What’s new: CMS has rescinded QSO-22-25-CLIA, which barred the use of SARS-CoV-2 tests outside of the FDA test’s instructions for use. We wrote about the memo last week.

• AHCA/NCAL strongly advocated that the memo should be rescinded because it limited the use of the BinaxNOW COVID-19 Ag Card being sent by the US Department of Health and Human Services (HHS) to symptomatic individuals.

What it means: Long term care providers can continue to use the BinaxNOW COVID-19 Ag Card being sent by HHS 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.
• 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.