code for primary service)) to the Medicare Telehealth Services List. These codes

do not currently appear on the Medicare Telehealth Services List nor had they previously been

added or removed. We are proposing to add these services to the Medicare Telehealth List with

provisional status for CY 2025, in addition to the other currently payable caregiver training

service codes (CPT codes 97550, 97551, 97552, 96202, 96203). These codes are new services

that were added to the PFS beginning in 2024. Given the limited utilization of those codes added

for 2024, there are not peer-reviewed studies supporting these codes’ ability to be furnished

remotely. Adding these services on a provisional basis will allow additional time for the

development of evidence of clinical benefit when these services are furnished via telehealth for

CMS to consider when evaluating these services for potential permanent addition to the

Medicare Telehealth Services List. Contingent upon finalizing the service code descriptions that

we propose in section II.E. of this proposed rule, we also propose that HCPCS code GCTD1-3

and GCTB1-2 be added to the Medicare Telehealth Services list for CY 2025 on a provisional

basis. We believe that these codes are similar to other services already available on the Medicare

Telehealth Services List, including education and training for patient self-management (CPT

codes 98960-98962), self-care/home management training (CPT codes 97535), and caregiver-

focused health risk assessment (CPT code 96161). Further, it appears that all elements of these

services may be furnished when using two-way interactive communications technology. Adding

these services on a provisional basis will allow additional time for the development of evidence

of clinical benefit when this service is furnished via telehealth for CMS to consider when

evaluating these services for potential permanent addition to the Medicare Telehealth Services

List.

c. Other Services Proposed for Addition to the Medicare Telehealth Services List

(1) Preexposure Prophylaxis (PrEP) of Human Immunodeficiency Virus (HIV)

As discussed in Section II.E. of this proposed rule, we are proposing national rates for

HCPCS codes G0011 (Individual counseling for pre-exposure prophylaxis (PrEP) by physician

or QHP to prevent human immunodeficiency virus (HIV), includes: HIV risk assessment (initial

or continued assessment of risk), HIV risk reduction and medication adherence, 15-30 minutes)

and G0013 (Individual counseling for pre-exposure prophylaxis (PrEP) by clinical staff to

prevent human immunodeficiency virus (HIV), includes: HIV risk assessment (initial or

continued assessment of risk), HIV risk reduction and medication adherence) pending the future

finalization of the NCD for Pre-Exposure Prophylaxis (PrEP) for Human Immunodeficiency

Virus (HIV) Infection. We believe these services are similar to services currently on the

Medicare Telehealth Services list, specifically HCPCS codes G0445 (High intensity behavioral

counseling to prevent sexually transmitted infection; face-to-face, individual, includes:

education, skills training and guidance on how to change sexual behavior; performed semi-

annually, 30 minutes) and CPT code 99211 (Office or other outpatient visit for the evaluation

and management of an established patient that may not require the presence of a physician or

other qualified health care professional) as these codes are the codes from which HCPCS codes

G0011 and G0013 were unbundled, respectively. As similarity to services currently on the

Medicare telehealth list is one of our criteria for permanent addition, we are proposing to add

HCPCS codes G0011 and G0013 to the Medicare Telehealth Services List with a permanent

status.

The services that we are proposing to add to the Medicare Telehealth Services List are

listed in Table 8.

TABLE 8: Services Proposed for Addition to the Medicare Telehealth Services List for CY

2025

Category

HCPCS

Long Description

Proposed Status

G0011

Individual counseling for pre-

exposure prophylaxis (PrEP) by

physician or QHP to prevent human

immunodeficiency virus (HIV),

includes: HIV risk assessment (initial

or continued assessment of risk), HIV

risk reduction and medication

adherence, 15-30 minutes

Permanent

PrEP for

HIV

G0013

Individual counseling for pre-

exposure prophylaxis (PrEP) by

clinical staff to prevent human

immunodeficiency virus (HIV),

includes: HIV risk assessment (initial

or continued assessment of risk), HIV

risk reduction and medication

adherence

Permanent

Home INR

Monitoring

G0248

Demonstration, prior to initiation of

home inr monitoring, for patient with

either mechanical heart valve(s),

chronic atrial fibrillation, or venous

thromboembolism who meets

medicare coverage criteria, under the

direction of a physician; includes:

face-to-face demonstration of use and

care of the inr monitor, obtaining at

least one blood sample, provision of

instructions for reporting home inr

test results, and documentation of

patient's ability to perform testing and

report results

Provisional

97550

Caregiver training in strategies and

techniques to facilitate the patient's

functional performance in the home

or community (eg, activities of daily

living [adls], instrumental adls [iadls],

transfers, mobility, communication,

swallowing, feeding, problem

solving, safety practices) (without the

patient present), face to face; initial

30 minutes

Provisional

97551

Caregiver training in strategies and

techniques to facilitate the patient's

functional performance in the home

or community (eg, activities of daily

living [adls], instrumental adls [iadls],

transfers, mobility, communication,

swallowing, feeding, problem

solving, safety practices) (without the

patient present), face to face; each

additional 15 minutes (list separately

in addition to code for primary

service)

Provisional

Caregiver

Training

97552

Group caregiver training in strategies

and techniques to facilitate the

patient's functional performance in

the home or community (eg, activities

of daily living [adls], instrumental

adls [iadls], transfers, mobility,

Provisional

Category

HCPCS

Long Description

Proposed Status

communication, swallowing, feeding,

problem solving, safety practices)

(without the patient present), face to

face with multiple sets of caregivers

Category

HCPCS

Long Description

Proposed Status

96202

Multiple-family group behavior

management/modification training for

parent(s)/guardian(s)/caregiver(s) of

patients with a mental or physical

health diagnosis, administered by

physician or other qualified health

care professional (without the patient

present), face-to-face with multiple

sets of

parent(s)/guardian(s)/caregiver(s);

initial 60 minutes

Provisional

96203

Multiple-family group behavior

management/modification training for

parent(s)/guardian(s)/caregiver(s) of

patients with a mental or physical

health diagnosis, administered by

physician or other qualified health

care professional (without the patient

present), face-to-face with multiple

sets of

parent(s)/guardian(s)/caregiver(s);

each additional 15 minutes (List

separately in addition to code for

primary service)

Provisional

GCTD1

Caregiver training in direct care

strategies and techniques to support

care for patients with an ongoing

condition or illness and to reduce

complications (without the patient

present), face-to-face; initial 30

minutes

Provisional

GCTD2

Caregiver training in direct care

strategies and techniques to support

care for patients with an ongoing

condition or illness and to reduce

complications (without the patient

present), face-to-face; each additional

15 minutes (List separately in

addition to code for primary service)

(Use GCTD2 in conjunction with

GCTD1)

Provisional

GCTD3

Group caregiver training in direct

care strategies and techniques to

support care for patients with an

ongoing condition or illness and to

reduce complications (without the

patient present), face-to-face with

multiple sets of caregivers

Provisional

GCTB1

Caregiver training in behavior

management/modification for

caregiver(s) of patients with a mental

or physical health diagnosis,

administered by physician or other

qualified health care professional

(without the patient present), face-to-

face; initial 30 minutes

Provisional

Category

HCPCS

Long Description

Proposed Status

GCTB2

Caregiver training in behavior

management/modification for

parent(s)/guardian(s)/caregiver(s) of

patients with a mental or physical

health diagnosis, administered by

physician or other qualified health

care professional (without the patient

present), face-to-face; each additional

15 minutes (List separately in

addition to code for primary service)

(Use GCTB2 in conjunction with

GCTB1)

Provisional

d. Frequency Limitations on Medicare Telehealth Subsequent Care Services in Inpatient and

Nursing Facility Settings, and Critical Care Consultations

When adding some services to the Medicare Telehealth Services List in the past, we have

included certain frequency restrictions on how often practitioners may furnish the service via

Medicare telehealth. These include a limitation of one subsequent hospital care service furnished

through telehealth every 3 days, added in the CY 2011 PFS final rule (75 FR 73317 through

73318), one subsequent nursing facility visit furnished through telehealth every 14 days, added

in the CY 2011 PFS final rule (75 FR73318), and one critical care consultation service furnished

through telehealth per day, added in the CY 2017 final rule (81 FR 80198). In establishing these

limits, we cited concerns regarding the potential acuity and complexity of these patients.

We temporarily removed these frequency restrictions during the PHE for COVID-19. In

the March 31, 2020 COVID-19 interim final rule with comment period (IFC) (85 FR 19241), we

stated that we did not believe the frequency limitations for certain subsequent inpatient visits,

subsequent NF visits, and critical care consultations furnished via Medicare telehealth were

appropriate or necessary for the duration of the PHE because this would have been a patient

population who would have otherwise not had access to clinically appropriate in-person

treatment. Although the frequency limitations resumed effect on May 12, 2023 (upon expiration

of the PHE), through enforcement discretion during the remainder of CY 2023 and notice-and-

comment rulemaking for CY 2024, Medicare telehealth frequency limitations have been

suspended for CY 2024 (88 FR 78876 through 78878) for the following codes relating to

Subsequent Inpatient Visits, Subsequent Nursing Facility Visits, and Critical Care Consultation

Services:

1. Subsequent Inpatient Visit CPT Codes:

● 99231 (Subsequent hospital inpatient or observation care, per day, for the evaluation

and management of a patient, which requires a medically appropriate history and/or

examination and straightforward or low level of medical decision making. when using total time

on the date of the encounter for code selection, 25 minutes must be met or exceeded.);

● 99232 (Subsequent hospital inpatient or observation care, per day, for the evaluation

and management of a patient, which requires a medically appropriate history and/or

examination and moderate level of medical decision making. when using total time on the date of

the encounter for code selection, 35 minutes must be met or exceeded.); and

● 99233 (Subsequent hospital inpatient or observation care, per day, for the evaluation

and management of a patient, which requires a medically appropriate history and/or

examination and high level of medical decision making. when using total time on the date of the

encounter for code selection, 50 minutes must be met or exceeded.)

2. Subsequent Nursing Facility Visit CPT Codes:

● 99307 (Subsequent nursing facility care, per day, for the evaluation and management

of a patient, which requires a medically appropriate history and/or examination and

straightforward medical decision making. when using total time on the date of the encounter for

code selection, 10 minutes must be met or exceeded.);

● 99308 (Subsequent nursing facility care, per day, for the evaluation and management

of a patient, which requires a medically appropriate history and/or examination and low level of

medical decision making. when using total time on the date of the encounter for code selection,

15 minutes must be met or exceeded.);

● 99309 (Subsequent nursing facility care, per day, for the evaluation and management

of a patient, which requires a medically appropriate history and/or examination and moderate

level of medical decision making. when using total time on the date of the encounter for code

selection, 30 minutes must be met or exceeded.); and

● 99310 (Subsequent nursing facility care, per day, for the evaluation and management

of a patient, which requires a medically appropriate history and/or examination and high level

of medical decision making. when using total time on the date of the encounter for code

selection, 45 minutes must be met or exceeded.)

3. Critical Care Consultation Services: HCPCS Codes

● G0508 (Telehealth consultation, critical care, initial, physicians typically spend 60

minutes communicating with the patient and providers via telehealth.); and

● G0509 (Telehealth consultation, critical care, subsequent, physicians typically spend

50 minutes communicating with the patient and providers via telehealth.)

We are proposing to remove the frequency limitations for these codes for CY 2025.

In the CY 2024 PFS final rule (88 FR 78877), we solicited comments from interested

parties on how practitioners have been ensuring that Medicare beneficiaries receive subsequent

inpatient and nursing facility visits, as well as critical care consultation services since the

expiration of the PHE. As discussed in that final rule, many commenters supported permanently

removing these frequency limitations, stating that they are arbitrary and re-imposing the

limitations would result in decreased access to care; that practitioners should be allowed to use

their clinical judgment to determine the type of visit, how many visits, and the type of treatment

that is the best fit for the patient so long as the standard of care is met; and that lifting these

limitations during the PHE has been instructive and demonstrates the value of continuing such

flexibilities. Many commenters urged us to permanently remove them. That said, some

commenters did not support removing these frequency limitations citing patient acuity and

safety, some commenters cited the importance of in-person care for patients in acute care

settings. Some commenters stated that telehealth patient assessments and evaluations are never

the same as in-person, hands on visits and should not be considered a viable replacement with no

limitations for in-person care. We are continuing to consider what changes we should be making

to how telehealth services are reimbursed under Medicare in light of the way practice patterns

may have changed following the PHE for COVID–19. Taking into account the information

received from commenters in the CY 2024 PFS final rule, we believe it is reasonable to continue

to pause certain pre-pandemic restrictions, such as the frequency limitations for the

abovementioned codes for CY 2025. Removing such restrictions for CY 2025 will allow us to

gather an additional year of data to determine how practice patterns are evolving and what

changes, if any, to frequency limitations should be made. We do not believe pausing such

frequency limitations for another year presents a level of safety risk requiring us to immediately

reinstate the limitations. Our analysis of claims data indicates that the volume of services that

would be affected by implementing these limitations is relatively low; in other words, these

services are not being furnished via telehealth with such frequency that frequency limits are

being met or exceeded very often or for many beneficiaries (claims data from 2020 - 2023

suggest that less than five percent received one or more of these services as a telehealth service).

Therefore, while claims data does not suggest that lifting these limitations during the PHE has

led to an increase in utilization, we continue to be interested in information from interested

parties on our concerns regarding the potential acuity and complexity of these patients and how

such acuity and complexity should complexity should influence our implementation of frequency

limitations.

e. Audio-Only Communication Technology to Meet the Definition of “Telecommunications

System”

Through our regulation at § 410.78(a)(3), we define “interactive telecommunications

system” as multimedia communications equipment that includes, at a minimum, audio and video

equipment permitting two-way, real-time interactive communication between the patient and

distant site physician or practitioner. Through emergency regulations and waiver authority under

section 1135(b)(8) of the Act, in response to the PHE for COVID–19, we allowed the use of

audio-only communications technology to furnish services described by the codes for audio-only

telephone evaluation and management services and behavioral health counseling and educational

services. Section 4113 of the CAA, 2023, extended the availability of telehealth services that can

be furnished using audio-only technology and provided for the extension of other PHE-related

flexibilities including removal of the geographic and location limitations under section 1834(m)

of the Act through December 31, 2024.

In the CY 2022 PFS final rule (86 FR 65060), in part to recognize the changes made by

section 123 of the CAA, 2021 that removed the geographic restrictions for Medicare telehealth

services for the diagnosis, evaluation, or treatment of a mental health disorder and the addition of

the patient’s home as a permissible originating site for these services, we revisited our regulatory

definition of ‘‘interactive telecommunications system’’ beyond the circumstances of the PHE.

Specifically, we finalized a policy to allow for audio-only services under certain circumstances

and revised the regulation at § 410.78(a)(3) to permit the use of audio-only equipment for

telehealth services furnished to established patients in their homes for purposes of diagnosis,

evaluation, or treatment of a mental health disorder (including substance use disorders) if the

distant site physician or practitioner is technically capable of using an interactive

telecommunications system as defined previously, but the patient is not capable of, or does not

consent to, the use of video technology. We also established this policy in part because mental

health services are different from most other services on the Medicare telehealth services list in

that many of the services primarily involve verbal conversation where visualization between the

patient and furnishing physician or practitioner may be less critical to the provision of the

service.

However, with the successive statutory extensions of the telehealth flexibilities

implemented in response to the PHE for COVID-19, most recently by the CAA, 2023, and our

adoption of other extensions where we have had authority to do so, we have come to believe that

it would be appropriate to allow interactive audio-only telecommunications technology when any

telehealth service is furnished to a beneficiary in their home (when the patient’s home is a

permissible originating site) and when the distant site physician or practitioner is technically

capable of using an interactive telecommunications system as defined previously, but the patient

is not capable of, or does not consent to, the use of video technology. While practitioners should

always use their clinical judgment as to whether the use of interactive audio-only technology is

sufficient to furnish a Medicare telehealth service, we recognize that there is variable broadband

access in patients’ homes, and that even when technologically feasible, patients simply may not

always wish to engage with their practitioner in their home using interactive audio and video.

Under current statute, with the expiration of the PHE-related telehealth flexibilities on December

31, 2024, the patient’s home is a permissible originating site only for services for the diagnosis,

evaluation, or treatment of a mental health or substance use disorder, and for the monthly ESRD-

related clinical assessments described in section 1881(b)(3)(B) of the Act.

We are proposing to revise the regulation at § 410.78(a)(3) to state that an interactive

telecommunications system may also include two-way, real-time audio-only communication

technology for any telehealth service furnished to a beneficiary in their home if the distant site

physician or practitioner is technically capable of using an interactive telecommunications

system as defined as multimedia communications equipment that includes, at a minimum, audio

and video equipment permitting two-way, real-time interactive communication, but the patient is

not capable of, or does not consent to, the use of video technology. Additionally, a modifier

designated by CMS must be appended to the claim for services described in this paragraph to

verify that these conditions have been met. These are CPT modifier “93” and, for RHCs and

FQHCs, Medicare modifier “FQ” (Medicare telehealth service was furnished using audio-only

communication technology). Practitioners have the option to use the “FQ” or the “93” modifiers

or both where appropriate and true, since they are identical in meaning.

f. Distant Site Requirements

In the CY 2024 PFS final rule (88 FR 78873 through 78874) we discussed that many

commenters expressed concerns regarding the expiring flexibility for telehealth practitioners to

bill from their currently enrolled location instead of their home address when providing

telehealth services from their home. CMS issued an FAQ, available at

https://www.cms.gov/files/document/physicians-and-other-clinicians-cms-flexibilities-fight-

covid-19.pdf, which extended the flexibility for telehealth practitioners to bill from their

currently enrolled location instead of their home address when providing telehealth services from

their home through December 31, 2023. Interested parties suggested that the expiration of this

flexibility poses a potential and imminent threat to the safety and privacy of health professionals

who work from home and furnish telehealth services. Commenters cited recent examples of

workplace violence in health care facilities, where direct harm to nurses and other medical staff

occurred. In addition to safety and privacy concerns, interested parties explained that a

significant number of practitioners would need to change their billing practices or add their home

address to the Medicare enrollment file, coordinating with the appropriate Medicare

Administrative Contractor in their jurisdiction, and this would present administrative burden. To

address these concerns, commenters requested that CMS take steps to protect telehealth

practitioners by adjusting enrollment requirements so that individual practitioners do not have to

list their home addresses on enrollment forms.

In response, CMS finalized, through CY 2024, that we would continue to permit a distant

site practitioner to use their currently enrolled practice location instead of their home address

when providing telehealth services from their home.

We have continued to hear from interested parties who have stressed the importance of

continuing this flexibility for the safety and privacy of health care professionals. Given the shift

in practice patterns toward models of care that include the practitioner’s home as the distant site,

we believe it would be appropriate to continue this flexibility as CMS considers various

proposals that may better protect the safety and privacy of practitioners. We are therefore

proposing that through CY 2025 we will continue to permit the distant site practitioner to use

their currently enrolled practice location instead of their home address when providing telehealth

services from their home.

2. Other Non-Face-to-Face Services Involving Communications Technology under the PFS

a. Direct Supervision via Use of Two-way Audio/Video Communications Technology

Under Medicare Part B, certain types of services, including diagnostic tests described

under § 410.32 and services incident to a physician’s (or other practitioner’s) professional

service described under § 410.26 (incident-to services), are required to be furnished under

specific minimum levels of supervision by a physician or other practitioner. We define three

levels of supervision in our regulation at § 410.32(b)(3): General Supervision, Direct

Supervision, and Personal Supervision. Notwithstanding the temporary measures implemented in

response to the PHE for COVID-19, direct supervision requires the physician (or other

supervising practitioner) to be present in the office suite and immediately available to furnish

assistance and direction throughout the performance of the service. It does not mean that the

physician (or other supervising practitioner) must be present in the room when the service is

performed. Again, notwithstanding the temporary measures implemented in response to the PHE

for COVID-19, we have established this “immediate availability” requirement to mean in-

person, physical, not virtual, availability (please see the April 6, 2020 IFC (85 FR 19245) and the

CY 2022 PFS final rule (86 FR 65062)).

Direct supervision is required for various types of services, including most incident-to

services under § 410.26, many diagnostic tests under § 410.32, pulmonary rehabilitation services

under § 410.47, cardiac rehabilitation and intensive cardiac rehabilitation services under §

410.49, and certain hospital outpatient services as provided under § 410.27(a)(1)(iv). In the

March 31, 2020 COVID-19 IFC, we amended the definition of “direct supervision” for the

duration of the PHE for COVID-19 (85 FR 19245 through 19246) at § 410.32(b)(3)(ii) to state

that the necessary presence of the physician (or other practitioner) for direct supervision includes

virtual presence through audio/video real-time communications technology. Instead of requiring

the supervising physician’s (or other practitioner’s) physical presence, the amendment permitted

a supervising physician (or other practitioner) to be considered “immediately available” through

virtual presence using two-way, real-time audio/visual technology for diagnostic tests, incident-

to services, pulmonary rehabilitation services, and cardiac and intensive cardiac rehabilitation

services. We made similar amendments at § 410.27(a)(1)(iv) to specify that direct supervision for

certain hospital outpatient services may include virtual presence through audio/video real-time

communications. The CY 2021 PFS final rule (85 FR 84538 through 84540) and the CY 2024

PFS final rule (88 FR 78878) subsequently extended these policies through December 31, 2024.

As stated in the CY 2024 PFS final rule, we extended this definition of direct supervision

through December 31, 2024, in order to align the timeframe of the policy with other PHE-related

telehealth policies that were extended most recently under the provisions of the CAA, 2023.

We note that in the CY 2021 PFS final rule (85 FR 84539) we clarified that, to the extent

our policy allows direct supervision through virtual presence using audio/video real-time

communications technology, the requirement could be met by the supervising physician (or other

practitioner) being immediately available to engage via audio/video technology (excluding

audio-only), and would not require real-time presence or observation of the service via

interactive audio and video technology throughout the performance of the service. We noted that

this was the case during the PHE and would continue to be the case following the PHE. While

flexibility to provide direct supervision through audio/video real-time communications

technology was adopted to be responsive to critical needs during the PHE for COVID–19 to

ensure beneficiary access to care, reduce exposure risk and to increase the capacity of

practitioners and physicians to respond to COVID–19, we expressed concern that direct

supervision through virtual presence may not be sufficient to support PFS payment on a

permanent basis, beyond the PHE for COVID–19, due to issues of patient safety. For instance, in

complex, high-risk, surgical, interventional, or endoscopic procedures, or anesthesia procedures,

a patient's clinical status can quickly change; in-person supervision would be necessary for such

services to allow for rapid on-site decision-making in the event of an adverse clinical situation.

In addition to soliciting comment in the CY 2021 PFS proposed rule on whether there should be

any additional ‘‘guardrails’’ or limitations to ensure patient safety/clinical appropriateness,

beyond typical clinical standards, as well as restrictions to prevent fraud or inappropriate use, we

solicited comment in the CY 2024 PFS proposed rule on whether we should consider extending

the definition of direct supervision to permit virtual presence beyond December 31, 2024.

Specifically, we stated that we were interested in input from interested parties on potential

patient safety or quality concerns when direct supervision occurs virtually; for instance, if direct

supervision of certain types of services with virtual presence of the supervising practitioner is

more or less likely to present patient safety concerns, or if this flexibility would be more

appropriate for certain types of services, or when certain types of auxiliary personnel are

performing the supervised service. We were also interested in potential program integrity

concerns that interested parties may have regarding this policy, such as overutilization or fraud

and abuse.

(1) Proposal to Extend Definition of “Direct Supervision” to Include Audio-Video

Communications Technology through 2025

As discussed in the CY 2024 PFS final rule (88 FR 78878), in the absence of evidence

that patient safety is compromised by virtual direct supervision, we are concerned about an

abrupt transition to our pre-PHE policy that defines direct supervision to require the physical

presence of the supervising practitioner. We noted that an immediate reversion to the pre-PHE

definition of direct supervision would prohibit virtual direct supervision, which may present a

barrier to access to many services, such as incident-to services, and that physicians and/or other

supervising practitioners, in certain instances, would need time to reorganize their practice

patterns established during the PHE to reimplement the pre-PHE approach to direct supervision

without the use of audio/video technology. We acknowledge the utilization of this flexibility and

recognize that many practitioners have stressed the importance of maintaining it, however we

seek additional information regarding potential patient safety and quality of care concerns. This

flexibility has been available and widely utilized since the beginning of the PHE, and we

recognize that may enhance patient access. However, given the importance of certain services

being furnished under direct supervision in ensuring quality of care and patient safety, and in

particular the ability of the supervising practitioner to intervene if complications arise, we

believe an incremental approach is warranted, particularly in instances where unexpected or

adverse events may arise for procedures which may be riskier or more intense. In light of these

potential safety and quality of care implications, and exercising an abundance of caution, we are

extending this flexibility for all services on a temporary basis only. We are therefore proposing

to continue to define direct supervision to permit the presence and “immediate availability” of

the supervising practitioner through real-time audio and visual interactive telecommunications

through December 31, 2025.

(2) Proposal to Permanently Define “Direct Supervision” to Include Audio-Video

Communications Technology for a Subset of Services

In the CY 2024 PFS proposed rule, we solicited comment on extending or permanently

establishing the virtual presence flexibility for certain services valued under the PFS given that

these services typically are performed in their entirety by auxiliary personnel as defined at §

410.26(a)(1). We stated such services would include incident-to services wholly furnished by

auxiliary personnel, Level I office or other outpatient E/M visits for established patients. We also

mentioned Level I Emergency Department (ED) visits in this list, but have since concluded that

ED services would not be wholly furnished by auxiliary personnel and, for that reason, have

excluded them from the discussion in this proposed rule. Based on our review, these specific

services present less of a patient safety concern than services for which there may be a need for

immediate intervention of the supervising practitioner; as noted in the CY 2024 PFS proposed

rule, allowing virtual presence for direct supervision of these services could balance patient

safety concerns with the interest of supporting access and preserving workforce capacity for

medical professionals while considering potential quality and program integrity concerns. After

reviewing the various comments in response to this solicitation, additional feedback provided by

interested parties, and conducting our own independent review, we believe these services are low

risk by their nature, do not often demand in-person supervision, are typically furnished entirely

by the supervised personnel, and allowing virtual presence for direct supervision of these

services would balance patient safety concerns with the interest of supporting access and

preserving workforce capacity.

We are proposing to adopt a definition of direct supervision that allows "immediate

availability” of the supervising practitioner using audio/video real-time communications

technology (excluding audio-only), but only for the following subset of incident-to services

described under § 410.26: (1) services furnished incident to a physician or other practitioner’s

service when provided by auxiliary personnel employed by the billing practitioner and working

under their direct supervision, and for which the underlying HCPCS code has been assigned a

PC/TC indicator of ‘5’;

and (2) services described by CPT code 99211 (Office or other

outpatient visit for the evaluation and management of an established patient that may not require

the presence of a physician or other qualified health care professional). As provided in the code

descriptor for CPT code 99211, an office or other outpatient visit for the evaluation and

management of an established patient may not require the presence of a physician or other

practitioner and may be furnished incident to a physicians’ service by a nonphysician employee

of the physician under direct supervision. The service described by CPT code 99211 and the

services that are identified with a PC/TC indicator of ‘5’ as listed in the PFS Relative Value Files

are services that are nearly always performed in entirety by auxiliary personnel. The vignette for

For a full list of all PFS payment status indicators and descriptions, see the Medicare Claims Processing Manual

(IOM Pub. 100–04, chapter 23, sections 30.2.2). For a full list of all PFS payment status indicators and descriptions,

see the Medicare Claims Processing Manual (IOM Pub. 100–04, chapter 23, sections 30.2.2 and 50.6). Specific

indicators by service are listed in the PFS Relative Value files at https://www.cms.gov/medicare/payment/fee-

schedules/physician/pfs-relative-value-files).

CPT code 99211 describes the provision of supervision and guidance to the clinical staff as

necessary. The code descriptor for this service specifies an E/M service that may not require the

presence of a physician or other professional; and the current valuation, which is relatively low

compared to other office and outpatient E/M services, suggests that this service would primarily

be provided by auxiliary personnel.

We are proposing an incremental approach whereby we will adopt without any time

limitation the definition of direct supervision permitting virtual presence for services that are

inherently lower risk: that is, services that do not ordinarily require the presence of the billing

practitioner, do not require direction by the supervising practitioner to the same degree as other

services furnished under direct supervision, and are not services typically performed directly by

the supervising practitioner.

For all other services required to be furnished under the direct supervision of the

supervising physician or other practitioner, we are proposing, as described above, to continue to

define "immediate availability” to include real-time audio and visual interactive

telecommunications technology only through December 31, 2025.

We are proposing to revise the regulations at § 410.32(b)(3)(ii) to state that through

December 31, 2025, the presence of the physician (or other practitioner) would include virtual

presence through audio/video real-time communications technology (excluding audio-only).

We are proposing to revise the regulation at § 410.26(a)(2) to state that for the following

services furnished after December 31, 2025, the presence of the physician (or other practitioner)

required for direct supervision shall continue to include virtual presence through audio/video

real-time communications technology (excluding audio-only): services furnished incident to a

physician’s service when they are provided by auxiliary personnel employed by the physician

and working under his or her direct supervision and for which the underlying HCPCS code has

been assigned a PC/TC indicator of ‘5’; and office and other outpatient visits for the evaluation

and management of an established patient that may not require the presence of a physician or

other qualified health care professional.

(3) Teaching Physician Billing for Services Involving Residents with Virtual Presence

In the CY 2021 PFS final rule (85 FR 84577 through 84584), we established a policy

that, after the end of the PHE for COVID-19, teaching physicians may meet the requirements to

be present for the key or critical portions of services when furnished involving residents through

audio/video real-time communications technology (virtual presence), but only for services

furnished in residency training sites located outside of an Office of Management and Budget

(OMB)-defined metropolitan statistical area (MSA). We made this location distinction consistent

with our longstanding interest in increasing beneficiary access to Medicare-covered services in

rural areas. We noted the ability to expand training opportunities for residents in rural settings.

For all other locations, we expressed concerns that continuing to permit teaching physicians to

bill for services furnished involving residents when they are virtually present, outside the

conditions of the PHE for COVID-19, may not allow the teaching physician to have personal

oversight and involvement over the management of the portion of the case for which the

payment is sought, under section 1842(b)(7)(A)(i)(I) of the Act. In addition, we stated concerns

about patient populations that may require a teaching physician’s experience and skill to

recognize specialized needs or testing and whether it is possible for the teaching physician to

meet these clinical needs while having a virtual presence for the key portion of the service. We

refer readers to the CY 2021 PFS final rule (85 FR 84577 through 84584) for a more detailed

description of our specific concerns. At the end of the PHE for COVID-19, and as finalized in

the CY 2021 PFS final rule, we intended for the teaching physician to have a physical presence

during the key portion of the service personally provided by residents in order to be paid for the

service under the PFS, in locations that were within a MSA. This policy applied to all services,

regardless of whether the patient was co-located with the resident or only present virtually (for

example, the service was furnished as a 3-way telehealth visit, with the teaching physician,

resident, and patient in different locations). However, interested parties expressed concerns

regarding the requirement that the teaching physician be physically present with the resident

when a service is furnished virtually (as a Medicare telehealth service) within an MSA. Some

interested parties stated that during the PHE for COVID-19, when residents provided telehealth

services, and the teaching physician was virtually present, the same safe and high-quality

oversight was provided as when the teaching physician and resident were physically co-located.

In addition, these interested parties stated that during telehealth visits, the teaching physician was

virtually present during the key and critical portions of the telehealth service, available

immediately in real-time, and had access to the electronic health record. After review of the

public comments, we finalized a policy that allowed the teaching physician to have a virtual

presence in all teaching settings, only in clinical instances when the service was furnished

virtually (for example, a 3-way telehealth visit, with all parties in separate locations). This

permitted teaching physicians to have a virtual presence during the key portion of the Medicare

telehealth service for which payment was sought, through audio/video real-time communications

technology, in all residency training locations through December 31, 2024.

As stated in the CY 2024 PFS final rule (88 FR 78880), we are concerned that an abrupt

transition to our pre-PHE policy may present a barrier to access to many services. We also

understand that teaching physicians have gained clinical experience providing services involving

residents with virtual presence during the PHE for COVID–19 and could help us to identify

circumstances where the teaching physician can routinely provide sufficient personal and

identifiable services to the patient through their virtual presence during the key portion of the

Medicare telehealth service. We sought comment and information to help us consider other

clinical treatment situations where it may be appropriate to continue to permit the virtual

presence of the teaching physician, while continuing to support patient safety, meeting the

clinical needs for all patients, and ensuring burden reduction without creating risks to patient

care or increasing opportunities for fraud. As summarized in the CY 2024 PFS final rule (88 FR

78881 through 78882), commenters encouraged us to establish this policy permanently and

include in-person services to promote access to care, stated that teaching physicians should be

allowed to determine when their virtual presence would be clinically appropriate, based on their

assessment of the patient’s needs and the competency level of the resident. While we continue to

consider clinical scenarios where it may be appropriate to permit the virtual presence of the

teaching physician, we are proposing to continue our current policy to allow teaching physicians

to have a virtual presence for purposes of billing for services furnished involving residents in all

teaching settings, but only when the service is furnished virtually (for example, a 3-way

telehealth visit, with the patient, resident, and teaching physician in separate locations). This

would permit teaching physicians to have a virtual presence during the key portion of the

Medicare telehealth service for which payment is sought in any residency training location

through December 31, 2025. The teaching physician’s virtual presence would continue to require

real-time observation (not mere availability) and excludes audio-only technology. The

documentation in the medical record must continue to demonstrate whether the teaching

physician was physically present or present through audio/video real-time communications

technology at the time of the Medicare telehealth service, which includes documenting the

specific portion of the service for which the teaching physician was present through audio/video

real-time communications technology.

(a) Request for Information for Teaching Physician Services Furnished under the Primary Care

Exception

The so-called primary care exception set forth at § 415.174 permits the teaching

physician to bill for certain lower and mid-level complexity physicians’ services furnished by

residents in certain types of residency training settings even when the teaching physician is not

present with the resident during the services as long as certain conditions are met, including that

the services are furnished by residents with more than 6 months of training in the approved

residency program; and that the teaching physician directs the care of no more than four

residents at a time, remains immediately available and has no other responsibilities while

directing the care, assumes management responsibility for beneficiaries seen by the residents,

ensures that the services furnished are appropriate, and reviews certain elements of the services

with each resident during or immediately after each visit. For a more detailed description of the

list of services currently allowed under the primary care exception policy, we refer readers to the

CY 2021 PFS final rule (85 FR 84585 through 84590).

We have received feedback from interested parties requesting that we permanently

expand the list of services that can be furnished under the primary care exception to include all

levels of E/M services and additional preventive services. These interested parties have stated

that the fact that high-value primary care and preventive services are not included in the scope of

the primary care exception discourages their integration in residency training in these primary

care settings, which has a negative impact on physician training, patient access, and longer-term

outcomes. Additionally, these interested parties have suggested that including all levels of E/M

services under the primary care exception could support primary care workforce development

and improve patient continuity of care without compromising patient safety; furthermore,

including additional preventive services within the primary care exception would increase the

utilization of high-value services.

We believe the primary care exception was intended to broaden opportunities for

teaching physicians to involve residents in furnishing services under circumstances that preserve

the direction of the care by the teaching physician and promote safe, high-quality patient care. As

such, we are requesting information to help us consider whether and how best to expand the

array of services included under the primary care exception in future rulemaking. We are

interested in hearing more about the types of services that could be allowed under the primary

care exception, specifically preventive services, and whether the currently required six months of

training in an approved program is sufficient for residents to furnish these types of services

without the presence of a teaching physician. We are seeking comment to help us consider

whether adding certain preventive services or higher level E/M services to the primary care

exception would hinder the teaching physician from maintaining sufficient personal involvement

in the care to warrant PFS payment for the services being furnished by up to four residents at any

given time. Similarly, we are requesting information on whether the inclusion in the primary care

exception of specific higher-level or preventive services would impede the teaching physician’s

ability to remain immediately available for up to four residents at any given time, while directing

and managing the care furnished by these residents.

3. Telehealth Originating Site Facility Fee Payment Amount Update

Section 1834(m)(2)(B) of the Act established the Medicare telehealth originating site

facility fee for telehealth services furnished from October 1, 2001, through December 31, 2002 at

$20.00, and specifies that, for telehealth services furnished on or after January 1 of each

subsequent calendar year, the telehealth originating site facility fee is increased by the percentage

increase in the Medicare Economic Index (MEI) as defined in section 1842(i)(3) of the Act. The

proposed MEI increase for CY 2025 is 3.6 percent and is based on the expected historical

percentage increase of the 2017-based MEI. For the final rule, we propose to update the MEI

increase for CY 2025 based on historical data through the second quarter of 2024. Therefore, for

CY 2025, the proposed payment amount for HCPCS code Q3014 (Telehealth originating site

facility fee) is $31.04. Table 9 shows the Medicare telehealth originating site facility fee and the

corresponding MEI percentage increase for each applicable time period.

TABLE 9: The Medicare Telehealth Originating Site Facility Fee

Time Period

MEI (%)

Facility Fee for Q3014

Oct. 1, 2001 to Dec. 31, 2002

$ 20.00

2003

3.0

$ 20.60

2004

2.9

$ 21.20

2005

3.1

$ 21.86

2006

2.8

$ 22.47

2007

2.1

$ 22.94

2008

1.8

$ 23.35

2009

1.6

$ 23.72

2010

1.2

$ 24.00

2011

0.4

$ 24.10

2012

0.6

$ 24.24

2013

0.8

$ 24.43

2014

0.8

$ 24.63

2015

0.8

$ 24.83

2016

1.1

$ 25.10

2017

1.2

$ 25.40

2018

1.4

$ 25.76

2019

1.5

$ 26.15

2020

1.9

$ 26.65

2021

1.4

$ 27.02

2022

2.1

$ 27.59

2023

3.8

$ 28.64

2024

4.6

$ 29.96

2025*

3.6

$ 31.04

*Reflects the most recent estimate of the CY 2025 MEI percentage increase and will be updated in the final rule

based on historical data through the second quarter of 2024.

4. Payment for Outpatient Therapy Services, Diabetes Self-Management Training, and Medical

Nutrition Therapy when Furnished by Institutional Staff to Beneficiaries in Their Homes

Through Communication Technology

For information related to outpatient physical therapy, occupational therapy, speech-

language pathology, diabetes self-management training (DSMT) and medical nutritional therapy

(MNT) services furnished by institutional staff in hospitals and other institutional settings to

beneficiaries in their homes through communication technology, please refer to section X.A. in

the CY 2025 Hospital Outpatient Prospective Payment System (OPPS) proposed rule (FR Doc.

2024-15087), on public inspection July 10, 2024, and publishing in the Federal Register of July

22, 2024.

E. Valuation of Specific Codes

1. Background: Process for Valuing New, Revised, and Potentially Misvalued Codes

Establishing valuations for newly created and revised CPT codes is a routine part of

maintaining the PFS. Since the inception of the PFS, it has also been a priority to revalue

services regularly to make sure that the payment rates reflect the changing trends in the practice

of medicine and current prices for inputs used in the PE calculations. Initially, this was

accomplished primarily through the 5-year review process, which resulted in revised work RVUs

for CY 1997, CY 2002, CY 2007, and CY 2012, and revised PE RVUs in CY 2001, CY 2006,

and CY 2011, and revised MP RVUs in CY 2010, CY 2015, and CY 2020. Under the 5-year

review process, revisions in RVUs were proposed and finalized via rulemaking. In addition to

the 5-year reviews, beginning with CY 2009, CMS and the RUC identified a number of

potentially misvalued codes each year using various identification screens, as outlined in section

II.C. of this proposed rule, Potentially Misvalued Services under the PFS. Historically, when we

received RUC recommendations, our process had been to establish interim final RVUs for the

potentially misvalued codes, new codes, and any other codes for which there were coding

changes in the final rule with comment period for a year. Then, during the 60-day period

following the publication of the final rule with comment period, we accepted public comment

about those valuations. For services furnished during the calendar year following the publication

of interim final rates, we paid for services based upon the interim final values established in the

final rule. In the final rule with comment period for the subsequent year, we considered and

responded to public comments received on the interim final values, and typically made any

appropriate adjustments and finalized those values.

In the CY 2015 PFS final rule with comment period (79 FR 67547), we finalized a new

process for establishing values for new, revised and potentially misvalued codes. Under the new

process, we include proposed values for these services in the proposed rule, rather than

establishing them as interim final in the final rule with comment period. Beginning with the CY

2017 PFS proposed rule (81 FR 46162), the new process was applicable to all codes, except for

new codes that describe truly new services. For CY 2017, we proposed new values in the CY

2017 PFS proposed rule for the vast majority of new, revised, and potentially misvalued codes

for which we received complete RUC recommendations by February 10, 2016. To complete the

transition to this new process, for codes for which we established interim final values in the CY

2016 PFS final rule with comment period (81 FR 80170), we reviewed the comments received

during the 60-day public comment period following release of the CY 2016 PFS final rule with

comment period (80 FR 70886), and re-proposed values for those codes in the CY 2017 PFS

proposed rule. We considered public comments received during the 60-day public comment

period for the proposed rule before establishing final values in the CY 2017 PFS final rule. As

part of our established process, we will adopt interim final values only in the case of wholly new

services for which there are no predecessor codes or values and for which we do not receive

recommendations in time to propose values.

As part of our obligation to establish RVUs for the PFS, we thoroughly review and

consider available information including recommendations and supporting information from the

RUC, the Health Care Professionals Advisory Committee (HCPAC), public commenters,

medical literature, Medicare claims data, comparative databases, comparison with other codes

within the PFS, as well as consultation with other physicians and healthcare professionals within

CMS and the Federal Government as part of our process for establishing valuations. Where we

concur that the RUC’s recommendations, or recommendations from other commenters, are

reasonable and appropriate and are consistent with the time and intensity paradigm of physician

work, we proposed those values as recommended. Additionally, we continually engage with

interested parties, including the RUC, with regard to our approach for accurately valuing codes,

and as we prioritize our obligation to value new, revised, and potentially misvalued codes. We

continue to welcome feedback from all interested parties regarding valuation of services for

consideration through our rulemaking process.

2. Methodology for Establishing Work RVUs

For each code identified in this section, we conduct a review that includes the current

work RVU (if any), RUC-recommended work RVU, intensity, time to furnish the preservice,

intraservice, and postservice activities, as well as other components of the service that contribute

to the value. Our reviews of recommended work RVUs and time inputs generally include, but

have not been limited to, a review of information provided by the RUC, the HCPAC, and other

public commenters, medical literature, and comparative databases, as well as a comparison with

other codes within the PFS, consultation with other physicians and health care professionals

within CMS and the Federal Government, as well as Medicare claims data. We also assess the

methodology and data used to develop the recommendations submitted to us by the RUC and

other public commenters and the rationale for the recommendations. In the CY 2011 PFS final

rule with comment period (75 FR 73328 through 73329), we discussed a variety of

methodologies and approaches used to develop work RVUs, including survey data, building

blocks, crosswalks to key reference or similar codes, and magnitude estimation (see the CY 2011

PFS final rule with comment period (75 FR 73328 through 73329) for more information). When

referring to a survey, unless otherwise noted, we mean the surveys conducted by specialty

societies as part of the formal RUC process.

Components that we use in the building block approach may include preservice,

intraservice, or postservice time and post-procedure visits. When referring to a bundled CPT

code, the building block components could include the CPT codes that make up the bundled code

and the inputs associated with those codes. We use the building block methodology to construct,

or deconstruct, the work RVU for a CPT code based on component pieces of the code.

Magnitude estimation refers to a methodology for valuing work that determines the appropriate

work RVU for a service by gauging the total amount of work for that service relative to the work

for a similar service across the PFS without explicitly valuing the components of that work. In

addition to these methodologies, we frequently utilize an incremental methodology in which we

value a code based upon its incremental difference between another code and another family of

codes. Section 1848(c)(1)(A) of the Act specifically defines the work component as the

resources that reflect time and intensity in furnishing the service. Also, the published literature

on valuing work has recognized the key role of time in overall work. For particular codes, we

refine the work RVUs in direct proportion to the changes in the best information regarding the

time resources involved in furnishing particular services, either considering the total time or the

intraservice time.

Several years ago, to aid in the development of preservice time recommendations for new

and revised CPT codes, the RUC created standardized preservice time packages. The packages

include preservice evaluation time, preservice positioning time, and preservice scrub, dress and

wait time. Currently, there are preservice time packages for services typically furnished in the

facility setting (for example, preservice time packages reflecting the different combinations of

straightforward or difficult procedure, and straightforward or difficult patient). Currently, there

are three preservice time packages for services typically furnished in the nonfacility setting.

We developed several standard building block methodologies to value services

appropriately when they have common billing patterns. In cases where a service is typically

furnished to a beneficiary on the same day as an E/M service, we believe that there is overlap

between the two services in some of the activities furnished during the preservice evaluation and

postservice time. Our longstanding adjustments have reflected a broad assumption that at least

one-third of the work time in both the preservice evaluation and postservice period is duplicative

of work furnished during the E/M visit.

Accordingly, in cases where we believe that the RUC has not adequately accounted for

the overlapping activities in the recommended work RVU and/or times, we adjust the work RVU

and/or times to account for the overlap. The work RVU for a service is the product of the time

involved in furnishing the service multiplied by the intensity of the work. Preservice evaluation

time and postservice time both have a long-established intensity of work per unit of time

(IWPUT) of 0.0224, which means that 1 minute of preservice evaluation or postservice time

equates to 0.0224 of a work RVU.

Therefore, in many cases when we remove 2 minutes of preservice time and 2 minutes of

postservice time from a procedure to account for the overlap with the same day E/M service, we

also remove a work RVU of 0.09 (4 minutes × 0.0224 IWPUT) if we do not believe the overlap

in time had already been accounted for in the work RVU. The RUC has recognized this

valuation policy and, in many cases, now addresses the overlap in time and work when a service

is typically furnished on the same day as an E/M service.

The following paragraphs discuss our approach to reviewing RUC recommendations and

developing proposed values for specific codes. When they exist, we also include a summary of

interested party reactions to our approach. We noted that many commenters and interested

parties have expressed concerns over the years with our ongoing adjustment of work RVUs

based on changes in the best information we had regarding the time resources involved in

furnishing individual services. We have been particularly concerned with the RUC’s and various

specialty societies’ objections to our approach given the significance of their recommendations

to our process for valuing services and since much of the information we used to make the

adjustments is derived from their survey process. We note that we are obligated under the statute

to consider both time and intensity in establishing work RVUs for PFS services. As explained in

the CY 2016 PFS final rule with comment period (80 FR 70933), we recognize that adjusting

work RVUs for changes in time is not always a straightforward process, so we have applied

various methodologies to identify several potential work values for individual codes.

We have observed that for many codes reviewed by the RUC, recommended work RVUs

have appeared to be incongruous with recommended assumptions regarding the resource costs in

time. This has been the case for a significant portion of codes for which we recently established

or proposed work RVUs that are based on refinements to the RUC-recommended values. When

we have adjusted work RVUs to account for significant changes in time, we have started by

looking at the change in the time in the context of the RUC-recommended work RVU. When the

recommended work RVUs do not appear to account for significant changes in time, we have

employed the different approaches to identify potential values that reconcile the recommended

work RVUs with the recommended time values. Many of these methodologies, such as survey

data, building block, crosswalks to key reference or similar codes, and magnitude estimation

have long been used in developing work RVUs under the PFS. In addition to these, we

sometimes use the relationship between the old time values and the new time values for

particular services to identify alternative work RVUs based on changes in time components.

In so doing, rather than ignoring the RUC-recommended value, we have used the

recommended values as a starting reference and then applied one of these several methodologies

to account for the reductions in time that we believe were not otherwise reflected in the RUC-

recommended value. If we believe that such changes in time are already accounted for in the

RUC’s recommendation, then we do not make such adjustments. Likewise, we do not arbitrarily

apply time ratios to current work RVUs to calculate proposed work RVUs. We use the ratios to

identify potential work RVUs and consider these work RVUs as potential options relative to the

values developed through other options.

We do not imply that the decrease in time as reflected in survey values should always

equate to a one-to-one or linear decrease in newly valued work RVUs. Instead, we believe that,

since the two components of work are time and intensity, absent an obvious or explicitly stated

rationale for why the relative intensity of a given procedure has increased, significant decreases

in time should be reflected in decreases to work RVUs. If the RUC’s recommendation has

appeared to disregard or dismiss the changes in time, without a persuasive explanation of why

such a change should not be accounted for in the overall work of the service, then we have

generally used one of the aforementioned methodologies to identify potential work RVUs,

including the methodologies intended to account for the changes in the resources involved in

furnishing the procedure.

Several interested parties, including the RUC, have expressed general objections to our

use of these methodologies and suggested that our actions in adjusting the recommended work

RVUs are inappropriate; other interested parties have also expressed general concerns with CMS

refinements to RUC-recommended values in general. In the CY 2017 PFS final rule (81 FR

80272 through 80277), we responded in detail to several comments that we received regarding

this issue. In the CY 2017 PFS proposed rule (81 FR 46162), we requested comments regarding

potential alternatives to making adjustments that would recognize overall estimates of work in

the context of changes in the resource of time for particular services; however, we did not

receive any specific potential alternatives. As described earlier in this section, crosswalks to key

reference or similar codes are one of the many methodological approaches we have employed to

identify potential values that reconcile the RUC-recommend work RVUs with the recommended

time values when the RUC-recommended work RVUs did not appear to account for significant

changes in time.

In response to comments, in the CY 2019 PFS final rule (83 FR 59515), we clarified that

terms “reference services”, “key reference services”, and “crosswalks” as described by the

commenters are part of the RUC’s process for code valuation. These are not terms that we

created, and we do not agree that we necessarily must employ them in the identical fashion for

the purposes of discussing our valuation of individual services that come up for review.

However, in the interest of minimizing confusion and providing clear language to facilitate

feedback from interested parties, we stated that we would seek to limit the use of the term,

“crosswalk,” to those cases where we are making a comparison to a CPT code with the identical

work RVU. (83 FR 59515) We note that we also occasionally make use of a “bracket” for code

valuation. A “bracket” refers to when a work RVU falls between the values of two CPT codes,

one at a higher work RVU and one at a lower work RVU.

We look forward to continuing to engage with interested parties and commenters,

including the RUC, as we prioritize our obligation to value new, revised, and potentially

misvalued codes; and we will continue to welcome feedback from all interested parties regarding

valuation of services for consideration through our rulemaking process. We refer readers to the

detailed discussion in this section of the valuation considered for specific codes. Table 13

contains a list of codes and descriptors for which we are proposing work RVUs for CY 2025;

this includes all codes for which we received RUC recommendations by February 10, 2024. The

proposed work RVUs, work time and other payment information for all CY 2025 payable codes

are available on the CMS website under downloads for the CY 2025 PFS proposed rule at

https://www.cms.gov/Medicare/Medicare-Fee-for-Service-

Payment/PhysicianFeeSched/index.html).

3. Methodology for the Direct PE Inputs to Develop PE RVUs

a. Background

On an annual basis, the RUC provides us with recommendations regarding PE inputs for

new, revised, and potentially misvalued codes. We review the RUC-recommended direct PE

inputs on a code-by-code basis. Like our review of recommended work RVUs, our review of

recommended direct PE inputs generally includes, but is not limited to, a review of information

provided by the RUC, HCPAC, and other public commenters, medical literature, and

comparative databases, as well as a comparison with other codes within the PFS, and

consultation with physicians and health care professionals within CMS and the Federal

Government, as well as Medicare claims data. We also assess the methodology and data used to

develop the recommendations submitted to us by the RUC and other public commenters and the

rationale for the recommendations. When we determine that the RUC’s recommendations

appropriately estimate the direct PE inputs (clinical labor, disposable supplies, and medical

equipment) required for the typical service, are consistent with the principles of relativity, and

reflect our payment policies, we use those direct PE inputs to value a service. If not, we refine

the recommended PE inputs to better reflect our estimate of the PE resources required for the

service. We also confirm whether CPT codes should have facility and/or nonfacility direct PE

inputs and refine the inputs accordingly.

Our review and refinement of the RUC-recommended direct PE inputs includes many

refinements that are common across codes, as well as refinements that are specific to particular

services. Table 14 details our refinements of the RUC’s direct PE recommendations at the code-

specific level. In section II.B. of this proposed rule, Determination of Practice Expense Relative

Value Units (PE RVUs), we address certain refinements that will be common across codes.

Refinements to particular codes are addressed in the portions of that section that are dedicated to

particular codes. We note that for each refinement, we indicate the impact on direct costs for

that service. We note that, on average, in any case where the impact on the direct cost for a

particular refinement is $0.35 or less, the refinement has no impact on the PE RVUs. This

calculation considers both the impact on the direct portion of the PE RVU, as well as the impact

on the indirect allocator for the average service. In this proposed rule, we also note that many of

the refinements listed in Table 14 result in changes under the $0.35 threshold and would be

unlikely to result in a change to the RVUs.

We note that the direct PE inputs for CY 2025 are displayed in the CY 2025 direct PE

input files, available on the CMS website under the downloads for the CY 2025 PFS proposed

rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-

Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. The inputs displayed there

have been used in developing the CY 2025 PE RVUs as displayed in Addendum B (see

https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-

outpatient/addendum-a-b-updates).

b. Common Refinements

(1) Changes in Work Time

Some direct PE inputs are directly affected by revisions in work time. Specifically,

changes in the intraservice portions of the work time and changes in the number or level of

postoperative visits associated with the global periods result in corresponding changes to direct

PE inputs. The direct PE input recommendations generally correspond to the work time values

associated with services. We believe that inadvertent discrepancies between work time values

and direct PE inputs should be refined or adjusted in the establishment of proposed direct PE

inputs to resolve the discrepancies.

(2) Equipment Time

Prior to CY 2010, the RUC did not generally provide CMS with recommendations

regarding equipment time inputs. In CY 2010, in the interest of ensuring the greatest possible

degree of accuracy in allocating equipment minutes, we requested that the RUC provide

equipment times along with the other direct PE recommendations, and we provided the RUC

with general guidelines regarding appropriate equipment time inputs. We appreciate the RUC’s

willingness to provide us with these additional inputs as part of its PE recommendations.

In general, the equipment time inputs correspond to the service period portion of the

clinical labor times. We clarified this principle over several years of rulemaking, indicating that

we consider equipment time as the time within the intraservice period when a clinician is using

the piece of equipment plus any additional time that the piece of equipment is not available for

use for another patient due to its use during the designated procedure. For those services for

which we allocate cleaning time to portable equipment items, because the portable equipment

does not need to be cleaned in the room where the service is furnished, we do not include that

cleaning time for the remaining equipment items, as those items and the room are both available

for use for other patients during that time. In addition, when a piece of equipment is typically

used during follow-up postoperative visits included in the global period for a service, the

equipment time will also reflect that use.

We believe that certain highly technical pieces of equipment and equipment rooms are

less likely to be used during all of the preservice or postservice tasks performed by clinical labor

staff on the day of the procedure (the clinical labor service period) and are typically available for

other patients even when one member of the clinical staff may be occupied with a preservice or

postservice task related to the procedure. We also noted that we believe these same assumptions

will apply to inexpensive equipment items that are used in conjunction with and located in a

room with non-portable highly technical equipment items since any items in the room in question

will be available if the room is not being occupied by a particular patient. For additional

information, we referred readers to our discussion of these issues in the CY 2012 PFS final rule

with comment period (76 FR 73182) and the CY 2015 PFS final rule with comment period

(79 FR 67639).

(3) Standard Tasks and Minutes for Clinical Labor Tasks

In general, the preservice, intraservice, and postservice clinical labor minutes associated

with clinical labor inputs in the direct PE input database reflect the sum of particular tasks

described in the information that accompanies the RUC-recommended direct PE inputs,

commonly called the “PE worksheets.” For most of these described tasks, there is a standardized

number of minutes, depending on the type of procedure, its typical setting, its global period, and

the other procedures with which it is typically reported. The RUC sometimes recommends a

number of minutes either greater than or less than the time typically allotted for certain tasks. In

those cases, we review the deviations from the standards and any rationale provided for the

deviations. When we do not accept the RUC-recommended exceptions, we refine the proposed

direct PE inputs to conform to the standard times for those tasks. In addition, in cases when a

service is typically billed with an E/M service, we remove the preservice clinical labor tasks to

avoid duplicative inputs and to reflect the resource costs of furnishing the typical service.

We refer readers to section II.B. of this proposed rule, Determination of Practice Expense

Relative Value Units (PE RVUs), for more information regarding the collaborative work of CMS

and the RUC in improvements in standardizing clinical labor tasks.

(4) Recommended Items that are not Direct PE Inputs

In some cases, the PE worksheets included with the RUC’s recommendations include

items that are not clinical labor, disposable supplies, or medical equipment or that cannot be

allocated to individual services or patients. We addressed these kinds of recommendations in

previous rulemaking (78 FR 74242), and we do not use items included in these recommendations

as direct PE inputs in the calculation of PE RVUs.

(5) New Supply and Equipment Items

The RUC generally recommends the use of supply and equipment items that already exist

in the direct PE input database for new, revised, and potentially misvalued codes. However,

some recommendations include supply or equipment items that are not currently in the direct PE

input database. In these cases, the RUC has historically recommended that a new item be created

and has facilitated our pricing of that item by working with the specialty societies to provide us

copies of sales invoices. For CY 2025 we received invoices for several new supply and

equipment items. Tables 17 and 18 detail the invoices received for new and existing items in the

direct PE database. As discussed in section II.B. of this proposed rule, Determination of Practice

Expense Relative Value Units, we encourage interested parties to review the prices associated

with these new and existing items to determine whether these prices appear to be accurate.

Where prices appear inaccurate, we encourage interested parties to submit invoices or other

information to improve the accuracy of pricing for these items in the direct PE database by

February 10th of the following year for consideration in future rulemaking, similar to our process

for consideration of RUC recommendations.

We remind interested parties that due to the relativity inherent in the development of

RVUs, reductions in existing prices for any items in the direct PE database increase the pool of

direct PE RVUs available to all other PFS services. Tables 17 and 18 also include the number of

invoices received and the number of nonfacility allowed services for procedures that use these

equipment items. We provide the nonfacility allowed services so that interested parties will note

the impact the particular price might have on PE relativity, as well as to identify items that are

used frequently, since we believe that interested parties are more likely to have better pricing

information for items used more frequently. A single invoice may not be reflective of typical

costs, and we encourage interested parties to provide additional invoices so that we might

identify and use accurate prices in the development of PE RVUs.

In some cases, we do not use the price listed on the invoice that accompanies the

recommendation because we identify publicly available alternative prices or information that

suggests a different price is more accurate. In these cases, we include this in the discussion of

these codes. In other cases, we cannot adequately price a newly recommended item due to

inadequate information. Sometimes, no supporting information regarding the price of the item

has been included in the recommendation. In other cases, the supporting information does not

demonstrate that the item has been purchased at the listed price (for example, vendor price

quotes instead of paid invoices). In cases where the information provided on the item allows us

to identify clinically appropriate proxy items, we might use existing items as proxies for the

newly recommended items. In other cases, we include the item in the direct PE input database

without any associated price. Although including the item without an associated price means

that the item does not contribute to the calculation of the final PE RVU for particular services, it

facilitates our ability to incorporate a price once we obtain information and are able to do so.

(6) Service Period Clinical Labor Time in the Facility Setting

Generally speaking, our direct PE inputs do not include clinical labor minutes assigned to

the service period because the cost of clinical labor during the service period for a procedure in

the facility setting is not considered a resource cost to the practitioner since Medicare makes

separate payment to the facility for these costs. We address code-specific refinements to clinical

labor in the individual code sections.

(7) Procedures Subject to the Multiple Procedure Payment Reduction (MPPR) and the OPPS

Cap

We note that the list of services for the upcoming calendar year that are subject to the

MPPR on diagnostic cardiovascular services, diagnostic imaging services, diagnostic

ophthalmology services, and therapy services; and the list of procedures that meet the definition

of imaging under section 1848(b)(4)(B) of the Act, and therefore, are subject to the OPPS cap;

are displayed in the public use files for the PFS proposed and final rules for each year. The

public use files for CY 2025 are available on the CMS website under downloads for the CY 2025

PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-

Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. For more information

regarding the history of the MPPR policy, we refer readers to the CY 2014 PFS final rule with

comment period (78 FR 74261 through 74263).

Effective January 1, 2007, section 5102(b)(1) of the Deficit Reduction Act of 2005 (Pub.

L. 109–171) (DRA) amended section 1848(b)(4) of the Act to require that, for imaging services,

if— (i) The TC (including the TC portion of a global fee) of the service established for a year

under the fee schedule without application of the geographic adjustment factor, exceeds (ii) The

Medicare OPD fee schedule amount established under the prospective payment system (PPS) for

HOPD services under section 1833(t)(3)(D) of the Act for such service for such year, determined

without regard to geographic adjustment under section 1833(t)(2)(D), the Secretary shall

substitute the amount described in clause (ii), adjusted by the geographic adjustment factor under

the PFS, for the fee schedule amount for such TC for such year. As required by section

1848(b)(4)(A) of the Act, for imaging services furnished on or after January 1, 2007, we cap the

TC of the PFS payment amount for the year (prior to geographic adjustment) by the Outpatient

Prospective Payment System (OPPS) payment amount for the service (prior to geographic

adjustment). We then apply the PFS geographic adjustment to the capped payment amount.

Section 1848(b)(4)(B) of the Act defines imaging services as “imaging and computer-assisted

imaging services, including X-ray, ultrasound (including echocardiography), nuclear medicine

(including PET), magnetic resonance imaging (MRI), computed tomography (CT), and

fluoroscopy, but excluding diagnostic and screening mammography.” For more information

regarding the history of the cap on the TC of the PFS payment amount under the DRA (the

“OPPS cap”), we refer readers to the CY 2007 PFS final rule with comment period (71 FR 69659

through 69662).

For CY 2025, we identified new and revised codes to determine which services meet the

definition of “imaging services” as defined at section 1848(b)(4)(B) of the Act for purposes of

this cap. Beginning for CY 2025, we are proposing to include the following services on the list

of codes to which the OPPS cap applies: CPT codes 0868T (High-resolution gastric

electrophysiology mapping with simultaneous patient-symptom profiling, with interpretation and

report), 0876T (Duplex scan of hemodialysis fistula, computer-aided, limited (volume flow,

diameter, and depth, including only body of fistula)), 74263 (Computed tomographic (ct)

colonography, screening, including image postprocessing), 9X059 (Computerized ophthalmic

diagnostic imaging (eg, optical coherence tomography [OCT]), posterior segment, with

interpretation and report, unilateral or bilateral; retina including OCT angiography), 93X94

(Vasoreactivity study performed with transcranial Doppler study of intracranial arteries,

complete (List separately in addition to code for primary procedure)), 93X95 (Emboli detection

without intravenous microbubble injection performed with transcranial Doppler study of

intracranial arteries, complete (List separately in addition to code for primary procedure)), and

93X96 (Venous-arterial shunt detection with intravenous microbubble injection performed with

transcranial Doppler study of intracranial arteries, complete (List separately in addition to code

for primary procedure)). We believe that these codes meet the definition of imaging services

under section 1848(b)(4)(B) of the Act, and thus, should be subject to the OPPS cap.

In the CY 2024 PFS final rule (88 FR 78894), we noted that in response to the CY 2024

PFS proposed rule, commenters requested that CMS remove CPT code 92229 (Imaging of retina

for detection or monitoring of disease; point-of-care autonomous analysis and report, unilateral

or bilateral) from the OPPS cap list because it does not include an associated PC or physician

interpretation and it is primarily utilized in the physician office setting. We are soliciting

comment on the appropriateness of applying the OPPS cap to services such as this for which the

interpretation component is not captured by work RVUs, and the service is not split into

technical and professional components. We are more broadly evaluating how services involving

assistive technologies are most accurately valued. We note that the OPPS rate for this service is

currently higher than what would be paid in a physician office setting, and therefore the OPPS

cap does not currently apply to CPT code 92229 as of 2024.

4. Valuation of Specific Codes for CY 2025

(1) Skin Cell Suspension Autograft (CPT codes 15XX1, 15XX2, 15XX3, 15XX4, 15XX5,

15XX6, 15XX7, and 15XX8)

In September 2023, the CPT Editorial Panel approved the creation of eight new CPT

codes to describe skin cell suspension autograft (SCSA) procedures. The code set includes a 000-

day global base code (CPT code 15XX1 (Harvest of skin for skin cell suspension autograft; first

25 sq cm or less)) and an add-on code (CPT code 15XX2 (Harvest of skin for skin cell

suspension autograft; each additional 25 sq cm or part thereof (List separately in addition to

code for primary procedure))) describing the harvesting component of the procedure, an XXX

global base code (CPT code 15XX3 (Preparation of skin cell suspension autograft, requiring

enzymatic processing, manual mechanical disaggregation of skin cells, and filtration; first 25 sq

cm or less of harvested skin) and an add-on code (CPT code 15XX4 (Preparation of skin cell

suspension autograft, requiring enzymatic processing, manual mechanical disaggregation of

skin cells, and filtration; each additional 25 sq cm of harvested skin or part thereof (List

separately in addition to code for primary procedure))) describing the preparation component of

the procedure, and two 090-day global base codes and two add-on codes for the application

component to distinguish between body areas: trunk, arms, and legs with CPT codes 15XX5

(Application of skin cell suspension autograft to wound and donor sites, including application of

primary dressing, trunk, arms, legs; first 480 sq cm or less) and 15XX6 (Application of skin cell

suspension autograft to wound and donor sites, including application of primary dressing, trunk,

arms, legs; each additional 480 sq cm or part thereof (List separately in addition to code for

primary procedure)); and face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, or

multiple digits with CPT codes 15XX7 (Application of skin cell suspension autograft to wound

and donor sites, including application of primary dressing, face, scalp, eyelids, mouth, neck,

ears, orbits, genitalia, hands, feet, and/or multiple digits; first 480 sq cm or less) and 15XX8

(Application of skin cell suspension autograft to wound and donor sites, including application of

primary dressing, face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or

multiple digits; each additional 480 sq cm or part thereof (List separately in addition to code for

primary procedure)).

We disagree with the RUC-recommended work RVUs of 3.00, 2.00, 2.51, 2.00, 10.97,

2.50, 12.50, and 3.00 for CPT codes 15XX1 through 15XX8, respectively, and are proposing

contractor-pricing for these CPT codes due to concerns with the coding structure of the code

family and the total physician time that results when these codes are billed multiple times on the

same date of service for the typical patient.

We note that our concerns with these CPT codes are expansive. Firstly, we note that these

CPT codes represent a segmentation of a single service that is performed sequentially on the

same date of service. We are seeking comment on whether the segmentation of the harvest,

preparation, and application is necessary when these are sequential service parts of one episode

of care, and could be simplified by having just two codes that encompass all three service parts

(harvest, preparation, and application), to differentiate the two different application areas. We

also are soliciting comment on the base and add-on codes’ incremental square centimeters,

considering that the typical size treatment area described in the vignettes could result in the add-

on codes being billed multiple times, particularly for the base application CPT code 15XX5 and

add-on CPT code 15XX6. Based on the meeting notes from the September 2023 CPT Editorial

Panel meeting, the specialty society initially structured their coding request to “bundle” the

service components into fewer codes, but it is unclear to us why these codes were further

segmented. We believe that the very large range of intraservice times from the 33 burn surgeons

may have been exacerbated by the harvest, preparation, and application components of the

service being segmented in this manner. Most notably, CPT code 15XX1, which describes the

first 25 sq cm of harvest, base code, had an intraservice survey time range of 5 to 480 minutes,

and CPT code 15XX7, which describes the first 480 sq cm of application to the face, scalp,

eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, had an

intraservice survey time range of 10 to 360 minutes.

We note that the survey median intraservice times for CPT codes 15XX1 through 15XX8

contradict numerous publicly available sources that describe much lower times for this service or

specific service parts. Most notably, the manufacturer of the RECELL Autologous Cell

Harvesting Device (RECELL® System) used in this service, indicates that a suspension of

Spray-On Skin™ Cells using a small sample of the patient’s own skin for the treatment of

thermal burn wounds and full-thickness skin defects is “prepared and applied at the point of care

in as little as 30 minutes.”

Additionally, Temple University Hospital published a news article

on December 20, 2019, just 11 months after the U.S. Food and Drug Administration (FDA)

approval of the RECELL® System for the treatment of acute thermal second and third-degree

burns in adult patients in January 2019, stating that the entire process of skin sample collection,

enzyme solution preparation, and suspension spraying/application “can take as little as 30

minutes” and “treat a wound up to 80 times the size of the donor skin sample.”

Additionally, an

article published in Europe PubMed Central states that the procedure takes approximately 30

minutes and is performed by a burn surgeon trained in how to use RECELL® System, and does

https://avitamedical.com/.

Temple Burn Center Using Spray-On SkinTM Cells Technology to Offer Patients a New, Less Invasive Option

for the Treatment of Severe Burns. (2019, December 20). https://medicine.temple.edu/news/temple-burn-center-

using-spray-skin-cells-technology-offer-patients-new-less-invasive-option.

not require specialized laboratory staff.

Additionally, a 2007 study aimed at comparing the

results from the RECELL® System and the classic skin grafting for epidermal replacement in

deep partial thickness burns showed a total procedure time of 59±4 minutes for the RECELL®

System group.

More granularly, the FDA’s Instructions for Use of the RECELL® Autologous Cell

Harvesting Device state that “if a skin sample is harvested and processed according to these

instructions, it should require between 15 and 30 minutes of contact with the Enzyme”.

Additionally, the National Institute for Health and Care Excellence (NICE) produced guidance

on using the RECELL® System based on the consideration of evidence submitted and the views

of expert advisers, and stated that the harvested skin is added to the proprietary enzyme solution

in a processing unit and heated for 15 to 30 minutes to disaggregate the cells. The skin is then

removed and scraped with a scalpel to develop a plume of cells. These cells are added to a buffer

solution, aspirated and filtered to create a cell suspension that contains keratinocytes,

melanocytes, fibroblasts and Langerhans cells.

This correlates to the preparation component of

the service described by CPT codes 15XX3 and 15XX4, for which the RUC recommended the

survey median time of 33 and 28 minutes, respectively.

We believe that the publicly available sources that make representations about the total

service and preparation times contradict the RUC-recommended median times based on the

survey of 33 burn surgeons. Moreover, when we considered how the add-on CPT codes 15XX2,

15XX4, 15XX6, and 15XX8 would be billed based on the typical patient described in the

Cooper-Jones B, Visintini S. A Noncultured Autologous Skin Cell Spray Graft for the Treatment of Burns. In:

CADTH Issues in Emerging Health Technologies. Canadian Agency for Drugs and Technologies in Health, Ottawa

(ON); 2016. PMID: 30855772.

G. Gravante, M.C. Di Fede, A. Araco, M. Grimaldi, B. De Angelis, A. Arpino, V. Cervelli, A. Montone, A

randomized trial comparing ReCell® system of epidermal cells delivery versus classic skin grafts for the treatment

of deep partial thickness burns, Burns, Volume 33, Issue 8, 2007, Pages 966-972, ISSN 0305-4179,

https://doi.org/10.1016/j.burns.2007.04.011.

https://www.fda.gov/media/169630/download.

National Institute for Health and Care Excellence. The ReCell Spray-On Skin system for treating skin loss,

scarring and depigmentation after burn injury. Medical technologies guidance [MTG21] [Internet]. 2014. [Accessed

16 Nov 2017]. https://www.nice.org.uk/guidance/mtg21/documents/the-recell-sprayon-skin-system-for-treating-

skin-loss-scarring-and-depigmentation-after-burn-injury-medical-technology-consultation-document.

vignettes, we believe the survey times are inflated compared to the publicly available sources,

likely due to how the survey respondents considered the service given the segmentation of the

code set. For example, the vignette for CPT code 15XX5 describing the application to the trunk,

arms, and legs says “A 35-year-old male sustained partial-thickness thermal burns on his trunk

and arms measuring 3,600 sq cm. A skin cell suspension autograft is applied to 480 sq cm of the

wound bed.” Of the 33 burn surgeons surveyed, 96 percent found this vignette to be typical.

Given the typical sq cm application area of 3,600 sq cm and the expansion ratio of harvested and

prepared skin to treatment skin for application of 1:80, the typical episode of care would

constitute 1 unit of both CPT codes 15XX1 and 15XX2 for harvesting, 1 unit of both CPT codes

15XX3 and 15XX4 for preparation, 1 unit of CPT code 15XX5 for the first 480 sq cm of

application, and 7 units of CPT code 15XX6 for the remaining 3,120 sq cm of application area.

When the RUC-recommended intraservice and total times (not including the post-operative visit

time for CPT code 15XX5) for all the units billed on the same date of service as sequential

service parts are summed, the intraservice time totals to 399 minutes and total time (not

including the post-operative visit time included in the global period for CPT code 15XX5) totals

to 529 minutes. The intraservice time total alone is nearly 6 and 2/3 hours.

We note the RUC recommended that CPT codes 15XX1 through 15XX8 be placed on the

New Technology list to be re-reviewed by the RUC for both work and PE for the September

2026 or January 2027 RUC meeting when 2025 Medicare utilization data is available, and at that

time, the RUC would consider if other specialties were performing the service and if the service

was performed in the non-facility setting. We look forward to re-reviewing these CPT codes

when recommendations are re-submitted with more robust and inclusive survey data. In the

meantime, we encourage the reconsideration of the family’s coding structure by the CPT

Editorial Panel given the challenging aspects of this service, including the fact that the current

coding structure represents a severely segmented single episode of care with troublesome billing

patterns for the typical patient, particularly for the add-on CPT code 15XX6 describing the

additional 480 sq cm increments of application on the trunk, arms, and legs. This code is

particularly concerning because the coding structure of the family requires 7 units of add-on CPT

code 15XX6 to be billed for the typical patient. Similarly, the typical patient described in the

vignettes for this family of codes would require 3 units of add-on CPT code 15XX8 due to the

coding structure.

We are also seeking feedback on the recommended global period for CPT code 15XX3.

The RUC recommended an XXX global period, which indicates that the global concept does not

apply, but we believe a 000-day global period, indicating an endoscopic or minor procedure with

related preoperative and postoperative relative values on the day of the procedure only in the fee

schedule payment amount, may be more appropriate given the nature of the service (which is

intertwined with the other codes in the series) and that the entire service cannot be completed

without 15XX3. This would allow the entire service to run within a surgical global period.

We note that we believe contractor-pricing is appropriate for CPT codes 15XX1 through

15XX8 until reconsideration of the coding structure and re-survey is complete, given the

concerning aspects of the CPT codes. We note that this service is currently billed for using

contractor-priced CPT code 17999 (Unlisted procedure, skin, mucous membrane and

subcutaneous tissue) and the eight new codes are expected to be a very low utilization.

(2) Hand, Wrist, & Forearm Repair & Recon (CPT codes 25310, 25447, 2X005, and 26480)

In September 2022, the RUC referred CPT codes 26480 and 25447 to the CPT Editorial

Panel for a code bundling solution. In May 2023, the CPT Editorial Panel approved a new

bundled code (CPT code 2X005) to report intercarpal or carpometacarpal joint suspension

arthroplasty, including transfer or transplant of tendon, with interposition when performed while

CPT code 25447 was revised to clarify that the code only included interposition of a tendon and

not suspension. This family of codes was surveyed for the September 2023 RUC meeting.

We disagree with the RUC-recommended work RVU of 9.50 for CPT code 25310

(Tendon transplantation or transfer, flexor or extensor, forearm and/or wrist, single; each

tendon) and we are instead proposing a work RVU of 9.00 based on the survey 25

percentile

result. In reviewing CPT code 25310, we noted that the recommended intraservice time was

unchanged at 60 minutes in the new survey; however, the RUC-recommended work RVU is

increasing from the current 8.08 to 9.50. Although we do not imply that changes in work time as

reflected in survey values must equate to a one-to-one or linear change in the valuation of work

RVUs, we believe that since the two components of work are time and intensity, increases in the

recommended work RVU should typically be reflected in increases in the surveyed work time.

We recognize that the total time for CPT code 25310 is increasing from 235 minutes to 263

minutes (an increase of 12 percent) due to changes in the code’s post-operative office visits

which will now take place at a higher level. However, this again does not match the increase in

the recommended work RVU, which is increasing from 8.08 to 9.50 (approximately 18 percent).

We believe that it would be more accurate to propose the survey 25

percentile work RVU of

9.00 for CPT code 25310 which matches this increase in the total work time. We also note that

the intensity of CPT code 25310 is decreasing, not increasing, as recommended by the RUC

which further suggests that a work RVU of 9.50 would not be appropriate for this code given the

surveyed work times.

We disagree with the RUC-recommended work RVU of 11.14 for CPT code 25447

(Arthroplasty, intercarpal or carpometacarpal joints; interposition (eg, tendon)) and we are

instead proposing a work RVU of 10.50 based on the survey 25

percentile result. In reviewing

CPT code 25447, we noted that the recommended intraservice time was decreasing from 100

minutes to 75 minutes in the new survey; however, the RUC recommended maintaining the

current work RVU of 11.14. Although we do not imply that changes in work time as reflected in

survey values must equate to a one-to-one or linear change in the valuation of work RVUs, we

believe that since the two components of work are time and intensity, decreases in the surveyed

work time should typically be reflected in decreases to the work RVU. We recognize that the

total time for CPT code 25447 is slightly increasing from 278 minutes to 281 minutes (an

increase of about 1 percent) due to changes in the code’s post-operative office visits which will

now take place at a higher level. However, we believe that the sizable decrease in surveyed

intraservice work time (a reduction of approximately 33 percent) better supports proposing the

survey 25

percentile work RVU of 10.50 instead of maintaining the current work RVU of

11.14. We also disagree with the RUC that the intensity of CPT code 25447 is unchanged due to

increases in the post-operative work; we believe that the sizable decrease in surveyed

intraservice work time indicates a modest decrease in intensity. We note again that the intensity

of CPT code 25310 is decreasing, not increasing, as recommended by the RUC which suggests

that a similar pattern is likely taking place with clinically similar procedures elsewhere in the

same code family.

We disagree with the RUC-recommended work RVU of 13.90 for CPT code 2X005

(Arthroplasty, intercarpal or carpometacarpal joints; suspension, including transfer or

transplant of tendon, with interposition, when performed) and we are instead proposing a work

RVU of 11.85 based on the survey 25

percentile result. We note that the RUC typically values

new codes such as CPT code 2X005 using this survey 25

percentile work RVU as opposed to

the survey median work RVU that it recommended. The RUC’s recommendations stated that

CPT code 2X005 should be valued higher than CPT code 25447 due to having higher intensity, a

relationship which is preserved at our proposed work RVUs of 11.85 and 10.50 respectively. The

RUC also stated in its recommendations that CPT code 2X005 should be valued higher than

reference CPT code 29828 (Arthroscopy, shoulder, surgical; biceps tenodesis) because it has

more intraservice time and total work time. However, the RUC also stated elsewhere in its

recommendations that the arthroscopy described by CPT code 29828 is more intense than the

arthroplasty procedures described by this family of codes, which we believe supports CPT code

29828 having a higher work RVU despite its lower work times. Based on this information, we

believe that proposing the survey 25

percentile work RVU of 11.85 is the most accurate

valuation for CPT code 2X005.

We disagree with the RUC-recommended work RVU of 9.50 for CPT code 26480

(Transfer or transplant of tendon, carpometacarpal area or dorsum of hand; without free graft,

each tendon) and we are instead proposing a work RVU of 9.00 based on the survey 25

percentile result. In reviewing CPT code 26480, we noted that the recommended intraservice

time was unchanged at 60 minutes in the new survey; however, the RUC-recommended work

RVU is increasing from the current 6.90 to 9.50. Although we do not imply that changes in work

time as reflected in survey values must equate to a one-to-one or linear change in the valuation of

work RVUs, we believe that since the two components of work are time and intensity, increases

in the recommended work RVU should typically be reflected in increases in the surveyed work

time. We recognize that the total time for CPT code 26480 is increasing from 227 minutes to 263

minutes (an increase of 16 percent) due to changes in the code’s post-operative office visits

which will now take place at a higher level. However, this again does not match the increase in

the recommended work RVU, which is increasing from 6.90 to 9.50 (approximately 38 percent).

We believe that it would be more accurate to propose the survey 25

percentile work RVU of

9.00 for CPT code 26480 which more closely matches this increase in the total work time. We

also note that CPT codes 25310 and 26480 were surveyed as having identical work times and

identical survey 25

percentile and survey median work RVUs. We concur with the RUC that

these two codes should be valued at the same work RVU, however we continue to believe that

the survey 25

percentile work RVU of 9.00 is a more accurate choice in both cases.

We are proposing the RUC-recommended direct PE inputs for all four codes in the family

without refinement.

(3) CAR-T Therapy Services (CPT codes 3X018, 3X019, 3X020, and 3X021)

In September 2023, the CPT Editorial Panel deleted four category III codes (0537T-

0540T) and approved the addition of four new codes (3X018-3X021) that describe only steps of

the complex CAR-T Therapy process performed and supervised by physicians. The RUC

recommended four different work RVUs for codes 3X018, 3X019, 3X020, and 3X021 and only

recommended direct PE values for code 3X021.

For CPT code 3X018 (Chimeric antigen receptor T-cell (CAR-T) therapy; harvesting of

blood-derived T lymphocytes for development of genetically modified autologous CAR-T cells,

per day) the RUC recommended a work RVU of 1.94. For CPT code 3X019 (Chimeric antigen

receptor T-cell (CAR-T) therapy; preparation of blood-derived T lymphocytes for transportation

(eg, cryopreservation, storage)) the RUC recommended a work RVU of 0.79. For CPT code

3X021 (Chimeric antigen receptor T-cell (CAR-T) therapy; CAR-T cell administration,

autologous) the RUC recommended a work RVU of 3.00. For CPT code 3X020 (Chimeric

antigen receptor T-cell (CAR-T) therapy; receipt and preparation of CAR-T cells for

administration) the RUC recommended a work RVU of 0.80 and for CPT code 3X020, we are

proposing the RUC-recommended work RVU of 0.80. We are proposing the RUC-recommended

work RVUs for CPT codes 3X018, 3X019, and 3X021 respectively.

As mentioned previously, the RUC recommended direct PE values for only one code,

CPT code 3X021, and the RUC recommended that the non-facility PE RVU for CPT codes

3X018-3X020 should be contractor-priced. However, contractor pricing can only be applied at

the whole code level, not to a single component of the valuation. Therefore, for CPT codes

3X018-3X020 we are treating these codes as having no recommended direct PE values and are

seeking comment on direct PE values for these codes. We are proposing the RUC-recommended

direct PE inputs for CPT code 3X021.

(4) Therapeutic Apheresis and Photopheresis (CPT codes 36514, 36516, and 36522)

In the CY 2024 PFS final rule, we finalized CPT codes 36514 (Therapeutic apheresis;

for plasma pheresis), 36516 (Therapeutic apheresis; with extracorporeal immunoadsorption,

selective adsorption or selective filtration and plasma reinfusion), and 36522 (Photopheresis,

extracorporeal) as potentially misvalued, as we believed there may have been a possible

disparity with the clinical labor type (88 FR 78848). As a result, the PE clinical labor type was

reviewed for these three codes at the January 2024 RUC meeting, with no work review. The PE

Subcommittee and the RUC agreed that clinical staff code L042A (RN/LPN) did not

appropriately represent the work of an Apheresis Nurse Specialist. There is not a clinical staff

code for an Apheresis Nurse Specialist; however, the RUC agreed with the specialty societies’

recommendation that the training and experience of an oncology nurse (clinical staff code

L056A, RN/OCN) would more accurately reflect the work of an apheresis nurse for these CPT

codes. The RUC submitted new PE recommendations for these three codes based on the use of

the L056A clinical labor type.

We are proposing the RUC-recommended direct PE inputs for CPT codes 36514, 36516,

and 36522 without refinement. The RUC did not make recommendations and we are not

proposing any changes to the work RVU for CPT codes 36514, 36516, and 36522.

(5) Intra-Abdominal Tumor Excision or Destruction (CPT codes 4X015, 4X016, 4X017, 4X018,

and 4X019)

In May 2023, the CPT Editorial Panel created five new codes to describe the sum of the

maximum length of intra-abdominal (that is, peritoneal, mesenteric, retroperitoneal), primary or

secondary tumor(s) or cyst(s) excised or destroyed: CPT code 4X015 (Excision or destruction,

open, intra-abdominal (i.e., peritoneal, mesenteric, retroperitoneal), primary or secondary

tumor(s) or cyst(s), sum of the maximum length of tumor(s) or cyst(s); 5 cm or less), CPT code

4X016 (Excision or destruction, open, intra-abdominal (i.e., peritoneal, mesenteric,

retroperitoneal), primary or secondary tumor(s) or cyst(s), sum of the maximum length of

tumor(s) or cyst(s); 5.1 to 10 cm), CPT code 4X017 (Excision or destruction, open, intra-

abdominal (i.e., peritoneal, mesenteric, retroperitoneal), primary or secondary tumor(s) or

cyst(s), sum of the maximum length of tumor(s) or cyst(s); 10.1 to 20 cm), CPT code 4X018

(Excision or destruction, open, intra-abdominal (i.e., peritoneal, mesenteric, retroperitoneal),

primary or secondary tumor(s) or cyst(s), sum of the maximum length of tumor(s) or cyst(s); 20.1

to 30 cm), and CPT code 4X019 (Excision or destruction, open, intra-abdominal (i.e., peritoneal,

mesenteric, retroperitoneal), primary or secondary tumor(s) or cyst(s), sum of the maximum

length of tumor(s) or cyst(s); greater than 30 cm). These new CPT codes will replace existing

CPT codes 49203 (Excision or destruction, open, intra-abdominal tumors, cysts or

endometriomas, 1 or more peritoneal, mesenteric, or retroperitoneal primary or secondary

tumors; largest tumor 5 cm diameter or less), 49204 (Excision or destruction, open, intra-

abdominal tumors, cysts or endometriomas, 1 or more peritoneal, mesenteric, or retroperitoneal

primary or secondary tumors; largest tumor 5.1-10.0 cm diameter), and 49205 (Excision or

destruction, open, intra-abdominal tumors, cysts or endometriomas, 1 or more peritoneal,

mesenteric, or retroperitoneal primary or secondary tumors; largest tumor greater than 10.0 cm

diameter) that described tumor excision or destruction based on the size of the single largest

tumor, cyst, or endometrioma removed, no matter the number of tumors. For CY 2025, the RUC

recommended a work RVU of 22.00 for CPT code 4X015, a work RVU of 28.65 for CPT code

4X016, a work RVU of 34.00 for CPT code 4X017, a work RVU of 45.00 for CPT code 4X018,

and a work RVU of 55.00 for CPT code 4X019.

We are proposing the RUC-recommended work RVUs of 22.00 for CPT code 4X015,

28.65 for CPT code 4X016, and 34.00 for CPT code 4X017.

We disagree with the RUC-recommended work RVU of 45.00 for CPT code 4X018 and

we are proposing a work RVU of 40.00 based on the survey 25

percentile. Compared to the

predecessor CPT code 49205, the intra-service time ratio for CPT code 4X018 suggests a work

RVU of 41.51 and the total time ratio suggests a work RVU of 38.02. These changes in surveyed

work time as compared with predecessor CPT code 49205 suggest that the recommended work

RVU of 45.00 is inappropriately high. We also note that the RUC recommended the survey 25

percentile work RVU for CPT codes 4X015, 4X016, and 4X017. Therefore, we believe that

proposing a work RVU of 40.00 for CPT code 4X018 keeps the valuation consistent with the

other CPT codes in this family. Our proposed work RVU of 40.00 for CPT code 4X018 is

supported by the following reference CPT codes with similar intra-service time (310 minutes)

and similar total time (814 minutes): reference CPT code 69970 (Removal of tumor, temporal

bone) with a work RVU of 32.41 with 330 minutes intra-service time and 793 minutes of total

time, and reference CPT code 33864 (Ascending aorta graft, with cardiopulmonary bypass with

valve suspension, with coronary reconstruction and valve-sparing aortic root remodeling (e.g.,

David Procedure, Yacoub Procedure)) with a work RVU of 60.80 with 300 minutes of intra-

service time and 838 minutes of total time. We believe the proposed work RVU of 40.00 is a

more appropriate value overall than 45.00 when compared to the range of codes with similar

intra-service time and similar total time.

We disagree with the RUC-recommended work RVU of 55.00 for CPT code 4X019 and

we are proposing a work RVU of 50.00 based on the survey 25

percentile. Compared to the

predecessor CPT code 49205, the intra-service time ratio for CPT code 4X019 suggests a work

RVU of 48.21 and the total time ratio suggests a work RVU of 48.86. These changes in surveyed

work time as compared with predecessor CPT code 49205 suggest that the recommended work

RVU of 55.00 is inappropriately high. We also note again that the RUC recommended the survey

percentile work RVU for CPT codes 4X015, 4X016, and 4X017. Therefore, we believe that

proposing a work RVU of 50.00 for CPT code 4X019 keeps the valuation consistent with the

other CPT codes in this family. Our proposed work RVU of 50.00 for CPT code 4X019 is

supported by the following reference CPT codes with similar intra-service time (360 minutes)

and similar total time (1,046 minutes): reference CPT code 61598 (Transpetrosal approach to

posterior cranial fossa, clivus or foramen magnum, including ligation of superior petrosal sinus

and/or sigmoid sinus) with a work RVU of 36.53 with 377.7 minutes intra-service time and

1,048.1 minutes of total time, and reference CPT code 47140 (Donor hepatectomy (including

cold preservation), from living donor; left lateral segment only (segments II and III)) with a

work RVU of 59.40 with 355 minutes of intra-service time and 1,073 minutes of total time. We

believe the proposed RVU of 50.00 is a more appropriate value overall than 55.00 when

compared to the range of codes with similar intra-service time and similar total time.

We also note that the RUC’s recommendations for the first three codes in the family

(CPT codes 4X015-4X017) maintained the same amount of intensity as their respective

predecessor codes, and in fact slightly decreased in intensity in the case of CPT codes 4X015 and

4X016. However, the RUC recommended a notable increase in intensity for CPT codes 4X018

and 4X019 over predecessor code 49205 due to its selection of the survey median work RVU in

both cases. We do not believe that this increase in intensity for CPT codes 4X018 and 4X019 is

warranted due to their clinical similarities to the previous coding in the family, especially given

that CPT code 49205 had the lowest intensity in the family. We believe that this intensity

argument further supports our choice to propose the survey 25

percentile work RVU for these

two codes, matching the RUC recommendations for CPT code 4X015-4X017.

We are proposing the RUC-recommended direct PE inputs for CPT codes 4X015, 4X016,

4X017, 4X018, and 4X019 without refinement.

(6) Bladder Neck and Prostate Procedures (CPT codes 5XX05 and 5XX06)

In September 2023, the CPT Editorial Panel created two Category I CPT codes to

describe the insertion or removal of a temporary device to remodel the bladder neck and prostate

using pressure to create necrosis and relieve lower urinary tract symptoms (LUTS) secondary to

benign prostate hyperplasia (BPH). These two new 000-day global Category I codes were

surveyed and reviewed for the January 2024 RUC meeting.

At the January 2024 RUC meeting, the specialty society indicated that CPT code

5XX05’s survey 25th percentile work RVU of 3.91 was too high for this procedure compared to

other services in the physician fee schedule with similar intra-service time. The specialty society

recommended, and the RUC agreed that the recommended work RVU for CPT code 5XX05

should be crosswalked to CPT code 52284 (Cystourethroscopy, with mechanical urethral

dilation and urethral therapeutic drug delivery by drug-coated balloon catheter for urethral

stricture or stenosis, male, including fluoroscopy, when performed). Because these procedures

are similar in intensity and both require precise placement of an intraurethral device, we concur

with the RUC and we are proposing the RUC recommended work RVU of 3.10 for CPT code

5XX05.

At the January 2024 RUC meeting, the specialty society indicated that CPT code

5XX06’s survey 25th percentile work RVU of 2.00 was too high for this procedure compared to

other services in the physician fee schedule with similar intra-service time. The specialty society

recommended, and the RUC agreed, that CPT code 5XX06 should have a direct work RVU

crosswalk to CPT code 27096 (Injection procedure for sacroiliac joint, anesthetic/steroid, with

image guidance (fluoroscopy or CT) including arthrography when performed). We are proposing

the RUC recommended work RVU of 1.48 for CPT code 5XX06.

We are also proposing the RUC-recommended direct PE inputs for CPT codes 5XX05

and 5XX06 without refinement. However, we note possible duplications in two of the supply

items within CPT code 5XX05. Specifically, supply item SB027 (gown, staff, impervious) is

already included in supply item SA042 (pack, cleaning and disinfecting, endoscope), and supply

item SB024 (gloves, sterile) is included in supply items SA058 (pack, urology cystoscopy visit).

We are seeking comments on whether a total of three SB027 impervious staff gowns and two

SB024 pairs of sterile gloves would be typical and necessary when providing this procedure.

(7) MRI-Monitored Transurethral Ultrasound Ablation of Prostate (CPT codes 5X006, 5X007,

and 5X008)

At the April 2023 CPT Editorial Panel meeting, three new CPT codes were approved for

MRI-monitored transurethral ultrasound ablation (TULSA). These codes were surveyed for the

September 2023 RUC meeting and recommendations submitted to CMS for inclusion in the CY

2025 PFS proposed rule.

For CY 2025, we are proposing the RUC-recommended work RVUs for all three CPT

codes. However, we note that interested parties may have concerns regarding the experience of

the survey respondents and the intra-service times provided in the survey data. We welcome

commenters to provide additional data that we could consider in the valuation of the work and

direct PE inputs for these CPT codes. We are proposing a work RVU of 4.05 for CPT code

5X006 (Insertion of transurethral ablation transducers for delivery of thermal ultrasound for

prostate tissue ablation, including suprapubic tube placement during the same session and

placement of an endorectal cooling device, when performed), a work RVU of 9.80 for CPT code

5X007 (Ablation of prostate tissue, transurethral, using thermal ultrasound, including magnetic

resonance imaging guidance for, and monitoring of, tissue ablation), and a work RVU of 11.50

for CPT code 5X008 (Ablation of prostate tissue, transurethral, using thermal ultrasound,

including magnetic resonance imaging guidance for, and monitoring of, tissue ablation; with

insertion of transurethral ultrasound transducers for delivery of the thermal ultrasound,

including suprapubic tube placement and placement of an endorectal cooling device, when

performed). We are also proposing the RUC-recommended direct PE inputs for CPT codes

5X006, 5X007, and 5X008 without refinement.

(8) Insertion of Cervical Dilator (CPT code 59200)

In the CY 2024 PFS final rule, we finalized CPT Code 59200 (Insertion of cervical

dilator (e.g., laminaria, prostaglandin) (separate procedure)) as potentially misvalued. The code

is to be used to report the total duration of time spent on a patient history and physical, reviewing

lab resulting, discussing risk and benefits of the procedure, obtaining consent, performing the

procedure, and assessing the patient post-procedure. The RUC reviewed the work RVU and PE

inputs for CPT code 59200 at their January 2024 meeting. We are proposing the RUC-

recommended work RVU of 1.20 for CPT code 59200. We are also proposing the RUC-

recommended direct PE inputs for CPT code 59200 without refinements.

(9) Guided High Intensity Focused Ultrasound (CPT code 6XX00)

In September 2023, the CPT Editorial Panel created a new Category I code to describe

magnetic resonance image guided high intensity focused ultrasound intracranial ablation for

treatment of a severe central tremor that is recalcitrant to other medical treatments. This service

is typically performed by a neurosurgeon without the involvement of a separate radiologist. This

new code replaces the existing Category III code 0398T.

We are not proposing the RUC-recommended work RVU of 18.95 for CPT code 6XX00

and are instead proposing a work RVU of 16.60 based on a crosswalk to CPT code 61626

(Transcatheter permanent occlusion or embolization (eg, for tumor destruction, to achieve

hemostasis, to occlude a vascular malformation), percutaneous, any method; non-central

nervous system, head or neck (extracranial, brachiocephalic branch)), which describes a similar

tumor destruction service that has similar time and intensity values to this service, and we

support this value by referencing CPT code 33889 (Open subclavian to carotid artery

transposition performed in conjunction with endovascular repair of descending thoracic aorta,

by neck incision, unilateral) and 33894 (Endovascular stent repair of coarctation of the

ascending, transverse, or descending thoracic or abdominal aorta, involving stent placement;

across major side branches). We do not believe that this service is significantly more intense

than the key reference codes, CPT codes 61736 (Laser interstitial thermal therapy (LITT) of

lesion, intracranial, including burr hole(s), with magnetic resonance imaging guidance, when

performed; single trajectory for 1 simple lesion) and 61737 (Laser interstitial thermal therapy

(LITT) of lesion, intracranial, including burr hole(s), with magnetic resonance imaging

guidance, when performed; multiple trajectories for multiple or complex lesion(s)), as the RUC-

recommended work value implies. Our proposed work RVU of 16.60 for CPT code 6XX00

largely matches the intensity of CPT code 61736 which we believe is a more accurate valuation

for this service, as opposed to the RUC recommendation which would have significantly more

intensity.

We are proposing the RUC-recommended direct PE inputs for CPT code 6XX00 without

refinement.

(10) Percutaneous Radiofrequency Ablation of Thyroid (CPT codes 6XX01 and 6XX02)

In January 2024, the RUC surveyed codes 6XX01 (Ablation of 1 or more thyroid

nodule(s), one lobe or the isthmus, percutaneous, including imaging guidance, radiofrequency)

and its respective add-on code 6XX02 (Ablation of 1 or more thyroid nodule(s), additional lobe,

percutaneous, with imaging guidance, radiofrequency (List separately in addition to code for

primary service) and recommended both work RVUs and PE values for this code family.

For CPT code 6XX01, the RUC recommended a work RVU of 5.75 and we are

proposing the RUC-recommended work RVU of 5.75.

For add-on code CPT 6XX02, the RUC recommended a work RVU of 4.25 and we are

proposing the RUC-recommended work RVU for this code. We are also proposing the RUC-

recommended direct PE values for both codes 6XX01 and 6XX02.

(11) Fascial Plane Blocks (CPT codes 6XX07, 6XX08, 6XX09, 6XX10, 6XX11, 6XX12, 64486,

64487, 64488, and 64489)

In September 2023, the CPT Editorial Panel created six new Category I CPT codes, CPT

code 6XX07 (Thoracic fascial plane block, unilateral; by injection(s), including imaging

guidance, when performed), 6XX08 (Thoracic fascial plane block, unilateral; by continuous

infusion(s), including imaging guidance, when performed), 6XX09 (Thoracic fascial plane

block, bilateral; by injection(s), including imaging guidance, when performed), 6XX10

(Thoracic fascial plane block, bilateral; by continuous infusion(s), including imaging guidance,

when performed), 6XX11 (Lower extremity fascial plane block, unilateral; by injection(s),

including imaging guidance, when performed), and 6XX12 (Lower extremity fascial plane block,

unilateral; by continuous infusion(s), including imaging guidance, when performed) to report

thoracic or lower extremity fascial plane blocks, typically used for post-operative pain

management. Four existing CPT codes describing transversus abdominis plane (TAP) blocks,

64486 (Transversus abdominis plane (TAP) block (abdominal plane block, rectus sheath block)

unilateral; by injection(s) (includes imaging guidance, when performed)), 64487 (Transversus

abdominis plane (TAP) block (abdominal plane block, rectus sheath block) unilateral; by

continuous infusion(s) (includes imaging guidance, when performed)), 64488 (Transversus

abdominis plane (TAP) block (abdominal plane block, rectus sheath block) bilateral; by

injections (includes imaging guidance, when performed)) 64489 (Transversus abdominis plane

(TAP) block (abdominal plane block, rectus sheath block) bilateral; by continuous infusions

(includes imaging guidance, when performed)), were included as part of this code family for

RUC review in January 2024.

We are proposing the RUC-recommended work RVU for all ten codes in this family. We

are proposing a work RVU of 1.50 for CPT code 6XX07, 1.74 for CPT code 6XX08, 1.67 for

CPT code 6XX09, 1.83 for CPT code 6XX10, 1.34 for CPT code 6XX11, 1.67 for CPT code

6XX12, 1.20 for CPT code 64486, 1.39 for CPT code 64487, 1.40 for CPT code 64488, and 1.75

for CPT code 64489.

We are also proposing the RUC recommended direct PE inputs for CPT codes 6XX08,

6XX09, 6XX10, 6XX12, 64487, 64488, and 64489. We disagree with one of the RUC

recommended direct PE inputs for CPT codes 6XX07, 6XX11, and 64486. The RUC stated they

believe that there is a rounding error in the CA019 clinical labor time, “Assist physician or other

qualified healthcare professional--directly related to physician work time (67%)”, for these three

codes. We disagree with the RUC that there are rounding errors in these codes and we are

proposing to maintain the current 7 minutes of CA019 clinical labor time for CPT codes 6XX07,

6XX11, and 64486. We note that this matches the pattern of CA019 clinical labor time for the

rest of the codes in the family, which remained the same or slightly decreased in each case. This

refinement to the CA019 clinical labor time also means that we are proposing a decrease of 0.5

minutes to the equipment time for the stretcher (EF018) and 3-channel ECG (EQ011) which

decreases from 25.5 to 25 minutes for these three codes. We are proposing all of the other RUC-

recommended direct PE inputs for CPT codes 6XX07, 6XX11, and 64486 without refinement.

(12) Skin Adhesives (CPT codes 64590 and 64595 and HCPCS codes G0168, G0516, G0517,

and G0518)

In April 2022, the RUC approved the use of SG007 (adhesive, skin (Dermabond)) for

CPT code 64590 (insertion or replacement of peripheral, sacral, or gastric neurostimulator

pulse generator or receiver, requiring pocket creation and connection between electrode array

and pulse generator or receiver) and 64595 (revision or removal of peripheral, sacral, or gastric

neurostimulator pulse generator or receiver, with detachable connection to electrode array). In

April 2023, the PE Subcommittee reviewed the following six codes on the Medicare Physician

Fee Schedule 64590, 64595, G0168, G0516, G0517, G0518 that utilize Dermabond (supply code

S6007) in order to identify justification for its use versus the generic version and present its

findings to the RUC for approval. The RUC reviewed all six codes for PE only and did not

submit work recommendations.

For CPT codes 64590 and 64595 and HCPCS code G0168 (Wound closure utilizing

tissue adhesive(s) only), the RUC recommends that CMS remove the supply input SG007

adhesive, skin (Dermabond) and add one unit of SH076 adhesive, cyanoacrylate (2ml uou). We

are proposing the RUC-recommended direct PE inputs for CPT codes 64590 and 64595 and

HCPCS code G0168. Similarly, for HCPCS codes G0516 (Insertion of non-biodegradable drug

delivery implants, 4 or more (services for subdermal rod implant), G0517 (Removal of non-

biodegradable drug delivery implants, 4 or more (services for subdermal implants), and G0518

(Removal with reinsertion, non-biodegradable drug delivery implants, 4 or more (services for

subdermal implants), the RUC recommends that CMS remove the supply input SG007 adhesive,

skin (Dermabond) and add one unit of SH076 adhesive, cyanoacrylate (2ml uou). We are

proposing the RUC-recommended direct PE inputs for HCPCS codes G0516-G0518.

(13) Iris Procedures (CPT codes 66680, 66682, and 6X004)

In April 2023, the CPT Editorial Panel deleted three related Category III CPT codes, CPT

code 0616T (Insertion of iris prosthesis, including suture fixation and repair or removal of iris,

when performed; without removal of crystalline lens or intraocular lens, without insertion of

intraocular lens), CPT code 0617T (with removal of crystalline lens and insertion of intraocular

lens), and CPT code 0618T (with secondary intraocular lens placement or intraocular lens

exchange). At the same time, CPT created a new Category I code 6X004 (Implantation of iris

prosthesis, including suture fixation and repair or removal of iris, when performed) which

describes insertion of an artificial iris into an eye with a partial or complete iris defect due to a

congenital defect or surgical or non-surgical trauma. The new Category I CPT code 6X004

replaced the three Category III codes to simplify reporting. Concurrent with these updates, the

RUC surveyed the two other 90-day global iris repair codes, CPT code 66680 (Repair of iris,

ciliary body (as for iridodialysis)) and CPT code 66682 (Suture of iris, ciliary body (separate

procedure) with retrieval of suture through small incision (eg, McCannel suture)).

We disagree with the RUC-recommended work RVU of 10.25 for CPT code 66680. We

are proposing a work RVU of 7.97 for CPT code 66680 based on a crosswalk to CPT code

67904 (Repair of blepharoptosis; (tarso) levator resection or advancement, external approach).

When we reviewed CPT code 66680, we found that the RUC recommended work RVU does not

maintain relativity with other 90-day global period codes with the same intraservice time of 45

minutes and similar total time around 182 minutes. The total time ratio between the current time

of 159 minutes and the recommended time established by the RUC survey of 182 minutes equals

1.145 percent. This ratio, 1.145 percent, when applied to the current work RVU of 6.39 would

suggest a work RVU of 7.31 which is far below the RUC’s recommended work RVU of 10.25.

Based on this total time ratio, we believe a more appropriate work valuation for CPT code 66680

is 7.97 based on a crosswalk to CPT code 67904.

We disagree with the RUC-recommended work RVU of 10.87 for CPT code 66682. We

are proposing a work RVU of 8.74 based on the total time ratio between the current time of

169.5 minutes and the recommended time established by the RUC survey of 202 minutes. This

ratio equals 1.192 percent, and 1.192 percent of the current work RVU of 7.33 suggests a work

RVU of 8.74 for CPT code 66682. When we reviewed CPT code 66682, we found that the

recommended work RVU was higher than nearly all of the other 90-day global codes with

similar time values. The RUC’s recommended work RVU does not maintain relativity with other

90-day global period codes with the same intraservice time value of 45 minutes and similar total

time of 202. We found that work RVU crosswalks to CPT codes of similar intraservice and total

time were too low, such as CPT code 45171 with a work RVU of 8.13. A more appropriate work

RVU for CPT code 66682 is 8.74 based on the total time ratio.

The RUC recommended a work RVU of 12.80 for CPT 6X004, the RUC survey 25th

percentile result, with an intraservice time of 60 minutes and a total time of 224 minutes. We

disagree with the RUC-recommended work RVU of 12.80 for CPT code 6X004. Although we

disagree with the RUC-recommended work RVU, we concur that the relative difference in work

between CPT codes 66682 and 6X004 is equivalent to the recommended interval of 1.93 RVUs.

Therefore, we are proposing a work RVU of 10.67 for CPT code 6X004, based on the

recommended interval of 1.93 additional RVUs above our proposed work RVU of 8.74 for CPT

code 66682. This proposed work RVU of 10.67 falls between the work RVU values of existing

codes with similar intraservice and total time values. For example, CPT code 65850 (60 minutes

of intraservice time and 233 minutes of total time) has a work RVU of 11.39 and CPT code

24164 with the same intraservice time and 228 minutes of total time has a work RVU of 10.00.

We believe that the work valuation of these CPT codes, which bracket our proposed work RVU

of 10.67, provide additional support for our proposed valuation.

We also disagree with the RUC’s recommended work RVUs for the codes in this family

because they suggest that there has been a tremendous increase in intensity as compared to how

these services have historically been valued. CPT code 66680 is more than doubling in intensity

at the RUC’s recommended work RVU of 10.25, which we do not believe to be the case given

that the code descriptor remains unchanged and the surveyed intraservice work time is

unchanged at 45 minutes. This same pattern holds true for CPT code 66682, which would be

increasing in intensity by more than 50% at the RUC’s recommended work RVU of 10.87, and

which similarly has no change in its code descriptor and a modest increase in its surveyed work

time. We concur that the intensity of these services has likely gone up over time, which is why

we are proposing modest intensity increases for both codes, however we continue to disagree

that the very substantial intensity increases recommended by the RUC would be accurate for this

code family. We believe that our proposed work RVUs are more in line with how these services

have historically been valued and better maintain relativity with the rest of the fee schedule.

We are proposing the direct PE inputs as recommended by the RUC for all three codes in

the family without refinement.

(14) Magnetic Resonance Examination Safety Procedures (CPT codes 7XX00, 7XX01, 7XX02,

7XX03, 7XX04, and 7XX05)

In September 2023, the CPT Editorial Panel created a new code family to describe

magnetic resonance (MR) examination safety procedures and capture the physician work

involving patients with implanted medical devices that require access to MR diagnostic

procedures: CPT code 7XX00 (MR safety implant and/or foreign body assessment by trained

clinical staff, including identification and verification of implant components from appropriate

sources (e.g., surgical reports, imaging reports, medical device databases, device vendors,

review of prior imaging), analyzing current MR conditional status of individual components and

systems, and consulting published professional guidance with written report; initial 15 minutes),

CPT code 7XX01 (MR safety implant and/or foreign body assessment by trained clinical staff,

including identification and verification of implant components from appropriate sources (e.g.,

surgical reports, imaging reports, medical device databases, device vendors, review of prior

imaging), analyzing current MR conditional status of individual components and systems, and

consulting published professional guidance with written report; each additional 30 minutes (List

separately in addition to code for primary procedure)), CPT code 7XX02 (MR safety

determination by a physician or other qualified health care professional responsible for the

safety of the MR procedure, including review of implant MR conditions for indicated MR exam,

analysis of risk versus clinical benefit of performing MR exam, and determination of MR

equipment, accessory equipment, and expertise required to perform examination with written

report), CPT code 7XX03 (MR safety medical physics examination customization, planning and

performance monitoring by medical physicist or MR safety expert, with review and analysis by

physician or qualified health care professional to prioritize and select views and imaging

sequences, to tailor MR acquisition specific to restrictive requirements or artifacts associated

with MR conditional implants or to mitigate risk of non-conditional implants or foreign bodies

with written report), CPT code 7XX04 (MR safety implant electronics preparation under

supervision of physician or other qualified health care professional, including MR-specific

programming of pulse generator and/or transmitter to verify device integrity, protection of

device internal circuitry from MR electromagnetic fields, and protection of patient from risks of

unintended stimulation or heating while in the MR room with written report), and CPT code

7XX05 (MR safety implant positioning and/or immobilization under supervision of physician or

qualified health care professional, including application of physical protections to secure

implanted medical device from MR-induced translational or vibrational forces, magnetically

induced functional changes, and/or prevention of radiofrequency burns from inadvertent tissue

contact while in the MR room with written report). For CY 2025, new CPT codes 7XX00 and

7XX01 are PE only services that represent the preparatory research and review completed by

clinical staff (that is, MRI technologist and/or a medical physicist) that will be utilized by the

physician or qualified health professional for the other four services (CPT codes 7XX02, 7XX03,

7XX04, and 7XX05) in this code family.

We are proposing the RUC-recommended work RVU of 0.60 for CPT code 7XX02, the

work RVU of 0.76 for CPT code 7XX03, the work RVU of 0.75 for CPT code 7XX04, and the

work RVU of 0.60 for CPT code 7XX05.

We are proposing the following refinements to the direct PE inputs. For CPT codes

7XX00, 7XX01, 7XX02, 7XX04, and 7XX05, we are proposing to refine the clinical labor for

the CA034 activity (Document procedure (nonPACS) (e.g. mandated reporting, registry logs,

EEG file, etc.)) performed by the MRI Technologist from 2 minutes to 1 minute. We note that

the clinical labor for the CA032 activity (Scan exam documents into PACS. Complete exam in

RIS system to populate images into work queue.) included in the direct PE inputs for reference

CPT code 70543 (Magnetic resonance (e.g., proton) imaging, orbit, face, and/or neck; without

contrast material(s), followed by contrast material(s) and further sequences) is a similar clinical

labor activity and has 1 minute of time. We also note that the Medical Physicist has 1 minute of

recommended clinical labor time for the CA034 activity for CPT code 7XX03. Therefore, we

believe that the MRI Technologist should have the same time (1 minute) for the CA034 activity

for the remaining codes in the family to maintain consistency across these services.

For CPT code 7XX01, we are proposing to refine the clinical labor for the CA021

activity (Perform procedure/service---NOT directly related to physician work time) from 27

minutes to 14 minutes. We believe this clinical labor time should be double the 7 minutes

assigned to the CA021 activity for CPT code 7XX00. The description for CPT code 7XX00 is

for the “initial 15 minutes” and CPT code 7XX01 is for “each additional 30 minutes,” that is,

double the time of CPT code 7XX00. We believe that the clinical labor associated with the

CA021 activity should match this pattern in which CPT code 7XX01 contains double the time of

CPT code 7XX00. This proposed refinement to the CA021 clinical labor also results in a

proposed decrease to the equipment time for the Technologist PACS workstation (ED050) from

45 minutes to 32 minutes.

For CPT code 7XX03, the RUC recommended 13 minutes of equipment time for the

Professional PACS Workstation (ED053) listed as a Facility PE input. We believe this was an

unintended technical error and we are proposing to remove this time from the direct PE inputs

for CPT code 7XX03.

For CPT codes 7XX04 and 7XX05, we proposing to refine the clinical labor time for the

CA024 activity (Clean room/equipment by clinical staff) from 2 minutes to 1 minute. According

to the PE recommendations, only the new equipment code EQ412 (Vitals monitoring system (MR

Conditional)) is being cleaned and not the entire room. We believe that 1 minute of clinical labor

time would be typical for cleaning the EQ412 equipment. Our proposed clinical labor refinement

also results in a proposed decrease to the equipment time for EL008 (room, MR) and EQ412 by 1

minute for these two codes.

For CPT code 7XX05, we are proposing to remove supply item SL082 (impression

material, dental putty (per bite block)). We believe this was an error since the PE

recommendations did not list SL082 as one of the included supplies for CPT code 7XX05 and it

does not appear as a supply input for any of the other codes in the family.

(15) Screening Virtual Colonoscopy (CPT code 74263)

As discussed in section III.K. of this proposed rule, we are proposing to exercise our

authority at section 1861(pp)(1)(D) of the Act to update and expand coverage for colorectal

cancer screening and adding coverage for the computed tomography colonography procedure.

Accordingly, we are assigning an active payment status for CPT code 74263 (Computed

tomographic (ct) colonography, screening, including image postprocessing). We note that, as

proposed above, the OPPS cap would apply to this code, and payment for the TC of this service

would be capped at the OPPS payment rate.

(16) Ultrasound Elastography (CPT codes 76981, 76982, and 76983)

This code family was flagged for re-review at the April 2023 RUC meeting by the new

technology/new services screen. Due to increased utilization of CPT code 76981 (Ultrasound,

elastography; parenchyma (eg, organ)), the entire code family was resurveyed for the September

2023 RUC meeting. We are proposing the RUC-recommended work RVUs of 0.59, 0.59, and

0.47 for CPT codes 76981, 76982 (Ultrasound, elastography; first target lesion), and 76983

(Ultrasound, elastography; each additional target lesion (List separately in addition to code for

primary procedure)), respectively. We are proposing the RUC-recommended direct PE inputs

for CPT codes 76981, 76982, and 76983 without refinement.

(17) CT Guidance Needle Placement (CPT code 77012)

CPT code 77012 (Computed tomography guidance for needle placement (eg, biopsy,

aspiration, injection, localization device), radiological supervision and interpretation) was

reviewed at the September 2023 RUC meeting to account for deferred updates to the vignette to

reflect the typical patient until updated utilization data was available to reflect coding changes

that occurred in 2019. We are proposing the RUC-recommended work RVU of 1.50 for CPT

code 77012.

We are proposing to refine the equipment time for the CT room (EL007) to maintain the

current time of 9 minutes. CPT code 77012 is a radiological supervision and interpretation

(RS&I) procedure and there has been a longstanding convention in the direct PE inputs, shared

by 38 other codes, to assign an equipment time of 9 minutes for the equipment room in these

procedures. We made the same refinement in the CY 2019 PFS final rule (83 FR 59553 through

59554) and continue to believe that it would not serve the interests of relativity to increase the

equipment time for the CT room in CPT code 77012 without also addressing the equipment

room time for the other radiological supervision and interpretation procedures. In response to the

CY 2019 proposal, several commenters stated that they agreed with CMS that other RS&I codes

use the 9 minutes for room time as a precedent, but that it is specific to angiographic rooms. We

agreed with the commenters that at least some portion of the procedure is performed in the CT

room, but we continue to believe that it would not serve the interests of relativity to increase the

equipment time for the CT room in CPT code 77012 without also addressing the equipment

room time for the other radiological supervision and interpretation procedures in a more

comprehensive fashion. We also disagreed with the commenters that this policy is specific to

angiography rooms, as CPT codes 75989 (Radiological guidance (ie, fluoroscopy, ultrasound, or

computed tomography), for percutaneous drainage (eg, abscess, specimen collection), with

placement of catheter, radiological supervision and interpretation) and 77012 both employ CT

rooms and currently utilize the standardized 9 minutes of equipment time, and CPT code 76080

(Radiologic examination, abscess, fistula or sinus tract study, radiological supervision and

interpretation) employs a radiographic-fluoroscopic room with the 9 minute standard equipment

time. We continue to believe that 9 minutes for EL007 is appropriate for this RS&I code,

therefore, we are proposing to maintain the current equipment room time of 9 minutes for EL007

until this group of procedures can be subject to a more comprehensive review. We are proposing

all other RUC-recommended direct PE inputs for CPT code 77012.

(18) Telemedicine Evaluation and Management (E/M) Services (CPT codes 9X075, 9X076,

9X077, 9X078, 9X079, 9X080, 9X081, 9X082, 9X083, 9X084, 9X085, 9X086, 9X087, 9X088,

9X089, 9X090, and 9X091)

In February 2023, the CPT Editorial Panel added a new Evaluation and Management

(E/M) subsection to the draft CPT codebook for Telemedicine Services. The Panel added 17

codes for reporting telemedicine E/M services: CPT code 9X075 (Synchronous audio-video visit

for the evaluation and management of a new patient, which requires a medically appropriate

history and/or examination and straightforward medical decision making. When using total time

on the date of the encounter for code selection, 15 minutes must be met or exceeded.); CPT code

9X076 (Synchronous audio-video visit for the evaluation and management of a new patient,

which requires a medically appropriate history and/or examination and low medical decision

making. When using total time on the date of the encounter for code selection, 30 minutes must

be met or exceeded.); CPT code 9X077 (Synchronous audio-video visit for the evaluation and

management of a new patient, which requires a medically appropriate history and/or

examination and moderate medical decision making. When using total time on the date of the

encounter for code selection, 45 minutes must be met or exceeded.); CPT code 9X078

(Synchronous audio-video visit for the evaluation and management of a new patient, which

requires a medically appropriate history and/or examination and high medical decision making.

When using total time on the date of the encounter for code selection, 60 minutes must be met or

exceeded. (For services 75 minutes or longer, use prolonged services code 99417)); CPT code

9X079 (Synchronous audio-video visit for the evaluation and management of an established

patient, which requires a medically appropriate history and/or examination and straightforward

medical decision making. When using total time on the date of the encounter for code selection,

10 minutes must be met or exceeded.); CPT code 9X080 (Synchronous audio-video visit for the

evaluation and management of an established patient, which requires a medically appropriate

history and/or examination and low medical decision making. When using total time on the date

of the encounter for code selection, 20 minutes must be met or exceeded.); CPT code 9X081

(Synchronous audio-video visit for the evaluation and management of an established patient,

which requires a medically appropriate history and/or examination and moderate medical

decision making. When using total time on the date of the encounter for code selection, 30

minutes must be met or exceeded.); CPT code 9X082 (Synchronous audio-video visit for the

evaluation and management of an established patient, which requires a medically appropriate

history and/or examination and high medical decision making. When using total time on the date

of the encounter for code selection, 40 minutes must be met or exceeded.); CPT code 9X083

(Synchronous audio-only visit for the evaluation and management of a new patient, which

requires a medically appropriate history and/or examination, straightforward medical decision

making, and more than 10 minutes of medical discussion. When using total time on the date of

the encounter for code selection, 15 minutes must be met or exceeded.)); CPT code 9X084

(Synchronous audio-only visit for the evaluation and management of a new patient, which

requires a medically appropriate history and/or examination, low medical decision making, and

more than 10 minutes of medical discussion. When using total time on the date of the encounter

for code selection, 30 minutes must be met or exceeded.)); CPT code 9X085 (Synchronous

audio-only visit for the evaluation and management of a new patient, which requires a medically

appropriate history and/or examination, moderate medical decision making, and more than 10

minutes of medical discussion. When using total time on the date of the encounter for code

selection, 45 minutes must be met or exceeded.); CPT code 9X086 (Synchronous audio-only visit

for the evaluation and management of a new patient, which requires a medically appropriate

history and/or examination, high medical decision making, and more than 10 minutes of medical

discussion. When using total time on the date of the encounter for code selection, 60 minutes

must be met or exceeded. (For services 75 minutes or longer, use prolonged services code

99417)); CPT code 9X087 (Synchronous audio-only visit for the evaluation and management of

an established patient, which requires a medically appropriate history and/or examination,

straightforward medical decision making, and more than 10 minutes of medical discussion.

When using total time on the date of the encounter for code selection, 10 minutes must be

exceeded.)); CPT code 9X088 (Synchronous audio-only visit for the evaluation and management

of an established patient, which requires a medically appropriate history and/or examination,

low medical decision making, and more than 10 minutes of medical discussion. When using total

time on the date of the encounter for code selection, 20 minutes must be met or exceeded.)); CPT

code 9X089 (Synchronous audio-only visit for the evaluation and management of an established

patient, which requires a medically appropriate history and/or examination, moderate medical

decision making, and more than 10 minutes of medical discussion. When using total time on the

date of the encounter for code selection, 30 minutes must be met or exceeded.)) CPT code 9X090

(Synchronous audio-only visit for the evaluation and management of an established patient,

which requires a medically appropriate history and/or examination, high medical decision

making, and more than 10 minutes of medical discussion. When using total time on the date of

the encounter for code selection, 40 minutes must be met or exceeded. (For services 55 minutes

or longer, use prolonged services code 99417)); CPT code 9X091 (Brief communication

technology-based service (eg, virtual check-in) by a physician or other qualified health care

professional who can report evaluation and management services, provided to an established

patient, not originating from a related evaluation and management service provided within the

previous 7 days nor leading to an evaluation and management service or procedure within the

next 24 hours or soonest available appointment, 5-10 minutes of medical discussion)).

In April 2023, the AMA-RUC noted that the survey instrument they used to develop

valuation recommendations for the telemedicine E/M codes did not include the time (when time

is used for code selection) in the new telemedicine E/M services descriptors, or the E/M services

displayed on the reference service list. The AMA-RUC made interim valuation recommendations

and conducted a new survey for September 2023, which included the minimum required times in

the code descriptors, and those minimum times were the same as appear in existing O/O E/M

services code descriptors (CPT codes 99202-99205, 99212-99215); the new survey in September

2023 included code descriptors and times approved by the CPT Editorial Panel in May 2023.

Also, additional specialties who perform E/M services participated in the second round of this

survey. For CY 2025, the RUC recommended the following work RVUs: a work RVU of 0.93

for CPT code 9X075, a work RVU of 1.6 for CPT code 9X076, a work RVU of 2.6 for CPT code

9X077, a work RVU of 3.50 for CPT code 9X078, a work RVU of 0.70 for CPT code 9X079, a

work RVU of 1.30 for CPT code 9X080, a work RVU of 1.92 for CPT code 9X081, a work

RVU of 2.60 for CPT code 9X082, a work RVU of 0.90 for CPT code 9X083, a work RVU of

1.60 for CPT code 9X084, a work RVU of 2.42 for CPT code 9X085, a work RVU of 3.20 for

CPT code 9X086, a work RVU of 0.65. for CPT code 9X087, a work RVU of 1.20 for CPT code

9X088.

In April 2023, the AMA-RUC Practice Expense Subcommittee approved the direct

practice expense inputs as recommended by the specialty societies without modification, and

CMS received these inputs as recommendations from the RUC. The specialty societies detailed

their methodology for making some changes to specific clinical activity codes to adapt those

clinical activity codes for telemedicine. The AMA edited both CA009 and CA013. The AMA

revision to CA009 deletes, “greet patient, provide gowning”; the AMA revision to CA013

deletes, “Prepare room, equipment and supplies”. CA009 now reads, “Ensure appropriate

medical records are available” and CA013 now reads, “Prepare patient for the visit (i.e. check

audio and/or visual”. The RUC, using the Practice Expense subcommittee recommendations,

also recommended to CMS that a camera and microphone “should be considered typical in the

computer contained in the indirect overhead expense.” This determination is consistent with

CMS’ longstanding position that items that are not specifically attributable to the individual

services should not be included for valuation of specific codes.

The AMA-RUC recommended the direct practice expense inputs as submitted by the

AMA-member specialty societies, and as affirmed by the AMA-RUC Practice Expense

Subcommittee. All supply and equipment costs were zeroed out from the reference services, and

as a result, the new telemedicine E/M codes did not include any supply or equipment costs in the

recommended direct practice expense inputs that the AMA submitted to CMS. The direct PE

inputs removed from the reference services to create the new telemedicine E/M codes are:

CA010 (obtain vital signs), CA024 (clean room/equipment by clinical staff), SA047 (pack, EM

visit), SM022 sanitizing cloth-wipe (surface, instruments, equipment), EQ189 (otoscope-

ophthalmoscope [wall unit]), EF048 (Portable stand-on scale), and EF023 (table, exam).

Sixteen of the telemedicine E/M codes describe use of either audio-video or audio-only

telecommunications technology to furnish the individual service. The CPT Editorial Panel

finalized eight codes for synchronous audio-video services (CPT codes 9X075 to 9X082), and

eight codes for synchronous audio-only services (CPT codes 9X083 to 9X0890), and one code

for an asynchronous service (CPT code 9X091). The audio-video and audio-only code family

subsets have parallel codes for new patients and established patients. Like other E/M codes, these

codes may be reported based on the level of medical decision making (MDM) or total time on

the date of the encounter. For each set of four codes, there is a code that may be reported for a

straightforward, low, moderate and high level of MDM.

The CPT Editorial Panel also established new CPT code 9X091 describing a brief virtual

check-in encounter that is intended to evaluate the need for a more extensive visit (that is, a visit

described by one of the office/outpatient E/M codes). The code descriptor for CPT code 9X091

mirrors existing HCPCS code G2012 (Brief communication technology-based service, e.g.

virtual check-in, by a physician or other qualified health care professional who can report

evaluation and management services, provided to an established patient, not originating from a

related e/m service provided within the previous 7 days nor leading to an e/m service or

procedure within the next 24 hours or soonest available appointment; 5-10 minutes of medical

discussion) and, per the CPT Editorial Panel materials, is intended to replace that code. As

described in CPT Editorial Panel final edits, CPT code 9X091 does not require the use of audio

or video technology and is expected to be patient-initiated. Furnishing the complete service

described by CPT code 9X091 must involve 5-10 minutes of medical discussion (and the code

descriptor does not include MDM as means of code selection). CPT code 9X091 should not be

reported if it originates from a related E/M service furnished within the previous 7 days, or, if the

clinical interaction leads to another E/M or procedure within the next 24 hours or the soonest

available appointment. The final CPT Editorial Panel draft language explains that if the virtual

check-in described by CPT 9X091 leads to an E/M visit in the next 24 hours, and if that E/M is

reported based on time, then the time from the virtual check-in may be added to the time of the

resulting E/M visit to determine the total time on the date of encounter for the resulting E/M. The

RUC recommended a work RVU of 0.30 for 9X091.

The CPT Editorial Panel also deleted three codes (99441-99443) for reporting telephone

E/M services. We note that CPT codes 99441, 99442, and 99443, each are assigned provisional

status on the Medicare telehealth services list, and would return to bundled status when the

telehealth flexibilities expire on December 31, 2024. For further background, we refer readers to

our discussions in previous rulemaking, where CMS explains the rationale for this policy (88 FR

78871-78878).

CMS has a long-standing interpretation of section 1834(m) of the Act as specifying the

circumstances under which Medicare makes payment for services that would otherwise be

furnished in person but are instead furnished via telecommunications technology. Specifically,

section 1834(m)(2)(A) of the Act expressly requires payment to the distant site physician or

practitioner of an amount equal to the amount that such physician or practitioner would have

been paid had such service been furnished without the use of a telecommunications system. This

means that we must pay an equal amount for a service furnished using a “telecommunications

system” as for a service furnished in person (without the use of a telecommunications system). In

the CY 2019 PFS final rule, we stated that “[w]e have come to believe that section 1834(m) of

the Act does not apply to all kinds of physicians’ services whereby a medical professional

interacts with a patient via remote communication technology. Instead, we believe that section

1834(m) of the Act applies to a discrete set of physicians’ services that ordinarily involve, and

are defined, coded, and paid for as if they were furnished during an in-person encounter between

a patient and a health care professional” (83 FR 59483). Under this interpretation, services that

are coded and valued based on the understanding that they are not ordinarily furnished in person,

such as remote monitoring services and communication technology-based services, are not

considered Medicare telehealth services under section 1834(m) of the Act and thus not subject to

the geographic, site of service, and practitioner restrictions included therein.

Information provided to CMS from the RUC indicates that CPT codes 9X075-9X090

describe services that would otherwise be furnished in person, and as such the services described

by these codes are subject to section 1834(m) of the Act. In the summary of the coding changes,

the AMA states that these services are “patterned after the in-person office visit codes.” The draft

CPT prefatory language states that “[t]elemedicine services are used in lieu of an in-person

service when medically appropriate to address the care of the patient and when the patient and/or

family/caregiver agree to this format of care.” The draft CPT prefatory language likewise states

that when a telemedicine E/M is billed on the same day as another E/M service “the elements

and time of these services are summed and reported in aggregate, ensuring that any overlapping

time is only counted once,” which indicates that the work of the telemedicine E/M service is

identical to the work associated with an in-person, non-telehealth E/M. The code descriptors and

requirements for billing the codes generally mirror the existing office/outpatient E/M codes with

the exception of the technological modality used to furnish the service. The audio-video

telemedicine E/M codes have nearly identical recommended work RVUs to parallel

office/outpatient E/M codes. In general, the audio-only telemedicine E/M codes have lower

recommended work RVUs than parallel office/outpatient E/M codes. The RUC stated that this is

because, when surveyed, specialty societies indicated that “the audio-video and in-person office

visits require more physician work than the audio-only office visits.”

Table 10 describes the similarities between 16 of 17 telemedicine E/M codes and the

parallel office/outpatient E/M codes. The table shows that except for the element of “modality”

(that is, audio-video or audio-only), the service elements of the new telemedicine E/M code

family are no different than the O/O E/M codes (for each enumerated row 1 through 16 the

columns display the analogous elements). When comparing code descriptors, as described at the

start of this section,, the only difference (as represented in Table 10 when comparing the

elements of E/M services represented by columns C, D, E, and F) is that these new telemedicine

E/M code descriptors lead with the phrase “synchronous audio-video” or “synchronous audio

only” before describing the visit in full exactly as the existing office/outpatient E/M visit codes

describe a visit in the long descriptor of the analogous service.

TABLE 10: Comparison of Elements and Work RVU between Telemedicine E/M

Codes (9X075 through 9X090) and Office/Outpatient E/M Codes (99202 through 99215)

Telemedicine

E/M HCPCS

RUC-

recommended

Work RVU

Modality

Level of Medical

Decision-

Making

Time

Threshold

(minutes)

New or

Established

Patient?

Analogous

Current

Office/Out

patient

E/M Code

Current

Work

RVU

9X075

0.93

Audio/Vi

deo (A/V)

Straightforward

new

99202

0.93

9X076

1.60

A/V

Low

new

99203

1.60

9X077

2.60

A/V

Moderate

new

99204

2.60

9X078

3.50

A/V

High

new

99205

3.50

9X079

0.70

A/V

Straightforward

established

99212

0.70

9X080

1.30

A/V

Low

established

99213

1.30

9X081

1.92

A/V

Moderate

established

99214

1.92

9X082

2.60

A/V

High

established

99215

2.80

9X083

0.90

Audio-

only

Straightforward

new

99202

0.93

9X084

1.60

Audio-

only

Low

new

99203

1.60

9X085

2.42

Audio-

only

Moderate

new

99204

2.60

9X086

3.20

Audio-

only

High

new

99205

3.50

9X087

0.65

Audio-

only

Straightforward

established

99212

0.70

9X088

1.20

Audio-

only

Low

established

99213

1.30

9X089

1.75

Audio-

only

Moderate

established

99214

1.92

9X090

2.60

Audio-

only

High

established

99215

2.80

There are services already describing audio-video and audio-only telemedicine E/M

codes on the Medicare telehealth services list—the office/outpatient E/M code set—that can be

furnished via synchronous two-way, audio/video communication technology generally and via

audio-only communication technology under certain circumstances to furnish Medicare

telehealth services in the patient’s home for the purpose of diagnosis and treatment of a mental

health disorder or SUD. Additionally, as stated above, section 1834(m)(2)(A) of the Act requires

us to pay an equal amount for a service furnished using a “telecommunications system” as for a

service furnished in person (without the use of a telecommunications system). Were we to accept

the AMA’s recommendations and add the telemedicine E/M codes to the Medicare telehealth

services list, we would need to establish RVUs for the telemedicine E/M codes to equal the

corresponding non-telehealth services to satisfy the requirements for payment under section

1834(m)(2)(A) of the Act.

We do not believe that there is a programmatic need to recognize the audio/video and

audio-only telemedicine E/M codes for payment under Medicare. We are proposing to assign

CPT codes 9X075-9X090 a Procedure Status indicator of “I”, meaning that there is a more

specific code that should be used for purposes of Medicare, which in this case would be the

existing office/outpatient E/M codes currently on the Medicare telehealth services list when

billed with the appropriate POS code to identify the location of the beneficiary and, when

applicable, the appropriate modifier to identify the service as being furnished via audio-only

communication technology.

Section 4113 of the Consolidated Appropriations Act (CAA), 2023 extended the

availability of Medicare telehealth services to beneficiaries regardless of geographic location or

site of service by temporarily removing such statutory restrictions under section 1834(m) of the

Act until the end of 2024. Under the current statute, the geographic location and site of service

restrictions on Medicare telehealth services will once again take effect for services furnished

beginning January 1, 2025. Although there are some important exceptions, including for

behavioral health services and ESRD-related clinical assessments, most Medicare telehealth

services will once again, in general, be available only to beneficiaries in rural areas and only

when the patient is located in certain types of medical settings. As previously discussed, the

introduction of new CPT coding to describe telemedicine E/M services does not change our

authority to pay for visits furnished through interactive communications technology in

accordance with section 1834(m) of the Act. We recognize that there are significant concerns

about maintaining access to care through the use of Medicare telehealth services with the

expiration of the statutory flexibilities that were successively extended by legislation following

the PHE for COVID-19. We understand that millions of Medicare beneficiaries have utilized

interactive communications technology for visits with practitioners for a broad range of health

care needs for almost 5 years. We are seeking comment from interested parties on our

understanding of the applicability of section 1834(m) of the Act to the new telemedicine E/M

codes, and how we might potentially mitigate negative impact from the expiring telehealth

flexibilities, preserve some access, and assess the magnitude of potential reductions in access and

utilization. On the latter point, we note that we have developed proposed PFS payment rates for

CY 2025, including the statutory budget neutrality adjustment, based on the presumption that

changes in telehealth utilization will not affect overall service utilization. We also note that

historically we have not considered changes in the Medicare telehealth policies to result in

significant impact on utilization such that a budget neutrality adjustment would be

warranted. However, we are unsure of the continuing validity of that premise under the current

circumstances where patients have grown accustomed over several years to broad access to

services via telehealth. We are seeking comment on what impact, if any, the expiration of the

current flexibilities would be expected to have on overall service utilization for CY 2025. We

refer readers to section IV.B. of this proposed rule for our discussion of budget neutrality

adjustments.

Given the similarity between CPT code 9X091 and HCPCS code G2012, we are

proposing to accept the RUC-recommended values for CPT code 9X091, and we are proposing

to delete HCPCS code G2012. For CPT code 9X091, we propose to accept the RUC-

recommended work RVU of 0.30, and are proposing the RUC-recommended direct PE inputs.

We note that our proposal does maintain the same direct PE inputs, which the RUC

recommendations leave unchanged from the current G2012 in total amount, and allocate the

same 3 minutes of time to the same level of staff (Clinical Staff code L037D, RN/LPN/MTA).

We believe that the coding and payment recommendations for CPT code 9X091, submitted to

CMS by the AMA RUC, accurately reflect the resources associated with this service and believe

that maintaining separate coding for purposes of Medicare payment could create confusion. We

note that, similar to our current policy for payment of HCPCS code G2012, CPT code 9X091

would be considered a communication technology-based service that is not subject to the

requirements in section 1834(m) of the Act applicable to Medicare telehealth services.

(19) Genetic Counseling Services (CPT code 9X100)

In September 2023, the CPT Editorial Panel deleted CPT code 96040 (Medical genetics

and genetic counseling services, each 30 minutes face-to-face with patient/family) and created

CPT code 9X100 (Medical genetics and genetic counseling services, each 30 minutes of total

time provided by the genetic counselor on the date of the encounter) for medical genetics and

genetic counseling services to be provided by the genetic counselor. Prior to its deletion, CPT

code 96040 would only be reported by genetic counselors for genetic counseling services, though

genetic counselors are not among the practitioners who can bill Medicare directly for their

professional services. As we stated in the CY 2012 PFS final rule (76 FR 73096 through 73097),

physicians and NPPs who may independently bill Medicare for their services and who are

counseling individuals would generally report office or other outpatient E/M CPT codes for

office visits that involve significant counseling, including genetic counseling; therefore CPT

code 96040 was considered bundled into O/O E/M visits.

For CPT code 9X100, we are proposing the RUC-recommended direct PE inputs. We

note that the code descriptor now specifies that the service is provided by a genetic counselor,

therefore we considered assigning Procedure Status “X” to CPT code 9X100. Because the PE

RVUs would not display for the code with that assignment and that may impact access to the

service with other payors, we are instead proposing bundled status (Procedure Status “B”) for

CPT code 9X100 to maintain the status of predecessor CPT code 96040, and we are seeking

feedback from interested parties regarding the appropriate procedure status for this code. CPT

guidelines for CPT code 9X100 state that a physician or other qualified healthcare professional

(QHP) who may report evaluation and management services would not be able to report CPT

code 9X100. Instead, these physicians and QHPs would use the appropriate evaluation and

management code.

(20) COVID Immunization Administration (CPT code 90480)

On August 14, 2023, new CPT codes were created to consolidate over 50 previously

implemented codes and streamline the reporting of immunizations for the novel coronavirus

(SARS-CoV-2, also known as COVID-19). The CPT Editorial Panel approved the addition of a

single administration code (CPT code 90480) for administration of new and existing COVID-19

vaccine products. The RUC reviewed the specialty societies’ recommendations for this code at

the September 2023 RUC meeting.

We are proposing the RUC-recommended work RVU of 0.25 for CPT code 90480

(Immunization administration by intramuscular injection of severe acute respiratory syndrome

coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, single dose). We are

also proposing the RUC-recommended direct PE inputs for CPT code 90480 without refinement.

(21) Optical Coherence Tomography (CPT codes 92132, 92133, 92134, and 9X059)

At the February 2023 CPT Editorial Panel meeting, CPT code 9X059 (Computerized

ophthalmic diagnostic imaging (eg, optical coherence tomography [OCT]), posterior segment,

with interpretation and report, unilateral or bilateral; retina including OCT angiography) was

created in response to new technology that allows imaging of the retina using optical coherence

tomography (OCT) with and without non-dye OCT angiography (OCT-A). This code family also

includes CPT code 92132 (Computerized ophthalmic diagnostic imaging (eg, optical coherence

tomography [OCT]), anterior segment, with interpretation and report, unilateral or bilateral),

CPT code 92133 (Computerized ophthalmic diagnostic imaging (eg, optical coherence

tomography [OCT]), posterior segment, with interpretation and report, unilateral or bilateral;

optic nerve) , and CPT code 92134 (Computerized ophthalmic diagnostic imaging (eg, optical

coherence tomography [OCT]), posterior segment, with interpretation and report, unilateral or

bilateral; retina). These codes were reviewed at the April 2023 RUC meeting. The RUC

determined the survey results were inaccurate due to underestimation of time, so the entire code

family was re-surveyed and reviewed at the September 2023 RUC meeting.

We are proposing the RUC-recommended work RVUs for all codes within the Optical

Coherence Tomography code family. We are proposing a work RVU of 0.29 for CPT code

92132, a work RVU of 0.31 for CPT code 92133, a work RVU of 0.32 for CPT code 92134, and

a work RVU of 0.64 for CPT code 9X059. We are also proposing the RUC-recommended direct

PE inputs for all four codes in the family.

(22) Transcranial Doppler Studies (CPT codes 93886, 93888, 93892, 93893, 93X94, 93X95,

93X96, and 93890)

The RUC’s Relativity Assessment Workgroup (RAW) requested action plans in

September 2022 to determine if specific code bundling solutions should occur for CPT codes

93890/93886, 93890/93892, 93892/93886, and 93892/93890. The RAW referred this issue to the

CPT Editorial Panel which created three new add-on codes to report when additional studies are

performed on the same date of services as a complete transcranial Doppler study. The RUC

reviewed these three new add-on codes, as well as CPT codes 93886, 93888, 93892 and 93893

for the September 2023 RUC meeting.

We are proposing the RUC-recommended work RVU for all seven codes in the

Transcranial Doppler Studies code family. We are proposing a work RVU of 0.90 for CPT code

93886 (Transcranial Doppler study of the intracranial arteries; complete study), a work RVU of

0.73 for CPT code 93888 (Transcranial Doppler study of the intracranial arteries; limited

study), a work RVU of 1.15 for CPT code 93892 (Transcranial Doppler study of the intracranial

arteries; emboli detection without intravenous microbubble injection), a work RVU of 1.15 for

CPT code 93893 (Transcranial Doppler study of the intracranial arteries; venous-arterial shunt

detection with intravenous microbubble injection), a work RVU of 0.81 for CPT code 93X94

(Vasoreactivity study performed with transcranial Doppler study of intracranial arteries,

complete), a work RVU of 0.73 for CPT code 93X95 (Emboli detection without intravenous

microbubble injection performed with transcranial Doppler study of intracranial arteries,

complete), and a work RVU of 0.85 for CPT code 93X96 (Venous-arterial shunt detection with

intravenous microbubble injection performed with transcranial Doppler study of intracranial

arteries, complete). We are also proposing the direct PE inputs as recommended by the RUC for

all seven codes in this family.

We note that the billing instructions for this code family specify that the three new add-

on codes should be used in conjunction with CPT code 93886, and that CPT code 93888 should

not be used in conjunction with CPT codes 93886, 93892, 93893, 93X94, 93X95, and 93X96.

However, we believe that it would be beneficial for the CPT Editorial Panel to state more

explicitly that CPT code 93X95 should not be used in conjunction with CPT code 93892 and that

CPT code 93X96 should not be used in conjunction with CPT code 93893. The work performed

in the add-on codes would be duplicative of the base codes in these situations and result in

unnecessary overbilling of services.

(23) RSV Monoclonal Antibody Administration (CPT codes 96380 and 96381)

At the September 2023 CPT meeting, the CPT Editorial Panel created two codes to report

passive administration of respiratory syncytial virus, monoclonal antibody, seasonal dose, with

and without counseling. CPT codes 96380 and 96381 were reviewed the following week at the

September 2023 RUC meeting and the RUC submitted recommendations to CMS.

We are proposing the RUC-recommended work RVU of 0.24 for CPT code 96380

(Administration of respiratory syncytial virus, monoclonal antibody, seasonal dose by

intramuscular injection, with counseling by physician or other qualified health care

professional) and the RUC-recommended work RVU of 0.17 for CPT code 96381

(Administration of respiratory syncytial virus, monoclonal antibody, seasonal dose by

intramuscular injection). We understand that these are interim work recommendations from the

RUC, and that the RUC intends to conduct a more complete review at a future RUC meeting

which we would then consider in future rulemaking. We are also proposing the direct PE inputs

as recommended by the RUC for both codes.

(24) Hyperthermic Intraperitoneal Chemotherapy (CPT codes 96547 and 96548)

In September 2022, the CPT Editorial Panel created two time-based add-on Category I

codes, CPT code 96547 (Intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC)

procedure, including separate incision(s) and closure, when performed; first 60 minutes (List

separately in addition to code for primary procedure)) and CPT code 96548 (Intraoperative

hyperthermic intraperitoneal chemotherapy (HIPEC) procedure, including separate incision(s)

and closure, when performed; each additional 30 minutes (List separately in addition to code for

primary procedure)), to report HIPEC procedures for 2024. At the January 2023 RUC meeting,

the RUC reached the conclusion that the survey data was flawed due to a lack of work definition

and guidelines, and the RUC recommended contractor pricing for CPT codes 96547 and 96548

for CY 2024 with further clarification from the CPT editorial panel. CMS proposed and finalized

contractor pricing for CPT codes 96547 and 96548 for 2024. At the May 2023 CPT Editorial

Panel meeting, new guidelines and descriptions of work activities were approved and the codes

were resurveyed for the September 2023 RUC meeting with recommendations for national

pricing.

We are proposing the RUC-recommended work RVU of 6.53 for CPT code 96547 and

the RUC-recommended work RVU of 3.00 for CPT code 96548. The RUC did not recommend,

and we are not proposing, any direct PE inputs for the Hyperthermic Intraperitoneal

Chemotherapy codes (CPT codes 96547 and 96548).

(25) Laser Treatment - Skin (CPT codes 96920, 96921, and 96922)

In April 2022, the RUC referred CPT codes 96920 (Excimer laser treatment for

psoriasis; total area less than 250 sq cm), 96921 (Excimer laser treatment for psoriasis; 250 sq

cm to 500 sq cm), and 96922 (Excimer laser treatment for psoriasis; over 500 sq cm) to the CPT

Editorial Panel to capture expanded indications beyond what was currently noted in the codes’

descriptions to include laser treatment for other inflammatory skin disorders such as vitiligo,

atopic dermatitis, and alopecia areata, which could result in changed physician work based on the

expanded indications. The coding change application was subsequently withdrawn from the

September 2023 CPT Editorial meeting when it was determined that existing literature was

insufficient and did not support expanded indications at that time. Therefore, these CPT codes

were re-surveyed and reviewed at the April 2023 RUC meeting without any revisions to their

code descriptors.

We disagree with the RUC-recommended work RVUs for CPT codes 96920, 96921, and

96922 of 1.00, 1.07, and 1.32, respectively. The RUC noted that there have been multiple

reviews of these CPT codes, and the valuation of the codes is currently based on the original

valuation over two decades ago in 2002 where the physician time values were lower than the

current times. A subsequent review in 2012 adopted new survey times while maintaining the

work RVUs from 2002 for CPT codes 96920 and 96922. The RUC noted that, for both CPT code

96920 and 96922 with the largest treatment area, the total times have not changed since first

implemented more than 20 years ago. While we understand that the physician times have

fluctuated over the course of several years and several reviews, yet the work RVUs have

remained mostly constant as shown in Table 11, this was not addressed in the 2012

recommendations, and we believe that our operating assumption regarding the validity of the

existing values as a point of comparison is critical to the integrity of the relative value system as

currently constructed. The work times currently associated with codes play a very important role

in PFS ratesetting, both as points of comparison in establishing work RVUs and in the allocation

of indirect PE RVUs by specialty. If we were to operate under the assumption that previously

recommended work times had been routinely over or underestimated, this would undermine the

relativity of the work RVUs on the PFS in general, in light of the fact that codes are often valued

based on comparisons to other codes with similar work times. We also believe that, since the two

components of work are time and intensity, absent an obvious or explicitly stated rationale for

why the relative intensity of a given procedure has increased, significant decreases in time

should be reflected in decreases to work RVUs.

TABLE 11: Physician Time and RVUs for CPT Codes 96920, 96921, and 96922

CPT Code

Intraservice

Time

Total Time

RUC

Recommended Work

RVU

2002

1.15

Current (from 2012)

1.15

96920

Recommended

1.00

2002

1.17

Current (from 2012)

1.30

96921

Recommended

1.07

2002

2.10

Current (from 2012)

2.10

96922

Recommended

1.32

For CPT code 96920, we are proposing a work RVU of 0.83 based on a crosswalk to

CPT code 11104 (Punch biopsy of skin (including simple closure, when performed); single

lesion), which has the same 10 minutes of intraservice time and 23 minutes of total time as CPT

code 96920. We note that of the 15 other 000-day global codes with a total time of 20 to 25

minutes, only four codes fall above the RUC-recommended work RVU of 1.00. While we

understand that commenters will dispute the validity of the current time values, we note that the

2002 intraservice time was 17 minutes, which yields an intraservice time ratio between the 2002

intraservice time and the recommended intraservice time of 10 minutes of 0.68 work RVUs ((10

minutes/17 minutes) * 1.15). We note our proposed work RVU of 0.83 maintains the intensity

associated with the 2002 review of CPT code 96920, which we believe to be more appropriate

than the significant increase in intensity that results from the RUC-recommended work RVU of

1.00 which nearly doubles the current intensity of the code. We have no evidence to indicate that

the intensity of CPT code 96920 is increasing to this degree given how the surveyed work time is

substantially decreasing.

For CPT code 96921, we are proposing a work RVU of 0.90 based on a total time ratio to

CPT code 96920 ((25/23)*0.83) and a crosswalk to CPT code 11301 (Shaving of epidermal or

dermal lesion, single lesion, trunk, arms or legs; lesion diameter 0.6 to 1.0 cm), which has 3

additional minutes of intraservice time and 1 additional minute of total time compared to CPT

code 96921. We also note that our proposed work RVU of 0.90 for CPT code 96921 maintains

the RUC-recommended incremental difference between CPT codes 96920 and 96921 of 0.07

work RVUs. Like CPT code 96920, we understand that commenters will dispute the validity of

the current time values, but we note that the 2002 intraservice time was 20 minutes, which yields

an intraservice time ratio between the 2002 intraservice time and the recommended intraservice

time of 12 minutes of 0.70 work RVUs ((12 minutes/20 minutes) * 1.17). Like CPT code 96920,

we note that proposed work RVU of 0.90 for CPT code 96921 maintains the intensity associated

with the 2002 review of CPT code 96921, which we believe is more appropriate than the

intensity increase that results from the RUC-recommended work RVU of 1.07 which again

nearly doubles the current intensity of the code.

For CPT code 96922, we are proposing a work RVU of 1.15 based on the RUC-

recommended incremental difference between CPT codes 96921 and 96922 of 0.25 work RVUs.

Like CPT code 96920 and 96921, we understand that commenters will dispute the validity of the

current time values, but we note that the 2002 intraservice time was 30 minutes, which yields an

intraservice time ratio between the 2002 intraservice time and the recommended intraservice

time of 18 minutes of 1.26 work RVUs ((18 minutes/30 minutes) * 2.10). We note that the RUC

recommended CPT code 96922 as having the lowest intensity of the three codes in this family

and that our proposed work RVU of 1.15 maintains in relationship to the other codes.

For the direct PE inputs, we are proposing to refine the clinical staff time for the CA024

activity “Clean room/equipment by clinical staff” to the standard of 3 minutes for CPT codes

96920, 96921, and 96922. We note that 3 minutes is the current CA024 time for these three CPT

codes. A rationale for extending clinical staff beyond the standard 3 minutes for the CA024

activity was absent from the PE Summary of Recommendations, therefore we believe the current

and standard 3 minutes is more appropriate than the RUC-recommended 5 minutes. We are also

proposing equipment times of 36, 38, and 44 minutes for the power table (EF031) and exam light

(EQ168) equipment for CPT codes 96920, 96921, and 96922, respectively, to account for the

proposed refinement for CA024 to the standard 3 minutes.

We also disagree with the RUC-recommended creation of new supply items for the

excimer laser and are proposing to re-include the equipment time for the excimer laser (EQ161)

using the current methodology where its cost is accounted for in the equipment of these CPT

codes’ direct PE. The RUC submitted recommendations to change this equipment item to new

supply items to account for the per-use cost to rent the equipment, stating that the business model

has changed from the standard equipment ownership that CMS recognizes using standardized

equipment formulas to a per-use rental or subscription model. While we understand that there

may have been a change in business model, we do not believe a rental, subscription, or per-use

fee of an equipment item that is still available to be purchased and is already accounted for with

our equipment methodology is appropriate, especially given its implications for direct PE costs

for these CPT codes. Therefore, we are proposing reincorporating equipment times of 36, 38, and

44 minutes for the EQ161 equipment for CPT codes 96920, 96921, and 96922, respectively,

based on the refined service period clinical labor times. We are proposing to remove the three

pay-per-use excimer lasers listed as supplies and recommended by the RUC for these three

codes.

We have repeatedly stated in past rulemaking that rental and licensing fees are typically

considered forms of indirect PE under our methodology. In the CY 2020 PFS final rule, we

omitted the inclusion of several invoices for the monthly rental price of a PET infusion cart

(ER109), and only accounted for the four purchase invoices for the equipment. We noted as well

for future reference that although we appreciated the submission of the rental invoices, we were

unable to use invoices for a monthly rental fee to determine the typical purchase price for

equipment. We believe that invoices for a monthly rental fee would not be representative of the

purchase price for equipment, in the same fashion that the rental fee for a car differs from its

purchase price (84 FR 62771). Similarly, while we appreciate the submission of per-use, rental,

and partnership invoices for the excimer laser, we believe that the excimer laser is appropriately

and adequately accounted for in the equipment formula, and note that EQ161 has a very high

cost per minute of $0.5895/minute. Compared to the nearly 700 other equipment items in our

database, only 55 equipment items have higher costs per minute (based on our standardized

formula which accounts for years of useful life, utilization rate, purchase price, and minutes per

year of use, discussed in detail in section II.B. of this proposed rule, Determination of PE RVUs)

and only 53 equipment items have higher purchase prices than the excimer laser at $151,200. We

do not believe that CPT codes 96920 through 96922 should be valued based on a significantly

more expensive pay-per-use rental version of the excimer laser when the same treatment is

cheaper and available as a purchasable form of equipment.

Therefore, we are seeking comment on the difference in direct PE costs between the

purchase and per-use rental of the laser. We note that using the equipment cost per minute

formula, discussed in detail of section II.B. of this proposed rule, Determination of PE RVUs,

yields direct PE costs of about $21.22, $22.40, and $25.94 for CPT codes 96920, 96921, 96922,

respectively. Alternatively, the new supply items for the per-use fee of the laser yielded direct PE

costs of $80, $83, and $100 for CPT codes 96920, 96921, 96922, respectively. These direct PE

disparities represent a 277 percent, 270.5 percent, and 285.5 percent increase for CPT codes

96920, 96921, 96922, respectively. Given this, we are interested in feedback from interested

parties on the payment disparity between this equipment as a per-use or rental versus how we

currently account for the purchase of equipment using the standard equipment formula, as we

understand that both manufacturers and physicians may be inclined to shift to a per-use or rental

business models to limit overhead for purchase and maintenance of expensive equipment.

(26) Physical Medicine and Rehabilitation (CPT codes 97012, 97014, 97016, 97018, 97022,

97032, 97033, 97034, 97035, 97110, 97112, 97113, 97116, 97140, 97530, 97533, 97535, 97537,

and 97542 and HCPCS code G0283)

The RUC’s Health Care Professionals Advisory Committee (HCPAC) previously

reviewed 19 physical medicine and rehabilitation codes in February 2017. In the CY 2024 PFS

proposed rule, CMS received public nominations on these same 19 therapy codes as potentially

misvalued (88 FR 78851-78852). An interested party asserted that the direct PE clinical labor

minutes reflected inappropriate multiple procedure payment reductions (MPPR), which were

duplicative of the CMS MPPR policy implemented in CMS’ claims processing systems. CMS

reviewed the clinical labor time entries for these 19 therapy codes and concluded that a payment

reduction should not have been applied in some instances to the 19 nominated therapy codes’

clinical labor time entries since the payment valuation reduction would be duplicative of the

MPPR applied during claims processing. CMS indicated that the valuation of these services

would benefit from additional review through the RUC’s HCPAC valuation process; they were

therefore reviewed by the HCPAC for PE only, with no work review, at the January 2024 RUC

meeting for inclusion in the CY 2025 PFS proposed rule.

The HCPAC’s direct PE recommendations were based on the typical number of services

reported per session, which was 3.5 units according to CMS data, to ensure that there was no

duplication in the standard inputs for preservice and postservice time. To account for the MPPR,

the HCPAC determined that 3.5 codes are billed per session, with the first paid at 100% and the

second and subsequent units paid at half and so forth for PE (for example, 1.00 + 0.5 + 0.5 +

0.25 = 2.25). This resulted in the HCPAC recommending that many of the standard clinical labor

times be divided by 2.25 to account for the MPPR, such as taking the standard 3 minutes for

greeting and gowning the patient and dividing it by 2.25 to arrive at the recommended time of

1.33 minutes (1.33 + 0.67 + 0.67 + 0.34 = 3 minutes). In most cases, the HCPAC recommended

using the standard equipment time formula aside from a few exceptions such as the use of the

whirlpool in CPT code 97022 which would require additional time for the cleaning of the

equipment.

Following the January 2024 RUC meeting, representatives from the American Physical

Therapy Association (APTA) and the American Occupational Therapy Association (AOTA) met

with CMS to express concern with the HCPAC’s recommended direct PE inputs for this family

of codes. Representatives from these trade associations stated that the HCPAC had

inappropriately recommended too few equipment minutes for these procedures. These interested

parties requested utilizing an alternate equipment time formula for the 19 reviewed therapy codes

based on adding together the intraservice work time together with the clinical labor for the

preservice and postservice portion of the service period. For 17 of the 19 reviewed therapy

codes, this alternate equipment time formula would result in an increase over the HCPAC’s

equipment time recommendations. Table 12 lists the direct PE costs of each HCPCS code under

their current pricing, under the HCPAC recommendations, and the alternate APTA and AOTA

recommendations:

TABLE 12: Direct PE Costs for Physical Medicine and Rehabilitation Codes

HCPCS

Current

HCPAC

APTA/AOTA

Utilization

97012

2.62

3.22

3.30

434,921

97014

3.60

4.16

4.33

ProcStat "I"

97016

2.94

3.50

3.67

876,440

97018

2.29

2.92

2.96

146,909

97022

8.04

7.27

7.18

135,480

97032

2.61

3.17

3.34

621,599

97033

6.61

6.74

6.90

33,953

97034

4.08

4.17

6,964

97035

4.03

4.41

4.65

1,358,936

97110

8.42

8.63

9.11

61,204,041

97112

10.23

9.87

11.08

24,990,205

97113

13.89

14.65

14.61

1,588,852

97116

8.35

8.58

9.03

4,011,592

97140

7.25

8.09

8.21

28,413,744

97530

15.01

14.38

16.40

29,187,934

97533

35.72

36.56

36.69

60,507

97535

11.50

11.64

12.67

3,118,258

97537

9.69

10.09

10.78

15,556

97542

9.26

9.41

10.42

98,989

G0283

3.60

4.16

4.33

5,721,078

After consideration of these recommendations, we are proposing the direct PE inputs as

recommended by the HCPAC for all 19 codes in the Physical Medicine and Rehabilitation code

family. We believe that the HCPAC’s equipment time recommendations better maintain

relativity with the rest of the fee schedule through primarily using standard equipment time

formulas, along with limited exceptions for additional equipment time in cases where more time

for equipment cleaning or patient positioning would be typical. We also believe that the alternate

equipment time formula recommended by APTA and AOTA leads to inconsistent equipment

times for many of these procedures, such as recommending 23.98 equipment minutes for CPT

code 97110 which is a timed code billed in 15-minute increments. Although we agree that some

additional equipment time beyond the timed 15 minutes would be typical for setup and cleaning,

9 additional minutes for each billing of CPT code 97110 would not appear to reflect typical

equipment usage.

Given the complexity of determining appropriate direct PE inputs across multiple billings

of these therapy codes, and the need to factor in the MPPR, we believe that this code family may

benefit from additional review, specifically review focused on the subject of appropriate

equipment minutes. The HCPAC review of these codes was primarily focused on the clinical

labor portion of the PE inputs and the equipment times did not receive the same degree of

scrutiny as the clinical labor. We believe that the HCPAC’s recommended direct PE inputs are

the most accurate values based on the current information that we have available, however this is

a topic that may warrant additional review to ensure that this family of codes is properly valued.

(27) Acupuncture - Electroacupuncture (CPT codes 97810, 97811, 97813, and 97814)

In September 2022, the RUC’s Relativity Assessment Workgroup identified the

acupuncture codes with 2020 Medicare utilization over 10,000 where the service was surveyed

by one specialty but is now performed by a different specialty. CPT codes 97810-97814 were

selected and surveyed for the April 2023 RUC meeting.

For CY 2025, we are proposing the RUC-recommended work RVUs for all four CPT

codes. We are proposing a work RVU of 0.61 for CPT code 97810 (Acupuncture, 1 or more

needles; without electrical stimulation, initial 15 minutes of personal one-on-one contact with

the patient), a work RVU of 0.46 for CPT code 97811 (Acupuncture, 1 or more needles; without

electrical stimulation, each additional 15 minutes of personal one-on-one contact with the

patient, with re-insertion of needle(s) (List separately in addition to code for primary

procedure)), a work RVU of 0.74 for CPT Code 97813 (Acupuncture, 1 or more needles; with

electrical stimulation, initial 15 minutes of personal one-on-one contact with the patient), and a

work RVU of 0.47 for CPT code 97814 (Acupuncture, 1 or more needles; with electrical

stimulation, each additional 15 minutes of personal one-on-one contact with the patient, with re-

insertion of needle(s) (List separately in addition to code for primary procedure)). We are also

proposing the RUC-recommended direct PE inputs for CPT codes 97810, 97811, 97813 and

97814 without refinement.

(28) Annual Alcohol Screening (HCPCS codes G0442 and G0443)

In April 2022, the Relativity Assessment Workgroup identified services with Medicare

utilization of 10,000 or more that have increased by at least 100 percent from 2015 through 2020,

including HCPCS codes G0442 (Annual alcohol misuse screening, 5 to 15 minutes) and G0443

(Brief face-to-face behavioral counseling for alcohol misuse, 15 minutes). In September 2022,

the RUC recommended that these services be surveyed for April 2023 after CMS published the

revised code descriptor for HCPCS code G0442 in the CY 2023 PFS final rule (87 FR 69523).

We are proposing the RUC-recommended work RVU of 0.18 for HCPCS code G0442

(Annual alcohol misuse screening, 5 to 15 minutes). We are also proposing the RUC-

recommended work RVU of 0.60 for HCPCS code G0443 (Brief face-to-face behavioral

counseling for alcohol misuse, 15 minutes).

The RUC recommended an increase in the work RVU for HCPCS code G0443 from 0.45

to 0.60 which we believe is warranted based on time and intensity of the service in preventing

alcohol misuse. In valuing this code, the time and work valuation is for separate and distinct

services from same-day E/M services since HCPCS codes G0442 and G0443 are typically billed

with an annual wellness visit (AWV) or office visit. We believe that the codes in the adjacent

Behavioral Counseling & Therapy family, which includes HCPCS codes G0445 (High intensity

behavioral counseling to prevent sexually transmitted infection; face-to-face, individual,

includes: education, skills training and guidance on how to change sexual behavior; performed

semi-annually, 30 minutes), G0446 (Annual, face-to-face intensive behavioral therapy for

cardiovascular disease, individual, 15 minutes), and G0447 (Face-to-face behavioral counseling

for obesity, 15 minutes), may be undervalued as their respective intensities may be lower than

what is warranted for these services. We believe that the intensity for these G-codes may be

more in line with the intensity of HCPCS code G0443 which we noted had an increase in

intensity as recommended by the RUC. As such, we believe that the Behavioral Counseling &

Therapy codes may benefit from additional review in the future to recognize the intensity of

these services.

We are proposing to maintain the current 15 minutes of clinical labor time for the CA021

“Perform procedure/service---NOT directly related to physician work time” activity for HCPCS

code G0442. This clinical labor activity is specifically noted as not corresponding to the

surveyed work time of 5 minutes, and we do not believe that it would be typical for the clinical

staff to administer the questionnaire, clarify questions as needed, and record the answers in the

patient’s electronic medical record in the RUC-recommended 5 minutes. We believe that the

current 15 minutes of clinical labor time would be more typical to ensure the accuracy of this

screening procedure. We are also proposing to maintain 15 minutes of corresponding equipment

time for the EF023 exam table as a result of our proposed clinical labor time refinement. We are

proposing the RUC-recommended direct PE inputs for HCPCS code G0443 without refinement.

We thank the RUC for their review of this code family and for highlighting an important

consideration specifically for services that fall under the Medicare preventive services benefit.

We are now considering how best to implement and maintain payment for preventive services

and may develop new payment policies in future rulemaking to address this issue more

comprehensively to ensure consistent access to these services. We considered the recommended

PE inputs for this code family, as well as for the Annual Depression Screening (HCPCS code

G0444) and Behavioral Counseling & Therapy services (HCPCS codes G0445, G0446, and

G0447) within this context, as noted below.

(29) Annual Depression Screening (HCPCS code G0444)

In 2012, HCPCS code G0444 (Annual depression screening, 5 to 15 minutes) was added

to the PFS (77 FR 68955 and 68956) to report annual depression screening for adults in primary

care settings that have staff-assisted depression care supports in place to assure accurate

diagnosis, treatment and follow up. In April 2022, the Relativity Assessment Workgroup

identified this service with Medicare utilization of 10,000 or more that have increased by at least

100 percent from 2015 through 2020. In September 2022, the RUC recommended that this

service be surveyed for April 2023 after CMS published the revised code descriptor in the CY

2023 PFS final rule (87 FR 69523).

We are proposing the RUC-recommended work RVU of 0.18 for HCPCS code G0444.

We are proposing to maintain the current 15 minutes of clinical labor time for the CA021

“Perform procedure/service---NOT directly related to physician work time” activity for HCPCS

code G0444. This clinical labor activity is specifically noted as not corresponding to the

surveyed work time of 5 minutes, and we do not believe that it would be typical for the clinical

staff to administer the questionnaire, clarify questions as needed, and record the answers in the

patient’s electronic medical record in the RUC- recommended 5 minutes. We believe that the

current 15 minutes of clinical labor time would be more typical to ensure the accuracy of this

screening procedure. We are also proposing to maintain 15 minutes of corresponding equipment

time for the EF023 exam table as a result of our proposed clinical labor time refinement.

(30) Behavioral Counseling & Therapy (HCPCS codes G0445, G0446, and G0447)

CMS created HCPCS codes G0445 (High intensity behavioral counseling to prevent

sexually transmitted infection; face-to-face, individual, includes education, skills training and

guidance on how to change sexual behavior; performed semi-annually, 30 minutes), G0446

(Annual, face-to-face intensive behavioral therapy for cardiovascular disease, individual, 15

minutes), and G0447 (Face-to-face behavioral counseling for obesity, 15 minutes) effective with

the 2012 Medicare PFS (77 FR 68892). HCPCS codes G0445-G0447 were identified to be

reviewed at the April 2023 RUC meeting because they were services with Medicare utilization of

10,000 or more that had increased by at least 100% from 2015 through 2020.

The specialty societies surveyed HCPCS codes G0445-G0447 for the April 2023 RUC

meeting but did not obtain the required number of survey responses. After the resurvey, which

occurred after the April 2023 RUC meeting, the specialty societies were again unable to achieve

the required minimum number of survey responses for any of the codes in this family for the

September 2023 RUC meeting. The RUC reviewed HCPCS codes G0445-G0447 at the

September 2023 RUC meeting. Given the insufficient number of survey responses and

considering that these are CMS-created time-based codes, the RUC determined it would be most

appropriate to maintain the current work values and flagged these codes for review in 3 years.

We are proposing the RUC-recommended work RVU of 0.45 for each of these three HCPCS

codes, G0445-G0447.

We are not proposing the RUC-recommended direct PE inputs for these codes because of

the insufficient number of survey responses, and further, we do not agree with some of the

RUC’s refinements to the direct PE inputs for this service. We are not proposing the RUC-

recommended direct PE inputs for G0445, G0446, and G0447, which include the SK062 patient

education booklet being eliminated in favor of the SK057 paper, laser printing (each sheet) in the

amount of 10 sheets and the equipment minutes being modified to equal the sum of clinical staff

time plus the physician/QHP time as reflected by the survey median. We do not agree that these

changes are substantiated given the insufficient number of survey responses and we are

proposing to maintain the current values for each of these direct PE inputs.

We are proposing the RUC recommended refinements to clinical staff time for HCPCS

code G0445. We are proposing to move two minutes from CA021 Perform procedure/service---

NOT directly related to physician work time to CA035 Review home care instructions,

coordinate visits/prescriptions. We agree with the RUC that this more accurately reflects the

clinical work involved in arranging follow-up and/or referrals with clinical and community

resources and providing educational materials. Currently, for HCPCS code G0445, PE includes a

whip mixer (EP086) and biohazard hood (EP016) among the equipment assigned to the code.

We are also proposing the RUC recommendations to eliminate both of these pieces of equipment

from the PE for HCPCS code G0445.

We note that the Behavioral Counseling & Therapy code family (HCPCS codes G0445-

G0447) should be reviewed in the future by the RUC and we anticipate the recommendations

that will come from the review for this family.

(31) Autologous Platelet Rich Plasma (HCPCS code G0465)

HCPCS code G0465 (Autologous platelet rich plasma (prp) or other blood-derived

product for diabetic chronic wounds/ulcers, using an fda-cleared device for this indication,

(includes as applicable administration, dressings, phlebotomy, centrifugation or mixing, and all

other preparatory procedures, per treatment)) was created for CY 2022 (retroactively dated back

to the effective date of the policy, April 13, 2021) and assigned contractor pricing (NCD 270.3,

CR 12403).

Following the publication of the CY 2023 PFS proposed rule, we received two comments

on the pricing of HCPCS code G0465, and the 3C patch system supply which is topically applied

for the management of exuding cutaneous wounds, such as leg ulcers, pressure ulcers, and

diabetic ulcers and mechanically or surgically debrided wounds (87 FR 69420). One commenter

submitted invoices associated with the pricing of the 3C patch system (SD343) supply for which

we established a price of $625.00 in the CY 2021 PFS final rule (85 FR 84498). The commenter

requested that CMS update its supply database based on invoices submitted for SD343 to reflect

an updated price of $750.00 per unit. The commenter also requested national pricing for HCPCS

code G0465, expressing concern that insufficient payment disproportionately impacts vulnerable

populations. The commenter requested a payment rate of $1,408.90 for HCPCS G0465 in the

office setting, stating that this rate would appropriately account for the purchase of the 3C patch,

as well as the other related costs and supply inputs required for point of care creation and

administration.

In response, we stated in the CY 2023 PFS final rule that we did not have enough

information to establish national pricing at this time for HCPCS code G0465 (87 FR 69420). We

stated that we would consider the commenters’ feedback for future rulemaking while

maintaining contractor pricing for CY 2023, which would allow for more flexibility for

contractors to establish appropriate pricing using available information. We appreciated the

invoice submission with additional pricing information for the SD343 supply and we updated our

supply database for supply code SD343 at a price of $678.57 based on an average of the

submitted invoices.

Since the publication of the CY 2023 PFS final rule, interested parties have continued to

request national pricing for HCPCS code G0465 due to their perception of inconsistent and

insufficient payment for this service by the MACs. CMS has asked the interested parties to

engage with the MACs to establish adequate payment for HCPCS code G0465. The interested

parties have continued to state that most MACs have not established consistent payment rates

and the rates are heterogeneous; some are significantly below the cost of performing this service,

leading to an unpredictable process and inadequate rates, creating barriers to access this service.

Due to these concerns, we are therefore proposing to establish national pricing for

HCPCS code G0465 for CY 2025. We are proposing to value HCPCS code G0465 using a

crosswalk to CPT code 15271 (Application of skin substitute graft to trunk, arms, legs, total

wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area), drawing from a

selection of relevant studies.

17,18,19,20

We are proposing a work RVU of 1.50 for HCPCS code

G0465 based on the crosswalk to CPT code 15271 because wound surface area sizes in current

literature appear to be less than 100 sq cm for patients with diabetes and/or chronic ulcers. We

are also proposing to use the direct PE inputs included with CPT code 15271 for valuing HCPCS

code G0465, with the additional inclusion of the 3C patch system (SD343) supply that we priced

in CY 2023. We note that the payment includes debridement, which may involve a wound

reaching the bone. Therefore, debridement may not be billed separately. In addition, we are

currently seeking comments on other available crosswalks from the broader medical community.

For example, CPT code 15277 (Application of skin substitute graft to face, scalp, eyelids, mouth,

neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area greater

than or equal to 100 sq cm; first 100 sq cm wound surface area, or 1% of body area of infants

and children) with a work RVU of 4.00 and CPT code 15273 (Application of skin substitute graft

to trunk, arms, legs, total wound surface area greater than or equal to 100 sq cm; first 100 sq cm

wound surface area, or 1% of body area of infants and children) with a work RVU of 3.50 could

also be viable crosswalk options. We are soliciting comments regarding our selection of CPT

code 15271 as a crosswalk code, as well as general comments and available studies regarding the

appropriate valuation of HCPCS code G0465.

(32) Temporary Female Intraurethral Valve-Pump (CPT codes 0596T and 0597T)

In the CY 2024 PFS proposed rule, an interested party nominated two Category III CPT

codes, CPT codes 0596T (Initial insertion of temporary valve-pump in female urethra) and

0597T (Replacement of temporary valve-pump in female urethra), as potentially misvalued. The

Gethin, G et al. “The profile of patients with venous leg ulcers: A systematic review and global

perspective.” Journal of tissue viability vol. 30,1 (2021): 78-88. doi:10.1016/j.jtv.2020.08.003.

Sheehan, Peter et al. “Percent change in wound area of diabetic foot ulcers over a 4-week period is a robust

predictor of complete healing in a 12-week prospective trial.” Plastic and reconstructive surgery vol. 117,7 Suppl

(2006): 239S-244S. doi:10.1097/01.prs.0000222891.74489.33.

Oyibo, S O et al. “The effects of ulcer size and site, patient's age, sex and type and duration of diabetes on the

outcome of diabetic foot ulcers.” Diabetic medicine : a journal of the British Diabetic Association vol. 18,2 (2001):

133-8. doi:10.1046/j.1464-5491.2001.00422.x.

Patry, Jérôme et al. “Outcomes and prognosis of diabetic foot ulcers treated by an interdisciplinary team in

Canada.” International wound journal vol. 18,2 (2021): 134-146. doi:10.1111/iwj.13505.

nominator expressed concern about variability in MAC pricing for the contractor-priced service.

Additionally, the nominator highlighted that the payment amounts determined by MACs were

inadequately low and did not account for the time and effort required to furnish the services. In

their submission, the nominator discussed their anticipated inputs for both codes. For CPT code

0596T, the nominator stated that a physician typically spends 60 minutes inserting the Vesiflo

inFlow System. The nominator stated that CPT code 0596T included various supplies,

equipment, and clinical labor time totaling $1,902.76, with the inflow supply items making up

about 99 percent of the total cost of supplies. For CPT code 0597T, the nominator stated that a

physician spends 25 minutes replacing the Vesiflo inFlow System and PE items were similar,

with supplies, equipment and clinical labor time costing $505.30, with the inflow supply items

making up about 98 percent of the total cost of supplies. We direct interested parties to the CY

2024 PFS final rule (88 FR 78850) for more detailed submission information regarding CPT

codes 0596T and 0597T. After reviewing, we concluded that these codes were not potentially

misvalued because they are Category III codes describing relatively new and low-volume

services. Category III codes are contractor priced under the PFS, meaning that each MAC can

establish pricing for the code within its jurisdiction, resulting in variability in payments.

This year, the nominator newly informed CMS that their analysis of national payment

rates showed that in most CMS jurisdictions, not only are these codes misvalued, but in most

cases, they are not valued at all, with fee schedule amounts in most CMS jurisdictions at or near

zero dollars. The nominator further emphasized that three physician experts, all employed in

major university medical centers, have highlighted the challenges posed by the combination of

high supply costs and inadequate fee schedule payments, which have hindered their ability to

provide services covered by these codes over several years. According to the nominator, these

selected physicians also expressed frustration with the reluctance of MACs to address or discuss

this issue. Moreover, the nominator highlighted high access barriers as a significant concern.

These barriers primarily affect Medicare's most vulnerable beneficiaries, particularly women

experiencing permanent urinary retention (PUR), although we note that no quantifiable evidence

was provided to support these statements. We acknowledge and appreciate the nominator's

efforts in reaching out to experts in the field and patients who rely on these services to elucidate

their significant needs.

Since these two Category III CPT codes were not identified as potentially misvalued and

were consequently priced by contractors, each MAC can set pricing for the code within its

jurisdiction. This could result in inevitable variability in MAC pricings until they receive a

higher number of claims, as stated by the nominator. Through our engagement with MACs, we

found that claims for the two Category III CPT codes are reviewed on a case-by-case basis for

medical necessity. If the claim is payable, the price will be determined at that time by the MAC.

Additionally, these codes were a topic of discussion within the MAC pricing workgroup, and we

observed that there was not a significant difference among the MACs in terms of allowances

based on the proposed pricing methodologies. However, there is variance in how MACs load

pricing for Category III codes. For instance, some MACs publish the price for the service before

they receive any claims, while others set the price only after they receive claims that help

determine the appropriate pricing. If a MAC does not load a price for a code before receiving any

claims, the service can still be paid, but the allowance has not been published.

We continue to hear concerns about these payment inconsistencies for CPT codes 0596T

and 0597T. As a result, we are recommending that the MACs establish more consistency in

pricing, enabling the appropriate inclusion of the Vesiflo system in the code's PE valuation.

Therefore, for CY 2025, we encourage interested parties to provide more accurate and

appropriate cost data, along with additional information regarding work RVU, work time,

indicators, and utilization estimates for the MACs. This should complement the information

provided by the nominator in the CY 2024 final rule (88 FR 78850) and will facilitate the

process. To aid in this process, we are adding three new supplies to our direct PE database based

on invoices submitted by interested parties: the inFlow Measuring Device at a price of $140

(SD370), the inFlow Valve-Pump Device at a price of $495 (SD371), and the inFlow Activator

Kit at a price of $1,250 (SD372). Although we are not proposing national pricing for these two

Category III codes, we do note for the benefit of the MACs that CPT code 0596T would

typically include one of each of these supplies, whereas CPT code 0597T would typically

include only one of the supplies (SD371).

We encourage the MACs to continue to engage with interested parties by providing

information on how they price these services. We welcome additional comments from the

broader medical community regarding the usage of this service, particularly concerning its safety

and effectiveness, as well as potential factors contributing to its low utilization.

(33) PE-only replacement code for Heart Failure System

Interested parties have expressed concern about the lack of coding and a billing

mechanism when practitioners incur costs replacing identified components of the

CardioMEMS™ Heart Failure System used in the physician service described by CPT code

33289 (Transcatheter implantation of wireless pulmonary artery pressure sensor for long-term

hemodynamic monitoring, including deployment and calibration of the sensor, right heart

catheterization, selective pulmonary catheterization, radiological supervision and interpretation,

and pulmonary artery angiography, when performed).

The CardioMEMS™ Heart Failure System furnished during this service allows

practitioners treating heart failure patients to wirelessly monitor and measure pulmonary artery

pressure and heart rate in patients with heart failure and transmit the information to the physician

to inform the treatment plan for the patient. The system includes two critical components: first, a

miniaturized, wireless monitor, which is implanted into a patient’s pulmonary artery, and second,

a smart pillow (the CardioMEMS™ Patient Electronics System), which captures and transmits

readings via safe radio frequency from the patient’s implanted CardioMEMS™ Heart Failure

System. Overall, the CardioMEMS™ Heart Failure System enables patients to transmit critical

heart failure status information to clinicians regularly, potentially eliminating the need for

frequent clinic or hospital visits.

Interested parties have highlighted the critical importance of the device for heart failure

patients who require close monitoring of weight and blood pressure to prevent fluid buildup

around the heart, and have requested that CMS establish coding to describe when practitioners

incur costs during clinical scenarios when crucial components of the system require replacement.

Given that these components are crucial for system functionality and there is no existing coding

framework to address their replacement, we believe that establishing appropriate coding and

payment mechanisms can facilitate the provision of these services more effectively in the office

and hospital settings. Given provided information, we propose assigning contractor pricing to

this PE-only code for CY 2025. We are proposing a new code, HCPCS code GMEM1 (Provision

of replacement patient electronics system (for example, system pillow) for home pulmonary

artery pressure monitoring including provision of materials for use in the home and reporting of

test results to physician or qualified health care professional). We are seeking feedback from

interested parties on our contractor pricing approach with the aim of establishing national pricing

through future rulemaking that can be billed under the OPPS and PFS specifying an ongoing care

visit for the CardioMEMS™ Heart Failure System along with the provision of the replacement

part. We are specifically looking for information from the broader medical community regarding

direct costs from invoices for the replacement component referenced above, utilization estimates,

and potential indicators. Additionally, we solicit comments on additional direct PE inputs that we

should consider.

(34) Portable X-Ray (HCPCS codes R0070-R0075)

Several Portable X-Ray (PXR) suppliers and trade organizations continue to express

longstanding concerns with how payment is established for transportation related to these

services (HCPCS codes R0070-R0075). CMS has worked with interested parties over the past

several years to understand the costs of these services while taking into consideration the MACs

perspective on pricing of these costs. Through recent ongoing discussions with interested parties,

we learned that interested parties are concerned with the recognition of costs incurred from PXR

services and are wanting more consistency in the pricing of these services, including the

application of an inflation factor.

We acknowledge the interested parties’ concerns and clarify that interested parties may

best engage with the MACs through appropriate reporting of cost data in the MAC requested

format. This information provided by interested parties can help MACs establish payment rates

that are more reflective of costs incurred. MACs are then able to consider this cost information

and apply an inflation factor to update changes in costs year over year.

However, CMS recognizes that we should maintain consistency in pricing these services

that are more indicative of changes in costs that occur yearly. While still preserving MAC

discretion, CMS highlights the usage of an ambulance inflation factor (AIF) that is typically used

to adjust ambulance services, which include transportation costs. The AIF is updated annually,

and we believe MACs may consider using the AIF to price PXR services when establishing

payment rates that are more consistent and reflective of costs incurred.

Additionally, interested parties highlighted inconsistency with language found in our

manual and program memoranda policies related to transportation costs. Therefore, to remain

consistent and transparent in the pricing of PXR services, we are proposing to revise language in

our Medicare Claims Processing manual (Chapter 13, 90.3 and Chapter 23, 30.5) to reflect any

updates to our guidance for these services.

(35) Non-chemotherapy Administration

CMS received inquiries from several external parties with concerns that MACs have

developed local coverage determinations (LCDs) and local coverage articles (LCAs) that down

code or restrict payment for complex and non-chemotherapeutic drug administration for CPT

code series 96401-96549, when used for the administration of several biologic and infusion

drugs, including drugs furnished to treat, for example, rheumatology related conditions.

CMS requested information in the CY 2024 PFS proposed rule (88 FR 52837) seeking

public feedback regarding the concerns of down coding or denials for the administration of non-

chemotherapeutic infusion drugs. We received comments that asked for additional clarification

from CMS regarding the payment guidelines for the complex non-chemotherapeutic

administration code series and updates to the IOM. Commenters urged CMS to provide

additional guidance clarifying the conditions under which these complex infusion drugs should

be payable.

In response to the comments received, and in response to continuing inquiries on

downcoding and or restrictions on payment for non-chemotherapy complex infusion services, we

are proposing an updated policy based largely on the IOM Medicare Claims Processing Manual,

Chapter 12, section 30.5, to include language currently consistent with CPT code definitions for

the complex non-chemotherapy infusion code series stating that the administration of infusion

for particular kinds of drugs and biologics can be considered complex and may be appropriately

reported using the chemotherapy administration CPT codes 96401-96549. We note that CPT

guidance describes requirements for these non-chemotherapy complex drugs or biologic agents

to include the need for staff with advanced practice training and competency, such as, a

physician or other qualified health care professional to monitor the patient during these infusions

due to the incidence of severe adverse reactions. There are also special considerations for

preparation, dosage, or disposal for these infusion drugs. These services do involve serious

patient risk which requires frequent consults with a physician or other qualified healthcare

professional. Based on these facts and comments, we are proposing to update our subregulatory

guidance accordingly.

This will also provide complex clinical characteristics for the MACs to consider as

criteria when determining payment of claims for these services. The current IOM language does

not include the unique characteristics of the administration of these drugs that could provide

additional context to the MACs when they are determining appropriate payment. Updating the

IOM with the increased detail of these codes would be responsive to the concerns and requests of

external parties and will ensure the IOM is consistent with published guidance.

Therefore, we are soliciting and welcome comments on our proposal to revise the IOM to

better reflect how complex non-chemotherapeutic drug administration infusion services are

furnished and billed.

(36) Hospital Inpatient or Observation (I/O) Evaluation and Management (E/M) Add-on for

Infectious Diseases (HCPCS code GIDXX)

Interested parties have continued to engage with CMS and provide recommendations to

recognize the increased work associated with diagnosis, management, and treatment of infectious

diseases that may not be adequately accounted for in current hospital inpatient or observation

E/M codes. Infectious diseases are unique in that they present infection control risks for the

patient and close contacts, including healthcare staff, that require attention to safely care for the

patient. They present unique challenges in diagnosis in that any previous healthcare interaction

could affect the individual resistance patterns of pathogens infecting the individual patient and

require close contact with public health agencies since resistance patterns are constantly

changing, so a much more extensive medical review is required. Additionally, individual

decisions regarding treatment are unique in that use in one patient affects resistance patterns of

the entire population, which requires additional expertise to inform antimicrobial selection and

management.

We believe that the timing is appropriate for establishing a payment rate for infectious

disease physician services since the COVID-19 PHE has ignited a hypervigilance for infectious

diseases. Therefore, for CY 2025, we are proposing a new HCPCS code to describe intensity and

complexity inherent to hospital inpatient or observation care associated with a confirmed or

suspected infectious disease performed by a physician with specialized training in infectious

diseases. The full proposed descriptor for the hospital I/O E/M visit complexity add-on code is

HCPCS code GIDXX (Visit complexity inherent to hospital inpatient or observation care

associated with a confirmed or suspected infectious disease by an infectious diseases consultant,

including disease transmission risk assessment and mitigation, public health investigation,

analysis, and testing, and complex antimicrobial therapy counseling and treatment. (add-on

code, list separately in addition to hospital inpatient or observation evaluation and management

visit, initial, same day discharge, or subsequent). We anticipate that HCPCS code GIDXX would

be reported by physicians with specialized infectious disease training.

We do not believe we should limit the scope of codes with which this proposed add-on

HCPCS code could be billed based on visit level; or initial, same day discharge, or subsequent

hospital inpatient or observation codes. We are proposing HCPCS code GIDXX as an add-on

code (ZZZ global period) separately reportable in addition to CPT codes 99221 (Initial hospital

inpatient or observation care, per day, for the evaluation and management of a patient, which

requires a medically appropriate history and/or examination and straightforward or low level

medical decision making. When using total time on the date of the encounter for code selection,

40 minutes must be met or exceeded.), 99222 (Initial hospital inpatient or observation care, per

day, for the evaluation and management of a patient, which requires a medically appropriate

history and/or examination and moderate level of medical decision making. When using total

time on the date of the encounter for code selection, 55 minutes must be met or exceeded.),

99223 (Initial hospital inpatient or observation care, per day, for the evaluation and

management of a patient, which requires a medically appropriate history and/or examination

and high level of medical decision making. When using total time on the date of the encounter for

code selection, 75 minutes must be met or exceeded.), 99231 (Subsequent hospital inpatient or

observation care, per day, for the evaluation and management of a patient, which requires a

medically appropriate history and/or examination and straightforward or low level of medical

decision making. When using total time on the date of the encounter for code selection, 25

minutes must be met or exceeded.), 99232 (Subsequent hospital inpatient or observation care,

per day, for the evaluation and management of a patient, which requires a medically appropriate

history and/or examination and moderate level of medical decision making. When using total

time on the date of the encounter for code selection, 35 minutes must be met or exceeded.),

99233 (Subsequent hospital inpatient or observation care, per day, for the evaluation and

management of a patient, which requires a medically appropriate history and/or examination

and high level of medical decision making. When using total time on the date of the encounter for

code selection, 50 minutes must be met or exceeded.), 99234 (Hospital inpatient or observation

care, for the evaluation and management of a patient including admission and discharge on the

same date, which requires a medically appropriate history and/or examination and

straightforward or low level of medical decision making. When using total time on the date of the

encounter for code selection, 45 minutes must be met or exceeded.), 99235 (Hospital inpatient or

observation care, for the evaluation and management of a patient including admission and

discharge on the same date, which requires a medically appropriate history and/or examination

and moderate level of medical decision making. When using total time on the date of the

encounter for code selection, 70 minutes must be met or exceeded.), and 99236 (Hospital

inpatient or observation care, for the evaluation and management of a patient including

admission and discharge on the same date, which requires a medically appropriate history

and/or examination and high level of medical decision making. When using total time on the date

of the encounter for code selection, 85 minutes must be met or exceeded.). Based on feedback

from commenters on the CY 2022 PFS proposed rule comment solicitation regarding infectious

diseases (86 FR 65125 through 65126) and feedback from interested parties, HCPCS code

GIDXX would include the following proposed service elements:

1. Disease Transmission Risk Assessment and Mitigation

● Developing, following, and supervising specialized, individualized infection control

protocols for an individual patient based on their diagnosis and risks in order to reduce risk of

disease transmission.

● Coordinating with human resources regarding infection prevention and control

measures to enable healthcare facility staff to safely care for patient.

● Counseling patients, family members and caregivers regarding infection prevention.

● Managing infection prevention and treatment protocols associated with transitions of

care for complex patients.

2. Public Health Investigation, analysis, and testing

● In-depth patient chart review that entails going back farther in time and assessing the

complete breadth of all health care interactions, with higher-level synthesis for complex

diagnoses.

● Communicating with the clinical microbiology lab and directly reviewing specimens.

● Coordinating specialized diagnostic evaluations (for example, identifying and

facilitating diagnostic laboratory tests only available at specialized laboratories, the state health

department, and/or the Centers for Disease Control & Prevention).

● Coordinating with Federal, State and local public health agencies and laboratories to

assist with contact tracing, obtaining specimens for specialized testing, and/or identifying prior

testing and treatment for communicable diseases in other jurisdictions.

3. Complex Antimicrobial Therapy Counseling & Treatment

● Counseling patients, family members, and caregivers regarding antimicrobial

stewardship and resistance for the patient.

● Engaging in complex medical decision-making associated with antimicrobial

prescribing including considerations such as antimicrobial resistance patterns, emergence of new

variants/strains, recent antibiotic exposure, interactions/complications from comorbidities

including concurrent infections, public health considerations to minimize development of

antimicrobial resistance, and emerging and re-emerging infections.

For HCPCS code GIDXX, we are proposing a work RVU of 0.89 based on the work

RVU for HCPCS code G2211 (Visit complexity inherent to evaluation and management

associated with medical care services that serve as the continuing focal point for all needed

health care services and/or with medical care services that are part of ongoing care related to a

patient's single, serious condition or a complex condition. (add-on code, list separately in

addition to office/outpatient evaluation and management visit, new or established)), which is

0.33, multiplied by a ratio of the work RVUs for CPT codes 99223 and 99213 (Office or other

outpatient visit for the evaluation and management of an established patient, which requires a

medically appropriate history and/or examination and low level of medical decision making.

When using total time on the date of the encounter for code selection, 20 minutes must be met or

exceeded.), 3.50 and 1.30, respectively. (This ratio is the work RVU of CPT code 99223 divided

by the work RVU of CPT code 99213, 3.50 divided by 1.30, which equals 2.69. Multiplying the

0.33 work RVU of HCPCS code G2211 times 2.69 results in our proposed work RVU of 0.89.)

We believe the relationship between the complexity add-on HCPCS code G2211 and a common

base code for the add-on code, CPT code 99213, would strike the correct balance to estimate the

time and complexity associated with the new HCPCS code GIDXX, compared to what we

believe will be a common base code for this new add-on code, CPT code 99223. HCPCS code

G2211 has a total time of 11 minutes, therefore, we are proposing a total time of 30 minutes for

HCPCS code GIDXX based on the same ratio (11 minutes times the same 2.69 ratio equals 30

minutes). HCPCS code G2211 has no direct PE inputs, and we are proposing the same for

HCPCS code GIDXX.

We believe that the proposed work RVU appropriately falls between the following

bracket add-on codes: HCPCS code G0316 (Prolonged hospital inpatient or observation care

evaluation and management service(s) beyond the total time for the primary service (when the

primary service has been selected using time on the date of the primary service); each additional

15 minutes by the physician or qualified healthcare professional, with or without direct patient

contact (list separately in addition to CPT codes 99223, 99233, and 99236 for hospital inpatient

or observation care evaluation and management services). (do not report g0316 on the same

date of service as other prolonged services for evaluation and management 99358, 99359,

99418, 99415, 99416). (do not report g0316 for any time unit less than 15 minutes)) with a work

RVU of 0.61 and the professional principal care management, chronic care management, and

complex chronic care management CPT codes 99425 (Principal care management services, for a

single high-risk disease, with the following required elements: one complex chronic condition

expected to last at least 3 months, and that places the patient at significant risk of

hospitalization, acute exacerbation/decompensation, functional decline, or death, the condition

requires development, monitoring, or revision of disease-specific care plan, the condition

requires frequent adjustments in the medication regimen and/or the management of the condition

is unusually complex due to comorbidities, ongoing communication and care coordination

between relevant practitioners furnishing care; each additional 30 minutes provided personally

by a physician or other qualified health care professional, per calendar month (List separately in

addition to code for primary procedure)), 99437 (Chronic care management services with the

following required elements: multiple (two or more) chronic conditions expected to last at least

12 months, or until the death of the patient, chronic conditions that place the patient at

significant risk of death, acute exacerbation/decompensation, or functional decline,

comprehensive care plan established, implemented, revised, or monitored; each additional 30

minutes by a physician or other qualified health care professional, per calendar month (List

separately in addition to code for primary procedure)), and 99489 (Complex chronic care

management services with the following required elements: multiple (two or more) chronic

conditions expected to last at least 12 months, or until the death of the patient, chronic

conditions that place the patient at significant risk of death, acute exacerbation/decompensation,

or functional decline, comprehensive care plan established, implemented, revised, or monitored,

moderate or high complexity medical decision making; each additional 30 minutes of clinical

staff time directed by a physician or other qualified health care professional, per calendar month

(List separately in addition to code for primary procedure)) with work RVUs of 1.00.

To help inform whether our proposed descriptor is appropriate and reflects the typical

service, we are seeking comment on the typical amount of time infectious disease physicians

spend on the proposed service elements and the relative intensity compared to similar service

elements of other CPT codes. We note that the valuation of HCPCS code GIDXX is meant to

capture the visit complexity inherent to hospital inpatient or observation care associated with a

confirmed or suspected infectious disease by an infectious diseases consultant that is not

accounted for in the appropriate hospital inpatient or observation E/M base code billed by the

infectious disease physician.

Interested parties have stated that consultations are a common E/M service performed by

infectious disease clinicians, particularly in the inpatient setting, but stated that these services are

no longer recognized by Medicare. Interested parties have also stated that this has resulted in a

significant reduction in reporting and payment for infectious disease physician services. We note

that we address this in the CMS Claims Processing Manual, Chapter 12, section 30.6.9 F, stating

that “Physicians may bill initial hospital care service codes (99221-99223), for services that were

reported with CPT consultation codes (99241 – 99255) prior to January 1, 2010, when the

furnished service and documentation meet the minimum key component work and/or medical

necessity requirements. Physicians may report a subsequent hospital care CPT code for services

that were reported as CPT consultation codes (99241 – 99255) prior to January 1, 2010, where

the medical record appropriately demonstrates that the work and medical necessity requirements

are met for reporting a subsequent hospital care code (under the level selected), even though the

reported code is for the provider’s first E/M service to the inpatient during the hospital stay.”

Accordingly, we are seeking comment on any potential barriers for infectious disease physicians

to use the initial and subsequent day hospital inpatient or observation codes, CPT codes 99221

through 99223 and 99231 through 99233, for consultations if they meet the coding requirements

for time and/or medical decision making (MDM). We note that understanding the barriers to

utilizing these codes is important, as these codes will serve as the base codes for HCPCS code

GIDXX, and will need to be billed by the infectious disease physician prior to billing HCPCS

code GIDXX.

Finally, we recognize that historically, the CPT Editorial Panel has frequently created

CPT codes describing services that we originally established using G codes and adopted them

through the CPT Editorial Panel process. We note that we would consider using any newly

available CPT coding to describe services similar to those described here in future rulemaking.

(37) Preexposure Prophylaxis (PrEP) of Human Immunodeficiency Virus (HIV)

To facilitate prompt beneficiary access to PrEP for CY 2024, we established 3 HCPCS G

codes that describe the service of counseling and administration of Human Immunodeficiency

Virus (HIV) pre-exposure prophylaxis drugs. Specifically, HCPCS codes G0011 (Individual

counseling for pre-exposure prophylaxis (PrEP) by physician or QHP to prevent human

immunodeficiency virus (HIV), includes: HIV risk assessment (initial or continued assessment of

risk), HIV risk reduction and medication adherence, 15-30 minutes) and G0013 (Individual

counseling for pre-exposure prophylaxis (PrEP) by clinical staff to prevent human

immunodeficiency virus (HIV), includes: HIV risk assessment (initial or continued assessment of

risk), HIV risk reduction and medication adherence) describe the counseling portion of the

service, and G0012 (Injection of pre-exposure prophylaxis (PrEP) drug for HIV prevention,

under skin or into muscle) describes the injection of the medication.

CMS released a Proposed NCD for Pre-Exposure Prophylaxis (PrEP) for Human

Immunodeficiency Virus (HIV) Infection Prevention on July 12, 2023. This proposed NCD

announced CMS’ intent to cover and pay for those drugs under the 1861(ddd) additional

preventive services authority, and a final decision on the NCD is forthcoming. For CY 2025, we

are proposing national rates for these HCPCS codes that reflect the relative resource costs

associated with the counseling and drug administration portions of the service, pending

finalization of the NCD. For HCPCS code G0011, we are proposing a work RVU of 0.45 based

off work and direct PE inputs crosswalked from HCPCS code G0445 (High intensity behavioral

counseling to prevent sexually transmitted infection; face-to-face, individual, includes:

education, skills training and guidance on how to change sexual behavior; performed semi-

annually, 30 minutes). For HCPCS code G0012, we are proposing a work RVU of 0.17 based on

the work and direct PE crosswalked from CPT code 96372 (Therapeutic, prophylactic, or

diagnostic injection (specify substance or drug); subcutaneous or intramuscular), and for

HCPCS code G0013 we are proposing a work RVU of 0.18 based on the work and direct PE

inputs crosswalked from CPT code 99211 (Office or other outpatient visit for the evaluation and

management of an established patient that may not require the presence of a physician or other

qualified health care professional). We appreciate having this opportunity for interested parties

to provide feedback on the most accurate way to value these services.

(38) Opfolda

For CY 2024, to facilitate beneficiary access to treatment of late-onset Pompe disease

with miglustat in combination with cipaglucosidae alfa-atga, we created a new HCPCS code,

G0138, describing the service of administration of cipaglucosidase alfa-atga (Pombiliti), which

includes the intravenous administration of cipaglucosidase alfa-atga, the provider or supplier’s

acquisition cost of miglustat, clinical supervision, and oral administration of miglustat. HCPCS

code G0138 (Intravenous infusion of cipaglucosidase alfaatga, including provider/supplier

acquisition and clinical supervision of oral administration of miglustat in preparation of receipt

of cipaglucosidase alfa-atga) was added to the PFS effective April 1, 2024, as a contractor

priced service. More information regarding the creation of HCPCS code G0138 can be found at

https://www.cms.gov/files/document/2023-hcpcs-application-summary-quarter-4-2023-drugs-

and-biologicals-updated-1/30/2024.pdf.

For CY 2025, we are proposing national pricing for this service that reflects the relative

resource costs associated with the infusion administration of Cipaglucosidae alfa-atga and

clinical supervision and provision of Miglustat oral with acquisition costs. We are proposing a

work RVU of 0.21 for HCPCS code G0138 based on a crosswalk from CPT code 96365

(Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial,

up to 1 hour). This includes a crosswalked total time of 9 minutes and an intraservice time of 5

minutes. We are also proposing to crosswalk the direct PE inputs from CPT code 96365 for use

in valuing HCPCS code G0138. However, we are adding 1 minute of L056A clinical staff time

during the preservice portion of the service period to capture the RN/OCN observation of the

patient during administration of the Opfolda pill. In addition, to account for the cost of the

provision of the self-administered Opfolda as a direct PE input, we are incorporating the

wholesale acquisition cost (WAC) data from the most recent available quarter. We are proposing

a price of $32.50 for the supply input that describes a 65mg capsule of Opfolda (supply code

SH111). We are seeking feedback from interested parties on our proposal of national pricing, as

well as our proposed work RVU and direct PE inputs for HCPCS code G0138 to ensure proper

payment for this service.

(39) Payment for Caregiver Training Services

a. Background

In the CY 2017 PFS final rule (81 FR 80330 through 80331), we finalized payment for

new CPT code(s) describing administration of a patient-focused health risk assessment

instrument as well as administration of a caregiver-focused health risk assessment instrument. In

the CY 2024 PFS final rule (88 FR 78914), we finalized the assignment of a payable status for

caregiver training services (CTS) for therapy and behavior management/modification services

(without the patient present) and finalized the RUC-recommended valuations for these services

to better recognize the role that caregivers play in reasonable and necessary care for Medicare

beneficiaries. These codes allow treating practitioners to report the training furnished to a

caregiver, in tandem with the diagnostic and treatment services furnished directly to the patient,

in strategies and specific activities to assist the patient in carrying out the treatment plan.

We finalized in the CY 2024 PFS final rule that payment may be made for CTS services

when the treating practitioner identifies a need to involve and train one or more caregivers to

assist the patient in carrying out a patient-centered treatment plan. We also finalized that because

CTS services are furnished outside the patient’s presence, the treating practitioner must obtain

the patient’s (or representative’s) consent for the caregiver to receive the CTS. Additionally, we

finalized that the identified need for CTS and the patient’s (or representative’s) consent for one

or more specific caregivers to receive CTS must be documented in the patient’s medical record.

These finalized policies apply to current CTS coding and we are also proposing for them to apply

to the newly proposed CTS coding that follows. We continue to receive questions and requests

from interested parties about how we can refine payment for these services.

b. Caregiver Assessment

In response to interested parties’ requests for assessment of a caregiver’s knowledge to be

included in caregiver training, we are clarifying that when reasonable and necessary, assessing

the caregiver’s skills and knowledge for the purposes of caregiver training services could be

included in the service described by CPT code 96161 (Administration of caregiver-focused

health risk assessment instrument (eg, depression inventory) for the benefit of the patient, with

scoring and documentation, per standardized instrument) to determine if caregiver training

services are needed. We also note that CPT code 96161 is currently on the Medicare Telehealth

list.

We note that, as specified in the CY 2017 PFS final rule (81 FR 80330), in particular

cases, caregiver-focused health risk assessments can be necessary components of services

furnished to Medicare beneficiaries. Examples where this service may be reasonable and

necessary may include assessment of maternal depression in the active care of infants,

assessment of parental mental health as part of evaluating a child’s functioning, assessment of

caretaker conditions as indicated where atypical parent/child interactions are observed during

care, and assessment of caregivers as part of care management for adults whose physical or

cognitive status renders them incapable of independent living and dependent on another adult

caregiver. Commenters cited that some examples of such individuals might include intellectually

disabled adults, seriously disabled military veterans, and adults with significant musculoskeletal

or central nervous system impairments (81 FR 80331).

We are proposing that because the caregiver-focused health risk assessment may be

furnished outside the patient’s presence, the treating practitioner must obtain the patient’s (or

representative’s) consent for the caregiver to receive the assessment. We are also proposing that

the definition of “caregiver” specified in the CY 2024 PFS final rule (88 FR 78917) will be the

same for caregiver training services and the caregiver-focused health risk assessment.

We are seeking comment on these proposals and clarifications.

c. Proposals and New Coding

(A) Proposed Direct Care Caregiver Training Services

i. Coding

We are proposing to establish new coding and payment for caregiver training for direct

care services and supports. The topics of training could include, but would not be limited to,

techniques to prevent decubitus ulcer formation, wound dressing changes, and infection control.

Unlike other caregiver training codes that are currently paid under the PFS, the caregiver training

codes for direct care services and support focus on specific clinical skills aimed at the caregiver

effectuating hands-on treatment, reducing complications, and monitoring the patient. For

example, in the direct care CTS codes, a caregiver could be taught how to properly change

wound dressings to promote healing and prevent infection. This skill, among other direct care

services, would not fall into the categories of CTS codes that currently exist (behavior

management/modification or strategies and techniques to facilitate the patient’s functional

performance in the home or community) but is integral in effectuating the patient’s treatment

plan. Like other codes describing caregiver training services, these proposed new codes would

reflect the training furnished to a caregiver, in tandem with the diagnostic and treatment services

furnished directly to the patient, in strategies and specific activities to assist the patient to carry

out the treatment plan. We believe that CTS may be reasonable and necessary when they are

integral to a patient's overall treatment and furnished after the treatment plan is established. The

CTS themselves need to be congruent with the treatment plan and designed to effectuate the

desired patient outcomes. We believe this is especially the case in medical treatment scenarios

where assistance by the caregiver receiving the CTS is necessary to ensure a successful treatment

outcome for the patient--for example, when the patient cannot follow through with the treatment

plan for themselves.

We are proposing three new HCPCS codes: GCTD1 (Caregiver training in direct care

strategies and techniques to support care for patients with an ongoing condition or illness and to

reduce complications (including, but not limited to, techniques to prevent decubitus ulcer

formation, wound dressing changes, and infection control) (without the patient present), face-to-

face; initial 30 minutes), GCTD2 (Caregiver training in direct care strategies and techniques to

support care for patients with an ongoing condition or illness and to reduce complications

(including, but not limited to, techniques to prevent decubitus ulcer formation, wound dressing

changes, and infection control) (without the patient present), face-to-face; each additional 15

minutes (List separately in addition to code for primary service) (Use GCTD2 in conjunction

with GCTD1)), and GCTD3 (Group caregiver training in direct care strategies and techniques

to support care for patients with an ongoing condition or illness and to reduce complications

(including, but not limited to, techniques to prevent decubitus ulcer formation, wound dressing

changes, and infection control) (without the patient present), face-to-face with multiple sets of

caregivers)).

We continue to believe that CTS may be reasonable and necessary when they are integral

to a patient’s overall treatment and furnished after the treatment plan is established. The medical

or direct care CTS themselves need to be congruent with the treatment plan and designed to

effectuate the desired patient outcomes. We believe this is especially the case in medical

treatment scenarios where assistance by the caregiver receiving the CTS is necessary to ensure a

successful treatment outcome for the patient—for example when the patient cannot follow

through with the treatment plan for themselves. Direct care training for caregivers of Medicare

beneficiaries should be directly relevant to the person-centered treatment plan for the patient in

order for the services to be considered reasonable and necessary under the Medicare program.

Each training activity should be clearly identified and documented in the treatment plan.

Additionally, this would not be billable for patients under home health plan of care, receiving at-

home therapy, or receiving DME services for involved medical equipment and supplies.

We are seeking additional information from commenters about potential service overlaps

and potential examples of direct care services to receive caregiver training to inform our final

policy. We are soliciting public comment on each of our proposals for direct care CTS.

ii. Valuation

For GCTM1, we propose a direct crosswalk to CPT Code 97550 (Caregiver training in

strategies and techniques to facilitate the patient’s functional performance in the home or

community (eg, activities of daily living [ADLs], instrumental ADLs [iADLs], transfers, mobility,

communication, swallowing, feeding, problem-solving, safety practices) (without the patient

present), face to face; initial 30 minutes), with a work RVU of 1.00 as we believe this service

reflects the resource costs associated when the billing practitioner performs HCPCS code

GCTM1. CPT code 97550 has an intraservice time of 30 minutes, and the physician work is of

similar intensity to our proposed HCPCS code GCTM1. Therefore, we are proposing a work

time of 30 minutes intraservice time (40 minutes of total time) for HCPCS code GCTM1 based

on this same crosswalk to CPT 97550. We are also proposing to use this crosswalk to establish

the direct PE inputs for HCPCS code GCTM1.

For GCTM2, we are proposing a direct crosswalk to CPT Code 97551 (Caregiver

training in strategies and techniques to facilitate the patient’s functional performance in the

home or community (eg, activities of daily living [ADLs], instrumental ADLs [iADLs], transfers,

mobility, communication, swallowing, feeding, problem solving, safety practices) (without the

patient present), face to face; each additional 15 minutes (List separately in addition to code for

primary service)), with a work RVU of 0.54 as we believe this service reflects the resource costs

associated when the billing practitioner performs HCPCS code GCTM2. CPT code 97551 has an

intraservice time of 17 minutes, and the physician work is of similar intensity to our proposed

HCPCS code GCTM2. Therefore, we are proposing a work time of 17 minutes for HCPCS code

GCTM2 based on this same crosswalk to CPT 97551. We also propose to use this crosswalk to

establish the direct PE inputs for HCPCS code GCTM2.

For GCTM3, we propose a direct crosswalk to CPT Code 97552 (Group caregiver

training in strategies and techniques to facilitate the patient's functional performance in the

home or community (eg, activities of daily living [ADLs], instrumental ADLs [iADLs], transfers,

mobility, communication, swallowing, feeding, problem solving, safety practices) (without the

patient present), face to face with multiple sets of caregivers), with a work RVU of 0.23 as we

believe this service reflects the resource costs associated when the billing practitioner performs

HCPCS code GCTM3. CPT code 97552 has an intraservice time of 9 minutes, and the physician

work is of similar intensity to our proposed HCPCS code GCTM1. Therefore, we are proposing

a work time of 9 minutes intraservice time (14 minutes total time) for HCPCS code GCTM3

based on this same crosswalk to CPT 97552. We are also proposing to use this crosswalk to

establish the direct PE inputs for HCPCS code GCTM3.

We are seeking comment on supplies/equipment that would be typical for the newly

created direct care strategies and techniques CTS codes.

We believe these services would largely involve contact between the billing practitioner

and the caregiver through in-person interactions, which could be conducted via

telecommunications, as appropriate. Therefore, we are proposing to add these codes to the

Medicare Telehealth Services List to accommodate a scenario in which the practitioner

completes the caregiver training service via telehealth. Please see section II.D. for more

information on Medicare Telehealth Services.

We are seeking comments on these proposals.

(B). Individual Behavior Management/ Modification Caregiver Training Services

i. Coding

We are proposing to establish new coding and payment for caregiver behavior

management and modification training that could be furnished to the caregiver(s) of an

individual patient. Current CPT coding (CPT 96202 and 96203) allows for “multiple-family

group behavior management/modification training services,” meaning that this caregiver training

service can only be furnished in a group setting with multiple sets of caregivers of multiple

beneficiaries (please reference 88 FR 78818 for discussion of CPT 96202 and 96203). We are

proposing two new HCPCS codes: GCTB1 (Caregiver training in behavior

management/modification for caregiver(s) of a patient with a mental or physical health

diagnosis, administered by physician or other qualified health care professional (without the

patient present), face-to-face; initial 30 minutes) and GCTB2 (Caregiver training in behavior

management/modification for caregiver(s) of a patient with a mental or physical health

diagnosis, administered by physician or other qualified health care professional (without the

patient present), face-to-face; each additional 15 minutes (List separately in addition to code for

primary service) (Use GCTB2 in conjunction with GCTB1)).

We continue to believe that CTS may be reasonable and necessary when they are integral

to a patient’s overall treatment and furnished after the treatment plan is established. The behavior

management/modification CTS themselves need to be congruent with the treatment plan and

designed to effectuate the desired patient outcomes. We believe this is especially the case in

medical treatment scenarios where assistance by the caregiver receiving the CTS is necessary to

ensure a successful treatment outcome for the patient—for example when the patient cannot

follow through with the treatment plan for themselves. Behavior management/modification

training for caregivers of Medicare beneficiaries should be directly relevant to the person-

centered treatment plan for the patient in order for the services to be considered reasonable and

necessary under the Medicare program. Each training activity should be clearly identified and

documented in the treatment plan. All other policies and procedures surrounding CPT 96202 and

96203 will also apply to these services (88 FR 78914-78920).

We are seeking comment on these proposals.

ii. Valuation

For GCTB1, we propose a direct crosswalk to CPT Code 97550 (Caregiver training in

strategies and techniques to facilitate the patient’s functional performance in the home or

community (eg, activities of daily living [ADLs], instrumental ADLs [iADLs], transfers, mobility,

communication, swallowing, feeding, problem solving, safety practices) (without the patient

present), face to face; initial 30 minutes), with a work RVU of 1.00 as we believe this service

reflects the resource costs associated when the billing practitioner performs HCPCS code

GCTB1. CPT code 97550 has an intraservice time of 30 minutes, and the physician work is of

similar intensity to our proposed HCPCS code GCTB1. Therefore, we are proposing a work time

of 30 minutes intraservice time (40 minutes of total time) for HCPCS code GCTB1 based on this

same crosswalk to CPT 97550. We also propose to use this crosswalk to establish the direct PE

inputs for HCPCS code GCTB1. We are seeking comment on supplies/equipment that would be

typical for the newly created individual behavior management/ modification CTS codes.

For GCTB2, we propose a direct crosswalk to CPT Code 97551 (Caregiver training in

strategies and techniques to facilitate the patient’s functional performance in the home or

community (eg, activities of daily living [ADLs], instrumental ADLs [iADLs], transfers, mobility,

communication, swallowing, feeding, problem solving, safety practices) (without the patient

present), face to face; each additional 15 minutes (List separately in addition to code for primary

service)), with a work RVU of 0.54 as we believe this service reflects the resource costs

associated when the billing practitioner performs HCPCS code GCTB2. CPT code 97551 has an

intraservice time of 17 minutes, and the physician work is of similar intensity to our proposed

HCPCS code GCTB2. Therefore, we are proposing a work time of 17 minutes for HCPCS code

GCTB2 based on this same crosswalk to CPT 97551. We also propose to use this crosswalk to

establish the direct PE inputs for HCPCS code GCTB2.

We are seeking comment on supplies/equipment that would be typical for the newly

created individual behavior management/ modification CTS codes.

We believe these services would largely involve contact between the billing practitioner

and the caregiver through in-person interactions, which could be conducted via

telecommunications as appropriate. Therefore, we are proposing to add these codes to the

Medicare Telehealth Services List to accommodate a scenario in which the practitioner

completes the caregiver training service via telehealth. Please see section II.D. for more

information on Medicare Telehealth Services.

We are seeking comments on these proposals.

(C). Patient Consent

In the CY 2024 PFS final rule (88 FR 78916), we finalized a requirement that the treating

practitioner must obtain the patient’s (or representative’s) consent for the caregiver to receive the

CTS and that the identified need for CTS and the patient’s (or representative’s) consent for one

or more specific caregivers to receive CTS be documented in the patient’s medical record.

We are proposing that consent for CTS can be provided verbally by the patient (or

representative). This would align consent requirements with other services paid under the PFS

that may be furnished without the patient present, such as certain care management services. This

proposal would apply to CPT codes 97550, 97551, 97552, 96202, and 96203, as well as any

caregiver training services HCPCS codes finalized in this year’s rule, and any subsequently

created caregiver training service codes. We are seeking comment on this proposal.

(D). Addition to Telehealth List

Please see section II.D. of this proposed rule, Payment for Medicare Telehealth Services,

for the discussion related to proposals to add CTS to the Medicare Telehealth list.

(40) Request for Information for Services Addressing Health-Related Social Needs (Community

Health Integration (G0019, G0022), Principal Illness Navigation (G0023, G0024), Principal

Illness Navigation-Peer Support (G0140, G0146), and Social Determinants of Health Risk

Assessment (G0136))

a. Background

In the CY 2024 PFS final rule (88 FR 78920), we finalized G-codes to reflect new coding

and payment for services describing Community Health Integration (CHI), G0019 (Community

health integration services performed by certified or trained auxiliary personnel, including a

community health worker, under the direction of a physician or other practitioner; 60 minutes per

calendar month), and G0022 (Community health integration services, each additional 30 minutes

per calendar month), which may include a community health worker (CHW), incident to the

professional services and under the general supervision of the billing practitioner. We finalized a

new stand-alone G code describing a SDOH Risk Assessment, G0136 (Administration of a

standardized, evidence-based Social Determinants of Health Risk Assessment, 5–15 minutes, not

more often than every 6 months). SDOH risk assessment refers to a review of the individual’s

SDOH or identified social risk factors that influence the diagnosis and treatment of medical

conditions. We also finalized PIN services, described by HCPCS code G0023 (Principal Illness

Navigation services by certified or trained auxiliary personnel under the direction of a physician

or other practitioner, including a patient navigator or certified peer specialist; 60 minutes per

calendar month) and G0024 (Principal Illness Navigation services, additional 30 minutes per

calendar month); G0140 (Principal Illness Navigation—Peer Support by certified or trained

auxiliary personnel under the direction of a physician or other practitioner, including a certified

peer specialist; 60 minutes per calendar month) and G0146 (Principal Illness Navigation—Peer

Support, additional 30 minutes per calendar month), to better recognize through coding and

payment policies when certified or trained auxiliary personnel under the direction of a billing

practitioner, which may include a patient navigator or certified peer support specialist, are

involved in the patient’s health care navigation as part of the treatment plan for a serious, high-

risk disease expected to last at least 3 months, that places the patient at significant risk of

hospitalization or nursing home placement, acute exacerbation/decompensation, functional

decline, or death.

b. Request for Information on Services Addressing Health-Related Social Needs

For CY 2025 we are issuing a broad request for information (RFI) on the newly

implemented Community Health Integration (CHI) (HPCCS codes G0019, G0022), Principal

Illness Navigation (PIN) (HCPCS codes G0023, G0024), Principal Illness Navigation- Peer

Support (PIN-PS) (HCPCS codes G0140, G0146), and Social Determinants of Health Risk

Assessment (SDOH RA) (HCPCS code G0136) services to engage interested parties on

additional policy refinements for CMS to consider in future rulemaking.

We are interested in better addressing the social needs of beneficiaries and requesting

information on the codes we created and finalized beginning in CY 2024 to fully encompass

what interested parties and commenters believe should be included in the coding and payment

we recently established. We are seeking comment on any related services that may not be

described by the current coding that we finalized in the CY 2024 PFS final rule and that are

medically reasonable and necessary “for the diagnosis or treatment of illness or injury” under

section 1862(a)(1)(A) of the Act. We believe we can work within the current coding framework

and explore additional opportunities to create codes that describe reasonable and necessary

services furnished by billing practitioners and the auxiliary personnel under their general

supervision. We are interested in feedback regarding any barriers to furnishing the services

addressing health-related social needs, and if the service described by the codes we established

are allowing practitioners to better address unmet social needs that interfere with the

practitioners’ ability to diagnose and treat the patient. This could include barriers specific to

certain populations, including rural and tribal communities, residents of the U.S. Territories,

individuals with disabilities, individuals with limited English proficiency, or other populations

who experience specific unmet social needs.

In response to the CY 2024 PFS proposed rule, we heard from commenters that CSWs

often connect individuals with community-based resources to address unmet social needs that

affect the diagnosis and treatment of medical problems. CSWs can bill Medicare directly for

services they personally perform for the diagnosis or treatment of mental illness but are not

authorized by statute to bill for services that are provided by auxiliary personnel incident to their

professional services. Since CHI and PIN codes are typically provided by auxiliary personnel

supervised by the billing practitioner, CSWs could serve as the auxiliary personnel. CSWs could

not directly bill Medicare for CHI and PIN services if they were provided by auxiliary personnel,

as they are not authorized to supervise, bill, and be paid directly by Medicare for services that are

provided by auxiliary personnel incident to their professional services. We believe the current

CHI and PIN coding accurately captures the services CSWs currently provide, including the

work involved in connecting beneficiaries with community-based resources for unmet social

needs that affect the diagnosis or treatment of medical problems. As we stated previously in the

CY 2024 PFS final rule (88 FR 78926), “the codes do not limit the types of other health care

professionals, such as registered nurses and social workers, that can perform CHI services (and

PIN services, as we discuss in the next section) incident to the billing practitioner’s professional

services, so long as they meet the requirements to provide all elements of the service included in

the code, consistent with the definition of auxiliary personnel at § 410.26(a)(1).” We are

clarifying that when we refer to “certified or trained auxiliary personnel” in the following codes:

G0019, G0022, G0023, G0024, G0140, G0146, this also includes CSWs.

We are requesting information if there are other types of auxiliary personnel, other

certifications, and/or training requirements that are not adequately captured in current coding and

payment for these services. We are also interested in hearing more about what types of auxiliary

personnel are typically furnishing these services, including the certifications and/or licensure that

they have. We are also interested in whether there are nuances or considerations that CMS

should understand related to auxiliary personnel and training, certifications or licensure barriers

or requirements that are specifically experienced by practitioners serving underserved

communities. This could include settings such as community mental health centers, community

health clinics including FQHCs and RHCs, tribal health centers, migrant farmworker clinics, or

facilities located in and serving rural and geographically isolated communities including the U.S.

Territories.

As noted in the CY 2023 PFS final rule (87 FR 69790) and explained in the CY 2023

PFS proposed rule (87 FR 46102), when we refer to community-based organizations, we mean

public or private not-for-profit entities that provide specific services to the community or

targeted populations in the community to address the health and social needs of those

populations. They may include community-action agencies, housing agencies, area agencies on

aging, centers for independent living, aging and disability resource centers or other non-profits

that apply for grants or contract with healthcare entities to perform social services. They may

receive grants from other agencies in the U.S. Department of Health and Human Services,

including Federal grants administered by the Administration for Children and Families (ACF),

Administration for Community Living (ACL), the Centers for Disease Control and Prevention

(CDC), the Substance Abuse and Mental Health Services Administration (SAMHSA), or State-

funded grants to provide social services. We stated that, generally, we believe such organizations

know the populations and communities they serve and may have the infrastructure or systems in

place to assist practitioners to provide CHI and PIN services. We stated that we understood that

many community-based organizations (CBOs) provide social services and do other work that is

beyond the scope of CHI and PIN services, but we believed they are well-positioned to develop

relationships with practitioners for providing reasonable and necessary CHI and PIN services.

We are interested in hearing more about CBOs and their collaborative relationships with

billing practitioners. The new codes for CHI and PIN services recognized CBOs and their role in

providing auxiliary personnel under the general supervision of the billing practitioners. We are

seeking comment regarding the extent to which practitioners are contracting with CBOs

(including current or planned contracting arrangements) for auxiliary personnel purposes, and if

there is anything else CMS should do to clarify services where auxiliary personnel can be

employed by the CBO, so long as they are under the general supervision of the billing

practitioner. Given that the CHI and PIN services may be provided incident to the billing

practitioner’s professional services, we are also seeking comment on whether the incident to

billing construct is appropriate for CBOs to supplement pre-existing staffing arrangements and

the CBO/provider interface. We are also seeking comment on CBOs' roles, the extent to which

practitioners are contracting with CBOs, incident to billing, and auxiliary personnel employed by

CBOs under general supervision of practitioners serving and located in rural, tribal and

geographically isolated communities, including the U.S. Territories.

We are also interested in any comments from interested parties across provider types and

from practitioners in geographically isolated communities (for example, rural, tribal, and island

communities) and otherwise underserved communities about coding Z codes on claims

associated with billing for CHI, PIN, and SDOH risk assessment codes. We recognize that when

screening for social needs, such needs may be identified and are interested in learning whether

practitioners are also capturing unmet social needs on claims using Z codes for social risk factors

or in some other way, and any barriers or opportunities to increase coding of Z codes when social

risk factors screen positive.

Over the past several years, we have worked to develop payment mechanisms under the

PFS to improve the accuracy of valuation and payment for the services furnished by physicians

and other health care professionals, especially in the context of evolving models of care and

addressing unmet social needs that affect the diagnosis and treatment of medical problems.

Given the Agency’s broader policy goals of increasing access to care, we are requesting

information from interested parties and commenters on anything else that we should consider in

the context of these codes and what else we could consider to be included in this newly

established code set.

We are seeking comments on ways to identify specific services and to recognize possible

barriers to improved access to these kinds of high-value, potentially underutilized services by

Medicare beneficiaries.

We are seeking public comment to understand more clearly how often evidence-based

care for persons with fractures, for example, is not provided and the reasons for this, and how

recent or new PFS codes, or their revaluation, might help resolve specific barriers to its

provision. The PFS currently includes many codes that pay for various components of care to

manage patients with fractures over a course of treatment, such as transitional care management

(TCM) and other care management services, evaluation and management visits (including the

inherent complexity add-on for office/outpatient visits), principal illness navigation services,

community health integration services, and the social determinants of health risk assessment. We

refer readers to our recent guidance on these services on the CMS website at

https://www.cms.gov/files/document/health-related-social-needs-faq.pdf. Medicare also pays for

bone mass measurement/density tests (MLN006559 –

https://www.cms.gov/medicare/prevention/prevntiongeninfo/medicare-preventive-services/mps-

quickreferencechart-1.html#BONE_MASS, and for outpatient osteoporosis medication under Part

D and, in some cases, Part B (https://www.medicare.gov/coverage/osteoporosis-drugs). These

services can be billed on their own, or in combination, where applicable. We note that in the CY

2020 PFS final rule (84 FR 62685) and CY 2021 PFS final rule (85 FR 84547), CMS indicated

that TCM may be billed concurrently with other care management codes when relevant,

medically necessary, and not duplicative.

We are proposing new coding in other sections of this CY 2025 proposed rule that might

be used to bill for managing fractures under a treatment plan, including the global post-operative

add-on code, HCPCS code GPOC1, in section II.G.5 of this proposed rule and the advanced

primary care management codes in section II.G.2 of this proposed rule. Interested parties have

indicated that orthopedic surgeons, skilled nursing facilities (SNFs), and other practitioners and

providers may not be providing comprehensive patient centered fracture management care for

quality, payment, or administrative reasons, and that there is inadequate “hand-off” when post-

discharge fracture care is transferred to practitioners in the community. They indicate a systemic

disconnect on which provider and/or specialty is responsible for osteoporosis diagnosis and

treatment, and that global surgical periods focus on acute fracture recovery rather than

addressing osteoporosis. We are interested in hearing if the proposed global postop add-on code

could help resolve these issues.

TABLE 13: CY 2025 Work RVUs for New, Revised, and Potentially Misvalued Codes

HCPCS

Descriptor

Current

work

RVU

RUC

work

RVU

CMS

work

RVU

CMS time

refinement

15XX1

Harvest of skin for skin cell suspension autograft; first 25

sq cm or less

NEW

3.00

Yes

15XX2

Harvest of skin for skin cell suspension autograft; each

additional 25 sq cm or part thereof (List separately in

addition to code for primary procedure)

NEW

2.00

Yes

15XX3

Preparation of skin cell suspension autograft, requiring

enzymatic processing, manual mechanical disaggregation

of skin cells, and filtration; first 25 sq cm or less of

harvested skin

NEW

2.51

Yes

15XX4

Preparation of skin cell suspension autograft, requiring

enzymatic processing, manual mechanical disaggregation

of skin cells, and filtration; each additional 25 sq cm of

harvested skin or part thereof (List separately in addition to

code for primary procedure)

NEW

2.00

Yes

15XX5

Application of skin cell suspension autograft to wound and

donor sites, including application of primary dressing,

trunk, arms, legs; first 480 sq cm or less

NEW

10.97

Yes

15XX6

Application of skin cell suspension autograft to wound and

donor sites, including application of primary dressing,

trunk, arms, legs; each additional 480 sq cm or part thereof

(List separately in addition to code for primary procedure)

NEW

2.50

Yes

15XX7

Application of skin cell suspension autograft to wound and

donor sites, including application of primary dressing, face,

scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands,

feet, and/or multiple digits; first 480 sq cm or less

NEW

12.50

Yes

15XX8

Application of skin cell suspension autograft to wound and

donor sites, including application of primary dressing, face,

scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands,

feet, and/or multiple digits; each additional 480 sq cm or

part thereof (List separately in addition to code for primary

procedure)

NEW

3.00

Yes

25310

Tendon transplantation or transfer, flexor or extensor,

forearm and/or wrist, single; each tendon

8.08

9.50

9.00

25447

Arthroplasty, intercarpal or carpometacarpal joints;

interposition (eg, tendon)

11.14

10.50

26480

Transfer or transplant of tendon, carpometacarpal area or

dorsum of hand; without free graft, each tendon

6.90

9.50

9.00

2X005

Arthroplasty, intercarpal or carpometacarpal joints;

suspension, including transfer or transplant of tendon, with

interposition, when performed

NEW

13.90

11.85

36514

Therapeutic apheresis; for plasma pheresis

1.81

36516

Therapeutic apheresis; with extracorporeal

immunoadsorption, selective adsorption or selective

filtration and plasma reinfusion

1.56

36522

Photopheresis, extracorporeal

1.75

3X018

Chimeric antigen receptor T-cell (CAR-T) therapy;

harvesting of blood-derived T lymphocytes for

development of genetically modified autologous CAR-T

cells, per day

NEW

1.94

3X019

Chimeric antigen receptor T-cell (CAR-T) therapy;

preparation of blood-derived T lymphocytes for

transportation (eg, cryopreservation, storage)

NEW

0.79

3X020

Chimeric antigen receptor T-cell (CAR-T) therapy; receipt

and preparation of CAR-T cells for administration

NEW

0.80

HCPCS

Descriptor

Current

work

RVU

RUC

work

RVU

CMS

work

RVU

CMS time

refinement

3X021

Chimeric antigen receptor T-cell (CAR-T) therapy; CAR-T

cell administration, autologous

NEW

3.00

4X015

Excision or destruction, open, intra-abdominal (ie,

peritoneal, mesenteric, retroperitoneal), primary or

secondary tumor(s) or cyst(s), sum of the maximum length

of tumor(s) or cyst(s); 5 cm or less

NEW

22.00

4X016

Excision or destruction, open, intra-abdominal (ie,

peritoneal, mesenteric, retroperitoneal), primary or

secondary tumor(s) or cyst(s), sum of the maximum length

of tumor(s) or cyst(s); 5.1 to 10 cm

NEW

28.65

4X017

Excision or destruction, open, intra-abdominal (ie,

peritoneal, mesenteric, retroperitoneal), primary or

secondary tumor(s) or cyst(s), sum of the maximum length

of tumor(s) or cyst(s); 10.1 to 20 cm

NEW

34.00

4X018

Excision or destruction, open, intra-abdominal (ie,

peritoneal, mesenteric, retroperitoneal), primary or

secondary tumor(s) or cyst(s), sum of the maximum length

of tumor(s) or cyst(s); 20.1 to 30 cm

NEW

45.00

40.00

4X019

Excision or destruction, open, intra-abdominal (ie,

peritoneal, mesenteric, retroperitoneal), primary or

secondary tumor(s) or cyst(s), sum of the maximum length

of tumor(s) or cyst(s); greater than 30 cm

NEW

55.00

50.00

59200

Insertion of cervical dilator (eg, laminaria, prostaglandin)

(separate procedure)

0.79

1.20

5X006

Insertion of transurethral ablation transducer for delivery of

thermal ultrasound for prostate tissue ablation, including

suprapubic tube placement during the same session and

placement of an endorectal cooling device, when

performed

NEW

4.05

5X007

Ablation of prostate tissue, transurethral, using thermal

ultrasound, including magnetic resonance imaging

guidance for, and monitoring of, tissue ablation;

NEW

9.80

5X008

Ablation of prostate tissue, transurethral, using thermal

ultrasound, including magnetic resonance imaging

guidance for, and monitoring of, tissue ablation; with

insertion of transurethral ultrasound transducer for delivery

of thermal ultrasound, including suprapubic tube placement

and placement of an endorectal cooling device, when

performed

NEW

11.50

5XX05

Cystourethroscopy with insertion of temporary device for

ischemic remodeling (ie, pressure necrosis) of bladder neck

and prostate

NEW

3.10

5XX06

Catheterization with removal of temporary device for

ischemic remodeling (ie, pressure necrosis) of bladder neck

and prostate

NEW

1.48

64486

Transversus abdominis plane (TAP) block (abdominal

plane block, rectus sheath block) unilateral; by injection(s)

(includes imaging guidance, when performed)

1.27

1.20

64487

Transversus abdominis plane (TAP) block (abdominal

plane block, rectus sheath block) unilateral; by continuous

infusion(s) (includes imaging guidance, when performed)

1.48

1.39

64488

Transversus abdominis plane (TAP) block (abdominal

plane block, rectus sheath block) bilateral; by injections

(includes imaging guidance, when performed)

1.60

1.40

64489

Transversus abdominis plane (TAP) block (abdominal

plane block, rectus sheath block) bilateral; by continuous

infusions (includes imaging guidance, when performed)

1.80

1.75

HCPCS

Descriptor

Current

work

RVU

RUC

work

RVU

CMS

work

RVU

CMS time

refinement

64590

Insertion or replacement of peripheral, sacral, or gastric

neurostimulator pulse generator or receiver, requiring

pocket creation and connection between electrode array

and pulse generator or receiver

5.10

64595

Revision or removal of peripheral, sacral, or gastric

neurostimulator pulse generator or receiver, with

detachable connection to electrode array

3.79

66680

Repair of iris, ciliary body (as for iridodialysis)

6.39

10.25

7.97

66682

Suture of iris, ciliary body (separate procedure) with

retrieval of suture through small incision (eg, McCannel

suture)

7.33

10.87

8.74

6X004

Implantation of iris prosthesis, including suture fixation

and repair or removal of iris, when performed

NEW

12.80

10.67

6XX00

Magnetic resonance image guided high intensity focused

ultrasound (MRgFUS), stereotactic ablation of target,

intracranial, including stereotactic navigation and frame

placement, when performed

NEW

18.95

16.60

6XX01

Ablation of 1 or more thyroid nodule(s), one lobe or the

isthmus, percutaneous, including imaging guidance,

radiofrequency

NEW

5.75

6XX02

Ablation of 1 or more thyroid nodule(s), additional lobe,

percutaneous, including imaging guidance, radiofrequency

(List separately in addition to code for primary procedure)

NEW

4.25

6XX07

Thoracic fascial plane block, unilateral; by injection(s),

including imaging guidance, when performed

NEW

1.50

6XX08

Thoracic fascial plane block, unilateral; by continuous

infusion(s), including imaging guidance, when performed

NEW

1.74

6XX09

Thoracic fascial plane block, bilateral; by injection(s),

including imaging guidance, when performed

NEW

1.67

6XX10

Thoracic fascial plane block, bilateral; by continuous

infusion(s), including imaging guidance, when performed

NEW

1.83

6XX11

Lower extremity fascial plane block, unilateral; by

injection(s), including imaging guidance, when performed

NEW

1.34

6XX12

Lower extremity fascial plane block, unilateral; by

continuous infusion(s), including imaging guidance, when

performed

NEW

1.67

76981

Ultrasound, elastography; parenchyma (eg, organ)

0.59

76982

Ultrasound, elastography; first target lesion

0.59

76983

Ultrasound, elastography; each additional target lesion

0.50

0.47

77012

Computed tomography guidance for needle placement (eg,

biopsy, aspiration, injection, localization device),

radiological supervision and interpretation

1.50

7XX00

MR safety implant and/or foreign body assessment by

trained clinical staff, including identification and

verification of implant components from appropriate

sources (eg, surgical reports, imaging reports, medical

device databases, device vendors, review of prior imaging),

analyzing current MR conditional status of individual

components and systems, and consulting published

professional guidance with written report; initial 15

minutes

NEW

0.00

HCPCS

Descriptor

Current

work

RVU

RUC

work

RVU

CMS

work

RVU

CMS time

refinement

7XX01

MR safety implant and/or foreign body assessment by

trained clinical staff, including identification and

verification of implant components from appropriate

sources (eg, surgical reports, imaging reports, medical

device databases, device vendors, review of prior imaging),

analyzing current MR conditional status of individual

components and systems, and consulting published

professional guidance with written report; each additional

30 minutes (List separately in addition to code for primary

procedure)

NEW

0.00

7XX02

MR safety determination by a physician or other qualified

health care professional responsible for the safety of the

MR procedure, including review of implant MR conditions

for indicated MR examination, analysis of risk vs clinical

benefit of performing MR examination, and determination

of MR equipment, accessory equipment, and expertise

required to perform examination, with written report

NEW

0.60

7XX03

MR safety medical physics examination customization,

planning and performance monitoring by medical physicist

or MR safety expert, with review and analysis by physician

or other qualified health care professional to prioritize and

select views and imaging sequences, to tailor MR

acquisition specific to restrictive requirements or artifacts

associated with MR conditional implants or to mitigate risk

of non-conditional implants or foreign bodies, with written

report

NEW

0.76

7XX04

MR safety implant electronics preparation under

supervision of physician or other qualified health care

professional, including MR-specific programming of pulse

generator and/or transmitter to verify device integrity,

protection of device internal circuitry from MR

electromagnetic fields, and protection of patient from risks

of unintended stimulation or heating while in the MR

room, with written report

NEW

0.75

7XX05

MR safety implant positioning and/or immobilization

under supervision of physician or other qualified health

care professional, including application of physical

protections to secure implanted medical device from MR-

induced translational or vibrational forces, magnetically

induced functional changes, and/or prevention of

radiofrequency burns from inadvertent tissue contact while

in the MR room, with written report

NEW

0.60

90480

Immunization administration by intramuscular injection of

severe acute respiratory syndrome coronavirus 2 (SARS-

CoV-2) (coronavirus disease [COVID-19]) vaccine, single

dose

0.25

92132

Computerized ophthalmic diagnostic imaging (eg, optical

coherence tomography [OCT]), anterior segment, with

interpretation and report, unilateral or bilateral

0.30

0.29

92133

Computerized ophthalmic diagnostic imaging (eg, optical

coherence tomography [OCT]), posterior segment, with

interpretation and report, unilateral or bilateral; optic nerve

0.40

0.31

92134

Computerized ophthalmic diagnostic imaging (eg, optical

coherence tomography [OCT]), posterior segment, with

interpretation and report, unilateral or bilateral; retina

0.45

0.32

93886

Transcranial Doppler study of the intracranial arteries;

complete study

0.91

0.90

93888

Transcranial Doppler study of the intracranial arteries;

limited study

0.50

0.73

HCPCS

Descriptor

Current

work

RVU

RUC

work

RVU

CMS

work

RVU

CMS time

refinement

93892

Transcranial Doppler study of the intracranial arteries;

emboli detection without intravenous microbubble

injection

1.15

93893

Transcranial Doppler study of the intracranial arteries;

venous-arterial shunt detection with intravenous

microbubble injection

1.15

93X94

Vasoreactivity study performed with transcranial Doppler

study of intracranial arteries, complete (List separately in

addition to code for primary procedure)

NEW

0.81

93X95

Emboli detection without intravenous microbubble

injection performed with transcranial Doppler study of

intracranial arteries, complete (List separately in addition to

code for primary procedure)

NEW

0.73

93X96

Venous-arterial shunt detection with intravenous

microbubble injection performed with transcranial Doppler

study of intracranial arteries, complete (List separately in

addition to code for primary procedure)

NEW

0.85

96380

Administration of respiratory syncytial virus, monoclonal

antibody, seasonal dose by intramuscular injection, with

counseling by physician or other qualified health care

professional

0.24

96381

Administration of respiratory syncytial virus, monoclonal

antibody, seasonal dose by intramuscular injection

0.17

96547

Intraoperative hyperthermic intraperitoneal chemotherapy

(HIPEC) procedure, including separate incision(s) and

closure, when performed; first 60 minutes (List separately

in addition to code for primary procedure)

6.53

96548

Intraoperative hyperthermic intraperitoneal chemotherapy

(HIPEC) procedure, including separate incision(s) and

closure, when performed; each additional 30 minutes

3.00

96920

Excimer laser treatment for psoriasis; total area less than

250 sq cm

1.15

1.00

0.83

96921

Excimer laser treatment for psoriasis; 250 sq cm to 500 sq

1.30

1.07

0.90

96922

Excimer laser treatment for psoriasis; over 500 sq cm

2.10

1.32

1.15

97012

Application of a modality to 1 or more areas; traction,

mechanical

0.25

97014

Application of a modality to 1 or more areas; electrical

stimulation (unattended)

0.18

97016

Application of a modality to 1 or more areas;

vasopneumatic devices

0.18

97018

Application of a modality to 1 or more areas; paraffin bath

0.06

97022

Application of a modality to 1 or more areas; whirlpool

0.17

97032

Application of a modality to 1 or more areas; electrical

stimulation (manual), each 15 minutes

0.25

97033

Application of a modality to 1 or more areas;

iontophoresis, each 15 minutes

0.26

97034

Application of a modality to 1 or more areas; contrast

baths, each 15 minutes

0.21

97035

Application of a modality to 1 or more areas; ultrasound,

each 15 minutes

0.21

97110

Therapeutic procedure, 1 or more areas, each 15 minutes;

therapeutic exercises to develop strength and endurance,

range of motion and flexibility

0.45

97112

Therapeutic procedure, 1 or more areas, each 15 minutes;

neuromuscular reeducation of movement, balance,

0.50

HCPCS

Descriptor

Current

work

RVU

RUC

work

RVU

CMS

work

RVU

CMS time

refinement

coordination, kinesthetic sense, posture, and/or

proprioception for sitting and/or standing activities

97113

Therapeutic procedure, 1 or more areas, each 15 minutes;

aquatic therapy with therapeutic exercises

0.48

97116

Therapeutic procedure, 1 or more areas, each 15 minutes;

gait training (includes stair climbing)

0.45

97140

Manual therapy techniques (eg, mobilization/

manipulation, manual lymphatic drainage, manual

traction), 1 or more regions, each 15 minutes

0.43

97530

Therapeutic activities, direct (one-on-one) patient contact

(use of dynamic activities to improve functional

performance), each 15 minutes

0.44

97533

Sensory integrative techniques to enhance sensory

processing and promote adaptive responses to

environmental demands, direct (one-on-one) patient

contact, each 15 minutes

0.48

97535

Self-care/home management training (eg, activities of daily

living (ADL) and compensatory training, meal preparation,

safety procedures, and instructions in use of assistive

technology devices/adaptive equipment) direct one-on-one

contact, each 15 minutes

0.45

97537

Community/work reintegration training (eg, shopping,

transportation, money management, avocational activities

and/or work environment/modification analysis, work task

analysis, use of assistive technology device/adaptive

equipment), direct one-on-one contact, each 15 minutes

0.48

97542

Wheelchair management (eg, assessment, fitting, training),

each 15 minutes

0.48

97810

Acupuncture, 1 or more needles; without electrical

stimulation, initial 15 minutes of personal one-on-one

contact with the patient

0.60

0.61

97811

Acupuncture, 1 or more needles; without electrical

stimulation, each additional 15 minutes of personal one-on-

one contact with the patient, with insertion of needle(s)

(List separately in addition to code for primary procedure)

0.50

0.46

97813

Acupuncture, 1 or more needles; with electrical

stimulation, initial 15 minutes of personal one-on-one

contact with the patient

0.65

0.74

97814

Acupuncture, 1 or more needles; with electrical

stimulation, each additional 15 minutes of personal one-on-

one contact with the patient, with insertion of needle(s)

(List separately in addition to code for primary procedure)

0.55

0.47

9X059

Computerized ophthalmic diagnostic imaging (eg, optical

coherence tomography [OCT]), posterior segment, with

interpretation and report, unilateral or bilateral; retina,

including OCT angiography

NEW

0.64

9X075

Synchronous audio-video visit for the evaluation and

management of a new patient, which requires a medically

appropriate history and/or examination and straightforward

medical decision making. When using total time on the

date of the encounter for code selection, 15 minutes must

be met or exceeded.

NEW

0.93

Yes

9X076

Synchronous audio-video visit for the evaluation and

management of a new patient, which requires a medically

appropriate history and/or examination and low medical

decision making. When using total time on the date of the

encounter for code selection, 30 minutes must be met or

exceeded.

NEW

1.60

Yes

HCPCS

Descriptor

Current

work

RVU

RUC

work

RVU

CMS

work

RVU

CMS time

refinement

9X077

Synchronous audio-video visit for the evaluation and

management of a new patient, which requires a medically

appropriate history and/or examination and moderate

medical decision making. When using total time on the

date of the encounter for code selection, 45 minutes must

be met or exceeded.

NEW

2.60

Yes

9X078

Synchronous audio-video visit for the evaluation and

management of a new patient, which requires a medically

appropriate history and/or examination and high medical

decision making. When using total time on the date of the

encounter for code selection, 60 minutes must be met or

exceeded.

NEW

3.50

Yes

9X079

Synchronous audio-video visit for the evaluation and

management of an established patient, which requires a

medically appropriate history and/or examination and

straightforward medical decision making. When using total

time on the date of the encounter for code selection, 10

minutes must be met or exceeded.

NEW

0.70

Yes

9X080

Synchronous audio-video visit for the evaluation and

management of an established patient, which requires a

medically appropriate history and/or examination and low

medical decision making. When using total time on the

date of the encounter for code selection, 20 minutes must

be met or exceeded.

NEW

1.30

Yes

9X081

Synchronous audio-video visit for the evaluation and

management of an established patient, which requires a

medically appropriate history and/or examination and

moderate medical decision making. When using total time

on the date of the encounter for code selection, 30 minutes

must be met or exceeded.

NEW

1.92

Yes

9X082

Synchronous audio-video visit for the evaluation and

management of an established patient, which requires a

medically appropriate history and/or examination and high

medical decision making. When using total time on the

date of the encounter for code selection, 40 minutes must

be met or exceeded.

NEW

2.60

Yes

9X083

Synchronous audio-only visit for the evaluation and

management of a new patient, which requires a medically

appropriate history and/or examination, straightforward

medical decision making, and more than 10 minutes of

medical discussion. When using total time on the date of

the encounter for code selection, 15 minutes must be met or

exceeded.

NEW

0.90

Yes

9X084

Synchronous audio-only visit for the evaluation and

management of a new patient, which requires a medically

appropriate history and/or examination, low medical

decision making, and more than 10 minutes of medical

discussion. When using total time on the date of the

encounter for code selection, 30 minutes must be met or

exceeded.

NEW

1.55

Yes

9X085

Synchronous audio-only visit for the evaluation and

management of a new patient, which requires a medically

appropriate history and/or examination, moderate medical

decision making, and more than 10 minutes of medical

discussion. When using total time on the date of the

encounter for code selection, 45 minutes must be met or

exceeded.

NEW

2.42

Yes

HCPCS

Descriptor

Current

work

RVU

RUC

work

RVU

CMS

work

RVU

CMS time

refinement

9X086

Synchronous audio-only visit for the evaluation and

management of a new patient, which requires a medically

appropriate history and/or examination, high medical

decision making, and more than 10 minutes of medical

discussion. When using total time on the date of the

encounter for code selection, 60 minutes must be met or

exceeded.

NEW

3.20

Yes

9X087

Synchronous audio-only visit for the evaluation and

management of an established patient, which requires a

medically appropriate history and/or examination,

straightforward medical decision making, and more than 10

minutes of medical discussion. When using total time on

the date of the encounter for code selection, 10 minutes

must be exceeded.

NEW

0.65

Yes

9X088

Synchronous audio-only visit for the evaluation and

management of an established patient, which requires a

medically appropriate history and/or examination, low

medical decision making, and more than 10 minutes of

medical discussion. When using total time on the date of

the encounter for code selection, 20 minutes must be met or

exceeded.

NEW

1.20

Yes

9X089

Synchronous audio-only visit for the evaluation and

management of an established patient, which requires a

medically appropriate history and/or examination,

moderate medical decision making, and more than 10

minutes of medical discussion. When using total time on

the date of the encounter for code selection, 30 minutes

must be met or exceeded.

NEW

1.75

Yes

9X090

Synchronous audio-only visit for the evaluation and

management of an established patient, which requires a

medically appropriate history and/or examination, high

medical decision making, and more than 10 minutes of

medical discussion. When using total time on the date of

the encounter for code selection, 40 minutes must be met or

exceeded.

NEW

2.60

Yes

9X091

Brief communication technology-based service (eg, virtual

check-in) by a physician or other qualified health care

professional who can report evaluation and management

services, provided to an established patient, not originating

from a related evaluation and management service

provided within the previous 7 days nor leading to an

evaluation and management service or procedure within the

next 24 hours or soonest available appointment, 5-10

minutes of medical discussion

NEW

0.30

9X100

Medical genetics and genetic counseling services, each 30

minutes of total time provided by the genetic counselor on

the date of the encounter

NEW

0.00

G0138

Intravenous infusion of cipaglucosidase alfaatga, including

provider/supplier acquisition and clinical supervision of

oral administration of miglustat in preparation of receipt of

cipaglucosidase alfa-atga

0.21

Yes

G0168

Wound closure utilizing tissue adhesive(s) only

0.31

G0283

Electrical stimulation (unattended), to one or more areas

for indication(s) other than wound care, as part of a therapy

plan of care

0.18

G0442

Annual alcohol misuse screening, 5 to 15 minutes

0.18

G0443

Brief face-to-face behavioral counseling for alcohol

misuse, 15 minutes

0.45

0.60

HCPCS

Descriptor

Current

work

RVU

RUC

work

RVU

CMS

work

RVU

CMS time

refinement

G0444

Annual depression screening, 5 to 15 minutes

0.18

G0445

High intensity behavioral counseling to prevent sexually

transmitted infection; face-to-face, individual, includes:

education, skills training and guidance on how to change

sexual behavior; performed semi-annually, 30 minutes

0.45

G0446

Annual, face-to-face intensive behavioral therapy for

cardiovascular disease, individual, 15 minutes

0.45

G0447

Face-to-face behavioral counseling for obesity, 15 minutes

0.45

G0465

Autologous platelet rich plasma (prp) or other blood-

derived product for diabetic chronic wounds/ulcers, using

an fda-cleared device for this indication, (includes as

applicable administration, dressings, phlebotomy,

centrifugation or mixing, and all other preparatory

procedures, per treatment)

1.50

Yes

G0516

Insertion of non-biodegradable drug delivery implants, 4 or

more (services for subdermal rod implant)

1.82

G0517

Removal of non-biodegradable drug delivery implants, 4 or

more (services for subdermal implants)

2.10

G0518

Removal with reinsertion, non-biodegradable drug delivery

implants, 4 or more (services for subdermal implants)

3.55

GMBT1

Supply of digital mental health treatment device and initial

education and onboarding, per course of treatment that

augments a behavioral therapy plan

NEW

GMBT2

First 20 minutes of monthly treatment management

services directly related to the patient’s therapeutic use of

the digital mental health treatment (DMHT) device that

augments a behavioral therapy plan, physician/other

qualified health care professional time reviewing data

generated from the DMHT device from patient

observations and patient specific inputs in a calendar

month and requiring at least one interactive communication

with the patient/caregiver during the calendar month

NEW

0.62

GMBT3

Each additional 20 minutes of monthly treatment

management services directly related to the patient’s

therapeutic use of the digital mental health treatment

(DMHT) device that augments a behavioral therapy plan,

physician/other qualified health care professional time

reviewing data generated from the DMHT device from

patient observations and patient specific inputs in a

calendar month and requiring at least one interactive

communication with the patient/caregiver during the

calendar month

NEW

0.61

GCDRA

Administration of a standardized, evidence-based

Atherosclerotic Cardiovascular Disease (ASCVD) Risk

Assessment, 5-15 minutes, not more often than every 12

months

NEW

0.18

GCDRM

Atherosclerotic Cardiovascular Disease (ASCVD) risk

management services; clinical staff time; per calendar

month

NEW

0.18

GCTB1

Caregiver training in behavior management/modification

for caregiver(s) of patients with a mental or physical health

diagnosis, administered by physician or other qualified

health care professional (without the patient present), face-

to-face; initial 30 minutes

NEW

1.00

HCPCS

Descriptor

Current

work

RVU

RUC

work

RVU

CMS

work

RVU

CMS time

refinement

GCTB2

Caregiver training in behavior management/modification

for parent(s)/guardian(s)/caregiver(s) of patients with a

mental or physical health diagnosis, administered by

physician or other qualified health care professional

(without the patient present), face-to-face; each additional

15 minutes

NEW

0.54

GCTD1

Caregiver training in direct care strategies and techniques

to support care for patients with an ongoing condition or

illness and to reduce complications (without the patient

present), face-to-face; initial 30 minutes

NEW

1.00

GCTD2

Caregiver training in direct care strategies and techniques

to support care for patients with an ongoing condition or

illness and to reduce complications (without the patient

present), face-to-face; each additional 15 minutes

NEW

0.54

GCTD3

Group caregiver training in direct care strategies and

techniques to support care for patients with an ongoing

condition or illness and to reduce complications (without

the patient present), face-to-face with multiple sets of

caregivers

NEW

0.23

GFCI1

Post discharge telephonic follow-up contacts performed in

conjunction with a discharge from the emergency

department for behavioral health or other crisis encounter,

4 calls per calendar month.

NEW

1.00

GIDXX

Visit complexity inherent to hospital inpatient or

observation care associated with a confirmed or suspected

infectious disease by an infectious diseases consultant,

including disease transmission risk assessment and

mitigation, public health investigation, analysis, and

testing, and complex antimicrobial therapy counseling and

treatment. (add-on code, list separately in addition to

hospital inpatient or observation evaluation and

management visit, initial, same day discharge, or

subsequent

NEW

0.89

GIPC1

Interprofessional telephone/Internet/electronic health

record assessment and management service provided by a

practitioner in a specialty whose covered services are

limited by statute to services for the diagnosis and

treatment of mental illness, including a verbal and written

report to the patient’s treating/requesting practitioner; 5-10

minutes of medical consultative discussion and review

NEW

0.35

GIPC2

Interprofessional telephone/Internet/electronic health

record assessment and management service provided by a

practitioner in a specialty whose covered services are

limited by statute to services for the diagnosis and

treatment of mental illness, including a verbal and written

report to the patient’s treating/requesting practitioner; 11-

20 minutes of medical consultative discussion and review

NEW

0.70

GIPC3

Interprofessional telephone/Internet/electronic health

record assessment and management service provided by a

practitioner in a specialty whose covered services are

limited by statute to services for the diagnosis and

treatment of mental illness, including a verbal and written

report to the patient’s treating/requesting practitioner; 21-

30 minutes of medical consultative discussion and review

NEW

1.05

HCPCS

Descriptor

Current

work

RVU

RUC

work

RVU

CMS

work

RVU

CMS time

refinement

GIPC4

Interprofessional telephone/Internet/electronic health

record assessment and management service provided by a

practitioner in a specialty whose covered services are

limited by statute to services for the diagnosis and

treatment of mental illness, including a verbal and written

report to the patient’s treating/requesting practitioner; 31 or

more minutes of medical consultative discussion and

review

NEW

1.40

GIPC5

Interprofessional telephone/Internet/electronic health

record assessment and management service provided by a

practitioner in a specialty whose covered services are

limited by statute to services for the diagnosis and

treatment of mental illness, including a written report to the

patient’s treating/requesting practitioner, 5 minutes or more

of medical consultative time

NEW

0.70

GIPC6

Interprofessional telephone/Internet/electronic health

record referral service(s) provided by a treating/requesting

practitioner in a specialty whose covered services are

limited by statute to services for the diagnosis and

treatment of mental illness, 30 minutes

NEW

0.70

GPCM1

Advanced primary care management services furnished to

patients requiring primary care provided by clinical

staff/physician/other qualified health care professionals

who are responsible for all primary care and serve as the

continuing focal point for all needed health care services,

per calendar month, with the following elements:

• Development, implementation, revision, and maintenance

of a patient-centered electronic care plan;

• Overall comprehensive care management;

o Systematic needs assessment (medical and psychosocial)

o Ensure receipt of preventive services

o Medication reconciliation, management and oversight of

self-management

• Ongoing communication and care coordination between

relevant practitioners furnishing care (e.g., community-

based care);

o Coordinate with any home- and community-based

clinical service providers, and document communication

with them regarding psychosocial needs and functional

deficits

• Timely management of care transitions (e.g., ED visit and

hospital discharges) and referrals;

o Create/exchange continuity of care document(s) timely

(format not prescribed)

o Communication (direct contact, telephone, electronic)

with the patient and/or caregiver within 7 calendar days of

discharge

• Enhanced communications opportunities and digital

access

o Offer asynchronous non-face-to-face methods other than

telephone, such as secure email or patient portal

o Ensure access to virtual visits and consultations and

digital health communication technology-based services,

such as interprofessional consultations with other

practitioners, virtual check-ins, e-visits, and remote

evaluation of images, to maintain ongoing communication

with patient, as appropriate.).

NEW

0.17

HCPCS

Descriptor

Current

work

RVU

RUC

work

RVU

CMS

work

RVU

CMS time

refinement

GPCM2

Advanced primary care management services furnished to

patients with multiple (two or more) chronic conditions

expected to last at least 12 months, or until the death of the

patient, which place the patient at significant risk of death,

acute exacerbation/decompensation, or functional decline,

provided by clinical staff/physician/other qualified health

care professionals who are responsible for all primary care

and serve as the continuing focal point for all needed health

care services, per calendar month, with the elements

included in GPCM1

NEW

0.77

GPCM3

Advanced primary care management services furnished to

Qualified Medicare Beneficiaries with multiple (two or

more) chronic conditions expected to last at least 12

months, or until the death of the patient, which place the

patient at significant risk of death, acute

exacerbation/decompensation, or functional decline,

provided by clinical staff/physician/other qualified health

care professionals who are responsible for all primary care

and serve as the continuing focal point for all needed health

care services, per calendar month, with the elements

included in GPCM1

NEW

1.67

GPOC1

Post-operative follow-up visit complexity inherent to

evaluation and management services addressing surgical

procedure(s), provided by a physician or qualified health

care professional who is not the practitioner who

performed the procedure (or in the same group practice),

and is of a different specialty than the practitioner who

performed the procedure, within the 090-day global period

of the procedure(s), once per 090-day global period, when

there has not been a formal transfer of care and requires the

following required elements, when possible and applicable:

● Reading available surgical note to understand the

relative success of the procedure, the anatomy that was

affected, and potential complications that could have arisen

due to the unique circumstances of the patient’s operation.

● Research the procedure to determine expected post-

operative course and potential complications (in the case of

doing a post-op for a procedure outside the specialty).

● Evaluate and physically examine the patient to

determine whether the post-operative course is progressing

appropriately.

● Communicate with the practitioner who performed the

procedure if any questions or concerns arise.

(List separately in addition to office/outpatient evaluation

and management visit, new or established)

NEW

0.16

GSPI1

Safety planning interventions, including the following

elements: recognizing warning signs of an impending

suicidal crisis; employing internal coping strategies;

utilizing social contacts and social settings as a means of

distraction from suicidal thoughts; utilizing family

members or friends to help resolve the crisis; contacting

mental health professionals or agencies; and restricting

access to lethal means; (List separately in addition to an

E/M visit or psychotherapy).

NEW

1.09

TABLE 14: CY 2025 Direct PE Refinements

HCPCS

code

HCPCS code

description

Input

Code

Input code description

Nonfacility (NF)

/ Facility (F)

Labor activity

(where applicable)

RUC

recommendation

or current value

(min or qty)

CMS

refinement

(min or

qty)

Comment

Direct

costs

change

(in

dollars)

64486

Tap block unil by

injection

L037D

RN/LPN/MTA

Assist physician or

other qualified

healthcare

professional---

directly related to

physician work

time (67% of

physician intra-

service time)

7.5

L13: Refined to correct

rounding error in clinical

labor calculation

-0.27

6XX07

Thrc fascial pln blk

uni njx

L037D

RN/LPN/MTA

Assist physician or

other qualified

healthcare

professional---

directly related to

physician work

time (67% of

physician intra-

service time)

7.5

L13: Refined to correct

rounding error in clinical

labor calculation

-0.27

6XX11

Lwr xtr fscl pln blk

uni njx

L037D

RN/LPN/MTA

Assist physician or

other qualified

healthcare

professional---

directly related to

physician work

time (67% of

physician intra-

service time)

7.5

L13: Refined to correct

rounding error in clinical

labor calculation

-0.27

77012

Ct scan for needle

biopsy

EL007

room, CT

E11: Refined equipment

time to conform with

other codes in the family

-51.17

7XX00

Mr sfty implt&/fb

asmt stf 1

L047A

MRI Technologist

Document

procedure

(nonPACS) (e.g.

mandated

reporting, registry

logs, EEG file, etc.)

L3: Refined clinical labor

time to conform with

identical labor activity in

other codes in the family

-0.76

HCPCS

code

HCPCS code

description

Input

Code

Input code description

Nonfacility (NF)

/ Facility (F)

Labor activity

(where applicable)

RUC

recommendation

or current value

(min or qty)

CMS

refinement

(min or

qty)

Comment

Direct

costs

change

(in

dollars)

7XX01

Mr sfty mplt&/fb

asmt stf ea

ED050

Technologist PACS

workstation

E16: No equipment times

were included; aligned

equipment time with

assist physician time

-0.29

7XX01

Mr sfty mplt&/fb

asmt stf ea

L047A

MRI Technologist

Document

procedure

(nonPACS) (e.g.

mandated

reporting, registry

logs, EEG file, etc.)

L3: Refined clinical labor

time to conform with

identical labor activity in

other codes in the family

-0.76

7XX01

Mr sfty mplt&/fb

asmt stf ea

L047A

MRI Technologist

Perform

procedure/service--

-NOT directly

related to physician

work time

G1: See preamble text

-9.88

7XX02

Mr safety deter

phys/qhp

L047A

MRI Technologist

Document

procedure

(nonPACS) (e.g.

mandated

reporting, registry

logs, EEG file, etc.)

L3: Refined clinical labor

time to conform with

identical labor activity in

other codes in the family

-0.76

7XX03

Mr sfty med physics

xm cstmz

ED053

Professional PACS

Workstation

G1: See preamble text

-0.80

7XX04

Mr safety implant

elec prepj

L047A

MRI Technologist

Clean

room/equipment by

clinical staff

G1: See preamble text

-0.76

7XX04

Mr safety implant

elec prepj

L047A

MRI Technologist

Document

procedure

(nonPACS) (e.g.

mandated

reporting, registry

logs, EEG file, etc.)

L3: Refined clinical labor

time to conform with

identical labor activity in

other codes in the family

-0.76

7XX05

Mr safety implt

pos&/immoblj

L047A

MRI Technologist

Document

procedure

(nonPACS) (e.g.

mandated

L3: Refined clinical labor

time to conform with

identical labor activity in

other codes in the family

-0.76

HCPCS

code

HCPCS code

description

Input

Code

Input code description

Nonfacility (NF)

/ Facility (F)

Labor activity

(where applicable)

RUC

recommendation

or current value

(min or qty)

CMS

refinement

(min or

qty)

Comment

Direct

costs

change

(in

dollars)

reporting, registry

logs, EEG file, etc.)

7XX05

Mr safety implt

pos&/immoblj

L047A

MRI Technologist

Clean

room/equipment by

clinical staff

G1: See preamble text

-0.76

7XX05

Mr safety implt

pos&/immoblj

SL082

impression material,

dental putty (per bite

block)

S4: Supply not mentioned

in SOR work description

-2.14

96920

Excimer lsr

psriasis<250sqcm

EQ161

laser, excimer

E13: Equipment item

replaces another item; see

preamble text

21.22

96920

Excimer lsr

psriasis<250sqcm

L037D

RN/LPN/MTA

Clean

room/equipment by

clinical staff

L1: Refined time to

standard for this clinical

labor task

-1.08

96920

Excimer lsr

psriasis<250sqcm

SD363

laser, excimer, pay per

use (under 250 cm2 )

S7: Supply item replaced

by another item; see

preamble

-80.00

96921

Excimer lsr psriasis

250-500

EQ161

laser, excimer

E13: Equipment item

replaces another item; see

preamble text

22.40

96921

Excimer lsr psriasis

250-500

L037D

RN/LPN/MTA

Clean

room/equipment by

clinical staff

L1: Refined time to

standard for this clinical

labor task

-1.08

96921

Excimer lsr psriasis

250-500

SD364

laser, excimer, pay per

use (250-500 cm2 )

S7: Supply item replaced

by another item; see

preamble

-83.00

96922

Excimer lsr

psriasis>500sqcm

EQ161

laser, excimer

E13: Equipment item

replaces another item; see

preamble text

25.94

96922

Excimer lsr

psriasis>500sqcm

L037D

RN/LPN/MTA

Clean

room/equipment by

clinical staff

L1: Refined time to

standard for this clinical

labor task

-1.08

96922

Excimer lsr

psriasis>500sqcm

SD365

laser, excimer, pay per

use (> 500cm2)

S7: Supply item replaced

by another item; see

preamble

-100.00

G0442

Annual alcohol

screen 15 min

L037D

RN/LPN/MTA

Perform

procedure/service--

-NOT directly

related to physician

work time

G1: See preamble text

5.40

HCPCS

code

HCPCS code

description

Input

Code

Input code description

Nonfacility (NF)

/ Facility (F)

Labor activity

(where applicable)

RUC

recommendation

or current value

(min or qty)

CMS

refinement

(min or

qty)

Comment

Direct

costs

change

(in

dollars)

G0444

Depression screen

annual

L037D

RN/LPN/MTA

Perform

procedure/service--

-NOT directly

related to physician

work time

G1: See preamble text

G0445

High inten beh couns

std 30m

EF023

table, exam

G1: See preamble text

0.03

G0445

High inten beh couns

std 30m

SK057

paper, laser printing

(each sheet)

S7: Supply item replaced

by another item; see

preamble

-0.20

G0445

High inten beh couns

std 30m

SK062

patient education booklet

0.5

S8: Supply item replaces

another item; see

preamble

1.40

G0446

Intens behave ther

cardio dx

EF023

table, exam

G1: See preamble text

0.03

G0446

Intens behave ther

cardio dx

SK057

paper, laser printing

(each sheet)

S7: Supply item replaced

by another item; see

preamble

-0.20

G0446

Intens behave ther

cardio dx

SK062

patient education booklet

0.5

S8: Supply item replaces

another item; see

preamble

1.40

G0447

Behavior counsel

obesity 15m

EF023

table, exam

G1: See preamble text

-0.02

G0447

Behavior counsel

obesity 15m

SK057

paper, laser printing

(each sheet)

S7: Supply item replaced

by another item; see

preamble

-0.20

G0447

Behavior counsel

obesity 15m

SK062

patient education booklet

0.5

S8: Supply item replaces

another item; see

preamble

1.40

TABLE 15: CY 2025 Direct PE Refinements – Equipment Refinements Conforming to Changes in Clinical Labor Time

HCPCS

code

HCPCS code

description

Input

Code

Input code

description

Nonfacility

(NF) /

Facility (F)

Labor

activity

(where

applicable)

RUC

recommendation

or current value

(min or qty)

CMS

refinement

(min or

qty)

Comment

Direct

costs

change

(in

dollars)

64486

Tap block

unil by

injection

EF018

stretcher

25.5

E15: Refined

equipment time to

conform to changes

in clinical labor time

-0.01

64486

Tap block

unil by

injection

EQ011

ECG, 3-

channel

(with SpO2,

NIBP, temp,

resp)

25.5

E15: Refined

equipment time to

conform to changes

in clinical labor time

-0.01

6XX07

Thrc fascial

pln blk uni

njx

EF018

stretcher

25.5

E15: Refined

equipment time to

conform to changes

in clinical labor time

-0.01

6XX07

Thrc fascial

pln blk uni

njx

EQ011

ECG, 3-

channel

(with SpO2,

NIBP, temp,

resp)

25.5

E15: Refined

equipment time to

conform to changes

in clinical labor time

-0.01

6XX11

Lwr xtr fscl

pln blk uni

njx

EF018

stretcher

25.5

E15: Refined

equipment time to

conform to changes

in clinical labor time

-0.01

6XX11

Lwr xtr fscl

pln blk uni

njx

EQ011

ECG, 3-

channel

(with SpO2,

NIBP, temp,

resp)

25.5

E15: Refined

equipment time to

conform to changes

in clinical labor time

-0.01

7XX04

Mr safety

implant elec

prepj

EL008

room, MR

E15: Refined

equipment time to

conform to changes

in clinical labor time

-3.28

7XX04

Mr safety

implant elec

prepj

EQ412

Vitals

monitoring

system (MR

Conditional)

E15: Refined

equipment time to

conform to changes

in clinical labor time

-0.32

7XX05

Mr safety

implt

pos&/immobl

EL008

room, MR

E15: Refined

equipment time to

conform to changes

in clinical labor time

-3.28

HCPCS

code

HCPCS code

description

Input

Code

Input code

description

Nonfacility

(NF) /

Facility (F)

Labor

activity

(where

applicable)

RUC

recommendation

or current value

(min or qty)

CMS

refinement

(min or

qty)

Comment

Direct

costs

change

(in

dollars)

7XX05

Mr safety

implt

pos&/immobl

EQ412

Vitals

monitoring

system (MR

Conditional)

E15: Refined

equipment time to

conform to changes

in clinical labor time

-0.32

96920

Excimer lsr

psriasis<250s

qcm

EF031

table, power

E15: Refined

equipment time to

conform to changes

in clinical labor time

-0.03

96920

Excimer lsr

psriasis<250s

qcm

EQ168

light, exam

E15: Refined

equipment time to

conform to changes

in clinical labor time

-0.01

96921

Excimer lsr

psriasis 250-

500

EF031

table, power

E15: Refined

equipment time to

conform to changes

in clinical labor time

-0.03

96921

Excimer lsr

psriasis 250-

500

EQ168

light, exam

E15: Refined

equipment time to

conform to changes

in clinical labor time

-0.01

96922

Excimer lsr

psriasis>500s

qcm

EF031

table, power

E15: Refined

equipment time to

conform to changes

in clinical labor time

-0.03

96922

Excimer lsr

psriasis>500s

qcm

EQ168

light, exam

E15: Refined

equipment time to

conform to changes

in clinical labor time

-0.01

G0442

Annual

alcohol screen

15 min

EF023

table, exam

E15: Refined

equipment time to

conform to changes

in clinical labor time

0.05

G0444

Depression

screen annual

EF023

table, exam

E15: Refined

equipment time to

conform to changes

in clinical labor time

0.05

TABLE 16: CY 2025 Invoices Received for Existing Direct PE Inputs

CPT/HCPCS

codes

Item Name

CMS

code

Current

price

Updated

price

Percent

change

Number

invoices

Estimated non-

facility allowed

services for

HCPCS codes

using this item

30140,

30901,

30903,30905,

30906,

31231,

31237,

31238,

43197, 43198

Atomizer tips

(disposable)

SL464

$0.00

2.66

625,876

65778

human

amniotic

membrane

allograft

mounted on a

non-

absorbable

self-retaining

ring

SD248

$931.33

$1,149.00

23%

52,203

88341

Anti CD45

Monoclonal

Antibody

SL495

$5.15

$8.73

70%

1,094,158

88341,

88342,

88344,

88360, 88361

Benchmark

ULTRA

automated

slide

preparation

system

EP112

$125,040.59

$130,000.00

2,683,605

88341,

88342,

88344,

88360, 88361

Reaction

buffer 10X

(Ventana 950-

300)

SL478

$0.037

$0.045

22%

2,683,605

88341,

88342,

88344,

88360, 88361

Liquid

coverslip

(Ventana 650-

010)

SL479

$0.051

$0.084

65%

2,683,605

88341,

88342,

88344,

88360, 88361

SSC (10X)

(Ventana 950-

110)

SL480

$0.051

$0.069

35%

2,683,605

88341,

88342,

88344,

88360, 88361

Cell

Conditioning 1

(Ventana 950-

124)

SL482

$0.560

$0.937

67%

2,683,605

88342

Confirm anti-

CD15 Mouse

Monoclonal

Antibody

(Ventana 760-

2504)

SL474

$4.90

$9.24

89%

1,157,793

92240, 92242

indocyanine

green (25ml

uou)

SL083

$76.94

$125.11

63%

36,974

93241,

93243,

93245, 93247

extended

external ECG

patch, medical

SD339

$260.35

$292.50

12%

510,943

CPT/HCPCS

codes

Item Name

CMS

code

Current

price

Updated

price

Percent

change

Number

invoices

Estimated non-

facility allowed

services for

HCPCS codes

using this item

magnetic tape

recorder

97810,

97811,

97813, 97814

needle,

acupuncture

SC075

$0.10

$0.199

99%

263,591

306 codes

pack, cleaning

and

disinfecting,

endoscope

SA042

$19.43

31.29

61%

7 codes

pack, drapes,

cystoscopy

SA045

$17.33

$14.99

-14%

Deleted from

all codes

pack, drapes,

laparotomy

(chest-

abdomen)

SA046

$7.26

67221

pack, ocular

photodynamic

therapy

SA049

$16.35

$26.35

61%

1,062

38 codes

pack, urology

cystoscopy

visit

SA058

$113.70

$37.63

-67%

145 codes

pack,

ophthalmology

visit (w-

dilation)

SA082

$3.91

$2.33

-40%

TABLE 17: CY 2025 New Invoices

CPT/HCPCS

codes

Item Name

CMS

code

Average

price

No. of

Invoices

NF Allowed

Services

5X006, 5X007,

5X008

TULSA-PRO TDC Cart

EQ41

1,638.60

2,300

5X007, 5X008

TULSA-PRO Disposable Kit

SA13

8,967.00

847

5XX05

iTIND device

SD36

2,695.00

295

6XX01

RF Electrodes 18 Gauge 70 mm Length

SD36

1,995.00

6XX01, 6XX02

RF Ablation System V1000 and RF

Pump

EQ41

49,950.0

7XX04, 7XX05

Disposable oximeter probe and clip (MR

Conditional)

SD36

6.40

19,215

7XX04, 7XX05

Vitals monitoring system (MR

Conditional)

EQ41

85,182.6

19,215

7XX05

Thermoplastic splint material 6”x9” (MR

Safe)

SG10

21.75

96920, 96921,

96922

Mupirocin 2% Topical Ointment 22

grams

SJ095

0.139

108,634

96920

laser, excimer, pay per use (under 250

cm2 )

SD36

80.00

73,369

96921

laser, excimer, pay per use (250-500 cm2

)

SD36

83.00

21,696

96922

laser, excimer, pay per use (> 500cm2)

SD36

100.00

13,569

9X059

tomographic device, optical coherence

angiography (OCTA)

EQ40

164,500.

360,890

G0138

Opfolda (65 mg capsule)

SH11

32.50

3,955

No codes

inFlow Measuring Device

SD37

140.00

No codes

inFlow Valve-Pump Device

SD37

495.00

No codes

inFlow Activator Kit

SD37

1,250.00

306 codes

(component of

SA042)

ortho-phthalaldehyde 0.55% (eg, Cidex

OPA)

SM03

0.554

306 codes

(component of

SA042)

ortho-phthalaldehyde test strips

SM03

1.556

7 codes (component

of SA045)

drape, surgical, legging

SB05

3.284

7 codes (component

of SA045)

drape, surgical, split, impervious,

absorbent

SB05

8.424

22510, 22511,

22513, 22514

Abdominal Drape Laparotomy Drape

Sterile (100 in x 72 in x 124 in)

SB05

8.049

12,721

67221 (component

of SA049)

kit, ocular photodynamic therapy (PDT)

SA13

26.00

1,062

67221 (component

of SA049)

y-adapter cap

SD36

0.352

1,062

145 codes

(component of

SA082)

post-mydriatic spectacles

SB05

0.328

TABLE 18: CY 2025 No PE Refinements

HCPCS

Description

15XX1

Hrv skn cll ssp agrft 1st 25

15XX2

Hrv skn cll ssp agrft ea add

15XX3

Prepj skn cll ssp agrft 1st

15XX4

Prepj skn cll ssp agrft ea

15XX5

App skn cl ssp agrft t/a/l 1

15XX6

App skn cl ssp agrf t/a/l ea

15XX7

App skn cll ssp f/n/g/hf 1st

15XX8

App skn cll ssp f/n/g/hf ea

25310

Transplant forearm tendon

25447

Repair wrist joints

26480

Transplant hand tendon

2X005

Arthrp ntrcrpl/crp/mtcrp ssp

36514

Apheresis plasma

36516

Apheresis immunoads slctv

36522

Photopheresis

3X018

Car-t hrv bld-drv t lymphcyt

3X019

Car-t prep t lymphcyt f/trns

3X020

Car-t receipt&prepj admn

3X021

Car-t admn autologous

4X015

Opn exc/dstr ntra-abd 5 cm/<

4X016

Opn exc/dstr ntra-abd 5.1-10

4X017

Opn exc/dst ntra-abd 10.1-20

4X018

Opn exc/dst ntra-abd 20.1-30

4X019

Opn exc/dstr ntra-abd >30 cm

59200

Insert cervical dilator

5X006

Ins trurl ablt trnsdc thr us

5X007

Ablt trurl prst8 tis thrm us

5X008

Ablt trurl prst8 tis trnsdcr

5XX05

Cysto insj dev ischmc rmdlg

5XX06

Cathj rmvl dev ischmc rmdlg

64487

Tap block uni by infusion

64488

Tap block bi injection

64489

Tap block bi by infusion

64590

Ins/rpl prph sac/gstr npg/r

64595

Rev/rmv prph sac/gstr npg/r

66680

Repair iris & ciliary body

66682

Repair iris & ciliary body

6X004

Implantation iris prosthesis

6XX00

Mrgfus strtctc ablt trgt icr

6XX01

Abltj 1/+thyr ndul 1lobe prq

6XX02

Abltj 1/+thyr ndul addl prq

6XX08

Thrc fascial pln blk uni nfs

6XX09

Thrc fascial pln blk bi njx

HCPCS

Description

6XX10

Thrc fascial pln blk bi nfs

6XX12

Lwr xtr fscl pln blk uni nfs

76981

Use parenchyma

76982

Use 1st target lesion

76983

Use ea addl target lesion

90480

Admn sarscov2 vacc 1 dose

92132

Cmptr ophth dx img ant segmt

92133

Cmptr ophth img optic nerve

92134

Cptr ophth dx img post segmt

93886

Intracranial complete study

93888

Intracranial limited study

93892

Tcd emboli detect w/o inj

93893

Tcd emboli detect w/inj

93X94

Vsrctv std tcd icr art compl

93X95

Emboli detcj wo iv mbubb njx

93X96

Ven-artl shunt det mbubb njx

96380

Admn rsv monoc antb im cnsl

96381

Admn rsv monoc antb im njx

97012

Mechanical traction therapy

97014

Electric stimulation therapy

97016

Vasopneumatic device therapy

97018

Paraffin bath therapy

97022

Whirlpool therapy

97032

Appl modality 1+estim ea 15

97033

App mdlty 1+iontphrsis ea 15

97034

App mdlty 1+cntrst bth ea 15

97035

App mdlty 1+ultrasound ea 15

97110

Therapeutic exercises

97112

Neuromuscular reeducation

97113

Aquatic therapy/exercises

97116

Gait training therapy

97140

Manual therapy 1/> regions

97530

Therapeutic activities

97533

Sensory integration

97535

Self care mngment training

97537

Community/work reintegration

97542

Wheelchair mngment training

97810

Acupunct w/o stimul 15 min

97811

Acupunct w/o stimul addl 15m

97813

Acupunct w/stimul 15 min

97814

Acupunct w/stimul addl 15m

9X059

Cptrz oph img pst sg rta oct

9X075

Synch audio-video new sf 15

9X076

Synch audio-video new low 30

9X077

Synch audio-video new mod 45

HCPCS

Description

9X078

Synch audio-video new hi 60

9X079

Synch audio-video est sf 10

9X080

Synch audio-video est low 20

9X081

Synch audio-video est mod 30

9X082

Synch audio-video est hi 40

9X083

Synch audio-only new sf 15

9X084

Synch audio-only new low 30

9X085

Synch audio-only new mod 45

9X086

Synch audio-only new high 60

9X087

Synch audio-only est sf 10

9X088

Synch audio-only est low 20

9X089

Synch audio-only est mod 30

9X090

Synch audio-only est high 40

9X091

Brief comunicaj tech-bsd svc

9X100

Genetic counseling svc ea 30

G0168

Wound closure by adhesive

G0283

Elec stim other than wound

G0443

Brief alcohol misuse counsel

G0516

Insert drug del implant, >=4

G0517

Remove drug implant

G0518

Remove w insert drug implant

F. Evaluation and Management (E/M) Visits

1. Office/Outpatient (O/O) Evaluation and Management (E/M) Visit Complexity Add-on

In the CY 2024 PFS final rule (88 FR 78970 through 78982), we finalized separate

payment for the O/O E/M visit complexity add-on code. The full descriptor for the O/O E/M

visit complexity add-on code, HCPCS code G2211, is (Visit complexity inherent to evaluation

and management associated with medical care services that serve as the continuing focal point

for all needed health care services and/or with medical care services that are part of ongoing

care related to a patient's single, serious condition or a complex condition. (Add-on code, list

separately in addition to office/outpatient evaluation and management visit, new or

established)).

The O/O E/M visit complexity add-on code “reflects the time, intensity, and PE resources

involved when practitioners furnish the kinds of O/O E/M visit services that enable them to build

longitudinal relationships with all patients (that is, not only those patients who have a chronic

condition or single high-risk disease) and to address the majority of a patient’s health care needs

with consistency and continuity over longer periods of time.” (88 FR 78970 through 78971). We

explained in the CY 2024 PFS final rule that it is the relationship between the patient and the

practitioner that is the determining factor for when the add-on code should be billed. The add-on

code captures the inherent complexity of the visit that is derived from the longitudinal nature of

the practitioner and patient relationship. The first part of the code descriptor, the “continuing

focal point for all needed health care services,” describes a relationship between the patient and

the practitioner when the practitioner is the continuing focal point for all health care services that

the patient needs. The second part of the add-on code also describes a relationship involving

medical services that are part of ongoing care related to a patient’s single, serious condition or a

complex condition. There is previously unrecognized but important cognitive effort of utilizing

the longitudinal relationship in making a diagnosis, developing a treatment plan, and weighing

the factors that affect a longitudinal doctor-patient relationship. The practitioner must decide

what course of action and choice of words in the visit itself would lead to the best health

outcome in the single visit while simultaneously building up an effective, trusting longitudinal

relationship with the patient. Weighing these various factors, even for a seemingly simple

condition, makes the entire visit inherently complex, which is what this add-on code is intended

to capture (88 FR 78973 through 78974).

We responded to concerns raised by commenters about potential duplicative payment and

potential misreporting of the code, noting that when procedures or other services are reported on

the same day by the same billing practitioner as a significant, separately identifiable O/O E/M

visit (the base codes that the visit complexity add-on code can be billed with), we believed that

the services involve resources that are sufficiently distinct from the costs associated with

furnishing stand-alone O/O E/M visits to warrant a different payment policy (88 FR 78971). We

finalized our proposal that the O/O E/M visit complexity add-on code is not payable when the

O/O E/M visit is reported with CPT Modifier -25, which denotes a significant, separately

identifiable O/O E/M visit by the same physician or other qualified health care professional on

the same day as a procedure or other service (88 FR 78974).

Some commenters expressed concern about our proposal to exclude payment for the visit

complexity add-on code when the O/O E/M base code is reported with Modifier -25 because

some preventive services such as the annual wellness visit (AWV) or a preventive vaccine are

often provided on the same day as a separately identifiable O/O E/M visit, appropriately billed

with Modifier -25. The commenters were concerned that practitioners might avoid the policy by

not providing a preventive service on the same day as another O/O E/M service. We

acknowledged that immunizations and AWVs were sometimes furnished on the same day as an

O/O E/M visit and that our policy would prevent payment of the add-on code with such office

visits billed with Modifier -25 and indicated that we would monitor utilization of the visit

complexity add-on code and continue engagement with interested parties as the policy is

implemented (88 FR 78975).

We have begun to monitor utilization of HCPCS code G2211 and are continuing to

engage with interested parties. We continue to hear from some practitioners that our non-

payment of the O/O E/M visit complexity add-on code when the O/O E/M base code is reported

on the same day as a preventive immunization or other Medicare preventive service is disruptive

to the way such care is usually furnished and contrary to our policy objective for establishing the

add-on payment. An early analysis of practitioner claims from the first few months of 2024

shows relatively few Medicare preventive services being billed on the day preceding or

following an O/O E/M visit. We cannot conclude from this analysis that our policy to deny

payment of the O/O E/M visit complexity add-on code when the O/O E/M base code is reported

on the same day as a preventive immunization or other Medicare preventive service is disruptive

to the way such care is usually furnished. However, we do agree with practitioners expressing

concerns that the current policy is not well-aligned with our policy objective for establishing the

add-on payment.

In response to these concerns, we are proposing to refine our current policy for services

furnished beginning in CY 2025. We are proposing to allow payment of the O/O E/M visit

complexity add-on code when the O/O E/M base code is reported by the same practitioner on the

same day as an AWV, vaccine administration, or any Medicare Part B preventive service

furnished in the office or outpatient setting. Allowing payment for the O/O E/M visit complexity

add-on code in this scenario as proposed would support our policy aims, which include paying

for previously unaccounted resources inherent in the complexity of all longitudinal primary care

office visits. In part, the O/O E/M visit complexity add-on code recognizes the inherent costs of

building trust in the practitioner-patient relationship. We believe that trust-building in the

longitudinal relationship is more significant than ever in making decisions about the

administration of immunizations and other Medicare Part B preventive services. We welcome

comments on this proposal.

G. Enhanced Care Management

1. Background

The CMS Center for Medicare and Medicaid Innovation (CMS Innovation Center) tests

innovative payment and service delivery models to reduce program expenditures while

preserving or enhancing quality of care. CMS Innovation Center models are assessed for their

impact on quality of care and expenditures under Medicare, Medicaid, and the Children’s Health

Insurance Program (CHIP) and the scope and duration of the model test may be expanded

through rulemaking if expected to either reduce spending without compromising quality of care

or enhance quality of care without increasing spending (section 1115A of the Act).

After more

than a decade of testing over 50 innovative payment and service delivery models, the CMS

Innovation Center has enabled broad transformative changes to service delivery and payment in

the Medicare, Medicaid, and CHIP programs which inspire additional transformation throughout

the health care delivery system. Participants in CMS Innovation Center models have

demonstrated improvements in care delivery and patient experience. The CMS Innovation Center

undertook a retrospective review and synthesis of select model evaluations where care delivery

changes have been observed, and the review indicated demonstrable evidence of enhanced care

delivery in several areas, such as care coordination, team-based care, and leveraging data to risk-

stratify patients.

Under the Medicare Physician Fee Schedule (PFS) statute at section 1848 of the Act, we

establish payment amounts for covered physicians’ services, and update our payment policies to

address changes, including changes in medical practice. In this proposed rule, we are proposing

to incorporate key payment and service delivery elements from CMS Innovation Center models

tested and evaluated over the prior decade into permanent coding and payment under the PFS.

Fowler, PhD, JD, E., Rudolph, MPH, N., Davidson, LCSW, MSW, K., Finke, MD, B., Flood, S., Bernheim, MD,

PhD, S. M., & Rawal, PhD, P. (2023). Accelerating Care Delivery Transformation — The CMS Innovation Center’s

Role in the Next Decade. New England Journal of Medicine, 4(11). https://doi.org/10.1056/cat.23.0228.

CMS. Synthesis of Evaluation Results across 21 Medicare Models, 2012-2020. Fowler, PhD. 2022.

https://www.cms.gov/priorities/innovation/data-and-reports/2022/wp-eval-synthesis-21models.

Specifically, we are proposing to recognize a primary care practice delivery model trend which

we will refer to as “advanced primary care” and which we propose to define using the 2021

National Academies of Sciences, Engineering, and Medicine (NASEM) report on Implementing

High-Quality Care as: “whole-person, integrated, accessible, and equitable health care by

interprofessional teams that are accountable for addressing the majority of an individual’s health

and wellness needs across settings and through sustained relationships with patients, families,

and communities.”

Using this definition, we are proposing to recognize the resources involved

in furnishing services using an “advanced primary care” approach to care under the PFS.

Under

this approach, the delivery of care is supported by a team-based care structure and involves a

restructuring of the primary care team, which includes the billing practitioner and the auxiliary

personnel under their general supervision, within practices. This restructuring creates several

advantages for patients, and provides more broad accessibility and alternative methods for

patients to communicate with their care team/practitioner about their care outside of in-person

visits (for example, virtual, asynchronous interactions, such as online chat), which can lead to

more timely and efficient identification of, and responses to, health care needs (for example,

practitioners can route patients to the optimal clinician and setting—to a synchronous visit, an

asynchronous chat, or a direct referral to the optimal site of care).

Practitioners using an

advanced primary care delivery model can more easily collaborate across clinical disciplines

through remote interprofessional consultations with specialists as well as standardize condition

management into evidence-based clinical workflows, which allow for closed-loop follow-up and

more real-time management for patients with acute or evolving complex issues. Practitioners can

National Academies of Sciences, Engineering, and Medicine. 2021. Implementing high-quality primary care:

Rebuilding the foundation of health care. Washington, DC: The National Academies Press.

https://doi.org/10.17226/25983.

Team-based approaches to care can achieve improved provider and care team satisfaction, improved team

communication, improved patient safety, and improved patient and family engagement in care. Coleman, M. Dexter.

D., & Nankivill, N. (2015, August). Factors affecting physician satisfaction and Wisconsin Medical Society

strategies to drive change. Wisconsin Medical Journal. 114(4), 135-142. Retrieved from

https://www.wisconsinmedicalsociety.org/professional/wmj/archives/volume-114-issue-4-august-2015/.

Ellner, A., Basu, N. & Phillips, R.S. From Revolution to Evolution: Early Experience with Virtual-First,

Outcomes-Based Primary Care. J GEN INTERN MED 38, 1975–1979 (2023). https://doi.org/10.1007/s11606-023-

08151-1.

then use synchronous interactions to build rapport with patients and families, partner on complex

decisions, and personalize their patients’ care plans.

Specifically, we are proposing to adopt coding and payment policies to recognize

advanced primary care management (APCM) services for use by practitioners who are providing

services under this specific model of advanced primary care, when the practitioner is the

continuing focal point for all needed health care services and responsible for all primary care

services. This new proposed coding and payment makes use of lessons learned from the CMS

Innovation Center’s testing of a series of advanced primary care models, such as Comprehensive

Primary Care (CPC),

Comprehensive Primary Care Plus (CPC+),

and Primary Care First

(PCF)

27,28

(see discussion in section II.G.2.a.(1) in this proposed rule) to inform the elements

upon which the delivery of APCM services under an advanced primary care delivery model

depend. As detailed below in sections II.G.2.b. through II.G.2.d., this proposed coding and

payment will incorporate elements of several specific, existing care management and

communication technology-based services (CTBS) into a bundle of services, that reflects the

essential elements of the delivery of advanced primary care, for payment under the PFS starting

in 2025.

In the context of the proposal, we are also interested in feedback on other related policies

for our consideration in future rulemaking. To gather information from interested parties to

inform potential future proposals, we have included an Advanced Primary Care Hybrid Payment

Request for Information (RFI) (Advanced Primary Care RFI) in this proposed rule. The

Advanced Primary Care RFI seeks feedback on whether and how we should consider additional

payment policies that reflect our efforts to recognize the delivery of advanced primary care,

including bundling of additional individual services, which may currently be furnished together

https://www.cms.gov/priorities/innovation/innovation-models/comprehensive-primary-care-initiative.

https://www.cms.gov/priorities/innovation/innovation-models/comprehensive-primary-care-plus.

https://www.cms.gov/priorities/innovation/innovation-models/primary-care-first-model-options.

Finke, Bruce, et al. “Addressing Challenges in Primary Care—Lessons to Guide Innovation.” JAMA Health

Forum, vol. 3, no. 8, 19 Aug. 2022, p. e222690, https://doi.org/10.1001/jamahealthforum.2022.2690.

as primary care services but paid separately. This focused approach to seeking feedback on

advanced primary care payment policies is an important step in our ongoing efforts to emphasize

accountable care and supports CMS’ goal of having 100 percent of Traditional Medicare

beneficiaries in accountable care relationships by 2030.

In addition to recognizing advanced primary care, this proposed rule also recognizes

physician and practitioner work that draws from evidence generated by the CMS Innovation

Center’s Million Hearts® model.

The Million Hearts® model found that quantitative

assessment of patients’ atherosclerotic cardiovascular disease (ASCVD) risk and providing high-

risk beneficiaries with cardiovascular-focused care management services improved quality of

care, including mortality.

We discuss a proposal in this section to establish coding and PFS

payment for these services based in part on the evidence generated by the Million Hearts®

model.

2. Advanced Primary Care Management (APCM) Services (HCPCS codes GPCM1, GPCM2,

and GPCM3)

a. Background

We have been analyzing opportunities to strengthen and invest in primary care in

alignment with the goals of the U.S. Department of Health and Human Services (HHS) Initiative

to Strengthen Primary Care.

Research has demonstrated that greater primary care physician

supply is associated with improved population-level mortality and reduced disparities,

and also,

that establishing a long-term relationship with a primary care provider leads to reduced

CMS White Paper on CMS Innovation Center’s Strategy: Driving Health System Transformation—A Strategy for

the CMS Innovation Center’s Second Decade (https://www.cms.gov/priorities/innovation/strategic-direction-

whitepaper).

https://www.cms.gov/priorities/innovation/innovation-models/million-hearts-cvdrrm.

Peterson G, Steiner A, Powell R, et al. Evaluation of the Million Hearts® Cardiovascular Disease Risk Reduction

Model: Fourth Annual Report. Mathematica. February 2022. https://www.cms.gov/priorities/innovation/data-and-

reports/2022/mhcvdrrm-fourthannevalrpt.

U.S. Department of Health and Human Services. (2023). Primary Care: Our First Line of Defense.

https://www.hhs.gov/sites/default/files/primary-care-issue-brief.pdf.

Basu S, Berkowitz SA, Phillips RL, Bitton A, Landon BE, Phillips RS. Association of Primary Care Physician

Supply With Population Mortality in the United States, 2005-2015. JAMA Intern Med. 2019;179(4):506–514.

doi:10.1001/jamainternmed.2018.7624.

https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2724393.

emergency department (ED) visits,

improved care coordination, and increased patient

satisfaction.

HHS recognizes that effective primary care is essential for improving access to

healthcare, for the health and wellbeing of individuals, families, and communities, and for

achieving health equity. The first coordinated set of HHS-wide actions to strengthen primary

care, as part of the Initiative, is in primary care payment; for example, adjusting payment to

ensure it supports delivery of advanced primary care. CMS Innovation Center models, described

in section II.G.2.a.(1) in this proposed rule, reflect the ongoing work within HHS and the unified,

comprehensive approach to HHS primary care activities that we are accomplishing through our

current statutory authorities and funding.

Over the last decade, we have updated PFS payment policies as appropriate, and we

remain committed to improving how Medicare payment recognizes the resources involved in

furnishing covered services that encompass aspects of advanced primary care furnished by

interprofessional care teams and typically concentrating on the delivery of appropriate preventive

care to patients and the management of individuals’ chronic conditions as they progress over

time. As part of the CY 2014 PFS final rule, we reaffirmed our support of primary care and

recognized care management as one of the critical components of primary care that contributes to

better health outcomes for individuals and reduced expenditure growth, and explained our

prioritization of the development and implementation of several initiatives (such as those

discussed in section II.G.2.a.(1) in this proposed rule) (77 FR 68978). Since then, we have

implemented coding and payment for many care management services to better recognize the

resources involved in furnishing medically necessary care management activities that generally

are performed outside the context of a face-to-face, in-person visit—most often by the billing

practitioner’s clinical staff on behalf of patients with complex health care needs, including

Willemijn L.A. Schäfer et al, “Are People’s Health Care Needs Better Met When Primary Care Is Strong? A

Synthesis of the Results of the QUALICOPC Study in 34 Countries,” Primary Health Care Research and

Development 20 (2019): e104. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6609545/.

Michael J. van den Berg, Tessa van Loenen, and Gert P Westert, “Accessible and Continuous Primary Care May

Help Reduce Rates of Emergency Department Use: An International Survey in 34 Countries,” Family Practice 33,

no. 1 (Feb. 2016): 42–50. https://academic.oup.com/fampra/article/33/1/42/2450446.

transitional care management in the CY 2013 PFS final rule (77 FR 68979); non-complex and

complex chronic care management (CCM) in the CY 2015, 2017, and 2019 PFS final rules (78

FR 74414, 83 FR 58577, and 81 FR 80244); and principal care management (PCM) in the CY

2020 PFS final rule (84 FR 62962). The CCM and PCM code families now include 5 sets of

codes which are reported monthly on a timed basis, each set with a base code of 20 to 60 minutes

and an add-on code for each additional 30 minutes. The code sets vary by the degree of

complexity of patient conditions (that is, non-complex and complex CCM for multiple chronic

conditions or PCM for a single high-risk condition), and whether the number of minutes spent by

clinical staff or the physician or non-physician practitioner (NPP) is used to meet time thresholds

for billing.

Additionally, we have established coding and payment for certain services where a

medical professional evaluates a patient’s medical information remotely using communication

technology. As discussed in the CY 2019 PFS final rule, this set of services is defined by and

inherently involves the use of communications technology, and includes certain remote patient

monitoring services, virtual check-in services, remote evaluation of pre-recorded patient

information, remote interpretations of diagnostic imaging tests, and interprofessional

consultations. We recognize that technological advances have changed and continue to change

the practitioner-patient care delivery interaction. We have recognized these technology-enabled

interactions through separately billable CTBS over the last several years. However, we

acknowledge, as we learn more about how advanced primary care services are furnished to

patients, that in some clinical care delivery scenarios, practitioners furnishing the type of care

highlighted in this discussion may furnish certain aspects of the CTBS services in complement to

care management services (for example, by allowing interprofessional care teams to answer

patient questions, refer patients to higher levels of care, view and interpret patient images, order

needed treatments, and offer reassurance or advice), in an effort to more efficiently manage the

quantity and quality of medical information that is necessary to support effective patient-centered

treatment plans.

Despite these important steps to pay separately for these care management services, there

has been limited uptake of care management services and Medicare still overwhelmingly pays

for primary care through traditional office/outpatient (O/O) Evaluation and Management (E/M)

visit codes, which describe a broad range of physicians’ services but do not fully distinguish and

account for the resources associated with primary care and other longitudinal care. As we stated

in the CY 2024 PFS final rule, we believe that because E/M visit codes are intended to be used

very broadly, the complexity of services required to provide this type of care is not fully

incorporated as part of the valuation of the work RVUs when the E/M code itself is used as the

primary way to report the work of the professional (88 FR 78972). In the CY 2024 PFS final

rule, we took steps to better recognize the inherent complexity of visits associated with primary

and longitudinal care of patients by finalizing a new add-on code (HCPCS code G2211) for use

by practitioners furnishing services as the continuing focal point for all the patient’s needed

health care services, such as a primary care practitioner (88 FR 78969). When furnishing primary

and longitudinal care, practitioners must be attuned to the factors that develop and maintain

trusting practitioner-patient relationships that enable effective diagnosis, management, and

treatment on an ongoing basis. In finalizing the O/O E/M visit complexity add-on code, we

recognized the feedback from interested parties indicating that the care management codes alone

may not have mitigated the deficiencies in the ability of existing E/M codes to reflect the time

and resources involved in furnishing visits in the context of longitudinal care—of which,

advanced primary care is one model. Many commenters responded, as reflected in the CY 2024

PFS final rule, that they did not view the coding and payment currently available under the PFS

as capable of recognizing the broad range of elements that define primary care (88 FR 52326).

Other commenters responded that they did not believe that the existing E/M service codes alone

reflect the work and resources involved in furnishing non-procedural care to Medicare

beneficiaries (88 FR 78976).

Over the years, interested parties have focused attention on the ongoing need to improve

how practitioners are paid, in and outside of payment bundles, including but not limited to the

possibility of E/M codes designed specifically to be billed in conjunction with care management

codes and the elimination of multiple disparities between the payment for E/M services in global

periods and those furnished individually. Based on feedback from the physician and practitioner

community, we understand that advanced primary care encompasses the work of

interprofessional teams who are accountable for addressing the majority of an individual’s health

and wellness needs across settings and through sustained relationships, which necessarily

involves time spent by primary care practitioners and their clinical staff outside of individual

E/M visits.

As with many services paid under the PFS, we balance making payment that recognizes

and supports technological developments in healthcare and the resources involved in evolving

medical practice to allow for appropriate and expanded access to innovative technologies and

newer services with promoting stability and efficiency in coding and billing rules for

practitioners and institutions. We recognize the important role of gathering input and information

from the CMS Innovation Center models (described in more detail in section II.G.2.a.(1) in this

proposed rule), comment solicitations, research from other public and private entities, the work

of all parties involved in furnishing primary care, and from the public at large. As previously

noted, interested parties have given ample feedback over the years to inform our recognition of

care management services; for example, as part of the CY 2022 PFS rulemaking, interested

parties specifically requested our consideration of a “30-day global period bundling care

management services” and we responded that we would consider this suggestion for future

rulemaking (86 FR 65118). We have continued to incorporate feedback into our rulemaking and

strengthen our care management code sets with the goal of better recognizing the elements of

advanced primary care as part of a multi-year strategy. Based on this feedback, we are proposing

to establish a set of codes to better describe advanced primary care management services

broadly, to provide more stability in payment and coding for practitioners in the context of

continued evolution in advanced primary care, as well as to provide us with a mechanism for

continued and intentional improvements to advanced primary care payment.

(1) Key Care Delivery Methods in Select CMS Innovation Center Models

We have prioritized the implementation or testing of a series of initiatives designed to

improve payment for, and encourage long-term investment in, primary care and care

management services. By supporting enhanced care management and coordination, these

initiatives contributed to the growing practice of advanced primary care and have also provided

valuable lessons learned that we are incorporating into our proposals.

Several CMS Innovation Center models address payment for care management services

and CTBS. The CPC initiative,

the CPC+ model,

and the PCF model

all included payments

for care management services that closely aligned with the care management services included in

the PFS. In these initiatives, primary care practices received risk-adjusted, per beneficiary per

month (PBPM) payments for care management services furnished to Medicare FFS beneficiaries

attributed to their practices. These model payments were designed to offer practices a stable,

predictable revenue stream that supported required infrastructure and appropriately compensated

practices for the enhanced services they would provide. Practices participating in CPC+

consistently cited these payments as the most useful type of model payment support they

received; these stable, prospectively paid payments typically served as the main funding source

for compensating care managers, behavioral health providers, and other staff hired to improve

https://downloads.cms.gov/files/cmmi/CPC-initiative-fourth-annual-report.pdf.

https://www.cms.gov/priorities/innovation/data-and-reports/2023/cpc-plus-fifth-annual-eval-report.

Evaluation of the Primary Care First Model. February 2024. https://www.cms.gov/priorities/innovation/data-and-

reports/2024/pcf-second-eval-rpt.

care delivery.

Because these payments were paid prospectively and could be used to support a

range of care management and coordination activities, they provided participants with greater

financial stability and flexibility to develop and expand capabilities to meet patients’ care

needs.

Table 19 identifies a number of CMS Innovation Center models and key care delivery

methods from each.

TABLE 19: Key Care Delivery Methods from Select CMS Innovation Center

Models

Model

Key Care Delivery Methods

Citation

ACO Investment Model (AIM)

AIM provided an opportunity for

participants to invest in care

transformation activities.

Specifically, AIM was an

opportunity for independent

primary care practices in rural

communities to hire population

health staff, such as care managers

or outreach coordinators. Care

managers conducted outreach,

scheduling, and patient education.

Care managers did this through a

variety of mechanisms including

phone, in the physician office, and

via home visits.

Evaluation of the Accountable Care

Organization Investment Model,

Final Report, September 2020,

available at:

https://www.cms.gov/priorities/inno

vation/data-and-reports/2020/aim-

final-annrpt

Comprehensive Primary Care

(CPC)

CPC practices provided

longitudinal and episodic care

management services for patients at

high or rapidly increasing risk

whom the practices believed were

most likely to benefit from

intensive support. By 2016, CPC

practices risk stratified 95% of their

empaneled patients, and provided

care management to 20% of those

patients. CPC practices also greatly

increased their use of dedicated care

managers over time. By 2016, 89%

of practices reported that, “care

managers who were members of the

[primary care] practice team

systematically provided care

management services to high-risk

patients” – an increase from 20% in

2012. Beneficiaries attributed to

CPC practices had slower growth in

hospitalizations and emergency

Evaluation of the Comprehensive

Primary Care Initiative, Fourth

Annual Report, May 2018,

available at:

https://downloads.cms.gov/files/cm

mi/CPC-initiative-fourth-annual-

report.pdfhttps://downloads.cms.go

v/files/cmmi/CPC-initiative-fourth-

annual-report.pdf

Long-Term Effects of the

Comprehensive Primary Care

Model on Health Care Spending

and Utilization. May 2022.

Available at:

https://www.ncbi.nlm.nih.gov/pmc/a

rticles/PMC9130381/.

O’Malley A, Singh P, Fu N, et al. Independent Evaluation of the Comprehensive Primary Care Plus (CPC+): Final

Report. Mathematica. December 2023. https://www.cms.gov/priorities/innovation/data-and-reports/2023/cpc-plus-

fifth-annual-eval-report.

O’Malley A, Singh P, Fu N, et al. Independent Evaluation of the Comprehensive Primary Care Plus (CPC+): Final

Report. Mathematica. December 2023. https://www.cms.gov/priorities/innovation/data-and-reports/2023/cpc-plus-

fifth-annual-eval-report.

For more information on how the Innovation Center is supporting primary care,

https://www.cms.gov/files/document/primary-care-infographic.pdf.

Model

Key Care Delivery Methods

Citation

department (ED) visits than those

being managed by practices not in

the model.

Comprehensive Primary Care

Plus (CPC+)

CPC+ practices used data and team-

based care to proactively identify

the needs of their patients and

efficiently manage their care.

Additionally, by the final year of

the model, about 97% of physicians

in CPC+ and comparison practices

reported the use of scheduled

phone, video, or e-visits for at least

some of their patients. Finally,

CPC+ had small favorable effects

on some claims-based, quality-of-

care measures of planned care and

population health and patient and

caregiver engagement.

Independent Evaluation of

Comprehensive Primary Care Plus.

Final Report, December 2023,

available at:

https://www.cms.gov/priorities/inno

vation/data-and-reports/2023/cpc-

plus-fifth-annual-eval-report.

Primary Care First (PCF)

All PCF practices provide 24/7

access to a care team practitioner

with real-time access to an

electronic health record (EHR).

Practices also provide risk-stratified

care management for all empaneled

patients and ensure beneficiaries

receive timely follow-up contact

from the practice after ED visits

and hospitalizations. Practices

commonly report expanding their

practice care team by hiring

additional clinical and non-clinical

staff to bolster longitudinal care

management services.

Evaluation of the Primary Care

First Model, Second Annual

Report, February 2024, available at:

https://www.cms.gov/priorities/inno

vation/data-and-reports/2024/pcf-

second-eval-rpt.

b. Proposed HCPCS G-Codes for Advanced Primary Care Management (APCM)

We are proposing to establish coding and make payment under the PFS for a newly

defined set of APCM services described and defined by three new HCPCS G-codes. To

recognize the resource costs associated with furnishing APCM services to Medicare

beneficiaries, we are proposing to establish and pay for three new G-codes that describe a set of

care management services and CTBS furnished under a broader application of advanced primary

care. This new coding and payment would reflect the recognized effectiveness and growing

adoption of the advanced primary care approach to care.

It would also encompass a broader

National Academies of Sciences, Engineering, and Medicine (NASEM). 2021. Implementing high-quality

primary care: Rebuilding the foundation of health care. Washington, DC: The National Academies Press.

https://doi.org/10.17226/25983.; Maeng DD et al. Reducing long-term cost by transforming primary care: evidence

from Geisinger's medical home model. Am J Manag Care. 2012 Mar;18(3):149-55. PMID: 22435908. Available

range of services and simplify the billing and documentation requirements, as compared to

existing care management and CTBS codes, for clinicians who care for their patients using an

advanced primary care model. We recognize that there are primary care physicians,

practitioners, and practices beyond those that have participated in CMS Innovation Center

primary care models (such as those discussed in section II.G.2.a.(1) in this proposed rule), that

may incur resource costs associated with their treatment of patients based on the advanced

primary care delivery model. Providing care using an advanced primary care delivery model

involves resource costs associated with maintaining certain practice capabilities and continuous

readiness and monitoring activities to support a team-based approach to care, where significant

resources are used on virtual, asynchronous patient interactions, collaboration across clinical

disciplines, and real-time management of patients with acute and complex concerns, that are not

fully recognized or paid for by the existing care management codes. We have observed medical

practice trends in primary care for several years. We note that in prior rulemaking, for example,

in the CY 2013 PFS final rule, we stated, “we further consider[ed] how advanced primary care

practices can fit within a fee-for-service model” (77 FR 68987), and in the CY 2015 PFS final

rule, we stated our commitment “to supporting advanced primary care, including the recognition

of care management as one of the critical components of primary care that contributes to better

health for individuals and reduced expenditure growth” (79 FR 67715). In the CY 2017 PFS final

rule, we discussed changes to retain elements of the CCM service that are “most characteristic of

the changes in medical practice toward advanced primary care” (81 FR 80251). As the delivery

of primary care has evolved to embrace advanced primary care more fully, we believe that it is

prudent to now adopt specific coding and payment policy to better recognize the resources

involved in care management under an advanced primary care delivery model.

here: https://pubmed.ncbi.nlm.nih.gov/22435908/.; Jones C et al. Vermont’s Community-Oriented All-Payer

Medical Home Model Reduces Expenditures and Utilization While Delivering High-Quality Care. Popul Health

Manag. 2016;19(3):196–205. Available here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4913508/.

Below, we explain the proposed new codes and their descriptors. In the next section, we

propose to define the elements of the scope of service for APCM that would be required for a

practitioner to bill Medicare for the APCM service, and we explain the proposed standards for

practices that furnish APCM services to ensure that the physicians and practitioners who bill for

these services have the capability to fully furnish advanced primary care, including APCM

services (see section II.G.2.c. of this proposed rule). At this time, we are proposing to identify

specific care management and CTBS services that are a part of advanced primary care delivery

and would be bundled into the PFS payment for the APCM services. As such, we will identify

the services that we are proposing would overlap substantially with the new codes and which

would not be separately billable with the APCM codes under our proposal (see section II.G.2.d.

of this proposed rule). Finally, we propose to establish relative values for these codes for

purposes of payment under the PFS (see section II.G.2.e. of this proposed rule).

We are proposing to establish the following G-codes and descriptors for APCM services, and as

explained in the next section, due to the similar scope of APCM and other care management and CTBS

services, we are proposing to include some of the same language from the CCM and PCM service

elements in the APCM code descriptors, as well as emphasize that certain practice capabilities and

requirements are inherent in these elements and must be met in order to bill for APCM services:

HCPCS code GPCM1 (Advanced primary care management services provided by clinical

staff and directed by a physician or other qualified health care professional who is responsible

for all primary care and serves as the continuing focal point for all needed health care services,

per calendar month, with the following elements, as appropriate:

● Consent;

++ Inform the patient of the availability of the service; that only one practitioner

can furnish and be paid for the service during a calendar month; of the right to

stop the services at any time (effective at the end of the calendar month); and that

cost sharing may apply.

++ Document in patient’s medical record that consent was obtained.

● Initiation during a qualifying visit for new patients or patients not seen within 3 years;

● Provide 24/7 access for urgent needs to care team/practitioner, including providing

patients/caregivers with a way to contact health care professionals in the practice to

discuss urgent needs regardless of the time of day or day of week;

● Continuity of care with a designated member of the care team with whom the patient is

able to schedule successive routine appointments;

● Deliver care in alternative ways to traditional office visits to best meet the patient’s

needs, such as home visits and/or expanded hours;

● Overall comprehensive care management;

++ Systematic needs assessment (medical and psychosocial).

++ System-based approaches to ensure receipt of preventive services.

++ Medication reconciliation, management and oversight of self-management.

● Development, implementation, revision, and maintenance of an electronic patient-

centered comprehensive care plan;

++ Care plan is available timely within and outside the billing practice as appropriate

to individuals involved in the beneficiary’s care, can be routinely accessed and updated

by care team/practitioner, and copy of care plan to patient/caregiver;

● Coordination of care transitions between and among health care providers and

settings, including referrals to other clinicians and follow-up after an emergency department

visit and discharges from hospitals, skilled nursing facilities or other health care facilities as

applicable;

++ Ensure timely exchange of electronic health information with other

practitioners and providers to support continuity of care.

++ Ensure timely follow-up communication (direct contact, telephone,

electronic) with the patient and/or caregiver after an emergency department visit and

discharges from hospitals, skilled nursing facilities, or other health care facilities, within

7 calendar days of discharge, as clinically indicated.

● Ongoing communication and coordinating receipt of needed services from

practitioners, home- and community-based service providers, community-based social

service providers, hospitals, and skilled nursing facilities (or other health care facilities),

and document communication regarding the patient’s psychosocial strengths and needs,

functional deficits, goals, preferences, and desired outcomes, including cultural and

linguistic factors, in the patient’s medical record;

● Enhanced opportunities for the beneficiary and any caregiver to communicate

with the care team/practitioner regarding the beneficiary’s care through the use of

asynchronous non-face-to-face consultation methods other than telephone, such as

secure messaging, email, internet, or patient portal, and other communication-

technology based services, including remote evaluation of pre-recorded patient

information and interprofessional telephone/internet/EHR referral service(s), to maintain

ongoing communication with patients, as appropriate;

++ Ensure access to patient-initiated digital communications that require a

clinical decision, such as virtual check-ins and digital online assessment and

management and E/M visits (or e-visits).

● Analyze patient population data to identify gaps in care and offer additional

interventions, as appropriate;

● Risk stratify the practice population based on defined diagnoses, claims, or other

electronic data to identify and target services to patients;

● Be assessed through performance measurement of primary care quality, total cost of

care, and meaningful use of Certified EHR Technology.).

HCPCS code GPCM2 (Advanced primary care management services for a patient with

multiple (two or more) chronic conditions expected to last at least 12 months, or until the death

of the patient, which place the patient at significant risk of death, acute

exacerbation/decompensation, or functional decline, provided by clinical staff and directed by a

physician or other qualified health care professional who is responsible for all primary care and

serves as the continuing focal point for all needed health care services, per calendar month, with

the elements included in GPCM1, as appropriate) and HCPCS code GPCM3 (Advanced primary

care management services for a patient that is a Qualified Medicare Beneficiary with multiple

(two or more) chronic conditions expected to last at least 12 months, or until the death of the

patient, which place the patient at significant risk of death, acute exacerbation/decompensation,

or functional decline, provided by clinical staff and directed by a physician or other qualified

health care professional who is responsible for all primary care and serves as the continuing

focal point for all needed health care services, per calendar month, with the elements included in

GPCM1, as appropriate).

HCPCS codes GPCM1 through GPCM3 would describe APCM services furnished per

calendar month, following the initial qualifying visit (see section II.G.2.c.(1) for more on the

initiating visit). Physicians and NPPs, including nurse practitioners (NPs), physician assistants

(PAs), certified nurse midwives (CNMs) and clinical nurse specialists (CNSs), could bill for

APCM services. As we will describe in more detail in section II.G.2.c., within the code

descriptors for GPCM1, GPCM2, and GPCM3, we are including the elements of the scope of

service for APCM as well as the practice capabilities and requirements that we believe to be

inherent to care delivery by the care team/practitioner who is billing under a practice using an

advanced primary care delivery model, and necessary to fully furnish and, therefore, bill for

APCM services.

As described in more detail below, within the code descriptors for GPCM1, GPCM2, and

GPCM3, we are proposing that the practitioner who bills for APCM services intends to be

responsible for the patient’s primary care and serves as the continuing focal point for all needed

health care services. We anticipate that most practitioners furnishing APCM services will be

managing all the patient’s health care services over the month and have either already been

providing ongoing care for the beneficiary or have the intention of being responsible for the

patient’s primary care and serving as the continuing focal point for all the patient’s health care

services. We anticipate that these codes will mostly be used by the primary care specialties, such

as general medicine, geriatric medicine, family medicine, internal medicine, and pediatrics, but

we are also aware that, in some instances, certain specialists function as primary care

practitioners – for example, an OB/GYN or a cardiologist. In contrast to situations where the

patient’s overall, ongoing care is being managed, monitored, and/or observed by a practitioner,

we believe that there are situations when care is provided by a practitioner who would not serve

as “the continuing focal point for all needed health care services.”

Similarly, there are some time- or condition-limited practitioner-patient relationships that

are clearly not indicative of the ongoing care that we anticipate practitioners would be

responsible for when furnishing APCM services. As we stated in the CY 2021 PFS proposed rule

and CY 2024 PFS final rule in the context of our policies for the O/O E/M visit complexity add-

on code (HCPCS code G2211), a practitioner whose “relationship with the patient is of a

discrete, routine, or time-limited nature; such as, but not limited to, a mole removal or referral to

a physician for removal of a mole; for treatment of a simple virus, for counseling related to

seasonal allergies, initial onset of gastroesophageal reflux disease; treatment for a fracture; and

where comorbidities are either not present or not addressed, and/or when the billing practitioner

has not taken responsibility for ongoing medical care for that particular patient with consistency

and continuity over time, or does not plan to take responsibility for subsequent, ongoing medical

care for that particular patient with consistency and continuity over time” (85 FR 84570 and

84571, 88 FR 78971). For example, a patient who spends one month of the year in another

location could require physicians’ services in that location if they experience exacerbation of one

of their chronic conditions, but the practitioner who treats them would not intend to manage or

monitor that patient’s overall, ongoing care. Finally, HCPCS code G2211 can also be billed

when medical services are “part of ongoing care related to a patient’s single, serious condition or

complex condition,” but this is different from the APCM requirement. A practitioner’s

management of one or more serious conditions (as is often the case with specialty care), without

more, does not mean that the practitioner is also responsible for all primary care services and the

focal point for all needed care (the requirement for APCM), and thus would not necessarily mean

that the practitioner could bill for APCM.

As is our current policy for other care management services, and consistent with both

CPT guidance and Medicare rules for CPT codes 99487, 99489, 99490, we are proposing that

HCPCS codes GPCM1, GPCM2, and GPCM3 may only be reported once per service period

(calendar month) and only by the single practitioner who assumes the care management role with

a particular beneficiary for the service period. That is, based on a patient’s status, a physician or

practitioner would identify the patient to receive Level 1, Level 2, or Level 3 APCM services

during a given service period (calendar month), and we would make payment for only one claim

for APCM services for that service period. At this time, we do not see the need or value of

proposing restrictions or complex operational mechanisms to identify a single physician or NPP

who may bill for APCM services for a specific beneficiary. However, we recognize that other

initiatives, such as the Medicare Shared Savings program, have operational mechanisms in place

to attribute patients to certain ACOs (§ 425.400). While a similar approach could be used to

attribute patients for APCM services, we are reluctant to introduce unnecessary complexity for

these services. As we continue to develop our policies in this area, we are seeking feedback from

interested parties on methodologies that could allow for identification of the beneficiary’s

primary care practitioner. We are also seeking comment on whether there should be additional

requirements to prevent potential care fragmentation or service duplication.

We anticipate that APCM services would ordinarily be provided by clinical staff incident

to the professional services of the billing practitioner in accordance with our regulation at §

410.26. We are proposing that APCM services would be considered a “designated care

management service” under § 410.26(b)(5) and, as such, could be provided by auxiliary

personnel under the general supervision of the billing practitioner.

Unlike the current coding to describe care management services, we are further proposing

that the code descriptors for GPCM1, GPCM2, and GPCM3 would not be time-based. Based on

feedback from the physician and practitioner community, we understand that ongoing care

management and coordination services are standard parts of advanced primary care, even in

months when documented clinical staff or billing professional minutes may not reach the

required thresholds for billing or the patient’s condition does not meet the clinical conditions for

care management services under the existing code set. In consideration of the extensive feedback

from interested parties, we have learned that practitioners who currently furnish monthly care

management services may already be providing APCM services in a variety of clinical

circumstances, documenting all necessary aspects of the patient-centered care furnished monthly

to the patient without meeting the requirements to bill for care management services, such as

satisfying the administrative requirement to count clinical staff minutes to reach specific time-

based thresholds. As we stated in the CY 2024 PFS final rule in the context of the O/O E/M visit

complexity add-on code (HCPCS code G2211), primary care physicians may diagnose and treat

a condition in an O/O E/M visit that is not expected to last as long as three months or would not

reasonably be expected to result in a risk of hospitalization, and the practitioner’s clinical staff

may provide significant care management and coordination services relating to that condition.

For example, COVID–19 cases are clinical circumstances that generally do not last three months

but may require significant acute management, care coordination, and follow-up within a given

month, particularly for patients with comorbidities (88 FR 78973). Practitioners may also

provide care management and coordination services to a patient whose condition meets the

criteria in one or more care management codes, but the documented minutes of service may not

reach the minimum time threshold to bill for a care management service. For example, the

practitioner might provide care coordination for a month that includes 20 minutes of consulting

with the patient’s other healthcare providers and modifying medications to address an acute

exacerbation of hypertension, but would not meet the requirements for billing the PCM service.

We also note that, unlike the current coding to describe certain CTBS services, we are proposing

that the code descriptors for GPCM1, GPCM2, and GPCM3 would not include the timeframe

restrictions for billing certain CTBS (for example, the restriction for virtual check-in services

that there is not a related E/M service provided within the previous 7 days or an E/M service or

procedure within the next 24 hours or the soonest available appointment). As addressed in the

CY2019 Final Rule, we have heard from interested parties that the timeframe restrictions for

billing certain CTBS are administratively burdensome (83 FR 59686).

We are also proposing that not all elements included in the code descriptors for APCM

services must be furnished during any given calendar month for which the service is billed.

APCM services are largely designed to be person-centered and focused on the individual patient,

such that the elements that are provided depend on medical necessity and individual patient need.

Therefore, we anticipate that all the APCM scope of service elements (for example,

comprehensive care management and care coordination) will be routinely provided, as deemed

appropriate for each patient, acknowledging that not all elements may be necessary for every

patient during each month (for example, the beneficiary may have no hospital admissions that

month, so there is no management of a care transition after hospital discharge). We also

anticipate that there may be some months where it may be appropriate for some service elements

to be performed more than once for the patient. For example, in one month a patient with heart

failure and chronic kidney disease receiving APCM Level 2 services (GPCM2) may be on a

stable medication regimen, receive communication about their care plan, but no virtual check-

ins. The next month, the patient may experience a heart failure exacerbation requiring inpatient

admission, and then receive as part of their APCM service timely communication and follow-up

with new labs ordered, multiple virtual check-ins ensuring that the patient understands their new

medications, a phone call to help the patient understand the lab results, and an interprofessional

consultation with the patient’s cardiologist to help decide if the patient’s diuretic dosage should

be changed.

However, even if not all elements of the APCM service are furnished each month for

which APCM is billed, we propose that billing practitioners and auxiliary personnel must have

the ability to furnish every service element and furnish these elements as is appropriate for any

individual patient during any calendar month. As described in more detail in section II.G.2.c. of

this proposed rule, we believe that maintaining certain advanced primary care practice

capabilities and requirements is inherent in these elements and must be met to fully furnish and

bill APCM. For example, if in our previous example, the patient with heart failure and chronic

kidney disease receiving Level 2 APCM experiences swollen legs, the patient should be able to

submit a photo or video to the practitioner via a secure communications system, and the

practitioner must be able to interpret and communicate remotely with the patient about those

images.

While we are proposing that specific minutes spent furnishing APCM services for

purposes of billing HCPCS codes GPCM1 – GPCM3 need not be documented in the patient’s

medical record, we would expect that any actions or communications that fall within the APCM

elements of service would be described in the medical record and, as appropriate, its relationship

to the clinical problem(s) they are intended to resolve and the treatment plan, just as all clinical

care is documented in the medical record.

We are seeking feedback on these service descriptions, and on whether there are elements

of other care management services that should be removed or altered for purposes of APCM

services.

Finally, while the service descriptors above are consistent across all three APCM levels

because the scope of service elements are consistent across all levels of APCM and the elements

that are provided depend on medical necessity and individual patient need, we are proposing that

the APCM codes would be stratified into three levels based on certain patient characteristics that

are broadly indicative of patient complexity and the consequent resource intensity involved in

the provision of these services in the context of advanced primary care. We are proposing that

the new APCM coding schema would be stratified based on APCM services being furnished

using the advanced primary care model to patients with one or fewer chronic conditions (“Level

1”); patients with two or more chronic conditions (“Level 2”); and Qualified Medicare

Beneficiaries (QMBs)

with two or more chronic conditions (“Level 3”) (see Table 20 for the

three APCM code levels).

This stratification of APCM into three levels allows us to distinguish

among different levels of patient complexity and more accurately reflect the resources required

to furnish APCM services for certain categories of beneficiaries. We anticipate that a practitioner

using the advanced primary care model would bill for APCM services for all or nearly all the

patients for whom they intend to assume responsibility for primary care.

Furthermore, we recognize the ways in which this new APCM coding intersects with

current care management codes around number of chronic conditions. We note that the current

care management codes are generally stratified in a similar, though more granular way, by the

degree of complexity of care based on the presence of chronic conditions and complexity of

medical decision making, who directly performs the service, and the time spent furnishing the

service. In establishing separate payment for CCM services in the CY 2014 PFS final rule, we

recognized that the resources involved in furnishing comprehensive, coordinated care

management services to patients with multiple (two or more) chronic conditions were greater

than those included in a typical non-face-to-face care management service, which we continued

to consider as bundled into the payment for face-to-face E/M visits (78 FR 43337). In the CY

2017 PFS final rule, based on robust feedback from interested parties indicating that the new

CCM codes did not fully capture the service time required to furnish care to beneficiaries with

See 42 CFR 435.123. The proposal includes both individuals in the QMB eligibility group who also have full

scope Medicaid coverage (“QMB-plus”) and individuals in the QMB eligibility group who do not have Medicaid

eligibility under any other Medicaid coverage group (“QMB-only”). However, this proposal would not include those

QMBs who are in the Medicare Part B Immunosuppressive Drug benefit, which provides coverage of

immunosuppressive drugs based on eligibility requirements described in § 407.55, because such individuals would

not qualify for Medicare coverage of the services described in this rulemaking. See 42 CFR 435.123(c)(2).

more complex conditions, we finalized new codes for patients with complex care management

needs. In the CY 2016 PFS final rule, in considering how to improve the accuracy of our

payments for care coordination, particularly for patients requiring more extensive care

management, we stated that we believe the care coordination and management for Medicare

beneficiaries with multiple chronic conditions, a particularly complicated disease or acute

condition, or certain behavioral health conditions often requires extensive discussion,

information-sharing, and planning between a primary care physician and a specialist (for

example, with a neurologist for a patient with Alzheimer’s disease plus other chronic diseases)

(80 FR 70919).

TABLE 20: Patient-Centered Risk Stratification for Billing APCM Codes

Level 1 [GPCM1]

Level 2 [GPCM2]

Level 3 [GPCM3]

Patients with one or fewer

chronic conditions.

Patients with two or more chronic

conditions.

Patients with two or more chronic

conditions and who are Qualified

Medicare Beneficiaries.

(1) Level 1 APCM

We are proposing the Level 1 APCM code for patients with one or fewer chronic

conditions because of the increased import and use of non-face-to-face interactions in advanced

primary care even for patients with relatively fewer health needs, which has increased over time

for several observable reasons, including broad evolution in information and communication

technology in everyday life, diffusion of practices first adopted for higher-acuity patients, and

continuing practices widely adopted during the COVID-19 pandemic that reduce reliance on in-

person interactions. We believe APCM services for a patient diagnosed with one or fewer

chronic conditions will require significantly less time and resources than one with two or more

chronic conditions since, in general, there would be fewer ongoing health needs and other health

care resources to coordinate, a lower risk of drug interactions, and less complicated physiology.

Based on CY 2010 Medicare claims data, the difference in annual expenditures per beneficiary

between patients with one or fewer chronic conditions and those with two or three chronic

conditions was $3,673.

Our current care management coding similarly delineates patient

complexity between patients with a single serious chronic condition (PCM codes) and those with

two or more serious chronic conditions (CCM codes). We anticipate that practitioners who

would furnish APCM services may have already had experience with care management services

coding and payment for much of this population. The Level 1 APCM code would also address

the current gap in coding and payment for care management services furnished using an

advanced primary care model for patients without multiple chronic conditions.

(2) Level 2 APCM

We are proposing the Level 2 APCM code for patients with two or more chronic

conditions because of the frequency of chronic conditions in the Medicare population. In fact,

nearly four in five Medicare beneficiaries have two or more chronic conditions.

Furthermore,

as noted previously, our current care management coding delineates patient complexity for the

CCM codes for patients with two or more serious chronic conditions, and we anticipate that

practitioners who would furnish APCM services may have already had experience with care

management services coding and payment for much of this population.

For example, someone with chronic kidney disease and heart failure requires regular

check-ins, coordination with specialty care, follow-up after hospital admissions for heart failure

exacerbations, regular modifications of the care plan, and more. These services are typically

described by the existing CCM services. The patient may also typically need to reach out more

often to their primary care practitioner with questions or new symptoms via the patient portal.

For instance, the person sends a message through the patient portal to ask whether or not they

should come into the primary care office after gaining ten pounds in the last week—which could

be a sign of increased fluid retention and the need for increased diuretic dosages to avoid pleural

Centers for Medicare and Medicaid Services. Chronic Conditions among Medicare Beneficiaries, Chartbook,

2012 Edition. Baltimore, MD. 2012. https://www.cms.gov/research-statistics-data-and-systems/statistics-trends-and-

reports/chronic-conditions/downloads/2012chartbook.pdf.

Lochner, K., Goodman, R., Posner, S., & Parekh, A. (n.d.). Multiple Chronic Conditions Among Medicare

Beneficiaries. CMS. https://www.cms.gov/mmrr/Downloads/MMRR2013_003_03_b02.pdf.

edema (an accumulation of fluid in the lungs). The primary care team books the patient for a

same-day urgent care appointment to assess for signs of swelling and pleural edema. Again, this

on-demand access to their primary care team can help treat the patient’s chronic conditions in a

patient-centered way and avoid unnecessary complications.

(3) Level 3 APCM

We are proposing the Level 3 APCM code for patients with QMB status and two or more

chronic conditions based on our understanding that people with both multiple chronic conditions

and social risk factors generally require even more time and resources from primary care

practitioners and their teams to ensure that the patient’s chronic conditions are managed

appropriately and effectively. We are proposing to use a patient’s QMB status as a method to

identify beneficiaries with social risk factors that generally necessitate relatively greater resource

requirements to effectively furnish advanced primary care than people without such risk factors.

There is significant evidence that such dually eligible beneficiaries, on average, are more

medically complex and have higher healthcare needs;

for example, dually eligible

beneficiaries are more likely to have poor functional status

and recent expenditure data found

that the difference in Medicare spending on a per person per year basis between dually eligible

and non-dually eligible Medicare beneficiaries was $13,198 in CY 2021.

QMBs are the largest eligibility group within the Medicare-Medicaid dually eligible

enrollee population, comprising of 66 percent of the 12.8 million individuals per the most recent

available data.

For the approximately 8.5 million dually eligible beneficiaries who are QMBs,

Kaiser Family Foundation. (n.d.). A primer on Medicare: What is the role of Medicare for dual-eligible

beneficiaries? Retrieved June 24, 2024, from https://www.kff.org/report-section/a-primer-on-medicare-what-is-the-

role-of-medicare-for-dual-eligible-

beneficiaries/#:~:text=A%20larger%20share%20of%20dual,beneficiaries%3B%20and%20more%20than%20half

%20(.

ASPE. Report to Congress: Social Risk Factors and Performance Under Medicare’s Value-Based Purchasing

Programs. December 2016. https://aspe.hhs.gov/reports/report-congress-social-risk-factors-performance-under-

medicares-value-based-purchasing-programs.

https://www.macpac.gov/wp-content/uploads/2024/01/Jan24_MedPAC_MACPAC_DualsDataBook-508.pdf.

Beneficiaries Dually Eligible for Medicare and Medicaid. Data from CY 2021. (January 2024). Medpac and

Macpac. https://www.macpac.gov/wp-content/uploads/2024/01/Jan24_MedPAC_MACPAC_DualsDataBook-

508.pdf.

Medicaid provides assistance for patients to meet Medicare’s cost-sharing requirements. The

QMB eligibility group helps to ensure full access to the Medicare benefit for the lowest income

enrollees by covering these costs. Individuals can qualify for QMB status if their income is

below 100 percent of the Federal Poverty Level ($15,300/year in 2024) and assets are no more

than $9,430/$14,130 (one person/married couple in 2024), although states can request CMS

approval to disregard certain income and assets.

Beneficiaries apply for this benefit with their

State’s Medicaid program and must be redetermined eligible at least annually.

There is growing recognition that social risk factors – such as income, education, access

to food and housing, and employment status – play a major role in health,

such that social risk

factors may affect a person’s ability to reach their health goals, as well as the diagnosis and

treatment of their medical problems. A report submitted to Congress by the Office of the

Assistant Secretary for Planning and Evaluation (ASPE) in response to the Improving Medicare

Post-Acute Care Transformation (IMPACT) Act of 2014 (Pub. L. 113-185) found that dual

Medicare-Medicaid enrollment as a marker for low income was typically the most powerful

predictor of poor outcomes on quality measures among social risk factors examined.

Beneficiaries with social risk factors may have worse health outcomes due to a host of factors,

including higher levels of medical risk, worse living environments (for example, availability of

community services, pollution, safety), greater challenges in adherence to medication regimens

and medical recommendations (for example, diet/lifestyle), and/or bias or discrimination.

Evidence suggests that many health outcomes are related more to social, environmental, and

Access to Care Issues Among Qualified Medicare Beneficiaries (QMB). (2015). Centers for Medicare & Medicaid

Services. https://www.cms.gov/Medicare-Medicaid-Coordination/Medicare-and-Medicaid-Coordination/Medicare-

Medicaid-Coordination-Office/Downloads/Access_to_Care_Issues_Among_Qualified_Medicare_Beneficiaries.pdf.

Long P, Abrams M, Milstein A, Anderson G, Apton KL, Dahlberg M, Whicher D. Effective care for high-need

patients. Washington, DC: National Academy of Medicine. 2017. https://nam.edu/wp-

content/uploads/2017/06/Effective-Care-for-High-Need-Patients.pdf; Schroeder, S. (2007, September 20). We Can

Do Better—Improving the Health of the American People. New England Journal of Medicine, 357(12), 1221–1228.

https://www.nejm.org/doi/full/10.1056/NEJMsa073350.

ASPE. Report to Congress: Social Risk Factors and Performance Under Medicare’s Value-Based Purchasing

Programs. December 2016. https://aspe.hhs.gov/reports/report-congress-social-risk-factors-performance-under-

medicares-value-based-purchasing-programs.

economic factors (which may be beyond practitioners’ control) than to clinical interventions.

Dual enrollees, and more specifically, QMBs, are therefore a category of Medicare beneficiaries

who we believe to be the most socially at-risk of poorer clinical outcomes. As stated in the ASPE

report, “Some of the observed relationship between social risk factors and outcomes may be the

result of underlying differences in medical complexity, frailty, disability, and/or functional

status. For example, dually-enrolled beneficiaries are more likely to have poor functional status,

and therefore, may be more likely to be readmitted after a hospitalization.” As another example,

a patient with diabetes, heart failure, and QMB status may experience food, transportation, or

housing insecurity that contributes to difficulty maintaining blood glucose control which can

contribute to medical complications including potentially preventable heart failure exacerbations.

The primary care practitioner’s team may need to check-in regularly to ensure, for example, that

the patient gets needed specialty care such as an ophthalmologic examination to avoid the ocular

manifestations of diabetes; and consider the availability of transportation vouchers so the patient

can attend the ophthalmology appointment. We are proposing the Level 3 APCM code to

recognize the unique characteristics of QMBs as beneficiaries with social risk factors for whom

significantly more resources are involved in comprehensive care management by practitioners

that furnish advanced primary care services to them.

Additionally, we note that patients with QMB status are not responsible for the Medicare

cost-sharing associated with covered Medicare Part A or B services, including for any APCM

services. Generally, States cover such cost-sharing on behalf of QMBs, although many states use

a “lesser-of” policy through which states pay less than the full cost sharing amounts.

We solicit

comments from States on how they would cover cost sharing for the proposed APCM bundle,

considering lesser-of policies.

World Health Organization. (2018). Health Impact Assessment (HIA): The determinants of health.

http://www.who.int/hia/evidence/doh/en/.

Under the ‘‘lesser of’’ policy, a State caps its payment of Medicare cost-sharing at the Medicaid rate for a

particular service. For example, if the Medicare rate for a service is $100, of which $20 is beneficiary coinsurance,

and the Medicaid rate for the service is $90, the state would only pay $10. If the Medicaid rate is $80 or lower, the

state would make no payment.

We are also seeking feedback on the use of QMB status and multiple (two or more)

chronic conditions as the basis to bill for APCM Level 3 (GPCM3), whether QMB status is an

appropriate indicator to identify beneficiaries with added social risk, and whether there is an

equivalent marker of social deprivation for use in commercial markets that might be a possible

alternative identifier.

c. APCM Service Elements and Practice-Level Capabilities

All the elements within the scope of APCM services are included in the service

descriptors for GPCM1, GPCM2, and GPCM3, listed in Table 22, and described in this section.

As described above, we are proposing that APCM services would include nearly the same scope

of service elements and conditions we established for CCM and PCM services (including

elements of 24/7 access and care continuity, care management and care plan, care coordination,

management of care transitions, and enhanced communication). We believe this is appropriate

because care management is a key component of care delivery using an advanced primary care

model. The proposed phrasing in the code descriptors for APCM services generally tracks the

code descriptors for CCM and PCM services, except for references to “time spent” or “minutes”

of service.

We are seeking to ensure that the APCM codes would fully and appropriately capture the

care management and CTBS services that are characteristic of the changes in medical practice

toward advanced primary care, as demonstrated in select CMS Innovation Center models. As we

do for CCM and PCM services, we propose to require for APCM services that the practitioner

provide an initiating visit and obtain beneficiary consent (see section II.G.2.c.(1) and II.G.2.c.(2)

of this proposed rule). As described in more detail below, we are proposing to incorporate as

elements of APCM services “Management of Care Transitions” and “Enhanced Communications

Opportunities.” For the “Management of Care Transitions” APCM service element, we are

proposing to specify timely follow-up during care transitions (see section II.G.2.c.(6) of this

proposed rule). For the “Enhanced Communications Opportunities” APCM service element, we

are proposing to incorporate access to CTBS services, including remote evaluation of pre-

recorded patient information and interprofessional telephone/internet/EHR referral service(s), to

maintain ongoing communication with the patient, as well as access to patient-initiated digital

communications that require a clinical decision, such as virtual check-ins and digital online

assessment and management and E/M visits (or e-visits) (see section II.G.2.c.(8) of this proposed

rule).

We are also proposing to specify for APCM services the practice-level characteristics and

capabilities that are inherent to, and necessarily present when a practitioner is providing covered

services using an advanced primary care delivery model. As described in more detail below,

included in the service descriptors for GPCM1, GPCM2, and GPCM3, and listed in Table 22,

our proposed practice-level capabilities that reflect care delivery using an advanced primary care

model are focused around 24/7 access and continuity of care (see section II.G.2.c.(3) of this

proposed rule), patient population-level management (see section II.G.2.c.(9) of this proposed

rule), and performance measurement (see section II.G.2.c.(10) of this proposed rule). These

practice capabilities are indicative of, and necessary to, care delivery using an advanced primary

care model. Further, APCM services, as we propose to define them, could not be fully

performed in the absence of these practice capabilities; and, in such cases, APCM services

should not be billed.

We are proposing that practitioners participating in the ACO REACH model, the Making

Care Primary model, and the Primary Care First model would satisfy the proposed initiating

visit, patient population-level management, and performance measurement APCM service

elements and practice-level capabilities by virtue of their model participation. These CMS

Innovation Center models promote advanced primary care delivery consistent with the proposed

APCM service elements and practice-level capabilities described in Table 21. The models all

utilize attribution methods that review the most recently available two years of Medicare claims

to identify whether a model participant is responsible for a Medicare beneficiary’s primary care,

aligning with the initiating visit requirements for APCM services. Additionally, these three

models also include risk stratification and quality and cost performance metrics that are aligned

or overlap with the Value in Primary Care MVP.

Around-the-clock access and

continuity of care, patient population-level management, and performance measurement are

indicative of, and necessary to, care delivery using an advanced primary care model. We are

also considering whether certain practitioners in other types of CMS Innovation Center models

also satisfy the proposed service elements and requirements and seek comments on this question.

See, e.g., ACO Realizing Equity, Access, and Community Health (REACH) Model Request for Applications.

Available at https://www.cms.gov/priorities/innovation/media/document/aco-reach-rfa, ACO Realizing Equity,

Access, and Community Health (REACH) Model PY 2024 Quality Measurement Methodology. Available at

https://www.cms.gov/files/document/aco-reach-quality-msr-meth-py24.pdf; Making Care Primary Payment and

Attribution Methodologies. Available at https://www.cms.gov/files/document/mcp-pymt-att-methodologies.pdf,

Primary Care First Payment and Attribution Methodologies PY 2024. Available at

https://www.cms.gov/files/document/pcf-py24-payment-meth.pdf.

TABLE 21: APCM Service Elements* and Practice-Level Capabilities

Consent

• Inform the patient of the availability of APCM services; that only one practitioner can furnish and be paid for

these services during a calendar month; of the right to stop services at any time (effective at the end of the calendar

month); and that cost sharing may apply* (may be covered by supplemental health coverage)

• Document in patient’s medical record that consent was obtained

Initiating Visit for New Patients (separately paid)

• Initiation during a qualifying visit for new patients

• An initiating visit is not needed: (1) if the beneficiary is not a new patient (has been seen by the practitioner or

another practitioner in the same practice within the past three years) or (2) if the beneficiary received another care

management service (APCM, CCM, or PCM) within the previous year with the practitioner or another practitioner in

the same practice.

24/7 Access to Care and Care Continuity

• Provide 24/7 access for urgent needs to care team/practitioner with real-time access to patient’s medical

information, including providing patients/caregivers with a way to contact health care professionals in the practice to

discuss urgent needs regardless of the time of day or day of week

• Continuity of care with a designated member of the care team with whom the patient is able to schedule

successive routine appointments

• Deliver care in alternative ways to traditional office visits to best meet the patient’s needs, such as home visits

and/or expanded hours, as appropriate

Comprehensive Care Management

• Overall comprehensive care management may include, as applicable

• Systematic needs assessment (medical and psychosocial)

• System-based approaches to ensure receipt of preventive services

• Medication reconciliation, management and oversight of self-management

Patient-Centered Comprehensive Care Plan

• Development, implementation, revision, and maintenance of an electronic patient-centered comprehensive care

plan which is available timely within and outside the billing practice as appropriate to individuals involved in the

beneficiary’s care, can be routinely accessed and updated by care team/practitioner, and copy of care plan to

patient/caregiver

Management of Care Transitions (for example, discharges, ED visit follow-up, referrals, as applicable)

• Coordination of care transitions between and among health care providers and settings, including transitions

involving referrals to other clinicians, follow-up after an emergency department visit, or follow-up after discharges

from hospitals, skilled nursing facilities or other health care facilities, as applicable

• Ensure timely exchange of electronic health information with other practitioners and providers to support

continuity of care.

• Ensure timely follow-up communication (direct contact, telephone, electronic) with the patient and/or

caregiver after ED visits and discharges from hospitals, skilled nursing facilities, or other health care facilities, within

7 calendar days of discharge, as clinically indicated

Practitioner, Home-, and Community-Based Care Coordination

• Ongoing communication and coordinating receipt of needed services from practitioners, home- and community-

based service providers, community-based social service providers, hospitals, and skilled nursing facilities (or other

health care facilities), as applicable, and document communication regarding the patient’s psychosocial strengths and

needs, functional deficits, goals, preferences, and desired outcomes, including cultural and linguistic factors in the

patient’s medical record

Enhanced Communication Opportunities

• Enhanced opportunities for the beneficiary and any caregiver to communicate with the care team/practitioner

regarding the beneficiary’s care through the use of asynchronous non-face-to-face consultation methods other than

telephone, such as secure messaging, email, internet, or patient portal, and other communication technology-based

services, including remote evaluation of pre-recorded patient information and interprofessional

telephone/internet/EHR referral service(s), to maintain ongoing communication with patients, as appropriate

• Ensure access to patient-initiated digital communications that require a clinical decision, such as virtual check-ins

and digital online assessment and management and E/M visits (or e-visits)

Patient Population-Level Management

• Analyze patient population data to identify gaps in care and offer additional interventions, as appropriate

• Risk stratify the practice population based on defined diagnoses, claims, or other electronic data to identify and

target services to patients

• A practitioners who is participating in a Shared Savings Program ACO, REACH ACO, Making Care Primary, or

Primary Care First satisfies this requirement

Performance Measurement

Be assessed on primary care quality, total cost of care, and meaningful use of CEHRT, which can be met in several

ways:

• For MIPS-eligible clinicians, by registering for and reporting the Value in Primary Care MVP**

• A practitioner who is part of a TIN participating in a Shared Savings Program ACO satisfies this requirement

through the ACO’s reporting of the APM Performance Pathway

• A practitioner who is participating in a Shared Savings Program ACO, REACH ACO, Making Care Primary, or

Primary Care First satisfies this requirement through the quality reporting, assessment and performance requirement

and other program and model requirements.

* Medicare beneficiaries who are enrolled in the QMB eligibility group do not have any Medicare cost-sharing

responsibility for copays, deductibles, and coinsurance.

** See discussion in section II.G.2.c.(10) of this proposed rule for a description of the timeline of MIPS reporting.

For APCM services billed in 2025, practitioners would register to report the MVP in 2025, and report the MVP in

2026 for the 2025 performance year/2027 MIPS payment year. For more details, see the 2024 MIPS Quick Start

Guide, available at https://qpp.cms.gov/mips/reporting-options-overview.

We are seeking comment on whether the proposed elements and requirements are

appropriately reflective of care management services for advanced primary care, and whether

there are proposed elements of APCM services or proposed practice capabilities that should be

modified or removed. We are also seeking feedback on ways to align the APCM services with

other Medicare programs and initiatives, such as the Shared Savings Program, ACO REACH,

and advanced primary care models, and the Quality Payment Program, including MIPS and

Advanced Alternative Payment Models (Advanced APMs). We seek to create a low burden way

for practitioners to furnish APCM services by appropriately recognizing ways in which they may

meet APCM billing requirements as part of these programs and initiatives. We note that under

the Quality Payment Program, practitioners who are MIPS eligible clinicians would report

measures and activities as specified by CMS under the four MIPS performance categories:

quality, cost, improvement activities, and Promoting Interoperability (PI). To report to MIPS for

a performance period (§ 414.1320(i)) for the PI performance category, a MIPS eligible clinician

must use Certified EHR Technology (CEHRT), as defined at paragraph (2) under CEHRT at §

414.1305, report on the objectives and associated measures as specified by CMS, and submit

required attestations as specified in § 414.1375(b)(3) (§ 414.1375(b)). Eligible clinicians who

participate in Advanced APMs under the Quality Payment Program are required under the terms

of those APMs to use CEHRT as specified in §414.1415(a)(1)(iii); and are paid under the terms

of those APMs based on MIPS-comparable quality measures as specified in §414.1415(b).

As described in the sections below, we are proposing that a billing practitioner who is

part of a Shared Saving Program ACO, or CMS Innovation Center ACO or participating in

Making Care Primary or Primary Care First would already satisfy the proposed practice-level

requirements for patient population-level management (see section II.G.2.c.(9) of this proposed

rule), and performance measurement (see section II.G.2.c.(10) of this proposed rule) by meeting

separately applicable participation requirements within the Shared Savings Programs and

models. As noted previously, we are considering whether practitioners in other types of CMS

Innovation Center models also satisfy certain proposed service elements and practice-level

requirements through their participation in the models, and seek comments on this question.

(1) Beneficiary Consent

Consistent with other care management services, we are proposing that the beneficiary’s

consent to receive APCM services must be documented in the medical record as a condition of

payment for APCM services, as not all Medicare beneficiaries for whom APCM services would

be medically necessary may want to receive these services. As we do for CCM and PCM

services, we are proposing to require billing practitioners to inform the beneficiary of the

availability of APCM services, and ensure the beneficiary is aware that Medicare cost-sharing

usually applies (though these costs may be covered through supplemental health coverage). The

practitioner should also inform the beneficiary that, by providing APCM services, they intend to

assume responsibility for all of the patient’s primary care services and serve as the continuing

focal point for all needed health care services; and that only one practitioner can furnish and be

paid for APCM services during a calendar month, but that their consent to receive APCM

services does not limit their option to receive Medicare covered health care services from other

practitioners. The practitioner should inform the beneficiary that APCM is an ongoing, monthly

service and of their right to stop APCM services at any time (effective at the end of the calendar

month), and that they only need to provide consent once to receive APCM services from the

practitioner. We are proposing that the practitioner would document in the beneficiary’s medical

record that this information was explained and note whether the beneficiary accepted or declined

APCM services. We note that practitioners can still elect to obtain written consent rather than

verbal consent.

Practitioners have informed us that beneficiary cost sharing is a significant barrier to

provision of similar care management services, such as CCM services. The proposed patient

consent requirement is intended to ensure that patients do not incur unexpected expenses for care

that is largely, or in significant part, non-face-to-face in nature. The proposed requirement for

patient consent would also help to avoid duplicative practitioner billing, as the patient would

understand that the practitioner intends to serve as the focal point for all their care, and that only

one practitioner can furnish and be paid for APCM services in any particular month.

We seek feedback on these proposed requirements, including how best to effectively

educate both practitioners and beneficiaries on the benefits of APCM, especially as it reflects a

new bundle of services that may have previously been separately billed, and whether a CMS-

provided template to facilitate patient consent would be helpful. We also seek feedback on

whether CMS should require practitioners to revisit consent for APCM services on an ongoing

basis with patients.

(2) Initiating Visit

Consistent with CCM services (CPT codes 99437, 99439, 99487, and 99489 – 99491)

and PCM services (CPT codes 99424 – 99427), we are proposing to require an initiating visit for

APCM services only for new patients instead of for all beneficiaries receiving APCM services.

Consistent with the definition of “new patient” as described in the CPT® 2024 Professional

Edition Code Book on page 4, we are proposing to define a “new patient” as a person who did

not receive any professional services from the physician or other qualified health care

professional or another practitioner in the same group practice within the previous 3 years.

The

initiating visit furnished in advance of APCM services establishes the beneficiary’s relationship

with the billing practitioner, ensures the billing practitioner assesses the beneficiary prior to

initiating APCM services, facilitates collection of comprehensive health information to inform

the care plan, and provides an opportunity to obtain beneficiary consent (although beneficiary

consent can be obtained outside of the initiating visit). We are proposing that the same services

that can serve as the initiating visit for CCM services could serve as the initiating visit for

APCM, including a Level 2 through 5 E/M visit, initial preventive physician exam (IPPE), or

TCM service, and we propose that the initiating visit could be provided in person or as a

Medicare telehealth service.

We are proposing that an initiating visit would not be required for “established patients”

based on certain circumstances that we believe demonstrate an established patient-practitioner

relationship in advance of furnishing APCM services: (1) if the beneficiary is not a new patient

(has been seen by the practitioner or another practitioner in the same practice within the past

three years) or (2) if the beneficiary received another care management service (including an

APCM service, non-complex or complex CCM service (CPT codes 99487, 99489, 99490, 99491,

99439, 99437), or PCM service (CPT codes 99424, 99425, 99426, 99427)) within the previous

year with the practitioner or another practitioner in the same practice. We do not believe there

necessarily is a need for an initiating visit for APCM services for patients with whom the

practitioner (or another in the same practice) has an established relationship; and we would not

want to require an initiating visit under circumstances where a visit may not be medically

American Medical Association. CPT Professional 2024. American Medical Association, 2023.

necessary. The proposed policy not to require an initiating visit for beneficiaries who have

received any professional service from the physician or other qualified health care professional

or another practitioner in the same group practice within the previous 3 years is consistent with

CPT’s definition of the term “established patient,” such that we believe this captures patients

who have been seen relatively recently and who have an existing relationship with the practice.

In the case of beneficiaries who have received care management services from a practitioner

within the practice in the past year, we believe this indicates that the patient is also an

“established patient” in that the patient has an existing relationship with the practice, and the

patient previously has consented to the receipt of care management services, which have

overlapping service elements with APCM services.

We note that these standards would be consistent with applicable Shared Savings

Program and CMS Innovation Center patient attribution standards in ACO REACH, Making

Care Primary, and Primary Care First. Any beneficiary eligible to be assigned to an ACO

because of an established care relationship between the beneficiary and a billing practitioner who

would be billing for APCM services under the ACO participant’s TIN, including beneficiaries

who voluntarily aligned to a practitioner in the ACO, would not be considered a new patient and

would not require an initiating visit. Medicare rules governing patient attribution to an ACO on

the basis of care provided by an ACO-participating clinician similarly establishes where an

existing care relationship exists. Similarly, beneficiaries eligible to be assigned to a REACH

ACO, or a Making Care Primary or Primary Care First practice because of an established care

relationship between the beneficiary and a billing practitioner who would be billing for APCM

services under the model participant’s TIN, including beneficiaries who voluntarily aligned to a

practitioner participating in one of these three models would not be considered a new patient and

would not require an initiating visit. While we are proposing certain exceptions to the initiating

visit requirement for APCM services, we note that an initiating visit may still be needed even

when not required, and the billing practitioner can always furnish and bill for medically

necessary visits, including before initiating APCM services.

We seek feedback on these proposed requirements, including whether additional services

could serve as the initiating visit and whether a different period of time (for example, patients not

seen within one or two years) would be more appropriate.

(3) 24/7 Access and Continuity of Care

Access and continuity build on the patient-practitioner relationship to ensure patients

receive the right care at the right time from the right care team member. We are proposing to

include for APCM services the same scope of service elements we established for CCM and

PCM services for 24/7 Access and Continuity of Care with some modifications. For 24/7 Access

to Care, the scope of the service element we propose for APCM services would be to provide

24/7 access for urgent needs to the care team/practitioner with real-time access to patient’s

medical records, including providing patients/caregivers with a way to contact health care

professionals in the practice to discuss urgent needs regardless of the time of day or day of week.

As described in the CY 2017 PFS final rule, this accurately reflects the potential role of

clinical staff or call-sharing services in addressing after-hours care needs, and that after-hours

services typically would and should address any urgent needs and not only those explicitly

related to the beneficiary’s chronic conditions (79 FR 67722). In advanced primary care models

of care, primary care practices should be at the center of that care—providing an effective “first

contact” for patients, supporting patients in their management of care, and coordinating across

different settings of care. Achieving this level of access to primary care requires timeliness and

an effective relationship with those in the practice who are providing that care. True access is

fully informed by knowledge about the patient and their care, which is only possible through

real-time access to the patient’s electronic health information. Access to primary care, informed

by health information technology (IT), makes the right care at the right time possible, potentially

avoiding costly urgent and emergent care. Practices can achieve 24/7 access to care informed by

health IT through call coverage by a practitioner with health IT system access. This can be a

practitioner from the practice or a covering practitioner who has system access. Many practices

and systems use nurse call lines or answering services working with standard protocols to

provide the initial point of contact after hours and effectively address common problems. In this

situation, an escalation protocol will engage a practitioner with system access when needed for

decision making. Other successful practices expand hours, add urgent care services or partner

with other practices to provide these services, or contract with existing urgent care providers to

manage and coordinate care after regular office hours.

For Continuity of Care, the scope of service element would be to provide continuity of

care with a designated member of the care team with whom the patient is able to schedule

successive routine appointments. Continuity of care refers to the ability of patients to receive

care from practitioners who know them and are known by them. This continuity builds and

reinforces a relationship based in trust and shared experience that is highly valued by both

practitioners and patients. Practice focus on continuity of care can translate to improved

preventive and chronic care, patient and practitioner satisfaction, lower hospital utilization, and

lower costs.

Depending on the type and setting of care, there are three components of

continuity that improve patient outcomes and experience:

relational continuity (defined as the

“ongoing therapeutic relationship between a patient (and often their family/caregiver)” which is

foundational in advanced primary care), informational continuity (where practitioners have

Hussey, P. S., Schneider, E. C., Rudin, R. S., Fox, D. S., Lai, J., & Pollack, C. E. (2014). Continuity and the costs

of care for chronic disease. JAMA Internal Medicine, 174(5), 742-748.; Bayliss, E. A., Ellis, J. L., Shoup, J. A.,

Zeng, C., McQuillan, D. B., & Steiner, J. F. (2015). Effect of continuity of care on hospital utilization for seniors

with multiple medical conditions in an integrated health care system. The Annals of Family Medicine, 13(2), 123-

129.; Nyweide, D. J., Anthony, D. L., Bynum, J. P., Strawderman, R. L., Weeks, W. B., Casalino, L. P., & Fisher E.

S. (2013). Continuity of care and the risk of preventable hospitalization in older adults. JAMA Internal Medicine,

173(20), 1879–1885.; Haggerty, J. L., Reid, R. J., Freeman, G. K., Starfield, B. H., & Adair, C. E. (2003).

Continuity of care: a multidisciplinary review. BMJ, 327, 1219. doi:10.1136/bmj.327.7425.1219; Gupta, R., &

Bodenheimer, T. (2013). How primary care practices can improve continuity of care. JAMA Internal Medicine,

173(20), 1885–1886. doi:10.1001/jamainternmed.2013.7341.; Willard R., & Bodenheimer T. (2012, April). The

building blocks of high-performing primary care: Lessons from the field. California Healthcare Foundation.

http://www.chcf.org/publications/2012/04/building-blocks-primary-care.

Haggerty, J. L., Reid, R. J., Freeman, G. K., Starfield, B. H., & Adair, C. E. (2003). Continuity of care: a

multidisciplinary review. BMJ, 327, 1219. doi:10.1136/bmj.327.7425.1219.

access to information on patients’ past events and personal circumstances to inform current care

decisions); and longitudinal continuity (which refers to ongoing patterns of healthcare visits that

occur with the same practice over time). A key strategy to optimize continuity is ensuring that all

practitioners and/or the care team have access to the same patient information to guide care

within health IT, and successful practices start with a review and discussion of the practice-level

data developed through measurement of continuity.

Practices can develop the capability to

measure continuity of care between the patient and the practitioner/care team using health IT,

practice management software, or other tracking mechanisms, allowing them to track

improvements over time.

As included in the APCM code descriptors, we are proposing to specify for the “24/7

Access to Care” APCM service element that the practice would maintain the capability to deliver

care in alternative ways to traditional office visits to best meet the patient population’s needs,

such as e-visits, phone visits, home visits, and/or expanded hours. This proposed standard for

alternatives to office visits is similar to several requirements tested in CMS Innovation Center

models (such as the CPC+ model’s requirement that participating practices regularly offer at

least one alternative to traditional office visits

), and reflects the understanding that providing

alternatives to traditional office visits is an essential element of the delivery of care under an

advanced primary care model of care. Moving care out of traditional office visits can reduce

demand and open supply for prioritized visits. By changing where and how care is delivered,

practices may have increased availability for patients with complex needs who may be better

served by more time-intensive visits in the office, at home, or in a nursing home. We are not

proposing that a practice would need to regularly deliver care in all these alternative ways—for

example, a practice may routinely offer e-visits and phone visits, but not regularly furnish home

Gupta, R., & Bodenheimer, T. (2013). How primary care practices can improve continuity of care. JAMA Internal

Medicine, 173(20), 1885–1886. doi:10.1001/jamainternmed.2013.7341.; Willard R., & Bodenheimer T. (2012,

April). The building blocks of high-performing primary care: Lessons from the field. California Healthcare

Foundation. http://www.chcf.org/publications/2012/04/building-blocks-primary-care.

https://www.cms.gov/priorities/innovation/innovation-models/comprehensive-primary-care-plus.

visits, and still demonstrate this primary care practice capability. Another practice might offer

extended hours on certain days to help patients who may find it hard to take off work to see their

clinician, and this would satisfy this practice requirement.

We seek feedback on these proposed requirements.

(4) Comprehensive Care Management

We are proposing for APCM services the “Comprehensive Care Management” service

element we established for CCM and PCM services with some modifications. Rather than “care

management for chronic conditions,” the APCM service element would be “overall

comprehensive care management” which, like the element for CCM and PCM services, may

include, as applicable, “systematic assessment of the patient’s medical, functional, and

psychosocial needs; system-based approaches to ensure timely receipt of all recommended

preventive care services; medication reconciliation with review of adherence and potential

interactions; and oversight of patient self-management of medications.” This care management

standard is similar to several requirements tested in CMS Innovation Center models (such as the

CPC+ model’s requirement that participating practices provide targeted, proactive, relationship-

based care management to all patients identified as at increased risk and likely to benefit from

intensive care management and provide short-term care management, including medication

reconciliation, to patients following hospital admission/discharge/transfer, including observation

stays, and, as appropriate, following an ED discharge)

and is an essential element of the

delivery of care under an advanced primary care model of care. Care management is a resource-

intensive process of working with patients, generally outside of face-to-face office visits, to help

them understand and manage their health, navigate the health system, and meet their health

goals. Practices working with patients who have complex care needs have found care

management to be an effective and necessary strategy for mitigating risk and improving health

outcomes. Practices have found it valuable to think in terms of two broad types of patients who

https://www.cms.gov/priorities/innovation/innovation-models/comprehensive-primary-care-plus.

might benefit from different approaches to care management: patients with some combination of

multiple comorbidities, complex treatment regimens, frailty and functional impairment,

behavioral and social risks, and serious mental illness who would often benefit from long-term,

proactive, and relationship-based longitudinal care management; and patients who are otherwise

stable and will benefit from short-term, goal-oriented episodic care management during periods

of increased risk like transitions of care; diagnosis of a new, serious illness or injury involving

complex treatment regimens; or newly unstable chronic illness.

Successful practices use on-site, non-physician, practice-based, or integrated shared care

managers to provide longitudinal care management for the highest risk cohort of patients, with

assistance from other practice staff, as needed. Multiple team members may engage in care

management, but each patient identified as eligible should have a clinically trained individual in

the practice who is accountable for active, ongoing care management that goes beyond office-

based clinical diagnosis and treatment.

Longitudinal care management is captured in health IT

and includes providing proactive care that moves beyond traditional office visits or crisis-driven

care (for example, ED care or hospitalization) and is not primarily visit-based. Although office

visits are opportunities to define goals, plan patient care, engage in shared decision making, and

build a trusting relationship, most care management activities take place by phone, patient portal,

e-mail, mail, or home visits (and through visits to skilled nursing facilities or hospitals to support

transitional care).

Practices use the concept of episodic care management to identify patients who have

acute or urgent needs using “triggering events” (for example, hospital discharge, new diagnoses,

medical crisis, major life event, decompensation in otherwise controlled chronic condition) for

short-term, problem-focused care management services. Episodic care management is generally

Taylor, E. F., Machta, R. M., Meyers, D. S., Genevro, J., & Peikes, D. N. (2013). Enhancing the primary care

team to provide redesigned care: The roles of practice facilitators and care managers. Annals of Family Medicine,

11(1), 80–83. doi:10.1370/afm.1462.

time-limited and problem focused and most often includes coordination of services and follow-

up, patient education and support for self-management, and medication reconciliation.

We seek feedback on these proposed requirements.

(5) Patient-Centered Comprehensive Care Plan

We are proposing for APCM services the “Comprehensive Electronic Care Plan” service

element we established for CCM and PCM services with some modifications. As included in the

APCM code descriptors, we are proposing to specify that the care plan is “patient-centered”

which, as for CCM and PCM services, “is available timely within and outside the billing

practice” as appropriate to individuals involved in the beneficiary’s care, can be routinely

accessed and updated by care team/practitioner, and “copy of care plan to patient/caregiver.”

Providing longitudinal care management, which is an essential element of the delivery of

care under an advanced primary care model of care, includes the process of personalized care

planning. The personalized care planning process helps practices engage and collaborate with

patients to ensure that their care aligns with patient preferences, goals, and values.

A care plan

is a mutually agreed-upon document that outlines the patient’s health goals, needs, and self-

management activities and is accessible to all team members providing care for the patient. The

care plan should be patient-friendly, accessible to the patient, and should limit use of unfamiliar

medical jargon and acronyms. The care plan should also be structured and standardized,

documented in health IT to enable sharing among patient, caregivers, and care team members.

All high-risk patients receiving longitudinal care management should have a personalized care

plan developed in a joint, open-ended conversation between the patient and care team.

Personalized care planning is a dynamic process; therefore, the care plan document should be

Coulter A., Entwistle, V. A., Eccles, A., Ryan, S., Shepperd, S., & Perera, R. (2015). Personalised care planning

for adults with chronic or long-term health conditions. Cochrane Database System Review, 3, CD010523.; Edwards,

S. T., Dorr, D. A., & Landon, B. E. (2017). Can personalized care planning improve primary care? JAMA, 318(1),

25–26.

updated at regularly defined intervals by the care team and patient. In addition, when patients’

health status, preferences, goals, and values change, their plans of care should, too.

As described in the CY 2020 final rule, we proposed language to describe the “typical”

care plan elements which do not comprise a set of strict requirements that must be included in a

care plan for purpose of billing but are intended to reflect those that are typically included in a

care plan as medically appropriate for a particular beneficiary. The comprehensive care plan for

all health issues typically includes, but is not limited to, the following elements: problem list;

expected outcome and prognosis; measurable treatment goals; cognitive and functional

assessment; symptom management; planned interventions; medical management; environmental

evaluation; caregiver assessment; interaction and coordination with outside resources and

practitioners and providers; requirements for periodic review; and when applicable, revision of

the care plan.

We seek feedback on these proposed requirements.

(6) Management of Care Transitions

We are proposing to adopt for APCM services the “Management of Care Transitions”

service element we established for CCM and PCM services with some modifications. Rather

than requiring that the practice must facilitate communication of relevant patient information

through electronic exchange of continuity of care documents with other health care providers

regarding these transitions, we are proposing more simply to require the billing practitioner to

“ensure timely exchange of electronic health information” with other practitioners and providers.

As included in the APCM code descriptors, we are also proposing to specify for the

“Management of Care Transitions” APCM service element that the care team/practitioner would

follow up with the patient and/or caregiver within 7 days after each ED visit and hospital

discharge. This proposed timely follow-up standard is similar to several requirements tested in

CMS Innovation Center models (such as the CPC+ model’s requirement that participating

practices ensure patients with ED visits received a follow-up interaction within one week of

discharge

and the MCP model’s requirement that participating practices implement episodic

care management to provide timely follow-ups for high-risk patients post ED visit and

hospitalization

), and we patterned the timely follow-up element after our policy for TCM

services which requires, for example, “communication (direct contact, telephone, electronic)

with the patient and/or caregiver with 2 business days of discharge” and a “face-to-face visit

within 7 calendar days of discharge.” Providing timely follow-ups for patients is an essential

element of the delivery of care under an advanced primary care model of care, and we believe

this will help achieve timely, seamless care across settings especially after discharge from a

facility. Key aspects of follow-up after ED visits and hospitalizations include identifying and

partnering with target hospitals and EDs where the majority of a practice’s patients receive

services to achieve timely notification and transfer of information following hospital discharge

and ED visits.

When developing a standardized process for data exchange and timely follow-

up, successful practices include the following processes: information and data exchange about

patients seen in an ED or admitted to/discharged from a hospital (for example, via HIE, hospital

portal, hospital-generated report, EHR, or additional health IT system); definition for “timely”

follow-up after discharge (for example, no later than within 2 days of discharge from hospital

admission or observation stay and within 1 week of discharge from the ED); protocols for when

follow-up will be done (for example, before discharge or following a standardized follow-up

protocol); process of incorporating into the patient’s medical record so the information is

available at the time of the follow-up visit or other patient contact; and standardized processes

and protocols for data exchange and formalized partnerships to develop an efficient workflow to

ensure timely follow-up and facilitate efficient and safe transitions of care.

https://www.cms.gov/priorities/innovation/files/x/cpcplus-practicecaredlvreqs.pdf.

https://www.cms.gov/priorities/innovation/innovation-models/making-care-primary.

Carrier, E., Yee, T., & Holzwart, R. A. (2011). Coordination Between Emergency and Primary Care Physicians

(NIHCR Research Brief No. 3). National Institute for Health Care Reform. http://nihcr.org/analysis/improving-care-

delivery/prevention-improving-health/ed-coordination/; Ventura, T., Brown, D., Archibald, T., et al. (2010,

January–February). Improving care transitions and reducing hospital readmissions: establishing the evidence for

community-based implementation strategies through the care transitions theme.

http://www.communitysolutions.com/assets/2012_Institute_Presentations/ caretransitioninterventions051812.pdf.

Practices use a variety of scheduling strategies to prioritize same-day or next-day access

for acutely ill patients and to provide timely follow-up for patients experiencing care transitions.

Successful practices are those that can strike the right balance between timely access to visits and

the offering patients a provider of their choice (Continuity of Care). Establishing standardized

protocols and pathways to improve and ensure responsiveness and timely callbacks to patients is

an effective way to impact patient–practitioner/care team communication and to ensure a

safeguard for addressing emergent and urgent patient phone calls. Successful practices routinely

evaluate the degree to which patients’ phone calls are answered promptly or returned within a

practices’ established guidelines (for example, non-urgent, emergent, urgent) and routed to the

appropriate practitioner or care team member, incorporating patients’ clinical needs and

preferences.

Such strategies are paramount for practices whose patients may be contacting the

practice with care needs that require care team prioritization and urgent reply.

We seek feedback on these proposed requirements.

(7) Practitioner, Home-, and Community-Based Care Coordination

We are proposing to adopt for APCM services the “Home- and Community-Based Care

Coordination” service element we established for CCM and PCM services with some

modifications. As included in the APCM code descriptors, we are proposing to specify that the

“ongoing communication and coordinating receipt of needed services” is with not only with

home- and community-based service providers, but also with “practitioners,” “community-based

social service providers, hospitals, and skilled nursing facilities (or other health care facilities), as

applicable.” We are also proposing to add more detail about the communication documented in

the patient’s medical record in that it would include “the patient’s psychosocial strengths and

Hempel, S., Stockdale, S., Danz, M., Rose, D. E., Kirsh, S., Curtis, I., & Rubenstein, L. V. (2018). Access

management in primary care: Perspectives from an expert panel (Research Report No. RR-2536-DVA). Rand

Corporation. https://www.rand.org/content/dam/rand/pubs/research_reports/RR2500/RR2536/RAND_RR2536.pdf.;

O’Brien, L. K., Drobnick, P., Gehman, M., Hollenbeak, C., Iantosca, M. R., Luchs, S., Manning, M., Palm, S. K.,

Potochny, J., Ritzman, A., Tetro-Viozzi, J., Trauger, M., & Armstrong, A. D. (2017). Improving responsiveness to

patient phone calls: A pilot study. Journal of Patient Experience, 4(3), 101–107. doi:10.1177/2374373517706611.

needs, and functional deficits, goals, preferences, and desired outcomes, including cultural and

linguistic factors.”

Coordinated referral management with specialty groups and other community or

healthcare organizations ensures referrals are properly managed, coordinated, and

communicated. These efforts help practices achieve goals of enhancing the quality of patient

care, improving the patient’s care experience, and lowering cost, particularly for practices

serving high-risk patient populations. Evidence suggests that the development of formal

relationships (for example, collaborative care agreements) between the primary care practice and

referred groups/organizations that define shared goals and responsibilities, facilitate the

coordinated referral management process.

The foundation of successful coordinated referral

management with specialty groups and other community or healthcare organizations is the

development of processes and procedures to ensure high-value referrals, such as collaborative

care agreements and electronic consultations (e-Consults). Establishing clear and agreed-upon

expectations regarding communication and clinical responsibilities with specialty practices and

other care organizations, through a collaborative care agreement, improves the process.

Collaborative care agreements often include the following elements: defining the types of

referrals, consultation, and co-management arrangements available; specifying who is

accountable for which processes and outcomes for care within the referral, consultation, or co-

management arrangement; and specifying what clinical and other information should be

provided, how the information is transferred, and timeliness expectations. The electronic e-

Consults process is typically conducted through a system-wide EHR or a secure, web-based

system by which a practice receives guidance from a specialty provider or other care

organization.

In this process, a practitioner sends a clinical question and relevant clinical

Medicare Payment Advisory Commission (MedPAC). (2012, June). Report to the Congress: Medicare and the

Health Care Delivery System. http://medpac.gov/docs/default-

source/reports/jun18_medpacreporttocongress_sec.pdf?sfvrsn=0.

Vimalananda, V., Gupte, G., Seraj, S., Orlander, J., Berlowitz, D., Fincke, B., & Simon, S. (2015, September).

Electronic consultations (e-consults) to improve access to specialty care: A systematic review and narrative

information to the specialist (or other care organization), who responds by providing a clinical

opinion and guidance and/or confirms the need for a face-to-face appointment with the patient.

This tool and process has the potential to streamline consultations, reduce cost and burden for

patients, and improve access to specialty care for high-value referrals. As part of the CY 2019

PFS final rule, we finalized interprofessional consultation services codes, which support payment

both to the treating, requesting (primary care) practitioner (CPT code 99452) and the receiving,

consultative specialist (CPT codes 99446–99449 and 99451) who engage in e-Consults, and so

some practitioners have already become accustomed to providing and billing for these services.

Strategies for addressing common health-related social needs (HRSNs) for a practice’s

high-risk patients include conducting needs assessments at regular intervals, creating a resource

inventory for the most pressing needs of the patient population, and establishing relationships

with key community organizations. Practices can focus on developing relationships with

community-based organizations that support patients’ most significant HRSNs. Practices can

also seek to find common ground with community and social service organizations, focus on the

structure and process of referrals, and develop a bidirectional flow of information. Successful

practices work with their patients to ensure there is a shared understanding of the purpose of the

referral and aim to understand bottlenecks and barriers to meeting their needs through the

process. Many practices identify a care team member to be a community referral resource for

their patients. Successful referrals can help practices determine the most useful and available

resources in their community.

We seek feedback on these proposed requirements.

(8) Enhanced Communications Opportunities

We are proposing to include for APCM services the element of “Enhanced

Communications Opportunities” we established for CCM and PCM services with some

synthesis. Journal of Telemedicine and Telecare 21(6), 323–330.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4561452/.

modifications. Specifically, we would add “internet and patient portal” as examples of

asynchronous non-face-to-face consultation methods and specify that the practitioner would

provide “other communication technology-based services, including remote evaluation of pre-

recorded patient information and interprofessional telephone/internet/EHR referral service(s), to

maintain ongoing communication with patients, as appropriate” as well as specify “access to

patient-initiated digital communications that require a clinical decision, such as virtual check-ins

and digital online assessment and management and E/M visits (or e-visits).” Providing

asynchronous non-face-to-face consultation methods and other CTBS services is an essential

element of the delivery of care under an advanced primary care model of care, and we believe

this will allow patients to access their usual source of care more conveniently (see section

II.G.2.c.(3) of this proposed rule). There is growing consensus that incorporating telehealth into

primary care will allow patients to access their usual source of care more conveniently.

Patients

using telehealth visits have reported high satisfaction, identifying convenience and perceived

high quality of care as contributors,

such that these may be a good alternative and, in some

cases, preferable to in-person communication.

Expansion of telehealth to address episodic and

chronic conditions has been a significant trend in the evolution of telehealth applications, and

there is some evidence that video visits may enable more timely communication of test results

than in-person appointments.

As noted in section II.G.2.b. of this proposed rule, we are not proposing timeframe

restrictions for this proposed element, which includes access to certain CTBS (for example, the

restriction for virtual check-in services that there is not a related E/M service provided within the

Levine DM, Linder JA. Retail Clinics Shine a Harsh Light on the Failure of Primary Care Access. J Gen Intern

Med. 2016;31(3):260-262.; Dorsey ER, Topol EJ. State of Telehealth. N Engl J Med. 2016;375(2): 154-161.;

Powell, Rhea E., et al. "Patient perceptions of telehealth primary care video visits." The Annals of Family Medicine

15.3 (2017): 225-229.

Polinski JM, Barker T, Gagliano N, Sussman A, Brennan TA, Shrank WH. Patients’ Satisfaction with and

Preference for Telehealth Visits. J Gen Intern Med. 2016;31(3):269-275.

Krishnan N, Fagerlin A, Skolarus TA. Rethinking Patient-Physician Communication of Biopsy Results—The

Waiting Game. JAMA Oncol. 2015;1(8):1025-1026.; Cusack CM, Pan E, Hook JM, Vincent A, Kaelber DC,

Middleton B. The value proposition in the widespread use of telehealth. J Telemed Telecare. 2008;14(4):167-168.

previous 7 days or an E/M service or procedure within the next 24 hours or the soonest available

appointment).

We seek feedback on these proposed requirements.

(9) Patient Population-Level Management

As specified in the proposed APCM code descriptors, we are proposing to establish an

APCM service element for Patient Population-Level Management that would include practice

capabilities for population-based, data-driven approaches to manage preventive and chronic care

for their patient population and to plan and implement strategies to improve care and outcomes.

We are proposing that all practices would use data to develop clear improvement strategies and

analytic processes to proactively manage population health, including analyzing patient

population data to identify gaps in care and risk-stratifying the practice population based on

defined diagnoses, claims, or other electronic data to identify and target services to patients (such

as those at risk for poor health outcomes), and then would offer additional interventions, as

appropriate.

These proposed patient population-level management standards are similar to several

requirements tested in CMS Innovation Center models, including CPC+, which found that model

participants used data to identify and resolve gaps in care. We have modeled the proposed

patient population-level management standards on the CPC+ care delivery requirements. In the

CPC+ Model, participating practices were required, for example, to “use a two-step risk

stratification process for all empaneled patients, addressing medical need, behavioral diagnoses,

and health-related social needs” and “define at least one subpopulation of patients with specific

complex needs, develop capabilities necessary to better address those needs, and measure and

improve the quality of care and utilization of this subpopulation.”

Central to the delivery of

advanced primary care is the organization of the practice into care teams that have the data they

need to manage their patient populations and that have time allocated to plan and implement

CPC+ Care Delivery Resource. January 2019.

practice improvement strategies.

Using evidence-based protocols, registries, and the registry

functionality of the EHR, reminders and outreach help practices deliver appropriate preventive

care and consistent evidence-based management of chronic conditions for the entire patient

population.

Measurement of clinically relevant data at the practice-level guides testing and

implementing strategies to improve care and outcomes. Patient population-level management

capabilities are essential to the delivery of care under an advanced primary care model of care

and enable practices to meet the preventive and chronic care needs of their entire patient

population. Regular use of data to identify populations or groups of patients with similar needs

allows practices and care teams to use streamlined strategies, including setting goals with

measurable outcomes, to positively impact their patient populations. Evidence shows that

primary care teams supported with real-time, population-level clinical outcomes data effectively

manage population health and address care gaps which eliminates external costs to close gaps in

care.

More specifically, risk stratification allows practitioners to identify beneficiaries for

longitudinal care management, track beneficiaries with higher levels of need and manage their

conditions, and prevent beneficiaries from falling through the cracks, while developing strategies

to address those patients who are at increased and rising risk and most likely to benefit from

targeted, proactive, relationship-based care management and other strategies essential to

APCM.

Empanelment, which assigns each active patient to a practitioner and/or care team with

consideration of patient and caregiver preferences, allows practices to build responsive care

CPC+ Care Delivery Resource. January 2019.

O'Malley AS, Draper K, Gourevitch R, Cross DA, Scholle SH. Electronic health records and support for primary

care teamwork. J Am Med Inform Assoc. 2015 Mar;22(2):426-34. doi: 10.1093/jamia/ocu029. Epub 2015 Jan 27.

PMID: 25627278; PMCID: PMC4394968.

https://www.cms.gov/priorities/innovation/files/x/cpcplus-practicecaredlvreqs.pdf.

Hayes, S. L., & McCarthy, D. (2016, December 7). Care Management Plus: Strengthening Primary Care for

Patients with Multiple Chronic Conditions. The Commonwealth Fund.

http://www.commonwealthfund.org/publications/case-studies/2016/dec/care-management-plus; Hong, C. S., Siegel,

A. L., & Ferris, T. G. (2014, August). Caring for High-Need, High-Cost Patients: What Makes for a Successful Care

Management Program? The Commonwealth Fund.

http://www.commonwealthfund.org/~/media/files/publications/issue-

brief/2014/aug/1764_hong_caring_for_high_need_high_cost_patients_ccm_ib.pdf; Lakin, J. R., Robinson, M. G.,

Obermeyer, Z., Powers, B. W., Block, S. D., Cunningham, R., Tumblin, J. M.m Vogeli, c., & Bernacki, R. E. (2019).

Prioritizing primary care patients for a communication intervention using the "Surprise Question": A prospective

cohort study. Journal of General Internal Medicine, 8.

teams to optimize patient care and to address the preventive, chronic, and acute needs of all

patients, and provides a way for practices to identify care gaps and proactively reach out to

patients who have not been seen or contacted in a while.

For example, we believe these

elements of advanced primary care management could increase screening rates and ultimately

improve care of chronic conditions, such as hypertension and diabetes.

We note that this Patient Population-Level Management requirement of the APCM

services would be met for practitioners billing for APCM services through a TIN that is

participating in an ACO in the Shared Savings Program by virtue of the practitioner’s

participation in the ACO which must meet eligibility requirements for population management,

care coordination and quality improvement, including required processes and patient-

centeredness criteria in § 425.112. We note that ACOs in the Shared Savings Program and their

practitioners are already engaged in analyzing the patient population for care gaps, risk-

stratifying patients to further identify those at risk for poor health outcomes, and identifying

patients for whom additional interventions are appropriate. Similarly, the ACO REACH, Making

Care Primary, and Primary Care First CMS Innovation Center Models all require their participants to

deploy population health strategies to identify and offer interventions to mitigate health risks.

Participants in these models and their practitioners are already engaged in population health

management as described in Table 21.

We seek feedback on these proposed requirements.

Grumbach, K., & Olayiwola, N. J. (2015). Patient empanelment: The importance of understanding who is at home

in the medical home. Journal of the American Board of Family Medicine, 28(2), 170–272.; Altschuler, J.,

Margolius, D., Bodenheimer, T., & Grumbach, K. (2012). Estimating a reasonable patient panel size for primary

care physicians with team-based task delegation. Annals of Family Medicine, 10(5), 396–400.

doi:10.1370/afm.1400.

ACO Realizing Equity, Access, and Community Health (REACH) Model Request for Applications. Available a:

https://www.cms.gov/priorities/innovation/media/document/aco-reach-rfa, Making Care Primary Request for

Applications. Available at https://www.cms.gov/files/document/mcp-rfa.pdf, Primary Care First Request for

Applications Cohort 2. Available at https://www.cms.gov/priorities/innovation/media/document/pcf-cohort2-rfa.

(10) Performance Measurement

We are proposing for the APCM services a practice-level requirement of performance

measurement of primary care quality, total cost of care, and meaningful use of CEHRT.

Performance measurement is a critical element of care management services delivered in the

context of advanced primary care, and it forms the basis for practice improvement efforts by

enabling practices to identify key measures for improvement activities (for example, cost and

utilization data, clinical quality measures, patient experience of care data). Quality measurement

improves care delivery, including prevention of heart attacks, increasing vaccination rates, and

improving patient safety,

and quality measures are also effective tools to ensure that high-

quality advanced primary care, including care management, is being delivered. Several

performance measurement requirements were tested in CMS Innovation Center models (such as

the CPC+ model’s requirement that participating practices use data at both the practice- and

panel-level to set goals to improve population health management and to continuously improve

patients’ health, experience, and quality of care, and decrease cost). Using data resources and

developing workflows and analytics to guide practice changes can help practices achieve

reductions in total utilization and cost of care, and improvements in patient experience and

quality of care. Improving upon key outcome measures requires engaged clinical and

administrative leadership and a commitment to continuous, data-driven improvement.

In the

context of the PFS, performance management through quality measurement as a practice-level

requirement also ensures integrity to the provision of advanced primary care because it holds

billing practitioners accountable to factors that are affected by several service elements of APCM

coding. For example, effective patient-population level management can mean the practices

close care gaps in diabetes management, and the billing practitioner would perform better on

diabetes quality measures that assess for a patient’s control of hemoglobin A1c.

https://www.ahrq.gov/patient-safety/quality-measures/21st-century/challenges.html.

https://www.cms.gov/priorities/innovation/innovation-models/comprehensive-primary-care-plus.

We are proposing that this performance measurement practice-level requirement can be

met in several ways. For MIPS-eligible clinicians, the requirement would be met by registering

for and reporting the “Value in Primary Care” MIPS Value Pathway (MVP). A practitioner who

is part of a TIN that is participating as a Shared Savings Program ACO or a REACH ACO, or a

Primary Care First or Making Care Primary practice would meet these requirements by virtue of

the Shared Savings Program and CMS Innovation Center quality reporting, assessment of quality

performance, accountability for total cost of care, and other program and model requirements.

In the CY 2024 PFS final rule (88 FR 80042 through 80047), we finalized “The Value in

Primary Care” Merit-based Incentive Payment System (MIPS) Value Pathway (MVP), which

focuses on the clinical theme of promoting quality care for patients in order to reduce the risk of

diseases, disabilities, and death; and it includes cost measures, Promoting Interoperability (PI)

measures, improvement activities, and quality measures for common chronic conditions (for

example, hypertension, diabetes, depression).

The Value in Primary Care MVP contains the

Adult Universal Foundation quality measure set, which is consistent with the National Quality

Strategy goal of using the Universal Foundation measures across as many programs as is

feasible.

This MVP is especially well-suited to reflect the delivery of care using the advanced

primary care model as it was developed to include quality metrics that reflect clinical actions that

should be considered the foundations of primary care. The quality measures include key

elements such as cancer screening, immunization, blood pressure management, behavioral

health, care coordination, person-centered care, and screening for social drivers of health. The

improvement activities include engaging community resources to address drivers of health,

implementing changes in the practice’s patient portal to improve communication and patient

engagement, reviewing practices in place on targeted patient population needs, and chronic care

Value in Primary Care. Quality Payment Program. https://qpp.cms.gov/mips/explore-mips-value-

pathways/2024/M0005.

https://www.cms.gov/medicare/quality/cms-national-quality-strategy/aligning-quality-measures-across-cms-

universal-foundation.

and preventive care management for empaneled patients, aspects of advanced primary care

already discussed in this proposal. The cost measures include costs for common chronic

conditions, such as asthma/chronic obstructive pulmonary disease (COPD), diabetes, depression,

and heart failure, as well as the Total Per Capita Cost (TPCC) measure, which assesses the

overall cost of care delivered to a patient with a focus on the primary care they receive from their

provider(s) and captures the broader healthcare costs influenced by primary care.

The Value in

Primary Care MVP serves to demonstrate performance measurement that is reflective of the care

furnished using advanced primary care delivery. To ensure performance measurement consistent

with the delivery of advanced primary care services, we are proposing as an element of the

APCM services that a practitioner who is a MIPS eligible clinician as defined in § 414.1305 can

satisfy the performance measurement requirement by registering for and reporting the Value in

Primary Care MVP for the performance year in which they bill for APCM services. A MIPS

eligible clinician can report to MIPS as an individual, subgroup, group, APM Entity, or in any

combination of these four participation options, and can participate in multiple ways to report

MVPs.

MIPS-eligible clinicians who report the MVP are also required to report the PI

performance category measures and attestations throughout the performance period in which

they bill for APCM services,

as required under § 414.1375(b) (§ 414.1365(c)(4)(i)) (see section

IV of this proposed rule for details on reporting the objectives and measures for the MIPS PI

performance category for CY 2025 performance period/2027 MIPS payment year). The

measures in the MIPS PI performance category include measures such as electronic referral

loops, receiving and reconciling health information, and providing patients with electronic access

to their health information, all of which are reflective of important communication and

https://qpp.cms.gov/docs/cost_specifications/2023-12-13-mif-tpcc.pdf.

https://qpp.cms.gov/mips/mvps/learn-about-mvp-reporting-option?option=Group.

The MIPS PI performance period is a minimum of 180 consecutive days in the calendar year that occurs 2 years

prior to the MIPS payment year (see 42 CFR 414.1320(i)).

coordination channels between primary care, other specialist practitioners caring for the patient,

and the patient themselves. In addition, as set forth in 42 CFR 414.1375(b)(3), the MIPS PI

performance category also requires submission of affirmative attestations: (1) regarding their

cooperation in good faith with ONC direct review of their CEHRT; and (2) that they did not

knowingly and willfully take action (such as to disable functionality) to limit or restrict the

compatibility or interoperability of CEHRT.

For CCM services (CPT codes 99437, 99439, 99487, and 99489 – 99491) and PCM

services (CPT codes 99424 – 99427), we established that practitioners must use CEHRT to

record certain patient health information in a structured format, provide patients with access to

their health information, and exchange all relevant patient health information, including in

providing the “Management of Care Transitions” element of CCM services. For the APCM

services, which are furnished as part of a practitioner’s care delivery using the advanced primary

care model, we are proposing for practitioners who are MIPS eligible clinicians a practice-level

requirement to register for and report the MVP, including but not limited to the PI performance

category measures which focus on meaningful use of CEHRT, ensuring that patients/caregivers

and physicians or other qualified practitioners or clinical staff have real-time access to patient’s

medical information. We believe that comprehensive CEHRT use is a critical element of care

management services delivered in the context of advanced primary care.

As we stated in adopting the CEHRT use element for CCM and PCM services, we

believe that the meaningful use of CEHRT is vital to ensure that practitioners are capable of

providing the full scope of services, such as timely care coordination and continuity of care (see

our prior discussion of this issue at 79 FR 67723 and 84 FR 62696), and we believe that

flexibility in how practices can provide the requisite 24/7 access to care, continuity of care, and

Note that, under the Quality Payment Program, CMS may reweight the MIPS PI performance category to zero

percent of the MIPS final score, and not require an individual, group, or virtual group to use CEHRT and

demonstrate whether they are a meaningful user of CEHRT, by granting a significant hardship exception or other

type of exception based on certain circumstances as set forth in 42 CFR 414.1380(c)(2)(i)(C).

management of care transitions, can facilitate appropriate access to these services for Medicare

beneficiaries. The meaningful use of CEHRT helps ensure that members of the care team have

timely access to the patient’s most updated health information and offer an integrated view of a

patient’s clinical history from different points of care, supporting continuing, quality, and

integrated healthcare while avoiding duplication of efforts and costs, such as repeated exams.

For example, practices use EHRs to identify high-risk patients with chronic conditions to better

coordinate care and can supplement the practice's EHR data with data from external sources (for

example, State-level quality organizations) to obtain a more comprehensive view of patients.

Practices can also integrate clinical data from EHRs, health plan claims data, and county-level

social services data to evaluate population needs, stratify by risk, and assess what programs

would be most effective for supporting at-risk patients.

Standardized communication methods,

enabled by CEHRT, are a significant part of the advanced primary care delivery model. Health

IT systems that include remote access to the care plan or the full EHR after hours, or a feedback

loop that communicates back to the primary care physician and others involved in the

beneficiary’s care regarding after-hours care or advice provided, are extremely helpful.

They

help ensure that the beneficiary receives necessary follow up, particularly if the patient is

referred to the ED, and follow up after an ED visit is required under the element of

“Management of Care Transitions.” Accordingly, we believe the use of CEHRT or remote access

to the care plan is fundamental to providing the APCM service elements of 24/7 Access to Care,

Continuity of Care, and Management of Care Transitions under an advanced primary care

delivery model. Requiring performance of the requirements in these measures and attestations to

the meaningful use of CEHRT is similar to several requirements tested in CMS Innovation

Center models (such as the PCF model’s requirement that participating practices adopt and

McDonald, C. J., Tang, P. C., Hripcsak, G. and In: (eds) Biomedical Informatics. Springer, L. (2014), "Electronic

Health Record Systems," in Biomedical Informatics, Shortliffe, E.H. and Cimino, J.J., eds. London: Springer, pp.

391-421.

Harvey, Jillian B., et al. "Understanding how health systems facilitate primary care redesign." Health Services

Research 55 (2020): 1144-1154.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3475839/#CR25.

maintain CEHRT for electronic clinical quality measure reporting, support data exchange with

other providers and health systems, and connect to their regional health information exchange

(HIE),

and the MCP model’s requirement that participating practices use EHR technology that

has been certified under the ONC Health IT Certification Program

). Furthermore, the Shared

Savings Program requires practitioners (that is, MIPS eligible clinicians, QPs and Partial QPs) in

all ACOs to demonstrate meaningful CEHRT use through the reporting of the MIPS Promoting

Interoperability annually beginning in 2025.

We recognize that many practitioners who are not MIPS eligible clinicians for a year

would be excluded from MIPS by achieving Qualifying APM Participant (QP) status based on

their levels of participation in an Advanced APM. Based on the characteristics of Advanced

APMs detailed in § 414.1415, including the requirement that payment is based on MIPS or

MIPS-comparable quality measures, practitioners who with QP status are necessarily engaging in

performance measurement through the Advanced APMs in which they participate in a way that

is consistent with advanced primary care. We also recognize there are other practitioners who are

not MIPS eligible clinicians for other reasons, such as practitioners who are newly enrolled in

Medicare or bill a low volume of Medicare services. These practitioners technically could bill for

APCM services. However, newly enrolled practitioners are only excluded from MIPS for one

year, after which the practitioner would either be a MIPS eligible clinician who would need to

report the MVP in order to bill for APCM services, or excluded from MIPS on another basis

such as QP status. In the case of practitioners with low Medicare volume, we anticipate that they

would be unlikely to bill for APCM services since the delivery of advanced primary care

generally involves time and resources to establish practice-level infrastructure, and the

economies of scale usually make this a more likely investment if the infrastructure can be

utilized across a larger patient panel.

https://www.cms.gov/priorities/innovation/innovation-models/primary-care-first-model-options.

https://www.cms.gov/priorities/innovation/innovation-models/making-care-primary.

We are also proposing that the performance measurement element of the APCM services

would be satisfied for practitioners billing for APCM services through a TIN that is participating

in a Shared Savings Program ACO for a performance year in which they furnish APCM services.

ACOs are currently required to report the APP quality measure set on behalf of their

practitioners, and would be required to report the APP Plus quality measure set as proposed in

Section III.G. of this proposed rule. Practitioners in ACOs are also already being held

accountable for reporting and performance and outcomes on many of the Universal Foundation

measures already, which are used in the Value in Primary Care MVP, and the APP Plus quality

measure set would fully align the Shared Savings Program’s quality performance standard with

the Universal Foundation measures upon the complete implementation of the APP Plus measure

set.

We propose to include the performance measurement requirement as an element of

APCM services furnished by practitioners. MIPS eligible clinicians who intend to report on the

Value in Primary Care MVP for the CY 2025 must register to report the Value in Primary Care

MVP as described under § 414.1365(b), a MIPS eligible clinician must register for an MVP

during between April 1 and November 30 of the applicable CY performance period to report the

MVP. MIPS eligible clinicians submit data on measures and activities in the first quarter of the

year following (CY 2026) the MIPS performance period. Under this proposal, a MIPS eligible

clinician billing for APCM services furnished in 2025 and who is satisfying the performance

measurement requirement through reporting the Value in Primary Care MVP, would need to

March 2026 on measures and activities in the Value in Primary Care MVP relating to services

furnished in 2025. A MIPS eligible clinician billing for APCM services furnished in 2026 and

who is satisfying the performance measurement requirement through reporting the Value in

Primary Care MVP, would need to register for the Value in Primary Care MVP between April

and November of 2026, and report data between January and March of 2027 on measures and

activities in the Value in Primary Care MVP relating to services furnished in 2026, and so on in

subsequent years.

As described above, we are seeking feedback on ways to align the APCM services with

other Medicare programs and initiatives, such as the Shared Savings Program and the Quality

Payment Program, including MIPS and Advanced APMs. We seek to create a low burden way

for practitioners to furnish APCM services by appropriately recognizing ways in which they may

meet APCM billing requirements as part of these programs and initiatives, including other ways

that practitioners may be fulfilling these performance measurement requirements. We are

seeking feedback on whether there are areas of duplication within the APCM service elements

and practice capabilities that we should consider addressing. We are also seeking comment on

how to appropriately align the time period for which the practitioner bills the monthly APCM

code with the calendar year reporting period covered by the MVP, and how we would verify and

enforce the performance measurement requirement of the APCM service.

We seek feedback on these proposed requirements.

d. Duplicative Services and Concurrent Billing Restrictions

In this section, we identify the services that would overlap substantially with APCM

services based on the proposed elements of the scope of service for APCM which we have built

into the service descriptors for GPCM1, GPCM2, and GPCM3 (see sections II.G.2.b. and

II.G.2.c. of this proposed rule). As such, we are proposing that APCM services could not be

billed by the same practitioner or another practitioner within the same practice for the same

patient concurrent with these other services: CCM, PCM, TCM, interprofessional consultation,

remote evaluation of patient videos/images, virtual check-in, and e-visits. Given that we have

intentionally designed the proposed elements of APCM services to track closely with the

elements of several other care management service and CTBS codes, these services are

substantially duplicative of APCM services. Further, these specific services (shown in Table 19)

are duplicative with APCM services because there is significant overlap in the patient

populations included in the code descriptors for these services and APCM services, such as

patients who have chronic conditions, high-risk conditions, or both complex and chronic

conditions.

TABLE 22: Care Management and CTBS which CMS Proposes are Substantially

Duplicative of APCM Services

Service

Description

Care Management Services (12 CPT Codes)

Chronic Care

Management

(CCM) (CPT

Codes 99487,

99489, 99490,

99491, 99439,

99437)

Management of all care for patients with two or more serious chronic conditions, timed, per

month

Principal Care

Management

(PCM) (CPT

Codes 99424,

99425, 99426,

99427)

Management of all care for patients with one serious chronic condition, timed, per month

Transitional

Care

Management

(TCM) (CPT

Codes 99495,

99496)

Management of transition from acute care or certain outpatient stays to a community setting,

with face-to-face visit (bundled into payment for the code), once per patient within 30 days

post-discharge

Communication Technology-Based Services (15 CPT Codes)

Interprofessional

Internet

Consultation

(IPC) (CPT

Codes 99446,

99447, 99448,

99449, 99451,

99452)

Consultations between or among certain kinds of medical practitioners.

Remote

Evaluation of

Patient

Videos/Images

(HCPCS code

G2250)

Remote evaluation of recorded video and/or images submitted by patient

Virtual Check-

In (HCPCS

codes G2251,

G2252)

Virtual check-in service to decide whether an office visit or other service is needed

Online Digital

E/M (e-Visit)

(CPT codes

98970, 98971,

98972, 99421,

99422, 99423)

Communication between patient and their provider through an online patient portal

As we have described in the sections above, comprehensive care management services

are essential to providing advanced primary care in the context of this proposal, and many of the

service elements for CCM/PCM/TCM shown in Table 19 are substantially the same as the

elements we are proposing for APCM services.

Also described above, providing CTBS is an essential element of the delivery of care

under an advanced primary care model of care. Recognizing this, we designed the proposed

APCM service elements to substantially overlap with the elements of the CTBS (for example,

interprofessional consultation and e-Visits) shown in Table 22. CTBS are used in delivery of

advanced primary care to maintain ongoing communication with patients and enable

interprofessional care teams to provide comprehensive support to manage chronic conditions

over time, which we believe will allow patients to access their usual source of care more

conveniently.

We also believe that interprofessional consultation can help promote integration

of behavioral health and primary care.

We also considered whether other care management services (such as Behavioral Health

Integration (BHI)), services addressing HRSNs (Community Health Integration (CHI), Social

Determinants of Health Risk Assessment, and Principal Illness Navigation (PIN)), and/or other

CTBS (Remote Physiologic Monitoring (RPM) and Remote Therapeutic Monitoring (RTM))

would be duplicative of the proposed APCM services. We believe that these services, when

appropriate, may complement APCM services rather than substantially overlap or duplicate

services, and that these other services are sufficiently different from the APCM services in the

nature and extent of the interventions and the qualifications of individuals providing the services,

to allow concurrent billing for services when appropriate. While these may be services that a

practitioner using the advanced primary care model would be likely to furnish, when appropriate,

they are not part of the core, routinely and universally essential elements of the advanced

primary care model. We also believe that several of these other services (such as BHI, CHI,

Levine DM, Linder JA. Retail Clinics Shine a Harsh Light on the Failure of Primary Care Access. J Gen Intern

Med. 2016;31(3):260-262.; Dorsey ER, Topol EJ. State of Telehealth. N Engl J Med. 2016;375(2): 154-161.;

Powell, Rhea E., et al. "Patient perceptions of telehealth primary care video visits." The Annals of Family Medicine

15.3 (2017): 225-229.

We are planning a separate proposal on expanding who can bill for IPC, including clinical psychologists, LCSWs,

marriage and family therapists (MFTs), and MHCs; see further discussion in section II.I of this proposed rule.

SDOH Risk Assessment, and PIN) could be supplemental to APCM for patients that have very

specific identified health care needs.

We are seeking more information from interested parties through our Advanced Primary

Care RFI about whether to consider incorporating additional service elements into the APCM

service elements and valuation for APCM codes; and whether and, if so, how to best incorporate

E/M services into future coding (see section II.G.3. of this proposed rule). We note that, for BHI

services, there is an established evidence base for approaches to caring for beneficiaries with

behavioral health conditions which involve integration in the primary care setting, are typically

provided by a primary care team, and include structured care management with regular

assessments of clinical status and modification of treatment. BHI is a term that refers broadly to

collaborative care that integrates behavioral health services with primary care. BHI is a team-

based approach to care that focuses on integrative treatment of patients with medical and mental

or behavioral health conditions. For BHI in particular, including CPT codes 99492, 99493,

99494, and 99484 and HCPCS code G0323, we are also seeking information regarding how

evolving changes in practice may warrant reconsideration of payment and coding policies.

We propose that the care management and CTBS codes that are identified in Table 19

could not be separately billed with the APCM codes for the same beneficiary by the same

practitioner, or a different one within the same practice, for the same service period. This would

prevent duplicative payments for substantially similar services and is consistent with how we

have paid for potentially overlapping care management services in the past.

As we refine our APCM policies, we note that we are not currently proposing to make

changes to the coding and payment policies for the existing care management and CTBS

services, other than to prohibit concurrent billing for the same patient during the same month by

the same practitioner or another in the same practice. For CY 2025, those codes would still be

available for practitioners who do not furnish care using the advanced primary care model or

who may prefer to document the existing care management and CTBS codes rather than use the

new proposed APCM codes.

We are also seeking comment on potential overlap between APCM services and other

services currently paid under the PFS, including but not limited to care management and care

coordination and other CTBS. If interested parties identify overlaps between APCM and other

services, we are seeking comment on whether the degree of overlap would warrant a policy to

restrict the services from being billed concurrently with APCM. We also seek comment on

whether any overlap would depend upon whether the same or a different practitioner reports the

services.

As we test new CMS Innovation Center models that include payments for the services

defined above, including CCM, PCM, TCM, interprofessional consultation, remote evaluation of

patient videos/images, virtual check-in, and e-visits, or as changes in the advanced primary care

model of care or more general changes to Medicare payment policy take place that affect

existing CMS Innovation Center models, consistent with existing policy, we will address

potential overlaps between payments made to model participants with our proposed payment for

APCM, elements of the proposed APCM service, and these duplicative services, and seek to

implement appropriate payment policies.

e. Valuation of APCM Services—GPCM1, GPCM2, and GPCM3

To improve the accuracy of payment for the kinds of services furnished as part of

advanced primary care and reduce the administrative burden associated with current coding and

billing rules, we are proposing to create three HCPCS codes to use for reporting the proposed

APCM service (GPCM1, GPCM2, and GPCM3) (sections II.G.2.b. and II.G.2.c. of this proposed

rule). Although these codes are unique in that they would be created to differentially pay for

advanced primary care management, the proposed APCM services incorporate elements of

existing services with the understanding that some patients will require more resources and some

fewer based on variability in patient complexity and needs (see section II.G.2.b of this proposed

rule). As we ordinarily do, we are proposing to base the PFS valuation for APCM codes on the

resources involved in furnishing the typical case of the service which may not necessarily reflect

the actual resources involved in furnishing every individual service.

In this section, we detail our proposed methods to identify a typical case and set of

resources involved in furnishing APCM, and the proposed valuation of these codes. To value

APCM, we compared the service elements described by the proposed APCM codes to the values

we have established for the specific care management and CTBS codes on which we modeled

the proposed the service elements of the APCM codes and which we built into the service

descriptors for GPCM1, GPCM2, and GPCM3 (see Table 19 and sections II.G.2.b. through

II.G.2.d. of this proposed rule). As stated above, we believe that the proposed elements of

APCM services reflect the comprehensive approach to care management involved in care

delivery using the advanced primary care model. This is a model of primary care that is being

integrated into current medical practice. As such, we believe that it would be appropriate to use

the current valuation and uptake of the codes on which we modeled the APCM codes to inform

our valuation of APCM services. Using Medicare FFS claims data and evidence from our

primary care models, we sought to understand how these different services have been used

historically and relate that information to the way we are thinking about the service elements for

APCM and the valuation of the three APCM code levels. We know that for Medicare

beneficiaries who receive care management services during a year, the non-complex CCM base

code is billed on average for five months and with three add-on codes during those five months.

We also know that initial information from practitioner interviews conducted as part of our CCM

evaluation efforts indicates that practitioners overwhelmingly meet and exceed the 20-minute

threshold time for billing the non-complex CCM base code; typically, these practitioners

reported spending between 45 minutes and an hour per month on CCM services for each patient,

with times ranging between 20 minutes and several hours per month (81 FR 80244). However,

this does not account for the care management services that are provided beyond one time-based

billing interval and without reaching the next; nor does it account for the resources involved in

maintaining certain advanced primary care practice capabilities and continuous readiness and

monitoring activities, including patient population monitoring and care needs assessment, to

fully furnish and bill APCM services as is medically reasonable and necessary for any individual

patient during any calendar month. Finally, this does not account for changes to utilization of

APCM that may occur as a result of the billing and documentation requirements for APCM

services when compared to the current coding and payment for care management and CTBS

services. While our aim is to value APCM services based on refined assumptions that we believe

better recognize likely utilization of the new proposed codes and the work required to furnish

APCM services, this is challenging without more information. We welcome comments on ideas

for other sources of data that would help us to assess APCM services valuation.

We considered various alternatives for valuing the APCM services and how these may

impact the broader health care landscape given that primary care is of such import across the

country. We are proposing to set baseline APCM code values for this first year based on

historical utilization of the care management services we have drawn upon in designing the

APCM codes. We note that utilization of the care management services has been significantly

higher than CTBS, and we found that CTBS are not typically billed for a patient in the same

month as care management services. It is unclear whether the kinds of services described by the

CTBS are not typically provided during these months or whether they are being provided but not

separately reported. We will continue to seek information, including from public comments on

this proposed rule, to help us identify the best approach to reflecting the proposed CTBS

elements incorporated into the APCM monthly bundle, and we are particularly interested in data

that could illuminate differences between what services are furnished and what is being reported

separately. We will continue to consider refinements to the valuation of APCM codes to reflect

available information about changes in the volume and mix of care management and

communication activities being furnished as part of APCM services in the delivery of advanced

primary care.

For APCM Level 1, we assumed the typical case would involve fewer resources than the

current care management services based upon the proposed GPCM1 code descriptor and a broad

eligible population that would require limited monthly APCM services; however, it would also

involve certain resources inherent to maintaining advanced primary care practice capabilities and

continuous readiness and monitoring activities, including patient population monitoring and care

needs assessment, to fully furnish and bill APCM. As described in sections II.G.2.b. and II.G.2.c.

above, certain elements of the APCM service require resources to maintain continuous readiness

and monitoring activities to furnish covered services consistent with the advanced primary care

model of care. We concluded that the APCM Level 1 services would be similar in work to that of

two billing units of the non-complex code for CCM services (CPT code 99490 (CCM services

provided by clinical staff per calendar month)) over the course of a year, and therefore based the

proposed inputs on CPT code 99490 multiplied by 1/6 (or 2 units over 12 months). Specifically,

we proposed a work RVU for GPCM1 of 0.17, which is the work RVU for CPT code 99490

multiplied by 1/6. The resulting proposed PE and MP RVUs are proportionately similar to those

for CPT code 99490 and are available in Addendum B (see

https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-

outpatient/addendum-a-b-updates).

Table 23 displays payment amount estimates using the

2024 PFS Conversion Factor.

For APCM Level 2, which describes APCM services to patients with two or more

chronic conditions we assumed the typical, higher intensity work associated with managing a

patient with multiple chronic conditions would involve significantly more resources and require

more, and more frequent, APCM service elements. We concluded that the APCM Level 2

https://www.cms.gov/medicare/payment/fee-schedules/physician/federal-regulation-

notices?DLSort=2&DLEntries=10&DLPage=1&DLSortDir=descending.

services would be similar to current utilization assumptions of five billing units of the non-

complex CCM code (CPT codes 99490) (CCM services provided by clinical staff per calendar

month) and three billing units of add-on codes annually, given that, for Medicare beneficiaries

who receive these CCM services during a year, the non-complex CCM base code is billed on

average for five months and with three add-on codes during those 5 months. Additionally, we are

proposing to account for what we believe to be continued underutilization of CCM services in

this patient population by adding one billing unit of the complex CCM code (CPT code 99490

(CCM services provided by clinical staff per calendar month) annually. As we noted in the CY

2020 PFS final rule, “utilization [of CCM services] has reached approximately 75 percent of the

level we initially assumed under the PFS when we began paying for CCM services separately

under the PFS; while these are positive results, we believe that CCM services (especially

complex CCM services) continue to be underutilized”, 81 FR 80244 and 84 FR 62688,

considering the number of eligible Medicare beneficiaries. In 2019, approximately 22.6 million

FFS beneficiaries were identified as being potentially eligible for CCM (or 63.4 percent of the

35.6 million Medicare FFS beneficiaries); however, the use of CCM services was low among

potentially eligible beneficiaries, such that just 4.0 percent of beneficiaries potentially eligible for

CCM received any CCM services.

Therefore, we based the proposed inputs on CPT code

99490 multiplied by 5/12 (or, five units over 12 months), plus CPT add-on code 99439 (CCM

services each additional 30 minutes by clinical staff directed by a physician or other qualified

health care professional, per calendar month) multiplied by 1/6 (or two units), plus CPT add-on

code 99489 (Complex CCM services each additional 30 minutes by clinical staff directed by a

physician or other qualified health care professional, per calendar month) multiplied by 1/12

The determination of potential eligibility for CCM was based on presence of two or more Chronic Condition

Warehouse (CCW) chronic condition flags, one of which was hypertension, hyperlipidemia, or diabetes.

Beneficiaries on Medicare Advantage, with end stage renal disease (ESRD) or using the hospice benefit were

excluded. ASPE. Analysis of 2019 Medicare Fee-for-Service (FFS) Claims for Chronic Care Management (CCM)

and Transitional Care Management (TCM) Services. March 2022.

https://aspe.hhs.gov/sites/default/files/documents/31b7d0eeb7decf52f95d569ada0733b4/CCM-TCM-Descriptive-

Analysis.pdf.

(one unit), plus CPT code 99487 (Complex CCM services provided by clinical staff directed by a

physician or other qualified health care professional, per calendar month) multiplied by 1/12

(one unit). Specifically, we proposed a work RVU for GPCM2 of 0.77, which is the sum of the

work RVU for CPT codes 99490, 99439, 99489, and 99487 multiplied by their respective

proportions above. The resulting proposed PE and MP RVUs are proportionately similar and are

available in Addendum B (see https://www.cms.gov/medicare/payment/prospective-payment-

systems/hospital-outpatient/addendum-a-b-updates).

Table 23 displays payment amount

estimates using the 2024 PFS Conversion Factor.

For APCM Level 3 (HCPCS code GPCM3), which describes APCM services to patients

with QMB status and two or more chronic conditions, we are proposing to value the service as a

relative increase to the valuation of APCM Level 2 based on recent Medicare expenditure data

for dually eligible Medicare beneficiaries. In CY 2021, per person per year spending on dually

eligible beneficiaries was $24,370 and for non-dually eligible beneficiaries was $11,172. The

difference between these two amounts is 218 percent. We have considered the likely resource

demands and intensity of the practitioner-patient interaction for this patient population,

consistent with our coding and valuation policies that reflect variations in resource cost and

patient-centered care delivery policies.

By taking into consideration the difference in Medicare

spending on a per person per year basis between dually eligible and non-dually eligible Medicare

beneficiaries, we believe that we can capture the increased resources involved in furnishing

APCM services to patients with QMB status and multiple chronic conditions. Therefore, we

based the proposed inputs for the APCM Level 3 code on the APCM Level 2 inputs multiplied

by 218 percent. Specifically, we proposed a work RVU for GPCM3 of 1.67, which is the

proposed work RVU for GPCM2 multiplied by 218 percent. The resulting proposed PE and MP

RVUs are proportionately similar to those and are available in Addendum B (see

https://www.cms.gov/medicare/payment/fee-schedules/physician/federal-regulation-

notices?DLSort=2&DLEntries=10&DLPage=1&DLSortDir=descending.

https://www.macpac.gov/wp-content/uploads/2024/01/Jan24_MedPAC_MACPAC_DualsDataBook-508.pdf.

https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-

outpatient/addendum-a-b-updates).

Table 23 displays payment amount estimates using the

2024 PFS Conversion Factor.

Table 23 includes the proposed placeholder codes (which, if finalized, will be replaced

with numeric G-codes announced in the final rule), short descriptors, crosswalk codes, proposed

RVUs (work, PE, and MP), and approximate payment rate. For illustration purposes, we

multiplied the proposed APCM relative values for work, practice expense (PE), and malpractice

(MP), without geographic adjustment, by the CY 2024 conversion factor (CF) ($32.7442) to

convert the proposed relative value units (RVUs) into approximate national payment rates.

TABLE 23: Proposed APCM Bundled Codes and Valuation

Code

Short Descriptor

Crosswalk Codes

CMS

Proposed

Work

RVU

CMS

Proposed

PE RVU

CMS

Proposed

MP RVU

CMS

Proposed

Full

RVU

Approximate

National

Payment Rate

GPCM1

APCM for patients with

up to one chronic

condition

99490

0.17

0.14

0.01

0.31

$10

GPCM2

APCM for patients with

multiple (two or more)

chronic conditions

99490, 99439, 99487,

99489

0.77

0.72

0.05

1.54

$50

GPCM3

APCM for QMBs

enrollees with multiple

chronic conditions

Calculated as a relative

increase from GPCM2

1.67

1.57

0.12

3.36

$110

We are seeking feedback on whether these proposed values appropriately reflect the

resource costs involved in furnishing these services, or whether adjustments to the proposed

values or additional coding may be needed. We are broadly interested in public comments and

input from interested parties on potential refinements in code and service definitions, including

how we might refine our utilization assumptions for these codes, and other important information

involving coding and payment for APCM services to better reflect the current practice of

advanced primary care, including elements of CTBS and care management services. We are

interested in developing a better understanding of the resource costs involved in furnishing

https://www.cms.gov/medicare/payment/fee-schedules/physician/federal-regulation-

notices?DLSort=2&DLEntries=10&DLPage=1&DLSortDir=descending.

comprehensive care management as part of advanced primary care to various patient

populations, including specifically QMBs.

We intend to engage in further discussions with the public over the next several years to

potentially refine our policies for 2025 and future years, and we expect that having APCM

utilization data, once the proposed codes are established, would inform future refinement of the

valuations for these codes.

Finally, as described in the Advanced Primary Care RFI that follows, we note that there

is potential for the valuation of these codes and future related codes to change and/or scale into

larger units if we expand them to incorporate more service elements (see section II.G.3. of this

proposed rule). As we receive more information about how these codes are being used and

implemented in medical practice, we anticipate that these codes and future related codes will be

refined over time. We note that the development of payment and coding policies for these and

other kinds of services under the PFS is typically an iterative process that responds to changes in

medical practice and may be best refined over several years through annual rulemaking for the

PFS, and through the development of CPT codes by the AMA’s CPT Editorial Committee.

As described in the next section, we believe that this new proposed APCM code set could

serve as a chassis to incorporate primary care model learnings over time under the PFS and an

additional pathway to accountable care for primary care practitioners.

3. Request for Information: Advanced Primary Care Hybrid Payment

a. Background

Recent evidence reviews show that while primary care is the only part of the health

system in which investments routinely result in not only improved outcomes but also increased

equity,

100

the practice and sustainability of the primary care sector is under significant strain.

101

100

National Academies of Sciences, Engineering, and Medicine (NASEM); Implementing High-Quality Primary

Care (https://nap.nationalacademies.org/read/25983).

101

Milbank Memorial Fund, The Health of US Primary Care: 2024 Scorecard (https://www.milbank.org/wp-

content/uploads/2024/02/Milbank-Scorecard-2024-ACCESS_v06.pdf).

The NASEM found that many of these challenges relate to a primary care payment system that

principally rewards visit volume versus creation and maintenance of longitudinal

102

care

relationships over time.

103

We have set a goal of having 100 percent of traditional Medicare

beneficiaries and the vast majority of Medicaid beneficiaries in accountable care relationships by

2030. Accountable care occurs when a person-centered care team takes responsibility for

improving quality of care, care coordination and health outcomes for a defined group of

individuals, to reduce care fragmentation and avoid unnecessary costs for individuals and the

health system.

104

Advanced primary care is a core mechanism for achieving this goal. With this

goal, we acknowledge the need to increase the capability of primary care clinicians to engage,

maintain, and promote longitudinal and accountable relationships with beneficiaries through

incentives and flexibilities to manage quality and total cost of care.

Over the past 11 years, the CMS Innovation Center has tested a number of primary care

models: CPC, CPC+, Maryland Primary Care Program, PCF, as well as the upcoming MCP and

ACO Primary Care Flex. Each of these primary care models has focused on testing what happens

when we pay for primary care services with hybrid payments (a mix of fee-for-service and

population-based payments), as described earlier. While these models have not met the criteria

for expansion to date, the findings suggest advanced primary care may reduce unnecessary

utilization and improve diabetes care and cancer screening rates.

In addition to testing new approaches to improve care for beneficiaries by supporting

primary care, we have focused on approaches to incorporating these innovations into Medicare

programs. For example, lessons learned from the CMS Innovation Center’s ACO models may be

incorporated into the Shared Savings Program. As such, part of the intent of our proposal to

102

Longitudinal care management is long-term, proactive, relationship-based care management that augments

routine and acute visits with intentional, proactive outreach, especially during times of illness and transitions of care.

103

NASEM, Implementing High-Quality Primary Care (https://nap.nationalacademies.org/read/25983).

104

https://www.cms.gov/priorities/innovation/key-concepts/accountable-care-and-accountable-care-organizations.

create new APCM payment and coding is that we would have a similar foundation to scale

advanced primary care model learnings over time.

Previous Innovation Center primary care model tests have helped us learn lessons to

inform our current and future work. For example, participants in primary care models have

indicated difficulty investing in and maintaining primary care redesign activities due to a range

of challenges. First, additional non-visit-based primary care payments have been generally

layered upon base payments still predominantly FFS in structure. As such, the incentives and

abilities of practices to focus on proactive, population-based non-visit activities may be limited if

the funding stream for these activities is limited in scope and duration.

105,106

(Examples of non-

visit-based activities include, but are not limited to: activities to improve care coordination,

implement data-driven quality improvement, or enhance targeted care management for

beneficiaries identified as high-risk.) Further, model funding for the clinical and administrative

staff needed to accomplish advanced primary care coordination and population health functions

is contingent on continued participation in these models.

107

Once the models end, practices are

left without the funding that they received under the models for the clinical and administrative

staff that had supported population health functions under the model. Moreover, because these

models involve additional payments tied to performance rather than changes to base primary care

payment, practices report that the funding they use to support non-visit activities is sometimes

received well after the non-visit services have occurred, leading to further challenges sustaining

these efforts fiscally. Solving these challenges is a key goal of future Innovation Center model

work.

108

105

Independent Evaluation of Comprehensive Primary Care Plus (CPC+): Final Report.

https://www.cms.gov/priorities/innovation/data-and-reports/2023/cpc-plus-fifth-annual-eval-report.

106

Schurrer J, Timmins L, Gruszczynski M, et al. Evaluation of the Primary Care First Model: Second Annual

Report. Mathematica. February 2024. https://www.cms.gov/priorities/innovation/data-and-reports/2024/pcf-second-

eval-rpt.

107

CMS defines population health as health behaviors and outcomes of a broad group of individuals, including the

distribution of such outcomes affected by the contextual factors within the group.

108

https://www.cms.gov/about-cms/what-we-do/cms-strategic-plan.

To strengthen the primary care infrastructure within FFS Medicare, we are exploring

opportunities to create new sustainable pathways to support advanced primary care, equitable

access to high-quality primary care, and continued transformation among a wide variety of

practices. One potential strategy to increase access to advanced primary care and prepare

practitioners in traditional Medicare to engage in more accountable care is through the creation

and ongoing refinement of specific billing and coding under the PFS that better recognizes

advanced primary care and incorporates the resources involved in furnishing longitudinal care

and maintaining relationships with patients over time. In section II.G.2. of this proposed rule, we

are proposing a set of APCM services that make use of lessons learned from the CMS Innovation

Center’s primary care models, grouping existing care management and CTBS service elements

into a bundle for use starting in CY 2025.

We are seeking feedback regarding potential further evolution in coding and payment

policies to better recognize advanced primary care. Through this Advanced Primary Care RFI,

we are committed to collaborating with interested parties to lay the path for a more transparent

movement to value-based care. Specifically, we are requesting input on a broader set of

questions related to care delivery and incentive structure alignment and five foundational

components:

● Streamlined Value-Based Care Opportunities

● Billing Requirements

● Person-Centered Care

● Health Equity, Clinical, and Social Risk

● Quality Improvement and Accountability

We encourage input on the questions below from diverse voices, including beneficiaries

and advocates, community-based organizations, providers, clinicians, researchers, unions, and all

other interested parties.

b. Solicitation of Public Comments

We are seeking feedback regarding potential changes to coding and payment policies for

advanced primary care services to be incorporated in traditional Medicare. For example, in the

future, coding for APCM services (proposed in section II.G.2. of this proposed rule) could be

revised to include additional service elements, including traditional E/M services. This

Advanced Primary Care RFI is designed to solicit feedback on how we can further the goals of

reducing administrative burden to refocus time on patient care; better recognizing the relative

resources involved in furnishing care; recognizing interdisciplinary, team-based primary care;

and supporting primary care sustainability and stability (especially for underserved

communities). Whenever possible, respondents are requested to draw their responses from

objective, empirical, and actionable evidence and to cite this evidence within their responses. We

anticipate potential changes to primary care coding and payment policies, such as use of coding

that recognizes groups of services furnished over a fixed time period, that would offer a new

opportunity within the PFS for primary care clinicians to move to payment structures that are not

fully dependent on billing for each discrete component of overall care and act as a step toward

accountability for the cost and quality of patient care. Therefore, we are seeking feedback on

building advanced primary care payment mechanisms that create pathways to recognize how

primary care practice has moved away from an encounter-based orientation toward population-

based care. This Advanced Primary Care RFI is the first step in ensuring ample opportunity for

public input, followed by notice and comment rulemaking in subsequent years.

(1) Streamlined Value-Based Care Opportunities

We are seeking to create a steppingstone for primary care clinicians, including those new

to value-based care, to move away from either encounters or other discrete components of

overall care as the dominant method of primary care payment and toward payments in larger

units that are better tied to the relative resource costs involved in population-based, longitudinal

care. Feedback from interested parties has been helpful when considering how to scale the

availability of payments into larger units, and incorporate population-based variability in

resources, all while driving toward accountability, and person-centered care. Ultimately, to

create more opportunities for beneficiaries to receive high-quality, accountable primary care, we

are focused on creating multiple pathways to recognize delivery of integrated care across

settings, and engagement in comprehensive, team-based, longitudinal care.

When considering the evolution of a hybrid payment system within the PFS, we seek

input on the following questions:

● How can CMS better support primary care clinicians and practices who may be new to

population-based and longitudinal care management?

● What are the primary barriers to providing particular strategies or supports needed for

pediatric clinicians and practices?

● How can CMS ensure that potential future advanced primary care payment will not

induce clinicians to leave effective accountable care relationships and clinician networks that

already produce positive results? Additionally, how can CMS support growth over time in

existing effective accountable care relationships and clinician networks?

● Should CMS evolve the proposed APCM services into an advanced primary care

payment that includes E/M and other relevant services, or maintain a separate code set for

APCM?

● If E/M services are bundled together for advanced primary care payments, how can

CMS ensure that there is not a disincentive for primary care clinicians to continue to provide

E/M visits, or increase accountability to E/M visits as warranted?

● As many codes depend on E/M visits (for example, as the base code for an add-on

code, or to initiate specific care management activities), how should CMS consider the

downstream impacts of incorporating E/M visits into advanced primary care payments?

● Should CMS consider incorporating other CTBS services into advanced primary care

hybrid payments, such as Remote Physiologic Monitoring and/or Remote Therapeutic

Monitoring?

● Should CMS consider incorporating other services that involve comprehensive care

management and care coordination, such as Behavioral Health Integration, End-Stage Renal

Disease Monthly Capitation Payment (ESRD MCP), Assessment/Care Planning for Cognitive

Impairment, and/or Advance Care Planning?

● Should CMS consider incorporating other services while the patient is under care of

home health agencies or hospices, such as Care Plan Oversight?

● Newly finalized HCPCS codes are eligible for use by other payers, including

commercial insurers, state Medicaid agencies, and others. We note that value-based alignment is

a key goal of CMS. If the APCM codes are finalized, they would be eligible for use by these

other payers as well. To what extent are other payers interested in adopting the APCM codes?

Are there any other changes that would be necessary for other payers to adopt the codes?

• CMS has historically used information presented by the Relative Value Scale Update

Committee to determine PFS payment rates. Are there other sources of data on the

relative value of primary care services that CMS should consider when setting hybrid

payment rates?

(2) Billing Requirements

Previous CMS Innovation Center primary care models have provided key lessons learned

about how to increase comfort with population-based payments, the importance of reducing the

administrative burden of billing, and how to begin addressing gaps in equitable access to

population-based payments.

109

Specifically, we have learned through Innovation Center

109

Independent Evaluation of Comprehensive Primary Care Plus (CPC+): Final Report.

https://www.cms.gov/priorities/innovation/data-and-reports/2023/cpc-plus-fifth-annual-eval-report; Independent

Evaluation of Primary Care First: Second Annual Report. https://www.cms.gov/priorities/innovation/data-and-

reports/2024/pcf-second-eval-rpt.

initiatives that retrospective reconciliation or adjustment of payments for services rendered can

be especially frustrating for practitioners, as it reduces the predictability and stability of

payments.

110

For these reasons, we are seeking to understand how advanced primary care hybrid

payments can balance program integrity, high-quality care, payment stability, and clinician

burden.

We seek input on the following questions:

● How can CMS reduce the potential burden of billing for population-based and

longitudinal care services?

● Are there particular types of items or services that should be excluded from the

advanced primary care bundle?

● Are there particular services paid under the PFS today that should be included in the

advanced primary care bundle?

● Care management activities are currently billed monthly. What episode lengths should

CMS consider when thinking about an advanced primary care bundle of services for hybrid

payment? Include evidence to support the proposed episode length.

● Should CMS attribute the advanced primary care clinical episode to a single clinician,

or consider weighted attribution and payment for multiple entities or clinicians? How could

weighted attribution and payment work? What rules or processes should CMS consider to

attribute the episode?

● Care management coding and payment have historically required an initiating visit

prior to starting monthly billing, to ensure that the services are medically reasonable and

necessary and consistent with the plan of care. Are there other ways that CMS could ensure the

clinician billing APCM is responsible for the primary care of the Medicare beneficiary?

110

Independent Evaluation of Primary Care First: Second Annual Report.

https://www.cms.gov/priorities/innovation/data-and-reports/2024/pcf-second-eval-rpt.

● Care management coding and payment require beneficiary cost sharing. Has

beneficiary cost sharing been a barrier to practitioners providing such services?

● Consistent with the initiating visit requirement in the APCM proposal, should CMS

require the billing of specific qualifying services for billing of an advanced primary care bundle

that is larger in scale and scope than APCM?

● Are there Health IT functions beyond what is proposed for APCM services that

clinicians should be required to have to bill for an advanced primary care bundle? What should

CMS consider in the design of the advanced primary care bundle to effectively incorporate

Health IT standards and functionality, to support interoperability and the aims of advanced

primary care?

● Should CMS limit the types of non-physician clinicians that can bill for an advanced

primary care bundle that is larger in scale and scope than APCM? If so, include evidence to

support the restriction.

● How should CMS reconcile instances where an advanced primary care bundle is

billed, but primary care services are then billed for and provided by separate entities?

(3) Person-Centered Care

Person-centered care integrates individuals’ clinical needs across providers and settings,

while addressing their social needs.

111

We strive for better, more affordable care and improved

health outcomes. Key to this mission are care innovations that empower beneficiaries and

clinicians, while reducing the administrative burden of providing episode-based and longitudinal

111

CMS White Paper on CMS Innovation Center’s Strategy: Driving Health System Transformation—A Strategy

for the CMS Innovation Center’s Second Decade (https://www.cms.gov/priorities/innovation/strategic-direction-

whitepaper).

care management. We are seeking comment on how an advanced primary care code(s) could be

structured to both increase efficiency and promote the use of high-value services.

We seek input on the following questions:

● What activities that support the delivery of care that is coordinated across clinicians,

support systems, and time should be considered for payment in an advanced primary care bundle

that are not currently captured in the PFS?

● How can CMS structure advanced primary care hybrid payments to improve patient

experience and outcomes?

● How can CMS structure advanced primary care hybrid payments to ensure appropriate

access to telephonic and messaging primary care services?

● What is the best reporting structure to ensure that targeted services are delivered

without causing undue or excessive documentation?

● How can CMS facilitate coordination between primary care clinicians that bill for

advanced primary care bundles and specialists to reduce costs and improve patient outcomes?

(4) Health Equity, Social and Clinical Risk

We define health equity as, “the attainment of the highest level of health for all people,

where everyone has a fair and just opportunity to attain their optimal health regardless of race,

ethnicity, disability, sexual orientation, gender identity, socioeconomic status, geography,

preferred language, or other factors that affect access to care and health outcomes.”

112

The CMS

Framework for Health Equity lays out how we are working to advance health equity by

designing, implementing, and operationalizing policies and programs that support health for all

the people served by our programs, eliminating avoidable differences in health outcomes

experienced by people who are disadvantaged or underserved, and providing the care and

support that our beneficiaries need to thrive.

113

For advanced primary care hybrid payments, this

112

https://www.cms.gov/pillar/health-equity.

113

Centers for Medicare & Medicaid Services, The CMS Framework for Health Equity (2022-2032). April 2022.

https://www.cms.gov/files/document/cms-framework-health-equity-2022.pdf.

may mean incorporating different types of social and clinical risk into the payment than have

typically been considered in traditional E/M or care management codes.

Recent models such as ACO REACH

114

and Making Care Primary

115

have incorporated

risk adjustment for social risk factors, such as Part D Low Income Subsidy enrollment status and

Area Deprivation Index, to better capture factors relevant to care of the patient. We seek input on

how advanced primary care billing and payment policy could be used to reduce health disparities

and social risk. Furthermore, we are seeking to balance a simple payment structure that

encourages the uptake of advanced primary care services, while ensuring that the risk adjustment

method used to develop the payment rates incentivizes the appropriate coding of patient

conditions and needs, including those that have previously been under-documented, such as

dementia and patient frailty.

116

We seek input on the following questions:

● What non-claims-based indicators could be used to improve payment accuracy and

reduce health disparities, and how can CMS ensure that they are collected uniformly and

documented consistently without unduly increasing administrative burden?

● What risk factors, including clinical or social, should be considered in developing

payment for advanced primary care services?

● How can CMS account for apparent changes in risk that are due to changes in coding

patterns rather than changes in health status?

● What risk adjustments should be made to proposed payments to account for higher

costs of traditionally underserved populations?

114

https://www.cms.gov/priorities/innovation/innovation-models/aco-reach.

115

https://www.cms.gov/priorities/innovation/innovation-models/making-care-primary.

116

National Academies of Sciences, Engineering, and Medicine (NASEM); Committee on the Decadal Survey of

Behavioral and Social Science Research on Alzheimer's Disease and Alzheimer's Disease-Related Dementias.

Reducing the Impact of Dementia in America: A Decadal Survey of the Behavioral and Social Sciences. National

Academies Press. July 26, 2021. https://nap.nationalacademies.org/catalog/26175/reducing-the-impact-of-

dementia-in-america-a-decadal-survey.

● What indicators are used to capture added social risk in commercial insurance? Should

CMS consider using these?

● What metrics should be used or monitored to adjust payment to ensure that health

disparities are not worsened as an unintended consequence?

● How can CMS ensure that advanced primary care hybrid payment increases access to

health care services for patients without a usual source of primary care?

● Are there steps CMS can take to ensure advanced primary care billing and coding is

utilized for dually eligible beneficiaries, and by safety net providers?

● Should CMS incorporate Community Health Integration and/or Principal Illness

Navigation services and payment into an advanced primary care bundle?

(5) Quality Improvement and Accountability

We are committed to affordable quality health care for all people with Medicare. We seek

feedback regarding how we can continue to strengthen beneficiary access to high-quality health

services within FFS Medicare. One goal of the CMS Innovation Center Strategy Refresh is to

increase the capability of practitioners furnishing advanced primary care to engage in

accountable care relationships with beneficiaries through incentives and flexibilities to manage

clinical quality, outcomes, patient experience, and total cost of care. As such, part of the intent of

evolving and creating over time advanced primary care hybrid payments is that the practitioners

who bill for these services are engaged in a relationship where they are responsible for the

quality and cost of care for the beneficiary, counting toward the overall 2030 goal of every

person with Traditional Medicare being in an accountable care relationship. This Advanced

Primary Care RFI seeks input from beneficiaries and their caregivers, primary care and other

clinicians, and health plans on how advanced primary care bundles could support that goal.

We seek input on the following questions:

● How can CMS ensure clinicians will remain engaged and accountable for their

contributions to managing the beneficiary's care?

● What are key patient-centered measures of quality, outcomes and experience that

would help ensure that hybrid payment enhances outcome and experience for patients?

● How could measures of quality, outcomes, and experience guard against and

decrement in access or quality?

● As described in the APCM proposal, reporting of the “Value in Primary Care” MVP

would be an APCM service element for MIPS eligible clinicians beginning in 2026. Since this

MVP contains measures focused on both the total cost and quality of care, would its inclusion as

an APCM service element be sufficient to count as “accountable care?” If not, what other service

delivery or quality reporting would be expected in “accountable care?”

● What should CMS consider so that that advanced primary care bundles could be used

to promote accountable care across payers, both commercial and Medicaid?

● What quality measures are other payers using to drive improvements in primary care?

● What utilization measures are other payers using to drive improvements in primary

care?

● What patient experience measures are other payers using to drive improvements in

primary care?

● Should CMS consider flexibilities for smaller practices to bill the advanced primary

care bundle? Should CMS consider flexibilities for entities exempt from MIPS to bill the

advanced primary care bundle?

● Would clinicians be willing to take on more accountability to further reduce the

frequency and/or administrative burden of billing?

● For APCM services, are there other key practice-level elements of the service that

should be considered for advanced primary care practices to bill for advanced primary care?

4. Cardiovascular Risk Assessment and Risk Management

a. Background

Cardiovascular disease (CVD) is a leading cause of death, disability, and health care

expenditures in the U.S.

117

The burden of CVD is unequal, with black Americans experiencing

higher rates of CVD-related morbidity than white Americans.

118

Atherosclerotic CVD

119

is also

distinct among leading causes of death for Americans in the proportion of CVD attributable to

behavioral causes,

120

making improvement in modifiable CVD risk factors (for example, diet,

exercise, smoking cessation) is a key treatment target to reduce the burden of CVD across

populations.

121

The CMS Innovation Center’s Million Hearts® Cardiovascular Disease (CVD) Risk Reduction

model

122

(hereafter referred to as Million Hearts® model) was launched in 2017 as part of the

ongoing HHS Million Hearts® Initiative.

123

The model's goals were to decrease the incidence of

first-time heart attacks and strokes among medium and high-risk Medicare beneficiaries over

five years and reduce Medicare spending on cardiovascular events. The model was implemented

as a randomized design where participant organizations in the intervention group agreed to (1)

calculate traditional Medicare beneficiaries’ risk of having a heart attack or stroke over 10 years,

and (2) provide cardiovascular care management services to high-risk patients (defined as a risk

of a cardiovascular event in the next decade of greater than thirty percent). The model also

identified medium-risk patients (more than fifteen percent risk of an event in the next decade) in

117

Heart Disease and Stroke Statistics—2023 Update: A Report from the American Heart Association Connie W.

Tsao, MD, MPH, FAHA et. al. Circulation. 2023;147:e93–e621.

118

Cardiovascular Health in African Americans: A Scientific Statement From the American Heart Association

Mercedes R. Carnethon, PhD, FAHA et al. Circulation. 2017;136:e393–e423.

119

What is Atherosclerosis? NIH NHLBI. https://www.nhlbi.nih.gov/health/atherosclerosis

120

Libby, P., Buring, J.E., Badimon, L. et al. Atherosclerosis. Nat Rev Dis Primers 5, 56 (2019).

https://doi.org/10.1038/s41572-019-0106-z.

121

Ebrahim S, Taylor F, Ward K, Beswick A, Burke M, Davey Smith G. Multiple risk factor interventions for

primary prevention of coronary heart disease. Cochrane Database Syst Rev. 2011;(1):CD001561

https://pubmed.ncbi.nlm.nih.gov/21249647/.

122

Sanghavi DM, Conway PH. Paying for prevention: a novel test of Medicare value-based payment for

cardiovascular risk reduction. JAMA. 2015;314(2):123-124.

https://jamanetwork.com/journals/jama/fullarticle/2300705.

123

Frieden TR, Berwick DM. The “Million Hearts” initiative: preventing heart attacks and strokes. N Engl J Med.

2011;365(13):e27. https://pubmed.ncbi.nlm.nih.gov/21913835/.

its evaluation. In exchange for doing so, CMS paid participant organizations $10 for each

eligible traditional Medicare beneficiary for whom the organizations assessed risk, and in the

first year of the model, $10 for each high-risk beneficiary during each month when

cardiovascular care management services were provided.

124

In subsequent years of the model

(2018 to 2022) participants were expected to reassess cardiovascular risk and were paid based on

cardiovascular risk reduction ($0 to $10 per beneficiary per month) for high-risk beneficiaries.

All CMS Innovation Center models are independently evaluated

125

and the evaluation of

the Million Hearts® model found the model reduced the rate of death from any cause for

medium and high-risk beneficiaries by four percent, as well as reduced the risk of death from a

cardiovascular event (that is, heart attack or stroke) by eleven percent.

126

We consider this to be

due to increased rates of cardiovascular risk assessment, discussion of cardiovascular risk by

participants’ clinicians, and the use of appropriate medications to reduce cardiovascular risk (for

example, aspirin and statins).

127

During the Million Hearts® (MH) model (which was tested from 2017-2022), there was a

recently-introduced ASCVD risk assessment tool to incorporate demographic (age, sex, race),

clinical (blood pressure, cholesterol, history of diabetes), and risk behavior (smoking status, use

of anti-hypertensives, use of statins, use of aspirin) established by the American College of

Cardiology (ACC),

128

as well as a longitudinal re-assessment tool used within the model.

129

This

124

Blue L, Kranker K, Markovitz AR, et al. Effects of the Million Hearts Model on Myocardial Infarctions, Strokes,

and Medicare Spending: A Randomized Clinical Trial. JAMA. 2023;330(15):1437–1447.

doi:10.1001/jama.2023.19597.

125

Evaluation of the Million Hearts Cardiovascular Disease Risk Reduction Model. Final Report. August 2023.

Mathematica. https://www.cms.gov/priorities/innovation/data-and-reports/2023/mhcvdrrm-finalannevalrpt.

126

Evaluation of the Million Hearts Cardiovascular Disease Risk Reduction Model, p. 43. Final Report. August

2023. Mathematica. https://www.cms.gov/priorities/innovation/data-and-reports/2023/mhcvdrrm-finalannevalrpt.

127

Evaluation of the Million Hearts Cardiovascular Disease Risk Reduction Model, p. 26. Final Report. August

2023. Mathematica. https://www.cms.gov/priorities/innovation/data-and-reports/2023/mhcvdrrm-finalannevalrpt.

128

Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS, Braun LT, de Ferranti S, Faiella-

Tommasino J, Forman DE, Goldberg R, Heidenreich PA, Hlatky MA, Jones DW, Lloyd-Jones D, Lopez-Pajares N,

Ndumele CE, Orringer CE, Peralta CA, Saseen JJ, Smith SC, Sperling L, Virani SS, Yeboah J. 2018 ACC guideline

on the management of blood cholesterol: a report of the American College of Cardiology Foundation/American

Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2018.

https://tools.acc.org/ldl/ascvd_risk_estimator/index.html#!/calulate/estimator/.

129

Lloyd-Jones DM, Huffman MD, Karmali KN, Sanghavi DM, Wright JS, Pelser C, Gulati M, Masoudi FA, Goff

DC Jr. Estimating Longitudinal Risks and Benefits From Cardiovascular Preventive Therapies Among Medicare

tool calculated the 10-year risk of a cardiovascular event for beneficiaries ages 40-79.

Subsequently, additional ASCVD risk assessment tools have been developed.

130

Today in clinical practice, ASCVD risk is generally calculated using a tool combining

demographic data, personal history (risk behaviors and medical history), and laboratory data

(lipid panel).

131

This information is used to calculate into a 10-year estimate of a patient’s

ASCVD risk for use in determining treatment advice provided by the treating practitioner. This

determination requires both data collection at a visit and laboratory data, which may not be

available at an initial visit. This change in clinical practice occurred over time after a series of

guidelines from the American Heart Association (AHA) recommended using ASCVD risk in

determining treatment decisions for patients without a prior history of CVD.

132

This treatment

guideline also includes recommendations for lifestyle modifications for all patients. The CMS

Innovation Center Million Hearts® model contributed to this change in clinical practice by

demonstrating through a rigorous randomized control trial that the quantitative assessment of 10-

year cardiovascular risk improves quality of care, including mortality, compared to prior

practice.

133

In the Million Hearts® model, cardiovascular-focused care management services

included an initiating visit where an ASCVD risk assessment is performed, structured recording

of patient health information using CEHRT, and a comprehensive care plan focused on

cardiovascular risk reduction (including the ABCS focused on in the Million Hearts® model),

Patients: The Million Hearts Longitudinal ASCVD Risk Assessment Tool: A Special Report From the American

Heart Association and American College of Cardiology. Circulation. 2017 Mar 28;135(13):e793-e813.

130

Leading Cardiologists reveal new cardiovascular disease prevention risk calculator.

https://newsroom.heart.org/news/leading-cardiologists-reveal-new-heart-disease-risk-

calculator#:~:text=The%20American%20Heart%20Association%20PREVENT,CKM%20syndrome%20into%20CV

D%20prevention.

131

2019 ACC/AHA Primary Prevention of Cardiovascular Disease.

https://www.ahajournals.org/doi/pdf/10.1161/CIR.0000000000000678.

132

Arnett DK et. al. 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease: A Report of

the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines.

Circulation. 2019 Sep 10;140(11):e596-e646. doi: 10.1161/CIR.0000000000000678.

133

Blue L, Kranker K, Markovitz AR, et al. Effects of the Million Hearts Model on Myocardial Infarctions, Strokes,

and Medicare Spending: A Randomized Clinical Trial. JAMA. 2023;330(15):1437–1447.

doi:10.1001/jama.2023.19597.

but did not require 24/7 access to care, management of care transitions, or home and community-

based coordination because these services are necessary for the management of complex

conditions placing a beneficiary at high risk of death, acute exacerbation/decompensation, or

functional decline, and these services are provided to prevent the development of these complex

chronic conditions. In the Million Hearts® model, cardiovascular-focused risk management

services were provided to beneficiaries at high risk for CVD (more than a thirty percent risk of a

cardiovascular event in the next 10 years).

We interpret the findings of the Million Hearts® model to be both reflective of and

perhaps augmenting an evolution in clinical practice toward quantitative ASCVD risk

assessment. We also do not believe the resources involved in these activities are appropriately

reflected in current coding and payment policies. As such, we are proposing to establish codes to

describe a separately billable cardiovascular disease risk assessment that is furnished in

conjunction with an E/M visit and cardiovascular-focused risk management, when reasonable

and necessary due to the presence of increased cardiovascular risk factors identified for the

individual patient.

b. ASCVD Risk Assessment

We are proposing a new stand-alone G-code, HCPCS code GCDRA, Administration of a

standardized, evidence-based Atherosclerotic Cardiovascular Disease (ASCVD) Risk Assessment

for patients with ASCVD risk factors on the same date as an E/M visit, 5-15 minutes, not more often

than every 12 months. Atherosclerotic Cardiovascular Disease (ASCVD) Risk Assessment refers

to a review of the individual’s demographic factors, modifiable risk factors for CVD, and risk

enhancers for CVD. We are proposing this new code to identify and value the work involved in

administering an ASCVD risk assessment when medically reasonable and necessary in relation

to an E/M visit.

We further propose that the ASCVD risk assessment must be furnished by the

practitioner on the same date they furnish an E/M visit, as the ASCVD risk assessment would be

reasonable and necessary when used to inform the patient’s diagnosis, and treatment plan

established during the visit. ASCVD risk assessment is reasonable and necessary for a patient

who has at least one predisposing condition to cardiovascular disease that may put them at

increased risk for future ASCVD diagnosis. These conditions could include but are not limited

to, obesity, a family history of CVD, a history of high blood pressure, a history of high

cholesterol, a history of smoking/alcohol/drug use, pre-diabetes, or diabetes. We further propose

that the ASCVD risk assessment would not be separately billable for patients with a

cardiovascular disease diagnosis or those who have history of a heart attack or stroke.

We are not proposing any specific tool that would have to be used for the ASCVD risk

assessment, although the assessment tool must be standardized and evidence-based. Proposed

elements of the ASCVD risk assessment service would include:

● Current (from the last 12 months) laboratory data (lipid panel) for inputs needed for the

risk assessment tool.

● Administration of a standardized, evidence-based ASCVD risk assessment tool that has

been tested and validated through research, and includes the following domains:

++ The output of the tool must include a 10-year estimate of the patient’s ASCVD risk.

This output must be documented in the patient’s medical record.

++ Demographic factors (such as age, sex).

++ Modifiable risk factors for CVD (such as blood pressure & cholesterol control,

smoking status/history, alcohol and other drug use, physical activity and nutrition,

obesity).

++ Possible risk enhancers (such as pre-eclampsia, pre-diabetes, family history of CVD).

++ Billing practitioners may choose to assess for additional domains beyond those listed

above if the tool used requires additional domains. Examples of tools include but are not limited

to, the ACC ASCVD Risk Estimator

134

and the ACC PREVENT tool.

135

CMS expects that the

tool that is used would not introduce discriminatory bias, consistent with Section 1557 final rule.

We are proposing for HCPCS code GCDRA to have a duration of 5–15 minutes for the

administration of an ASCVD risk assessment tool, billed no more often than once every 12

months.

We are requesting comments on these proposals, as well as information pertaining to potential

clinician education for these proposed codes.

(1) Proposed Valuation for ASCVD Risk Assessment GCDRA

We propose a direct crosswalk to HCPCS Code G0136 (Administration of a

standardized, evidence-based SDOH assessment, 5–15 minutes, not more often than every 6

months), with a work RVU of 0.18 as we believe this service reflects the resource costs

associated when the billing practitioner performs the service described. HCPCS code G0136 has

an intra-service time of 15 minutes, and the physician work is of similar intensity to proposed

HCPCS code GCDRA. Therefore, we are proposing a work time of 15 minutes for HCPCS code

GCDRA based on this same crosswalk to G0136. We are also proposing to use this crosswalk to

establish the direct PE inputs for HCPCS code GCDRA.

We are seeking comments on these proposals.

c. Atherosclerotic Cardiovascular Disease Risk Management Services (GCDRM)

Over the past several years, we have worked to develop payment mechanisms under the PFS to

improve the accuracy of valuation and payment for the services furnished by physicians and

other healthcare professionals, especially in the context of evolving changes in medical practice

using evidence-based models of care, such as the Million Hearts® model. We are proposing to

134

Lloyd-Jones DM, Huffman MD, Karmali KN, Sanghavi DM, Wright JS, Pelser C, Gulati M, Masoudi FA, Goff

DC Jr. Estimating Longitudinal Risks and Benefits From Cardiovascular Preventive Therapies Among Medicare

Patients: The Million Hearts Longitudinal ASCVD Risk Assessment Tool: A Special Report From the American

Heart Association and American College of Cardiology. Circulation. 2017 Mar 28;135(13):e793-e813.

135

Leading Cardiologists reveal new cardiovascular disease prevention risk calculator.

https://newsroom.heart.org/news/leading-cardiologists-reveal-new-heart-disease-risk-

calculator#:~:text=The%20American%20Heart%20Association%20PREVENT,CKM%20syndrome%20into%20CV

D%20prevention.

establish a G-code to describe ASCVD risk management services that incorporate the “ABCS”

of CVD risk reduction (aspirin, blood pressure management, cholesterol management, and

smoking cessation) for beneficiaries at medium or high risk for ASCVD (>15 percent in the next

10 years) as previously identified through an ASCVD risk assessment. We believe that ASCVD

risk management services include continuous care and coordination to reduce or eliminate

further elevation of ASCVD risk over time, and potentially prevent the development of future

cardiovascular disease diagnoses or first-time heart attacks or strokes.

We are proposing new G-code, GCDRM, Atherosclerotic Cardiovascular Disease (ASCVD) risk

management services with the following required elements: patient is without a current

diagnosis of ASCVD, but is determined to be at medium or high risk for CVD (>15 percent in the

next 10 years) as previously determined by the ASCVD risk assessment; ASCVD-Specific care

plan established, implemented, revised, or monitored that addresses risk factors and risk

enhancers and must incorporate shared decision-making between the practitioner and the

patient; clinical staff time directed by physician or other qualified health care professional; per

calendar month. Atherosclerotic Cardiovascular Disease (ASCVD) risk management services

refer to the development, implementation, and monitoring of individualized care plans for

reducing cardiovascular risk, including shared decision-making and the use of the ABCS of

cardiovascular risk reduction, as well as counseling and monitoring to improve diet and exercise.

We propose that the elements of the Atherosclerotic Cardiovascular Disease (ASCVD) risk

management service would include:

● ASCVD Specific Risk Management, which may include:

++ Promoting receipt of preventive services (including tobacco cessation

counseling, diabetes screening, diabetes self-management training)

Medication management (including aspirin or statins to maintain or decrease

risk of CVD)

++ Ongoing communication and care coordination via certified electronic health

record (EHR) technology

-- Synchronous, non-face-to-face communication methods must be offered

● ASCVD-Specific, Individualized, Electronic Care Plan

++ Must address modifiable risk factors and risk enhancers specific to CVD, as

applicable, such as:

--blood pressure and cholesterol control

-- smoking, alcohol, and other drug use status, history, and cessation

-- physical activity and nutrition

-- obesity

++ Plan must be established, implemented, and monitored and must incorporate

shared decision-making between the practitioner and the patient

Although there is no minimum service time requirement for ASCVD risk management

services in a month, each of the proposed elements must be addressed to bill for the service,

unless a particular element is not medically indicated or necessary at that time for that specific

patient. For example, the element of smoking cessation would not be addressed for a patient who

does not use tobacco. Documentation of each service element in the patient’s medical record is

required.

Physicians and non-physician practitioners (NPPs) who can furnish E/M services could

bill for ASCVD risk management services. We anticipate that ASCVD risk management services

would ordinarily be provided by clinical staff incident to the professional services of the billing

practitioner in accordance with our regulation at § 410.26. We are proposing that ASCVD risk

management services would be considered a “designated care management service” under §

410.26(b)(5) and, as such, could be provided by auxiliary personnel under the general

supervision of the billing practitioner.

We are proposing that patient consent must be obtained before starting ASCVD risk

management services. Like other care management services, ASCVD risk management services

would typically be provided by clinical staff outside of face-to-face patient visits. Consent can be

written or verbal and must be documented in the medical record. Consent should also include

informing the patient about these services, as well as potentially applicable Medicare cost-

sharing.

We are proposing that ASCVD risk management services could be billed no more often

than once per calendar month, and that payment is limited to one practitioner per beneficiary per

month. Patients must be determined to be at medium or high risk for CVD (>15 percent in the

next 10 years) as previously determined by the ASCVD risk assessment and must not have a

current diagnosis of cardiovascular disease or have a history of heart attack or stroke.

We are seeking comments on each of these proposals.

(1) Proposed Valuation for ASCVD risk management services (GCDRM)

We propose a direct crosswalk to CPT Code 99211 (Office or other outpatient visit for

the evaluation and management of an established patient that may not require the presence of a

physician or other qualified health care professional), with a work RVU of 0.18 as we believe

this service reflects the resource costs associated when the billing practitioner performs HCPCS

code GCDRM. CPT code 99211 has a physician intraservice time of 5 minutes, and the

physician work is of similar intensity to our proposed HCPCS code GCDRM. Therefore, we are

proposing a work time of 5 minutes for HCPCS code GCDRM based on this same crosswalk to

CPT 99211. We are also proposing to use this crosswalk to establish the direct PE inputs for

HCPCS code GCDRM, with modifications to reflect non-face-to-face services. These

modifications include eliminating PE inputs used in face-to-face services such as preparing and

cleaning the room. We are seeking comments on these proposals.

5. Strategies for Improving Global Surgery Payment Accuracy

a. Background

Currently, there are approximately 4,100 physicians’ services that are coded and valued

under the PFS as global surgical packages (herein “global packages”). Global packages are

single codes that are valued to include all services provided during a specified period of days (0-

day, 10-day, or 90-day global packages) by a physician (or another practitioner in the same

group practice (as defined at 42 CFR 411.352)) for a specific surgical procedure. The Medicare

Physician Fee Schedule (MPFS) look-up tool provides information on each procedure code,

including the global surgery indicator. This tool is available at

https://www.cms.gov/medicare/physician-fee-schedule/search/overview.

The global packages include:

● The surgical procedure itself, including day-of pre-service activities and day-of

recovery care;

● Post-operative evaluation and management (E/M) visits and discharge services

provided during specified post-operative periods (10- or 90-day periods for most minor and

major procedures, respectively; 0-day global packages do not include post-operative visits);

● Pre-operative visits on the day of the procedure (for services with 10- and 90-day

periods) and pre-operative visits on the day prior to the procedure (for major procedures with 90-

day periods only);

● Services provided during the post-operative period (for services with 10- and 90-day

periods) related to the procedure (for example, treatment of complications, pain management).

Any medical care that requires a return to the operating room during the global period is

paid separately and starts a new global period. Like other services paid under the PFS, post-

operative visits that are part of the global packages can vary by level and site of service. Global

packages, including the pre-operative, day-of, and post-operative visits associated with the

surgical procedure, are valued using our annual PFS rulemaking process.

As we discussed in the CY 2015 PFS final rule, we have identified and articulated several

concerns with the global packages related to the accuracy of valuation and payment under the

PFS. Foremost, we have longstanding concerns regarding whether the packages are valued based

on estimates consistent with the number and kind of services actually being furnished. Findings

from multiple OIG reports suggest that practitioners perform fewer post-operative visits than are

expected and accounted for in the valuation of the global packages. We provided a detailed

discussion of these concerns in the CY 2015 PFS final rule (79 FR 67582 through 67591).

Similarly, we described concerns that global packages as currently constructed may cause

potential distortions in valuation among PFS services, and that the structure of the current

packages assumes a single model of care delivery (a single practitioner or other practitioners in

the same group practice furnishing the surgical procedure and all associated care) and does not

appropriately address scenarios where the surgical procedure and follow-up care are provided by

different practitioners in different group practices. Taking these findings and concerns into

account, we finalized a policy to transition all 10-day and 90-day global packages to 0-day global

packages, which would allow any post-operative visits furnished after the day of the procedure to

be billed separately as standalone visits by any practitioner who furnishes them. However, in

2015, through amendments made by section 523 of the Medicare Access and CHIP

Reauthorization Act of 2015 (MACRA; Pub. L. 114-10, enacted April 16, 2015), we were

prohibited under section 1848(c)(8)(A) of the Act from implementing this finalized policy.

Further, under section 1848(c)(8)(B), we were required to collect data beginning in 2017 on the

number and level of post-operative visits typically provided to patients during 10- and 90-day

global periods and to use this newly collected data and other data beginning in 2019 to improve

the accuracy of global package valuation.

In response to these requirements, over the past 9 years, we have:

● Initiated research contracts and implemented a data-collection process to analyze data

to understand the extent to which post-operative visits are furnished to patients and improve the

accuracy of payment rates for the global surgical packages. This research contract was funded by

CMS (HHSM-500-2014-00036I) and carried out within the Payment, Cost, and Coverage

Program in RAND Health Care.

● Released three reports (located at https://www.cms.gov/medicare/payment/fee-

schedules/physician/global-surgery-data-collection) on the number of E/M visits furnished

during post-operative periods, the most recent finding that only 4 percent of expected post-

operative visits in 10-day global packages and 38 percent of expected post-operative visits

following 90-day global packages were furnished to patients.

● Fielded and released a report on a survey of selected global packages, collecting

information related to the level and complexity of medical visits furnished during post-operative

periods. This research contract was funded by CMS (HHSM-500-2014-00036I) and carried out

within the Payment, Cost, and Coverage Program in RAND Health Care.

● Released two reports on potential approaches for revaluing the global packages based

on these findings.

● Analyzed the prevalence of transfer of care modifiers (-54 for surgical care only; -55

for post-operative management only; and -56 pre-operative management only) applied to global

packages.

More recently, in the CY 2023 PFS proposed and final rules, we reviewed the prior work

and conversations around the accuracy of global package valuations and solicited comments

from the public on (1) suggested strategies for revaluing these services, (2) information on how

changes to healthcare delivery and payment may be impacting the relevance or accuracy of

global package payments, and (3) possible impact of changes to global packages on health care

access for beneficiaries (see 87 FR 69432 through 69437). In response to the comment

solicitation in the CY 2023 PFS proposed rule, some commenters generally disagreed with our

findings that the post-operative visits in the global packages are not performed as frequently as

assumed in our valuation of global surgical packages. However, opposition from commenters

was based on anecdotal assertions rather than alternative data. Many of these commenters’

specific points restated earlier comments submitted in response to our request for feedback in the

CY 2020 PFS proposed rule on claims-based reporting of post-operative visits, survey findings

on the level of visits, and potential revaluation approaches. Some commenters supported

eliminating 10-day global package periods and requested that the AMA RUC review these

services. However, these commenters also acknowledged that the AMA RUC review process

could take years. In addition to the comments we received in response to the CY 2023 PFS

proposed rule, we have received feedback over several years from many interested parties

regarding the findings from claims-based reporting of post-operative visits and considered

revaluation methodologies presented in our prior reports.

Overall, we have continued exploring ways to improve the accuracy of valuation and

payment for global packages to ensure appropriate payments to the practitioners providing pre-

operative, surgery, and post-operative care to Medicare beneficiaries while considering feedback

from interested parties. In addition, commenters have not proposed specific alternative strategies

to revalue global surgical packages.

Separately, we continue to review approaches to better describe physicians’ services in

the context of the evolving care delivery landscape and to allow practitioners to furnish patient-

centered care. Our review work includes considering care delivery models discussed with

interested parties (and developed though our CMS Innovation Center work), reviewing our

policies and billing requirements, identifying care elements that could serve as the building

blocks for describing newer, impactful services, and seeking opportunities to reduce

administrative burdens for practitioners while ensuring accurate payment. Through this lens, we

have also recently reviewed our billing requirements and payment policies for the global

packages, concurrent with continued analysis of the Medicare claims data.

While ongoing, our review highlights opportunities for us to clarify or revise

longstanding policy and billing instructions for global packages, using data and experience

gathered over the last several years, consistent with our overall objectives to pay more accurately

for services and to right-size the valuation of PFS services based on how practitioners currently

furnish these services. In this proposed rule, we discuss proposals (1) to revise our transfer of

care policy for global packages to address instances where one practitioner furnishes the surgical

procedure and another practitioner furnishes related post-operative E/M visits during the global

period, and (2) to develop a new add-on code that would account for resources involved in post-

operative care provided by a practitioner who did not furnish the surgical procedure. We believe

that addressing the use of transfer of care modifiers, and the resources involved when

practitioners who do not furnish the surgical procedure provide post-operative care, are essential

steps in aligning payment with the way in which surgical procedures are currently furnished as

evidenced in our data, and would make meaningful progress toward more accurate payment for

these services in particular and improve relative valuation for PFS services overall.

b. Clarifying the Scope of Global Surgical Packages

We have valued global packages to include the surgical procedure and services furnished

during the specified global period related to the surgical procedure when furnished by the

practitioner who performs the surgery (hereafter in this section, the proceduralist) or by another

practitioner in the same group practice as the proceduralist.

Under current Medicare payment policy, certain services furnished during the global

period by the proceduralist or by another practitioner in the same group practice may be

separately billed with an appropriate modifier:

● Initial decision for surgery: E/M service billed with modifier -57 (Decision for

Surgery).

● E/M services unrelated to the procedure: billed with modifier -24 (Unrelated E/M

Service During a Global Period).

● Other services unrelated to the procedure (including underlying condition treatment,

diagnostic tests, distinct procedures) not including care for complications/returns to the operating

room: no modifier required.

● Failure of a less extensive procedure requiring a more extensive procedure: no

modifier required.

● Organ transplant immunosuppressive therapy: no modifier required.

● Critical care services unrelated to surgery: billed with modifier -FT if in the post-

operative period.

In general, except where a formal transfer of care modifier applies, a practitioner other than the

proceduralist or a practitioner in the same group practice as the proceduralist can bill separately

for an E/M visit for services they furnish during the global period for a global package, including

post-operative E/M visits related to the procedure. We established formal transfer of care

modifiers to apply in cases where the work, time, and resources involved in furnishing services

included in the global packages are split between the proceduralist (or another practitioner in the

same group practice) and other practitioners providing related post-operative visits during the

global period. Under our current transfer of care policy, transfer of care modifiers must be

reported when a formal transfer of care arrangement is documented by both the proceduralist and

another practitioner providing the related post-operative visits. Based on our analysis of

Medicare fee-for-service claims data, these formal transfer of care modifiers are rarely used and,

when they are, it is often with respect to certain ophthalmologic procedures (for example,

cataract surgery).

Based on our analysis of claims data, we believe that it may be helpful to review our

current policy regarding the applicability of transfer of care modifiers for the medical and billing

communities. Under our current policy, the scope of the global package extends to services

furnished by the entire group practice of the proceduralist, including services furnished by

practitioners in the group practice who are a different specialty from the proceduralist. In other

words, the PFS payment for post-operative visits and other services furnished during the global

period that are related to the surgical procedure and provided by the proceduralist or a

practitioner in the same group practice as the proceduralist is bundled into the global package,

and those services are not separately billable. If the proceduralist or a practitioner in the same

group practice as the proceduralist wants to bill during the global period for a service furnished

to the surgical patient, but unrelated to the global package, the correct modifier must be used to

indicate that the service is not related to the global package. Without a modifier to indicate

otherwise, during the global period for a global package, all E/M services furnished to the patient

by the proceduralist or another practitioner in the same group practice as the proceduralist are

presumed to be related to, and included in the payment for, the global package. Modifiers for

separate payment (such as modifier -24) are required when services unrelated to the global

package are billed by the proceduralist or a practitioner in the same group practice as the

proceduralist during the global period.

c. Strategies to Address Global Package Valuation

We recognize that we are precluded under section 1848(c)(8)(A) of the Act from

revisiting the policy we established in the CY 2015 PFS final rule to revalue all 10-day and 90-

day global packages to 0-day global packages (79 FR 67582-67591). Further, we note that

transitioning all global packages to 0-day global periods could take several years and require

substantial CMS resources (see CY 2014 PFS final rule (77 FR 44737 through 44738) for

previous discussion). We have also considered revaluing 10-day and 90-day global packages to

reflect the observed number of post-operative visits furnished to patients based on data we have

collected over nearly a decade and note that this approach would be quicker to implement,

assuming there would be straightforward ways to revalue the services with the data. However,

interested parties have continued to express uncertainty about the validity of claims-based counts

of post-operative visits. This uncertainty stems primarily from CMS not having complete

information surrounding the use of the transfer of care modifiers since they are not currently

routinely used. The same interested parties also object conceptually to revaluing the 10-day and

90-day global packages using the “building block” framework, where each component of a

service, including bundled post-operative visits, contributes to total valuation to align valuation

with the number of post-operative visits typically provided to patients. Some interested parties

have expressed larger concerns about the redistributive impacts across the PFS among specialties

if we were to implement and revalue all global packages.

We acknowledge the practical challenges involved in revaluing 10-day and 90-day global

packages, whether they remain as 10-day and 90-day periods with fewer post-operative visits or

are transitioned to 0-day global packages, and continue to carefully consider how to best improve

global package valuation given access to administrative claims data and other inputs that help us

understand the scope of services provided to patients within global packages. Ultimately, we

want to ensure payments to practitioners and the relative values assigned to global surgical

packages are accurate and, to the extent possible, driven by real-world objective and updatable

information regarding the relative resources involved in furnishing the services.

For CY 2025, we are focused on different aspects of our policy objectives for global

packages and propose the following policies, which are not mutually exclusive, to obtain

information and allow for more accurate payment to reflect time and resources spent on post-

operative care associated with the current global packages. We will continue to assess and

monitor for potential future opportunities to improve our payment approach for the global

packages more broadly.

Additionally, in developing our proposed policies to pay more accurately for the global

packages, we also considered whether, when, or how our policies may be affected when services

are provided by the proceduralist, versus another practitioner who did not perform the procedure

but is providing follow up care. We also recognize that there may be multiple practitioners in the

same or different specialties in the same group practice and considered how our policies should

apply to practitioners in a range of specialties within the same group practice. We are seeking

comment on these considerations in the context of our proposed policies and welcome feedback

that may further inform our payment policy for global packages. Additionally, as we continue to

better understand what services are being furnished in the global period, by whom, and how the

global surgical packages are valued and billed, we are seeking comment on how remote

monitoring and other types of new technologies represent new resource costs and/or produce

efficiencies and effectiveness of post-operative care. This information could be useful both for

purposes of valuation for surgical and post-operative care, as well as for policies regarding when

specific PFS codes should be reported during global periods for global packages.

d. Expand Applicability of Transfer of Care Modifiers

We created transfer of care payment modifiers at the inception of the PFS. Under our

current policy, these modifiers are required to be appended to the relevant global package code

when billing for services that are within the scope of the global package (within the global period

and related to the surgical procedure) only when the proceduralist and one or more other

practitioners who are not in the same group practice as the proceduralist formally document their

agreement to provide distinct portions of the global package.

The following transfer of care modifiers describe the different portions of the global

surgical package that could be provided by different practitioners:

● Modifier -54 Surgical Care Only: this modifier is appended to the relevant global

package code to indicate that the proceduralist performed only the surgical procedure portion of

the global package.

● Modifier -55 Post-operative Management Only: this modifier is appended to the

relevant global package code to indicate that the practitioner performed only the post-operative

management portion of the global package.

● Modifier -56 Pre-operative Management Only: this modifier is appended to the

relevant global package code to indicate that the practitioner performed only the pre-operative

portion of the global package.

For each of these modifiers, the payment for the global package is adjusted based on the

applicable percentage noted in the PFS Relative Value files

(https://www.cms.gov/medicare/payment/fee-schedules/physician/pfs-relative-value-files).

As previously noted, we currently require the transfer of care modifiers (-56 pre-

operative care, -54 for procedures, and -55 for post-operative care) to be appended in cases

where there is a formal documented transfer of care agreement, that is, “in the form of a letter or

an annotation in the discharge summary, hospital record, or Ambulatory Surgical Center (ASC)

record” (CMS Manual System, Pub 100-04 Medicare Claims Processing, Transmittal 11287). In

our recent analyses of 2022 Medicare claims data, we identified that these modifiers were rarely

used other than for certain ophthalmology global packages. We found over 99 percent of claim

lines for 90-day surgical procedures billed with modifier –54 were ophthalmology services

(primarily cataract-related procedures). We also identified a difference in the number of claim

lines annually for a given 90-day global package with modifier –54 and with modifier –55. In

other words, there are sometimes more claim lines billed with modifier –54 than there are

corresponding lines with modifier –55 and vice versa during a year. We note that modifier –56

(pre-operative management only) is only very rarely used in practice. These recent observations

suggest (1) the overwhelming concentration of reported transfer of care modifiers is in

ophthalmology procedures, and (2) a potential mismatch in billing for formal transfer of care

cases between proceduralists and other practitioners providing post-operative care.

While we recognize the benefits to continuity of care when the proceduralist also

provides pre-operative and follow-up care for the procedure, we also recognize that it is not

always feasible, or even perhaps typical practice for the same practitioner to furnish all portions

of the global package; for example, in instances when the practitioner furnishing the procedure

does not schedule a post-operative visit(s) on the day of the procedure or plans for the patient to

follow up with their primary care provider, or when the practitioner performing the surgery

arranges alternative follow-up care because it would be difficult for the beneficiary to travel to

return for follow-up care. Because our current policies require use of the transfer of care

modifiers only where there is a formal documented agreement between practitioners to provide

specific portions of the global package, we believe there are many practical and potentially

common circumstances under which the transfer of care modifiers would not be required or used.

Beginning for services furnished in 2025, we are proposing to broaden the applicability

of the transfer of care modifiers for the 90-day global packages. We are proposing to require the

use of the appropriate transfer of care modifier (modifier -54, -55, or -56) for all 90-day global

surgical packages in any case when a practitioner plans to furnish only a portion of a global

package (including but not limited to when there is a formal, documented transfer of care as

under current policy, or an informal, non-documented but expected, transfer of care).

Practitioners billing for a global package procedure code with modifier -54 and other

practitioners in the same group practice as that practitioner would still be able to bill during the

global period for any separately identifiable E/M services they furnish to the patient that are

unrelated to the global package procedure. To do so, the practitioner would append modifier -24

to the claim line for the E/M service.

This proposed policy, which would be a first step toward improved valuation and

payment while retaining the fundamental structure of the global packages, would provide us with

more accurate information on the resources involved in furnishing components of global surgical

packages. This proposal would prevent duplicative Medicare payment for post-operative care

because the global surgical package payment would be adjusted based on the appended modifier,

and payment for post-operative care would not be made both as part of a global surgical package

and through separately billed E/M visits. We also anticipate that the proposed policy would

provide us with insight into changes in standards of practice and post-operative patient care for

services that are not billed with transfer of care modifiers pursuant to our current policy (that is,

services other than certain ophthalmology procedures).

We acknowledge the potential challenge associated with anticipating whether other

practitioners will furnish portions of the global package and, accordingly, appending the

appropriate modifier when billing global package services.

We are interested in understanding and are seeking comment on the circumstances under

which practitioners in separate group practices furnish different portions of the care included in

global packages, and what that means for reporting the transfer of care modifiers. While we are

making proposals related to the 90-day global periods beginning for services furnished in 2025,

we are also seeking comment on whether we should consider proposing these changes for the 10-

day global packages in future rulemaking.

e. Payment for Global Packages

Under our current policy for global packages where the transfer of care modifiers are

used (required only where there is a formal transfer of care arrangement), the total combined PFS

payment made for the global package during the global period does not exceed the total global

surgical package payment established for the procedure when billed without any transfer of care

modifier. In general, we continue to believe this is the appropriate result when more than one

practitioner furnishes portions of a global package. Under our proposal, we would require that

practitioners performing the surgical procedure but not intending to furnish the post-operative

portions of a 90-day global service would appropriately append the -54 modifier that we have

previously discussed, which would adjust the portion of payment received to accurately reflect

the service furnished.

More specifically, as noted in the discussion above, the transfer of care modifiers

correspond to three distinct portions of the global package (pre-operative services, the surgical

procedure itself, and post-operative care). We have assigned a proportion of the global package

payment to each portion of the service based on longstanding assumptions. Under our current

policy, the payment for the entire global package is paid to the billing practitioner unless a

transfer of care modifier is included on the claim. Payment is only adjusted if a transfer of care

modifier is included on the claim. We are requesting comments, as we further develop our

payment policies for global packages, on how best to determine the appropriate payment

proportions for the three portions of the global package, which impact payment to the different

practitioners who furnish the different portions of the service.

We are continuing to consider approaches to establishing the payment allocations for

portions of the global package when the transfer of care modifiers are used, and anticipate

revising the allocations through future rulemaking. We are seeking comment on potential

approaches to revise these payment allocations and how they could be established to better

reflect current medical practice and conventions for post-operative follow-up care. We seek to

identify a procedure-specific, data-driven method for assigning shares to portions of the global

package payment to more appropriately reflect the resources involved in each portion. We

would appreciate and carefully consider recommendations from interested parties, including the

AMA RUC, on what those allocation percentages should be, based on how the global package

codes are valued and any other relevant information.

We have contracted with RAND to support data collection and analysis in the past and, as

identified in RAND’s prior reports and described in detail, we surmise that the policy to

apportion and pay for the three portions of the global package based on the presence of transfer

of care modifiers does not always work smoothly. In considering RAND’s reports, one reason

for this is that fewer post-operative visits are provided to patients compared to the number of

visits reflected in the valuation of global packages. The global packages reflect a certain number

of post operative visits (noted in the Physician Time File) that typically occur during the post-

operative global period. However, there is no easy way within a global package to separate the

RVUs for the procedure itself from the RVUs for post-operative visits that are not typically

provided to patients. If our allocation of the global package payment based on the presence of

transfer of care modifiers were to undervalue the surgical procedure portion or the post-operative

care portion of the global package, we are concerned that we could unintentionally introduce

incentives that influence current medical practice for transfers of care. This gets at RAND’s prior

recommendation that we revalue global packages to reflect the actual number of post-operative

visits provided to patients. After revaluation, separating the procedure and post-operative

payments would reflect observed data and mitigate any possible inappropriate incentives in place

for practitioners to initiate transfers of care and support use of transfer of care modifiers as

medically appropriate. This approach has the advantage of anchoring the valuation of separate -

54 and -55 components using real-world information on post-operative visits reported to CMS

rather than on historical assumptions or current survey data reflecting estimates of the typical

number and level of visits.

In our internal review of the percentages assigned for the pre-operative, surgical care, and

post-operative portions of the global package, we found that there are a small number of codes

that do not have any assigned percentages in our files even though these codes are identified as

global packages. HCPCS codes 77750 (Infusion or instillation of radioelement solution (includes

3-month follow-up care)), HCPCS code 77761 (Intracavitary radiation source applic simple),

HCPCS code 77762 (Intracavitary radiation source applic intermed), and HCPCS code 77763

(Intracavitary radiation source applic complex) do not have assigned percentages in our RVU

files. It is our understanding, however, that the MACs have local edits in place to ensure

appropriate payment for these services when billed with the transfer of care modifiers. We are

seeking comment on whether we should consider, first, whether these codes are appropriately

categorized as 90-day global package codes. If these are appropriately considered to be 90-day

global package codes, we are seeking comment on what the assigned percentages should be for

the pre-operative, surgical care, and post-operative portions of the service.

f. Post-operative Care Services Add-on Code

We recognize the importance of continuity in surgical and post-operative care. However,

we recognize that there are instances where post-operative care is not furnished by the

proceduralist or another practitioner in the same group practice, or even by a practitioner who is

in the same specialty as the proceduralist, despite there being no formal transfer of care. We also

recognize that there is an extra level of complexity involved when a practitioner sees a patient

post-operatively after a surgical procedure performed by another practitioner in those

circumstances. The practitioner providing the post-operative care may not be involved in

creating the surgical plan, and may not have access to the operative notes to know how the

surgery went or be abreast of any particular considerations related to the procedure that may

factor in medical care decisions for the post-operative care. As such, we recognize that there are

comparatively more resource costs incurred when a practitioner who did not furnish the surgical

procedure in a global package provides the follow-up care. We are proposing to address these

scenarios, which can occur in a few different ways, by establishing a new add-on code that

would account for resources involved in post-operative care for a global package provided by a

practitioner who did not furnish the surgical procedure and does not have the benefit of a formal

transfer of care. However, we note that when a patient is seen by practitioners in the same group

practice or specialty as the surgeon, the same resources are not incurred during follow-up and

therefore, the add-on code should not be billed by another practitioner in the same group

practice as the practitioner who performed the surgical procedure, or in the same specialty as the

practitioner who performed the surgical procedure. In the case of a practitioner providing follow

up care who is of a different specialty and not within the same group practice as the

proceduralist, researching the procedure to determine expected post-operative course and

potential complications may be needed, which would warrant using the add-on code. We also

acknowledge that sometimes the proceduralist does not schedule the patient to follow up with

them post-operatively and directs the patient to follow up with other practitioners as needed,

such as with the patient’s primary care provider. The patient may independently choose to

follow up with their primary care provider or another practitioner based on other considerations

such as convenience of the practice location or ease of scheduling. We understand and

acknowledge that the patient can choose to see another practitioner without the knowledge of the

practitioner who performed the procedure.

To more appropriately reflect the time and resources involved in these kinds of visits, we are

proposing to make payment using a new add-on code to be billed with an office/outpatient E/M

visit for post-operative follow-up care during the global period of a global package to capture

additional resources associated with practitioners who were not involved in furnishing the

surgical procedure. This follow-up care may include, but is not limited to, obtaining and

reviewing the surgical notes and surgical history, monitoring for signs and symptoms of

infection, taking into account any considerations from the surgical procedure that may affect the

medical care, and monitoring for any potential post-operative complications that may arise. It is

often difficult in these circumstances for the practitioner who did not perform the surgical

procedure to know how the wound looked after the procedure, and so it is more challenging to

recognize possible changes that may have occurred since the time of the procedure (when this is

something the operating surgeon would have been able to know). This new code would be billed

by the practitioner who furnishes the post-operative office/outpatient E/M visits when that

practitioner is not the proceduralist and is not in the same specialty or group practice as the

proceduralist. Documentation in the medical record must justify use of the add-on code and that

the E/M visit was, as clinically understood by the reporting practitioner, related to a post-

operative visit furnished during the 90-day post operative period. As noted earlier, we are

proposing to expand the required use of the transfer of care modifiers as a first step toward

improving payment for the global packages to promote improved valuation and payment for

these services. Instituting an add-on code to capture the time and intensity of post-operative work

absent a formal transfer of care, would be an essential step in recognizing how the services are

currently furnished and make meaningful progress toward ‘right-sizing’ the structure of the

global packages.

Given the history of the global packages since data collection began, as specified in

section 1848(c)(8) of the Act, and in consideration of our policies for post-operative care and our

proposal requiring the use of the transfer of care modifiers in a broader set of circumstances, we

believe that the timing is appropriate to establish an add-on code and payment for post-operative

care provided in the office/outpatient setting by a practitioner other than the proceduralist (or

another practitioner in the same specialty) to account for the additional time, intensity, and

resources that are involved in post-operative care. We are proposing a new HCPCS code,

GPOC1, to capture the additional time and resources spent in providing follow up post-operative

care by a practitioner who did not perform the surgical procedure and who has not been involved

in a formal transfer of care agreement.

We propose the following code and descriptor for the proposed add-on code:

GPOC1 (Post-operative follow-up visit complexity inherent to evaluation and management

services addressing surgical procedure(s), provided by a physician or qualified health care

professional who is not the practitioner who performed the procedure (or in the same group

practice), and is of a different specialty than the practitioner who performed the procedure,

within the 090-day global period of the procedure(s), once per 090-day global period, when

there has not been a formal transfer of care and requires the following required elements, when

possible and applicable:

● Reading available surgical note to understand the relative success of the procedure,

the anatomy that was affected, and potential complications that could have arisen due to the

unique circumstances of the patient’s operation.

● Research the procedure to determine expected post-operative course and potential

complications (in the case of doing a post-op for a procedure outside the specialty).

● Evaluate and physically examine the patient to determine whether the post-operative

course is progressing appropriately.

● Communicate with the practitioner who performed the procedure if any questions or concerns

arise. (List separately in addition to office/outpatient evaluation and management visit, new or

established)).

We are proposing that HCPCS code GPOC1 would be reported by a physician or other

practitioner who did not perform the surgical procedure for a global package and provides related

post-operative visits during the global period despite the absence of a formal transfer of care.

We are proposing that the add-on code (HCPCS code GPOC1) would only be reported with an

office or other outpatient E/M visit for the evaluation and management of a new or established

patient. We would expect the documentation in the medical record to indicate the relevant

surgical procedure, to the extent the billing practitioner can readily identify it, in order to aid in

our understanding of the post-operative care being furnished and when there is no transfer of

care modifier appended on the claim.

We are proposing that this code could be billed only once during the 90-day global period

for the global package because we believe the practitioner would only have additional resource

costs upon the first visit following the procedure. We are proposing to assign a ZZZ global

period payment indicator for HCPCS code GPOC1, as this allows the add-on code to be billed

during the post-operative time frame that applies to payment for each surgical procedure and,

under our proposed policy, this code would be reportable with an E/M visit. The ZZZ global

period payment indicator would identify this code as a service that is related to another service

paid under the PFS and is always included in the global period of the other service.

g. Proposed Valuation for GPOC1 Add-On Code

We note that the proposed valuation of HCPCS code GPOC1 is meant to capture the

additional resource costs, including for visit complexity inherent to office/outpatient care

associated with a post-operative visit that is not accounted for in the appropriate office/outpatient

E/M base code billed by the physician or practitioner. Therefore, we believe that CPT code

90785 (Interactive complexity (List separately in addition to the code for primary procedure))

serves as an appropriate reference for the purposes of valuing HCPCS code GPOC1. CPT code

90785 was created to capture additional work that occurs during diagnostic psychiatric

evaluation, psychotherapy, psychotherapy performed with an E/M service and group

psychotherapy sessions, and the service refers to specific communication factors that complicate

the delivery of a psychiatric/psychotherapy procedure. However, we believe there may be

relatively less work involved for GPOC1 when compared to the work of CPT code 90785,

considering the amount of time needed to gather the operative history and conduct the elements

discussed above. Therefore, we are proposing a work RVU of 0.16, which represents

approximately half of the assigned work for minutes of CPT code 90785. Additionally, we are

proposing a work time of 5.5 minutes (or half of the 11 minutes established for CPT code

90785), personally performed by the billing practitioner including the elements discussed above

during the post-operative E/M visit furnished during the global period, that is, no later than 90-

days following a 90-day global code, respectively. CPT code 90785 has no direct PE inputs, and

we are proposing the same for HCPCS code GPOC1.

To help inform whether our proposed valuation reflects the typical service, we are

seeking comment the typical time and intensity physicians and practitioners spend over and

above a separately billed E/M visit when providing post-operative care to a patient when they did

not perform the surgical procedure, gathering the surgical history as well as the pre-operative,

intra-operative, and post-operative, and on the proposed service elements and the relative

intensity compared to similar service elements of other CPT codes. For the individual

practitioner, not having an intimate knowledge of the procedure itself and not having a

before/after comparison to look at for the wound can all complicate their E/M visit. The

proposed work RVUs are intended to account for the additional relative resource costs in time

and intensity in addition to those involved in the E/M visit.

Finally, we recognize that historically, the CPT Editorial Panel has frequently created

CPT codes describing services for which we originally established G-codes and adopted them

through the CPT Editorial Panel process. We note that we would consider using any newly

available CPT coding to describe services similar to those described here in future rulemaking.

For discussion of our expected utilization assumptions for this service, see the discussion

in the Regulatory Impact Analysis section of this proposed rule.

H. Supervision of Outpatient Therapy Services in Private Practices, Certification of Therapy

Plans of Care with a Physician or NPP Order, and KX Modifier Thresholds

1. Supervision of Outpatient Therapy Services in Private Practices

In the CY 2024 PFS final rule, we finalized our proposal to allow remote therapeutic

monitoring (RTM) services to be furnished by occupational therapy assistants (OTAs) and

physical therapy assistants (PTAs) under the general supervision of occupational therapists

(OTs) and physical therapists (PTs) in private practice, in an effort to align with the general

supervision policy for these services for physicians and other practitioners described in the CY

2023 final rule (88 FR 78990). We also noted that we would consider for possible future

rulemaking the commenters’ responses to our request for information (RFI) on changing the

supervision of therapy assistants in the private practice setting to general supervision for all

therapy services (88 FR 78990 through 78992).

In the CY 2024 PFS proposed rule, we reviewed the statutory provisions at sections

1861(p) and 1861(g) (by cross-reference to section 1861(p)) of the Act that describe outpatient

physical therapy and occupational therapy services furnished to individuals by physical

therapists (PTs) and occupational therapists (OTs) meeting licensing and other standards

prescribed by the Secretary if the services meet the necessary conditions for health and safety.

These statutory provisions refer separately to outpatient therapy services furnished by a provider

of services (such as a rehabilitation agency) and those services furnished in the therapist’s office

or the individual’s home, thus distinguishing therapists who work for an institutional provider of

therapy services from therapists who furnish and bill independently for these outpatient therapy

services (88 FR 52358 through 52359). In regulations, we have addressed these therapists as

physical or occupational therapists in private practice (PTPPs and OTPPs) (63 FR 58868 through

58870). The regulations specific to services furnished by occupational or physical therapists in

private practice are found at §§ 410.59(c) and 410.60(c), respectively.

We also summarized a history of related regulatory provisions in the CY 2024 PFS

proposed rule. In the CY 2005 PFS final rule with comment period (69 FR 66236, 66351 through

66354), we explained that the personnel requirements that are applicable for Home Health

Agencies (HHAs) at 42 CFR part 484 for therapists, therapy assistants and speech-language

pathologists (SLPs) apply to all outpatient physical therapy, occupational therapy, and speech-

language pathology services. In the CY 2005 PFS final rule, we also added a basic rule at §§

410.59(a) and 410.60(a), respectively, by cross-referencing the qualifications for OTs and their

OTAs and PTs and their PTAs for all occupational therapy and physical therapy services,

respectively, including those who work in private practices, to 42 CFR part 484. Later, in the CY

2008 PFS final rule (72 FR 66328 through 66332), we updated the qualification standards at 42

CFR part 484 for OTs, OTAs, PTs, PTAs, and SLPs.

In the CY 2024 PFS proposed rule, through our RFI on general supervision of OTAs and

PTAs by OTPPs and PTPPs, respectively, we solicited public comment, along with supporting

data, for our consideration for possible future rulemaking about the following: (a) the questions

and concerns we highlighted related to access, patient safety, and utilization; (b) revising

§§ 410.59(a)(3)(ii) and (c)(2) and 410.60(a)(3)(ii) and (c)(2) to permit general supervision of

OTAs and PTAs by the OTPP and PTPP, respectively, when furnishing therapy services; and (c)

any appropriate exceptions to allowing general supervision in the furnishing of therapy services

(88 FR 52358 through 52359).

In the CY 2024 PFS final rule, we reviewed the comments we received in response to the

proposed rule (please refer to (88 FR 78990 through 78992)). We noted that we would consider

these comments for possible future rulemaking – see our review of comments on the RFI in the

CY 2024 PFS final rule (88 FR 78992).

Over the past several years and again more recently, we have heard from interested

parties that the direct supervision requirements in the private practice setting are problematic for

OTPPs and PTPPs who must remain on-site and immediately available when Medicare patients

are treated in order to bill for therapy services furnished by their supervised OTAs and PTAs. As

a remedy to this situation, interested parties have requested that we revise our requirement for

PTPPs and OTPPs to provide direct supervision of OTAs and PTAs to align with the general

supervision policies for OTs and PTs that work in Medicare institutional settings that provide

therapy services (for example, rehabilitation agencies, outpatient hospitals, SNFs and

comprehensive outpatient rehabilitation facilities (CORFs), etc.), to allow for the general

supervision of their therapy assistants. These interested parties tell us that their respective State

laws and policies allow general supervision of therapy assistants (most often requiring the OT or

PT to be in touch with their therapy assistants via telecommunication) in at least 44 States for

PTAs,

136

and all but one State for OTAs.

Some interested parties have reported that allowing for general supervision of OTAs and

PTAs by OTPPs and PTPPs, respectively, would allow for patients to have increased access to

outpatient therapy services, even with ongoing healthcare workforce shortages. The shortages of

OTs

137

and OTAs,

138

PTs,

139

and PTAs,

140

are noted by the United States Bureau of Labor

Statistics, which shows thousands of open positions in all of these fields. Interested parties noted

that over 22,000 PTs left the workforce in 2021.

141

Additionally, these interested parties noted

136

Federation of State Boards of Physical Therapy Jurisdiction Licensure Reference Guide

https://www.fsbpt.net/lrg/Home/SupervisionRequirementLevelsBySetting.

137

Bureau of Labor Statistics, U.S. Department of Labor, Occupational Outlook Handbook, Occupational

Therapists,

at https://www.bls.gov/ooh/healthcare/occupational-therapists.htm (visited April 17, 2024).

138

Bureau of Labor Statistics, U.S. Department of Labor, Occupational Outlook Handbook, Occupational Therapy

Assistants and Aides,

at https://www.bls.gov/ooh/healthcare/occupational-therapy-assistants-and-aides.htm (visited April 17, 2024).

139

Bureau of Labor Statistics, U.S. Department of Labor, Occupational Outlook Handbook, Physical Therapists,

at https://www.bls.gov/ooh/healthcare/physical-therapists.htm (visited April 17, 2024).

140

Bureau of Labor Statistics, U.S. Department of Labor, Occupational Outlook Handbook, Physical Therapist

Assistants and Aides, at https://www.bls.gov/ooh/healthcare/physical-therapist-assistants-and-

aides.htm (visited April 17, 2024).

141

See the report by Definitive Healthcare dated October 2022 at

https://www.definitivehc.com/sites/default/files/resources/pdfs/Addressing-the-healthcare-staffing-shortage.pdf.

that workforce shortages have greater impact on private practices in rural and underserved areas

where hourly wages are lower, and the OTPPs and PTPPs in these areas tend to have small

practices. The interested parties stated that Medicare’s direct supervision policy, which requires

the PTPP and the PTA to both be present when a Medicare patient is treated, does not allow

small practices with one PT and one or two PTAs, for example, to work different or overlapping

schedules in order to accommodate all patients’ availability by allowing the OTA/PTA to work

before or after the OTPP/PTPP normal hours. The interested parties also stated that the direct

supervision requirement can unfairly delay care for Medicare patients when, for example, a

PTPP or OTPP is out sick, the practice does not have alternative coverage, and appointments for

Medicare patients must be canceled.

In light of this input, we believe that the direct supervision requirement for OTPPs and

PTPPs of OTAs and PTAs, respectively, may have had an unintended consequence of limiting

access to needed therapy services. As noted by interested parties, both the OTPP/PTPP and their

respective OTA/PTA must be present in the office in order to bill and receive Medicare payment

for therapy services furnished by OTAs and PTAs. This means, for example, that an OTPP/PTPP

cannot bill and receive payment for therapy services furnished to a Medicare patient in their

home when furnished by an OTA/PTA, without the presence of the OTPP/PTPP. The direct

supervision requirement for OTAs and PTAs in the private practice setting is more stringent than

the supervision requirements for OTAs and PTAs in institutional settings. For example, as we

noted in the CY 2024 PFS proposed rule, 42 CFR 485.713 specifies that when an OTA or PTA

provides services at a location that is off the premises of a clinic, rehabilitation agency, or public

health agency, those services are supervised by a qualified occupational or physical therapist

who makes an onsite supervisory visit at least once every 30 days. We also cited Table 4 in our

Report to Congress, titled “Standards for Supervision of PTAs and the Effects of Eliminating the

Personal PTA Supervision Requirement on the Financial Caps for Medicare Therapy

Services,”

142

in the CY 2024 PFS proposed rule to demonstrate that the minimum level of

supervision by PTs and OTs for services performed by PTAs and OTAs working in institutional

settings is a general level of supervision, in accordance with various regulations (88 FR 52359).

Therefore, we believe that a change from direct to general supervision would allow OTPPs and

PTPPs the flexibility to better accommodate patients’ availability and act to ensure access to

necessary therapy services. A change from direct to general supervision would also allow OTPPs

and PTPPs to bill and receive Medicare payment for therapy services furnished by their OTAs

and PTAs when they are not in the office or patient’s home at the same time.

We also believe that it is important to better align our supervision policies for OTPPs and

PTPPs with the majority of state-established supervision levels for therapy assistants providing

occupational therapy and physical therapy services. We note that the majority of states allow

OTs and PTs to provide general supervision of their respective OTAs and PTAs when furnishing

occupational therapy and physical therapy services. We believe that States are well aware of the

health and safety needs for their residents who receive therapy services from OTs and their

supervised OTAs, and PTs and their supervised PTAs. Given these beliefs and the input from

interested parties, we are proposing to revise our regulations at §§ 410.59(a)(3)(ii) and (c)(2) and

410.60(a)(3)(ii) and (c)(2) to allow for general supervision of OTAs and PTAs by OTPPs and

PTPPs, when the OTAs and PTAs are furnishing outpatient occupational and physical therapy

services, respectively. We expect that this proposal would both increase access to therapy

services and more closely align Medicare policy with the majority of State practice acts for

occupational therapy and physical therapy. This will parallel the 44 States that allow general

supervision of PTAs and the 49 States that allow general supervision of OTAs (most often

described as requiring the PT or OT to be in touch via telecommunication). For the States with

more restrictive supervision levels, such as direct supervision, those therapy services are always

142

See Table 4 of the Report to Congress titled Standards for Supervision of PTAs and the Effects of Eliminating the

Personal PTA Supervision Requirement on the Financial Caps for Medicare Therapy Services at

https://www.cms.gov/Medicare/Billing/TherapyServices/Downloads/61004ptartc.pdf.

furnished to the extent that is permitted under State law. We note that while we are proposing to

allow for general supervision by OTPPs and PTPPs of their OTAs/PTAs, an OTPP or PTPP

would still be required to provide direct supervision to unenrolled OTs and PTs, respectively, in

accordance with §§ 410.59(c)(2) and 410.60(c)(2).

We are soliciting comment on our proposals.

2. Certification of Therapy Plans of Care with a Physician or NPP Order

Sections 1861(p), (g), and (ll)(2) of the Act require that an individual outpatient is under

the care of a physician and for whom a plan for the physical therapy, occupational therapy, or

speech-language pathology services that are to be furnished has been established by a physician

or by a qualified PT, OT, or SLP and is periodically reviewed by a physician. Sections

1835(a)(2)(C) and 1835(a)(2)(D) of the Act require that payment for Medicare therapy services

may be made for outpatient physical therapy, occupational therapy, and speech-language

pathology services only if a physician certifies (and recertifies, where such services are furnished

over a period of time) that: (a) the services are or were required because the patient needs or

needed therapy services; (b) a plan for furnishing such services was established by a physician or

qualified therapist providing such services, and is periodically reviewed by the physician; and (c)

the services are or were furnished while the individual was under the care of a physician.

In accordance with the statute and § 424.24(b), Medicare Part B pays for outpatient

physical therapy and speech-language pathology services furnished by providers only if a

physician certifies the content specified in § 424.24(c)(1) or (4). We recognize that it may not be

clear that § 424.24(c) applies to the occupational therapy services furnished by providers, since

occupational therapy services are currently only explicitly mentioned in the recertification

requirements at § 424.24(c)(4).

We note that there are multiple references to § 424.24(c) in the Medicare Benefit Policy

Manual, Pub. 100-02, chapter 15, sections 220.1 - Conditions of Coverage and Payment for

Outpatient Physical Therapy, Occupational Therapy, or Speech-Language Pathology Services,

220.1.2 - Plans of Care for Outpatient Physical Therapy, Occupational Therapy, or Speech-

Language Pathology Services, and 220.1.3 - Certification and Recertification of Need for

Treatment and Therapy Plans of Care, which convey our current policy that all outpatient

physical therapy, occupational therapy, and speech-language pathology services are subject to

requirements for certification and recertification at § 424.24, whether furnished by providers or

by suppliers such as therapists in private practice (TPPs). We note that while section 1835 of the

Act explicitly refers to services furnished by providers of services, which would include

hospitals and other institutional providers as defined in section 1861(u) of the Act, and clinics,

rehabilitation agencies, or public health agencies as further described in section 1835(a) of the

Act, we have interpreted the requirements of section 1835(a)(2)(C) and 1835(a)(2)(D) as

applying to therapy services furnished by both providers and suppliers. See Medicare Benefit

Policy Manual, Pub. 100-02, chapter 15, sections 220.1, 220.1.2, and 220.1.3. We believe that

this interpretation is based on the certification and recertification requirements under section

1835(a) of the Act as a way to effectuate the requirement in sections 1861(p), (g), and (ll)(2) of

the Act that the patient is under the care of a physician, and that the plan of treatment/care for the

physical therapy, occupational therapy, or speech-language pathology services has been

established by a physician or by a qualified PT, OT, or SLP and is periodically reviewed by a

physician. Additionally, we thought it was important to establish conforming policies for these

therapy services in both the outpatient provider and private practice settings.

Due to the foregoing concerns, we are proposing to revise the headings of paragraphs (c)

introductory text and (c)(1)(i) to include the term “occupational therapy” after physical therapy.

We propose to replace the term speech pathology with the accepted term speech-language

pathology in 42 CFR 424.24(c)(1)(i). We are also proposing to add the term “occupational

therapist” to 42 CFR 424.24(c)(3)(ii) between physical therapist and speech-language

pathologist.

The regulations at 42 CFR 424.24(c) require that a physician, nurse practitioner (NP),

physician assistant (PA), or clinical nurse specialist (CNS) who has knowledge of the case sign

the initial certification for the patient’s plan of treatment. We remind readers that plan of

treatment is synonymous with the “plan of care” mentioned above. This terminology appears in

several sections of Pub. 100-02, chapter 15, and both terms may be used interchangeably. In

accordance with § 424.24(c)(2), the initial certification must be obtained as soon as possible after

the plan is established by a PT, OT, or SLP. In Pub. 100-02, chapter 15, section 220.1.3 for

Certification and Recertification of Need for Treatment and Therapy Plans of Care, we specify

that the physician or nonphysician practitioner (NPP) must sign the initial plan of care (POC)

with a dated signature or verbal order within 30 days from the first day of treatment, including

evaluation (or 14 days if a verbal order), in order for the PT, OT, or SLP to be paid for the

services. For this reason, the manual also states that the therapist should forward the treatment

plan to the physician/NPP as soon as it is established rather than waiting to do so. The manual

allows for a delayed certification when the physician or NPP completes certification and includes

a reason for the delay, and delayed certifications are accepted without justification up to 30 days

after the due date.

The regulations at § 424.24(c)(4) require recertification at least every 90 days, and the

plan or other documentation in the patient's medical record must indicate the continuing need for

physical therapy, occupational therapy, or speech-language pathology services. The physician,

nurse practitioner, clinical nurse specialist, or physician assistant who reviews the plan must

recertify the plan by signing the medical record. Pub. 100-02, chapter 15, section 220.1.4.C

clarifies that payment and coverage conditions require that the plan of care be reviewed as often

as necessary but at least whenever it is certified or recertified, in order to meet the certification

requirements. We explained in the CY 2008 PFS final rule, when changing the plan of care

recertification interval from 30 to 90 days, this was done in order to allow more flexibility to the

physician/NPP to order the appropriate amount of therapy for each patient’s needs (72 FR

66333). Thus, a physician or non-physician practitioner (NPP) may certify or recertify a plan of

care at an interval the physician or NPP determines is appropriate, as long as the amount of time

between each recertification does not exceed 90 calendar days. As many episodes of therapy

treatment are completed in less than 30 calendar days, we expect that physicians and NPPs will

continue to certify plans of care that appropriately estimate the duration of needed therapy

treatment for a patient, even if the duration is less than 90 days.

Over the past two years, representatives of several therapy-related organizations have

requested that CMS reduce the administrative burden involved with attempting to obtain signed

plans of treatment from the physician/NPP. They expressed concern that therapists are held

accountable for the action or inaction of physicians/NPPs who may be overwhelmed with

paperwork. These interested parties report that therapists make exhaustive efforts to obtain the

physician/NPP’s signature – some reporting that they contact physician offices (via phone, email,

or fax, etc.) more than 30 times. Without the required signature, the therapist will not meet the

conditions to be paid for the services they deliver. These interested parties recommend that

payment for therapy services should be determined by the medical necessity of the service and

whether the therapist has met their statutory and regulatory requirements. Some of these

interested parties have noted that Pub. 100-02, chapter 15, section 220.1.1, states that the

physician/NPP order provides evidence that the patient is under the care of a physician and that

the services are medically necessary. Interested parties told us that while CMS allows treatment

to begin before the physician’s/NPP’s signature is obtained, PTs, OTs, and SLPs in private

practice do so at their own risk, knowing that they might not be paid for the services if the

physician’s office does not send back the signed plan of treatment. Accordingly, such interested

parties have said that care is delayed while awaiting a physician's signature, which could place

the beneficiary’s health at risk due to the delay in obtaining outpatient therapy services.

While we do not require an order or referral for a Medicare patient to see a PT, OT, or

SLP, we have explained that the presence of a signed order from the treating physician satisfies

statutory requirements that therapy is/was medically necessary and the patient is/was under the

care of a physician (Pub. 100-02, chapter 15, section 220.1.1). However, with this order

documented in the medical record, after the therapist evaluates the patient and establishes the

plan of treatment, based on the evaluation’s findings, the therapist forwards the patient’s plan of

treatment back to the referring physician/NPP to obtain a dated signature for the same patient

with the same diagnosis to meet coverage and payment conditions to satisfy the initial

certification requirement ─ creating an administrative burden for both the physician/NPP and the

therapist. Interested parties have reported to us that most patients seeking outpatient therapy

services have written orders from their physician, not to be confused with a written plan of

treatment. These interested parties have suggested that we amend the regulation at § 424.24(c) to

permit the presumption of a physician/NPP signature for purposes of certification and

recertification in cases where a signed written order or referral from the patient’s physician/NPP

is on file and there is written documentation in the patient’s medical record to substantiate the

method and date (such as a fax, email, etc.) that the therapist forwarded the plan of care to the

physician/NPP.

Additionally, interested parties representing all therapy disciplines requested that CMS

allot time for plan of treatment changes. Interested parties requested that when a physician/NPP

orders the therapy services, the physician/NPP be allotted ten business days to modify the plan of

treatment by contacting the therapist directly after receiving it from the therapist. For patients

without a physician/NPP order, interested parties requested that physician/NPPs be given 30

days after receipt of the plan of treatment to modify the treatment plan.

After reviewing our current regulatory requirements and considering the suggestions of

interested parties, we believe it would be appropriate to propose to amend the regulation at §

424.24(c) for those cases when a patient has a signed and dated order/referral from a

physician/NPP for outpatient therapy services. Since our policy has been to accept the physician

or NPP’s signature on the plan of treatment to be their certification of the treatment plan’s

conditions in the content requirements of § 424.24(c)(1) ─ that the patient needs or needed

physical therapy, occupational therapy or speech-language pathology services, the services were

furnished while the individual was under the care of a physician, NP, PA, or CNS, and the

services were furnished under a plan of treatment that meets the requirements of § 410.61 ─ we

propose that a signed and dated order/referral from a physician/NPP combined with

documentation of such order/referral in the patient’s medical record along with further evidence

in the medical record that the therapy plan of treatment was transmitted/submitted to the

ordering/referring physician or NPP is sufficient to demonstrate the physician or NPP’s

certification of these required conditions. Rather than characterizing this proposal as a

“presumption,” we are taking the view that when the patient’s medical record includes a signed

and dated written order or referral indicating the type of therapy needed, CMS (and our

contractors) would treat the signature on the order or referral as equivalent to a signature on the

plan of treatment. We believe our proposal would be reflective of the intent of the

ordering/referring physician/NPP when that order/referral is on file in the patient’s medical

record. We further believe that this would still be consistent with the initial certification required

under section 1835(a) of the Act for providers of therapy services and our current policy for

therapy in the private practice setting. When the ordering/referring physician writes the referral

for the type of therapy services they determine their patient needs or needed, they also review the

treatment plan the therapist established at the time it is forwarded to them, and they verify that

the services are or were furnished while the patient is or was under their care. As such, we

propose to carve out an exception to the physician signature requirement at § 424.24(c) by

adding a new paragraph (c)(5). The proposed policy would be an exception to the physician

signature requirement for purposes of an initial certification in cases where a signed and dated

order/referral from a physician, NP, PA, or CNS is on file and the therapist has documented

evidence that the plan of treatment has been delivered to the physician, NP, PA, or CNS within

30 days of completion of the initial evaluation. However, at this time, we are not proposing and

do not intend to establish an exception to the signature requirement for purposes of

recertification of the therapy plan of treatment. We believe that physicians and NPPs should still

be required to sign a patient’s medical record to recertify their therapy treatment plans, in

accordance with § 424.24(c)(4), to ensure that a patient does not receive unlimited therapy

services without a treatment plan signed and dated by the patient’s physician/NPP.

Under our proposal, CMS or its contractors would be able to treat the physician/NPP

signature on the order or referral as equivalent to a signature on the plan of treatment for

purposes of the initial certification if that physician/NPP has not signed and returned the patient’s

plan of treatment to the therapist within 30 days of the initial evaluation, but only in cases where

the patient’s physician/NPP has signed and dated the written order or referral and indicated the

type of therapy needed, and that written order or referral is on file in the medical record. This

proposed policy would not affect a contractor’s ability or authority to determine whether therapy

services are reasonable and necessary for a given beneficiary. Lastly, because there is no

requirement for a physician/NPP order or referral for patients to obtain outpatient therapy

services, we propose to make clear in proposed § 424.24(c)(5) that the references to an order or

referral in § 424.24(c)(5) shall not be construed to require an order or referral for outpatient

physical therapy, occupational therapy, or speech-language pathology services. We welcome

comments on this proposal.

In addition, we are soliciting comments to gather more information about the need for a

regulation that would address the amount of time for changes to plans of treatment. Our

regulations at 42 CFR 410.61(d), which are further clarified in our manual provisions in Pub.

100-02, chapter 15, section 220.1.2.C, currently allow for changes to the treatment plan by the

physician/NPP without time restrictions. Interested parties have suggested that CMS allow

physicians/NPPs to have just ten business days from the date of receipt of a plan of care to

modify that plan of care (in the case of a patient with an order for the therapy services).

Additionally, we are also soliciting comment as to whether there should be a 90 calendar day

time limit on the order/referral for outpatient therapy services in cases where the order/referral is

intended to be used in relation to the proposed regulatory amendment for the initial certification

of the treatment plan at § 424.24(c)(5) discussed above ─ that 90-day limit would span from the

order/referral date until the initial treatment of the patient, including the evaluation furnished by

the PT, OT, or SLP. We also seek feedback about whether this limit, or one of a different

duration, should be incorporated into the regulatory provision we proposed above for §

424.24(c)(5).

We want to clarify that we are not proposing to amend § 424.27 for CORF physical

therapy, occupational therapy, and speech-language pathology treatment plans to align with our

proposed amendments at § 424.24 because section 1861(cc) of the Act and regulation at 42 CFR

410.105(c) require these treatment plans to be established by a physician.

We are soliciting comments on these proposals and comment solicitations.

3. KX Modifier Thresholds

The KX modifier thresholds were established through section 50202 of the Bipartisan

Budget Act of 2018 (Pub. L. 115-123, February 9, 2018) (BBA) and were formerly referred to as

the therapy cap amounts. These per-beneficiary amounts under section 1833(g) of the Act (as

amended by section 4541 of the Balanced Budget Act of 1997) (Pub. L. 105–33, August 5, 1997)

are updated each year based on the percentage increase in the Medicare Economic Index (MEI).

Specifically, these amounts are calculated by updating the previous year’s amount by the

percentage increase in the MEI for the upcoming calendar year and rounding to the nearest

$10.00. Thus, for CY 2025, we propose to increase the CY 2024 KX modifier threshold amount

by the most recent forecast of the 2017-based MEI. For CY 2025, the proposed MEI increase is

estimated to be 3.6 percent and is based on the expected historical percentage increase of the

2017-based MEI. Multiplying the CY 2024 KX modifier threshold amount of $2,330 by the

proposed CY 2025 percentage increase in the MEI of 3.6 percent ($2,330 x 1.036) and rounding

to the nearest $10.00 results in a proposed CY 2025 KX modifier threshold amount of $2,410 for

physical therapy and speech-language pathology services combined and $2,410 for occupational

therapy services. We propose to update the MEI increase for CY 2025 based on historical data

through the second quarter of 2024, and we would use such data, if appropriate, to determine the

final MEI percentage increase and the CY 2025 KX modifier threshold amounts in the CY 2025

PFS final rule.

Section 1833(g)(7)(B) of the Act describes the targeted medical review (MR) process for

services of physical therapy, speech-language pathology, and occupational therapy services. The

threshold for targeted MR is $3,000 through CY 2027. Effective beginning with CY 2028, the

MR threshold levels would be annually updated by the percentage increase in the MEI, per

section 1833(g)(7)(B) of the Act. Consequently, for CY 2025, the MR threshold is $3,000 for

physical therapy and speech-language pathology services combined and $3,000 for occupational

therapy services. Section 1833(g)(5)(E) of the Act states that CMS shall identify and conduct

targeted medical review using factors that may include the following:

(1) The therapy provider has had a high claims denial percentage for therapy services

under this part or is less compliant with applicable requirements under this title.

(2) The therapy provider has a billing pattern for therapy services under this part that is

aberrant compared to peers or otherwise has questionable billing practices for such services, such

as billing medically unlikely units of services in a day.

(3) The therapy provider is newly enrolled under this title or has not previously furnished

therapy services under this part.

(4) The services are furnished to treat a type of medical condition.

(5) The therapy provider is part of a group that includes another therapy provider

identified using the factors described previously in this section.

We track each beneficiary’s incurred expenses for therapy services annually and count

them towards the KX modifier and MR thresholds by applying the PFS rate for each service less

any applicable MPPR amount for services of CMS-designated “always therapy” services (see the

CY 2011 PFS final rule at 75 FR 73236). We also track therapy services furnished by critical

access hospitals (CAHs), applying the same PFS-rate accrual process, even though they are not

paid for their therapy services under the PFS and may be paid on a cost basis (effective January

1, 2014) (see the CY 2014 PFS final rule at 78 FR 74406 through 74410).

When the beneficiary’s incurred expenses for the year for outpatient therapy services

exceed one or both of the KX modifier thresholds, therapy suppliers and providers use the KX

modifier on claims for subsequent medically necessary services. Using the KX modifier, the

therapist and therapy provider attest that the services above the KX modifier thresholds are

reasonable and necessary and that documentation of the medical necessity for the services is in

the beneficiary’s medical record. Claims for outpatient therapy services exceeding the KX

modifier thresholds without the KX modifier included are denied.

I. Advancing Access to Behavioral Health Services

1. Safety Planning Interventions and Post-Discharge Telephonic Follow-up Contacts

a. Background

In the CY 2024 PFS proposed rule, we sought comment on whether there is a need for

potential separate coding and payment for interventions initiated or furnished in the emergency

department (ED) or other crisis settings for patients with suicidality or at risk of suicide, such as

safety planning interventions and/or telephonic post-discharge follow-up contacts after an

emergency department visit or crisis encounter, or whether existing payment mechanisms are

sufficient to support furnishing such interventions when indicated. Several commenters

encouraged CMS to enable wider implementation under Medicare of the Safety Planning

Intervention (SPI) and the Post-Discharge Telephonic Follow-up Contacts Intervention (FCI) and

expressed that the current payment mechanisms are not sufficient, noting that the lack of

adequate payment mechanisms and suitable billing codes for these interventions are barriers that

are essential to address. The commenters noted that EDs are not the only care setting where

there is need and opportunity to enhance suicide prevention, but that elevated suicide risk is

particularly prevalent among ED patients. One commenter noted that a designated code for SPI

would make it significantly easier to document that SPI was furnished, including in quality

reporting and value-based payment programs.

More than 49,000 people died by suicide in 2022 and death by suicide is growing

significantly in older adults, who comprise most of the Medicare population. We recognize data

showing that suicide by intentional overdose is a growing concern, particularly among young

people, older people, and Black women, although researchers acknowledge the complexities of

distinguishing intentional from unintentional death.

143

b. Safety Planning Interventions (SPI)

Safety planning interventions involve a patient working with a clinician to develop a

personalized list of coping strategies and sources of support that the person can use in the event

of experiencing thoughts of harm to themselves or others. This is not a suicide risk assessment,

but rather, an intervention provided to people determined to have elevated risk. Safety planning

interventions have also been used to reduce the risk of overdose. The basic components of a

safety plan include the following: (1) recognizing warning signs of an impending suicidal crisis

or actions that increase the risk of suicide; (2) employing internal coping strategies; (3) utilizing

social contacts and social settings as a means of distraction from suicidal thoughts and/or taking

steps to reduce the risk of suicide; (4) utilizing family members, significant others, caregivers,

and/or friends to help resolve the crisis; (5) contacting mental health professionals, crisis

services, or agencies; and (6) making the environment safe, including restricting access to lethal

means, as applicable.

144

One important aspect of making an environment safe could be, for

example, addressing a person’s access to lethal means, such as firearms.

143

https://www.nih.gov/news-events/news-releases/suicides-drug-overdose-increased-among-young-people-elderly-

people-black-women-despite-overall-downward-tren.

144

Barbara Stanley, Gregory K. Brown, Safety Planning Intervention: A Brief Intervention to Mitigate Suicide Risk,

Cognitive and Behavioral Practice, Volume 19, Issue 2, 2012, Pages 256-264, ISSN 1077-7229,

https://doi.org/10.1016/j.cbpra.2011.01.001.

We understand that safety planning is consistent with current practice standards and that

many hospitals and clinicians in other settings are already providing some or all of these services

to the people who need them, including through the Department of Veterans Affairs (VA).

145146

However, in one survey of EDs, only 15.3 percent could confirm routinely implementing safety

planning with all of the structured elements mentioned above. Provision of individual safety

planning elements ranged from 24.8 percent (n = 492) to 79.2 percent (n = 1710), with 2 of 6

elements being routinely provided more than 50 percent of the time: lists of professionals or

agencies to contact in a crisis (1710 [79.2 percent]) and helping patients to recognize warning

signs of suicide (1075 [52.2 percent]).

147

Suicide risk among people with substance use

disorders who also are at high risk for or may have experienced an intentional overdose is not

well recognized.

148

Therefore, we are proposing to establish separate coding and payment under the PFS

describing safety planning interventions. Specifically, we are proposing to create an add-on G-

code that would be billed along with an E/M visit or psychotherapy when safety planning

interventions are personally performed by the billing practitioner in a variety of settings. We

recognize that training and expertise are needed to perform these interventions safely and

appropriately and are seeking comment regarding whether clinical staff who meet the definition

of auxiliary personnel defined at 42 CFR 410.26(a)(1) or who are employed by a hospital could

participate in furnishing this service under the supervision of the billing practitioner in certain

settings with the relevant training needed to perform the service as well as what sort of training

would be needed.

145

https://www.mentalhealth.va.gov/docs/vasafetyplancolor.pdf.

146

https://www.mirecc.va.gov/visn19/research/our-research/implementation.asp.

147

Bridge JA, Olfson M, Caterino JM, Cullen SW, Diana A, Frankel M, Marcus SC. Emergency Department

Management of Deliberate Self-harm: A National Survey. JAMA Psychiatry. 2019 Jun 1;76(6):652-654. doi:

10.1001/jamapsychiatry.2019.0063. PMID: 30865243; PMCID: PMC6552299.

148

Ries RK, Livengood AL, Huh D, et al. Effectiveness of a Suicide Prevention Module for Adults in Substance Use

Disorder Treatment: A Stepped-Wedge Cluster-Randomized Clinical Trial. JAMA Netw Open. 2022;5(4):e222945.

doi:10.1001/jamanetworkopen.2022.2945.

The proposed G-code is HCPCS code GSPI1: Safety planning interventions, including

assisting the patient in the identification of the following personalized elements of a safety plan:

recognizing warning signs of an impending suicidal crisis; employing internal coping strategies;

utilizing social contacts and social settings as a means of distraction from suicidal thoughts;

utilizing family members, significant others, caregivers, and/or friends to help resolve the crisis;

contacting mental health professionals or agencies; and making the environment safe; (List

separately in addition to an E/M visit or psychotherapy). We welcome comments on the

proposed elements of the safety planning code.

We are proposing to value HCPCS code GSPI1 based on the valuation for CPT code

90839 (Psychotherapy for crisis), which describes 60 minutes, and which we believe describes a

similar level of intensity as HCPCS code GSPI1. For HCPCS code GSPI1, we are assuming a

typical time of 20 minutes, resulting in a proposed work RVU of 1.09 (based on one third of the

work value currently assigned to CPT code 90839, which is 3.28). We welcome comments on

whether 20 minutes accurately captures the typical amount of time spent with a patient on safety

planning interventions, including all six elements enumerated in this section. Additionally, we

welcome comments on whether these interventions typically occur in the context of an

encounter, such as an E/M visit or psychotherapy, or whether there may be times when they may

be furnished as a standalone service and whether we should consider allowing this code to be

billed on its own. We also welcome comments regarding which clinician types might be most

likely to bill such a code on its own.

c. Post-Discharge Telephonic Follow-up Contacts Intervention (FCI)

Some research suggests that patients seen in the ED with deliberate self-harm, intentional

overdose, and/or suicidal ideation have been associated with substantially increased risk of

suicide and other mortality during the year following their visit to the ED.

149

FCI is a specific

149

Goldman-Mellor S, Olfson M, Lidon-Moyano C, Schoenbaum M. Association of Suicide and Other Mortality

With Emergency Department Presentation. JAMA Netw Open. 2019 Dec 2;2(12):e1917571. doi:

10.1001/jamanetworkopen.2019.17571. PMID: 31834399; PMCID: PMC6991205.

protocol of services for individuals with suicide risk involving a series of telephone contacts

between a provider and patient in the weeks and sometimes months following discharge from the

emergency department and other relevant care settings, that occurs when the person is in the

community and is designed to reduce the risk for subsequent adverse outcomes. FCI calls are

typically 10-20 minutes in duration and aim to encourage use of the Safety Plan (as needed in a

crisis) and updating it to optimize effectiveness, expressing psychosocial support, and helping to

facilitate engagement in any indicated follow-up care and services. We note that this service

would not be within the scope of Medicare telehealth services and not subject to the restrictions

described in Section 1834(m) because these services are specifically structured to be delivered

via audio-only phone calls and are not a substitute for an in-person service.

In a recent study led by the Joint Commission, which surveyed a national sample of

hospitals to assess the prevalence of SPI and several other recommended suicide prevention

services, fewer than half of responding hospitals reported furnishing any post-discharge follow-

up contacts. Of these, only 33 percent (16 percent of responding hospitals overall) reported

reaching discharged patients “most of the time.” Further, among hospitals that furnish follow-up

contacts, fewer than half reported covering any of the main aims of FCI, for example, 41 percent

review the Safety Plan, 49 percent provide psychosocial support, and 38 percent facilitate

outpatient care.

150

However, some studies have demonstrated that SPI and other services may be able to

reduce suicidal behaviors. For example, in the ED-SAFE trial for emergency department (ED)

patients identified with elevated suicide risk, the intervention included SPI and up to seven post-

discharge follow-up calls with the patient “focused on identifying suicide risk factors, clarifying

values and goals, safety and future planning, facilitating treatment engagement/adherence, and

150

https://www.sciencedirect.com/science/article/pii/S1553725024000679?via%3Dihub.

facilitating patient-significant other problem-solving.”

151

In the SAFE VET study

152

of ED

patients identified with elevated suicide risk, the intervention included SPI and at least two

follow-up calls with patients “to monitor suicide risk, review and revise the SPI, and support

treatment engagement.”

153

Each of these studies reported significantly lower suicide behaviors –

attempts and/or deaths – among intervention patients compared to the respective control

conditions.

In light of this, we are proposing to create a monthly billing code to describe the specific

protocols involved in furnishing post-discharge follow-up contacts that are performed in

conjunction with a discharge from the emergency department for a crisis encounter, as a bundled

service describing four calls in a month, each lasting between 10-20 minutes. The proposed G-

code is HCPCS code GFCI1: Post discharge telephonic follow-up contacts performed in

conjunction with a discharge from the emergency department for behavioral health or other

crisis encounter, per calendar month. We seek comment on whether we should consider

finalizing a specified duration that HCPCS code GFCI1 could be billed) following discharge, for

example, allowing this code to be billed for up to two months following discharge or whether a

longer duration would be appropriate, the number of calls per month, the billing structure (for

example, four calls for each discharged patient), and any other relevant feedback.

We are proposing to price this service based on a direct crosswalk to CPT code 99426

(Principal care management; first 30 minutes of clinical staff time directed by a physician or

other qualified healthcare professional), which is assigned a work value of 1.00 work RVUs.

Since CPT code 99426 describes care management for a single condition, we believe the work

151

Miller IW, Camargo CA Jr, Arias SA, Sullivan AF, Allen MH, Goldstein AB, Manton AP, Espinola JA, Jones R,

Hasegawa K, Boudreaux ED; ED-SAFE Investigators. Suicide Prevention in an Emergency Department Population:

The ED-SAFE Study. JAMA Psychiatry. 2017 Jun 1;74(6):563-570. doi: 10.1001/jamapsychiatry.2017.0678.

PMID: 28456130; PMCID: PMC5539839.

152

https://pubmed.ncbi.nlm.nih.gov/29998307/.

153

Stanley B, Brown GK, Brenner LA, Galfalvy HC, Currier GW, Knox KL, Chaudhury SR, Bush AL, Green KL.

Comparison of the Safety Planning Intervention With Follow-up vs Usual Care of Suicidal Patients Treated in the

Emergency Department. JAMA Psychiatry. 2018 Sep 1;75(9):894-900. doi: 10.1001/jamapsychiatry.2018.1776.

PMID: 29998307; PMCID: PMC6142908.

would be similar in nature and intensity. We note that under this proposal, proposed HCPCS

code GFCI1 could be billed regardless of whether proposed HCPCS code GSPI1 was also

furnished and billed for the same patient. We propose that the billing practitioner would need to

meet a threshold of at least one real-time telephone interaction with the patient in order to bill

HCPCS code GFCI1, and that unsuccessful attempts to reach the patient would not qualify as a

real-time telephone interaction. We welcome comments on this proposed threshold to bill

HCPCS code GFCI1, recognizing that while practitioners may attempt to reach the patient, there

may be times when the patient cannot be reached. We are also proposing that the billing

practitioner could not count time or effort more than once for the purposes of billing this code

and another service.

Additionally, as we recognize that behavioral health practitioners, training programs, and

institutions have worked conscientiously to have risk assessment and safety planning for high-

risk patients integrated into their workflows for many years and that discharge instructions and

after visit planning may represent one of many final products from the synthesis of all the steps

involved in these encounters, we note that we do not intend to unnecessarily disaggregate aspects

of streamlined clinical workflows that providers are successfully using to treat high risk patients.

Moreover, we also recognize that practitioners may currently be billing for safety planning

activities using existing coding, such as E/M visits, psychotherapy, and crisis management codes

or potentially for follow-up calls using existing care management services. However, to the

extent that this intervention is part of the standard of care, we believe that Medicare payment

should accurately reflect the additional resource costs involved in furnishing this service.

Lastly, as applicable Part B cost sharing would apply for HCPCS code GFCI1, we are

proposing to require the treating practitioner to obtain verbal (or written) beneficiary consent in

advance of furnishing the services described by GFCI1, which would be documented by the

treating practitioner in the medical record, similar to the conditions of payment associated with

care management and other non-face-to-face services paid under the PFS. We note that under

this proposal, obtaining advance consent would include: (1) ensuring that the patient is aware

that Medicare cost sharing applies to these services; (2) furnishing and receiving the necessary

information to enable the patient to receive these services (for example, obtaining the patient’s

telephone number(s)); and (3) confirming that the patient consents to the contacts.

2. Digital Mental Health Treatment (DMHT)

We are proposing Medicare payment to billing practitioners for digital mental health

treatment (DMHT) devices furnished incident to or integral to professional behavioral health

services used in conjunction with ongoing behavioral health care treatment under a behavioral

health treatment plan of care. We are refining the digital cognitive behavioral therapy “digital

CBT” terminology that we have used previously (88 FR 52262, 52370 through 52371, 88 FR

78818, 79012 and 79013). We are proposing Medicare payment to billing practitioners for digital

mental health treatment (DMHT) devices furnished incident to or integral to professional

behavioral health services used in conjunction with ongoing. In this proposed rule we use the

term “digital mental health treatment (DMHT) device” to include the term “digital CBT” we

used in prior rulemaking and in general to refer to software devices cleared by the Food and

Drug Administration (FDA) that are intended to treat or alleviate a mental health condition, in

conjunction with ongoing behavioral health care treatment under a behavioral health treatment

plan of care, by generating and delivering a mental health treatment intervention that has a

demonstrable positive therapeutic impact on a patient’s health. We note first that the Diagnostic

and Statistical Manual of Mental Disorders-5 (DSM) does not refer to psychiatric disorders but

to mental disorders. In this section, following the DSM, we use the term behavioral health

conditions and mental disorders interchangeably and to mean psychiatric disorders as referenced

in FDA regulation, 21 CFR 882.5801. Second, we note that FDA guidance refers to

computerized behavioral therapy by the acronym CBT. We aim to both provide access to vital

behavioral health services and gather further information about the delivery of digital behavioral

health therapies, their effectiveness, their adoption by practitioners as complements in the care

they furnish, and their use by patients for the treatment of behavioral health conditions. We also

recognize that there are certain statutory limitations on payment for products under the broader

category of “digital health interventions.” We acknowledge that the field of digital therapeutics is

evolving and are open to feedback from the public on this topic, including the CPT Editorial

Panel. Additionally, we recognize that historically, the CPT Editorial Panel has frequently

created CPT codes describing services that we originally established using G codes and adopted

them through the CPT Editorial Panel process. We note that we would consider using any newly

available CPT coding to describe services similar to those described here in future rulemaking.

a. Background

Over the last 5 years the AMA CPT Editorial Panel and CMS have developed coding and

separate payment for monitoring physiologic status using software enabled devices that capture

and record or transmit data that may be reported to and interpreted by practitioners to manage a

patient under a specific treatment plan. (83 FR 59452, 59574) Medicare payment has long been

available for practitioner provision of monitoring equipment and other kinds of devices provided

incident to or integral to the practitioner’s professional services. Most recently we have finalized

payment for devices which record data related to signs, symptoms, and functions of a therapeutic

response (typically for use in association with physical or occupational therapy care) (86 FR

64996, 65114-65116).

However, technologies that rely primarily on software, licensing, and analysis fees, with

minimal costs in equipment and hardware may not have been typical and are not well accounted

for in our practice expense (PE) methodology. PE resources involved in furnishing services are

characterized as either direct or indirect costs. Direct costs of the PE resources involved in

furnishing a service are estimated for each HCPCS code and include clinical labor, medical

supplies, and medical equipment. Indirect costs include administrative labor, office expenses,

and all other expenses. Indirect PE is allocated to each service based on physician work, direct

costs, and a specialty-specific indirect percentage. The source of the specialty specific indirect

percentage is the Physician Practice Information Survey (PPIS), last administered in 2007 and

2008, prior to the adoption of digital therapy technologies (86 FR 65037). Nevertheless, in past

rulemaking, we have recognized that in some cases practitioners do incur resource costs for the

purchase and ongoing use of software (86 FR 65038).

In the CY 2023 PFS final rule, we finalized our proposal to accept the RUC

recommendation to contractor price CPT code 98978 (Remote therapeutic monitoring (e.g.,

therapy adherence, therapy response); device(s) supply with scheduled (e.g., daily) recording(s)

and/or programmed alert(s) transmission to monitor cognitive behavior therapy, each 30 days),

a PE-only device code (86 FR 69523, 69646). At the time, specialty societies indicated that the

technologies for this service are still evolving, and that as a result, there were no invoices for

devices specific to the cognitive behavioral therapy monitoring services described by the code

that could be shared. There was no professional work associated with the code.

In the CY 2024 PFS proposed rule, we requested information on digital therapeutics for

behavioral health. Among many questions, we asked how practitioners determine which patients

might be best served by digital therapeutics and how practitioners monitor the effectiveness of

prescribed interventions on an ongoing basis once the intervention has begun. We also asked

how the treating clinician was involved in the services received. We asked what scientific and

clinical evidence of effectiveness CMS should consider when determining whether digital

therapeutics for behavioral health, including care for substance use disorders, depression, sleep

disorders and other conditions are reasonable and necessary. We asked whether DMHT devices

were used as incident to supplies or independent of a patient visit with a practitioner and if

practitioners in such cases issued an order for such devices (88 FR 52262, 52370 through

52371). These factors related to the nature of this treatment compared to other PFS services pose

challenges for fitting DMHT services into the existing benefit structure under the PFS.

Setting appropriate pricing under the PFS has also presented challenges. As noted

previously, technologies that rely primarily on software, licensing, and analysis fees, with

minimal costs in equipment and hardware are not well accounted for in our practice expense

(PE) methodology, even though these items may be appropriately considered practice expenses.

Consequently, over the past several years, we have relied on a crosswalk methodology to

approximate relative resource costs for these kinds of services relative to other PFS services, or

contractor pricing.

Interested parties requested that we adopt coding specifically for DMHT devices, where

the digital software device is the actual therapy/intervention (the algorithm software is the

DMHT) as opposed to a therapeutic monitoring device that transmits patient data as described by

CPT code 98978 for which we finalized contractor pricing in CY 2023. Interested parties have

also asked us to set national pricing for the service to supply the DMHT device and

education/onboarding that reflects the direct practice expense incurred by practitioners when

furnishing DMHT. One of the interested parties submitted invoices to provide data we could use

as the basis to set payments for DMHT coding. The interested party submitted four invoices

reflecting considerable variation in the cost of the DMHT treatment over 30-day and 90-day

periods. There is still more variation in pricing for comparable products that are available for

considerably lower prices in various markets, with prices ranging from free to $140 per year,

based on an online search (https://www.carepatron.com/app/cbt-therapy-apps, accessed March

20, 2024).

As the field of innovative products including digital therapeutics and computerized

behavioral therapy devices for psychiatric or mental disorders develops and expands, the FDA

and Substance Abuse and Mental Health Services Administration (SAMHSA) among other

agencies such as the Veterans Health Administration (VHA) are also monitoring the

development of the field of digital therapeutic devices, including for behavioral health purposes.

For example, VHA is providing digital behavioral health applications as self-help tools, not

independent treatment interventions. The FDA has a regulatory framework, discussed below in

this section, to classify devices and review computerized behavioral therapy devices for

psychiatric disorders.

b. Payment for Digital Mental Health Treatment (DMHT) Devices

We recognize that digital therapeutics may offer innovative means to access certain

behavioral health care services. The FDA definition of devices encompasses software intended

by the manufacturer to be used, alone or in combination for the specific medical purpose of

diagnosis, prevention monitoring treatment or alleviation of disease and does not achieve its

primary intended action by pharmacological, immunological or metabolic means.

154

SAMHSA

has defined digital therapeutics (DTx) in the behavioral health context as “health software

intended to treat or alleviate a disease, disorder, condition, or injury by generating and delivering

a medical intervention that has a demonstrable positive therapeutic impact on a patient’s

health.”

155

SAMHSA also notes that “DTx may be used independently or in concert with

medications, devices, or other therapies to optimize patient care and health outcomes.” Given

nationwide behavioral health workforce shortages combined with increasing demand for

behavioral health care services, some Medicare beneficiaries may have limited access to these

services.

156

This proposal encompasses only part of what may be a spectrum of broadly similar

products, most of which might require a new statutory Medicare benefit category. Our proposed

coding and payment policy only applies to DMHT devices that have been cleared by the FDA.

Many digital platforms and applications are marketed as behavioral health and wellness

interventions; this proposal does not extend to such platforms and applications in part because

other than some DTx, few have evidence demonstrating improved behavioral health outcomes.

157

154

https://www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imdrf-tech-131209-samd-key-definitions-

140901.pdf.

155

https://store.samhsa.gov/product/advisory-digital-therapeutics-management-and-treatment-behavioral-

health/pep23-06-00-001.

156

https://bhw.hrsa.gov/sites/default/files/bureau-health-workforce/data-research/behavioral-health-2013-2025.pdf.

157

https://store.samhsa.gov/product/advisory-digital-therapeutics-management-and-treatment-behavioral-

health/pep23-06-00-001.

We propose to create three new HCPCS codes for DMHT devices modeled on coding for

RTM services. Effective beginning in CY 2025, we propose that physicians and practitioners

who are authorized to furnish services for the diagnosis and treatment of mental illness would be

able to bill a new HCPCS code: GMBT1 (Supply of digital mental health treatment device and

initial education and onboarding, per course of treatment that augments a behavioral therapy

plan) for furnishing a DMHT device. GMBT1 would be payable only if the DMHT device has

been FDA cleared and the billing practitioner is incurring the cost of furnishing the DMHT

device to the beneficiary. Furnishing of the DMHT device must be incident to the billing

practitioner’s professional services in association with ongoing treatment under a plan of care by

the billing practitioner. The billing practitioner must diagnose the patient and prescribe or order

the DMHT device. The patient could then use the DMHT device at home or perhaps in an office

or other outpatient setting, if that is how the device has been cleared by FDA for use under 21

CFR 882.5801. The DMHT device furnished must have demonstrated a reasonable assurance of

safety and effectiveness. The FDA makes a determination of safety and effectiveness under 21

CFR 860.7. When making this determination, the FDA will consider a variety of factors

including users, conditions of use, probable benefit to health weighed against probable injury,

and reliability. The regulation at 21 CFR 860.7, states that “[t]here is reasonable assurance that a

device is safe when it can be determined, based upon valid scientific evidence, that the probable

benefits to health from use of the device for its intended uses and conditions of use, when

accompanied by adequate directions and warnings against unsafe use, outweigh any probable

risks.” GMBT1 would not be payable in cases where the billing practitioner incurs no cost in

acquiring and furnishing the DMHT device, or a patient procures the DMHT device independent

of the practitioner. We will continue to monitor how DMHT devices are used as part of overall

care.

We seek comment about other parameters that we should consider regarding the services

described by GMBT1:

● Whether payment should be made if the practitioner furnishes a digital device that has

not been cleared by FDA for mental health treatment for a specific use, even if the digital device

has been cleared by the FDA for another specific use;

● Whether payment should be made for DMHT devices cleared by the FDA not only

under 21 CFR 882.5801 but also under other regulations;

● Whether and how payment might be limited if a patient discontinues use of the DMHT

device before completing a course of treatment; and

● Whether and how payment might be limited to a set number of DMHT devices per

calendar month per patient.

In light of the pricing variability, as discussed above, we are proposing contractor pricing

for code GMBT1. We seek comment regarding what national pricing methodology we might

consider, including what potential crosswalks would be appropriate.

We are also proposing to establish payment for two additional new codes. These

proposed codes are GMBT2 (First 20 minutes of monthly treatment management services

directly related to the patient’s therapeutic use of the digital mental health treatment (DMHT)

device that augments a behavioral therapy plan, physician/other qualified health care

professional time reviewing data generated from the DMHT device from patient observations

and patient specific inputs in a calendar month and requiring at least one interactive

communication with the patient/caregiver during the calendar month) and GMBT3 (Each

additional 20 minutes of monthly treatment management services directly related to the patient’s

therapeutic use of the digital mental health treatment (DMHT) device that augments a

behavioral therapy plan, physician/other qualified health care professional time reviewing data

generated from the DMHT device from patient observations and patient specific inputs in a

calendar month and requiring at least one interactive communication with the patient/caregiver

during the calendar month). Under this proposal, GMBT1 requires that the billing practitioner

who diagnosed the patient and prescribed or ordered the DMHT device or that billing

practitioner’s clinical staff must monitor the patient’s therapeutic response to the DMHT device

and adjust the behavioral health therapy plan as needed. GMBT2 and GMBT3 should only be

billed when there is ongoing use of the DMHT device and should not be billed in cases where the

patient discontinues use of the DMHT device.

For GMBT2 (first 20 minutes of monthly treatment management services directly related

to use of the DMHT device), we propose valuing the first 20 minutes of treatment management

services based on a direct crosswalk to CPT code 98980 (remote therapeutic monitoring first 20

minutes), which is assigned a work RVU of .62. For GMBT3 (each additional 20 minutes of

monthly treatment management services directly related to DMHT device), we propose to value

this code based on a crosswalk to CPT code 98981 (remote therapeutic monitoring each

additional 20 minutes), which is assigned a work RVU of .61. We believe that the work and PE

described by these crosswalk codes are analogous to the services described in GMBT2 and

GMBT3, respectively, because they include similar physician/other qualified health care

professional time in a calendar month requiring at least one interactive communication with the

patient/caregiver during the calendar month. We welcome comments on the proposed RVUs.

3. Interprofessional Consultation Billed by Practitioners Authorized by Statute to Treat

Behavioral Health Conditions

a. Background

In the CY 2019 PFS final rule (83 FR 59489), we finalized payment for six CPT codes

regarding interprofessional consultations (99451, 99452, 99446, 99447, 99448, 99449). The six

codes describe assessment and management services conducted through telephone, internet, or

electronic health record consultations furnished when a patient’s treating physician or other

qualified healthcare professional requests the opinion and/or treatment advice of a consulting

physician or qualified healthcare professional with specific specialty expertise to assist with the

diagnosis and/or management of the patient’s condition without the need for the patient’s face-

to-face contact with the consulting physician or qualified healthcare professional. We established

coding and payment for these services to reflect changing healthcare practices, technology, and

the shift to treatment of chronic conditions in the Medicare population. In the CY 2019 PFS final

rule (83 FR 59491), we established a policy to limit billing of these codes to the types of

practitioners who can independently bill Medicare for E/M visits. We did not finalize the

expansion of practitioners beyond those who can furnish E/M visits in the CY 2019 PFS final

rule due to our belief that interprofessional consultations are primarily for the ongoing evaluation

and management of the patient, including collaborative medical decision making among

practitioners (83 FR 59491).

In the CY 2024 PFS proposed rule (88 FR 52369), we sought comment on expanding

access to behavioral health services, including whether we should consider new coding to allow

interprofessional consultation to be billed by practitioners in specialties whose covered services

are limited by statute (Clinical psychologists at section 1861(ii) of the Act, Clinical social

workers at section1861(hh) of the Act, Marriage and Family Therapists and Mental Health

Counselors at sections 1861(lll)(1) and 1861(lll)(3)of the Act, respectively) to services for the

diagnosis and treatment of mental illness (which includes substance use disorders). The CPT

codes describing interprofessional consultation (CPT codes 99451, 99452, 99446, 99447, 99448,

99449) are currently limited to being billed by practitioners who can independently bill Medicare

for E/M visits. As such, they cannot be billed by clinical psychologists, clinical social workers,

marriage and family therapists, or mental health counselors because these practitioners cannot

independently bill Medicare for E/M visits. We are proposing new codes that would allow

clinical psychologists, clinical social workers, marriage and family therapists, and mental health

counselors to bill for interprofessional consultations with other practitioners whose practice is

similarly limited, as well as with physicians and practitioners who can bill Medicare for E/M

services and would use the current CPT codes to bill for interpersonal consultations. These new

codes would facilitate interprofessional consultations between treating/requesting practitioners

and consultant practitioners, whether one or both of the practitioners is in a specialty whose

practice is limited to the diagnosis and treatment of mental illness. When the treating/requesting

practitioner or consultant practitioner is a physician or practitioner authorized to bill Medicare

for E/M services, the practitioner would continue to bill using the current CPT codes that

describe interprofessional consultation, listed previously in this section. Depending on which

practitioner type is billing, and assuming all service requirements of the code descriptors are met,

the consulting practitioner could bill the applicable codes, either HCPCS code (GIPC1-5) or CPT

code (99451, 99452, 99446, 99447), determined by the amount of time spent on the consultation

and whether a written and verbal consultation is provided or only a written consultation is

provided. Similarly, depending on which practitioner type is billing, and assuming all service

requirements of the code descriptors are met, the treating/requesting practitioner could bill either

HCPCS code GIPC6 or CPT code 99449 for the time spent on their referral service.

We believe that proposing payment for these interprofessional consultations performed

via communications technology such as telephone or internet (including videoconference) is

consistent with our ongoing efforts to appropriately recognize and reflect behavioral health care

within the PFS. Currently, there is no payment mechanism to recognize the time and effort of

performing these services by clinical psychologists, clinical social workers, marriage and family

therapists, or mental health counselors. We have also previously received comments from

interested parties that by not making separate payment for these services, CMS would not be

accurately paying for the work of both the treating and consulting practitioner in a consultative

scenario. With the proliferation of team-based approaches to care that are often facilitated by

electronic medical record technology, we believe that making separate payment for

interprofessional consultations undertaken for the benefit of treating a patient will contribute to

payment accuracy under the PFS for behavioral health services.

b. Coding

To further expand access to behavioral health services, we are proposing payment for six

new G codes: GIPC1 (Interprofessional telephone/Internet/electronic health record assessment

and management service provided by a practitioner in a specialty whose covered services are

limited by statute to services for the diagnosis and treatment of mental illness, including a verbal

and written report to the patient’s treating/requesting practitioner; 5-10 minutes of medical

consultative discussion and review), GIPC2 (Interprofessional telephone/Internet/electronic

health record assessment and management service provided by a practitioner in a specialty

whose covered services are limited by statute to services for the diagnosis and treatment of

mental illness, including a verbal and written report to the patient’s treating/requesting

practitioner; 11-20 minutes of medical consultative discussion and review), GIPC3

(Interprofessional telephone/Internet/electronic health record assessment and management

service provided by a practitioner in a specialty whose covered services are limited by statute to

services for the diagnosis and treatment of mental illness, including a verbal and written report

to the patient’s treating/requesting practitioner; 21-30 minutes of medical consultative

discussion and review), GIPC4 (Interprofessional telephone/Internet/electronic health record

assessment and management service provided by a practitioner in a specialty whose covered

services are limited by statute to services for the diagnosis and treatment of mental illness,

including a verbal and written report to the patient’s treating/requesting practitioner; 31 or

more minutes of medical consultative discussion and review), GIPC5 (Interprofessional

telephone/Internet/electronic health record assessment and management service provided by a

practitioner in a specialty whose covered services are limited by statute to services for the

diagnosis and treatment of mental illness, including a written report to the patient’s

treating/requesting practitioner, 5 minutes or more of medical consultative time), and GIPC6

(Interprofessional telephone/Internet/electronic health record referral service(s) provided by a

treating/requesting practitioner in a specialty whose covered services are limited by statute to

services for the diagnosis and treatment of mental illness, 30 minutes). We welcome comments

on this proposal.

Additionally, since these codes describe services that are furnished by the

treating/requesting practitioner and the consultant practitioner without the involvement of the

patient, we are proposing to require the treating practitioner to obtain the patient’s consent in

advance of these services, which would be documented by the treating practitioner in the medical

record, similar to the conditions of payment associated with the CPT interprofessional

consultation codes and certain other non-face-to-face services paid under the PFS. Obtaining

advance patient consent includes ensuring that the patient is aware that Medicare cost sharing

applies to these services, including informing the patient that there may be cost sharing for two

services (one for the treating/requesting practitioner’s service and another for the consultant

practitioner’s service). We welcome comments on this proposal.

c. Valuation

We are proposing to value the six proposed new G codes based on crosswalks to the six

CPT codes for interprofessional consultations for practitioners who can independently bill

Medicare for E/M visits (CPT codes 99451, 99452, 99446, 99447, 99448, 99449). We are

proposing a work RVU of 0.35 for GIPC1 based on a crosswalk to CPT code 99446, a work

RVU of 0.70 for GIPC2 based on a crosswalk to CPT code 99447, a work RVU of 1.05 for

GIPC3 based on a crosswalk to CPT code 99448), a work RVU of 1.40 for GIPC4 based on a

crosswalk to CPT code 99449, a work RVU of 0.70 for GIPC5 based on a crosswalk to CPT

code 99451, and a work RVU of 0.70 for GIPC6 based on a crosswalk to 99452. Since there are

no direct PE inputs assigned to the six CPT codes describing interprofessional consultation

services on which we are basing the proposed valuation for the new HCPCS codes GIPC1

through GIPC6, we are not proposing any direct PE inputs for these codes. We welcome

comments on this proposal.

4. Comment Solicitation on Payment for Services Furnished in Additional Settings, including

Freestanding SUD Treatment Facilities, Crisis Stabilization Units, Urgent Care Centers, and

Certified Community Behavioral Health Clinics (CCBHCs)

In the CY 2024 OPPS final rule (88 FR 81809 through 81858), we finalized payment for

IOP services furnished in hospital outpatient departments (HOPDs), Community Mental Health

Centers (CMHCs), Federally Qualified Health Centers (FQHCs), and Rural Health Clinics

(RHCs), and Opioid Treatment Programs (OTPs). We note that Section 4124 of the

Consolidated Appropriations Act (CAA), 2023, authorized payment for IOP services in HOPDs,

CMHCs, FQHCs, RHCs, and that we additionally used existing statutory authority to propose

and finalize payment for IOP services furnished in OTPs. CMS is monitoring utilization and

uptake of IOP services in these settings. We have heard from other treatment settings that

furnish IOP services that do not fall into the categories of HOPDs, CMHCs, FQHCs, RHCs, or

OTPs, such as freestanding SUD facilities, that have an interest in billing Medicare for these

services. In light of this, we are seeking comment on whether IOP services are furnished in other

settings in order to determine whether potential coding and payment for IOP services under the

PFS would facilitate these services being billed in additional settings.

In particular, we are interested in feedback on the following questions, as well as any

other relevant feedback:

● To what extent do freestanding SUD facilities or other entities that furnish IOP

services employ practitioner types who can supervise auxiliary personnel and bill Medicare for

their services? For example, do they typically employ physicians, clinical psychologists, nurse

practitioners, clinical nurse specialists, certified nurse midwives and physician assistants who are

eligible to provide general supervision to auxiliary personnel who furnish behavioral health

services?

● Would bundled payments under the PFS similar to those finalized in the CY 2024

OPPS final rule (88 FR 81809-81858) better facilitate billing for IOP services in a broader range

of settings?

● If CMS outlined how freestanding SUD facilities could bill Medicare under the PFS,

would there be an impact in underserved areas?

● To what extent do freestanding SUD facilities see patients with Medicare or who are

dually eligible for Medicare and Medicaid?

Additionally, we are seeking comment on entities that offer community-based crisis

stabilization, including 24/7 receiving and short-term stabilization centers, that provide

immediate access to voluntary and/or involuntary care, without the need for a referral. Regarding

such crisis stabilization units, we are interested in feedback on the following questions, as well as

any other relevant feedback:

++ What kind of services do crisis stabilization units provide? Do crisis stabilization

units provide services similar to those described by the psychotherapy for crisis codes (CPT

codes 90839 and 90840)?

++ Does the definition of crisis stabilization unit vary by State? If so, what are the

variations and similarities across States?

++ If CMS outlined how crisis stabilization units could bill Medicare under the PFS,

would there be an impact in underserved areas?

++ To what extent do crisis stabilization units see patients with Medicare or who are

dually eligible for Medicare and Medicaid?

++ To what extent do crisis stabilization units employ practitioner types who can

supervise auxiliary personnel and bill Medicare for their services. For example, do crisis

stabilization units typically employ physicians, clinical psychologists, nurse practitioners,

clinical nurse specialists, certified nurse midwives and physician assistants who are eligible to

provide general to auxiliary personnel who furnish behavioral health services?

Additionally, as a separate example, we've received information from interested parties

that there is a similar concern regarding urgent care centers more broadly. These interested

parties note that hospital emergency departments are often used by beneficiaries to address non-

emergent urgent care needs that could be appropriately served in less acute settings, but where

other settings, such as physician offices, urgent care centers or other clinics, are not available or

readily accessible. Patients enter EDs to treat common conditions like allergic reactions,

lacerations, sprains and fractures, common respiratory illnesses (for example, flu or RSV), and

bacterial infections (for example, strep throat, urinary tract infections or foodborne illness).

Conditions like these often can be treated in less acute settings. We are interested in system

capacity and workforce issues broadly and are interested in hearing more on those issues,

including how entities such as urgent care centers can play a role in addressing some of the

capacity issues in emergency departments. In particular, we are interested in feedback on the

following questions, as well as any other relevant feedback:

● What types of services would alternative settings to EDs need to offer to meet

beneficiaries’ non-emergent, urgent care needs?

● Does the current “Urgent Care Facility” Place of Service code (POS 20) adequately

identify and define the scope of services furnished in such settings? Is this place of service code

sufficiently distinct from others such as “Walk-in Retail Health Clinic (POS 17) and “Office”

(POS 11)? If not, how might these Place of Service code definitions be modified?

● Does the existing code set accurately describe and value services personally performed

by professionals and costs incurred by the facility in these settings?

● How might potential strategies to reduce overcrowding and wait times in EDs advance

equity in access to health care services?

Lastly, we are seeking comment regarding Certified Community Behavioral Health

Clinics (CCBHCs). Specifically, we are interested in feedback on the following questions:

++ What kind of services do CCBHCs provide? Do they provide IOP services, services

for the treatment of substance use disorders, psychotherapy, behavioral health integration,

community health integration, or principal illness navigation services to patients with either

Medicare or another payer?

++ If CMS outlined how CCBHCs could bill Medicare under the PFS, would there be an

impact in underserved areas?

++ To what extent do CCBHCs see patients with Medicare or who are dually eligible for

Medicare and Medicaid?

++ To what extent do CCBHCs employ practitioner types who can supervise auxiliary

personnel and bill Medicare for their services? For example, do CCBHCs employ physicians,

clinical psychologists, nurse practitioners, clinical nurse specialists, certified nurse midwives and

physician assistants who are eligible to provide general supervision to auxiliary personnel who

furnish behavioral health services?

J. Proposals on Medicare Parts A and B Payment for Dental Services Inextricably Linked to

Specific Covered Services

1. Medicare Payment for Dental Services

a. Overview

Section 1862(a)(12) of the Act generally precludes payment under Medicare Parts A or B

for any expenses incurred for services in connection with the care, treatment, filling, removal, or

replacement of teeth or structures directly supporting teeth. (Collectively here, we will refer to

“the care, treatment, filling, removal, or replacement of teeth or structures directly supporting

teeth” as “dental services.”) That section of the statute also includes an exception to allow

payment to be made for inpatient hospital services in connection with the provision of such

dental services if the individual, because of their underlying medical condition and clinical status

or because of the severity of the dental procedure, requires hospitalization in connection with the

provision of such services. Our regulation at § 411.15(i) similarly excludes payment for dental

services except for inpatient hospital services in connection with dental services when

hospitalization is required because of: (1) the individual’s underlying medical condition and

clinical status; or (2) the severity of the dental procedure.

Fee for service (FFS) Medicare Parts A and B also make payment for certain dental

services in circumstances where the services are not considered to be in connection with dental

services within the meaning of section 1862(a)(12) of the Act. In the CY 2023 PFS final rule (87

FR 69663 through 69688), we clarified and codified at § 411.15(i)(3) that Medicare payment

under Parts A and B could be made when dental services are furnished in either the inpatient or

outpatient setting when the dental services are inextricably linked to, and substantially related

and integral to the clinical success of, other covered services. We also added several examples

of clinical scenarios that are considered to meet that standard under § 411.15(i)(3) and amended

that regulation to add more examples in the CY 2024 PFS final rule (88 FR 79022 through

79029).

In the CY 2023 PFS final rule, we also established a process whereby we accept and

consider submissions from the public (the “public submission process”) to assist us to identify

additional dental services that are inextricably linked to, and substantially related and integral to

the clinical success of, other covered services (87 FR 69663 through 69688). Hereafter in this

section we will refer to these services as dental services that are “inextricably linked to other

covered services.”

We also note that the examples provided in our regulation at § 411.15(i)(3)(i) are not

exclusive. Medicare administrative contractors (MACs) retain discretion to determine on a

claim-by-claim basis whether a patient’s circumstances do or do not fit within the terms of the

preclusion or exceptions specified in section 1862(a)(12) of the Act and § 411.15(i).

In the CY 2024 PFS final rule, we discussed our plans to issue educational and outreach

materials to inform billing and payment for finalized policies for dental services. We reiterated

our commitment to review submissions we receive through the public submissions process. We

also expressed our intention to continue to engage in discussions with the public on a wide

spectrum of issues relating to Medicare payment for dental services that may be inextricably

linked to other covered services. We also described our partnership with the Agency for

Healthcare Research and Quality (AHRQ) to assist us to review available clinical evidence and

consider the relationship between dental services and specific covered medical services and to

identify other potential clinical circumstances in which dental services are inextricably linked to

other covered services (88 FR 79029).

In this proposed rule, we (1) describe recent literature review conducted by our partner

agency, AHRQ, on the potential connection between sickle cell disease and hemophilia and

dental services; (2) summarize submissions we received through the public submission process

for consideration in CY 2025 rulemaking; (3) propose to codify in section § 411.15(i)(3)(i)(A)

additional policies to permit payment for certain dental services that are inextricably linked to

other covered services (certain dental services for patients receiving dialysis services to treat

end-stage renal disease (ESRD)); (4) request public comment and information related to other

clinical scenarios that may involve dental services that are inextricably linked to other covered

services; and (5) include proposals related to Medicare billing and payment policy for dental

services. We also include a request for information regarding oral sleep apnea appliances.

b. Consideration of Dental Services that may be Inextricably Linked to Other Covered Services

We have partnered with AHRQ to help us consider the relationship between dental

services and other specific covered services. Specifically, AHRQ reviews available clinical

evidence regarding this relationship, and provides analysis of clinical scenarios where dental

services may be inextricably linked to other covered services. To better address the public's

immediate dental needs, AHRQ conducted rapid response reports instead of comprehensive

assessments. With these rapid response reports, we can better specify which payments can be

made under Medicare Parts A and B for certain dental services that are inextricably linked to

other covered services.

Through the public submissions process for consideration in CY 2024 rulemaking,

interested parties nominated dental services for individuals living with sickle cell disease (SCD)

or hemophilia, urging us to consider adding payment for these services (88 FR 52374). The

submissions included information and references supporting the inclusion of dental services that

are inextricably linked to, and substantially related and integral to the clinical success of, the

covered services used in the treatment of SCD or hemophilia, because such dental services serve

to mitigate the substantial risk to the success of the medical services. Submissions supported the

importance of preventing dental infections among individuals with SCD to reduce the need for

the extensive procedures that may lead to bleeding complications and hospitalization. They also

provided information detailing increased dental caries and periodontal disease in people with

SCD,

158

many of whom lose a number of teeth, which greatly limits nutrition, general well-

being, and overall quality of life. Interested parties recommended that we adopt a policy to allow

payment for dental services for individuals with hemophilia (88 FR 79032). They emphasized

that periodic dental care reduces the risks of dental complications that may require hemostatic

therapy or oral surgeries requiring clotting factor replacement treatment.

159,160,161

Many

submitters suggested that maintaining good oral health leads to improved outcomes for patients

with these two conditions.

Acknowledging the importance of dental health to overall well-being of patients with

these two types of diseases, in the CY 2024 proposed rule, we summarized information provided

by submitters utilizing the public submission process and solicited comment on whether certain

dental services are inextricably linked to covered services in the treatment of SCD (88 FR

52374). In the CY 2024 PFS final rule, we noted that several commenters suggested expanding

dental service coverage for individuals with SCD. They supported covering dental services

essential for treating SCD, including hydroxyurea therapy. Another commenter advocated for

158

Kakkar M, Holderle K, ShethM, Arany S, Schiff L, Planerova A. Orofacial Manifestation and Dental Management

of Sickle Cell Disease: A Scoping Review. Anemia. 2021 Oct22; 2021:5556708. Doi: 10.1155/2021/5556708. PMID:

34721900; PMCID: PMC8556080.

159

Raso S, Napolitano M, Sirocchi D, Siragusa S, Hermans C. The important impact of dental care on haemostatic

treatment burden in patients with mild haemophilia. Haemophilia. 2022 Nov;28(6):996–999.

doi:10.1111/hae.14626. Epub 2022 Jul 25. PMID: 35879819.

160

Srivastava A, Santagostino E, Dougall A, Kitchen S, Sutherland M, Pipe SW, Carcao M, Mahlangu J, Ragni MV,

Windyga J, Llina´s A, Goddard NJ, Mohan R, Poonnoose PM, Feldman BM, Lewis SZ, van den Berg HM, Pierce GF;

WFH Guidelines for the Management of Hemophilia panelists and co-authors. WFH Guidelines for the

Management of Hemophilia, 3rd edition. Haemophilia. 2020 Aug;26 Suppl 6:1–158. doi: 10.1111/hae.14046. Epub

2020 Aug 3. Erratum in: Haemophilia. 2021 Jul;27(4):699. PMID: 32744769.

161

Peisker A, Raschke GF, Schultze-Mosgau S. Management of dental extraction in patients with Haemophilia A

and B: a report of 58 extractions. Med Oral Patol Oral Cir Bucal. 2014 Jan 1;19(1):e55–60. doi:

10.4317/medoral.19191. PMID:24121912; PMCID: PMC3909433.

expanding coverage for dental services in cases of pain crises or dental abscesses in individuals

with SCD. They emphasized that improved access to dental care could improve the quality of

life for individuals with SCD and reduce healthcare costs by enabling more suitable treatment

options and decreasing hospital stays. One commenter questioned the clinical basis for

providing dental benefits for SCD or hemophilia due to their low prevalence in the Medicare

population. Ultimately, after consideration of public comments, we did not expand the examples

under § 411.15(i)(3)(i) to include additional covered medical services for SCD. We concluded

that the information provided by commenters did not sufficiently demonstrate that dental

services are essential to the clinical success of hydroxyurea therapy or other treatments for SCD

(88 FR 79032). Please refer to CY 2024 final rule (88 FR 79031 through 79032) for more

detailed information.

In the CY 2024 PFS proposed rule, we similarly solicited comments on hemophilia

regarding whether certain dental services are considered so integral to the primary covered

services that the necessary dental interventions are inextricably linked to, and substantially

related and integral to clinical success of, the primary covered services for individuals with

hemophilia (88 FR 52382). Several commenters advocated for allowing Medicare Part A and

Part B payment for dental services for individuals with hemophilia citing guidelines from

Hemophilia Treatment Centers (HTCs), the Centers for Disease Control and Prevention (CDC),

and the World Federation of Hemophilia (WFH). They emphasized the importance of good oral

health to prevent complications like gum bleeding and major dental surgeries, especially in those

with severe/moderate hemophilia. Another commenter supported this perspective, noting that

regular dental care reduces the need for clotting factor replacement therapy. While we

acknowledged the importance of maintaining oral health to prevent complications such as serious

gum bleeding, especially problematic for those with hemophilia, we also reiterated that for the

purposes of the PFS payment policy for dental services inextricably linked to covered medical

services, our statute and regulations require that specific evidence supports the integral

connection between dental services and clinical success in managing hemophilia-related medical

services, and, therefore, we did not expand the examples under § 411.15(i)(3)(i) to include

additional covered medical services for hemophilia. Please refer to CY 2024 final rule (88 FR

79032 through 79033) for more detailed information.

While interested parties have suggested the interaction of oral health care for SCD or

hemophilia, we noted that further research is necessary to find specific evidence supporting

specific medical services for which dental services are inextricably linked to their clinical

success. To gain further understanding of any potential relationship between dental services and

specific covered SCD or hemophilia medical services, we again partnered with researchers at the

Agency for Healthcare Research and Quality (AHRQ) to review available clinical evidence

regarding the relationship between dental services and covered SCD or hemophilia medical

services. AHRQ created two rapid response reports, which summarized recent evidence, aiming

to inform CMS policy development related to the possible linkage between dental services and

treatment modalities and services for SCD or hemophilia patients. For more detailed information

about the search strategies and findings, please refer to the two AHRQ rapid response reports

available at https://effectivehealthcare.ahrq.gov/products/sickle-cell-dental/research and

https://effectivehealthcare.ahrq.hgov/products/hemophilia-dental/research.

1. Consideration of Dental Services that may be Inextricably Linked to Covered Services for the

Treatment of Sickle Cell Disease

As stated in the AHRQ rapid response report, SCD is a genetic hematologic disorder

affecting approximately 100,000 individuals in the U.S.,

162

characterized by abnormal

hemoglobin formation in red blood cells, leading to complications such as pain, infection, acute

chest syndrome, and stroke. Hydroxyurea, a commonly used therapeutic measure,

163

which

162

Prevention CDC. Learn more about sickle cell disease, Centers for Disease Control and Prevention. (Available at

https://www.cdc.gov/ncbddd/sicklecell/index.html).

163

U.S. Food and Drug Administration. FDA approves hydroxyurea for treatment of pediatric patients with sickle

cell anemia, U.S. Food and Drug Administration. (Available at https://www.fda.gov/drugs/resources-information-

approved-drugs/fda-approves-hydroxyurea-treatment-pediatric-patients-sickle-cell-anemia).

increases fetal hemoglobin levels, which has a higher affinity for oxygen than adult hemoglobin.

This therapy can prevent sickling or curvature of red blood cells and help SCD patients. SCD

patients can experience dental complications due to ischemia,

164

including delayed tooth

eruption, enamel disorders, and tongue cell changes. Ischemic and inflammation affects enamel,

gums, and jawbones that can cause paresthesia and tooth pain. In response to a producing more

red blood cells to make up for anemia, bone marrow expansion can lead to malocclusion and

reduced bone density.

165,166

The AHRQ’s rapid response report highlights that despite

hydroxyurea's long-term use to treat SCD, uncertainty remains regarding whether dental care

before, during, or after treatment of SCD with hydroxyurea (and other lesser prescribed

treatments) influences clinical outcomes in patients.

In their rapid response, the Preferred Reporting Items for Systematic Reviews and Meta-

Analyses (PRISMA) flow diagram, a flow diagram used in systematic reviews and meta-

analyses intended to describe findings of the review, revealed that initially, 762 records were

identified from large databases, and 934 records were identified from grey literature sources

covering 57 years. Following the exclusion of ineligible studies, a total of five unique records

were included, extracted, and evaluated in the rapid response report. The rapid response report

found that no studies examined the specific impact of dental care on SCD treatment outcomes;

however, the rapid response identified three relevant clinical practice guidelines and two reviews

with recommendations for dental care for patients with SCD. According to the rapid response,

all guidelines and reviews highlighted the importance of preventive dental measures, with the

Sickle Cell Society in the UK recommending the inclusion of a hematologist in the dental care

team for SCD patients. However, these guidelines primarily focused on managing SCD during

dental services rather than the impact of dental care on the improvement of SCD treatment

164

da Fonseca M, Oueis HS, Casamassimo PS. Sickle cell anemia: a review for the pediatric dentist. Pediatr Dent

2007;29(2):159-69. (In eng).

165

Hsu LL, Fan-Hsu J. Evidence-based dental management in the new era of sickle cell disease: A scoping review. J

Am Dent Assoc 2020;151(9):668-677.e9. (In eng). DOI: 10.1016/j.adaj.2020.05.023.

166

Kane SF. The effects of oral health on systemic health. Gen Dent 2017;65(6):30-34. (In eng).

outcomes, which differs from the regulatory standard in § 411.15(i)(3)(i) that the dental services

are inextricably linked to, and substantially related and integral to the clinical success of, other

covered services.

The two rapid reviews with recommendations highlighted several key areas of dental

management for SCD patients. They emphasized the importance of preventive dental care to

reduce the risk of oral infections, periodontal diseases, and major dental procedures.

Additionally, the studies recommended that a complete blood count should be evaluated prior to

invasive dental procedures to mitigate infection risks in SCD patients.

167,168

Overall, the findings

from the AHRQ rapid response reports underscore the gaps in the current literature concerning

the management of oral health care for individuals with SCD. The body of evidence evaluating

dental services before, during, or after the treatment of SCD is lacking in primary clinical data

and is limited to available clinical practice guidelines and reviews with recommendations. While

guidelines and reviews have addressed particular aspects of dental care, such as early

intervention and the importance of collaboration between dentists and hematologists, there is an

absence of primary evidence that informed the potential effect of dental care on SCD treatment

outcomes.

2. Consideration of Dental Services that may be Inextricably Linked to Covered Services for the

Treatment of Hemophilia

As stated in their report, hemophilia is a rare inherited disorder characterized by the

deficiency or absence of blood-clotting proteins, affecting approximately 20,000-33,000 males in

the U.S.

169

There are three distinct types of hemophilia (A, B, and C) according to the specific

clotting factor that is deficient or missing (VIII, IX, and XI, respectively). Treatment for all

167

Kawar N, Alrayyes S, Yang B, Aljewari H. Oral health management considerations for patients with sickle cell

disease. Dis Mon 2018;64(6):296-301. (In eng). DOI: 10.1016/j.disamonth.2017.12.005.

168

Kakkar M, Holderle K, Sheth M, Arany S, Schiff L, Planerova A. Orofacial Manifestation and Dental

Management of Sickle Cell Disease: A Scoping Review. Anemia 2021;2021:5556708. (In eng). DOI:

10.1155/021/5556708.

169

Prevention CfDCa. Hemophilia Treatment. (https://www.cdc.gov

/ncbddd/hemophilia/treatment.html#:~:text=The%

20best%20way%20to%20treat,concentrates%2C%20into%20a%20person's%20vein.).

three types of hemophilia is similar but may vary based on the severity of disease, and typically

involves replacing the deficient or missing clotting factor.

170

Anticoagulation issues in

hemophilia patients can pose challenges for dental specialists due to the increased risk of

secondary bleeding after oral surgery.

171

Severe hemophilia patients face spontaneous bleeding

in joints, muscles, or soft tissues, sometimes life-threatening, while mild to moderate cases may

experience excessive bleeding, including after dental extractions.

172

According to the rapid response reports provided by AHRQ, clotting factor replacement

therapy is the standard treatment for individuals with hemophilia. Replacement therapy, which

can be self-administered or given at a hemophilia treatment center, can be used to stop a

spontaneous bleeding episode (episodic care), or to prevent bleeding from occurring

(prophylactic care). However, consistent/prolonged factor replacement can cause antibody

inhibitor development.

173

While clotting factor replacement therapy remains the standard

treatment for hemophilia, uncertainty persists regarding whether dental care before, during, or

after treatment of hemophilia improves clinical outcomes in patients. Excessive bleeding, often

associated with invasive or traumatic dental procedures, poses challenges when treating patients

with hemophilia. Hence, the timing of dental treatment in relation to factor replacement therapy

may influence outcomes.

In AHRQ's rapid response, a total of 1,414 records from large databases and 2,238

records from grey literature, spanning 73 years, were identified. Strictly following the exclusion

criteria depicted in the PRISMA diagram, the response included, extracted, and evaluated a total

of four unique publications in this rapid response. The rapid response report identified four

170

Ibid.

171

Givol N, Hirschhorn A, Lubetsky A, Bashari D, Kenet G. Oral surgery-associated postoperative bleeding in

haemophilia patients - a tertiary centre's two decade experience. Haemophilia 2015;21(2):234-240. (In eng). DOI:

10.1111/hae.12573.

172

Oomen I, Camelo RM, Rezende SM, et al. Determinants of successful immune tolerance induction in hemophilia

A: systematic review and meta-analysis. Res Pract Thromb Haemost 2023;7(1):100020. (In eng). DOI:

10.1016/j.rpth.2022.100020.

173

Castaman G, Matino D. Hemophilia A and B: molecular and clinical similarities and differences. Haematologica

2019;104(9):1702-1709. (In eng). DOI: 10.3324/haematol.2019.221093.

publications: two practice guidelines and two reviews with recommendations. The included

publications advised hemophilia patients to consult hematologists or hemophilia treatment

centers before dental procedures. They emphasized interdisciplinary collaboration between

dentists and hematologists for treatment planning. Included guidelines recommended

performing dental services during hemophilia treatment with coagulation factor replacement

therapy. However, all four reviewed publications mainly addressed hemophilia A and B, with

little mention of hemophilia C. Similar to the findings related to SCD, the body of evidence

evaluating dental services before, during, or after the treatment of hemophilia is lacking in

primary clinical data and is currently limited to available guidelines. These guidelines

emphasize the importance of professional dental care during hemophilia treatment with clotting

factor replacement therapy to reduce bleeding complications, rather than the inextricable link

between certain dental services and covered services for hemophilia, which is the regulatory

standard in § 411.15(i)(3)(i) for clinical scenarios under which payment can be made for dental

services under Medicare Parts A and B.

After reviewing AHRQ’s comprehensive rapid reviews for both SCD and hemophilia, we

found the evidence related to the linkage between dental services and outcomes for covered

medical services for both SCD and hemophilia lacking in the current research and literature.

Both rapid responses noted a limited number of studies examining the impact of dental care on

outcomes for individuals with SCD or hemophilia. Currently, the evidence base does not appear

to support that dental services may be inextricably linked to covered services for SCD or

hemophilia. Also, the body of evidence evaluating dental services before, during, or after the

treatment of SCD and hemophilia lacks primary clinical data and relies on available guidelines

and reviews. Given limited information, however, both the SCD and hemophilia rapid responses

support the need for preventive care and patient education as essential practices for both SCD

and hemophilia patients to minimize the likelihood of oral infections, periodontal disease, and

major dental procedures. In addition, both rapid response reports recommend collaborative

efforts between dentists, hematologists, and specialized clinics as crucial for improved patient

care, despite the lack of primary evidence informing the potential effect of dental care on

treatment. While both rapid response reports discuss their findings on the importance of a

multidisciplinary approach, both rapid response reports also found that the current reviews and

guidelines do not address dental care as a standard of care that is inextricably linked to

hemophilia or SCD treatment. Instead, their focus was on managing the respective conditions

during dental services, not on the inextricable linkage between the dental and medical services.

In conclusion, interested parties, including industry organizations, public commenters,

and organizations submitting through the public submissions process, requested that CMS

consider the conditions of SCD and hemophilia for the purposes of the Medicare Parts A and B

payment policy for dental services that are inextricably linked to other covered services. As part

of our commitment to exploring the inextricable link between dental and covered services

associated with SCD and hemophilia, we partnered with AHRQ to generate comprehensive rapid

responses on these topics. However, the AHRQ’s rapid response reports show that the current

evidence base does not appear to support that dental services may be inextricably linked to

services for SCD or hemophilia within the meaning of the standard at § 411.15(i)(3), and we are

not proposing to add these conditions to our regulation. Moreover, the findings of the AHRQ

rapid response reports highlight that this area merits further study by researchers and industry in

order to further explore potential connections between dental services and improved outcomes

for individuals with SCD or hemophilia. Given the new and evolving therapies and treatments in

this space, we will consider conducting additional evaluations as new studies are carried out to

examining the impact of dental services on SCD and hemophilia outcomes and will take any

future studies into consideration.

We continue to seek clinical evidence demonstrating the integral connection between

dental services and other covered services for SCD and hemophilia, and we welcome any

comments or literature regarding these two conditions. We are not proposing to amend §

411.15(i)(3)(i) as we have not identified additional dental services that are inextricably linked to

certain services associated with SCD or hemophilia. However, we remain open to considering

any such services identified by public commenters, and, if sufficient evidence is presented, we

may consider adding such services to our regulations in the final rule. In addition, we encourage

interested parties to supply additional submissions for consideration in future PFS rulemaking

through the public submission process, which may include relevant medical evidence, peer-

reviewed literature, clinical guidelines, or supporting documentation as described in section

II.J.1.c. of this proposed rule.

c. Submissions Received Through Public Submission Process

As we have in the CY 2023 and CY 2024 PFS final rules, we continue to encourage

interested parties to engage with us regularly and to submit recommendations through our public

submissions process for our consideration of additional clinical scenarios where dental services

may be inextricably linked to covered services under § 411.15(i)(3)(i). Through our annual

public submissions process, interested parties should provide clinical evidence and other

documentation to support their recommendations (87 FR 69685). We are using the PFS annual

rulemaking process to discuss public submissions and to consider whether the clinical scenario

described in the submissions should be added to § 411.15(i)(3)(i) as an example of a

circumstance where payment can be made for dental services inextricably linked to other

covered services. Using our annual notice and comment rulemaking process to discuss

submitted recommendations allows the public to comment and submit further medical evidence

and important feedback to assist us in evaluating whether certain dental services furnished in

certain clinical scenarios would meet the standard to permit Medicare payment for the dental

services.

We review clinical evidence included in submissions and public comments in

rulemaking, as well as information and analysis provided by AHRQ in rapid response reports, to

assess whether there is an inextricable link between certain dental services and certain covered

services. We would find that there is an inextricable link where the standard of care for a service

is such that the practitioner would not proceed with the procedure or service without performing

the dental service(s), for example, because the covered services would or could be significantly

and materially compromised absent the provision of the inextricably-linked dental services, or

where dental services are a clinical prerequisite to proceeding with the primary medical

procedure and/or treatment. As such, documentation accompanying recommendations should

include medical evidence to support that certain dental services are inextricably linked to certain

covered services. Specifically, as we specified in the CY 2023 PFS final rule, we request that the

medical evidence included in submissions through the public submissions process should:

(1) Provide support that the provision of certain dental services leads to improved

healing, improved quality of surgery outcomes, and the reduced likelihood of readmission and/or

surgical revisions because an infection has interfered with the integration of the medical implant

and/or interfered with the medical implant to the skeletal structure;

(2) Be clinically meaningful and demonstrate that the dental services result in a material

difference in terms of the clinical outcomes and success of the procedure such that the dental

services are inextricably linked to other covered services; and,

(3) Be compelling to support that certain dental services would result in clinically

significant improvements in quality and safety outcomes (for example, fewer revisions, fewer

readmissions, more rapid healing, quicker discharge, and quicker rehabilitation for the patient)

(87 FR 69686).

This evidence should include at least one of the following:

(1) Relevant peer-reviewed medical literature and research/studies regarding the medical

scenarios requiring medically necessary dental care;

(2) Evidence of clinical guidelines or generally accepted standards of care for the

suggested clinical scenario;

(3) Other ancillary services that may be integral to the covered services; and/or

(4) Other supporting documentation to justify the inclusion of the proposed medical

clinical scenario requiring dental services (87 FR 69686).

Submissions should focus on the inextricably linked relationship between dental services

and other services necessary to diagnose and treat the individual’s underlying medical condition

and clinical status, and whether it would not be clinically advisable to move forward with the

other covered services without performing certain dental services. To be considered for purposes

of CY 2026 PFS rulemaking, submissions through our public submissions process should be

received by February 10, 2025, via email at [email protected]. To

facilitate processing, interested parties should include the words “dental recommendations for

CY 2026 review” in the subject line of their email submission. We continue to stress to

submitters that recommendations must include at least one of the types of evidence listed earlier.

We further note that we may also consider recommendations that are submitted as public

comments during the comment period following the annual publication of the PFS proposed rule.

We thank all those who submitted recommendations for additional clinical scenarios for

which they believe Medicare payment for dental services will be consistent with the policies we

codified at § 411.15(i)(3)(i), under which Medicare payment may be made for dental services

when they are inextricably linked to other covered services. We received thirteen submissions

from various organizations and individuals on or before February 10, 2024. Several submitters

represented dozens or hundreds of other organizations in making these recommendations. We

received one submission after the deadline that presented nominations for clinical scenarios

addressed by other submitters, and a proposal outside the scope of clinical scenarios where

dental services may be inextricably linked to covered medical services under § 411.15(i)(3)(i).

One submitter recommended that oral health care is essential to the success of treatments

for individuals with sickle cell disease and other hematologic disorders. The submitter asserted

that providing appropriate and timely dental care is a crucial component for the successful

treatment of many hematologic diseases, including SCD, hemophilia, and many blood cancers,

such as acute myeloid leukemia, acute lymphoblastic leukemia, chronic lymphocytic leukemia,

chronic myeloid leukemia, and multiple myeloma. The submitter noted that we finalized that

payment can be made for certain dental services prior to or contemporaneously with

chemotherapy, CAR T-Cell therapy, and the administration of high-dose bone-modifying agents

(anti-resorptive therapy), when used in the treatment of cancer. The evidence submitted showed

that among individuals with a sickle cell crisis, those with dental infections were 72% more

likely to be admitted to the hospital than those without dental infections. The same submitter also

requested that we consider payment of dental services following organ transplantations

(including bone marrow or hematopoietic stem cell transplantation (HSTC)) because

maintenance of oral hygiene after HSCT minimizes the severity of oral and dental infections,

which is important because chronic graft versus host disease (cGVHD) is common following

allogeneic HSCT. The submitter stated that frequent dental evaluations of patients with cGVHD

are critical because of the increased rate of dental caries associated with this disease;

furthermore, gingivitis and periodontal disease should be monitored and managed appropriately

to avoid additional infection. Finally, the submitter also stated that multiple tooth extractions

without replacement of dentition leave patients with a poor capacity to eat and may negatively

impact the success of the transplant and quality of life. This submitter also recommended

including cell and gene therapy for SCD as a clinical treatment scenario for future consideration

of potentially inextricably linked dental services.

Another submitter asserted that patients frequently present with complications extending

three years or more following the direct treatment of not only head and neck cancers but also

other cancer types. The submitter also asserted that a comparable trend may be seen in patients

experiencing complications following anti-resorptive drug therapy, for non-cancer-related

conditions. They recommended that payment be available for specific dental services during a

minimum of 2 years post-treatment for head and neck cancer and up to 5 years for those who

have received radiotherapy. They emphasized the current evidence and literature as supporting

the provision of Medicare payment for a minimum of 2 years, with the understanding that some

patients may require dental or oral healthcare beyond this period due to delayed or late-onset

complications, and that the timeline for the emergence of oral or dental complications post-

treatment is not uniformly linear and can significantly vary among patients. They also stated that

literature supports the extension of Medicare payment to include certain dental services furnished

post-anti-resorptive therapy, when used in the treatment of cancer for at least two years

following treatment. Lastly, this submitter stated there is an inextricable risk of the development

of severe dental and oral complications, such as osteoradionecrosis/ medication-related

osteonecrosis of the jaw, in patients who have undergone the specific treatments for which we

have identified certain inextricably linked dental services. They suggested that once patients

receive these treatments, patients are perpetually at risk for developing such complications and

recommended that current Medicare payment for dental services should align with the long-term

healthcare needs of these patients.

We are not accepting the commenters’ suggestion to include specific time limits within

the exception in § 411.15(i)(3). We note again that MACs have the flexibility to determine on a

claim-by-claim basis whether payment can be made for certain dental services for beneficiaries,

such as those receiving other immunotherapies that may involve a lymphodepleting component,

consistent with § 411.15(i)(3). That regulation states the general rule that Medicare Parts A and

B payment can be made for certain dental services that are inextricably linked to, and

substantially related and integral to the clinical success of, covered services; and then provides a

non-exclusive list of examples of clinical scenarios under which payment can be made. Thus, a

MAC has discretion to decide on a case-by-case basis that payment can be made for certain

dental services in other circumstances not specifically addressed under § 411.15(i)(3)(i)

Several submitters recommended that we provide for payment of medically necessary

dental services for individuals with autoimmune diseases who are initiating or undergoing

immunosuppressive or immunomodulator therapy (“immunosuppressive therapy”). They stated

that immunosuppressive therapy can be severely complicated and compromised by oral/dental

disease and conditions. The submitters provided references to numerous clinical studies and

other supporting documentation in support of dental services in these clinical circumstances

being inextricably linked to immunosuppressive therapies for which payment may be made in

accordance with § 411.15(i)(3). They noted that while higher dosing is used for cancer

chemotherapy and organ transplant rejection prevention, the therapy’s duration is generally much

shorter than when used in autoimmune disease therapy and that the longer-term duration of use

for managing symptoms of autoimmune disease can expose patients to ongoing serious risk of

complicating infections for decades. They relayed that the American College of Rheumatology

states it is vital for patients to receive appropriate dental evaluation and prompt treatment so they

can continue their immune suppressant medications. The submitter explained that dental

infections could spread more easily, and therefore faster, when host immunity is compromised

by immunosuppressing/immunomodulating drugs via three pathways for the bacteria to spread:

locally through facial spaces, through the bloodstream, and by aspiration. They stated that

outcomes similar to systemic infection or sepsis and other complications can follow for those

receiving immunosuppressive therapy to treat autoimmune diseases. They recommended

immunosuppressive therapy to treat autoimmune diseases should not proceed until a dental or oral

exam is performed to address the oral complications and/or clear the patient of an oral or dental

infection. We discuss these recommendations and supporting evidence in section II.J.4. of this

proposed rule.

Several submitters recommended that dental treatments can be integral to the clinical

success of covered nephrology-related medical services including services received by

beneficiaries who are immunocompromised by end-stage renal disease (ESRD), chronic kidney

disease (CKD), other renal diseases, as well as kidney transplant candidates maintained on

immunosuppressive medications. They stated that all of these patients are at increased risk of

infection, complications, and malnutrition from dentally sourced pathogens. Submitters stated

that Medicare ESRD beneficiaries on dialysis are at greater risk for developing complications

such as cardiovascular conditions, malnutrition, anemia, and infections, making dental services

more critical to the success of kidney care treatments. They further stated that pre-

transplantation dental care involves eliminating possible sources of oral infection that can lead to

a systemic infection following transplant and that without access to dental services, individuals

on dialysis may not qualify for kidney transplantation or may have severe complications after the

transplant. One of the submitters noted that dialysis clinicians report that many bloodstream

infections (BSI) begin with bacteria in the mouth and that regular dental visits could have a

positive impact on reducing BSI. They added that the Society for Vascular Surgery has noted

that transient bacteremia from dental infections can seed hemodialysis access grafts. Among

strategies to prevent infection of vascular grafts, recommended preoperative measures include

identifying and treating remote site infections, including dental sites. We discuss these

recommendations and supporting evidence in section II.J.2. of this proposed rule.

More than half of the submissions expressed support for almost identical proposals from

a couple of other submitters, recommending that dental services are inextricably linked to

covered medical services used for the treatment of Medicare beneficiaries with diabetes. They

agreed that the delivery of appropriate dental services in accordance with clinical guidelines and

standard of care is substantially related and integral to the optimal outcome of these covered

medical services. They offered clinical studies documenting that treatment of oral infections,

such as periodontitis and its related inflammation, meaningfully improves the treatment and

management of diabetes. They stated, by contrast, the absence of treatment of chronic dental

infections complicates covered medical treatment for the management of diabetes and

exacerbates insulin resistance, worsens glycemic control, and other diabetes related

complications. They noted that the relationship between oral diseases and diabetes mellitus is

complex. Diabetes is known to increase the risk and severity of oral diseases, such as

periodontitis (gum inflammation and bone loss), tooth loss, dry mouth, and oral fungal

infections. Additionally, oral diseases are documented as affecting blood glucose control and

contributing to the development of diabetes complications, such as retinopathy, neuropathy,

cardiovascular disease, and kidney disease. They believe reciprocal management of glycemic

control and periodontal disease decreases risk for and actual cases and severity of diabetes and

periodontal disease. We discuss these recommendations and the supporting clinical evidence in

section II.J.3 of this proposed rule.

2. Proposed Additions to Current Policies Permitting Payment for Dental Services Inextricably

Linked to Other Covered Services

We have received information and requests from interested parties, including entities

submitting information through the public submissions process as well as organizations

providing comments in response to prior rulemaking efforts, that an inextricable linkage exists

between dental services and dialysis treatment services for individuals diagnosed with end-stage

renal disease (ESRD) who are receiving dialysis services, particularly those experiencing

comorbidities. Commenters and submitters have stated that dental treatment is inextricably

linked and integral, and substantially related to the clinical success and outcomes of covered

dialysis medical services.

In the CY 2024 PFS final rule, we stated that commenters had provided comments in

response to the CY 2024 PFS proposed rule supporting the coverage of annual dental

examinations, and treatment as clinically indicated, for individuals with chronic kidney disease

and ESRD. The commenters stated that chronic immunosuppression increases the risk of dental

infections leading to potentially deadly complications including BSI, peritoneal dialysis-

associated peritonitis, and the exacerbation of chronic cardiovascular conditions. They also

stated that when established by patient-specific medical and dental parameters, dental services

can be unquestionably integral to the outcome of covered medical procedures. We thanked the

commenters for the information they submitted regarding these suggestions; however, at that

time, commenters did not provide sufficient evidence to support an inextricable link between

certain dental services and certain covered services for chronic kidney disease and ESRD (88 FR

79034).

Additionally, submitters provided information through the public submissions process as

described in section II.J.1.c. of this proposed rule for our consideration in CY 2025 rulemaking.

The submitters stated that there is a connection between dental services to identify and address

dental or oral infections and covered medical services for individuals receiving dialysis in the

treatment of ESRD.

ESRD is a medical condition in which a person's kidneys successively experience loss of

functionality on a permanent basis, leading to the need for a regular course of long-term dialysis

or a kidney transplant to maintain life.

174

Chronic kidney disease (CKD) is a progressively debilitating disease and is marked by

the presence of kidney damage or reduction in the kidneys’ filtration rate. CKD is a state of

progressive loss of kidney function, in that the disease worsens over time and cannot be reversed,

ultimately resulting in the need for renal replacement therapy, generally dialysis or

transplantation.

175

The Kidney Disease Improving Global Outcomes (KDIGO) Foundation

established guidelines that define five stages of CKD using kidney damage markers, including

factors that determine proteinuria (level of protein in the urine) and glomerular filtration rate

(level of kidney function/filtration) in its KDIGO 2012 Clinical Practice Guideline for the

Evaluation and Management of Chronic Kidney Disease.

176

Chronic kidney disease is generally

defined as the presence of two factors (glomerular filtration rate [GFR] less than 60 mL/min and

albumin greater than 30 mg per gram of creatinine) along with abnormalities of kidney structure

or function for greater than three months. Stage 5 of CKD is labeled end-stage renal disease

174

https://www.cms.gov/medicare/coordination-benefits-recovery/overview/end-stage-renal-disease-esrd.

175

https://www.ncbi.nlm.nih.gov/books/NBK535404/.

176

https://kdigo.org/wp-content/uploads/2017/02/KDIGO_2012_CKD_GL.pd.f

(ESRD) with a GFR of less than 15 mL/min.

177

According to the NIH, more than 500,000

people in the United States live with ESRD.

178

Per the American Academy of Family Physicians, individuals with ESRD are typically

referred to nephrologists for the development of treatment plans. Collectively the various

modalities utilized to replicate kidney function are referred to as renal replacement therapy

(RRT). Most ESRD patients are treated with dialysis, regardless of whether transplantation

ultimately occurs. Generally, kidney transplantation typically yields the best patient outcomes;

however, not all patients with ESRD are eligible for or able to undergo transplantation, and

therefore continue dialysis treatment.

179

Standards of medical care for CKD outline the need for

monitoring for signs of progression of the disease and early referral to specialists for RRT.

180

Dialysis is generally supplied via two primary modes: hemodialysis or peritoneal dialysis. In

hemodialysis, blood is filtered through a dialyzer, outside of the body. A dialyzer is sometimes

referred to as an “artificial kidney.”

181

To access the circulatory system, several access points

may be placed and utilized, including an arteriovenous (AV) fistula, AV graft, and in some cases

a central venous catheter.

182,183,184

In peritoneal dialysis, a fixed catheter is placed in the

abdomen, and dialysis solution is administered into the abdomen. The solution absorbs wastes

and excess fluid from the patient’s body.

185,186

Submissions we received through the public submissions process for consideration in CY

2025 rulemaking provided information regarding the potential linkage between dental services

and specific covered medical services associated with ESRD and dialysis including:

● CPT codes 36901-36906: Dialysis circuit procedures;

177

https://www.ncbi.nlm.nih.gov/books/NBK499861/.

178

https://www.ncbi.nlm.nih.gov/books/NBK499861/.

179

Am Fam Physician. 2021;104(5):493-499. https://www.aafp.org/pubs/afp/issues/2021/1100/p493.html.

180

https://pubmed.ncbi.nlm.nih.gov/29763036/.

181

https://www.niddk.nih.gov/health-information/kidney-disease/kidney-failure/hemodialysis.

182

https://www.ncbi.nlm.nih.gov/books/NBK563296/.

183

https://www.mayoclinic.org/tests-procedures/hemodialysis/about/pac-20384824.

184

https://www.cdc.gov/dialysis/patient/.

185

https://www.mayoclinic.org/tests-procedures/peritoneal-dialysis/about/pac-20384725

186

https://www.niddk.nih.gov/health-information/kidney-disease/kidney-failure/peritoneal-dialysis.

● CPT codes 90935, 90937, 90940: Hemodialysis procedures;

● CPT code 90961: Physician or other qualified healthcare professional visits for ESRD;

● CPT codes 90989-90999: Other dialysis procedures; and,

● DRG code 872: Hospitalization for septicemia or severe sepsis.

We note that Medicare provides coverage for individuals with ESRD, regardless of age,

when certain requirements are met.

187

We also note that dialysis procedures may be utilized for individuals who do not have

ESRD in the treatment of acute intoxication or poisoning. For example, in the case of a patient

experiencing poisoning, dialysis hemoperfusion may be employed, which passes the blood

through a column packed with granules that include a resin that act as absorbents. In this

procedure, physicochemical properties of an absorbent are used to remove toxins. Conversely, in

hemodialysis utilized in the treatment of ESRD, there is a concentration gradient between the

blood and the solvent across the dialysis membrane.

188

We note that the patient accessing

dialysis treatment for the treatment of acute intoxication or poisoning would not present with the

same diagnostic profile, treatment needs, nor face the same risks of immunodeficiency and

infection as individuals with ESRD as described below.

189

Periodontal diseases and dental caries are the main chronic infectious diseases of the oral

cavity. Periodontal diseases include a group of chronic inflammatory diseases that affect the

periodontal supporting tissues of teeth and encompass destructive and nondestructive diseases.

Gingivitis is inflammation of the soft tissue without apical migration of the junctional

epithelium. It is a reversible, nondestructive disease that does not involve loss of periodontal

tissues. Periodontitis is inflammation of the periodontium that is accompanied by apical

187

https://www.cms.gov/medicare/coordination-benefits-recovery/overview/end-stage-renal-disease-esrd.

188

Durakovic Z. Combined hemoperfusion and hemodialysis treatment of poisoning with cholinesterase inhibitors.

Korean J Intern Med. 1993 Jul;8(2):99-102. doi: 10.3904/kjim.1993.8.2.99. PMID: 8031730; PMCID:

PMC4532091. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4532091.

189

Ouellet G, Bouchard J, Ghannoum M, Decker BS. Available extracorporeal treatments for poisoning: overview

and limitations. Semin Dial. 2014 Jul;27(4):342-9. https://pubmed.ncbi.nlm.nih.gov/24697909/.

migration of the junctional epithelium, leading to destruction of the connective tissue attachment

and alveolar bone loss.

190

Periodontitis serves as a prime example of a disrupted balance between the local

microbiome and the host's inflammatory response, a condition known as dysbiosis. Although the

inflammatory response is ostensibly triggered to manage the microbial threat, it proves to be

ineffective and inadequately regulated in individuals prone to the condition. This leads to the

inflammatory destruction of the periodontium, which encompasses the tissues that encase and

support the teeth, including the gingiva, periodontal ligament, and alveolar bone. Without

appropriate treatment, this disease can progress to tooth loss, adversely affecting chewing,

appearance, and overall quality of life.

191

In 2017, the American Academy of Periodontology (AAP) and the European Federation

of Periodontology (EFP) co-presented the 2017 Classification of Periodontal and Peri-Implant

Diseases and Conditions. This disease classification framework serves to guide treatment

planning for periodontitis and aims to support customized approaches to patient care. The

revised classification includes a multi-dimensional staging and grading system for periodontitis

classification, a recategorization of various forms of periodontitis, and a classification for peri-

implant diseases and conditions.

192

Individuals with ESRD experience compromised immune systems as the immune system

and the kidneys are closely integrated and interdependent. In healthy individuals, the kidneys

contribute to immune homeostasis and regulation, while components of the immune system

mediate many acute forms of renal disease and play a central role in the progression of chronic

kidney disease. A dysregulated immune system can have either direct or indirect renal effects.

193

190

Albandar, J. M. (2005). Epidemiology and risk factors of periodontal diseases. Dent Clin North Am, 49(3), 517-

532, v-vi. doi:10.1016/j.cden.2005.03.003.

191

Hajishengallis, G., & Chavakis, T. (2021). Local and systemic mechanisms linking periodontal disease and

inflammatory comorbidities. Nature Reviews Immunology, 21(7), 426-440. doi:10.1038/s41577-020-00488-6.

192

https://www.perio.org/wp-content/uploads/2019/08/Staging-and-Grading-Periodontitis.pdf.

193

Tecklenborg J, Clayton D, Siebert S, Coley SM. The role of the immune system in kidney disease. Clin Exp

Immunol. 2018 May;192(2):142-150. doi: 10.1111/cei.13119. Epub 2018 Mar 24. PMID: 29453850; PMCID:

PMC5904695.

Moreover, uremia, the buildup of waste products in the blood that occurs as a result of declining

or decreasing kidney function, can lead to inflammation and reduction in the immune system’s

ability to function as evidenced by an increased risk of viral-associated cancers, increased

susceptibility to infections, and decreased vaccination responses in patients with ESRD.

194

ESRD is also characterized by diminished endocrine and metabolic functions of the kidney with

subsequent retention and accumulation of toxic metabolites.

195

Additionally, the presence of

indwelling catheters and grafts utilized for the administration of dialysis, malnutrition,

dysregulated inflammation, and acquired immune dysfunction due to uremia contribute to the

immune deficiency in ESRD and increase susceptibility to infection.

196

Notably, infection is the

second leading cause of death in hemodialysis patients.

197,198

Several submitters providing information through the public submissions process stated

that comorbidities frequently occur in the ESRD patient population and can cause complications

for the patient, potentially jeopardizing the outcomes of the dialysis treatment. For example,

submitters stated that comorbid diabetes can result in clinical complications for individuals

receiving dialysis services in the treatment of ESRD, stating that periodontitis can worsen blood

glucose control in diabetics by increasing levels of inflammatory mediators and may interfere

with insulin, resulting in clinical complications. Additionally, periodontitis is associated with

oral health-related quality of life in individuals with ESRD. One study evaluated whether

periodontitis may be independently associated with oral health-related quality of life (OHRQoL)

in individuals with ESRD. Researchers assessed 180 adults with ESRD and evaluated for

194

Betjes MG. Immune cell dysfunction and inflammation in end-stage renal disease. Nat Rev Nephrol. 2013

May;9(5):255-65. doi: 10.1038/nrneph.2013.44. Epub 2013 Mar 19. PMID: 23507826.

https://pubmed.ncbi.nlm.nih.gov/23507826/.

195

Costantinides F, Castronovo G, Vettori E, Frattini C, Artero ML, Bevilacqua L, Berton F, Nicolin V, Di Lenarda

R. Dental Care for Patients with End-Stage Renal Disease and Undergoing Hemodialysis. Int J Dent. 2018 Nov

13;2018:9610892. doi: 10.1155/2018/9610892. PMID: 30538746; PMCID: PMC6258100.

196

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7404977/.

197

U.S. Renal Data System. USRDS 2015 Annual Data Report: Atlas of End-Stage Renal Disease in the United

States, Bethesda, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases,

2015.

198

Dalrymple LS, et al. Infection-related hospitalizations in older patients with ESRD. Am. J. Kidney Dis.

2010;56:522–530. doi: 10.1053/j.ajkd.2010.04.016.

impacts on various domains, and found that periodontitis exerts an influence on OHRQoL in

individuals with ESRD, with a more severe condition impacting different domains.

199

Moreover,

a prospective cohort study aimed to determine the association between an index of

radiographically assessed oral health, Panoramic Tomographic Index (PTI), and cardiovascular

and all-cause mortality, major adverse cardiovascular events (MACEs) and episodes of

bacteremia and laboratory measurements during a three-year prospective follow-up in chronic

kidney disease (CKD) stage 4–5 patients not on maintenance dialysis at baseline. The study

showed that radiographically assessed and indexed dental health is independently associated with

all-cause and cardiovascular mortality and MACEs in CKD stage 4–5 patients transitioning to

maintenance dialysis and renal transplantation during follow-up (but not with the incidence of

bacteremia).

200

Submitters providing information through the public process also stated that BSI, poor

glycemic control, and other complications arising from dental infection can jeopardize the

clinical success of medical therapies employed to manage ESRD. Research provided by

submitters described that issues and changes in the mouth and oral cavity, such as periodontitis

and other consequences of poor oral health, frequently occur in patients with CKD and may

contribute to increased morbidity and mortality because of systemic consequences such as

inflammation, infections, protein-energy wasting, and atherosclerotic complications.

201

Several submitters also stated that addressing oral health issues, including identifying and

resolving dental infections through the provision of dental and oral services, can be inextricably

linked and integral and related to the clinical success of Medicare covered dialysis services for

199

Oliveira, L. M., Sari, D., Schoffer, C., Santi, S. S., Antoniazzi, R. P., & Zanatta, F. B. (2020). Periodontitis is

associated with oral health-related quality of life in individuals with end-stage renal disease. Journal of Clinical

Periodontology, 47(3), 319-329. doi:10.1111/jcpe.13233.

200

Jarvisalo, M. J., Jokihaka, V., Hakamaki, M., Lankinen, R., Helin, H., Koivuviita, N. S., . . . Metsarinne, K.

(2021). Dental health assessed using panoramic radiograph and adverse events in chronic kidney disease stage 4-5

patients transitioning to dialysis and transplantation-A prospective cohort study. PLOS ONE, 16(9), e0258055.

doi:10.1371/journal.pone.0258055.

201

Harun Akar, Gulcan Coskun Akar, Juan Jesus Carrero, Peter Stenvinkel, and Bengt Lindholm. Systemic

Consequences of Poor Oral Health in Chronic Kidney Disease Patients, Clin J Am Soc Nephrol 6: 218–226, 2011.

doi: 10.2215/CJN.05470610.

the treatment of ESRD. The submitters stated that the consequences of poor oral health are

worse for ESRD patients than the general population due to ESRD patient characteristics such as

advanced age, higher prevalence of comorbid diabetes, polypharmacy, and impaired immune

function, and that medically necessary dental care may improve the clinical success of the

dialysis services.

A few submitters supplied a general position paper on the need for dental care and

services in the ESRD patient population receiving dialysis services, describing the unique risks

for individuals with ESRD and the increased risk of infection from oral sources. Specifically,

the position paper states that “oral diseases represent a potential and preventable cause of poor

health outcomes in people with ESRD due to their relation to infection, inflammation, and

malnutrition. Oral health represents a potential determinant of health outcomes in patients with

end-stage renal diseases (ESRD).”

202

Several submitters also provided a cohort outcomes study

of 675 randomly selected individuals receiving peritoneal dialysis services.

203

The study

outcomes described that “poor oral health was associated with lower educational levels, diabetes,

older age, marriage, and worse nutritional indicators (including lower time-averaged serum

albumin and phosphate concentrations).”

204

The research further isolated that poor oral health is independently associated with an

increased risk of peritonitis, an infection of the peritoneum where the peritoneal access graft is

placed, and mortality in patients receiving peritoneal dialysis. The authors describe that “after

adjusting for age, sex, comorbidities, serum albumin, shared frailty by study sites, and PD

vintage, poor oral health was associated with increased risks of peritonitis (adjusted hazard ratio

[HR] = 1.45, 95 percent confidence interval [CI]: 1.06–2.00) and all-cause mortality (adjusted

202

Costantinides F, Castronovo G, Vettori E, Frattini C, Artero ML, Bevilacqua L, Berton F, Nicolin V, Di Lenarda

R. Dental Care for Patients with End-Stage Renal Disease and Undergoing Hemodialysis. Int J Dent. 2018 Nov

13;2018:9610892. doi: 10.1155/2018/9610892. PMID: 30538746; PMCID: PMC6258100.

203

Sirirat Purisinsith, Patnarin Kanjanabuch, Jeerath Phannajit, Bruce Robinson, Kriang Tungsanga, et al. “Oral

Health-Related Quality of Life, A Proxy of Poor Outcomes in Patients on Peritoneal Dialysis.” doi:

https://doi.org/10.1016/j.ekir.2022.07.008 (August 5, 2022).

204

Ibid.

HR = 1.55, 95 percent CI: 1.04–2.32) but not hemodialysis (HD) transfer (adjusted HR = 1.89,

95 percent CI: 0.87–4.10) compared to participants with good oral health.” Furthermore, the

study explained that “poor oral health status was present in one-fourth of peritoneal dialysis

patients and was independently associated with a higher risk of peritonitis and death.”

205

Moreover, submitters provided information that suggests that patients with ESRD receiving

hemodialysis services and receiving preventive oral and dental services experience increased

survival while those not receiving dental services were associated with increased mortality. A

prospective cohort outcomes study of 4,205 hemodialysis patients assessed the impact of dental

health on mortality from 2010 to 2012. The study described that “in adults treated with

hemodialysis, poorer dental health was associated with early death, whereas preventive dental

health practices were associated with longer survival.”

206

Additionally, in a systematic review supplied by several submitters, studies show that

patients on RRT (for example hemodialysis, peritoneal dialysis, and/or transplantation)

experience a high prevalence of dental caries, common chronic infection resulting from tooth-

adherent cariogenic bacteria.

207

The observational data presented in the review suggests a link

between oral health and mortality in patients on RRT.

208

The review highlighted the need for

further research in this area but also stated that improved, multidisciplinary, patient-centered

dental care concepts are required to support dental and overall oral health in individuals on RRT.

Several submitters also noted that the Society for Vascular Surgery has stated that

transient bacteremia from dental infections can seed hemodialysis access grafts. Among

strategies to prevent infection of vascular grafts, recommended preoperative measures include

205

Ibid.

206

See, e.g., Palmer S. C., Ruospo M., Wong G., et al. Oral-D study investigators. Dental health and mortality in

people with end-stage kidney disease treated with hemodialysis: a multinational cohort study. American Journal of

Kidney Diseases. 2015;66:666–676.

207

https://www.ncbi.nlm.nih.gov/books/NBK551699/.

208

Deborah Kreher et.al., Prevalence of Dental Caries in Patients on Renal Replacement Therapy—A Systematic

Review J. Clin. Med. 2023, 12, 1507. https://doi.org/10.3390/jcm12041507.

identifying and treating remote site infections, including dental or oral sites of infection.

209, 210

Statements regarding best practices for managing infection control advise that sources of

infection, including those within the oral cavity, should be addressed in order to minimize the

risk of broader infection in the ESRD patient receiving hemodialysis.

211

In conclusion, the evidence base indicates that evaluation for and treatment of oral

infection leads to improved outcomes and reduced risk of mortality for individuals with ESRD

receiving covered dialysis services.

In the CY 2023 PFS final rule, we agreed with commenters that there is clinical evidence

to support that medically necessary dental care may advance the clinical success of organ

transplants and finalized that payment can be made under Medicare Parts A and B for dental

services such as dental examinations, including necessary treatment, performed as part of a

comprehensive workup prior to organ transplant surgery and medically necessary diagnostic and

treatment services immediately necessary to eliminate or eradicate the infection or its source that

are provided before transplantation because such services are inextricably linked to, and

substantially related and integral to the clinical success of, the organ transplant procedure (87 FR

69676).

Furthermore, we stated that we appreciated commenters’ feedback regarding those

individuals who are awaiting organ transplantation and the commenters’ request that Medicare

provide payment for medically necessary dental services prior to transplantation. We described

that in a case where an individual is awaiting organ transplantation, we believe that it is

appropriate for Medicare to provide payment for, including but not limited to, an oral or dental

examination, and medically necessary diagnosis and treatment for only those services that are

209

Surgical Site Infection Toolkit, CDC, SSI Toolkit Activity C: ELC Prevention Collaboratives (cdc.gov).

210

Pear S, Patient Risk Factors and Best Practices for Surgical Site Infection Prevention,

https://www.halyardhealth.com/wp-content/uploads/patient_risk_factors_best_practices_ssi.pdf.

211

Ibid.

considered immediately necessary to eliminate or eradicate the infection or its source prior to the

organ transplant (87 FR 69676).

In consideration of research and recommendations provided by the public and our

analyses of the studies and research available regarding the connection between dental services

and the clinical success of dialysis services for individuals with ESRD, we believe that dental

services to diagnose and treat infection prior to dialysis services in the treatment of ESRD

represent a clinically analogous scenario to dental services for which Medicare payment under

Parts A and B is currently permitted when furnished in the inpatient or outpatient setting, such as

prior to organ transplant. The clinical evidence supports that the medically necessary dental care

may similarly advance the clinical success of dialysis services in the treatment of ESRD because

an oral or dental infection can present substantial risk to the success and outcomes of these

procedures (including the risk of systemic infection, BSI, sepsis, and death).

As such, we believe that if a patient requiring dialysis services in the treatment of ESRD

has an oral infection, the success of those dialysis services could be compromised if the infection

is not properly diagnosed and treated prior to the covered medical services. Without an oral or

dental examination to identify such an infection and the provision of necessary treatment, such as

restorative dental services, to eradicate the infection prior to the dialysis procedure, the patient’s

ability to complete the dialysis services could be seriously complicated or compromised and the

risk of infection would further increase the risk of mortality for the patient.

Examples of restorative dental services to eradicate infection could include: extractions

(removal of the entire infection, such as pulling of teeth - for example, CDT D7140, D7210),

restorations (removal of the infection from tooth/actual structure, such as fillings - for example,

CDT D2000-2999), periodontal therapy (removal of the infection that is surrounding the tooth,

such as scaling and root planning - for example, CDT D4000-4999, more specifically D4341,

D4342, D4335 and D4910), or endodontic therapy (removal of infection from the inside of the

tooth and surrounding structures, such as root canal - for example, CDT D3000-3999).

If such an infection is not treated prior to dialysis services in the treatment of ESRD, then

there is an increased likelihood for morbidity and mortality resulting from spreading of the local

infection to BSI and sepsis. Likewise, we believe that infections occurring during the course of

dialysis treatment should similarly be addressed and resolved in order to minimize the risk of

infection and death for the patient with ESRD receiving dialysis services.

Because an oral or dental infection can present substantial risk to the success of dialysis

treatment for ESRD, we believe dental services furnished to identify, diagnose, and treat oral or

dental infections prior to or contemporaneously with dialysis services in the treatment of ESRD

are not in connection with the care, treatment, filling, removal, or replacement of teeth or

structures directly supporting teeth, but instead are inextricably linked to, and substantially

related and integral to the clinical success of, these other covered medical services. We note

that, in these circumstances, the necessary treatment to eradicate an infection may not be the

totality of recommended dental services for a given patient. For example, if an infected tooth is

identified in a patient requiring dialysis services in the treatment of ESRD, the necessary

treatment would be to eradicate the infection, which could result in the tooth being extracted.

Additional dental services, such as a dental implant or crown, may not be considered

immediately necessary to eliminate or eradicate the infection or its source prior to surgery.

Therefore, such additional services would not be inextricably linked to, and substantially related

and integral to the clinical success of, Medicare-covered dialysis services when used in the

treatment of ESRD. As such, no Medicare payment would be made for the additional services

that are not immediately necessary prior to or contemporaneously with dialysis for ESRD to

eliminate or eradicate the infection.

In conclusion, we are proposing to add this clinical scenario to the examples of clinical

scenarios under which payment can be made for certain dental services in our regulation at §

411.15(i)(3)(i)(A). Specifically, we propose to amend the regulation at paragraph A to include

dental or oral examination performed as part of a comprehensive workup in either the inpatient

or outpatient setting prior to Medicare-covered dialysis services when used in the treatment of

ESRD; and medically necessary diagnostic and treatment services to eliminate an oral or dental

infection prior to, or contemporaneously with Medicare-covered dialysis services when used in

the treatment of ESRD. We seek comments on all aspects of this proposal.

3. Request for Comment on Dental Services Integral to Specific Covered Services to Treat

Diabetes

As described in section II.J.1.c. of this proposed rule, we have received information from

interested parties, including submitters providing evidence through the public submissions

process as well as commenters on prior proposed rules suggesting that dental services are

inextricably linked to treatment services for individuals with diabetes mellitus. Several

interested parties using the public submissions process have urged us to provide Medicare

payment for dental services for individuals diagnosed with diabetes for consideration in CY 2025

rule making. These submissions included information and references supporting oral and dental

treatment of advanced periodontitis among individuals with diabetes to improve markers related

to management of the diabetes.

Submitters stated that clinical studies demonstrate that dental treatments for oral

infections, such as advanced periodontitis and related inflammation, meaningfully advance and

improve the treatment of, management of, and outcomes for patients with diabetes. Submitters

also stated that conversely, the absence of treatment of chronic dental infections in turn

complicates covered medical treatment for the management of diabetes and potentially

exacerbates insulin resistance, worsens glycemic control, and other diabetes-related

complications, leading to poor outcomes for the individuals with diabetes. Submitters also noted

that studies demonstrate cost savings when dental services are employed in the treatment of

individuals with diabetes and also serve to advance health equity among vulnerable populations.

Submitters provided information detailing the increased risk of dental caries and

periodontal disease in people with diabetes, many of whom lose teeth, which greatly limits

nutrition, general well-being, and overall quality of life. Submitted studies demonstrated the

bidirectional nature of periodontal disease and diabetes, suggesting that both conditions influence

each other and can worsen or conversely improve outcomes.

As described by submitters, numerous basic and clinical studies describe the relationship

between oral diseases and inflammation in persons with diabetes, which increases risks for

micro- and macrovascular complications including retinopathy, nephropathy, neuropathy,

cardiovascular diseases, and stroke. Several submitters stated that there is a documented

reduction in hospitalizations in persons with diabetes who receive conservative periodontal

treatment. Consequently, submitters stated that periodontal treatment is recommended for

patients with diabetes by American Diabetes Association Clinical Guidelines and is also

promoted by the American Association of Clinical Endocrinologists and others.

212

Diabetes mellitus is a chronic, metabolic disease characterized by elevated levels of

blood glucose (or blood sugar), which, over time, may lead to serious damage to the heart, blood

vessels, eyes, kidneys, and nerves. Type 2 diabetes, which usually occurs in adults, causes the

body to become resistant to insulin or not to make enough insulin. Type 1 diabetes, previously

referred to as juvenile diabetes or insulin-dependent diabetes, is a chronic condition in which the

pancreas produces little or no insulin.

213

A primary goal for the treatment of diabetes is glycemic control and requires accurate

individualization and customization of available treatment options. Interventions to address

lipoproteins, blood pressure, weight control, mental health, and lifestyle are important factors

that contribute to quality of life and the frequency of diabetes-associated complications.

214

212

Nuha A. El Sayed, Grazia Aleppo, Vanita R. Aroda, Raveendhara R. Bannuru, Florence M. Brown, Dennis

Bruemmer, Billy S. Collins, Kenneth Cusi, Sandeep R. Das, Christopher H. Gibbons, John M. Giurini, Marisa E.

Hilliard, Diana Isaacs, Eric L. Johnson, Scott Kahan, Kamlesh Khunti, Mikhail Kosiborod, Jose Leon, Sarah K.

Lyons, Lisa Murdock, Mary Lou Perry, Priya Prahalad, Richard E. Pratley, Jane Jeffrie Seley, Robert C. Stanton,

Jennifer K. Sun, Crystal C. Woodward, Deborah Young-Hyman, Robert A. Gabbay; on behalf of the American

Diabetes Association, Summary of Revisions: Standards of Care in Diabetes—2023. Diabetes Care 1 January 2023;

46 (Supplement_1): S5–S9. https://doi.org/10.2337/dc23-Srev.

213

https://www.who.int/health-topics/diabetes.

214

Melmer A, Laimer M. Treatment Goals in Diabetes. Endocr Dev. 2016;31:1-27. doi: 10.1159/000439364. Epub

2016 Jan 19. PMID: 26824869. https://pubmed.ncbi.nlm.nih.gov/26824869/.

According to recent statistics from the Centers for Disease Control and Prevention,

approximately 38 million people in the United States may have diabetes, and the CDC estimates

that 1 in 5 of them do not know they have the condition. Approximately 98 million U.S. adults

likely have prediabetes, and more than 8 in 10 of them may not know they have prediabetes.

Notably, diabetes is the eighth leading cause of death in the United States (and may be

underreported). Type 2 diabetes accounts for approximately 90 to 95 percent of all diagnosed

cases of diabetes, while Type 1 diabetes accounts for approximately 5-10 percent. The CDC

reports that over the last 20 years, the number of adults diagnosed with diabetes has more than

doubled as the American population has aged and become more overweight or obese.

215

One key marker for the measurement of glycemic control, a key goal in the treatment of

diabetes, in individuals with diabetes is the hemoglobin A1c test. The hemoglobin A1c (also

referred to as glycated hemoglobin, glycosylated hemoglobin, HbA1c, or A1c) test is used to

evaluate a person's level of glucose control and shows an average of the blood sugar level over

the past 90 days and represents a percentage.

216

Submitters through the public submissions process provided multiple research studies

regarding the interaction between dental services and outcomes for medical services to treat

diabetes. The Cochrane Library (ISSN 1465-1858) is a collection of databases that contain high-

quality, independent evidence to inform healthcare decision-making. The Cochrane Library is

owned by Cochrane and published by Wiley.

217

In the Cochrane Review entitled Treatment of

periodontitis for glycaemic control in people with diabetes mellitus, evidence from 30 trials

(results from 2,443 participants) showed that periodontitis treatment reduces blood sugar levels

(measured by HbA1c) in diabetic patients on average by 0.43 percentage points (for example,

from 7.43 to 7 percent; 4.7 mmol/mol) 3 to 4 months after receiving the treatment compared with

no active treatment or usual care. A difference of 0.30 percent (3.3 mmol/mol) was seen after 6

215

https://www.cdc.gov/diabetes/basics/quick-facts.html.

216

https://www.ncbi.nlm.nih.gov/books/NBK549816/.

217

https://www.cochranelibrary.com/about/about-cochrane-library.

months (12 studies), and 0.50 percent (5.4 mmol/mol) at 12 months (one study).

218

All studies in

the review used a parallel randomized controlled trials (RCT) design and followed participants

for between 3 and 12 months. The studies generally focused on people with type 2 diabetes,

save one study that included participants with type 1 or type 2 diabetes. Most studies were

mixed in terms of whether metabolic control of participants at baseline was good, fair, or poor

and were carried out in secondary care. Researchers compared periodontitis treatment with

control, which could be no (or delayed) treatment or usual care (oral hygiene instruction (OHI)

or supragingival scaling with or without OHI). The degree and nature of advanced periodontitis

were not specifically defined in the context of the studies. Additionally, the studies did not

control for other types of interventions deployed in the treatment of diabetes (that is, strategies

used to manage glycemic control), so patients may have been receiving other types of treatment

during the study periods.

The types of periodontal treatment provided covered a wide range of oral services:

subgingival instrumentation, surgical periodontitis treatment ‐ flap surgery or gingivectomy;

antimicrobial therapy (encompassing antibacterials and antibiotics), either locally applied

(including mouth rinses, gels, or dentifrices) or systemically administered; other drug therapy

with a possible benefit of improving the periodontal condition of the participant; other novel

interventions to manage periodontitis; supragingival scaling (also known as professional

mechanical plaque removal (PMPR)); oral hygiene instruction; and/or, education or support

sessions to improve self‐help or self‐awareness of oral hygiene.

In summary, the Cochrane review demonstrated that individuals with diabetes who have

periodontitis who receive dental services for the treatment of the periodontitis experience a

statistically significant reduction of HbA1c. Again, measurement of HbA1c is a metric for

gauging glycemic control and is a primary goal of treatment for all individuals with diabetes.

218

Simpson TC, et al. Treatment of periodontitis for glycaemic control in people with diabetes mellitus. Cochrane

Database Syst Rev. 2022;4:CD004714 https://www.ncbi.nlm.nih.gov/pubmed/35420698.

The study suggests that individuals with diabetes who also have a diagnosis of periodontitis who

receive treatment to address the periodontitis subsequently experience a reduction in HbA1c.

The study authors described the clinical outcomes related to preventive dental care, conservative

periodontal treatment, and reduction in HbA1c as statistically and clinically significant.

Moreover, the authors of the research stated that “further trials evaluating no treatment vs usual

care are unlikely to change this conclusion.”

219

Submitters providing information through the public submissions process suggested that

dental services could be inextricably linked to the following specific medical services in the

treatment of diabetes:

● CPT 36901-36906: Dialysis circuit procedures.

● CPT 82947: Chemistry procedures, blood glucose testing.

● CPT 83036: Hemoglobin A1C testing.

● CPT 90935, 90937, 90940: Hemodialysis procedures.

● CPT 90961: Physician or other qualified healthcare professional visits for ESRD.

● CPT 90989-90999: Other dialysis procedures.

● CPT 92227-92229: Diabetic retinopathy screening.

● CPT 99091: Collection and interpretation of physiologic data.

● CPT 99202-99215: Evaluation and Management (E/M) Services.

● CPT 99211: Office visit for an established patient.

● CPT 99487: Complex chronic care management services.

● CPT 99490-99491: Chronic care management services.

● CPT 99497: Remote physiologic monitoring services.

● CPT 99605-99607: Medication Management.

● CPT 99802-99804: Assessment, Intervention, Face to Face (F2F).

219

Simpson TC, et al. Treatment of periodontitis for glycaemic control in people with diabetes mellitus. Cochrane

Database Syst Rev. 2022;4:CD004714 https://www.ncbi.nlm.nih.gov/pubmed/35420698.

● DRG 637: Hospitalization for diabetes with major complications.

● G0108: Diabetes Self-Management Training.

● G0109: Group Diabetes Self-Management Training.

● G0270: Nutrition Therapy.

● G0466: FQHC visit new patient.

● G0467: FQHC visit established patient.

As described in this section, research provided by submitters suggests that periodontal

treatment for an individual with both a diagnosis of diabetes and periodontitis led to improved

HbA1c measures.

We have explained that there are instances where dental services are so integral to other

medically necessary services that they are inextricably linked to the clinical success of that

medical service(s), and, as such, they are not in connection with the care, treatment, filling,

removal, or replacement of teeth or structures directly supporting teeth within the meaning of

section 1862(a)(12) of the Act. Rather, these dental services are inextricably linked to the

clinical success of an otherwise covered medical service and are payable under Medicare Parts A

and B.

In the case of an individual with diabetes who also has a diagnosis of periodontitis, oral

services and treatment to address the periodontitis potentially lead to a reduction in HbA1c, a

marker of glycemic control that may be used to determine the effectiveness of interventions for

treatment of diabetes. In the description of the studies submitted, the research seems to indicate

that the improvement of glycemic control as evidenced by the HbA1c is due to the provision of

treatment for the periodontitis. The dental and oral services may not be integral to other specific

medically necessary, covered services, but rather the dental and oral services may serve to

influence clinical outcomes directly. The studies compare the impact of the treatment for the

periodontitis to the impact of pharmacological interventions.

We recognize that evidence submitted by interested parties demonstrates that an

individual with both a diagnosis of diabetes and a diagnosis of periodontitis who in turn receives

periodontal treatment services may experience improvements in markers for HbA1c, which is a

key target outcome for the patient population with diabetes. However, the interaction between

these diagnoses and the potential improvements due to periodontal treatment services does not

appear to align with the framework we have established to pay for dental services inextricably

linked to covered services; in our framework, the delivery of certain dental services are integral

to the successful completion of or outcomes related to the covered services.

Under § 411.15(i)(3), we have specified that payment can be made for certain dental

services that are inextricably linked to other services when the specific covered services with

which the dental services are inextricably linked are identified. The studies that have been

provided to CMS through submissions have not identified any specific covered services for the

treatment of diabetes to which dental services are inextricably linked. Rather, the studies

indicate that the primary treatment of periodontal disease in patients with diabetes generally

leads to better outcomes in the management of the patients’ diabetes. While the research makes

the case that the dental services are medically necessary for patients with diabetes, medical

necessity alone does not permit payment for dental services given the broad statutory prohibition

under section 1862(a)(12) on payment for services “in connection with the care, treatment,

filling, removal, or replacement of teeth or structures directly supporting teeth.” In the case of

patients with diabetes, the research does not appear to show that certain dental services are

inextricably linked with certain other covered services for the treatment of diabetes, in

accordance with our regulation at § 411.15(i)(3) such that the statutory prohibition under section

1862(a)(12) does not apply.

We note that some of the examples of medical services for diabetes treatment provided

by submitters are general in nature and not specific to patients with diabetes who may also have

periodontal disease, including CPT codes 99202-99215: Evaluation and Management (E/M)

Services that broadly describe outpatient office visits for the diagnosis and medical management

of practically any illness, disease, or condition.

Additionally, submitters providing evidence for our consideration suggested that the

services described by codes for diabetes self-management training (for example, G0108:

Diabetes Self-Management Training, and G0109: Group Diabetes Self-Management Training)

are services with which dental services may be inextricably linked. However, we were not

persuaded by this evidence and do not believe that dental services would be inextricably linked

to improved outcomes for services for DSMT. Therefore, we seek comment from the public

regarding specific covered services for management of patients with diabetes with which dental

services may be inextricably linked. At this time, we are not proposing to amend §

411.15(i)(3)(i) as we have not identified additional dental services that are inextricably linked to

certain services in the treatment of diabetes. However, we note that we remain open to

considering any such services identified by public commenters, and, if sufficient evidence is

presented, we may consider adding such services to our regulations in the final rule.

In the context of payment for dental services for an individual with diabetes, we seek

information from the public regarding what the coordination between a medical and dental

professional would entail in the scenario where an individual with a diagnosis of diabetes

presents with suspected periodontitis. In the CY 2023 PFS final rule, we explained that we

would make payment when a doctor of dental medicine or dental surgery (referred to as a

dentist) furnishes dental services that are an integral part of the covered primary procedure or

service furnished by another physician, or non-physician practitioner, treating the primary

medical illness. However, if there is no exchange of information, or integration, between the

medical professional (physician or other non-physician practitioner) in regard to the primary

medical service and the dentist in regard to the dental services, then there would not be an

inextricable link between the dental and covered medical service within the meaning of our

regulation at § 411.15(i)(3). Without both integration between the Medicare enrolled medical

and dental professional, and the inextricable link between the dental and covered services,

Medicare payment for dental services would be prohibited under section 1862(a)(12) because the

services are in connection with the care, treatment, filling, removal, or replacement of teeth or

structures directly supporting teeth; though they may be covered by types of supplemental health

or dental coverage (87 FR 69687 through 69688).

In a situation where a medical professional believes that an individual with a diagnosis of

diabetes may also have a diagnosis of periodontitis, how are recommendations conveyed

between the medical and dental professionals? What coordination, if any, occurs between the

medical and dental professionals? We expect that inextricably linked services related to the

treatment of periodontitis in an individual with diabetes would require significant

communication between the medical and dental professionals.

Additionally, we have stated that an inextricable linkage may exist between dental

services and covered services when the standard of care for the medical service is such that the

practitioner would not proceed with the medical procedure or service without performing the

dental services, because the covered medical services would or could be significantly and

materially compromised, or where dental services are a clinical prerequisite to proceeding with

the primary medical procedure and/or treatment (87 FR 69669). While evidence supports that

individuals with diabetes and periodontitis who receive periodontal treatment experience

improvements in their HbA1c markers, dental services do not appear to serve as a precondition

to overall treatment for the diabetes. We seek information from the public on how oral treatment

services may be a clinical prerequisite in the treatment protocol for the care of individuals with

diabetes.

We note that there does not appear to be a clear or singular definitional framework for

categorizing the state of diabetes, such as “controlled” or “uncontrolled” diabetes. Research

submitted by the public discusses improvements in glycemic control as evidence by HbA1c

markers, but does not delineate the characteristics of a patient that would require direct clinical

intervention (pharmacological, behavioral, usage of DME such as insulin pumps, etc.) versus a

patient that would not require interventions given that their disease state is not within a

concerning range requiring direct medical treatment.

In the current literature, there are two types of severity measures that can help

categorizing the state of diabetes: the severity of diabetes itself and the severity of periodontal

disease among individuals with diabetes. With respect to the severity of diabetes, the American

Diabetes Association recommends that most adults with diabetes aim for a HbA1c level below

7.0% (<53 mmol/mol), along with other recommended targets such as blood pressure below

130/80 mmHg and LDL cholesterol below 100 mg/dL.

220

In the current literature, uncontrolled

hyperglycemia is typically defined as a HbA1c level above 8.0% (>64 mmol/mol), according to

guidelines from various medical organizations including the ADA, American College of

Physicians, Association of Clinical Endocrinologists, and American College of

Endocrinology.

221,222,223,224

Based on the literature, this threshold serves as a "take action" point

in managing diabetes and has been used in previous studies to indicate poor glycemic control.

Achieving and maintaining target HbA1c levels is essential for individuals with diabetes (as well

as the general population) and is a key goal of treatment. Moreover, we note that for the

purposes of Quality Payment Program (QPP) measures, CMS has issued measures for diabetes

(e.g. Quality ID #1 (NQF 0059): Diabetes: Hemoglobin A1c (HbA1c) Poor Control (>9%)).

225

220

American Diabetes Association. “Standards of medical care in diabetes--2011.” Diabetes care vol. 34 Suppl

1,Suppl 1 (2011): S11-61. doi:10.2337/dc11-S011.

221

Liu, Longjian et al. “Burden of Uncontrolled Hyperglycemia and Its Association with Patients Characteristics

and Socioeconomic Status in Philadelphia, USA.” Health equity vol. 4,1 525-532. 30 Dec. 2020,

doi:10.1089/heq.2020.0076.

222

Qaseem, Amir et al. “Glycemic control and type 2 diabetes mellitus: the optimal hemoglobin A1c targets. A

guidance statement from the American College of Physicians.” Annals of internal medicine vol. 147,6 (2007): 417-

22. doi:10.7326/0003-4819-147-6-200709180-00012.

223

Cortez-Espinosa, Nancy et al. “Abnormal expression and function of Dectin-1 receptor in type 2 diabetes mellitus

patients with poor glycemic control (HbA1c>8%).” Metabolism: clinical and experimental vol. 61,11 (2012): 1538-

46. doi:10.1016/j.metabol.2012.03.020.

224

Hu, Huanhuan et al. “Hba1c, Blood Pressure, and Lipid Control in People with Diabetes: Japan Epidemiology

Collaboration on Occupational Health Study.” PloS one vol. 11,7 e0159071. 20 Jul. 2016,

doi:10.1371/journal.pone.0159071.

225

https://qpp.cms.gov/docs/QPP_quality_measure_specifications/CQM-

Measures/2023_Measure_001_MIPSCQM.pdf.

The measure is described as “Percentage of patients 18-75 years of age with diabetes who had

hemoglobin A1c > 9.0% during the measurement period.” Furthermore, measures of HbA1c

may fluctuate over time; therefore, a strict threshold could lead to incentives for multiple rounds

of testing in order to aim for the levels established. In general, guidelines exist, but standards

vary for defining diabetes states based on multiple severity measures.

In addition, the severity of periodontal disease is not uniformly defined. ICD-10 codes, such as

K05.2 for Aggressive Periodontitis and K05.3 for Chronic Periodontitis may be utilized to

describe more severe instances of periodontitis (and in this instance when such diagnosis codes

are also partnered with diagnoses related to diabetes for a particular individual). Another

approach involves using the Armitage criteria for periodontal diagnosis.

226,227

Severity

assessment can be based on the clinical attachment level (CAL), with CAL between 1 mm and 2

mm classified as slight, 3 mm and 4 mm as moderate, and ≥5 mm as severe.

228

Again, some

standards exist relative to the staging of periodontitis, but such criteria vary. Additionally, we

believe that the current practice of medicine would allow for variation in clinical attributes as

well as judgment and discernment by the referring practitioner regarding the clinical status of the

individual when determining the need for consultation with other practitioner types, including

the dentist. We seek comment on whether clinical standards exist that describe and define the

disease state of diabetes that would serve to inform the selection of treatment modalities,

including potential referrals to dental professionals with respect to concerns related to oral

health. We also seek comment from the public regarding the ways that CMS could ensure that

practitioners do not decrease the quality of diabetes treatment in an effort to maintain a

beneficiary’s potential access to Medicare payment for dental services.

226

Armitage, G C. “Development of a classification system for periodontal diseases and conditions.” Annals of

periodontology vol. 4,1 (1999): 1-6. doi:10.1902/annals.1999.4.1.1.

227

Caton, Jack G et al. “A new classification scheme for periodontal and peri-implant diseases and conditions -

Introduction and key changes from the 1999 classification.” Journal of clinical periodontology vol. 45 Suppl 20

(2018): S1-S8. doi:10.1111/jcpe.12935.

228

Pinho, M Morado et al. “Periodontitis and atherosclerosis: an observational study.” Journal of periodontal

research vol. 48,4 (2013): 452-7. doi:10.1111/jre.12026.

Evidence supplied by submitters also described periodontitis but without clear and

consistent definitional structure. The 2017 World Workshop on the Classification of Periodontal

and Peri-Implant Diseases and Conditions resulted in a new classification of periodontitis

characterized by a multidimensional staging and grading system. The staging considers the

aspects of severity, complexity, extent, and distribution while the grading contemplates primary

criteria such as progression and grade modifiers, including risk factors such as smoking and

diabetes.

229

For the purposes of our consideration of medical services for the treatment of diabetes for

individuals with diabetes who have periodontitis, we seek comment from the public on clinical

criteria that would determine eligibility for effectiveness of periodontal treatment as described in

the Cochrane review and other studies. We do not believe that a condition such as gingivitis or

early stages of periodontitis would require oral treatment that in turn would influence the

outcomes for an individual with diabetes. However, we seek information to address the

following questions. At what stages and grading would the periodontitis be considered advanced

and/or requiring dental and oral treatment intervention? What types of practitioners are able to

make determinations regarding the staging of periodontitis? We also seek comment on patient

eligibility. What determines patient eligibility for treatment for advanced periodontitis? Are

there other criteria for consideration?

Additionally, we seek comment on the duration of potential periodontal treatment. How

is the length of treatment determined? If a patient’s clinical status improves with respect to the

periodontal disease, what factors determine when periodontal treatment comes to an end? What

does maintenance treatment entail? What services are provided in treatment of advanced

periodontal disease? What is the service definition? Are services bundled? If yes, what is

included in the bundle? When are the services provided and over what period? Is it provided

229

Tables from Tonetti, Greenwell, Kornman. J Periodontol 2018;89 (Suppl 1): S159-S172.

https://www.perio.org/wp-content/uploads/2019/08/Staging-and-Grading-Periodontitis.pdf.

over a calendar month period? A single day? Multiple days? Are services timed? Who

provides the services? What specific terminology is involved? Are these services ever provided

under supervision? Or “incident to” by other clinical staff?

We also seek information on how services for advanced periodontal disease are provided.

Where and how are services for treatment of advanced periodontal disease provided? Are there

any special rules, such as obtaining advance consent or performance of an initiating visit?

We also seek information regarding coding and billing of periodontal services. What

coding is utilized for the treatment services for advanced periodontal disease? What claims

format is employed for the submission of claims with related oral and dental services (for

example, 837D and/or 837P)?

Additionally, we seek comment from the public regarding the risk of recurrence of

periodontal disease for this patient population. What is the level of risk for re-development of

advanced periodontitis and likelihood of recurrence?

We also seek information regarding the role of caries in management of diabetes. What

is the prevalence of caries in this patient population? What is the impact of caries on

management of diabetes?

We also seek information regarding the disease state of the diabetes itself and its

interaction with dental services. Does evidence exist to support that certain characteristics

related to diabetes management (for example, maintenance of HbA1c) are more closely tied to

certain oral interventions’ ability to yield clinical improvements?

We reiterate that section 1862(a)(12) of the Act generally precludes payment under

Medicare Parts A or B for any expenses incurred for services in connection with the care,

treatment, filling, removal, or replacement of teeth or structures directly supporting teeth. Thus,

payment is permitted only where the dental services are inextricably linked to covered medical

services. We believe that general maintenance and management of oral disease processes clearly

falls within the statutory exclusion and therefore Medicare would not permit payment for routine

dental and oral services.

We note that many submitters stated that good dental and oral health benefits a patient’s

overall health in general. Several commenters responding to the CY 2023 PFS proposed rule

also expressed that good oral hygiene, along with routine dental services, contributes to better

outcomes for patients. We recognized in the CY 2023 PFS final rule in response to those

comments that there is a great deal of evidence suggesting that dental health is generally an

important component of overall health; however, we are interested in comments on whether

certain dental services are considered so integral to the primary covered services that the

necessary dental interventions are inextricably linked to, and substantially related and integral to

clinical success of, the primary covered services such that they are not subject to the statutory

preclusion on Medicare payment for dental services under section 1862(a)(12) of the Act (88 FR

79033).

In summary, we seek comment on whether certain dental services are inextricably linked

to certain other covered services for diabetes, supported by clinical evidence as described in

section II.J.1.c. of this proposed rule. We also seek comment specifically on whether dental

services such as prophylaxis are a standard of care in the management of diabetes. We are

committed to continuing to explore the potential inextricable relationship between dental

services and covered medical services utilized in treatment for individuals with diabetes. We

thank submitters for the information they provided through the public submissions process and

may consider revisions to the clinical examples codified in our regulations at § 411.15(i)(3)(i)

based upon additional data and information received in response to this proposed rule.

4. Request for Comment on Dental Services Integral to Specific Covered Services to Treat

Systemic Autoimmune Disease Requiring Immunosuppressive Therapies

We have received information from submitters suggesting that certain dental services are

inextricably linked to immunosuppressive therapies for individuals with autoimmune disorders.

According to the NIH’s National Institute of Environmental Health Sciences, a healthy

immune system is able to defend the body against disease and infection. However, if the

immune system malfunctions, it may mistakenly attack healthy cells, tissues, and organs. This

scenario is called autoimmune disease, and these attacks can affect any part of the body, weaken

bodily function, and in some cases become life-threatening.

230

There are over 100 autoimmune

diseases, including Type 1 diabetes, multiple sclerosis, lupus, rheumatoid arthritis, and

inflammatory bowel disease. There are also other autoimmune diseases that are rare and difficult

to diagnose. In some cases, patients may suffer for years before receiving a proper diagnosis,

and most of these diseases have no cure. Additionally, some autoimmune diseases require

lifelong treatment for system management.

231

Autoimmune diseases are continuously affecting more people. Estimates indicate that as

many as 50 million people in the U.S. have an autoimmune disease, making it the third most

prevalent disease category, surpassed only by cancer and cardiac disease. Generally speaking, a

person’s genes in combination with infections and other environmental exposures likely play a

significant role in disease development, though in some instances pathology may be unknown.

Additionally, nearly 80 percent of people with a chronic autoimmune condition are women.

232

Symptoms of autoimmune diseases can include: fatigue, pain, dermatologic manifestations,

weight loss or gain, insomnia, fever, and myriad other symptoms.

233

Many treatment modalities are employed in the management of autoimmune diseases.

Treatments could include use of oral medications, including steroids, anti-inflammatory

medications, as well as infusion immunotherapy. Some autoimmune conditions may present in a

localized fashion, such as Sjogren’s, and many of the independent organ inflammations, require

immunosuppressive therapies, and may progress to a more systemic involvement. Conversely,

230

https://www.niehs.nih.gov/health/topics/conditions/autoimmune.

231

Ibid.

232

Ibid.

233

https://www.womenshealth.gov/a-z-topics/autoimmune-diseases.

some systemic autoimmune diseases, like sarcoidosis, may not require immunosuppression in

mild cases.

Submissions through the public submissions process urged us to provide that payment

can be made for dental services for individuals with autoimmune diseases receiving

immunosuppressive therapy. In submissions, several interested parties have asserted that

immunosuppressive therapies utilized in the treatment of autoimmune disease have similar

immunosuppressive effects as those of toxic chemotherapy utilized in the treatment of cancer

and that these treatments are analogous to the clinical examples finalized in CY 2024 PFS

rulemaking for dental services inextricably linked to covered medical services in the treatment of

cancer.

Submitters stated that oral and dental treatment is also often integral to the successful

care and management of beneficiaries with autoimmune diseases who are initiating or

undergoing immunosuppressive or immunomodulator therapy because the absence of medically

necessary oral and dental treatment can pose serious complications to those beneficiaries and the

covered medical services they receive. Submitters state that, for example, dental infections can

spread quickly when host immunity is compromised by immunosuppressing or

immunomodulating drugs utilized in treatment. As such, submitters note that the American

College of Physicians has described that the implications of dental disease in patients who are

undergoing immunosuppressive therapy extend beyond their oral disease, with potentially life-

threatening complications if the dental problems are not treated. For these reasons, submitters

state that the covered services upon which immunocompromised patients depend (for example,

immunosuppressive therapy) should not proceed until a dental or oral exam is performed to

address the oral complications and/or clear the patient of an oral or dental infection.

Submitters provided information regarding specific covered services that they believe

could be associated with treatments for immunosuppressive therapy for the treatment of

autoimmune disease and that may increase infection risk, such as:

● CPT codes 99212-99215: Evaluation and Management (E/M) Services.

● CPT codes 96365-96368: Infusion services.

Submitters also provided coding information related to drug therapies, such as CPT codes

for immunosuppressant drugs, including:

● J0129: Abatacept (Orencia) for Rheumatoid Arthritis.

● J0135: Adalimumad (Humira) for Crohn’s, Ulcerative Colitis, Rheumatoid Arthritis.

● J0490: Belimumab (Benlysta) for systemic lupus erythematosus (SLE), Lupus

Nephritis, and Sjögren’s.

● J0491: Anifrolumab-fnia (Saphnelo) for systemic lupus erythematosus (SLE).

● J1303: Ravulizumab-cwvz (Ultomiris) for Generalized Myasthenia Gravis.

● J1438: Etanercept (Enbrel) for Rheumatoid Arthritis, Ankylosing Spondylitis.

● J1595: Glatiramer (Copaxone) for Multiple Sclerosis.

● J1602: Golimumab (Simponi) for Rheumatoid Arthritis, UC, Ankylosing Spondylitis.

● J1745: Infliximab (Remicade) for Crohn’s, Ulcerative Colitis, Rheumatoid Arthritis.

● J2250: Upadacitinib (Rinvoq) for Rheumatoid Arthritis, Ulcerative Colitis, Crohn’s.

● J2323: Natalizumab (Tysabri) for Multiple Sclerosis.

● J2350: Ocrelizumab (Ocrevus) for Multiple Sclerosis.

● J3262: Tocilizumab (Actemra) for Scleroderma-associated lung fibrosis.

● J3357: Ustekinumab (Stelara) for Crohn’s, Ulcerative Colitis, Psoriatic Arthritis.

● J3380: Vedolizumab (Entyvio) for Crohn’s, Ulcerative Colitis.

● J3590: Secukinumab (Cosentyx) for Plaque Psoriasis.

● J7500: Azathioprine (Imuran) for Lupus, Crohn’s, Sjögren’s.

● J7517: Mycophenolate (Cellcept) for Lupus, Sjögren’s.

● J9070: Cyclophosphamide (Cytoxan) for Sjögren’s, Vasculitis.

● J9250: Methotrexate for Sjögren’s, Rheumatoid Arthritis (unresponsive to other

treatment).

● J9302: Ofatumumab (Kesimpta) for Multiple Sclerosis.

● J9312: Rituximab (Rituxan) for Rheumatoid Arthritis, Sjögren’s.

● J9332: Efgartigimod (Vyvgart) for Myasthenia Gravis.

Submitters also provided coding information for potential medical services for medical

treatment for pulmonary diseases when aspiration of dental pathogens risk or cause the initiation

and/or recurrence of complications, such as:

● CPT codes 99212-99215: Evaluation and Management (E/M) Services.

● CPT code 99291: Critical Care Services.

● DRG code 177: Hospitalization for respiratory infections and inflammation.

● DRG code 190: COPD with complications.

Submitters also provided coding regarding medical treatment for dentally sourced

dissecting maxillofacial space infections:

● CPT 41000: Intraoral incision and drainage of abscess.

● CPT 87181: Antibiotic susceptibility study.

● CPT 96365: Infusion of antibiotic.

● CPT codes 99281-99285: Emergency department services.

● CPT codes 99291-99292: Critical care services.

● DRG code 135: Sinus procedures with CC/MCC.

● DRG code 141: Major head and neck procedures with CC.

● DRG code 872: Hospitalization for septicemia or severe sepsis.

Submitters providing information through the public submissions process stated that if

dental or oral infections are left undetected or untreated in the population of individuals

undergoing immunosuppressive therapy for autoimmune disease, serious complications may

occur and negatively impact the course and outcome of the covered medical procedures, which

submitters state is analogous to previously finalized policies for dental services inextricably

linked to covered cancer treatment for the patient. Several submitters pointed out that we stated

in the CY 2024 PFS final rule that proceeding without a dental or oral exam of the mouth prior to

chemotherapy could lead to systemic infection or sepsis, among other complications, and that

similar outcomes can follow for those receiving immunosuppressive therapy to treat autoimmune

diseases.

The submitters noted that in the CY 2024 PFS final rule, we described that AHRQ

identified evidence to support that dental evaluation/treatment prior to cancer treatment led to

decreased incidence and/or less severity of serious oral infections and complications like oral

mucositis and encouraged CMS to explore this connection to confirm that dental evaluations and

treatment prior to immunosuppressive therapy would lead to decreased incidence of serious oral

infections in a similar fashion. The submitters also stated that they believe it is critical that

beneficiaries with an autoimmune disease that requires immunosuppressive therapy have access

to necessary dental services, as proper dental care for this population can reduce the incidence of

serious infection and improve overall patient outcomes for the covered service.

We appreciate the evidence and information provided by submitters and agree that we

should continue to research whether there is a connection between dental and oral evaluations

and treatment prior to immunosuppressive therapy and outcomes for said therapies, including the

potential decreased incidence of serious oral infections.

However, we seek comment on whether the level of immunosuppression utilized in the

treatment of autoimmune diseases is analogous to the immunosuppression levels employed in the

treatment of cancer. We believe that the level of immunosuppression for systemic autoimmune

disease has different characteristics versus therapies utilized in chemotherapy used in the

treatment of cancer. For example, the usage of monoclonal antibodies in the treatment of

autoimmune disease may not render the same level of immunosuppression and subsequent

susceptibility to infection as chemotherapy used in the treatment of cancer.

We also seek information on the connection between immunosuppressive therapy in the

treatment of autoimmune disease and the likelihood of systemic infection and sepsis.

Specifically, we seek information regarding the likelihood of dental and oral sources as the locus

of the seeding of infection in this patient population. Additionally, we seek information

regarding standards of care or clinical guidelines that recommend that a dental infection be

addressed before proceeding with the immunosuppressive treatment or the administration of

drugs or whether oral antibiotics would be prescribed to resolve the infection and that the therapy

would advance without direct dental or oral services to address the infection.

We also seek information regarding whether there is differential impact between drugs

that are administered in an office setting or similar versus those medications that are taken in an

oral fashion.

We thank submitters for the information they provided through the public submissions

process. We believe that additional information is necessary to consider whether there is an

inextricable link between dental services and covered services to treat systemic autoimmune

disease requiring immunosuppressive therapies and seek comment from the public. We remain

open to considering any such services identified by public commenters, and, if sufficient

evidence is presented, we may consider adding such services to § 411.15(i)(3) in the final rule.

5. Implementation of Payment for Dental Services Inextricably Linked to Other Specific

Covered Services

In the CY 2024 PFS final rule (88 FR 79035 through 79039), we solicited comments on

whether we should provide additional guidance that would aid in processing claims for dental

services that are inextricably linked to a Medicare-covered medical service. Some commenters

suggested the usage of a modifier on the dental claim format that would better identify when

dental services are inextricably linked to specific covered medical services. As we continue to

consider improvements to our payment policies and have gained experience around the provision

of dental services inextricably linked to covered medical services, we have explored tools and

resources that may help to facilitate the implementation and coordination of dental services that

are currently covered under Medicare, including the possible usage of modifiers and diagnosis

codes. The usage of modifiers on a dental claim would seek to identify the dental service as a

service the billing practitioner identifies as inextricably linked to a specific covered medical

service and for which there was an exchange of information, or integration, between the medical

and dental professional (physician, including a dentist, or other non-physician practitioner) as

specified in the CY 2023 PFS final rule (87 FR 69663 through 69688). We have explained that

if there is no exchange of information, or integration, between the medical professional

(physician or other non-physician practitioner) regarding the primary medical service and the

practitioner furnishing the dental services, then there would not be an inextricable link between

the dental and covered medical service within the meaning of our regulation at § 411.15(i)(3).

Furthermore, integration between medical and dental professionals can occur when these

professionals coordinate care. This level of coordination can occur in various forms such as, but

not limited to, a referral or exchange of information between the medical professional (physician

or non-physician practitioner) and the dentist. This coordination should occur between a dentist

and another medical professional (physician or other non-physician practitioner) regardless of

whether both individuals are affiliated with or employed by the same entity.

Currently, the KX modifier is submitted on a Medicare Part B claim to indicate that the

service or item is medically necessary, and that the healthcare provider has included appropriate

documentation in the medical record to support or justify the medical necessity of the service or

item. We believe that usage of the KX modifier in the context of claims for dental services

inextricably linked to covered services would be appropriate and support claims processing and

program integrity efforts.

Based on comments received and summarized in the CY 2024 PFS final rule (88 FR

79037), interested parties requested that we provide more guidance on how a practitioner

submitting claims for dental services can attest that the dental and medical services are

inextricably linked, and that the criteria have been met to support payment. We believe that the

use of the KX modifier would allow practitioners to signal that the dental services meet the

criteria to support payment. Also, use of the KX modifier may improve the MACs’ ability to

ascertain the volume of claims that are being submitted for dental services inextricably linked to

covered services.

Therefore we are proposing that, effective January 1, 2025, the KX modifier would be

required for claims submission for dental services inextricably linked to covered medical

services on both the dental claim format 837D and the professional claim format 837P. We are

proposing that practitioners who bill for dental services for which they seek payment in

accordance with § 411.15(i)(3) must include the KX modifier on the 837D or 837P claim to

indicate that they believe that the dental service meets the established payment criteria; that the

practitioner has included appropriate documentation in the medical record to support or justify

the medical necessity of the service or item and that demonstrates the inextricable linkage to

covered medical services; and that coordination of care between the medical and dental

practitioners has occurred. To help with this transition to potentially requiring use of the KX

modifier for claims submission for dental services inextricably linked to covered medical

services beginning in 2025, practitioners now have the option to utilize the KX modifier as

proposed, for services with dates of service in CY 2024. This optional usage in CY 2024 would

not be mandatory and would serve to support both clinician and MAC claims processing

activities. We intend to provide additional instruction and education through subregulatory

guidance regarding this voluntary phase of the usage of the KX modifier on claims submitted for

dental services inextricably linked to covered medical services. We seek comment on all aspects

of this proposal.

While the KX modifier indicates that the services are medically necessary, the GY

modifier (along with three other HCPCS denial modifiers) serves to indicate that a service is not

covered because it is outside of the scope of Medicare coverage authorized by the statute. We

reiterate that denial modifiers should be used when physicians, practitioners, or suppliers want to

indicate that the item or service is statutorily non-covered.

Use of the GY modifier could support MAC efforts to adjudicate claims and remove from

the claims processing pipeline those claims that do not require further processing. We are

seeking comment on whether we should recommend the usage of the GY modifier on the 837D

or 837P dental claim format in instances where a Medicare claim denial is sought for purposes of

submission to third party payers or when the service does not fit within a Medicare benefit

category and is statutorily excluded from coverage.

Additionally, in general, the Act and our regulations mandate the submission of

diagnostic coding (for example, ICD-10 codes) on Medicare claims. Section 1842(p)(1) of the

Act states that “each request for payment, or bill submitted, for an item or service furnished by a

physician or practitioner specified in subsection (b)(18)(C) for which payment may be made

under this part shall include the appropriate diagnosis code (or codes) as established by the

Secretary for such item or service.” Under this section, each bill or request for payment for

physicians’ services under Medicare Part B must include the appropriate diagnostic code “as

established by the Secretary” for each item or service for which the Medicare beneficiary

received treatment. In the March 4, 1994 final rule entitled Medicare Program; Diagnosis

Codes on Physician Bills, we codified that each bill or request for payment for a service

furnished by a physician under Medicare Part B must include appropriate diagnostic coding for

the diagnosis or the symptoms of the illness or injury for which the Medicare beneficiary

received care and revised our regulations at § 424.32, Basic requirements for all claims, to state

specifically that a claim for physician services must include appropriate diagnostic coding using

diagnostic information (59 FR 10290).

Additionally, in the CY 2023 PFS final rule, we stated that dentists are included in the

statutory definition of physician at section 1861(r)(2) of the Act and would generally be

considered and treated as a physician for purposes of enrollment, compliance, and other

administrative programs (87 FR 69673). Therefore, dentists, who are physicians for the purposes

of the Medicare program, are required to submit diagnosis codes on claims for physician services

as described in the statute and regulations. Furthermore, we note that diagnosis code information

is currently required on the submission of the professional claim form 837P; professional claims

lacking such information are returned to the healthcare provider and are not processed.

In the CY 2023 PFS final rule (87 FR 69679 through 69680), we acknowledged the need

to address and clarify certain operational issues related to Medicare payment for dental services

inextricably linked to covered services and noted that we were working to address these issues,

including claims processing questions raised by the commenters. We stated that we anticipated

resolving many of the additional operational issues raised by commenters potentially as soon as

CY 2024, including efforts to adopt the dental claim form (837D). Similarly, in the CY 2024

PFS final rule (88 FR 79036), we stated that we continue to work to address issues raised by

commenters, such as questions related to claims processing and efforts to accommodate the

dental claim form within our claims processing systems, effective 2024. The efforts related to

adopting the dental claim form are ongoing, and as efforts advance to address the

implementation and functionality of claims processing systems for the dental claim form, we

intend to provide appropriate guidance and education to interested parties.

We anticipate that our systems will be able to process claims submitted using the dental

claim form 837D (OMB Control No. 0938-1471) by January 1, 2025. Consistent with the

statutory and regulatory requirements discussed above, we intend to require a diagnosis code to

be included on claims submitted for physicians’ services for dental services inextricably linked

to covered medical services on both the 837P and 837D formats, beginning on January 1, 2025.

However, given the complexities related to the operational launch of and transition to the 837D

dental claims format, we are also considering further delaying the requirement to include a

diagnosis code on the 837D form. For example, interested parties have indicated that in current

dental practice, claims processing systems may not require the submission of a diagnosis code on

claims for dental services, and therefore dental practices may need time to adjust to this

requirement for the 837D form. We believe that it may be appropriate to delay this requirement

for a limited time to support clinicians and billing entities as they seek to change their workflows

and transition to using the 837D form. We seek comment on our intention to require the

inclusion of a diagnosis code on the 837D form beginning on January 1, 2025. We are

particularly interested in any operational challenges that interested parties may face in attempting

to comply, as well as other considerations that we should take into account with regard to the

timing of this requirement.

In the CY 2023 PFS final rule, we stated that we believed that MACs are appropriately

situated to establish contractor prices for dental services inextricably linked to covered services

until we have additional pricing data that could enable national pricing (87 FR 69680).

Therefore, dental services inextricably linked to covered services are currently contractor priced.

However, we have received feedback from the MACs regarding pricing information for dental

services inextricably linked to covered services, and the MACs have requested information that

would support their efforts to assign payment amounts for such dental services. The MACs

retain broad flexibility with respect to assigning payment amounts to claims for dental services

inextricably linked to covered services; however, we seek to facilitate the sharing of available

pricing information with the MACs for these purposes. Thus, we seek comment from the public

on potential sources of payment information for the pricing of dental services inextricably linked

to covered services. We note, for example, that publicly available data (such as Fair Health cost

data) are available for purchase; however, we understand that this information may not directly

inform payment amounts in a manner useful for the payment of Medicare claims for dental

services. According to Fair Health’s website, cost estimate information is based on claims for

medical and dental services paid for by private insurance plans, including the country's largest

insurers.

234

We are also aware of other fee schedules, such as those used by state governments

for state employees, or discount fee schedules, such as discount dental programs (for example,

https://www.dentalbenefitprogram.com/groupfees.php?id=NEV). We aim to support the

234

https://www.fairhealthconsumer.org/#answer2; Accessed May 22, 2024.

ongoing efforts by the MACs to price these services and seek any information from the public

that may serve to support and inform the MAC development of payment amounts for dental

services inextricably linked to covered services.

6. Request for Information: Services Associated with Furnishing Oral Appliances Used for the

Treatment of Obstructive Sleep Apnea

Section 1861(s) of the Act defines the term “medical and other health services” that may

be covered under Medicare, including physicians’ services under section 1861(s)(1), services and

supplies furnished incident to a physician’s professional service under section 1861(s)(2)(A), and

durable medical equipment (DME) under section 1861(s)(6) of the Act.

235

In addition to the statutory definition of DME, § 414.202 of our regulations defines DME

as equipment furnished by a supplier or a home health agency that meets the following

conditions:

• Can withstand repeated use.

• Effective with respect to items classified as DME after January 1, 2012, has an

expected life of at least 3 years.

• Is primarily and customarily used to serve a medical purpose.

• Generally is not useful to an individual in the absence of an illness or injury.

• Is appropriate for use in the home.

For items to be considered DME, all five criteria of the definition must be met. The CMS

policies for determining whether an item meets the definition of DME are further outlined in the

Medicare Benefit Policy Manual (CMS Pub. 100-02), Chapter 15, section 110.1. With respect to

the first and second criteria, DME items must be able to withstand repeated use in the home,

potentially by successive patients.

Different types of oral appliances are fabricated and furnished by licensed dentists (DDS

or DMD) to reposition oral and pharyngeal tissues in an effort to create and maintain a patient's

airway during sleep for treatment of obstructive sleep apnea. Obstructive sleep apnea is a

medical disorder in which a person frequently stops breathing during sleep. It results from an

235

https://www.ssa.gov/OP_Home/ssact/title18/1861.htm.

obstruction of the upper airway during sleep that occurs because of inadequate motor tone of the

tongue and/or airway dilator muscles. A treating practitioner may prescribe use of an oral

appliance as the first line of treatment for obstructive sleep apnea, or in cases where other

treatments, such as use of a continuous positive airway pressure (CPAP) device and/or bi-level

positive airway pressure device have been tried and failed.

The following two HCPCS Level II codes were established effective January 1, 2006, for

these devices:

● E0485 “Oral device/appliance used to reduce upper airway collapsibility, adjustable or

non-adjustable, prefabricated, includes fitting and adjustment”.

● E0486 “Oral device/appliance used to reduce upper airway collapsibility, adjustable or

non-adjustable, custom fabricated, includes fitting and adjustment”.

A very limited subset of custom fabricated oral appliances used to treat obstructive sleep

apnea (HCPCS code E0486) have been covered for Medicare beneficiaries by the Durable

Medical Equipment Medicare Administrative Contractors (DME MACs) under the DME benefit.

These devices are considered durable equipment by the DME MACs because of the presence of

a fixed mechanical hinge.

An additional HCPCS code was established effective April 1, 2022, to describe custom

fabricated oral appliances without a fixed mechanical hinge:

● K1027 “Oral device/appliance used to reduce upper airway collapsibility, without

fixed mechanical hinge, custom fabricated, includes fitting and adjustment”.

The DME MACs have not covered any of the prefabricated devices (HCPCS code

E0485) based on a determination that there is insufficient evidence to support that these items are

effective therapy for obstructive sleep apnea. The DME MAC Local Coverage Determination

for the devices is available at https://www.cms.gov/medicare-coverage-

database/view/lcd.aspx?lcdId=33611&ver=25.

For several years, manufacturers of products without fixed mechanical hinges that

dentists use in custom fabricating oral appliances have raised concerns regarding why their

versions of the custom fabricated oral appliances have not been classified as DME. There have

been an increasing number of requests for HCPCS codes and Medicare benefit category

determinations from several different manufacturers of these products. Using the public meeting

consultation process outlined in regulations at § 414.240, we obtained public consultation

regarding these various products. National Medicare benefit category determinations have not

been established for these appliances because we have not been able to confirm that any of the

custom fabricated devices can withstand repeated use. As indicated above, equipment must be

able to withstand repeated use in order to be classified as DME, which means they are items that

can normally be rented and used by successive patients (repeated use).

We are not aware of any oral appliances used to treat obstructive sleep apnea, regardless

of whether they include a fixed mechanical hinge, that are prefabricated, or custom fabricated,

and can withstand repeated use. These are oral appliances that do not seem to be the kind of

equipment that could potentially be rented and used by successive patients. In addition, national

fee schedule amounts have not been established for the devices with the mechanical hinge

because of complexities related to pricing of the professional services of the dentist that are

integral to the fabrication and furnishing of the device. The DME MACs have been paying

claims for devices they have been covering as DME under code E0486 using local fee schedule

amounts. Before making a final determination regarding whether these devices could be

classified as DME, we are requesting information that would help us determine if oral appliances

used to treat obstructive sleep apnea can withstand repeated use (furnished as rental equipment

for use by successive patients).

As described in section II.J.1.a. of this proposed rule, section 1862(a)(12) of the Act

generally precludes payment under Medicare Parts A or B for any expenses incurred for services

in connection with the care, treatment, filling, removal, or replacement of teeth or structures

directly supporting teeth. Oral sleep apnea appliances and similar appliances are used in the

direct treatment of sleep apnea. A treating practitioner may prescribe the use of an oral sleep

apnea appliance as the first line of treatment for obstructive sleep apnea, a medical condition, or

in instances where other treatments, such as use of a CPAP device and/or bi-level positive airway

pressure device have been tried and failed. Therefore, we believe that these appliances and

related services, while utilized in the mouth and situated on the teeth, would not be considered

services in connection with the care, treatment, filling, removal, or replacement of teeth or

structures directly supporting the teeth. Rather, we believe that oral sleep apnea appliances,

when prescribed by a practitioner for the treatment of a medical condition such as obstructive

sleep apnea, as medically reasonable and necessary and therefore may be payable by Medicare.

Further, we believe that payment for oral sleep apnea appliances would not fall within the

payment policy for dental services inextricably linked to covered medical services, as the

appliances are not services for dental care, but are instead services and supplies for the purposes

of directly treating a medical condition unrelated to teeth or structures directly supporting the

teeth (for example, sleep apnea).

The statutory definition of physician includes a doctor of dental surgery or of dental

medicine in section 1861(r)(2) of the Act, and, to the extent payment for dental services is not

precluded under section 1862(a)(12) of the Act, medically necessary services furnished by a

dentist may be covered and paid as physicians’ services under section 1861(s)(1) and (2), and

section 1848 of the Act.

We are requesting information regarding the types of services furnished by a dentist or

other practitioner related to oral sleep apnea appliances. Specifically, we are seeking

information regarding details that may inform or support a future proposal regarding a code

assignment for services related to oral sleep apnea appliances under the Medicare physician fee

schedule.

We are requesting details and information regarding the services related to the

furnishment of oral appliances used to treat obstructive sleep apnea, as described in the questions

below:

● Patient eligibility criteria: to whom is the service related to the furnishing of oral

appliances being provided? How is the nuisance snorer differentiated from the medical

condition of sleep apnea? What criteria are used to determine whether the provision of these

services may be medically reasonable and necessary?

● Services provided: What is the service definition for oral sleep apnea appliances? Is a

bundle of services provided? If yes, what services are included in the bundle? What does the

process for evaluating, furnishing, and fitting of oral sleep apnea appliances involve? What work

is involved? Which elements of the services are essential (particularly in terms of what work is

essential to the effectiveness of the device)? What are the costs associated with providing these

services? What are the payment amounts for these services?

● Timing of services: What is the service period? Are the services provided over a

period of time? Are services timed in any way?

● Practitioner type: Who provides these services? What credentialing is required? Is

supervision required? Who would be billing for these services? Would incident to payment

policy rules apply?

● Location of services: Where and how are services for oral sleep apnea appliances

provided? Are all services provided in an in-person setting? Does the patient have to be present

for all elements of this service? Does the service involve direct contact with the patient in each

instance?

● Considerations for Telehealth: Are any of these services provided, or capable of being

provided, via telehealth?

● Site of service: Can services related to oral sleep apnea appliances be provided by

hospital-based physicians?

● Other considerations: What billing procedures exist for these oral sleep apnea

appliances? What existing and/or additional coding may currently describe these types of

services? In addition to the HCPCS Level II codes described above (for example, E0485 and

E0486), we believe that the CDT codes D9947 through D9957 may describe both the fabrication

of the appliance as well as services provided during and after fabrication.

We will review any information provided by the public and consider potential

refinements to PFS payment policy accordingly. We reiterate that we do not believe the

evaluation services or fabrication and fitting of oral sleep apnea appliances by dentists or other

physicians or non-physician practitioners would be subject to the prohibition on payment for

dental services under section 1862(a)(12) or the payment policy for dental services inextricably

linked to covered services. However, we seek information regarding the services associated with

the provision of these appliances and may consider code creation or other refinements in the

context of the Medicare physician fee schedule. Additionally, we note that as described in

section II.C. of this proposed rule, individuals and groups may nominate codes that they believe

may be potentially misvalued codes through our public nomination process for potentially

misvalued codes, which was established in the CY 2012 PFS final rule with comment period (76

FR 73026, 73058 through 73059). Individuals could consider nominating codes related to oral

sleep apnea appliances for consideration under this process. Nominations may be submitted to

CMS in one of two ways: via email or through postal mail. Email submissions should be sent to

the CMS email box at [email protected], with the phrase

“Potentially Misvalued Codes” and the referencing CPT code number(s) and/or the CPT

descriptor(s) in the subject line. Physical letters for nominations should be sent via the U.S.

Postal Service to the Centers for Medicare & Medicaid Services, Mail Stop: C4–01–26, 7500

Security Blvd., Baltimore, Maryland 21244. Envelopes containing the nomination letters must

be labeled “Attention: Division of Practitioner Services, Potentially Misvalued Codes.”

Nominations for consideration in our next annual rule cycle should be received by our February

10th deadline.

K. Payment for Skin Substitutes

In the CY 2023 PFS proposed rule (87 FR 46027 through 46029), we outlined several

objectives related to refining skin substitute policies under Medicare, including: (1) ensuring a

consistent payment approach for skin substitute products across the physician office and hospital

outpatient department settings; (2) ensuring that appropriate HCPCS codes describe skin

substitute products; (3) using a uniform benefit category across products within the physician

office setting, regardless of whether the product is synthetic or comprised of human or animal-

based material, to incorporate more consistent payment methodologies; and (4) maintaining

clarity for interested parties on CMS skin substitutes policies and procedures. When considering

potential changes to policies involving skin substitutes, we noted that we believe it would be

appropriate to take a phased approach over multiple rulemaking cycles to examine how we could

appropriately incorporate skin substitutes as supplies under the PFS ratesetting methodology.

After receiving feedback from commenters requesting more information on how CMS intends to

achieve a consistent payment approach for skin substitute products, we did not finalize any

policies in the CY 2023 PFS final rule.

In alignment with our objectives, in the CY 2024 PFS final rule, we solicited comments

on different approaches CMS could use to identify appropriate practice expense (PE) direct costs

for skin substitute products, such as reviewing various sources for price information, including

performing market research, reviewing invoices submitted by interested parties, or cost

information on Medicare claims. Discussing these approaches in the CY 2024 PFS final rule

provided interested parties with more details about payment mechanisms CMS is considering

under our PFS ratesetting methodology.

The CY 2024 PFS proposed rule did not contain a specific proposal for changing how

skin substitute products are paid under the PFS; however, we continue to pursue our objectives

for refining skin substitute payment policies under Medicare, as mentioned above. More

specifically, we continue examining ways to treat skin substitute products as incident-to supplies

under the PFS ratesetting methodology. Additionally, we believe continuing this dialogue with

interested parties on payment for skin substitute products will help inform potential policy

changes for future rulemaking.

We recognize that skin substitute products may vary in composition, size, and

applicability and will continue to consider these distinct characteristics in proposing a consistent

payment approach and policy. We also note an increase in HCPCS Level II coding request

applications for newly developed skin substitute products and are considering broadly all of our

relevant payment policies. Such policies, for example, include the discarded drug refund policy

and the Part B drug inflation rebate policy and how these policies may align with the usage and

payment for skin substitute products. In the CY 2024 PFS final rule (88 FR 79060 through

79061), we finalized that billing and payment codes that describe products currently referred to

as skin substitutes are not counted for identifying refundable drugs for calendar quarters during

2023 and 2024. While we continue to consider making changes to the Medicare Part B payment

policies for such products, similar to last year, for CY 2025, we are proposing that billing and

payment codes that describe products currently referred to as skin substitutes would not be

counted for purposes of identifying refundable drugs for calendar quarters in 2025. We plan to

revisit discarded drug refund obligations for skin substitutes in future rulemaking. In section

III.I. of this proposed rule, CMS is proposing to codify existing policy by including products

currently referred to as skin substitutes on the list of product categories that are not considered

Part B rebatable drugs in proposed § 427.101(b)(5).

III. Other Provisions of the Proposed Rule

A. Drugs and Biological Products Paid Under Medicare Part B

1. Requiring Manufacturers of Certain Single-Dose Container or Single-Use Package Drugs to

Provide Refunds with Respect to Discarded Amounts (§§ 414.902 and 414.940)

a. Background

Section 90004 of the Infrastructure Investment and Jobs Act (Pub. L. 117-58, November

15, 2021) (hereinafter referred to as “the Infrastructure Act”) amended section 1847A of the Act

to redesignate subsection (h) as subsection (i) and insert a new subsection (h), which requires

manufacturers to provide a refund to CMS for certain discarded amounts from a refundable

single-dose container or single-use package drug (hereinafter referred to as “refundable drug”)

for calendar quarters beginning January 1, 2023.

In the CY 2023 PFS final rule (87 FR 69710 through 69734), we finalized many policies

to implement this provision. First, we finalized the requirement that billing providers and

suppliers report the JW modifier for all separately payable drugs and biologicals (hereinafter

referred to as “drugs”) with discarded drug amounts from single use vials or single use packages

payable under Part B, beginning January 1, 2023 (87 FR 69719). We also finalized the

requirement that billing providers and suppliers report the JZ modifier for all such drugs with no

discarded amounts beginning no later than July 1, 2023, and we stated that we would begin

claims edits for both the JW and JZ modifiers beginning October 1, 2023 (87 FR 69718 through

69719). After the issuance of the CY 2023 PFS final rule, CMS published a JW Modifier and JZ

Modifier Policy Frequently Asked Questions (FAQ) document

236

to provide further guidance on

the correct use of these modifiers.

Second, we adopted a definition of “refundable single-dose container or single-use

package drug” at § 414.902, which also specifies exclusions from this definition (87 FR 69724).

These three exclusions are: radiopharmaceutical or imaging agents, certain drugs requiring

236

https://www.cms.gov/medicare/medicare-fee-for-service-payment/hospitaloutpatientpps/downloads/jw-modifier-

faqs.pdf.

filtration, and drugs approved by FDA on or after November 15, 2021 for which payment has

been made under Part B for fewer than 18 months.

Third, regarding reports to manufacturers, we specified that we would send reports

(including information described in section 1847A(h)(1) of the Act) for each calendar quarter, on

an annual basis, to each manufacturer of a refundable drug (87 FR 69726).

Fourth, we finalized how the refund amount will be calculated, which is specified in

regulation at § 414.940 (87 FR 69731). We stated we would issue a preliminary report based on

available claims data from the first two quarters of CY 2023 to provide manufacturers

information regarding discarded amounts of refundable drugs prior to the initial refund report (87

FR 69725). In these reports, which were sent in December of 2023, we included preliminary

information on estimated discarded amounts of refundable drugs for each labeler code based on

available claims data from the first 2 quarters of CY 2023 for any refundable drug for which

discarded units were billed using the JW modifier. More information about discarded drugs,

including the discarded drug refund and the JW and JZ modifier policy, can be found at

https://www.cms.gov/medicare/payment/part-b-drugs/discarded-drugs.

Fifth, we addressed drugs with unique circumstances for which we can, through notice-

and-comment rulemaking, increase the applicable percentage otherwise applicable for

determining the refund. Section 1847A(h)(3)(B)(ii) of the Act provides that, in the case of a

refundable drug that has unique circumstances involving similar loss of product as that described

in section 1847A(h)(8)(B)(ii) of the Act, the Secretary may increase the applicable percentage

otherwise applicable as determined appropriate by the Secretary. We adopted an increased

applicable percentage of 35 percent for drugs reconstituted with a hydrogel and with variable

dosing based on patient-specific characteristics (87 FR 69731). Lastly, we adopted a dispute

resolution process through which manufacturers can challenge refund calculations, and we

established enforcement provisions, including manufacturer audits, provider audits, and civil

money penalties required by statute (87 FR 69732 through 69734).

In the CY 2024 PFS final rule (88 FR 79047 through 79064), we finalized the date of the

initial refund report to manufacturers, the date for subsequent reports, method of calculating

refunds for discarded amounts in lagged claims data, method of calculating refunds when there

are multiple manufacturers for a refundable drug, increased applicable percentages for certain

drugs with unique circumstances, and a future application process by which manufacturers may

apply for an increased applicable percentage for a drug, which would precede proposals to

increase applicable percentages in rulemaking.

We also finalized that drugs separately payable under Part B from single-dose containers

that are furnished by a supplier who is not administering the drug are required to be billed with

the JZ modifier, since we believe it is unreasonable to collect discarded drug data from

beneficiaries. We were concerned that claim rejections may occur in the absence of a claims

modifier to designate that a drug was dispensed, but not administered, by the billing supplier.

b. Application for increased applicable percentage

Section 1847A(h)(3)(B)(ii) of the Act permits the Secretary to increase the applicable

percentage for a refundable drug that has unique circumstances through notice and comment

rulemaking. In the CY 2024 PFS final rule (88 FR 79057 through 79060), we finalized an

application process (CMS-10835, OMB 0938-1435) by which manufacturers could apply for an

increased applicable percentage for a drug and may request that we consider an individual drug

to have unique circumstances for which an increased applicable percentage is appropriate. We

explained that manufacturers could benefit from a formal process through which they can

provide information, including that which may not be publicly available, in order to request an

increase in their refundable drug’s applicable percentage and provide justification for why the

drug has unique circumstances for which such an increase is appropriate, including in the case of

a drug with an applicable percentage that has already been increased by virtue of its unique

circumstances. We finalized the application deadline of February 1 of each year, adopted a

deadline of August 1 for the FDA-approval of the drug and the deadline for notifying and

submitting the FDA-approved label to CMS of September 1 of the year before the year in which

the increased applicable percentages would apply. We codified this process in regulation at §

414.940(e). The application process requires the applicant to provide a written request

comprising FDA-approved labeling for the drug; justification for the consideration of an

increased applicable percentage based on such unique circumstances; and justification for the

requested increase in the applicable percentage.

We received one application for increased applicable percentage for CY 2025 from the

manufacturer of Leukine

(sargramostim). Leukine

is a leukocyte growth factor that is

primarily used in hematological malignancies to increase white blood cell counts. The applicant

submitted the information required under § 414.940(e)(1), including its justification for

consideration for increased applicable percentage, and justification for the requested applicable

percentage of 72 percent. The applicant did not submit FDA-approved labeling for the drug for

the particular adjuvant uses described in the application (further described below in this

paragraph) due to ongoing cancer vaccine adjuvant trials. The applicant states that there are

several manufacturers in late-stage (Phase II and Phase III) development using Leukine

as a

vaccine adjuvant in oncology indications, specifically in stimulating the immune response of

dendritic cells when used alongside these vaccines. Cancer treatment vaccines are different from

the vaccines that work against viruses (for example, influenza). These vaccines try to get the

immune system to mount an attack against cancer cells in the body. Instead of preventing

disease, they are meant to get the immune system to attack a disease that already exists.

237

The

applicant stated that it has no ownership stake in the development of these vaccines and does not

possess control or influence over the design and execution of the clinical trials. The estimated

completion dates for Phase III clinical trials vary, with the earliest expected in March 2025

238

and the latest in March 2029.

239

The adjuvant use of Leukine

in predetermined dosage

237

https://www.cancer.org/cancer/managing-cancer/treatment-types/immunotherapy/cancer-vaccines.html.

238

https://clinicaltrials.gov/study/NCT04229979.

239

https://clinicaltrials.gov/study/NCT05100641.

introduces a new use of the drug that is distinct from its six FDA-approved indications, all of

which have dosages that are based on body weight or body surface area (BSA). The adjuvant

use dosages of Leukine

in clinical trials are generally much smaller than dosages for indications

in the FDA-approved labeling. The smallest dose of Leukine

used for vaccine adjuvant

purposes of which the applicant is aware (that is, 70 mcg) would lead to as much as 72 percent of

the drug being discarded from a single-dose 250 mcg lyophilized vial, which is the only size

available commercially. The applicant suggested that if use of these small doses were to become

more common, the percentage of discarded units could increase the discarded drug refund

amount that could be owed by the applicant, even though the applicant lacks control or

knowledge of the potential variability of the discarded amounts that may occur if Leukine

were

used for such purposes. If an FDA approval for adjuvant use of Leukine

were to occur by

another manufacturer, the available presentations of Leukine

would likely not be optimized for

the small doses being studied in these trials.

As part of CMS’s review of the application, we analyzed existing claims data from the

first quarter of 2023 through the first quarter of 2024 and found the percentage of units discarded

for the Healthcare Common Procedure Coding System (HCPCS) code for Leukine

(J2820)

ranged from 1.2 percent to 3.8 percent, which is below the applicable percentage of 10 percent.

Since we do not yet know the impact of a new adjuvant indication with a type of immunotherapy

commonly referred to as cancer vaccines

240

on the current percentage of units discarded, we are

not proposing an increased applicable percentage without additional information. Because it is

not yet known whether Leukine

will be approved for additional indications with varying dosage

requirements and the information provided by the applicant; and available data does not provide

enough information for CMS to determine whether Leukine

has unique circumstances that

would prompt an increase in the applicable percentage, we are not proposing an increase in the

applicable percentage for the drug at this time.

240

https://www.cancerresearch.org/treatment-types/cancer-vaccines.

The applicant may reapply in a future application cycle when more information becomes

available.

c. Clarifications for the definition of refundable single-dose container or single-use package drug

(1) Exclusions for drugs for which payment has been made under Part B for fewer than 18

months

Section 1847A(h)(8)(B)(iii) of the Act excludes from the definition of refundable drug a

drug approved or licensed by FDA on or after November 15, 2021, and for which payment has

been made under Part B for fewer than 18 months. This is codified in the definition of

refundable single-dose container or single-use package drug in § 414.902. In the CY 2023 PFS

final rule (87 FR 69720 through 69731), we finalized that the 18-month period begins on the first

day of the calendar quarter following the date of first sale as reported to CMS for the first

National Drug Code (NDC) assigned to the HCPCS code. We expected that the first date of sale

would approximate the date of payment of the first Part B claim, and we finalized that we would

use the first date of sale because it is more operationally feasible than identifying the date when

the first Part B claim was paid for a new drug. We did not receive any opposing comments to

this approach when the policy was proposed (87 FR 69719 through 69724). Since then,

however, we have found one instance where the date of first sale for a drug, as reported to CMS,

does not adequately approximate the first date for which payment was made under Part B.

We propose that, while we would continue to use the first date of sale reported to CMS

for most refundable drugs, we would use the date on which the drug is first paid under Part B if

the date of first sale as reported to CMS does not adequately approximate the first date of

payment under Part B due to an applicable National Coverage Determination (NCD). Under the

exception, the first date for which the drug is actually paid under Part B (not the date of first sale)

would be used to determine the beginning of the 18-month exclusion period.

For example, in the case of Leqembi

(lecanemab-irmb), the second drug targeting

cerebral amyloid-beta plaques in Alzheimer’s disease to receive FDA approval, the first date of

sale reported to CMS via the Average Sales Price (ASP) portal was in January 2023, as it was

marketed and sold under accelerated approval granted on January 6, 2023. However, because

Leqembi

is subject to the NCD for Monoclonal Antibodies Directed Against Amyloid for the

Treatment of Alzheimer’s Disease under coverage with evidence development (CED),

241

and

because Leqembi

was initially marketed and sold under accelerated approval, Leqembi

coverage under Part B required the product to be furnished in a randomized controlled trial

(RCT) conducted under an investigational new drug (IND) application.

242

In public comments

on the CY 2024 proposed rule, the manufacturer of Leqembi

explained that Leqembi

’s Phase

III confirmatory trial was already fully enrolled and complete prior to FDA granting accelerated

approval, and as such, there was no RCT in which to enroll Medicare beneficiaries. Leqembi

received traditional approval on July 6, 2023. The first Part B payments for Leqembi

did not

occur until after traditional FDA approval of the drug on July 6, 2023, and Medicare paid for the

drug beginning that month in CED studies using a registry.

243

Under policies finalized in the CY

2023 PFS final rule, the 18-month exclusion period for Leqembi

would begin on April 1, 2023,

which marks the first day of the calendar quarter after the drug’s first date of sale as reported to

CMS in January 2023. We believe that, in this situation, our current policy of using the date of

first sale as reported in ASP data does not adequately approximate the beginning of the 18-month

period for which payment has been made for the drug under Part B.

Under this proposed rule, the 18-month exclusion for Leqembi

would be October 1,

2023, through March 31, 2025 (that is, six full calendar quarters following the date that the drug

was first paid under Medicare Part B).

To maintain operational feasibility of this provision and better align the policy with

statutory language when the date of first sale reported to CMS does not adequately approximate

241

Section 200.3 of the Medicare National Coverage Determinations Manual.

242

https://www.cms.gov/medicare/coverage/coverage-evidence-development/monoclonal-antibodies-directed-

against-amyloid-treatment-alzheimers-disease-ad.

243

https://www.cms.gov/newsroom/press-releases/statement-broader-medicare-coverage-leqembi-available-

following-fda-traditional-approval.

the date of first payment under Medicare Part B, we are proposing to amend the exclusions in the

definition of refundable single-dose container or single-use package drug at § 414.902. We note

that we are also proposing to revise the structure of the definition of Refundable single-dose

container or single-use package drug and as part of that restructuring, we are proposing that

exclusions would be defined at paragraph (2) of the definition. Moreover, we are proposing to

add a fourth exclusion to paragraph (2) to address drugs for which the date of first sale does not

adequately approximate the first date of payment under Part B due to an applicable NCD. We

anticipate that instances of inadequately approximating the date of first payment under Medicare

Part B based on the date of first sale due to an applicable NCD will be rare, as coverage of a drug

under Part B is not often restricted by an NCD.

(2) Clarification for identifying single-dose containers

In the CY 2023 PFS final rule (87 FR 69719), we finalized that the definition of

refundable drug would apply to drugs paid under Medicare Part B (that is, under any payment

methodology) that are described in FDA-approved labeling as being supplied in a “single-dose”

container or “single-use” package. This definition also includes drugs described in FDA-

approved labeling as a part of a “kit” that is intended for a single dose or single use. We also

finalized that for a drug to meet the definition of refundable drug, all NDCs assigned to the

drug's billing and payment code must be single-dose containers, as described in each product's

labeling.

During our analysis in identifying refundable drugs for the preliminary reports (which are

based on available JW modifier data from the first and second quarters of 2023), we learned that

some product labeling

244

does not specify the package type terms (for example, whether the

product is supplied in a single-dose or single-use package or a multiple-dose preparation). This

may occur in drugs that were approved prior to October 2018 because at that time, FDA issued

244

“Product labeling” in this document means the container label, carton labeling, or prescribing information.

guidance

245

regarding the selection of the appropriate package terms to address bacterial and

viral infections among patients resulting from improper use of single-dose containers such as

vials, ampules, and prefilled syringes. The guidance defines a single-dose container as a

container of a sterile medication for parenteral administration (injection or infusion) that is not

required to meet the antimicrobial effectiveness testing requirements. The guidance further

states a single-dose container is designed for use with a single patient as a single

injection/infusion and, when space permits, the label should include the correct package type

term and appropriate discard statements. Discard statements include instruction for discarding

or, if appropriate, storage guidance for drugs remaining after preparation. The guidance defines

a multiple-dose container as a container of sterile medication for parenteral administration that

has met antimicrobial effectiveness testing requirements or is excluded from such testing

requirements. In addition, the guidance defines the term “single-patient-use” container, which

describes a package that contains multiple doses of an injectable medical product that is intended

to be used in a single patient.

Some drugs approved prior to the release of this guidance (that is, those prior to October

2018) and some Orphan drugs do not include the package type terms and explicit discard

statements. Examples of drugs without the package type terms and discard statements include

certain manufacturers of digoxin (approved in 1954), oxytocin (approved in 1980),

diphenhydramine (approved in 1982), phenobarbital (orphan drug without FDA approval).

Several of these drugs are available in small containers with only a few mL of labeled drug in the

containers.

In this proposed rule, we are proposing to include injectable drugs with a labeled volume

of 2 mL or less and that lack the package type terms and explicit discard statements in their

product labeling to be single-dose containers in the definition of refundable single-dose container

or single-use package drugs. We identified 2 mL as a threshold for this proposal for several

245

https://www.fda.gov/media/117883/download.

reasons. For intramuscular administration, the maximum volume administered at one time for

diphenhydramine and digoxin is less than or equal to 2 mL. We also note that for adults, the

maximum volume

246

for intramuscular administration is typically limited to 3 mL. For drugs

administered intravenously and supplied in containers containing 2 mL or less, like digoxin and

phenobarbital, dosages are calculated based on body weight, potentially leading to discarded

amounts. We believe that preparation of these drugs would likely be used for a single dose based

on the range of dose sizes for these drugs and the amount of drug in the container. In other

words, it is unlikely that more than one dose could be prepared from the amount of drug in the

container.

Another category of drugs approved before 2018 that lack discard statements is drugs

contained in ampules (also spelled as ampoules or ampuls, hereinafter referred to as “ampules”).

The term ampule is an airtight vial made of glass, plastic, metal, or any combination of these

materials.

247

Examples of drugs currently contained in ampules include epinephrine (approved

in 1939), lidocaine hydrochloride (1948), dicyclomine (1950), digoxin (1954), chlorpromazine

(1957), fentanyl citrate (1968), promethazine (1973), alprostadil (1981), nalbuphine (1993), and

tacrolimus (1994). Drugs contained in ampules are accessed by breaking the concaved part (“the

neck”), and the content should be passed through a sterile filter to remove any residual glass

particles.

248

Therefore, we are proposing to amend the definition of refundable single-dose container

or single-use package drug to include drugs contained in ampules and for which there is no

discard statement. We are proposing to classify drugs supplied in ampules to be drugs in single-

dose containers for purposes of this discarded drug policy because this approach would be

consistent with the description of single-dose container in the October 2018 FDA guidance. We

246

Open Resources for Nursing (Open RN); Ernstmeyer K, Christman E, editors. Nursing Skills [Internet]. 2nd

edition. Eau Claire (WI): Chippewa Valley Technical College; 2023. Chapter 18 Administration of Parenteral

Medications. Available from https://www.ncbi.nlm.nih.gov/books/NBK596739/.

247

40 CFR 273.9.

248

Pharmaceutical Compounding—Sterile Preparations. USP-NF 2023. November 1, 2023.

note that some drugs contained in ampules may be excluded from the definition of refundable

drug under section 1847A(h)(8)(B)(ii) of the Act because dosage and administration instructions

included in the product labeling require filtration during the drug preparation process, prior to

dilution and administration, and require that any unused portion of such drug after the filtration

process be discarded after the completion of such filtration process. This exclusion would still

be applicable for ampules that can demonstrate that they meet that exclusion. However, this is

not the case for the product labeling of all drugs contained in ampules.

In summary, we are proposing to amend the definition of Refundable single-dose

container or single-use package drug at § 414.902 by including “single-patient-use container” as

a package type term and adding three types of products that may be considered refundable

single-dose container or single-use package drugs under paragraph (1). These are:

(1) Product furnished from a single-dose container or single-use package based on FDA-

approved labeling or product information.

(2) Product furnished from an ampule for which product labeling does not have discard

statement or language indicating the package type term, like “single-dose container,” “single-use

package,” “multiple-dose container,” or “single-patient-use container”.

(3) Product furnished from a container with a total labeled volume 2 ml or less for which

product labeling does not have language indicating the package type term, like “single-dose

container,” “single-use package,” “multiple-dose container,” or “single-patient-use container”.

As noted above, we are also revising the organization of this definition in the regulatory text.

We welcome comments on these proposals.

(3) Skin substitutes

As discussed in the CY 2023 PFS final rule (87 FR 69650 through 69655), CMS aims to

create a consistent coding and payment approach for the suite of products currently referred to as

skin substitutes. In the CY 2024 PFS final rule (88 FR 79060 through 79061), we finalized that

billing and payment codes that describe products currently referred to as skin substitutes are not

counted for purposes of identifying refundable drugs for calendar quarters during 2023 and 2024.

While we continue to consider making changes to the Medicare Part B payment policies for such

products, similar to last year, for CY 2025, we are proposing again that billing and payment

codes that describe products currently referred to as skin substitutes not be counted for purposes

of identifying refundable drugs for calendar quarters in 2025. We plan to revisit discarded drug

refund obligations for skin substitutes in future rulemaking. More information regarding the

payment of skin substitutes is available in section II.K. of this proposed rule.

d. Discarded amounts

Effective January 1, 2017, providers and suppliers were required to report the JW

modifier on all claims that bill for drugs separately payable under Medicare Part B with unused

and discarded amounts (that is, discarded amounts) from single-dose containers or single-use

packages. In the CY 2023 PFS, we finalized the requirement to use the JW modifier for single-

dose container drugs that are separately payable under Part B, and we finalized the use of the JW

modifier (or any successor modifier that includes the same data) to identify discarded billing

units of a billing and payment code for the purpose of calculating the refund amount as described

in section 1847A(h)(3) of the Act. In that final rule, to align with the JW modifier policy, we

also finalized the requirement that, beginning July 1, 2023, the JZ modifier is required when

there are no discarded amounts of a single-dose container drug for which the JW modifier would

be required if there were discarded amounts.

In the CY 2023 PFS final rule (87 FR 69723), we discussed the applicability of the JW

and JZ modifiers to drugs that are not administered by the billing supplier, including drugs

furnished through a covered item of DME that may be administered by the beneficiary. In such

cases, we stated that the reporting requirement does not apply to drugs that are self-administered

by a patient or caregiver in the patient's home. In the JW Modifier and JZ Modifier Policy FAQ

document

249

released on January 5, 2023, we reiterated that suppliers who dispense but do not

actually administer a separately payable drug are not expected to report the JW or JZ modifier.

Then, in the CY 2024 PFS final rule (88 FR 79062), we finalized a change to this policy,

such that drugs separately payable under Part B from single-dose containers that are furnished by

a supplier who is not administering the drug be billed with the JZ modifier. This meant that the

JW modifier would not be used on these claims. As we stated in that rule, in the absence of a

claims modifier to designate that a drug was dispensed, but not administered, by the billing

supplier (as finalized in the CY 2023 PFS), we were concerned that claims rejections may occur.

Therefore, this change in policy required the JZ modifier on all such claims to ensure claims

rejections did not occur unnecessarily. On October 16, 2023, we updated the JW Modifier and JZ

Modifier Policy FAQ document to include the requirement of the JZ modifier by the supplier.

However, after this policy was finalized, interested parties have requested further clarification on

how to appropriately bill for discarded amounts from single-dose containers when there are

amounts discarded during preparation by the billing supplier who is not administering the drug.

To provide additional clarity, we are now proposing to require the JW modifier if a billing

supplier is not administering a drug, but there are amounts discarded during the preparation

process before supplying the drug to the patient. Such a supplier would report the JZ modifier if

no amounts were discarded during the preparation process before supplying the drug to the

patient.

We believe this proposal is appropriate because drug preparation occurs before supplying

a drug to the beneficiary and the billing supplier can determine the discarded amount at the site

of drug preparation. These discarded units should be billed using the JW modifier in the same

way as a drug that is administered incident-to physician service. In addition, suppliers and other

interested parties have expressed that suppliers are accustomed to using the JW modifier in this

249

https://www.cms.gov/medicare/medicare-fee-for-service-payment/hospitaloutpatientpps/downloads/jw-modifier-

faqs.pdf.

context already. Therefore, we propose to require the JW modifier if a billing supplier is not

administering a drug, but there are amounts discarded during the preparation process before

supplying the drug to the patient. For example, if a billing supplier prepares a dose from a

single-dose vial labeled as containing a total of 50 billing units such that 45 billing units of the

drug are used in the prepared dose and 5 billing units are discarded during preparation, and then

the drug is supplied to the patient (but not administered by the supplier), the claim should be

submitted on two lines: 45 units (without a modifier) and 5 units with the JW modifier. We

reiterate that suppliers who dispense a drug, but do not actually administer the drug, are not

expected to monitor or bill for discarded amounts that are discarded after the drug is supplied

because they are not at the site of administration to measure discarded amounts. For example, if

the patient who was supplied the above dose with 45 billing units subsequently only receives 35

of those billing units, the above billing supplier would not be expected to account for the 10

subsequently discarded billing units on the claim.

We welcome comments on this proposal.

2. Payment Limit Calculation When Manufacturers Report Negative or Zero Average Sales

Price (ASP) Data (§ 414.904)

a. Background

Drugs payable under Medicare Part B fall into three general categories: those furnished

incident to a physician's service (hereinafter referred to as “incident to”) (section 1861(s)(2) of

the Act), those furnished via a covered item of durable medical equipment (DME) (section

1861(s)(6) of the Act), and other drugs for which coverage is specified by statute (for example,

certain vaccines described in sections 1861(s)(10)(A) and (B) of the Act). Payment limits for

most drugs separately payable under Medicare Part B are determined using the methodology in

section 1847A of the Act, and in many cases, payment is based on the average sales price (ASP)

plus a statutorily mandated 6 percent add-on. If CMS determines a payment limit for a drug, it is

published in the ASP pricing file or Not Otherwise Classified (NOC) pricing file,

250

which are

both updated quarterly.

CMS generally calculates the payment limits for drugs payable under Part B on a

quarterly basis using the manufacturer’s ASP (as defined in § 414.902). Manufacturers are

required to report ASP to CMS pursuant to sections 1847A(f)(2) and 1927(b)(3) of the Act.

Manufacturers are instructed to calculate ASP in accordance with section 1847A(c) of the Act

and § 414.804(a).

For each NDC, in most cases, the manufacturer’s ASP is a positive dollar value, along

with a positive number of units sold (hereinafter referred to as “positive manufacturer’s ASP

data”). However, sometimes the reported data is not positive manufacturer’s ASP data.

Specifically, a manufacturer could report that an NDC has a negative or zero-dollar value for the

manufacturer’s ASP with a positive, negative, or zero number of units sold, or a positive dollar

value for the manufacturer’s ASP with a negative or zero number of units sold (each of these

scenarios is hereinafter referred to as “negative or zero manufacturer’s ASP data”). Such

negative or zero manufacturer’s ASP data could occur because of lagged discounts, units

returned to the manufacturer, drug shortages, discontinuation of a drug, or other reasons that are

not known to CMS. Negative or zero manufacturer’s ASP data can occur when a manufacturer

calculates its ASP in accordance with section 1847A of the Act.

First, section 1847A(c)(3) of the Act requires that the manufacturer's calculation of its

ASP for an NDC must include volume discounts, prompt pay discounts, cash discounts, free

goods that are contingent on any purchase requirement, chargebacks, and rebates (other than

rebates under the Medicaid drug rebate program or the Medicare Prescription Drug Inflation

Rebate Program) (hereinafter referred to as “price concessions”). Second, section

1847A(c)(5)(A) of the Act requires each manufacturer to apply a methodology based on a 12-

month rolling average for the manufacturer to estimate costs attributable to price concessions if

250

https://www.cms.gov/medicare/payment/part-b-drugs/asp-pricing-files.

there is a lag in the reporting of the information on rebates and chargebacks under section

1847A(c)(3) of the Act. These provisions may result in the inclusion of large price concessions

from a quarter or quarters with a higher sales price prior to price concessions in the ASP

calculation for a subsequent quarter with a much lower sales price, which can result in negative

dollar value ASP. The same situation could happen in a quarter if more units were returned to

the manufacturer than are sold, which can result in a negative dollar value ASP as well as a

negative number of units sold. The requirement to use a rolling average for lagged price

concessions is codified at § 414.804(a)(3), which states that, to the extent data on price

concessions are available on a lagged basis, the manufacturer must estimate its ASP in

accordance with the described methodology in that paragraph. In certain instances, as stated

above, lagged price concessions can lead to negative or zero manufacturer’s ASP data.

In 2022, the U.S. Department of Health and Human Services Office of Inspector General

(OIG) issued a report assessing potential inaccuracies in manufacturer reporting of ASP and

noted that manufacturers believe additional guidance may be needed to reduce distortions and

inconsistencies in the calculation of payment limits.

251

The report found that several

manufacturers would like additional guidance regarding reporting of negative ASP data and how

CMS uses negative ASP data in payment limit calculations. CMS concurred with the OIG’s

recommendation to actively review current guidance and determine whether additional guidance

would ensure more accurate and consistent ASP calculations.

Accordingly, we reviewed our current guidance and determined that it is appropriate for

us to provide additional guidance regarding how CMS will handle payment for drugs separately

payable under Part B when the manufacturer’s ASP for at least one NDC within the billing and

payment code (that is, HCPCS code) of the drug is negative or zero. Currently, when all NDCs

assigned to a HCPCS code have negative or zero manufacturer's ASP data, CMS establishes the

payment limit in other ways. As appropriate given the data available for a drug, CMS will either

251

OEI-BL-21-00330. https://oig.hhs.gov/oei/reports/OEI-BL-21-00330.asp.

calculate a payment limit for a billing and payment code based on other applicable and available

pricing data or not include a payment limit for the billing and payment code on the ASP pricing

file. When a payment limit for a drug separately payable under Part B is not included in the ASP

pricing file, the payment limit is based on either the published or Wholesale Acquisition Cost

(WAC) or invoice pricing, as described in section 20.1.3, Chapter 17 of the Medicare Claims

Processing Manual.

252

CMS previously contemplated how to set a payment limit in certain situations in which

ASP data is “not available” for multiple source drugs. In the CY 2011 PFS final rule (75 FR

73461 through 73465), CMS addressed situations in which ASP data for some, but not all, NDCs

in a multiple source drug billing and payment code are not available for the calculation of an

ASP payment limit (for example, if a manufacturer's entire submission of data was not received

or manufacturer’s ASP data for specific NDCs was not reported).

253

In that rule, we finalized a

process, consistent with authority in section 1847A(c)(5)(B) of the Act, to update payment limits

based on the manufacturer’s ASP reported for the most recent quarter for which data is available.

We specified that if manufacturer’s ASP data is not available for some but not all NDCs in a

multiple source drug billing and payment code prior to the publication deadline for quarterly

payment limits and such unavailability of manufacturer’s ASP data significantly changes the

quarterly payment limit for the billing and payment code when compared to the prior quarter’s

payment limit, CMS will calculate the payment limit by carrying over the most recent available

manufacturer’s ASP price from a previous quarter for an NDC, adjusted by the weighted average

of the change in the manufacturer’s ASPs for the NDCs that were reported for both the most

recently available previous quarter and the current quarter, and codified this policy in §

414.904(i).

254

In that final rule, we explained that such circumstances are limited to when a

252

https://www.cms.gov/%E2%80%8BRegulations-and-

Guidance/%E2%80%8BGuidance/%E2%80%8BManuals/%E2%80%8BDownloads/%E2%80%8Bclm104c17.pdf.

253

https://www.govinfo.gov/content/pkg/FR-2010-11-29/pdf/2010-27969.pdf.

254

https://www.ecfr.gov/current/title-42/part-414/section-414.904#p-414.904(i).

manufacturer's data for a multiple source drug product with sales during a quarter is missing, and

efforts to obtain manufacturer reported ASP data before Medicare ASP payment limits

publication deadlines have not been successful. We continue to believe that this process, which

we apply in cases ASP data is “not available” for some but not all NDCs associated with a

multiple source billing and payment code, is appropriate.

b. Approach to payment limit calculations when manufacturer’s ASP data is not available

As described in the previous section, we determined that it is appropriate for CMS to

provide additional guidance regarding how we will handle payment for drugs separately payable

under Part B when the reported manufacturer’s ASP for at least one NDC within the billing and

payment code (that is, HCPCS code) of the drug is negative or zero (that is, has negative or zero

manufacturer’s ASP data). As detailed below, we are proposing to consider ASP data to be not

“available” for the purposes of calculating a payment limit in circumstances in which negative or

zero manufacturer’s ASP data is reported, consistent with section 1847A(c)(5)(B) of the Act.

We are also proposing how CMS would calculate a payment limit in these circumstances,

consistent with section 1847A(c)(5)(B) of the Act.

Our current policy does not address how payment limits are calculated for several

situations in which a drug separately payable under Part B does not have available ASP data.

The set of situations in which this might occur include circumstances in which either some or all

NDCs for a billing and payment code have a negative or zero manufacturer’s ASP data; in which

negative or zero manufacturer’s ASP data is reported for a drug which has been discontinued;

and vary further depending on whether a drug is multiple source or single source (both as defined

in § 414.902). In each of these circumstances, there are various other pricing data available that

we believe can appropriately be used to calculate a payment limit.

Therefore, we are proposing, consistent with section 1847A(c)(5)(B) of the Act, a

methodology for calculating payment limits in certain circumstances based on manufacturer’s

ASP for the most recent quarter for which data is available. Specifically, we propose to specify

that positive manufacturer’s ASP data are considered “available” and that negative or zero

manufacturer’s ASP data are considered “not available” for purpose of CMS calculating a

payment limit under the statute. We believe it is appropriate to consider negative or zero

manufacturer’s ASP data to be not available because if used to calculate a payment limit, this

data can result in a negative or zero payment limit, which would require CMS to collect payment

from providers and suppliers for a drug, rather than make payment for a drug. Negative or zero

payment limits for a drug are not reasonable because Medicare does not expect to collect

payment from providers and suppliers for their provision of separately payable drugs. Therefore,

we are proposing to specify the methodology we will use for calculating the payment limit in

such circumstances to ensure reasonable payment amounts based on the best available data for

separately payable drugs. Below, we propose how payment limits would be determined using

available ASP data for each scenario.

c. Single and multiple source drugs when negative or zero manufacturer’s ASP data is reported

for some, but not all NDCs

In the case that a drug separately payable under Part B has negative or zero

manufacturer’s ASP data reported for some, but not all, NDCs associated with a billing and

payment code for that drug, we are proposing to calculate a payment limit using only NDCs with

positive manufacturer’s ASP data (and omitting NDCs with negative or zero manufacturer’s ASP

data) for that drug and propose to codify this at § 414.904(i). We are proposing this policy to

apply to both single source drugs, including biosimilar biological products, and multiple source

drugs. We believe this is appropriate because it would result in payment limits based on the most

recent positive manufacturer’s ASP data reported by manufacturers with NDCs associated with a

billing and payment code.

However, we note that, as discussed in section III.A.2.a of this proposed rule, CMS

already has a policy in place for multiple source drugs for which the absence of ASP data would

result in a significant change (that is, a 10 percent or greater change) in the ASP payment limit

compared to the payment limit of the previous quarter, as finalized in the CY 2011 PFS final rule

(75 FR 73461 through 73465). In that discussion (75 FR 73462), we noted several examples of

situations in which data is not available to be included in the calculation of a payment limit, such

as when a manufacturer's entire submission was not received or when the manufacturer’s ASP

data for specific NDCs has not been reported. We do not intend for our proposed policy to

override that existing policy; rather, we intend for the proposed policy described above to

address circumstances not addressed in that rulemaking (that is, we intend to address

circumstances of single source drugs when negative or zero manufacturer’s ASP data is reported

for some, but not all NDCs, and of multiple source drugs when negative or zero manufacturer’s

ASP data is reported for some, but not all NDCs and the absence of such data from the

calculation of the payment limit does not result in a significant change in the payment limit

compared to the payment limit of the previous quarter) and thus fill a policy gap. In addition, the

circumstances we provided as examples in which ASP data is not available in the CY 2011 PFS

final rule continue to be circumstances we consider manufacturer’s ASP data not available under

current § 414.904(i) (which we propose to move within § 414.904(i) to fit within the structure of

the proposed new set of payment limit methodologies); but, as noted in section III.A.2.b, we are

expanding what we consider to be not available to include circumstances in which negative or

zero manufacturer’s ASP data is reported.

d. Multiple source drugs with only negative or zero manufacturer’s ASP data

In the case of a multiple source drug (as defined in § 414.902) separately payable under

Part B that has negative or zero manufacturer’s ASP data reported for all NDCs associated with a

billing and payment code for that drug (and at least one NDC for the is actively being marketed

(that is, not discontinued)), we are proposing to carry over all positive manufacturer’s ASP data

from the most recently available previous quarter with positive manufacturer’s ASP data for at

least one NDC until at least one NDC for the drug has positive manufacturer’s ASP data for a

quarter. Specifically, we are proposing to calculate the payment limit for the applicable quarter

using data from the most recent calendar quarter for which data is available, i.e., for which there

is positive manufacturer’s ASP data. We believe this is appropriate because, similar to the

methodology described in section III.A.2.c, it would result in payment limits based on the most

recent positive manufacturer’s ASP data reported by manufacturers with NDCs associated with a

billing and payment code. Similarly, we believe the most recent available positive

manufacturer’s ASP data from NDCs associated with a billing and payment code are more likely

to be reflective of providers’ acquisition costs for drugs associated with that billing and payment

code in a given quarter than other pricing data, and unlikely to result in challenges to access for

these drugs for providers and beneficiaries.

We note that because section 1847A of the Act provides for payment limit calculations

that differ between single-source drugs (as defined in section 1847A(c)(6)(D) of the Act and §

414.902) and multiple source drugs (as defined in section 1847A(c)(6)(C) of the Act and §

414.902), we are proposing different ways to determine payment limits for each, in cases in

which only negative or zero manufacturer’s ASP data is reported, to reflect these differences.

Specifically, the payment limit for single source drugs is described in section 1847A(b)(1)(B) of

the Act; for multiple source drugs, the payment limit is described in section 1847A(b)(1)(A) of

the Act. The payment limit for single source drugs is determined using the lesser of ASP or

WAC; but WAC is not used for multiple source drugs whose ASP exceeds WAC. Nonetheless,

our proposals for the calculation of the payment limit for single source and multiple source drugs

with only negative or zero manufacturer’s ASP data are consistent in that, where ASP is used, we

propose to use the most recent available positive manufacturer’s ASP data from at least one

NDC for the drug. We believe using similar input data in our calculation of the payment limit is

consistent with our goal to ensure reasonable payment amounts based on the best available data

for separately payable drugs.

We are proposing to amend § 414.904(i) to include the above proposal regarding how

CMS would calculate the payment limit in circumstances in which only negative or zero

manufacturer’s ASP data is reported for a multiple source drug.

e. Single source drugs with only negative or zero manufacturer’s ASP data, excluding biosimilar

biological products

In the case of a single source drug, excluding biosimilar biological products (both as

defined in §414.902), separately payable under Part B that has negative or zero manufacturer’s

ASP data reported for all NDCs associated with a billing and payment code for that drug (and at

least one NDC for the drug is actively being marketed (that is, not discontinued)), we are

proposing to set the payment limit for the given quarter for the single source drug at the lesser of

the following until at least one NDC for the drug has positive manufacturer’s ASP data for a

quarter:

● 106 percent of the volume-weighted average of the most recent available positive

manufacturer’s ASP data from a previous quarter in which at least one NDC for the drug has

positive manufacturer’s ASP data for a quarter. If the payment limit from the quarter with the

most recent available positive manufacturer’s ASP data was based on 106 percent of the WAC

because of the application of § 414.904(d)(1), that payment limit would be carried over; or

● 106 percent of the WAC for the given quarter. If there is more than one WAC per

billing unit for the drug, the payment limit would be set using the lowest WAC per billing unit.

We would only use the lesser of the positive manufacturer’s ASP or WAC data from that

previous quarter or the WAC data from the given quarter until positive manufacturer’s ASP data

is available for a future quarter. Once positive manufacturer’s ASP data for a drug is available

again in a future quarter, CMS will have data available to input into the routinely used

methodologies described in section 1847A(b) of the Act and § 414.904.

As discussed above, we believe it is appropriate to propose different policies for

determining payment limits for single and multiple source drugs when negative or zero

manufacturer’s ASP data is reported because of statutory differences in the payment limit

calculations.

f. Biosimilars with only negative or zero manufacturer’s ASP data

In circumstances in which negative or zero manufacturer’s ASP data is reported for all

NDCs for a biosimilar biological product (defined at § 414.902) (hereinafter referred to as a

“biosimilar”) for a given quarter (and at least one NDC for the biosimilar is actively being

marketed (that is, not discontinued)), and positive manufacturer’s ASP data is available for

another biosimilar(s) with the same reference biological product (hereinafter referred to as a

“reference product”) for the given quarter, we are proposing to set the payment limit for the

given quarter equal to the sum of the following until at least one NDC for the particular

biosimilar for which all NDCs report negative or zero manufacturer’s ASP data has positive

manufacturer’s ASP data for a quarter:

● The volume-weighted average of the positive manufacturer’s ASP data from all other

biosimilars with the same reference product, and

● 6 percent (or 8 percent for qualifying biosimilar biologicals as defined in § 414.902, as

appropriate) of the amount determined under section 1847A(b)(4) of the Act for the reference

biological product (as defined in § 414.902) for the given quarter.

We believe this is appropriate because Section 351(i)(2) of the Public Health Service Act

defines the terms biosimilar and biosimilarity to mean that a biosimilar is highly similar to its

reference product, notwithstanding minor differences in clinically inactive components, and that

there are no clinically meaningful differences between the biosimilar and the reference product

in terms of the safety, purity, and potency of the product. In addition, biosimilars with the same

reference product likely compete in the marketplace since both rely on FDA’s previous

determination of safety, purity, and potency for the reference product clinical data for approval.

For these reasons, we believe that when a biosimilar has only negative or zero manufacturer’s

ASP data, the volume-weighted average of positive manufacturer’s ASP data of biosimilars with

the same reference product would be an appropriate payment limit for a biosimilar that, under

this proposal, would be considered to have ASP data that is not available. As such, we are

proposing to calculate the payment limit for a biosimilar with only negative or zero

manufacturer’s ASP data based on the positive manufacturer’s ASP data of other biosimilars

with the same reference product.

We note that in the CY 2016 PFS final rule (80 FR 71096 through 71101), we finalized

that we would group all biosimilars with a common reference product in a single billing and

payment code with a single payment rate, in a manner similar to how we price multiple source or

generic drugs because of the significant similarities between each biosimilar and its reference

product. In the CY 2018 PFS final rule (82 FR 53182 through 53187), we changed the initial

policy and finalized separate coding and payment for biosimilars. In that final rule, we stated that

that there is a program need for assigning Part B biosimilars into separate billing and payment

codes; specifically, that this policy change addressed concerns about the public interest in a

stronger marketplace, access to these drugs in the United States marketplace, and provider and

patient choice and competition. Our proposal for biosimilars with negative or zero

manufacturer’s ASP data reported for all NDCs is consistent with the CY 2018 PFS rulemaking,

as it would not result in grouping biosimilars with a shared reference product in a single billing

and payment code. Rather, it would allow CMS to calculate an operationally reasonable payment

limit using positive manufacturer’s ASP data for highly similar products in limited instances.

This proposal would also provide payment limit stability that could help avoid potential

access issues for providers and beneficiaries that could otherwise occur if we were to calculate a

payment limit for a drug with negative or zero manufacturer’s ASP data that is far below the

provider’s cost for acquiring the drug. If a biosimilar’s ASP falls below zero only after several

quarters of declining but still positive manufacturer’s ASP data, the most recent positive

manufacturer’s ASP data from a previous quarter for a drug may be significantly lower than the

volume-weighted average of the biosimilars with the same reference product as the biosimilar

with negative ASP data. In such a case, the payment limit based on the ASPs of competitor

biosimilars would be higher than if we were constrained to use ASP data only from the

biosimilar that has most recently reported negative or zero manufacturer’s ASP data. We note

that under the methodology proposed in section III.A.2.c, in circumstances in which some, but

not all NDCs of a single or multiple source drug are negative or zero, we would similarly

calculate the payment limit using only NDCs with positive manufacturer’s ASP data from the

given quarter and omitting those that had declined to zero or a negative value in ASP or sales.

Likewise, we believe that such an approach would likely result in a payment limit reflective of

providers’ acquisition costs of biosimilars and be helpful in avoiding access issues for providers

and beneficiaries.

In circumstances in which negative or zero manufacturer’s ASP data is reported for all

NDCs for a biosimilar for a given quarter and either no other biosimilars have been approved for

the same reference product or no other biosimilars with the same reference product report

positive manufacturer’s ASP data for the given quarter, we propose that we would set the

payment limit for the given quarter equal to the sum of the following until at least one NDC for

the biosimilar has positive manufacturer’s ASP data for a quarter:

● The volume-weighted average of the most recent available positive manufacturer’s

ASP data from a previous quarter, and

● 6 percent (or 8 percent for qualifying biosimilar biologicals, as appropriate) of the

amount determined under section 1847A(b)(4) of the Act for the reference biological product (as

defined in § 414.902) for the given quarter.

In situations in which CMS would use the volume-weighted average of the most recent

available positive manufacturer’s ASP data from a previous quarter, we would only use positive

manufacturer’s ASP data from that previous quarter until positive manufacturer’s ASP data is

available for a future quarter. This proposed methodology is similar to the proposed

methodology for multiple source drugs and single source drugs that are not biosimilars when

manufacturers report negative or zero manufacturer’s ASP for all NDCs.

In addition to the payment approaches we are proposing for biosimilars with only

negative or zero manufacturer’s ASP data, we considered two alternatives for which we are

seeking public comment. Under the first alternative, the volume-weighted ASP calculation

would include the ASP data and billing units sold of its reference product for a given quarter

along with those of the other biosimilars that reference the same reference product in the

volume-weighted average calculation. We believe including the reference product’s data in the

blended calculation for a biosimilar’s payment limit in the limited circumstance described could

be appropriate in determining an operationally reasonable payment limit because the FDA

approval for the biosimilar relies in part on FDA’s previous determination of safety, purity, and

potency for the reference product, and the biosimilar and reference product are necessarily

approved for at least one shared condition of use, as required under the 351(k) approval

pathway;

255

therefore, the case that the two are comparable is at least as strong as that for any

two biosimilars with the same reference product. If it is preferable, as we propose, to base the

payment limit on the available positive manufacturer’s ASP data submitted by manufacturers of

market competitor biosimilars (in this context, biosimilars that reference the same reference

product), then including the ASP data and billing units sold of the reference product would also

increase the likelihood that positive data in such a group is available, particularly in the case that

a reference product only has one biosimilar. Under this alternative, the payment limit would be

set equal to the sum of the volume-weighted average of the positive manufacturer’s ASP data

from all other biosimilars with the same reference product and the reference product plus 6 or 8

percent, as appropriate, of the amount determined under section 1847A(b)(4) of the Act for the

reference biological product for the given quarter. We are seeking public comments about

255

https://www.fda.gov/science-research/fda-stem-outreach-education-and-engagement/development-biosimilar-

351k-bla-clinical-pharmacology-study-database.

whether including ASP data from the reference product in a variant of the proposed calculation

would produce a more appropriate payment limit for a biosimilar with only negative or zero

manufacturer’s ASP data.

Under the second alternative, we would calculate payment limits for all biosimilars with

only negative or zero manufacturer’s ASP data in the manner described above for biosimilars

when either no other biosimilars have been approved for the same reference product or no other

biosimilars with the same reference product report positive manufacturer’s ASP data for the

given quarter. That is, under this alternative we would not consider the manufacturer’s ASP data

of other biosimilars with the same reference product; rather, we would base the payment limit of

the biosimilar on the volume-weighted average of the its own most recent available positive

manufacturer’s ASP data from a previous quarter and either 6 or 8 percent, as appropriate, of the

amount determined under section 1847A(b)(4) of the Act for the reference biological product for

the given quarter. We are interested in comments from interested parties about whether, and if

so, why, it is preferable for the payment limit to be calculated only using manufacturer’s ASP

data from the biosimilar that reports negative or zero manufacturer’s ASP data in a given quarter.

g. Discontinued drugs

Generally, for single source drugs and multiple source drugs for which negative or zero

manufacturer’s ASP data is reported for all NDCs and for which all relevant applications (for

example, new drug applications (NDAs), biologics license applications (BLAs), or abbreviated

new drug applications (ANDAs)) have a marketing status of “discontinued” on the FDA

website,

256, 257

we propose that the drug be priced by MACs consistent with section 20.1.3 in

Chapter 17 of the Medicare Claims Processing Manual for developing payment limits for

256

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm.

257

https://purplebooksearch.fda.gov/.

covered drugs when CMS does not supply the payment allowance limit on the ASP drug pricing

file.

258

Once a drug is discontinued, as indicated by the marketing status on the FDA website

(either at Drugs@FDA

259

for drugs or the Purple Book

260

for biologicals), the manufacturer

might not have sales to calculate an ASP and, therefore, the manufacturer often reports zero sales

for the drug or a negative number for its calculated ASP or number of sales. However, even if a

drug has a marketing status of discontinued on the FDA website, there may theoretically be

available product that could be billed by the provider until the expiration date of the last lot sold

for the drug. Relatedly, we have observed that very few claims are paid for drugs following their

discontinuation. For these reasons, setting a payment limit for drugs with a marketing status of

discontinued on the FDA website is not expected to be practically useful for claims processing

and is not a prudent use of CMS resources.

h. Summary

We are proposing to amend § 414.904(i) to reflect CMS’s approach to setting a payment

limit in circumstances in which negative or zero manufacturer’s ASP data is reported by a

manufacturer for a drug. Specifically, we are proposing to codify that in cases where negative or

zero manufacturer’s ASP data is reported for some, but not all, NDCs of a multiple source drug,

we would calculate the payment limit using the positive manufacturer’s ASP data reported for

the drug, except for the existing carryover policy for multiple source drugs that we would apply

when unavailable data results in a significant change in the ASP payment limit. We are

proposing to move this carryover policy for multiple source drugs within § 414.904(i) to fit

within the structure of the proposed new set of payment limit methodologies. We are also

proposing to codify that in the case of a multiple source drug for which negative or zero

258

Medicare Claims Processing Manual Chapter 17, section 20.1.3: https://www.cms.gov/regulations-and-

guidance/guidance/manuals/downloads/clm104c17.pdf.

259

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm.

260

https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/purple-book-lists-licensed-biological-

products-reference-product-exclusivity-and-biosimilarity-or.

manufacturer’s ASP data is reported for all NDCs, we would set the payment limit using the

most recent available positive manufacturer’s ASP data from a previous quarter until at least one

NDC for the drug has positive manufacturer’s ASP data for a quarter.

We are proposing to codify that in cases where negative or zero manufacturer’s ASP data

is reported for some, but not all, NDCs of a single source drug that is not a biosimilar, we would

calculate the payment limit using the positive manufacturer’s ASP data reported for the drug. We

are proposing to codify that for single source drugs that are not biosimilars with all negative or

zero manufacturer’s ASP data for a given quarter, the payment limit would be, until at least one

NDC for the drug has positive manufacturer’s ASP data for a quarter, the lesser of 106 percent of

the volume-weighted average of the most recent available positive manufacturer’s ASP data for

at least one NDC from a previous quarter and 106 percent of the WAC, and we would use 106

percent of the lowest WAC per billing unit if there is more than one WAC per billing unit

available.

We are also proposing to codify that in cases where negative or zero manufacturer’s ASP

data is reported for some, but not all, NDCs of a biosimilar, we would calculate the payment

limit using the positive manufacturer’s ASP data reported for the biosimilar. Lastly, we are

proposing to codify two scenarios when the manufacturer reports negative or zero

manufacturer’s ASP for all NDCs for a biosimilar for a given quarter:

● When positive manufacturer’s ASP data is available for another biosimilar(s) with the

same reference product for the given quarter, we are proposing to set the payment limit equal to

the sum of the volume-weighted average of the positive manufacturer’s ASP data from all other

biosimilars with the same reference product plus 6 percent (or 8 percent for a qualifying

biosimilar biological) of the amount determined under section 1847A(b)(4) of the Act for the

reference biological product for the given quarter; and

● When either no other biosimilars have been approved for the same reference product

or no other biosimilars with the same reference product report positive manufacturer’s ASP data

for the given quarter, we are proposing to set the payment limit equal to the sum of the volume-

weighted average of the most recent available positive manufacturer’s ASP data from a previous

quarter plus 6 percent (or 8 percent for a qualifying biosimilar biological) of the amount

determined under section 1847A(b)(4) of the Act for the reference biological product for the

given quarter.

We welcome comments on these proposals.

3. Payment of radiopharmaceuticals in the physician office

Section 303(c) of the Medicare Prescription Drug, Improvement, and Modernization Act

of 2003 (MMA) (Pub. L. 108–173, enacted December 8, 2003) revised the payment

methodology for most Medicare-covered Part B drugs by adding section 1847A to the Act,

which established a new average sales price (ASP) drug payment methodology for separately

payable Medicare Part B drugs, beginning January 1, 2005. Specifically, section 303(h) of the

MMA states, “Nothing in the amendments made by this section [303 of the MMA] shall be

construed as changing the payment methodology under [Medicare] Part B…for

radiopharmaceuticals, including the use by carriers of invoice pricing methodology.”

In accordance with the law, radiopharmaceuticals are not required to be paid using payment

methodology under section 1847A of the Act, as currently described in the Medicare Claims

Processing Manual (MCPM) Chapter 17, section 20.1.3. The manual instructs MACs to

determine payment limits for radiopharmaceuticals based on the methodology in place as of

November 2003, before the passage of the MMA, in the case of radiopharmaceuticals furnished

in settings other than the hospital outpatient department. Currently, payment can vary by MAC.

For example, payment can be based on 95 percent of Average Wholesale Price (AWP), invoices,

or other reasonable payment methods/data made available when the product is contractor

priced.

261, 262, 263, 264, 265, 266

CMS has heard from MACs and other interested parties that there is confusion about

which exact methodologies are available to MACs for pricing of radiopharmaceuticals in the

physician office setting, as different MACs had different methodologies in place as of November

2003. MACs are uncertain whether they can use any of these payment policies that were in

place, or only the policy that was in place for their jurisdiction as of November 2003.

Accordingly, while we evaluate our broader policies in this space for future rulemaking,

we are proposing to clarify that any payment methodology that was being used by any MAC

prior to the enactment of the MMA can continue to be used by any MAC, including the use of

invoice pricing. That is, we are proposing to clarify that any methodology that was in place to set

pricing of radiopharmaceuticals in the physician office setting prior to November 2003 can be

used by any MAC, whether or not that specific MAC used the methodology prior to November

2003.

Thus, we are proposing to codify in regulations at § 414.904(e)(6) that, for

radiopharmaceuticals furnished in a setting other than the hospital outpatient department, MACs

shall determine payment limits for radiopharmaceuticals based on any methodology used to

determine payment limits for radiopharmaceuticals in place on or prior to November 2003. Such

methodology may include, but is not limited to, the use of invoice-based pricing.

We welcome comments on these proposals.

261

How Does Palmetto GBA Price Drugs and Biologics?, Palmetto GBA.

https://www.palmettogba.com/palmetto/jjb.nsf/DIDC/8EELKH2211~Specialties~Drugs%20and%20Biologicals.

262

Radiopharmaceutical Fee Schedule 2024 Update, Noridian. https://med.noridianmedicare.com/web/jeb/fees-

news/fee-schedules/radiopharmaceutical-fees.

263

Radiopharmaceutical Drugs – Billing Instructions, A Celerian Group Company.

https://www.cgsmedicare.com/partb/pubs/news/2013/0313/cope21543.html.

264

Reimbursement Guidelines for Radiopharmaceuticals HCPCS Level II Codes, Novitas Solutions.

https://www.novitas-solutions.com/webcenter/portal/MedicareJL/pagebyid?contentId=00231502.

265

Reimbursement Guidelines for Radiopharmaceuticals Procedure Codes (Prior to January 2023), First Coast

Service Options, Inc. https://medicare.fcso.com/Coverage_News/0494780.asp.

266

Radiopharmaceutical Reimbursement, National Government Services.

https://www.ngsmedicare.com/web/ngs/fee-schedule-lookup-

details?lob=93617&state=97256&rgion=93623&selectedArticleId=4920515.

4. Immunosuppressive therapy (§§ 410.30 and 414.1001)

a. Background

Medicare Part B coverage of drugs used in immunosuppressive therapy was established

by section 9335(c) of the Omnibus Budget Reconciliation Act of 1986 (Pub. L. 99–509) (OBRA

'86). OBRA '86 added subparagraph (J) to section 1861(s)(2) of the Act to provide Medicare Part

B coverage for immunosuppressive drugs, furnished to an individual who receives an organ

transplant for which Medicare payment is made, for a period not to exceed 1 year after the

transplant procedure. Coverage of these drugs under Medicare Part B began January 1, 1987.

Section 4075 of the Omnibus Budget Reconciliation Act of 1987 (Pub. L. 100-203) (OBRA ’87)

revised section 1861(s)(2)(J) of the Act so that the scope of coverage was expanded from

coverage of ‘‘immunosuppressive drugs’’ to coverage of ‘‘prescription drugs used in

immunosuppressive therapy.’’ For the purposes of this proposed rule, we refer to this benefit as

the immunosuppressive drug benefit.

In the Medicare Coverage of Prescription Drugs Used in Immunosuppressive Therapy

final rule (60 FR 8951 through 8955), we finalized policies for the scope of drugs for which

payment may be made under this benefit. We finalized that payment may be made for

prescription drugs used in immunosuppressive therapy that have been approved for marketing by

the U.S. Food and Drug Administration (FDA) and meet one of the following conditions:

(1) The approved labeling includes the indication for preventing or treating the rejection

of a transplanted organ or tissue.

(2) The approved labeling includes the indication for use in conjunction with

immunosuppressive drugs to prevent or treat rejection of a transplanted organ or tissue.

(3) Have been determined by a Part B carrier, in processing a Medicare claim, to be

reasonable and necessary for the specific purpose of preventing or treating the rejection of a

patient's transplanted organ or tissue, or for use in conjunction with immunosuppressive drugs

for the purpose of preventing or treating the rejection of a patient's transplanted organ or tissue.

(In making these determinations, the carriers may consider factors such as authoritative drug

compendia, current medical literature, recognized standards of medical practice, and professional

medical publications.)

We also finalized the period of coverage eligibility for a transplant patient.

267

Lastly, we

established the policy that drugs are covered under this provision irrespective of whether they

can be self-administered. We codified these policies at § 410.31 (later redesignated as § 410.30).

We note that we do not maintain a list of drugs covered under this benefit; rather, MACs

are expected to maintain a list of these drugs, as stated in section 80.3, Chapter 17 of the

Medicare Claims Processing Manual. MACs are expected to keep informed of FDA approvals

of immunosuppressive drugs and update guidance as applicable.

While the eligibility timeframe has been extended and eligibility has been expanded since

the immunosuppressive drug benefit under Medicare Part B was revised by OBRA ’87, the scope

of drugs payable under this benefit has not changed. Some examples of how the benefit has been

extended and expanded include: section 13565 of the Omnibus Reconciliation Act of 1993

(OBRA ’93) (Pub. L. 103–66), amended section 1861(s)(2)(J) of the Act to extend the duration

of coverage for the immunosuppressive drug benefit to 36 months from the hospital discharge

date following a covered transplant procedure for drugs furnished after CY 1997; section 113 of

the Medicare, Medicaid and SCHIP Benefits Improvement and Protection Act of 2000 (Pub. L.

106–554) (BIPA) revised section 1861(s)(2)(J) of the Act to eliminate the time limits for

coverage of prescription drugs used in immunosuppressive therapy under the Medicare program;

and most recently, section 402 of the Consolidated Appropriations Act, 2021 (Pub. L. 116-260)

267

Since the establishment of the benefit by the enactment of OBRA ’86, the period of coverage for a transplant

patient under section 1861(s)(2)(J) of the Social Security Act has been subsequently amended by section 202 of the

Medicare Catastrophic Coverage Act of 1988 (Pub. L. 100–360), the Medicare Catastrophic Coverage Repeal Act of

1989 (Pub. L. 101–234), section 13565 of the Omnibus Reconciliation Act of 1993 (OBRA ’93) (Pub. L. 103–66),

section 160 of the Social Security Act Amendments of 1994 (Pub. L. 103–432), section 113 of the Medicare,

Medicaid and SCHIP Benefits Improvement and Protection Act of 2000 (Pub. L. 106–554) (BIPA 2000). The last of

these statutory changes eliminates the time limits for coverage of prescription drugs used in immunosuppressive

therapy under the Medicare program, effective with immunosuppressive drugs furnished on or after December 21,

2000.

amended section 226A(b)(2) to allow certain individuals whose Medicare entitlement based on

ESRD would otherwise end 36 months after a kidney transplant to continue enrollment under

Medicare Part B only for the coverage of immunosuppressive drugs described in section

1861(s)(2)(J) of the Act.

After reviewing our longstanding policies for the immunosuppressive drug benefit and

engaging with interested parties about current practices and challenges, we are proposing

policies aimed to reduce barriers faced by beneficiaries receiving immunosuppressive drugs

under this benefit, as described below.

b. Compounded Immunosuppressive Drugs with Oral or Enteral Routes of Administration

As discussed in the previous section, the immunosuppressive drug benefit currently

includes immunosuppressive therapies that have been approved for marketing by the FDA (and

meet other regulatory requirements at § 410.30). Interested parties have expressed concern that

compounded formulations of immunosuppressive drugs (for example, a liquid formulation of an

immunosuppressive drug not commercially available from a manufacturer but prepared by a

pharmacist) are not included in the immunosuppressive therapy benefit because these

formulations are not approved by the FDA (that is, FDA does not review these drugs to evaluate

their safety, effectiveness, or quality before they reach patients

268

), which is a regulatory

requirement under the current benefit. These interested parties communicated that compounded

formulations are frequently used in the treatment of transplant recipients who cannot swallow

oral capsules or tablets due to age or oral-motor dysfunction. Some examples of drugs

compounded for preventing or treating the rejection of a transplanted organ or tissue include, but

are not limited to, azathioprine,

269

cyclophosphamide,

270

and tacrolimus.

271

268

https://www.fda.gov/drugs/human-drug-compounding/compounding-laws-and-policies.

269

United States Pharmacopeia (2024). USP Monographs, Azathioprine Compounded Oral Suspension. USP-NF.

Rockville, MD: United States Pharmacopeia.

270

United States Pharmacopeia (2024). USP Monographs, Cyclophosphamide Compounded Oral Suspension. USP-

NF. Rockville, MD: United States Pharmacopeia.

271

United States Pharmacopeia (2024). USP Monographs, Tacrolimus Compounded Oral Suspension. USP-NF.

Rockville, MD: United States Pharmacopeia.

We recognize certain patient groups, such as those with dysphagia, those with enteral

feeding tubes (for example, a nasogastric feeding tube or a percutaneous endoscopic gastrostomy

(PEG) tube), and many pediatric patients

272,273

covered under Medicare rely on compounded

immunosuppressive drugs for maintenance therapy and believe that their inclusion in the

immunosuppressive drug benefit would help to ensure that each beneficiary is able to access the

most clinically appropriate formulation of an immunosuppressive drug.

274,275,276

Nonadherence

to lifelong maintenance immunosuppressive therapy contributes to unfavorable post-transplant

outcomes, with obstacles to accessing medication being a prominent risk factor for such

nonadherence.

277

Therefore, we are proposing revisions at § 410.30 to include orally and

enterally administered compounded formulations with active ingredients derived only from

FDA-approved drugs where approved labeling includes an indication for preventing or treating

the rejection of a transplanted organ or tissue, or for use in conjunction with immunosuppressive

drugs to prevent or treat rejection of a transplanted organ or tissue, or have been determined by a

MAC, in processing a Medicare claim, to be reasonable and necessary for this specific purpose

as outlined in the immunosuppressive drug benefit. As we intend this proposal to enhance access

and address adherence concerns for patients who are not able to swallow capsules or tablets and

we do not believe there are access concerns with other types of formulations, we propose to limit

the included compounded formulations to those products with oral and enteral routes of

administration (for example, oral suspensions or solutions).

272

In the United States, children under 18 years of age comprise only 0.14 percent of the total Medicare ESRD

population. Source: CY 2024 End-Stage Renal Disease Prospective Payment System final rule (88 FR 76374)

273

Lentine, K, Smith, JM, Lyden, GR, Miller, JM, Dolan, TG, Bradbrook, K, Larkin, L, Temple, K, Handarova, DK,

Weiss, S, Israni, AK, Snyder, JJ (2024). OPTN/SRTR 2022 Annual Data Report: Kidney. American Journal of

Transplantation, 24(2), S19–S118. https://doi.org/10.1016/j.ajt.2024.01.012

274

Silva RME, Portela RDP, da Costa IHF, et al. Immunosuppressives and enteral feeding tubes: An integrative

review. J Clin Pharm Ther. 2020;45:408–418. https://doi.org/10.1111/jcpt.13093

275

Goorhuis JF, Scheenstra R, Peeters PM, Albers MJ. Buccal vs. nasogastric tube administration of tacrolimus after

pediatric liver transplantation. Pediatr Transplant. 2006 Feb;10(1):74-7. doi: 10.1111/j.1399-3046.2005.00402.x.

PMID: 16499591

276

Liverman, R, Chandran, MM, Crowther, B. Considerations and controversies of pharmacologic management of

the pediatric kidney transplant recipient. Pharmacotherapy. 2021 Jan;41(1): 77-102.

https://doi.org/10.1002/phar.2483.

277

Fine RN, Becker Y, De Geest S, et al. Nonadherence consensus conference summary report. Am J

Transplant. 2009; 9(1): 35-41. doi: 10.1111/j.1600-6143.2008.02495.x.

We solicit comment on these proposals.

c. Immunosuppressive Refill Policy and Supplying Fee

Section 303(e)(2) of the MMA added section 1842(o)(6) of the Act which requires the

Secretary to pay a supplying fee (less applicable deductible and coinsurance) to pharmacies for

certain Medicare Part B drugs and biologicals, as determined appropriate by the Secretary,

including for immunosuppressive drugs described in section 1861(s)(2)(J) of the Act.

In the CY 2005 PFS, we established a supplying fee of $50 for the initial oral

immunosuppressive prescription supplied in the first month after a transplant (69 FR 66312

through 66313). In the CY 2006 Physician Fee Schedule, we established a supplying fee of $16

for all subsequent prescriptions after the initial prescription supplied during a 30-day period (70

FR 70233 through 70236).

Following the CY 2006 rulemaking, we issued program instruction

278

to the MACs that

prohibits payment for refills of immunosuppressive drug prescriptions in most circumstances and

limits payment for prescriptions to 30-day supplies. We state in Chapter 17 of the Medicare

Claims Processing Manual that contractors should limit payment for prescriptions to those of 30-

day supplies, except in special circumstances, because dosage frequently diminishes over time; it

is not uncommon for the provider to change the prescription from one drug to another; and

coinsurance liability on unused drugs could be a financial burden to the beneficiary.

We have heard from interested parties that both the 30-day limit on supplies and

prohibition on payment for refills no longer align with current practice for treating patients on

maintenance immunosuppression regimens who are prescribed a stable dosage for months or

years and receive refillable supplies for several months’ use at a time. Frequent dosage

adjustments for some immunosuppressive drugs that require therapeutic drug monitoring and

dose titration based on blood concentrations, such as tacrolimus, tend to occur more often in

278

Section 80.3, Chapter 17 of the Medicare Claims Processing Manual

newly transplanted recipients, and less frequently once patients are on stable regimens.

279

Other

immunosuppressive drugs, such as mycophenolate mofetil, do not require routine therapeutic

drug monitoring and have fixed recommended dosages per labeling where patients may be

maintained on stable dosages for several months unless patients experience complications.

280

Transplant recipients must take immunosuppressive drugs on a lifelong basis to prevent

rejection, maintain allograft function, and, for some transplanted organs, prevent death. Most

patients are eventually prescribed stable maintenance immunosuppressive drug dosages post-

transplant for extended periods of time. For example, liver transplant guidelines recommend

review of the immunosuppressive drug regimen at least every 6 months.

281

For transplant

beneficiaries, we believe that the limitation on payment to a maximum 30-day supply of

immunosuppressive therapy by our program instruction is an unnecessary burden that poses a

greater risk to adherence than does the potential for a sudden change in dosage needs. There is

considerable concern among providers and advocates that interrupted access to

immunosuppressive drugs caused by running out of or having insufficient medication supply can

decrease medication adherence, increase risk of organ transplant rejection, and ultimately

decrease the rate of survival of transplant recipients.

282,283

We agree with interested parties that it

would be beneficial to patients to reduce barriers that complicate access to immunosuppressive

medication and reasonable for CMS to make programmatic changes consistent with this

objective.

279

Tacrolimus [package insert]. Northbrook, IL: Astellas Pharma, Inc.; 2022.

https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050708s055,010115s007lbl.pdf.

280

Cellcept [package insert]. San Francisco, CA: Genentech USA, Inc.; 2022.

https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050722s050,050723s050,050758s048,050759s055lbl.p

df.

281

Lucey MR, Terrault N, Ojo L, et al. Long-term management of the successful adult liver transplant: 2012 practice guideline

by the American Association for the Study of Liver Diseases and the American Society of Transplantation. Liver Transpl. 2013

Jan;19(1):3-26. doi: 10.1002/lt.23566.

282

Nelson J, Alvey N, Bowman L, et al. Consensus recommendations for use of maintenance immunosuppression in

solid organ transplantation: Endorsed by the American College of Clinical Pharmacy, American Society of

Transplantation, and the International Society for Heart and Lung Transplantation. Pharmacotherapy. 2022; 42:599-

633. doi: 10.1002/phar.2716.

283

Chisholm MA, Lance CE, Williamson GM, Mulloy LL. Development and validation of an immunosuppressant

therapy adherence barrier instrument. Nephrol Dial Transplant. 2005 Jan;20(1): 181–188.

https://doi.org/10.1093/ndt/gfh576.

Accordingly, we are proposing two changes regarding supplying fees and refills for

immunosuppressive drugs. First, we are proposing to allow payment of a supplying fee for a

prescription of a supply of up to 90 days. To reflect this proposal, we are proposing to revise §

414.1001 to allow payment of a supplying fee to a pharmacy for first prescriptions and for

prescriptions following the first prescription for greater than a 30-day supply. We are proposing

additional modifications at § 414.1001 to combine paragraphs (a) (for supplying fees) and (b)

(for supplying fees following a transplant). Accordingly, we are also proposing to remove

paragraph (b) and redesignate paragraphs (c) and (d) as paragraphs (b) and (c), respectively. We

intend to further study the supplying fee schedule for immunosuppressive drugs and are not

proposing to make any changes to the supplying fee amounts at this time (meaning the current

30-day supplying fees would apply to any amount of days’ supply). The dispensing and

supplying fees under Part B (§ 414.1001) have been shown to be higher than dispensing fees

paid in the commercial market.

284

So, until additional study is done regarding input costs for

dispensing drugs billed to Medicare Part B and subsequent notice-and-comment rulemaking can

be done, if appropriate, in response to such information, we aim to continue the current fee

schedule regardless of the days’ supply dispensed. Second, we are proposing to allow payment

of refills for these immunosuppressive drugs. Under our proposal, if finalized, the prescribing

healthcare provider may adjust the days’ supply up to 90 days and allow refills for an

immunosuppressive drug based on the individual circumstance of the beneficiary in accordance

with applicable state laws.

We welcome comments on these proposals.

5. Blood clotting factors (§ 410.63)

a. Background

284

https://www.pcmanet.org/rx-research-corner/mandating-pharmacy-reimbursement-increase-

spending/08/31/2021/#:~:text=The%20average%20dispensing%20fee%20in,the%20state's%20Medicaid%20FFS%

20rate.

Hemophilia is a genetic bleeding disorder resulting in a deficiency of coagulation Factor

VIII (hemophilia A) or coagulation Factor IX (hemophilia B) due to mutations in the respective

clotting factor genes.

285,286

Prophylactic use of clotting factors has been proven to improve

quality of life by preventing joint bleeds but requires maintenance therapy, usually throughout

the life of the patient. Preventing joint damage early is crucial because the initial damage will

progress, irrespective of whether further bleeds occur in the affected joints.

287

Currently, clotting

factor treatments include: plasma-derived products, which are virally inactivated and made from

human donor plasma; recombinant products, such as recombinant Factors VIIa, VIII, IX, X,

XIII, which are created using genetically engineered cells and recombinant technology; and a

monoclonal antibody product that binds to specific receptor sites of missing clotting factor,

which is needed for effective hemostasis.

288,289

Individuals with hemophilia generally self-infuse

clotting factor at home, often learning to do so in childhood.

290,291,292

Section 2324 of the Deficit Reduction Act of 1984 (Pub. L. 98-369) added subparagraph

(I) to section 1861(s)(2) of the Act to provide Medicare Part B coverage of blood clotting factor

treatments for hemophilia patients who are competent to use such factors to control bleeding

without medical supervision (that is, self-administered), and items related to the administration

of such factors; this is codified at § 410.63(b). As set forth in 1842(o)(1)(C) of the Act, payment

for clotting factor product is the amount provided for under section 1847A of the Act.

In January of 2003, the Comptroller General of the United States published a report

entitled “Payment for Blood Clotting Factor Exceeds Providers Acquisition Cost”

293

(hereinafter

285

https://www.hemophilia.org/bleeding-disorders-a-z/types/hemophilia-a, accessed April 9, 2024.

286

https://www.hemophilia.org/bleeding-disorders-a-z/types/hemophilia-b, accessed April 9, 2024.

287

Aledort LM, Haschmeyer RH, Pettersson H. A longitudinal study of orthopaedic outcomes for severe factor-VIII-

deficient haemophiliacs. The Orthopaedic Outcome Study Group. J Intern Med. 1994 Oct;236(4):391-9.

288

Srivastava A, et al. Haemophilia. 2020;26(suppl 6):1-158.

289

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2483adba-fab6-4d1b-96c5-c195577ed071.

290

GAO-03-184 Medicare: Payment for Blood Clotting Factor. www.gao.gov/assets/gao-03-184.pdf.

291

Valentino, L. A., Baker, J. R., Butler, R., Escobar, M., Frick, N., Karp, S., … Skinner, M. (2021). Integrated

Hemophilia Patient Care via a National Network of Care Centers in the United States: A Model for Rare

Coagulation Disorders. Journal of Blood Medicine, 12, 897–911. https://doi.org/10.2147/JBM.S325031.

292

https://www.hemophilia.org/bleeding-disorders-a-z/treatment/current-treatments, accessed April 9, 2024.

293

https://www.gao.gov/assets/gao-03-184.pdf.

referred to the January 2003 report). Among other things, the report found that “providers incur

additional costs associated with delivering clotting factor that are not separately reimbursed by

Medicare.” Specifically, the report cited delivery costs generated in inventory management,

specialized refrigerated storage, shipping, and the provision of ancillary supplies such as needles,

syringes, and tourniquets to patients that were not accounted for by Medicare payment for the

clotting factor product alone.

After the release of the January 2003 report, section 303I(1) of the MMA amended

section 1842(o) of the Act by adding a new paragraph (5), requiring the Secretary to establish a

furnishing fee for the items and services associated with the furnishing of blood clotting factor.

Specifically, section 1842(o)(5) of the Act requires that for clotting factors furnished on or after

January 1, 2005, the Secretary shall provide for a separate payment to the entity which furnishes

blood clotting factors for items and services related to the furnishing of such factors in an amount

that the Secretary determines to be appropriate. Accordingly, the clotting factor furnishing fee

was codified at § 410.63(c), which states that the furnishing fee is added on a per unit basis to the

clotting factor.

In 2005, CMS established a furnishing fee of $0.14 per unit of clotting factor. The

clotting factor furnishing fee is increased by the percentage increase in the Consumer Price Index

(CPI) for Medical Care for the 12-month period ending with June of the previous year, as

required by Section 1842(o)(5)(C) of the Act, and updated annually in chapter 17, section 80.4.1

of the Medicare Claims Processing Manual. For 2024, the clotting factor furnishing fee is $0.250

per unit. Chapter 17 of the Medicare Claims Processing Manual, section 80.4.1 indicates that

“CMS includes this clotting factor furnishing fee in the nationally published payment limit for

clotting factor billing codes” along with the pricing file, which denotes which HCPCS codes

have the furnishing fee added. The payment limit in the pricing file includes the payment limit

for the clotting factor product (under methodology in section 1847A of the Act) plus furnishing

fee.

As was the case at the time the clotting factor furnishing fee regulations were originally

finalized, we continue to believe the products eligible for payment of the clotting factor

furnishing fee and those eligible for payment as clotting factor products are the same subset of

products: that is, self-administered clotting factor products, as described above. Similar to

section 1861(s)(2)(I) of the Act, section 1842(o)(5) of the Act specifically contemplates that

clotting factors are self-administered. In particular, section 1842(o)(5)(A)(ii) of the Act specifies

that the furnishing fee can take into account “ancillary supplies and patient training for the self-

administration of such factors.” As stated in the CY 2005 PFS final rule, the furnishing fee

accounts for the costs associated with supplying the clotting factor, including patient training

necessary for self-administration of such factors (69 FR 47523; 69 FR 66311). Thus, the clotting

factor furnishing fee, as implemented, pays for services and supplies in connection with the

patient’s self-administration of the product.

We note that section 1842(o)(5)(A) of the Act directed the Secretary to “review[…] the

January 2003 report” when establishing the separate payment for entities which furnish blood

clotting factors to the patient. The January 2003 report refers to self-administration of clotting

factor and the benefits beneficiaries receive from home-use of the product throughout the report.

For example, the report states, “Individuals with hemophilia generally self-infuse clotting factor.

Clotting factor can be infused on demand, when a bleeding episode occurs, or for prevention,

known as prophylactic use. By self-infusing, individuals can avoid waiting for care at a medical

facility.”

Most notably, for purposes of understanding the Medicare clotting factor payment

inadequacy that was addressed by Congress by adding the furnishing fee, the report states “[t]he

method of delivery of clotting factor has implications for Medicare payment. Most outpatient

drugs covered by Medicare are administered in a physician’s office. When a beneficiary visits a

physician in order to receive a drug, the physician receives one payment from Medicare for the

drug and another payment through the physician fee schedule for administering the drug.

Clotting factor, however, is generally not administered in a physician’s office.” That is, the

report highlighted that Medicare payment for clotting factor, in particular, was inadequate

because there are costs associated with supplying the clotting factor, but because it is self-

administered, the furnishing of clotting factor was generally not eligible for the administration

fee. Generally, the report noted that payment for supplying other outpatient drugs covered by

Medicare Part B were adequate because they are eligible for the administration fee. Again, as

stated above, Congress addressed this issue by creating the furnishing fee for these self-

administered clotting factor products in the MMA.

More recently, gene therapies have been FDA-approved for the treatment of hemophilia.

These gene therapies introduce a functional gene to the patient, which provides the genetic

information needed for the patient to produce the missing or nonfunctional protein. A viral

vector in the gene therapies, engineered with adeno-associate virus, delivers the functional copy

of the clotting factor gene into the patient's liver cells. The viral vector then releases the

functional gene which integrates into the cell's DNA and starts producing the missing clotting

factor protein (that is, Factor VIII or Factor IX) to restore normal clotting function.

In the case of hemophilia A or B, the gene therapy introduces the functional gene that

enables the patient to produce Factor VIII or Factor IX, respectively, on their own. Unlike

clotting factors, which promptly restore balance in the coagulation cascade at the point of

deficiency or bridge activated Factor IX and Factor X to restore the function of missing activated

Factor VIII,

294

allowing for stable blood clot formation and hemostasis, the gene therapies do not

directly integrate into the coagulation cascade.

295,296

In the coagulation cascade, clotting factors

become activated in response to damaged tissues or exposure to collagen at the injury site. This

activation initiates the conversion of prothrombin to thrombin. Thrombin then converts

294

Genentech, Inc. Hemlibra (emicizumab-kxwh) injection, for subcutaneous use. South San Francisco, CA:

Genentech, Inc.; 2023. Package insert.

295

Hoffman, M., & Monroe, D. M. (2001). A cell-based model of hemostasis. Thrombosis and Haemostasis, 85(6),

958-965

296

Schenone M, Furie BC, Furie B. The blood coagulation cascade. Curr Opin Hematol. 2004 Jul;11(4):272-7.

fibrinogen into fibrin strands, forming the blood clot. Clotting factors restore normal clotting

function by replacing deficient factors through repeated, dose-adjustable infusions or injections.

In contrast, a single administration of gene therapies maintains a consistent and adequate level of

clotting factors over the long term by enabling the self-production of the clotting factor

proteins—an indirect method that relies on the patient’s cells to increase clotting factor levels.

However, as the self-production of clotting factor proteins takes time, the sustained outcomes of

gene therapies may take several weeks to fully manifest. Interested parties have asked if CMS

considers these gene therapies to be clotting factors for which the clotting factor furnishing fee

would be paid.

Gene therapies for hemophilia are administered via a one-time, single-dose intravenous

infusion in a setting where personnel and equipment are immediately available to treat infusion-

related reactions. They are not typically administered by the patient in his or her home, and close

monitoring is required for at least three hours after the end of the infusion.

297

While these gene

therapy products may have a similar goal to clotting factor products, in that both products are

designed to improve outcomes for patients with hemophilia, gene therapy products prompt the

body to make clotting factors, but are not clotting factors themselves. Given that the

administration would occur incident to a physician service (that is, the product is not self-

administered), the differing mechanism of action from replacing deficient factors (that is,

triggering the body to make clotting factors rather than infusing clotting factors into the body),

and the requirement of close monitoring by a healthcare professional post-infusion, these gene

therapies do not have the characteristics described in the January 2003 report that is referenced in

section 1842(o)(5) of the Act, which the Secretary relied on in drafting § 410.63(c). Therefore,

they do not constitute “clotting factors” for purposes of Medicare payment.

297

Carvalho M, Sepodes B, Martins APPatient access to gene therapy medicinal products: a comprehensive

reviewBMJ Innovations 2021;7:123-134.

Accordingly, gene therapies for hemophilia are eligible for payment as drugs or

biologicals under Part B as part of (or incident to) a physician’s service. The “incident to”

coverage is limited to drugs that are not usually self-administered and the physician generally

must incur a cost for the drug and must bill for it. Furnishing entities will bill for its

administration, and the administration fees will reflect the resources necessary to furnish the

drug. For example, certain CPT codes for administering drugs include preparation of the dose

and patient monitoring. Specifically, CPT codes 96401 - 96549 (chemotherapy administration

and nonchemotherapy injections and infusions) include clinical labor activities such as clinical

staff preparation of chemotherapy agent(s) as well as evaluation and management services.

298

For the reasons explained above, we do not believe gene therapies for hemophilia meet

the definition of a clotting factor for purposes of Medicare payment, but even if they did, they

still would not be eligible for the furnishing fee because the costs associated with furnishing

these gene therapies would already be reflected in applicable administration codes paid under the

Physician Fee Schedule. In accordance with § 410.63(c)(1), a clotting factor furnishing fee is not

payable when the costs associated with furnishing a clotting factor are paid through another

payment system. In this case, the payment system is the payment system established under the

Physician Fee Schedule. Furnishing fees for drugs that are physician administered would result

in physicians being paid twice for incidental costs of administering the drug because the

furnishing fee is intended to compensate for supplies like needles, syringes, and tourniquets as

well as storage costs, and so is the Part B payment for administering the drug. We do not believe

this double payment is appropriate, nor do we believe this is what Congress intended in directing

CMS to establish a clotting factor furnishing fee.

Accordingly, in this proposed rule, we are proposing to update § 410.63(b) to clarify

existing CMS policy that blood clotting factors must be self-administered to be considered

clotting factors for which the furnishing fee applies. Additionally, we are proposing to clarify at

298

Section 30.5, Chapter 12 of the Medicare Claims Processing Manual.

§ 410.63(c) that the furnishing fee is only available to entities that furnish blood clotting factors,

unless the costs associated with furnishing the clotting factor are paid though another payment

system, including the Physician Fee Schedule. That is, we are proposing to clarify through

revisions to § 410.63 that clotting factors (as specified in section 1861(s)(2)(I) of the Act) and

those eligible to receive the clotting factor furnishing fee (as specified in section 1842(o)(5) of

the Act) are the same subset of products.

B. Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs)

1. Background on RHC and FQHC Payment Methodologies

As provided in 42 CFR part 405, subpart X, of our regulations, RHC and FQHC visits

generally are defined as face-to-face encounters between a patient and one or more RHC or

FQHC practitioners during which one or more RHC or FQHC qualifying services are furnished.

RHC and FQHC practitioners are physicians, NPs, PAs, CNMs, clinical psychologists (CPs),

licensed marriage and family therapists, mental health counselors, and clinical social workers,

and under certain conditions, a registered nurse or licensed practical nurse furnishing care to a

homebound RHC or FQHC patient in an area verified as having shortage of home health

agencies. Transitional Care Management (TCM) services can also be paid by Medicare as an

RHC or FQHC visit. In addition, Diabetes Self-Management Training (DSMT) or Medical

Nutrition Therapy (MNT) sessions furnished by a certified DSMT or MNT program may also be

considered FQHC visits for Medicare payment purposes. Only medically necessary medical,

mental health, or qualified preventive health services that require the skill level of an RHC or

FQHC practitioner are RHC or FQHC billable visits. Services furnished by auxiliary personnel

(for example, nurses, medical assistants, or other clinical personnel acting under the supervision

of the RHC or FQHC practitioner) are considered incident to the visit and are included in the

per-visit payment.

RHCs generally are paid an all-inclusive rate (AIR) for all medically necessary medical

and mental health services and qualified preventive health services furnished on the same day

(with some exceptions). The AIR is subject to a payment limit, meaning that an RHC will not

receive any payment beyond the specified limit amount. As of April 1, 2021, all RHCs are

subject to upper payment limits determined in accordance with section 1833(f) of the Act.

FQHCs were paid under the same AIR methodology until October 1, 2014. Beginning on

that date, in accordance with section 1834(o) of the Act (as added by section 10501(i)(3) of the

Patient Protection and Affordable Care Act (Pub. L. 111-148)), FQHCs began to transition to the

FQHC PPS system, in which they are paid based on the lesser of the FQHC PPS rate or their

actual charges. The FQHC PPS rate is adjusted for geographic differences in the cost of services

by the FQHC PPS geographic adjustment factor (GAF). The rate is increased by 34 percent

when an FQHC furnishes care to a patient that is new to the FQHC, or to a beneficiary receiving

an initial preventive physical examination (IPPE) or has an annual wellness visit (AWV).

Both the RHC AIR and FQHC PPS payment rates were designed to reflect the cost of all

services and supplies that an RHC or FQHC furnishes to a patient in a single day. The rates are

not adjusted at the individual level for the complexity of individual patient health care needs, the

length of an individual visit, or the number or type of practitioners involved in the patient’s care.

Instead for RHCs, all costs for the facility over the course of the year are aggregated and an AIR

is derived from these aggregate expenditures. The FQHC PPS base rate is updated annually by

the percentage increase in the FQHC market basket reduced by a productivity adjustment. For

CY 2025, CMS is proposing to rebase and revise the FQHC market basket to reflect a 2022 base

year; see section III.B.7 of this proposed rule.

2. General Care Management Services in RHCs and FQHCs

a. Background

We have been engaged in a multi-year examination of coordinated and collaborative care

services in professional settings, and as a result established codes and separate payment in the

PFS to independently recognize and pay for these important services. The care coordination

included in services, such as office visits, does not always adequately describe the non-face-to-

face care management work involved in primary care and similar care relationships. Payment for

office visits may not reflect all the services and resources required to furnish comprehensive,

coordinated care management for certain categories of beneficiaries, such as those who are

returning to a community setting following discharge from a hospital or skilled nursing facility

(SNF) stay.

Before we get into the detailed background of our RHC and FQHC payment policies for

care coordination services, we want to acknowledge that we have used several terms to describe

these services and are providing clarification. We use the terms “care coordination” services

interchangeably with the term “care management” services in preamble and manual guidance to

describe the type of work discussed above. We began to use the term “general care

management” when we established the HCPCS code G0511 for CY 2018. Use of “general care

management” is meant to describe certain non-face-to-face care management work involved in

primary care that we have identified as appropriate for separate payment as discussed in the

following paragraphs.

As we discussed in the CY 2016 PFS final rule (80 FR 71081 through 71088), to address

the concern that the non-face-to-face care management work involved in furnishing

comprehensive, coordinated care management for certain categories of beneficiaries is not

adequately paid for as part of an office visit, beginning on January 1, 2015, practitioners billing

under the PFS are paid separately for chronic care management (CCM) services when CCM

service requirements are met. We explained that RHCs and FQHCs cannot bill under the PFS for

RHC or FQHC services and individual practitioners working at RHCs and FQHCs cannot bill

under the PFS for RHC or FQHC services while working at the RHC or FQHC. Although many

RHCs and FQHCs pay for coordination of services within their own facilities and may

sometimes help to coordinate services outside their facilities, the type of structured care

management services that are now payable under the PFS for patients with multiple chronic

conditions, particularly for those who are transitioning from a hospital or SNF back into their

communities, are generally not included in the RHC or FQHC payment. Therefore, separate

payment was established in the CY 2016 PFS final rule (80 FR 71080 through 71088) for RHCs

and FQHCs that furnish CCM services. We believe the non-face-to-face time required to

coordinate care is not captured in the RHC AIR or the FQHC PPS payment, particularly for the

rural and/or low-income populations served by RHCs and FQHCs. Allowing separate payment

for CCM services in RHCs and FQHCs is intended to reflect the additional resources necessary

for the unique components of CCM services.

In the CY 2018 PFS final rule (82 FR 53169 through 53180), we finalized revisions to

the payment methodology for CCM services furnished by RHCs and FQHCs and established

requirements for general behavioral health integration (BHI) and psychiatric collaborative care

management (CoCM) services furnished in RHCs and FQHCs, beginning on January 1, 2018.

We also initiated the use of HCPCS codes G0511 and G0512. HCPCS code G0511 is a general

care management code for use by RHCs or FQHCs when at least 20 minutes of qualified CCM

or general BHI services are furnished to a patient in a calendar month. HCPCS code G0512 is

for psychiatric CoCM and can be billed by RHCs or FQHCs when at least 60 minutes of

qualified psychiatric CoCM services are furnished to a patient in a calendar month.

For CY 2018 the payment amount for HCPCS code G0511 was set at the average of the 3

national non-facility PFS payment rates for the CCM and general BHI codes and updated

annually based on the PFS amounts. That is, for CY 2018 the 3 codes that comprised HCPCS

code G0511 were CPT code 99490 (20 minutes or more of CCM services), CPT code 99487 (60

minutes or more of complex CCM services), and CPT code 99484 (20 minutes or more of BHI

services).

In the CY 2019 PFS final rule (83 FR 59683), we explained that another CCM code was

introduced for practitioners billing under the PFS, CPT code 99491, which would correspond to

30 minutes or more of CCM furnished by a physician or other qualified health care professional

and is similar to CPT codes 99490 and 99487. Therefore, for RHCs and FQHCs, we added CPT

code 99491 as a general care management service and included it in the calculation of HCPCS

code G0511. Starting on January 1, 2019, RHCs and FQHCs were paid for HCPCS code G0511

based on the average of the national non-facility PFS payment rates for CPT codes 99490,

99487, 99484, and 99491 (83 FR 59687).

In the CY 2021 PFS final rule (85 FR 84697 through 84699), we explained that the

requirements described by the codes for principal care management (PCM) services were similar

to the requirements for the services described by HCPCS code G0511; therefore, we added

HCPCS codes G2064 and G2065 to HCPCS code G0511 as general care management services

for RHCs and FQHCs. Consequently, effective January 1, 2021, RHCs and FQHCs are paid

when a minimum of 30 minutes of qualifying PCM services are furnished during a calendar

month. The payment rate for HCPCS code G0511 for CY 2021 was the average of the national

non-facility PFS payment rate for the RHC and FQHC care management and general behavioral

health codes (CPT codes 99490, 99487, 99484, and 99491), and PCM codes (HCPCS codes

G2064 and G2065). We noted that in the CY 2022 PFS final rule (86 FR 65118), HCPCS codes

G2064 and G2065 were replaced by CPT codes 99424 and 99435. Therefore, for CY 2022 the

payment rate for HCPCS code G0511 was the average of the national non-facility PFS payment

rate for CPT codes 99490, 99487, 99484, 99491, 99424, and 99425).

In the CY 2023 PFS final rule (87 FR 69735 through 69737), we included chronic pain

management (CPM) services described by HCPCS code G3002 in the general care management

HCPCS code G0511 when at least 30 minutes of qualifying non-face-to-face CPM services are

furnished during a calendar month. We explained since HCPCS code G3002 is valued using a

crosswalk to the PCM CPT code 99424, which is currently one of the CPT codes that comprise

HCPCS code G0511, there was no change made to the average used to calculate the HCPCS

code G0511 payment rate to reflect CPM services.

Most recently, in the CY 2024 PFS final rule (88 FR 79071 through 79073) we included

the CPT codes that are associated with the suite of services that comprise remote physiologic

monitoring (RPM) and remote therapeutic monitoring (RTM) in the general care management

HCPCS code G0511 when these services are furnished by RHCs and FQHCs. In addition, we

included community heath integration (CHI), principal illness navigation (PIN), and PIN – peer

support services in HCPCS code G0511 when these services are furnished by RHCs and FQHCs

(88 FR 79073 through 79081). We noted that for each of these newly included services that they

must be medically reasonable and necessary, meet all requirements, and not be duplicative of

services paid to RHCs and FQHCs under the general care management code for an episode of

care in a given calendar month. We also clarified RHCs and FQHCs may bill HCPCS code

G0511 multiple times in a calendar month, as long as all of the requirements are met and

resource costs are not counted more than once (88 FR 79075).

Additional information on care management requirements is available on the CMS Care

Management webpage and on the CMS RHC and FQHC webpages.

299,300,301

b. Proposed Regulatory Update (§ 405.2464(c))

During our development of the proposals discussed in section III.B.2.c. and III.B.2.d. of

this proposed rule, we determined that the language located in § 405.2464(c) could use additional

information to streamline and provide clarity on our payment policy for care coordination

services. For example, using consistent terms, effective dates, and the description of the basis of

payment. Therefore, we propose technical changes to § 405.2464(c) to accurately reflect the

iterations of our payment policy for care coordination services as detailed in this background

section.

c. Proposed Payment Policy for General Care Management Services

As discussed previously, in the last few years of PFS payment rules we have expanded

the scope of care management services billable using HCPCS code G0511. Prior to CY 2024,

299

https://www.cms.gov/medicare/payment/fee-schedules/physician/care-management.

300

https://www.cms.gov/center/provider-type/rural-health-clinics-center.

301

https://www.cms.gov/medicare/payment/prospective-payment-systems/federally-qualified-health-centers-fqhc-

center.

HCPCS code G0511 was based on the national average non-facility PFS payment rate for each

base code identified as billable general care management services. That is, we added each

payment rate divided by the total number of codes to arrive at the payment amount for HCPCS

code G0511. This payment amount was a flat rate that was not subsequently adjusted for locality.

In the CY 2024 PFS final rule (88 FR 79076 through 79079), we explained continuing to

calculate the value of HCPCS code G0511 using an approach based on an average may no longer

be appropriate payment for those services since we are simply dividing by the number of codes

that comprise HCPCS code G0511 and as that number of services with lower payment rates

increases, the payment rate decreases. We noted that while the policy may address providing a

payment for furnishing non-face-to-face services, the magnitude of the value may not

appropriately account for the costs. Therefore, we finalized a revised methodology for the

calculation of HCPCS code G0511 by looking at the actual utilization of the services. We used a

weighted average of the services that comprise HCPCS code G0511. For the utilization data of

the services, we used the most recently available utilization data from the services paid under the

PFS in the physician office setting. We explained that the physician office setting may provide

an appropriate proxy for utilization of these services in the absence of actual data because this

setting most closely aligns with the types of services furnished in RHCs and FQHCs since they

typically furnish primary care.

To ensure we accounted for payments accurately, we explained that we looked at PFS

utilization of the base code for the service and any applicable add-on codes used in the same

month as well as any base codes reported alone in a month for all of the services comprising

general care management (that is, the array of services that made up HCPCS code G0511). We

believed we needed to account for the payment associated with the base code along with an

applicable add-on code in our calculation as this demonstrates a complete encounter. Then to

arrive at the payment rate for HCPCS code G0511 for CY 2024, we took the weighted average of

the base code and add-on code pairs, in addition to the individual base codes for all of the

services that comprise HCPCS code G0511 by using the CY 2021 PFS utilization.

We determined that this approach was a more accurate representation of the payment

since it is consistent with practitioners billing under the PFS, and it accounts for the additional

time spent in care coordination.

Subsequent to the issuance of the CY 2024 PFS final rule, interested parties have

requested that CMS give them the ability to bill Medicare for each of the care management

services that comprise HCPCS code G0511 when they are furnished in RHCs and FQHCs.

RHCs, FQHCs, and associations supporting access to health care for rural populations have

expressed concerns regarding the transparency of the services being billed with HCPCS code

G0511. We note, in the CY2024 PFS final rule we stated that HCPCS code G0511 could be

billed multiple times in a calendar month for each care management code that comprised HCPCS

code G0511 as long as all requirements were met, there was no overlapping of resource time and

services were furnished in accordance with CPT coding guidelines and conventions. However,

providing this guidance triggered questions on how CMS tracks which general care management

service is being furnished if the bundled code is reported so they would know when it was

appropriate to bill multiple care management services on a single claim. RHCs and FQHCs have

also requested the ability to bill the add-on codes that describe additional minutes spent on

furnishing care management services and often ask for guidance on how to account for additional

time spent.

We have also heard from interested parties that RHCs and FQHCs would not find it

burdensome to report the actual HCPCS code that describes the care management service

furnished, which was the main concern we had when we implemented HCPCS code G0511 (82

FR 53172). We understand that RHCs and FQHCs have become more sophisticated with billing

and therefore reporting multiple codes has become less burdensome than in CY 2018 when we

implemented G0511. In addition, we have heard that RHCs and FQHCs are interested in having

more exposure and recognition in playing their part the delivery of quality primary care and

believe that this could be achieved with data that shows their utilization of services which could

also be used in future payment refinements.

Due to these concerns, we have reevaluated our payment policy for care management

services. We agree with interested parties that it is important to identify the actual services being

furnished and understand the utilization of these services, especially given our strong interest in

their volume and their contribution to initiatives on health equity and social needs of services in

the care coordination space. Therefore, we are proposing to require RHCs and FQHCs to bill the

individual codes that make up the general care management HCPCS code, G0511. The current

list of base and add-on codes that make-up G0511 are listed in Table 24, titled “General Care

Management HCPCS Codes and Descriptors.” Under this proposal, HCPCS code G0511 would

no longer be payable when billed by RHCs and FQHCs. We note that the payment amounts for

some services that made up G0511 are less than the payment amount for G0511 and if an RHC

or FQHC mostly furnishes these services, they could see a potential decline in payment. We are

also proposing to allow RHCs and FQHCs to bill the add-on codes for additional time spent once

the minimum threshold of time was met to account for a complete encounter. This could

potentially offset any decrease in payments. Payment for these services would be the national

non-facility PFS payment rate when the individual code is on an RHC or FQHC claim, either

alone or with other payable services and the payment rates are updated annually based on the

PFS amounts for these codes. We believe that these proposals promote transparency in billing

and payment and allowing RHCs and FQHCs to bill the individual care management codes

would take into account the complexity of the service and the time spent furnishing the service.

TABLE 24: General Care Management HCPCS Codes and Descriptors

HCPCS

code

Short Descriptors

Long Descriptors

99091

Collj & interpj data ea 30 d

Collection and interpretation of physiologic data (e.g. Blood

pressure, glucose monitoring) digitally stored and/or

transmitted by the patient and/or caregiver to the physician or

other qualified health professional, qualified by education,

training, licensure/regulation (when applicable) requiring a

minimum of 30 minutes of time, each 30 days

99424

Prin care mgmt phys 1st 30

Principal care management services, for a single high-risk

disease, with the following required elements: one complex

chronic condition expected to last at least 3 months, and that

places the patient at significant risk of hospitalization, acute

exacerbation/ decompensation, functional decline, or death, the

condition requires development, monitoring, or revision of

disease-specific care plan, the condition requires frequent

adjustments in the medication regimen, and/or the management

of the condition is unusually complex due to comorbidities,

ongoing communication and care coordination between

relevant practitioners furnishing care; first 30 minutes provided

personally by a physician or other qualified health care

professional, per calendar month

99425

Prin care mgmt phys ea addl

Principal care management services, for a single high-risk

disease, with the following required elements: one complex

chronic condition expected to last at least 3 months, and that

places the patient at significant risk of hospitalization, acute

exacerbation/ decompensation, functional decline, or death, the

condition requires development, monitoring, or revision of

disease-specific care plan, the condition requires frequent

adjustments in the medication regimen and/or the management

of the condition is unusually complex due to comorbidities,

ongoing communication and care coordination between

relevant practitioners furnishing care; each additional 30

minutes provided personally by a physician or other qualified

health care professional, per calendar month (List separately in

addition to code for primary procedure)

99426

Prin care mgmt staff 1st 30

Principal care management services, for a single high-risk

disease, with the following required elements: one complex

chronic condition expected to last at least 3 months, and that

places the patient at significant risk of hospitalization, acute

exacerbation/ decompensation, functional decline, or death, the

condition requires development, monitoring, or revision of

disease-specific care plan, the condition requires frequent

adjustments in the medication regimen and/or the management

of the condition is unusually complex due to comorbidities,

ongoing communication and care coordination between

relevant practitioners furnishing care; first 30 minutes of

clinical staff time directed by physician or other qualified

health care professional, per calendar month

99427

Prin care mgmt staff ea addl

Principal care management services, for a single high-risk

disease, with the following required elements: one complex

chronic condition expected to last at least 3 months, and that

places the patient at significant risk of hospitalization, acute

exacerbation/ decompensation, functional decline, or death, the

condition requires development, monitoring, or revision of

disease-specific care plan, the condition requires frequent

adjustments in the medication regimen and/or the management

of the condition is unusually complex due to comorbidities,

ongoing communication and care coordination between

relevant practitioners furnishing care; each additional 30

HCPCS

code

Short Descriptors

Long Descriptors

minutes of clinical staff time directed by a physician or other

qualified health care professional per calendar month (List

separately in addition to code for primary procedure)

99437

Chrnc care mgmt phys ea addl

Chronic care management services, provided personally by a

physician or other qualified health care professional, with the

following required elements: multiple (two or more) chronic

conditions expected to last at least 12 months, or until the death

of the patient, chronic conditions place the patient at significant

risk of death, acute exacerbation/ decompensation, or

functional decline, comprehensive care plan established,

implemented, revised or monitored; each additional 30 minutes

by a physician or other qualified health care professional, per

calendar month (List separately in addition to code for primary

procedure)

99439

Chrnc care mgmt staf ea addl

Chronic care management services, each additional 20 minutes

of clinical staff time directed by a physician or other qualified

health care professional, per calendar month

99453

Rem mntr physiol param setup

Remote monitoring of physiologic parameter(s) (e.g. Weight,

blood pressure, pulse oximetry, respiratory flow rate) initial

set-up and patient education on use of equipment

99454

Rem mntr physiol param dev

Remote monitoring of physiologic parameter(s) (e.g. Weight,

blood pressure, pulse oximetry, respiratory flow rate) initial

device(s) supply with daily recording(s) or programmed alert(s)

transmission, each 30 days

99457

Rem physiol mntr 1

20 min

Remote physiologic monitoring treatment services, clinical

staff/physician/other qualified health care professional time in a

calendar month requiring interactive communication with the

patient/caregiver during the month; first 20 minutes

99458

Rem physiol mntr ea addl 20

Remote physiologic monitoring treatment services, clinical

staff/physician/other qualified health care professional time in a

calendar month requiring interactive communication with the

patient/caregiver during the month; each additional 20 minutes

(list separately in addition to code for primary procedure)

99474

Self-meas bp 2 readg bid 30d

Self-measured blood pressure using a device validated for

clinical accuracy; separate self-measurements of two readings

one minute apart, twice daily over a 30-day period (minimum

of 12 readings), collection of data reported by the patient

and/or caregiver to the physician or other qualified health care

professional, with report of average systolic and diastolic

pressures and subsequent communication of a treatment plan to

the patient

99484

Care mgmt svc bhvl hlth cond

Care management services for behavioral health conditions, at

least 20 minutes of clinical staff time, directed by a physician

or other qualified health care professional time, per calendar

month, with the following required element: initial assessment

or follow-up monitoring, including using applicable validated

rating scales, behavioral health care planning about behavioral

or psychiatric health problems, including revision for patients

not progressing or whose status changes, facilitating and

coordinating treatment such as psychotherapy,

pharmacotherapy, counseling, or psychiatric consultation,

continuity of care with an appointed member of the care team

99487

Cplx chrnc care 1st 60 min

Complex chronic care management services, with the following

required elements: multiple (two or more) chronic conditions

expected to last at least 12 months, or until the death of the

patient, chronic conditions place the patient at significant risk

of death, acute exacerbation/decompensation, or functional

decline, establishment or substantial revision of comprehensive

care plan, moderate or high complexity medical decision

making; first 60 minutes of clinical staff time directed by a

HCPCS

code

Short Descriptors

Long Descriptors

physician or other qualified health care professional, per

calendar month

99489

Cplx chrnc care ea addl 30

Complex chronic care management services, with the following

required elements: multiple (two or more) chronic conditions

expected to last at least 12 months, or until the death of the

patient, chronic conditions place the patient at significant risk

of death, acute exacerbation/decompensation, or functional

decline, establishment or significant revision of comprehensive

care plan, moderate or high complexity medical decision

making; each additional 30 minutes of clinical staff time

directed by a physician or other qualified health care

professional, per calendar month (List separately in addition to

code for primary procedure)

99490

Chrnc care mgmt staff 1st 20

Chronic care management services with the following required

elements: multiple (two or more) chronic conditions expected

to last at least 12 months, or until the death of the patient,

chronic conditions place the patient at significant risk of death,

acute exacerbation/decompensation, or functional decline,

comprehensive care plan established, implemented, revised, or

monitored; first 20 minutes of clinical staff time directed by a

physician or other qualified health care professional, per

calendar month

99491

Chrnc care mgmt phys 1st 30

Chronic care management services, provided personally by a

physician or other qualified healthcare professional, at least 30

minutes of physician or other qualified healthcare professional

time, per calendar month, with the following required elements:

multiple (two or more) chronic conditions expected to last at

least 12 months, or until the death of the patient, chronic

conditions place the patient at significant risk of death, acute

exacerbation/decompensation, or functional decline,

comprehensive care plan established, implemented, revised, or

monitored

98975

Rem ther mntr 1st setup&edu

Remote therapeutic monitoring (e.g. therapy adherence,

therapy response); initial set-up and patient education on use of

equipment

98976

Rem ther mntr dev sply resp

Remote therapeutic monitoring (e.g. therapy adherence,

therapy response); device(s) supply with scheduled (e.g. daily)

recording(s) and/or programmed alert(s) transmission to

monitor respiratory system, each 30 days

98977

Rem ther mntr dv sply mscskl

Remote therapeutic monitoring (e.g. therapy adherence,

therapy response); device(s) supply with scheduled (e.g. daily)

recording(s) and/or programmed alert(s) transmission to

monitor musculoskeletal system, each 30 days

98980

Rem ther mntr 1st 20 min

Remote therapeutic monitoring treatment management

services, physician or other qualified health care professional

time in a calendar month

requiring at least one interactive communication with the

patient or caregiver during the calendar month; first 20 minutes

98981

Rem ther mntr ea addl 20 min

Remote therapeutic monitoring treatment management

services, physician or other qualified health care professional

time in a calendar month requiring at least one interactive

communication with the patient or caregiver during the

calendar month; each additional 20 minutes (list separately in

addition to code for primary procedure)

G0140

Nav srv peer sup 60 min pr m

Principal Illness Navigation – Peer Support by certified or

trained auxiliary personnel under the direction of a physician or

other practitioner, including a certified peer specialist; 60

minutes per calendar month, for specified activities

HCPCS

code

Short Descriptors

Long Descriptors

G0146

Nav srv peer sup add 30 pr m

Principal Illness Navigation—Peer Support, additional 30

minutes per calendar month (List separately in addition to

G0140)

G3002

Chronic pain mgmt 30 mins

Chronic pain management and treatment, monthly bundle

including, diagnosis; assessment and monitoring;

administration of a validated pain rating scale or tool; the

development, implementation, revision, and maintenance of a

person-centered care plan that includes strengths, goals, clinical

needs, and desired outcomes; overall treatment management;

facilitation and coordination of any necessary behavioral health

treatment; medication management; pain and health literacy

counseling; any necessary chronic pain related crisis care; and

ongoing communication and care coordination between

relevant practitioners furnishing care, e.g. physical therapy and

occupational therapy, and community-based care, as

appropriate. Required initial face-to- face visit at least 30

minutes provided by a physician or other qualified health

professional; first 30 minutes personally provided by physician

or other qualified health care professional, per calendar month.

(when using G3002, 30 minutes must be met or exceeded)

G3003

Chronic pain mgmt addl 15m

Each additional 15 minutes of chronic pain management and

treatment by a physician or other qualified health care

professional, per calenda month. (List separately in addition to

G3002. When using G3003, 15 minutes mut be met or

exceeded).

G0323

Care manage beh svs 20mins

Care management services for behavioral health conditions, at

least 20 minutes of clinical psychologist or clinical social

worker time, per calendar month, with the following required

elements: initial assessment or follow-up monitoring, including

the use of applicable validated rating scales; behavioral health

care planning in relation to behavioral/psychiatric health

problems, including revision for patients who are not

progressing or whose status changes; facilitating and

coordinating treatment such as psychotherapy, coordination

with an/or referral to physicians and practitioners who are

authorized by Medicare law to prescribe medications and

furnish E/M services counseling and/or psychiatric

consultation; and continuity of care with a designated member

of the care team)

G0019

Comm hlth intg svs sdoh 60

Community health integration services performed by certified

or trained auxiliary personnel, including a community health

worker, under the direction of a physician or other practitioner;

60 minutes per calendar month, in the following activities to

address social determinants of health (SDOH) need(s) that are

significantly limiting the ability to diagnose or treat problem(s)

addressed in an initiating visit.

G0022

Comm hlth intg svs add 30 m

Community health integration services, each additional 30

minutes per calendar month (List separately in addition to

G0019)

G0023

Pin srv 60 min pr m

Principal Illness Navigation services by certified or trained

auxiliary personnel under the direction of a physician or other

practitioner, including a patient navigator or certified peer

specialist; 60 minutes per calendar month, in the following

activities: • Person-centered assessment, performed to better

understand the individual context of the serious, high risk

condition. ++ Conducting a person-centered assessment to

understand the patient’s life story, strengths, needs, goals,

preferences, and desired outcomes, including understanding

cultural and linguistic factors. ++ Facilitating patient-driven

goal setting and establishing an action plan. ++ Providing

HCPCS

code

Short Descriptors

Long Descriptors

tailored support as needed to accomplish the practitioner’s

treatment plan. • Identifying or referring patient (and caregiver

or family, if applicable) to appropriate supportive services.

G0024

Pin srv add 30 min pr m

Principal Illness Navigation services, additional 30 minutes per

calendar month (List separately in addition to G0023).

We are proposing revisions at § 405.2464(c) to reflect the proposed payment method for

care management services furnished in RHCs and FQHCs beginning January 1, 2025. We

welcome comments on this proposed payment methodology.

d. New Codes for Advanced Primary Care Management (APCM) Services

As discussed in section II.G of this proposed rule, HHS and CMS have been analyzing

opportunities to strengthen and invest in primary care in alignment with the goals of the HHS

Initiative to Strengthen Primary Care.

302

Research has demonstrated that greater primary care

physician supply is associated with improved population-level mortality and reduced

disparities,

303

and also that establishing a long-term relationship with a primary care provider

leads to reduced emergency department (ED) visits,

304

improved care coordination, and

increased patient satisfaction.

305

HHS recognizes that effective primary care is essential for

improving access to healthcare, for the health and wellbeing of individuals, families, and

communities, and for achieving health equity. The first coordinated set of HHS-wide actions to

strengthen primary care, as part of the Initiative, is in primary care payment; for example,

adjusting payment to ensure it supports delivery of advanced primary care. CMS Innovation

Center models, described in section II.G.2.a.(1) of this proposed rule, reflect the ongoing work

302

U.S. Department of Health and Human Services. (2023). Primary Care: Our First Line of Defense.

https://www.hhs.gov/sites/default/files/primary-care-issue-brief.pdf.

303

Basu S, Berkowitz SA, Phillips RL, Bitton A, Landon BE, Phillips RS. Association of Primary Care Physician

Supply With Population Mortality in the United States, 2005-2015. JAMA Intern Med. 2019;179(4):506–514.

doi:10.1001/jamainternmed.2018.7624.

https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2724393.

304

Willemijn L.A. Schäfer et al, “Are People’s Health Care Needs Better Met When Primary Care Is Strong? A

Synthesis of the Results of the QUALICOPC Study in 34 Countries,” Primary Health Care Research and

Development 20 (2019): e104. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6609545/.

305

Michael J. van den Berg, Tessa van Loenen, and Gert P Westert, “Accessible and Continuous Primary Care May

Help Reduce Rates of Emergency Department Use: An International Survey in 34 Countries,” Family Practice 33,

no. 1 (Feb. 2016): 42–50. https://academic.oup.com/fampra/article/33/1/42/2450446.

within HHS and the unified, comprehensive approach to HHS primary care activities that we are

accomplishing through our current statutory authorities and funding.

In recent years, CMS has implemented significant changes aimed at better capturing the

resources required for care management services, including chronic care management (CCM),

principal care management (PCM), and transitional care management (TCM) and more recently,

community health integration (CHI), principal illness navigation (PIN) and PIN-peer support

services. For RHCs and FQHCs, we have established payment for these suites of care

management services outside of the RHC AIR and FQHC PPS. The policy requirements for

RHCs and FQHCs furnishing these various care coordination services are consistent with those

finalized under the PFS.

In section II.G.2.b. of this proposed rule, we are proposing to establish coding and make

payment under the PFS for a newly defined set of APCM services described and defined by three

new HCPCS G-codes. This new coding would reflect the recognized effectiveness and growing

adoption of the advanced primary care approach to care. It would also encompass a broader

range of services and simplify the billing and documentation requirements, as compared to

existing care management codes. The proposed coding for APCM incorporates elements of

several existing care management services into a bundle that we have already considered to be

care coordination services paid separately to RHCs and FQHCs using HCPCS code G0511. For

example, CCM and PCM. In addition, the coding for APCM incorporates elements of

communication technology-based services (CTBS) into a bundle that we have already considered

to be virtual communications paid separately to RHCs and FQHCs using HCPCS code G0071.

For example, remote evaluation of patient videos/images, virtual check-in, and e-visits.

Therefore, to allow RHCs and FQHCs the ability to simplify the billing and documentation

requirements associated with furnishing APCM services we are proposing to allow RHCs and

FQHCs to bill for these services and receive separate payment. Consistent with section II.G.2.b.

of this proposed rule, the APCM code sets vary by the degree of complexity of patient conditions

(that is, non-complex and complex CCM for multiple chronic conditions or PCM for a single

high-risk condition), and whether the number of minutes spent by clinical staff or the physician

or non-physician practitioner (NPP) is used to meet time thresholds for billing. The proposed

HCPCS codes are described below:

HCPCS code GPCM1 (Advanced primary care management services provided by clinical

staff and directed by a physician or other qualified health care professional who is responsible

for all primary care and serves as the continuing focal point for all needed health care services,

per calendar month, with the following elements, as appropriate:

● Consent;

++ Inform the patient of the availability of the service; that only one practitioner

can furnish and be paid for the service during a calendar month; of the right to

stop the services at any time (effective at the end of the calendar month); and that

cost sharing may apply.

++ Document in patient’s medical record that consent was obtained.

● Initiation during a qualifying visit for new patients or patients not seen within 3 years;

● Provide 24/7 access for urgent needs to care team/practitioner, including providing

patients/caregivers with a way to contact health care professionals in the practice to

discuss urgent needs regardless of the time of day or day of week;

● Continuity of care with a designated member of the care team with whom the patient is

able to schedule successive routine appointments;

● Deliver care in alternative ways to traditional office visits to best meet the patient’s

needs, such as home visits and/or expanded hours;

● Overall comprehensive care management;

++ Systematic needs assessment (medical and psychosocial).

++ System-based approaches to ensure receipt of preventive services.

++ Medication reconciliation, management and oversight of self-management.

● Development, implementation, revision, and maintenance of an electronic patient-

centered comprehensive care plan;

++ Care plan is available timely within and outside the billing practice as

appropriate to individuals involved in the beneficiary’s care, can be routinely

accessed and updated by care team/practitioner, and copy of care plan to

patient/caregiver;

● Coordination of care transitions between and among health care providers and

settings, including referrals to other clinicians and follow-up after an emergency

department visit and discharges from hospitals, skilled nursing facilities or other health

care facilities as applicable;

++ Ensure timely exchange of electronic health information with other

practitioners and providers to support continuity of care.

++ Ensure timely follow-up communication (direct contact, telephone,

electronic) with the patient and/or caregiver after an emergency department visit

and discharges from hospitals, skilled nursing facilities, or other health care

facilities, within 7 calendar days of discharge, as clinically indicated.

● Ongoing communication and coordinating receipt of needed services from

practitioners, home- and community-based service providers, community-based social

service providers, hospitals, and skilled nursing facilities (or other health care facilities),

and document communication regarding the patient’s psychosocial strengths and needs,

functional deficits, goals, preferences, and desired outcomes, including cultural and

linguistic factors, in the patient’s medical record;

● Enhanced opportunities for the beneficiary and any caregiver to communicate with the

care team/practitioner regarding the beneficiary’s care through the use of asynchronous

non-face-to-face consultation methods other than telephone, such as secure messaging,

email, internet, or patient portal, and other communication-technology based services,

including remote evaluation of pre-recorded patient information and interprofessional

telephone/internet/EHR referral service(s), to maintain ongoing communication with

patients, as appropriate;

++ Ensure access to patient-initiated digital communications that require a

clinical decision, such as virtual check-ins and digital online assessment and

management and E/M visits (or e-visits).

● Analyze patient population data to identify gaps in care and offer additional

interventions, as appropriate;

● Risk stratify the practice population based on defined diagnoses, claims, or other

electronic data to identify and target services to patients;

● Be assessed through performance measurement of primary care quality, total cost of

care, and meaningful use of Certified EHR Technology.).

HCPCS code GPCM2 (Advanced primary care management services for a patient with

multiple (two or more) chronic conditions expected to last at least 12 months, or until the death

of the patient, which place the patient at significant risk of death, acute exacerbation/

decompensation, or functional decline, provided by clinical staff and directed by a physician or

other qualified health care professional who is responsible for all primary care and serves as the

continuing focal point for all needed health care services, per calendar month, with the elements

included in GPCM1, as appropriate) and HCPCS code GPCM3 (Advanced primary care

management services for a patient that is a Qualified Medicare Beneficiary with multiple (two or

more) chronic conditions expected to last at least 12 months, or until the death of the patient,

which place the patient at significant risk of death, acute exacerbation/decompensation, or

functional decline, provided by clinical staff and directed by a physician or other qualified

health care professional who is responsible for all primary care and serves as the continuing

focal point for all needed health care services, per calendar month, with the elements included in

GPCM1, as appropriate).

As we’ve established previously, care coordination services are RHC/FQHC services and

as such, we are proposing to align once again with the PFS and adopt the new codes for APCM

services. Additionally, allowing separate payment for APCM services in RHCs and FQHCs is

intended to reflect the additional time and resources necessary for the unique components of care

coordination services.

Further, in alignment with our proposal earlier in this section to require RHCs and

FQHCs to utilize the same coding as when billing under the PFS and no longer use HCPCS code

G0511, which described many care coordination services, we are proposing to require RHCs and

FQHCs when furnishing APCM to use the codes created for the PFS, that is, the three HCPCS

G-codes described above. We would pay for these services in addition to the RHC AIR or FQHC

PPS because we consider these services as non-face-to-face services and similar to other care

management services such as chronic care management, principal care management, and remote

physiological monitoring, where these services are not captured in the RHC AIR or FQHC PPS

payment. Similarly, we are proposing that payment for these services would be paid at the PFS

non-facility rate.

It is important to note that if RHCs and FQHCs report these new codes, they are per

calendar month bundles. If the RHC/FQHC decides to bill for APCM then they would not bill

for individual services. For further discussion on duplicative services and concurrent billing

restrictions with regard to APCM policies, we refer readers to section II.G.2.d. of this proposed

rule.

e. Request for Information – Aligning with Services Paid Under the PFS

As we discuss in section III.B.2.a. of this proposed rule, over the last several years we

have been increasing our focus on care coordination. These services have evolved to focus on

preventing and managing chronic disease, improving a beneficiary’s transition from the hospital

to the community setting, or on integrative treatment of patients with behavioral health

conditions. We have acknowledged that the care coordination included in services such as office

visits does not always describe adequately the non-face-to-face care management work involved

and may not reflect all the services and resources required to furnish comprehensive, coordinated

care management for certain categories of beneficiaries. Therefore, under the PFS we have

proposed new services over the years that practitioners billing under the PFS can be paid

separately under the PFS. We have noted previously that RHCs and FQHCs cannot bill under the

PFS for RHC or FQHC services and individual practitioners working at RHCs and FQHCs

cannot bill under the PFS for RHC or FQHC services while working at the RHC or FQHC.

Therefore, we have proposed payment policies for RHCs and FQHCs that complement the new

services for care coordination under the PFS to align the RHC and FQHC resource cost for those

services with payment.

The increase in frequency of this complementary rulemaking has triggered us to consider

operational efficiencies internally that we believe could result in more transparency and clarity

for interested parties. Since RHCs and FQHCs are generally paid under encounter-based

payment systems, we have not systematically analyzed all services paid under the PFS (nor do

we analyze all new services proposed) to determine if they are included as a part of the visit

versus are eligible for additional payment. Another reason that we do not analyze every code is

because frequently codes created under the PFS for billing practitioners are to more

appropriately account for resources paid under the PFS. Codes for these purposes are not

applicable for RHCs and FQHCs since they are not paid under the PFS.

Generally, for PFS services that are a part of the office visit, there is no separate payment

under the RHC AIR or FQHC PPS methodologies. On the contrary, care coordination services

where the focus is on care management, coordination, or certain activities needed to manage

chronic illnesses or adapt to new models of care, we have allowed separate payment for RHCs

and FQHCs.

We are seeking comment on how we can improve the transparency and predictability

regarding which HCPCS codes are considered care coordination services. Our goal is to classify

care coordination services on the PFS in a way that makes it automated in the downstream effect

on RHCs and FQHCs. We believe establishing a streamlined policy regarding which services are

separately paid for RHCs and FQHCs versus included as part of the visit is more transparent. In

addition, a policy where codes are communicated and updated through sub-regulatory guidance

may be more efficient.

3. Telecommunication Services

a. Background

Section 3704 of the Coronavirus Aid, Relief, and Economic Security Act (the CARES

Act) (Pub. L. 116-136, March 27, 2020) directed the Secretary to establish Medicare payment for

telehealth services provided by RHCs and FQHCs serving as a distant site (that is, where the

practitioner is located) during the PHE for COVID-19. Separately, section 3703 of the CARES

Act expanded CMS' emergency waiver authority to allow for a waiver of any of the statutory

telehealth payment requirements under section 1834(m) of the Act for telehealth services

furnished during the PHE. Specifically, section 1834(m)(8)(B) of the Act, as added by the

CARES Act, requires that the Secretary develop and implement payment methods for FQHCs

and RHCs that serve as a distant site during the PHE for the COVID-19 pandemic. The payment

methodology outlined in the CARES Act requires that rates shall be based on rates that are

similar to the national average payment rates for comparable telehealth services under the

Medicare PFS. CMS established rates based on the average amount for all PFS telehealth

services on the telehealth list, weighted by volume.

In the CY 2022 PFS final rule with comment (86 FR 65211), we revised the regulatory

requirement that an RHC or FQHC mental health visit must be a face-to-face (that is, in-person)

encounter between an RHC or FQHC patient and an RHC or FQHC practitioner. We revised the

regulations under § 405.2463 to state that an RHC or FQHC mental health visit can also include

encounters furnished through interactive, real-time, audio/video telecommunications technology

or audio-only interactions in cases where beneficiaries are not capable of, or do not consent to,

the use of devices that permit a two-way, audio/video interaction for the purposes of diagnosis,

evaluation or treatment of a mental health disorder. We noted that these changes aligned with

similar mental health services furnished under the PFS. We also noted that this change allows

RHCs and FQHCs to report and be paid for mental health visits furnished via real-time,

telecommunication technology in the same way they currently do when these services are

furnished in-person.

In addition, we revised the regulation under § 405.2463 to state that there must be an in-

person mental health service furnished within 6 months prior to the furnishing of the

telecommunications service and that an in-person mental health service (without the use of

telecommunications technology) must be provided at least every 12 months while the beneficiary

is receiving services furnished via telecommunications technology for diagnosis, evaluation, or

treatment of mental health disorders, unless, for a particular 12-month period, the physician or

practitioner and patient agree that the risks and burdens outweigh the benefits associated with

furnishing the in-person item or service, and the practitioner documents the reasons for this

decision in the patient's medical record (86 FR 65210 and 65211).

As discussed in the CY 2023 PFS final rule (87 FR 69738), the Consolidated

Appropriations Act, 2022 (CAA, 2022) (Pub. L. 117-103, March 15, 2022) included the

extension of several Medicare telehealth flexibilities established during the public health

emergency (PHE) for COVID-19 for a limited 151-day period beginning on the first day after the

end of the PHE for COVID-19. Specifically, Division P, Title III, section 304 of the CAA, 2022,

delayed the in-person requirements under Medicare for mental health services furnished through

telehealth under the PFS and for mental health visits furnished by RHCs and FQHCs via

telecommunications technology until the 152nd day after the end of the PHE for COVID–19.

Therefore, in the CY 2023 PFS final rule (87 FR 69737), we revised the regulations under

§§ 405.2463 and 405.2469 again to reflect these provisions.

Further, in the CY 2024 PFS final rule (88 FR 79065), we discussed that the CAA, 2023

(Pub. L. 117-328, December 29, 2022) further extended the Medicare telehealth flexibilities

enacted in the CAA, 2022 for a period beginning on the first day after the end of the PHE for

COVID-19 and ending on December 31, 2024, if the PHE ends prior to that date. Specifically

related to RHCs and FQHCs, section 4113(c) of the CAA, 2023 amended section 1834(m)(8) of

the Act to extend payment for telehealth services furnished by FQHCs and RHCs for the period

beginning on the first day after the end of the COVID-19 PHE and ending on December 31,

2024, if the PHE ends prior to that date. We noted that payment continued to be made under the

methodology established for telehealth services furnished by FQHCs and RHCs during the PHE,

which is based on payment rates that are similar to the national average payment rates for

comparable telehealth services under the PFS.

We explained that section 4113(d) of the CAA, 2023 continues to delay the in-person

requirements under Medicare for mental health services furnished through telehealth under the

PFS and for mental health visits furnished by RHCs and FQHCs via telecommunications

technology. That is, for RHCs and FQHCs, in-person visits will not be required until January 1,

2025, or, if later, the first day after the end of the PHE for COVID-19. Therefore, we stated that

we will continue to apply the delay of the in-person requirements under Medicare for mental

health services furnished by RHCs and FQHCs. We noted that the Department of Health and

Human Services declared an end to the Federal PHE for COVID-19 under section 319 of the

Public Health Service Act on May 11, 2023.

306

Therefore, we revised the regulations under

§§ 405.2463 and 405.2469 again to reflect these provisions (88 FR 79066 through 79067).

b. Direct Supervision via Use of Two-way Audio/Video Communications Technology

Under Medicare Part B, certain types of services are required to be furnished under specific

minimum levels of supervision by a physician or practitioner. See section II.D.2.a. for the

306

https://www.hhs.gov/coronavirus/covid-19-public-health-emergency/index.html.

discussion regarding direct supervision for services provided using telecommunications

technologies under the PFS.

In the CY 2024 PFS final rule (88 FR 79067), we explained that extending this definition

of direct supervision for RHCs and FQHCs under our regulations at §§405.2413, 405.2415,

405.2448, and 405.2452 through December 31, 2024, would align the timeframe of this policy

with many of the previously discussed PHE-related telehealth policies that were extended under

provisions of the CAA, 2023. In addition, we were concerned about an abrupt transition to the

pre-PHE policy of requiring the physical presence of the supervising practitioner beginning after

December 31, 2023, given that RHCs and FQHCs have established new patterns of practice

during the PHE for COVID-19. We also believed that RHCs and FQHCs would need time to

reorganize their practices established during the PHE to reimplement the pre-PHE approach to

direct supervision without the use of audio/video technology. Similar to services furnished in

physician office setting, RHC and FQHC services and supplies furnished incident to physician’s

services are limited to situations in which there is direct physician supervision of the person

performing the service, except for certain care coordination services which may be furnished

under general supervision. For CY 2024, we continued to define “immediate availability” as

including real-time audio and visual interactive telecommunications through December 31, 2024,

and solicited comment on whether we should consider extending the definition of ‘‘direct

supervision’’ to permit virtual presence beyond December 31, 2024.

(1) Proposal for CY 2025

In the CY 2024 PFS proposed rule, we solicited comment on potential patient safety or

quality concerns when direct supervision occurs virtually in RHCs and FQHCs; for instance, if

certain types of services are more or less likely to present patient safety concerns, or if this

flexibility would be more appropriate when certain types of auxiliary personnel are performing

the supervised service. We were also interested in potential program integrity concerns such as

overutilization or fraud and abuse that interested parties may have in regard to this policy.

Comments provided were overall supportive of our proposal to continue to define

“immediate availability” to include availability through virtual means, stating that it will benefit

healthcare providers while greatly enhancing patient access to quality care, particularly in

underserved areas. Commenters also noted that direct supervision has become increasingly

challenging and the option to provide virtual direct supervision has enhanced the quality and

provision of healthcare services beneficiaries have received in medically underserved, rural

communities.

We note that in section II.D.2.a. of this proposed rule, there is a proposal to permanently

adopt a definition of direct supervision that allows "immediate availability” of the supervising

practitioner using audio/video real-time communications technology (excluding audio-only), but

only for the following subset of incident-to services described under § 410.26, (1) services

furnished incident to a physician or other practitioner’s service when provided by auxiliary

personnel employed by the billing practitioner and working under their direct supervision, and

for which the underlying HCPCS code has been assigned a Professional Component/Technical

Component indicator of ‘5’; and (2) services described by CPT code 99211 (Office or other

outpatient visit for the evaluation and management of an established patient that may not require

the presence of a physician or other qualified health care professional). In addition, under the

PFS we are proposing for all other services required to be furnished under the direct supervision

of the supervising physician or other practitioner, to continue to define "immediate availability”

to include real-time audio and visual interactive telecommunications technology only through

December 31, 2025.

After evaluating the information gathered through the comment solicitation, we believe

that we should maintain the current flexibility in RHCs and FQHCs as it continues to support

access and preserve workforce capacity. We believe that there is value in allowing RHC and

FQHC services to be furnished under direct supervision where virtual presence meets the

definition of “immediately available” as status quo, so that we may further evaluate the services

along with the analysis occurring for the remaining services that we are contemplating under the

PFS. We note that there may be nuances in the RHC and FQHC settings since generally payment

is at the AIR or PPS rate and not at the individual service code level to carve out services

limited/obvious services from other services. We could seek to establish a final policy in RHCs

and FQHCs once a final policy is determined under the PFS, to avoid confusion since they are

taking an incremental approach at the code level for CY 2025.

Therefore, we are proposing to maintain the virtual presence flexibility on a temporary

basis, that is, the presence of the physician (or other practitioner) would include virtual presence

through audio/video real-time communications technology (excluding audio-only) through

December 31, 2025.

c. Telecommunications Technology

As discussed above, section 3704 of the Coronavirus Aid, Relief, and Economic Security

Act (the CARES Act) (Pub. L. 116-136, March 27, 2020) directed the Secretary to establish

Medicare payment for telehealth services provided by RHCs and FQHCs serving as a distant site

(that is, where the practitioner is located) during the PHE for COVID-19. Separately, section

3703 of the CARES Act expanded CMS' emergency waiver authority to allow for a waiver of

any of the statutory telehealth payment requirements under section 1834(m) of the Act for

telehealth services furnished during the PHE. Specifically, section 1834(m)(8)(B) of the Act, as

added by the CARES Act, required that the Secretary develop and implement payment methods

for FQHCs and RHCs that serve as a distant site during the PHE for the COVID-19 pandemic.

The payment methodology outlined in the CARES Act requires that rates shall be based on rates

that are similar to the national average payment rates for comparable telehealth services under

the Medicare PFS. Therefore, CMS established rates based on the average amount for all PFS

telehealth services on the telehealth list, weighted by volume. RHCs and FQHCs bill for these

Medicare telehealth services using HCPCS code G2025.

In the CY 2022 PFS final rule with comment (86 FR 65211), we revised the regulatory

requirement that an RHC or FQHC mental health visit must be a face-to-face (that is, in person)