November 30, 2022

Volume XII, Number 334

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EFFECTIVE IMMEDIATELY: CMS No Longer Allowing Labs to Perform COVID Tests Outside of the Test’s Authorization

Effective September 26, 2022, CMS rescinded its December 7, 2020, enforcement discretion for the Use of COVID-19 tests on asymptomatic individuals outside the test’s instructions for use. In a memo of the same date, CMS immediately rescinded its previous statement regarding this enforcement discretion but stated that labs will have 30 days, or until October 26, 2022, to come into compliance. Specifically, CMS will:

  • no longer allow Certificate of Waiver Labs to perform SARS-CoV-2 molecular and antigen Point of Care tests on asymptomatic individuals outside of the test’s authorizations;

  • no longer allow non-waived labs to perform SARS-CoV-2 molecular and antigen tests on asymptomatic individuals outside of the test’s authorizations without establishing performance specifications;

  • require all CLIA certified labs to follow manufacturer instructions for use for SARS-CoV-2; and

  • require labs to establish performance specifications as required by the CLIA regulations before reporting patient test results.

CMS finds that the original justification supporting the enforcement discretion is not longer compelling due to the widely available home testing.  Accordingly, CMS will begin citing facilities for failure to comply with these requirements.

Copyright ©2022 Nelson Mullins Riley & Scarborough LLPNational Law Review, Volume XII, Number 279
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Courtney G. Tito Partner Nelson Mullins
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