Attn: CLIA Providers
CMS Rescinds September 26, 2022 memo: CMS 22-25-CLIA
CMS issued CMS-22-25-CLIA on September 26, 2022 which rescinded the December 7, 2020 guidance regarding the enforcement discretion under CLIA for the use of tests for SARS-CoV-2 on asymptomatic individuals outside of the test’s authorization when an Emergency Use Authorization has been granted by the FDA.
Effective October 7, 2022, CMS rescinded CMS-22-25-CLIA memo. However, the Updated CLIA POC Enforcement Discretion guidance dated October 7, 2022 remains in effect. As a result, CMS will allow enforcement discretion for Certificate of Waiver labs to perform SARS-CoV-2 molecular and antigen Point of Care (POC) tests on asymptomatic individuals outside of the test’s authorization for the duration of the COVID-19 public health emergency.
In addition, CMS indicates that they will not cite nonwaived facilities when modified authorized, cleared, or approved SARS-CoV-2 molecular or antigen POC tests are performed in such manner without establishing performance specifications.
All CLIA certified laboratories are required to follow the manufacturer’s instructions for use with regards to the intended use for SARS-CoV-2.
Questions
For questions or concerns relating to this memorandum, please contact LabExcellence@cms.hhs.gov.
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