U.S. organ transplant rules get an overhaul
A powerful but obscure panel, which governs which chronically ill people get critical organ transplants and when, overhauled its rules for these decisions last week, transforming the long-time geography-based system.
Under the new system, the patient with the most urgent need for a transplant will have first claim on any organ from a compatible donor within a 150-mile radius, then a 250-mile radius and on up to a 500-mile radius. This process will continue with the priority given to the sickest people. There are generally fewer than 50 patients nationwide who would qualify for this priority "at any given moment," according to the United Network for Organ Sharing, or UNOS.
The Dec. 3 vote from the UNOS board followed decades of gridlock among the nation's top transplant centers over the existing policy that prioritized transplant candidates based on where they lived in proximity to donors. It was prompted by a major lawsuit from critically ill transplant candidates who couldn't get access to livers and HHS intervention last summer.
At stake was the controversial system of 11 regions whose borders essentially demarcated zones for organs to move from donor to the waiting patient. Geography still plays a role, supporters of the change said, but ultimately puts patient need ahead.
"We erred in favor of the patients, and that is a welcomed change," said Dr. Sander Florman, director of the Recanati/Miller Transplantation Institute of New York's Mount Sinai Health System.
The geography-based policy had long roiled the transplant community because certain regions like the South and the Midwest (colloquially referred to as the "stroke belt") have a much higher number of available livers with fewer transplant candidates waiting for them.
Other regions, including states like California and New York had the opposite scenario: a proliferation of transplant candidates and not enough donors.
UNOS contracts with the Organ Procurement and Transplantation Network, or OPTN, the group tasked by HHS with setting organ distribution policy. Last year the UNOS board slightly tweaked its allocation rules but was criticized for not tackling the geography issue. The group did however establish an ad hoc committee to study geographic disparities.
Then in July, six plaintiffs—liver transplant candidates from California, Massachusetts and New York—sued HHS, UNOS and OPTN in a federal District Court in New York. They alleged the regional system violates the federal mandate for an equitable distribution policy.
By the end of July, the top deputy of HHS' Health Resources and Services Administration weighed in. HRSA Administrator George Sigounas cited a critical comment filed in May on behalf of the transplant candidates. He told the OPTN president in a letter that the group needed to eliminate the regional system by UNOS' December 2018 meeting.
Between then and the time the new policy was adopted, one of these plaintiffs died while still waiting for a liver. New York's Wilnelia Cruz had contracted a liver disease from a blood transfusion she received as a baby and, insured through Medicaid, could not afford to travel to a transplant center in a region with shorter wait periods.
The UNOS liver committee, made up of stakeholders including transplant surgeons from the different regions, were split over two different policies. They narrowly approved a proposal that would have given local priority to a broader group of transplant candidates. The UNOS board responded Dec. 3 with its change to prioritize the sickest patients within a 500-mile radius, and approved the new policy by a 30-7-2 vote.
This action by the UNOS board left some on the other side of the debate with lingering concerns.
Dr. George Loss, chief of the surgery department at Ochsner Health System's transplant center in Louisiana, said though the policy is "trying to do good" he is worried that people in the South could lose access to transplants.
"In the Carolinas, Mississippi, Indiana and Florida—all those places will have declines in the number of transplants performed when you're losing livers to places where the demand is relentless," Loss said.
While the plan has positive elements, he added, he is "extremely worried" about the potential regional swing in volume of transplants.
"I'm worried it will hurt people in the South in ways that we could have predicted and muted," he said.
Specifically, he is concerned people in states that didn't expand Medicaid will lose access to livers because they won't be able to show that they can afford the drugs to keep the transplanted organ viable.
The other issue for Loss is the cost: the American Society of Transplantation in 2015 estimated that a more national system would increase spending on air transport by about $76 million, although it would be "largely offset" by savings as transplant candidates would likely receive their organs sooner, eliminating some major treatment costs. The study also projected fewer total transplants.
"There are two sides to this debate: Those who are looking for draconian effects as the right thing to do, and the other side that wants to increase the size of the pie and not give people a pass for not doing things locally," Loss said.
Both ways are expensive, but Loss said he would prefer to see the money that will be spent on jet fuel and transport rather go to "create more ways to have more organs in more places."
"Why is it that in some areas of California they only use 60% of available livers and in Louisiana it's 98% of available livers?" he said.
Ultimately, Florman said, while all organ procurement organizations can do better about securing organs, different regions of the country will always have differences in donors versus transplant candidates.
"California has one of the best organ procurement organizations in the country, and worse disparity than New York," he said, adding that New York has increased its procurement efforts and the number of available organs by 50%. But there is still a "drastic disparity."
"This isn't about New York and California, Georgia and Louisiana," Florman said. "It's good for patients everywhere and still gives local priority. But if you are the sickest person out there you will have more access to a liver. It isn't a state's liver; it's putting the patient need just ahead of geography, which we have never done before."
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