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FOR IMMEDIATE RELEASE
January 28, 2026
Contact: CMS Media Relations
(202) 690-6145 | CMS Media Inquiries
CMS Proposes Rule to Strengthen Oversight of Organ Procurement Organizations and Protect Patients
The Centers for Medicare & Medicaid Services (CMS) today announced a proposed rule to strengthen federal oversight of Organ Procurement Organizations (OPOs). The proposal sharpens the framework for upcoming OPO re-certification cycles and reinforces clear, enforceable standards to protect patients and ensure every viable organ is safely recovered and transplanted.
More than 100,000 Americans are waiting for a life-saving organ transplant; every eight minutes another person is added to the transplant list, and 17 people die each day while waiting. OPOs are the critical link between donor hospitals and transplant programs, responsible for securing consent, recovering organs, and ensuring safe, timely delivery to recipients.
“Organ procurement organizations must serve as trusted stewards of every donated organ,” said HHS Secretary Robert F. Kennedy, Jr. “Where the previous administration failed to act, this administration has stepped in to protect patient safety and ensure that every potential donor’s life is treated with the dignity and sanctity it deserves.”
“Every missed opportunity for organ donation is a life lost,” said CMS Administrator Dr. Mehmet Oz. “CMS will not tolerate unsafe practices or failures that put patients at risk and weaken trust in the system. This proposed rule strengthens accountability, clarifies expectations, and gives us stronger tools to remove underperforming organizations, protect patients, and honor the incredible gift of life. The results of the first Trump Administration’s 2020 reforms prove that clear standards and enforcement save lives, and we are building on that progress.”
The proposed rule would:
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Enhance performance measures and tighten documentation: Exclude pancreata used for islet cell research for the transplantation rate outcome measure and add recordkeeping requirements to ensure research organs are used in bona fide islet cell research.
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Define and deter unsafe practices: Codify a clear definition of “unsound medical practices,” expand examples of reportable adverse events, and strengthen quality-improvement expectations so serious governance, safety, or organ-handling failures can be identified and addressed quickly.
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Maximize use of medically complex organs: Require OPOs to assess their performance in placement of organs from medically complex donors (e.g., older donors or donors with less-than-optimal health status) and take actions to improve such performance when possible, expanding opportunities for life-saving matches.
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Increase accountability and smart competition: Build on the comprehensive framework established in 2020 by holding underperforming organizations accountable and removing barriers that disincentivize higher performing OPOs from competing for failing areas.
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Remove a barrier to new OPO certification: Remove an outdated regulatory requirement limiting certification eligibility, paving the way for future certification of new OPOs.
Today’s proposal complements the U.S. Department of Health and Human Services and its Health Resources and Services Administration’s (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.
The proposed rule is open for public comment for 60 days following publication in the Federal Register. Comments can be submitted at: federalregister.gov/public-inspection/2026-01833/medicare-and-medicaid-programs-organ-procurement-organizations-conditions-for-coverage-revisions-to.
Visit the Fact Sheet: https://www.cms.gov/newsroom/fact-sheets/organ-procurement-organizations-opos-conditions-coverage-revisions-cms-3409-p-proposed-rule.
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