10/7/2022: CMS is rescinding QSO-22-25-CLIA effective immediately. CMS will continue to exercise enforcement discretion under CLIA for the duration of the COVID-19 public health emergency for the use of authorized SARS-CoV-2 molecular and antigen POC tests on asymptomatic individuals outside of the test’s authorization.

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09/29/2022: Per QSO-22-25-CLIA, effective immediately, CMS is rescinding 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. 

Review the memorandum on the CMS site here.