Transplant Hospitals Fight New Formula for Allocating Kidneys

June 15, 2021, 9:35 AM

A second federal appeals court is wading into a long-running dispute over how best to allocate organs from deceased donors.

The U.S. Court of Appeals for the Eighth Circuit will hear arguments June 17 over a policy change in how kidneys are distributed. Transplant candidates within a 250 nautical-mile circle around a donor’s hospital now get priority. Before the change took effect March 15, kidneys were allocated based on geographic boundaries that roughly followed state lines.

The United Network for Organ Sharing (UNOS), which coordinates organ donations and transplants, argues its fixed circle policy aims to make organ allocations more equitable for everyone, particularly in areas like New York City where the demand is greater than the supply.

However, six transplant hospitals and a patient waiting for a kidney want the policy blocked by a federal appeals court. They argue it was rushed through without proper notice and comment, and will result in fewer transplants every year.

It’s a case challenging administrative procedure that has high stakes with nearly 100,000 people nationwide waiting for a kidney transplant affected by the policy and hundreds of thousands of dollars on the line for hospitals that perform these procedures.

The total amount in billed charges per kidney transplant in 2020 was estimated to be $442,500, according to a Milliman Research report on cost estimates for organ and tissue transplants.

Doctors say UNOS used a flawed metric based on the size of a transplant center’s waiting list to create the fixed circle policy, which fails to consider the medical needs of patients and makes allocating kidneys more complex.

“At the end of the day, I think all of this began with really good intentions, but I think somewhere in all of this it was all reactionary instead of someone stepping back and saying what’s the root cause of this problem, said Jayme Locke, director of the University of Alabama at Birmingham Comprehensive Transplant Institute. UAB Hospital is a named plaintiff in the case.

“We’ve only replaced one arbitrary boundary with another arbitrary boundary,” she said.

Lungs, Then Livers

Litigation in 2017 is what changed the allocation policy for lungs. A change to liver allocations followed after an attorney in 2018 sent a critical comment letter to the Department of Health and Human Services on behalf of New York hospitals, arguing UNOS’s use of geographic regions to distribute donated livers was arbitrary and unlawful.

The National Organ Transplant Act created the Organ Procurement and Transplantation Network to establish criteria for distributing organs and coordinate donations. UNOS has run that network under a contract with the HHS since 1986.

In response to the critical comment letter, the HHS determined the boundaries couldn’t be justified under the law and directed UNOS to revise the policy for livers and other organs, leading to the fixed circle policy for kidney donations.

Some of the same hospitals fighting the kidney allocation policy brought a nearly identical challenge to the liver allocation change, which they ultimately lost. The U.S. Court of Appeals for the Eleventh Circuit affirmed the district court’s refusal to block the policy, holding that the secretary of health and human services didn’t have to go through an administrative review process to enact the change.

The parties are still fighting over private emails sent to and from UNOS volunteers that were obtained by the hospitals during discovery in that litigation. UNOS is appealing a district court order that allows the documents to be unsealed.

The hospitals pushing for the emails to be made public say they validate concerns “that self-interested members of the organ transplant community plotted with UNOS leadership to steer the organ allocation policy to a predetermined destination that enriches them financially while harming those living in rural and disadvantaged regions.”

UNOS argues the public has no right to access documents that were irrelevant to the court’s decision in the case and that releasing them could chill the Organ Procurement and Transplantation Network’s decision-making process “by disincentivizing frank and candid discussion of organ allocation policy.”

Donation Disparities

UNOS says the fixed circle policy for kidney donations is performing as expected. Deceased donor transplants from January to June are up from 7,151 in 2020 to 8,215 in 2021, according to data from the organization. In the same period in 2019, 6,921 deceased donor transplants took place.

The new policy “eliminated a number of very dated, arbitrary, illogical boundaries that were drawn,” Joel Newman, an UNOS spokesman, said.

Under the old policy, patients in areas like New York and California could wait seven to 10 years for a transplant when in other areas of the country people might only have had to wait three or four years, he said.

But Locke said the fixed circle policy isn’t increasing deceased donor transplants. The opioid epidemic and the Covid-19 crisis are factors in that increase because more people are dying, she said.

“What the real question to be asking is what’s the discard rate,” she said, referring to donated organs that must be discarded because they can’t reach a patient in time. “It’s too early to answer that question with kidneys and livers.”

There were 100 fewer liver transplants in the first nine months after the new policy for liver allocations was implemented when UNOS had projected there would be eight fewer transplants annually, the hospitals said in their appeal.

“Indeed, if their kidney projections are wrong to the same degree as their liver projections, the Fixed Circle Policy will result in 750 fewer transplants, and 300 excess deaths, over a five-year period,” they argue.

A Long Wait Gets Longer

Tim Wolfe thought he was next in line for a kidney, but his doctor told him it could be another four to five years because of the policy change. The 41-year-old Vermont resident has already been waiting for almost four years.

“It came as a pretty big blow,” said Wolfe, who must start dialysis unless he can find a living donor. For each year a patient is on dialysis, their odds of dying increase 7%.

Wolfe’s doctor, Michael Chobanian, the program and medical director of solid organ transplant at Dartmouth-Hitchcock Medical Center in New Hampshire, said his facility is getting fewer organs for transplants because the policy change expanded the donor pool, increasing competition. Organs from donors in the New Hampshire region are now going to individuals at transplant centers out of state that have more people on their waiting list. Those organs wouldn’t have been offered to those people under the old policy.

“The answer isn’t to take organs from other places,” he said. “There’s a real danger in this new system that if organs travel too far, many of them might not work. The longer the organ is out of the body and in an ice chest without oxygen or blood supply, there’s a chance it doesn’t recover.”

Neither Wolfe nor Dartmouth-Hitchcock Medical Center is part of the litigation.

UNOS says there’s just not enough organs to go around.

“What we as the national network are charged to do is come up with a policy that is in service of all of the patients nationwide, that really tries to make each individual candidate’s chances of getting a transplant as equivalent as possible to the next person,” Newman said.

The case is Adventist Health System v. U.S. Dep’t of Health and Human Servs., 8th Cir., No. 21-01589.

To contact the reporter on this story: Lydia Wheeler in Washington at lwheeler@bloomberglaw.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloombergindustry.com; Brent Bierman at bbierman@bloomberglaw.com

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