10/06/2022

CMS Memo QSO-22-25-CLIA (Asymptomatic COVID Testing)

On September 26, the Centers for Medicare & Medicaid Services (CMS) issued a memo rescinding a directive from 2020 for enforcement discretion related to the use of point of care tests outside of emergency use authorizations (EUA). The rescission means that any providers conducting point of care testing must do so within the parameters of the Food and Drug Administration (FDA) authorization or EUA for that particular test. 

LeadingAge Ohio heard from many providers concerned about their ability to use point of care antigen tests on asymptomatic individuals in situations such as testing due to COVID-19 exposure. This FDA page shows the 31 tests that are currently authorized for use on asymptomatic individuals. Providers should refer to this page and to the manufacturer’s instructions for questions related to authorization for testing asymptomatic individuals.