Task Force to Study Point–of–Care Testing for Lead Poisoning

Task Force to Study Point–of–Care Testing for

Lead Poisoning

Dr. Clifford S. Mitchell

Chairperson

January 16, 2014

The Honorable Martin O’Malley

Governor

State of Maryland

Annapolis, MD 21401-1991

The Honorable Thomas M. Middleton The Honorable Peter A. Hammen

Senate Finance Committee House Health and Government Operations

3 East Committee

Miller Senate Building Room 241

Annapolis, MD 21401 House Office Building

Annapolis, MD 21401

RE: Final Report of the Task Force to Study Point–of–Care Testing for

Lead Poisoning

Dear Governor O’Malley, Chair Middleton, and Chair Hammen:

Pursuant to House Bill 303, Chapter 365 of the Acts of 2013, the Task Force to Study Point–

of–Care Testing for Lead Poisoning submits this report on the findings and recommendations of

the Task Force related to point-of-care testing for lead poisoning.

I hope this information is useful. If you have questions about this report, please contact

me at 410-767-7438 or cliff.mitchell@maryland.gov.

Sincerely,

Dr. Clifford S. Mitchell

Chairperson

cc: Christi Megna, JD

Laura Herrera, MD, MPH

Donna Gugel, MHS

Sarah Albert, MSAR #9606

EPORT TO THE GENERAL ASSEMBLY

Y THE

ASK FORCE ON POINT OF CARE TESTING

FOR LEAD POISONING

HAPTER 365

Maryland Department of Health and Mental Hygiene

January 2014

TABLE OF CONTENTS

ONTENTS

Executive Summary ....................................................................................................................3

Background and Introduction ......................................................................................................4

Lead Poisoning and Lead Testing in Maryland ............................................................................4

Clinical Laboratory Improvement Amendments and the Waiver Process .....................................5

Technology of Point of Care Lead Testing ..................................................................................5

Potential Benefits of Point of Care Testing in Maryland ..............................................................7

Barriers to Point of Care Testing in Maryland .............................................................................8

Technological Barriers ............................................................................................................8

Economic Barriers ...................................................................................................................9

Regulatory Barriers .................................................................................................................9

Barriers and Opportunities at the Level of Providers .............................................................. 10

Use of Point of Care Testing in Other States.............................................................................. 10

Reimbursement for Point of Care Testing .................................................................................. 12

Findings and Recommendations ................................................................................................ 13

Appendix 1. Membership of the Task Force on Point of Care Testing for Lead Poisoning ........ 17

Appendix 2. Meeting Schedule of the Task Force ..................................................................... 18

Appendix 3. Testing Rates for Children Ages 0 – 72 Months by Jurisdiction, 2012. ................. 19

Appendix 4. Economic Analysis of POC Lead Testing ............................................................. 21

EXECUTIVE SUMMARY

Chapter 365 (House Bill 303), enacted by the Maryland General Assembly in 2013, established a

Task Force to Study Point of Care Testing for Lead Poisoning (the Task Force). The goal of the

Task Force was to study and make recommendations regarding the use of and reimbursement for

point-of-care (POC) testing to screen and identify children with elevated blood-lead levels. The

following information was to be included in the study:

(1) The benefits of point-of-care testing waived under the federal Clinical Laboratory

Improvement Amendments (CLIA);

(2) The use of point-of-care testing in other states;

(3) Barriers to point-of-care testing, including regulatory barriers related to licensing of

medical laboratories;

(4) Determining appropriate reimbursement for point-of-care testing and reporting; and

(5) Any other items the task force considers important relating to point-of-care testing.

The recommendations adopted by the Task Force are:

(1) Maryland should encourage the use of POC testing for lead;

(2) The Task Force encourages the Laboratories Administration to consider ways of

promoting the wider use of POC tests for lead, particularly by making it easier for

providers to implement POC testing using either a LeadCare II CLIA-waived test, a

filter paper Tamarac™ test, or any other future approved POC test;

(3) The Task Force urges the Department of Health and Mental Hygiene (DHMH) and

the Department of the Environment (MDE) to consider additional practices to

increase testing rates;

(4) Any decision to promote more widespread use of POC testing should be accompanied

by an active outreach to providers, parents, members of the public, payors and others,

to actively promote the use of the POC testing to increase testing rates, and to explain

why increased testing is important in eradicating lead exposure and lead poisoning.

BACKGROUND AND INTRODUCTION

Chapter 365 (House Bill 303), enacted by the Maryland General Assembly in 2013, established a

Task Force to Study Point of Care Testing for Lead Poisoning. Exposure to lead remains the

most significant and widespread environmental hazard for children in Maryland (MD). While

the prevalence of elevated blood lead levels in children has declined significantly over the years,

there are still children who continue to be exposed to lead through a variety of exposure sources.

With the recognition that there are no “safe levels” of lead in the body, and in light of the US

Centers for Disease Control and Prevention’s (CDC) new recommendations making 5

micrograms per deciliter a level of concern, the challenge is how best to target testing of MD

children. The goal of the Task Force was to study and make recommendations regarding the use

of and reimbursement for point-of-care (POC) testing to screen and identify children with

elevated blood-lead levels. The following information was to be included in the study:

 The benefits of point-of-care testing waived under the federal Clinical Laboratory

Improvement Amendments (CLIA);

 The use of point-of-care testing in other states;

 Barriers to point-of-care testing, including regulatory barriers related to licensing of

medical laboratories;

 Determining appropriate reimbursement for point-of-care testing and reporting; and

 Any other items the task force considers important relating to point-of-care testing.

The membership and meeting schedule of the Task Force are shown in Appendices 1 and 2.

LEAD POISONING AND LEAD TESTING IN MARYLAND

Lead poisoning and lead exposure remain significant public health problems in Maryland. In

2011, 110,539 Maryland children aged 0 – 72 months were tested for blood lead levels, of whom

364 (0.3%) were identified with a blood lead level ≥10micrograms per deciliter (μg/dL).

Overall, this represents a testing rate of 21.7% of the children born during this period who would

be in the eligible age-range, state-wide. The highest testing rates for children 0-72 months were

found in jurisdictions that require testing of all children at age 1 and 2 years, including Somerset

County (34.3%), Baltimore City (33%), Allegany County (27.2%), and Worcester County

(26.4%). A detailed breakdown of testing rates by jurisdiction is provided in Appendix 3.

A statute enacted by the Maryland General Assembly in 2000 requires testing of children at 12

and 24 months of age residing in “at risk” areas of the State.

Additionally, all children living in

Baltimore City or children receiving Medicaid services, regardless of their residence in the State,

are designated as “at risk” and are required to be tested. A lead exposure risk assessment

questionnaire, assessing children for exposures to known sources of lead is also required of all

children at their 12 and 24-month visits. Under MD law, a child under six years of age must

Source: Maryland Department of the Environment. Childhood Blood Lead Surveillance in Maryland, Annual

Report 2012 (“MDE Annual Surveillance Report”). Accessed November 28, 2013 at:

http://mde.maryland.gov/programs/Land/Documents/LeadReports/LeadReportsAnnualChildhoodLeadRegistry/Lead

ReportCLR2012.pdf.

Md. Code Ann., Health-General § 18-106

have evidence of appropriate screening within 30 days of entering a child care center, family

child care home, or nonpublic nursery school. In addition, the parent of a child who resides in or

previously lived in an “at risk” area must provide documentation of lead testing at first

enrollment into pre-kindergarten, kindergarten, or first grade.

Concern about the overall state testing rate, and about testing rates in specific areas and

populations, have been the focus of discussions in the Maryland Lead Poisoning Prevention

Commission, and have also prompted DHMH to reassess the targeting strategy used to identify

“at risk” areas.

CLINICAL LABORATORY IMPROVEMENT AMENDMENTS AND THE WAIVER PROCESS

The U.S. Centers for Medicare & Medicaid Services is responsible for the regulation of all non-

research laboratory testing on humans through the Clinical Laboratory Improvement

Amendments process (commonly known as CLIA). CLIA requires that all entities that perform

even one test, including a waived test on, "materials derived from the human body for the

purpose of providing information for diagnosis, prevention or treatment of any disease or

impairment of, or the assessment of the health of, human beings" meet certain federal

requirements. If any entity performs tests for these purposes, it is considered under CLIA to be a

laboratory and must register with the CLIA program.

In accordance with COMAR 10.10.03.01, a person is required to possess a license before

offering to perform or performing a medical laboratory test or examination in this State.

Individuals performing such tests must apply for both the CLIA and Maryland lab license

through the Office of Health Care Quality. The fees are $150 and $200 every two years for the

CLIA and Maryland license respectively. Both are renewed every two years.

Currently in Maryland, blood lead testing in a clinical laboratory is a permitted, not excepted

test, and requires enrollment in a proficiency testing program per COMAR 10.10.05.01. To have

a test added to the excepted list requires recommending excepted test status to the Secretary's

Laboratory Advisory Committee. The Laboratory Advisory Committee's responsibilities include

making a recommendation to the Secretary in favor of or against granting a test excepted status.

The pertinent regulation explaining this process can be found at COMAR 10.10.02.01 (E).

TECHNOLOGY OF POINT OF CARE LEAD TESTING

Lead exposure and lead poisoning are classically measured through the blood lead level (BLL).

This test measures the amount of lead in blood. The test involves the following components:

• Sample collection – blood is obtained through a venipuncture sample (venous), which

generally takes place in a provider office or commercial laboratory site; a collection with

a capillary tube (again typically in a provider’s office, it has the advantage of requiring a

much smaller blood sample); or the collection of a blood spot on filter paper, which can

Maryland Family Law Article 5-556.1

take place in virtually any setting. A key factor in test accuracy at this stage is the use of

appropriate cleaning techniques, to prevent lead dust on the surface of either the skin or

the sample collection equipment from contaminating and falsely elevating the reported

lead result.

• Sample analysis – lead in the blood is measured by various techniques, commonly in

commercial diagnostic laboratories by graphite furnace atomic absorption spectrometry.

Important aspects of the test are the laboratory’s internal quality analysis and quality

control (QA/QC), as well as proficiency testing, which refers to a program in which an

external agency sends an unknown sample periodically to the diagnostic laboratory for

testing, thus providing a source of external quality checks on the diagnostic laboratory.

• Reporting – Once analyzed, the results must be reported to the health care provider. This

can be done in some cases electronically directly from the instrument to a provider

through electronic messaging; typically, it is through a fax or mailed (paper) report.

Alternatively, the results may be displayed by the instrument and require transcription.

In addition to reporting to the provider, in Maryland all blood lead tests for children must

be reported to the Childhood Lead Registry, based at the Maryland Department of the

Environment (MDE).

Point of care (POC) testing commonly refers to testing in which the test takes place in the

location where the patient is being seen, although a distinction must be made between the

collection of a sample and the processing of the test to determine the results of the test.

Generally, POC testing refers to a system whereby the sample is collected, analyzed, and the

results delivered all in the same location and same time that the patient is being evaluated. An

example would be a urine dipstick test done in the provider’s office while the patient is in the

office.

In the case of blood lead tests, there are two systems commonly used for POC testing, although

one only involves collection of the sample at the site, and so is not a true POC test as described

above. This test, available from Tamarac Medical, Inc., involves collection of a small amount of

blood on a filter paper, which is then sent to a laboratory for analysis and reporting. In this

respect, although sample collection is simplified compared with either venous or capillary

samples, there are still test attributes that resemble other non-POC tests – the sample must be

sent to an offsite laboratory for analysis, then reported back to the provider.

The only US Food and Drug Administration (FDA) -approved POC test for blood lead in use

today in the United States is manufactured by Magellan Diagnostics of Billerica, MA, currently

being marketed as the LeadCare II. This device is a CLIA-waived POC test that involves

collection of a blood sample (either capillary or venous), testing of a drop of blood by anodic

stripping voltammetry (a technique to measure the amount of lead in blood by measuring the

electric current needed to oxidize lead in the blood), and direct reporting to the operator by a

visual display panel. Blood is collected either in a capillary tube or by venipuncture, then mixed

with reagents and placed in the machine. The results are displayed directly by the machine.

It is important to recognize that the LeadCare II test is intended as a screening test only; if an

elevated BLL is detected on screening, the provider must confirm the results through a venous

blood level using a different approved laboratory method.

POTENTIAL BENEFITS OF POINT OF CARE TESTING IN MARYLAND

The Task Force heard from a number of health care providers and others about some of the

advantages of POC testing. These included:

 Providers uniformly reported that the likelihood of getting a blood lead test is much

higher with POC testing, due to the ease of testing in the office, the ability to provide

immediate feedback to the patient and family, and the ability to perform a capillary blood

draw, rather than a venous sample. In the absence of POC testing, patients receive a

provider order for a lab test, go to the lab, have blood drawn, and wait for the sample to

be sent to the lab, processed, and the results reported to the provider, and then wait for the

provider to contact them or see them back again.

 With POC testing, the entire process takes place during one office visit, so if the BLL is

not at or above the level of concern, and the patient and family learn the results

immediately. If the BLL is below the reference value (5µgldL), the family is advised

about the importance of prevention; if the BLL is of concern, the family is informed

immediately and the patient is referred immediately for a confirmatory test. This also

improves follow-up and reduces the time required to act on a confirmed elevated BLL.

 Because the number of separate provider and lab visits is fewer, the cost to the patient

and family should be less. Less administrative staff time is needed to contact

patients/families and arrange for follow-up visits. It is not clear whether insurers would

realize savings from POC testing, however, because this depends on the rate of

confirmatory testing needed, how many repeat office visits could be avoided in the

alternative scenarios, the cost of commercial laboratory tests versus POC testing, and

other variables.

 Improved compliance for blood lead testing.

 The effect of POC testing on patient flow through clinics and emergency departments

may depend on whether the tests are incorporated as part of overall testing and

vaccination. One provider reported to the Task Force that POC testing did not

significantly affect the overall clinic flow, but this may depend on the frequency of

testing and other factors.

ARRIERS TO POINT OF CARE TESTING IN MARYLAND

Technological Barriers

The Task Force identified a number of potential technical barriers, although it appears there are

solutions for all of them. With respect to the accuracy of the lead POC test, it appears that the

test has sufficient accuracy under normal operating conditions to serve as a valid screening

device, when used as recommended by the manufacturer. The issues identified by the Task

Force include:

Quality Assurance and Quality Control (QA/AC) – The reagent test kits come with

sufficient reagent to do two QA/QC tests per 48-test kit. Questions were raised by Task

Force members about whether the two QA/QC tests would be sufficient if the test kits

were used slowly over a long period of time. Nothing was offered by other states or

presenters that indicated this was a problem, but it might be an issue to be addressed in

standard operating procedures or laboratory guidance.

Proficiency Testing –Proficiency testing is a way of ensuring the ongoing reliability of

testing procedures. FDA’s CLIA waiver means that proficiency testing is not required

for the lead POC device. However, a number of states do require proficiency testing,

and Maryland has previously approved other CLIA-waived tests for the Excepted list but

required proficiency testing. A proficiency test requirement might slightly alter the

economic and practice decisions of some providers, but probably not a large number.

Reporting –The Task Force noted that there is no direct electronic reporting capacity

which would allow the test results to be reported directly to the Maryland Childhood

Lead Registry (CLR). The software package developed by the manufacturer has a

number of limitations which may make it problematic for practices to use, and this raises

an issue for the expansion of POC tests. MDE currently allows providers to fax lead

POC reports to the CLR. However, if use of lead POC devices increases, this would

entail a significant data entry increase for the CLR, requiring additional personnel and

increasing the opportunity for data entry errors.

Another possibility for reporting would be for the State to provide a direct data entry

platform for provider offices, similar to Immunet, the immunization registry where

providers enter and access vaccination information for their patients directly. This would

also be an advantage for patients who may switch providers. The Task Force heard that

the use of an Immunet-like system, or the direct coupling of blood lead test results with

Immunization data was being done in a number of states, including Rhode Island,

Wisconsin, Michigan, and New Jersey. The Task Force also heard from the CLR that

there could be some issues of reporting accuracy with a direct coupling of the systems,

but the concept was worthy of discussion. Another possibility, integration of lead

reporting within provider electronic health records (EHRs) which could then be accessed

directly by the CLR, would require a series of technological and statutory innovations

that are not yet available.

Economic Barriers

The Task Force heard that Medicaid rates for lead tests, which are based on Medicare, are not

necessarily what all insurers will pay to reimburse practices for POC tests. The reimbursement

rates vary considerably, from no additional reimbursement for some insurers that bundle

payments for testing, to separate reimbursement for sample collection, POC test, and counseling

provided by other MCOs.

The Task Force also had a discussion regarding value-based purchasing (VBP) and the metrics

applied to Medicaid Managed Care Organizations (MCOs) to assess their performance. Some

Medicaid MCOs have expressed concern about differences between Healthcare Effectiveness

Data and Information Set (HEDIS) quality measures they report, and the measures for lead

testing rates in place in Maryland Medicaid for VBP. According to Medicaid, the measures for

VBP are more specific to Maryland, which has more lead poisoning and lead exposure than

many other parts of the country. While this might not constitute an economic barrier for POC

testing, it was raised by MCOs in the context of the Task Force’s discussion, and is included here

for consideration in that context.

Another potential barrier is that reimbursement for counseling based on the blood lead test may

be different for health care providers providing the counseling in an obviously clinical location,

than reimbursement for counseling that occurs in other locations such as a WIC clinic. The Task

Force heard that in some cases where the counseling occurs in such a location, there may be

difficulty in obtaining reimbursement for counseling services. The Task Force also heard that in

some locations providers can charge a well-child care office visit, but are not permitted to use

other evaluation and management (E/M) codes at the same time.

Regulatory Barriers

As noted in the section on CLIA and the waiver process (page 5), this POC test can be placed on

the Excepted List for Maryland based on an assessment and recommendation from the

Laboratory Advisory Committee to the Laboratories Administration. To date, the Laboratory

Advisory Committee has not considered this issue. Task Force members and others raised a

number of issues that might be considered by the Laboratory Advisory Committee, including:

 Quality control and proficiency testing – the Task Force heard from both members and

others that FDA (or some other entity) should hold manufacturers accountable for

incorporating QC and PT into waived test device design.

 Proper device use – Task Force members had questions about how to assure that

providers complied with the manufacturers’ instructions for device operation, particularly

for quality assurance and quality control.

 Reporting to the Maryland Childhood Lead Registry – Task Force members want to

ensure appropriate mechanisms to provide test results to surveillance programs, as

required by Maryland law.

 Challenges in how to code tests for billing and mandatory reporting purposes.

Barriers and Opportunities at the Level of Providers

The Task Force heard that other states use a number of strategies to encourage the use of POC

testing by providers. One such strategy involves integration of POC testing with the Women,

Infants, and Children (WIC) program, which already does blood collection to assess hemoglobin

levels. Wisconsin and several other states have been able to increase screening by integrating

POC testing with WIC blood collection.

Another strategy was described by Wisconsin, in which MCOs created “opportunity reports” for

providers, quality reports that summarized the experience of the provider compared to external

and/or internal MCO benchmarks, or other appropriate internal/external comparisons. Each

provider was periodically supplied with an “opportunity report” that tracked how the provider

was doing in lead testing.

Finally, there was also discussion of whether lead testing would be considered a “standard of

care” measure.

USE OF POINT OF CARE TESTING IN OTHER STATES

The Task Force dedicated an entire meeting to hearing from other states, and also looked at

publically available data from other states. The experience of these states is instructive.

Wisconsin-- In 2005, less than one-third of Wisconsin Medicaid children received their

mandatory tests for lead at one and two years of age. In 2008, heath care providers in Wisconsin

started to use POC testing for lead and Medicaid MCOs worked together with WIC to pay for

lead testing at WIC clinics. Some of the considerations that went into WIC’s decision to adopt

POC testing:

1. The WIC clinics were able to bill for the POC lab test, although this required discussions

with Medicaid. They were also able to bill separately for blood draws for lead tests,

doubling their reimbursement.

2. They were not always able to participate in proficiency training.

3. Transmitting all of the lead test results to the state lead registry was a hurdle that had to

be overcome. The eventual solution involved incorporating the lead registry with the

immunization registry.

Wisconsin has ongoing challenges, but overall results have been extremely positive and their

Medicaid testing rates have increased by 40%. One of the biggest factors in improving testing

rates has been to issue individual “report cards” with testing rates to every Medicaid provider. In

addition, Wisconsin found it very helpful to “marry” lead test data to their immunization registry,

so that providers had access to both registries in a single application.

Texas – Texas also conducts blood lead POC testing through the WIC program; the regulations

to do so were only changed within the past year. Medicaid has also put in an amendment related

to POC test reimbursement rates. Although all providers are supposed to report their test results

to the lead registry, billing data shows that providers are billing for more tests than they are

reporting to the registry. Medicaid is planning corrective actions related to reporting, but the

Task Force does not have the details of these proposals. The Texas Health Department sends a

letter to providers using LeadCare II about the requirement to report all blood lead results.

Providers send in paper reports, and many agencies (such as Head Starts) send a big batch of

results for July – October during school enrollment. The Texas Health Department lead program

is working with Texas Medicaid to increase reporting, but this remains problematic. They have

seen an increase in higher blood lead levels, but don’t know whether levels of 15 µg/dL and

above levels are real or a result of user error in performing the test. One issue they have noted is

that some POC tests are being confirmed with the same venous sample used for the original POC

test (rather than a separate venipuncture). Texas does not require proficiency testing, but they do

encourage staff training.

Massachusetts – Massachusetts has approximately 60 lead POC users. Very few are using POC

testing for screening in the office; in most cases samples are batch tested at a central location.

Massachusetts is confident about reporting, but requires proficiency testing. The test is currently

considered to be a moderately complex test by the State Laboratory, similar to Maryland. Their

experience with reporting of blood lead test results to the lead registry is similar to that of other

POC systems. One problem they have identified is that it is difficult to distinguish a clinical lab

with a LeadCare II device from a commercial laboratory provider. Massachusetts has also

identified the need for a universal laboratory reporting system for electronic reporting. The free

software currently available for the LeadCare II system has limitations. For example, the field

for lead test results allowed only three characters, which in some cases required rounding of

decimal results: for example, 24.7 became 24. Ordinarily, Massachusetts would consider that a

result of 24.7 to be 25µg/dL, but it was rounded down in data base. Magellan, the LeadCare II

manufacturer, was not interested in expanding or updating the software. Adding data by

providers is a burden, so software upgrades would be very helpful. Generally, Massachusetts’s

experience is that 75% – 80% of children tested are between the age of 9 – 48 months (the state

screening requirement). Massachusetts has very good compliance, in part because children

cannot be enrolled in group or family day care without lead testing. Massachusetts uses a

standard that is different from the American Academy of Pediatrics and the CDC

recommendations because they determined that enough children were lead poisoned after age 2

to require testing up to age 4. Massachusetts is not necessarily supporting the use of POC testing

with the LeadCare II, because of concerns about the lack of proficiency testing.

New Jersey– New Jersey requires testing at 12 months, 24 months, and any child between three

and six years of age who has never previously been screened. With respect to POC lead tests,

New Jersey is moving cautiously because of costs of testing and a desire to have administrative

procedures in place. Currently, they are not treating the lead POC test as CLIA-waived, and

require three rounds of proficiency tests. New Jersey is considering a waiver after two

successful rounds of required proficiency tests, and started a pilot project in May 2012, when

they were able to trade Lead Care I for Lead Care II machines. New Jersey State Laboratories

have also provided some standard operating procedures (SOPs), which they are reviewing with

clinical laboratories. New Jersey is also doing memorandas of understanding (MOUs) with some

local health department (LHD) pilot sites. According to these MOUs, a medical director must

be onsite at the LHD and all elevated test results must have venous confirmation. New Jersey

has been working with the manufacturer (Magellan) regarding reagent expiration. They also

have some issues with reporting, involving de-duplication of test results by date of birth. In

addition, they are working with the New Jersey Medicaid program on reimbursement rates and

confirmation of Medicaid participants. Generally, they have found the provider community to be

very receptive to lead POC testing, and are planning to expand their pilot to look at children

under 6 and adults participating in recovery/reconstruction using post-hurricane Sandy funds. In

summary, New Jersey is planning to expand the use of lead POC testing, but is working on

specific issues/requirements:

• Proficiency testing – they currently require three rounds, but are moving towards

requiring two rounds of testing;

• Results reporting to the State registry – they do know roughly where the machines are,

but don’t always know who is doing the testing or who is getting a test (name, DOB

confirmation are issues).

REIMBURSEMENT FOR POINT OF CARE TESTING

The Task Force members solicited input from the provider community and other stakeholders to

develop some rough cost figures for analysis of implementing and maintaining a POC testing

program within a clinical practice. According to this information, an estimate of costs for

running a lead POC testing program within a practice would include the following:

Table 1. Estimated operational costs for point of care testing for lead in Maryland.

Program Component

Cost

Comments

LeadCare II device

$1,850 - $2,059

CLIA waiver registration

$150.00

Every 2 years

Maryland fee for lead testing

$200.00

Every 2 years

Maryland application fee for

lead test

$100.00

Every 2 years

Test kits

$2,928

Based on 144 tests free with

machine purchase, then 366

tests at $8/test

Staff time

$893

Based on 2 tests/day/provider,

or 510 tests/year

Proficiency testing (if

required)

$460.00

Based on data from Wisconsin

Total costs

$6,581 - $6,790

Based on these assumptions, the Task Force estimates that with current Medicaid reimbursement

rates of $12.52 per test, a practice would break even with 434 tests in the first year and 429 tests

in the second year. With either a higher reimbursement rate or additional reimbursement for the

sample collection, the breakeven point would occur even sooner. Additional details of the

economic analysis are presented in Appendix 4.

Based on input from Task Force members, other states, and clinical practitioners, the testing

could be incorporated in typical practices without significant difficulty or alteration of patient

flow. One clinician noted that he was able to send all of his POC test results to the Maryland

Childhood Lead Registry by fax, and the CLR was then able to enter the data manually. It

should be noted that while it is likely that practices would be able to submit faxed reports to the

CLR, it is not clear that the CLR has sufficient personnel to enter the additional test results, and

there is also the issue of additional transcription/data entry errors with manual data entry.

FINDINGS AND RECOMMENDATIONS

The Task Force considered a number of options in making its recommendations. The options

included:

Option 1: No changes to the current status of POC testing, which would leave it off the

Excepted List, but still allowed.

Option 2: Encourage POC testing by urging the Laboratory Advisory Committee and

the Laboratories Administration to place the LeadCare II test (or similar POC

tests, if available in the future) on the Excepted List.

Option 3: Encourage POC testing by urging the Laboratory Advisory Committee and

the Laboratories Administration to place the LeadCare II test (or similar POC

tests, if available in the future) on the Excepted List, but with qualifications

related to proficiency testing, quality assurance and quality control, and

reporting to the Maryland Childhood Lead Registry, discussed above.

In addition, the Task Force noted some of the reimbursement issues that were raised in the

course of the meetings and discussed potential recommendations related to those issues.

Based on evidence reviewed by the Task Force, the following findings and recommendations are

offered.

Finding 1: Point of care testing has been used successfully in Maryland and other states.

When used in conjunction with other incentives, POC testing appears to encourage testing of

children for lead exposure.

The Task Force heard consistently that POC testing has been used successfully in other states

and in Maryland as a test to screen patients for lead exposure. There appear to be no significant

issues regarding its reliability or validity, and it has obtained approval from the FDA as a CLIA-

waived test. The Task Force heard from other states about some striking examples of programs

that successfully used POC testing, in combination with other measures (outreach to providers,

use of POC tests in WIC clinics, alterations in reimbursement formulas, report cards to providers

on their individual testing rates), to increase the rate of lead testing for children. There is no

reason to assume the same measures would not have similar effects in Maryland.

Recommendation 1: Maryland should encourage the use of POC testing for lead.

The Task Force heard consistent evidence from health care providers and other states

that use of lead POC testing had led to increased testing rates, without any evidence that

patient safety had been compromised. POC testing appears to make for a better

experience for patients and their families through more immediate connection between

test results, patient education and intervention, and improved satisfaction. To encourage

lead POC testing, Maryland should consider reducing barriers discussed in Finding 2.

Finding 2: Administrative and technological barriers to the expanded use of POC testing for

lead in Maryland include: (1) The current regulatory status of the LeadCare II device as a

non-excepted CLIA-waived test, which is more restrictive than necessary to assure patient

safety, and serves as a deterrent to increased use of the device; and (2) The lack of an easy

mechanism with which to report POC test results to the Maryland Childhood Lead Registry.

According to the Laboratories Administration, the Laboratory Advisory Committee has not

previously had a request to consider whether the LeadCare II device (or any other lead POC test)

should be on the Excepted List.

Recommendation 2: The Task Force encourages the Laboratories Administration to

consider ways of promoting the wider use of POC tests for lead, particularly by making

it easier for providers to implement POC testing using either a LeadCare II CLIA-

waived test, a filter paper Tamarac™ test, or any other future approved POC test. Any

decision to encourage the wider use of POC testing for lead with the LeadCare II or

another approved POC test should be made in conjunction with policies that address

quality assurance/quality control, proficiency testing, the use of standard operating

procedures and mandatory reporting to the Maryland Childhood Lead Registry.

The Task Force heard from experts, other states, practitioners, and the industry, that

several issues should be considered in deciding whether to adopt widespread use of POC

testing. The Task Force feels particularly strongly that in deciding whether to promote

wider use of the LeadCare II device, the Laboratory Advisory Committee and

Laboratories Administration should strongly consider the following:

(1) Users of the device should have standard operating procedures to supplement

manufacturer’s recommendations that guide issues such as quality control and

quality assurance, transportation and location of the device, temperature control

for reagents, etc.;

(2) Proficiency testing should be required as a condition of being on the Excepted

list; and

(3) The manufacturer should be required or encouraged to address the issue of

direct reporting of results to the Maryland Childhood Lead Registry, or there

should be some other mechanism to ensure reporting to the Childhood Lead

Registry.

Finding 3: It appears that with current reimbursement rates, health care providers should be

able to recover the costs of lead POC tests with moderate testing frequency. However, there

are potential economic barriers for certain providers, particularly those providers with small

practices, and those whose managed care organization contracts do not specifically reimburse

for either lead testing or sample collection. There may be additional disincentives if lead POC

testing is carried out outside of provider offices.

Recommendation 3: The Task Force urges DHMH and MDE to consider additional

practices to increase testing rates, including:

• Promotion of lead testing in WIC clinics;

• Working with Medicaid and private insurers to make testing easier through

examining reimbursement rates and costs including reimbursement for sample

collection; and

• Creation of “opportunity reports” for each provider, showing how that provider is

doing relative to appropriate internal and external benchmarks.

Recommendation 4: Any decision to promote more widespread use of lead POC testing

should be accompanied by an active outreach to providers, parents, members of the

public, payors and others, to actively promote increased testing, and to explain why

increased testing is important in eradicating lead exposure and lead poisoning.

The use of lead POC testing would make it easier for federally qualified health centers

and other ambulatory care centers to extend testing to other at-risk populations, including

older children not previously tested and pregnant women. The Task Force noted that the

Maryland State Legislature might want to consider revising Maryland’s requirements for

blood lead testing in children up to age 6 for children who have not previously been

tested. If testing takes place by age 2, no further testing is required.

The Task Force gratefully acknowledges the assistance of the following individuals who

provided information about their state programs:

State

Individuals

Massachusetts Department of Public

Health

Paul Hunter, Director, Childhood Lead Poisoning

Prevention Program, Environmental Health Bureau

Francine Medaglia, Clinical Coordinator, Childhood

Lead Poisoning Prevention Program, Environmental

Health Bureau

New Jersey Department of Health

Crystal Owensby, Coordinator, Child Health Program

Rhode Island Department of Health

Dr. Peter Simon, MD, MPH, Assistant Medical Director

Rhode Island Department of Health

Texas Department of State Health

Services

Teresa Willis, Blood Lead Surveillance, Environmental and

Injury Epidemiology and Toxicology Unit

Wisconsin Department of Health

Services

Charles Warzecha, Director of Environmental Health

Margie Coons, Director, Lead Screening Program

Appendix 1. Membership of the Task Force on Point of Care Testing for

Lead Poisoning

Clifford S. Mitchell, MS, MD, MPH (Chairman) – Director, Environmental Health Bureau,

Prevention and Health Promotion Administration, Maryland Department of Health and Mental

Hygiene

Paul Celli – Coordinator for Laboratory Licensing and Surveying, Office of Health Care Quality,

Maryland Department of Health and Mental Hygiene

Shaketta Denson, Esquire. – Family Advocate Attorney, Coalition to End Childhood Lead

Poisoning

Michael J. Ichniowski, MD – Maryland Chapter, American Academy of Pediatrics

Pat McLaine, DrPH, MPH, RN – Assistant Professor, University of Maryland School of Nursing,

and Chairperson, Maryland Lead Poisoning Prevention Commission

Mary Mussman, MD, MPH – Physician Advisor, Office of the Deputy Secretary for Health Care

Financing, Maryland Department of Health and Mental Hygiene

Honorable Shirley Nathan-Pulliam – Maryland House of Delegates

Honorable Nathaniel Oaks – Maryland House of Delegates

Amy Richardson, MD, MBA – Medical Director, Johns Hopkins HealthCare

Tina Wiegand – Manager, Childhood and Newborn Screening Program, Laboratories

Administration, Maryland Department of Health and Mental Hygiene

APPENDIX 2. MEETING SCHEDULE OF THE TASK FORCE

 Meeting Dates:

– September 26, 2013

– October 1 9:00 AM

– *October 3 Joint Meeting with Maryland Lead Poisoning

Prevention Commission

– October 10 9:00 AM

– October 24 9:00 AM

– November 14 9:00 AM

– December 2 2:00 PM

APPENDIX 3. TESTING RATES FOR CHILDREN AGES 0 – 72 MONTHS BY JURISDICTION,

2012.

APPENDIX 4. ECONOMIC ANALYSIS OF POC LEAD TESTING

Start-up Expense

COSTS*

Component

Cost

Remarks

Lead Care II device

2058.79

(Based on current price quote)

CLIA waiver registration

150.00

(every 2 years)

MD fee for lead testing

200.00

(every 2 years)

MD Application fee

100.00

(every 2 years)

Proficiency testing

460.00

(from Wisconsin's cost)

Test kits

336.68

(Test per kit, based on current price quote)

TOTAL

2968.79

REIMBURSEMENT

Alternative 1

1802.88

Assumes $12.52/test reimbursement and first

3 test kits free (144 free tests)

Alternative 2:

3242.88

Assumes $12.52 and $10 collection fee/test

reimbursement and first 3 test kits free (144

free tests)

Testing reimbursement/expense

Less staff time cost @$1.75/test -252.00

$2990.88

At this reimbursement rate, the start-up expense is fully covered after performing the initial 144 tests.

Each 48-test kit would reimburse $1080.96, with an expense of $336.68 for the kit and staff time of an

additional $84 for a total expense of $420.68. This would net a practice $660.28 for every test kit at this

level of reimbursement.