REGULATORY UPDATE: CLIA Final Rule Increases Certain Fees, Addresses Personnel Qualifications

The Centers for Medicare and Medicaid Services and Centers for Disease Control and Prevention issued a final rule on Dec. 28 that updates CLIA fees, histocompatibility and personnel requirements, and alternative sanctions for Certificate of Waiver laboratories. The provisions, with some exceptions, will take effect Jan. 27.

Updates to CLIA Fees

In the rule, CMS finalized its proposal to implement a process for sustainable funding for the CLIA program. The final rule includes the following adjustments:

• New authorized fees to cover administrative costs for various survey-related activities, such as follow-up surveys, specialties surveys, complaint surveys, desk reviews and certificate replacements.
• An 18% overall increase in existing fees to enhance program stability.
• A $25 increase in the Certificate of Waiver laboratories certificate fee to meet obligations to the Food and Drug Administration in determining test categorization.
• A plan for biennial fee increases that factor in consumer price index adjustments and potential additional across-the-board increments.

Histocompatibility and Personnel Requirements

CMS finalized its proposal to amend histocompatibility and personnel regulations under CLIA to address obsolete regulations and update the regulations to incorporate recent changes in technology. However, the final rule included several notable modifications:

• CMS removed the proposed inclusion of a nursing degree as a qualification for high complexity testing personnel. AABB submitted comments to CMS in August 2022 strongly opposing this proposal.
• CMS clarified that individuals meeting the doctoral degree criteria must possess an earned doctoral degree.
• CMS updated the final rule's text on personnel to better mirror the agency’s intentions from the proposed rule, involving technical adjustments, reformatting citations and revising cross-references.

Of particular interest to the blood and biotherapies community, the agency finalized its AABB-supported proposal to revise the language under 42 CFR 493.1463(b)(4) to clarify that the director or technical supervisor may delegate to the general supervisor “evaluating and documenting the competency of all testing personnel.” This delegation includes both the semi-annual and annual competency assessment and allows general supervisors in laboratories that perform both moderate and high complexity testing to perform competency assessment on both moderate and high complexity testing personnel.

Alternative Sanctions for Certificate of Waiver Laboratories

The final rule updates alternative sanctions that include civil money penalties, a directed plan of correction, a portion of a plan of correction, and on-site state monitoring, allowing for these sanctions to be applied to Certificate of Waiver laboratories. Section III.C. of the final rule describes these provisions in detail.

Those with questions related to the final rule may contact LabExcellence@cms.hhs.gov.