CMS SARS-CoV-2 Laboratory Testing Comparison

CMS is committed to taking critical steps to ensure America’s clinical laboratories can respond to the threat of the 2019 Novel Coronavirus (COVID-19) and other respiratory illnesses to ensure patient health and safety. • Laboratories need a Clinical Laboratory Improvement Amendments (CLIA) certificate to perform severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) testing. Under CLIA, laboratories are prohibited from testing human specimens for the purpose of diagnosis, prevention, treatment, or health assessment without a valid CLIA certificate. This also applies to facilities not typically considered to be laboratories that are performing SARS-CoV-2 testing. • This guidance is a part of the Centers for Medicare & Medicaid Services (CMS) effort to clarify: o The types of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) testing and whether the tests are being offered under an Emergency Use A20-Xuthorization (EUA) issued by FDA or as described in FDA’s COVID-19 Test Guidance o The CLIA certifications under which each test can be performed o An explanation of requirements under each testing scenario o Updated information for Medicare beneficiaries on testing services and coverage.