The Rapidly Evolving Path to Equitable Liver Allocation

The path to equitable liver allocation has been evolving rapidly, so we wanted to provide an update of events that have affected the implementation of the new policy.

In December 2018, the Organ Procurement and Transplant Network (OPTN), which is charged under federal law with developing organ allocation policy, adopted a new “Acuity Model” for livers. This policy, which was generated over several years of intense analysis, development, and debate, would have prioritized patient medical need over where patients happen to live. It was slated to take effect on May 1, 2019.

 During the spring, Members of the U.S. Congress sent letters to the Department of Health and Human (HHS) services registering their opinions of the policy. Some favored it while others expressed concern. HHS Secretary Alex Azar testified before a congressional committee that he believed the new policy is legal and appropriate and that federal law requires his office to defer to OPTN, which is comprised of organ transplant experts and patient representatives, in this area.

 On April 23, Emory University Hospital and Piedmont Hospital, in Georgia, and the University of Michigan and University of Kansas of Hospital Authority filed a lawsuit in Georgia requesting a temporary restraining order (TRO) against the policy. HHS and UNOS agreed to delay the implementation of the new policy until May 14 in order to settle the dispute.

 On May 13, the U.S. District Court Judge ruled in favor of the new liver allocation policy, and denied the opposition's temporary restraining order. However, the following day, the Judge reversed her decision by staying the policy pending plaintiff's appeal to the 11th Circuit. The Judge's third ruling confirmed that the new policy was stayed and the old, inequitable policy, based on arbitrarily crafted districts and regions, should go back in to effect. UNOS then advised the court it would revert to the old policy on May 23.

 This has been a complicated, fast-moving process. While we remain pleased with the core victory in the case (the denial of the TRO), the judge has effectively given the plaintiffs what they wanted—a delay in implementation of the new policy. Lawyers from UNOS are seeking an expedited briefing in the 11th Circuit to mitigate the effects of the delay. We will continue to provide information as the situation evolves.

 

Billy Wynne