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HHS/CMS | RIN: 0938-AT47 | Publication ID: Spring 2024 |
Title: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories (CMS-3326) | |
Abstract:
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. |
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Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Completed Actions |
Major: No | Unfunded Mandates: No |
CFR Citation: 42 CFR 493 | |
Legal Authority: 42 U.S.C. 263a 42 U.S.C. 1302 42 U.S.C. 1395x(e) |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: Federal |
Federalism: No | |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Related Agencies: Joint: HHS/CDC; | |
Agency Contact: Cameron Ingram Special Assistant Department of Health and Human Services Centers for Medicare & Medicaid Services Center for Clinical Standards and Quality, MS: C2-22-13, 7500 Security Boulevard, Baltimore, MD 21244 Phone:202 690-5443 Email: cameron.ingram@cms.hhs.gov |