New US liver transplant policy raises cost and equity concerns, according to new study

By Deidre McPhillips, CNN

(CNN) — Changes to the policy that governs how liver transplants are allocated in the United States were meant to increase the number of transplants and make the process more equitable, but a new study raises concerns that it’s putting certain underserved communities at a greater disadvantage.

The new liver allocation policy changed the geographic parameters that guide which patients receive donated organs. Instead of operating within defined regional service areas, the new policy prioritizes the sickest liver candidates who are listed at transplant hospitals that are within a 500-nautical mile radius of the donor hospital. It was implemented in February 2020 by the United Network for Organ Sharing, which is contracted by the federal government’s Organ Procurement and Transplant Network.

In a study published Wednesday in the medical journal JAMA Surgery, researchers assessed outcomes during the first year under the new policy for 22 transplant centers that represent about a quarter of the national volume. They found that liver transplant costs were about 11% higher than they were the year before, largely due to costs associated with increased air travel to transport donor livers.

For this sample of transplant centers – which were not identified in the study – the overall number of liver transplants decreased by 6%, and the change in transplants relative to donors suggests higher discard rates, according to the study.

“Transplant centers from low-income states, those serving populations with more racial and ethnic minority individuals, and centers from states with poorer-performing health systems are facing greater costs, despite fewer patients having transplants since the policy implementation,” the study authors wrote.

Geographic disparities have long been a challenge facing the transplant system, and the issue is particularly inherent to liver transplants because they cannot remain viable between donor and transplant as long as many other organs, such as hearts and lungs.

Rural areas face broad disadvantages when it comes to organ transplants, but the study suggests that the new liver allocation policy may create even more disproportionate burdens. Researchers found that rural centers had significantly greater drops in the number of liver transplants, increases in imported livers and larger increases in hospital and flight costs.

For the University of Arkansas for Medical Sciences, the new 500-nautical mile radius might mean that staff travel to Chicago, Houston or Nashville to get a donor liver to bring back to a transplant patient in Little Rock.

“That’s expensive, but if it’s the best thing to get people to transplanted – time will tell – we just want to do what’s right to honor those gifts by donors,” said Dr. Lyle Burdine, director of the medical center’s solid organ transplant program.

The center prepared for the change in liver transplant policy by adding staff to help with the increased logistical burden and by developing a program that preserves the organ longer during the transition between donor and transplant recipient.

“The only thing that we haven’t then been able to do – and no transplant center has been able to do – is change reimbursement rates by hospital payers for this increased cost. That’s still stuck in probably the late 1990s,” Burdine said. “And the financial pressures in health care are really felt at the fringes.”

A related commentary, also published in JAMA Surgery on Wednesday, suggests that broader and longer-term analysis is important before making a judgement on how the new policy is working.

While it’s clear that not all transplant centers are “equally resilient in responding to changes in national allocation policy,” the sample of centers used in the new analysis might not be nationally representative, wrote the authors, led by Dr. Daniela Ladner, founding director of the Northwestern University Transplant Outcomes Research Collaborative. Federal data suggests that liver transplants did increase in the US overall, despite the decrease observed in the sample of 22 centers.

The new policy was implemented at the height of the Covid-19 pandemic, which could have skewed outcomes and findings. And the “field is changing rapidly,” they wrote, especially with emergence of new technologies like normothermic perfusion pumps that allow donor livers to travel longer distances.

At the University of Kansas Medical Center, liver transplant volume fell about 40% in the first two years under the new allocation policy, costs increased about 15% per transplant, and the number of livers that came from the local donors fell from about 90% to about 15%, said Dr. Timothy Schmitt, who is the director of transplantation for the health system.

Some of these changes were expected based on models that forecasted how the new policy would play out, he said. But it also created a situation where patients who get a liver transplant are quite a bit sicker than they would have been under the old policy.

“That has really caused us to have a difference in practice,” Schmitt said. Now, some patients who would have been considered good candidates for liver transplant might not even be put on the waitlist because they won’t survive the wait time. “There are more difficult conversations to be hard because people are going to be waiting a lot longer.”

However, the United Network for Organ Sharing assessed national outcomes after one year under the new policy and found promising results.

“Although we look at regional effects and center effects, the most important thing is that we focus on the patients and what’s happening nationally,” said Dr. Scott Biggins, chair of the federal government’s liver transplantation committee. “This policy did lower waitlist mortality, did increase access to liver transplant nationally and didn’t have much of any detrimental effect on the outcome after transplant in terms of post-transplant survival.”

In the four years since the latest liver transplant policy was implemented, the committee has also started work on another update to the policy that would make the allocation process more “continuous” instead of “categorical,” Biggins said.

Right now, liver allocations are predominantly concerned with reaching the sickest patients soonest based on individual patient scores on a model for end-stage liver disease. But the new model would also focus on improving efficiency in the system instead of relying completely on urgency, he said.

This update could address some of the concerns that Schmitt has – he would appreciate a more “matrixed allocation scheme” that allows for flexibility that accounts for travel costs in some way.

Projections for the potential update to transplant policy are still being worked through, and it will be years before they’re finalized after seeking input from the public and other stakeholders.

“As we move forward, there’s a lot of opportunity here to focus on the patients rather than bottom lines,” Biggins said. “Health care is a business but our focus is on improving the lives and health of our patients, and the best way we can get organs to people who are in need is should be the North Star here.”

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