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HHS/CMS | RIN: 0938-AT55 | Publication ID: Fall 2022 |
Title: Proficiency Testing Regulations Related to Analytes and Acceptable Performance (CMS-3355) | |
Abstract:
This final rule responds to comments received on the proposal to update proficiency testing (PT) regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to address current analytes (that is, substances or constituents for which the laboratory conducts testing) and newer technologies. This rule may also make additional technical changes to PT referral regulations to more closely align them with the CLIA statute. |
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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 |
Legal Deadline:
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Overall Description of Deadline: MMA section 902 requires Medicare final rules publish within 3 years of a proposed or interim final rule. A notice may publish in the Federal Register before the 3-year deadline extending the timeline by 1-year. We do not intend to delay publishing the final regulation if we are able to publish it sooner. |
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Small Entities Affected: No | Federalism: No |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
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 |