An U.S. House Energy and Commerce subcommittee just heard testimony on this report:

https://michiganadvance.com/2025/07/23/repub/organ-donation-groups-seek-to-reassure-us-house-panel-after-deeply-concerning-report/

Organ donation groups seek to reassure US House panel after ‘deeply concerning’ report
By Jennifer Shutt - July 23, 2025

WASHINGTON — The heads of several organ transplant organizations testified before Congress on Tuesday that they are working to earn back the public’s trust following the release of a scathing report.

In a rare example of bipartisanship on Capitol Hill, both Republicans and Democrats on a U.S. House Energy and Commerce subcommittee expressed concern with several cases and interest in enhanced oversight of the entities that manage organ donation.

The central issue, according to testimony from witnesses and comments from lawmakers, is that organ donations increasingly come from people experiencing circulatory death as opposed to brain death.

Dr. Raymond Lynch, chief of the Organ Transplant Branch at the Health Resources and Services Administration within the U.S. Department of Health and Human Services, said that “historically that was a less common pathway,” but now represents about 50% of all donations.

“This is complex care. It’s technically demanding, but it’s knowable and fixable,” Lynch said. “This is something that can be done safely.”

Energy and Commerce Committee Chairman Brett Guthrie, R-Ky., detailed a case in his home state where a man began showing signs of “improved neurological function” after his family had agreed to let doctors remove his organs for donations.

The case later became the subject of an oversight investigation and a corrective action plan from the Health Resources and Services Administration that focused on the behavior of the Organ Procurement Organization for that region.

The HRSA reports states that the man arrived at “a hospital in northern Kentucky with cardiovascular collapse after an unintentional overdose of methamphetamine.” As part of his treatment, health care providers administered three different sedatives.

The report states that while the patient “did survive the events surrounding the attempted withdrawal of life support and organ procurement, the repeated assessment by (Kentucky Organ Donor Affiliates) that it is ‘satisfied and confident in the donation process’ is incongruous with the facts of the medical record.”

Guthrie said the report showed a “deeply concerning pattern” and that the committee wanted “to have an open and honest discussion about these failures.”

“HRSA determined that of the 351 documented cases reviewed in this investigation, 103 or nearly 30% had concerning features,” Guthrie said. “HRSA found concerning patterns that included failures to recognize increased neurological function in patients who were previously identified as candidates for organ donation, failure to work collaboratively with medical teams and failure to safeguard decision making or follow best practices.”

The United States has more than 50 different Organ Procurement Organizations responsible for different geographic areas. They determine which patients are eligible to donate organs. They are not supposed to be involved in determining when a potential donor is declared dead by a hospital’s medical team.

Guthrie said he didn’t intend to change his status as an organ donor but emphasized the need for improvement.

‘Troubling record’

Lynch declined to go into detail during the public hearing but said HRSA has several ongoing investigations into potential wrongdoing within the organ procurement system. He also said that anyone wishing to file a complaint can do so on the agency’s website.

“There are numerous cases that have been reported to HRSA,” Lynch testified. “We have ongoing reviews and we have made referrals to partner agencies. The corrective action plan that we have for Kentucky, as we were hearing about these other cases in other areas, also includes a plan to make the (Organ Procurement and Transplantation Network) make this safe nationwide.”

New York Democratic Rep. Paul Tonko asked Lynch about a section in the HRSA report that “identified a troubling record of the Kentucky OPOs communication with patient families.”

“In one case, the OPO employees seeking consent to begin preparation for organ donation spoke with the patient’s brother, who had a cognitive impairment. This individual was described as, and I quote, childlike, in case records,” Tonko said. “In a separate case, the OPO spoke with two family members who were, quote, clearly inebriated.”

Lynch said the records HRSA reviewed during its investigation didn’t explain why that happened, but he said the inability “to consider the humanity and the autonomy of these patients and their families is troubling.”

Tonko said the HRSA report indicated that OPO staff appeared to have used “a manipulative and overly aggressive strategy” in the Kentucky case.

“The sister of the Kentucky patient has said that she was never told that her brother had started to wake up after she had given consent for donation,” Tonko said. “She says she only found out years later.”

Corrective plan for Kentucky

Lynch said the corrective action plan for the Kentucky Organ Procurement Organization, formerly known as Kentucky Organ Donor Affiliates but now called Network for Hope, requires its staff to keep families updated and ensures that “if at any point, either the health care team or the family has a concern, that there is a pause in the process to allow for adjudication of that.”

He also indicated there could be more understanding in how staff handle discussions about whether to donate a person’s organs.

“This is, as you pointed out, one of the most horrible and challenging times in a family’s life,” Lynch said. “The events that lead to somebody becoming a potential organ donor are usually sudden and tragic. Interacting with a grieving family, helping them to make educated decisions, providing compassionate and fair information and a complete sense of what the procurement process will look like, those are skills.

“They are skills that some OPOs clearly perform better than others, but they are skills for which the OPO is responsible.”

Organization welcomes oversight

Barry Massa, chief executive officer at Network for Hope — an Organ Procurement Organization that covers Kentucky as well as parts of Indiana, Ohio and West Virginia — testified before the committee that the HRSA report’s contents “are serious and alarming.”

“That case was very complex, and during a very complex time,” Massa said. “If you recall, in 2021 we were in the midst of COVID, and I think that impacted the communication that we had between our hospital and our team. And while I’m not using that as an excuse, I do think it added to the complexity of it.”

Massa testified under oath that the organization never wants to repeat what happened in that case, plans to follow the recommendations detailed in the HRSA report and welcomes more oversight from Congress.

Network for Hope, he said, had also implemented some changes of its own, including a checklist for nurses and physicians to use.

Massa later clarified that “while OPOs are the ones determining if a patient is suitable for donation, as far as determining death, that is actually done by the physician.”

Split responsibility

Other members of the panel explained that the oversight of organ procurement and donation is fragmented and needs improvement.

Maureen McBride, chief executive officer at the United Network for Organ Sharing, testified that the Centers for Medicare & Medicaid Services has oversight over hospitals and the Organ Procurement and Transplantation Network “has oversight under HRSA of the transplant hospitals, the OPOs and the histocompatibility labs.”

“That split in oversight does leave room for communication gaps and opportunities for further improvement,” McBride said. “So I do think consolidation of the entire transplant ecosystem under a single government regulatory body could provide benefits to the transplant community.”

Dr. Richard Formica, former president of the Organ Procurement and Transplantation Network Board of Directors, said the process includes “two domains of responsibility” and suggested they be moved under one oversight agency.

Formica said lawmakers could figure out a way that after a patient is identified as a potential organ donor, there be one set of procedures to follow on both the hospital side, which is currently managed by the Centers for Medicare & Medicaid Services, and the organ donation system, managed by HRSA.

“We’d have one set of oversight. We’d have one set of protocols,” Formica said. “We could work on those protocols and then we can act on those protocols and refine them as they go forward, instead of refining one and having to wait for the other one, and back and forth.”

When it comes right down to it, I don't think standardization will help. The complaint process and congressional oversight maybe a little, but mostly if it is public and raises awareness.

Keep your family close, everyone.

The motivation, as always, is money:

https://www.thefp.com/p/nonprofits-reap-millions-for-organ

Nonprofits Reap Millions for Organ Transplants. Lawmakers Are Investigating Them.
By Gabe Kaminsky - July 23, 2025

The Indiana Donor Network, a nonprofit in Indianapolis, sits on at least $81 million in assets and touts its mission as “saving lives and enhancing the quality of life through organ, tissue, and eye donation and transplantation.” But federal prosecutors have begun to question that pledge—concerned about its use of private jets for personal trips among the charity’s staff and donors.

Now, that group and two other nonprofits are under the microscope in a new investigation launched by Republicans in Congress—who say they may have overbilled the government for Medicare costs.

On Wednesday, Jason Smith—a Missouri Republican who leads the powerful House Ways and Means Committee—wrote to the Indiana Donor Network, the LifeShare Network, and the New Jersey Organ and Tissue Sharing Network to alert them of his concerns about their potential mishandling of federal dollars. In letters, Smith requested their financial records and other documents as part of a probe into their compliance with a program allowing the groups to be reimbursed through Medicare—the health insurance program for people age 65 or older.

“Recent reports of fraud, abuse, and corruption at several of these organizations are deserving of investigation in order to maintain public trust in our nation’s organ donations network and to ensure these entities are operating within their stated tax-exempt purpose,” Smith told The Free Press. He said the committee “will pursue any and all legislative means to ensure accountability and prevent waste, fraud, and abuse within our public healthcare system.”

The Wednesday letters, which were obtained by The Free Press, constitute what the Ways and Means Committee believes to be the first step in a broader investigation into possible corruption in the healthcare sector, including as it relates to government-funded reimbursements. The House committee has jurisdiction over Medicare, Medicaid, and other social services programs, and it helps to shape tax laws.

On Sunday, The New York Times reported that some organ transplant groups in states have worked to pressure families into surgeries—as an apparent means to profit even if organ removal might be premature.

News of the congressional investigation comes the same week that the Trump administration’s Health and Human Services Department announced it found “disturbing practices” by a major organ procurement organization (OPO) called Network for Hope that serves Kentucky, southwest Ohio, and parts of West Virginia. OPOs, like the three groups targeted by the House panel, are tax-exempt and receive federal contracts to work with hospitals to identify organ donors. In turn, the OPO program is overseen by the Center for Medicare and Medicaid Services—an agency that reimburses nonprofits for the costs of preserving and transporting organs.

The Indiana Donor Network, one of the OPOs under scrutiny, formed in 1987 and disclosed more than $92 million in annual revenue on its tax forms filed last year. In February, the network said it transplanted a record 1,388 organs in 2024. Its services are in high demand: Almost 100,000 people at any time, for instance, are estimated to be waiting for a kidney. The average wait time is three to five years, according to the Kidney Transplant Waitlist.

The letter to the Indiana Donor Network’s president and CEO, Kellie Tremain, said the House committee is looking at the potential misuse of jet charter flights for nonmedical purposes. It cited a Wall Street Journal report from November 2024. The Washington Post also reported on a probe into the organ transplant system in February 2024.

According to the Indiana Donor Network, flights that are unrelated to its mission accounted for only 1 percent of all its flights, and the group no longer conducts these kinds of charter flights.

“The committee wants to confirm that these flights were not incorrectly submitted on your Medicare Cost Report and reimbursed with taxpayer dollars,” Smith wrote in the letter, which, like the other two, was also signed by David Schweikert, an Arizona Republican congressman.

The Indiana Donor Network paid its board members and senior leadership more than $4.7 million in its last fiscal year, according to tax records.

They asked who at the group had the authority to charter flights, for flight logs in recent years, and whether the network paid any federal excise tax on charter flights for personal travel. Nonprofits may be subject to this type of tax for any number of reasons, including for flying and fuel, according to the National Business Aviation Association.

The committee is also examining compensation at the charity. The network paid its board members and senior leadership more than $4.7 million in its last fiscal year, according to tax records. The IRS holds that charities should pay these people a compensation that is “reasonable,” though it does not specify limits. Violations can lead the IRS to revoke an organization’s nonprofit status.

The Oklahoma City–based LifeShare Network, led by CEO Jeff Orlowski, is also facing congressional scrutiny. It is the parent of LifeShare Transplant Donor Services of Oklahoma as well as the LifeShare Foundation and another entity, LifeShare Tissue Services, Inc.

The LifeShare Network “serves as the administrative resource to its subsidiaries, allowing them to focus on their primary functions of procuring more organs and tissue resulting in more lives saved,” according its website.

The complex organizational structure has prompted concerns from the committee, which fielded responses on OPOs earlier this year through a public call for information. The lawmakers said the four LifeShare entities list Orlowski and two other people as executives, and that the arrangement “raises concerns that such intertwined business structures could be ripe for abuse.”

“The committee is concerned that there are not only potential risks of conflicts of interest between such related organizations, but that the Medicare reimbursement model for OPOs could allow cost shifting between these related parties to seek profitable tissue at the expense of taxpayers,” Smith and Schweikert wrote in the letter, which asked for an organizational chart, data for any financial transactions between the groups, and details on any of their conflict-of-interest policies. Nonprofits typically have conflict of interest policies that aim to ensure board directors do not benefit financially or otherwise from charitable activities. Federal regulations bar nonprofits from using the entities for “private benefit” or “private inurement.”

The committee’s letter to the New Jersey Organ and Tissue Sharing Network was addressed to its CEO and president, Carolyn Welsh. Republicans are investigating its Medicare reimbursements for pancreatic research “as well as any reimbursements for kidneys that were labeled ‘intent to transplant’ that were ultimately never transplanted,” the letter said.

The committee, according to the letter, received reports that claim the group took Medicare reimbursements for unperformed research and knowingly collecting kidneys that are not suitable for transplantation. “The claims state that this resulted in organs being left in freezers or incinerated rather than being used for its stated research purpose,” the letter said. It asked for reimbursement reports, statistics on recovered kidneys, and other financial records.

In the letters, the Republicans listed a deadline of two weeks for responses. Two people close to the House committee said that subpoenas are not off the table to try to compel the groups to release documents if they do not share any voluntarily. “I strongly encourage the OPOs receiving these letters to swiftly provide the committee with the requested documentation,” Smith also told The Free Press.

The Free Press has reached out for comment to the Indiana Donor Network, the LifeShare Network, and the New Jersey Organ and Tissue Sharing Network.