New procedures for lung transplants in the United States have gone into effect, changing the rules for who gets a transplant. This is happening just as the Biden administration’s plan to overhaul all organ transplant procedures, announced in March, is moving ahead, with the goal to make sure organs are not wasted and are given to the right recipients.
The lung transplant changes, effective March 9, are the “first to utilize an approach known as continuous distribution,” according to an explanation by the Organ Procurement and Transplantation Network. “Under the new framework, all of the factors used in the organ match are included in a single, weighted score calculated for each lung transplant candidate and each lung offer from a donor. Under the previous lung allocation policy, a set of different matching classifications (such as donor compatibility, candidate urgency, and distance from donor hospital to transplant hospital) were determined individually and then applied in a sequence to decide the order of lung matches.”
The O.P.T.N. said it had done statistical modeling of the new framework, showing that it will “not only reduce the number of lung candidates who die awaiting a lung transplant, but it will increase transplant access for a number of candidates.” This includes candidates who are the most medically urgent, younger than 18 years old, a prior living organ donor, more likely to have immune system rejection of many organs, short in stature and expected to live longer after a transplant.
“All lung transplant candidates will now receive a lung composite allocation score (lung CAS),” the network explained, saying continuous monitoring for effectiveness would begin immediately. The policy is explained here.
Transplant system overhaul
Separate from but related to the lung transplant changes is the broader system overhaul being planned by the Biden administration. The system has been run for decades by the United Network for Organ Sharing, a national nonprofit known as U.N.O.S. Under contract, the network runs the collection and distribution of organs. In March, though, the administration announced that it was inviting other organizations to compete for this work. The organ collection and distribution system has long been criticized for being antiquated, for wasting organs and for endangering the lives of potential transplant recipients.
“The Biden administration is now putting the network’s job out to bid, hoping to foster competition in a system that has effectively operated as a monopoly,” Sheryl Gay Stolberg wrote in The New York Times. “Officials say their first task is to upgrade the outdated computer system that matches organs to patients.
“More than 100,000 people in the United States are awaiting organ transplants in a system that has long been defined by an imbalance between supply and demand. Patients sometimes wait years for donated organs, and about 6,000 Americans a year — 17 each day, according to the federal government — die while waiting.”
Effects on real people
While the changes will not take place for some time, changes are regarded as overdue by many.
The Markup, a news website, posted a two-part investigation in March into the algorithm that determines who gets a liver transplant. “The algorithm was changed three years ago to allow donated livers to travel farther than ever before,” one of the writers, Malena Carollo, wrote recently on the site. “Proponents said the change was meant to get the sickest patients a liver no matter where they lived. But those making the new policy dismissed surgeons, advocates, and academics around the country who worried that it would hurt rural areas and the poor while causing more livers to be wasted.”
“Life-saving liver transplants have plummeted in some Southern and Midwestern states with higher death rates from liver disease, while New York and California have made big gains,” Carollo and her partner, Ben Tanen, wrote in their series.
After the 2020 algorithm changes, they wrote, “The analysis of data from federal health authorities found sharp declines in life-saving surgeries in Puerto Rico and seven states, all but one Southern or Midwestern: Alabama, Louisiana, Kansas, North Carolina, South Dakota, Iowa, and Pennsylvania. Meanwhile, New York and California, whose transplant industry officials lobbied for the new policy, logged their highest numbers of liver transplants in more than a decade in 2021 — 603 and 959, respectively.”
Not surprisingly, crowdfunding sites like GoFundMe have a lot of transplant fundraising appeals.
Support for changes not universal
Not everyone supports the transplant regulation changes the administration proposed in March. The mother of a heart transplant recipient in Arizona wrote an Op-Ed recently opposing them.
“Leading the attacks against our transplant system are special interest groups, political think tanks and companies that use media opportunities, government lobbying and self-produced research to make sensationalized claims of poor performance,” the mother, Melissa McQueen, wrote.
“The government’s proposed solution to the claims is to take on multiple new contractors to manage the O.P.T.N., which could ultimately encourage a for-profit model. That would greatly disadvantage thousands of recipients and their families who are currently waiting for new organs.”
McQueen, whose son received a heart transplant in 2009, is an organ donation advocate and co-founder of Transplant Families, an organization based in Arizona that gives support for pediatric transplant families, and a board member for the O.P.T.N.
Schedule for action
While the changes announced in March came with few details, a schedule for action by the Health Resources and Service Administration, which is in charge of the initiative, is coming into view for the Organ Procurement and Transplantation Network.
“The initiative is focused on five key areas: technology, data transparency, governance, operations, and quality improvement and innovation. As part of our commitment to transparency around the Modernization Initiative, H.R.S.A. is providing an update on our upcoming action steps,” a May update announced.
“The O.P.T.N. Modernization Initiative is centered on putting patients first, prioritizing information flow to clinicians, promoting innovation through continuous competition, and enhancing transparency and accountability. H.R.S.A.’s planned approach and timelines for the first year of the multi-year modernization process focuses on design, implementation, and oversight, including contract solicitations that will be released Fall 2023 and Spring 2024. In addition, H.R.S.A. continues to pursue the legislative changes and increased funding included in the President’s Fiscal Year 2024 budget to implement and advance the Modernization Initiative.”
The plan begins with market research in the summer of 2023, and continues with work to maintain the existing system as well as implementing another system to make sure there are no disruptions in service.
“Therefore, H.R.S.A. will support two significant multi-vendor solicitations between now and Spring 2024 – with the first solicitation to be issued this Fall 2023. This action will be followed by a Spring 2024 solicitation to further the next generation O.P.T.N.” Details on the schedule can be found on this update page.
“A report last year by the National Academies of Sciences, Engineering and Medicine found that the organ transplant system was ‘demonstrably inequitable,’ and suffered from ‘significant nonuse of donated organs,’ the academies said in announcing the study. Roughly one in five donated kidneys is not used, the study said,” Stolberg wrote. “In 2021 … the Health and Human Services Department said that Black people were four times more likely, and Latinos 1.3 times more likely, than white people to have kidney failure. But Black and Latino people who are on dialysis are less likely to be put on organ donation lists and get transplants.”
More information is available at the Organ Donation and Transplantation dashboard.
