Lawmakers Pressed for Organ Transplant System Oversight (2)

Much work remains to improve the organ donation and transplantation system despite passage of legislation overhauling the program more than a year ago, a panel of medical providers and patient advocates told a House panel Wednesday.

The Oversight and Investigations Subcommittee of the House Energy and Commerce Committee heard a litany of disturbing allegations at the hearing, as the full committee also investigates the operations, oversight, and business practices of the organ donation and transplant system. Roughly 100,000 people are on the waiting list for an organ transplant in the US. And 17 people die each day waiting for an organ, said committee chair Cathy McMorris Rodgers (R-Wash.).

The committee’s members have asked the Department of Health and Human Services and the United Network for Organ Sharing—the group that manages the federal transplant program— for information about past failings of the troubled system as well as ongoing plans to improve it through legislation passed last year.

“The problem is that we’ve got 40 years where it has been no oversight at all” of the organ procurement organizations that solicit donor organs, said Seth Karp, surgeon-in-chief at Vanderbilt University Medical, during testimony at the hearing. That’s led to “poor education, poor standard of practice, poorly trained people,” he said.

Congress unanimously passed H.R. 2544, the Securing the U.S. Organ Procurement and Transplantation Network Act, which President Joe Biden signed into law Sept. 22, 2023.

The legislation allows—for the first time—competitive bidding on multiple contracts to manage the Organ Procurement and Transplantation Network (OPTN), which maintains a national registry to help match organ donors with recipients. It was meant to break the monopoly hold of the United Network for Organ Sharing, or UNOS, which has solely managed the OPTN network under federal contract since the 1980s.

Program Troubles

Allegations of the program’s failings that were aired at the hearing included stories of presumably brain-dead organ donors who were found to be still alive as surgeons prepared to remove their organs.

“No one really knew what to do,” Robert Cannon, associate professor of surgery at the University of Alabama at Birmingham, said in testimony about one particular incident. An administrator at the unnamed hospital said it was likely a “brain stem reflex” that made the patient appear to be breathing, Cannon said.

That official recommended the team proceed with the organ removal, “which, of course, would have been murder, if we had done so,” Cannon said. “So, yes, we closed the patient and we got out of Dodge. We wanted nothing to do with this.”

The patient was later declared brain dead, but when Cannon was again asked several days later to harvest the same patient’s organs, he said he declined.

“It’s like a bad Netflix movie,” said Rep. Kelly Armstrong (R-N.D.).

In a statement, the Association of Organ Procurement Organizations criticized the hearing’s “false, misleading, and unsupported allegations, featuring an unbalanced panel of witnesses who reinforce the narrative that erodes public trust in the organ transplantation system.”

The group was “disheartened” by the hearing’s focus on OPOs “without notifying the national organization or inviting us to serve as a witness,” the group said. “It is unclear how a hearing can address organ donation and transplantation without including critical stakeholders.”

UNOS also criticized the hearing for being less about the legislation and more about witnesses’ “unfounded allegations” that could “jeopardize confidence” in the organ donation and transplant system. “They continued to promulgate untruths and misunderstandings about the OPTN and how the United Network for Organ Sharing (UNOS) has operated it for decades, with oversight by HRSA,” the organization said in a statement.

The “troubling accusations” from witnesses included “instances of alleged malfeasance by hospital staff, surgeons, and organ procurement organizations,” the UNOS statement said. The group said the safety of patients “is UNOS’ top priority,” adding that “Any concern that the health or safety of patients has been jeopardized must immediately be reported to the relevant authorities for full investigation.”

The group said it “fully supports” the efforts of the Health Resources and Services Administration at the HHS efforts to modernize OPTN operations, and “has called for a federal tracking system for organs, increased patient empowerment tools to support patients’ choices regarding their transplantation care, and improvements to hospitals’ donor referral processes to organ procurement organizations.”

Questions on Implementation

In the year since the law (Public Law 118-14) was enacted, members of Congress have questioned implementation of the legislation by the HRSA. Representatives of HRSA and OPTN President Richard Formica declined requests to testify at the hearing citing insufficient advance notice.

In their absence, panelists told the committee that the legislation has already spurred improvements, like more funding of organ transplant operations.

But they all called for continued strong oversight of OPTN and HRSA’s efforts to modernize the nation’s troubled transplant system.

Greg Segal, founder and CEO of Organize, a patient advocacy organization, told the committee he fears for his personal safety due to his work with whistleblowers to expose wrongdoing in the organ donation and transplant sector.

After 40 years of UNOS and the OPTN having the same board members, which raised conflict of interest concerns, HRSA recently announced that the OPTN board has become “separately incorporated” from the UNOS board, and that a newly constituted OPTN board will be put in place.

In addition, the agency awarded a contract to support the newly incorporated OPTN board to the American Institutes for Research, a national nonprofit organization. The group will “be responsible for eliminating conflicts of interest and ensuring that data, evidence, and the voices of clinical leaders, scientific experts, patients, and donor families drive the Board’s decisions,” a HRSA announcement said.

The group will also conduct a special election to establish a truly independent OPTN Board of Directors.

Karp said Congress should commit HRSA to replacing the board with impartial independent board members.