[Congressional Record Volume 144, Number 150 (Tuesday, October 20, 1998)]
[Senate]
[Pages S12693-S12694]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                      ORGAN TRANSPLANT REGULATIONS

  Mr. HATCH. Mr. President, I rise to speak on a patient care issue of 
enormous importance: regulations being promulgated by the Secretary of 
Health and Human Services (HHS) with respect to organ transplantation.
  I have long championed the need for our country to bring the 
innovations of medical science to the forefront of patient treatment, 
be it through pharmaceutical development, gene mapping, or artificial 
organ development. Nowhere has this been more necessary than in the 
realm of organ transplantation.
  Over 14 years ago, with the passage of the National Organ Transplant 
Act (NOTA), Congress intervened to advance medical science at a time 
when our health care system was not keeping pace with the tremendous 
advances medicine had to offer. As a result, we examined the role of 
the private sector and the Federal government in organ transplantation 
to formulate an equitable policy for individuals throughout this 
country to have access to organ transplantation when appropriate and 
necessary.
  We needed a better system than that which existed at the time, and 
that is what NOTA established. As the author of the National Organ 
Transplant Act (NOTA) in 1984, which was cosponsored by our colleagues 
Sentors Nickles, Thurmond, Grassley and Roth, I am proud of our 
accomplishment, and I continue to maintain a very keen interest in our 
country establishing and operating a viable, effective organ transplant 
network.
  There is no question that passage of NOTA has allowed us to save 
thousands of lives. The medical community has been transplanting over 
4,000 livers each year. We have seen valuable transplant technology and 
services spread from only a handful of research institutions to 
hospitals in rural America.
  In my home State of Utah, LDS Hospital has been able to increase its 
liver transplant volume over 15-fold since its inception only 13 years 
ago. We have aspired to promote a system which allows medical science 
to reach the people it was meant to serve, and I believe we are in 
large part achieving that goal, in great measure due to enactment of 
NOTA.
  Today, I stand before the the Senate to urge that we not 
precipitously reverse that work by allowing implementation of a new 
system which could threaten to undermine many of the successful organ 
transplant centers who are doing so much good in this Nation. Utah's 
own successful transplant center comes to mind, although centers in 
several other States such as Alabama, Louisiana, and South Carolina 
would also be jeopardized if this regulation goes into effect.
  While we in America are fortunate to enjoy the best health care in 
the world, we also have concerns about the availability of life saving 
care should an organ fail. Advances in medicine have made once rare 
transplants commonplace. Yet, there is a scarcity of organs, despite 
the hard work of local organ procurement agencies, transplant centers, 
and, indeed, developers of artificial technology such as the work being 
done on artificial hearts at the University of Utah.
  Added to this concern about the availability of organs is a growing 
anxiety about the impact of HHS's proposed transplant allocation rules. 
A large source of this concern is within the hard-working transplant 
community. In fact, the Department of Health and Human Services has 
indicated that more than 85% of the almost 18,000 comments received 
oppose the organ procurement transplant network final rule.
  In particular, we are seeing a rising concern about variations in the 
availability of organs from region to region. The HHS response, which 
is to, in effect, nationalize distribution, seems logical at first, but 
upon further reflection is a flawed policy with potentially devastating 
near-term effects on many transplant centers. By diverting resources 
from relatively ``organ-rich'' to relatively ``organ-poor'' regions, 
the HHS rules penalize communities which have worked to build up 
successful programs, including those which have done so much to improve 
the harvesting rates of much-needed organs.
  I commend Secretary Shalala for bringing the need to further improve 
the organ transplant system to the forefront. One positive step is the 
recent rule requiring all 5,200 U.S. acute care hospitals to notify an 
organ procurement organization of every death as a condition of 
Medicare participation. Health Care Financing Administrator Nancy Ann 
Min-Deparle estimates that this step alone will increase organ 
donations by up to 20 percent.
  While this was a widely supported step, the proposed rules governing 
the Organ Procurement and Transplant Network have not enjoyed the same 
enthusiasm.
  In January, I joined 41 other Senators who wrote to Secretary Shalaha 
expressing concern that the proposed final rule could be used as 
vehicle to turn organ allocation into a political process. Her response 
did not alleviate my concerns, nor those of the transplant community.
  We cannot damage the public trust in the organ network, nor in the 
decisions

[[Page S12694]]

of health professionals who operate the transplant system. While it 
will never be an easy task to allocate such a critical scarce 
resource--organs--we cannot let this become nothing more than a turf 
war between large and small transplant centers.
  Large centers play an important role by being at the heart of the 
innovations which have brought us the technical advances making current 
liver transplant possible. Smaller centers also make many contributions 
including making such technology more accessible to Americans. This 
allows the patient to be closer to family and loved ones during this 
stressful time.
  We must find a way to increase the organs and reduce the perceived 
inequities in the current system. We need the facts to address the 
problem.
  For this reason, I support the provision, which I understand will be 
contained in the omnibus appropriations bill, that will place a one-
year moratorium on the implementation of the HHS rules. This moratorium 
will allow us to learn the facts necessary to improve the availability 
of transplantation.
  Mr. President, what we have at stake is not just the amelioration of 
a flawed organ transplant procurement and allocation system, but the 
future of allocating scare health care resources of all types. It 
behooves us to proceed carefully on this matter of utmost concern.

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