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• Posted March 23, 2023

Feds Propose Overhaul of U.S. Organ Transplant System

A single nonprofit has what amounts to a monopoly over all organ transplants performed in the United States, but the federal government said Wednesday that it plans to change that.

The Health Resources and Services Administration (HRSA), which has contracted with the United Network for Organ Sharing (UNOS) to run the Organ Procurement and Transplantation Network for 37 years, announced it will invite organizations to bid for contracts for different parts of the transplant system's functions.

"Every day, patients and families across the United States rely on the Organ Procurement and Transplantation Network [OPTN] to save the lives of their loved ones who experience organ failure,"HRSA Administrator Carole Johnson said in a news release announcing the change. "At HRSA, our stewardship and oversight of this vital work is a top priority. That is why we are taking action to both bring greater transparency to the system and to reform and modernize the OPTN."

Among the plan's many changes are steps to improve the technologies used by surgeons and transplant coordinators.

Network structure would also change, including adding a strong, independent board of directors. A new public dashboard should also make the donation and receipt process more transparent.

Sen. Ron Wyden (D-Ore.), tweeted that the plan is "a big victory for families across the country ... 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."'

Wyden is chairman of the Senate Finance Committee, which has been investigating problems in the transplant system for three years, the Washington Post reported.

HRSA head Johnson said she plans to ask Congress to change the law and raise the cap on what her agency can spend on contractors, but she added that she has legal authority to do so even if Congress doesn't.

The challenge is that the 1984 National Organ Transplant Act established the network with UNOS as a "quasi-governmental agency,"even though it's a nonprofit.

UNOS said in a statement Wednesday 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 White House's U.S. Digital Service called UNOS's technological system archaic in a confidential 2021 assessment for HRSA. It also recommended breaking up UNOS's monopoly over that technology, the Post reported.

"UNOS has allowed the organ donation system to become mismanaged, unsafe and self-enriching,"Greg Segal, founder and CEO of Organize, a nonprofit patient advocacy group, told the Post. "Today's announcement that HHS will break up UNOS's monopoly, and bring in competent and transparent new contractors, is a transformative and unequivocal win for patients."

UNOS oversees a transplantation network that includes about 250 hospitals that perform transplants. Also in the network are 56 government-chartered nonprofits that collect organs and labs that test organ compatibility.

In 2022, a record 42,887 organ transplants were performed. Yet nearly 104,000 people remain on waiting lists for organs. About 22 people die each day while waiting, even as organs are discarded, damaged while being delivered or not collected, the Post reported.

The greatest need is for kidneys. And disparities exist, with white, affluent people more likely to receive the organs they need than poor and minority patients, the Post reported.

UNOS is also in charge of policies determining who gets organs, which includes a plummeting number of liver transplants in Southern and Midwestern states under new donation rules. Wasted livers have increased under the new rules, the Post reported.

UNOS's interim chief executive Maureen McBride said last month that UNOS was seeking an increase in fees paid by patients waiting for transplants to improve the system's technology, the Post reported.

Another problem with the network has been that entities whose performance jeopardizes transplants have historically had little accountability in the system, the Post said. In 2019, the government began holding groups more accountable for compliance.

Among other issues were 70 deaths and 249 diseases in seven years because of screening mistakes, including in the first uterus transplant in U.S. history. In that case, the donor organ was infected with a life-threatening fungal infection and had to be removed, the newspaper said.

A Post analysis also found in 2018 that the transplant network could double organs provided by persuading transplant surgeons to include organs from older people or those with more health issues.

In 2020, 21.3% of procured kidneys were not transplanted and were later discarded, the Post reported, citing the Scientific Registry of Transplant Recipients. That data analysis operation is separate from UNOS.

Other countries have lower discard rates, such as 9.1% in France between 2004 and 2014 and 10% to 12% in the United Kingdom, the Post reported.

The National Academies of Sciences, Engineering, and Medicine has also recommended separating information technology into a different contract or requiring UNOS to modernize.

More information

The National Institute on Aging answers questions for older adults who would like to know about organ donation.

SOURCE: Health Resources and Services Administration, news release, March 22, 2023; Washington Post