CMS communication for waived Covid testing devices
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Have y'all seen this? It looks like our waived EUA devices won't be able to test asymptomatic patients unless it's allowed in the IFU. Not sure how this will affect our operations at this point, but I wish they had saved this for a later time!
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The Centers for Medicare and Medicaid Services (CMS) has rescinded QSO-22-25-CLIA, which barred the use of SARS-CoV-2 tests outside of the FDA test’s instructions for use. AHCA/NCAL highlighted the memo in a recent blog post.
This means the BinaxNOW COVID-19 Ag Card being sent to long term care providers from the HHS program can continue to be used on both asymptomatic and symptomatic individuals.
Specifically, CMS indicates that for the duration of the public health emergency, it will not cite facilities with a CLIA Certificate of Waiver when authorized SARS-CoV-2 molecular or antigen POC tests are performed on asymptomatic individuals outside of the test’s authorization. In addition, CMS will not cite nonwaived facilities when modified authorized, cleared or approved SARS-CoV-2 molecular or antigen POC tests are performed in such manner without establishing performance specifications.