Every day, roughly 30 Americans die awaiting organ transplants, while an estimated 28,000 available organs annually are never transplanted due to inefficiencies in the donor system. Compounding this tragedy, some reports indicate that grieving families, expecting to save lives, can be misled into donating their loved ones’ tissues for use in research and cosmetic surgeries — a multibillion-dollar industry.
With over 100,000 patients on the organ waiting list, the nation’s 55 organ procurement organizations are tasked with contacting the families of the dying and recently deceased to inquire about lifesaving organ donations. Yet behind this noble mission lies a shadowy process that raises serious questions about transparency and consent practices.
‘Families believe their consent allows for transplant of their loved [ones’] organs, which, if the death has occurred, cannot happen.’
Persistent lack of transparency
Issues within the organ procurement and transplantation industry have persisted for decades, according to studies and reports.
In 2001, the federal Department of Health and Human Services Office of Inspector General advised tissue banks to provide families with written material detailing how donated tissue may be used.
However, several surveys from 2010 to 2015 consistently found that most families were unaware that tissue could be sold for profit or used for cosmetic purposes. One study found that out of 1,000 families surveyed, only three received written materials explaining the donation process. Another study reported that 70% of families polled stated they would object to their loved ones’ tissues going to for-profit businesses, yet fewer than 20% knew this could happen.
Dr. Laura Siminoff, a professor at Temple University’s College of Public Health, has conducted several studies over the years concerning organ and tissue donation, including the two previously mentioned.
Siminoff told Blaze News, “The complexity emerges from the highly emotional and stressful environment in which these conversations take place. Patients are in an intensive care setting, which is often noisy and confusing. OPO staff who are charged with having complex donation discussions with families need to bring a high level of emotional sensitivity and the ability to convey complicated information so that families can make informed and authentic decisions.”
A Department of Health and Human Services report noted that “families are asked to give their consent at a point in time when they are extremely vulnerable,” adding that they are often asked to provide consent over the phone instead of in person.
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After-death process
When an individual passes away in a health care institution that receives Medicare or Medicaid funding, the care facility is required to notify its local OPO.
Each OPO acts as a federal contractor responsible for procuring organs in its designated area. OPOs operate effectively as monopolies because they do not face competition from other organizations.
Even if the patient was not registered as an organ donor, the patient’s next of kin can still authorize donation on his or her behalf.
In addition to organs, the OPO may also pursue consent for tissue donation, which includes cornea, skin, bone, veins, connective tissue, and other materials.
If approved, the OPO will harvest the tissue and give it to a tissue bank. Tissue banks, which can be for-profit businesses, may then sell that material back to biomedical researchers, pharmaceutical companies, research centers, and even plastic surgeons.
While organ transplants are nearly always lifesaving, tissue transplants can be used for elective life-enhancing, research, or cosmetic purposes.
Ethical concerns in donation practices
While OPOs are intended to facilitate lifesaving organ donations, their practices have raised ethical concerns about transparency and profiteering.
The Indiana Funeral Directors Association provided a document to Congress to inform lawmakers about oversight and regulation gaps within OPO processes.
The association, which is openly supportive of organ and tissue donations, explained that “families are often caught off guard or surprised by the barrage of phone calls from donor networks just moments after their loved ones die seeking approval for tissue donation.”
‘It’s misleading. OPOs hide the realities of what is really happening — and who is making money — off the backs of vulnerable donor patients.’
Most disturbingly, the IFDA stated that families are misled to believe the donation will save lives because OPOs neglect to distinguish between organ transplants and tissue donations.
“In order for organs to be transplanted, the person dying must be kept alive. Tissue donation is done after the death occurs,” the IFDA explained. “Families believe their consent allows for transplant of their loved [ones’] organs, which, if the death has occurred, cannot happen.”
The Association of Organ Procurement Organizations confirmed that for organ donation viability, a donor “patient must die in a hospital while on a ventilator” and meet other “specific medical criteria.”
Andy Clayton, the executive director of the IFDA, told Blaze News that “families have articulated to us they don’t understand it.”
“They’re thinking [they donated] organs, when in fact, all it was was tissue. And that tissue was harvested, then sold,” Clayton said. “The ones that have talked to me, and I share with them the facts, are very alarmed that that wasn’t disclosed to them.”
“We are not against donation,” Clayton continued. “We would certainly applaud a family that decides to donate organs or tissue, as long as they’re informed and they know the truth.”
Further, the IFDA’s one-pager to lawmakers emphasized the “lucrative business” of tissue procurement, highlighting the 2023 revenue for several locally operating OPOs, with one exceeding $100 million.
Some assessments indicate that tissue can be priced up to $500 per gram. With an estimated 2.5 million tissue grafts performed each year, the global tissue banking market is projected to reach $5.17 billion by 2030.
The AOPO argued that there are circumstances in which tissue donation can be lifesaving or life-transforming, including “skin grafts to treat burn victims, heart valves to save infants born with heart defects, and musculoskeletal tissues to restore mobility for injured patients.”
“A single tissue donor has the potential to heal or improve the lives of up to 75 people,” the association noted.
“Dealing with the passing of a loved one is tragic,” Rep. Marlin Stutzman (R-Ind.) told Blaze News. “While organ procurement organizations are well-intentioned, fielding calls from them about relinquishing parts of your loved one’s body within days after death can feel off-putting or even predatory. Despite the difficulty in subject matter, more transparency is needed for families going through a loss when it comes to tissues and organs being removed from a loved one at the end of life.”
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Regulatory gaps and informed consent
HHS’ Food and Drug Administration, Centers for Medicare and Medicaid Services, and Health Resources and Services Administration provide broad oversight of OPOs, including the safety and quality of tissue used in transplantation, as well as the performance standards to qualify for taxpayer reimbursement funding.
While federal law, § 486.342, requires OPOs to have a written protocol to inform donor families about the donation process, including a list of the organs and tissues that will be recovered and the “most likely uses” for those donations, some argue that families still lack informed consent.
‘It’s just a corrupt industry overseeing itself, which is to say, covering up patient harms and backroom deals.’
Greg Segal, the founder and CEO of Organize, told Blaze News that donor families are unaware of how often tissue donations are used for cosmetic testing by for-profit businesses or other purposes that are not explicitly disclosed to them.
“It’s misleading. OPOs hide the realities of what is really happening — and who is making money — off the backs of vulnerable donor patients,” he stated.
Organ transplant information must be reported to the Organ Procurement and Transplantation Network, which is operated under contract with HHS, and the United Network for Organ Sharing, a nonprofit organization, has historically managed this contract. Yet there is no similar mandatory universal tracking system for tissue, only a voluntary accreditation through the American Association of Tissue Banks.
Segal explained that the AATB has been allowed to act as a “quasi-regulator” for the tissue industry.
“It’s just a corrupt industry overseeing itself, which is to say, covering up patient harms and backroom deals,” he explained. “Why would the American Association of Tissue Banks, populated and funded by tissue banks and taxpayer-funded organ contractors, be doing real investigations into who is misleading families and then hold themselves accountable?”
Furthermore, UNOS provides OPOs with a framework that determines who on the donation list will be provided with the next available organ, based on need and other factors. Yet no similar framework exists for tissue operations, allowing OPOs to use their discretion to determine who receives donations.
“If I’m running an OPO and I’m recovering $25 million worth of tissue this year, and there is no transparency, there’s no accountability, and there’s no algorithmic framework for where I’m supposed to give it, I can decide where I want to give it. OPO executives basically just ask themselves, ‘Who’s going to offer me a really nice consulting deal? Which tissue bank is going to put me on the board and then pay me for my board service?'” Segal explained.
The lack of mandatory oversight has led to concerns about conflicts of interest within the tissue industry. For instance, some OPO executives sit on the boards of the AATB and the OPTN, as well as the boards of tissue processing companies.
Segal stated that some OPOs have “massive investments in the tissue banks.”
“Executives don’t have to disclose to the government or to the public if they have personal financial interests, whether that be equity or stock or so-called ‘consulting agreements,'” Segal continued. “There’s a lot of money that changes hands, which is why both the Senate Finance Committee and the Energy and Commerce Committee are investigating self-dealing.”
Even the AATB admits that while it follows “U.S. antitrust laws closely,” its role “focuses exclusively on quality and safety rather than business practices.”
“AATB works to promote the safety, quality, and availability of donated human tissue, not to oversee business operations or financial models,” the nonprofit told Blaze News.
Though it is a lucrative industry, the AOPO insisted that OPOs do not sell tissue. However, it noted that they can receive “reimbursements” for procuring tissues.
The AOPO told Blaze News, “It is important to understand that OPOs do not sell tissues. Instead, specialized organizations that prepare donated tissues into grafts for clinical use may reimburse OPOs for the recovery services provided, similar to how hospitals are reimbursed for providing care. These reimbursements support donation-related operations.”
When asked how OPOs profit from tissue harvesting, Segal explained, “OPOs harvest tissue from dead people — many of whom had no idea what they were really consenting to — and then the OPOs give that tissue to a processor, which, in return, gives them money. You can decide what you want to call it, but I’d say it’s a sale.”
Financial incentives and profiteering
The profitability of tissue sales has reportedly exacerbated issues within the lifesaving organ donation system, prompting some OPOs to run their own tissue bank businesses.
Some critics claim that the current system effectively incentivizes OPOs to prioritize staffing their tissue recovery operations over their organ transplant teams. A 2020 report from the Bridgespan Group found that “OPOs have greater financial incentives to focus more on tissue recovery compared to their incentives to recover lifesaving organs.”
To improve the metrics of organs procured per donor, some OPOs may opt not to obtain organs from single-organ donors. This decision further worsens the shortage of available organs, according to a 2020 letter from the House Subcommittee on Economic and Consumer Policy.
‘There’s never been any accountability for OPOs. More than 95% of Americans support organ donation; that actually polls higher than puppies and ice cream.’
In 2013, even the AOPO admitted that the “current system has created a disincentive for OPOs to pursue organ recovery when there may be a lower yield of organs transplanted per donor.”
The AOPO told the White House Office of Management and Budget, “If an OPO is in jeopardy of decertification … the OPO is incentivized (for fear of being decertified) to not pursue or even evaluate the potential for donation of these types of donors,” referring to “marginal organ donors that generally yield fewer organs (or no organs).”
“This practice results in fewer organs being transplanted and more lives lost,” the AOPO wrote at the time.
in 2019, HHS proposed a rule it believed would result in an additional 5,000 to 10,000 lifesaving transplants each year by pushing all OPOs to reach compliance with the minimum performance standards
During a September congressional hearing, Segal contended that there should be enough available organs — with the exception of kidneys — for every individual in need of a transplant but that inefficiencies in procurement have prevented this.
OPOs are not required to meet donation and transplantation target rates to remain on hospitals’ mandatory notification lists. Remaining on those lists also helps an OPO fuel its potential tissue procurement business, since it is already the hospital’s first point of contact for organ recovery.
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Pushing for systemic overhaul
The House Energy and Commerce Subcommittee on Oversight and Investigations held a hearing in September in which several witnesses — Dr. Seth Karp, surgeon in chief of the Vanderbilt University Medical Center; Dr. Robert Cannon, associate professor of surgery and surgical director for liver transplant at the University of Alabama at Birmingham; Dr. Jesse Roach, senior vice president of government relations for the National Kidney Foundation; and Segal — testified that OPOs lack enforceable regulations.
Segal exposed “widespread abuse” allegations within the organ donation industry, which he argued have hindered the exposure of corruption and inefficiencies.
Segal stated, “There’s never been any accountability for OPOs. More than 95% of Americans support organ donation; that actually polls higher than puppies and ice cream. And yet the OPTN’s own research has found that OPOs only recover organs from one out of five potential donors. They are monopolies, and they’ve never had any enforceable regulations, and their performance has greatly suffered.”
Some of Segal’s concerns were far more troubling than donor family consent issues. Segal stated that he was aware of allegations of “harvesting of organs from patients who whistleblowers believe would otherwise have survived” and “unsafe patient care, including the hastening of death with fentanyl and the falsification of medical records.”
Cannon corroborated many of Segal’s assertions.
Cannon told lawmakers, “OPOs also lack sufficient oversight and accountability with regard to organ allocation, sometimes resulting in actions that are abusive and harmful to patients.”
“I have had an OPO administrator recommend I proceed with organ procurement in the face of concerns a donor may still be alive,” he continued. “I have seen a 21-year-old patient dying from liver failure have an ideal donor organ taken away from her by an OPO that was unwilling to provide one additional hour for a plane to be mobilized. Our complaint in this instance went unanswered. Unfortunately, stories such as these are not isolated instances.”
To fix the broken organ procurement and donation system, Cannon told lawmakers to “tear it down to the studs and rebuild it.”
‘At least 28 patients may not have been deceased at the time organ procurement was initiated — raising serious ethical and legal questions.’
The witnesses advocated for terminating the current cost-reimbursement structure of OPOs, which allow the organizations to be fully reimbursed for all expenses related to organ donations. The federal government largely moved away from this model within the health care system because it has been proven to produce poor outcomes and is vulnerable to potential abuses.
The Organ Donation and Transplantation Alliance’s website warns that cost-based reimbursement comes with a “financial risk” of “over-reporting as well as under-reporting organ acquisition costs claimed for Medicare reimbursement.”
“Prior Office of Inspector General (OIG) audits noted that transplant centers stated they lacked awareness and understanding of Medicare requirements or had inadvertently claimed non-allowable costs on the Medicare Cost Report,” the alliance noted.
Segal claimed that OPOs are not just combining organ and tissue donation when seeking consent from donor families, but they also label various expenses as “organ and tissue”-related items to receive CMS reimbursements, which should cover only organ operations. This allows OPOs to “subsidize all the costs related to tissue,” he said.
The AOPO, which represents 47 federally designated nonprofit OPOs, insisted that organ and tissue donation are “entirely separate clinical processes” that “never compete with each other,” adding that “accusations that they do contradict yearly government data, which demonstrates a 14-year increase in organ donation and transplantation rates. OPOs strive to save lives by recovering every viable organ, irrespective of financial models.”
Recent investigations and HHS reforms
The House Committee on Energy and Commerce held another hearing on July 22 regarding the organ procurement and transplant system, during which lawmakers questioned witnesses from HRSA, UNOS, and the OPTN. Lawmakers also heard from Barry Massa, the chief executive officer of the Network of Hope, an OPO.
The hearing mainly focused on a disturbing incident that took place in 2021 involving a Kentucky man named Anthony Thomas Hoover. He was set to undergo surgery for organ retrieval when the surgeon discovered that he was still alive, despite having been previously declared dead. The OPO assigned to the case, which later merged with the Network of Hope, faced accusations of attempting to proceed with the organ procurement process despite clear signs of life.
The surgery to remove Hoover’s organs was terminated, and he survived. NPR reported in 2024 that he was still alive three years after the incident.
Massa maintained that the correct process was followed in the Hoover case, though he admitted that there were “a lot of unique things that could have been done better.”
Trump’s HHS has signaled that it plans to hold OPOs responsible. On July 21, the agency stated HHS Secretary Robert F. Kennedy, Jr. has threatened to shut down “deficient” OPOs.
HHS reported that HRSA examined 351 cases in which organ donation was authorized but not performed, noting that nearly 30% “showed concerning features, including 73 patients with neurological signs incompatible with organ donation.”
“At least 28 patients may not have been deceased at the time organ procurement was initiated — raising serious ethical and legal questions,” HHS wrote.
HRSA also instructed the OPTN to reopen the Hoover case, which was closed without any action under the former Biden administration.
‘I’m kind of thinking, “Well, we need to publicize it, but we kind of don’t want to publicize it because then we’d hurt the number of people that are actually going to donate their organs.” So this is a problem.’
During July’s committee hearing, Raymond Lynch with HRSA, who noted no OPO has ever previously lost its certification, confirmed that the agency has additional open investigations into the industry.
Blaze News asked HHS how it will ensure that OPOs provide clear information to donor families.
An HHS spokesperson stated that the department “is committed to ensuring that organ procurement organizations provide grieving families with clear, compassionate information while prioritizing lifesaving organ donation.”
“Through HRSA-led reforms, including standardized communication training, outcome-based performance metrics, transparent public reporting, and stronger oversight, HHS is holding OPOs accountable to uphold the highest standards of ethics, transparency, and patient-centered care,” HHS stated. “Through the Organ Transplantation Affinity Group, HHS supports standardized communication training — emphasizing trauma-informed care, cultural sensitivity, and family experience — backed by national experts.”
The agency also stated that recent CMS and HRSA reforms will evaluate OPOs “based on actual organ donation and transplant rates (not organizational activity or self-reported data), with benchmarks and underperformance triggering reevaluation or decertification.”
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Industry’s response
When asked for comment, the AOPO and AATB expressed concerns that reporting these allegations, which they insisted were false, could have life-and-death consequences by deterring people from donating organs.
The AOPO claimed that the IFDA’s letter to Congress contained “demonstrably false statements” and dismissed the cited studies as “over a decade old.” The AATB similarly claimed that the studies were “not only outdated but also inaccurate.”
“Today, thousands of people are removing themselves from U.S. organ donation registries, and that is directly tied to the spread of myths and accusations like the ones in the IFDA letter. This has a human cost: Less donors means that more patients who need lifesaving transplants must continue to wait and possibly die in the interim,” the AOPO told Blaze News.
Both the AOPO and the AATB insisted that donor families are encouraged to ask questions about the donation process and place limits on their loved ones’ donations.
During September’s congressional hearing, then-Rep. Debbie Lesko (R-Ariz.) summed it up this way after listening to the witnesses’ troubling concerns about the organ and tissue procurement industry: “I’m kind of thinking, ‘Well, we need to publicize it, but we kind of don’t want to publicize it because then we’d hurt the number of people that are actually going to donate their organs.’ So this is a problem.”
Critics of the existing organ donation framework make it clear that they endorse donation and are not aiming to discourage Americans from registering as donors. However, they argue that the fear among the industry that negative publicity might shrink the donor pool does not excuse organizations from necessary oversight. Instead, heightened scrutiny and transparency could optimize procurement processes, ultimately fostering greater efficiency and saving more lives by breaking free from the inefficiencies of the current monopolistic, self-policing structure.
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