CMS Rescinds enforcement discretion for use of non-FDA approved POC Antigen testsThe Centers for Medicare & Medicaid Services (CMS) released an update to QSO Memo QSO-22-25-CLIA which rescinds enforcement discretion for the use of SARS-CoV-2 tests not FDA approved for use among asymptomatic individuals outside of the test's instructions for use.
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. Thus, in December 2020, CMS released a memo saying it 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 CMS has now rescinded this memo as many POC Ag tests are now approved for both symptomatic patients AND serial screening of asymptomatic patients making the waiver no longer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.
AHCA/NCAL recommends that all LTC providers operating with a CLIA Certificate of Waiver using SARS-CoV-2 POC Ag tests 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 consist?ent 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.
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). The FDA website has a list of all manufacturers with Ag tests where facilities can find the manufacturer's instructions for use. Providers may want to consider purchasing Ag tests that can be used in all situations to avoid inadvertently misusing antigen tests.
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