The College of American Pathologists (CAP) and 22 other laboratory health and medical groups urged the Biden administration to extend the comment period for the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories. The Centers for Medicare & Medicaid Services signaled a change in the CLIA fee schedule when it released the proposed 2023 CLIA Fees; Histocompatibility alternative Waived Testing Sanctions regulation on July 22, 2022.
Instead of the typical 60-day comment period, a 30-day comment period for stakeholders was implemented for the original regulation. To ensure that interested organizations have a sufficient opportunity to comment as required by law, the group requested that the Biden administration offer a 60-day comment period, as stated in an Aug. 3 letter written by CAP and the 22 other laboratory health and medical groups.
In the letter, the groups state that they “recognize and appreciate the goal of swift rulemaking. However, to ensure that these rules can meet the goals of quality patient care without causing unintended consequences, it is imperative that stakeholders be given sufficient time to provide comprehensive, thoughtful, and well-reasoned comments.”
The proposed rule outlines a number of funding increases for the CLIA program, including substantial fee increases (20%) for clinical laboratories, follow-up surveys, surveys of substantiated complaints, and revised certificates. The proposed rule also updates CLIA regulations regarding laboratory personnel and histocompatibility regulations and alters the CLIA requirements for Certificate of Waiver laboratories with regard to alternative sanctions (such as the imposition of civil money penalties, a directed plan of correction, a directed portion of a plan of correction, and on-site state monitoring).