Mr. Michael Hash
Acting Administrator
Health Care Financing Administration
Hubert Humphrey Building, Room 324-G
200 Independence Avenue, SW
Washington, DC 20201

Dear Mr. Hash:

The American Association for Clinical Chemistry (AACC) and American Society for Microbiology (ASM) recently learned that the Health Care Financing Administration (HCFA) may soon publish a national limitation amount for HIV-1 Viral Load Testing, CPT 87536. We are concerned that the new fee may not accurately reflect the cost of performing this testing, thereby resulting in fewer laboratories providing this critical service.

Until 1996, each stage of HIV-1 Viral Load Testing was paid separately. In 1997, however, HCFA instructed Medicare contractors to "gap-fill" a single code to cover all stages of testing. Since then, the average Medicare payment for HIV viral load testing has declined from $187 in 1996 to $104 in 1999-with wide variations in payment amounts among contractors. Laboratories in Montana get reimbursed $64 for performing such tests whereas testing facilities in Connecticut get $174. Such discrepancies imply that the contractors may have used differing methodologies in determining the viral load testing fee, thereby diminishing the aggregate value of their data.

We are concerned that if HCFA uses these data to set a national limitation amount, which is binding on all Medicare contractors, it will set a payment level too low for many laboratories to cost-effectively provide this testing. We have heard estimates that the new national payment level may be as low as $75, even though the reagents in the test kit needed to provide the service can cost over $75. This simply does not make sense. Therefore, we urge HCFA to carefully review the contractor data, and the validity of the methodologies employed, before making any payment decisions that may jeopardize patients' access to care.

Also, we urge the Agency to consider using the Inherent Reasonableness process, established by the Balanced Budget Act of 1997, to determine the appropriate payment amount for HIV-1 viral load testing. HCFA is currently using this mechanism to set the Pap smear reimbursement rate. We think this process, which brings all parties together to review and discuss payment data, is the best method for resolving this problem.

If we can be of any further assistance to you on this matter, or you have any questions about our comments, please contact Vince Stine, Director, Government Affairs, AACC (202) 835-8721 or Ted Cartwright, Manager, Public Affairs, ASM, at (202) 942-9296.



American Association for Clinical Chemistry
American Society for Microbiology

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