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HHS/CMS RIN: 0938-AU54 Publication ID: 2026 
Title: Amendments to Rules Governing Organ Procurement Organizations (CMS-3409) 
Abstract:

This final rule revises the Conditions for Coverage for Organ Procurement Organizations (OPOs) to clarify outstanding procedural questions and enable OPOs to make better informed decisions to achieve high performance resulting in the successful procurement, distribution, and transplantation of more life-saving organs. 

 
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 
EO 14192 Designation: Other 
CFR Citation: 42 CFR 486   
Legal Authority: 42 U.S.C. 1395hh    42 U.S.C. 1302   
Legal Deadline:
Action Source Description Date
Final  Statutory  MMA sec. 902 requires Medicare final rules publish within 3 years of a proposed or interim final rule.  01/30/2029 

Overall Description of Deadline: Per the CMS notice published December 30, 2004 (69 FR 78442), except for certain Medicare payment regulations and certain other statutorily-mandated regulations, we schedule all Medicare final regulations for publication within the 3-year standardized time limit in the current Unified Agenda. We do not intend to delay publishing a Medicare final regulation for 3 years if we are able to publish it sooner.

Timetable:
Action Date FR Cite
NPRM  01/30/2026  91 FR 4190   
NPRM Comment Period End  03/31/2026 
Final Action  01/00/2029 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Related RINs: Related to 0938-AU55 
Agency Contact:
Alpha-Banu Wilson
Director, Division of Acute Care Providers
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Center for Clinical Standards and Quality, 7500 Security Boulevard,
Baltimore, MD 21244
Phone:410 786-8687
Email: alphabanu.wilson@cms.hhs.gov