Letter to Alex Azar, Secretary of US Health & Human Services Department - Engel, Lamalfa Defend Optn New Liver Allocation Policy

Letter

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.

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