Laboratory Question for the Week of March 21, 2016

Laboratory Compliance Question of the Week

Question:

Can you provide the requirements for Medicare coverage of HPV testing?

Answer:

In July 2015, the Centers for Medicare & Medicaid Services (CMS) added this screening test as an additional preventive service benefit for asymptomatic beneficiaries aged 30 to 65 years in conjunction with the Pap smear test. It will be covered once every five years. The effective date of the coverage is for claims with dates of service on or after July 9, 2015.

To be covered, the provider must use the appropriate U.S. Food and Drug Administration (FDA) approved laboratory tests, and the tests must be used according to the FDA-approved labeling

as well as be in compliance with the Clinical Laboratory Improvement Act (CLIA) regulations.

The memo related to the national coverage determination can be found at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R189NCD.pdf

Disclaimer: Every reasonable effort was made to ensure the accuracy of this information at the time it was published. However, due to the nature of industry changes over time we cannot guarantee its validity after the year it was published.