CMS requests your input on possible updates to the CLIA regulations

Sept. 5, 2023
CMS CLIA communications update.

The Centers for Medicare & Medicaid Services are looking for input from interested parties to update the CLIA regulations in histopathology, cytology, and clinical cytogenetics. The Histopathology, Cytology, and Clinical Cytogenetics Regulations under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 Request for Information (RFI) published on July 13, 2023 as part of the CY2024 Physician Fee Schedule proposed rule (CMS-1784-P).

The RFI includes requests for input on topics including:  

  • Whether, and how, CLIA should provide oversight of histopathology slide preparation
  • Individual personnel qualifications required to stain and process pathology slides
  • An acceptable time interval to review of a gross tissue specimen
  • Standards for pathologists to remotely examine histopathology and cytology slides and images
  • Standards for examining clinical cytogenetics images at a remote location apart from the primary CLIA-certified site

To read the RFI visit, beginning on page 904, section P, and submit your comment(s). 

Comments must be received no later than September 11, 2023.