The Centers for Medicare and Medicaid Services (CMS) extended the comment period to September 26th for a proposed rule titled “Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories.” The rule specifically proposes: “CLIA Fee increases (20 percent across the board effective immediately after the final rule is published) to provide sustainable funding for the CLIA program; additional fees for follow-up surveys, substantiated complaint surveys, and revised certificates; a nominal increase in Certificate of Waiver fees to distribute the administrative costs of test complexity determination for waived test systems; an amendment of the histocompatibility and personnel regulations to address obsolete regulations and account for technological advances (per America’s Blood Center’s (ABC) previous comments to CMS in 2018); and amending the provisions governing alternative sanctions (including civil money penalties, a directed plan of correction and onsite monitoring) for Certificate of Waiver laboratories.”
ABC and more than 20 organizations previously signed-on to a letter on August 3rd requesting an extension of the comment period.