CMS updated QSO-22-25-CLIA rescinding enforcement discretion for the use of SARS-CoV-2 tests which are not FDA-approved for use among asymptomatic individuals outside of the test’s instructions for use.

• Providers operating with a CLIA Certificate of Waiver should check the manufacturer’s instructions for any COVID-19 antigen tests they have on hand and use them consistent with the instructions and FDA approval.

At the start of the pandemic, some but not all of the SARS-CoV-2 Point-of-Care (POC) Antigen (Ag) tests were limited to use on individuals who are symptomatic.

• In December 2020, a CMS memo said the agency would use enforcement discretion to allow providers with CLIA Certificate of Waiver to use these tests outside of the FDA approved manufacturer’s use.
• CMS has now rescinded this memo as many POC Ag tests are now approved for both symptomatic patients and serial screening of asymptomatic patients making the waiver no longer necessary.
• Most Ag tests are currently approved for testing among individuals with symptoms of COVID-19 or serial testing on asymptomatic individuals (e.g., tested twice over three days with at least 24 hours (and no more than 48 hours) between tests).

Action for facilities: LTC providers operating with a CLIA Certificate of Waiver using SARS-CoV-2 POC Ag tests should check the manufacturer’s instructions for the tests they have on hand to ensure they FDA approved for both symptomatic and asymptomatic individuals.

• If not, they must restrict the use of the tests to situations consistent with FDA approval.
• Providers should check the FDA list for allowed uses of existing antigen tests and use them consistent with the FDA and manufacturer’s approval. 
• Providers that violate the manufacturer’s use may be subject to enforcement actions related to the facility’s CLIA Certificate of Waiver.
• Providers may want to consider purchasing Ag tests that can be used in all situations to avoid inadvertently misusing antigen tests.