The Centers for Medicare & Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) issued Final Rulemaking [CMS-3326-F] to update the Clinical Laboratory Improvement Amendments of 1988 (CLIA) fees and clarify the CLIA fee regulations. This rule implements a process for sustainable funding for the CLIA program through a biennial two-part increase of CLIA fees. The CLIA fees incorporate limited/specific laboratory fees, including fees for follow-up surveys, substantiated complaint surveys, and revised certificates. The rule also includes a nominal increase in Certificate of Waiver (CoW) fees for the administrative overhead costs of test complexity determination for waived tests and test systems. In addition, CMS provides clarification of the methodology used to determine program compliance fees.
This final rulemaking also amends the histocompatibility and personnel regulations under CLIA to address obsolete regulations and update the regulations to incorporate technological changes and changes in laboratory practices and amends the provisions governing alternative sanctions (including civil money penalties, a directed plan of correction, a directed portion of a plan of correction, and onsite state monitoring) to allow for the imposition of such sanctions against non-compliant laboratories operating under Certificates of Waiver, rather than being limited only to imposing principal sanctions of revocation, suspension or limitation of a laboratory’s CLIA certificate.
These regulations are effective January 27, 2024, except for instruction 3, amending § 493.2; instructions 14 through 19, amending §§ 493.945, 493.1273, 493.1274, 493.1278, 493.1359, and 493.1405; instruction 20 removing § 493.1406; instructions 21 through 30, amending §§ 493.1407, 493.1411, 493.1417, 493.1423, 493.1443, 493.1445, 493.1449, 493.1451, 493.1455, and 493.1461; instruction 31 removing § 493.1462; and instructions 32 through 36, amending §§ 493.1463, 493.1469, 493.1483, 493.1483, 493.1489, and 493.1491, which are effective December 28, 2024.
The release of the final rulemaking takes into consideration continued improvements in the accuracy and precision of testing since 1992 as well as new and emerging technologies. For these reasons, CMS and CDC have updated the CLIA regulations for Fees, Histocompatibility, Personnel, and Alternative Sanctions for CoW Laboratories to ensure patients receive the highest quality of care from CLIA-certified laboratories.
The final rule can be downloaded from the Federal Register at:https://www.federalregister.gov/public-inspection.
