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Clinical Policy Bulletin:
HIV Testing
Number: 0542


Policy

  1. Aetna considers human immunodeficiency virus (HIV) testing medically necessary for screening persons for HIV infection, according to the recommendations of the U.S. Preventive Services Task Force and the Centers for Disease Control and Prevention.

    Aetna considers initial testing for HIV with a DA-approved antigen/antibody combination immunoassay that detects HIV-1 and HIV-2 antibodies and HIV-1 p24 antigen medically necessary to screen for established infection with HIV-1 or HIV-2 and for acute HIV-1 infection. No further testing is required for specimens that are nonreactive on the initial immunoassay.

    Aetna considers further testing of specimens with a reactive antigen/antibody combination immunoassay result (or repeatedly reactive, if repeat testing is recommended by the manufacturer or required by regulatory authorities) medically necessary, if tested with an FDA-approved antibody immunoassay that differentiates HIV-1 antibodies from HIV-2 antibodies. Reactive results on the initial antigen/antibody combination immunoassay and the HIV-1/HIV-2 antibody differentiation immunoassay should be interpreted as positive for HIV-1 antibodies, HIV-2 antibodies, or HIV antibodies, undifferentiated.

    Aetna considers testing of specimens that are reactive on the initial antigen/antibody combination immunoassay and nonreactive or indeterminate on the HIV-1/HIV-2 antibody differentiation immunoassay to be medically necessary when tested with an FDA-approved HIV-1 nucleic acid test (NAT) according to the following criteria:

    • A reactive HIV-1 NAT result and nonreactive HIV-1/HIV-2 antibody differentiation immunoassay result indicates laboratory evidence for acute HIV-1 infection.
    • A reactive HIV-1 NAT result and indeterminate HIV-1/HIV-2 antibody differentiation immunoassay result indicates the presence of HIV-1 infection confirmed by HIV-1 NAT.
    • A negative HIV-1 NAT result and nonreactive or indeterminate HIV-1/HIV-2 antibody differentiation immunoassay result indicates a false-positive result on the initial immunoassay.

    Note: Laboratories should use this same testing algorithm, beginning with an antigen/antibody combination immunoassay, with serum or plasma specimens submitted for testing after a reactive (preliminary positive) result from any rapid HIV test.

  2. Aetna considers the Orasure oral HIV test kit (OraSure Technologies, Bethlehem, PA) medically necessary for the same indications as standard HIV testing.

  3. Aetna considers the OraQuick Rapid HIV-1 Antibody point-of-care test kit (OraSure Technologies, Bethlehem, PA) an adequate alternative to laboratory HIV blood tests for medically necessary indications for HIV testing. 

Note: Aetna does not cover home HIV test kits that do not require a physician's prescription under any plans.  These include:

  • Confide Home HIV Test (Johnson & Johnson)*
  • Home Access At Home HIV Test.

* The Confide Home HIV Test kit was withdrawn from the market in 1997 due to lack of consumer interest.



Background

According to the U.S. Preventive Services Task Force (USPSTF, 2005), human immunodeficiency virus (HIV) testing is indicated in individuals with the following risk factors for HIV infection:

  • Individuals whose past or present sex partners were HIV-infected, bisexual, or injection drug users; or
  • Men and women having unprotected sex with multiple partners; or
  • Men and women who exchange sex for money or drugs or have sex partners who do; or
  • Men who have had sex with men after 1975; or
  • Past or present injection drug users; or
  • Persons being treated for sexually transmitted diseases (STDs); or
  • Persons with a history of blood transfusion between 1978 and 1985.

Persons who request an HIV test despite reporting no individual risk factors may also be considered at increased risk, since this group is likely to include individuals not willing to disclose high-risk behaviors.

The USPSTF (2005) states that there is good evidence of increased yield from routine HIV screening of persons who report no individual risk factors but are seen in high-risk or high-prevalence clinical settings.

High-risk settings include any of the following:

  • Adolescent health clinics with a high prevalence of STDs
  • Clinics serving men who have sex with men
  • Correctional facilities
  • Homeless shelters
  • STD clinics
  • Tuberculosis clinics.

High-prevalence settings are defined by the Centers for Disease Control and Prevention (CDC) as those known to have a 1 % or greater prevalence of infection among the patient population being served.  Where possible, clinicians should consider the prevalence of HIV infection or the risk characteristics of the population they serve in determining an appropriate screening strategy.  Data are currently lacking to guide clinical decisions about the optimal frequency of HIV screening.

The USPSTF (2005) recommended that clinicians screen all pregnant women for HIV.  The USPSTF made no recommendation for or against routinely screening for HIV in adolescents and adults who are not at increased risk for HIV infection.

In 2006, CDC revised its recommendations for HIV screening of patients in all healthcare settings.  Major revisions include a recommendation for routine HIV screening for patients aged 13 to 64 years after the patient is notified that testing will be performed unless the patient declines (opt-out screening).  The CDC recommended that persons at high-risk for HIV infection should be screened for HIV at least annually.

The American College of Physicians (ACP) and HIV Medicine Association developed a guidance statement on screening for HIV in health care settings (Qaseem et al, 2009).  In accordance to the CDC's 2006 recommendation, the ACP/HIV Medicine Association stated that in all health-care settings, screening for HIV infection should be performed routinely for all patients aged 13 to 64 years.  Healthcare providers should initiate screening unless prevalence of undiagnosed HIV infection in their patients has been documented to be less than 0.1 %.  In the absence of existing data for HIV prevalence, healthcare providers should initiate voluntary screening until they establish that the diagnostic yield is less than 1 per 1,000 patients screened, at which point such screening is no longer warranted.

Recommendations for HIV screening in pregnant women were revised to include such screening in the routine panel of prenatal screening tests for all pregnant women (CDC, 2006).  The CDC recommended that HIV screening after the pregnant woman is notified that testing will be performed unless the patient declines (opt-out screening).  The CDC recommended repeat HIV testing in the third trimester for all women at high-risk for HIV, for women in jurisdictions with elevated HIV or AIDS incidence, and for women receiving healthcare in facilities with at least 1 diagnosed HIV case per 1,000 pregnant women per year.

In a Cochrane review, Bateganya et al (2007) discussed home-based HIV voluntary counseling and testing delivery models, which, given the low uptake of facility-based testing models, may be an effective method to get more patients on treatment and prevent new infections in developing countries.  The authors concluded that home-based testing and/or delivery of HIV test results at home, rather than in clinics, appears to lead to higher uptake in testing.  However, given the limited extant literature and the limitations in the included existing studies, there is insufficient evidence to recommend large-scale implementation of the home-based testing model.  

The Orasure oral HIV test kit (OraSure Technologies, Bethlehem, PA) is an HIV test kit that uses oral mucosal transudate for testing rather than blood testing.  The kit is manufactured by SmithKline Beecham Consumer Healthcare and is provided to physicians for use in their office.  This HIV test kit requires physician involvement and is used for the same indications as standard HIV testing.

The OraQuick Rapid HIV-1 Antibody point-of-care test kit (OraSure Technologies, Bethlehem, PA) is a rapid, point-of-care test designed to detect antibodies to HIV-1 in fingerstick whole blood and venipuncture whole blood specimen within approximately 20 mins.  In the clinical studies submitted to the U.S. Food and Drug Administration (FDA) by the manufacturer, OraQuick correctly identified 99.6 % of people who were infected with HIV-1 (sensitivity) and 100 % of people who were not infected with HIV-1 (specificity).  As with all HIV screening tests, a reactive test result needs to be confirmed by an additional, more specific Western blot test.

In a Cochrane review, Bateganya et al (2010) examined the effect of home-based HIV voluntary counselling and testing (VCT) on uptake of HIV testing.  These investigators searched MEDLINE (February 2007), EMBASE (February 2007), CENTRAL (February 2007), AIDSearch (February 2007), LILACS, CINAHL and Sociofile.  They also contacted relevant researchers.  The original review search strategy was updated in 2008.  Randomized controlled trials comparing home-based HIV VCT with other testing models were used for this analysis.  Two review authors independently selected studies, assessed methodological quality, and extracted data.  They planned to conduct statistical analysis using the Review Manager software and calculate summary statistics (relative risks (RRs) with 95 % confidence intervals (CI)) for primary outcomes.  Only 1 study from developing countries met the inclusion criteria and was included in the review.  The study, a cluster randomized trial (10 clusters, n = 849) compared VCT uptake between an optional location (including home-based) and a local clinic location in a population-based HIV survey.  The study showed a higher uptake of VCT among participants in the optional-location group.  Uptake was significantly greater in the optional-location group in those who were pre-test counselled only (RR = 4.6; 95 % CI: 3.58 to 5.91); pre-test counselled and tested (RR = 4.6; 95 % CI: 3.51 to 5.92); and post-test counselled and received the test result (RR = 4.8; 95 % CI: 3.62 to 6.21).  This study, however, had significant methodological problems limiting further analysis and interpretation.  The authors concluded that although home-based HIV VCT has the potential to enhance VCT uptake in developing countries, insufficient data exist to recommend large-scale implementation of home-based HIV testing.  They stated that further studies are needed to determine if home-based VCT is better than facility-based VCT in improving VCT uptake.

The USPSTF released updated recommendations for HIV screening in April, 2013, including two Grade A recommendations. The USPSTF recommends that clinicians screen for HIV infection in adolescents and adults ages 15 to 65 years. Younger adolescents and older adults who are at increased risk should also be screened. The USPSTF also recommends that clinicians screen all pregnant women for HIV, including those who present in labor who are untested and whose HIV status is unknown.

In June, 2014 the CDC updated recommendations for screening for HIV to include an algorithm for a sequence of tests used in combination to improve the accuracy of the laboratory diagnosis of HIV. The recommendations concern testing of serum or plasma specimens. Previous CDC recommendations only employed tests for HIV antibodies, but the updated recommendations also include tests for HIV antigens and HIV nucleic acid. The recommendations have been issued because studies from populations at high risk for HIV demonstrated that antibody testing alone may miss a considerable percentage of HIV infections detectable by virologic tests.  Advantages of these updated recommendations include improved accuracy of laboratory diagnosis of acute HIV-1 infection, equally accurate laboratory diagnosis of established HIV-1 infection, improved accuracy of laboratory diagnosis of HIV-2 infection, a decrease in the number of indeterminate results, and faster turnaround time for most test results (CDC, 2014).

 
CPT Codes / HCPCS Codes / ICD-9 Codes
CPT codes covered if selection criteria are met:
86689
86701
86702
86703
87389
87390
87391
87534
87535
87536
HCPCS codes covered if selection criteria are met:
G0432 Infectious agent antigen detection by enzyme immunoassay (EIA) technique, qualitative or semi-quantitative, multiple-step method, HIV-1 or HIV-2, screening
G0433 Infectious agent antigen detection by enzyme-linked immunosorbent assay (ELISA) technique, antibody, HIV-1 or HIV-2, screening
G0435 Infectious agent antigen detection by rapid antibody test of oral mucosa transudate, HIV-1 or HIV-2, screening
S3645 HIV-1 antibody testing of oral mucosal transudate
ICD-9 codes covered if selection criteria are met:
042 Human immunodeficiency virus [HIV] disease
V01.7 Contact with or exposure to other viral diseases
V08 Asymptomatic human immunodeficiency virus [HIV] infection status
V73.89 Special screening examination for other specified viral diseases


The above policy is based on the following references:
  1. Sy FS, Rhodes SD, Choi ST, et al. The acceptability of oral fluid testing for HIV antibodies. A pilot study in gay bars in a predominantly rural state. Sex Transm Dis. 1998;25(4):211-215.
  2. Granade TC, Phillips SK, Parekh B, et al. Detection of antibodies to human immunodeficiency virus type 1 in oral fluids: A large-scale evaluation of immunoassay performance. Clin Diagn Lab Immunol. 1998;5(2):171-175.
  3. Gallo D, George JR, Fitchen JH, et al. Evaluation of a system using oral mucosal transudate for HIV-1 antibody screening and confirmatory testing. OraSure HIV Clinical Trials Group. JAMA. 1997;277(3):254-258.
  4. Soto-Ramirez LE, Hernandez-Gomez L, Sifuentes-Osornio J, et al. Detection of specific antibodies in gingival crevicular transudate by enzyme-linked immunosorbent assay for diagnosis of human immunodeficiency virus type 1 infection. J Clin Microbiol. 1992;30(11):2780-2783.
  5. Epitope, Inc. OraSure® HIV-1 oral specimen collection device. Product Information. Beaverton, OR: Epitope; 2000. Available at: http://www.orasure.com/orasurehiv1.htm. Accessed March 24, 2000.
  6. Home Access Corp. Home Access -- The leader in FDA approved home HIV. Hoffman Estates, IL: Home Access; 1998-2000. Available at: http://www.homeaccess.com. Accessed March 24, 2000.
  7. Centers for Diseae Control and Prevention. HIV prevention through early detection and treatment of other sexually transmitted diseases -- United States. Recommendations of the Advisory Committee for HIV and STD Prevention. MMWR Recomm Rep.1998;47(RR-12):1-24.
  8. Pugatch DL, Levesque BG, Lally MA, et al. HIV testing among young adults and older adolescents in the setting of acute substance abuse treatment. J Acquir Immune Defic Syndr. 2001;27(2):135-142.
  9. No authors listed. HIV testing among pregnant women--United States and Canada, 1998-2001. MMWR Morb Mortal Wkly Rep. 2002;51(45):1013-1016.
  10. Centers for Disease Control and Prevention (CDC); Health Resources and Services Administration; National Institutes of Health; HIV Medicine Association of the Infectious Diseases Society of America. Incorporating HIV prevention into the medical care of persons living with HIV. Recommendations of CDC, the Health Resources and Services Administration, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. MMWR Recomm Rep. 2003;52(RR-12):1-24.
  11. Mundy L, Merlin T, Bywood P, Parrella A. Uni-Gold (TM) Recombigen (R) HIV test to detect antibodies to HIV-1 in the plasma and whole blood of individuals at risk of HIV infection. Horizon Scanning Prioritising Summary - Volume 4. Adelaide, Australia: Adelaide Health Technology Assessment (AHTA) on behalf of National Horizon Scanning Unit (HealthPACT and MSAC); 2004.
  12. U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER). Frequently asked questions about the OraQuick Rapid HIV-1 Antibody Test. Frequently Asked Questions. Rockville, MD: FDA; updated April 4, 2003. Available at: http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/ucm091996.htm. Accessed September 2, 2004.
  13. U.S. Preventive Services Task Force (USPSTF). Screening for HIV: Recommendation statement. Rockville, MD: Agency for Healthcare Research and Quality (AHRQ); 2005.
  14. Chou R, Smits AK, Huffman LH, et al. Prenatal screening for HIV: A review of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med. 2005;143(1):38-54.
  15. Chou R, Huffman LH, Fu R, et al. Screening for HIV: A review of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med. 2005;143(1):55-73.
  16. Branson BM, Handsfield HH, Lampe MA, et al; Centers for Disease Control and Prevention (CDC). Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. MMWR Recomm Rep. 2006;55(RR-14):1-17.
  17. Bateganya MH, Abdulwadud OA, Kiene SM. Home-based HIV voluntary counseling and testing in developing countries. Cochrane Database Syst Rev. 2007;(4):CD006493.
  18. American Academy of Pediatrics Committee on Pediatric AIDS. HIV testing and prophylaxis to prevent mother-to-child transmission in the United States. Pediatrics. 2008;122(5):1127-1134.
  19. Qaseem A, Snow V, Shekelle P, et al; Clinical Efficacy Assessment Subcommittee, American College of Physicians. Screening for HIV in health care settings: A guidance statement from the American College of Physicians and HIV Medicine Association. Ann Intern Med. 2009;150(2):125-131.
  20. Palfreeman A, Fisher M, Ong E; HIV Testing Guidelines Writing Committee. Testing for HIV: Concise guidance. Clin Med. 2009;9(5):471-476.
  21. Poljak M, Smit E, Ross J. 2008 European Guideline on HIV testing. Int J STD AIDS. 2009;20(2):77-83.
  22. Richard M, Banks R. Point-of-care HIV testing: A review of the clinical and cost-effectiveness and diagnostic accuracy. Health Technology Inquiry Service (HTIS). Ottawa, ON: Canadian Agency for Drugs and Technologies in Health (CADTH); April 8, 2009.
  23. Bateganya M, Abdulwadud OA, Kiene SM. Home-based HIV voluntary counselling and testing (VCT) for improving uptake of HIV testing. Cochrane Database Syst Rev. 2010;(7):CD006493.
  24. Pant Pai N, Sharma J, Shivkumar S, et al. Supervised and unsupervised self-testing for HIV in high- and low-risk populations: A systematic review. PLoS Med. 2013;10(4):e1001414.
  25. U.S. Preventive Services Task Force (USPSTF). Screening for HIV: Recommendation statement. Rockville, MD: Agency for Healthcare Research and Quality (AHRQ); 2013.
  26. Turner SD, Anderson K, Slater M, et al.  Rapid point-of-care HIV testing in youth: A systematic review. J Adolesc Health. 2013;53(6):683-691.
  27. Centers for Disease Control and Prevention and Association of Public Health Laboratories. Laboratory Testing for the Diagnosis of HIV Infection: Updated Recommendations. Available at http://stacks.cdc.gov/view/cdc/23447. Published June 27, 2014. Accessed August 3, 2014.


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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna 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 Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
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