Major Overhaul of Organ Transplant System Oversight Proposed

The proposed changes come amid growing concern regarding the U.S. organ transplant system.

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Organ procurement organizations—the groups responsible for connecting organ donors with patients—will face big changes if a rule proposed by the Centers for Medicare & Medicaid Services (CMS) is finalized.

The changes come in the wake of disturbing practices in organ procurement organizations.

The new rules proposed on Jan. 28 aim to ensure patient safety, hold underperforming organizations accountable, and increase the number of successful transplants.

“Organ procurement organizations must serve as trusted stewards of every donated organ,” Health Secretary Robert F. Kennedy Jr. said in a statement.

Dr. Mehmet Oz, administrator of CMS, said, “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.”

Increase Accountability, Competition

First, the rule clarifies what constitutes “unsound” practice.

Unsound medical practices are failures by organ procurement organizations that create an imminent threat to patient health and safety or pose a risk to patients or the public.

These practices would include failures in governance, patient or potential donor evaluation and management, and procurement, allocation, and transport practices and procedures.

Next, the federal government proposes to rate an organization’s performance within its service area rather than giving it an overall grade.

There are 56 organ procurement organizations in the United States. If an organization is in the lowest performance tier for an area, it could lose its right to serve that area. Mid-level performers would have to compete against other organizations to keep their territory.

Also, the rule removes an old requirement that allowed only organizations certified between 2002 and 2005 to participate. This would open the door for new, high-performing groups to enter the field.

More than 170 million people in the United States are registered organ donors, and more than 100,000 patients are awaiting a transplant, according to a spokesperson for the Department of Health and Human Services.

This system must be “safe, fair, and effective,” the spokesperson said in an email to The Epoch Times.

“We have worked closely with our colleagues at CMS on areas of shared oversight, including review of this proposed rule, reflecting a strong understanding of where our responsibilities intersect and a shared commitment to patient safety,” the spokesperson said.

Improved Efficiency

Other changes include making the appeals process faster and more efficient so that disputes about a procurement organization’s performance are settled quickly.

To get more people off transplant waiting lists, the federal government wants to maximize the use of medically complex organs.

These organs are from donors who are older or have underlying health conditions that require extra care when matching their organs with recipients.

Procurement organizations would be required to track how well they are placing these complex organs.

Problems to Correct

In July 2025, the Department of Health and Human Services revealed that a federal investigation found “clear negligence” at a major organ procurement organization serving Kentucky, southwest Ohio, and part of West Virginia.

After examining 351 cases, the investigation identified more than 103 cases (29.3 percent) where organs were authorized for collection even though patients showed signs of life.

In December 2025, whistleblowers continued to report on a broken organ transplant chain involving stories of cancerous organs and the silencing of those who tried to speak out.

At the same time, the U.S. government has been moving to cut ties with China’s organ transplant system because of long-standing reports of forced organ harvesting from prisoners of conscience.

In September 2025, during a military parade in Beijing, a “hot mic” captured a private conversation between Chinese leader Xi Jinping and Russian President Vladimir Putin. They discussed living to age 150 through continued organ replacements.

Two days later, the Department of Health and Human Services called for the United States to sever all ties with China’s organ transplant system to protect the “sanctity of human life.”

Eva Fu contributed to this report.