The Centers for Medicare & Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) have prepared a Request for Information (RFI) seeking public comment on revisions to Clinical Laboratory Improvement Amendments (CLIA) regulations as part of the CY 2024 Physician Fee Schedule proposed rule (CMS-1784-P).
The Histopathology, Cytology, and Clinical Cytogenetics Regulations under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 RFI will ask for input on updating histopathology, cytology, and clinical cytogenetics regulations to account for new innovations and technology performed in laboratories while continuing to ensure the safety and quality of patient care. 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 and make public comment(s), visit: https://www.federalregister.gov/public-inspection/2023-14624/medicare-and-medicaid-programs-cy-2024-payment-policies-under-the-physician-fee-schedule-and-other no later than September 11, 2023.
