Trump administration reverses new liver distribution policy after federal court injunction

The U.S. Department of Health and Human Services’ (HHS) organ donation oversight agency has reversed a controversial liver redistribution policy that many organ donation advocates in Arkansas and across the U.S. say will allow live-saving organs donated locally to be allocated to patients far away.

On May 20, the department’s Health Resources and Services Administration (HRSA) instructed the United Network for Organ Sharing (UNOS), which is HHS’ federal contractor for the nation’s organ donation and transplantation system, to revert to the liver distribution policy in place prior to May 14, 2019, which is based on delivering organs to patients on the waiting list closer to the transplant hospital.

That decision came after a federal court in Atlanta issued a restraining order for UNOS not to do any further work implementing the new liver allocation policy approved by the agency’s board of directors in December 2018. UNOS hurriedly attempted to put the new policy in place two weeks ago, opting for a new system where livers would be sent anywhere in a 500-nautical mile radius from the donation site, such as the University of Arkansas at Medical Sciences (UAMS), to patients in other states with the most critical need.

UNOS and supporters of the new regulations say it is designed to make the system work more efficiently and fairly for all transplant patients regardless of where they live, what hospital they choose for their care, or how sick they must be before they are likely to get a transplant. The policy will also reconfigure how geography is considered when matching donated livers with transplant recipients based on experience gained with the previous, decades-old system.

The former system was based on the arbitrary geographic boundaries of the 58 organ procurement organizations (OPOs) and 11 transplant regions. During the federal comment period in 2016 on the new liver allocation policy following years of heated debate and public feedback, Dr. Daniel Borja-Cacho at UAMS and Alan Cochran, executive director of the Arkansas Regional Organ Recovery Agency (ARORA), voted with Region 3 against the new liver allocation policy.

Borja-Cacho, is the director of the Liver Transplant Program at UAMS. Cochran was hired in late 2014 by ARORA, one of the nation’s 58 OPOs, after the agency’s former director, CFO and legal counsel were all fired. In public comments filed with the Federal Register where eight of UNOS’s 11 regional service areas voted against the new policy, Barjo-Cacho and Cochran were among 224 out of 283 top executives in Region 3 that submitted “no” votes.

“The community has spoken,” the Arkansas officials said in more than 500 pages of public comments submitted to the HHS.

In the federal lawsuit in the U.S. District Court for the Northern District of Georgia, U.S. District Judge Amy Totenberg has threatened the Trump administration and UNOS with contempt of court and a number of sanctions over the new policy to give the sickest patients the first shot at a liver, not those closer to home.

After implementing the policy ahead of the federal court ruling, UNOS last week offered a mea culpa to the medical community and those patients on the national waiting list, sending out a notice on May 24 that the National Liver Review Board would not be moving forward with the new liver policy.

“UNOS wants to reassure the donation and transplant community that despite the legal proceedings underway, donated livers continue to be allocated to patients on the waiting list; there is no disruption to this important work,” said agency officials.

Although the new liver allocation policy is on hold, the Atlanta federal court is likely to issue a ruling later this year that could ultimately side with UNOS and allow the sickest patients to leapfrog those closer to a donated liver as determined by the agency’s new scoring metric. If so, UNOS officials have stated publicly that patients in urban areas and larger states like New York and California are likely to have access to more livers than rural communities and smaller states such as Arkansas and Mississippi.

In 2018, there were 1,271 medical patients on the waiting lists for liver donations in the vast region that includes Alabama, Arkansas Florida, Georgia, Louisiana, Mississippi and Puerto Rico. Last year, there were a total of 1,342 liver transplants in Region 3, including 1,333 from deceased donors.

Nationally, there are nearly 114,000 patients on the waiting list for a life-saving kidney, liver, heart, lung, intestine or pancreas in the U.S. In Arkansas, there are three hospitals that provide organ transplants for the 240 patients on the state’s organ donation waiting list, including UAMS, Arkansas Children’s Hospital and Baptist Medical Center. In 2018, UAMS completed all 37 liver transplants in Arkansas.

Due to the liver distribution policy and near shutdown of New York’s largest OPO, some members of Congress are looking to overhaul the nation’s organ donation network and remove UNOS as the federal contractor. In recent years, the national waiting for livers and other critical organs has grown as ARORA and most of the other 57 organ donation groups across the country have turned their focus to the harvesting of tissue, skin, eyes, bones, ligaments, heart valves and other non-life-saving body parts, which brings in billions of dollars each year to those nonprofit agencies.