On July 26, 2022, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule that includes a proposal to provide sustainable funding for the CLIA program through a biennial two-part increase of CLIA fees. CMS is proposing to increase laboratory fees as follows:
- Assessing and collecting fees when the following activities are performed: follow-up surveys to confirm correction of deficiencies, review and approval of testing when a laboratory adds a new specialty or subspecialty of testing to its services, complaint surveys when the findings are substantiated, desk reviews to ensure successful laboratory proficiency testing; and issuing revised or replacement certificates.
- Proposing a 20% across the board increase to existing fees
- Collecting a one-time $25 certificate fee increase on Certificate of Waiver (CoW) laboratories to recover the cost of the categorizing waived tests (simple tests) by the Food and Drug Administration (FDA) at the termination of the public health emergency
- Proposing a formula to increase user fees every two years to account for inflation as per the Consumer Price Index-Urban (CPI-U), if needed to meet program obligations
The proposed rule also includes removal of specific histocompatibility regulations already covered in the general requirements and laboratory director responsibilities and a decrease in the burden on laboratories for high-complexity and moderate-complexity testing by allowing one individual to fulfill multiple responsibilities while still maintaining the laboratory’s ability to perform accurate and reliable testing.
In addition, the 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 on-site state monitoring) to allow for the imposition of such sanctions on CoW laboratories.
The proposed rule can be viewed at Federal Register :: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories. Comments are due August 25, 2022.