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HHS/CMS RIN: 0938-AT55 Publication ID: Spring 2022 
Title: Proficiency Testing Regulations Related to Analytes and Acceptable Performance (CMS-3355) 

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.

Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 42 CFR 493   
Legal Authority: 42 U.S.C. 263a   
Legal Deadline:
Action Source Description Date
Final  Statutory  Under MMA sec. 902, 3-year deadline extended for 1 additional year.  02/04/2023 

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.

Action Date FR Cite
NPRM  02/04/2019  84 FR 1536   
NPRM Comment Period End  04/05/2019 
NPRM Comment Period Extended  04/08/2019  84 FR 13857   
NPRM Comment Period Extended End  06/04/2019 
Final Rule Timeline Extension Notice  01/19/2022  87 FR 2736   
Final Action  02/00/2023 
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