Attn: Clinical Laboratories
CMS Publishes Proposed Rule for Clinical Laboratories
On July 26, 2022, the Centers for Medicare and Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) issued proposed rule, CMS-3326-P, located at: Federal Register: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories. The proposed rule would update the CLIA fees, histocompatibility and personnel requirements, and alternative sanctions for Certificates of Waiver (CoWs) laboratories.
CMS is issuing this proposed rule to update the CLIA fees and clarify the CLIA fee regulations. The rule includes a proposal to provide sustainable funding for the CLIA program through a biennial 2-part increase of CLIA fees. CMS is proposing to incorporate limited specific fees for laboratories, including fees for follow-up surveys, substantiated complaint surveys, and revised certificates.
This proposed rule would also amend histocompatibility and personnel regulations under CLIA to address obsolete regulations and update the regulations to incorporate changes in technology. In addition, this proposed rule would update alternative sanctions that include civil money penalties, a directed plan of correction, a portion of a plan of correction, and onsite state monitoring, allowing for these sanctions to be applied to CoW laboratories.
There will be a 30-day public comment period. You may go to https://www.federalregister.gov/ and search for CMS-3326-P to submit a comment to CMS.
A fact sheet about the CLIA Program is available here.
Questions related to the proposed rule can be sent to LabExcellence@cms.hhs.gov.
|
