The Centers for Medicare & Medicare Services (CMS) Center for Clinical Standards and Quality/Quality, Safety & Oversight Group (OSOG) has updated the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Post-Public Health Emergency (PHE) Guidance.
The revisions were released on September 23, 2025. Key updates:
Laboratories are still not required to report COVID-19 testing results once the PHE is declared over.
CMS has defined which enforcement discretions will continue to be exercised post-PHE.
Within six months after September 23, 2025, locations where remote cytology slide reviewing is taking place will need to be formally certified by CLIA. CMS will no longer use enforcement discretion for these locations after six months.
Enforcement discretion regarding i-STAT cTnI test cartridge for moderate complexity tests will no longer be active after March 30, 2026, according to CMS.
