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- CMS Will Still Allow COVID-19 Tests to be Used Outside Instructions for Use
The Centers for Medicare & Medicaid Services (CMS) has decided to leave in place a policy that allows laboratories to use SARS-CoV-2 tests on asymptomatic patients outside of a test’s instructions for use. The agency is expected to exercise enforcement discretion in this area for the rest of the public health emergency.
On September 26, the CMS initially said it would rescind its policy that allowed laboratories to use tests intended for only patients with symptoms of the coronavirus on asymptomatic individuals. The clinical laboratory could not use the tests on asymptomatic patients unless the clinical laboratory was a high-complexity laboratory and established performance specifications for asymptomatic patients.
However, the CMS reversed this decision on October 7 by stating it rescinded the rescission published September 26. The CMS would 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 point of care tests on asymptomatic individuals outside of the test’s authorization.
For questions related to the CMS’ communication, laboratories are instructed to email LabExcellence@cms.hhs.gov. More information is also available on the CMS CLIA Program website.