0938-AT47 202110 The Regulatory Plan and the 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) Personnel, Histocompatibility, Alternative Sanctions for Certificate of Waiver Laboratories, and Fees (CMS-3326)

This proposed rule would update histocompatibility and personnel regulations under CLIA to address obsolete regulations and update regulations to incorporate changes in technology. This rule would also make 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 would update 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 Proposed 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 03/00/2022 No 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