Program Overview & Objectives
Eligibility Requirements
HIV Drug Resistance Assays
Participating Laboratories
Program Overview
The HIV Resistance Testing Program (HRTP) is a collaborative effort between two state Department of Health Services’ programs—the Office of AIDS (OA) and the Viral and Rickettsial Disease Laboratory (VRDL). OA is responsible for the administrative and policy issues and VRDL is responsible for coordinating the contracted laboratories and data collection and review.
Program Objectives
- To provide access to HIV resistance testing services (genotypic or phenotypic) for low income, HIV-infected Californians who do not have other third party coverage for this service.
- To ensure that physicians who are ordering resistance testing under the program have educational and consultative services available to them.
- To collect appropriate data for monitoring the resistance testing program’s utilization, for evaluation, and for use in future studies
- To provide a central specimen repository for program evaluation, quality assurance, and future studies.
The client’s medical provider shall determine the type of resistance test (genotype or phenotype) to be used, the contracted laboratory to perform the test, the number of tests per individual, and the frequency of testing. Because of limited resources and local demand, the Department of Health Services, the Early Intervention Program, or the Local Health Jurisdiction may establish a cap on the number of free tests a client may receive each year under this state program.
The program will utilize a voucher-based program for reimbursement similar to the state’s Viral Load Testing Program. However, since the reimbursement amount varies for the type of resistance test ordered, two types of vouchers will be provided: one for genotypic testing (reimbursed at $400) and the other for phenotypic testing (reimbursed at $750). All vouchers are printed on three-part carbonless paper, are sequentially numbered, and should be kept in a secure location. One major difference between the resistance test program and the viral load test program is that resistance tests will not be performed until the appropriate voucher is completed accurately. Therefore, it is critical for each clinic to ensure that all voucher data elements are completed accurately and in a timely manner in order for the specimen to be processed.
The contractor shall report resistance test results to the ordering clinician within fourteen (14) calendar days after the sample and completed voucher are received in the case of genotypic resistance tests and twenty-one (21) calendar days after the sample and completed voucher are received in the case of phenotypic tests.
Participating Early Intervention Program sites and non-Early Intervention Program sites will submit specimens consisting of two (2) tubes of frozen plasma, containing at least 1 mL each, and a completed and accurate resistance test voucher to any one of the approved contractors. The contractor shall provide all necessary instructions for specimen collection and processing, including provisions for transport to the contractor’s laboratory and subsequent shipment of one frozen plasma sample to the VRDL in Berkeley.
Program Eligibility
To be eligible for this program, a client must:
- Be HIV-infected
- Have no medical insurance/third party coverage for this service
- Not be Medi-Cal eligible
- Have an annual federal adjusted gross income below $50,000
Eligibility is similar to the requirements of the AIDS Drug Assistance Program. However, individuals are not subject to a co-payment or any share-of-cost based on income below $50,000.
Clinic staff must determine client eligibility using the above screening criteria in order for clients to receive free resistance testing services under this program. Staff must document eligibility and conduct annual reviews to determined continued eligibility. It is the client’s responsibility to provide accurate and complete information to establish eligibility and to update clinic staff on any changes in income or third-party payer coverage, which would affect their eligibility.
NOTE: California’s Medi-Cal Program is in the process of providing resistance test reimbursement for all eligible beneficiaries. While the official provider notification bulletin may not be released until December 2000, billing can be retroactive to September 22, 2000.
Clinical Guidelines
Detailed information addressing clinical guidelines for resistance testing will be forwarded shortly under separate cover. Until guidelines are received, questions concerning HIV resistance testing can be directed to the National HIV Telephone Consultation Service (Warmline) as described below.
Education and Consultation Service
The Department of Health Services, Office of AIDS is contracting with the Pacific AIDS Education Training Center to provide clinician education and client specific consultation regarding the use and interpretation of resistance tests and/or clinical problems associated with antiretroviral drug resistance. Comprehensive consultation from an expert panel of highly experienced HIV clinicians will also be available. This service can be accessed via the National HIV Telephone Consultation Service (Warmline). The toll free number is (800) 933-3413 and is available Monday-Friday, 7:30 a.m. to 5:00 p.m. PST.
HIV Drug Resistance Assays
The following assays are covered by the HRTP:
Genotype:
Phenotype:
Participating Laboratories
Contra Costa County Public Health Laboratory
Gladstone-UCSF Laboratory of Clinical Virology
Los Angeles County Public Health Laboratory
Quest Diagnostics, Inc.
Rheumatology Diagnostics Laboratory, Inc.
Specialty Laboratories
Stanford University Medical Center Diagnostic Virology Lab
USC Pathology Reference Laboratory
ViroLogic, Inc.
Return to Test Information Table - Genotypic
Return to Test Information Table - Phenotypic
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