CMS Finalizes Rule to Help More Organs Reach Patients and Strengthen Accountability for Organ Procurement Organizations
The U.S. Department of Health & Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), has finalized a rule to help more donated organs reach patients by strengthening oversight of Organ Procurement Organizations (OPOs). OPOs connect donor hospitals and transplant programs by securing authorization for donations, recovering organs, and coordinating safe, timely delivery for transplantation. This rule builds upon President Trump’s 2019 Executive Order, Advancing American Kidney Health, and helps advance a key goal of the Department’s Kidney Care National Plan to reform organ transplantation
While more than 49,000 transplants were performed in the United States in 2025, over 100,000 Americans are waiting for lifesaving transplants. To improve access to transplants, the final rule allows high-performing OPOs to compete for multiple donation service areas, clarifies OPO recertification procedures, and reinforces longstanding process performance standards.
“Every donated organ carries the chance to save a life,” said HHS Secretary Robert F. Kennedy, Jr. “Under President Trump’s leadership, we are holding failing organizations accountable, strengthening patient safeguards, and helping high-performing organizations reach more patients. We will honor donors’ gifts by demanding results.”
“Americans waiting for lifesaving transplants cannot afford poor performance by OPOs, and CMS is committed to holding these organizations accountable,” said CMS Administrator Dr. Mehmet Oz. “With today’s new rule, CMS is building on the success of organ procurement reforms from the first Trump Administration to promote clearer documentation, higher donation rates, and swifter consequences for bad actors.”
The final rule establishes clear requirements when one OPO takes over from another and strengthens oversight of unsafe practices. It also changes how CMS measures transplant performance so that pancreata used only for islet cell research do not count as transplants. This will make sure that OPO transplant performance scores reflect organs transplanted into patients.
Key provisions of the final OPO rule include:
- Enhanced oversight of unsound medical practices: The rule defines “unsound medical practices” to clarify when CMS may use its existing authority to immediately decertify a noncompliant OPO to protect patients.
- Adverse events and quality improvement: OPOs now have clearer guidance to spot, investigate, and prevent adverse events.
- Pancreata for islet cell research: A donor whose pancreas is procured only for islet cell research continues to count toward the OPO’s donation rate, but pancreata used for islet cell research no longer count toward the transplantation rate in the absence of a transplant.
- Documentation of research organs: OPOs must now track and record what happens to organs sent for research, including pancreata used for islet cell research.
- Licensure: An OPO’s medical director must hold a license in at least one state or territory the OPO serves.
- Decertification pathways: CMS clearly spells out the circumstances under which CMS may decertify an OPO.
- Appeals process: The rule codifies a process for discretionary CMS Administrator review of hearing officer decisions and updates appeals timeframes.
- Competition and donation service area transitions: Outgoing OPOs must cooperate with incoming ones, and incoming OPOs must submit a transition plan with progress updates to facilitate uninterrupted organ donation operations in the service area.
- Certification requirements: The rule removes a requirement limiting certification to OPOs recertified between 2002 and 2005.
Today’s action builds on the first Trump Administration’s 2020 OPO rule, which established transparent, reliable, and objective performance measures and increased competition for open donation service areas. Since CMS issued that rule, organ donations have increased by 36% nationwide, transplants have increased by 30%, and the number of lowest-performing OPOs continues to decline.
The OPO final rule complements HHS' recently released Kidney Care National Plan, a comprehensive strategy to prevent kidney failure before it begins, restore competition and choice in dialysis care, and reform the nation's organ transplant system. Further information on the Kidney Care National Plan is available at: https://www.hhs.gov/press-room/kidney-care-national-plan-fact-sheet.html.
The final rule is available in the Federal Register at: https://public-inspection.federalregister.gov/2026-22381.pdf.
View the final rule fact sheet at: https://www.cms.gov/newsroom/fact-sheets/medicare-medicaid-programs-organ-procurement-organizations-conditions-coverage-revisions-conditions.
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