A U.S. district judge in Atlanta on Friday threatened the federal government and its contractor with contempt of court and sanctions over a new policy that decides which patients receive the scarce livers that Americans donate for transplant.
The idea behind the change is to give the sickest patients the first shot at livers, loosening the geographic barriers that used to keep the organs much closer to wherever they were donated.
Georgia and Midwestern hospitals and patients, including Emory University Hospital and Piedmont Healthcare, have sued. They say the new policy will not only direct more livers away from them for the benefit of patients in other states, it will, if allowed to continue, lead to more deaths and result in fewer viable livers generally as tissues die during longer transit times.
Following a legal roller coaster this week, the new allocation system has now been operating since Tuesday. That’s amid a demand from the judge that the U.S. Department of Health and Human Services and the nonprofit contractor put a halt to it. With increasing ire at their actions and responses in court, she has ordered the officials to explain themselves in a hearing Monday.
“It’s awful,” said Diane Craig of Rockledge, in Middle Georgia. Her 42-year-old husband, Che Craig, has been unconscious in Piedmont Hospital this week on full life support and in deteriorating condition. The Craigs are not a party to the lawsuit.
“Whenever we got here I was under the assumption he needs his liver now and he’ll be getting it soon,” she said. “And that did not happen yet.”
Craig and her husband’s doctors have no way of knowing whether a liver has passed them by since Tuesday that would have come their way before. This week, under the new policy, his doctor’s team performed two transplants, both using livers from out-of-state donors, and one of those came from a 70-year-old donor with cardiovascular disease. Last week, before the policy change, they did four, with the donors healthy and most of the livers coming from within Georgia.
That’s just two weeks of anecdotes; each side in the fight has copious data and computer models to show its proposal will save the most lives and cause the least harm.
The new policy’s aim is to provide livers to the sickest patients, rather than those who can wait a little longer but are closer. It would loosen geographic borders for organ donation in a way that would likely send more Georgia livers to patients outside the state, perhaps 60 per year.
Patients in states such as California and New York would likely get more.
The drama started early this week when Judge Amy Totenberg of the U.S. District Court in Atlanta, who is overseeing the case, ruled that regardless of the merits of the case, legally she couldn’t put an emergency halt to the system while it went through the courts. But less than 48 hours later, dealing with a different legal question, she said Thursday night that she could now order the halt; she did, telling the government and its contractor to stop any further rollout of the policy.
But in the meantime, shortly after midnight Tuesday, the HHS contractor, the United Network of Organ Sharing, had flipped the switch and begun the new system. When they got her new order Thursday night to stop further implementation, they told her that they were in fact in compliance because there was nothing “further” to do.
They also invited her to clarify whether she meant something different. They added that they couldn’t just flip a switch the other way. That would take four weeks.
On Friday, Totenberg issued a blistering response citing “significant issues of (the government and UNOS’) compliance,” their “lack of candor” and “the absence of any actual reliable evidence before the court.” She ordered them to appear Monday and present “proper first-hand evidence” why they can’t comply with her order to stop.
It’s been turbulent for Dr. Harrison Pollinger, the program director for the Piedmont Transplant Institute. He spent Tuesday and Wednesday telling four patients in immediate need of livers that it would now be harder to get them, then told them about the system reverting to normal, then the latest confusion.
“It’s really frustrating,” he said.
Up in New York, Dr. Sander Florman was also frustrated — but with Georgians and their allies. In interviews, each of the doctors say that for them it’s about patients, and that lives are at stake.
“There are literally people dying because of the arbitrary and illegal system we have,” said Florman, who is director of the transplant program at Mount Sinai Hospital in New York City. “This is commonsense logic.”
Indeed, this week for the first time patients in Florman’s program received livers from Connecticut and New Jersey. Those states sit right next door and even share the same metropolitan area, but previously they were virtually walled off from liver sharing because of the administrative boundaries drawn long ago.
As much as Florman criticizes the long-standing system, the Georgia doctors are no fans of it either. Their argument, though, is that the new system is incorrectly designed, too.
The issue is deeply divisive among transplant surgeons, and they’ve been trying to design a better system for decades. Under the new system, Florman’s patients, depending on how sick they are, can receive a liver from as far away as 500 miles in any direction. So a Georgia liver that might have stayed in Georgia before can now go to Virginia. And the liver that might have gone to a Virginia patient could now be available to New York.
UNOS, the organization tasked by the federal government with producing the policy, is steadfast in touting its benefits.
“This new policy is projected to reduce wait-list mortality by roughly 100 fewer deaths each year,” UNOS said in a statement, adding that it would correct inequities.
Filings in the lawsuit dispute the government’s data, saying the opposite may be true.
“It’s a higher risk for patients, of higher cost, potentially death,” Pollinger said, referring to the greater distance a donated liver has to travel, and the poorer health care that liver patients across Georgia receive that causes them to die on wait lists.
One problem, say the plaintiffs in the lawsuit, is that the states that stand to gain from the change have gamed the numbers. Taking the example of New York, they say, its doctors add more discretionary points onto a patient’s score that determines the severity of his or her disease and medical need for a new liver. That amped-up score not only gives the impression that the current system is more inequitable than it is, the plaintiffs say, it will now result in those patients instantly moving to the top of the list under a new system.
Florman disputed that, saying the medical circumstances of New York patients called for different scores.
The new policy calls for a national board that would take over allotting the severity scores now determined by regional panels. The goal is to even out the scores nationwide.
Why people in one state donate more livers than those in another is an open question, though suggestions fly.
New York has the third-highest need for donated organs, according to the insurance plan Excellus, but the nation’s second-lowest registration rate for organ donors.
Thousands more New Yorkers die from stroke than Georgians, meaning their organs could be healthy for donation. And while New York doctors point to the number of foreigners in New York with different customs, in fact New York state residents are far more likely than Georgians to be native-born residents of their state. But Georgians are more likely to donate.
Craig and her husband just want him to live.
“To me, my husband is the sickest. I think that’s how everybody’s going to answer that question,” Craig said. “I just hope that people do the right thing. That’s the biggest thing I can say.”
WHY IT MATTERS
More than 8,000 livers are donated for transplant in the U.S. each year, but it’s not enough for the patients who need them. The government is trying to implement a new system for deciding which patients receive the available livers.
States such as California and New York, which stand to benefit from the new system, say it will help the sickest patients and save lives. Georgia and Midwestern hospitals and patients say the new proposal is based on faulty data, will direct livers to other states and cost lives. Georgia patients may receive about 60 fewer livers per year, according to some projections.
HOW IT WORKS
Liver patients get a “MELD” score. The higher a patient’s score, the idea goes, the sicker they are and the more that patient needs a liver. MELD scores are generally recognized as open to flaws and doctors are allowed to change them for specific reasons.
Under the long-standing system for allocating livers, the organs generally stayed within an administrative region, depending on a patient’s score. Under the new system, borders would be irrelevant; a liver would be offered to patients within a 500-mile radius, starting first in a smaller radius to patients with higher scores. That could lead to domino effects of patients in a state such as New York, where few people donate livers, receiving more livers from states south of them, which donate more.
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