Legislation Clears the Path for Transplant System Reform

Bridget M. Kuehn
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A July Capitol Hill visit from an ASN delegation highlighted the need to fast-track passage of legislation to reform and modernize the U.S. transplant system. The visit was the latest in years of advocacy by patient and clinician organizations seeking to improve the nation's transplant system and make transplantation more accessible.

The Securing the U.S. Organ Procurement and Transplantation Network (SUS OPTN) Act passed the U.S. House of Representatives and the Senate with bipartisan support in late July (1, 2), 1 week after ASN advocates visited their members of Congress asking for swift enactment of the legislation. ASN and 29 other organizations representing patients with kidney diseases and their clinicians supported the legislation (3). The passage of the SUS OPTN Act provides the Health Resources & Services Administration (HRSA) the ability to fully implement its “OPTN Modernization Initiative,” which aims to increase transparency, accountability, competition, and efficiency in the OPTN.

“It just gives HRSA the green light to go ahead with the Modernization Initiative,” said ASN President Michelle Josephson, MD, FASN, professor of medicine and surgery at The University of Chicago Pritzker School of Medicine, IL. “This is step one.”

Need for modernization

Roslyn Mannon, MD, chair of ASN's Policy and Advocacy Committee and professor of medicine in the Division of Nephrology and vice chair of research in the Department of Medicine at the University of Nebraska Medical Center in Omaha, remembers that early in her career, many transplant programs were small “mom and pop” operations driven by trailblazers at local hospitals. The National Organ Transplant Act of 1984 established the first national organ recovery and allocation system, and the United Network for Organ Sharing (UNOS) received the first federal contract to operate the OPTN and has operated it ever since (4). Mannon noted the remarkable accomplishments in the field of transplant since then. There are now 56 organ procurement organizations and 250 transplant centers in the United States, and by 2022, the system had completed 1 million organ transplants. But Mannon acknowledged room to continue to progress and address shortcomings in the system.

“I recognize the incredible work our field has done,” she said. “But it also feels like our field is lagging.”

Mannon shared that concerns from transplant teams and patients have not been addressed in some cases. For example, archaic technology and hardships for transplant centers not located near a major transportation hub can lead to delays in receiving organs. Additionally, it has been difficult to track organs in transit. That has been incredibly frustrating considering how easy it is to track far less valuable online purchases from retail sites, she noted.

“These are precious commodities,” Mannon said. “These are people's organs helping other people.”

A 2022 Senate hearing outlined the results of a Senate investigation into the U.S. transplant system and its contractors (5). Investigators alleged inadequate system oversight, a lack of technical expertise, and mismanagement leading to excessive numbers of unused organs. Additionally, the White House Digital Service recommended breaking up UNOS’ “monopoly” on the transplant system to help address problems with outdated software, system failures, and overreliance on manual data entry (6).

Vineeta Kumar, MD, a transplant nephrologist at The University of Alabama at Birmingham, said the system is not necessarily working poorly now, but she noted that much has changed in the last four decades. For example, the complexity and volume of patients have increased.

“We’ve learned over decades of experience that we want to be able to do more better,” she said. “We need a new set of tools that are different than [what] we needed four decades ago.”

The U.S. transplant system is the largest in the world but also has the highest rate of discarded organs, said Sumit Mohan, MD, MPH, professor of medicine and epidemiology at Columbia University and medical director of the kidney transplant program at Columbia University Irving Medical Center in New York. The system discards one in four donated kidneys, and most are transplantable, said Mohan, who also serves on ASN's Quality Committee. The number of discards is also growing, he noted.

“That is simply unacceptable,” he said. “The majority of those kidneys would have been used in another system.”

The exact reasons for the high discard rate are unclear, partly because there are inadequate data to understand what caused a kidney discard, Mohan explained. But there are likely multiple contributing factors. Some possible contributors are previous performance measures that rewarded centers for the transplanted organ's performance, which incentivized cherry-picking the best organs available and putting patients on the waiting list most likely to have a successful transplant, he said. Kumar agreed that the current quality metrics for transplant centers, which are used by payors like Medicare, may inadvertently incentivize centers to keep their local waitlist small.

“In that process, you can really limit access,” Kumar said. She noted that having more granular data might allow more meaningful quality metrics. But doing that requires both more sophisticated data systems and appropriate resources for good data entry into the system—both stated goals of the OPTN Modernization Initiative.

Kidney allocation procedures may also lead to kidney discards, Mohan noted. For example, if multiple transplant centers are offered and turn down an organ, the organ may spend too much time on ice to be transplanted.

“Transplant is a team sport,” Kumar said. “Every cog in the wheel has to function in rhythm with the other wheel to turn, but not everything in transplant is aligned for that.”

There are about 100,000 people on the kidney waiting list and about 25,000 kidney transplants each year, a disparity that discarded kidneys may exacerbate, Mannon noted. About 6000 patients on the waiting list die each year. Additionally, about half a million people are on dialysis, but it is not clear why more of them are not on the transplant waiting list, Mohan said. He said nephrologists believe most would be good transplant candidates. There have also been persistent racial, ethnic, and socioeconomic disparities in which patients receive transplants, Mohan highlighted.

“We need a more patient-centered, more transparent system,” he said. “As a system, we are not doing well from an access-to-care standpoint.”

Policy fixes

HRSA's OPTN Modernization Initiative aims to address some of the shortcomings of the current system, focusing on upgrading information technology systems and making transplant more transparent, opening competition for contracts, and increasing accountability (7). Specifically, the initiative is focused on five key tasks: technology, data transparency, governance, operations, and quality improvement and innovation. HRSA has also created a dashboard highlighting de-identified information on organ donors, procurement, transplant waitlists, and wait time (8).

“At HRSA, our stewardship and oversight of this vital work [are] a top priority,” said HRSA Administrator Carole Johnson in a statement from the agency (9). “That is why we are taking action to both bring greater transparency to the system and to reform and modernize the OPTN. The individuals and families that depend on this life-saving work deserve no less.”

Statutory restrictions on HRSA's administration of the transplant system needed to be lifted to fully implement the Modernization Initiative. Mohan explained that the previous law required the OPTN contractor to be a nonprofit and have experience overseeing the OPTN. Since UNOS has run the OPTN for 40 years, it was effectively the only contractor eligible to apply.

“It [the SUS OPTN Act] gives HRSA a lot more flexibility to do the things we think it needs to do,” Mohan said.

“The notion of modernization is something to embrace,” Mannon said. “This is a great opportunity to move the field forward.”

The SUS OPTN Act lifts the restriction that the contractor be a nonprofit with experience and opens the possibility of creating multiple contracts for individual tasks such as governance or technology. Mohan said this would allow HRSA to award contracts to vendors with the right technology, logistics, or governance expertise. It also requires separate contracts for OPTN's Board of Directors and its operations. Currently, the OPTN and UNOS are so closely aligned that many of the same people serve on the two organizations’ Boards of Directors and as officers in the organizations. But HRSA wishes to separate the two organizations, create independent governance boards, and spread some of the tasks of the OPTN among multiple contractors.

The SUS OPTN Act and Modernization Initiative open a national conversation on how to improve the transplant system and a discussion about new ways to achieve the system's goals, said Kumar. She noted that, currently, many dialogues about how to improve the system are occurring in silos—the modernization process can bring people together to develop meaningful improvements and help break down those silos that hinder communication and patient care.

“It's a step forward to making things better for our patients and the transplant enterprise in general,” she said.

Josephson emphasized that greater investment in the transplant system is needed to help upgrade its information technology and ensure independent oversight of the system. The Biden administration's fiscal year 2024 budget proposed doubling federal investment in organ transplantation and procurement, from $36 million to $67 million. Securing the additional funding will require Congressional approval of the budget request.

“It puts into place the opportunity to make structural improvements,” Josephson said. “That is an exciting thing.”

Mohan said that upgrading the system's information technology and increasing the amount of data it tracks is essential. The entire system relies on technology and accurate data to support the allocation of organs and monitor the transplant system's performance.

“We need a lot more data than we currently collect to be able to do all those tasks in a meaningful, robust, and accurate way,” he said.

Mannon noted that having a competitive contracting process brings the U.S. transplant system more in line with other U.S. government functions and that the prospect of losing a contract for poor performance may incentivize contractors to perform better. “Competition has always been an important aspect of how this country has moved forward,” she said.

Mohan noted that HRSA's OPTN Modernization Initiative includes a preference for a nonprofit organization to be the contractor for the governance tasks, which he says makes sense. The key to success will be strong oversight from HRSA, he said.

“The onus falls to HRSA to do a better job of managing the contracts,” he said. “They must do a much better job of ensuring the contractors are delivering. If HRSA does that well, it won't matter whether the contractor is for-profit or nonprofit.”

Ongoing advocacy from ASN and other organizations dedicated to the needs of patients with kidney diseases and their caregivers is also essential.

“What we all have to do is to help HRSA succeed,” Josephson said. “If they succeed, we succeed. We have to be honest with them about what's good and bad [in the system] and focus on improving areas that need improvement and keeping things that work.”

Disclaimer: The views of Drs. Kumar, Mannon, and Mohan are their own and do not represent the official views of their institutions or ASN.