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San Diego County Ryan White CARE Act Program for Resistance Testing


written by Michelle E. Roland, M.D.
published on HIVresistanceWeb: May 1, 2000

As more clinical trials are completed (see "Therapeutic Decision Making Based on Antiretroviral Drug Resistance Testing: Are We There Yet?") and revised national Guidelines become clearer in their recommendations for the use of resistance testing in guiding antiretroviral therapy choices (see "HIV Drug Resistance Testing Policy, Reimbursement and Education Updates: February 2000"), clinics, public health departments and public and private insurers are developing policies and programs to guide the provision of these tests. The San Diego Office of AIDS Coordination was one of the first to develop such a program in cooperation with community providers to maximize the number of tests available to people living with HIV/AIDS in San Diego County.

Consultation Services
Consultation services are provided by the AIDS Education and Training Center (AETC), a federally funded program whose main objective is to provide Ryan White medical providers with HIV/AIDS clinical training, continuing education and professional support/consultation. The Consult Team includes 4 pharmacists and 2 physicians experienced in antiretroviral management. Consultation is based on review of the patient's prior antiretroviral therapy, current treatment regimens, most recent viral load/CD4 and resistance assay results. The consultation, available by telephone, is recommended by the San Diego HIV Planning Council to assist providers in making optimal treatment decisions. The decision about treatment regimen choices is the provider's; there is no obligation to follow the AETC recommendations.

Eligibility
Initially, only phenotypic assays were available, but genotypic tests are now being incorporated into the program. There is a current limit of one test per year due to limited funding. A summary of the current guidelines, approved by the San Diego HIV Health Services Planning Council on December 15, 1999, follows:

  1. Viral load must be confirmed <5,000 copies/mL (PCR), or 2,500 copies/mL (b-DNA).
  2. Patient must be on a stable antiretroviral regimen for at least one month prior to resistance testing.
  3. Patient must be potentially able to tolerate at least two antiretroviral medications he/she is not currently taking.
  4. Patient must have a demonstrated history of treatment adherence.
The following baseline data are collected on the order form:
  • Most recent CD4 count and viral load (PCR or bDNA) with their respective test dates.
  • Ethnicity, home geographic region of the county, risk status and case management status.
  • Current antiretroviral regimen in the first column (1), any previously taken antiretrovirals (2), and proposed regimen in the third column (3). Include medications that were used for seven days.
  • Date the patient's current regimen was started.
Follow-up data are also requested, including:
  • CD4 and viral load tests between four and eight weeks after the patient has begun his or her new regimen.
  • New regimen and the date the patient started the regimen.
  • If a consult was obtained, indicate if their recommendations were used.

Maximizing Resources
The program requires participating clinics to seek prior authorization or the county will bill them for the full cost of the test. Resistance test providers have sometimes been able to secure payments through combinations of CPT codes, and Medicare and some state Medicaid programs will pay for testing in certain circumstances, but third-party reimbursement is still sporadic at best. Some insurers now have policies providing coverage (e.g. Aetna) and others are developing such policies now (see "HIV Drug Resistance Testing Policy, Reimbursement and Education Updates: February 2000"). If the patient has private insurance, the provider is asked to document their medical need for testing in as much detail as possible and approach their insurer before contacting this program. If denied, they are asked to check the appropriate box on the Ryan White CARE Act / HIV Resistance Testing Program Request form and attach any Explanations of Benefits or other denial forms.

For questions about this program, call Terry Lew, San Diego Office of AIDS Coordination, at (619) 515-6931 or log onto their Web site at http://www.sdaidsinfo.org.



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