Attn: Clinical Laboratory Improvement Amendments (CLIA) Providers
CMS issues QSO-releases QSO-23-15-CLIA – Post-Public Health Emergency Guidance
Background
On May 11, 2023, the Centers for Medicare & Medicaid Services (CMS) issued QSO-23-15-CLIA. CMS has been committed to taking critical steps to ensure America’s clinical laboratories could respond to the threat of COVID-19 to ensure patient health and safety. The intent of the CLIA program is to ensure that laboratory test results provided to individuals and their health care providers are accurate and reliable. During the Public Health Emergency (PHE) posed by COVID-19, there was an urgent need to expand laboratory capacity. In response, CMS exercised enforcement discretion and used other flexibilities to address this critical need.
During the PHE, CMS 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.
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.
Contact
For questions or concerns relating to this memorandum, please contact LabExcellence@cms.hhs.gov.
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