Temporary enforcement discretion at work for now for asymptomatic SARS-CoV-2 antigen testing
The US Centers for Medicare and Medicaid Services (CMS) recently provided clarification for clinical laboratories about using SARS-CoV-2 antigen testing to test asymptomatic individuals. The key element in the late August 2020 policy guidance is that “CMS requires facilities with a CLIA Certificate of Waiver to follow the manufacturer’s instructions (Instructions For Use) when performing laboratory testing.”
Typically, emergency use authorizations (EUA) for SARS-CoV-2 antigen tests are only authorized by the US Food and Drug Administration (FDA) for testing specimens from individuals who are suspected of COVID-19 by their healthcare provider. Also referred to in the CMS clarification is FDA guidance for healthcare providers ordering authorized tests outside their authorization (e.g., antigen tests for asymptomatic individuals).
Of note in the CMS guidance, however, is the temporary exercise of enforcement discretion for antigen testing, stated as: “CMS will temporarily exercise enforcement discretion for the duration of the COVID-19 public health emergency under CLIA for the use of SARS-CoV-2 POC antigen tests on asymptomatic individuals. Specifically, CMS will not cite facilities with a CLIA Certificate of Waiver when SARS-CoV-2 POC antigen tests are performed on asymptomatic individuals, as described in the FDA FAQ.”