2022-15300: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories

Summary

This proposed rule would update the Clinical Laboratory Improvement Amendments of 1988 (CLIA) fees and clarify the CLIA fee regulations. This proposed rule includes a proposal to provide sustainable funding for the CLIA program through a biennial two-part increase of CLIA fees. We are proposing to incorporate limited/specific laboratory fees, including fees for follow-up surveys, substantiated complaint surveys, and revised certificates. We are also proposing to distribute 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 proposing to clarify the methodology used to determine program compliance fees. This proposed rule would ensure the continuing quality and safety of laboratory testing for the public. This proposed rule would also amend histocompatibility and personnel regulations under CLIA to address obsolete regulations and update the regulations to incorporate technological changes. In addition, this proposed rule would amend 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.

The agency’s own summary, as published.

What this changes

Amends 1 part of the Code of Federal Regulations — the standing rules this notice rewrites.

• 42 CFR 493 Laboratory Requirements