Engel, LaMalfa Defend OPTN New Liver Allocation Policy

Washington, D.C. –U.S. Representatives Eliot Engel (NY-16) and Doug LaMalfa (CA-01) are pushing back against efforts to delay implementation of a new national liver allocation policy that would eliminate arbitrary geographic boundaries and prioritize patient need.

The “Acuity Circles Model” would substantially reduce the average sickness of patients at the time of transplant nationwide, reduce costs to the transplant system, and save lives. It was adopted by the Organ Procurement and Transplant Network (OPTN) Board of Directors in December 2018, following several years of deliberation informed by scientific analysis and extensive public comment, and was set to go into effect this week. However, implementation of the policy has been delayed as a result of a lawsuitfiled by those that have historically benefitted from the existing, broken liver allocation system.

Engel and LaMalfa, two proponents of the new need based policy, recently rallied a bipartisan group of lawmakers in support of OPTN’s liver allocation system reforms.

“I am deeply disappointed that opponents of OPTN’s new liver allocation policy have thrown an issue that should be handled by transplant and public health experts to the courts,” Congressman Engel said. “Current law is clear: allocation of organs should be based on patients’ medical need, not where they live. It’s shameful to think a patient in New York or California in dire need of a new liver can be prevented from receiving the care they need due to their zip code. We are hopeful the courts will quickly allow OPTN’s new policy to go into effect.”

“OPTN’s new policy brings fairness and transparency in liver allocations, ensures we are adhering to Congressional intent, and saves lives,” said Congressman LaMalfa. “Experts and professionals in this field debated this new policy in a fair and open process, welcoming public input. While it’s disappointing to see opponents now using the courts to interfere and delay this progress, I’m hopeful we can soon move forward on providing a more equitable system for all patients, regardless of who they are or where they live.”

This past March, Reps. Engel and LaMalfa led 81 of their House colleagues in a letter to Health and Human Services Secretary Alex Azar urging implementation of the new policy. Text of the letter can be found below:

 

March 6, 2019

The Honorable Alex Azar

Secretary

U.S. Department of Health & Human Services

200 Independence Avenue, S.W.

Washington, D.C. 20201

Dear Secretary Azar:

We write to voice our support for the new liver allocation policy that was recently passed the Organ Procurement and Transplantation Network (OPTN) Board of Directors. The existing liver allocation policy created wide disparities in access to transplants and violates the National Organ Transplant Act (NOTA) and implementing regulations. The new policy will end decades of legal noncompliance and, more importantly, save lives and reduce health care costs.

We thank the Department of Health and Human Services (HHS) and your designee, OPTN, for your demonstrated commitment to addressing geographic disparities in access to liver transplantation. We encourage all parties to maintain that commitment by ensuring this new policy is implemented without delay.

The new liver allocation policy was adopted by the OPTN Board of Directors, which includes representatives of transplant, clinical, and professional disciplines throughout the United States, as well as representatives of transplant candidates and recipients, their family members, and family members of both deceased and living donors. This group is uniquely qualified to weigh the varied medical, cost, and policy elements that are necessary for equitable organ allocation.

Under the current liver allocation policy, six patients awaiting liver transplants in various areas of the country—one of whom has sadly since passed away—filed a lawsuit against HHS and OTPN demanding that liver allocation be based on medical priority. HHS and OPTN correctly acknowledged that the existing policy violated NOTA and voted to implement the new policy. 

In reaching their decision, OPTN’s Board of Directors and other committees reviewed a comprehensive body of evidence from a variety of sources, including the Scientific Registry of Transplant Recipients and the United Network for Organ Sharing. They considered unprecedented analysis of over 50 different models with over 400 simulations embodied in nine official reports to HHS and OPTN over the last six years, as well as multiple rounds of extensive public comment. This was the furthest thing from a rash decision; it was a painstaking, data-driven deliberation that adopted, in the final analysis, a model that favors patient need over geography. 

Members of Congress from regions that have historically benefited from the current liver allocation policy are now calling for a reversal of OPTN’s decision and maintenance of the unjust status quo. Despite clear evidence to the contrary, they fear that allocating livers more equitably and prioritizing the sickest patients will harm patients in their states. 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.

The liver allocation policy scheduled for implementation in May, called the “Acuity Model,” eliminates inequities by ensuring that transplants are prioritized by the medical need of patients wherever they may live (rural or urban), whatever their socioeconomic status, and regardless of the organ procurement infrastructure in their area. While the performance of Organ Procurement Organizations (OPOs) can and should be improved in some regions, there is no legal or practical nexus between OPO performance and organ allocation. Congress specifically excluded OPO performance as an element of organ allocation and some of the best-performing OPOs, like California, have some of the longest liver wait times.

OPTN was designated by Congress to develop and adopt policies that comply with NOTA and uphold the congressional intent “to ensure patients that no matter who they were,or where they live… have a fair chance of receiving a necessary organ transplant.” We urge you to take all measures necessary to ensure that the new OPTN-approved policy is implemented without delay.

On behalf of the more than 16,000 people waiting nationwide for a lifesaving liver transplant, thank you for your consideration of and attention to this important issue.

Billy Wynne