CMS has proposed changes to the CLIA regulations. The proposed changes were published in the Federal Register dated July 26, 2022. The open comment period ends at 5pm August 25, 2022.
The proposed changes focus on (1) Changes in Fees (2) personnel qualifications and (3) Alternative sanctions for Certificate of Waiver Laboratories which would allow for the imposition of alternative sanctions for non-compliance all CLIA-certified laboratories. Courtemanche & Associates is sharing both the FACT SHEET developed by CMS and the 47 page Federal Register . Both documents provide guidance on how to submit comments.
Please reach out to the C&A team with further questions or for assistance with your regulatory compliance needs.