CMS’s CLIA Rule Now Fully in Effect

On December 28, 2024, the Centers for Medicare & Medicaid Services’ (CMS) final rule updating the Clinical Laboratory Improvement Amendments regulations went fully into effect. The final rule increased CLIA’s fees, changed provisions concerning alternative sanctions, amended histocompatibility requirements, and (most importantly) adopted new laboratory testing personnel requirements.  

ASCP’s and the ASCP Board of Certification’s (ASCP BOC) diligent lobbying on the rule was instrumental in shaping the final outcome of the rule, as 99 percent of the 20,574 comments received by CMS came from ASCP and its members, credential holders and others. As part of its lobbying campaign, ASCP also rallied the laboratory and medical community to ensure that certain personnel changes, such as those concerning the degree and training requirements for high complexity testing, were adopted in the final rule. ASCP and the ASCP BOC worked with key stakeholders, such as the American Medical Association, American Hospital Association, and American Clinical Laboratory Association to press for essential changes to the proposed rule.  

ASCP and the ASCP BOC urged that the degrees acceptable for high complexity testing should include a solid foundation of the academic sciences critical to laboratory testing. As a result, CMS rescinded its proposal to accept bachelor’s degrees in nursing as qualifying degrees. CMS adopted other ASCP/ASCP BOC recommendations, including: (1) establishing a degree equivalency requirement, (2) eliminating physical science as a recognized degree for high complexity testing, (3) clarifying training and experience requirements, (4) adopting updated degree nomenclature for medical laboratory science, and (5) updating the CLIA high complexity personnel requirements for individuals completing a military laboratory training program. ASCP’s and the ASCP BOC’s lobbying efforts provided a solid victory for quality patient care. 

While much of the final rule went into effect 30 days after the rule’s December 28, 2023, publication, CMS delayed implementation of the histocompatibility and personnel provisions of the final rule to ensure that clinical laboratories and laboratory accreditation organizations had sufficient time to comply with the new requirements. These provisions are now in effect. As a result, the rule’s new degree requirements are in full force. To ensure that its members are aware of the important changes, ASCP provided an analysis of the key policies we urged CMS to adopt. This analysis is available here.