October 9, 2009 - ASM Comments on CMS Proposed Decision Memo for Screening for the Human Immunodeficiency Virus (HIV) Infection

Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

To Whom It May Concern:

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.


Vickie S. Baselski, Ph.D., Chair, Committee on Professional Affairs
Susan E. Sharp, Ph.D., Chair, Committee on Laboratory Practices