On December 28, 2023, the Centers for Medicare & Medicaid Services published a final rule in the Federal Register that updated CLIA fees and regulations. Specifically, the final rule adjusts laboratory fees to provide sustainable funding for the CLIA program; revises certain requirements for both the histocompatibility test specialty as well as personnel qualifications and responsibilities for CLIA laboratories; and provides additional discretion to CMS by allowing it to impose alternative sanctions against noncompliant Certificate of Waiver laboratories, rather than being limited only to imposing principal sanctions of revocation, suspension, or limitation of a laboratory’s CLIA certificate. Some of the regulatory changes were made effective January 27, 2024, and others will be effective December 28, 2024.
By statute, the CLIA program is funded through user fees assessed on certified laboratories. CMS said the increased fees were necessary as the program will not be self-supporting by the end of FY 2023 without an additional fee increase. CMS says that the one-time 18% across-the-board increase would generate approximately 12.1 million dollars annually while the inflation factor would generate approximately 4.6 million dollars. The updated CLIA user fees are as follows:
1) Imposing an 18% across-the-board increase to existing fees
2) Fees to cover program costs for the following:
- Performing follow-up/validation surveys to determine correction of deficient practices
- Adding a specialties survey fee when necessary to determine compliance of one or more specialties outside a survey cycle
- Performing a substantiated complaint survey
- Performing a desk review of unsuccessful proficiency testing performance
- Issuing a revised or replacement certificate
3) Increasing the certificate fee for Certificate of Waiver laboratories by $25 to offset program obligations to the FDA
4) Increasing fees every two years based on a two-part calculation of the Consumer Price Index-Urban (CPI-U) inflation adjustment, and, if applicable, an additional across the board increase.
Other regulatory updates include CLIA personnel requirements, which will necessitate updates to laboratories’ policies and procedures as follows:
1) Removed the proposed addition of a nursing degree qualification for high-complexity testing personnel
2) Revised the language of the regulations addressing laboratory director qualifications to specify that an individual qualifying under the doctoral degree algorithm must have an earned doctoral degree
3) Require lab directors to be on-site at the each laboratory they direct at least once every 6 months, with at least a 4-month interval between the two on-site visits
4) Revised regulations providing additional educational/qualification options, technical updates, reformatting of regulatory citations, and updating regulatory cross references
The full final rule can be viewed at: https://www.govinfo.gov/content/pkg/FR-2023-12-28/pdf/2023-28170.pdf.
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