Carole Johnson, administrator of the federal Health Resources and Services Administration, the agency responsible for the network, suggests dividing responsibility for some of the functions conducted by its nonprofit manager, the United Network for Organ Sharing. UNOS is the sole entity that operates the US transplant system.
He said in an interview that he will invite other organizations to occupy those areas. They will 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 that we think are important to the operation of the transplant network,” Johnson said.
A spokeswoman for UNOS did not respond to an email seeking comment on the proposal Tuesday night.
Under UNOS, which has a $6.5 million annual contract with HRSA, the network is plagued by problems: Too many organs are thrown away, damaged in transit or simply not collected, faulty technology sometimes endangers transplants, and poor performers face little accountability.
The proposal also aims to install a strong board of directors separate from UNOS, create a public dashboard for the vast amount of data generated by the system and bring more transparency to the sometimes opaque process of how matching patients and organs.
The Biden administration provided $67 million in the proposed fiscal 2024 budget for what Johnson called a “modernization” of the transplant network — nearly double the amount in the current budget.
“What’s very important to us is making sure we’re doing everything possible to improve the system that patients and families rely on,” Johnson said.
A major obstacle facing the plan is that UNOS’s grip on the network is largely written into the 1984 National Organ Transplant Act. It establishes the network — UNOS is in mind — as a “quasi-government agency.” And despite the fact that UNOS is a contractor to the federal government, it considers the technology that underlies the country’s transplant system to be its own.
Johnson said he will ask Congress to amend that law and raise the limit on what it can spend on contractors. But he also insisted he has the legal authority to move forward if Congress doesn’t act. Requests for bids could go out as soon as this fall, he said.
Sen. Ron Wyden (D-Ore.), chairman of the Senate Finance Committee, which has been investigating problems with the transplant system for three years, hailed the plan as “a huge victory for families across the country … , it became clear that UNOS fell short of the requirements for this contract and the expectations of Americans waiting for a transplant.”‘
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 HHS monopolizing UNOS, and bringing in competent and transparent new contractors, is a change and a clear win for patients.
A key element of the plan appears to be improving the technology that surgeons, transplant coordinators and others have long complained about. In a confidential assessment for 2021 for HRSA, the White House’s US Digital Service called UNOS’s technological system is outdated and it is said to be in need of a “major overhaul.” The technical agency also recommended breaking UNOS’s monopoly on that technology.
In February, the system went down once in 40 minutes, the kind of event that shouldn’t happen, according to UNOS’s interim chief executive, Maureen McBride. He said in an interview last month that the nonprofit is seeking an increase in fees paid by patients awaiting transplants to fund improvements in its technology, for expected growth in the number of organs transplanted and the more high distance they must travel.
HRSA, however, proposes a “modular” system of improvements that can be tested independently of each other and gradually come together in a new structure while the old one is still in operation. 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 US 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 nonprofits that collect organs in their regions; laboratories that test organs for compatibility and disease; and other ancillary services. Together, they are responsible for 42,887 organ transplants in 2022, a record.
UNOS’ multiyear contract is up for renewal this year. It is primarily funded by fees paid by patients to be listed for transplants.
UNOS also oversees sometimes controversial policies that determine which patients get priority for life-saving kidneys, hearts, livers, and other organs because demand outstrips supply. It checks network members for errors and maintains waiting lists. And it runs the complex technology that connects the entire business.
Some of the 56 organ procurement groups also failed to meet government standards for collecting organs in their regions. Each holds a monopoly for their area. After decades of allowing 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 reported that 70 people died and 249 developed illnesses in seven years after errors in the screening of transplanted organs.
Critics have long said UNOS does little to address many of the complaints about 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 transplanted 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 the dumping rate are disputed, with network members often blaming each other.
European countries report lower disposal rates for stones, 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 of 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 the division of information technology into a separate contract, or requiring UNOS to modernize when the current Its contract is up for re-bidding.
UNOS’ shortcomings were compounded by HRSA’s own shortcomings, another target of Johnson’s proposal.
The agency lacks technical expertise, cannot force UNOS or other parts of the transplant network to turn over data, and is reluctant to push for more intensive demonstration of UNOS technology, according to the report and interview by Digital Service in 2021. That allowed UNOS to “wiggle around almost all of the new contract requirements for [transplant network’s] technology by hand-waving innovation with technical jargon, while making no meaningful progress,” reported Digital Service.
It also leaves HRSA only monitoring UNOS rather than exercising supervisory authority as government agencies typically do with their contractors, the report said.
Joseph Menn contributed to this report.