Patient Advocates: New Liver Distribution Policy Doesn't Solve Inequity Issues

Originally published in Inside Health Policy

The highly charged conversation around liver distribution–namely, whether where you live should determine whether you get a transplant–is heating up as the committee delegated with policy decisions on the issue meets this week to vote on a new proposal that patient advocates worry would keep sick people locked in an unfair system.

“Where you live will remain the single greatest determinant of where you will get a transplant,” says Sander Florman, director of the Recanati/Miller Transplantation Institute at Mount Sinai Health System.

Policy decisions over liver distribution across the country falls under HRSA's purview. The committee that votes on policy, the United Network for Organ Sharing (UNOS), contracts with HRSA's division of transplantation and serves as the national Organ Procurement and Transplantation Network (OPTN).

In the late nineties, UNOS took charge after the Institute of Medicine was called in to resolve the bitter debate over how to share available livers -- because there are always fewer livers available than people who need them. Up to that point, the only measure used to decide whether someone qualified for a transplant was waiting time: Whoever was on the waiting list the longest would get the next liver. The IOM stated that the main determinant should be need, and decided that a disease severity score needed to be developed. The Institute also said that “allocation should not be an accident of geography,” Florman says.

In 1999, UNOS split the United States into 11 regions to ease administration of its policies. These regions are mapped on the HRSA OPTN website and are updated constantly with the number of organs available in those regions as well as the number of people awaiting transplant. They weren't meant to demarcate borders beyond which organs couldn't travel for transplant, Florman says, yet they have become just that. The data of these regions also show the deep disparities across the country: California and New York have the fewest available organs and the greatest need -- stats that are reversed in Southern states especially. New York has the extra problem of comprising nearly the entirety of a single region. Other regions are comprised of several states.

UNOS succeeded in determining a disease severity score -- known as MELD (Model for End-Stage Liver Disease) -- but “completely ignored” distribution fairness, Florman says, even though it was determined that an organ is a national resource, not a local one.

On Oct. 10, the OPTN/UNOS Liver and Intestinal Organ Transplantation Committee advanced a proposal that members changed from an earlier version that posted for public comment in August. The final vote to adopt the proposal is set for the committee's Dec. 4-5 meeting.

In this revision, UNOS proposes to add points to the MELD score of a person who is either within the same donor service area as a liver donor, or within 150 miles of the donor hospital. The committee also proposes that livers from deceased donors age 70 or older, or who die of cardiorespiratory death, won't be sent outside the donor service area.

The revised proposal also sets the threshold of how sick a person has to be to get a liver from another region to a MELD of 32 even though the earlier proposal from August would have set it at 29.

The highest MELD score is 40, which is when the statisticalchance of a person dying within three months if he or she doesn't get a liver transplant is 100 percent. This exacerbates the already deeply unfair geographic bias of the distribution, says Ira Copperman, co-president of New York-based Transplant Support Organization (TSO).

“The final rule says fairness, but there's no indication of fairness shown by way of liver allocation,” Copperman said. “It is far from fair.”

In an October statement, OPTN/UNOS liver and organ transplantation committee chair Julie Heimbach says the group agrees on “the need to improve access to transplantation for the most urgent waitlisted candidates, and we believe this is a way to move forward toward that goal.”

But Patient Advocates Disagree.

The Coalition for Organ Distribution Equity says that setting the MELD sharing threshold at 29 was already a concern but was nevertheless preferable to 32 because it is “the point at which risk of death for patients rises dramatically.” It also matches with the national median score of a typical patient at the time of transplant, the group says.

“An increase in the MELD threshold from 29 to 32 neutralizes the nationwide impact to a point [the coalition] can no longer support,” CODE says.

Copperman blames politics for the committee's failure to address the geography problem. He said members of UNOS -- which is made up of stakeholders from every region -- simply represent their constituencies; so, if people in their region can find a level from someone at any MELD score, the committee won't step in to make sure a liver goes from Kansas to California. He said for most people in places like New York or California the option is to uproot and move to another state just to have better chance on the waiting list.

“You won't have a support system but you'll get your liver,” Copperman said, who got involved with advocacy on the issue because his spouse is a transplant recipient and he has 18 years of experience at every level of the transplant process.

Stats on HRSA's OPTN website state that more than 7,000 people died awaiting transplant while on the wait list or within 30 days of leaving the list.

“Despite advances in in medicine and technology, and increased awareness of organ donation and transplantation, there continues to be a gap between supply and demand,” the OPTN site says. “More progress is needed to ensure that all candidates have a chance to receive a transplant.”

HRSA did not have a comment on the criticisms of the latest OPTN proposal. As of press time, ONUS did not respond to a request for comment.

Florman calls the committee's revised policy “about as watered-down as anything.”

“It will qualify as a change, but it really can't change anything more: Where you live will remain the single greatest determinant of when you will get a liver transplant.”

Florman says if UNOS can't instate real reforms that will change this determinant, the Institute of Medicine should step in again. Like Copperman, he says the issue is UNOS' structure: Votes are cast by members who benefit from the current system.

“UNOS has a responsibility to protect patients and laypeople,” Florman said. “If they can't do that, they should say they can't.”

Billy Wynne