0938-AT47 202304 Unified Agenda of Federal Regulatory and Deregulatory Actions 0938 Centers for Medicare & Medicaid Services CMS 0900 Department of Health and Human Services HHS Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories (CMS-3326)

This final rule updates histocompatibility and personnel regulations under CLIA to address obsolete regulations and updates regulations to incorporate changes in technology. This rule also makes a change to regulations related to the imposition of alternative sanction for Certificate of Waiver (CoW) laboratories in order to more closely align the regulations with the CLIA statute.  Additionally, this rule updates fees for determination of program compliance and additional fees for laboratories established under CLIA regulations as well as the collection of other fees we are authorized to collect, such as fees for revised certificates, post survey follow-up visits, complaint investigations, and activities related to imposition of sanctions.  

]]> Other Significant Previously Published in The Unified Agenda Final Rule Stage No No 42 CFR 493 42 U.S.C. 263a 42 U.S.C. 1302 42 U.S.C. 1395x(e) No RFI Notice With Comment Period 01/09/2018 83 FR 1004 RFI Comment Period End 03/12/2018 NPRM 07/26/2022 87 FR 44896 NPRM Comment Period End 08/25/2022 NPRM Comment Period Extension Notice 08/29/2022 87 FR 52712 NPRM Comment Period Extension End 09/26/2022 Final Action 12/00/2023 No Federal No No No 0920 Centers for Disease Control and Prevention CDC Joint Jessica Wright Health Insurance Specialist 0938 Centers for Medicare & Medicaid Services CMS 410 786-3838 jessica.wright@cms.hhs.gov Center for Clinical Standards and Quality, MS: C2-21-16, 7500 Security Boulevard, Baltimore MD 21244