[Senate Hearing 106-412]
[From the U.S. Government Publishing Office]



                                                        S. Hrg. 106-412
 
                        DONATED ORGAN ALLOCATION
                                 POLICY

=======================================================================

                                HEARING

                                before a

                          SUBCOMMITTEE OF THE

            COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE

                       ONE HUNDRED SIXTH CONGRESS

                             FIRST SESSION

                               __________

                            SPECIAL HEARING

                               __________

         Printed for the use of the Committee on Appropriations



                               



 Available via the World Wide Web: http://www.access.gpo.gov/congress/senate
                                 ______
                    U.S. GOVERNMENT PRINTING OFFICE
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_______________________________________________________________________
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                           ISBN 0-16-060350-1



                      COMMITTEE ON APPROPRIATIONS

                     TED STEVENS, Alaska, Chairman
THAD COCHRAN, Mississippi            ROBERT C. BYRD, West Virginia
ARLEN SPECTER, Pennsylvania          DANIEL K. INOUYE, Hawaii
PETE V. DOMENICI, New Mexico         ERNEST F. HOLLINGS, South Carolina
CHRISTOPHER S. BOND, Missouri        PATRICK J. LEAHY, Vermont
SLADE GORTON, Washington             FRANK R. LAUTENBERG, New Jersey
MITCH McCONNELL, Kentucky            TOM HARKIN, Iowa
CONRAD BURNS, Montana                BARBARA A. MIKULSKI, Maryland
RICHARD C. SHELBY, Alabama           HARRY REID, Nevada
JUDD GREGG, New Hampshire            HERB KOHL, Wisconsin
ROBERT F. BENNETT, Utah              PATTY MURRAY, Washington
BEN NIGHTHORSE CAMPBELL, Colorado    BYRON L. DORGAN, North Dakota
LARRY CRAIG, Idaho                   DIANNE FEINSTEIN, California
KAY BAILEY HUTCHISON, Texas          RICHARD J. DURBIN, Illinois
JON KYL, Arizona
                   Steven J. Cortese, Staff Director
                 Lisa Sutherland, Deputy Staff Director
               James H. English, Minority Staff Director
                                 ------                                

 Subcommittee on Labor, Health and Human Services, and Education, and 
                            Related Agencies

                 ARLEN SPECTER, Pennsylvania, Chairman
THAD COCHRAN, Mississippi            TOM HARKIN, Iowa
SLADE GORTON, Washington             ERNEST F. HOLLINGS, South Carolina
JUDD GREGG, New Hampshire            DANIEL K. INOUYE, Hawaii
LARRY CRAIG, Idaho                   HARRY REID, Nevada
KAY BAILEY HUTCHISON, Texas          HERB KOHL, Wisconsin
TED STEVENS, Alaska                  PATTY MURRAY, Washington
JON KYL, Arizona                     DIANNE FEINSTEIN, California
                                     ROBERT C. BYRD, West Virginia
                                       (Ex officio)

                           Professional Staff

                            Bettilou Taylor
                             Mary Dietrich
                              Jim Sourwine
                               Aura Dunn
                        Ellen Murray (Minority)

                         Administrative Support

                             Kevin Johnson
                       Carole Geagley (Minority)



                            C O N T E N T S

                              ----------                              
                                                                   Page
Statement of Dr. William F. Raub, Science Advisor, Department of 
  Health and Human Services......................................     1
Opening statement of Senator Arlen Specter.......................     1
Prepared statement of Senator Arlen Specter......................     3
Summary statement of Dr. William F. Raub.........................     4
Prepared statement of Dr. William F. Raub........................     6
Enhancing organ donation.........................................     6
Equitable allocation of organs...................................     7
Information and data.............................................     7
Oversight by the Federal Government..............................     7
Statement of Dr. Jorge Reyes, Director of Pediatric Transplant 
  Surgery, Children's Hospital, Pittsburgh, and Professor of 
  Surgery at the University of Pittsburgh........................     8
Prepared statement of Dr. Jorge Reyes............................    12
Projected adverse impact on donation.............................    13
Patient travel...................................................    14
Protection of pediatric patients.................................    14
National system of fairness......................................    15
Opening statement of Senator Rick Santorum.......................    15
Statement of Howard M. Nathan, President and CEO, Gift of Life 
  Donor Program, Philadelphia, PA................................    17
Prepared statement of Howard M. Nathan...........................    19
The final rules continue to provide the Secretary with unilateral 
  authority contrary to the intent of NOTA and the Secretary's 
  own comments...................................................    20
Putting patients first: Increasing the organs available for 
  transplantation................................................    22
Waiting list growing.............................................    23
Statement of Cleo Gilmore, Yeadon, PA............................    29
Prepared statement of Cleo Gilmore...............................    31
Statement of Dr. Warren D. Hulnick, Transplant Recipients 
  International Organization.....................................    32
Prepared statement of Dr. Warren D. Hulnick......................    35
Letter from Dr. Warren D. Hulnick................................    36
Organ allocation policy, the Kansas City declaration.............    36
Letter from Joseph F. O'Neill....................................    37
Statement of David Somerville....................................    38
Prepared statement of David Somerville...........................    40



                    DONATED ORGAN ALLOCATION POLICY

                              ----------                              


                        FRIDAY, DECEMBER 3, 1999

                           U.S. Senate,    
    Subcommittee on Labor, Health and Human
     Services, and Education, and Related Agencies,
                               Committee on Appropriations,
                                                    Pittsburgh, PA.
    The subcommittee met at 9:30 a.m., in the gold room, 
Allegheny Courthouse, Pittsburgh, PA, Hon. Arlen Specter 
(chairman) presiding.
    Present: Senator Specter.
    Also present: Senator Santorum.
STATEMENT OF DR. WILLIAM F. RAUB, SCIENCE ADVISOR, 
            DEPARTMENT OF HEALTH AND HUMAN SERVICES


               opening statement of senator arlen specter


    Senator Specter. Good morning, ladies and gentlemen. We 
will begin the hearing of the Appropriations Subcommittee on 
Labor, Health and Human Services and Education. We will be 
joined by my distinguished colleague, Senator Rick Santorum, 
who had other commitments and could not be with us until 
approximately 10 a.m, but we had already scheduled this hearing 
to begin at 9:30, and so we will commence on time.
    The hearing today will consider the Nation's organ 
transplant system, which has come into considerable national 
controversy of events in the course of the past several years. 
The regulations had been delayed until October 1, 1998, and 
then were subject to a further delay until October of 1999, and 
the contentious issues came into focus in the subcommittee 
which I chair, so that this year we tried to work out the 
matter to get the regulations implemented in a reasonably 
prompt manner.
    The Senate bill, which came out of our subcommittee, had no 
delay. Then there were efforts in the House of Representatives 
to have another year's delay, and that was finally reduced to a 
delay of 90 days, which in my opinion was too long, and then 
the matter came to a head in negotiations in a conference which 
I chaired on November 10.
    To get a fuller picture, I asked Secretary of Health and 
Human Services Donna Shalala to join us and we actually brought 
her back. She was en route in the early evening of November 10 
to Georgetown. She came back to the conference, and for about 
1\1/2\ hours we had a very spirited discussion, to put it 
mildly, as to what-all happened.
    Secretary Shalala wanted no delay. She was joined in that 
position by my views, but also by Congressman John Porter, who 
is the chairman of the House Subcommittee, and urging a longer 
delay were Congressman Bill Young, who chairs the full House 
Appropriations Committee and also Congressman David Obey of 
Wisconsin, who is the ranking democrat on the House Committee, 
and so we had quite a discussion, and finally we resolved the 
matter with the 42-day delay, 21 days for comments and 21 days 
for any changes that the Secretary might want to make on the 
regulations. I had thought that that was acceptable to the 
leadership.
    We have a curious situation in Washington with subcommittee 
and full committee chairmen working matters out, but then the 
package is considered by the leadership, and I had reported all 
this to Senator Lott and thought we had his acquiescence.
    But while that was the final product on the appropriations 
bill which was signed into law by the President on Monday of 
this week, October 29, there was an additional provision added 
to another bill for a 90-day delay, which surprised me, and I 
wrote to Senator Lott expressing my dismay about that, noting 
that I did not want to join the growing number of Members who 
were threatening to hold up the final legislation in Congress. 
I thought that enough was enough on what we had gone through, 
that a 42-day delay was adequate.
    The law provides that the last bill dominates, and that 
bill hasn't been signed yet, this worker's bill, but the issue 
is not concluded, because there will be an effort made to 
change all that has been done on authorizing legislation next 
year.
    The people who want to upset the regulation are going to 
have a tough time, because I'm prepared to lead a filibuster in 
the Senate, and my colleague, Senator Santorum, is prepared to 
lead a filibuster in the Senate along with me.
    Senator Santorum added an important provision in the final 
appropriations bill, which precludes going through the whole 
administrative procedure, where there has to be an elongated 
period for comments and delays, and he worked that out in what 
is called the colloquy with Senator Lott and Senator Schumer, 
and I agreed to it, but that was under the leadership of 
Senator Santorum.
    But as I say, this matter is going to come back before the 
Congress on authorizing legislation next year, but I thought it 
would be useful to have this hearing today to explore the 
matter with people in Pittsburgh, because the University of 
Pittsburgh Medical Center has become a national leader, and I 
approached this issue as a U.S. Senator on what I think is the 
best policy for the country as a whole on the Secretary's 
regulations, and that happens to correspond with what is 
helpful to the Pittsburgh region on a parochial basis to give 
recognition to the organ transplant center which we have here 
in Pittsburgh.
    The issue on liver transplants, which is the leading organ 
issue, shows a great disparity Nation-wide, with Massachusetts 
having an average waiting time of 569 days for a liver 
transplant. The Kansas average is 12 days. That puts my State 
of birth at a considerable advantage over Massachusetts and 
also a considerable advantage over Pennsylvania, which has the 
sixth longest waiting period, at 237 days.
    The proposed regulations by the Secretary would still give 
some regional input, but would require the region to be at 
least populated by some 9 million people, and the statistics 
show that the number of organ transplants performed each year 
in the United States has grown from 12,618 in 1988 to almost 
21,000 in 1998. The number of centers performing such surgery 
has grown from 235 in 1988 to 278 at the present time.
    The donor availability has grown in a lesser way from 
slightly under 6,000 in 1988 to more than 9,900 in 1998, but 
almost 5,000 patients die each year, some 13 a day, while 
awaiting organ transplantation, and so we're obviously dealing 
with a matter of life and death, and we want to have a fair 
system.

                           prepared statement

    We really want to take it out of the province of the 
Congress to try to get it to the medical experts to see to it 
that we take care of the sickest first, and have a system which 
is fair Nation-wide.
    [The statement follows:]
              Prepared Statement of Senator Arlen Specter
    The Senate Appropriations Subcommittee on Labor, Health and Human 
Services, and Education will come to order. This morning, the 
subcommittee will discuss liver allocation policy.
    The issue of how to allocate livers to patients has been 
exceptionally contentious. The Department of Health and Human Services 
has been proposing new rules to broaden the geographical basis for 
organ allocation and raising the priority of patients with severe 
disease. Ever since these changes were proposed, there has been a 
battle royal between proponents and opponents.
    Last year, the Appropriations Committee agreed, with great 
reluctance, to a 1 year delay in the regulation so that the Institute 
of Medicine could conduct a study and issue a report. The I.O.M. did so 
and the Department moved ahead with a revised final rule on October 20. 
Then came the cry for an additional delay.
    During the fiscal year 2000 conference between the House and the 
Senate on the Labor-HHS-Education appropriations bill, I invited Donna 
Shalala, the Secretary of HHS, to come to the conference. She was on 
her way home when we reached her. She immediately turned around and 
headed back to Capitol Hill. For more than an hour and a half, we had a 
meeting with the House chairman, Bill Young, who wanted a 90 day delay 
and the ranking House Democrat, David Obey, who also argued strongly 
for a delay. I urged that we not have any delay as did Congressman John 
Porter, chairman of the House subcommittee. Finally we hammered out an 
agreement for 42 days--21 days for additional comments and 21 more days 
for a response to those comments.
    I had thought that closed the matter and reported back to the 
leadership. The general rule is to leave these issues with the 
subcommittee chairmen and we hammered it out. Then I found out that 
there was another bill with the 90 day extension in it that the 
President will need to sign.
    George Schultz, when he was Secretary of State, once made a 
prophetic comment that ``nothing is ever settled in Washington''--he 
hit it right on the mark--nothing is ever truly settled inside the 
beltway. I thought the delay was settled when we struck the deal, but 
it turned out not to be the case; we may settle it with finality when 
the delay period expires.
    We are here to discuss the HHS proposed rule and what the impact of 
the delay might mean. We have assembled two panels of witnesses. Our 
witnesses include Secretary Shalala's Science Advisor, Dr. William 
Raub; Dr. Reyes (pronounced Rayes) of Children's Hospital of 
Pittsburgh; Mr. Howard Nathan who runs the Delaware Valley Transplant 
Group; Dr. Warren Hulnick and Mr. Cleo Gilmore--liver recipients from 
Pennsylvania.
    To ensure that we have sufficient time for questions and answers, I 
ask that each witness limit their opening remarks to 5 minutes. Your 
statements will be included in their entirety at the appropriate place 
in the record.

                Summary statement of Dr. William F. Raub

    Senator Specter. We have two very distinguished panels here 
today, some witnesses to speak in favor of the Secretary's 
position, some witnesses to speak in opposition, and we turn 
now to the panel, and our first witness is Dr. William Raub, 
the Science Advisor for the U.S. Department of Health and Human 
Services, previously having served as Science Advisor to the 
White House Office of Science and Technology, and had been 
Acting Director of the National Institutes of Health, a native 
of Alden Station, PA, with a B.A. degree from Wilkes College 
and a Ph.D in physiology from the University of Pennsylvania, 
so there is lots of Pennsylvania contacts.
    Thank you, Dr. Raub. Our practice in the subcommittee is to 
put a time limit on for the 5 minutes to allow the maximum time 
for questions and answers after the testimony is completed, so 
the floor is yours, Dr. Raub.
    Dr. Raub. Thank you very much, Senator Specter. I 
appreciate the opportunity to provide comments on behalf of the 
Department of Health and Human Services (HHS) regarding organ 
procurement and transplantation in general and the amended rule 
for the organ procurement and transplantation network, in 
particular. In developing the original OPTN rule in April 1998 
and the amended version in October----
    Senator Specter. The abbreviation of OPTN?
    Dr. Raub. That is the Organ Procurement and Transplantation 
Network. HHS has made extraordinary efforts to elicit and 
consider the views of all parties with an interest in organ 
procurement and transplantation. HHS remains committed to 
implementing the rule as soon as authorized to do so.
    With your permission, Mr. Chairman, I will submit my full 
statement for the record and limit my remarks to four points 
regarding the performance of the OPTN----
    Senator Specter. Without objection, your entire statement 
will be made a part of the record.
    Dr. Raub [continuing]. And the role of HHS in fostering 
reforms. First, organ donation and procurement:
    The extraordinary success of organ transplantation over the 
last several decades has caused demand to exceed supply by a 
considerable margin. HHS recognizes that increasing organ 
donation and procurement must be the first priority for 
everyone involved in organ transplantation.
    To that end, in December 1997 HHS launched its national 
organ and tissue initiative, which has two primary elements: A 
regulation requiring hospitals participating in medicare to 
expand their reporting of deaths to organ procurement 
organizations and a $5 million grant program to learn what 
works in organ donation.
    The regulation is modeled upon Pennsylvania's reporting law 
and was inspired in part by the success of the Delaware Valley 
Organ Procurement Organization. We are pleased to report that 
cadaveric organization increased by almost 6 percent last year, 
and we are hopeful that the upward trend will continue. 
Nevertheless, with demand growing faster than supply, we 
recognize that putting patients first requires continued 
emphasis on how organs are shared, which brings me to my second 
point, equitable organ allocation.
    HHS believes that organs should be allocated in a way that 
treats patients equitably, in accordance with the National 
Organ Transplant Act, otherwise known as NOTA.
    Transplant candidates with essentially equivalent medical 
emergencies should have essentially equivalent likelihood of 
receiving an organ, irrespective of their place of residence or 
the geographic location of the transplant program in which they 
are registered.
    The current OPTN organ transplantation policies fail the 
test of fairness. That is why implementing the relevant Federal 
statutes, both NOTA and section 1138 of the Social Security 
Act, to reduce inequities in organ allocation is one of the 
principal objectives of the amended OPTN rule.
    The Institute of Medicine or IOM shares our concerns about 
improving the current system of organ allocation. Its 
congressionally mandated 1999 report entitled, Organ 
Procurement and Transplantation, includes comments specifically 
about livers, and I quote:

    The fairness of the organ procurement and transplantation 
system and its effectiveness in meeting its stated goals would 
be significantly enhanced if the allocation of scarce donated 
livers were done over larger populations than is now the case.

    Such broad geographic sharing is eminently practical, 
because, thanks to advances in organ preservation technology, 
transport of organs over long distances without loss of 
viability now is routine.
    My third point relates to data and information. Deciding 
whether, when, and where to seek transplantation is a complex, 
high-stakes task. Patients and referring physicians confronting 
these decisions deserve up-to-date and easy-to-use information 
about individual transplant programs. The current OPTN data 
publication policies fail this test of timeliness and ease of 
use.
    That is why another principal objective of the OPTN 
regulation is to promote a stream of readily accessible and 
readily understood reports containing program-specific 
information that is both accurate and timely. The IOM report 
also recognizes this need. Recent initiatives by the OPTN 
contractor in this area are laudable, but further improvements 
are needed.
    My fourth and final point relates to oversight of the OPTN. 
HHS believes that it must continue to be an active partner with 
the private sector in pursuing the goals of the OPTN. Indeed, 
the raison d'etre of the OPTN rule is to clarify the nature and 
extent of oversight by HHS while strengthening the role of 
transplantation professionals, patients, patient advocates, and 
other individuals and organizations throughout the private 
sector.
    The IOM report advocates a strong role for the Federal 
Government, especially as an advocate for patients, donors, and 
their families. In recognition of this need, and in response to 
provisions of the Consolidated Omnibus and Emergency 
Supplemental Appropriations Act of 1999, HHS has increased its 
efforts to assess performance of transplant programs.
    With the assistance of staff from the United Network for 
Organ-Sharing, HHS analyzed OPTN patent outcome data for liver 
and heart transplants. Despite risk adjustments, that is, 
adjustments for differences in the mix of patients' health from 
program to program, the analyses revealed substantial 
differences in outcome from one transplant program to another. 
The Department has encouraged the contractor, in its management 
of the OPTN and its operation of the scientific registry, to 
broaden the scope of data collection and make increased use of 
program-specific performance analysis.

                           prepared statement

    In conclusion, Mr. Chairman, HHS believes that the OPTN 
rule, as amended on October 20, 1999, should go into effect at 
the earliest possible time. We look forward to further 
collaboration with you and your colleagues, as well as members 
of the transplant community, toward our shared goals of 
increasing organ donation and fashioning a more effective and 
equitable organ transplantation effort for the United States.
    Thank you.
    Senator Specter. Thank you very much, Dr. Raub.
    [The statement follows:]
               Prepared Statement of Dr. William F. Raub
    Good morning, Senator Specter. I am William Raub, Deputy Assistant 
Secretary for Science Policy at the Department of Health and Human 
Services (HHS). Thank you for the opportunity to provide comments on 
behalf of HHS regarding organ procurement and transplantation--
including the amended rule that was put forward in October for the 
Organ Procurement and Transplantation Network (OPTN).
    HHS first issued the OPTN final rule on April 2, 1998. This was the 
culmination of a process that began in 1994 with the issuance of a 
Notice of Proposed Rule Making, included additional public comment 
periods in 1996 and 1998, and featured a special three-day public 
hearing in late 1996 chaired by the then Assistant Secretary for 
Health, Dr. Philip Lee. In short, HHS made extraordinary efforts to 
seek out and consider the views of all parties with an interest in 
organ procurement and transplantation.
    Nevertheless, the April 1998 final rule was made subject to a 
legislatively prescribed moratorium that continued until October, 1999. 
In association with the moratorium, the Congress called upon the 
Institute of Medicine (IOM) and the General Accounting Office (GAO) to 
study key issues related to organ procurement and transplantation and 
authorized HHS to consult further with the transplant community 
regarding the rule. In October, 1999, HHS amended the rule to embody 
the results of its careful consideration of the IOM and GAO reports; 
its extensive consultations with transplant surgeons, transplant 
physicians, the United Network for Organ Sharing (UNOS)--the OPTN 
contractor, patients and patient advocates, and other members of the 
transplant community; and its analysis of public comments. Recent 
legislative action would delay the effective date of the amended rule 
for an additional period. HHS remains committed to implementing the 
rule as soon as authorized to do so.
    The Preamble to the amended rule issued in October includes a 
detailed description and explanation of the changes HHS made to the 
original final rule; the pertinent portion of that Preamble is attached 
for inclusion in the hearing record. The remainder of my statement 
focuses on several major issues associated with the performance of the 
OPTN and the role of HHS in fostering reforms to serve patients better.
                        enhancing organ donation
    The extraordinary success of organ transplantation over the last 
several decades has caused demand to outstrip supply by a considerable 
margin. As a consequence, more than 4000 people will die next year 
while awaiting an organ transplant. Moreover, HHS expects the number of 
transplant candidates to continue to grow indefinitely.
    HHS recognizes that increasing organ donation and procurement must 
be the first priority for everyone involved with organ transplantation. 
To that end, in December, 1997, HHS launched its National Organ and 
Tissue Initiative to foster partnerships between public- and private-
sector organizations to enhance public education about the need for 
donation and to recruit potential donors. The initiative has two 
primary elements:
  --a regulation, modeled upon legislation in Pennsylvania, requiring 
        hospitals participating in Medicare to expand their reporting 
        of deaths to Organ Procurement Organizations and
  --a $5 million grant program to learn more about what works in organ 
        donation.
    We are pleased to report that cadaveric organ donation increased by 
almost 6 percent last year as a result of our collective efforts, and 
we are hopeful that the upward trend will continue. Nevertheless, with 
the need for transplantation growing faster than the supply of organs, 
we recognize that our commitment to putting patients' needs first 
requires continued emphasis on equitable organ allocation.
                     equitable allocation of organs
    HHS believes that organs should be allocated in a way that treats 
patients equitably in accordance with the National Organ Transplant Act 
(NOTA). This means that standardized medical criteria, developed in 
accordance with sound medical judgment and patient and public 
involvement, should be the cornerstone of allocation policy. This means 
that patients should receive organs in a medically appropriate priority 
order. This means that transplant programs should be monitored to 
ensure that they are complying with enforceable policies and that 
education and graduated sanctions should apply to centers that do not 
comply with the rules. This means that organs should be shared across 
large population areas, consistent with medical and logistical limits 
of organ viability, so as to increase the likelihood that medically 
suitable organs will be available for the highest priority patients. 
Finally, this means that patients with essentially equivalent medical 
priority should have essentially equivalent likelihood of receiving a 
transplant, irrespective of their place of residence or the geographic 
location of the transplantation program at which they are wait-listed.
    The current OPTN organ allocation policies fail these tests of 
fairness. That is why implementing the relevant federal statutes--the 
NOTA as well as section 1138 of the Social Security Act--to reduce 
inequities in organ allocation is another of the principal objectives 
of the amended OPTN regulation that HHS issued in October.
    Our concern about improving the current system of organ allocation 
system through broader sharing of organs is shared by the Institute of 
Medicine (IOM) in its Congressionally mandated 1999 report ``Organ 
Procurement and Transplantation''. Commenting specifically on 
allocation of donor livers, IOM concluded that ``the fairness of the 
organ procurement and transplantation system, and its effectiveness in 
meeting its stated goals, would be significantly enhanced if the 
allocation of scarce donated livers were done over larger populations 
than is now the case''.
                          information and data
    Deciding whether, when, and where to seek transplantation is a 
complex, high-stakes task. Patients and referring physicians 
confronting these decisions deserve up-to-date and easy-to-use 
information about individual transplant programs. The current OPTN data 
publication policies fail this test of timeliness and ease of use. In 
particular, program-specific performance data on transplant programs 
typically are three years old when published and are packaged in a form 
that the average person has difficulty using. That is why another 
principal objective of the OPTN regulation is to promote a stream of 
readily accessible and readily understood reports containing program-
specific information that is both accurate and timely--i.e., reports 
issued at six-month intervals and covering periods ending six-months 
before the publication date. The IOM report also recognizes this need 
and calls upon the OPTN contractor to address it. Recent initiatives by 
the OPTN contractor in this area are laudable, but further improvements 
are needed.
                  oversight by the federal government
    HHS believes that it must continue to be an active partner with the 
private-sector in striving to fulfill the goals of the OPTN. Indeed, 
the raison d'etre of the OPTN rule is to clarify the nature and extent 
of oversight by HHS while strengthening the role of transplantation 
professionals, patients, patient-advocates, and other individuals and 
organizations throughout the private sector. The OPTN rule strives to 
ensure a predictable and enduring balance among the various groups 
whose expertise and perspective are indispensable to the OPTN's 
success.
    The IOM report addresses this issue unequivocally:
    ``The federal government, as well as the transplantation community, 
has a legitimate and appropriate role to play in ensuring that the 
organ procurement and transplantation system serves the public 
interest, especially the needs and concerns of patients, donors, and 
families affected by it. The [IOM] learned of numerous instances in 
which weak governance tends to undermine the effectiveness of the 
system. . . Weak oversight has compromised accountability at all 
levels, permitted poor procedures for data collection and analysis to 
persist, and allowed the system to operate without adequate assessment 
of performance.
    ``Vigilant and conscientious oversight and review of programs and 
policies are critically important to ensuring accountability on the 
part of the OPTN and other participants in the organ procurement and 
transplantation system. The Final Rule appropriately places this 
responsibility with the federal government. The [IOM] believes that 
this is an important aspect of the Final Rule and charge that should be 
pursued by the federal government in close cooperation with the full 
range of participants in the transplant community.''
    In recognition of the need for strong public-sector oversight of 
the OPTN and in response to provisions of the Consolidated Omnibus and 
Emergency Supplemental Appropriations Act of 1999, HHS has increased 
its efforts to assess the performance of transplant programs. With the 
assistance of staff from the United Network for Organ Sharing (UNOS), 
the contractor for both the OPTN and the Scientific Registry, HHS staff 
analyzed OPTN patient outcome data for liver and heart transplants with 
respect to three critical issues:
  --the likelihood that, having been listed as a transplant candidate, 
        a patient will receive an organ within one year;
  --the likelihood that a patient will die within one year of listing 
        while awaiting transplantation; and
  --the likelihood that a patient will still be alive one year after 
        listing, irrespective of whether he or she underwent a 
        transplant procedure.
    Despite risk adjustment (i.e., adjustment for differences in the 
mix of patients' health status from program to program), the analyses 
revealed substantial differences in outcomes from one transplant 
program to another.
    The principal findings for liver transplants illustrate this:
  --ten percent of the programs have a risk-adjusted rate of 
        transplantation within one year of listing of 71 percent or 
        more; whereas, for another ten percent of the programs, the 
        rate is 25 percent or less;
  --the likelihood of dying within one year of listing while awaiting a 
        transplant ranges from less than 8 percent to more than 22 
        percent; and
  --the likelihood of surviving one year after listing as a transplant 
        candidate or a recipient ranges from approximately 86 percent 
        to almost 65 percent.
    The analogous values for heart transplants are 72-36 percent 
(transplantation within one year of listing), 9-23 percent (death 
within one year of listing while awaiting a transplant), and 84-67 
percent (survival for one year after listing irrespective of whether 
transplanted or not).
    In the course of performing these analyses, Department staff 
identified gaps in the data currently collected by the Scientific 
Registry--e.g., additional clinical details about patients' conditions 
at the time of listing (which could improve risk adjustment) and 
additional data on clinical complications (which could help in 
assessing quality of life following transplantation). The Department 
intends to encourage UNOS, in its management of the OPTN and its 
operation of the Scientific Registry, to broaden the scope of data 
collection and make increased use of program-specific performance 
analyses.
    In conclusion, Mr. Chairman, HHS believes that the OPTN rule, as 
amended on October 20, 1999, should go into effect at the earliest 
possible time. We look forward to further collaboration with you and 
your colleagues--as well as members of the transplant community--toward 
our shared goals of increasing organ donation and fashioning a more 
effective and equitable organ transplantation effort for the United 
States.

                        NONDEPARTMENTAL WITNESS

STATEMENT OF DR. JORGE REYES, DIRECTOR OF PEDIATRIC 
            TRANSPLANT SURGERY, CHILDREN'S HOSPITAL, 
            PITTSBURGH, AND PROFESSOR OF SURGERY AT THE 
            UNIVERSITY OF PITTSBURGH
    Senator Specter. We turn now to Dr. Jorge Reyes, Director 
of Pediatric Transplant Surgery at Children's Hospital in 
Pittsburgh, and professor of surgery at the University of 
Pittsburgh. Dr. Reyes has been in Pittsburgh for more than a 
decade, and in addition to his clinical responsibilities he 
serves on the Subcommittee for the Development of National 
Sharing of Split Livers, as well as the Liver and Intestine 
Committee of the United Network for Organ Sharing.
    Thank you for joining us, Dr. Reyes. Perhaps you could 
begin by defining for us the term, split livers.
    Dr. Reyes. Splitting a liver involves taking one category 
of organ, a donor liver from a brain-dead donor, and separating 
it into two halves. The smaller half would go to a child, the 
larger component would go to an adult. It can be done 
successfully with good graft and patient survival, and it 
increases the number of patients transplanted.
    We can do it after removing the liver or before removing 
the liver from the cadaveric donor. It gives us the ability to 
share between centers. We can split a liver here and send a 
piece elsewhere, or go to another center when we are in dire 
need of a liver, split it, leave the main larger piece for the 
recipient locally, and bring the smaller piece for one of our 
patients.
    Senator Specter. Is it available only to split it in two? 
Could you split it in three?
    Dr. Reyes. At the present time the technology is available 
only to split it in two.
    Senator Specter. Thank you very much. Would you start Dr. 
Reyes' time again, please?
    Dr. Reyes. Thank you, Senator.
    Senator Specter. We will not charge you for that. 
[Laughter.]
    Dr. Reyes. My message to the committee is simple. The 
current national allocation policy for liver transplantation is 
fundamentally unfair, especially for children, and results in a 
needless loss of life of patients awaiting transplants. Over 
the last 4 years, alternative allocation policies have been 
proposed and considered by UNOS that would save more lives and 
equalize the current large disparities in patient waiting times 
and deaths.
    During the last year, UNOS has grudgingly made small 
changes to the policies, but those changes have not provided 
any significant benefit to patients. The regulations proposed 
by the Secretary of Health have outlined standards for policies 
that will benefit patients that are waiting for transplantation 
of all types of organs.
    UNOS data and the Institute of Medicine report show that 
there are wide disparities in the opportunity for patients in 
similar medical circumstances to receive life-saving organs. 
The predominant cause of inequities in the system is that 
donated organs, especially livers, are tracked within the small 
local service areas of the 63 organ procurement organizations, 
or OPO's. As a result, patients who are less sick often get 
priority over others who are more sick elsewhere.
    There are those who question the principle reflected in the 
HHS regulation of providing priority for those who are most 
medically urgent. This is, however, the current UNOS principle, 
and the one that UNOS has applied since its inception. UNOS 
reaffirmed this principle when it adopted regional sharing for 
Status 1 liver patients this year. It is also a principle 
supported by the IOM.
    One question which UNOS will not answer, however, is why 
stop with UNOS Status 1 patients? We all agree that those with 
no chance of----
    Senator Specter. Why stop with UNOS Status 1 patients?
    Dr. Reyes. Yes.
    Senator Specter. Can you amplify that, please?
    Dr. Reyes. The severity of patients is separated into 
Status 1, those patients that are in immediate life-threatening 
situations from hepatitis, from not receiving--for example, 
they get a bad liver and the liver isn't working. Those 
patients run the highest risk of mortality.
    However, there are those patients with chronic liver 
disease that are very sick that are in the intensive care unit 
on life support. Those are Status 2A patients. The chronic 
liver-diseased patients that are hospitalized but not on life 
support are 2B, and those patients with chronic liver disease 
that are home waiting are Status 3.
    So for Status 1 the UNOS has supported and has made 
adjustments to criteria that would support more wider regional 
sharing for those Status 1 patients. For example, if we have a 
Status 1 here in Pittsburgh and a liver appears in 
Philadelphia, and they don't have a Status 1 for that liver, it 
could potentially come here for our patient regionally. That is 
supported because it makes sense.
    However, we ask, why not make it under a wider sharing 
region? Why stop at that region, and why stop just for the 
Status 1, because the Status 1's have shown better survival, 
but for the Status 2A's the survival is not bad. It's 73.6 
percent, and so the survival even for Status 2A's is still 
good. The argument against 2A's would be that they're not good 
survivors. Well, we say they are, and the statistics by UNOS 
supports that, that patients, even if they're chronic liver 
disease in Status 2A are just as good survivors as the Status 
1's.
    We all agree that those with no chance of survival should 
not be transplanted, and the HHS regulation indicates that UNOS 
should address futile transplants, but the chances of survival 
of 76.3 percent Nation-wide for the most medically urgent are 
so good that the system must not condemn these individuals to 
death based solely on where they live while others who could 
survive years without a liver transplant receive them.
    Patients who come to Pittsburgh for liver transplantation 
do so for different reasons, including proximity, our expertise 
with certain types of liver disease, our ability to perform 
liver small bowel transplants, the lack of medicare approved 
liver transplant programs where they reside, they are veterans 
who have a VA program, or they have been turned down at other 
programs.
    We currently have patients waiting from Pennsylvania and 
from at least 20 other States, yet because of the current 
allocation policy patients who choose to seek their care here 
face a chance of receiving an organ that is nearly two times 
less than the national average.
    The performance standard set forth in the regulation can be 
met without adopting a single national waiting list. Many of 
these alternatives are superior to the current system, in that 
there are increased number of lives saved. HHS, which 
represents no parochial interest, has issued regulations that 
leave issues of medical judgment with physicians but challenges 
the OPTN to propose new organ allocation policies that will 
promote patient benefit and the saving of patient lives at the 
highest performance criteria.
    Critics of the regulation have mischaracterized its 
contents and have predicted dire consequences. The IOM report 
specifically addresses those criticisms. Opponents of the HHS 
regulations have asserted that it will adversely impact the 
number of donated livers procured each year. This assertion is 
unfounded, and the IOM found no basis to support this. In fact, 
UNOS surveys and a Gallup Poll have found the opposite.
    I believe in my heart that organ donation is likely to be 
increased, not decreased, as the general public learns that the 
system is becoming fair. The sharing of the gift of life across 
State lines brings us together as Americans by breaking down 
the geographic boundaries of States and OPO's.
    I would also bring to your attention that the major patient 
group advocates for candidates, recipients, and their families 
and donor families have all endorsed the Secretary's 
regulations. These groups know better than others how the 
public feels concerning organ allocation. Critics of the HHS 
regulation also claim that it will lead to greater patient 
travel. I disagree, as does the IOM report. Patient travel is 
already a part of the transplant system.
    The regulation affecting the geography on the donation of 
organs also has the potential of literally being a life-saver 
for children awaiting transplantation. A 1998 paper prepared by 
transplant surgeons from the University of South Carolina 
suggests a greater geographic sharing of donated organs and 
more access may save a significant portion of the approximately 
75 children who die each year while waiting for a liver 
transplant.
    The data suggest that as many as 600 pediatric donor organs 
per year are being transplanted into adults, rather than giving 
those organs the opportunity of being split and saving more 
pediatric lives.
    In conclusion, the Secretary's regulation of the OPTN and 
organ allocation does not take any medical decisionmaking away 
from me or from any other transplant surgeon. I will still be 
responsible for medical decisions.
    Moreover, it does not dictate any single national 
allocation system. Instead, it guides UNOS to develop an 
alternative policy. It is the responsible role of the HHS to 
act on behalf of the American public, transplant candidates, 
and the families of all organ donors, to guide the development 
of organ allocation policies that are consistent with the 
spirit of American generosity and compassion.
    The IOM report supported the oversight role of HHS as 
established in the proposed recommendations and recommended 
more active oversight of and involvement by HHS in organ 
donation and allocation. Allow the regulation to go into effect 
and defeat H.R. 2418 and the Senate companion bill, which is a 
death knell for patients and goes totally against the IOM 
report.

                           prepared statement

    I want to also express my personal thanks and those of the 
institutions that I represent to you and to Senator Santorum 
for the valiant efforts which you have undertaken on behalf of 
the organ transplant patients of America.
    Thank you.
    Senator Specter. Thank you, Dr. Reyes.
    [The statement follows:]
                 Prepared Statement of Dr. Jorge Reyes
    My name is Jorge Reyes, M.D. I am a liver transplant surgeon at the 
Starzl Transplantation Institute and Chief of Pediatric Transplantation 
at Children's Hospital of Pittsburgh. My message to the committee is 
simple: The current national allocation policy for liver 
transplantation is fundamentally unfair, especially for children, and 
results in the needless loss of life of patients awaiting transplants. 
Over the last four years, alternative allocation policies have been 
proposed and considered by UNOS that would save more lives and equalize 
the current large disparities in patient waiting times and deaths. 
During the last year, UNOS has grudgingly made small changes to the 
policies, but those changes have not provided any significant benefit 
to patients. The Regulations proposed by the Secretary of Health and 
Human Services will require UNOS to consider more seriously, and to 
adopt one of these policies, or others, which benefit the patients 
awaiting a transplant.
    UNOS data and the Institute of Medicine Report show conclusively 
that wide disparities in the opportunity for patients to receive a 
life-saving organ exist for patients in similar medical circumstances 
listed at centers in different parts of the country. If you live in New 
England and are listed at a transplant center in Boston, the IOM report 
clearly shows that your chances of receiving an organ in time to save 
your life are substantially lower than if you are listed at a 
transplant center in Nashville, Tennessee. These differences are unfair 
and unnecessary.
    The predominant cause of inequities in the system is that donated 
organs, especially livers, are trapped within the small, local service 
areas of the 63 organ procurement organizations, or OPOs, that are 
currently active. With one exception, donated livers are offered to all 
patients within an OPO service area before being offered to any 
patients outside of that area. As a result, individuals who are less 
sick often get priority over others who are more sick elsewhere. The 
exception, as the result of a recent UNOS change, is that in most 
instances, a liver will be shared within one of 11 UNOS Regions for a 
Status 1 patient, before being offered to Status 2A, 2B or 3 patients 
in the OPO area.
    The operation of the current policy in a more usual circumstance is 
best shown by an example. Consider a transplant center with a waiting 
list where one patient has a short 7-day life expectancy, and a second 
patient not yet hospitalized for his liver disease. The more medically 
urgent patient meets the definition of UNOS Status 2A, and the other is 
in UNOS Status 3. Say that both patients are the same weight, age and 
blood type. If a compatible organ is procured in the OPO servicing the 
transplant center, UNOS' current liver allocation policy dictates that 
the donated liver would go to the Status 2A patient, if there is no 
compatible Status 1 patient in the region. This makes sense, since the 
Status 2A patient will die soon without a transplant. Consider, though, 
if these two patients are listed at centers in separate geographic 
areas. If a donated liver becomes available within the OPO of the 
Status 3 patient, that patient would receive the organ, if there is no 
compatible Status 1 patient in the region, while the Status 2A patient 
would continue to wait, and potentially die while waiting.
    At some transplant centers the vast majority of transplants 
performed are on Status 3 patients, while at the same time more 
medically urgent patients wait and die elsewhere in the country. 
Although Status 1, and the less urgent Status 2A patients, comprise 
only a tiny fraction (approximately 2 percent) of the candidates 
waiting for liver transplants in the U.S. at any time, they account for 
nearly half of the patient deaths on the waiting list.
    Consider this example from 1998. We had a young child in our 
hospital as a Status 1 patient. He was critically ill, in need of a 
liver and small bowel, and was listed at the University of Miami as 
well. Organs became available in Miami's UNOS region and arrangements 
were being made to send the organs to Pittsburgh until a surgeon from 
another Florida program insisted that the organs remain local for 
transplant into a Status 3 child. The next day the patient in 
Pittsburgh died. Had we received the organs from outside our region 
this child might be alive today.
    There are those who question the principle reflected in the HHS 
regulation of providing priority for those who are most medically 
urgent. This is, however, the current UNOS principle, and the one that 
UNOS has applied since its inception. UNOS reaffirmed this principle 
when it adopted regional sharing for Status 1 liver patients this year. 
It is also a principle supported by the IOM. One question which UNOS 
will not answer, however, is why stop with UNOS Status 1 patients? We 
all agree that those with no chance of survival should not be 
transplanted and the HHS regulation indicates that UNOS should address 
futile transplants. But the chances of survival (76.3 percent 
nationwide) for the most medically urgent are so good that the system 
must not condemn these individuals to death, based solely on where they 
live, while others who could survive years without a liver transplant 
receive one.
    The patients on the waiting list in Pittsburgh are disadvantaged by 
the inequities in the current system, as are patients at numerous other 
transplant programs, large and small, across the country. Patients who 
come to Pittsburgh for liver transplantation do so for different 
reasons, including: the proximity of their residence, our expertise 
with specific types of liver disease, our ability to perform liver 
small bowel transplantation (one of only three programs in the country 
that routinely perform this procedure), the lack of a Medicare approved 
liver transplant program in their area, they are a veteran of the U.S. 
Military or, because they have been turned down by other liver 
transplantation programs. We currently have patients waiting from 
Pennsylvania and from at least 20 other states. Yet, because of the 
current allocation policy, patients who choose to seek their care here 
face a chance of receiving an organ that is nearly two times less than 
the national average.
    The performance standards set forth in the regulation can be met 
without adopting a single national waiting list. Many of these 
alternatives are superior to the current system in that there are an 
increased number of lives saved. Over the past several years, a wide 
variety of alternative policies have been considered by UNOS 
committees, but only one regional sharing plan, for UNOS Status 1 liver 
patients, has been adopted. Many of the proposals are superior to the 
current system and meet the provisions of the regulation. The IOM 
Report recommended a policy of organ distribution in areas of not less 
than 12 million people as a way of benefiting patients and having a 
more equitable system. At a May 7, 1998 meeting of the UNOS Liver and 
Intestine Committee, a motion was passed that the Committee could 
indeed develop a policy that meets the policy goals of the regulation, 
while avoiding some of the logistical difficulties attendant to a 
single national list policy. Recent statements by UNOS at its November 
1999 Board meeting reaffirmed that UNOS can adopt policies that comply 
with the regulations. Given these admissions that UNOS can comply with 
the Regulations, UNOS should propose such allocation policies now.
    HHS, which represents no parochial interest, has issued regulations 
that leave issues of medical judgment with transplant doctors, but 
challenges the OPTN to propose new organ allocation policies that will 
promote patient benefit and the saving of patient lives as the highest 
performance criteria.
    Critics of the regulation have mischaracterized its contents, and 
based upon the mischaracterization have predicted dire consequences. 
The IOM Report specifically addressed the criticisms and concluded that 
they were essentially without merit. I would only add a few comments 
about criticisms of the regulation for the committee's consideration:
                  projected adverse impact on donation
    Opponents of the HHS regulations have asserted that it will 
adversely impact the number of donated livers procured each year. This 
assertion is unfounded and the IOM found no basis of support. In fact, 
when UNOS surveyed the general public in 1994, it learned that 60 
percent of recipients, and 58 percent of candidates, assigned the 
lowest priority to keeping organs locally. 54 percent of recipients and 
50 percent of candidates assigned top priority to the patient who has 
the least amount of time to live. Making waiting time ``about the same 
for all patients nationally'' was a top priority for over one-third of 
those surveyed. Similarly, in an OPTN poll in 1990, over 75 percent of 
respondents disagreed with the statement that ``donor organs should go 
to someone in the area where the donor lived.'' The attitude of donor 
families is well illustrated by the testimony of Patricia Hodgson to 
the Human Resources Subcommittee of the House Government Reform and 
Oversight Committee at a hearing on April 8, 1998, in Milwaukee, 
Wisconsin. Ms. Hodgson is a nurse who donated her husband's organs. Her 
testimony included the statement:
    ``I didn't ask or care if Jim's organs went north, south, east or 
west or stayed here in Wisconsin. My intent was that someone was to be 
given another chance to live.''
    We know that the people of Pennsylvania are encouraged by the 
recovery of Daniel Canal, a 13-year old Maryland boy who received a 
multiple organ transplant in Miami with organs donated by a generous 
family in Pennsylvania. I believe in my heart that organ donation is 
likely to be increased, not decreased, as the general public learns of 
more events such as this. The sharing of the gift of life across state 
lines brings us together as Americans by breaking down the geographic 
boundaries of states, and OPOs.
    I would also bring to your attention that the major patient 
groups--advocates for candidates, recipients and their families, and 
donor families--such as the American Liver Foundation, Transplant 
Recipients International Organization, National Transplant Action 
Committee, and the Minority Organ and Tissue Transplant Education 
Program, have all endorsed the Secretary's regulation. These groups 
know better than others how the public feels concerning organ 
allocation.
                             patient travel
    Critics of the HHS regulation claim that it will lead to greater 
patient travel. I disagree as does the IOM Report. Patient travel is 
already a part of the transplant system. Indeed, equalizing the chances 
for patients to receive a donated organ will remove one of the several 
incentives for patients to travel to a distant center.
    Based on findings of the IOM, one out of four transplant recipients 
traveled out of state to receive a liver transplant. For 46 percent of 
the population, including the residents of the 14 states without a 
liver transplant center, travel is a necessity. Many other liver 
candidates choose to travel out of state, even if there is an in state 
program, for such reasons as: to seek the expertise of a specific 
center with regard to their condition, to comply with the dictates of 
health care insurance, to avoid a high mortality rate or long waiting 
times at a local center, or due to the refusal of a local center to 
list the patient. And although these patients traveled out of state, 
organs procured in their state of residence generally did not follow 
them.
    Finally, when you consider that 32 percent of Louisiana patients 
and 28 percent of Oklahoma patients, according to 1994 and 1995 UNOS 
data, travel elsewhere for their transplants you have to wonder if 
their recently enacted state organ hoarding laws truly benefit all the 
residents of those states.
    Critics also contend that Medicaid beneficiaries will be hurt by 
these regulations because of patient travel concerns. Again, the IOM 
Report found there was no basis for this criticism.
                    protection of pediatric patients
    The regulation, by curtailing the effect of geography on the 
allocation of donated organs, also has the potential of literally being 
a ``life saver'' for children awaiting transplantation. A 1998 paper 
prepared by transplant surgeons from the University of South Carolina 
and UNOS suggests that greater geographic sharing of donated livers and 
more access may save a significant portion of the approximately 75 
children who die each year while waiting for a liver transplant. There 
are a limited number of pediatric transplant centers and many OPO 
service areas and some UNOS regions have none. The data from the study 
suggest that as many as 600 pediatric donor organs per year are being 
transplanted into adults, rather than children, in part because the 
organs are donated in areas with no pediatric transplant centers or 
patients. Since many pediatric patients are in Status 1 or 2B, they 
will benefit from the performance standards in the regulation which 
call for more equal access to organs for the sicker patients in wider 
geographic areas.
                               conclusion
    The Secretary's regulation of the OPTN and organ allocation does 
not take any medical decision-making away from me or from any other 
transplant surgeon. I will still be responsible for medical decisions 
regarding my patients. Moreover, it does not dictate any single liver 
allocation system. Instead, it guides UNOS to develop an alternative 
policy, perhaps similar to one of the many that UNOS has considered 
over the past several years, and to propose it to the federal 
government for review.
    It is the responsible role of HHS to act on behalf of the American 
public, transplant candidates and the families of all organ donors, to 
guide the development of organ allocation policies that are consistent 
with the spirit of American generosity and compassion. The IOM Report 
supported the oversight role of HHS as established in the proposed 
regulations and recommended more active oversight of, and involvement 
by, HHS in organ donation and allocation. The voice of the public has 
been heard and it says to share the gift of life with the most 
medically urgent transplant candidates no matter where they live. The 
voice of the IOM, in a study specifically commissioned by the U.S. 
House and Senate, has also been heard supporting the regulations and 
the policies which they establish. I urge this Committee to hear these 
voices. Allow the regulations to go into effect and defeat H.R. 2418, 
and the Senate companion bill, which is a death-knell for patients and 
goes totally against the IOM Report.
    I want to also express my personal thanks, and those of the 
institutions that I represent, to you and to Senator Santorum for the 
valiant efforts which you have undertaken on behalf of the transplant 
patients of America. We know you care and that helps.

                      national system of fairness

    Senator Specter. Senator Santorum has joined us. I will 
yield to him in a moment before we turn to Mr. Nathan, but 
before we do, I want to summarize briefly what we have talked 
about.
    At the outset I summarized the background as to the 
negotiations with Secretary Shalala and the conference on the 
subcommittee bill, and how we had sustained a year's moratorium 
last year, and they had wanted another year's moratorium and 
reduced it to 90 days.
    We had negotiated a 42-day period, and then a subsequent 
bill added back the 90-day period, and I told them about your 
leadership in the colloquy with Senator Lott and Senator 
Schumer, specifying that there would not be within any period 
the necessity to go back and have comments and republication on 
the extension of procedural steps.
    I also said that the purpose of this hearing was to get 
more factual information because the matters will be before the 
Congress again next year with the candid statements of those 
who oppose the regulation trying to nullify it, and our 
commitment, yours and mine, to lead a filibuster which would 
require 60 votes to cut off, and if that were to be achieved, 
which I think unlikely, that a presidential veto would be in 
order to back up Secretary Shalala's position, and that would 
require 67 votes.
    But we wanted to have this hearing to get the specifics on 
a national system of fairness, which coincidentally is of 
benefit to the University of Pittsburgh Medical Center and much 
of this region.
    So with that brief summary, I will yield to you, Senator 
Santorum.

               Opening statement of Senator Rick Santorum

    Senator Santorum. First of all, let me congratulate you for 
holding this hearing and more importantly congratulate you for 
the excellent work you have done on behalf of this issue. As 
chairman of the subcommittee you have been besieged, now, for 2 
years, and I know this was one of the last remaining issues 
that you had to deal with in trying to get your bill done, and 
to stand up, as you did, to our Leader in the Senate and to 
last year the Speaker of the House, or who was to be the next 
Speaker of the House, the chairman of the Appropriations 
Committee, Bob Livingston, and a whole host of other people who 
have been fighting this battle on the other side.
    You have valiantly stood in the trenches and were able to 
achieve the 42-day, subsequently 90-day moratorium which 
effectively--and I think that is the point that I tried to make 
to my colleagues, which effectively is 180 days, because it is 
90 days before the Secretary's role becomes effective, then 
UNOS has 90 days to develop a liver transplant policy and a 
year, better than a year to develop a transplant organ 
allocation policy for all other organs.
    So for those who are concerned that the Congress will not 
have time to make a statement, to act on this issue, there is 
plenty of time if there is a serious desire on anybody's part 
to deal with this issue congressionally.
    The system we are operating under was due for 
reauthorization back in 1993, and so when a lot of people came 
forward to me and to Senator Specter and said, look, we need 
this delay because we are going to bring up the 
reauthorization, we need to have time to reauthorize this bill, 
I said, you have had 6 years to reauthorize this bill and to 
say that somehow or another you are going to wave your wand and 
get it done next year because we are going to give you another 
moratorium--that is what Congressman Livingston told me last 
year when I got into a shouting match with him on this issue, 
that he needed another year to reauthorize the bill.
    This is a very controversial subject. It is a very 
controversial subject because you have--and I hate to put it in 
these terms. You have, I believe, one side of the issue that is 
driven by economics, and economic survival, and it is a very 
different world in the smaller transplant centers, or the newer 
transplant centers, than it is in the older and established 
centers, and they are in need of organs to basically survive in 
business.
    When you see the States reacting like Louisiana and New 
Jersey--and I think there are four or five others who have said 
that no organs can leave their States. I looked at Louisiana, 
for example, that I think 68 percent of the people in Louisiana 
that get transplants get them from outside of Louisiana, so 
here are people from--their own citizens who cannot get organs 
from people in their States, because they keep the organs. Now, 
does that benefit the citizens of Louisiana, or does it benefit 
the transplant centers in Louisiana?
    So who are we really trying to benefit here, the citizens 
or the economy, and that is the reason I have gotten so 
passionate about this issue, because this should not be about 
economics. This should be about saving people's lives, and the 
system that the Secretary--and Dr. Raub knows this. I do not 
often agree with the Secretary, but on this issue I could not 
agree more with the Secretary, and I have stood shoulder to 
shoulder with her in trying to make sure that this allocation 
system can move forward so we can begin to save lives that are 
needlessly being lost in this country, not just here in 
Pittsburgh but all over the country.
    We are going to continue to fight this battle. This is not 
even close to being over. We are really in the thick of it. 
There will be a reauthorization. Senator Frist has promised 
that he will try to move a reauthorization out of the Labor 
Committee in the early part of next year. I have talked to 
Senator Frist. I think he comes at this issue from an honest 
perspective, and I am hopeful that he will try to move a fair 
bill.
    But as Senator Specter said, this is not a bill that 
reflects in the best interest of patient care and is in the 
best interests of the people who are on those lists who 
desperately need these organs to survive, and Senator Specter 
and I will block this legislation to the last drop of our blood 
on the floor of the Senate.
    Senator Specter. We may need transplants. [Laughter.]
    Senator Santorum. We may need transfusions. I do not know 
about transplants. But to me this is that important an issue. 
It is not about economics. There are transplant centers in and 
around Pennsylvania that are not supporting this proposal. 
There are those here that do.
    This is about doing what is right for patients, and I want 
to associate myself with my good colleague and senior colleague 
from Pennsylvania for his excellent work, and look forward to 
working with him to make sure that these regulations or 
something very similar to it are finally enacted into law and 
we have a fair organ allocation policy.
    Senator Specter. Thank you very much, Senator Santorum. I 
would say that you and I stand shoulder-to-shoulder with 
Secretary Shalala. That is three blocks of granite.
STATEMENT OF HOWARD M. NATHAN, PRESIDENT AND CEO, GIFT 
            OF LIFE DONOR PROGRAM, PHILADELPHIA, PA
    Senator Specter. We now turn to our third distinguished 
panelist, Mr. Howard Nathan, who is president and CEO of the 
Gift of Life Donor Program in Philadelphia, which is the organ 
procurement organization for the entire Delaware Valley. He has 
been with the Delaware Valley Transplant Program for more than 
two decades and is responsible for the coordination of organ 
procurement and allocation in Eastern Pennsylvania.
    A native of Johnstown, he earned his bachelor's degree from 
Juniata College in Huntingdon and attended both the University 
of Pennsylvania and the University of Pittsburgh, so your 
credentials are excellent. Just do not run for State-wide 
office. [Laughter.]
    Mr. Nathan and I chatted briefly. He has an opposing view 
to Secretary Shalala's regulation, and it is our practice and 
the practice generally in the Congress to hear all points of 
view, regardless of what the Senators on the subcommittee might 
think.
    Welcome, Mr. Nathan, and the floor is yours.
    Mr. Nathan. Thank you, Senator Specter and Senator 
Santorum. I appreciate the opportunity.
    As the Senator said, I am from the Philadelphia area, but 
we cover the eastern half of Pennsylvania for organ donation, 
which represents actually about two-thirds of the State's 
population. My organization, Gift of Life, has been around for 
25 years. It used to be called Delaware Valley Transplant 
Program until this year. It represents 12 hospitals that 
perform organ transplants and 3,000 patients awaiting organ 
transplantation.
    We are proud of our efforts here in Pennsylvania. Our 
sister organization, CORE, which is based here in Pittsburgh, 
has some of the highest donation rates in the country because 
of comprehensive State laws that have been implemented to 
increase donations.
    Just to give you an idea, in the last 2 years, in 1997 and 
1998, our organization was the number 1 program in the country, 
with 291 organ donors in 1997 and 298 in 1998, representing 
over 1,850 life-saving transplants. This year to date our organ 
donors have gone over 300 for the first 11 months, representing 
930 patients who received transplants. We are very proud of 
that record, and we are hoping that some of the things that we 
have done that I will talk about later federally will emulate 
Pennsylvania's success.
    One of the things that I guess I regret to report is that I 
feel that the current media debate about allocation has cast 
doubt in the public's mind about the system that really has 
aided hundreds of thousands of people who have received organ 
and tissue transplants over the past several decades.
    My feeling is by continuously focusing on allocation 
instead of the real issue of increasing donations the public 
attitude toward donation may have been negatively impacted. 
Gift of Life does not disagree that organ allocation policies 
must be continuously evaluated, appropriately updated, and 
administered in an equitable and fair manner, but we strongly 
urge that careful consideration be done so that the manner in 
which it occurs is different than it is today, in the front 
headlines of the papers.
    To date, I feel that there has been a lack of focus, and 
that changes of the allocation system of the OPTN that have 
been implemented have actually changed some of the things that 
we have been arguing about over the past 3 years. One of which 
we talked about was this Status 1 sharing of livers regionally 
so that patients within a certain region of the country who are 
the sickest get priority for an organ that becomes available.
    One of the things we are concerned about with the regs is, 
we believe it gives the Secretary unilateral authority that is 
contrary to the intent of NOTA and in some cases to the 
Secretary's own comments. We believe that the current system 
allows for open debate with Government input, among the medical 
community and the public, for continuous evaluation and policy 
change regarding broader organ-sharing.
    As you said before, the Gift of Life certainly agrees with 
the IOM report that the provision of the final rule for organ-
sharing take place over as broad a geographic area to ensure 
that organs reach the appropriate patients is appropriate. In 
fact, the OPTN contractor has implemented that, as I said, with 
this Region 1, or the regional status-sharing.
    Interestingly, the size of the population base is about 9.8 
million, which is similar to our population in the Gift of Life 
area, and we recognize there may be a need to expand the 
sharing areas in other parts of the United States, as Senator 
Santorum said, in smaller parts of the country where the 
population bases aren't that big and that patients who are not 
as sick get transplants.
    I see my time is running short.
    Senator Specter. You can take a little longer, Mr. Nathan.
    Mr. Nathan. Thanks. We feel that, moreover, establishing 
broader organ-sharing policies through the population base and 
waiting time rather than other issues, including things such as 
geography, may be unfeasible in certain parts of the country, 
because organs have a limited viability outside the body.
    There are numerous situations where transplanting an organ 
quickly is required. All donor organs are not created equal, 
and what I mean by that is, as the transplant surgeons are 
continuously trying to expand the donor pool, such as utilizing 
organs from older-aged donors--as old as 82 years old livers 
have been successfully transplanted--the only way that surgeons 
will use those organs is if they can transplant them within 
hours of the removal, and in some cases that sharing is not 
possible, and those are the type of things that I think medical 
judgment has to come into play to make decisions about when we 
are setting up organ allocation policies.
    Issues surrounding data collection, as Dr. Raub indicated, 
the Secretary would like more information available to patients 
making decisions about transplantation. We agree with that, but 
we also feel that the current OPTN contractor has some of the 
best medical information for patients in the country, and it is 
now online through a system called UNET, which provides a great 
deal of information on listing outcomes for specific 
transplants, and is accessible to all members of the community.
    Our issue focuses along this area regarding the Secretary's 
ability to hold unilateral decisionmaking. We also feel that 
the development of the Advisory Council is somewhat redundant, 
because it really exists through much of the medical community 
that already participates in the extensive debates through the 
OPTN contract.
    One other issue has to do with OPO performance criteria. 
One of the issues right now is that some OPO's may be 
decertified by the Health Care Finance Administration, because 
of what is called poor performance. I do not disagree that 
every OPO should do whatever they can, and I feel that they do 
try to perform as well as possible, and in certain instances 
there may be a need for replacement of organizations. However, 
until performance criteria are well-defined, I do not think 
that any organization should be decertified.
    Some of the amendments reflected, as well as the amendment 
in the NOTA bill, say that HCFA should work with the organ 
procurement organization to issue organ procurement 
certification standards that make sense.
    Last but not least, as I indicated, we are very proud of 
the success here in Pennsylvania. In our region of the State, 
two-thirds of the State, organ donation has increased 65 
percent just in the last 2 years, and the number of transplants 
available has increased 70 percent. Our sister organization, 
CORE, this year has begun to experience increased organ 
donation rates, and has always been a high performer.
    We are hopeful that the Federal rules implemented for 
routine referral will continue to increase procurement, and my 
feeling is that the system is not totally broken. What we must 
do, as citizens of the country, is to make sure that more and 
more focus becomes on organ donation rather than organ 
allocation.
    Thank you very much.
    Senator Specter. I thank you, Mr. Nathan.
    [The statement follows:]
                 Prepared Statement of Howard M. Nathan
    I am Howard M. Nathan, the President and C.E.O. of Gift of Life 
Donor Program (``Gift of Life''). Gift of Life is the nonprofit organ 
procurement organization (``OPO'') that serves patients and hospitals 
in the eastern half of Pennsylvania, Southern New Jersey, and Delaware 
and has a population base of 9.8 million. For over 25 years, Gift of 
Life has served more than 160 acute care hospitals in the tri-state 
region; it has been certified by the Health Care Financing 
Administration (``HCFA'') since 1988 as the OPO for its service area.
    Gift of Life currently serves over 3,300 patients awaiting life-
saving organ transplants at 12 regional transplant hospitals. In 
addition, it has cooperative relationships with three regional eye 
banks and three tissue banks. Gift of Life has consistently been 
recognized as one the nation's top performing OPOs. We are proud of our 
efforts on behalf of the patients we serve. In 1997 and 1998, Gift of 
Life was the most active OPO in the United States, coordinating a 
national record number of organ donors (291 and 298 respectively) for 
any OPO service area in the United States resulting in 1,844 life 
saving transplants. Gift of Life's performance year to date in 1999 
again places it as the most active OPO in the country. We have again 
coordinated a national record number of 308 organ donors the first 11 
months of this year coordinating over 930 transplants year to date.
    I am also appearing today as President of the national Coalition on 
Donation (``Coalition''). The Coalition is an alliance of the entire 
transplant community, including 48 national organizations and 50 local 
grassroots coalitions with the primary mission of educating the public 
about organ and tissue donations and creating a willingness to donate. 
You may be familiar with the Coalition's unified national message, 
``Share Your Life, Share Your Decision'' which was developed by the Ad 
Council and utilized in the Coalition's highly visible Michael Jordan 
public education campaign, as well as the Ad Council campaigns on organ 
and tissue donation. Numerous partnerships with nationally recognized 
advertising and media agencies have been formed to utilize these 
talents and deliver a common message to the public. Other partnering 
efforts have been undertaken. For example, supported by Congress' 
efforts in enacting the National Donor Card Insert Act, the Coalition 
worked with the U.S. Department of Treasury and Department of Health & 
Human Services in 1997 to provide 70 million people the opportunity to 
indicate their wish to become organ or tissue donors by including donor 
cards in the envelopes that contained IRS tax refunds. I believe it is 
critical that we refocus the nation's attention on donation if we are 
to combat the donor organ shortage.
    My other experiences in transplantation include past President of 
the Association of Organ Procurement Organizations (``AOPO'') and three 
times elected to the Board of the current Organ Procurement and 
Transplantation Network (``OPTN'') contractor, the United Network for 
Organ Sharing.
    Working with Gift of Life and our elected representatives, as well 
as other organizations such as the Coalition on Donation, AOPO, and 
UNOS for more than 20 years, has granted me the opportunity to work 
closely not only with transplant hospitals and OPOs, but with donor 
families and transplant recipients at both the local and national 
levels. I understand that a single message regarding donation must be 
communicated through comprehensive public education initiatives. This, 
in conjunction with providing all potential donor families with the 
donor option, is critical to combating the organ donor shortage.
    Regrettably, I must report that the current debate in the media 
regarding organ allocation has cast doubt on a system that has aided 
hundreds of thousands of patients. By continuously focusing on 
allocation instead of the real issue--increasing organ donations, the 
public's attitude towards organ donation may have been negatively 
impacted. Gift of Life does not disagree that organ allocation policies 
must be continuously evaluated, appropriately updated and administered 
in an equitable and efficient manner, but strongly urges that careful 
consideration be given to the manner in which those acts occur. To 
date, Gift of Life believes there has been a disturbing lack of focus 
on the changes in the organ allocation and listing policies that have 
already been implemented by the OPTN contractor in cooperation with the 
transplantation community during the past three years. At the same time 
the important issue of increasing organ donation has taken a ``back 
seat'' rather than being the primary focus.
    Today, I will highlight those aspects of the October 20, 1999 Rules 
regarding the Organ Procurement and Transplantation Network (the 
``Final Rules'') that I support, as well as those areas in which I 
believe the Final Rules will not further the interests of patients 
nationally. I will also provide data on the success of measures that 
have been undertaken to increase organ donation in this country and 
offer a challenge to the Congress to further commit its resources to 
organ donation efforts.
   the final rules continue to provide the secretary with unilateral 
   authority contrary to the intent of nota and the secretary's own 
                                comments
    Gift of Life recognizes the efforts of all within the public and 
private sectors of the transplant community to fully evaluate and 
consider the issues surrounding allocation and to identify policies 
that will fairly deal with patients. Gift of Life supports certain of 
the policy positions highlighted in the Preamble to the Final Rules and 
the Final Rules itself. However, Gift of Life maintains the position 
that ultimately many of these issues are medical issues, and that the 
Final Rules continue to allow for excessive discretionary decision 
making by the Secretary on medical issues. We believe that the current 
system (OPTN) allows for open debate among the medical community and 
the public for continuous evaluation and policy change.
Policies for the equitable allocation of organs
            Broader regional sharing
    Gift of Life agrees with the Institute of Medicine (``IOM'') Report 
and the provision of the Final Rule providing that organ sharing take 
place ``over as broad a geographic area as feasible'' to ensure that 
organs can reach the patients who need them most, and for whom 
transplantation is appropriate. In fact, the current OPTN contractor 
has already implemented broader sharing policies, such as regional 
sharing of livers for Status-1 patients. Gift of Life serves a 
population base of approximately 9.8 million, similar to the optimal 
size recommended by the IOM and critically ill patients can routinely 
receive organs if regional organ donor efforts are effective. We also 
recognize that there may be a need to expand the sharing in other parts 
of the United States where population bases are somewhat smaller. As 
noted above, Gift of Life's organ and transplantation efforts have 
experienced significant growth in the last several years. Gift of Life 
attributes this growth to the successful partnering with the hospital 
and community on ``Routine Referral'' laws and the suitability criteria 
applied by its regional transplant centers and surgeons. In particular, 
Pennsylvania Act 102, passed in 1994, has been a national model for 
increasing organ donations.
    However, neither the Final Rules, nor accompanying statements, 
recognize or contemplate the concerns voiced by the medical community 
that broader regional sharing to provide for the transplant of the 
sickest patients first might result in adverse patient outcome and 
survival rates. This is an issue that must be the subject of ongoing 
evaluation and monitoring. The process of developing and modifying the 
allocation policies must be sufficiently flexible and dynamic to allow 
for ongoing change. Our concern is that the Final Rules do not allow 
for this type of dynamic process given the timeframes provided for and 
the role of the Secretary.
    Moreover, establishing and applying ``broader organ sharing 
policies'' solely through population base, rather than other issues 
(including other limitations, such as geographic ones) may be 
infeasible in certain parts of the country. Because organs have a 
limited time of viability outside of the body, there are numerous 
situations where transplanting an organ quickly is required. All donor 
organs are not created equal. Transplant surgeons are continuously 
trying to expand the donor pool such as utilizing organs from older age 
donors, and the viability and ultimate utilization of such an organ may 
be compromised through broad based sharing. Therefore, medical 
judgement must always be considered. Shorter cold ischemic times (time 
donor organ is outside of the body) result in more successful 
transplantations and significantly less wastage.
            Patient listing criteria
    Gift of Life also acknowledges and supports the changes that have 
already been made by the OPTN contractor to the patient listing 
criteria applicable to liver and heart patients. While historically 
there have been discrepancies in waiting times by region, those 
discrepancies were in a large part based on a system of listing 
patients that is no longer prevalent with the above policy changes. We 
also believe that it will be impossible to equilibrate waiting times as 
a primary measure in organ allocation since medical factors should 
always take precedent.
Data collection protocols
    We concur with the emphasis on the collection of data as provided 
in the Final Rules. We note, however, that one of the best medical 
databases in the country is the one that has been established by the 
OPTN contractor. The UNET system provides for comprehensive data on 
listing, outcomes and specific transplant centers and is accessible to 
all members of the public. In order to evaluate the success of any 
organ allocation and other transplantation policies, including those 
most recently implemented by the OPTN contractor, all of the 
participants must commit resources to the timely development and 
accessibility of data.
Medical decision making
    Gift of Life also agrees with the Secretary's comments accompanying 
the release of the Final Rules that transplant professionals must make 
medical decisions. However, Gift of Life is concerned that while that 
may be the Secretary's intent, it is not a position reflected in the 
Final Rules. The Secretary continues to hold unilateral decision making 
on the content of policies, which should be determined by the medical 
community.
    Although the Secretary points to the Advisory Committee on Organ 
Transplantation established under the Final Rules as the expert body 
that will be providing her with the medical science expertise on 
proposed allocation policies, she continues to make all final decisions 
and need not accommodate the directives of this body. We feel this may 
be redundant as the expertise already exists within the OPTN and its 
committees. Moreover, it is interesting that the OPTN Contractor Board 
and membership is to be comprised of representatives and persons 
knowledgeable in the field. No where in the Final Rules is there 
criteria regarding the composition or qualifications of members of the 
Advisory Committee. Its oversight function is limited in that while the 
Final Rules provide that ``the Secretary will refer significant 
proposed policies to the Advisory Committee. . . .'', and ``may'' seek 
the advice of the Committee on other proposed policies, the Secretary 
is not required to adhere to the advice of the Committee or make 
changes upon the Committee's recommendation. In fact, that section of 
the Final Rules which provides for the establishment of the Advisory 
Committee does not even require the Secretary to obtain the Committee's 
input, but instead provides that the Secretary ``may seek the comments 
of the Advisory Committee on proposed OPTN polices''.
    Consequently, on this important issue it appears that the Final 
Rules continue to confer upon the Secretary the unilateral authority to 
establish policies impacting transplantation. This is inconsistent with 
the intent of Congress when it enacted the National Organ and 
Transplantation Act (``NOTA'').
OPO performance criteria
    The Preamble to the Final Rules highlights the issue of OPO 
performance, an issue that has also been the subject of extensive 
debate. The Preamble recommends that incentives be developed to reward 
``high performing OPOs''. Gift of Life believes that OPOs should be 
held accountable to the patients and families they serve. However, 
performance criteria should be well defined and should measure more 
than the number of donors and the population base that an OPO supports. 
Until such time as criteria are well defined and validated, no action 
to decertify an OPO should be taken with the possible consequence of 
disrupting the care of the families of donors and recipients. This view 
has been reflected in statements made by the President, as well as an 
amendment to the NOTA reauthorization bill. Just as the Administration 
has recognized that a dialogue with the transplant community is 
necessary before changes should be proposed or implemented, Gift of 
Life requests that the Administration establish a dialogue with the 
Association of Organ Procurement Organizations on the issue of OPO 
certification standards. Also, the Administration should issue further 
guidance to the transplant community as to what performance measures 
the Administration believes relevant and the types of ``incentives'' 
that are contemplated.
      putting patients first: increasing the organs available for 
                            transplantation
    The federal government must continue to support efforts to increase 
organ and tissue donation in this country. It is only by increasing the 
number of organs and tissues that are donated that we can reduce the 
number of people that die or suffer needlessly while awaiting 
transplant. Monies must be provided to support donor education and 
awareness programs.
    Earlier this year, I testified before the Commerce Committee of the 
U.S House of Representatives at a hearing entitled ``Putting Patients 
First: Increasing Organ Supply for Transplantation''. It has been the 
experience of Gift of Life that repeated and focused educational 
programs will increase donor awareness and will increase the number of 
organ donors. In Pennsylvania, between the years of 1995 and 1999, the 
actual number of donors that Gift of Life coordinated increased by 65 
percent. Similarly the number of actual organ transplants that Gift of 
Life coordinated was 70 percent greater than the number Gift of Life 
coordinated in 1995. This growth occurred at a time when organ 
donations nationally increased an average of less than 2-5 percent a 
year.
    This increase followed the enactment by the Pennsylvania 
legislature of a comprehensive donor awareness and education bill 
referred to as Routine Referral legislation. The Routine Referral 
legislation, among other items, requires that all hospital patient 
deaths be referred to the OPO for a determination regarding suitability 
and that all families of potential donors be advised of the donor 
option. Federal rules, modeled after this Pennsylvania law and our 
experience with the law, began being implemented nationally in August 
1998. It is applicable to all Medicare and Medicaid participating 
hospitals. Preliminary data reveals that national organ donation rates 
for calendar year 1998 were 5.3 percent higher than donation rates for 
calendar year 1997. Likewise, in 1999, I suspect that the rates might 
have been even higher but for the continued public controversy 
regarding allocation.
    Expanded public education programs, combined with best practices in 
hospitals can lead to increased consent rates. Even with the growth in 
donation experienced in Pennsylvania, Gift of Life along with CORE, the 
OPO serving the western half of the state, are working with the state 
Department of Health and Transportation on new initiatives to heighten 
awareness and increase donation. Captioned ``Wanna make your license 
look great?'', this new multi-media public education campaign 
encourages Pennsylvanians to elect the donor designation on their 
drivers' licenses. We believe that continued focused attention on this 
issue will lead to increased donation.
    However, we will not be as successful if the current controversy is 
continued. The current system is not broken and does not require an 
overhaul. We must ensure that we continue the national public service 
and education programs designed to make citizens aware of the ``Gift of 
Life'' that is theirs to give. We also must safeguard the gifts of life 
that have already been made and not further harm public trust in the 
existing system. It is not ``red, tape'' that prevents patients from 
getting needed transplants, rather the organ donor shortage, which must 
be addressed by increased public awareness and education.

                          waiting list growing

    Senator Specter. Senator Santorum and I will begin with 5-
minute rounds, and we may have more than one, depending upon 
how the Q and A goes, and I would begin with your final point, 
Mr. Nathan, about trying to get more organ donations.
    The statistics show that the number of patients awaiting 
transplantation has grown from about 14,000 in 1988 to some 
66,000 persons on waiting lists for organ transplantation 
today. What is your suggestion, Mr. Nathan, as to how we might 
stimulate more donations?
    Mr. Nathan. Well, I think three ways. One is to make sure 
that the Federal regulations for routine referral in all 
hospitals in the country are followed by every hospital in the 
country to see organ donation as a priority, so that every time 
an individual dies in this country, that person, the first 
question that is posed to that person's family is, was that 
person an organ donor. We think that that has to continue to be 
a priority, that HCFA must make sure that that is occurring in 
hospitals across the country in partnership with the OPO's.
    Senator Specter. Can you give us your next two as briefly 
as you can? I want to move on with the questions.
    Mr. Nathan. Sorry. The second has to do with more 
awareness. I'm also president of the National Coalition--
there's a campaign called, Share Your Life, Share Your 
Decision, and we believe that money has to be given to promote 
this, and market this as a cause that is important to citizens 
of the country.
    I think last, the last surrounds having families think 
about this before it becomes an issue in their lives, and that 
also surrounds public education, so we do approach families.
    Senator Specter. Dr. Raub, Mr. Nathan raises an objection 
which has been heard broadly. Quite a number of my colleagues 
wrote me objecting to the Secretary's regulations on the ground 
that she had unilateral authority.
    One reading of the statute is that the Secretary's 
regulations are guidelines but UNOS is going to have the final 
say. The United Network for Organ-Sharing will come forward 
with a plan, and that that will be the final determinant. 
Actually, what will happen under the existing legislation as 
you see it?
    Dr. Raub. What we have tried to capture in the rule is the 
opportunity for the Organ Procurement Transplantation Network 
to come forward with its proposal for how organs would be 
allocated, first livers, and then all of the others. We want to 
rely very heavily on the medical judgment that we believe will 
be----
    Senator Specter. Is that from UNOS?
    Dr. Raub. UNOS is the contractor, yes, sir.
    Senator Specter. If they come forward with a plan, is that 
binding on the Secretary?
    Dr. Raub. No, it is not binding on the Secretary. It will 
be subject to review at the Department. We are hopeful that the 
plan will be responsive to the principles in the regulation.
    Senator Specter. Does the Secretary then have the authority 
to veto the UNOS plan and establish whatever plan she 
unilaterally wishes?
    Dr. Raub. In theory, yes, sir, but in practice that is not 
the way the Secretary would do it. If she were unhappy with the 
plan submitted, she would indicate that to the contractor and 
any problem she has with it, and ask them to address it again.
    Senator Specter. Well, that is an issue which I think we 
need to focus on, as to how we develop that. If you have 
ultimate authority in the Secretary, and final say, it raises a 
lot of hackles, and understandably so.
    If there are some guidelines--and I do not have the magic 
formula at my finger tips, but I think it is something we need 
to grapple with so that it is ultimately a medical decision, 
perhaps some vast abuse of discretion, or some standard of 
review, but I would like you to transmit that concern to the 
Secretary. Senator Santorum and I doubtless will, too.
    Before my yellow light expires, Dr. Reyes, let me take up a 
question with you, and that is this issue on timeliness that 
Mr. Nathan raises. Timing is everything. I recall perhaps the 
most famous transplant of all, which occurred right here in 
Pittsburgh for Governor Casey on June 14, 1993, a day I 
remember very well.
    I had a problem of my own that particular day, and it was a 
magnificent double transplant, and Governor Casey has done 
remarkably well, although I think it not inappropriate to note 
that he is not feeling too well at the moment. Our thoughts and 
prayers are with him. Governor Casey testified at a field 
hearing we had on September 12 last year to get his views on 
transplant.
    What is the reality on the objection raised by some as to 
the time limits, as to how long you can keep a liver or other 
organs viable?
    Dr. Reyes. Mr. Nathan's observation was based upon a donor 
that was 80 years old, and I believe that that is a fair 
observation, where if you have an older donor, or a donor from 
what we call an expanded pool that are very unstable, that you 
would qualify as poor donors, that is not the type of organs 
that you want to keep in preservation solutions for 16 hours.
    The ideal donors, which is hard to define, are donors that 
are younger, that are very stable, and that at the time the 
organs are removed, the liver looks good.
    Senator Specter. Under best condition, how long would the 
liver last?
    Dr. Reyes. 16 hours. I feel comfortable with 16 hours. I 
can get a liver into anybody from any organ procured anywhere 
in Canada within 16 hours.
    Senator Specter. Thank you very much.
    Senator Santorum.
    Senator Santorum. Thank you very much, Mr. Chairman. 
Several questions. When was NOTA passed? What year was it 
passed?
    Dr. Raub. 1984.
    Senator Santorum. How many centers were doing transplants 
in 1984, do you have any idea?
    Dr. Raub. Not off-hand, sir. A few dozen.
    Senator Santorum. How many are doing it now?
    Dr. Raub. Over 200.
    Senator Santorum. Under NOTA when there were only a few 
centers, all of those centers were given a voice in UNOS, 
correct, and now with 200-plus centers, all of them are given 
equal voice in UNOS, right?
    Dr. Raub. They all have a voice.
    Senator Santorum. What was the survival of an organ 
outside, that was harvested in 1984, a liver, do you know?
    Dr. Reyes. It was about 60 percent survival.
    Senator Santorum. I am talking about the liver. How long 
could it be preserved?
    Dr. Reyes. Less than 8 hours.
    Senator Santorum. The point I want to make with that sort 
of fact scenario is, this is a very different world today, and 
we have a law that is outdated, and we allocated in the 
Congress to a group of hospitals, UNOS, basically a group of 
transplant centers an authority that we would never, never have 
done if there were 200-and-some today.
    We would never have passed a UNOS today, and so I, too, 
have concerns about the Secretary's authority, and that has 
been the greatest complaint that I have heard, and I am not an 
ends-justifies-the-means kind of guy, so I still have those 
concerns.
    I recognize why she is doing what she is doing, because the 
world has changed dramatically since 1984. When you harvested 
an organ in 1984, one of the reasons there was geographic 
sharing is because you could not send an organ very far, and so 
you had to share geographically.
    Now that is not the case, but we have not really changed 
the rules to reflect the transition in technology, and to sort 
of rely upon that and saying, well, we have to keep it in place 
because that is the way we have done it, does not make a whole 
lot of sense to me when the world has changed.
    The other thing is--and Mr. Nathan, I am not questioning 
anybody's motivations, but I think economic survival is a big 
issue in this arena for a lot of centers, and to me, that 
cannot be an issue. That just cannot be an issue.
    What has to be the issue here is how we best allocate a 
very scarce resource, and I understand the complaints about the 
Secretary's authority, but the reason the Secretary is claiming 
this authority is because a system that has become so 
decentralized with so many voices from so many minor players 
representing their economic interest has destroyed the 
integrity of the system, and so that is why she has asserted 
her authority, and frankly we should have done so years before, 
and we have failed to do it.
    Now, that does not in my mind--and I agree with Senator 
Specter, that does not give the Secretary license to do what 
may be the right thing, but questioning whether that is the 
right legal thing to do, but I certainly sympathize with what 
she believes is the need to do it.
    I would just hope we have the courage in the next Congress 
and in this Congress coming up next year to take back the 
system of organ allocation and give it to who it belongs to, 
which is in this case the Government, and not a group of 
private transplant centers all over the country.
    They should not be allocating--I disagree. They should not 
be allocating, because it has turned into too much of an 
economic football, and we cannot have a system that has public 
mistrust based on economics on such an issue that is too 
critical to be put in that category.
    Now, having said that, I keep looking at your testimony 
here, Mr. Nathan, and it keeps coming back to the same thing. 
You have a problem with the Secretary's unilateral authority. I 
keep talking to my colleagues, and one of the things I keep 
hearing, particularly from my conservative brethren, is, we do 
not like the fact that Secretary Shalala is just taking 
something that is not in the law and doing it.
    What I do not see, in all candor, here is really any 
problem with a lot of the substance of what she is doing. I do 
not--I mean, you are nit-picking here a little bit on 
substance. That is what it looks like to me, and correct me if 
I am wrong here, but when you pull out an 80-year-old donor and 
say, that is my problem, that is nit-picking a little bit.
    Dr. Raub, excuse me, is there enough flexibility in this 
regulation to take care of the 80-year-old donor problem?
    Dr. Raub. Yes, sir, there is.
    Senator Santorum. I think there is, and so you also say 
that broader regional sharing to provide for the transplant of 
the sickest patients first might result in adverse patient 
outcome and survival rates. The Institute of Medicine did not 
say that. Dr. Reyes, did they say that?
    Dr. Reyes. No.
    Senator Santorum. There really are not any facts out there 
that suggest that is the case. I mean, you say we should listen 
to this. Well, OK, we will listen to it, but unless you have 
any facts to suggest that there is something here that is real, 
again, it is sort of throwing some flags up, but what you keep 
coming back to in every area is, you just do not like the 
Secretary telling you what to do. OK, but let us just be honest 
that that is what the issue is here, that is all.
    Mr. Nathan. The reality is I want the focus to be on 
donation because that is what I do, and because we are the ones 
who are facing the families, and we have to tell them the 
system is fair, it does work on behalf of patients.
    Our concern is, and my coordinator's concern is that when 
they talk to families, there is concerns when it is on the 
front page of the paper that the Federal Government is going to 
revamp the system because it is unfair. I do not believe it is 
unfair.
    I have been on the board of UNOS three different occasions. 
I participated on almost every committee. Although it is the 
medical community, half the membership of UNOS are public 
members. There are more than 480 voting members. Half of them 
are not transplant centers, and there are patient committees 
and minority committees to talk about these issues, and so I 
feel there has been healthy debate, including from Pittsburgh. 
I think they clearly were listened to.
    Senator Santorum. They are usually pretty quiet, so that is 
sort of surprising. [Laughter.]
    Mr. Nathan. Not behind the scenes, so there are some things 
that I agree with and some things I disagree with. The primary 
one was having a group of people who truly understand the 
dynamic system that occurs, because it is constantly changing. 
If somebody told me 10 years ago we were going to remove organs 
from an 82-year-old, I would have laughed.
    When I started the donor age was 45. I just turned 46, so I 
would have been too old to be a heart donor 10 years ago, and 
so it is a dynamic process, and the medical people have to get 
it straight, to meet behind the scenes to make sure the system 
is fair, and certainly that the Government has to bless it but 
not necessarily override it.
    Senator Santorum. I know my time has expired, but I agree 
with you that the issue has to be--and I always mention in 
every talk I ever give on this issue that this would not be a 
serious issue if we had enough organ donors.
    I mean, I always bring out my little license here and my 
little green stamp underneath my picture that says organ donor, 
and I always ask everybody else to take out their wallets and 
show me whether you are an organ donor or not, and if you are 
not, do something about it, because there is no reason you 
should not be.
    So I agree with you, and I think it is important to do it.
    Mr. Nathan. Those are the kinds of systems that I am 
begging people to set up in other States. Take a model--that 
that registry has 3.2 million people on the registry. It is the 
second highest in the country. If other States would start to 
do this, those places where there are these problems with 
sharing, they have problems with sharing but the reason why is 
their donor rates are not as large. They need to do more things 
to increase donations.
    Senator Specter. Thank you, Senator Santorum. That is an 
easier question which Senator Santorum just articulated, when 
we ask someone to take out their wallet, than others might pose 
under analogous circumstances, just seeing the organ donor on 
their driver's license.
    You had your hand up, Dr. Raub.
    Dr. Raub. May I comment further about the Secretary's role? 
A few points. One, the Secretary does not intend to practice 
medicine, and we all believe that if a future Secretary did, a 
future Congress would not allow that to happen, so we believe 
the rule in fact has the basic protections in it.
    Second, the rule has performance criteria these proposals 
from the community need to meet.
    Third, the amended rule includes a new advisory committee 
that in the open light of day would be a forum where experts 
could consider the proposals from the transplant community, and 
there would also be an oversight and critique on any judgment 
by the Secretary, and so we think we have built-in significant 
protections to ensure there is not arbitrary or capricious or 
uninformed action by the current Secretary.
    Senator Specter. We want to move on to the next panel, but 
let me just raise one other question, or get an amplification 
on the question, and that is what Dr. Reyes has emphasized, and 
Mr. Nathan now says we have a fair system. When I look at these 
statistics on availability, or average waiting time on the 
liver transplant, Massachusetts 569 days, Kansas 12 days, 
Pennsylvania sixth to longest waiting period, 237 days, how 
about the basic issue of fairness, Mr. Nathan, in terms of 
those statistics?
    Mr. Nathan. When you take those apart, Senator Specter, the 
reality is, when you look at the most urgent patients, the 
Status 1 patients, and even the Status 2A's, which are the most 
urgent people, the people who are in danger----
    Senator Santorum. Which you have not regionally adjusted. 
You have not done that with the 2A's.
    Mr. Nathan. That is correct. I do not disagree with you, 
Senator. That may be something that is the next step we have to 
talk about. When you take those apart, Senator, the waiting 
times do not differentiate that much between region to region, 
or OPO to OPO.
    The waiting times begin to spread out when you get to the 
less critical people, and because of how people list patients, 
because of prior systems that have now been, I think, 
corrected, and Jorge may agree with me that the listing 
criteria when someone is placed on the list has changed, such 
that you do not put someone on the waiting list 5 years before 
they need a liver transplant.
    Some of those days' waiting that you have said have a lot 
to do with those people who are not critically ill. They may 
need a liver transplant at some time, but they are not in 
danger of dying, and if you look at the most critically ill 
patients, which has been the argument, there is not that much 
difference in the waiting time.
    Clearly, people die, no question about it, and we have to 
stop that, but I am not sure, and I have not been convinced yet 
that national sharing, for example, would solve that problem.
    Senator Specter. Dr. Reyes, Mr. Nathan says he hopes you 
agree with him.
    Dr. Reyes. I disagree. For the Status 1's and the Status 2 
there really is a significant difference in waiting time, and I 
have some recent statistics that for Status 1 the minimum time 
is 2 days and the maximum time 16. For Status 2, the minimum 
time goes from 7 to a maximum time of 71 days.
    Now, depending on why the patient is in the hospital, those 
days can make a big difference. Right now, I have in our 
intensive care until at Children's Hospital one boy that has 
been waiting for 2 weeks as a Status 1 for an organ, and 
another boy that has been waiting for a month as a Status 1 for 
an organ, and so there are significant differences.
    Senator Specter. It would be useful, I think, to this 
subcommittee and to the Senate and the House generally to 
really get some finite statistics which bring the distinctions 
which you raise, Mr. Nathan and Dr. Reyes, because we need to 
be informed with precision as to the various classifications. 
When I look at the various categories in the lifetime and the 
complexities here, that needs to be front and center before we 
take up these issues.
    A final comment, Dr. Raub.
    Dr. Raub. Just another fact related to that. The 
differences in categories 1A and 2A for livers cannot be very 
long, because one has to have 7 days estimated to live to be in 
that category. So, by the nature of the system, it would be a 
much smaller zone than would be true for the other categories.
    Senator Specter. Well, as that impacts on the people in the 
longer period, we need more information as to what category 
these 569 people in Massachusetts, on their waiting, and maybe 
they cannot have that for aggravated liver problem, the people 
in Kansas. Kansas until not too long ago was a dry State. 
[Laughter.]
    Senator Santorum.
    Senator Santorum. No further questions.
    Senator Specter. OK. Thank you very much, Dr. Raub, Mr. 
Nathan, Dr. Reyes. We appreciate your being with us.
    We now want to turn to panel 2, and our witnesses are Mr. 
Cleo Gilmore, Dr. Warren Hulnick, and Mr. David Somerville.
STATEMENT OF CLEO GILMORE, YEADON, PA
    Our first witness is Mr. Cleo Gilmore from Yeadon, 
Pennsylvania, a former sales executive for Ortho McNeil, a 
division of Johnson & Johnson. He has been listed and treated 
for liver disease at the University of Pittsburgh Medical 
Center, but at UPMC's urging he was also placed on the organ 
waiting list at the University of Miami and was able to get his 
transplant there. He is a graduate of Penn State and married 
with one child.
    Mr. Gilmore, thank you very much for joining us, and the 
floor is yours, and if you could summarize within 5 minutes, we 
would appreciate it.
    Mr. Gilmore. Thank you, Mr. Chairman. In 1994 I was 
diagnosed with primary sclerosing cholangitis. That was the 
same fatal disease that recently took the life of football 
great Walter Payton. Fortunately, my fate was different than 
that of Mr. Payton's. After a long and difficult road, I 
received a liver transplant at Jacksonville Memorial Hospital 
in March of 1996.
    When I was first diagnosed, I was getting my care at one of 
the local transplant centers in Philadelphia. It was not long 
before my condition started to worsen, and in November of 1995 
I ended up in the hospital for over 3 weeks. In January of 
1996, my doctors in Pennsylvania began to get very concerned 
about my condition. They did not think that they would be able 
to find a donor liver in time to save my life, so they 
suggested that I contact the University of Miami, because they 
had a shorter waiting list.
    At my own expense, I flew to Miami to be evaluated for 
transplant. I was immediately put on the Miami transplant list 
and sent back home to Philadelphia with my pager. Now, I was on 
two lists, two transplant lists, one in Pennsylvania and one in 
Florida.
    Sure enough, a few weeks later a donor liver was found for 
me in Florida, and once again at my own expense I chartered a 
plane to Miami to receive my liver transplant. The cost for 
that flight was $8,000. Despite having excellent insurance 
coverage, I was deeply in debt following my transplant just 
because of the travel expenses alone.
    My story is not unique. There are many patients across the 
country who go to great lengths and expense to find a donor 
organ. Unfortunately, there are many, many more patients who 
lack the resources to double-list or to shop for shorter 
waiting lists like I did. If you do not have the resources, 
then you are at the mercy of the transplant system.
    I was fortunate. The fact is that the current transplant 
system is not fair. In my case, I was on two waiting lists at 
two different hospitals. When the liver was found in Miami, why 
couldn't they just send it up to me in Pennsylvania, instead of 
forcing me to leave my family and my support system in 
Philadelphia? It is just not fair.
    Mr. Chairman, I know you have been working hard to change 
the system, and I appreciate your efforts. The last time I 
spoke about this issue was in 1996, at a 3-day hearing 
conducted by the Department of Health and Human Services. I was 
one of over 100 witnesses.
    Since then, I understand that the HHS has received 
thousands and thousands of comments on this issue. I think the 
Secretary has done a very good job responding to those 
comments, and I support the HHS transplant regulations. They 
will ensure that all patients have a fair and equal chance of 
finding a donor organ, and that donated organs will go to the 
patients who need them the most.
    A person should not get a transplant just because they live 
close to the donor. In my case I would have gladly waited 
longer if somebody sicker than me needed the organ more. We all 
have to wait our turn, but it was very frustrating to sit and 
wait while healthy people get transplants and I was so close to 
dying. The HHS regulations will make the transplant system fair 
for everyone.
    But despite your efforts, Mr. Chairman, Congress has put 
the regulation on hold again for the third time, and it is 
clear to me the goal of UNOS and many members of the transplant 
community and some Members of Congress is to kill these 
regulations no matter how many lives it may cost in the long 
run.
    The comment period has now gone on for 3 years since that 
first hearing. Now it is time to take action. The regulations' 
opponents have waged a successful propaganda campaign in order 
to make their case. However, this July the truth came out in 
the form of a report from the Institute of Medicine. The report 
was ordered by Congress last year. The IOM supported the HHS 
regulations and dispelled the myths that had been promoted by 
those opposing the regulations.
    One of the claims that opponents make is that the HHS 
regulations will make it difficult for minorities and low 
income patients to access the organ transplant system. The IOM 
found no evidence to support that claim. As my story shows, it 
is those patients with limited resources who have a difficult 
time getting transplants. Many of those patients are inner city 
minorities.
    I was able to get a liver transplant because I had the 
resources to escape the discrimination that rules our organ 
transplant system. If I was not able to pay for a charter 
flight to Florida, I might not be here today.
    It is well-documented that African Americans wait nearly 
twice as long as whites for kidney transplants. This is not 
fair. Some of the reason for this difference is biological, but 
a change in the allocation system could even out the playing 
field dramatically.
    I believe that a fair system based upon the broad sharing 
of donated organs is what Congress intended when it started 
this program 15 years ago. That goal can only be achieved if 
the regulations are allowed to go into effect.
    Now, in addition to trying to kill these regulations, some 
of your colleagues in Congress have introduced a bill to 
rewrite the transplant act. The impact of this bill is 
frightening to me. Not only would the bill cripple the 
Secretary, it would also ensure that the very organization that 
created this poorly run system, the same organization that has 
spent millions lobbying against the HHS regulations, would be 
guaranteed the network contract forever.

                           prepared statement

    Mr. Chairman, I encourage you to keep up the good fight. As 
you can see today, patients and professionals from both sides 
of the State of Pennsylvania support your efforts to change the 
system. I hope you will do everything you can do to implement 
these regulations in addition to stopping efforts like the OPTN 
amendments that would cripple the transplant system.
    Thank you for holding this hearing today.
    Senator Specter. Thank you very much, Mr. Gilmore, for 
testifying about your situation. It is very important.
    [The statement follows:]
                   Prepared Statement of Cleo Gilmore
    Thank you, Mr. Chairman. In 1994 I was diagnosed with sclerosing 
cholangitis--the same fatal disease that recently took the life of 
football great Walter Payton. Luckily, my fate was different than Mr. 
Payton's. In March of 1996 I received a liver transplant at the 
University of Miami Jackson Memorial Hospital. However, the road from 
when I was diagnosed to when I received my transplant was a long and 
difficult one.
    When I was first diagnosed, I was getting my care at one of the 
local transplant centers in Philadelphia. It wasn't long before my 
condition started to worsen and in November 1995 I was referred to the 
University of Pittsburgh Medical Center. I ended up in the hospital for 
over 3 weeks. In January of 1996, my doctors in Pennsylvania began to 
get very concerned about my condition and didn't think that they would 
be able to find a donor liver in time to save my life. So they 
suggested that I contact the University of Miami because they had a 
shorter waiting list.
    At my own expense, I flew to Miami to be evaluated for a 
transplant. I was put on the Miami transplant list and sent home to 
Philadelphia with my pager. Now I was on two transplant lists--one in 
Pennsylvania and one in Florida. Sure enough, a few weeks later a donor 
liver was found for me in Florida and, once again at my own expense, I 
chartered a plane to Miami to receive my liver transplant. The cost for 
that flight was $8000. Despite having excellent insurance coverage, I 
was deeply in debt following my transplant just because of the travel 
expenses alone.
    My story is not unique. There are many patients across the country 
who go to great lengths and expense to find a donor organ. 
Unfortunately, there are many, many more patients who lack the 
resources to double list or to shop for shorter waiting lists. If you 
don't have the resources then you are at the mercy of the transplant 
system.
    The fact is that the current transplant system is not fair. It is 
designed to favor those transplant centers with political clout while 
forcing patients like me to make huge sacrifices or face certain death. 
In my own situation, I was on two waiting lists at two different 
hospitals. When the liver was found in Miami, why couldn't they just 
send it up to me in Pennsylvania instead of forcing me to leave my 
family and my support system in Philadelphia? It's just not fair.
    Mr. Chairman, I know that you have been working hard to change the 
system and I appreciate your efforts. I am here today because I am very 
upset at the political games that are being played in Washington over 
this matter.
    The last time I spoke about this issue was in 1996 at a three-day 
hearing conducted by the Department of Health and Human Services. I was 
one of over 100 witnesses. Since then, I understand that HHS has 
received thousands and thousands of comments on this issue.
    I think the Secretary has done a very good job responding to those 
comments and being sensitive to all interests in the transplant field. 
I support the HHS transplant regulations. They will ensure that all 
patients have a fair and equal chance of finding a donor organ. The 
emphasis on medical need is also important. Donated organs should go to 
the patients who need them the most. A person shouldn't get a 
transplant just because they live close to the donor. In my case, I 
wouldn't have minded if I had to wait longer so that someone who was 
sicker than me could have gotten a transplant. We all have to wait our 
turn. But, it was very frustrating to sit and wait, or to go to great 
sacrifice and expense, while healthy people got transplants and I was 
so close to dying. The HHS regulations would make the transplant system 
fair for everyone.
    But, despite your efforts, Mr. Chairman, Congress has put the 
regulations on hold again for the third time so that the public could 
comment on the newest revisions. I don't believe that Congress put the 
HHS organ transplant regulations on hold again in order to give people 
a chance to comment. It is clear from this patient that the goal of 
UNOS, many members of the transplant community, and some members of 
Congress is to kill these regulations no matter how many lives it may 
cost in the long run. The comment period has now gone on for three 
years since that first hearing. Now, it is time for action. And time 
for change.
    In order to make their case; those opposing the transplant 
regulations have waged a successful propaganda campaign based on a 
number of misleading statements. Last year, when Congress delayed the 
regulations, a study was also ordered from the Institute of Medicine. 
The goal of that study was to find the truth.
    This July, the IOM came out with its report. The IOM supported the 
HHS regulations and dispelled the myths that had been promoted by those 
opposing the regulations. One of the claims opponents make is that the 
HHS regulations will make it difficult for minorities and low-income 
patients to access the organ transplant system. The IOM found no 
evidence to support that claim.
    As my story shows, it is those with limited resources, many of who 
are inner city minorities that cannot access the current system. I was 
able to get a liver transplant because I had the resources to escape 
the discrimination that rules our organ transplant system. If I wasn't 
able to pay for a charter flight to Florida I might not be here today.
    It is well documented that African Americans wait nearly twice as 
long as whites for kidney transplants. This is not fair. Some of the 
reason for this difference is biological. But, a change in the 
allocation system could even out the playing field dramatically. The 
HHS regulations would require the network contractor UNOS to make 
necessary changes to the geographically based system that is currently 
in place and bring fairness back into the system. I believe that a fair 
system--based upon the broad sharing of donated organs--is what 
Congress intended when it started this program 15 years ago. That goal 
can only be achieved if the regulations are allowed to go into effect.
    Now, in addition to trying to kill these regulations some of your 
colleagues in Congress are trying to make dramatic changes to the act 
that governs our national transplant system. The Organ Procurement and 
Transplantation Network Amendments of 1999 would take away any 
authority that the Secretary has to govern the transplant system. The 
impact of this bill is frightening to me. Not only would the bill 
cripple the Secretary, it would also insure that the very organization 
that created this poorly run system, the same organization that has 
spent millions lobbying against the HHS regulations, would be 
guaranteed the network contract forever.
    Mr. Chairman, I encourage you to keep up the good fight. As you can 
see today, patients and professionals from both sides of the state of 
Pennsylvania support your efforts to change the system. I hope that you 
will do everything you can to implement these regulations. I also hope 
that you will do everything you can to stop efforts like the OPTN 
Amendments Act that would cripple the transplant system.
    Thank you for holding this hearing today. There are almost 70,000 
people now waiting for organ transplants in this country who are hoping 
that Congress will do the right thing in this debate. Mr. Chairman, I 
know you will continue your efforts to steer your colleagues in the 
right direction. Thank you.
STATEMENT OF DR. WARREN D. HULNICK, TRANSPLANT 
            RECIPIENTS INTERNATIONAL ORGANIZATION
    Senator Specter. We turn now to Dr. Warren Hulnick, a 
retired dentist who received a liver transplant at the 
University of Pittsburgh Medical Center. He has been a patient 
advocate for many years, and he is past president of the 
Pittsburgh Chapter of the Transplant Recipients International 
Organization.
    He earned his dental degree from NYU and two master's 
degrees from the University of Pittsburgh. Welcome, Dr. 
Hulnick. We look forward to your testimony.
    Dr. Hulnick. Thank you, Senator. Thank you for allowing me 
to present my views on the current situation in organ 
allocation and for your hard work on this contentious issue. I 
also want to thank Senator Specter and the committee for 
holding this hearing today.
    I am a 58-year-old liver transplant recipient. I received 
my transplant at the University of Pittsburgh Medical Center 
almost 13 years ago. Prior to my surgery, I was a dentist 
practicing in Staten Island, New York. After my transplant I 
moved to Pittsburgh and obtained MBA and MHA degrees and worked 
as an independent contractor at the Graduate School of Public 
Health. I am currently retired.
    I am a member of TRIO, the Transplant Recipients 
International Organization, and past member of its 
international board of directors, and past president of the 
Pittsburgh Chapter. I currently serve as the appointed U.S. 
Region 2 representative to the Patient Affairs Committee of 
UNOS. I also volunteer at the Thomas E. Starzl Transplant 
Institute, working mostly with liver transplant candidates. It 
is from these several viewpoints that I speak today.
    In January 1987, when I received my transplant, donated 
organs were given to the most medically needy patient within 
logistical limits. The liver I received was recovered in 
Alabama. With the geography-based allocation system in place 
today, I might not have survived the wait. There were no 
arbitrary boundaries for organ placement, and the system 
functioned smoothly.
    While it is true that there are more transplant programs in 
existence today, in theory patients should receive organs 
according to medical necessity, but that is not the case. When 
an organ is donated, it is not donated for the benefit of a 
particular geographic area or OPO or transplant program, but it 
is to benefit the most medically needy patient.
    I feel the position taken by Secretary Shalala that donated 
organs need to be offered to the most medically needy patients 
within acceptable limits is correct and equitable. To me, there 
is nothing illogical about sending a liver to a Status 1 or 
Status 2A patient, those considered the sickest, 1,000 miles 
away, rather than transplanting it to a Status 3 patient living 
in the local area where it was recovered. That Status 3 patient 
is not in urgent need of transplantation. However, the 
allocation system currently in place encourages this type of 
activity.
    My view is also shared by TRIO. TRIO is a nonprofit 
organization. Its membership includes transplant recipients, 
candidates and their families, donor families, medical 
professionals, and others interested in organ and tissue 
transplantation.
    Much of TRIO's activity is centered around advocacy for 
transplant-related issues, and the education of the public 
about transplantation and organ donation. TRIO as an 
organization has strongly supported the Secretary's proposed 
rule changes because they benefit patients, not organizations. 
The system of organ allocation needs to be patient-driven, not 
for the benefit of transplant centers.
    As a member of UNOS's Patient Affairs Committee, I have 
seen what I feel is an attempt to reduce patient input in the 
affairs of UNOS. According to the orientation booklet given to 
all committee members, and also what UNOS tells the public and 
the media, and I quote: ``the Patient Affairs Committee is 
charged with advising the UNOS board of directors and other 
committees about patient and donor family perspectives on 
proposed policies and issues.''
    At the meetings, the atmosphere is quite different. Both 
the committee chair and the cochair are appointed by the UNOS 
president, not chosen by committee members. To me, this is 
rather undemocratic and can serve to spin the agenda away from 
issues and discussion contrary to the UNOS's stated or 
preferred policies.
    Frequently, UNOS staff members are present, not to provide 
support to the committee, but to participate in and frequently 
dominate discussion. I feel that their presence is a hindrance 
to free and open discussion. I found the situation so 
uncomfortable that I felt it necessary to inform Secretary 
Shalala that many patients do not have a voice under the 
current system. I offer this letter and the HHS response to me 
for the record.
    Senator Specter. It will be admitted. Thank you.
    Dr. Hulnick. In my contacts with potential liver transplant 
candidates, many with little knowledge of what they are 
becoming involved in, there is an enormous need for an easy-to-
access, current, correct, understandable information about 
liver transplantation, the most frequently asked questions 
involve hospital length of stay, cost, ability to return to 
normal life and, of course, survival rates. Increased efforts 
must be made to provide this information.
    Over the last year, too, more patients are asking questions 
involving allocation. Many are afraid that without a change in 
the allocation system they will not survive long enough to 
receive a transplant because of the long waiting list.
    At UPMC, many patients are from outside the Pittsburgh 
area, enlarging the list, yet with the current system, if they 
receive a transplant the liver would most likely come from 
Western Pennsylvania. This, in turn, disadvantages local 
patients, since the donor pool is shared with these outsiders.
    If one were to look at the patient populations at the 
centers who are seeking to keep the allocation system local, 
most likely the large percentage of patients would be local 
also. This is totally unfair. Organs should go to those in most 
need, no matter where the patient is. They should not go to 
patients based on where the organ is recovered.
    In closing, I would say we need to make the organ 
allocation system patient-driven. Organ transplantation must be 
removed from corporate profits and returned to medical practice 
as soon as possible, because too many lives are being 
unnecessarily lost with the current system.

                           prepared statement

    As we all know, increasing organ donation would help 
alleviate the problem, but until we can recover enough organs 
for everyone on the waiting list, we must work with what is 
available and make it operate to its maximum efficiency. Thank 
you for this opportunity.
    Senator Specter. Thank you, Dr. Hulnick, for giving us your 
views.
    [The statement and letters follow:]
              Prepared Statement of Dr. Warren D. Hulnick
    Senator Specter, Senator Santorum: Thank you for allowing me to 
present my views on the current situation in organ allocation and for 
your hard work on this contentious issue. I also want to thank Senator 
Specter and the Committee for holding this hearing today.
    I am a 58 year old liver transplant recipient. I received my 
transplant at UPMC almost 13 years ago. Prior to my surgery I was a 
dentist practicing on Staten Island, NY. After my transplant I moved to 
Pittsburgh, attained MBA and MHA degrees at Pitt, and worked as an 
independent contractor at the Graduate School of Public Health. I 
currently retired.
    I am a member of TRIO, the Transplant Recipient's International 
Organization, a past member of its International Board of Directors and 
Past-President of the Pittsburgh Chapter. I currently serve as the 
appointed UNOS Region 2 representative to the Patient Affairs Committee 
of UMOS. I also volunteer at the Thomas E. Starzl Transplant Institute 
of UPMC working mostly with liver transplant candidates.
    It is from these several viewpoints that I speak today.
    In January 1987, when I received my transplant, donated organs were 
given to the most medically needy patient, within logistical limits. 
The liver I received was recovered in Alabama. With the geography based 
allocation system in place today, I might not have survived the wait. 
There were no arbitrary boundaries for organ placement and the system 
functioned smoothly. While it true that there are more transplant 
programs in existence today, in theory patients should receive organs 
according to medical necessity. But that is not the case. When an organ 
is donated it is not for the benefit of a particular geographic area or 
OPO or Transplant Program, but it is to benefit the most medically 
needy patient. I feel the position taken by Secretary Shalala, that 
donated organs need to be offered to the most medically needy patient 
within acceptable limits is correct and equitable. To me, there is 
nothing illogical about sending a liver to a Status 1 or Status 2A 
patient--those considered the sickest--1,000 miles away, instead of 
tranplanting a Status 3 patient living in the local area where it was 
recovered. The Status 3 patient is not in urgent need of 
transplantation. However, the allocation system currently in place 
encourages this type of activity.
    My views are also shared by TRIO. TRIO is a non-profit organization 
whose membership includes transplant recipients, candidates, their 
families, donor families, medical professionals and others interested 
in organ and tissue transplantation. Much of TRIO's activity is 
centered around advocacy for transplant related issues and education of 
the public about transplantation and organ donation. TRIO has strongly 
supported the Secretary's proposed rule changes because they benefit 
patients not organizations. The system of organ allocation needs to be 
patient driven, not for the benefit of transplant centers.
    As a member of UNOS' Patient Affairs Committee I have seen what I 
feel is an attempt to reduce patient input in the affairs of UNOS. 
According to the Orientation Booklet given to all committee members and 
also what UNOS tells the public and the media: ``The Patient Affairs 
Committee is charged with advising the UNOS Board of Directors and 
other committees about patient and donor family perspectives on 
proposed policies and issues. . . .'' At the meeting the atmosphere is 
quite different. Both the Committee chair and co-chair are appointed by 
the UNOS Board not chosen by committee menders. To me this is rather 
undemocratic and can serve to ``spin'' the agenda away from issues and 
discussion contrary to UNOS' stated or preferred policies. Frequently 
UNOS staff members are present, not to provide support to the committee 
but to participate in and frequently dominate discussion. I feel that 
their presence is a hindrance to free and open discussion. I found this 
situation so uncomfortable that I felt it necessary to inform Sec. 
Shalala that many patients do not have a voice under the current 
system. I offer this letter and the HHS response to me for the record.
    In my contacts with potential liver transplant candidates, many 
have little knowledge about what they are becoming involved in. There 
is an enormous need for easy-to-access, current, correct, 
understandable information about liver transplantation. The most 
frequently asked questions involve hospital length of stay, costs, 
ability to return to normal life and of course survival rates. 
Increased efforts must be made to provide this information. Over the 
last year or two, more patients are asking questions involving 
allocation. Many are afraid that without a change in the allocation 
system they will not survive long enough to receive a transplant 
because of the long waiting list. At UPMC, many patients are from 
outside the Pittsburgh area, enlarging the list. Yet with the current 
system, if they receive a transplant, the liver would most likely come 
from Western Pennsylvania. This in turn, disadvantages local patients, 
since the donor pool is shared with ``outsiders''. If one would look at 
the patient populations at the centers who are seeking to keep the 
allocation system ``local, most likely the large percentage of patients 
would be ``local'' also. This is totally unfair. Organs should go to 
those in most need, no matter where the patient is; they should not go 
to patients based on where the organ is recovered.
    In closing, I would say we need to make the organ allocation system 
patient driven. Organ transplantation must be removed from ``corporate 
profits'' and returned to medical practice as soon as possible because 
too many lives are being unnecessarily lost with the current system.
    As we all know, increasing organ donation would help alleviate the 
problem, but until we can recover enough organs for everyone on the 
waiting lists, we must work with what is available and make it operate 
to its maximum efficiency.
    Thank you again for this opportunity.
                                 ______
                                 

                   Letter From Dr. Warren D. Hulnick

                                 Warren D. Hulnick, D.D.S.,
                                     Pittsburgh, PA, April 5, 1999.
Hon. Donna E. Shalala, Ph.D.,
Secretary, U.S. Department of Health and Human Services,
Washington, DC.
    Dear Secretary Shalala: I am the representative from Region 2 to 
the United Network for Organ Sharing (UNOS) Patient Affairs Committee 
and a liver transplant recipient of more than 12 years. As such, I must 
express my concern with the method with which this Committee operates, 
especially on matters involving the organ allocation controversy. 
Discussion is controlled by the appointed committee chair and/or vice-
chair, who both follow the UNOS party line in opposing your efforts of 
reform. Members who are known to hold differing views are often not 
recognized or are cut short during discussions.
    At our recent meeting (March 18-19), a member prepared a document 
(copy attached) for discussion that summarized the organ allocation 
controversy and called for several resolutions to aid in solving the 
problem. As the Chairman introduced the agenda item, he remarked that 
he sought to ``frame the discussion'' and mentioned that he had 
considered not placing the item on the Agenda at all. This statement 
essentially stifled any discussion.
    According to the Orientation Booklet given to all committee members 
and what UNOS tells the public and the media: ``The Patient Affairs 
Committee is charged with advising the UNOS Board of Directors and 
other committees about patient and donor family perspectives on 
proposed policies and issues. . . .'' I fail to see how not placing an 
item on an agenda or stifling discussion because it espouses a contrary 
opinion aids in advising the Board of Directors, especially on 
controversial subjects.
    I also find it unusual that UNOS staff are present at the meetings, 
not to serve as support personnel but to participate in and at times 
dominate discussion. Their presence is a deterrent to open and free 
discussion, as some Committee members take their opinion as official 
doctrine and appear to not wish to oppose them, perhaps in fear of 
losing their committee appointment.
    I can offer no solution to the problems I perceive, except perhaps 
that a new organization, more attuned to the concerns of candidates, 
recipients and donor families rather than transplant centers, be 
selected to operate the Organ Procurement and Transplantation Network, 
or your Department increase its oversight authority to more closely 
supervise the operation of UNOS.
            Very truly yours,
                                          Warren D. Hulnick, D.D.S.

Enclosure (1).
          Organ Allocation Policy, the Kansas City Declaration
    Whereas: The recently deadlocked negotiations between the 
Department of Health and Human Services (DHHS) and the United Network 
For Organ Sharing (UNOS) have had a deleterious effect on the 
transplant community and the public at large, and
    Whereas: The DHHS position, in the literal interpretation of its 
proposed transplant policy, imposes potentially non-medical, and 
potentially counter-productive protocols for the allocation of organs, 
i.e. The Secretary's rules and regulations, and unnecessarily 
politicizes what should be a primarily medically determined process, 
and
    Whereas: The current localized policies promulgated by UNOS create 
unnecessary inequities in waiting time and in patient access to 
transplantation resulting in the public perception that the policy does 
not always serve the best interests of patients and the nation's public 
health, and
    Whereas: The transplant community has made many revisions in its 
policies in recent years, thereby contributing to a sense of constant 
change and indecisiveness, and
    Whereas: The current policies have led to fragmentation and the 
absence of consistent national standards as evidenced, for example, in 
the initiatives in a number of states to legislate a prohibition 
against organs leaving the political boundaries of the states e.g. (LA, 
AZ, etc.), and in the varying practices and standards across the 
country, and
    Whereas: The professional transplant community with the best 
intentions and objectives has been unable to achieve agreement with 
DHHS on a medically driven sound and fair allocation system, and both 
realize it is in their best interest and in the best interest, 
especially, of patients to do so, and
    Whereas: An effective, fair and credible system of allocation is 
essential to creating the public trust that will increase organ 
donation as the only ultimate solution to inequity, and
    Whereas: The Immediate Past President of UNOS, Dr. Lawrence 
Hunsicker, in presentations across the country in 1998 urged the 
patient community to take the lead in facilitating the emergence of a 
national consensus on this issue, and
    Whereas: The Patient Affairs Committee is best positioned in terms 
of broad representation of the diverse segments of the transplant 
community (donor groups, recipients, OPOs, transplant centers) and 
knowledge of the multiple factors effecting donation, allocation and 
delivery of solid organs,
    Be It Resolved: The Patient Affairs Committee recommends that UNOS 
develop a new allocation policy for all organs based on the following 
principles.
    1. All organs will be allocated to the patient who has accumulated 
the most amount of waiting time, whose medical status is highest for 
transplantation in keeping with the agreed upon listing and status 
criteria as overseen by the organ-specific regional review committees, 
and for whom the prognosis is positive.
    2. Organs will be allocated to the patient who is listed at a 
center where the delivery of the organ is possible within medically 
established ischemic times, regardless of the location of the 
procurement.
    3. That fluid and constantly changing regions, as determined by 
place of procurement, varying somewhat in size for different organs as 
ischemic times dictate, will require that the number of OPO's either be 
consolidated or organized in a collaborative structure to insure 
efficiency and eradicate unproductive competitiveness and duplication 
of effort.
    4. That the number of licensed transplant centers be keyed to a 
minimum number of organ transplantations annually in order to insure 
maximum outcomes and adequacy of qualified staff.
    5. That UNOS continue to rapidly facilitate the development and 
clear articulation of objective medical standards, insofar as possible, 
for the classification of patients in terms of illness and prognosis as 
well as in regard to safe ischemic times for transportation appropriate 
to specific organs.
                                 ______
                                 

                     Letter From Joseph F. O'Neill

           Department of Health and Human Services,
              Health Resources and Services Administration,
                                       Rockville, MD, May 13, 1999.
Warren D. Hulnick, D.D.S.,
Pittsburgh, PA.
    Dear Dr. Hulnick: Thank you for your letter of April 5 to Secretary 
Shalala and the accompanying proposed resolutions to develop new United 
Network for Organ Sharing (UNOS) organ allocation policies. The 
resolutions discussed in the paper presented before the Patient Affairs 
Committee are noteworthy and support many of the concepts underlying 
the Department's Final Rule for the Organ Procurement and 
Transplantation Network (OPTN). However, your letter raises serious 
concerns regarding the opportunity for open and free discussion of 
controversial issues brought before the Patient Affairs Committee. I 
have asked D.W. Chen, M.D., M.P.H., Director of the Division of 
Transplantation to discuss these concerns directly with UNOS, without 
identifying you or your committee, so that your role and activities 
within the Patient Affairs Committee would not be jeopardized.
    One of the features of the Department's Final Rule for the OPTN, 
issued April 2, 1998, gives the Secretary authority to review 
complaints raised concerning OPTN policies. The Rule fully supports 
meaningful input from the members of the OPTN and other stakeholders in 
the development of OPTN policies. As stated in the Rule, ``the 
Department believes that the transplantation network must be operated 
by professionals in the transplant community, and that both allocation 
and other policies of the OPTN should be developed in an open 
environment that includes the public, particularly transplant patients 
and donor families.'' This section of the Rule implies a very strong 
role for the Patient Affairs Committee in policy development. The 
Department supports and encourages open and constructive communication 
and debate on policy development, as well as other issues impacting the 
OPTN. Open forums and freedom to discuss differences of opinion freely, 
especially within UNOS Committee meetings, are critically important to 
addressing often complex and contentious issues within the OPTN.
    As you know, the Omnibus Consolidated and Emergency Supplemental 
Act, 1999, has delayed the effective date of the Final Rule until 
October, at the earliest, and requires the Institute of Medicine (IOM), 
under contract with the General Accounting Office (GAO), to study organ 
allocation issues. The Department believes that the IOM and the 
Congress will recognize the necessity of the Secretary's authority to 
oversee OPTN policy development. However, until the final Rule becomes 
effective, HHS has limited ability to review alleged improper 
activities of OPTN members which may lead to complaints.
    We would encourage you to discuss your perceptions with other 
members of the Patient Affairs Committee and work toward achieving a 
consensus view on this matter. Consensus building is the method by 
which UNOS policies are developed, and in order to create fair and 
objective policies, we need representatives from the patient community 
willing to speak out especially when contentious issues are discussed. 
Thank you for bringing this issue to the attention of the Secretary. We 
will address your concerns anonymously and directly with the 
appropriate representatives at UNOS. If you have any additional 
questions, please contact D.W. Chen, M.D., M.P.H., Director, Division 
of Transplantation, Office of Special Programs, Room 4-81, Rockville, 
Maryland; telephone number (301) 443-7577.
            Sincerely,
                           Joseph F. O'Neill, M.D., M.P.H.,
                                                          Director.
STATEMENT OF DAVID SOMERVILLE
    Senator Specter. Our next panelist is Mr. David Somerville 
from Latrobe, PA. He suffers from an autoimmune disease that 
attacks the bile ducts and the biliary system. Mr. Somerville 
is listed as a Status 3 under the United Network for Organ-
Sharing criteria. He and his wife of 31 years, Kathy, have 
three children.
    He spent most of his career in community service. Most 
recently he worked as an insurance salesman. He was diagnosed 
with liver disease in 1993, and he now spends most of his time 
volunteering for the Center for Organ Recovery and Education.
    Thank you for coming in today, Mr. Somerville, and we look 
forward to your testimony.
    Mr. Somerville. Good morning, Mr. Chairman and Senator 
Santorum. Unlike my two predecessors that have spoken on this 
panel, they have received the gift of life. I am waiting for 
the miracle to occur yet. Thank you for the opportunity to 
testify today.
    My name is David Somerville, and I am from Latrobe, PA. I 
am 51 years old, and I have primary sclerosing cholangitis, an 
autoimmune disease that attacks the bile ducts and biliary 
system. This is the same disease that claimed the life of pro 
football Hall of Fame legend Walter Payton.
    I was diagnosed with this condition in 1993. Since then, 
and in the past 6 years I have been waiting for liver 
transplant at the University of Pittsburgh Medical Center. I am 
currently listed in the United Network for Organ-Sharing 
criteria as a Status 3.
    For the better part of my life I worked in community 
service as a salesman for a large insurance company. In 1968 I 
married my college sweetheart, Kathy, whom I met at Lockheed 
University and enjoyed raising my three kids. For me, life was 
good, and in 1993 I started to feel something was not right. I 
went through a series of rigorous tests and was ultimately 
delivered the devastating news that I had liver disease. How 
could this happen to me? To be told that I could not survive 
without a transplant is inconceivable. In fact, in 1983 I had 
run a 26-mile marathon in Erie, PA.
    When I was first put on the transplant list there were 
little symptoms of my disease, but the longer I remain on the 
list the symptoms get worse and continue to rob me of the life 
I once had. Living with liver disease is unpredictable. 
Recently, I have had to have my medications changed to manage 
my condition. It is a struggle every day, and I pray my waiting 
will soon be over.
    While I have been on the waiting list for a long time, I am 
fortunate that the medical staff here at UPMC is able to manage 
my illness and keep my spirits up. I try to fill my time as 
best I can by volunteering with the local organ procurement 
agency, the Center for Organ Recovery and Education, CORE. I 
also am part of the local support group in Westmoreland County 
that meets once a month in Greensburg, PA. There are 
approximately 12 to 20 people at each meeting.
    In the short time I have known these patients we have 
formed a bond that is unbreakable. Among this group I am in the 
minority. There are more patients waiting for hearts. Several 
of them are in worse shape than I am. It saddens me that they 
are the ones who end up not getting transplanted due to the 
lack of organs. In fact, 25 percent of patients waiting for 
hearts and lungs will never get that chance.
    Our support group has seen first-hand the effects of this, 
and as much as I would love to get my liver transplant, I would 
gladly wait if I knew there were sicker people who needed it.
    There needs to be a broader sharing of organs if people are 
to get a fair chance. The United Network for Organ-Sharing's 
first and last words are ``United'' and ``Sharing.'' When you 
break those words down there are no regional boundaries. It is 
time to make organs available for everyone, no matter where 
they live. We need to put a human face on this issue. Too many 
people are dying needlessly. Please do your parts, Senator 
Specter and Senator Santorum, to make patients a priority in 
this debate.
    While more work needs to be done on the legislative side, 
it is up to the rest of us to do our part. Many of you are well 
aware of the recent passing of football legend Walter Payton. 
If people do not know enough about the importance of organ 
donation before, they do now. We need to make sure that steps 
are being taken to ensure people sign an organ donor card so we 
will not have to hear about patients dying from the lack of 
organs.
    Some people say organ donation is a personal choice, but I 
am challenging Americans to look at the big picture. Imagine if 
you had a mother or father on dialysis for many years while 
waiting for a kidney transplant. Imagine if your child was born 
with a liver disease and needed a transplant to save his or her 
life. Would you not start thinking differently about organ 
donation?
    There are currently 66,000 people on the UNOS waiting list. 
Think about that. That is enough to fill Three Rivers Stadium.
    Yesterday, I spoke to some local high school students and 
encouraged them to become organ donors. It is my hope that they 
will make that personal choice.
    As one of 66,000 waiting for a new chance at life, I am 
asking that the rest of you make that choice, for it can make 
those of us who are waiting very happy.

                           prepared statement

    In conclusion, in putting a human face to this issue as one 
of 66,000 waiting, I am also a son, I am a husband, I am a 
father, I am a son-in-law, I am a brother, I am a brother-in-
law, I am a nephew, I am an uncle, I am a cousin, and those are 
nine opportunities in my immediate family. Multiply that by 
66,000, and we have a lot of people that are involved in this 
issue.
    Thank you for the opportunity to speak.
    Senator Specter. Well, thank you very much, Mr. Somerville. 
You have a great multiplication factor in terms of how many 
lives you are touching.
    [The statement follows:]
                 Prepared Statement of David Somerville
    Good morning, Mr. Chairman and Senator Santorum. Thank you for the 
opportunity to testify today. My name is David Somerville and I am from 
Latrobe, Pennsylvania. I am 51-years old and have primary sclerosing 
cholangitis, an autoimmune disease that attacks the bile ducts and 
biliary system. This is the same disease that claimed the life of Pro 
Football Hall of Fame legend Walter Payton. I was diagnosed with this 
condition in 1993. Since then, and for the past six years, I have been 
waiting for a liver transplant at the University of Pittsburgh Medical 
Center. I am currently listed under the United Network for Organ 
Sharing criteria as a status three.
    For the better part of my life I worked in community service and 
was a salesman for a large insurance company. In 1968 I married Kathy 
Ritchie and enjoyed raising our three kids. For me, life was good. Then 
in 1993, I started to feel something wasn't right. I went for a series 
of vigorous tests and was ultimately delivered the devastating news. I 
now have liver disease. How could this happen to me? I was always a 
healthy man. In 1983, I ran a 26-mile marathon in Erie, Pa. To be told 
I could not survive without a transplant was inconceivable. When I was 
first put on the transplant list, there were little symptoms of my 
disease, but the longer I remain on the list the symptoms get worse and 
continue to rob me of the life I once had. Living with liver disease is 
unpredictable. Recently, I had to have my medications changed to manage 
my condition. It is a struggle everyday and I pray my waiting will be 
over soon.
    While I have been on the waiting list for a long time, I am 
fortunate that the medical staff here at UPMC is able to manage my 
illness and keep my spirits up when I am at an emotional low point. I 
try to fill my time as best I can by volunteering with the local organ 
procurement agency, the Center for Organ Recovery and Education. I also 
am part of a local support group in Westmoreland County that meets once 
a month in Greensburg. There are approximately 12 to 20 people at each 
meeting. In the short time I have known these patients, we have formed 
a bond that is unbreakable. Among this group, I am in the minority. 
There are more patients waiting for hearts. Several of them are in 
worse shape than I am. It saddens me that they are the ones who end up 
not getting transplanted due to the lack of organs. In fact, 25 percent 
of patients waiting for hearts and lungs will never get that chance. My 
support group has seen firsthand the effects of this, and as much as I 
would love to get my liver transplant, I would gladly wait if I knew 
there were sicker people who needed it.
    There needs to be a broader sharing of organs if people are to get 
a fair chance. The United Network for Organ Sharing's first and last 
words are ``united'' and ``sharing.'' When you break those words down, 
there are no regional boundaries. It's time to make organs available 
for everyone, no matter where they live. We need to put a human face on 
this issue. Too many people are dying needlessly. Please do your part 
Senator Specter and Senator Santorum to make patients a priority in 
this debate.
    While more work needs to be done on the legislative side, it is up 
to the rest of us to do our part. Many of you are well aware of the 
recent passing of football legend Walter Payton. If people didn't know 
enough about the importance of organ donation before, they do now. We 
need to make sure that steps are being taken to ensure people sign an 
organ donor card so we won't have to hear about patients dying from the 
lack of organs.
    Some people say organ donation is a personal choice. But I am 
challenging Americans to look at the big picture. Imagine if you had a 
mother or father on dialysis for many years while waiting for a kidney 
transplant. Imagine if your child was born with a liver disease and 
needed a transplant to save his or her life. Wouldn't you start 
thinking differently about organ donation?
    There are currently 66,000 people on the UNOS waiting list. Think 
about that. That's enough to fill Three Rivers Stadium. Yesterday, I 
spoke to some local high school students and encouraged them to become 
organ donors. It is my hope that they will make that personal choice. 
As one of 66,000 waiting for a new chance at life, I am asking that the 
rest of you make that choice, for it can make those of us waiting very 
happy.
    Thank you for the opportunity to speak.

    Senator Specter. Mr. Gilmore, you took a charter to Miami? 
Were your circumstances that extreme at that particular moment?
    Mr. Gilmore. Yes.
    Senator Specter. They leave almost every hour from 
Philadelphia's International Airport.
    Mr. Gilmore. I know. Unfortunately, when I got the call, I 
got the call around 10 p.m. at night, and there was nothing 
else flying out of Philadelphia.
    Senator Specter. So it was more the life expectancy of the 
liver than your life expectancy?
    Mr. Gilmore. That is right. They wanted to get me into 
surgery at 8 a.m. the next morning, and there is always a risk 
if you wait and if you tarry long.
    Senator Specter. So the liver became available at that 
moment, and you were notified, and off you went?
    Mr. Gilmore. Yes, that is right.
    Senator Specter. Well, I was going to ask you why you did 
not fly to Wichita, but now I know the answer.
    Dr. Hulnick, you have commented that had the current system 
been in place you might have died. Can you amplify why the 
current system would have left you in a more precarious 
position than at the time you got the transplant?
    Dr. Hulnick. At the time I got my transplant, fortunately 
for me it was almost 13 years ago, and the University of 
Pittsburgh was essentially the only program that was doing 
liver transplants.
    Senator Specter. So they had more availability of livers to 
transplant because of that?
    Dr. Hulnick. Yes, and if it were today the liver would have 
stayed around Alabama, and perhaps nothing would have become 
available in Western Pennsylvania, and I would not have 
survived. But given the circumstances and the timing, that 
there were just so few liver transplant programs active at that 
time that they were able to more broadly share the livers.
    Senator Specter. Mr. Somerville, you described yourself as 
a Status 7 person. I am sorry, Status 3 person, pardon me, and 
I have a chart here that explains that to some extent, but 
could you explain what that means, and explain the difference 
between 1, 2A, 2B, and 3?
    Mr. Somerville. To the best of my ability. Under Status 3 I 
am under a doctor's care and occasionally admitted to the 
hospital because of conditions that my medical condition 
warrants, and I take regular medications and such, but I am 
ambulatory. I am not attached to the hospital per se.
    Mr. Specter. Mr. Gilmore, what status were you when you had 
your liver transplant?
    Mr. Gilmore. To my recall, I believe I was a Status 3, 
because I was outside of the hospital. Occasionally I would 
have to go back in the hospital and I would become a Status 2.
    Senator Specter. Dr. Reyes, why do we not put Mr. 
Somerville on the Miami list as well?
    Dr. Reyes. I have actually sent patients to Miami that 
were----
    Senator Specter. You have to speak up a little bit.
    Dr. Reyes. I have actually sent patients to Miami. We 
transplanted a boy 15 years ago. He subsequently became an 
adult and he needed a retransplant. He lived in Chicago, was 
listed there, double-listed in Nebraska, was triple-listed 
here, and actually the program in Chicago was working up his 
mother, his 65-year-old mother for a liver-related transplant 
that I thought was dangerous to the mother, and I told him go 
to Miami. He did, and he was transplanted 2 days ago.
    Senator Specter. Let us come back to my question. How about 
Mr. Somerville for Miami?
    Dr. Reyes. Mr. Somerville could also go to Miami. Patients 
are free to double-list or triple-list.
    Senator Specter. I am about to get you a new patient, Dr. 
Reyes. Mr. Somerville, why not send him to Miami? Could you 
practice medicine here this morning? The question is, why 
doesn't Mr. Somerville get sent to Miami or Wichita?
    Dr. Reyes. Senator, we allow all of our patients, 
independent of their status, to go anywhere for a second 
opinion, or to be double-listed. I support it. I think 
particularly with my patients I talk to their parents. These 
babies belong to their parents. They do not belong to me. I do 
not hold on to the patients. I do not hold on to the organs. I 
let them go where they feel, where they as patients feel that 
they can get the best care.
    Mr. Somerville feels he can get his best care here at this 
center, and I would support that.
    Senator Specter. Well, Mr. Somerville, I am not satisfied 
with that answer, so I come back to you. Have any of your 
doctors--and I know Dr. Reyes is not your doctor, or I have no 
reason to believe that he is. Have your doctors at Pittsburgh 
Medical Center suggested you go some place else to get a liver 
transplant?
    Mr. Somerville. They have not, but my insurance company 
has, the one that I work for. I have chosen to remain here at 
the University of Pittsburgh Medical Center, and I think I also 
found out during the 1996 hearings with HHS that there was 
testimony that was given that people with chronic problems such 
as primary sclerosing cholangitis really are above Status 3, 
perhaps to Status 2.
    Senator Specter. Well, have you considered going to another 
center?
    Mr. Somerville. That is a discussion we have had. At the 
present time, my situation is manageable.
    Senator Specter. But that could change at any time?
    Mr. Somerville. That could change. It is an unpredictable 
disease.
    Senator Specter. Well, my thought would be, if I were in 
your position--and I do not want to practice medicine here this 
morning. I will say that I practiced a fair amount of it, 
however, with myself, and found it very rewarding to do that, 
that it is something you ought to give consideration to. It is 
pretty much a tough line here as to how you protect yourself, 
and if you can get a transplant in Miami, like Mr. Gilmore did, 
more power to you.
    These medical decisions are really difficult. Doctors do 
their very, very best, but I found there is nothing like a 
little personalized research.
    Mr. Somerville. I received wonderful medical care at this 
center. The doctors understand me. They know me. The transplant 
coordinators know my situation, and it is somewhat personalized 
to the effect that I feel I am perhaps getting the best medical 
service in the country, and that is perhaps the reason why I 
have not opted to go elsewhere.
    Senator Specter. To personalize it a little bit, the day 
that Governor Casey had his transplant I had a resection of a 
brain lesion, and there was a tiny regrowth, and I got a pretty 
much unanimous opinion to go through another surgery, and I 
found with a lot of research that I had--to give a little more 
publicity to the University of Pittsburgh Medical Center right 
down the street here, I solicited about 35 different opinions--
it may be a little easier for me to get through to the 
specialist in Seattle or Dallas than some--and finally got this 
gamma knife, and knock on wood, so far it is fine, but I have 
had a couple of other encounters where a little activism can be 
a very healthy thing.
    Senator Santorum.
    Senator Santorum. I do not have any questions, other than I 
would just like to comment that I appreciate your taking your 
time and efforts in testifying before this committee, and your 
other testimony and your work within the transplant community 
in support of our efforts here in the Congress. You are the 
reason we are doing this, and I cannot thank you enough for 
your energy that you have given to the cause, and I thank you.
    Senator Specter. Thank you very much, Senator Santorum, for 
joining me today and for your leadership, and for your tenacity 
on this, as on so many other issues.
    One thought which occurs to me is really the lack of 
publicity about this issue. Senator Santorum puts his finger on 
it when he puts his finger on his driver's license, and I think 
this would be a good subject for a movie, or, better yet, a 
television movie which would portray Mr. Gilmore's life, or Mr. 
Somerville's life, or Dr. Hulnick's life.
    Senator Santorum. There was a TV movie last year, or 
earlier this year, Nicholas.
    Senator Specter. I see quite a few heads nodding, but only 
about an eighth of the audience.
    Senator Santorum. Maybe we can get CBS to do a rerun.
    Senator Specter. Maybe we will get Steven Spielberg to do 
one. We will get a lot of attention.
    Dr. Reyes, did you have a comment?
    Dr. Reyes. Unfortunately, most of the media attention that 
this issue has gotten has been negative publicity.
    Senator Specter. Why is that?
    Dr. Reyes. Because of the debates over the regulations. I 
believe, as Mr. Nathan I am sure would support, that if there 
is positive media coverage of organ donation and organ 
procurement and results with transplantation, organ donation 
rates will go up.
    These problems, these issues in Congress, the delays, et 
cetera, paint this problem in a negative way with the public. I 
sat on the Liver and Test Committee for 6 years with the other 
representatives of other centers trying to find better 
policies. We could not do it.
    Members from HHS sat with us, never said a word until 3 
years before the regs came, and we were urged--we were urged to 
come up with a policy. We could not do it. It was only with the 
recommendations by the Secretary that we received guidelines 
and standards. That is all.
    The Secretary did not come down with the gavel. She did not 
come down telling us that she was going to take our toys away. 
She came down with standards. We still had the ability to set 
policy, but the Secretary is setting the standards. I think if 
we can accept that, then we can move on with the business of 
developing the policy according to fairness and the standards 
that have been set, and then focus on organ donation. We have 
to do that, and that is what UNOS should be doing, focusing on 
the organ donation.
    Senator Specter. Well, as Mr. Gilmore and Mr. Somerville 
have mentioned Walter Payton, could his life have been saved 
with a transplant, an early transplant?
    Senator Santorum. He had cancer on top of it.
    Senator Specter. Mr. Gilmore, do you want the last word?
    Mr. Gilmore. Yes. I just wanted to mention very briefly 
that, like Mr. Somerville, I, too, am very active in trying to 
share information with the Philadelphia community, especially 
with African Americans, as far as becoming organ donors. I 
agree that is a key component to this issue.
    But a key issue also, I believe, is the discrimination that 
also exists not only between Mrs. Smith, who is a Status 1 
patient here, and Mr. Jones, who is a Status 3 patient in Miami 
and ends up getting the transplant over Mrs. Smith, but also in 
terms of African Americans, if you look at the economic 
realities with African Americans, with the majority of 
minorities, Hispanics, the fact is they are unable to transport 
back and forth like I did from Philadelphia to Miami and spend 
$8,000 for a jet, and be in debt $15,000 like I was.
    I was fortunate to have the resources to travel, but most 
Americans, I would believe, and especially African Americans, 
cannot do that.
    Senator Specter. When you say African Americans have to 
wait twice as long, is that related to their inability to take 
a charter jet, as you did, to find an available organ?
    Mr. Gilmore. It is an economic issue. Yes, there are some 
biological issues involved as well, but primarily it is an 
economic issue.
    Senator Specter. Is there any economic issue besides the 
jet to get to where the organ is? Is it the cost of the 
transplant?
    Mr. Gilmore. That is an issue, I guess, if they do not have 
the best insurance. That certainly is an issue.
    Senator Specter. But are you suggesting there is any 
discrimination, aside from the dollars and cents, against 
somebody because of minority status?
    Mr. Gilmore. No, I am not suggesting that, but what I am 
suggesting is, when an African American--a relative of mine, 
for example, knows my situation and knows what I have been 
through, and he says, well, Cleo, that is fine for you, but I 
do not have $8,000 to travel to Florida, and so basically, 
Cleo, what you are telling me is that in order to get a 
transplant I have to do what you did, and I do not have those 
resources, he is indirectly, I guess, chronicling in his mind 
that there is some unfairness in the system with African 
Americans and with Hispanics.
    As I said, fortunately I had the resources. I had a 401(k) 
plan. I had the resources to travel. But this is just not the 
case with most people, and without question--and I would 
encourage Mr. Somerville to do some active research. That is 
what I did. I believe that doing the research saved my life.
    At the time I had a bilirubin level of 33. I was yellow. I 
had lost over 50 pounds. I was at death's door, I really was, 
and by the same token I was not sick enough to be in the 
intensive care unit. I was somewhere in between, and I am sure 
that there were patients who did not get a transplant because I 
happened to get mine before they did, because I was able to 
travel.
    Now, on the one hand, one could say, well, Cleo, what you 
may end up doing, this may end up slapping you in the face one 
day, because who knows, I may need another transplant one day. 
Primary sclerosing cholangitis is an autoimmune disease, which 
means that it can recur.
    But I am here to tell you that if that ever happened again 
I would like to see a system based on fairness rather than 
based on economics.
    Senator Specter. Well, we are trying to do our best to 
extend health coverage in a variety of ways with full 
deductibility, and small businesses joining together, and a 
whole variety of approaches, but it is one which we will try to 
address in this area as well.

                         conclusion of hearing

    Thank you all very much for being here, that concludes our 
hearing. The subcommittee will stand in recess subject to the 
call of the Chair.
    [Whereupon, at 11:10 a.m., Friday, December 3, the hearing 
was concluded, and the subcommittee was recessed, to reconvene 
subject to the call of the Chair.]

                                  
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