On December 7, 2020, the Centers for Medicare and Medicaid Services issued a policy to exercise enforcement discretion under CLIA for the use of authorized SARS-CoV-2 molecular or antigen tests on asymptomatic individuals outside of the test’s authorization.
At the time that this flexibility was extended, it maximized the availability of COVID testing to the general public; however, home (self) testing is now widely available.
EFFECTIVE IMMEDIATELY:
All CLIA-certified laboratories are required to follow the manufacturer’s instructions for use regarding the intended use for SARS-CoV-2 testing.
