The CAP and 22 other laboratory health and medical groups urged the Biden Administration to extend the comment period for the recently proposed Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories. The Centers for Medicare & Medicaid Services (CMS) released the proposed 2023 CLIA Fees; Histocompatibility alternative Waived Testing Sanctions regulation, signaling a change in the CLIA fee schedule, including histocompatibility requirements, personnel requirements, and allowing for alternative sanctions for waived testing. The original regulation was slated for only a 30-day comment period from stakeholders like the CAP, unlike the usual 60-day comment period. The group asked the Biden Administration to provide a 60-day comment period to ensure that interested organizations and individuals have a meaningful opportunity to comment as required by law.

In the August 3 letter, the group asked the Biden Administration to provide a 60-day comment period to ensure that all stakeholders have the time to provide comprehensive and quality comments that will impact laboratory regulations. In the letter, the group “recognizes and appreciates 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.”

This proposed rule:

• Outlines numerous increases in funding for the CLIA program, including significant fee increases (20%) for clinical laboratories, follow-up surveys, substantiated complaint surveys, and revised certificates;
• Clarifies the methodology used to determine program compliance fees.
• Amends laboratory personnel and histocompatibility regulations under CLIA; and
• Changes the CLIA requirements pertaining to alternative sanctions (including the imposition of civil money penalties, a directed plan of correction, a directed portion of a plan of correction, and onsite state monitoring) for Certificate of Waiver laboratories.