Liver Transplant Policy

Floor Speech

BREAK IN TRANSCRIPT

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 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.

BREAK IN TRANSCRIPT

Source