New Liver Allocation Policy to Go into Effect February 4; Threats Remain

January 27, 2020

GNYHA has long been at the forefront of the effort to bring the liver allocation system into compliance with the National Organ Transplant Act, which states that organs must, to the greatest extent possible, be allocated based on medical need, not geography. In mid-2018, GNYHA’s Board of Governors authorized the Association to support and coordinate a lawsuit challenging the current liver allocation system. That suit was brought on behalf of several courageous patients on waitlists in New York and other states, and it immediately resulted in an HHS directive to the United Network for Organ Sharing (UNOS)/Organ Procurement and Transplant Network (OPTN) to reform the system to remove arbitrary geographic boundaries as the guiding force behind liver allocation. In late 2018, HHS approved a new, GNYHA-supported liver allocation system—the “acuity circles” model, which largely rectifies the longstanding inequity in the liver allocation system and is projected to save approximately 140 lives in its first year.

A group of transplant centers in states that benefit from the current system immediately attacked the new policy. As the litigation winded through the process, policy implementation has been delayed. However, the plaintiffs were defeated at every stage in preliminary proceedings.

The US District Court for the Northern District of Georgia earlier this month denied a plaintiffs’ motion for a preliminary injunction on the acuity circles model—a significant victory for the nation’s sickest patients. Since then, UNOS and OPTN announced that the new policy will be implemented on February 4. While we are thrilled with this development, we fully expect the plaintiffs will attempt other maneuvers in the courts and possibly on Capitol Hill to further delay implementation.

Since the Court’s decision was released, lawmakers on both sides of the issue have spoken out. We thank Representative Eliot Engel (D-NY), a longtime champion of liver allocation reform, for issuing a strong press release about the court ruling that stated: “Up to this point, liver allocation has been limited by arbitrary geographic boundaries. The new policy will ensure livers are distributed based on medical need. No longer will a zip code limit a patient’s ability to receive lifesaving care.” The press release also includes a quote from GNYHA President and CEO Kenneth E. Raske applauding the acuity circles model and Rep. Engel’s leadership.

Unfortunately, Senators Roy Blunt (R-MO) and Jerry Moran (R-KS), who are both from states that benefit from the current policy, sent a letter to HHS Secretary Azar requesting that the implementation of the new policy be delayed until the conclusion of ongoing litigation. We disagree and believe that OPTN/UNOS must go forward with the February 4 implementation date. We have been in contact with our allies to ensure that they know of this development, and have taken steps to respond. The Blunt-Moran letter can be found here.

This situation remains extremely fluid and we will keep our members apprised of any relevant developments. More information on this issue can be found in GNYHA’s position paper. GNYHA and our allies remain prepared to use every avenue, whether regulatory, legal, or legislative, to ensure that these reforms are implemented in a timely fashion and in good faith.