Proposed CMS regulations would tighten accountability for organ procurement organizations, expand competition, and respond to documented failures in patient protection.
By yourNEWS Media Newsroom
Organ procurement organizations, the entities responsible for recovering donated organs and matching them with transplant recipients, would face sweeping new oversight and performance standards under a proposed rule released by the Centers for Medicare & Medicaid Services, according to reporting by The Epoch Times.
The proposal, unveiled Jan. 28, follows mounting scrutiny of the U.S. organ transplant system and comes in the wake of investigations that exposed unsafe and negligent practices within some procurement organizations. Federal officials said the changes are intended to strengthen patient safety, improve transplant outcomes, and hold underperforming organizations accountable.
“Organ procurement organizations must serve as trusted stewards of every donated organ,” Health and Human Services Secretary Robert F. Kennedy Jr. said in a statement. “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.”
CMS Administrator Dr. Mehmet Oz said the rule would give the agency clearer enforcement authority and improve oversight of organizations that fail to meet standards.
A central feature of the proposal is a clearer definition of what constitutes “unsound” medical practice. Under the rule, unsound practices would include failures that create an imminent threat to patient health or pose risks to donors, recipients, or the public. These failures would encompass deficiencies in governance, donor and patient evaluation, and organ procurement, allocation, and transport procedures, as detailed in CMS fact sheets.
Rather than issuing a single overall grade for each organization, CMS would assess performance by service area. There are currently 56 organ procurement organizations nationwide. Under the proposed framework, organizations ranking in the lowest performance tier within a service area could lose the right to operate there, while mid-level performers would be required to compete with others to retain their territories.
The proposal would also eliminate a long-standing requirement that limited participation to organizations certified between 2002 and 2005, a change intended to allow new, high-performing groups to enter the system and increase competition.
The U.S. organ donation and transplant network serves more than 170 million registered donors and over 100,000 patients waiting for transplants, according to the Department of Health and Human Services. A department spokesperson said the system must be “safe, fair, and effective,” adding that HHS has coordinated closely with CMS on the proposed rule to ensure overlapping oversight responsibilities are aligned and focused on patient protection.
The rule also aims to improve efficiency by streamlining the appeals process, allowing disputes over performance determinations to be resolved more quickly. To reduce transplant waiting lists, CMS is proposing new requirements to better track and maximize the use of medically complex organs, including those from older donors or individuals with underlying health conditions.
The proposal follows a series of high-profile failures. In July 2025, HHS disclosed that a federal investigation found “clear negligence” at a major procurement organization serving parts of Kentucky, Ohio, and West Virginia. The investigation determined that in more than 103 cases, organs were authorized for recovery even though patients showed signs of life.
In December 2025, whistleblowers continued to report systemic breakdowns in the transplant chain, including cases involving cancerous organs and allegations that individuals who raised concerns were silenced. At the same time, the U.S. government moved to cut ties with China’s organ transplant system amid long-standing allegations of forced organ harvesting.
Those concerns were amplified in September 2025 when a hot mic incident during a military parade in Beijing captured Chinese leader Xi Jinping and Russian President Vladimir Putin discussing extending human life through repeated organ replacements. Two days later, HHS formally called for severing all U.S. ties with China’s transplant system, citing the need to protect the “sanctity of human life.”
Federal officials said the proposed CMS rule is intended to address these failures and rebuild trust in a system that determines life-or-death outcomes for tens of thousands of patients each year.
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