Health and Human Services Department, Centers for Medicare & Medicaid Services
This final rule revises the Conditions for Coverage for Organ Procurement Organizations (OPOs) to clarify outstanding procedural questions and provide additional operational flexibility for OPOs to achieve high performance resulting in the successful procurement, distribution, and transplantation of more life-saving organs. This rule revises definitions, revises the designation requirements for OPOs, clarifies when an OPO's service area is open for competition, and updates the process for appeals. We are committed to holding all OPOs accountable for their performance and this final rule does not revise the focus on improving the volume of donors and transplants assessed in the outcome measures or the tier structure used for re-certification and de-certification of OPOs.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Centers for Medicare & Medicaid Services 42 CFR Part 486 [CMS-3409-F] RIN 0938-AU54 ( printed page 69390) AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS). ACTION: Final rule. SUMMARY: This final rule revises the Conditions for Coverage for Organ Procurement Organizations (OPOs) to clarify outstanding procedural questions and provide additional operational flexibility for OPOs to achieve high performance resulting in the successful procurement, distribution, and transplantation of more life-saving organs. This rule revises definitions, revises the designation requirements for OPOs, clarifies when an OPO's service area is open for competition, and updates the process for appeals. We are committed to holding all OPOs accountable for their performance and this final rule does not revise the focus on improving the volume of donors and transplants assessed in the outcome measures or the tier structure used for re-certification and de-certification of OPOs. DATES: These regulations are effective on January 4, 2027. FOR FURTHER INFORMATION CONTACT: The Clinical Standards Group, (410) 786-6633, HealthandSafetyInquiries@cms.hhs.gov . SUPPLEMENTARY INFORMATION: I. Executive Summary and Severability A. Executive Summary 1. Purpose At any given time, at least 100,000 people are on the waiting list for a lifesaving transplant and every 8 minutes, another person is added to the transplant w…
Citation: 91 FR 69390
