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MEDICAL POLICY SUBJECT: VIRAL LOAD ASSAY OR EFFECTIVE DATE: 07/02/99 POLYMERASE CHAIN REACTION ARCHIVED DATE: 02/28/01 TESTING TO MONITOR EDITED DATE: 11/10/05, 11/16/06, 12/20/07, 11/20/08, PROGRESSION OF HIV 12/17/09, 12/16/10, 12/15/11, 12/20/12, POLICY NUMBER: 2.02.08 12/19/13, 11/20/14, 12/17/15, 11/17/16 PAGE: 1 OF: 2 CATEGORY: Laboratory Tests If a product excludes coverage for a service, it is not covered, and medical policy criteria do not apply. If a commercial product, including an Essential Plan product, covers a specific service, medical policy criteria apply to the benefit. If a Medicare product covers a specific service, and there is no national or local Medicare coverage decision for the service, medical policy criteria apply to the benefit. POLICY STATEMENT: Viral Load Assay is medically appropriate when the use of viral load assay is linked to treatment. The following are examples of clinical use: I. Assess prognoses in HIV-infected individuals, II. Monitor disease progression in HIV-infected individuals III. Initiate antiretroviral therapy in HIV-infected individuals, IV. Change antiretroviral therapy in HIV-infected individuals, or V. Delay antiretroviral therapy in HIV-infected individuals. DESCRIPTION: Viral load assay or polymerase chain reaction is a laboratory test used to monitor the progression of HIV. The polymerase chain reaction can be used not only to detect the presence of viral sequences but also to provide a semiquantitative or a precise evaluation of the number of copies of genome present. The HIV life cycle permits both DNA and RNA to be targeted. It is a rapid and simple quantitative assay for HIV RNA in plasma or sera that should prove valuable in determining the natural history of infection, dissecting viral pathogenesis and monitoring the efficacy of therapeutic intervention. By monitoring the level of virus, physicians are hopeful that they will be able to adjust therapy in a more timely fashion and keep the viral load down at a level where the immune system is still functioning. CODES: Number Description Eligibility for reimbursement is based upon the benefits set forth in the member’s subscriber contract. CODES MAY NOT BE COVERED UNDER ALL CIRCUMSTANCES. PLEASE READ THE POLICY AND GUIDELINES STATEMENTS CAREFULLY. Codes may not be all inclusive as the AMA and CMS code updates may occur more frequently than policy updates. CPT: 86701 Antibody; HIV-1 86702 Antibody; HIV-2 86703 Antibody; HIV-1 and HIV-2, single result 87534 Infectious agent detection by nucleic acid (DNA or RNA); HIV-1, direct probe technique 87535 Infectious agent detection by nucleic acid (DNA or RNA); HIV-1, amplified probe technique, includes reverse transcription when performed 87536 Infectious agent detection by nucleic acid (DNA or RNA); HIV-1, quantification, includes reverse transcription when performed 87537 Infectious agent detection by nucleic acid (DNA or RNA); HIV-2, direct probe technique 87538 Infectious agent detection by nucleic acid (DNA or RNA); HIV-2, amplified probe technique, includes reverse transcription when performed Proprietary Information of Excellus Health Plan, Inc. A nonprofit independent licensee of the BlueCross BlueShield Association. SUBJECT: VIRAL LOAD ASSAY OR POLYMERASE CHAIN REACTION TESTING TO MONITOR PROGRESSION OF HIV POLICY NUMBER: 2.02.08 CATEGORY: Laboratory Tests 87539 EFFECTIVE DATE: 07/02/99 ARCHIVED DATE: 02/28/01 EDITED DATE: 11/10/05, 11/16/06, 12/20/07, 11/20/08, 12/17/09, 12/16/10, 12/15/11, 12/20/12, 12/19/13, 11/20/14, 12/17/15, 11/17/16 PAGE: 2 OF: 2 Infectious agent detection by nucleic acid (DNA or RNA); HIV-2, quantification, includes reverse transcription when performed Copyright © 2016 American Medical Association, Chicago, IL HCPCS: No codes ICD9: 042 Symptomatic acquired immunodeficiency syndrome (AIDS) 079.53 Human immunodeficiency virus, type 2 [HIV-2] 647.60 Other viral diseases complicating pregnancy (including HIV-1 and II) 795.71 Nonspecific serologic evidence of human immunodeficiency virus [HIV] V08 Asymptomatic HIV infection B20 Human immunodeficiency virus (HIV) disease B97.35 Human immunodeficiency virus, type 2 (HIV 2) as the cause of diseases classified elsewhere O98.419 Viral hepatitis complicating pregnancy, unspecified trimester O98.519 Other viral diseases complicating pregnancy, unspecified trimester O98.719 Human immunodeficiency virus (HIV) disease complicating pregnancy, unspecified trimester R75 Inconclusive laboratory evidence of human immunodeficiency virus (HIV) Z21 Asymptomatic human immunodeficiency virus (HIV) infection status ICD10: REFERENCES: BlueCross BlueShield Association. Plasma HIV-1 RNA quantification for HIV-1 infection. Medical Policy Reference Manual #2.01.22. 2009 Jul 09. Holodniy M. Clinical application of reverse transcription-polymerase chain reaction for HIV Infection. Clinics Lab Med 1994 Jun;14(2):335-339. Mascolini M. Can new HIV assays put more science and less art in antiviral prescribing? Jnl Phys Assoc AIDS Care. 1994 Aug:8-16. Mascolini M. Viral load earns experts’ kudos at HIV surrogate marker conference. Jnl Phys Assoc AIDS Care 1994 Dec:15-18. Saag MS, et a. HIV viral load markers in clinical practice. Nature Med 1996 Jun;2(6):625-629. Sninsky JJ, et al. The application of quantitative polymerase chain reaction to therapeutic monitoring, AIDS 1993;7:S29S34. KEY WORDS: HIV-1, HIV-2, HIV testing. CMS COVERAGE FOR MEDICARE PRODUCT MEMBERS There is currently a National Coverage Determination (NCD) for Human Immunodeficiency Virus (HIV) Testing (Prognosis Including Monitoring). Please refer to the following NCD website for Medicare Members: https://www.cms.gov/medicare-coverage-database/details/ncddetails.aspx?NCDId=46&ncdver=1&bc=AgAAgAAAAAAA&. Proprietary Information of Excellus Health Plan, Inc.