During the PHE, the Centers for Medicare & Medicaid Services did not enforce certain CLIA regulations, provided that laboratories followed the specific parameters outlined in CLIA PHE guidance. CMS also relaxed or changed policies and procedures to provide more flexibility within the CLIA regulations and highlighted flexibilities that already existed.
The exercise of some of these enforcement discretions and broad flexibilities will be terminated by the end of the PHE, as they were intended to address the acute and extraordinary circumstances of a rapidly evolving pandemic and not replace existing requirements.
CMS exercised certain enforcement discretions and flexibilities that, while useful during the initial response to COVID-19, are no longer needed. In determining whether to continue the exercise of these enforcement discretions and flexibilities, CMS considered impacts on the communities we serve, including underserved communities, and the potential barriers and opportunities the exercise of these enforcement discretions and flexibilities created. To ensure the accuracy, reliability, and timeliness of laboratory results, CMS has determined that it will no longer excuse noncompliance with certain CLIA regulatory requirements once the PHE has terminated.
Memorandum Summary:
- CMS only has authority to require reporting of SARS-CoV-2 test results until the end of the Federal PHE declaration. As a result, the CLIA requirement for laboratories to report SARS-CoV-2 test results will expire with the termination of the PHE.
- CMS is clarifying the post-PHE status of the temporary exercise of enforcement discretion and other flexibilities CMS utilized during the COVID-19 PHE.
