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HHS/CMS | RIN: 0938-AT47 | Publication ID: Fall 2021 |
Title: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Personnel, Histocompatibility, Alternative Sanctions for Certificate of Waiver Laboratories, and Fees (CMS-3326) | |
Abstract:
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. |
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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: Proposed Rule Stage |
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 |
Small Entities Affected: No | Federalism: No |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Related Agencies: Joint: HHS/CDC; | |
Agency Contact: Jessica Wright Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Center for Clinical Standards and Quality, MS: C2-21-16, 7500 Security Boulevard, Baltimore, MD 21244 Phone:410 786-3838 Email: jessica.wright@cms.hhs.gov |