The Centers for Medicare and Medicaid Services (CMS) has rescinded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This comes after AHCA/NCAL strongly advocated that this memo should be rescinded as it limited the use of the BinaxNOW COVID-19 Ag Card being sent by the U.S. Department of Health and Human Services (HHS) to symptomatic individuals.
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.