Controversial Liver Transplant Policy Delayed After Lawsuit

April 24, 2019 – 6:22 p.m. By Andrew Siddons, CQ

The Department of Health and Human Services on Wednesday agreed to delay a controversial change to the way donated livers are matched with sick patients, following a lawsuit filed Monday against the policy.

The change was supposed to go into effect on April 30, but under an agreement reached after an initial hearing Wednesday in the U.S. District Court for the Northern District of Georgia, the administration said it would postpone the policy for two weeks while the court weighs the lawsuit.

The lawsuit and the delay are the latest roadblocks for a decadeslong effort to alter a system viewed as inequitable by states with longer wait times for liver transplants. But major transplantation hospitals in states with better-than-average organ donation rates fear that livers donated locally will go elsewhere. The new policy, they say, will result in fewer total transplants being performed and more patients dying.

The stakes are high for patients throughout the country who are waiting for a new liver, as well as for the hospitals who perform a combined 8,000 of the $800,000 procedures each year. Lawmakers representing both groups of constituents are also watching the issue, and are split on whether the allocation system should be altered.

The outcome of the lawsuit could also herald more changes, or an affirmation of the status quo, as the government contractor that runs the national organ transplant network considers similar changes for other organs.

The demand for a new liver is greater than the supply — around 11,500 people are waiting compared to 8,000 transplants in 2017 — so patients are prioritized with a score that determines transplant need. The United States is split into 11 regions for organ allocations, within which livers are supposed to stay unless there are no local matches.  

The regional allocation system has long been seen as arbitrary, a view the Trump administration shares.

New Jersey and Pennsylvania are in the same region, but New York is not, so a liver donated from Newark would go to a healthier patient in Pittsburgh before it would go to someone sicker in nearby New York City. In the summer of 2018, after a separate lawsuit challenged that system, the Trump administration ordered a change.

The new policy is still geographically based and meant to give the sickest local patients first dibs, but instead of regions, it is based on concentric distances from the location of the donated organ. Supporters of the change say it will help sicker patients no matter where they live.

However, the organ donation rate varies across the country. More livers are available in the Midwest and South than on the coasts. As a result, it’s easier to get a liver if you’re in some of the more organ-rich regions. The change is not sitting well with people from those areas.

“This policy will needlessly compromise the health of the donor organ from increased travel and ultimately puts patients at greater risk,” said Timothy Schmitt, director of transplantation and transplant surgeon at the University of Kansas Hospital, one of the hospital plaintiffs in the lawsuit challenging the pending policy.

Congressional Interest

In Congress, positions on the issue are falling along regional rather than strictly partisan lines. But ultimately it might be hard for Congress to reach a consensus on whether to intervene. While Senate Republican leaders would prefer the status quo, House Speaker Nancy Pelosi, D-Calif., and Senate Minority Leader Charles E. Schumer, D-N.Y., hail from states that will benefit from the change.  

For livers, the biggest determining factor in whether a matching candidate will get a transplant currently is being in the same arbitrary region as the donated organ. The regions vary dramatically in population and area, and are subdivided into areas based on the range of local organ procurement organizations that match donors to recipients. Those service areas, which also factor into the allocation system, also vary greatly. Vermont is split between two different regions; the Dallas-Ft. Worth area is split into separate service areas that spread far into west and south Texas.

Previous efforts to change the system went nowhere because of objections from Midwestern and Southern states that don’t want to see their shorter waiting lists for livers grow longer.

The most recent movement on the issue began in late 2017. Around Thanksgiving, a lawsuit was filed to challenge the region-based allocation system for lungs. Recognizing that it was unlikely to successfully defend the lung policy, the organ network within days approved a new system based on a 250-mile radius from the donation hospital.

Then in December, the network proposed a change to the liver allocation that would prioritize candidates who were either in the same region or within a 150-mile radius.  

But emboldened by the success of the lung lawsuit, a group of patients in California, New York and Massachusetts filed a similar one on the new proposed liver policy. Even the new plan, they said, would result in an inequitable distribution based on the arbitrary regional boundaries. For example, they argued, a liver from Memphis would go to a healthier person in Richmond, Va. — 750 miles away — before it would go to a sicker person in St. Louis, Mo., 250 miles away.  

In light of the lawsuit, the organ network acknowledged that the regional system conflicts with HHS policy. At the Trump administration’s request officials developed the new system, which does not rely on those regional boundaries.

Under the new system, patients are prioritized based on being within 150, 250 or 500 miles of the donation hospital. If there are no high-priority matches within those distances, patients within those distances with lower sickness scores would be next, followed by sicker patients nationwide.

The lawsuit was stayed by a judge in February as the government crafted the new system. If the new system takes effect, the plaintiffs from coastal states will likely be satisfied, according to their attorney, Motty Shulman.

But opponents call the new policy unlawful. In their lawsuit, they argue that the administration failed to follow administrative procedures in letting the network develop the change.

The plaintiffs in this lawsuit — patients and major transplant hospitals in states like Kansas, Michigan, Missouri and elsewhere — argue that the new policy was rushed and resulted in a narrow window for reviewing public comments, with a decision made before all of the public input had been considered.

Critics of the change say it will benefit patients who are better off economically at the expense of poorer patients. They argue that makes the new policy illegal under previous guidelines, which require policies to reduce socioeconomic inequities.

In January, 22 senators wrote to express similar concerns. Signers of that letter included Majority Leader Mitch McConnell of Kentucky, the chairmen of the Finance and Appropriations committees, and three Democrats, including Michigan’s senators and Alabama’s Doug Jones.

Then in March, a group of House members, including Republicans from New York and California, wrote their own letter countering those assertions. Critics “fear that allocating livers more equitably and prioritizing the sickest patients will harm patients in their states,” they wrote. “In fact, the newly adopted policy will save many more lives, reduce the average sickness of patients at the time of transplant nationwide and, correspondingly, reduce costs to the transplant system.”  

At an April hearing of the Senate Appropriations Subcommittee that oversees HHS, two Republican members -- Roy Blunt of Missouri, the panel chairman, and Jerry Moran of Kansas -- pressed Secretary Alex Azar about the change.

Azar acknowledged issues with the process and offered his apologies, and argued that HHS asked the organ network to ensure they considered all of the comments that came in at the last minute. There wasn’t much more he could do, he said, noting the network stood by its decision.

“Congress deliberately set out the system to keep people like me from dictating the allocations,” he said.

Azar instead urged lawmakers to work with the administration to address the underlying issue that makes liver allocation policy such a difficult problem.

The most important thing to do, he said, would be to “increase the supply of livers that we have for transplantation.”

Billy Wynne