The Centers for Medicare & Medicaid Services and Centers for Disease Control and Prevention released a final rule on Dec. 28, 2023, updating the Clinical Laboratory Improvement Amendments of 1988 (CLIA) fees.
The final rule implements a two-part increase of CLIA fees to take place every two years and a “nominal increase” in Certificate of Waiver fees. The rule also incorporates limited/specific laboratory fees, including fees for follow-up surveys, substantiated complaint surveys, and revised certificates, and clarifies the methodology that is used to determine program compliance fees.
Additionally, certain requirements have been revised for the histocompatibility test specialty and personnel qualifications for CLIA laboratories “to address obsolete regulations and update the regulations to incorporate technological changes.” Finally, the rule enables CMS to impose alternative sanctions against Certificate of Waiver laboratories.
Most regulatory provisions in the final rule are effective Jan. 27, 2024. Other specified provisions are effective Dec. 28, 2024.