On September 23, 1999, the California State Office of AIDS held an ad hoc meeting of HIV clinicians, public health laboratory directors, and advocates to "develop recommendations in the areas of reimbursement, education and research for HIV resistance testing policy and program development in California." Background presentations included descriptions of (1) available funding sources for uninsured populations, (2) the State's viral load testing program for ADAP-eligible patients, (3) the educational programs of the Pacific AIDS Education and Training Centers (AETC), and (4) the relevant clinical data regarding the potential utility of resistance testing in clinical practice.
The group recommended that the State Office of AIDS form working groups to further define and develop the following areas: (1) medical criteria required to order a resistance test, by priority categories, (2) clinician criteria that would result in a requirement for mandatory consultation prior to ordering a test and upon receipt of the results, and a mechanism to provide such consultation, (3) minimal data collection necessary to evaluate the use of resistance tests in this program, and (4) where such testing should occur (e.g., local or central public health labs) and which test(s) should be used.
The patient populations targeted by such a program includes patients without private or public health insurance. It does not include patients who have Medi-Cal. Medi-Cal does not have an explicit policy on payment for these tests, but is currently providing at least partial reimbursement. HRSA (Health Resources and Service Administration) is currently in the process of developing policy regarding the use of Ryan White CARE Act funds for HIV laboratory tests and diagnostics. In general, the draft policy supports payment for such tests when they are "supported by professional panels, associations, or organizations." The current U.S. Department of Health and Human Services Guidelines for the Use of Antiretroviral Agents in HIV-Infected Adults and Adolescents are in the process of being revised and are expected to more strongly support the use of resistance tests in certain clinical circumstances. HRSA policy on the use of CARE funds, and the California State Office of AIDS future policy and programs, are likely to reflect such changes in the Guidelines.
Participants at the California meeting were in general agreement that these tests are likely to prove clinically useful in some circumstances, although there was significant disagreement about what specific patients (given their antiretroviral treatment history) would be most likely to benefit. There was also disagreement about the strength of the currently available data supporting the clinical use of resistance tests. There was general agreement that these tests are often difficult to interpret and that the State Office of AIDS should take a proactive role in developing, or supporting the development of both educational programs and consultative services for clinicians interested in ordering these tests through any State-funded mechanism.
Michael Reyes, MD, MPH, Director of the Pacific AETC stated that he is interested in expanding the National HIV Telephone Consultation Service (800-933-3413) to include a structured program that would offer and track consultations attached to this service, and would take the lead in developing the education and consultation component of this program. The State Office of AIDS has a contract with U.C. Davis for medical consultation, and will ask that group to propose clinical guidelines to determine patient eligibility criteria required to order a resistance test (e.g., first virologic breakthrough, antiretroviral-naive patients with primary HIV infection, extremely antiretroviral experienced, etc.) when state funding becomes available. Other concerns being considered include: (1) the feasibility, and desirability, of having a central public health lab perform all the assays with a single methodology vs having local labs perform assays using a variety of different methodologies, (2) the amount of data collection that should be required to evaluate which clinicians are using the tests and for which patient types, and (3) other administrative issues.
To receive minutes of this meeting, contact Toni Post at (916)-322-5561 or tpost@dhs.ca.gov.
Related HIVresistanceWeb articles:
FDA's CBER Defining Regulatory Requirements for Genotypic Resistance Tests
Clinical Availability and Reimbursement Status of Antiretroviral Drug Resistance Assays
