Troubled US organ transplant system targeted for overhaul

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 US 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.

A spokeswoman for UNOS did not respond to an email seeking comment on the proposal Tuesday evening.

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.

The proposal also aims to install a strong board of directors independent of UNOS, create a public dashboard for the volume of data the system generates and bring 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 facing the plan is that UNOS’s grip on the network is virtually written into the 1984 National Organ Transplant Act. It established the network – with UNOS in mind – as a “quasi-governmental agency,” And despite the fact that UNOS is a contractor with the federal government, it considers the technology that undergirds the nation’s transplant system itself.

Johnson will ask Congress to amend that law and raise the cap on what it can spend on contractors. But he also said he 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 plan’s key element appears to be improving the technology that surgeons, transplant coordinators and others have long complained about. In a confidential 2021 assessment for HRSA, the White House’s US Digital Service called UNOS’s technological archaic system 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 independently tested from 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.

UNOS, located in Richmond, sits at the center of the transplant system. It oversees what is formally known as the Organ Procurement and Transplant Network, a collection of about 250 hospitals that perform transplants; 56 government-chartered non-profits that collect organizations 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 life saving kidneys, hearts, livers and other organs because demand far outstrips supply. It 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 Senate Finance Committee, which has been investigating the transplant system for three years, reported that 70 people died and 249 developed diseases over a seven-year period after mistakes in the screening of transplanted organs.

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

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 2004-2014, 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 the 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.

The Washington Post’s Joseph Menn contributed to this report.