[Congressional Record (Bound Edition), Volume 145 (1999), Part 20]
[Senate]
[Page 29135]
[From the U.S. Government Publishing Office, www.gpo.gov]



                  ORGAN DONATION REGULATORY RELIEF ACT

  Mr. TORRICELLI. Mr. President, I rise today to address a potential 
crisis in our nation's system of organ donation. Last year, the U.S. 
Department of Health and Human Services (HHS) proposed regulations that 
would have had devastating effects on community-based transplant 
programs by prohibiting states from offering organs to their own 
sickest residents before making them available nationwide. In response 
to the overwhelming concerns of patients and health care professionals 
nationwide, Congress delayed the implementation of the regulations and 
commissioned a study by the Institute of Medicine to examine the impact 
of the regulations on the nation's current system.
  The study drew several conclusions which demonstrate how the current 
system is effective and why the proposed regulations are misguided. For 
example, the study found that the current system of organ 
transplantation is reasonably equitable and effective for the sickest 
patients. It also found that the proposed regulations would increase 
the overall cost of transplantation in the U.S. Perhaps most important, 
the study found that the current system does not discriminate because 
of race or any other factors and that the waiting list for an organ 
transplant are treated fairly.
  These conclusions support the long-held concerns of the organ 
transplant community that the regulations, which would direct the 
United Network for Organ Sharing (UNOS) to develop a system which 
removes geography as a factor in organ donation, may actually increase 
waiting times in states, like New Jersey, with efficient systems.
  These unintended consequences will be felt most greatly among 
patients with disadvantaged backgrounds. In New Jersey, we are 
extremely fortunate to have a system that is fair and efficient. New 
Jersey's unique system of certificate of need and charity care ensures 
that the most critical patients get organs first regardless of 
insurance. A national organ donation system will force the smaller 
transplant centers that serve the uninsured and underinsured to close 
as the vast majority of organs go to the handful of the nation's 
largest transplant centers with the longest waiting lists. Without 
access to smaller programs, many patients will be faced with the 
hardship of registering with out-of-state programs that may turn them 
away due to lack of insurance. Those who are accepted will be forced to 
travel out of state at great medical risk and financial hardship.
  In light of these concerns, the conferees of the FY 2000 Labor, 
Health, and Human Services, and Education bill included language 
extending the moratorium on the regulations for a period of three 
months. While this is a very positive step, I am concerned that this 
moratorium would not provide sufficient time for Congress to consider 
this issue as part of the debate on the reauthorization of the National 
Organ Transplant Act.
  I am pleased to join my colleagues Senators Sessions, Hutchinson, 
Warner, Mack, Shelby, Nickles, Inhofe, Thurmond, Ashcroft, McConnell, 
Roberts, Kohl, Feingold, Cleland, Hollings, Breaux, Graham, Collins, 
Grams, Lautenberg, Enzi, Murskowski, Gorton, Landrieu, Robb, and 
Lincoln to introduce the Organ Donation Regulatory Relief Act of 1999.
  This bipartisan legislation will delay the Secretary's ability to 
issue regulations regarding the nation's organ donation system until 
Congress considers the complex issues surrounding organ procurement and 
allocation as part of the reauthorization of the National Organ 
Transplant Act.
  For the past 15 years, the national organ procurement and allocation 
system has existed without federal regulation. During this time, each 
State has developed a unique system to meet their individual needs. 
Many states, such as New Jersey, have focused on serving uninsured and 
underprivileged populations. Clearly improvements can be made to 
increase the efficiency and effectiveness of organ donation nationwide. 
The legislation will ensure Congress has ample time to consider these 
important issues prior to allowing the implementation of far-reaching 
regulations that will revamp the system.

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