[Congressional Record Volume 164, Number 200 (Wednesday, December 19, 2018)]
[Senate]
[Pages S7884-S7885]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                        LIVER TRANSPLANT POLICY

  Mr. MORAN. Mr. President, I am here to speak tonight because 
something is not right. I want to express my real concern with the 
recent decision of the national liver allocation policy made by the 
Organ Procurement Transplant Network made on December 4.
  This sounds like something that is far away and perhaps of no real 
consequence, but the decision that was made has huge consequences on 
every American and should be receiving more attention than it has to 
date because the number of organs that are available for transplant and 
where those organs will be available is being determined by this small 
group of people.
  The decision they made throws aside expert advice from transplant 
surgeons and hospitals on best practices. It also carries the risk of 
decreasing organ donation rates, as donors learn their organs will not 
be used in their own communities but will be shipped someplace in the 
country. Places in the country today have donor programs designed to 
encourage donors to donate their organs, and part of that is the 
understanding that those organs are going to be available for your 
family, your friends and neighbors, and people within your community.
  This decision limits the availability and access to donated organs in 
areas that currently have low wait times and damages the ability of our 
major transplant hospitals to perform these services for patients. In 
December of 2017, following two rounds of public comment period and 
extensive deliberation by the OPTN board, that board approved a 
compromise allocation policy that served the transplant community's 
best interests. This served as a policy reform that was worked out over 
years to better benefit the entire country based upon compromise by 
transplant experts, patients, and stakeholders.
  However, the next year in 2018, a lawsuit was filed based upon the 
HRSA allocation policies, and in the face of that single voice of 
criticism, they disregarded years of work and compromise that was 
reached the year before. It is unfortunate that the basis for this 
policy change was litigation, not a determination of how best to 
improve the Nation's organ transplant, procurement, and allocation 
process. HRSA has rushed to respond to this lawsuit by abdicating their 
duty to implement good policy, instead allowing a single case to divert 
liver allocation policy across the entire United States.
  In October, I had a meeting with Dr. George Sigounas, the 
Administrator of HRSA. He described to me the importance of the comment 
period on these policies and how seriously his Agency would take them, 
especially considering that they were the very institutions and doctors 
who would go on to perform these transplants.
  Shortly thereafter, I was disappointed to learn these comments were 
not comments made by the public, by these institutions, the doctors who 
perform transplants--that these comments were not even considered by 
the individuals tasked with crafting and advising the latest policy. In 
fact, Sue Dunn, the president of OPTN, has informed a number of 
commenters in the transplant community that their concerns over new 
policy were not even read by the board that approved the new policy. 
The reason these comments were not considered was due to the fact that 
OPTN's comment system was so overloaded in the days leading up to the 
decision that it caused a complete shutdown of that process.
  So many transplant hospitals, surgeons, and medical professionals had 
deep enough concerns that they took the time out of their day to 
express them. These are the people tasked with saving lives through 
transplants each and every day. Yet their opinions, in essence, were 
deemed invalid. So many comments were submitted that the entire system 
shut down, and OPTN's response was simply to ignore them.
  Further, OPTN did not choose to reconsider their damaging policies in 
the face of widespread opposition from the medical community. OPTN 
continues to push forward against all common sense in their pursuit to 
radically alter the way organs are distributed across the United 
States. Decisions on national organ allocation should be grounded in 
expert opinions rather than in a response to a single lawsuit. HRSA and 
OPTN are making a grave mistake in pushing this damaging policy that 
carries a significant cost--human lives.
  In the meeting I had with Dr. Sigounas, as I indicated, he told me 
these comments should not just be comments but present actual 
suggestions of what the policy should be. I

[[Page S7885]]

know of institutions and organizations that did that, and to learn they 
were disregarded causes me to have great concerns.
  The Senator from Missouri, Mr. Blunt, and I have probed Secretary 
Azar, the Secretary of Health and Human Services, on this subject, and 
we are eagerly awaiting his justification for what appears to be a 
major significant error. It appears that HRSA and OPTN making policy in 
such a reckless fashion has become the normal state of affairs. 
Additional oversight may be necessary to ensure that fairness in organ 
allocation policy is protected and some common sense prevails in future 
policy. I know there is a group of Senators who are working on 
legislation to do just that.
  I am very disappointed in the actions of HRSA, OPTN, and UNOS. This 
process has been flawed from start to finish, guided not by what is 
best for the country but how to sidestep a single lawsuit.
  Organ procurement and allocation policy is too important. It is about 
life and death and is too important to be simply decided by lawsuits 
and countersuits, which I fear now will become the way of addressing 
this issue.
  I will continue to work to protect our hospitals, our doctors, and 
particularly our patients--Americans--from this policy that disregarded 
all input from those in the transplant community. This discussion 
cannot be seen as anything coming to a close. It is far from over. I 
remain committed to finding answers, changing the tide, and putting 
patients and providers first in these life-or-death scenarios.
  I thank you.
  I yield the floor.
  The PRESIDING OFFICER. The Senator from Ohio.

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