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August 26, 2022

CMS Extends Comment Period for CLIA Fees Proposed Rule

By America's Blood Centers

The Centers for Medicare and Medicaid Services (CMS) extended the comment period to September 26th for a proposed rule titled β€œClinical 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.

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      • Strengthening the Cyber Resilience of the Blood Community
      • Reducing Unnecessary Regulatory Burdens
      • Modernizing the Licensure Process
      • Exempt Blood Center LDTs from Diagnostic Regulation Reforms
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      • Expanding the Use of Blood in Ambulances
      • Strengthening the Blood Supply
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