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National Coverage Determination (NCD)

Human Immunodeficiency Virus (HIV) Testing (Prognosis Including Monitoring)

190.13

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Tracking Information

Publication Number
100-3
Manual Section Number
190.13
Manual Section Title
Human Immunodeficiency Virus (HIV) Testing (Prognosis Including Monitoring)
Version Number
1
Effective Date of this Version
11/25/2002
Ending Effective Date of this Version
Implementation Date
01/01/2003
Implementation QR Modifier Date

Description Information

Benefit Category
Diagnostic Laboratory Tests


Please Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

Item/Service Description

HIV quantification is achieved through the use of a number of different assays which measure the amount of circulating viral RNA.  Assays vary both in methods used to detect viral RNA as well as in ability to detect viral levels at lower limits.  However, all employ some type of nucleic acid amplification technique to enhance sensitivity, and results are expressed as the HIV copy number. 

Quantification assays of HIV plasma RNA are used prognostically to assess relative risk for disease progression and predict time to death, as well as to assess efficacy of antiretroviral therapies over time.

HIV quantification is often performed together with CD4+ T cell counts which provide information on extent of HIV induced immune system damage already incurred.
Indications and Limitations of Coverage

Indications

  1. A plasma HIV RNA baseline level may be medically necessary in any patient with confirmed HIV infection.
  2. Regular periodic measurement of plasma HIV RNA levels may be medically necessary to determine risk for disease progression in an HIV-infected individual and to determine when to initiate or modify antiretroviral treatment regimens.
  3. In clinical situations where the risk of HIV infection is significant and initiation of therapy is anticipated, a baseline HIV quantification may be performed. These situations include:
    1. Persistence of borderline or equivocal serologic reactivity in an at-risk individual.
    2. Signs and symptoms of acute retroviral syndrome characterized by fever, malaise, lymphadenopathy and rash in an at-risk individual.

Limitations

  1. Viral quantification may be appropriate for prognostic use including baseline determination, periodic monitoring, and monitoring of response to therapy.  Use as a diagnostic test method is not indicated.
  2. Measurement of plasma HIV RNA levels should be performed at the time of establishment of an HIV infection diagnosis.  For an accurate baseline, 2 specimens in a 2-week period are appropriate.
  3. For prognosis including anti-retroviral therapy monitoring, regular, periodic measurements are appropriate.  The frequency of viral load testing should be consistent with the most current Centers for Disease Control and Prevention guidelines for use of anti-retroviral agents in adults and adolescents or pediatrics.
  4. Because differences in absolute HIV copy number are known to occur using different assays, plasma HIV RNA levels should be measured by the same analytical method. A change in assay method may necessitate re-establishment of a baseline.
  5. Nucleic acid quantification techniques are representative of rapidly emerging and evolving new technologies. As such, users are advised to remain current on FDA-approval status.

Note: Scroll down for links to the quarterly Covered Code Lists (including narrative).
Cross Reference

Also see the Medicare Claims Processing Manual, Chapter 120, Clinical Laboratory Services Based on Negotiated Rulemaking.
Claims Processing Instructions

Transmittal Information

Transmittal Number
17
Coverage Transmittal Link
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/r17ncd.pdf
Revision History

07/2004 - Published NCD in the NCD Manual without change to narrative contained in PM AB-02-110. Coding guidance now published in Medicare Lab NCD Manual. Effective and Implementation dates NA. (TN 17) (CR 2130)

07/2002 - Implemented NCD. Effective date 11/25/02. Implementation date 1/01/03. (TN AB-02-110) (CR 2130)
Other

Covered Code Lists (including narrative)

April 2024 (PDF) (ICD-10)
January 2024 (PDF) (ICD-10)
October 2023 (PDF) (ICD-10)
July 2023 (PDF) (ICD-10)
April 2023 (PDF) (ICD-10)
January 2023 (PDF) (ICD-10)
October 2022 (PDF) (ICD-10)
July 2022 (PDF) (ICD-10)
April 2022 (PDF) (ICD-10)
January 2022 (PDF) (ICD-10)
October 2021 (PDF) (ICD-10)
July 2021 (PDF) (ICD-10)
April 2021 (PDF) (ICD-10)
January 2021 (PDF) (ICD-10)
October 2020 (PDF) (ICD-10)
July 2020 (PDF) (ICD-10)
April 2020 (PDF) (ICD-10)
January 2020 (PDF) (ICD-10)
October 2019 (PDF) (ICD-10)
July 2019 (PDF) (ICD-10)
April 2019 (PDF) (ICD-10)
January 2019 (PDF) (ICD-10)
October 2018 (PDF) (ICD-10)
July 2018 (PDF) (ICD-10)
April 2018 (PDF) (ICD-10)
January 2018 (ICD-10)
October 2017 (ICD-10)
July 2017 (ICD-10)
April 2017 (ICD-10)
January 2017 (ICD-10)
October 2016 (ICD-10)
January 2016 (ICD-10)
October 2015 (ICD-10, ICD-9)
October 2014 (ICD-10, ICD-9)

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National Coverage Analyses (NCAs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with NCAs, from the National Coverage Analyses database.

Coding Analyses for Labs (CALs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with CALs, from the Coding Analyses for Labs database.

Additional Information

Other Versions
Title Version Effective Between
Human Immunodeficiency Virus (HIV) Testing (Prognosis Including Monitoring) 1 11/25/2002 - N/A You are here
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CPT only copyright 2002-2011 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.
Reasons for Denial
Note: This section has not been negotiated by the Negotiated RuleMaking Committee. It includes CMS’s interpretation of it’s longstanding policies and is included for informational purposes. Tests for screening purposes that are performed in the absense of signs, symptoms, complaints, or personal history of disease or injury are not covered except as explicity authorized by statue. These include exams required by insurance companies, business establishments, government agencies, or other third parties. Tests that are not reasonable and necessary for the diagnosis or treatment of an illness or injury are not covered according to the statue. Failure to provide documentation of the medical necessity of tests may result in denial of claims. The documentation may include notes documenting relevant signs, symptoms, or abnormal findings that substantiate the medical necessity for ordering the tests. In addition, failure to provide independent verification that the test was ordered by the treating physician (or qualified nonphysician practitioner) through documentation in the physician’s office may result in denial. A claim for a test for which there is a national coverage or local medical review policy will be denied as not reasonable and necessary if it is submitted without an ICD-9-CM code or narrative diagnosis listed as covered in the policy unless other medical documentation justifying the necessity is submitted with the claim. If a national or local policy identifies a frequency expectation, a claim for a test that exceeds that expectation may be denied as not reasonable and necessary, unless it is submitted with documentation justifying increased frequency. Tests that are not ordered by a treating physician or other qualified treating nonphysician practitioner acting within the scope of their license and in compliance with Medicare requirements will be denied as not reasonable and necessary. Failure of the laboratory performing the test to have the appropriate Clinical Laboratory Improvement Act of 1988 (CLIA) certificate for the testing performed will result in denial of claims.
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