[Congressional Record Volume 145, Number 155 (Friday, November 5, 1999)]
[Senate]
[Pages S14090-S14091]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. SESSIONS (for himself, Mr. Hutchinson, Mr. Warner, Mr. 
        Torricelli, Mr. Mack, Mr. Shelby, Mr. Nickles, Mr. Inhofe, Mr. 
        Thurmond, Mr. Ashcroft, Mr. McConnell, Mr. Roberts, Mr. Kohl, 
        Mr. Feingold, Mr. Cleland, Mr. Hollings, Mr. Bruaux, Mr. 
        Graham, Ms. Collins, Mr. Grams, Mr. Lautenberg, Mr. Enzi, and 
        Mr. Murkowski):
  S. 1873. A bill to delay the effective date of the final rule 
regarding the Organ Procurement and Transplantation Network; to the 
Committee on Health, Education, Labor, and Pensions.


       organ procurement and transplantation network legislation

  Mr. SESSIONS. Mr. President, I am proud today to join with Senators 
Tim Hutchinson, Warner, Torricelli, Mack, Shelby, Nickles, Inhofe, 
Thurmond, Ashcroft, McConnell, Roberts, Kohl, Feingold, Cleland, 
Hollings, Breaux, Graham, Collins, Grams, Lautenberg, Enzi, Murkowski, 
Gorton, Landrieu, Robb and Lincoln in introducing the Organ Donation 
Regulatory Relief Act of 1999.

[[Page S14091]]

  This legislation is designed to prevent an unprecedented Federal 
takeover of our Nation's organ transplant system by the Department of 
Health and Human Services. This act would nullify a highly 
controversial rule issued by the Secretary of Health and Human 
Services, Donna Shalala, that would give her sole authority to approve 
or disapprove organ allocation policies that are currently established 
by the private-sector transplant community throughout this country.
  This move by the administration would preempt Congress' role in 
encouraging a fair and equitable transplant system through the 
authorization of the National Organ Transplant Act. My bill would 
simply nullify the proposed HHS rule until such time as Congress passes 
amendments to the National Organ Transplant Act.
  This bill would preserve Congress' prerogative to consider changes or 
improvements to the current system while maintaining the private-sector 
role of thousands of patients, families, volunteers, and medical 
professionals that are now responsible for our organ transplant policy. 
It will allow Congress the time needed to consider new initiatives to 
encourage more organ donation which is the heart of our organ shortage 
problem.
  In my home State of Alabama, the University of Alabama-Birmingham, 
has one of the most effective and finest organ transplant centers in 
the world. It is the largest liver transplant facility in the world. I 
am extremely proud of their efforts. Let me just say this, this system 
has been built up carefully, utilizing State law and other laws. It 
works very effectively.
  I am very concerned that Federal Government policies have now been 
proposed that would upset this. It has not only upset the University of 
Alabama-Birmingham but transplant centers, and mainly university 
hospitals all over the country. And that is why we believe action needs 
to be taken at this time.
  I believe the current plan is fair and does a good job of acquiring 
and allocating organs for transplantation. For example, since the 
passage of the National Organ Transplant Act in 1984, the number of 
people receiving organs has increased annually, and the survival rate 
has improved steadily.
  A recent study by the Institute of Medicine came to the same 
conclusion:

       The committee found that the current system is reasonably 
     equitable for the most severely ill (Status 1) liver 
     patients, since the likelihood of receiving a transplant is 
     similar across organ procurement organizations for these 
     patients.

  The Institute of Medicine study contradicted the underlying rationale 
in some numbers that I believe were unwisely interpreted. They underlie 
this rationale for the controversial ``rule'' on organ allocation that 
has been proposed by the Department of Health and Human Services.
  In a careful analysis of 68,000 liver patient records, the Institute 
of Medicine panel said:

       . . . the ``overall median waiting time'' that patients 
     wait for organs--the issue that seems to have brought the 
     committee to the table in the first place--is not a useful 
     statistic for comparing access to or equity of the current 
     system of liver transplantation, especially when aggregated 
     across all categories of liver transplant patients.

  HHS has maintained that reducing regional differences in waiting 
times was the primary goal of their new rule on organ allocation. The 
HHS rule is a solution in search of a problem and would only inhibit 
the continual improvements made by the transplant community since the 
passage of NOTA 15 years ago.

  The HHS policy is also shortsighted in its wholesale preemption of 
State laws regarding organ transplantation. Many of the beneficial 
policies that have served to improve organ procurement and donation are 
based on State laws, such as the organ donor checkoff on driver's 
licenses, and the HHS preemption fails to recognize that fact.
  This year's Labor-HHS appropriations bill provided for a 3-month 
moratorium on the implementation of the rule from the time of its 
enactment. But, unfortunately, this may not and probably will not 
provide adequate time for Congress to consider this very complicated 
issue in the context of amendments to the National Organ Transplant 
Act.
  That is why it is necessary, indeed, imperative. And that is why 26 
Senators have signed on to this legislation in such a short period of 
time. It is imperative that we nullify the rule so that these life-and-
death issues can be considered without fear of a clock running out on 
ways to improve the current system and provide the gift of life to so 
many Americans.
  Hospitals and the physicians who operate in those hospitals are the 
key to the success of the organ transplant program. They receive phone 
calls at all hours of the night, and they go out and retrieve those 
organs from people who have been killed. And they have to do it under 
short periods of time. If they are going to do that simply to send off 
the organs to some hospital of which they are not committed personally 
or to patients of which they are not serving, they will not be as 
effective in retrieving the organs. Not as many people will benefit and 
not as many people will have their lives saved as a result.
  I believe that HHS' actions are unwise. It reminds me of that old 
adage: If it ain't broke, don't fix it.
  We do not have and have not seen a real complaint from the citizens 
of America over the operation of our organ transplant system. This has 
been created by unelected bureaucrats here in Washington, and it is not 
healthy, in my view.
  But there will be a full opportunity, if this bill is passed, to 
allow the Health, Education, Labor, and Pensions Committee, of which I 
am a member, to hold hearings and review the facts in order to develop 
the best transplant program we possibly can. If we can improve the 
system, I say let's do it. But let's be sure we do not break something 
that is not broken already.
  So I thank the outstanding work of several of my colleagues on this 
important issue, including Senators Tim Hutchinson, John Warner, Robert 
Torricelli, and Senator Don Nickles, the assistant majority leader. 
Without their leadership, this legislation could not have come to 
fruition.
  Mr. President, I ask unanimous consent that the text of the bill be 
printed in the Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                S. 1873

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. NULLIFICATION AND REQUIREMENT FOR FURTHER 
                   RULEMAKING.

       (a) Limitation.--Notwithstanding any other provision of 
     law, the final rule relating to the Organ Procurement and 
     Transplantation Network, promulgated by the Secretary of 
     Health and Human Services and published in the Federal 
     Register on April 2, 1998 (63 Fed. Reg. 16296 et. seq. adding 
     part 121 to title 42, Code of Federal Regulations) and 
     amended on October 20, 1999 (64 Fed. Reg. 56649 et seq.)), 
     shall have no force or legal effect.
       (b) No Implementation or Authority.--The Secretary of 
     Health and Human Services shall not implement or exercise 
     further regulatory authority with respect to the Organ 
     Procurement and Transplantation Network, as well as 
     regulatory authority under sections 1102, 1106, 1138, and 
     1871 of the Social Security Act (42 U.S.C. 1302, 1306, 1320b-
     8, and 1395hh), prior to the date of enactment of amendments 
     to reauthorize and revise part H of title III of the Public 
     Health Service Act (42 U.S.C. 273 et seq.).
                                 ______