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National Coverage Determination (NCD)

Serologic Testing for Acquired Immunodeficiency Syndrome (AIDS)

190.9

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Tracking Information

Publication Number
100-3
Manual Section Number
190.9
Manual Section Title
Serologic Testing for Acquired Immunodeficiency Syndrome (AIDS)
Version Number
1
Effective Date of this Version
08/12/1987
Ending Effective Date of this Version
Implementation Date
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

Serologic testing is employed to detect antibodies to the AIDS virus, which is currently identified by the term "human immunodeficiency virus (HIV)." The virus originally was named "human T-cell lymphotropic virus, type III (HTLV-III), a term that remains in common usage.

Antibodies may be detected by a variety of immunoassay techniques, the most common being an enzyme linked immunosorbent assay (ELISA). When an assay is reactive on initial testing, it should be repeated on the same specimen. A more specific test, (Western blot, immunofluorescent assay) is usually performed following repeatedly reactive ELISA results.
Indications and Limitations of Coverage

These tests may be covered when performed to help determine a diagnosis for symptomatic patients. They are not covered when furnished as part of a screening program for asymptomatic persons.

NOTE: Two enzyme-linked immunosorbent assay (ELISA) tests that were conducted on the same specimen must both be positive before Medicare will cover the Western blot test.
Cross Reference
Claims Processing Instructions

Transmittal Information

Transmittal Number
33
Revision History

07/1987 - Provided coverage when needed to help determine a diagnosis for symptomatic patients and coverage when furnished as part of a screening program for asymptomatic people. Effective date 08/12/1987. (TN 17)
Other

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
Serologic Testing for Acquired Immunodeficiency Syndrome (AIDS) 1 08/12/1987 - 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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