The national system for allocating and distributing human organs for transplantation is on the verge of a transformation that advocates have sought for years.
After an outcry from providers and patients and a major congressional investigation, lawmakers overwhelmingly passed the Securing the U.S. Organ Procurement and Transplantation Network Act of 2023 in July. President Joe Biden, who requested an overhaul in his fiscal 2024 budget proposal, is expected to sign the bill, which would end the United Network for Organ Sharing's nearly four-decade monopoly over the system and enable other organizations to participate.
UNOS, as the nonprofit organization is known, has been subject to accusations of mismanagement, lengthy waiting lists, lost organs, fatalities and a failure to address disparities in donations and distributions among racial and ethic minorities. “From the top down, the U.S. transplant network is not working, putting Americans’ lives at risk,” the Senate Finance Committee concluded in a 2022 report.
Here’s what you need to know about the looming changes to the organ transplant system:
What would the bill do?
The legislation would authorize the Health Resources and Services Administration to seek bidders to compete with UNOS to participate in the Organ Procurement and Transplantation Network. The goal is a modernized system that boosts the supply of donated organs and creates a swifter and more equitable allocation process, according to the lawmakers who spearheaded the bill, which the House approved by voice vote and the Senate unanimously adopted. Rep. Dr. Larry Bucshon (R-Ind.) and Senate Finance Committee Chair Ron Wyden (D-Ore.) were the lead sponsors.
The Health and Human Services Department, which would gain enhanced oversight authority, endorsed the measure after Congress completed its work.
“With this new law, we will be able to give you far more transparency in how this is done. With this new law, we will give you far more accountability. If we can get those two things, then the operations just start to match the need,” HHS Secretary Xavier Becerra said during an event with Wyden in Portland, Oregon, on Aug. 7.
UNOS did not oppose the measure and intends to remain involved in the Organ Procurement and Transplantation Network, a spokesperson wrote in an email. “We are committed to working with [HRSA] and other stakeholders to ensure the best possible system for patients and donors. No organization knows the incredibly complex system and the transplant community as well as UNOS, and we look forward to demonstrating how our expertise should remain an integral part of the system,” the spokesperson wrote.
Congressional action followed administrative efforts to improve the organ transplantation system in recent years.
HRSA announced a plan in March to update the Organ Procurement and Transplantation Network and increase spending on procurement and transplantation. In 2019, then-President Donald Trump issued an executive order triggering regulatory actions to make more kidneys available. The following year, the Centers for Medicare and Medicaid Services published a final rule modifying how organ procurement organizations are assessed. UNOS formulated its own changes to the system in 2018.
The legislation also broadly aligns with the goals an influential National Academies of Sciences, Engineering and Medicine panel outlined last year.
Why is the government acting now?
The Finance Committee investigation that commenced in 2020 culminated decades of scrutiny on the organ transplant system's shortcomings and UNOS' culpability for them. The organization came under fire from Democrats and Republicans during a series of hearings, most recently in July.
The National Organ Transplant Act of 1984 established the Organ Procurement and Transplantation Network and effectively handed over the system to UNOS starting in 1986. As the sole contractor, UNOS runs the process, including overseeing waiting lists, monitoring organ matches, supervising logistics, managing information technology and maintaining patient safety.
About 104,000 people are on organ waiting lists and an estimated 17 patients on those lists die each day, HRSA reported. More than 42,800 organ transplants occurred in the U.S. last year, according to UNOS.
What are the system’s flaws?
Advocates for remaking the organ transplantation system and eliminating the UNOS monopoly charge that the organization is responsible for wasted or damaged organs and manages the process in ways that exacerbate disparities among racial and ethnic minorities and people who live in rural areas. Black and Latino patients, for example, are more likely to be diagnosed with end-stage renal disease but are less likely to make the kidney waiting list than white patients, CMS reported in 2021.
“What ultimately has been plaguing patients for years is there's been a deeply unaccountable, opaque and often conflicted system, which does not come anywhere close to facilitating as many transplants as we all should expect,” said Greg Segal, founder and CEO of Organize, a patient advocacy group.
During a hearing last year, the Finance Committee revealed that patients, families, staff and transplant centers submitted more than 1,100 formal complaints about the organ transplant system between 2010 and 2020.
Among the committee's findings was that some organ procurement organizations, which are tasked with recovering organs from deceased donors, fail to complete mandatory tests for blood types, diseases and infections. The probe also found that 249 patients developed ailments from transplanted organs between 2008 and 2015, and more than one-fourth of them died.
The HHS Office of Inspector General reported this month that Medicare paid organ procurement organizations more than $660,000 for unallowable professional and public education overhead costs, including meals, donations and gifts, and entertainment from May 31, 2015, through June 30, 2019. The investigative agency attributed the errors to administrative mistakes and misinterpretations of CMS regulations.
The White House's U.S. Digital Service criticized UNOS for inadequate technology, logistics and oversight in a 2021 report.
Who supports the legislation?
Organizations including the American Society of Nephrology, Kidney Care Partners, the Renal Healthcare Association, the National Kidney Foundation, Organize and the Federation of American Scientists, along with providers such as DaVita and Fresenius Medical Care, endorsed the legislation in a letter sent to Finance Committee members in May. "Our organizations stand ready to collaborate with you, other members of the U.S. Congress, HRSA, the U.S. Department of Health and Human Services and other stakeholders to inform and support the forthcoming implementation process of this vital modernization effort," 30 groups wrote in the letter.
The American Hospital Association favors remaking the organ transplantation system. “The hope is that you'll get a number of bids from organizations that have particular expertise and the electronic backbone that would enable them to make those matches swiftly, accurately, even more effectively done,” said Nancy Foster, vice president for quality and patient safety policy.
The National Patient Advocate Foundation applauded the bill. “Patients need to be able to trust our healthcare system. We achieve trust through equitable policies that emphasize transparency and accountability. The new, bipartisan legislation gives HRSA the tools to achieve better results and restore trust in the organ transplant system,” a spokesperson wrote in a statement.
Enabling HRSA to contract with a variety of organizations with different areas of expertise will result in a superior system, said Jennifer Erickson, a senior fellow at the Federation of American Scientists who was organ donation policy lead for the White House Office of Science and Technology Policy under President Barack Obama. “If you are very good at logistics or getting things safely and quickly around the country, that is a different skill set from [being] very good at identifying patient safety problems and addressing them," she said.
What are the downsides?
The AHA and others harbor concerns about the consequences of rapidly dismantling a system to which the healthcare sector is accustomed.
“The fear, of course, from some of our transplant centers is that when you break up a contract so that different organizations run different pieces of it, it can create discontinuity," Foster said. "To the extent that any differences in the way one organization thinks the system should proceed versus another organization that has a different part of it thinks it should proceed, that can create chaos."
Divvying up contracts among new entrants and transitioning to new processes could create gaps in the system, said Dr. Ryutaro Hirose, professor of surgery and vice chair of clinical operations and value at the University of California, San Francisco. “The transition has to be seamless and perfect, otherwise things could fall through the cracks and people may die,” he said.