Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Conditions for Coverage, Final Rule (CMS‑3409-F)
Overview
The Centers for Medicare & Medicaid Services (CMS) published a final rule that will continue to strengthen federal oversight of Organ Procurement Organizations (OPOs). This final rule expands on the December 2020 final rule that set the framework for performance metrics and created a tiered system to recertify or decertify OPOs based on their performance on both donation and transplant measures. It also clarifies designations to multiple donation service areas (DSAs), recertification processes, procedures for competition, appeals, information management, and other operational details.
Background
In 2019, President Trump issued Executive Order 13879 “Advancing American Kidney Health,” directing the Secretary to enhance the procurement and utilization of organs available through deceased donation and to establish more transparent, reliable, and enforceable objective metrics for evaluating an OPO’s performance. In response, CMS published the Organ Procurement Organization (OPO) Conditions for Coverage (CfCs) rule in December 2020. In January 2026, CMS published an additional proposed rule revising the OPO CfCs to clarify outstanding procedural questions and to enable OPOs to make more informed decisions to achieve high performance resulting in the successful procurement, distribution, and transplantation of more lifesaving organs (91 FR 4190).
This final rule revises the CfCs for OPOs to clarify outstanding procedural questions for recertification and competition. This rule also revises definitions, clarifies the designation requirements for OPOs, clarifies when an OPO’s service area will be open for competition, and updates the appeals process. CMS remains committed to holding all OPOs accountable for their performance and will be moving to decertify tier 3 OPOs as indicated in the 2020 final rule.
This final rule does not change the focus on improving donor and transplant volume, as assessed in the outcome measures, nor does it change the tier structure used for OPO recertification and decertification. The outcome measures focus on two rates — the donation rate and the transplantation rate. OPOs that have both DSAs ranking at or above the upper benchmark are placed in tier 1 and eligible for recertification for another four years. OPOs that have DSAs ranking in tier 2 are the next highest performers. Tier 2 OPO DSAs meet or exceed the lower benchmark on both measures but do not rate high enough to reach tier 1 on both measures. OPOs with DSAs that are in tier 2 are also eligible for recertification but must compete to retain their DSAs. Lastly, OPOs with tier 3 DSAs are the lowest performing OPOs with one or both measures below the lower benchmark. OPOs that only have tier 3 DSAs will be decertified and cannot compete for any other open DSA.
The OPO final rule complements HHS’ recently released Kidney Care National Plan, a comprehensive strategy to restore competition and choice in dialysis care, reform the nation's organ transplant system, and prevent kidney failure before it begins. The plan identifies where federal action can improve kidney care across the entire spectrum of kidney disease and deliver greater choice and superior outcomes to Americans.
Key Provisions for Strengthening Quality, Safety, and Oversight
Unsound medical practices
The rule defines “unsound medical practices” as failures by OPOs that create an imminent threat to patient health and safety or pose a risk to patients or the public. These practices include, but are not limited to, failures in governance; patient or potential donor evaluation and management; and procurement, allocation, and transport practices and procedures. This gives CMS a clear, enforceable basis for urgent decertification to protect patients and maintain public trust in the system.
Adverse Events and Quality Assessment and Performance Improvement (QAPI)
The rule removes the examples currently listed in the definition of “adverse event” and adds a revised list to the QAPI requirements. All OPOs must have QAPI programs that use data to monitor and improve their own performance. OPOs are specifically required to have policies for identifying, reporting, analyzing, and preventing adverse events that occur during the organ donation process. This change gives clear information so that all OPOs can act to prevent adverse events, investigate all adverse events, and take appropriate action to prevent future similar events.
Pancreata Used for Islet Cell Research
The rule clarifies that a donor whose pancreas is procured only for islet cell research counts as a donor for the donation rate measure. It removes pancreata used for islet cell research from the transplant rate measure, so islet cell research activity alone will no longer count as a transplant in the absence of a transplant.
These refinements better incentivize both pancreata islet cell research and transplantation while more precisely measuring performance.
Documentation of Research Organs
This rule requires OPOs to maintain records on the disposition of organs recovered for bona fide research studies. This will foster OPO accountability in the responsible disposition of any organ sent for research, including pancreata that are used for islet cell research.
Human Resources
The rule requires an OPO’s medical director to hold a license in at least one of the states or territories within one of the OPO’s service areas, or as required by applicable law. This requirement addresses OPOs that operate in more than one DSA.
Key Provisions for Incentivizing Fair and Equitable Competition to Increase Organ Donation and Transplantation
Nonrenewal of Tier 2 OPO Agreements for Designation
The rule clarifies that CMS will not renew an OPO’s agreement for designation to a DSA if the OPO is no longer designated to that DSA. This could occur if an OPO with a tier 2 DSA is unsuccessful in the competition process and fails to retain its DSA. In this situation, the OPO may compete for other DSAs or potentially be assigned a DSA by CMS in certain situations.
Decertification
The rule identifies circumstances in which CMS may involuntarily end an OPO’s agreement:
- The OPO no longer meets the requirements for certification, including process performance measures.
- All of the OPO’s DSAs fall into tier 3 in the final assessment period.
- An OPO is unsuccessful in competition to retain its tier 2 DSA, is not designated to any DSA, and does not have any performance data at the end of the following recertification cycle.
- In cases of urgent need, CMS may decertify an OPO immediately.
This change clarifies that tier 2 status alone is not a basis for decertification, thereby allowing OPOs with tier 2 DSAs to be recertified.
Appeals process
The rule codifies a process for discretionary review by the CMS Administrator after a hearing officer issues a decision.
Competition and DSA transitions
The rule clarifies, without changing the regulation itself, how existing competition selection criteria apply under the tier system for recertification. In addition, it adds a new requirement for incumbent OPOs to cooperate with the successor OPO during a transition. It also requires the successor OPO to submit a transition plan with periodic progress reports to CMS. Together, these requirements support uninterrupted service to patients and donor families during a DSA transition.
Requirements for certification
The rule removes the requirement that an OPO must have been recertified under Medicare between Jan. 1, 2002, and Dec. 31, 2005.
The OPO Final Rule complements the U.S. Department of Health and Human Services and its Health Resources and Services Administration (HRSA) ongoing modernization of the national organ transplant system, including new governance, technology, and oversight improvements, to strengthen safety, transparency, and public trust. CMS’ OPO oversight and HRSA’s Organ Procurement and Transplantation Network modernization advance a common goal: safer procurement and more lifesaving transplants.