|
Medical Policy: 02.04.11
Original Effective Date: December 2005
Reviewed: August 2011
Revised:
Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Description:
Human Immunodeficiency Virus (HIV) is an RNA virus characterized by a high replication rate throughout all stages of infection. The reverse transcription enzyme required for replication is error prone, resulting in a high rate of mutations, further leading to a multitude of related viruses within the host. It has been estimated that every possible single-point mutation occurs more than 10,000 times per day in infected individuals. Some of these mutations may be innocuous while others may confer resistance to anti-viral drugs.
Current recommendations for initial drug therapy include the use of combination therapy with antivirals with different mechanisms of action designed to reduce the viral load to as low level as possible. This therapeutic principle is based on the concept that cessation of detectable HIV replication decreases the opportunity for accumulation of mutations that may give rise to drug-resistant viral variants. These regimens are referred to as HAART (highly activated antiretroviral therapy). If initial drug therapy fails, as evidenced by rising HIV viral loads, it is likely that the emergent virus is drug-resistant, unless failure is related to drug noncompliance. The treatment option then is salvage therapy, designed using drugs to which the virus likely remains sensitive.
Genotypic assays detect drug resistance mutations that are present in the relevant viral genes. Certain assays sequence the entire reverse transcriptase and protease genes, whereas others use probes to detect selected mutations known to confer drug resistance. Genotypic assays can be performed quickly, and results can be reported in one to two weeks of sample collection.
Phenotypic testing directly tests for drug resistance in the virus isolated from the patient by measuring the virus's ability to grow in different concentrations of antiretroviral drugs. While a more direct measure of drug resistance compared to genotyping, the phenotyping technique is labor intensive and interpretation is technically challenging. Results are typically available in two to three weeks.
There is no definitive prospective data to support the use of phenotypic assays versus genotypic assays in different clinical situations. Additionally, there is insufficient evidence to support the use of combined genotypic and phenotypic testing. No randomized studies have compared combination-directed therapy to either phenotypic or genotypic alone.
 Top
Prior Approval:
Not applicable
Top
Policy:
Phenotypic or genotypic assays may be considered medically necessary for the following:
-
Patients with virologic failure during HAART
-
Patients with suboptimal suppression of viral load following initiation of anti-retroviral therapy
-
Patients with acute (new onset) HIV infection
-
Pregnant patient with HIV
Combined genotypic and phenotypic testing is considered investigational.
Drug susceptibility phenotype prediction using genotypic comparison to known genotypic/phenotypic database is considered investigational.
Top
Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
- 87900 Infectious agent drug susceptibility phenotype prediction using regularly updated genotypic bioinformatics
- 87901 Infectious agent genotype analysis by nucleic acid (DNA or RNA); HIV 1, reverse transcriptase and protease
- 87903 Infectious agent phenotype analysis by nucleic acid (DNA or RNA) with drug resistance tissue culture analysis, HIV 1; first through 10 drugs tested
- 87904 Infectious agent phenotype analysis by nucleic acid (DNA or RNA) with drug resistance tissue culture analysis, HIV 1; each additional drug tested (List separately in addition to code for primary procedure)
Top
Selected References:
- Tural C, Ruiz L, Holtzer C et al. Clinical utility of HIV-1 genotyping and expert advice: the HAVANA trial. AIDS 2002; 16(2):209-18.
- Cohen CJ, Hunt S, Sension M et al. A randomized trial assessing the impact of phenotypic resistance testing on antiretroviral therapy. AIDS 2002; 16(4):579-88.
- Meynard JL, Vray m, Morand-Joubert L et al. Phenotypic or genotypic resistance testing for choosing antiretroviral therapy after treatment failure: a randomized trial. AIDS 2002; 16(5):727-36.
- Parkin N, Chappey C, Maroldo L et al. Phenotypic and genotypic HIV-1 drug resistance assays provide complementary information. J Acquir Immune Defic Syndr 2002; 31(2):128-36.
- Dybul M, Fauci AS, Bartlett JG et al. Guidelines for using antiretroviral agents among HIV-infected adults and adolescents. Ann Intern Med 2002; 137(5 pt 2):381-433.
- U.S. Public Health Service Task Force. Recommendations for use of antiretroviral drugs in pregnant HIV-1 infected women for maternal health and interventions to reduce perinatal HIV-1 transmission in the United States. MMWR Recomm Rep 2002; 51(RR-18):1-38.
- Yeni PG, Hammer SM, Hirsch MS et al. Treatment for adult HIV infection. 2004 Recommendations of the International AIDS Society-USA Panel. JAMA 2004; 292:251-65.
- ECRI. Human Immunodeficiency Virus (HIV) Drug-resistance testing to Guide Choice of Antiretroviral Regimen. Plymouth Meeting (PA): ECRI Health Technology Assessment Information Service; 2004 Jul. (Windows on Medical Technology; No. 111).
- Blue Cross Blue Shield Association. HIV Genotyping and Phenotyping. Medical Policy Reference Manual. 2005.
- Aberg JA, Gallant JE, et al. Primary care guidelines for the management of persons infected with human immunodeficiency virus: recommendations of the HIV Medicine Association of the Infectious Diseases Society of America. Clin Infect Dis 2004 Sep 1;39(5):609-29.
- Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1 infected adults and adolescents. Bethesda (MD): Department of Health and Human Services (DHHS); 2008 Jan 29. 128 p.
Top
Policy History:
Top
Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
practice and are neither employees nor agents of Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.
|
 |
