Organ transplants were a hot topic around the capitol this past week.
On Thursday, the Biden administration proposed a measure to streamline procedures in which an HIV-positive organ can be given to a recipient with the bloodborne disease.
A day prior, the House oversight panel and a prominent senator lit a fire under ongoing work to decentralize the country’s organ transplant system. The former held a hearing in which witnesses testified on misconduct among organ procurement organizations, while the latter penned a letter to the Health Resources and Services Administration (HRSA) criticizing its progress on “much-needed,” Congressionally mandated reforms.
Faster kidneys, livers for HIV-positive candidates
A 2013 law permits organ transplant in which both the donor and candidate have HIV, but only under clinical research protocols and with the blessing of an institutional review board. Those requirements were intended to better gauge the safety and effectiveness of such transplants.
However, the government now feels that it’s collected enough data on liver and kidney transplants. Under a proposed rule unveiled Thursday, the requirements would be removed for these procedures—a move the administration said should pave the way for more transplants and reduce stigmas and health disparities associated with HIV.
“All across this country, there are HIV-positive Americans who need an organ transplant and HIV-positive Americans who are ready and willing to donate,” Health and Human Services Secretary Xavier Becerra said in a release. “Unfortunately, the process of approving those transplants is too slow and too few transplant centers participate due to burdensome requirements, resulting in unnecessary suffering for all involved. Our new policy removes these requirements for HIV-positive kidney and liver transplants and will expand access to organ transplantation for people with HIV and increase overall transplant volumes for all Americans irrespective of their HIV status.”
Other types of organ transplants for which there are “significantly less data available” will still be subject to the research and institutional review board requirements. Still, the administration said that its National Institutes of Health will be convening a working group to revisit the criteria for these other procedures to help build an evidence base of outcomes data.
Witnesses outline fraud, safety misconduct allegations in oversight hearing
Since 1986, the private nonprofit United Network for Organ Sharing (UNOS) has served as the sole contractor for the country’s Organ Procurement and Transplantation Network (OPTN).
Concerns about its performance and those of the organ procurement organizations it coordinates in that role led to a 2023 law breaking up UNOS’ “monopoly” in favor of open bidding and other network reforms, a change the group said it welcomed. In tandem with the law, HRSA has pushed forward with requests for contract proposals, technology overhauls and board of director appointments—though that process has reportedly hit a few snags.
On Wednesday, the House Energy and Commerce Subcommittee on Oversight and Investigations held a hearing reviewing the state of the OPTN one year following the overhaul law’s signing. Subcommittee members said they were concerned about potential “inefficiencies” in organ coordination and potential conflicts of interest.
“The current state of organ transplantation in our country is inadequate and must be addressed,” Subcommittee Chair Morgan Griffith, R-Virginia, said in his opening comments. “There are over 100,000 individuals waiting for an organ transplant and about 17 people die each day waiting for one. Notwithstanding the need for viable organs, according to one study, there are more than 28,000 viable organs that are not recovered each year. We must do better.”
Though representatives from HRSA, the OPTN and UNOS were not in attendance, the hearing’s witnesses—a mix of surgeons, a transplant network watchdog and the government relations head of the National Kidney Foundation’s government relations—told lawmakers that they were right to be concerned.
Greg Segal, the head of a transplant advocacy group called Organize, described an allegation being reviewed by the Kentucky Attorney General’s Office in which surgeons refused to secure an organ from a patient turned out to be alive and conscious.
Segal described to another such incident without giving specifics. Robert Cannon, M.D., surgical director for liver transplant at the University of Alabama at Birmingham, said he had a similar firsthand experience at a different institution. Another member of the care team warned that the patient who had been declared brain-dead had breathed. Yet Cannon was instructed to continue with the procedure, “which of course, would have been murder,” but refused.
Beyond these alleged incidents, the witnesses described Medicare and Medicaid fraud among the 56 organ procurement organizations participating in the OPTN. They also criticized the OPTN’s board of directors, who they said still have clear ties to UNOS and have acted in the group’s self-interests despite HRSA’s efforts to rework the board. Each of the claims landed on receptive ears, with lawmakers raising doubts about HRSA’s performance in overseeing the network.
“I’ve been on this committee a long time, and these are some of the most serious allegations that I’ve seen,” Rep. Michael Burgess, M.D., said of the Medicare fraud allegations. “… But then the damage to the patients, the damage to the credibility of the system in which you all work—I almost don’t know how you recover from that.”
In a statement, UNOS said the witnesses allegations were “unfounded” and threatened to “jeopardize confidence in our country’s donation and transplantation system.”
“Among the troubling accusations made at today’s hearing were instances of alleged malfeasance by hospital staff, surgeons and organ procurement organizations,” the group said. “If true, UNOS reminds the public that such allegations must be reported to applicable government authorities and law enforcement for further investigation. The safety of patients is UNOS’ top priority.”
The Association of Organ Procurement Organizations similarly condemned the hearing and testimonies. In its own statement, the group said “it appears that—once again—our lawmakers are being directed away from the truths about our system to instead discuss a litany of false, misleading and unsupported allegations, featuring an unbalanced panel of witnesses who reinforce the narrative that erodes public trust in the organ transplantation system.”
Sen. Cassidy questions HRSA on reform delays
Criticisms of the country’s organ transplantation system and HRSA weren’t limited to the House. Also on Wednesday, Senate Health, Education, Labor, and Pensions (HELP) Committee Ranking Member Bill Cassidy, M.D., R-Louisiana—a cosponsor of the OPTN overhaul bill—a penned a letter to HRSA seeking answers on delays in the implementation.
“[HRSA] just recently issued final requests for proposals (RFPs) to support multiple contract awards related to board of directors’ support and operations in May and formally incorporated an independent board of directors in June,” he wrote. “Additionally, HRSA has yet to release details about steps to improve the OPTN’s IT infrastructure through the forthcoming Next Gen contract solicitations.”
Cassidy outlined a fourteen-point list of implementation questions for HRSA—such as what steps the OPTN is taking to prevent future conflicts of interest among board members and management roles—with a Sept. 24 deadline.
“As the agency tasked with overseeing the OPTN, [HRSA] must ensure that the OPTN improves its efficiency so that more patients can receive the gift of a lifesaving organ,” he wrote.
There were a record 46,632 organ transplants performed in 2023, according to HRSA, though more than 103,000 people remained on the national transplant waiting list as of March.