Troubled U.S. organ transplant system targeted for overhaul

Brian Shepard, former chief executive of the United Network for Organ Sharing, testifies in August 2022 before senators investigating failures of the Organ Procurement and Transplant Network. Jabin Botsford/The Washington Post

The government announced plans Wednesday to overhaul the troubled U.S. organ transplant system, including breaking up the monopoly power of the nonprofit organization that has run it for the past 37 years.

If successful, the proposal would leave little unaffected in the sprawling, multibillion-dollar network that sends kidneys, livers and other organs from deceased donors to severely ill recipients. That system has long been criticized as inadequate: Nearly 104,000 people are on waiting lists for organs, most of them kidneys; 22 people die each day awaiting transplants, with poor and minority patients generally faring worse than affluent and White people.

Carole Johnson, administrator of the federal Health Resources and Services Administration, the agency responsible for the network, is proposing to break up responsibility for some of the functions performed by its nonprofit manager, the United Network for Organ Sharing. UNOS is the only entity ever to operate the U.S. transplant system.

She said in an interview that she would invite other organizations to take over those areas. They would bid for separate contracts, creating the first competitive environment in the history of the transplant system.

“Our goal is to get best in class for all the functions we think are essential to running the transplant network,” Johnson said.

Under UNOS, which holds a $6.5 million annual contract with HRSA, the network has been plagued by problems: Too many organs are discarded, damaged in transit or simply not collected, faulty technology sometimes jeopardizes transplants, and poor performers face little accountability.

UNOS said in a statement Wednesday that it “supports HRSA’s plan to introduce additional reforms into the nation’s organ donation and transplantation system,” and welcomed a competitive bidding process.

“We believe we have the experience and expertise required to best serve the nation’s patients and to help implement HRSA’s proposed initiatives,” the statement said.

But the federal proposal would also change how the network is structured, installing a strong board of directors independent of UNOS, creating a public dashboard for the voluminous data the system generates and bringing more transparency to the sometimes opaque process of how patients and organs are matched.

The Biden administration has committed $67 million in its proposed fiscal 2024 budget for what Johnson is calling a “modernization” of the transplant network – nearly double the amount in the current budget.

“What’s so critical to us is ensuring we are doing everything possible to improve the system that patients and families depend on,” Johnson said.

One major obstacle to the plan is that UNOS’s grip on the network is virtually written into the 1984 National Organ Transplant Act. It established the network to be run by a nonprofit that would function as a “quasi-governmental agency” under a single contract – with UNOS in mind. And although UNOS is a contractor with the federal government, it considers the technology that undergirds the nation’s transplant system its own.

Johnson said she will ask Congress to amend that law and raise the cap on what it can spend on contractors. But she also asserted that she has the legal authority to move forward if Congress does not act. Bid solicitations could go out as soon as this fall, she said.

The early reaction on Capitol Hill appeared positive on both sides of the aisle.

“For too long, it’s been clear that UNOS has fallen short of the requirements for this contract and the expectations of Americans waiting for a transplant,” said Sen. Ron Wyden (D-Ore.), chairman of the Senate Finance Committee, which has investigated problems in the transplant system for three years.

“Thousands of patients are dying every year and billions of taxpayer dollars are wasted because of gross mismanagement,” said Sen. Charles E. Grassley (R-Iowa). “The system is rife with fraud, waste and abuse, corruption, even criminality.”

Patient advocates also lauded the plan. Greg Segal, founder and CEO of Organize, a nonprofit patient advocacy group, said “UNOS has allowed the organ donation system to become mismanaged, unsafe and self-enriching. Today’s announcement that [the government] will break up UNOS’s monopoly, and bring in competent and transparent new contractors, is a transformative and unequivocal win for patients.”

But Stephen Gray, surgical director of the liver transplant program at George Washington University Hospital, said he thinks UNOS does a good job of managing a commodity – organs – in drastically short supply.

“I really question whether getting rid of them would change anything,” Gray said.

BOOSTING TECHNOLOGY

The plan’s key element appears to be improving the technology that surgeons, transplant coordinators and others have long complained about. In July, The Washington Post reported that a confidential 2021 assessment for HRSA by the White House’s U.S. Digital Service called UNOS’s technological system archaic and said it should be “vastly restructured.” The technical agency also recommended breaking up UNOS’s monopoly over that technology.

In February, the system went down once for 40 minutes, the kind of event that should never happen, according to UNOS’s interim chief executive, Maureen McBride. She said in an interview last month that the nonprofit was seeking an increase in the fee paid by patients awaiting transplants to fund improvements in its technology, for anticipated growth in the number of organs transplanted and the increased distances they must travel.

HRSA, however, is proposing a “modular” system of improvements that could be tested independently of one another and gradually knit together into a new structure while the old one is still running. That setup would also allow for each component to be improved individually, without having to rewrite the entire program.

Richmond-based UNOS sits at the center of the U.S. transplant system, a collection of about 250 hospitals that perform transplants; 56 government-chartered nonprofits that collect organs in their regions; labs that test organs for compatibility and disease; and other auxiliary services. Together, they were responsible for 42,887 organ transplants in 2022, a record.

UNOS’s multiyear contract comes up for renewal this year. It is funded mainly by fees patients pay to be listed for transplants.

UNOS also oversees sometimes controversial policies that determine which patients have priority for lifesaving kidneys, hearts, livers and other organs, for which demand far outstrips supply. For example, a data analysis published this week by The Post and the Markup revealed that the number of lifesaving liver transplants has plummeted in some Southern and Midwestern states that struggle with higher death rates from liver disease under new donation rules adopted in 2020. The number of wasted livers also has shot up under the rules.

In addition, UNOS reviews errors by members of the network and maintains waiting lists. And it runs the complex technology that connects the whole enterprise.

Some of the 56 organ procurement groups also fail to meet government standards for collecting organs in their regions. Each holds a monopoly for its area. After decades of allowing the groups to calculate and report their own compliance data, the government in 2019 took steps to hold the worst of them accountable.

In August, The Post reported that the Senate Finance Committee investigation had found 70 deaths and 249 diseases over a seven-year period after mistakes in the screening of transplanted organs.

The Post also detailed how the first uterus transplant in U.S. history failed in 2019, for example, because the organ came from a donor infected with a life-threatening fungal infection.

A 2018 Post analysis showed the transplant network could produce more than twice as many organs, primarily by pursuing additional organs from people often dismissed as too sick, too old or too complicated and persuading transplant surgeons to accept those organs.

Critics have long said UNOS does little to address many of the complaints about chronically underperforming organ procurement organizations. But only the Centers for Medicare and Medicaid Services, another agency in the Department of Health and Human Services, can revoke an organ procurer’s license. That has never happened in the history of the transplant system.

DISCARDED ORGANS

In 2020, 21.3 percent of procured kidneys were not transplanted, according to the Scientific Registry of Transplant Recipients, a data analysis operation that is part of the transplant network but separate from UNOS. The reasons for that discard rate are in dispute, with members of the network often blaming one another.

European countries report much lower discard rates for kidneys, according to various studies. France had a kidney discard rate of 9.1 percent from 2004 to 2014, a 2019 study found. The United Kingdom has a rate ranging from 10 to 12 percent. Eurotransplant, a consortium of eight countries including Germany, reported a rate of about 8 percent.

Last year, the National Academies of Sciences, Engineering and Medicine came to the same conclusion as the government’s Digital Service, recommending splitting information technology into a separate contract, or requiring UNOS to modernize when its current contract comes up for rebidding.

UNOS’s shortcomings have been compounded by HRSA’s own failings, another target of Johnson’s proposal.

The agency lacks technical expertise, can’t force UNOS or other parts of the transplant network to turn over data, and has been reluctant to push for more intensive demonstrations of UNOS’s technology, according to the Digital Service’s 2021 report and interviews.

That has allowed UNOS “to wiggle through and around most new contract requirements for the [transplant network’s] technology by hand-waving at change with technical jargon, while making no substantive progress,” the Digital Service reported.

It also leaves HRSA merely monitoring UNOS instead of exercising supervisory authority as government agencies commonly do with their contractors, the report said.