12/08/2020: Lab Advisory: CMS Revises Enforcement Discretion for SARS-CoV-2 Point-of-Care Tests

CDC's Laboratory Outreach Communication System (LOCS)

Audience: Clinical Laboratory Professionals

Level: Laboratory Advisory

On Monday, December 7, 2020, the Centers for Medicare & Medicaid Services (CMS) updated the frequently asked questions (FAQs) to include revised Clinical Laboratory Improvement Amendments (CLIA) enforcement discretion guidance during the COVID-19 public health emergency, for the use of SARS-CoV-2 molecular and antigen tests authorized by the U.S. Food and Drug Administration (FDA) in the following situations:

  • When the POC tests are performed on asymptomatic individuals outside of the test’s Emergency Use Authorization (EUA) based on the recommendations and information provided by FDA
  • When nonwaived facilities modify the point-of-care tests and perform them for asymptomatic individuals without establishing performance specifications

Refer to the updated FAQs for more information.

Online CDC resources:

Register for CDC Health Alert Network (HAN) notifications, including updates about COVID-19. Enter your email address, search for HAN, and sign up.

For questions, please contact us at LOCS@cdc.gov.

Thank you,

The Laboratory Outreach Communication System

Laboratory Outreach Communication System | Division of Laboratory Systems (DLS)

Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)

Centers for Disease Control and Prevention (CDC)