Screening for the Human Immunodeficiency Virus (HIV) Infection

HIV Health Care Access Working Group

October 9, 2009

Centers for Medicare and Medicaid Services (CMS)
7500 Security Boulevard
Baltimore, MD 21244
Attn: William Larson, MA
william.larson@cms.hhs.gov

RE: Proposed Decision Memo for Screening for the Human Immunodeficiency Virus (HIV) Infection (CAG-00409N)

We are writing on behalf of the HIV Health Care Access Working Group to offer our strong support for Medicare coverage of HIV testing. The Working Group is a coalition of 112 national and community-based AIDS services organizations that represent HIV medical providers, advocates, public health workers and people living with HIV/AIDS.

Routine HIV testing is critical to identifying people with HIV earlier so that they can be linked to lifesaving care. HIV treatment is one of the most effective medical interventions available today and yet too few people in the U.S. are able to fully benefit from it.

In addition to benefiting the individual, routine HIV testing has significant public health prevention benefits. One in five people with HIV in the U.S. are not aware of their diagnosis and approximately 25 percent of the individuals that are unaware of their status account for 54 percent of new HIV infections. Identifying people with HIV earlier provides them with the opportunity to more fully benefit from HIV treatment and to take precautions to prevent further spread of the disease.

We urge CMS to expand its analysis to include coverage for routine HIV testing as a standard component of medical care as recommended by the Centers for Disease Control and Prevention and the American College of Physicians along with a number of other organizations. Coverage for an annual test for only those who are deemed at risk and for pregnant women is inadequate to identifying people with HIV. Routine HIV testing has been found to be cost effective and to reduce HIV transmission rates in areas with prevalence rates as low as .2%. Other studies have documented that in the absence of routine HIV testing medical settings are missing opportunities for diagnosing individuals with HIV earlier. A review of data from the South Carolina health department found that people with HIV that were diagnosed late had a median of four medical visits prior to their diagnosis.

Medicare coverage of routine HIV testing presents a critical opportunity for identifying people with HIV earlier so that they can be linked to lifesaving care and treatment, and for reducing the overall incidence and prevalence of HIV in the U.S. Members of the working group would be pleased to meet with you to discuss this issue in more detail. For more information, please contact either co-chair of the Working Group, Laura Hanen of the National Alliance of State and Territorial AIDS Directors at (202) 434-8091 or Robert Greenwald of the Treatment Access Expansion Project at (617) 390-2584.
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Marks G, Crepaz N, Janssen R. Estimating sexual transmission of HIV from persons aware and unaware that they are infected with the virus in the USA. AIDS. 2006;20:1447-1450. Organizations that endorse the routine testing include American College of Obstetricians and Gynecologists, AIDS Healthcare Foundation, American Academy of HIV Medicine, American Academy of Pediatrics, American College of Nurse-Midwives, American College of Emergency Physicians, American College of Physicians, American Medical Association, Association of State and Territorial Health Officials, Emergency Nurses Association, HIV Medicine Association, National HIV/AIDS Clinicians’ Consultant Center, and the National Medical Association. Paltiel AD, et al. Expanded HIV screening in the United States effect on clinical outcomes, HIV transmission, and costs. Ann Intern Med. 2006;145:797-806. Walensky, RP, et l. Cost-effectiveness of HIV testing and treatment in the United States. Clin Inf Dis 45(s4):S248-S254, 2007. Sanders GD, Bayoumi AM, Holodniy M, Owens DK. Cost-effectiveness of HIV screening in patients older than 55 years of age. Ann Intern Med. 2008;148:889-903. CDC. Missed opportunities for earlier diagnosis of HIV infection – South Carolina, 1997-2005. MMWR. Dec 2006. 55(47);1269-1272.

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The American Society for Microbiology (ASM) appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services “Proposed Decision Memo for Screening for the Human Immunodeficiency Virus (HIV) Infection (CAG-00409N)” issued on September 9, 2009. The ASM is the largest educational, professional, and scientific society dedicated to the advancement of the microbiological sciences and their application for the common good. The Society represents approximately 40,000 microbiologists professionally employed in a variety of areas, including biomedical, agriculture and environmental microbiology, as well as clinical microbiology and immunology.

Many of ASM members are involved in clinical laboratory medicine. These individuals direct clinical microbiology, immunology, and molecular diagnostic laboratories, are licensed or accredited to perform such testing, are industry representatives marketing products for use, or are researchers involved in laboratory diagnosis. ASM also includes clinician members involved in infectious disease prevention and management. Therefore, the ASM has significant interest in the process of establishing national coverage decisions for medically necessary laboratory testing including screening in select circumstances to ensure appropriate patient care for Medicare beneficiaries.

We strongly support the proposal outlined in CAG-00409N to cover HIV screening using a Food and Drug Administration-cleared HIV antibody test on an annual basis, in Medicare beneficiaries at increased risk for HIV infections, as defined in the US Preventive Services Task Force (USPSTF) guidelines, and voluntary screening of pregnant Medicare beneficiaries. However, the ASM strongly recommends that risk factors be reconsidered to include other infectious diseases that are highly associated with HIV infection. In particular, in accordance with the Centers for Disease Control and Prevention (CDC) recommendations, “Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings” (MMWR 2006; 55(RR14): 1-17. http://www.cdc.gov/mmwr/PDF/rr/rr5514.pdf), patients initiating treatment for tuberculosis should be eligible for screening. In addition, in patients seeking treatment for sexually transmitted diseases, HIV screening should be available at each visit for a new complaint rather than on an annual basis.

ASM considers screening of only those individuals deemed to be at increased risk to represent a minimum coverage standard. Many individuals are at risk without knowledge or understanding of such risk. Further, individuals may fail to report the risk factors defined in the coverage decision proposal and fail to request an HIV test. It is recommended that there be no delay in issuance of a coverage decision based on the USPSTF guidelines, but, that there be a careful reconsideration of the more expansive guidelines from the CDC as noted above, and from the American College of Physicians (ACP) and HIV Medicine Association (Ann Int Med 2009; 150: 125-131. http://www.annals.org/cgi/reprint/0000605-200901200-00300v1.pdf). The ACP-HIV Medicine Association guidelines recommend that clinicians adopt routine screening for HIV and encourage patients to be tested, and the CDC guidelines emphasize the value of routine screening particularly in healthcare settings serving client populations at increased risk. We also concur with the recommendations that repeat screening in individuals not in a risk category defined by one of the guidelines be performed based on clinical judgment.

Finally, it is critical that the NCD provide explicit coding guidance for both the antibody testing procedures (CPT or HCPCS codes) including need for duplicate sample testing as well as the diagnosis/condition codes (ICD-9-CM). It may be useful to reference the recent Association of Public Health Laboratories document on “HIV Testing Algorithms: A Status Report” to review alternatives currently in use for screening (http://www.aphl.org/hiv/statusreport). For diagnosis/condition coding, it is not clear which, if any, current ICD-9-CM codes represent all of the conditions justifying screening. Particularly when performed upon patient request with no documented risk factors, the condition coding strategy needs clear definition.

HIV infection has significant consequences both clinically and financially; it is a disease whose costs can be controlled in part through early detection and rapid implementation of treatment. In addition, early detection supports aggressive prevention strategies, which further help to control the consequences of HIV infection. A Medicare National Coverage Decision supporting HIV screening in appropriate patient populations is a critical component of a national strategy to control HIV infection.

Thank you for the opportunity to comment. Please contact the ASM at 202-942-9262 if there are additional questions or concerns.

Sincerely,

Vickie S. Baselski, Ph.D., Chair
Committee on Professional Affairs
ASM Public and Scientific Affairs Board

Susan E. Sharp, Ph.D., Chair
Committee on Laboratory Practices
Public and Scientific Affairs Board ASM Public and Scientific Affairs Board

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RE: Proposed Coverage Decision Memorandum for Screening for the Human Immunodeficiency Virus (HIV) Infection (CAG-00409N)

The National Association of Community Health Centers, Inc. (NACHC) is pleased to respond to the above-cited proposed decision memorandum from the Department of Health and Human Services (HHS) on the proposed coverage for screening for HIV infection. NACHC is the national membership organization for federally qualified health centers (hereinafter interchangeably referred to as “health centers” or “FQHCs”) throughout the country, and is a 501(c) (3) non-profit organization.

BACKGROUND
There are, at present, approximately 1200 FQHCs nationwide serving close to 20 million patients. Most of these FQHCs receive federal grants under Section 330 of the Public Health Service Act (42 U.S.C. 254b) from the Bureau of Primary Health Care (BPHC), within the Health Resources and Services Administration (HRSA) of the Department of Health and Human Services (HHS).

Under this authority, health centers fall into four general categories (1) those centers serving medically underserved areas, (2) those serving homeless populations within a particular community or geographic area, (3) those serving migrant or seasonal farm worker populations within similar community or geographic areas, and (4) those serving residents of public housing.

To qualify as a Section 330 grantee, a health center must be located in a designated medically underserved area or serve a medically underserved population. In addition, a health center’s board of directors must be made up of at least fifty-one percent (51%) users of the health center and the health center must offer services to all persons in its area, regardless of one’s ability to pay.

BPHC’s grants are intended to provide funds to assist health centers in covering the otherwise uncompensated costs of providing comprehensive preventive and primary care and enabling services to uninsured and underinsured indigent patients, as well as to maintain the health center’s infrastructure. Patients from eligible communities, who are not indigent and able to pay or who have insurance, whether public or private, are expected to pay for the services rendered. Approximately 35 percent of health center patients are Medicaid recipients, approximately 7.5 percent are Medicare beneficiaries, and approximately 40 percent are uninsured.

COMMENTS ON THE PROPOSED COVERAGE

NACHC applauds CMS’ decision to cover the screening for HIV infections. This coverage will allow health centers to better serve Medicare beneficiaries nationwide. We appreciate the opportunity to share the following comments to the proposed decision.

Ensure Adequate Reimbursement for Health Centers

NACHC requests that CMS ensure that health centers are properly reimbursed for the provision of HIV screens for their Medicare patients. Medicare currently reimburses health centers an all-inclusive FQHC per visit rate for the reasonable cost of the provision of certain Medicare covered services—however that per visit rate is limited by a CMS –instituted per visit cap. NACHC has frequently questioned the accuracy and legality of this per visit cap and believes that as many as 70% of FQHCs incur costs that exceed this limit. The health centers that are at or above the Medicare cap, in effect, will not be reimbursed for the provision of HIV screening. While NACHC believes that it is critical for CMS to reexamine and raise its current inadequate Medicare FQHC cap, we suggest that an immediate solution with regard to HIV screening would be for CMS to increase this cap immediately to reflect the additional cost health centers will incur in providing HIV screening.

Allow for Coverage of Screening for All Medicare Beneficiaries

NACHC is supportive of the expansion of additional preventive services, including the proposed annual voluntary HIV screening of Medicare beneficiaries at increased risk for HIV infection per United States Preventive Services Task Force (USPSTF) guidelines. However, limiting covered HIV screening only to beneficiaries with an identified risk factor will result in missed opportunities for early diagnosis and treatment. The CDC recommends opt-out HIV screening for patients in all healthcare settings regardless of risk factors. NACHC would like to recommend voluntary screenings under Part A or Part B for all Medicare beneficiaries regardless of risk factors. NACHC recommends expanding HIV screening for all Medicare beneficiaries in order to ensure comprehensive care.

Sufficient Coordination between Government Agencies

Fragmentation of services is difficult for health centers to handle. FQHCs utilize a variety of funding streams in their efforts to provide care to their patients. For example, North Carolina’s Medicaid program provides FQHCs with free access to HIV test kits. Other health centers rely on grants from other federal agencies (i.e., Health Resources and Services Administration (HRSA)) to assist them with paying for HIV screenings, especially for the uninsured. NACHC requests that HHS assure there is communication and coordination of benefits within the Department in order to provide beneficiaries with quality comprehensive care and reduce the gaps in service delivery and availability.

NACHC appreciates the opportunity to comment on this proposed decision and would welcome the opportunity to further discuss these concerns. If you have questions, please contact Susan Sumrell, Associate Director of Regulatory Affairs, at 202.296.3800.

Respectfully Submitted,

Roger Schwartz, Esq.
Associate Vice President, Executive Branch Liaison
Legislative Counsel

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October 7, 2009

Ms. Charlene Frizzera
Acting Administrator
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Room 445-G, Hubert H. Humphrey Building
200 Independence Avenue, SW
Washington, D.C. 20201

RE: Administrative File: CAG-00409N
Proposed Coverage Decision Memorandum forScreening for the Human Immunodeficiency Virus (HIV) Infection

Dear Acting Administrator Frizzera:

On behalf of the California Medical Association,we are writing to offer our support for the proposed expansion of Medicare coverage to include HIV screening. Such screening is crucial for the early detection and treatment of HIV and is appropriate for Medicare beneficiaries as recommended by the U.S. Preventive Services TaskForce, the Centers for Disease Control (CDC) and the studies cited in the proposed regulation. However, we are also recommending that Medicare cover and pay for more than one screening per year for high-risk individuals. Multiple HIV tests for high-risk patients is not only recommended by the medical community but is cost-effective coverage for the Medicare program.

CMA recommends that CMS allow up to three tests per year, based on a patient’s recent risk or exposure history. There are four circumstances that warrant additional testing.

A. Pregnancy
The CDC recommends that all women receive a second HIV test during the third trimester of pregnancy but particularly for women who are known to be high risk or who reside in jurisdictions withelevated incidence of HIV or AIDS.

B. Recent Exposure
The CDC and the National Guideline Clearinghouse, sponsored by the Agency for Healthcare Research and Quality, state that the standard of care is for a follow-up test to be performed within 3-6 months for persons with recent high-risk sexual or drug-related activity but without a specific exposure date, because of the delay inseroconversion. The guidelines state, “If a recent exposure to an infected partner or partner of unknown HIV status has occurred within the previous three months, the patient may still be in the window period where HIV antibodies have not yet been produced, but p24 antigen and/or HIVribonucleic acid may test positive. Repeat testing at least 3 months after the exposure should be performed.
(Websites:http://www.guidline.gov/summary;http://www.cdc.gov/hiv/topics/testing/resources/factsheets/rt_counseling.htm)

C. Ongoing Exposure
A second test during the year is also recommended if a patient does not respond to counseling about reducing risk and continues high-risk sexual or drug-related behavior. The renowned HIV/AIDS expert John G. Bartlett, MD of Johns Hopkins University recommends repeat testing every 6 to 12 months for such individuals (http://www.uptodateonline.com/patients/content/topic ”Patient Information: Symptoms of HIV Infection”).

D. Indeterminate Western Blot
And finally, CDC recommends retesting if an initial test confirmation by Western Blot is indeterminate(http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5019a1.htm).

ICD-9 and CPT Codes To Allow Payment for Additional Tests for High-Risk Patients
CMA strongly urges CMS to cover additional tests when they are warranted for high-risk individuals as prescribed above. If this is not possible, CMA requests that CMS employ certain ICD-9 and CPT codes to allow physicians to bill for additional tests for high-risk patients. This payment methodology is currently used by CMS to cover additional preventive screening tests for other high-risk conditions, such as diabetes and pap testing. We would only recommend that the special code or modifier be a single code that can apply to all HIV situations for which repeat screeningin a given year is indicated.

Finally, we urge that HIV antibody testing by any FDA-approved method be covered.

We thank you for your consideration of these comments. We applaud CMS’ proposal to expand coverage for preventive screening and care.

Sincerely, Dev GnanaDev, MD
President, California Medical Association

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[These Comments are also being submitted to the CAG inquiries email address]

October 9, 2009

Lawrence Schott, MD, MS
Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: Proposed Decision Memo for Screening for HIV (CAG-00409N)

Dear Dr. Schott:

On behalf of the American Clinical Laboratory Association (“ACLA”), I am pleased to submit these comments on the Proposed Decision Memo (“Proposed Decision”) for screening for HIV infection (CAG-00409-N). The Proposed Decision states that CMS has determined that the evidence is adequate to conclude that screening for HIV infection is reasonable and necessary for early detection of HIV and proposes Medicare coverage of the testing.

ACLA is an association of clinical laboratories throughout the country, including local, regional and national laboratories and we strongly support the decision of CMS to cover screening for HIV infection. ACLA is an organization devoted to educating the public and lawmakers about the vital role played by clinical laboratory testing in protecting the public health. Laboratory testing is crucial to the early detection of diseases, such as HIV, and early detection, in turn, is crucial to stemming the spread of such diseases, and to allowing patients to obtain early and effective treatment. ACLA applauds CMS for taking this important and significant step, which will benefit Medicare beneficiaries across the nation.

ACLA does have two comments, however, on the specifics of the Proposed Decision, which are set out below. First, CMS has erred in proposing to limit coverage to FDA approved tests for the reasons set out below. Second, ACLA urges CMS not to establish special HCPCS and screening codes to be used when billing for screening HIV services, as it has done with other services. Such codes simply create confusion and added burdens for all parties; therefore, CMS should simply use the current CPT code for billing purposes. These issues are set out in greater detail below.

1. CMS Should Cover HIV Screening Performedby LDTs, as well as by FDA Approved Kits.

CMS states that it proposes to cover HIV screening performed “with an FDA-approved enzyme immunoassay (EIA), enzyme-linked immunosorbent assay (ELISA) or rapid HIV antibody test.” ACLA believes that this definition of covered testing is too narrow and would exclude many tests that are commonly used for detection of HIV.

While some laboratory testing is performed with FDA-approved or -cleared “test kits,” testing is also frequently performed with assays developed in-house by a clinical laboratory for use within that laboratory. Such tests, termed Laboratory-Developed Tests (“LDT”), are not subject to FDA clearance or approval; however, the laboratories performing such tests are subject to regulation by CMS under the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”). Laboratories performing LDTs must do their own validation of the tests to ensure their accuracy and establish other performance criteria. FDA itself has recognized the value of LDTs and has stated that it will exercise its enforcement discretion with regard to many of these tests. In fact, in its Final Rule with regard to Analyte Specific Reagents, which are components of many LDTs, FDA stated that “the use of in-house developed tests has contributed to enhanced standards of medical care in many circumstances.”

Many HIV screening tests performed by clinical laboratories will be done using LDT methodologies. If CMS limits coverage only to those tests that are FDA-approved or cleared, it could result in the denial of a significant number of tests. Traditionally, CMS has covered tests, regardless of whether they were performed using an FDA-cleared or –approved test kit or as an LDT validated by the performing laboratory in accordance with CLIA regulations. For example, when HIV viral load testing was first developed, CMS specifically noted that it was frequently done using “testing procedures developed in-house by individual laboratories and commonly referred to as ‘home brews.’” CMS specifically permitted coverage of these “home brew” tests. Thus, there is no basis for limiting the coverage in this situation either.

Further, there is no requirement in Medicare law that a test be FDA-approved or cleared before it can be covered. Medicare does exclude coverage of some devices that are deemed experimental; however, there is no basis for suggesting that HIV screening tests performed as LDTs would meet this criterion. As a result, there is no basis for excluding HIV screening tests from coverage, simply because they are performed using LDTs. Medicare should cover all HIV screening, regardless of whether it is done using an FDA approved or cleared kit or as an LDT. The language of the Proposed Decision should be changed to reflect this determination.

2. To Avoid Confusion and Added Burdens, CMS Should Not Establish Unique Screening Codes for these Services.

ACLA has one additional comment with regard to the billing and payment for such tests. While we recognize that it does not specifically relate to the issue of coverage, we did want to highlight it as CMS moves forward with its consideration of this issue. CMS should not establish any special coding requirements for the new screening HIV test as it has done in certain other instances, because such special screening codes often create numerous billing and reimbursement problems.

Where a screening benefit is established under Medicare, CMS has sometimes established a separate HCPCS code to distinguish the screening test from other diagnostic uses of the test. It has done this in the case of screening Pap smears covered by Medicare as well as screening PSAs. At the same time, CMS often also sets up a specific ICD-9 code or codes to be used to show the purpose of the test was for screening. For example, in the case of PSAs, the test is to be billed using the screening HCPCS code (G0103) and the ICD-9 code, V76.44 (special screening for malignant neoplasms, prostate). ACLA is concerned that CMS may consider doing the same thing with regard to coverage of HIV screening.

The creation of such special billing requirements for screening services creates numerous billing problems for physicians, laboratories, patients and for the contractors who pay the claims. First, in order to determine whether to use the usual CPT code or the special screening HCPCS code, laboratories must somehow determine the physician’s purpose in ordering the service. Laboratories have developed numerous approaches to deal with this issue, but they all create their own problems. For example, with PSA, laboratories may have two separate offerings on their requisition, a diagnostic and a screening PSA. However, physicians often do not understand the billing and payment implications of the two different types of PSAs; therefore, they may order a screening PSA with a diagnostic ICD-9 code, and a diagnostic PSA with a screening ICD-9 code. All of these situations require the laboratory to make separate inquiries to the physician to obtain the appropriate information for billing purposes.

The directive to use a particular ICD-9 code in order to indicate that a test is for screening, which CMS has also done for PSA testing, creates even more opportunities for confusion. As a matter of compliance, laboratories bill the ICD-9 code that is submitted with the testing from the physician. When CMS established a specific code for a screening PSA, laboratories had to educate physicians and their staffs to use that one code when ordering the screening PSA. However, not surprisingly, given the other demands on physicians and their staffs, it is fairly common for a laboratory to receive an order for a screening PSA with the wrong ICD-9 code, including the wrong screening diagnosis code, which can result in the test being denied and the patient being liable.

For example, sometimes a physician orders a PSA test, but instead of submitting V76.44, the specific code for a screening PSA, the physician submits the code for routine medical examination. This is not unusual because the physician or his staff may know the PSA is a screening service, but may not know to use a special code. When the laboratory receives that order, it will bill using the screening code received from the physician. Since the Medicare billing system only recognizes one code to demonstrate a screening PSA, it rejects other screening codes as a non-covered screening service, which can result in patient liability. The patient will then receive a bill for a non-covered screening service, which is a nonsensical given that the screening service is actually a covered benefit. This creates unnecessary stress and confusion for the patient, and frustration for his physician, the laboratory, and the contractor, as they attempt to set things right. ACLA is concerned that if CMS does approve HIV as a screening service, there will be a replay of the confusion detailed above. As ACLA has noted in the past, there is a simple solution that will avoid this situation, and we strongly urge CMS to implement it, rather than to create a new set of screening HCPCS and ICD-9 codes. As ACLA has noted in the past, it would be preferable and less confusing for all, if CMS neither assigned new HCPCS codes nor defined specific screening ICD-9 codes to be used to identify the screening services. Where a screening benefit exists, such as HIV screening, the laboratory should simply bill the standard CPT code applicable to the service, and submit the diagnosis code provided by the physician. If the code submitted is a diagnosis code, then it would be paid as a diagnostic service; if the code submitted is one of the numerous existing screening codes, then it would be paid as a screening service. The actual payment does not vary in either case. In other words, the very same adjudication logic in the payment system that currently determines when HIV testing is to be denied as a routine screening service should be used in the future to allow the claim to be covered and paid on the basis of routine screening under the new benefit. This approach would alleviate much of the confusion, claims denials, resubmissions, and beneficiary anxiety that currently exist. As a result, we urge CMS neither to establish new HCPCS codes for the HIV screening services nor to define screening specific ICD-9 codes, if they are covered by the Medicare program.

As noted, our strong preference is for there to be no new HCPCS or screening codes specified if HIV screening is covered. However, if—despite the reasons set out above—CMS follows its past practice and does establish new HCPCS codes for HIV screening tests, then CMS should help to prevent the type of confusion and wasted effort detailed above. Therefore, it must provide sufficient explanation and background to laboratories and physicians to explain how the new codes should be used with other existing codes and modifiers for HIV testing. Further, if CMS is going to require a screening diagnosis code to indicate that the test is a covered screening service, then CMS should establish a broad list of codes that it will recognize as demonstrating that the test is a covered screening service. When CMS only establishes a single code, it almost guarantees confusion in billing and frustration for beneficiaries. As a result, CMS should establish a broad list of specific ICD-9 diagnosis codes, similar to the screening codes used in the laboratory coverage policies resulting from the Laboratory Negotiated Rulemaking that could be used to as support for an HIV screening test. An adequate subsequent public comment period should also be offered for responses to any such coding proposals. We hope you find these comments useful. If you have any questions or comments, please do not hesitate to contact us.

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Lawrence Schott, M.D., M.S.
Medical Officer, Division of Medical and Surgical Services
Centers for Medicare and Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, MD 21244-1850

Dear Dr. Schott:

Thank you for the opportunity to submit comments on the Centers for Medicare and Medicaid Services (CMS) proposed National Coverage Decision for Screening for the Human Immunodeficiency Virus (HIV) Infection. Bristol-Myers Squibb has been developing medicines to treat HIV infection for over 20 years.

We commend CMS for selecting HIV Screening as the first expanded preventive service coverage as provided by the Medicare Improvements for Patients and Providers Act of 2008. Indeed, this selection is noteworthy because although HIV prevention and disease management have improved significantly since the beginning of the epidemic, the most recent data from 2006 indicate that approximately 56,300 new HIV infections still occur each year in the US alone, and that approximately one million people are living with HIV infection.(1)(2) These statistics underscore the importance of the agency’s proactive action on this disease.

We are concerned, however, that due to statutory constraints, the agency’s action is limited to covering screening only for those Medicare beneficiaries with known high-risk behaviors. The Centers for Disease Control and Prevention’s (CDC) recommendation since 2006 has instead been that all patients aged 13-64 should be routinely screened for HIV.(3) These recommendations have been endorsed by the HIV Medical Association, the American College of Physicians, and other professional organizations.(4) Awareness of HIV status allows infected individuals to seek appropriate medical care and is associated with a significant reduction in risky behaviors that facilitate HIV transmission.(5) About 21% of Americans currently living with HIV do not know their HIV status (2), and many of them do not consider themselves at risk for HIV or may not disclose their high risk behaviors to their health care provider. In these situations, routine screening offers a more effective approach to ensuring that HIV-positive individuals get the appropriate medical care that they need.

The proposed coverage decision is a positive step, but it still precludes many Medicare beneficiaries from the benefit of routine screening for HIV. We believe that diagnosing people with HIV is critical in slowing the progression and spread of the disease and improving clinical outcomes for those affected.

Sincerely,

George J Hanna, MD
Vice President, Virology Medical Affairs

References:
(1)Centers for Disease Control and Prevention. Estimates of New HIV Infections in the United States. Atlanta, GA: Centers for Disease Control and Prevention, US Department of Health and Human Services; August 2008. Available at http://www.cdc.gov/hiv/topics/surveillance/resources/factsheets/pdf/incidence.pdf. Accessed April 2009.

(2)Centers for Disease Control and Prevention. New Estimates of U.S. HIV Prevalence, 2006. Atlanta, GA: Centers for Disease Control and Prevention, US Department of Health and Human Services; October 2008. Available at http://www.cdc.gov/hiv/topics/surveillance/resources/factsheets/pdf/prevalence.pdf. Accessed April 2009.

(3)Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings, MMWR September 22, 2006 / 55(RR14);1-17.

(4)Lubinski,C, HIV Policy: The Path Forward—A Joint Position Paper of the HIV Medicine Association of the Infectious Diseases Society of America and the American College of Physicians, CID 2009:48 (15 May), p 1335-1344.

(5)Marks G, Crepaz N, Senterfitt JW, Janssen RS. Meta-analysis of high-risk sexual behavior in persons aware and unaware they are infected with HIV in the United States: implications for HIV prevention programs. J Acquir Immune Defic Syndr 2005;39:446-53.

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October 8, 2009

Mr. William Larson
Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: Proposed Decision Memo for Screening for Human Immunodeficiency Virus (HIV) (CAG-00409N)

Dear Mr. Larson:

Thank you for the opportunity to comment on the proposed decision memo for screening for the Human Immunodeficiency Virus (HIV) infection. Roche Diagnostics is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. We applaud efforts by the Centers for Medicare & Medicaid Services (CMS) to use new statutory authority to expand coverage for screening and preventive services appropriate for the Medicare population. In particular, we support and encourage CMS to finalize its proposed decision to cover HIV screening for high-risk or pregnant Medicare beneficiaries.

As we noted in our comments on the proposed national coverage analysis for HIV screening, Medicare spent $4.5 billion on care for beneficiaries with HIV or Acquired Immunodeficiency Syndrome (AIDS) in 2008, and Medicare expenditures for this population are expected to continue to rise. Early detection of HIV status makes it possible to treat infected individuals before they develop significant and expensive AIDS-related complications. It also can help HIV-positive individuals avoid transmitting the disease to non-infected partners. Persons unaware of their HIV infection are estimated to account for more than half of the new cases of HIV.

Expanding Medicare coverage to include annual HIV screening for high-risk beneficiaries will provide clinicians with the opportunity to identify infected individuals in the Medicare population before they become symptomatic. Screening pregnant beneficiaries will help prevent the transmission of HIV to newborns. In addition, screening will also provide an additional opportunity to educate high-risk patients, even those who are not HIV-positive, about prevention.

Screening and preventive services are vital tools to provide patients with more effective, safer, and the most cost-effective treatment. Such services can help better target health care resources and improve quality of life. Accordingly, we recommend that the agency proceed with a National Coverage Determination on HIV screening. We also look forward to working with CMS to expand coverage for other appropriate screening services in the future.

Sincerely,

Tadd S. Lazarus, M.D.
Whitney Green
Medical Director
Senior Vice President

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Representing over 52,000 physicians, the American College of Obstetricians and Gynecologists (ACOG) supports the national coverage decision to include screening for human immunodeficiency virus as part of preventive screening services covered by Medicare Part B. An estimated 280,000 people are living with undiagnosed HIV infections in the United States and as ACOG has worked to promote screening guidelines among our Fellows, we have found that reimbursement issues continue to pose barriers to routine HIV screenings.

ACOG particularly supports the proposed decision to cover voluntary HIV screening for pregnant Medicare beneficiaries. Women comprise 27% of new HIV infections, up from 8% in 1985. Pregnant women are at an increased risk of transmitting HIV to their child without early testing and treatment. Studies show that women who are diagnosed and begin antiretroviral treatment early in pregnancy can reduce the rate of transmission from 25% to less than 2%. ACOG Committee Opinion No. 418 recommends HIV screening for all pregnant women as early as possible in each pregnancy, repeat testing in the third trimester for women living in areas with high HIV prevalence and women known to be at high risk for acquiring HIV infection, and testing at labor and delivery for women with undocumented HIV status. ACOG Committee Opinion No. 411 recommends routine HIV screening in non-pregnant women ages 19-64 and targeted screening for women outside that age range with risk factors. Early diagnosis and treatment of HIV not only improves chances of survival, it also enables women who are infected with HIV to take steps to avoid unintended pregnancy, protect their sexual partners, and reduce the likelihood of mother-to-child transmission for women who are pregnant.

While ACOG supports the proposed decision to cover HIV screening for Medicare beneficiaries, ACOG also supports opt-out screening, in which the patient is notified that an HIV test will be performed as a routine part of care, unless the patient declines. Studies show that opt-out screening produces a higher testing rate than other screening methods. A CDC study summary published in the November 2, 2002 Morbidity and Mortality Weekly Report showed that states with opt-out prenatal HIV-testing policies had higher rates of testing than other states. Tennessee had a testing rate of 85% and Arkansas had a testing rate of 71%, compared to a testing rate of 57% in 1997 before the opt-out law was implemented. In addition, the Perinatal Guidelines Project found that the majority of women accept testing recommended by their physician. ACOG strongly encourages you to add an opt-out policy to the proposed decision.

ACOG appreciates the reference to health disparities in the background section of the proposed decision memo; ACOG also recognizes the importance of routine screenings in addressing health care disparities. ACOG Committee Opinion No. 414, released in August 2008, stated that women of color comprise 80% of new HIV cases among women. Most acquire it from heterosexual contact, often from a partner with undisclosed risk factors for HIV. This can have a tremendous impact on the rate of mother-to-child transmission. A combination of testing, education, and behavioral intervention can help reduce the rate of infection among women of color.

The recommendations are widely agreed upon and readily available to physicians, but reimbursement barriers limit their ability to fully implement the recommendations. As HIV treatments improve, many at-risk individuals have become complacent about testing and safe sex practices, causing the efforts at reducing HIV rates to flat line and even reverse in some areas. Expanding coverage for HIV screening in Medicare Part B is a necessary part of eliminating the barriers to routine HIV screenings, and ACOG greatly appreciates the steps this proposed decision takes to accomplish this.

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October 8, 2009

Tamara Syrek Jensen, JD
Acting Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Dear Ms. Syrek Jensen:

Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services' (CMS's) proposed national coverage determination (NCD) for Screening for the Human Immunodeficiency Virus (HIV) Infection (CAG-00409N). America's Health Insurance Plans (AHIP) is the national association representing nearly 1,300 member companies providing health insurance coverage to more than 200 million Americans. We are pleased to submit these comments on behalf of our members.

General Comments
AHIP and our member plans support CMS's efforts to ensure that Medicare beneficiaries receive access to safe and effective preventive health services, procedures, and treatments that can improve health outcomes, as determined by current and robust clinical evidence. AHIP and our member plans support the inclusion of HIV screening as a covered preventive health benefit for Medicare beneficiaries if ordered by an appropriate clinician. Appropriate education and follow-up care is also an integral part of HIV screening and should be emphasized.

As stated in the Medicare Improvements for Patients and Providers Act of 2008, CMS may add coverage of "additional preventive services" if certain statutory requirements are met, with one of the requirements being that the service was recommended with a grade of A or B by the United States Preventive Services Task Force (USPSTF). The evidence reviews performed by the USPSTF, the leading independent panel of private-sector experts in prevention and primary care which is sponsored by the Agency for Healthcare Research and Quality (AHRQ), are considered the gold standard for clinical preventive services and our member organizations look to their recommendations as a key resource.

• The USPSTF's review and recommendation for HIV Screening, published in 2005 and amended in 2007, states that the USPSTF "strongly recommends that clinicians screen for human immunodeficiency virus (HIV) all adolescents and adults at increased risk for HIV infection and all pregnant women.

AHIP and our member plans concur that there is adequate evidence demonstrating the benefit of HIV screening to the Medicare population and supports CMS's proposed national coverage determination. However, we recommend that CMS revise the proposed language describing coverage for those beneficiaries at increased risk for HIV by removing the word "annual" from their proposed coverage determination language, in order to be consistent with the USPSTF recommendation. Our recommended language would state:

1. Voluntary HIV screening of Medicare beneficiaries at increased risk for HIV infection per USPSTF guidelines:
   • Men who have had sex with men after 1975
   • Men and women having unprotected sex with multiple [more than one] partners
   • Past or present injection drug users
   • Men and women who exchange sex for money or drugs, or have sex partners who do
   • Individuals whose past or present sex partners were HIV-infected, bisexual or injection drug users
   • Persons being treated for sexually transmitted diseases
   • Persons with a history of blood transfusion between 1978 and 1985
   • Persons who request an HIV test despite reporting no individual risk factors, since this group is likely to include individuals not willing to disclose high-risk behaviors; and
2. Voluntary HIV screening of pregnant Medicare beneficiaries.
   

Thank you for the opportunity to comment on this important issue.

Sincerely,

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California Academy of Preventive Medicine
2201 6th Avenue
Sacramento, CA 95818

October 7, 2009

Dear Sir:

The California Academy of Preventive Medicine (CAPM) is a state-wide organization of Preventive Medicine physicians and an affiliate of the American College of Preventive Medicine. Many Preventive Medicine physicians work in state or local health departments.

CAPM is supportive of the Centers for Medicare and Medicaid Services proposal to cover yearly screening for Human Immunodeficiency Virus (HIV). However, we recommend the following changes/additions:

• As yearly screening is not sufficient for certain high risk populations, pregnant women or those persons recently exposed, the number of tests covered per year should be at the discretion of the physician, up to a maximum of three times per year
• CPT codes that the American Medical Association and the American Academy of HIV Medicine have listed as appropriate for HIV testing should be covered
• Any FDA-approved HIV antibody test should be covered, not only tests using the ELISA method.

Thank you for your consideration of our input.

Respectfully,
Caroline A Peck, MD, MPH, FACOG
President

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To the Centers for Medicare and Medicaid Services (CMS):

In comments dated April 11, 2009, on behalf of Community HIV/AIDS Mobilization Project (CHAMP), the AIDS Vaccine Advocacy Coalition (AVAC) and myself, we requested that CMS amend its NCD to include HIV screening coverage for all individuals between 13 and 64 yeas of age regardless of recognized risk factors, as recommended by the CDC and a wide range of medical authorities. In those comments, we also requested that CMS accept our materials as a Track#1 Formal Request for an NCD to provide coverage for HIV screening and testing for all individuals between 13-64 under Medicare Part B if the NCD could not be immediately expanded. A copy of our submittal is also being sent to CAGinquiries@cms.hhs.gov for purposes of this new comment period.

We request that the coverage decision analysis reconsider the material we put forward and which has not yet been reviewed in CMS'' current proposal, including:

1) CMS Guidance which states that "Cost effectiveness is not a factor CMS considers in making NCDs. In other words, the cost of a particular technology is not relevant in the determination of whether the technology improves health outcomes or should be covered for the Medicare population through an NCD;" (CMS, Guidance. Factors CMS Considers in Opening a National Coverage Determination, April 11, 2006."and

2) the use of a Track#1 Formal Request for an NCD as described in our April 11, 2009 submittal.

On that basis, we believe the CMS coverage can and should be expanded as recommended by the Centers for Disease Control and other experts.

Thank you for your attention to our request.

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Section 1.E of my previously submitted testimony on behalf of Beyond AIDS requires wording correction in the section heading and the first and fourth paragraphs following, to eliminate inconsistency within the testimony regarding the maximum number of HIV screening tests that may be required by current medical guidelines under certain circumstances. The revised section 1.E should read as follows:

E. ICD-9-CM CODING FOR REPEAT TESTING

As noted above, our first choice is that you cover HIV screening up to three times a year rather than annually. However, we are aware that CMS has had an alternative way of designating the permitted frequency of screening tests, when recommended frequency is based on risk.

We have reviewed The Guide to Medicare Preventive Services, 3rd Edition (posted at http://www.cms.hhs.gov/MLNProducts/downloads/mps_guide_web-061305.pdf). There are several other types of preventive screening that are routinely authorized at a certain frequency, however with added risk, more frequent screening is authorized. The higher risk cases are generally identified by means of an ICD-9 CM code, but there is not a consistent system for doing this.

In the case of both pelvic examinations and Pap testing, routine screening is covered every two years, but with high risk as documented with ICD-9 CM code V15.89 ("other"), screening every 12 months is authorized for each of these (pp. 106 and 117 of the Guide). In the case of diabetes screening, routine screening is covered annually, however it can be done every 6 months if prediabetes is documented using a modifier, "TS," after the code V77.1 (page 55 of the Guide). Colonoscopy is routinely covered only every 10 years, but higher risk patients can have screening up to every 2 years. However, in this case, it is complicated to code for the higher risk patients: 14 separate acceptable ICD-9 CM codes based on past history are listed in Tables 2 and 3 of the Guide (p. 131 of the Guide).

It is our strong suggestion that for HIV screening, if a special code or modifier is required for more frequent screening than once per year, it be a single, simple code or modifier that can apply to all of the situations (A, B, and C above) for which repeat screening during a given year is indicated.

I would like to alert you to two current ICD-9 CM codes that may be helpful: V65.44, Human immunodeficiency virus [HIV] counseling, and V01.79, exposure to HIV virus. I have not located modifiers or codes that indicate greater or lesser risk.

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October 7, 2009

Mr. William Larson
Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244
Re: National Coverage Analysis for Screening for Human Immunodeficiency Virus (CAG-00409N)

Dear Mr. Larson:

The AIDS Institute supports the Centers for Medicare and Medicaid Services in its decision to move forward to include HIV screening as a covered service under Medicare. We are pleased that Medicare is including additional preventive services, which will help beneficiaries remain healthy and in the long term, save the Medicare system money in care and treatment services. It is widely accepted that identifying a person with HIV early will lead to better health outcomes and serve as a mode of prevention. With an estimated 321,000 people infected with HIV but not aware of it, it is important for these people to know their HIV status so they can seek treatment and prevent the infection of others.

In an effort to increase HIV testing, in September 2006 the Centers for Disease Control and Prevention issued new recommendations that call for routine voluntary opt-out HIV screening in all medical settings for people ages 13 to 64. According to the CDC, “the objectives of these recommendations are to increase HIV screening of patients, including pregnant women, in health-care settings; foster earlier detection of HIV infection; identify and counsel persons with unrecognized HIV infection and link them to clinical and prevention services; and further reduce perinatal transmission of HIV in the United States.” The AIDS Institute supports these recommendations and its implementation.

While The AIDS Institute supports Medicare coverage of HIV screening “for all adolescents and adults at increased risk for HIV infection and all pregnant women,” the current proposal does not go far enough and does not comply with current CDC recommendations for routine HIV testing. Therefore, The AIDS Institute recommends that Medicare cover HIV screening for all Medicare beneficiaries, not just those labeled “at risk” or “all pregnant women”. Additionally, we believe Medicare coverage for testing those who are deemed “at risk” should be more than just one time a year. Medicare should allow coverage for any time a person requests an HIV test.

One of the barriers to implementing CDC’s routine HIV testing recommendations has been the issue of reimbursement. The Center for Medicare and Medicaid Services can play a large role in alleviating this barrier by ensuring that both Medicare and Medicaid reimburse for routine HIV screening. The proposal you are advancing at this time is an excellent first start, but it is our hope that CMS will initiate further efforts to expand Medicare and Medicaid reimbursement for voluntary routine opt-out HIV testing in all medical settings in compliance with the CDC recommendations in the near future.

Thank you very much.

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RE: SUPPORT FOR CMS PROPOSAL FOR COVERAGE OF HIVSCREENING, WITH RECOMMENDED MODIFICATIONS INFREQUENCY, AND SPECIFICS ON BILLING

(Note: This testimony will also be e-mailed foreasier readability of outlining, quotations, andtables enclosed)

Beyond AIDS, a national organization dedicated tomore effective public health policy for thecontrol of the HIV epidemic, strongly supports theexpansion of Medicare coverage to include HIVscreening. This will be a step forward indetecting the estimated 25% of all HIV infectionsin the U.S. that have not yet been identified, andwill help to advance the prevention and control ofthe HIV epidemic.

I have appreciated the opportunity to discuss thismatter with Mr. Larson several times on the phonesince the preliminary intent was posted. Ournational board has authorized me to provide thefollowing testimony during the September-Octobercomment period.

Our organization is pleased that Medicare willfinally be paying for HIV screening as recommendedby CDC. We are also pleased that you recognizethat older citizens can be exposed to HIV and thatyou cite a VA study by Owens et al in conjunctionwith a cost-effectiveness analysis by Walensky etal, to justify screening of sexually activeelderly Medicare recipients.

However, we have some specific recommendations,including a change in the proposal, to permitscreening of high-risk individuals more than oncea year. We are disappointed that in your otherwiseextensive search of the literature, you do notcite recommendations for repeat screening within3-6 months of initial screening when risk ofrecent or continuing exposure is great, or duringthe third trimester for pregnant women; and thatfor high risk exposures, there are recommendationsto test a total of three times: at baseline, 4-6weeks, and 6 months.

We also have included in Sections 1.E and 2 somerecommendations for billing codes for HIVscreening, which should be passed on to the staffwho will be developing the implementation.

Our organization also urges that CMS proceedspeedily and concurrently with developingproposals to cover additional services with ClassA and B recommendations from the U.S. PreventiveServices Task Force, that are not already coveredby Medicare, in accordance with the authorizationof Congress in the Medicare Improvements forPatients and Providers Act of 2008.

1. REPEAT HIV TESTS WITHIN A YEAR:
Beyond AIDS recommends that the limit on HIV testsper year be raised from one to up to three, basedon recent risk or exposure history. A simpleincrease in the number of tests authorized peryear would provide the flexibility to deal withthe many indications for repeat testing. It wouldalso avoid unnecessary billing rejectionsresulting from the physician or laboratory notknowing that a previous test had been performed,when a new test is ordered for reasonableindications as described below. The expense wouldnot be great because most patients would not bescreened even annually, and only those at highrisk would be offered more than one test a year. However, if that is not acceptable to CMS, we urgethe use of a simple CPT code or modifier asdescribed in 1.E below, to pay for a second andeven a third test based on risk, as per guidelinesin 1.A through 1.D below.

A. PREGNANCY
Two tests during pregnancy are often indicated,and should be acceptable. Following is an excerptfrom the September 22, 2006 CDC recommendations onHIV testing in healthcare settings, found at thefollowing Web site:http://www.cdc.gov/mmWR/PDF/rr/rr5514.pdf :

"A second HIV test during the third trimester,preferably < 36 weeks of gestation, iscost-effective even in areas of low HIV prevalenceand may be considered forall pregnant women. A second HIV test during thethird trimester is recommended for women who meetone or more of the following criteria:

—Women who receive health care in jurisdictionswith elevated incidence of HIV or AIDS among womenaged 15–45 years. In 2004, these jurisdictionsincludedAlabama, Connecticut, Delaware, the District ofColumbia, Florida, Georgia, Illinois, Louisiana,Maryland, Massachusetts, Mississippi, Nevada, NewJersey, New York, North Carolina, Pennsylvania,Puerto Rico, Rhode Island, South Carolina,Tennessee, Texas, and Virginia.†

—Women who receive health care in facilities inwhich prenatal screening identifies at least oneHIV-infected pregnant woman per 1,000 women screened.

B. RECENT EXPOSURE

The standard of care is that a follow-up testwithin 3-6 months is also indicated for personswith recent high-risk sexual or drug-relatedactivity but without a specific exposure date,because of the delay in seroconversion so that afirst test may not pick up recent infection. Thisis recommended by the National GuidelineClearinghouse, sponsored by the same Agency forHealthcare Research and Quality that sponsors theU.S. Preventive Services Task Force. Here is anexcerpt from their following Web site: http://www.guideline.gov/summary/summary.aspx?doc_id=12376&nbr=6406&ss=6&xl=999

"If a recent exposure to an infected partner orpartner of unknown HIV status has occurred withinthe previous three months, the patient may stillbe in the window period where HIV antibodies havenot yet been produced, but p24 antigen (detectedas part of the fourth generation or "combo" tests)and/or HIV ribonucleic acid (RNA) may testpositive. Repeat testing after at least 3 monthshas lapsed since the exposure (see frequency ofrepeat testing below) should be performed. (Gradeof Recommendation C, Evidence Level IV)"

The Centers for Disease Control and Prevention(CDC) recommends retesting if there might havebeen recent exposure. Here is a quote from theirpage on rapid testing,http://www.cdc.gov/hiv/topics/testing/resources/factsheets/rt_counseling.htm:

"During the initial visit, the provider candefinitively tell clients whose rapid HIV testresult is negative that they are not infected,unless they have had a recent (within 3 months)known or possible exposure to HIV. Retestingshould be recommended for these clients becausesufficient time needs to elapse in order beforeantibodies develop that can be detected by the test."

CDC also recommends that when risk is high, aswith an occupational needlestick exposure, tworetests should be done at 4-6 weeks and a thirdtime at 6 months, at the following Web site: http://wonder.cdc.gov/wonder/PrevGuid/p0000318/p0000318.asp. The Massachussetts Department of Public Healthrecommends two follow-up tests at 4-6 weeks andalso at 6 months following non-occupationalexposure, on the following Web site: http://www.mass.gov/?pageID=eohhs2terminal&L=6&L0=Home&L1=Provider&L2=Guidelines+and+Resources&L3=Guidelines+for+Clinical+Treatment&L4=Diseases+%26+Conditions&L5=HIV%26%2347%3BAIDS&sid=Eeohhs2&b=terminalcontent&f=dph_aids_p_exposure_nonoccupational&csid=Eeohhs2 While Medicare would already cover testing fordefinite HIV exposure, when the source of theexposure refuses to be tested but is high risk,coverage for HIV testing may need to be done usingthe new HIV screening proposal. Following is text from a recent 2009 issue of “Upto Date for Patients” on Testing for HIV, by therenowned HIV/AIDS expert John G. Bartlett, MD ofJohns Hopkins, also recommending up to three testsin a year:

"Frequency of testing — Initial testing for HIVcan be done at any time, but may need to berepeated if a person is concerned about recentexposure. Repeat testing is usually recommended at6, 12, and 24 weeks after a suspected exposure.(See "Patient information: Symptoms of HIVinfection").

C. ONGOING EXPOSURE

In addition, a second test during the year isneeded if the patient does not respond tocounseling about reducing risk, and when seenagain later during the year admits continuedhigh-risk sexual or drug-related behavior. Eachtesting becomes an opportunity to personalize andreinforce the counseling and helping the patientto consider the potential danger of the ongoingbehavior.

Following is additional pertinent text from therecent 2009 issue of “Up to Date for Patients” onTesting for HIV, by John G. Bartlett, MD, alreadycited:

"Periodic testing is recommended for persons whoare at risk for infection. (See "Risk factors forHIV infection" above). Most healthcare providersrecommend repeat testing every six to 12 monthsfor such persons."

D. INDETERMINATE WESTERN BLOT

CDC recommends retesting in one or more months ifan initial test confirmation by Western Blot isindeterminate, on the following Web site: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5019a1.htm:

"Most persons with an initial indeterminateWestern blot result who are infected with HIV-1will develop detectable HIV antibody within 1month… Thus, clients with an initial indeterminateWestern blot result should be retested for HIV-1infection >1 month later. Persons with continuedindeterminate Western blot results after 1 monthare unlikely to be HIV-infected and should becounseled as though they are not infected unlessrecent HIV exposure is suspected."

E. ICD-9-CM CODING FOR A SECOND TEST

As noted above, our first choice is that you coverHIV screening up to two times a year rather thanannually. However, we are aware that CMS has hadan alternative way of designating the permittedfrequency of screening tests, when recommendedfrequency is based on risk.

We have reviewed The Guide to Medicare PreventiveServices, 3rd Edition (posted at http://www.cms.hhs.gov/MLNProducts/downloads/mps_guide_web-061305.pdf). There are several other types of preventivescreening that are routinely authorized at acertain frequency, however with added risk, morefrequent screening is authorized. The higher riskcases are generally identified by means of anICD-9 CM code, but there is not a consistentsystem for doing this.

In the case of both pelvic examinations and Paptesting, routine screening is covered every twoyears, but with high risk as documented with ICD-9CM code V15.89 (“other”), screening every 12months is authorized for each of these (pp. 106and 117 of the Guide). In the case of diabetesscreening, routine screening is covered annually,however it can be done every 6 months ifprediabetes is documented using a modifier, “TS,”after the code V77.1 (page 55 of the Guide). Colonoscopy is routinely covered only every 10years, but higher risk patients can have screeningup to every 2 years. However, in this case, it iscomplicated to code for the higher risk patients:14 separate acceptable ICD-9 CM codes based onpast history are listed in Tables 2 and 3 of theGuide (p. 131 of the Guide).

It is our strong suggestion that for HIVscreening, if a special code or modifier isrequired for more frequent screening, it be asingle, simple code or modifier that can apply toall of the situations (A, B, and C above) forwhich repeat screening during a given year isindicated.

I would like to alert you to two current ICD-9 CMcodes that may be helpful: V65.44, Humanimmunodeficiency virus [HIV] counseling, and V01.79, exposure to HIV virus. I have not locatedmodifiers or codes that indicate greater or lesserrisk.

2. TESTING METHODS AND CPT CODES THAT SHOULD BECOVERED:

HIV antibody testing by any FDA-approved methodshould also be covered, to assure that there willnot be denials for oral (“saliva”) methods and anynew technology that does not involve the ELISAmethod.

According to the CMS Web page “HCPCS – Generalinformation” (found at http://www.cms.hhs.gov/MedHCPCSGeninfo/), medicalservices billed to Medicare can be coded either byCPT codes or by specially assigned HCPCS codes. For some types of screening, such ascardiovascular and diabetes testing, CPT codes arerequested (pp. 44-45 and 55 of the Guide). Forothers, such as pelvic exams and Pap testing, Gand P series HCPCS codes are used (pp. 105 and 117of the Guide). We have scanned the list ofSchedule G of the HCPCS codes and have found noneso far assigned to HIV screening. Until such timeif ever that such codes are established, wesuggest that the the list of CPT codes recommendedfor use in relation to HIV screening, by the AMAand the American Academy of HIV Medicine beaccepted. These are found at the following Web site: http://www.mass.gov/Eeohhs2/docs/dph/aids/ama_aahivm_reimbursement_guide.pdf

Here is a list of the CPT codes from that site,for laboratories and physicians, that should beacceptable in connection with the CMS proposal tocover HIV screening. The lab code for combinedHIV-1 and 2 testing is standard (86702-92).

Test Product:Test productCPT Code Rapid test modifier Description86689 Antibody; HTLV or HIV antibody, confirmatorytest (e.g, Western Blot)86701 92 Antibody; HIV-186702 92 Antibody; HIV-286703 92 Antibody; HIV-1 and HIV-2, single assay87534 Infectious agent detection by nucleic acid(DNA or RNA); HIV-1, direct probe technique87535 Infectious agent detection by nucleic acid(DNA or RNA);HIV-1, amplified probe technique87536 Infectious agent detection by nucleic acid(DNA or RNA);HIV-1, quantification87390 Infectious agent antigen detection by enzymeimmunoassay technique, qualitative orsemi-quantitative, multiple step method;

HIV-1 Test Administration:

CPT Code Description36415 Collection of venous blood by venipuncture

Office Services:OOOffice serviceCPT Code Description99385 Initial comprehensive preventive medicineservice evaluation and management 18–39 years ofage (new patient)99386 Initial comprehensive preventive medicineservice evaluation and management40–64 years ofage (new patient)99395 Periodic comprehensive preventive medicinereevaluation and management18–39 years of age(established patient)99396 Periodic comprehensive preventive medicinereevaluation and management40–64 years of age(established patient)99211-99215 HIV counseling for patients withpositive test results; office or other outpatientvisit for the evaluation and management of anestablished patient

Thank you for considering our testimony. BeyondAIDS will continue to be available to CMS toconsult on the above matters as may be helpful.

Sincerely,
Ronald P. Hattis, MD, MPH
President, Beyond AIDS
Voice: (909) 838-4157
Fax: (888) BEY-AIDS
ronhattis@beyondaids.org

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October 5, 2009

Centers for Medicare and Medicaid Services (CMS)
Attn: William Larson, MA
7500 Security Boulevard
Baltimore, MD 21244

RE: Call for Comments, Proposed Decision for Screening for the Human Immunodeficiency Virus (HIV) Infection (CAG-00409N)

On behalf of Harlem United Community AIDS Center, Inc. (Harlem United), I am writing to express our appreciation for this opportunity to submit comments to the Centers for Medicare and Medicaid Services (CMS) on its Proposed Decision Memo for Screening for Human Immunodeficiency Virus (HIV) Infection. We commend CMS on its recognition that Medicare should provide coverage for HIV screening; extending coverage for individuals at “high risk” of infection, based on the U.S. Preventive Services Taskforce (USPSTF) recommendations. Screening individuals is a significant step toward the goal of eradicating HIV. Moreover, we are pleased that CMS is proposing to expand its coverage policy to include HIV testing for any Medicare beneficiary who requests a test. We have long-advocated that HIV testing should be routine and, as such, coverage should be provided for anyone who requests testing. However, to help expand HIV testing and increase the number of individuals who know their HIV status, we strongly urge CMS to encourage – if not mandate – providers to routinely offer HIV testing and discuss HIV with all of their patients, irrespective of their personal risk profile. We also suggest that HIV testing be offered as part of the Initial Preventive Physical Exam also known as the “Welcome to Medicare Exam.”

Harlem United values working with policymakers to effectively advance legislative, regulatory, and programmatic efforts to support HIV prevention, care, and treatment, thus improving the lives of those living with and at risk for HIV/AIDS. We serve individuals and families living with HIV and AIDS in the greater Harlem and South Bronx neighborhoods of New York City. Touching the lives of more than 6,000 people each year through our programs, Harlem United offers its clients an array of evidence-based, outcome-driven, culturally-sensitive medical and support services, including: primary health care and dental care; mental health and substance abuse counseling; individual psychotherapy and case management; and supportive housing. Our prevention division has a testing department that conducted more than 4,000 HIV screenings in 2008.

With approximately 56,000 new infections each year in the United States, and an estimated 22 percent of infected individuals being unaware of their HIV status, Harlem United maintains that efforts must be intensified to prevent infection, increase awareness of HIV status, and move newly infected individuals swiftly into culturally-sensitive, holistic, and appropriate treatment and prevention services. The nation is at a watershed moment in our ability to eradicate HIV stemming because of two recent, groundbreaking developments. First, there is a growing body of evidence that shows individual HIV treatment can reduce community viral loads and thus reduce HIV incidence. In other words, individuals receiving regular treatment whose viral loads are undetectable are unlikely to transmit the virus. Second, research has found that early treatment is of greatest benefit to individuals with HIV and guidelines should recommend early treatment, perhaps even upon diagnosis.

Together these developments demonstrate a paradigmatic shift in HIV prevention strategies, marking the first time in the history of HIV that there is an overlapping benefit: what is good for the individual – early treatment – is good for the community (reduced community viral loads as a result of treatment successes). Both of these findings illustrate the need for a nationally coordinated and vigorous scale-up of routine HIV testing. While testing and treatment cannot be the nation’s sole prevention strategy, scaled-up testing and universal access to treatment, as early as diagnosis, will contribute to a dramatic reduction in overall HIV infection rates.

We commend the agency for encouraging “physicians to provide annual voluntary HIV screening to Medicare beneficiaries at increased risk for HIV infection or who request an HIV test despite reporting no individual risk factors, as well as to provide voluntary HIV screening to pregnant Medicare beneficiaries.” However, we are concerned that by relying on individuals to request tests too many people will continue to remain unaware of their HIV status. It has been known for some time that new infections have been driven in large part by people who were unaware of their status and unwittingly transmitted the virus. By providing broad coverage of HIV testing – for all individuals who request it and/or who are at risk – and by requiring providers to offer testing to all Medicare beneficiaries – CMS will be eliminating a significant barrier to much-needed routine HIV testing and help increase the number of people who are aware of their HIV status, which will – in turn – help reduce the transmission of HIV. Moreover, we believe that private sector payers and all providers will be more likely to offer and cover HIV testing if the Medicare program leads the way in this regard. Finally, we believe that HIV testing should be offered as part of the “Welcome to Medicare Exam” also known as the Initial Preventive Physical Exam (IPPE). The IPPE covers a one-time preventive physical exam within the first 12 months that you have Medicare Part B. It is essential that testing become part of the battery of routine screenings that take place in the course of a doctor''s visit.

Please know we support CMS’s proposed decision to cover HIV screening, as described in the proposed coverage decision. We, again, encourage you to consider requiring or otherwise encouraging providers to routinely offer HIV testing to all Medicare beneficiaries and including HIV testing in the IPPE.

If we can be a resource to you, or if you require additional information, please do not hesitate to contact Soraya Elcock, Vice President for Policy and Government Relations(esoraya@harlemunited.org or 212/803-2890). Thank you very much for this opportunity to submit comments and we appreciate your consideration of our views and recommendations.

Sincerely,

Patrick J. McGovern
Executive Director

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October 2, 2009

Tamara Syrek Jensen, JD
Acting Director, Coverage and Analysis Group
Center for Medicare & Medicaid Services
7500 Security Boulevard
C1-09-06
Baltimore, MD 21244

Re: CAG-00409N
Proposed Coverage Decision for Screening for HIV Infection

Dear Ms. Syrek Jensen,

I wanted to compliment you and The Center for Medicare and Medicaid Services (CMS) on your efforts to expand national coverage ofHIV screening. I also appreciate the informative in-depth review in the Proposed Decision Memo posted on September 9,2009. This is a critically important issue for HIV prevention and care for the country.

I wanted to share with you some comments from the Division ofmv/AIDS Prevention at the Centers for Disease Control and Prevention (CDC) for consideration in the final coverage determination. In its grade A recommendation for HIV screening of all adolescents and adults at increased risk for HN infection, the US Preventive Services Task Force (USPSTF) specifies in its Recommendation Statement "a person is considered at increased risk (and thus should be offered HIV testing) ifhe or she reports 1 or more individual risk factors or receives health-care in a high-prevalence or high-risk clinical setting." The Proposed Coverage Decision includes the individual risk factors specified by the USPSTF, but omits the important provision related to receipt of health-care in a high-prevalence or high-risk clinical setting.

We strongly encourage CMS to include this criterion as part ofthe coverage determination. As noted in the CMS review, individual risk factors in many Medicare beneficiaries may go unrecognized because only 38% ofmen and 22% ofwomen reported having discussed sex with a physician since reaching 50 years of age. Yet, CDC surveillance data estimate that 24% of all people with HIVIAIDS are ≥50 years old. Authorizing coverage for HIV screening in highprevalence settings would not only help identify a much larger proportion ofadults with unrecognized HIV infection, but also would reflect an integral part of the USPSTF grade A recommendation, thus falling within CMS authority.

As a minor point, the Decision Summary specifies that CMS proposes to cover "screening with an FDA-approVed enzyme immunoassay (EIA) enzyme-linked immunosorbent assay (ELISA) or rapid illY antibody test." We suggest you instead specify "FDA-approved assay" in order to accommodate technical developments. Two automated assays recently approved by the FDA (and used for mv screening in many hospitals) are cbemiluminescent assays, and thus technically would not be included under the current language ofthe proposed determination.

Thank you in advance for your consideration. Please do not hesitate to contact me if further discussion would be useful. I look forward to the final detenninatioD.

Sincerely,

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Screening for HIV is required for both hematopoietic stem cell recipients and donors. Federal Law (section 361 of the Public Health Service Act; regulations described in 21 CFR 1271) requires HIV testing for donor eligibility. Standards of the Foundation for Accreditation of Cellular Therapy(FACT)also requires this testing.

There have been case reports in the solid organ transplant as well as blood transfusion literature regarding transmission of HIV from donor to transplant recipient.

To protect hematopoietic stem cell transplant recipients, the Be The Match Foundation (National Marrow Donor Program)also requires when matching donors to recipients that donors are screened for HIV.

CMS should cover HIV testing testing for both hematopoietic transplant donors and recipients.

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The Centers of Medicare and Medicaid Services (CMS) proposal for screening for the Human includes a list of persons with a defined risk of acquiring or transmitting HIV infection. The Centers for Disease Control and Prevention’s 2006 Revised Recommendations for HIV Testing of Adults, Adolescents and Pregnant Women in Health-Care Settings, states that HIV screening is recommended for patients in all health-care settings after the patient is notified that testing will be performed unless the patient declines (opt-out screening). The objectives of the recommendations are to increase HIV screening of patients, including pregnant women, in health-care settings; foster earlier detection of HIV infection; identify and counsel persons with unrecognized HIV infection and link them to clinical and prevention services; and further reduce perinatal transmission of HIV in the United States.

These revised CDC recommendations advocate routine voluntary HIV screening as a normal part of medical practice, similar to screening for other treatable conditions. Screening is a basic public health tool used to identify unrecognized health conditions so treatment can be offered before symptoms develop and, for communicable diseases, so interventions can be implemented to reduce the likelihood of continued transmission. HIV infection is consistent with all generally accepted criteria that justify screening: 1) HIV infection is a serious health disorder that can be diagnosed before symptoms develop; 2) HIV can be detected by reliable, inexpensive, and noninvasive screening tests; 3) infected patients have years of life to gain if treatment is initiated early, before symptoms develop; and 4) the costs of screening are reasonable in relation to the anticipated benefits. Among pregnant women, screening has proven substantially more effective than risk-based testing for detecting unsuspected maternal HIV infection and preventing perinatal transmission. In our experience as the Texas Department of State Health Services (DSHS), performing HIV testing throughout the state in various prevalence settings, we have seen that in even high prevalence settings that that risk based and/or opt-in testing misses many HIV infected persons. Texas began performing opt out HIV testing within its STD clinics in 2000. Opt-out testing was first initiated after it was observed, on the basis of blinded prevalence surveys, that nearly half of the HIV-positive patients who visited the clinic were never tested for HIV.If any limitation is placed on payment for HIV screening tests such as meeting at risk criteria or "voluntarily" requesting testing, the payment for screening and subsequently screening programs may be limited. In addition, health care professionals may not be able assess a patient’s risk and therefore may not perform an HIV test due to time constraints and/or an inhibition or skill in asking about a patient’s risk for HIV infection. Infections will be missed, along with an opportunity to effectively intervene in further disease transmission and the opportunity to successfully link patients into care and achieve positive health outcomes.

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I am writing on behalf of Merck and Co., Inc. to support Medicare coverage for HIV screening among Medicare beneficiaries.

COVERAGE FOR RISK-BASED HIV SCREENING REPRESENTS AN IMPORTANT STEP IN HELPING TO IDENTIFY MEDICARE BENEFICIARIES WITH HIV INFECTION. Persons remain at risk for HIV throughout their entire lives, and the number of HIV infected older adults is growing. In 2006, 10% (5,800) of newly diagnosed HIV cases in the U.S. were in persons age 50 or greater, and the number of seniors citizens living with HIV/AIDS grew by more than 15% each year from 2004 to 2007 in the 34 states and 5 dependent areas with confidential name-based HIV infection reporting.(1) Coverage for risk-based HIV screening will ensure that Medicare beneficiaries that are recognized to be at risk for HIV infection will have the opportunity to be diagnosed and treated in a timely fashion.

AS ADDITIONAL DATA, ANALYSES AND UPDATED USPSTF RECOMMENDATIONS BECOME AVAILABLE, WE ENCOURAGE CMS TO EVALUATE EXPANDING COVERAGE FROM RISK-BASED TO ROUTINE HIV SCREENING OF MEDICARE BENEFICIARIES.The CDC estimates that, nationwide, one quarter of HIV-infected individuals are unaware of their infection, leading to half of all new infections.(2,3) , Because risk-based screening does not identify a substantial portion of people with HIV early in disease, the American College of Physicians, the HIV Medicine Association(4) and the CDC(5) recommend routine as opposed to risk-based HIV screening of all adolescents and adults. Routine screening would ensure that more people with HIV infection are diagnosed earlier so that they can obtain life-saving care and are less likely to further spread the disease.(6)

We recognize that the current CMS proposed decision is bound by statutory considerations. Specifically, Medicare may only pay for additional preventive services if the services are "Recommended with a grade of A or B by the United States Preventive Services Task Force." In its guidance on HIV screening, the USPSTF makes no recommendation for or against routine screening for HIV in adolescents or adults, assigning it a grade "C" recommendation.(7) This is in contrast to the grade "A" recommendation that the USPSTF assigns to risk-based HIV screening. The USPSTF risk-based HIV screening recommendations are considered a conservative approach(8) by the HIV Medicine Association of the Infectious Diseases Society of America and the American College of Physicians who believe that routine HIV testing in Medicare is a better approach. We encourage CMS to continue to monitor and assess the accumulating medical evidence and cost-effectiveness information available regarding the benefits of routine HIV screening, as well as the recommendations of the USPSTF in this area.

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September 30, 2009

Centers for Medicare and Medicaid Services (CMS)
7500 Security Boulevard
Baltimore, MD 21244
Attn: William Larson, MA
william.larson@cms.hhs.gov

RE: Proposed Decision Memo for Screening for the Human Immunodeficiency Virus (HIV) Infection (CAG-00409N)

Dear Mr. Larson:

I am writing on behalf of the HIV Medicine Association (HIVMA) to offer our strong support for Medicare coverage of HIV screening. We commend the Centers for Medicare and Medicaid Services (CMS) for issuing a proposed decision memo supporting coverage of such screening for certain individuals, and urge you to finalize this determination without delay.

The HIVMA represents more than 3,600 HIV medical providers and researchers that are working on the frontlines of the HIV epidemic in communities across the country. In previous (April 10, 2009) comments, we strongly supported CMS' initiation of national coverage analysis in this area. At that time, we emphasized our strong support for the Centers for Disease Control and Prevention's (CDC) 2006 Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings.ⁱ We also referenced the clinical guidelines jointly developed by the HIVMA and the American College of Physicians (ACP) that call for clinicians to adopt routine screening for HIV.ⁱⁱ We are pleased to see those guidelines referenced in your September 9, 2009 proposed decision memo.

As echoed in our previous comments, HIV treatment is one of the most effective medical interventions available today and yet too few people in the U.S. are able to fully benefit from it. One in five people with HIV in the U.S. are not aware of their diagnosis. Thirty-six percent of people with HIV in the U.S. progress to AIDS within one year of diagnosis. Nearly fifty percent of people living with HIV lack reliable access to care. Routine voluntary HIV testing in clinical settings, including emergency rooms, is critical to identifying people with HIV earlier so that they can be linked to lifesaving care and take precautions to prevent further spread of the disease.

Such screening is highly appropriate for the Medicare population, since people age 50 and older make up 15% of new HIV cases according to the CDC. Many older adults discount their potential risk for HIV or other STDs, and physicians do not routinely address sexual health issues with their older patients, who sometimes have limited knowledge about HIV. HIV screening for Medicare patients will not only raise awareness of HIV in older persons, but it will also find new infections in people who thought they were not at risk for HIV.

We understand that CMS' present coverage proposal for HIV screening is limited to the current U.S. Preventive Services Task Force (USPSTF) grade 'A' recommendation which applies only to certain defined populations deemed to be at 'high risk' for contracting HIV. We appreciate this positive step, but strongly encourage CMS to re-consider expanded national coverage analysis of routine HIV testing for all Medicare patients on an opt-out basis, as recommended by the CDC, ACP and HIVMA and supported by more than 10 other medical organizations. In doing so, CMS will help us realize significant progress in bringing medical practice in line with the latest scientific findings, not yet fully reflected in the USPTF recommendation.

As documented in CMS' own analysis, numerous studies have demonstrated the cost effectiveness of routine HIV testing using standard measures such as quality of life years (QALY) gained and in terms of a reduction in HIV transmission rates in areas with prevalence rates as low as .2%.^{iii iv v} Other studies have documented failures in diagnosing individuals with HIV in regular contact with the medical care system indicating the need for HIV testing to be a routine component of medical care. In an examination of South Carolina health department data, people with HIV that were diagnosed late had a median of four medical visits prior to their diagnosis.^vi Medicare coverage of HIV testing ¨C especially if expanded to include routine screenings in all healthcare settings for all Medicare patients ¨C will foster the earlier detection of HIV infection, help healthcare workers identify and counsel persons with previously unrecognized HIV infection and link them to clinical and prevention services, and further reduce transmission of HIV in the United States. Early detection is fundamental to linking people with HIV to care earlier and to decreasing the incidence and prevalence of HIV infection in the U.S. We would add that a significant barrier to implementing routine HIV testing, which has been recommended by the CDC since 2006, has been the absence of funding and reimbursement systems to support testing performed as a screening tool. The delay in medical practice keeping pace with the science in this area is costly to the more than 230,000 individuals that remain undiagnosed and to the health care system. It is 2.6 times more expensive per year to treat individuals at the later stages of the disease.^vii

On behalf of our clinician members working on the frontlines of the HIV epidemic, I urge CMS to move forward quickly with finalizing a national coverage decision in favor of HIV testing and consider expanding the analysis to include coverage for routine HIV testing under Medicare. We would be pleased to meet with you to discuss this issue further. Please do not hesitate to contact me through the HIVMA executive director Andrea Weddle to arrange a meeting or to discuss this issue in more detail. She can be reached at (703) 299-0915 or aweddle@hivma.org.

Sincerely,

Arlene Bardeguez, MD, MPH
Chair, HIV Medicine Association Board of Directors

CITATIONS:
i Centers for Disease Control and Prevention. 2006. Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings. Available online http://www.cdc.gov/hiv/topics/testing/guideline.htm. Accessed April 9, 2009.
ii Qaseem, A, et al. Screening for HIV in Health Care Settings: A Guidance Statement from the American College of Physicians and the HIV Medicine Association. Ann Intern Med. 2009;150:125-131.
iii Paltiel AD, et al. Expanded HIV screening in the United States effect on clinical outcomes, HIV transmission, and costs. Ann Intern Med. 2006;145:797-806.
iv Walensky, RP, et l. Cost-effectiveness of HIV testing and treatment in the United States. Clin Inf Dis 45(s4):S248-S254, 2007.
v Sanders GD, Bayoumi AM, Holodniy M, Owens DK. Cost-effectiveness of HIV screening in patients older than 55 years of age. Ann Intern Med. 2008;148:889-903.
viCDC. Missed opportunities for earlier diagnosis of HIV infection ¨C South Carolina, 1997-2005. MMWR. Dec 2006. 55(47);1269-1272.
vii Chen RY, et al.. Distribution of health care expenditures for HIV-infected patients. Clin Inf Dis 42:1003-1010, 2006

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The Massachusetts Department of Public Health Bureau of Infectious Disease Office of HIV/AIDS supports CMS covering the cost of HIV screening for eligible members. Coverage for screening will increase the number of people who know their HIV status, facilitate access to care earlier in the course of infection, and decrease the number of new infections. Although the U.S. Preventive Services Task Force (USPSTF) falls short of recommending comprehensive routine HIV screening (screening of all individuals regardless of risk) routine HIV screening for individuals at increased risk provides the foundation for universal screening and should be made accessible through government sponsored health care coverage.

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As an emergency physician, I strongly support CMS reimbursement for HIV testing of Medicare and Medicaid patients. Medicaid patients especially are a vulnerable population group with decreased access to medical care in the inner cities. Having performed bedside HIV testing in our inner city emergency department over the past year, we have identified many HIV positive patients who did not know they were positive prior to testing. Many were early in the course of their HIV disease. Identifying HIV early has undoubtedly prevented further spread by these individuals and has allowed patients testing positive access to more aggressive medical care/education to treat/manage their HIV. Preventative medicine is a valuable service to all patients and saves the health care system money in the long run allowing resources to be spread further. Testing for HIV is a great/smart preventative service to offer Medicare and Medicaid patients. Other insurers often follow in CMS''s footsteps on matters like these. Please support reimbursement for HIV testing so we as clinicians can bring this service to the patients we see. If widespread testing can be done in Africa, we can and should definitely do it here in the U.S. Without reimbursement for the testing though testing will not be done.

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It is unduly restrictive to limit the definition to "HIV screening with an FDA-approved enzyme immunoassay (EIA), enzyme-linked immunosorbent assay (ELISA) or rapid HIV antibody test" when the definition should be expanded to include other licensed methodologies such as Chemiluminescence Immunoassay (ChIA) which are enzyme based however with more sensititive detection endpoints than colorimetric ELISAs/EIAs. The generally accepted definition of rapid is less than 60 minutes as well, which would also include more methodologies available to institutions and reduce confusion over literal interpretations of the policy.

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