Proposed Rule Would Revise CLIA fees, Update Histocompatibility and Personnel Requirements

The Centers for Medicare and Medicaid Services (CMS) and Centers for Disease Control and Prevention (CDC) issued a proposed rule on Friday that would update CLIA fees, histocompatibility and personnel requirements, and alternative sanctions for Certificate of Waiver (CoW) laboratories. The agency also released an accompanying fact sheet.  

According to CMS, if enacted, the proposed rule would provide sustainable funding for the CLIA program through a biennial increase of CLIA fees. The agency is proposing to incorporate limited/specific fees for laboratories, including fees for follow-up surveys, substantiated complaint surveys and revised certificates. CMS is also proposing to offset the administrative overhead costs of test complexity determination for waived tests with an increase to CoW fees. 

In addition, the proposed rule would also amend histocompatibility and personnel regulations under CLIA to address obsolete regulations and update the regulations to incorporate recent changes in technology.  

With respect to personnel requirements, the proposed rule aims to decrease the burden on laboratories by allowing one individual to fulfill multiple responsibilities while maintaining the laboratory’s ability to perform accurate testing. Additionally, in response to changes in the names of academic degrees since the previous CLIA update, the rule proposes an additional coursework-based mechanism for individuals with nontraditional degrees to meet education requirements. 

The proposed rule would also update 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 CoW laboratories. 

CMS is accepting comments on the proposed rule (CMS-3326-P) until 5 p.m. ET on Aug. 25. AABB is preparing a submission on behalf of the blood and biotherapies community and encourages members to share their feedback by Aug. 10 via email to advocacy@aabb.org.