HHS on Wednesday said it would delay implementing a planned overhaul of the national liver distribution system after major medical centers and transplant patients sued to block the plan.
The agency will delay implementing the policy for two weeks, until May 14, to allow time for the court to weigh in. The judge ordered a hearing for May 7.
The complaint filed Tuesday alleged the new policy would remove 256 transplants from the medical centers, according to the government's own projections. Emory University Hospital and Piedmont Hospital in Georgia, the University of Michigan and the University of Kansas Hospital Authority were among the plaintiffs in the lawsuit filed in the U.S. District Court in Atlanta.
The health systems argued that since they will perform fewer transplants each year, those transplant candidates will be "at risk of imminent death absent the transplant they would have otherwise received."
They also argued the policy will lead to at least 20% fewer liver transplants performed within "the most socioeconomically disadvantaged regions in the country."
Each liver transplant in 2017 cost an average $812,500 including care before and after surgery as well as drug therapies, according to Milliman. The hospital transplant admission alone accounted on average for more than half of those charges, or $463,200.
The national liver allocation system has been the subject of heated political battles, as it pits regional interests and transplant centers against one another. Under the old rules defended by the plaintiffs, livers were kept largely within regional borders.
Southern and Midwestern states have more organs than others, most notably New York and California where demands for transplants are high.
Distribution is overseen by a single entity, the Organ Procurement and Transplantation Network, or OPTN, a group that contracts with the Health Resources and Services Administration. The OPTN contracts with the United Network for Organ Sharing, or UNOS, whose liver board made the distribution rules change in December after pressure from HRSA and a lawsuit from patients who struggle to get priority on a liver wait list.
But the rules change elevated the scrutiny of UNOS, as Sens. Roy Blunt (R-Mo.) and Jerry Moran (R-Kan.) met with HHS Secretary Alex Azar, wrote letters in dispute, and even confronted him about the new policy during a Senate hearing.
Before filing the lawsuit, the transplant centers sent a critical comment letter to HRSA, urging the agency not to implement the new policy and to develop an alternative. HRSA Administrator George Sigounas responded that he did not believe that "further HHS actions are warranted."
He added that OPTN "has committed to a robust plan for post-implementation monitoring" of the new policy, "including reviews of transplant recipient demographics such as race and socioeconomic factors."
UNOS spokesperson Joel Newman said in a statement that the organization will "review the complaint and respond as appropriate."
However, he added, "we believe that we have developed a sound policy that provides a fairer, more equitable system for all liver patients—no matter where they live—as they wait for a lifesaving transplant."
"The reality is that, on average, three people die every day in the U.S. while waiting for a liver transplant, and because this new policy will save more lives by reducing the number of patients who die while waiting, we believe it is an improved policy and a step in the right direction," Newman said.
The National Coalition for Transplant Equity, which supports the new policy, said 114 fewer people are projected to die while awaiting a transplant under the new policy, according to government data cited by the plaintiffs.
As the clock ticks toward implementation of the new policy, people currently awaiting transplant have used the public comment forum on OPTN's website to vent their worries they will lose their chance at a liver with a different system in place.
One anonymous poster expressed his "strong opposition" to "the proposed transition to overhaul the entire organ allocation system as a response to the legal action."
Another commenter, Timothy Marcum, who is on the transplant wait list at both Vanderbilt University in Nashville and the Mayo Clinic in Jacksonville, Fla., said that if the scoring system that denotes medical necessity for a transplant changes, "I will die before I get a liver transplant."
