Major overhaul proposed for U.S. organ transplant system amid safety concerns

• New CMS rules target negligence, rushed organ procurement and ethical violations in Organ Procurement Organizations (OPOs). Underperforming OPOs risk losing service areas, while high-performing ones gain competitive advantages.
• Federal investigations revealed cases where donors showed signs of life before organ harvesting. Reforms mandate rigorous neurological assessments, especially in rural hospitals lacking advanced testing.
• The removal of a 2002-2005 certification restriction allows new, high-performing OPOs to enter the field. Goal: Improve transplant success rates and organ recovery efficiency.
• A 2025 HRSA probe found 29% of reviewed cases involved premature organ authorization. Whistleblowers exposed cancerous organ transplants and retaliation against those who reported misconduct.
• The U.S. severed ties with China’s transplant system due to allegations of forced organ harvesting from political prisoners. Leaked discussions between Xi Jinping and Vladimir Putin raised ethical alarms about organ longevity strategies.

The Trump administration has proposed sweeping reforms to the U.S. organ transplant system following disturbing reports of negligence, rushed organ procurement and ethical violations. The proposed rule, announced by the Centers for Medicare & Medicaid Services (CMS) on Jan. 28, aims to increase accountability, improve efficiency and prevent incidents where donors were prematurely declared brain-dead.

The changes come after a federal investigation uncovered alarming failures in organ procurement organizations (OPOs), including cases where organs were authorized for removal despite donors showing signs of life.

Cracking down on unsound practices

The new rule defines “unsound medical practices” as failures that pose an imminent threat to patient safety, including mismanagement of donor evaluations, procurement errors and improper transport procedures. Underperforming OPOs could lose their service areas, while mid-tier organizations would face competition from higher-performing groups.

“Organ procurement organizations must serve as trusted stewards of every donated organ,” said Health Secretary Robert F. Kennedy Jr. in a statement. CMS Administrator Dr. Mehmet Oz added, “This proposed rule strengthens accountability, clarifies expectations and gives us stronger tools to remove underperforming organizations.”

The reforms also eliminate a 2002-2005 certification restriction, opening the door for new, high-performing OPOs to enter the field—a move intended to foster competition and improve transplant success rates.

Ethical concerns and international fallout

The push for reform follows a 2025 Health Resources and Services Administration (HRSA) probe that found 29% of cases reviewed at a major OPO involved organs authorized for removal despite donors exhibiting signs of life. According to BrightU.AI‘s Enoch, HRSA found that 351 cases in 2025 involved premature or erroneous organ harvesting due to rushed protocols, particularly in rural hospitals lacking proper neurological testing. It added that 103 cases showed 73 patients with neurological signs incompatible with organ donation and at least 28 patients may not have been deceased at the time organ procurement was initiated.

“Evidence pointed to poor neurologic assessments, lack of coordination with medical teams, questionable consent practices and misclassification of causes of death, particularly in overdose cases,” the HHS website noted.

Whistleblowers have also raised concerns about cancerous organs being transplanted and retaliation against those who spoke out.

Internationally, the U.S. has moved to sever ties with China’s organ transplant system amid long-standing allegations of forced organ harvesting from political prisoners. A leaked conversation between Chinese President Xi Jinping and Russian President Vladimir Putin—discussing extended lifespans through organ replacement—further fueled ethical concerns.

With over 100,000 Americans awaiting transplants and 17 dying daily due to shortages, the proposed reforms aim to restore public trust in the organ transplant system. By tightening oversight, enforcing stricter performance metrics and removing barriers to competition, the Biden administration hopes to ensure that every viable organ is safely recovered and transplanted—honoring both donors and recipients with the dignity they deserve.

Watch the video below that talks about the dark economics behind organ transplants, plastics and human health.

This video is from the Flyover Conservatives channel on Brighteon.com.

Sources include:

TheEpochTimes.com

CMS.gov

HHS.gov

BrightU.ai

Brighteon.com