CMS Issues QSO on Use of POC COVID-19 Test Kits (SNF/AL)

The Centers for Medicare & Medicaid Services issued QSO-22-25-CLIA on September 26, 2022, to share updated guidance on using Point of Care (POC) antigen COVID-19 test kits. The memorandum rescinds the December 7, 2020, guidance regarding the enforcement discretion under CLIA for the use of tests for SARS-CoV-2 on asymptomatic individuals outside of the test’s authorization when an Emergency Use Authorization has been granted by the FDA.

What’s Changed? Effective immediately, CMS is rescinding the enforcement discretion that allowed Certificate of Waiver labs to perform SARS-CoV-2 molecular and antigen POC tests on asymptomatic individuals outside of the test’s authorization. 

The association encourages all members to check the supply of POC antigen test kits on hand to ensure that the manufacturer’s instructions include use for both symptomatic and asymptomatic individuals. If additional kits are needed to maintain a supply for testing asymptomatic individuals, please order more kits from MDHHS.