CMS seeks feedback on aligning CLIA regulations with modern lab practices

In collaboration with the Centers for Disease Control and Prevention (CDC), CMS published a request for information (RFI) on July 16, seeking feedback on potential updates to certain Clinical Laboratory Improvement Amendments (CLIA) regulations. The RFI focuses on four key areas related to lab practices, technologies, and risks.

First, CMS is seeking feedback on the use of clinical breath testing, which rapidly expanded during the COVID-19 pandemic. The agency wants more information on the types of breath tests labs perform, the methodologies and technologies used, the types of facilities performing these tests, and current specimen storage practices.

The agency is also asking the public to comment on several lab processes and procedures, including the following:

• Pathology specimen block retention
• Specimen preparation activities and personnel
• Suboptimal specimens
• Establishment and verification of performance specifications
• Calibration verification
• Post-analytic interpretation and use of artificial intelligence
• Data‑only facilities
• Remote direct observation competency assessment

Additionally, the RFI asks for feedback on whether existing CLIA regulations adequately address emergency preparedness and response. Specifically, CMS is seeking comments on lab continuity planning, biosafety and security practices, and cybersecurity measures.

Lastly, the agency is looking for more information on molecular diagnostics, next-generation sequencing, pharmacogenomics, and other specialized testing areas that have experienced rapid expansion in recent years.

Comments on the RFI are due by September 14, 2026.