On Dec. 28, 2023, the Centers for Medicare and Medicaid Services (CMS) released a final rule that updates Clinical Laboratory Improvement Amendments of 1988 (CLIA) fees and clarifies CLIA regulations. CLIA regulates approximately 320,000 laboratory entities, ranging from small physician office labs to large hospital-based and independent labs.

CMS’ final rule authorizes new fees to cover administrative costs for various surveys, including follow-up, specialties, and complaint surveys in addition to desk reviews and certificate replacements. It also increases existing fees by 18% and raises the cost of the Certificate of Waiver laboratories certificate fee by $25.

The final rule also makes changes to CLIA histocompatibility and personnel requirements. Notably, the rule removes the proposed inclusion of a nursing degree as a qualification for high complexity testing personnel. The American Hospital Association and the College of American Pathologists argued that nurse training does not provide adequate knowledge and skills needed to interpret complex test results.

However, the rule does permit a proposal to allow individuals with a Doctor of Clinical Laboratory Science (DCLS) degree to qualify for high complexity laboratory director positions. The College of American Pathologists (CAP) had supported CMS’ effort to clarify doctorate-level degrees within CLIA, but CAP strongly opposed including the DCLS degree as a qualifying degree under CLIA to direct laboratories. CAP is concerned that this inclusion as a qualifying degree will cause confusion among the public about the distinctions between a clinical pathologist and those with DCLS degrees.

CMS has also amended provisions governing alternative sanctions such as civil money penalties, a directed plan of correction, a directed portion of a plan of correction, and onsite state monitoring. The final rule will allow CMS to impose these sanctions on non-compliant laboratories operating under Certificates of Waiver (CoW). CoW laboratories only perform waived tests, which are simple laboratory examinations that have an insignificant risk of an erroneous result, such as a dipstick pregnancy test.

Much of the rule goes into effect January 27, 2024.