On Monday, the U.S. Department of Health and Human Services (HHS) announced a “major initiative to begin reforming the organ transplant system following an investigation.”
A rule change put in place by the Center for Medicare & Medicaid Services and HHS which was intended to encourage organ donation instead appears to have taken a devastating turn. The HHS investigation ordered by Secretary Robert F. Kennedy, Jr. found multiple abuses “by a major procurement organization” — which Kennedy called “horrifying.”
HHS shared the findings of its investigation with The New York Times (NYT), which the outlet then published in an article on the growing coercion involved in harvesting organs from human beings.
Key Takeaways:
- Following a complaint, HHS opened an investigation into “disturbing practices” in organ donation that led to the procurement (or attempted procurement) of organs from patients who were not brain dead.
- The practice, known as circulatory death donation, began to increase in 2021 after HHS began grading procurement organizations on how many transplants they arranged and planned to end contracts with organizations that failed to meet the national average.
- Organ procurement organization workers then began pressuring families and doctors to give them organs from patients who were still responsive — even from a woman whose heart was still beating and a man who cried and moved.
- HHS has now mandated that corrective actions must be taken with safeguards improved to protect patients.
The Backstory:
The HHS investigation comes five years after a rule was put in place by the Centers for Medicare and Medicaid and HHS in December 2020 (near the end of the first Trump administration), which stated:
This final rule revises the Organ Procurement Organizations (OPOs) Conditions for Coverage (CfCs) to increase donation rates and organ transplantation rates by replacing the current outcome measures with new transparent, reliable, and objective outcome measures and increasing competition for open donation service areas (DSAs).
The regulations were in effect from 2021-2024, during the tenure of the Biden administration. The document stated that those regulations would be “effective on February 1, 2021, except for amendment number 3 (further amending § 486.302), which is effective July 31, 2022. Implementation date: The regulations will be implemented on August 1, 2022.”
In an effort to encourage organ donation, the new rule would grade procurement organizations on how many transplants they arranged, with CMS/HHS planning to end contracts with organizations that operated below average.
Some of these organizations then began to push for ‘circulatory death’ donations, breaking rules to find more donors.
Some approached patients’ families before they had decided to withdraw life support. In addition, once a living patient was approved for donation, hospitals at times put that person in the care of a resident who was too inexperienced to know the difference between signs of recovery and simple reflexes.
Those doctors were more likely to defer to the procurement organizations for guidance.
The Details:
In its July 21 press release, HHS announced that an investigation found “disturbing practices by a major organ procurement organization.”
As a result of the investigation by HHS’ Health Resources and Services Administration (HRSA), HRSA has now mandated that corrective actions must be taken by OPOs and the Organ Procurement and Transplantation Network (OPTN) must improve safeguards to protect patients.
“Under HRSA’s directive, data about any safety-related stoppages of organ donation called for by families, hospitals, or OPO staff must be reported to regulators, and the OPTN must update policies to strengthen organ procurement safety and provide accurate, complete information about the donation process to families and hospitals,” said HHS.
“Our findings show that hospitals allowed the organ procurement process to begin when patients showed signs of life, and this is horrifying,” said HHS Secretary Robert F. Kennedy, Jr. “The organ procurement organizations that coordinate access to transplants will be held accountable. The entire system must be fixed to ensure that every potential donor’s life is treated with the sanctity it deserves.”
Circulatory death donation
The New York Times article from July 20 included the story of Misty Hawkins, a 42-year-old woman who had choked and was in a coma. Her mother decided to remove life support and donate Misty’s organs. After she was removed from the ventilator and declared dead, a surgeon began to cut into her chest. That’s when he noticed Misty’s heart was still beating and she appeared to be breathing. She was alive and another victim of circulatory death donation.
This type of organ donation has been on the rise, accounting for a third of all organ donations in 2024, according to The Times. That’s about 20,000 organs from patients who are alive with some brain activity, but are considered by doctors to be near death.
Fifty-five medical workers across 19 states told the NYT they had personally witnessed at least one disturbing case of circulatory death organ donation in which organ transplant coordinators persuaded hospital workers to administer morphine, propofol, and other drugs to hasten the deaths of patients. The Times reported (emphasis added):
… [S]ome organ procurement organizations — the nonprofits in each state that have federal contracts to coordinate transplants — are aggressively pursuing circulatory death donors and pushing families and doctors toward surgery.
Hospitals are responsible for patients up to the moment of death, but some are allowing procurement organizations to influence treatment decisions.
Ignoring signs of life
The case that spurred HRSA’s investigation was that of a neurologically injured patient in Kentucky. HHS ordered the Organ Procurement and Transplantation Network (OPTN) to investigate potential preventable harm done to him in an effort by a federally-funded organ procurement organization (OPO) to harvest his organs.
The investigation revealed negligence by the OPO despite the OPTN Board of Directors claiming there were no major concerns based on its internal review.
The Times reported that the Kentucky man, Anthony Thomas Hoover, began to wake up as he was about to be removed from life support. And even though he cried, pulled his legs to his chest, and shook his head, officials still tried to move forward with the removal of his life support and organs.
HHS found that officials ignored the man’s signs of alertness and that there were 350 cases in Kentucky alone over the last four years in which plans to remove a person’s organs were canceled. It also determined that 103 cases showed “concerning features,” including 73 cases in which patients “showed neurological signs incompatible with organ donation.”
While most of the patients did die, some recovered and left the hospital. Hoover is still alive today, four years after the incident.
“Part of killing someone”
The Times also learned that there are a confirmed 12 such cases across nine states, as reported by healthcare workers.
Bryany Duff, a surgical technician in Colorado, told the NYT that one patient, a middle-aged woman, was crying and looking around as doctors sedated her and removed her from a ventilator. She lived for a few more hours.
“I felt like if she had been given more time on the ventilator, she could have pulled through,” said Duff. “I felt like I was part of killing someone.” Duff quit her job and even temporarily left the medical field. “It really messed with me for a long time. It still does.”
Another patient, this time in Miami, had broken his neck. When procurement agents came to harvest his organs, he began crying and biting on his breathing tube, which a procurement organization employee believed to be a sign that he didn’t want to die. But clinicians sedated him, took him off life support, waited for him to die, and took his organs.
Benjamin Parsons was paralyzed and was asked to consent to donating his organs as he was coming off sedatives. Even when he said no, procurement coordinators wanted to continue with the process.
Danella Gallegos was 38 and homeless when she was hospitalized in 2022 and slipped into a coma. Doctors told her family she would not recover, and they agreed to donate her organs. On the day of the planned harvesting, her sisters were with her when Gallegos began to move. The doctor asked her to blink her eyes, and she did.
Yet, the procurement organization said it was just a reflex and suggested doctors give her morphine to reduce movements. The doctor refused, and Gallegos made a full recovery.
“All they cared about is getting organs,” said Neva Williams, an intensive care nurse at the hospital. “They’re so aggressive. It’s sickening.”
Why It Matters:
Pro-life groups have long warned about potential ethical issues with organ donation, including the way brain death is evaluated and whether patients are being pursued for their organs before they are actually dead.
The patients included in the NYT reporting each had some unique circumstance that may have led to a devaluing of their lives — apart from the fact that they were on life support. Gellagos was homeless; Hawkins had a lifelong cognitive disability; Hoover had suffered a drug overdose; Parsons was paralyzed; the Miami man had broken his neck.
In Canada, where assisted suicide for the chronically ill and disabled is legal, it is being used as a way to secure organs. Organ-donation organizations in both Ontario and Quebec contact patients who are scheduled to be killed by their doctors to ask them to donate their livers, kidneys, and spleens.
Now, it seems that to keep their federally funded organizations running, procurement organizations in the U.S. are attempting similar measures by pressuring families into donating loved ones’ organs before their deaths.
HHS did not mention in its press release whether it would change its previous decision to begin grading procurement organizations on how many transplants they arranged or if it would renounce the previous threat to end contracts with organizations that operate below the average.
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