Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories
other · Centers for Medicare and Medicaid Services · Rule · Published 2023-12-28 · Effective 2024-01-27 · 88 FR 89976
Document
Document number
2023-28170
Federal Register citation
88 FR 89976
CFR reference
42 CFR 493
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Centers for Medicare and Medicaid Services
Publication date
2023-12-28
Effective date
2024-01-27
HHS docket
CMS-3326-F
Abstract
This final rule updates the Clinical Laboratory Improvement Amendments of 1988 (CLIA) fees and clarifies the CLIA fee regulations. This final rule implements a process for sustainable funding for the CLIA program through a biennial two-part increase of CLIA fees. We are finalizing the incorporation of limited/specific laboratory fees, including fees for follow-up surveys, substantiated complaint surveys, and revised certificates. We are also finalizing the distribution of the administrative overhead costs of test complexity determination for waived tests and test systems with a nominal increase in Certificate of Waiver (CoW) fees. In addition, we are finalizing the clarification of the methodology used to determine program compliance fees. This final rule ensures the continuing quality and safety of laboratory testing for the public. This final rule also amends histocompatibility and personnel regulations under CLIA to address obsolete regulations and update the regulations to incorporate technological changes. In addition, this final rule 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 on CoW laboratories.