Sending Office: Honorable Kevin Yoder
Support a Fair, Evidence Driven Organ Allocation Policy
Join a Bipartisan Letter in support of fair organ allocation policy
The process of allocating organs from donors to their recipients is of vital importance to every American. At this moment, the fairness of that process is at risk. Please join Representative Kevin Yoder and Representative Eddie Bernice Johnson in writing
to Health and Human Services Secretary Azar to oppose the newest attempt to undermine the organ allocation process.
In 2016, the Department of Health and Human Services proposed a new policy for organ allocation. If this new rule had been finalized, it would have resulted in markedly diminished access to liver transplant services in the Midwest, Southeast, Northwest,
Hawaii and the Pacific Basin. Each of these regions has had a strong push to increase organ donation rates and procurement practices, and now other areas of the country are looking to capitalize on those efforts. We led a letter opposing this rule, and worked
successfully with HHS to change this policy to a more fair and balanced alternative.
Now the system is at risk again. In December of 2017, after months of expert input and discussion, HHS came to a new consensus driven policy that would treat states fairly. In recent months, it has come to our attention that HHS is now looking to scrap this
rule in favor of creating a new policy yet again, undermining the evidence based policy from December 2017. HHS only has until December 2018 to finalize a policy, which will limit opportunities for dissent and thoughtful consideration.
This process is too important to be decided arbitrarily, ignoring the input of experts and law makers. We are extremely concerned that abandoning the December 2017 Policy will lead to lower rates of organ donation and higher death rates among patients waiting
We ask you to join us in a bipartisan letter opposing changes to the December 2017 organ allocation policy.
The deadline to cosign is C.O.B. on September 21, 2018. The text of the letter and a current list of co-signers are below.
Kevin Yoder Eddie Bernice Johnson
Member of Congress Member of Congress
Rep. Eddie Bernice Johnson
Rep. Pete Sessions
Rep. Andy Barr
Rep. Jim Banks
Rep. Luke Messer
Rep. Steve King
The Honorable Alex M. Azar, II
U.S. Department of Health and Human Services
200 Independence Avenue SW
Washington, DC 20201
Dear Secretary Azar,
We write today to urge that you immediately rescind the directive of Health Resources and Services Administration (HRSA) Administrator George Sigounas to the Organ Procurement and Transplantation Network (OPTN) dated July 31, 2018. The directive requires
OPTN to implement a new policy for the allocation and distribution of livers from deceased donors and halt implementation of the liver distribution and allocation policy that was approved by the OPTN/United Network for Organ Sharing (UNOS) Board of Directors
in December 2017 (the December 2017 Policy). Administrator Sigounas’s directive is a clear departure from the evidence-based and consensus-driven process that led to the December 2017 Policy, and we urge to you reverse course on this misguided and hasty policy
The December 2017 Policy was approved by the OPTN/UNOS Board of Directors after years of debate and consensus-building. It was based on substantial deliberations among experts in the liver transplant community, two separate public notice-and-comment processes,
two day-long public forums, and intensive review of multiple data sets analyzing the impact the proposal would have on various components of transplantation. The December 2017 Policy was designed to address longstanding concerns about the geographic equity
of donated livers by providing increased access for the sickest patients over a broader geographic area. This framework was the product of extensive expert-driven debate that was envisioned when Congress established the OPTN to set organ transplant policy
in the United States.
On May 30, 2018, a letter was submitted to HHS from a New York law firm that asked the Department to direct OPTN to abandon the December 2017 Policy. This letter was deemed a “critical comment” by HHS. On July 13, 2018, a lawsuit was filed in the U.S. Southern
District of New York on behalf of plaintiffs in New York, Massachusetts and California, alleging that the use of Donation Service Areas (DSAs) and OPTN Regions in the allocation methodology for donated livers is illegal. In response to the lawsuit and the
letter, HRSA directed OPTN on July 31, 2018 to remove DSAs and OPTN regions from its allocation methodology prior to the OPTN Board Meeting in December 2018.
We are extremely concerned by this new course of action taken by HRSA and OPTN, as the December 2017 Policy is in compliance with the law. Administrative agencies should not respond to pending litigation by ordering destabilizing and potentially reckless
changes in policy. We are also dismayed at the accelerated process through which this change is being pursued, limiting opportunity for dissent or thoughtful consideration of the potential direct and indirect consequences. These concerns are shared by the
Attorney Generals from four states who demanded that the directive be rescinded in a letter to you on August 21, 2018.
The abandonment of the December 2017 policy will have far reaching effects that will create significant patient access concerns within our districts and states. For example, initial stakeholder analysis of the proposals under consideration by the OPTN Liver
and Intestine Committee predict changes in the number of liver transplants in some states may decrease by as much as 50%. These significant variances in overall transplant volume will endanger patient access to liver transplant services in areas of the country
that already have limited access to liver transplant programs.
Removing DSAs and OPTN Regions from the liver allocation and distribution policy will not solve the core issue confronting the transplant community today – a shortage of donated organs. There has been significant progress made to improve and sustain the
successful performance of organ donation efforts in the Midwest, Southeast, and Northwest. The Department, through the Centers for Medicare & Medicaid Services oversight of organ procurement organizations (OPO), should be pursuing policies that promote better
OPO performance in all parts of the country – not policies that harvest organs from high-performing regions to the benefit of low-performing areas. The redistribution of livers brought about by removing DSAs and OPTN Regions from the liver distribution and
allocation policy will disincentivize organ donation, reduce organ availability in rural and minority communities, and destabilize local transplant centers. These are unacceptable outcomes.
We strongly urge that you immediately rescind the directives outlined in the July 31 letter from Administrator Sigounas, halt any activities to alter or eliminate the December 2017 Policy, and allow the December 2017 Policy to be fully implemented on schedule.
We look forward to your prompt reply to this urgent matter.
Kevin Yoder Eddie Bernice Johnson
Member of Congress Member of Congress
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