[House Hearing, 106 Congress]
[From the U.S. Government Publishing Office]



 
    ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK AMENDMENTS OF 1999

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

                                HEARING

                               before the

                            SUBCOMMITTEE ON
                         HEALTH AND ENVIRONMENT

                                 of the

                         COMMITTEE ON COMMERCE
                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED SIXTH CONGRESS

                             FIRST SESSION

                                   on

                               H.R. 2418

                               __________

                           SEPTEMBER 22, 1999

                               __________

                           Serial No. 106-75

                               __________

            Printed for the use of the Committee on Commerce

                    ------------------------------  



                     U.S. GOVERNMENT PRINTING OFFICE
59-992CC                     WASHINGTON : 1999





                         COMMITTEE ON COMMERCE

                     TOM BLILEY, Virginia, Chairman

W.J. ``BILLY'' TAUZIN, Louisiana     JOHN D. DINGELL, Michigan
MICHAEL G. OXLEY, Ohio               HENRY A. WAXMAN, California
MICHAEL BILIRAKIS, Florida           EDWARD J. MARKEY, Massachusetts
JOE BARTON, Texas                    RALPH M. HALL, Texas
FRED UPTON, Michigan                 RICK BOUCHER, Virginia
CLIFF STEARNS, Florida               EDOLPHUS TOWNS, New York
PAUL E. GILLMOR, Ohio                FRANK PALLONE, Jr., New Jersey
  Vice Chairman                      SHERROD BROWN, Ohio
JAMES C. GREENWOOD, Pennsylvania     BART GORDON, Tennessee
CHRISTOPHER COX, California          PETER DEUTSCH, Florida
NATHAN DEAL, Georgia                 BOBBY L. RUSH, Illinois
STEVE LARGENT, Oklahoma              ANNA G. ESHOO, California
RICHARD BURR, North Carolina         RON KLINK, Pennsylvania
BRIAN P. BILBRAY, California         BART STUPAK, Michigan
ED WHITFIELD, Kentucky               ELIOT L. ENGEL, New York
GREG GANSKE, Iowa                    THOMAS C. SAWYER, Ohio
CHARLIE NORWOOD, Georgia             ALBERT R. WYNN, Maryland
TOM A. COBURN, Oklahoma              GENE GREEN, Texas
RICK LAZIO, New York                 KAREN McCARTHY, Missouri
BARBARA CUBIN, Wyoming               TED STRICKLAND, Ohio
JAMES E. ROGAN, California           DIANA DeGETTE, Colorado
JOHN SHIMKUS, Illinois               THOMAS M. BARRETT, Wisconsin
HEATHER WILSON, New Mexico           BILL LUTHER, Minnesota
JOHN B. SHADEGG, Arizona             LOIS CAPPS, California
CHARLES W. ``CHIP'' PICKERING, 
Mississippi
VITO FOSSELLA, New York
ROY BLUNT, Missouri
ED BRYANT, Tennessee
ROBERT L. EHRLICH, Jr., Maryland

                   James E. Derderian, Chief of Staff

                   James D. Barnette, General Counsel

      Reid P.F. Stuntz, Minority Staff Director and Chief Counsel

                                 ______

                 Subcommittee on Health and Environment

                  MICHAEL BILIRAKIS, Florida, Chairman

FRED UPTON, Michigan                 SHERROD BROWN, Ohio
CLIFF STEARNS, Florida               HENRY A. WAXMAN, California
JAMES C. GREENWOOD, Pennsylvania     FRANK PALLONE, Jr., New Jersey
NATHAN DEAL, Georgia                 PETER DEUTSCH, Florida
RICHARD BURR, North Carolina         BART STUPAK, Michigan
BRIAN P. BILBRAY, California         GENE GREEN, Texas
ED WHITFIELD, Kentucky               TED STRICKLAND, Ohio
GREG GANSKE, Iowa                    DIANA DeGETTE, Colorado
CHARLIE NORWOOD, Georgia             THOMAS M. BARRETT, Wisconsin
TOM A. COBURN, Oklahoma              LOIS CAPPS, California
  Vice Chairman                      RALPH M. HALL, Texas
RICK LAZIO, New York                 EDOLPHUS TOWNS, New York
BARBARA CUBIN, Wyoming               ANNA G. ESHOO, California
JOHN B. SHADEGG, Arizona             JOHN D. DINGELL, Michigan,
CHARLES W. ``CHIP'' PICKERING,         (Ex Officio)
Mississippi
ED BRYANT, Tennessee
TOM BLILEY, Virginia,
  (Ex Officio)

                                  (ii)
                    ------------------------------  



                            C O N T E N T S

                               __________
                                                                   Page

Testimony of:
    Gibbons, Robert D., Professor of Biostatistics, School of 
      Medicine, Department of Psychiatry, University of Illinois 
      at Chicago, accompanied by Mitchell W. Spellman, Professor 
      of Surgery Emeritus and Dean of Medical Services Emeritus, 
      Harvard Medical School, and Susanne Stoiber, Executive 
      Officer, Institute of Medicine.............................    31
    Irwin, Craig, President, National Transplant Action Committee    45
    Miller, Joshua, Division of Transplantation, Department of 
      Surgery, University of Miami School of Medicine............    40
    Payne, William, Director, Liver Transplant Program, Fairview 
      Medical Center.............................................    26
    Rabkin, John M., Chief, Liver/Pancreas Transplantation 
      Heptobiliary Surgery, Oregon Health Sciences University....    51
    Raub, William F., Deputy Assistant Secretary for Planning and 
      Evaluation/Science Policy, Department of Health and Human 
      Services...................................................    20
Material submitted for the record by:
    Center for Donation and Transplant, letter dated September 
      16, 1999, to Hon. Michael R. McNulty.......................    94
    Clarian Health, letter dated September 22, 1999, to Hon. 
      Thomas J. Bliley, Jr.......................................    87
    Fiske, Charles, prepared statement of........................    82
    Gibbons, Robert D., Professor of Biostatistics, School of 
      Medicine, Department of Psychiatry, University of Illinois 
      at Chicago, letter to Hon. Diana DeGette, enclosing 
      response for the record....................................    99
    Jacksonville Transplant Center:
        Letter dated July 26, 1999, to Hon. Corrine Brown........    94
        Letter dated July 26, 1999, to Hon. Charles T. Canady....    95
        Letter dated July 26, 1999, to Hon. Tillie Fowler........    95
        Letter dated July 26, 1999, to Hon. Cliff Stearns........    96
    LifeCenter:
        Letter dated August 6, 1999, to Hon. Rob Portman.........    89
        Letter dated August 6, 1999, to Hon. John A. Boehner.....    90
        Letter dated August 6, 1999, to Hon. Steve Chabot........    91
    LifeSource, letter dated July 29, 1999, to Hon. Bill Luther..    91
    Louisiana State University Medical Center, letter dated 
      September 21, 1999, to Hon. Thomas J. Bliley, Jr...........    86
    Meredith, Thomas L., letter dated June 24, 1999, to Hon. Ed 
      Bryant.....................................................    97
    Mississippi Organ Recovery Agency, Inc., letter dated July 
      14, 1999, to Hon. Chip Pickering...........................    93
    National Kidney Foundation, prepared statement of............    85
    Raub, William F., Deputy Assistant Secretary for Planning and 
      Evaluation/Science Policy, Department of Health and Human 
      Services, responses to questions of Hon. Diana DeGette.....   100
    Saint Louis University Hospital, letter dated September 21, 
      1999, to Hon. Thomas J. Bliley, Jr.........................    89
    Shands HealthCare, letter dated September 21, 1999, to Hon. 
      Thomas J. Bliley, Jr.......................................    88
    Stark, Hon. Pete, a Representative in Congress from the State 
      of California, prepared statement of.......................    84
    Tennessee Donor Services, letter dated September 21, 1999, to 
      Hon. Ed Bryant.............................................    98
    Tennessee Transplant Society, letter dated August 2, 1999, to 
      Hon. Bill Frist............................................    94
    University Hospital, The, letter dated September 3, 1999, to 
      Hon. Steve Chabot..........................................    96
    University Hospitals of Cleveland, letter dated August 26, 
      1999, to Hon. Thomas C. Sawyer.............................    93
    University of Alabama at Birmingham, letter dated September 
      20, 1999, to Hon. Thomas J. Bliley, Jr.....................    87
    University of Florida, letter dated August 11, 1999, to Hon. 
      Karen Thurman..............................................    92
    University of Medicine and Dentistry of New Jersey, letter 
      dated September 20, 1999, to Hon. Thomas J. Bliley, Jr.....    86
    University of Texas, letter dated September 2, 1999, to Hon. 
      Joe Barton.................................................    88
    Weir, Bruce, President, Transplant Recipients International 
      Organization, Inc., prepared statement of..................    84

                                 (iii)

  


    ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK AMENDMENTS OF 1999

                              ----------                              


                     WEDNESDAY, SEPTEMBER 22, 1999

                  House of Representatives,
                             Committee on Commerce,
                    Subcommittee on Health and Environment,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 10 a.m., in 
room 2322, Rayburn House Office Building, Hon. Michael 
Bilirakis (chairman) presiding.
    Members present: Representatives Bilirakis, Burr, Bilbray, 
Ganske, Coburn, Bryant, Brown, Waxman, Pallone, Green, Barrett, 
and Eshoo.
    Also present: Representative Klink.
    Staff present: Marc Wheat, majority counsel; Clay Alspach, 
legislative clerk; and John Ford, minority counsel.
    Mr. Bilirakis. The hearing will come to order. Good 
afternoon. I am pleased to convene this hearing on H.R. 2418, 
the Organ Procurement and Transplantation Network Amendment of 
1999. I was pleased to introduce this bipartisan legislation 
with my colleague, Gene Green of Texas.
    Last summer this subcommittee held a joint hearing with the 
Senate Labor Committee to review our Nation's system for organ 
allocation, and more specifically the changes proposed by the 
Department of Health and Human Services. The Department's 
proposed changes to the Organ Procurement and Transplantation 
Network and the policies that it sets for all patients have 
been, to say the very least, as we all know, controversial. A 
majority of the comments received by the Department were very 
critical of the regulation, and certainly we in Congress have 
heard from many experts in the field about the consequences, 
unintended or otherwise, of the Department's regulations.
    We will have the opportunity to hear a range of views on 
these issues generally and H.R. 2418 in particular from our 
witnesses today.
    Of course, many of us have already heard directly from our 
constituents. Recently, I received a letter from Kathy Gibson, 
a 49-year-old constituent who received two kidney transplants 
within the past year. The second transplant, which was a 
success, followed an unsuccessful first transplant using her 
husband's kidney. Kathy received her second kidney through Life 
Link Foundation, a nonprofit community service entity in Tampa 
that operates four of the Nation's 62 organ procurement 
organizations. She wrote to tell me how grateful she was for 
Life Link's assistance saying, ``I have nothing but good things 
to say regarding my transplant team from Tampa General Hospital 
and Life Link Transplant Institute. They found me the gift of 
life.''
    H.R. 2418 was drafted with people like Kathy Gibson in 
mind. The bill recognizes the decisions regarding organ 
procurement and transplantation are best left to the medical 
community, as Congress intended in passing the National Organ 
Transplant Act of 1984. Those experts at the forefront of 
changes in the medical profession are best suited to adjust 
policies in light of new technology and new medical 
understanding.
    H.R. 2418 also addresses the underlying problem of an 
inadequate organ supply by promoting incentives to increase 
organ donation. For example, the bill includes innovative 
provisions to help reduce the financial burden on living 
donors. As the National Kidney Foundation has noted, these 
provisions will help increase the supply of organs needed for 
many men and women waiting for a matching organ to be 
transplanted.
    I want to welcome all of our witnesses. I appreciate their 
time and effort in joining us and look forward to hearing their 
testimony. As you know, we changed the time for this from 2 to 
2:30 for a very good reason. I appreciate your understanding in 
that regard.
    I will now recognized the ranking member Mr. Brown for an 
opening statement.
    Mr. Brown. Thank you, Mr. Chairman. I would like to also 
thank today's witnesses for joining us and a special thank you 
to Representative Klink, who has joined us. He is not a member 
of the subcommittee, but he has a special interest and 
knowledge of this issue, especially in this western end of his 
State and his district.
    I would like to commend you, Mr. Chairman, for bringing 
increased attention to a process within our health care system 
that is critical to the lives of so many Americans, the process 
of allocating an obviously scarce number of donated organs for 
those individuals throughout the country waiting for and 
praying for them. Your bill is intended to correct some 
important problems and forestall others. It addresses the lack 
of enforcement mechanisms to ensure that network participants 
comply with quality standards. It reflects a view I believe 
that we all share; that is, organ allocation decisions be 
shielded from political bias.
    However, Mr. Chairman, I am concerned that in an effort to 
wall off organ donation allocation decisions from political 
influence, H.R. 2418 also shields the organ allocation 
contractor from the accountability and subordination to the 
public that it should have. The bill appears to deny the 
Secretary of Health and Human Services the right to exert any 
authority over any allocation decisions that are scientific, 
clinical or medical in nature. The private contractor that 
coordinates the organ allocation could not be challenged on 
decisions of that nature. Since no legitimate organ allocation 
decisions are made outside the context of scientific, clinical 
and medical considerations, this effectively undercuts the 
Secretary's oversight of the contractor's activities. The 
Secretary, charged with representing the public and the public 
interest, would be unable to hold the organ allocation 
contractor to its contract.
    Let's explore a scenario, one we certainly hope would never 
happen. Let's say a private contractor hired to allocate 
donated organs determines, based on scientific and medical 
data, that malnourished children should be the last to receive 
donor organs because malnourishment is correlated with the 
rejection of donor organs. Even if that decision reflects the 
best science that medicine has to offer, is it the right thing 
to do from a public policy perspective? Obviously not. 
Malnourishment is not just correlated with rejecting donor 
organs, it is also correlated, obviously, with poverty, with 
the public agreeing to choose which child's life to save based 
on family income.
    As I read it, under H.R. 2418 the public would in the end 
have no say in that matter. The organ allocation contractor 
could implement the rule without--regardless of public policy 
implications and without any public input. I am concerned that 
the organ allocation contractor would have more power than the 
entity it contracts with, particularly when the entity speaks 
on behalf of the public. I question the wisdom of setting a 
precedent like this when, for government contractor 
relationships, it advocates the government's responsibility and 
alleviates the contractor of accountability.
    Mr. Chairman, I support the goal of ensuring an allocation 
system free of political bias and designed to deter internal 
breaches of quality. But the system as a whole and those who 
administer it must also be held accountable. The Institute of 
Medicine made a recommendation that I think would reconcile the 
need for public accountability and the importance of keeping 
politics out of organ allocation decisions. They recommended 
the establishment of an external independent scientific review 
board that would be charged with periodically assessing the 
organ allocation system. Starting there we can achieve our 
goals without compromising the integrity of the government/
contractor relationship.
    I look forward to hearing our witnesses' perspectives on 
this issues. I would like again to express my appreciation to 
the chairman for his efforts.
    Mr. Bilirakis. I thank the gentlemen.
    Dr. Ganske for an opening statement?
    Mr. Ganske. Thank you, Mr. Chairman. In the interest of 
hearing testimony from our first panel, I just want to say I 
appreciate you having the hearing, and I look forward to the 
testimony. Thanks.
    Mr. Bilirakis. Mr. Waxman, opening statement?
    Mr. Waxman. Thank you very much, Mr. Chairman. Only 5 
months have passed since our last hearing on organ allocation, 
but a great deal has changed. For some time I have been deeply 
troubled by the debate over the Department's final rule. I have 
heard outright misrepresentations and gross misinformation 
aimed at scaring patients, communities of color and the poor 
into believing that the administration wanted to make it harder 
for them to obtain organ transplants. UNOS has spent nearly $1 
million lobbying Congress, dollars which should have gone 
toward saving lives.
    Today we finally have the cure for this lobbying and 
rhetorical excess. The Institute of Medicine has provided us 
with a blueprint for a more equitable and efficient organ 
allocation system. They have reminded us that we must put 
patients, not UNOS, not transplant centers, not transplant 
surgeons, first. The IOM concluded that the final rule should 
be implemented. They concluded that HHS should exercise 
legitimate oversight responsibilities articulated in the final 
rule. They documented how weak oversight has compromised 
accountability at all levels, and they found that broader 
sharing of organs won't hurt donation rates or close small 
transplant centers.
    The IOM report reveals a national organ allocation system 
badly in need of reform, but H.R. 2418 ignores the IOM report. 
Patients across the country say that this bill would only make 
things or change things for the worse. It would strip the 
Secretary of her oversight authority over UNOS. It would 
insulate UNOS from competition and accountability. It would 
grant sole authority over life-and-death decisions to an 
organization that has fought to keep patient outcome data 
secret, shielded its decisionmaking from public input, and 
enforced its policies in a politically expedient manner.
    Today a patient seeking a transplant has practically no 
idea how well our transplant centers are performing. The data 
is hidden somewhere in UNOS. After years of resistance, UNOS 
has finally made some patient outcome data available, but that 
data is for the years 1988 to 1994. That means that patients 
are still in the dark about the centers' current performance.
    Yesterday at our request the Department provided myself, 
Mr. Dingell, Mr. Klink, and Mr. Stark with patient outcome data 
for every transplant center in the country. This data is up-to-
date and was obtained under congressional mandate from UNOS. 
This data shows that a patient's chances of survival depends 
very much on where you get your transplant. Depending on the 
transplant center, a patient's likelihood of getting a liver 
transplant within a year of listing can range anywhere from 25 
to 70 percent. Depending on the transplant center, if you are 
waiting for a liver transplant, your likelihood of dying within 
a year of listing can range from 7 to 22 percent.
    This new data would help transplant patients make better 
decisions, but this data is blinded and the transplant centers 
are only identified by number. This afternoon I will formally 
request that the Department provide us with the identities of 
the transplant centers. When we receive this information, we 
will provide transplant patients with all of this recent 
information about every transplant center in the country, 
information which UNOS should have made public a long time ago.
    I want to thank you, Mr. Chairman, for holding this 
hearing. I look forward to this afternoon's testimony.
    Mr. Bilirakis. I thank the gentleman.
    Dr. Coburn for an opening statement.
    Mr. Coburn. Thank you, Mr. Chairman. I am not going to be 
able to stay for the whole hearing because of other 
obligations, but I wanted to make a couple points as we talked 
about the IOM study. The IOM study, the Institute of Medicine, 
is the same institute that said we shouldn't track HIV by 
partner notification. They are the same people who 
underestimated the sexually transmitted disease epidemic in 
this country. Although they are valuable in their input, what 
they say, in this physician's eyes, is not always 100 percent 
accurate. I think that needs to be said without demeaning or 
taking discredit for the efforts of those in the Institute of 
Medicine.
    The second thing that I would say and offer is my own State 
has done a great job in terms of increasing the number of 
transplant organs available. I have a great deal of difficulty 
thinking that if families in Oklahoma have a loved one who 
lives in Oklahoma, and Oklahoma is working hard in their one 
good transplant center to perfect and improve survivability, 
that Big Brother should not have the right to tell Oklahomans 
that they can't direct an organ for their own State brothers 
and sisters.
    That is what we are really talking about here. There is a 
States rights issue and a personal issue that has been ignored 
in this process. I raise that because it is a concern to me. I 
am not sure that it will be heated, but it is an important 
thing if we really want States to be active. And should all 
organ transplants be run by the Federal Government? That is 
where we are headed, and I am not sure that is a great idea. I 
am not sure it is great for innovation. I am not sure it is 
great for patient longevity. I am not sure it is great for 
people who are receiving transplants.
    As a physician, I know transplant centers when they start 
don't have good rates. As they perfect and get better, they 
improve. So I would just hope that we would consider those 
thoughts as we hear this testimony and ask the questions. With 
that, I yield back and thank you, Mr. Chairman, for this 
hearing.
    Mr. Bilirakis. I thank the gentleman.
    Mr. Green, for an opening statement.
    Mr. Green. Thank you, Mr. Chairman, for scheduling this 
hearing on H.R. 2418 today. I am pleased to be an original 
cosponsor because I believe it ensures that medicine and 
science instead of Federal employees will develop our Nation's 
organ transplant policy.
    The Department of Health and Human Services released their 
final rule on organ transplantation last year. They did so to 
equalize the waiting time differences for sicker patients 
around the country. They claim that a national waiting list 
would reduce some of the differences, which admittedly can be 
too long, and make the organ transplantation process fair. 
However, a recent Institute of Medicine report found that the 
current system is equitable for the most severely ill patients. 
While their report also found that broader sharing between OPOs 
and States in regions would be better, it is important to note 
that this initiative is already being implemented within the 
transplant community.
    I agree with the intent of the promulgated HHS regulation. 
However, I believe that the regulation would leave small and 
medium-size transplant centers at a significant operating 
disadvantage, which would ultimately cause them to shut their 
doors, leaving thousands of needy patients with few options.
    The problem with organ allocation policy is not the way 
they are allocated, but the number we have to allocate. Instead 
of trying to force new regulations on a transplant community 
that has nearly unanimously rejected them because they could 
harm patients, we need to focus on ways to encourage more 
people to donate healthy organs. I support creating the fair 
organ allocation system, not one that so many patient groups, 
transplant surgeons, and organ procurement organizations 
believe would do more harm than good. I believe any policy 
needs to be dictated by the true experts in this issue, the 
transplant community. That is why I am proud to be a cosponsor. 
I would hope the administration recognizes the shortfall of 
their rule and would reach out to the transplant community and 
reach a compromise. Short of that, we have no choice but to 
pass legislation.
    Again, Mr. Chairman, I appreciate your willingness to 
address this issue in a timely and equitable manner. I believe 
many of today's witnesses will express many concerns raised to 
me by both the Houston medical community and the Texas Medical 
Center in Houston. Thank you.
    Mr. Bilirakis. I thank the gentleman.
    Mr. Bryant.
    Mr. Bryant. Thank you, Mr. Chairman, and I thank you for 
convening this hearing. I, too, am proud to be a cosponsor of 
H.R. 2418 because I believe it is a good bill and the right way 
to handle this matter. I think we are here today because--in 
large part because of HHS's final rule on Organ Procurement and 
Transplantation Network, which was published in April. 
Obviously, this has been a controversial issue since the 
beginning. In fact, we have as a Congress placed a 1-year 
moratorium on this. The moratorium is about to expire.
    I think many of us do have serious concerns about this rule 
for several reasons; I think particularly its effect, potential 
effect, on local transplantation and small transplant centers. 
I think that we could go on, but I did want to incorporate as 
part of my statement and I will at this time ask unanimous 
consent to put the full letter that I am about to read a 
portion of----
    Mr. Bilirakis. Without objection, so ordered.
    Mr. Bryant. [continuing] as well as the letter from the 
Tennessee Transplant Society, dated August 2, 1999.
    Mr. Bilirakis. Without objection.
    Mr. Bryant. This is a letter--again, I will just take 
portions out--from a gentleman who has a great deal of 
credibility in this area. He is a donor father. His wife also 
was a kidney recipient. He has been on numerous organizations 
involving transplants, most particular a member of the national 
board of TRIO. He states in a quite lengthy letter that the 
policies that have come out of the National Organ and 
Transplant Act back in the mid-1980's, while not perfect, are 
good. He congratulates us or commends Congress on our wisdom, 
primarily because ``it established a private partnership 
between the medical community and the patient population which 
is independent from undue political influence by government 
operatives however well they might be intended. Difficult 
decisions involving the allocation of scarce organ resources 
have been made by informed private partnership rather than by a 
core of government attorneys and bureaucrats.''
    It goes on to say that there is a fear that a large 
transplant center with political clout would monopolize 
transplantation procedures by manipulating proposed rules 
dictated by HHS personnel. Proponents may dismiss such concerns 
as paranoia, but these worries are indeed genuine and have been 
supported by the monopolistic track record of certain large 
centers. Those of us who have had the opportunity to experience 
that could tell you that some of the smaller regional 
transplant centers understand firsthand the excellence and 
talent available in many locations throughout the country. The 
benefit which I have seen countless times is under the existing 
system, families are able to provide local support for patients 
that do not have to travel long distances to receive life-
saving transplant operations.
    He goes on, if I might add, to say that ``I can report to 
you that many of us who have been in the most difficult 
situation have been acutely concerned that hope be provided 
first to those in need in our local region. We do not want 
these precious gives to be treated as just some other 
government-owned part, shipped across country to a large center 
currently in favor with Federal rulemakers.''
    He closes by, ``Keep transplantation a predominantly 
medical issue with rules established by the existing 
partnership of medical experts, patients, and donor families.''
    I agree with the sentiments of my constituent and would 
tell you further that I do look forward to the witnesses that 
we have here today. Like Dr. Coburn, I have another hearing 
that I have to jump back and forth between, so I apologize. I 
may not be here for your full testimony, I am going to try to 
come back and forth, but I would like to make that my way of 
explanation.
    Again, Mr. Chairman, thank you for what you are doing in 
this area.
    Mr. Bilirakis. I thank you, sir.
    Mr. Pallone for an opening statement.
    Mr. Pallone. Thank you, Mr. Chairman. The National Organ 
Transplant Act reauthorization is long overdue. Increasing the 
supply of organs for transplantation is a critical policy issue 
in this Nation and an acute problem in my home State of New 
Jersey. The Federal Government can help realize this goal in 
two broad ways. First, it must maintain an equitable organ 
allocation system, and second, it must develop a new and 
improved process for evaluating the Nation's organ procurement 
program. In my opinion, H.R. 2418 of which I am a cosponsor 
along with the chairman and Mr. Green, ensures both of these 
points.
    We must move swiftly to reauthorize the National Organ 
Transplant Act, and as we do so, however, we must keep some 
basic principles in mind. The recently completed Institute of 
Medicine report recommends creation of organ allocation areas 
independent of the current organ procurement organization 
population structure. An optimal population size of 
approximately 9 million is suggested for the organ allocation 
areas. They should be accomplished through new regional sharing 
agreements, not through consolidation of OPOs. The report notes 
that achieving optimum results and procuring organs for 
transplants is highly dependent on good working relationships 
at the local level among hospitals, OPOs, transplant centers 
and on others. The committee does not want its recommendations 
to detract from or interfere with present operations where they 
are working effectively.
    I want to say that New Jersey's 6 transplant centers which 
service approximately 8.5 million residents already fits this 
model.
    Congress specifically charged the Institute of Medicine 
with the review of access to transplantation services for low-
income populations and racial and ethnic minority groups. This 
review included an examination of the impact of State policies 
regarding payments for services for patients outside of the 
States in which the patients reside. The report states the most 
important predictors of equity in access to transplant services 
lie outside the transplantation system; that is, access health 
insurance and high-quality health care services. The fact is 
that many minority and ethnic groups and low-income groups do 
not have access to health insurance and high-quality health 
care services. This fact of life cannot be divorced from a the 
review of how well organ donation transplantation works. This 
critical area must be given as much consideration and note as 
policies regarding allocations, or we will produce a caste 
system for organ transplantation with only the rich being able 
to afford transplants.
    The IOM report noted that Federal oversight of the national 
transplant system is useful in some areas. I feel strongly that 
the medical community must be free to make critical clinical 
decisions regarding transplants, but I welcome Federal 
oversight in the area of appeals, enforcement of national organ 
transplantation policy, and imposition of sanctions when deemed 
necessary to further the operation of the national transplant 
system.
    I have learned from constituents in my area that many 
variables affect organ donor rates. The current performance 
standards used by the Federal Government do not accurately 
assess OPO performance because they are based on total 
population and not the number of potential donors. In New 
Jersey, for example, the number of potential donors is 
significantly reduced by the State's high incidence of cancer 
and AIDS. The diverse nature of New Jersey's people also make 
organ donation education and procurement particularly 
challenging.
    Adherence to the current performance standards without 
regard to these operations which occur from one area of the 
country to another may needlessly lead to the termination of 
OPOs with strong relationships in their communities which are 
addressing their coverage area donor potential in an effective 
manner.
    Organ procurement organizations cannot fully concentrate on 
programs to increase the supply of organs when they are 
burdened by the mandate to meet unpredictable national average 
performance standards over a 2-year period. Such a short cycle 
does not help. OPOs implement best practices to increase the 
organ supply. The population-based performance measures used by 
HCFA has been widely criticized by the Institute of Medicine, 
the GAO, the Harvard School of Public Health and others as 
being significantly flawed for assessing OPO performance. Mr. 
Chairman, unless overturned, these inappropriate measures may 
very well result in the decertification of OPOs that are 
actually excellent performers. To that end I support the 
inclusion of language in the reauthorization calling on HHS to 
suspend the current OPO recertification process until a fair 
process that relates to true performance are developed in 
cooperation with the OPO community.
    I believe that H.R. 2418 will allow organ procurement 
organizations the freedom to do their good work of educating 
and procuring precious organs in an efficient manner, and 
therefore I look forward to working with you, Mr. Chairman, to 
directly help those Americans in need of transplantation by 
passing this good bill. Thank you.
    Mr. Chairman, could I ask, I would like to ask unanimous 
consent to submit for the record a statement by Peggy Dreker of 
Kearny, New Jersey. Ms. Dreker is the cofounder of the New 
Jersey chapter of the Transplant Recipients International 
Organization. Her testimony recounts the hardship she and her 
family experienced when their 2-year-old son needed a liver 
transplant. And he had--both she and her husband had to travel 
back and forth to Pittsburgh for 3 years to save their son's 
life. No offense to my friend from Pennsylvania, Pittsburgh is 
actually a nice place, but it is unfortunate they had to travel 
back and forth to Pittsburgh during this time. Their testimony 
illustrates why we need to pass H.R. 2418, and I would ask that 
it be included in the record.
    Mr. Bilirakis. Without objection that is part of the 
record.
    [The prepared statement of Peggy Dreker follows:]
  Prepared Statement of Peggy Dreker, New Jersey Chapter, Transplant 
                 Recipients International Organization
    Good Morning, I am Peggy Dreker. I live in Kearny, New Jersey which 
is located about 15 miles outside of New York City. I am the co-founder 
of the New Jersey Chapter of TRIO, Transplant Recipients International 
Organization. I serve on the Board of Directors of the New Jersey Organ 
and Tissue Sharing Network, the organ procurement agency in New Jersey, 
and I am currently the Treasurer of that board. I am here today in 
another role, that of a Mom who would like to share my experience with 
the transplant community. I am also here because I am concerned that 
part of the new HHS regulations will hurt many potential recipients and 
many New Jersey residents. I am concerned that these changes will limit 
patient access to transplant services which can add a tremendous 
financial and family burden to the transplant patient. I am also here 
today to tell you that the NJ chapter of TRIO strongly supports HR 2418 
sponsored by Congressman Bilirakis and cosponsored by New Jersey's 
Congressman Pallone.
    I would like to share with you my story which is typical of many 
families that have had family members transplanted and therefore, the 
tremendous need for local services.
    In December of 1984, when taking my six week old son Daniel, for a 
regular check up, the pediatrician pointed out that he was bit 
jaundiced and recommended that he have blood work done. He referred us 
to a pediatric gastroenterologist, Dr. Lucy McLoughlin at United 
Hospital in Newark, New Jersey. Daniel was hospitalized immediately on 
Christmas Eve. One week later on new Year's Eve, Daniel was diagnosed 
as having liver disease. In my mind I thought, OK, they know what the 
problem is and we are in a children's hospital, let's get this thing 
fixed quickly. I was in for a rude awakening when Dr. McLoughlin 
informed us that the only way to ``fix'' Daniel's problem was through a 
liver transplant. In 1985, I considered this just another thing that 
needed to be done. Imagine my shock and surprise when I discovered that 
an organ would not be available ``on demand'' just because my son 
needed it. I was appalled, and shocked but mostly scared. During this 
time we began a relationship with the physicians and nurses that so 
lovingly cared for my son and in turn for me. I was glad we had this 
relationship with the staff of the hospital knowing a liver transplant 
would mean a long hospital stay. That's when the final blow came. The 
doctor informed us the closest place for Daniel to receive his 
transplant was Children's Hospital at the University of Pittsburgh. I 
was shocked that as a life-long New Jersey resident, my husband and I 
both worked in New Jersey and yet health care was not available in the 
State for my son. I immediately wrote to the Commissioner of Health in 
New Jersey who informed me that transplant services were only available 
regionally and we were fairly lucky that Pittsburgh wasn't too far away 
from New Jersey.
    While trying to deal with a sick infant in the intensive care unit, 
the real world also went on. I decided to resign from my position 
working for the County. My employer had been very generous extending my 
maternity leave but I felt I could not ask for an indefinite leave. 
This also meant that I would lose my medical coverage. We had just 
purchased a home and were counting on our two incomes to pay the 
mortgage. This plan was shot. We also realized that many of Daniel's 
expenses were not being covered by our insurance which we always 
thought was so inclusive.
    When Daniel was two months old he was placed on the national 
transplant list from Children's Hospital in Pittsburgh. Daniel weighed 
under eight pounds and was literally starving to death. He was on a 
constant feeding tube and his color was changing from a glow in the 
dark yellow to a sallow shade of green.
    Getting a bit desperate, I decided to call the White House seeking 
help for Daniel. We were referred to the Transplant Office headed by 
Michael Batten. The local media in New Jersey/New York picked up on 
this correspondence and within two days of Daniel's arrival home we 
were besieged by the media. We decided to go along with this attention 
hoping that it would raise awareness for Daniel's plight. A reporter 
from the New York Times followed us around for a week trying to put a 
diary together of what it was like waiting to get a transplant. The 
local communities in the area rallied together to raise funds and 
awareness for Daniel. This was a wonderful thing but it did take away 
from our privacy and family life. Little did we know how important 
those funds would become.
    In August of 1985, we received a call saying there was an organ 
available for Daniel. This was after a false alarm in June where we 
used up all our favors of a free plane ride, ambulance and police 
escorts. In 1985, time was of the essence getting to the transplant 
center. Within one hour, my husband arrived home for work, we begged 
cash from anyone who had it, contacted the airline to get on a regular 
scheduled flight to Pittsburgh, and packed clothing for all of us not 
sure how long we would be gone. We made arrangements with the local 
police department and the State Police since we had under one hour to 
get to Newark Airport. All of this while handling a sick infant who was 
still on a feeding pump, special formula and who cried constantly. By 
the time we left our home, it finally dawned on me that we were leaving 
a lot more than a house; I would have no family, no friends, no 
familiar physicians and nurses and no husband who would have to come 
back home shortly to return to work. I would be handling Daniel's 
health on my own. My first view of the city of Pittsburgh was strapped 
on a stretcher in the back of speeding ambulance with my tiny son on my 
chest sleeping.
    On August 5, 1985 my son Daniel received the gift of life from a 
total stranger, another infant who had died. Daniel's surgery lasted 
well over 10 hours as we were left standing in the waiting room of the 
hospital with everything we owned and no place to stay. We ended up 
showering at the University of Pittsburgh dorms. Daniel was blessed 
with the best medical and nursing care. Unfortunately, within three 
days it was determined that Daniel would need another liver. By this 
time my husband had returned to work in New Jersey. My family drove the 
eight hours out to Pittsburgh to locate a cheap furnished apartment for 
me to live. Paying rent is not covered under your insurance. The 
community fund-raising money came in handy for this. Daniel was 
hospitalized in Pittsburgh from August 5, 1985 through April 10, 1986 
before he was released with the knowledge that a second transplant was 
still needed. During this time, I would stay with Daniel in the 
hospital six days and nights a week. On Saturday morning, my husband 
would fly out to Pittsburgh and stay about 24 hours before returning 
back home. Daniel did not recognize him and would cry whenever he 
walked into the room. The total feeling of isolation was relieved only 
by the wonderful nursing staff who quickly became my new family. During 
this long period of hospitalization we developed a dependence on the 
physicians, as they developed a familiarity with my son on a daily 
basis. Six months later, when my son was finally discharged, the sense 
of anxiety of leaving the transplant center was upsetting. We were now 
back to using our original physicians back home in New Jersey. At the 
time, my son was the first and only transplant patient Dr. McLoughlin 
cared for. As of today, she cares for 40 post transplant children.
    For the next 18 months, Daniel and I would fly back to Pittsburgh 
every three weeks or so because of the tubes that were left in him 
while he was waiting for another liver. Imagine if you can, traveling 
with a baby with a liver drain coming out the right side, a feeding 
tube coming out of his nose and a broviac catheter coming from his 
neck. I would leave the plane in Pittsburgh airport, put Daniel in the 
stroller, put the feeding pump on my shoulder, drag a set of luggage 
wheels with a suitcase and a baby walker, and carry a pack with diaper, 
bottles and supplies I needed if one of his tubes happened to break 
loose, which they frequently did. That was just to get through the 
airport before I could hail a cab. I would then pack this into the cab 
and head to the hospital. Thirty dollars later we arrived at the 
hospital. By this time, Daniel was screaming and I had reached my wits 
end. This procedure went on for the next year or more.
    On October 26, 1987 we received a call that a second liver was 
available for Daniel. This time all the commercial flights from the 
three surrounding airports had stopped for the evening. We ended up 
chartering a small private plane from a friend of a friend that we had 
never even met. We again packed up our things and tried to put our 
lives on hold.
    Daniel had been blessed with this second gift of life. Surgery went 
well. We quickly reverted back to our hospital routine as my husband 
left us again in Pittsburgh to go back to work. We used the money 
raised by the communities to pay the rent on our apartment so we still 
had that. Daniel spent about eight weeks in the hospital and another 
month in Pittsburgh before he was sent home on Christmas Eve 1987--
three years after the original diagnosis.
    Since Daniel's ordeal, New Jersey has worked very hard establishing 
quality transplant programs for its residents. The thought of returning 
back to a time where accessibility to a transplant center could impede 
a person getting a transplant is appalling. The three years that my son 
and I lived away from home hurt my family, my marriage, my finances and 
ended my career.
    Today, Daniel is a healthy fifteen year old. In the last 15 years a 
lot has changed in New Jersey.
    There are now more transplant centers and pediatric transplant 
programs are available. Someone in my position would not have to leave 
the state to get medical care for a child.
    I fear that the new HHS regulations on organ allocation will send 
us back to 1985, back to a time when there was not easy access to 
transplants for many people. In New Jersey the state has allowed more 
transplant centers to open, but only when there is a proven need. So 
there are not too many centers and they all have reasonable waiting 
lists. We also have worked hard at the New Jersey Organ and Tissue 
Sharing Network to increase the number of organs procured. The New 
Jersey Organ and Tissue Sharing Network does an excellent job in 
procuring organs and its potential yield from New Jersey's population 
is very high. We need to continue this, please don't let it be taken 
away by regulations that threaten transplant services to New Jersey 
residents and unfair federal agency review regulations that fail to 
take into consideration population characteristics that inhibit 
donation. It just doesn't make sense to me to destroy a system that 
works so well, a system that provides good outcomes and that so many 
people rely on. People need transplant services in their states like 
they need cardiac services, obstetric services and cancer care. Don't 
set policy that consolidated transplant services to regional areas. 
Americans will suffer.
    I am not the only one who feels this way. I am surrounded by people 
at the Sharing Network and organizations like TRIO where people, like 
me, have experienced what it is like to have to go out of state. We are 
appalled by the HHS regulations and strongly support HR 2418. In fact, 
the New Jersey Chapter of TRIO has actively opposed the HHS 
regulations, as have Arkansas, Ohio, Louisiana, New Mexico, Hawaii, 
Memphis/Nashville, South West Florida, Main and Rhode Island Chapters 
of TRIO. We support Congressmen Bilirakis and Pallone's legislation 
that will further enhance organ donation and transplantation for all 
Americans.
    I know that the current system is not perfect and I think there are 
some aspects of the new regulations that are good that have been 
incorporated in HR 2418. We can not allow the unbridled hunger for 
organs by mega transplant centers to dictate organ allocation schemes. 
It is the responsibility of the federal government to support policy 
that encourages the decentralization of transplant services so that 
Americans in need do not have to experience the hardships I endured 
with Daniel. Regular people like me need access to transplants, 
preferably close to home. HR 2418 supports this policy.
    Thank you.

    Mr. Bilirakis. I might add at this point the opening 
statement of all members of the subcommittee will made a part 
of the record, and would now recognize Ms. Eshoo for an opening 
statement.
    Ms. Eshoo. Thank you, Mr. Chairman. I can't help but think 
of the joint hearing on this very issue that this committee had 
with our Senate counterparts a year ago this last June, June 
18, 1998. So I want to thank you and salute you for having yet 
another hearing on this issue. It is a very important one. It 
is one of literally life and death for people in our country, 
and it is a difficult issue to take on, but one that deserves 
the kind of examination that you are giving to it. So I thank 
you for having the hearing.
    Very recently--my staff didn't put this in the written open 
commentary, but I can't help but think of it. Very recently a 
company, I think within the boundary of my congressional 
district, had online the sale or the posting of an organ 
online. It is a company that does essentially public auctions. 
Now, the response to that was absolutely extraordinary and 
overwhelming. The company did say out of respect, please don't 
bid on this. But I think if we were to peel away some of the 
veil of that in terms of its high profile in terms of the news, 
what it underscores is not only the demand, but the urgency.
    Any one of us that would need to have an organ replaced in 
order to live--just imagine that--would want to have that organ 
available right now. So what we are dealing with is how best 
and how fairly to do this. As we speak, I am sure that people 
are going to think, well, this one is from such and such a 
district, this is what they have in their district, that is why 
they are saying it. We need to rise above that because the 
American people obviously deserve to have a system that is 
going to speak to the urgency at hand. In fact, if this hearing 
lasts 2 hours, someone will die waiting for an organ. That, 
too, underscores the urgency. A mere one-third of the more than 
60,000 Americans now on waiting lists will receive a donated 
organ this year. With today's technology, really, people 
shouldn't be dying because they can't get an organ in time. We 
know that the system can't feed the demand, so we have more to 
do than what we are just dealing with here.
    But of those organ that are donated, what is the best 
system, how should they be disbursed, so to speak. I don't want 
to sound cold or bureaucratic about this, because we are 
talking about human beings' lives.
    Last Congress we enacted a 1-year moratorium on the HHS 
proposed rule so that the Institute of Medicine, the IOM, could 
study its potential effect. That study, released in July, 
resoundingly supported HHS's proposed rule. They concluded 
that, ``broader sharing is likely to result in more of the most 
medically urgent patients receiving first attention when 
waiting for donated livers.''
    The IOM study goes on to refute many of the criticisms that 
were raised about final rule. Broader sharing of organs does 
not require a national waiting list. Treating more medically 
urgent patients first does not mean wasting organs on patients 
too sick to benefit from a transplant. Broader sharing does not 
mean reduced services to minorities or closure of smaller 
transplant centers. The substantial health benefits of broader 
sharing would outweigh the marginal effects of cost.
    We have the medical knowledge to do successful organ 
transplants. We need to make sure that we have in place a 
system, match that, and have a record that we have a system 
that makes the most of available organs.
    Let me just close by saying the following: In the aftermath 
of the joint hearing that we had with the Senate, I was a 
fairly new member of the committee. And the message that went 
out across the country, the impact of just having the hearing, 
really astounded me. It was yet another underscoring of the 
need to do better.
    Some have heavily criticized the organization that is in 
place and how they do their work. That is not what I am here 
for. I think that all of us together, wherever we come from, 
whatever we have in our districts, whatever take we have on 
this, have to really at the end of the day be devoted to 
filling any kind of gap that exists. So I am looking forward to 
hearing from the panelists today.
    What I drew out of that hearing was that we do have some 
shortcomings. It is not for a committee or organization to do--
it is not good enough. I used to say when I was in local 
government, don't tell me about your organization, tell me how 
effective your organization is for the people I represent.
    So with that, Mr. Chairman, I hope that the people that 
testify will inform and enlighten us as to the results of the 
study and how they can direct themselves toward what is being 
proposed. I think they are steps in the right direction myself, 
and I appreciate your having this hearing. I think it is timely 
and critical. Thank you.
    Mr. Bilirakis. I thank the gentlelady.
    Mr. Barrett.
    Mr. Barrett. Thank you, Mr. Chairman. I thank you also for 
holding this very important hearing.
    This is an issue that I think combines so many different 
human elements and so many economic elements together at the 
same time that it is bound to raise emotions on all sides. As 
Ms. Eshoo said, I think all of us look at this issue a little 
differently depending upon where we come from, whether we have 
a large center, small center, no center, or how close we are to 
a center.
    But I look at the issue, and notwithstanding all of the 
emotions, health issues, the urgency issues, I think frankly 
what we are talking about here is very much an economic issue. 
These centers are big money-makers. And each one of us who has 
a center wants for economic reasons to maintain the economic 
resource that we have located in our own communities. There is 
nothing wrong with that. For those people who represent large 
centers, I understand where they are coming from. From people 
like myself, who come from mid-sized centers, I trust that the 
people who represent the large centers also understand where we 
are coming from.
    In the end, of course, we want to do what is right for the 
patient. But there is no correct answer written in the back of 
the book as to what is the right answer for the patient.
    The part of the country that I represent, the upper 
Midwest, does very, very well in producing several things. 
Ironically, we are dealing with one on the floor right now. We 
do very well in producing milk in the State of Wisconsin, as 
does Minnesota. There is another product that we do very well 
in the Midwest, and that is organs. For whatever reason, the 
people in our part of the country are very generous when it 
comes to giving organs. I would like to think that it is 
because we have this down-to-earth group of people who care 
about other people and society and are willing to make that 
sacrifice. Others might have other explanations as to why that 
occurs, but the fact is that if you look at Wisconsin and 
Minnesota in particular, we remain relatively high in the 
number of organs we produce. Correspondingly, we have health 
care centers and transplant centers that use some of these 
organs.
    I get back to the economic argument because I look at the 
report from the Office of the Inspector General fostering 
equity in patient access to transplantation, local access to 
liver transplantation, where the inspector general says that 80 
percent of the liver transplants are done in 35 cities in this 
country. So right now people are traveling to cities, 35 
different cities, to get organ transplants. Now we are going to 
fight about which city they go to.
    I am obviously of the school of thought to say, well, if we 
want regions of the country to continue putting their emphasis 
on procuring organs, it makes sense not to penalize those 
regions of the country that do a good job of procuring organs. 
We could have taken another approach in our part of the country 
and instead of trying to harvest organs, we could have tried to 
harvest a waiting list and get as many people as we could on a 
waiting list so that there would be a lot of sick patients that 
would be on our waiting list. I personally think that that in 
the big picture is counterproductive. To say that what we 
should be doing is having the transplant centers put all of 
their emphasis on developing waiting lists, I think, is 
inevitably going to mean is they are going to put less emphasis 
on recruiting new organs.
    I certainly heard--or rather the analysis that said that 
people don't care whether they know who the person is who is 
receiving the organ, that it doesn't make any difference to 
them. Again, I might be living in not exactly in Garrison 
Keillor country, but close to it, where it does matter to 
people if they know somebody. We have stories in our community 
about somebody who donated this organ marrying someone who 
donated that organ, and there is this nice little storybook 
ending from people who have met through this network.
    So it is not big east coast stuff, it is not big west coast 
stuff, it is corny Midwest stuff, but I think it works.
    I think what happens is that we should be putting more 
emphasis on increasing the supply of organs and stop fighting 
over where people are going to go, because again, as the 
inspector general's report says, 80 percent of the people are 
traveling. Let's not fight among the hospitals to develop 
waiting lists. Let's work together to get more people to give 
organs.
    I would yield back the balance of my time.
    Mr. Bilirakis. I thank the gentleman for his remarks.
    Mr. Klink is not a member of this subcommittee, and that is 
the only reason that we passed over him in his opening 
statement. The rules state that I must do that. But in any 
case, he has a great interest in this subject, as he does in 
most health care subjects, and the Chair is pleased to invite 
him to make an opening statement if he wishes.
    Mr. Klink. I certainly thank the chairman for his courtesy. 
He has always been very courteous. Even in this case where he 
knows that he and I come down on different sides of this issue, 
he has gone out of his way to allow my voice to be heard, and I 
appreciate that.
    If ever there was an issue that deserves to be protected 
from political maneuvering, it is indeed the issue of organ 
allocation. This is one of the few issues that we in Congress 
will deal with where there is no doubt about it, it is life or 
death. If you are the one that is waiting for the organ, you 
either get the organ, or you die. There is nothing abstract 
about it.
    Regardless of how each of us approaches this issue, I hope 
that all of us agree the best thing for everyone is to get this 
dispute out of the annual appropriations process by for once 
and all establishing the rules for how our organ network should 
operate.
    As I have seen this and I have studied it, there are two 
issues that are before us today: One, how do we make the 
allocation system fair and equitable; and, two, who should be 
responsible for setting and enforcing the policies for sharing 
organs? Should it be HHS or a government contractor?
    While the bill before us today is a sincere attempt by two 
of my dearest friends in the legislative body here to rewrite 
those rules, I must respectfully speak against H.R. 2418 
because it does nothing, I think, to make the system more 
equitable because it delegates too much policymaking authority 
to a largely unaccountable government contractor. The fact is 
that every year people die unnecessarily because the current 
organ allocation system is broken. Whether or not you get an 
organ that can save your life will depend on where you live. 
But under the current system, depending on where the organ was 
harvested, it could be given to someone with years to live 
while someone in the next town across the wrong border may die 
while waiting for a transplant.
    One of the most difficult organs to transplant is the 
liver. Pioneered at the University of Pittsburgh, upwards to 90 
percent of all of the liver transplant surgeons today were 
either trained at the University of Pittsburgh or by doctors 
who were trained there. Yet facilities like Pittsburgh and 
other highly regarded transplant centers which take on the most 
difficult and riskiest transplantations are struggling because 
they have the longest transplant list in the country.
    While these centers are highly regarded, many of their 
patients don't come to them because of their reputation. The 
fact is that many of the patients come there and only seek them 
out after they have been turned down by their local transplant 
centers. There is very strong evidence to suggest that many 
smaller transplant centers avoid the riskier transplants on the 
sicker patients because they are more difficult and would 
adversely impact their reputation should they not be 
successful. Without national standards for how people get 
listed or how organs should be shared, the organs do not follow 
the people that need them. This is not right, and it should be 
fixed.
    Ever since the rule was announced last April, its 
proponents have argued that the Secretary should not be allowed 
to set organ allocation policy because it involves a medical 
question that should best be left to medical professionals in 
the transplant community. I have to tell my colleagues that 
this argument causes me great difficulty when I know that if we 
share organs more broadly, lives would be saved.
    I agree with the views of those in the transplant community 
should be given great weight, but I disagree with the notion in 
this bill that the Secretary should totally refer to a 
contractor on questions that are, ``scientific, clinical, or 
medical in nature.'' The biggest opponent of any change and the 
proponent of this bill is the OPTN contractor, UNOS, who has a 
vested interest in not having the Department of Health and 
Human Service looking over their shoulders. Sadly, UNOS has 
budgeted upwards to $1 million of patients' fees to lobby 
against the proposed changes. That is money that should have 
been spent saving lives.
    The argument that the Secretary is unqualified to deal with 
medical questions causes me great difficulty when I know that 
every year Medicare and Medicaid pay for more than 50 percent 
of the transplants in this country. I think it would be highly 
irresponsible for us as taxpayers to pay for those transplants 
without making sure that the money is spent equitably. Not only 
would we be delegating sole authority over allocation policy to 
a private contractor, which I think would be an 
unconstitutional delegation of legislative authority, but as 
the agency that oversees most of our health policy, I don't 
understand how the Secretary becomes less qualified to deal 
with allocation policy than she is in making scientific, 
clinical, or medical decisions as she oversees, Medicare, 
Medicaid, NIH, or the FDA. As the ranking Democrat on Oversight 
and Investigation, I fully agree with the Institute of Medicine 
that says ``vigilant and conscientious oversight and the review 
of programs and policies are critically important to ensuring 
accountability on the part of the OPTN, and that the HHS final 
rule appropriately places this responsibility with the Federal 
Government.''
    Again, I would close by saying that I must oppose H.R. 2418 
as it is currently written because I feel it fails to improve 
the allocation system, and it gives too much policy-setting 
authority to an unaccountable Federal contractor while severely 
restricting the Secretary's authority to oversee the transplant 
network. People are dying because they happen to live in the 
wrong zip code and because States don't want to share their 
organs. Nowhere else in society would we allow a monopoly like 
this to continue. We have to put an end to this craziness. The 
No. 1 priority of organ allocation has to be medical necessity, 
not geography, period.
    Mr. Chairman, again, I thank you so much. I yield back my 
time, and I ask unanimous consent, to not prolong your hearing, 
I would like to submit questions for the witness in writing.
    Mr. Bilirakis. Without objection that will be the case. Of 
course, written questions are always provided to the witnesses 
to be responded to.
    [Additional statements submitted for the record follow:]
Prepared Statement of Hon. Barbara Cubin, a Representative in Congress 
                       from the State of Wyoming
    Thank you, Mr. Chairman, for holding this important and timely 
hearing on organ allocation. I think many people, myself included, are 
happy to see legislation introduced that will address the problems 
associated with the 1998 proposed rule on a new organ allocation 
policy.
    I have grave concerns about Secretary Shalala's proposed rule. The 
``sickest-patient-first'' standard, applied on a national basis, would 
result in more deaths and fewer successful transplants.
    In rural states, where most of the population is spread over large 
areas and many people live in rural communities, the number of 
transplants would drop, decreasing access to care if the ``sickest-
patient-first'' standard were applied.
    A national list would give transplant programs in high-population 
areas access to more organs. Regions with small populations would have 
fewer. The northwestern region's success in supplying quality, cost-
effective transplants to all regions of the country could be reversed 
under this standard.
    I believe that decisions regarding organ procurement and 
transplantation policy are best left to the medical community, 
patients, and donor families. Local and regional distribution areas 
have many advantages including giving people local access to 
transplantation and shorter distances to travel with the transplant 
organ. Our current allocation system achieves a balanced and fair 
distribution of organs for all who await a life saving transplant.
    I would like to commend the chairman, the subcommittee, and those 
involved in the drafting of H.R. 2418. This bill recognizes the 
importance of maintaining the regional boundaries in the current organ 
allocation system, and ensuring that medical experts ultimately make 
the decisions regarding organ transplantation.
    I would like to thank our witnesses for appearing here today, and 
look forward to hearing their testimony. Thank you, Mr. Chairman.
                                 ______
                                 
 Prepared Statement of Hon. Tom Bliley, Chairman, Committee on Commerce
    Thank you, Chairman Bilirakis, for convening this afternoon's 
hearing on H.R. 2418, the Organ Procurement and Transplantation Network 
Amendments of 1999.
    It has been well over a year since the Administration issued its 
regulation on the Organ Procurement and Transplantation Network. Some 
claim that the regulation changed the HHS Secretary's oversight 
authority into a policy-making authority. Policy control of the Network 
is not what Congress intended, and that is not what the law permits.
    The Organ Procurement and Transplantation Network was authorized by 
Congress to make decisions without political interference. The 
decisions they make safeguard the interests of not just those who are 
presently on a waiting list, but those unknown persons who will be 
placed on a waiting list in the future.
    Mr. Chairman, your bill would safeguard the independence of the 
Network. It also would increase the level of accountability of the 
Network by mandating timely reports on the performance of transplant 
centers within the Network. The bill includes an innovative enforcement 
mechanism that would mandate the payment of liquidated damages by 
transplant centers that try to cheat under the Network rules. You are 
also to be applauded for the provision that would offer assistance for 
living donors seeking to donate an organ to someone in another state.
    It is evident that a great deal of work and consultation went into 
this bill, Mr. Chairman, and I congratulate you for bringing H.R. 2418 
to this stage in the authorizing process. I support your bill, Mr. 
Chairman, and I look forward to the testimony this afternoon and to a 
mark-up in the near future.
                                 ______
                                 
    Prepared Statement of Hon. John D. Dingell, a Representative in 
                  Congress from the State of Michigan
    Mr. Chairman, a hearing on the subject of organ allocation is 
timely and I thank you for scheduling it. I know that we have many 
other issues to discuss and hopefully resolve before this session ends.
    Mr. Chairman, there are a lot of reasons why we must reach some 
kind of collective and durable agreement on the future course of organ 
allocation policy. Let me name a few. First, patients need and deserve 
an allocation program that is efficient and equitable. The ongoing 
struggle over the current organ allocation system is discouraging and 
harmful to the many persons across this country who are in need of an 
organ transplant. Second, the professional transplant community 
consists of talented and dedicated professionals. Their views and 
concerns are important and need to be weighed in any organ allocation 
policy we develop. Third, the public has an important interest in organ 
allocation policy. I think the point is sometimes overlooked that when 
we speak of the proper role of the Secretary, we are ultimately 
speaking of the public's interest in this matter. The Secretary is a 
steward of the public interest and is accountable as such. In my view, 
this is more so when we note the fact that a third or more of all organ 
transplants are paid for with taxpayer-funded health insurance programs 
such as Medicare and Medicaid.
    Some will argue that organ allocation is purely a matter of 
medicine and science and that public officials have no business in such 
matters. This is a curious argument. We debate public policies on such 
medical and scientific issues as limits on stem cell and cloning 
research, pain management, the scope and direction of public research 
funded by the NIH, availability of FDA approved pharmaceutical 
products, reimbursement for medical procedures, protection of human 
research subjects, and so on. The argument that medicine and science 
are not proper areas for public scrutiny is a dangerous notion and 
therefore should be rejected.
    Let me be specific. H.R. 2418 divorces the operations of a 
government contractor from any meaningful oversight by or 
accountability to the Department of Health and Human Services, the 
agency from which the contractor derives its authority to operate an 
organ allocation system. Without that government contract, the Organ 
Procurement and Transplantation Network would have no authority to 
operate. As I have already noted, my concerns in this area are 
amplified by the fact that Medicare and Medicaid pay for a substantial 
percentage of all organ transplants. There simply must be greater 
accountability of the Network to the Secretary than H.R. 2418 would 
provide.
    I am also concerned that H.R. 2418 does not do enough to alleviate 
the shortage of organs. One example that comes to mind is the cost of 
immunosuppressive drugs. A major reason for long term failure of 
transplants is a lack of compliance with the life long drug therapy 
that is required for transplant patients. The major reason for a lack 
of compliance with immunosuppressive drug therapy is the lack of 
resources to pay for them. The result is that the organ fails and 
another is needed. We should examine this question and determine 
whether providing drug coverage for those who need it would be cost 
effective and help reduce the shortage of organs.
    We should also take a look at other ways to encourage donations. 
These include, for living donors, extended leave, expanded 
reimbursement for costs beyond that proposed in H.R. 2418, and expanded 
insurance coverage. More aggressive outreach by medical, educational, 
and legal professionals, as well as other community leaders, to promote 
awareness of the need for donations is also desirable.
    Mr. Chairman, I support the concept of engaging in an effort aimed 
at trying to resolve the issues that have been so divisive. I see 
encouraging signs of movement from almost every direction. HHS has 
indicated that it is willing to repropose its allocation regulation in 
an effort to deal with some of the criticisms leveled against its 
earlier version. The study by the Institute of Medicine, particularly 
with respect to the role of waiting times, may also have had an 
influence on the Department's thinking. The transplant community, for 
its part, has in some cases shown a recognition of the merit of broader 
regions for sharing organs. There is not a complete meeting of the 
minds yet, but I sense that the differences may be smaller than a year 
ago.
    I am certainly willing to work with you and my colleagues on this. 
I thank the witnesses for appearing here today, and look forward to 
continued progress in increasing the supply of organs and making their 
allocation more equitable.
                                 ______
                                 
 Prepared Statement of Hon. Nathan Deal, a Representative in Congress 
                       from the State of Georgia
    Thank you, Mr. Chairman for holding this important hearing 
regarding H.R. 2418, the Organ Procurement and Transplantation Network 
Amendments of 1999. As a cosponsor of this legislation, I appreciate 
your efforts in addressing this issue and encourage the subcommittee to 
support this bill which is important to my constituents and the State 
of Georgia.
    As you know, this legislation reinforces the original intent of the 
National Organ Transplant Act of 1984 that is responsible for 
developing and maintaining the medical criteria and standards for organ 
procurement and transplantation resting with the medical community. It 
is my belief that properly trained physicians should be responsible for 
transplant issues, and we must ensure that these functions remain the 
sole discretion of the Organ Procurement and Transplantation Network 
(OPTN).
    Furthermore, it is vital that we increase the supply of donated 
organs around the country so that more people may receive transplants 
and we can achieve a just and equitable allocation system. To that end, 
H.R. 2418 includes provisions that require the OPTN to actively 
increase the supply of donated organs and authorize the Secretary of 
Health and Human Services to award grants related to increasing organ 
donation. Finally, the bill strengthens patient confidentiality 
safeguards and mandates that transplant centers provide specific 
information to the patients.
    If implemented, the Department of Health and Human Services' Final 
Rule on this matter will harm the state of Georgia. Currently, 
Georgians employ one of the best organ procurement systems in the 
country that results in better access to transplants. I fear that 
Georgians will no longer be as likely to donate their organs if the 
Final Rule is implemented and find it troubling that my state would be 
punished for our successful organ procurement program.
    Again, I appreciate your efforts in introducing this legislation. I 
look forward to hearing from our witnesses and recommend that the 
subcommittee move ahead in this process to pass H.R. 2418.

    Mr. Bilirakis. The Chair calls the panel forward. Please 
come forward.
    Dr. William Raub is the Deputy Assistant Secretary for 
Planning and Evaluation/Science Policy with the Department of 
Health and Human Services. Dr. William Payne is the director of 
the liver transplant program, Fairview Medical Center, 
Minneapolis, Minnesota. Dr. Robert G. Gibbons, professor of 
biostatistics, School of Medicine, Department of Psychiatry, 
University of Illinois, Chicago; Dr. Joshua Miller, Division of 
Transplantation, Department of Surgery, University of Miami 
School of Medicine; Mr. Craig Irwin, president of the National 
Transplant Action Committee out of Portland, Oregon; and Dr. 
John M. Rabkin, chief of liver transplantation, Oregon Health 
Sciences University, Portland, Oregon.
    Gentlemen, the committee welcomes you. Before we hear from 
the first witness, I unfortunately have a negative statement to 
make. I want to remind our witnesses, not only here but 
forevermore, that the committee expects to receive testimony 2 
days prior to the hearing. The purpose of this rule, I think it 
is kind of obvious, is to allow members and their staffs 
sufficient time to review the statements and educate themselves 
on the testimony that will be at the hearing.
    The testimony from the administration was not received 
until 1 p.m. Today. Now, anyone tell me that that is unfair. 
That is unacceptable, and it shows, I think, blatant disrespect 
for the members of the subcommittee. And I know that the 
administration had to be aware that a hearing like this was 
going to take place because of the controversy that is 
involved.
    The committee noticed this hearing 1 week prior to the 
hearing date, providing ample time for invited witnesses to 
produce testimony. And please, Dr. Raub, this is certainly no 
reflection upon you personally, but I appreciate it if you 
would maybe pass the word on to the Department to give us the 
courtesy of submitting their testimony at least 2 days prior to 
the hearing. We have gotten complaints from the minority, too, 
in this regard so it doesn't come just from the majority. I 
think that you can understand that.
    Mr. Brown, did you have anything that you wanted to comment 
in this regard?
    Mr. Brown. Only that I agree with your assessment, Mr. 
Chairman.
    Mr. Bilirakis. All right. The committee ordinarily gives 
the administration witness 10 minutes to testify and the others 
5 minutes. But I am going to--you are all busy people, have 
taken time away from your schedules to be here. Anywhere 
between 5 and 10 minutes would be appreciated because I know 
that you have an awful lot of valuable things to say to us.
    Dr. Raub, we would ask you to kick it off, sir.

 STATEMENTS OF WILLIAM F. RAUB, DEPUTY ASSISTANT SECRETARY FOR 
 PLANNING AND EVALUATION/SCIENCE POLICY, DEPARTMENT OF HEALTH 
 AND HUMAN SERVICES; WILLIAM PAYNE, DIRECTOR, LIVER TRANSPLANT 
PROGRAM, FAIRVIEW MEDICAL CENTER; ROBERT D. GIBBONS, PROFESSOR 
OF BIOSTATISTICS, SCHOOL OF MEDICINE, DEPARTMENT OF PSYCHIATRY, 
 UNIVERSITY OF ILLINOIS AT CHICAGO, ACCOMPANIED BY MITCHELL W. 
  SPELLMAN, PROFESSOR OF SURGERY EMERITUS AND DEAN OF MEDICAL 
SERVICES EMERITUS, HARVARD MEDICAL SCHOOL, AND SUSANNE STOIBER, 
   EXECUTIVE OFFICER, INSTITUTE OF MEDICINE; JOSHUA MILLER, 
DIVISION OF TRANSPLANTATION, DEPARTMENT OF SURGERY, UNIVERSITY 
 OF MIAMI SCHOOL OF MEDICINE; CRAIG IRWIN, PRESIDENT, NATIONAL 
 TRANSPLANT ACTION COMMITTEE; AND JOHN M. RABKIN, CHIEF, LIVER/
 PANCREAS TRANSPLANTATION HEPTOBILIARY SURGERY, OREGON HEALTH 
                      SCIENCES UNIVERSITY

    Mr. Raub. Thank you, Mr. Chairman. Good afternoon, Chairman 
Bilirakis, Congressman Brown, other members of the 
subcommittee. I am William Raub, Deputy Assistant Secretary for 
Science Policy at the Department of Health and Human Services. 
I appreciate your invitation to testify.
    I will discuss H.R. 2418 and also will testify in general 
about national organ transplantation policies and the 
constructive discussions we have had with our colleagues in the 
transplant community about those policies. With your 
permission, I will submit my full statement for the record.
    Thanks in part to the passage of NOTA in 1984, organ 
transplantation now is a routine and widely endorsed procedure. 
Many organizations and individuals deserve high praise for this 
achievement: The United Network for Organ Sharing; surgeons, 
physicians, nurses and other health professional who have 
committed themselves to the practice of transplantation 
medicine; laboratory and clinical scientists who continue to 
generate new knowledge and technology that drives 
transplantation medicine to ever greater success; the staff of 
organ procurement organizations who work so diligently to 
acquire and transport organs to transplant programs; patients 
who provide invaluable insights as to how OPTN processes might 
be improved; and most of all, organ donors and their loved one 
whose decisions to share the gift of life enable 
transplantation medicine to flourish.
    Through the efforts of the Organ Procurement 
Transplantation Network, organ transplantation has become 
available to more and more chronically ill patients. Last year 
more than 21,000 Americans received organ transplants, but more 
than 4,000 people on transplant waiting lists died because of 
the scarcity of donated organs. As these lists grow, many more 
will die as the system continues to strain under the demand for 
organs.
    In light of this demand, we in the administration believe 
that our first priority must be to increase organ donation. To 
that end, in December 1997, the Department launched its organ 
and tissue donation initiative to foster partnerships between 
public and private-sector organizations, to enhance public 
education about the need for donation, and to recruit potential 
donors. We believe that we must work to ensure that the OPTN 
operates equitably and provides the best possible outcomes for 
patients.
    This role for the Federal Government was recently affirmed 
by the Institute of Medicine, ``The Federal Government as well 
as the transplantation community has a legitimate and 
appropriate role to play in assuring 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.''
    Thus, in commending the OPTN for its accomplishments, we 
cannot ignore the persistent flaws and unfairness in the 
system. The most medically urgent patients do not always 
receive priority. Patients with similar levels of disease may 
have different outcomes depending on where they live or list. 
Distrust among transplant surgeons and hospital administrators 
sometimes impedes broader sharing of organs. True measures of 
equity to judge the OPTN do not exist.
    In recognition of a need for public sector oversight of the 
OPTN, and in response to provisions of the Consolidated Omnibus 
and Emergency Supplemental Appropriations Act of 1999, the 
Department has increased its efforts to assess the performance 
of transplant programs. With the assistance of staff from UNOS, 
the contractor for both the OPTN and the scientific registry, 
the Department staff analyzed OPTN outcome data for liver and 
heart transplants with respect to three critical issues: One, 
the likelihood that, having been listed as a transplant 
candidate, a patient would receive an organ within 1 year; two, 
the likelihood that a patient will die within 1 year of listing 
while awaiting transplantation; and three, the likelihood that 
a patient would still be alive 1 year after listing 
irrespective of whether he or she underwent a transplant 
procedure.
    After risk adjustment, that is adjustment for differences 
in the mix of patients' health status from program to program, 
the analysis revealed substantial differences in outcome from 
one transplant program to another. These findings warrant 
attention by the OPTN. In the course of performing these 
analyses, the Department staff identified gaps in the data 
currently collected by the scientific registry; for example, 
additional clinical details about patients' condition 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.
    Many of the flaws in the OPTN are addressed in the final 
rule issued by the Department in April, 1998, after extensive 
public comment and 3 days of public hearings.
    The rule requires the OPTN to develop policies that will 
result in standard listing practices and medically based 
definitions of patient status categories. The rule also 
requires policies that will encourage broader geographic 
sharing of organs so that the most medically urgent patients 
receive transplants based on sound medical judgment. The rule 
leaves the policy decisions to the OPTN with oversight by the 
Department.
    I again quote from the IOM report: ``Vigilant and 
conscientious oversight and review of program 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.''
    The Department concurs with the IOM. This is the balance we 
sought in the rule.
    Mr. Chairman, we have taken very seriously the charge we 
were given by the Congress last year to work cooperatively with 
the transplant community to clarify the intent and the effect 
of the rule. We very much appreciate the many hours that those 
in the community have spent meeting with us and their 
constructive approach in identifying apparent problems and 
potential solutions through oral and written comments. In 
addition, we have carefully reviewed the IOM report and 
recommendations and have met with representatives of the IOM 
expert committee on two separate occasions. Also we are 
fortunate to have additional data pursuant to the study 
provisions of the omnibus bill.
    In response to these helpful comments and discussions, we 
have committed to revise the rule in important areas. For 
example, we intend to clarify the rule so that there is no 
doubt that the OPTN will develop allocation policies. We intend 
to ease any lingering concerns of the transplant community 
about the Secretary's regulatory authority by instituting an 
independent advisory committee, as recommended by IOM, to 
review major differences between the Secretary and OPTN on 
policy matters.
    Other areas of potential clarification or revision have 
been discussed in detail with transplant community 
representatives. I believe our revisions will address the major 
concerns we have heard from the transplant community, yet 
maintain the essential framework of the rule requiring 
standardization of certain practices and encouraging broader 
geographic sharing of organs.
    Consistent with the law, it is our intent that the rule 
once revised go forward to address inequities in the system 
identified by the Department and IOM. However, congressional 
review of the OPTN is essential; and the Department looks 
forward to working together with you, Mr. Chairman, and other 
Members of the Congress to develop legislation to reauthorize 
NOTA. Reauthorization should primarily address the needs of 
patients and also maintain the requirement of NOTA that there 
be a national, equitable system of organ allocation in the 
United States. We recommend that reauthorization reinforce the 
role of the Federal Government in overseeing the OPTN in 
accordance with the IOM recommendations and that the statute 
continue to leave management and policy development of the OPTN 
in the private sector.
    The Department is concerned that H.R. 2418 does not do 
enough to preserve and strengthen many of the attributes of the 
OPTN that have placed transplantation firmly within the medical 
mainstream. Indeed in some instances the bill takes a step 
backward. The Department therefore opposes H.R. 2419 in its 
current form. My full statement contains comments on specific 
provisions.
    In summation, Mr. Chairman and members of the subcommittee, 
the Department is committed to working with you and the members 
of the transplant community to create policies that improve the 
quality of care and the equity of our organ allocation system. 
While we have had our differences, our recent discussions with 
the transplant community have been quite promising. We hope 
that this spirit of cooperation can extend to our discussions 
on reauthorization of NOTA as well. Thank you for the 
opportunity to testify today.
    [The prepared statement of William F. Raub follows:]
 Prepared Statement of William F. Raub, Deputy Assistant Secretary for 
  Science Policy, Office of the Assistant Secretary for Planning and 
  Evaluation, Office of the Secretary, Department of Health and Human 
                                Services
    Good afternoon, Chairman Bilirakis, Congressman Brown, and other 
members of the Subcommittee. I am William Raub, Deputy Assistant 
Secretary for Science Policy at the Department of Health and Human 
Services. I appreciate your invitation to be here today to discuss H.R. 
2418, a bill to reauthorize the National Organ Transplant Act (NOTA). I 
also will testify in general about national organ transplantation 
policies and the constructive discussions we have had with our 
colleagues in the transplant community about those policies.
    Thanks in large part to the passage of NOTA in 1984, the transplant 
network is very different from the system that existed then. Organ 
transplantation is no longer experimental; it is routine. The 
figurative handful of centers comprising the network in 1984 has grown 
into an enterprise of 891 organ-specific transplant programs. 
Technological advances allow excised organs to last much longer and to 
be transported much farther than they could fifteen years ago.
    In many respects, NOTA and the transplant network it spawned have 
served patients well. We have an organized national system requiring a 
structured approach to organ transplantation that did not previously 
exist. Allocation of scarce organs is done more cooperatively than in 
the past. Advances in drugs for immuno-suppression and techniques for 
lengthening cold ischemic time have resulted in high survival rates for 
transplant patients.
    Many organizations and individuals deserve high praise for the 
achievements of the Organ Procurement and Transplantation Network 
(OPTN): the United Network for Organ Sharing (UNOS); surgeons, 
physicians, nurses, and other health professionals who have committed 
themselves to the practice of transplantation medicine; laboratory and 
clinical scientists who continue to generate new knowledge and 
technology that drives transplantation medicine to ever-greater 
success; staff of the Organ Procurement Organizations (OPOs), who work 
so diligently to acquire and transport organs to transplant programs; 
patients, who provide invaluable insights as to how OPTN processes 
might be improved; and, most of all, organ donors and their loved ones, 
whose decisions to share the gift of life enable transplantation 
medicine to flourish.
    Their efforts have made organ transplantation available to more and 
more chronically ill patients. Last year more than 21,000 Americans 
received organ transplants. But more than 4,000 people on transplant 
waiting lists died because of the scarcity of donated organs. As these 
lists grow, many more will die as the system continues to strain under 
the demand for organs.
    We in the Administration believe that our first priority must be to 
increase organ donation. To that end, in December 1997, the Department 
launched its National Organ and Tissue Donation 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 centerpieces of this initiative are a rule, 
modeled upon legislation in Pennsylvania, requiring hospitals 
participating in Medicare to expand their reporting of imminent deaths 
and deaths to OPOs and a new $5 million grant program to learn more 
about what works in organ donation. We are pleased to report that organ 
donation increased by more than 5 percent last year as a result of our 
collective efforts, and we are hopeful that the upward trend will 
continue. Nevertheless, we recognize that the need for transplantation 
is growing faster than the supply of organs and that continued emphasis 
on both organ donation and equitable organ allocation is necessary.
    A second priority for the Administration is to ensure that the OPTN 
established by NOTA works equitably and provides the best possible 
outcomes for patients. The role of the federal government in this area 
was recently affirmed by the Institute of Medicine (IOM), which was 
directed by Congress last year to study the national organ 
transplantation network. Two months ago, IOM reported that:
        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.
    As I said, the OPTN should be commended for its wonderful 
accomplishments. Nevertheless, we cannot ignore the persistent flaws 
and unfairness in the system. The most medically urgent patients do not 
always receive priority. Patients with similar levels of disease may 
have different outcomes, depending on where they live or list. Distrust 
among transplant surgeons and hospital administrators sometimes impedes 
broader sharing of organs. True measures of equity to judge the OPTN do 
not exist.
    In recognition of the need for public-sector oversight of the OPTN 
and in response to provisions of the Consolidated Omnibus and Emergency 
Supplemental Appropriations Act of 1999, the Department has increased 
its efforts to assess the performance of transplant programs. With the 
assistance of staff from UNOS, the contractor for both the OPTN and the 
Scientific Registry, Department 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 a 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.
    After 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 65 percent 
        to almost 86 percent.
    The analogous values for heart transplants are 36-72 percent 
(transplantation within one year of listing), 9-23 percent (death 
within one year of listing while awaiting a transplant), and 67-84 
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.
    Although these findings warrant further study to determine the 
precise reasons for such variances in patient outcomes, one thing is 
clear. Where a patient lives or lists often does more to determine 
whether he or she gets a transplant than do medical considerations. 
Patients in like circumstances are being treated differently, in clear 
contradiction of the premise of NOTA that we have an equitable national 
system of organ transplantation in the United States.
    Many of the flaws that I have discussed are addressed in the final 
rule for the OPTN that was issued by the Department in April, 1998, 
after extensive public comment and three days of public hearings. The 
rule requires the OPTN to develop policies that will result in standard 
listing practices and medically based definitions of patient status 
categories. The rule also requires policies that will encourage broader 
geographic sharing of organs so that the most medically urgent patients 
receive transplants, based on the sound medical judgment of physicians 
under this general rubric. The rule leaves the policy decisions to the 
OPTN with oversight by the Department.
    In reference to the final rule, I again quote from the IOM report:
        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.
    The Department clearly concurs with the IOM. There should be 
vigilant government oversight and close cooperation with the transplant 
community. This is the balance we sought in the HHS rule.
    Mr. Chairman, we have taken very seriously the charge we were given 
by the Congress last year to work collaboratively with the transplant 
community to clarify the intent and effect of the rule. We very much 
appreciate the many hours that those in the community have spent 
meeting with us and their constructive approach in identifying apparent 
problems and potential solutions through oral and written comments. In 
addition, we have carefully reviewed the IOM report and recommendations 
and have met with representatives of the IOM committee on two separate 
occasions. As I have indicated, we are also fortunate to have 
additional data pursuant to the study provisions in the omnibus bill.
    In response to these helpful comments and discussions, we have 
committed to revise the rule in important areas. For example, we intend 
to clarify the rule so there is no doubt that the OPTN will develop 
allocation policies. We intend to ease any lingering concerns of the 
transplant community about the Secretary's regulatory authority by 
instituting an independent advisory committee--as recommended by IOM--
to review major differences between the Secretary and OPTN on policy 
matters. Other areas of potential clarification or revision have been 
discussed in detail with transplant community representatives. I 
believe our revisions will address the major concerns we have heard 
from the transplant community yet maintain the essential framework of 
the rule requiring standardization of certain practices and encouraging 
broader geographic sharing of organs.
    Consistent with the law, it is our intent that the rule, once 
revised, go forward to address inequities in the system identified by 
the Department and IOM. However, congressional review of the OPTN is 
essential, and the Department looks forward to working together with 
you, Mr. Chairman, and other members of Congress to develop legislation 
to reauthorize NOTA. Reauthorization should primarily address the needs 
of patients and also maintain the requirement of NOTA that there be a 
national, equitable system of organ transplantation in the United 
States. We recommend that reauthorization reinforce the role of the 
federal government in overseeing the OPTN, in accordance with the IOM 
recommendations, and that the statute continue to leave management and 
policy development of the OPTN in the private sector.
    The Department is concerned that H.R. 2418 does not do enough to 
preserve and strengthen many of the attributes of the OPTN that have 
placed transplantation firmly within the medical mainstream. Indeed, in 
some instances, the bill takes a step backward. The Department, 
therefore, opposes H.R. 2418 in its current form. The following 
paragraphs describe our principal concerns.

 While calling for a national system to match organs and 
        individuals who need organ transplants, the bill does nothing 
        to decrease the reliance on arbitrary geographic boundaries and 
        the inequities that result. Commenting specifically on 
        allocation of 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.'' Medical outcomes, waiting time and the possibility of 
        fatality should not depend on the geographic location of a 
        transplant program at which a patient is wait-listed.
 H.R. 2418 does not ensure that patients and referring 
        physicians can obtain the kinds of program-specific information 
        they need to make decisions about whether, when, and where to 
        seek transplantation. Although H.R. 2418 provides for program-
        specific data on such items as the probability of receiving an 
        organ transplant, the waiting time for similarly situated 
        patients, and the medical outcomes for similarly situated 
        patients, the bill does not specify that this information also 
        be timely and easy to use. Out-of-date information can lead 
        referring physicians and patients to make less than optimal 
        decisions.
 H.R. 2418 would erode the role of the federal government in 
        providing oversight of the OPTN. The OPTN, by its structure, is 
        not able to incorporate into its activities the public policy 
        considerations that underpin the NOTA. The Department 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 overarching purpose of the OPTN rule is to clarify the 
        nature and extent of oversight by the Department while ensuring 
        a continued prominent role for transplantation professionals, 
        patients / patient-advocates, and other organizations and 
        individuals in the private sector.
 As you know, under the U.S. Constitution, a private entity 
        cannot perform functions inherent to the federal government. 
        Yet the bill does not stipulate that binding policies for the 
        OPTN be approved by the federal government.
 Although H.R. 2418 requires that the Board of the OPTN have 
        physician representation of no less than 50 percent, it makes 
        no such percentage requirements for patients and donor 
        families, who we believe should have a significant 
        representation on the Board.
    In summation, Mr. Chairman and members of the Subcommittee, the 
Department is committed to working with you and the members of the 
transplant community to create policies that improve the quality of 
care and the equity of our organ allocation system. While we have had 
our differences, our recent discussions with the transplant community 
have been quite promising. We hope that this spirit of cooperation can 
extend to our discussions on reauthorization of NOTA as well. Thank you 
for the opportunity to testify today.

    Mr. Ganske [presiding]. Thank you, Mr. Raub. By the way, 
why was your testimony so late?
    Mr. Raub. Sir, the invitation to the Department, as I 
understand it, arrived at the end of last week. We worked very 
hard over the----
    Mr. Ganske. The invitation I am told arrived last Tuesday.
    Mr. Raub. That is not my knowledge, sir, but I have no 
reason to dispute your statement.
    Mr. Ganske. Okay. If it arrived last Tuesday, why did we 
not receive your testimony until today? Will you take personal 
responsibility and find out what the delay was?
    Mr. Raub. Yes, sir, I will.
    Mr. Ganske. Thank you. Dr. Payne?

                   STATEMENT OF WILLIAM PAYNE

    Mr. Payne. Thank you, Mr. Chairman and distinguished 
members of the committee. It is an honor to testify today as 
the current President of UNOS, the United Network for Organ 
Sharing. I am Bill Payne, a liver transplant surgeon and 
Director of the Liver Transplant Program at the University of 
Minnesota.
    On behalf of UNOS I will be speaking in support of H.R. 
2418. First, however, I would like to provide a brief report on 
three major improvements made since we last appeared before 
you.
    In June, the UNOS board of directors voted to institute a 
major change to the liver allocation policy by establishing 
region-wide sharing for the most urgent patients. This new 
policy, which has been in development for several years, 
addresses many of the concerns that have been raised with 
regard to allocation over the last year.
    Each year more than 4,000 people die needlessly because of 
the organ shortage. I am pleased to report that UNOS recently 
completed a pilot test of its new critical pathway for organ 
donor management developed under our contract with HRSA. The 
study revealed a 10.4 percent increase in the number of organs 
recovered per donor at pilot sites.
    This is extremely important news. The organ supply has 
remained roughly the same for years despite everyone's best 
efforts. As this new organ recovery technique is implemented 
nationally we expect a 10 percent increase, the largest in a 
decade.
    Finally, UNOS recently unveiled an impressive array of new 
on-line data for patients and the public. By updating our 
Internet site we have an all new section called ``Transplant 
Patient Data Source.'' we are now providing the latest 
statistics on survival rates on every transplant program in the 
country, the size of waiting lists and waiting times at each 
center and OPO, and the supply of donated organs nationally by 
State and by transplant center.
    This unique research tool offers patients the critical 
information they need to evaluate transplant centers in a user 
friendly format. Consumer information and scientific data of 
this kind is unprecedented, available nowhere else in medicine. 
In fact, we recently asked Arthur Andersen to conduct a study 
to evaluate the data published by leading major health 
organizations. Arthur Andersen polled 40 Federal public health 
agencies and national private health care organizations and 
found that other than the small bone marrow transplant 
registry, none of the organizations polled collects or analyzes 
center-specific data or health care-related outcome data and 
makes it available to the public to the extent that UNOS does.
    With regard to H.R. 2418, I am proud to represent the UNOS 
membership in strongly supporting this legislation. Mr. 
Chairman, we very much appreciate your leadership on this issue 
and commend you for your hard work and the truly bipartisan 
support for this legislation. We support this bill for many 
reasons.
    First, the bill reinforces the original intent of NOTA. It 
was Chairman Bliley and other members of this committee who 
designed the current public-private structure that keeps the 
delicate medical decisionmaking with doctors and the medical 
community. H.R. 2418 preserves the original intent of NOTA by 
restating that the responsibility for developing, establishing 
and maintaining medical criteria and standards for organ 
procurement and transplantation rests in the private sector and 
the medical community.
    This inclusive and democratic policymaking process ensures 
that transplantation policy reflects the consensus of the 
community while addressing the issues facing practitioners and 
patients every day.
    Second, the bill also updates NOTA by providing new 
direction in important areas such as enforcement, 
accountability, and patient confidentiality. It provides 
several new means by which the network can enforce its 
policies. It also includes new requirements improving the 
network's public accountability. Specific and detailed data 
reporting requirements will now be mandated by law. The bill 
also provides for a new periodic evaluation of the network's 
performance by the GAO to be submitted to Congress for review. 
UNOS strongly endorses these new oversight measures.
    The bill also ensures that in an effort to provide more 
information to the public, the confidentiality of patients pre 
and post transplant will not be compromised. We wholeheartedly 
support this important protection for patients.
    Finally and perhaps most importantly, the bill provides new 
incentives for donation. Simply put, too few people give the 
gift of life. The medical community struggles daily with 
families torn with grief over the loss of a loved one who 
through fear or mistrust choose not to allow organs to live on. 
This bill represents further commitment by Congress to help us 
increase donation.
    Mr. Chairman, we believe all of these provisions are great 
improvements to NOTA and that a reauthorization is timely and 
necessary. We urge the committee to pass it, and again thank 
you for the opportunity to appear before you today. I would be 
happy to answer any questions you may have.
    [The prepared statement of William Payne follows:]
  Prepared Statement of William Payne, President, United Network for 
                             Organ Sharing
    Mr. Chairman, distinguished members of the Committee, it is an 
honor to be here today to testify as the current President of the 
United Network for Organ Sharing, or UNOS. My name is Bill Payne, and I 
am a liver transplant surgeon currently serving as Chief of Staff at 
Fairview University Medical Center in Minneapolis, Minnesota, where I 
also am Director of the Liver Transplant Program.
    UNOS members elect a new president each June, and my predecessors 
have appeared before you in the past. Therefore, you know that UNOS has 
been the Organ Procurement and Transplantation Network--the OPTN, or 
Network--since the passage of NOTA in 1986, and continues to operate 
this national Network under contract with the Department of Health and 
Human Services. Because we have testified before you in the past, I 
will only briefly recount who UNOS is and what we do.
    As a private membership organization, UNOS includes every 
transplant center and organ procurement organization in the United 
States. The corporation qualifies under federal law as a charitable, 
tax-exempt scientific and educational organization. Although we employ 
almost 200 full-time staff, the important clinical and scientific work 
of UNOS, as well as the critical establishment of national transplant 
standards and policies, is accomplished by thousands of volunteers.
    UNOS incorporates and embodies the entire organ transplant 
community in this country. It comprises surgeons, physicians, nurses, 
ethicists, and allied health professionals, as well as patients, 
patient advocates, and donor family members, all of whom have dedicated 
hundreds of thousands of hours to the operation of this critical life-
saving Network.
    It has been a year since UNOS last appeared before this Committee 
to testify on issues relating to organ transplantation. And, as you 
know, much has happened since then. I want to take this opportunity to 
inform you of several significant changes that have been made since we 
appeared last. In the last year, UNOS has:

 Implemented new liver allocation policies;
 Increased the supply of organs; and
 Published new, extensive data for patients and the public.
                          new unos initiatives
New Liver Allocation Policy
    Today's liver allocation policy is significantly different than 
when this issue was last before the Committee. In June, the UNOS Board 
of Directors voted to institute a dramatic change to the liver 
allocation policy that has been in development for several years. The 
new policy establishes region-wide sharing for the most urgent 
patients--the subset of patients doctors agree have the best chance of 
a successful transplant. This policy is founded on broad community 
consensus because it achieves the benefits of broader sharing while 
avoiding the problems that many think are inherent in the distribution 
of livers over excessively large areas, such as increased retransplants 
or decreased access at smaller centers. This action is a major step 
toward the goal of broader sharing of livers and addresses many of the 
concerns that have been raised with regard to allocation over the last 
year.
    This new sharing policy is also consistent with the Institute of 
Medicine's (IOM) recent recommendation that livers be shared in areas 
with a base population of 9 million versus the much smaller organ 
procurement organization (OPO) service areas. Since UNOS' 11 regions 
range in population from 10 million to 40 million, these areas are 
significantly larger than those recommended by the IOM. Needless to 
say, we will still be examining the IOM's recommendations to determine 
its advantages or disadvantages over the current system.
Increasing the Organ Supply
    Regarding organ donation, I am pleased to report that UNOS has 
developed a new technique that has the potential to increase the 
overall number of transplantable organs by more than 10 percent. As you 
know, the organ supply has remained roughly the same for years, despite 
the best efforts of everyone involved in transplantation. UNOS recently 
completed a pilot test of the new UNOS Critical Pathway for organ donor 
management developed under our contract with the Health Resources and 
Services Administration (HRSA).
    The study revealed that use of this new protocol resulted in a 10.4 
percent increase in the number of organs recovered per donor at the 
test sites. The study also demonstrated that use of the Pathway reduced 
costs and did not increase the time spent in donor management. As the 
Pathway is implemented across the country, we expect to see a 
nationwide increase in the organ supply on the order of 10 percent, the 
largest increase in more than a decade.
New Data Available for Patients
    Another significant change that has taken place since we were 
before the Committee last involves new information and data that we 
have made available to the public. Two weeks ago, UNOS unveiled an 
online resource to provide the transplant community and the public with 
unprecedented access to organ transplant information by utilizing the 
latest in Internet technology.
    Available on our web site (www.unos.org/patients), Transplant 
Living is a new site offering patients and their families a single, 
comprehensive source for everything they want and need to know to 
handle the often tough decisions involved in obtaining an organ 
transplant. It is designed to help those who have just discovered they 
need a transplant better understand the process, and help them feel 
they are making the best choices for their care.
    Among its many resources, the web site features Transplant 101, 
designed to be a step-by-step guide for patients and their families for 
every stage of the organ transplant process. There is helpful 
information on financing transplants, local support groups, 
instructions on how to get on waiting lists, as well as past 
experiences from transplant recipients, professionals and family 
members of organ donors
    The UNOS Internet site has been updated with a new section called, 
Transplant Patient DataSource. This part of our web site provides the 
latest statistics on:

 Survival rates for every transplant program in the country;
 The size of waiting lists and waiting times at each center and 
        OPO; and
 The supply of donated organs, nationally, by state, and by 
        transplant center.
    This unique research tool offers patients the critical information 
they need to evaluate transplant centers when making decisions about 
obtaining a life-saving organ. This kind of consumer information and 
scientific data is unprecedented because nowhere else in medicine is 
this level of detailed, institution-specific data available.
    UNOS is extremely proud to have been able to step into this 
leadership role in medicine, not only for the United States, but for 
the entire world. Through our partnership with HHS, under our contracts 
with HRSA, and through other funding arrangements, we have been able to 
provide more extensive data for patients and the public than any other 
public or private institution in medicine.
    Ask yourself this question: If your doctor told you today that you 
had a life-threatening condition, could you find information about 
where you could receive treatment, and the track record at each 
hospital where it is provided? Could you learn the number of similar 
cases and the results at each of those centers, including every 
center's survival rate?
    Unless the treatment you need is an organ or bone marrow 
transplant, the answer is no.
Arthur Andersen Study
    We recently asked the world's leading information and management 
consulting firm, Arthur Andersen, LLP, to conduct a study to evaluate 
the extent to which leading major health organizations collect outcomes 
data and provide center-specific information to the public.
    Arthur Andersen polled 40 federal public health agencies and 
national private health care organizations and found that other than 
the bone marrow transplant registry, none of the organizations polled 
collect or analyze center-specific data or healthcare-related outcome 
data, or make it available to the public to the extent that UNOS does. 
Three of the organizations noted that they make efforts to track other 
types of data, e.g. number of cases, case demographics, etc., but that 
the data is not made publicly available.
    We believe the findings of this survey by Arthur Andersen confirm 
the unique and unprecedented depth of information UNOS now makes 
available to anyone interested in organ transplants.
UNet
    Beyond the new, improved outreach to patients and their families, 
UNOS is launching a similar, but secure, Internet-based transplant 
information resource to help doctors and the transplant community match 
donors to recipients faster and more efficiently. UNETsm 
replaces an older, less user-friendly computer system, and should 
eliminate many of the time-consuming telephone calls and faxes required 
to coordinate the donation, allocation, and transplantation of life 
saving organs. UNETsm is scheduled to go online next week, 
offering physicians and organ centers unprecedented, real-time access 
to the latest organ transplant information.
    Both of these Internet-based efforts are a direct response to 
feedback and suggestions from UNOS' network of patients, families, 
doctors and medical professionals. With its lifesaving charter, UNOS 
continually evaluates different ways to improve the system and help 
make donation and transplant data readily available.
                          nota reauthorization
    With regard to H.R. 2418, the bill that is before the Committee 
today, I am proud to represent the UNOS membership in strongly 
supporting this legislation. As I stated in my July 14, 1999 letter to 
you, Mr. Chairman, we very much appreciate your leadership on this 
issue and commend you for your hard work in developing this legislation 
and the bipartisan support it has received.
    Since 1990, when NOTA was last reauthorized, many of us in the 
transplant community have been anxious about the state of 
transplantation, and the Federal government's commitment to the public-
private partnership established in NOTA. We are enthusiastic about the 
prospect of NOTA reauthorization and the opportunity to update and 
strengthen current law. Specifically, we support H.R. 2418 for the 
following reasons.
H.R. 2418 Reinforces the Original Intent of NOTA
    It was Chairman Bliley and other members of this Committee who 
designed the current public-private partnership that we now know as the 
Organ Procurement and Transplantation Network. The beauty of this 
structure is that it keeps delicate and informed medical decision 
making in the medical and transplant community and out of the political 
realm.
    We at UNOS, as the Network contractor since its inception, believe 
that the vision of NOTA's original authors has been a successful model 
of great service to patients. The current system serves as a check and 
balance system, producing the best medical decisions and the best 
transplant policies for current and potential organ donors and 
recipients.
    H.R. 2418 preserves the original intent of NOTA by restating that 
the responsibility for developing, establishing and maintaining medical 
criteria and standards for organ procurement and transplantation rests 
in the private sector and the medical community. With doctors, 
patients, donor families, procurement coordinators, ethicists, 
government officials, and others participating in a democratic policy 
making process, transplantation policy can reflect a consensus of the 
community while addressing the issues facing practitioners and patients 
every day.
H.R. 2418 Creates New Enforcement and Accountability Requirements
    Within the framework of the original NOTA, H.R. 2418 updates NOTA 
by providing new direction in important areas such as enforcement, 
accountability, and patient confidentiality.
    Enforcement: Over the years, the transplant community has been 
concerned that the Network lacked any real mechanisms to enforce its 
policies. H.R. 2418 provides for several actions that the Network may 
take in this regard. This approach is contrasted with what many have 
regarded as the only enforcement mechanism available to the Network 
under current law: the severe penalty of a hospital or OPO losing its 
eligibility to be a Medicare provider (so severe a penalty that it is 
unlikely to ever be invoked). The bill's proposed intermediate actions 
include:

 Payment of damages by Network participants who are found to be 
        non-compliant with Network policies through a peer review 
        process;
 Suspension of a transplant program's ability to receive organs 
        for transplantation; and
 Public designation as a member not in good standing.
    Accountability: In addition to new enforcement mechanisms, H.R. 
2418 includes new important requirements designed to make the Network 
more accountable to Congress, the Secretary of Health and Human 
Services and the public. For the first time, specific and detailed data 
reporting requirements will be mandated by law. This ensures that the 
extensive data that UNOS has recently made available to the public will 
always be available in the future. The bill also provides for a new 
periodic evaluation of the Network's performance by the Comptroller 
General of the United States, which shall be submitted to Congress for 
its review. Never before have such oversight measures been required by 
law, and we support them.
    Patient Confidentiality: As a significant new addition to NOTA, 
H.R. 2418 contains a specific provision to protect patient 
confidentiality. This provision ensures that, in an effort to provide 
more information to the public regarding transplant hospital waiting 
lists and outcomes, the confidentiality of patients--pre- and post-
transplant--will be protected. Many people do not realize the depth of 
information that patients must disclose to be placed on a waiting list 
to receive an organ transplant. As with any medical information, 
disclosure of this information--even if unintended--can have 
devastating effects on people lives. We wholeheartedly support this 
important protection for patients.
H.R. 2418 Provides New Incentives for Donation
    Perhaps most important are the bill's provisions aimed at 
increasing donation. All of us involved in organ transplantation 
struggle regularly with our frustration over the shortage of donor 
organs. Each year, nearly 4,000 people die needlessly because too few 
people give the gift of life. The medical community struggles daily 
with families torn with grief over the loss of a loved one, who, 
through fear or mistrust, choose not to allow organs to live on.
    We know that Congress is committed to helping us bridge the gap. 
There have been several recent steps taken such as the passage of the 
Organ Donor Leave Act. For the past several years, Congress has also 
been generous in appropriating more funds dedicated to educating people 
about organ donation. This bill continues that trend.
    The bill also provides resources to HHS to seek out the ``best 
practices'' in organ procurement so they can be duplicated around the 
country. I, for example, come from a state that has a great success 
rate in recovering organs. These funds could help facilitate 
information sharing and training between OPOs, hospital personnel and 
others around the country, allowing for the best and most successful 
ideas to be replicated.
Summary
    Mr. Chairman, we believe all of these provisions are great 
improvements to NOTA and that a reauthorization is timely and 
necessary. We support the bill and urge the Committee to pass it. 
Again, thank you for the opportunity to appear before you today.

    Mr. Ganske. Thank you. Mr. Gibbons?

                 STATEMENT OF ROBERT D. GIBBONS

    Mr. Gibbons. Good afternoon, Mr. Chairman and members of 
the committee. My name is Robert Gibbons and I am a professor 
of biostatistics at the University of Illinois in Chicago, and 
also a member of the Institute of Medicine's Committee on Organ 
Procurement and Transplantation. With me today is another 
member from the IOM committee, Dr. Mitchell Spellman, who is 
Professor of Surgery Emeritus and also Dean of Medical Services 
Emeritus for Harvard University Medical School. And also with 
me is Susanne Stoiber, the Executive Officer of the Institute 
of Medicine.
    We are pleased to have this opportunity on behalf of our 
fellow committee members and the Institute of Medicine to talk 
to you about our report on organ procurement and 
transplantation. Copies of the report's executive summary have 
been submitted for the record and preliminary print of the full 
report has been available to members of this subcommittee.
    The IOM was asked by Congress to review the regulation 
published by the Department of Health and Human Services in 
April 1998. Congress asked IOM to review its potential effect 
on access to transplantation services, organ donation rates, 
waiting times, survival rates and cost of organ transplantation 
services.
    Much of the public debate that led up to Congress asking 
for our report centered on the observation that the time it 
takes to receive a liver transplant varies greatly depending on 
the location of the transplant center where the patient was 
placed on the waiting list; namely, geographic heterogeneity. 
Our committee quickly discerned that on the one hand this claim 
was highly overstated, but on another it diverted attention 
from very real and very important issues.
    The reason this view is misleading is that it aggregated 
data across all the levels of severity of patients. Patients in 
liver Transplantation are broken down into four status groups 
depending on the severity of their condition. The most severely 
ill patients, which are called status 1 patients, have a life 
expectancy of approximately a week. By contrast, the less 
severely ill patients, status 3 patients and sometimes status 
2B patients, may wait months or even years for a transplant.
    Among the status 1 patients, the severely ill patients, 
there is very little variation in waiting time. On average 
these patients who do get transplanted do so within 4 days. 
This is not the case for the less severely ill patients who can 
wait months or possibly years based on differing policies and 
practices among the transplant centers on when these patients 
are placed on the list.
    It is these listing practices that gave the overall 
impression that there were large heterogeneity in the median 
waiting times. Important to note is that more than 50 percent 
of the patients are, in fact, status 3 patients accounting for 
the variation in the median.
    In terms of our analysis, for a variety of reasons the IOM 
committee focused its attention on livers. We reviewed over 
68,000 liver transplant records for every liver transplant 
patient on the list from 1995 through 1999. This was a huge 
data base.
    Attached to my testimony is a map showing the configuration 
of the 63 organ procurement organizations, which I will call 
OPOs from here on, covering the U.S. and its territories. The 
populations covered by these OPOs varied from 1 million to 12 
million people.
    We determined in an important finding that OPOs serving 
larger populations are associated with improved access overall 
for those patients most in need of a transplant. The committee 
found specifically that for status 1 patients, those most 
severely ill patients most in need of a transplant, they would 
receive transplants--they wait a comparable period of time 
across the country, about 4 days on average. However, 
transplantation rates do vary for patients who are not as ill, 
with smaller OPOs having a larger proportion of status 2B and 
status 3 patients receiving transplants relative to the larger 
OPOs. Consequently patients who are less ill sometimes receive 
transplants before more severely ill patients who are served by 
a different organ procurement organization.
    Based on the data available and our analysis, these 
differences begin to disappear when the population served by 
the OPO reached 9 million people or more. For that reason, and 
because the probability of a suitable match between a donated 
liver and a status 1 patient increases as the size of the 
population covered increases, we concluded that liver 
allocation areas should be established to cover an area large 
enough to serve at least 9 million people.
    There were many other findings by the committee, but I will 
highlight a couple. Our analyses indicated that the longer that 
status 2B and status 3 patients are on the list, the lower 
their likelihood is that they will die or receive a transplant. 
This finding also led the committee to the conclusion that the 
time on the waiting list is not an appropriate criterion for 
allocating organs among the less severely ill patients.
    Finally, we also looked at existing sharing arrangements 
and we found that the existing sharing arrangements did, as we 
would expect, increase status 1 transplantation rates and 
decrease the rate of transplantation of the less severely ill 
patients without increasing their pretransplantation mortality 
rates.
    There were several concerns expressed about the notion of 
broader sharing. The first was whether or not there would be a 
limitation on minority access or access to low-income patients. 
The committee did not find any evidence in support of these 
concerns.
    Information available to the committee indicated that the 
smallest transplant centers are not a major source of access 
for racial and ethnic minorities. Moreover, we found the 
evidence that small centers would be forced to close under 
broader sharing arrangements to be inconclusive.
    We also heard concern that distributing organs across a 
wider area would discourage donation and again we found no 
evidence in support of this idea.
    Finally, we also found that broader sharing would 
significantly increase the cost of transplantation and although 
it will increase the cost, only marginally compared to the 
total expenditures for transplantations.
    Finally, the committee concluded that achieving the goals 
of the National Organ Transplant Act requires an active Federal 
role in review and oversight and this should be done in 
collaboration with representatives of those involved in 
transplantation, including patients, donor families, 
physicians, nurses, OPOs and transplant centers. At the heart 
of this there should be an independent scientific review board 
that should assist with policies and procedures, making sure 
that they are well grounded in medical science; that there is a 
cohesive and strategic approach to the entire transplantation 
system; that the interests of transplant patients and donor 
families are given paramount concern; and credibility and trust 
are maintained with patients in the transplant community and 
the general public.
    Thank you.
    [The prepared statement of Robert D. Gibbons follows:]
 Prepared Statement of Robert D. Gibbons, Professor of Biostatistics, 
                   University of Illinois at Chicago
    Good afternoon Mr. Chairman and members of the Committee. My name 
is Robert D. Gibbons. I am a Professor of Biostatistics at the 
University of Illinois at Chicago and a member of the Institute of 
Medicine (IOM) Committee on Organ Procurement and Transplantation 
Policy. With me is another member of the IOM committee, Mitchell W. 
Spellman, M.D., Ph.D. Dr. Spellman is professor of surgery, emeritus, 
and dean for medical services, emeritus, at the Harvard Medical School. 
[Also with me is Ms. Susanne Stoiber, the Executive Officer for the 
IOM.]
    We are pleased to have this opportunity--on behalf of our fellow 
committee members and the Institute of Medicine--to talk about our 
report on organ procurement and transplantation. Copies of the report's 
Executive Summary have been submitted for the record, and a preliminary 
print of the full report has been available to the members of this 
Subcommittee. I have a short oral statement and Dr. Spellman and I [OR, 
the three of us] will be pleased to answer any questions you may have 
about the report.
                       the committee's assignment
    The IOM was asked by the Congress to review a regulation published 
by the Department of Health and Human Services (DHHS) in April 1998. 
That regulation set forth various requirements and procedures to be 
followed by the Organ Procurement and Transplantation Network (OPTN) in 
carrying out its responsibilities under the National Organ Transplant 
Act (NOTA). The Congress suspended implementation of the regulation and 
asked the IOM to review its potential effect on several important 
issues, including:

 Access to transplantation services by low-income populations 
        and racial and ethnic minorities;
 Organ donation rates;
 Waiting times for organ transplants;
 Patient survival rates and organ failure rates; and
 Costs of organ transplantation services.
    Our report examines each of these issues, and sets forth several 
conclusions and recommendations.
                       the initial public debate
    Much of the public debate, leading up to the Congress asking for 
our report, centered on the observation that the time it takes to 
receive a liver transplant varies greatly, depending upon the location 
of the transplant center where the patient has been placed on the 
waiting list. This geographic inequity was put forward as evidence that 
the current system is grossly inequitable. Our Committee quickly 
discerned, however, that this was not the best way to evaluate the 
data. One the one hand, it overstated the inequities, for reasons I 
will briefly explain; but on the other hand, it diverted attention from 
some very real and very important issues. The reason this view was 
misleading is that it aggregated the data for all patients awaiting a 
liver transplant, instead of breaking the data down into the four 
status groups into which patients are classified, depending on the 
severity of their condition. The most severely ill patients--those 
having a life expectancy of a week or less--are in status 1. There is 
very little variation in the waiting time for these patients; it is a 
matter of a few days for those who receive a transplant. The least 
severely ill patients-- those in status 3--may wait months or even 
years for a transplant. Since more than half of all patients on the 
waiting lists are in status 3, the data for these patients are what 
determines the overall variation in median waiting times used in the 
arguments noted above. But this tells us very little about the equity 
or effectiveness of the system, since differing policies and practices 
among transplant centers on when status 3 patients should be placed on 
a waiting list means that these patients form a very heterogeneous 
group.
                        the committee's analysis
    For a variety of reasons, the IOM Committee focused its attention 
on livers. In order to review the issues in greater depth, the 
Committee obtained, from the OPTN, approximately 68,000 records 
covering all the patients awaiting a liver transplant during the period 
from 1995 to 1999. Of particular interest were the consequences of the 
current OPTN policies on allocating donated organs among patients, and 
the likely consequences of the changes in those policies called for by 
the DHHS regulation.
    Organ Procurement Organizations (OPOs) are statutorily created 
entities responsible for the procurement of donated organs and for 
coordinating the allocation of those organs among patients on the 
waiting lists of transplant centers. Attached to my testimony is a map, 
showing the configuration of the 63 OPOs covering the U.S. and its 
territories. At the present time, with a few important exceptions, when 
these OPOs obtain an organ donated for transplantation, they seek to 
allocate it to a patient located within their own defined geographical 
area. Only if they cannot find a suitable patient within their own area 
do they seek to find a patient located in one of the other--typically 
adjacent--OPO areas. The populations covered by these OPO areas vary 
from approximately 1 million to about 12 million. We determined that 
OPOs serving larger populations are associated with improved access for 
those patients most in need of a transplant.
    The Committee found that status 1 patients (those with the highest 
medical urgency for a transplant) who receive transplants wait for a 
comparable period of time all across the country--about 4 days on 
average. Moreover, the transplantation rates and the pre-
transplantation mortality rates for status 1 patients do not vary 
significantly from one OPO to another, despite substantial variations 
in the size of the OPOs. (Size of OPO was defined either by the size of 
the population served or the number of transplants performed within the 
OPO service area.) However, only about one-half of the patients listed 
as status 1 receive a transplant.
    Transplantation rates do vary for patients who are not as ill, with 
smaller OPOs having a larger proportion of status 2B and status 3 
patients receiving transplants than larger OPOs. Consequently, patients 
who are less ill sometimes receive transplants before more severely ill 
patients who are served by a different organ procurement organization. 
Based on the data available to the Committee, these differences begin 
to disappear when the population served by the OPO reaches 9 million or 
more.
    For that reason, and because the probability of a suitable match 
between a donated liver and a status 1 patient increases as the size of 
the population covered increases, we concluded that liver allocation 
areas should be established to cover an area large enough to serve at 
least 9 million people. Nine million is as far as our available data 
could take us. Logic suggests that larger areas would be even more 
effective in arranging a suitable match. These areas, however, should 
not be so geographically broad as to pose difficulties or delays in 
transporting organs, which could threaten the viability of the organ 
and the success of transplantation. The allocation areas for organs 
other than livers will differ depending on how long they can survive 
outside the body.
    It is important to note that improvements in the rates of 
transplantation for status 1 patients do not appear to come at the 
expense of other patients. Our analysis indicated that the longer 
status 2B and status 3 patients are on the waiting list, the lower is 
the likelihood that they will either die or receive a transplant. This 
finding also lead the Committee to the conclusion that time on the 
waiting list is not an appropriate criterion for allocating organs 
among status 2B and status 3 patients.
    There are currently in effect several arrangements under which two 
or more OPOs share donated organs on a statewide or regional basis, at 
least for status 1 patients. The Committee could make only a 
preliminary analysis of the data available for such sharing 
arrangements, but that analysis tends to confirm the Committee's view 
that broader sharing is beneficial. The analysis shows that that such 
sharing: (1) increases status 1 transplantation rates; (2) decreases 
status 2B pre-transplantation mortality rates; and (3) decreases the 
rate of transplantation of status 3 patients without increasing their 
pre-transplantation mortality rates.
             concerns expressed about broader organ sharing
    The Committee heard some people in the transplant community express 
concern that broader sharing of organs might reduce access to organs 
for minorities and low-income patients. This would be true, they 
stated, if broader sharing resulted in the closure of some of the 
smaller transplant centers.
    The Committee did not find any evidence to support these concerns. 
For low-income patients, regardless of their racial and ethnic 
backgrounds, there is an appropriate concern that they may not be 
referred to a transplant center for an evaluation for transplantation. 
This is because appropriate referral depends in large part on whether 
they have access to health insurance and high-quality health services. 
Once patients are referred for an organ transplant--again regardless of 
their race or ethnicity--there appear to be no significant disparities 
either in their placement on a waiting list or in access to 
transplantation.
    Information available to the Committee indicated that the smallest 
transplant centers are not a major source of access for racial and 
ethnic minorities. Moreover, we found the evidence that small centers 
would be forced to close under broader organ sharing to be 
inconclusive.
    The Committee also heard concern that distributing organs across a 
wider geographic area would discourage donation and drive down organ 
donation rates. Organ donation rates are affected by many variables, 
including cultural attitudes about donation and transplantation, the 
age and race of the potential donor, the progression of illness in the 
potential donor, the manner in which families of potential donors are 
approached, and the various policies and practices of hospital staff 
and OPOs. The biggest shortcoming at present appears to be that many 
potential donors are not identified and their families not approached 
about the possibility of donation. The Committee found little 
evidence--if any--to support the notion that families would decline to 
donate, or that health professionals involved in organ procurement 
would be less diligent in their efforts, if they knew a donated organ 
would be used outside the donor's immediate geographic area. The 
Committee believes current efforts to increase donation should be 
sustained and that broader allocation arrangements should be made in a 
way that does not undermine current effective working relationships 
between OPOs and hospitals.
    Another concern expressed to the Committee was that broader sharing 
would significantly increase the cost of transplantation. Based on data 
provided to the Committee by the General Accounting Office (GAO), as 
well as the published literature, the Committee concluded that total 
expenditures associated with organ procurement and transplantation are 
likely to increase as a result of broader sharing. OPOs and transplant 
teams may both experience higher transportation costs. In addition, a 
larger number of sicker patients will receive transplants and there 
will likely be more re-transplants' both of which would increase costs. 
The Committee was unable to estimate the magnitude of the increase, but 
believes it would be marginal compared to the total expenditures for 
transplantation
                      federal oversight and review
    The Committee believes that, when Congress passed the National 
Organ Transplant Act, it intended for there to be a cohesive, well-
coordinated system encompassing all aspects of transplantation. The 
Committee also believes that we do not have such a system at this time 
and that we cannot have such a system without effective, comprehensive 
oversight. We therefore concluded that achieving the goals of the 
National Organ Transplant Act requires an active federal role in review 
and oversight, and that this should be in collaboration with 
representatives from all those involved in transplantation, including 
patients, donor families, physicians and nurses, OPOs, and transplant 
centers. 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.
    At the present time, responsibilities are dispersed throughout the 
system, creating impediments to oversight and review, permitting poor 
procedures for data analysis and dissemination to persist, and allowing 
the system to operate without adequate assessment of performance. The 
Committee acknowledges that many aspects of organ procurement and 
transplantation require effective arrangements and decision making at a 
local level. However, a more centralized mechanism for oversight and 
review would improve the quality assurance that donors and recipients 
deserve. This is not to say that the federal government should be 
making medical judgments regarding individual patients, but rather that 
its responsibility is to ensure that the policies that guide the 
operation of the system are equitable and well-grounded in medical 
science. 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.
    To assist in this activity, there needs to be independent 
scientific review. The Committee recommends that an independent, 
multidisciplinary advisory board be appointed to assist in the 
oversight of the program. Such a board could help to assure that: (1) 
policies and procedures are well grounded in medical science: (2) there 
is a cohesive, strategic approach to the entire transplantation system: 
(3) the interests of transplant patients and donor families are given 
paramount concern: and (4) credibility and trust are maintained with 
patients, the transplantation community and the general public.
    In addition, the Committee concluded that better performance 
measures should be developed for each of the components of the 
transplantation system, and that data about the system should be 
reliably and regularly gathered, independently assessed, and made 
widely available. The Committee's concerns about oversight and review 
cut across the individual issues specified in its charge and relate in 
general to all organ transplantation, not just liver transplantation.
                       committee recommendations
    Based on its review and analysis of the data and information 
available to it, the Committee reached the following recommendations:
Recommendation 1: Establish Organ Allocation Areas for Livers
        The committee recommends that the DHHS Final Rule be 
        implemented by the establishment of Organ Allocation Areas 
        (OAAs) for livers--each serving a population base of at least 9 
        million people (unless such area exceeds the limits of 
        acceptable cold ischemic time). OAAs should generally be 
        established through sharing arrangements among organ 
        procurement organizations to avoid disrupting effective current 
        procurement activities.
Recommendation 2: Discontinue Use of Waiting Time as an Allocation 
        Criterion for Patients in Statuses 2B and 3
        The heterogeneity and wide range of severity of illness in 
        statuses 2B and 3 make waiting time misleading within these 
        categories. For this reason, waiting time should be 
        discontinued as an allocation criterion for status 2B and 3 
        patients. An appropriate medical triage system should be 
        developed to ensure equitable allocation of organs to patients 
        in these categories. Such a system may, for example, be based 
        on a point system arising out of medical characteristics and 
        disease prognoses rather than waiting times.
Recommendation 3: Exercise Federal Oversight
        The Department of Health and Human Services should exercise the 
        legitimate oversight responsibilities assigned to it by the 
        National Organ Transplant Act, and articulated in the Final 
        Rule, in order to manage the system of organ procurement and 
        transplantation in the public interest. This oversight should 
        include greater use of patient-centered, outcome-oriented 
        performance measures for OPOs, transplant centers, and the 
        OPTN.
Recommendation 4: Establish Independent Scientific Review
        The Department of Health and Human Services should establish an 
        external, independent, multidisciplinary scientific review 
        board responsible for assisting the Secretary in ensuring that 
        the system of organ procurement and transplantation is grounded 
        on the best available medical science and is as effective and 
        as equitable as possible.
Recommendation 5: Improve Data Collection and Dissemination
        Within the bounds of donor and recipient confidentiality and 
        sound medical judgment, the OPTN contractor should improve its 
        collection of standardized and useful data regarding the system 
        of organ procurement and transplantation and make it widely 
        available to independent investigators and scientific reviewers 
        in a timely manner. DHHS should provide an independent, 
        objective assessment of the quality and effectiveness of the 
        data that are collected and how they are analyzed and 
        disseminated by the OPTN.

                              References:

    DHHS (U.S. Department of Health and Human Services). 1998b. Organ 
Procurement and Transplantation Network; Final Rule (42 CFR Part 121). 
Federal Register 63(63):16296-16338.
    GAO (U.S. General Accounting Office). 1997. Report to the ranking 
minority member, Committee on Labor and Human Resources, U.S. Senate. 
Organ Procurement Organizations: Alternatives Being Developed to More 
Accurately Assess Performance. GAO/HEHS-98-26. Washington, D.C.: GAO.
    IOM (Institute of Medicine). 1999. Organ Procurement and 
Transplantation Policy. Washington, D.C.: National Academy Press.
    UNOS (United Network for Organ Sharing) 1999. Available at: 
www.unos.org. Accessed July 1, 1999.

       Committee on Organ Procurement and Transplantation Policy

    EDWARD D. PENHOET (Chair), Dean, School of Public Health, 
University of California at Berkeley
    NAIHUA DUAN, Statistics Group, RAND Corporation, Santa Monica 
(until May 6, 1999)
    NANCY Neveloff DUBLER, Director, Division of Bioethics, Montefiore 
Medical Center, Professor of Bioethics, Albert Einstein College of 
Medicine, New York
    CHARLES K. FRANCIS, President, Charles R. Drew University of 
Medicine and Science, Los Angeles
    ROBERT D. GIBBONS, Professor of Biostatistics, Departments of 
Biostatistics and Psychiatry, University of Illinois at Chicago
    BARBARA GILL, Clinical Nurse Specialist, Abilene Cardiothoracic and 
Vascular Surgery of Texas, Abilene
    EVA GUINAN, Associate Professor of Pediatrics, Harvard Medical 
School, Boston
    MAUREEN HENDERSON, Professor Emeritus of Epidemiology and Medicine, 
University of Washington, Seattle
    SUZANNE T. ILDSTAD, Director, Institute for Cellular Therapeutics, 
University of Louisville
    PATRICIA A. KING, Carmack Waterhouse Professor of Law, Medicine, 
Ethics, and Public Policy, Georgetown University, Washington, D.C.
    MANUEL MARTINEZ-MALDONADO, Vice Provost for Research and Professor 
of Medicine, Oregon Health Sciences University, Portland
    GEORGE E. MCLAIN, Assistant Chief of Anesthesiology, Martin 
Memorial Medical Center, Stuart, Florida
    DAVID MELTZER, Assistant Professor, Section of General Internal 
Medicine, Department of Economics, and Harris School of Public Policy 
Studies, University of Chicago
    JOSEPH E. MURRAY, Professor of Surgery, Emeritus, Harvard Medical 
School, Boston
    DOROTHY NELKIN, University Professor, New York University 
Department of Sociology and School of Law, New York
    MITCHELL W. SPELLMAN, Director of Academic Alliances and 
International Exchange Programs, Harvard Medical International, Harvard 
Medical School, Boston
[GRAPHIC] [TIFF OMITTED] T9992.001

    Mr. Bilirakis. Thank you very much. Dr. Miller, when did 
you arrive? I was able to escape late yesterday after that 
storm which swerved from dead on Pinellas County down to your 
area.
    Mr. Miller. We ducked and it missed us. It went around the 
south tip of the State, so we were all fortunate.
    Mr. Bilirakis. They are crazy, aren't they? In any case, 
sir, you are welcome. Please proceed.

                   STATEMENT OF JOSHUA MILLER

    Mr. Miller. I appreciate the opportunity to testify at this 
hearing on the important legislation that you have introduced, 
Mr. Chairman, which would reauthorize programs relating to 
organ procurement and transplantation. I am Dr. Joshua Miller, 
Codirector of the Division of Transplantation at the University 
of Miami School of Medicine in Miami, Florida. I am appearing 
today as the immediate past President of the American Society 
of Transplant Surgeons, the ASTS, a professional organization 
of surgeons, physicians and scientists who during the past 25 
years of our existence have pioneered and continue to advance 
the frontiers of life-sustaining organ transplantation.
    ASTS members have the responsibility for directing 
transplantation clinical and research programs at America's 
major medical centers. As part of this responsibility, we 
helped forge the National Organ Transplant Act, NOTA, into law 
in partnership with the U.S. Congress over a decade and a half 
ago.
    We were instrumental in conceiving an organ procurement and 
distribution network and, in partnership with the Health Care 
Finance Administration of the Department of Health and Human 
Services, helped to organize it and to put it into action 
during the same period.
    We are here now 15 years later to work with you in 
reauthorizing NOTA and providing a clear congressional 
guideline for how that network can provide the maximum benefit 
to our patients as we move into the 21st century.
    Because of the explosive success of organ transplantation 
in the latter part of the 20th century there are now more than 
65,000 Americans, an additional 3,000 since I last testified 
before your subcommittee in April, Mr. Chairman, with end-stage 
failure of hearts, livers, lungs, pancreases, and kidneys 
awaiting life-saving and life-sustaining transplants. This is a 
potentially explosive situation because as the number of 
patients on waiting lists climbs inexorably toward 100,000, 
concern and frustration over the allocation of these scarce 
organs is bound to grow. Our fear is that this mounting public 
concern is leading to increased efforts to politicize what is 
and ought to remain a medical decisionmaking process.
    We strongly believe that Congress in enacting NOTA and 
establishing the Organ Procurement and Transplantation Network, 
the OPTN, in the private sector under government contract 
intended for this highly specialized and expert OPTN to make 
organ allocation policy based on sound medical and ethical 
principles and scientific data independent of political 
influence, and that is how it has essentially operated these 
past 15 years.
    But as you are aware, Mr. Chairman, several sections of the 
final rule governing the OPTN published by the Secretary of 
Health and Human Services a year ago April could be interpreted 
as setting the stage for the Secretary of DHHS to make specific 
allocation policy. This effort by the Department was the result 
of the fairly recent intense criticism by a vocal minority of 
one very specialized aspect of the OPTN, liver allocation. We 
have repeatedly expressed our concerns to DHHS in the course of 
a number of meetings this past summer. We have suggested 
changes in a rule that we largely agree with, this rule that we 
largely agree with, changes designed to prevent the baby that 
we jointly conceived from being thrown out with the bath water, 
changes that among other things would clarify that the 
Secretary must not dictate specific transplantation practices 
or medical judgments. We were also greatly concerned that the 
rule might unwittingly tamper with the very delicate but very 
real local influences on organ donation that we discussed in my 
last appearance before your committee.
    We believe the legislation you have drafted makes it clear 
that there is a most legitimate oversight role for DHHS in 
ensuring that the policies which guide the operation of the 
system are adhered to, and we support that oversight role for 
DHHS.
    We would also like to submit for the record a white paper 
our society issued just last Friday summarizing our views on 
the issues that we have been discussing with DHHS and on some 
of the recommendations included in the report delivered to 
Congress in midsummer by the Institute of Medicine. We know 
Members of Congress have been provided with a variety of 
interpretations of this IOM report both by DHHS and by the OPTN 
contractor, UNOS, generally claiming vindications for their 
positions. And as is so often the case, we believe the truth 
falls somewhere in between.
    I would like to just mention two important points that the 
IOM report makes what I believe go to the heart of our concern 
over leaving medical decisions in the hands of medical 
professionals.
    Throughout 1998 and right up through this summer, DHHS, in 
urging Congress to allow the final rule to be imposed without 
delay, contended that significant regional differences in the 
length of time patients spend on waiting lists for livers 
demonstrated a fundamental unfairness of the current system. 
The ASTS testified before Congress more than a year ago as we 
repeatedly informed the Department that there really were only 
small differences in waiting times for patients in the most 
urgent categories and that median waiting times for all liver 
patients as used by the Department were really not a good 
measure of fairness.
    The Institute of Medicine after analyzing data, and as was 
just mentioned, ``Overall median waiting time, which has 
dominated the policy debate, is a poor measure of differences 
in access to transplantation.''
    It further suggested that differences in waiting time for 
less urgent patients are so, ``misleading''--that was the word 
that the IOM used, misleading--that it proposed waiting time no 
longer be an allocation criteria in less urgent categories of 
liver patients.
    The public focus on waiting time as the driver of the need 
for quick fix, quick change in the allocation of livers is 
exactly the kind of politicization of the medical 
decisionmaking process that concerns us.
    And I would like to touch briefly on one other 
recommendation of the IOM that we move toward a system of 
broader sharing of livers for patients in most urgent need 
because we do believe that this recommendation has merit. In 
fact, less than a month after the IOM issued its report the 
OPTN put into effect a new policy of broader regional sharing 
for status 1 liver patients, the most urgent category, and this 
was already in the due process pipeline. This policy will 
hopefully ensure that those most critical liver patients to the 
best of our medical ability today have access to life-saving 
organs. This I believe is indicative that the establishment of 
allocation policies by the OPTN is a dynamic process through 
which change does take place in response to new information and 
analysis. Could this change have occurred earlier? Probably. 
Does the current system function perfectly? Of course not. Is 
there room for improvement in the performance of the current 
contractor? Absolutely. There is always room for improvement in 
the operation of the network through refinements like those 
suggested in our legislation.
    Our society's interests lie in the structure and operation 
of the network and its relationship to DHHS. Our interest is 
not to be specifically protective of the incumbent contractor 
that is operating the network. We also very much believe that 
the OPTN should be responsive to independent external review 
and assessment. We would favor strengthening the section you 
already included in the legislation relative to General 
Accounting Office evaluations of the network.
    We have a small number of other changes we would be pleased 
to discuss with you, Mr. Chairman, which we believe would 
further strengthen the NOTA reauthorization effort. But again 
let me conclude my prepared remarks by thanking you for the 
leadership you have demonstrated sponsoring this most important 
piece of legislation, and I would welcome any questions that I 
might be able to answer.
    Thank you.
    [The prepared statement of Joshua Miller follows:]
  Prepared Statement of Joshua Miller, American Society of Transplant 
                                Surgeons
    I appreciate the opportunity to testify at this hearing on the 
important legislation that you have introduced, Mr. Chairman, which 
would reauthorize programs relating to organ procurement and 
transplantation.
    I am Dr. Joshua Miller, Professor of Surgery, Microbiology , 
Immunology and Pathology, and Chief of the Division of Kidney and 
Pancreas Transplantation, at the University of Miami School of Medicine 
in Miami, Florida.
    I am appearing today as the Immediate Past President of the 
American Society of Transplant Surgeons (the ASTS), the professional 
organization of Surgeons, Physicians, and Scientists who, during the 
past 25 years of our existence, have pioneered and continued to advance 
the frontiers of life-sustaining organ transplantation. ASTS members 
have the responsibility for directing transplantation clinical and 
research programs at America's major medical centers.
    As part of this responsibility we helped forge the National Organ 
Transplant Act into law in partnership with the United States Congress 
over a decade and a half ago. We conceived of an organ procurement and 
distribution network, and, in partnership with the Health Care 
Financing Administration of the Department of Health and Human 
Services, helped organize it and put it into action during the same 
period.
    Now, we are here--15 years later--to work with you in reauthorizing 
NOTA and providing clear Congressional guidelines for how that network 
can provide the maximum benefit to the maximum number of patients as we 
move into the 21st Century.
    Because of the explosive success of organ transplantation in the 
latter half of the 20th century, there are now more than 65,000 
patients--an additional three thousand since I last testified before 
your Subcommittee in April--with end-stage failure of hearts, livers, 
lungs, pancreases, and kidneys awaiting life-saving transplants.
    This is a potentially explosive situation, Mr. Chairman, because as 
the number of patients on waiting lists climbs inexorably toward and 
passes 100,000 Americans, concern and frustration over the allocation 
of these scarce organs is bound to grow. Our fear is that, inevitably, 
this mounting public concern over who-gets-an-organ-and-when will lead 
to increased efforts to politicize what is, and ought to remain, a 
medical decision-making process.
    We strongly believe that Congress, in enacting NOTA and 
establishing the Organ Procurement and Transplantation Network in the 
private sector under government contract, intended for the OPTN to make 
organ allocation policy based on sound medical principles and 
scientific data independent of political influence. And that is how it 
has operated these past 15 years.
    But as you are aware, Mr. Chairman, several sections of the Final 
Rule governing the OPTN published by Secretary of Health and Human 
Services Donna Shalala a year ago April could be interpreted as setting 
the stage for the Secretary of DHHS to make specific allocation policy.
    We have repeatedly expressed our concerns over this to DHHS, in the 
course of a number of meetings this past summer. We have suggested 
changes that, among other things, would clarify that the Secretary must 
not dictate specific transplant practices or medical judgments.
    We believe the legislation you have drafted, Mr. Chairman, makes it 
clear there is a legitimate oversight role for DHHS in ensuring that 
the policies which guide the operation of the system are equitable, 
based on sound medical science, and are adhered to. We support that 
oversight role for DHHS.
    But we do want to again express our appreciation to you, Mr. 
Chairman, for making it clear in this legislation that the 
responsibility for ``developing, establishing, and maintaining medical 
criteria, and standards,'' and policy concerning allocation, belongs 
with the Network. And those policies should be modified by the Network, 
as necessary, on the basis of sound medical science and developing 
medical practices.
    We would also like to submit for the record, along with these 
remarks Mr. Chairman, a white paper our society issued just last Friday 
summarizing our views on a variety of the issues we have been 
discussing with DHHS. It also contains our views on some of the 
recommendations included in the report delivered to Congress in 
midsummer by a Committee of the Institute of Medicine.
    We know Members of Congress have been provided with a variety of 
interpretations of this IOM report, both by DHHS and by the OPTN 
contractor, the United Network for Organ Sharing, among others, 
generally claiming vindication for their positions. As is so often the 
case, we believe the truth falls somewhere between.
    I would like to just mention a couple of important points that the 
IOM report makes, however, that I believe go to the heart of our 
concern over leaving medical decisions in the hands of medical 
professionals.
    Throughout 1998 and right up through this summer, DHHS--in urging 
Congress to allow the Final Rule to be imposed without delay--contended 
that significant regional differences in the length of time patients 
spend on waiting lists for livers demonstrate a fundamental unfairness 
of the current system.
    We suggested in testimony before Congress more than a year ago--as 
we repeatedly suggested to the Department--there really were only small 
differences in waiting time for patients in the most urgent categories, 
and that median waiting times for all liver patients, as used by the 
Department, were really not a good measure of fairness.
    The Institute of Medicine--after analyzing years of data--
concluded, and I quote: ``Overall median waiting time, which has 
dominated the policy debate, is a poor measure of differences in access 
to transplantation.'' It further suggested that differences in waiting 
time for less urgent patients are so ``misleading''--that was the word 
the IOM used-that it proposed waiting time no longer be an allocation 
criterion in less urgent categories of liver patients.
    The public focus on waiting times as the driver of the need for 
quick change in the allocation of livers is exactly the kind of 
politicization of the medical decision-making process that concerns us.
    I would also like to touch briefly on another recommendation by the 
Institute of Medicine--that we move toward a system of broader regional 
sharing of livers for patients in most urgent need--because we do 
believe that this recommendation has a great deal of merit.
    The IOM committee concluded, after crunching the data, that the 
most urgent liver patients--Status 1 patients--would be more likely to 
receive an organ expeditiously if contiguous OPOs were grouped into 
what it called Organ Allocation Areas each serving a population base 
greater than nine million.
    Less than a month after the IOM issued its report, the OPTN put 
into effect a new policy of broader regional sharing for Status 1 liver 
patients--the most urgent category--which hopefully will insure that 
these most critical liver patients have access to a life-saving organ 
sooner than might have been the case.
    I believe this is indicative, Mr. Chairman, of the fact that the 
establishment of allocation policies by the OPTN is a dynamic process 
through which change does take place in response to new information and 
analysis, and changes in medical science and medical practice.
    Could this change have occurred earlier? Probably. Does the current 
system function perfectly? Of course not. Is there room for improvement 
in the performance of the current contractor? Absolutely.
    There is always room for improvement in the operation of the 
network through refinements, like some suggested in your legislation.
    And I might add that our Society's interests lie in the structure 
and operation of the network, the composition of the network and its 
relationship to DHHS, and the composition and authority of the network 
board of directors and committees, which establish policy for the 
network. Our interest is not to be specifically protective of the 
incumbent contractor that operates the network.
    We also very much believe that the OPTN should be responsive to 
independent external review and assessment. We would favor 
strengthening the section you already included in the legislation, Mr. 
Chairman, relative to General Accounting Office evaluations of the 
network.
    We have a small number of other changes we would be pleased to 
discuss with you, Mr. Chairman, which we believe would further 
strengthen the NOTA reauthorization effort. But again, let me conclude 
my prepared remarks by thanking you for the leadership you have 
demonstrated in sponsoring this most important piece of legislation.
    Thank you.

    Mr. Bilirakis. Thank you, Mr. Miller. You heard the bells, 
and the bad news is that there is no good news. The bad news is 
that we have a 15-minute vote followed by two 5-minute votes, 
so we are talking probably 35, 40 minutes. I would have liked 
to have been able to get through at least the witnesses, but we 
just won't really have time to do that because I hate to cut 
you off at 5 minutes. So I am just going to have to ask you to 
be as patient--continue to be as patient as you have been. We 
are going to break probably until about 4:30 or shortly 
thereafter.
    Mr. Ganske. Mr. Chairman?
    Mr. Bilirakis. Yes?
    Mr. Ganske. I ask unanimous consent for 1 minute.
    Mr. Bilirakis. One true 1 minute? Without objection.
    Mr. Ganske. Thank you, Mr. Chairman. As probably one of the 
few Congressmen who has scrubbed with Dr. Starzl and also did 
my general surgical training at the University of Oregon Health 
Sciences Center, I have some understanding of this issue.
    I am disturbed with the administration on this. I think you 
have put your foot in a tar baby where you shouldn't be. Mr. 
Chairman, I see that on your bill you have cosponsors Gene 
Green, Bill Jefferson, Ken Bentsen, Peter Deutsch, Carlos 
Romero-Barcelo, Ralph Hall, Bart Gordon, David Wu, Jim Clyburn, 
Frank Pallone, Martin Frost, Sheila Jackson Lee, Jerry Kleczka, 
Peter DeFazio, Maurice Hinchey, Earl Hilliard, Tammy Baldwin, 
and a whole bunch of Republicans, and guess what, Mr. Chairman? 
You can now put my name on your cosponsor list. Thank you very 
much.
    Mr. Bilirakis. I thank the gentleman and I believe that 
there are some that are probably not on that list.
    Thank you for that. Dr. Gibbons, you have heard some of the 
comments made by Mr. Miller. I know that Dr. Payne, I am sorry 
I was called out by a large group of people that wanted to see 
me about another matter. That is the life up here but hopefully 
you all can talk about some of the comments that you have 
heard. We are trying to do the right thing. Granted, there is 
parochialism here. There is no question about it. But at the 
same time I think for the most part we do want to do what is 
right.
    Well, anyhow, maybe you can have a little bit of interplay 
among yourself until we return. Thank you.
    [Brrief recess.]
    Mr. Bilirakis. We are back. Mr. Irwin, President of the 
National Transplant Action Committee. By the way, thanks again 
for your patience and your understanding. Please proceed, sir.

                    STATEMENT OF CRAIG IRWIN

    Mr. Irwin. Thank you, Mr. Chairman. I am here today 
speaking on behalf of not only The National Transplant Action 
Committee but also TRIO, Transplant Recipients International 
Organization, and MOTTEP, the Minority Organ Transplant and 
Tissue Education Program. Collectively we represent thousands 
of transplant patients throughout the United States.
    Unfortunately, Dr. Clyde Calendar of MOTTEP nor Mr. Bruce 
Weir, President of TRIO, were able to be here today but I am 
joined by Lisa Kory, President of TRIO.
    I am here to speak in opposition to H.R. 2418, the Organ 
Procurement and Transplantation Network Amendments of 1999. 
This legislation comes amid considerable debate over the rules 
promulgated by the Department of Health and Human Services last 
year. Those rules are scheduled to go into effect on October 
21.
    Our three organizations believe that transplant patients 
and their families must be the focus of our public policy in 
this area of health care. Patients should be able to access 
critical information about the transplant system and the 
quality of care in our Nation's transplant hospitals. Patients 
deserve to be treated fairly by the organ allocation system. 
Some patients have choices among transplant centers, however, 
many don't. A patient's chance of finding a suitable donor 
shouldn't be a matter of who you are or where you live. And 
patients and their families either directly or through HHS 
deserve to have a significant role in the development of public 
policies impacting the Nation's transplant system.
    These beliefs are consistent with the goals and intent of 
the National Organ Transplant Act. To quote the intent of 
Congress: The organ procurement and transplantation network was 
created in order to facilitate an equitable allocation of 
organs among patients. The OPTN's responsibilities are great 
and the purpose of the act will be served only if the policies 
of the OPTN are sound and are soundly developed. The allocation 
of organs may well be a life or death decision for patients.
    And although the act gives the contractor authority to 
develop medical policies regarding the safe allocation and 
transportation of organs, it does not give the contractor 
public policy authority. Instead it gives administrative 
authority to the Secretary.
    Unfortunately, what has evolved is a patchwork system of 
organ allocation designed to meet the expectations and needs of 
transplant centers instead of the patients. Many patients and 
advocates who have worked hard to help others and have much to 
offer are often left out of the OPTN policy setting process 
because of their views. And critical data is often difficult to 
obtain and is often old and useless.
    I am pleased to hear of Mr. Waxman's remarks regarding the 
availability of comprehensive data, and we look forward to 
reviewing that data and making it available to patients around 
the country.
    These problems have continued to surface throughout the 
years. The concerns of patients have been echoed by the 
Congress and reflected by changes to the act in 1988 and 1990.
    In 1990, Congress eased the minimum qualifications that 
must be met by an entity seeking the OPTN contract stating 
that, ``By modifying this requirement, the committee intends to 
provide the Secretary with the opportunity to seek out the best 
possible potential applicants for this critical role.''
    This change along with changes the committee has made to 
the OPTN board of directors reflect deep concern on the part of 
the committee in the manner in which the OPTN has functioned. 
That same year, Congress amended the act to mandate that the 
OPTN assist organ procurement organizations in the nationwide 
distribution of organs equitably among transplant patients.
    The bill now before this committee represents a complete 
reversal from these patient-driven policies and statements. 
H.R. 2418 would make dramatic changes to the manner in which 
organs are allocated to patients on the waiting list. New 
factors could now be considered in addition to equity. Fairness 
would no longer be the benchmark. Secretarial oversight would 
essentially be eliminated with no recourse to change or amend 
policies which might be detrimental to patients. The right of 
patients and the public to become members of the OPTN would be 
eliminated. There would be no further competition for the OPTN 
contract. UNOS would be the only organization meeting the 
contract criteria.
    H.R. 2418 contradicts the past actions by this committee. 
The bill also ignores the recommendations of the recent report 
by the Institute of Medicine, which was required by Congress, 
submitted to this committee. The report contains key 
recommendations impacting transplant patients. The IOM calls 
for more oversight, not less, of the OPTN. In addition, the 
report calls for independent comprehensive review by a body 
reporting to the Secretary and not affiliated with the OPTN 
contractor.
    The IOM concluded that broader sharing as called for by the 
regulation would have the net effect of saving more lives by 
increasing transplantation rates for those with the greatest 
risk of dying, decreasing pre-transplant mortality rates for 
the next level of patients on the waiting list and decreasing 
the number of the healthiest patients transplanted without 
increasing their risk of dying.
    Finally, the report dispels the many myths promoted by the 
opponents of the regulation, many of which we have heard today. 
Paramount is the myth that minorities would be hurt by the 
regulations.
    Although the IOM found that there is essentially parity and 
equity in liver allocation, the report also concluded that 
minorities would not be hurt by the regulations. The HHS 
regulations will move the system toward greater fairness and a 
more patient-driven system. H.R. 2418 will move us in the 
opposite direction.
    Mr. Chairman, when the committee last took up the 
reauthorization in 1993, you took exception to the full 
committee's desire to simply call for a study of organ 
allocation. You were quite eloquent in recognizing that sick 
people will continue to die merely because of UNOS-created 
geographic boundaries. You asked the Secretary to do what the 
committee would not, operate the program closer to the original 
congressional intent when the act was passed in 1984.
    Mr. Chairman, you were right then. Your conclusions apply 
equally today and your views have been validated by the IOM. On 
behalf of the 65,000 patients now waiting for transplants in 
the United States, we ask that you not change directions now.
    Thank you.
    [The prepared statement of Craig Irwin follows:]
   Prepared Statement of Craig Irwin, President, National Transplant 
                            Action Committee
    National Transplant Action Committee (NTAC) is a consumer advocacy 
organization founded in 1992. We currently have approximately 1500 
members across the United States. NTAC has been a leading advocate for 
organ transplant patients and their families as directed by our Patient 
Public Policy Committee.
                    analysis and comment on hr 2418
    NTAC strongly opposes HR 2418, the ``Organ Procurement and 
Transplantation Network Amendments of 1999. The bill now before the 
Committee would make drastic changes to the National Organ Transplant 
Act (NOTA) and the management of the nation's Organ Procurement and 
Transplantation Network (OPTN).
    1. The bill establishes the private contractor as an ``independent 
partner'' with the federal government. It requires the Department of 
Health and Human Services (HHS) to ``cooperate'' with the contractor as 
well as eliminates the oversight role of HHS. It reduces the role of 
the Secretary to taking and reviewing comments but grants no authority 
to HHS to protect or promote the public health interest through an 
administrative role.
    2. Eliminates the independent Scientific Registry
    3. Gives the OPTN contractor greater authority over which 
information is released to patients and the public. Grants the 
contractor new ``authority'' by which to withhold vital information 
from the public.
    4. Excludes members of the public and patients from being members 
of the OPTN. Membership is only permitted to ``entities'' in the 
transplant field.
    5. The bill would eliminate the release of center specific data and 
replace it with less helpful OPO specific data.
    6. Gives the contractor broad judicial authority and the right to 
penalize transplant centers. Such penalties may include the withholding 
of organs from transplant centers that do not adhere to network rules.
    7. Administrative and procedural activities between the Secretary 
and the contractor would now have to be conducted on a mutually 
consensual basis. Gives the contractor sole discretion over 
``scientific, clinical, and medical decisions'' regardless of the 
impact of such decisions on the public health interest.
    8. Any subsequent contractor must be approved by the OPOs and 
transplant centers. Requires the OPTN contractor to have ``experience'' 
in organ transplantation.
    9. Changes the criteria for the allocation of donated organs. 
Expands consideration of allocation policies to include issues of 
equity and ethics. It also eliminates the requirement that organs be 
distributed on a ``nationwide'' basis ``equitably among patients on the 
waiting list.''
    NTAC believes that each one of these provisions would have an 
adverse impact on organ transplant patients and the public's health 
care interest. We support the current National Organ Transplant Act and 
the Final Rule promulgated by HHS governing the OPTN. We are concerned 
that HR 2418 is aimed at derailing the HHS rules before they go into 
effect on October 21, 1999.
    The OPTN is currently operated by the United Network for Organ 
Sharing (UNOS) based in Richmond, VA. UNOS has operated the network 
since its inception in 1986. HR 2418 as written would eliminate the 
Secretary's discretion to contract with the best possible candidate to 
operate the OPTN. Under the Bill, UNOS could essentially operate the 
OPTN without regard to the public health interest and without oversight 
by HHS and still not jeopardize its standing as the OPTN contractor.
    Throughout the years, patients, transplant centers, the 
Administration, and the public have raised concerns about the manner in 
which UNOS has operated the OPTN. These concerns have been echoed by 
Congress and reflected in amendments to the National Organ Transplant 
Act in 1988 and 1990. Although the Act has not been formally amended 
since 1990 congressional hearings in 1993 and 1995 have resulted in 
similar actions attempting to address troubling concerns over UNOS 
activities.
    Timely, accurate, and useful information is critical to the public, 
policy makers, and especially transplant patients. UNOS has shown a 
blatant disregard for the public interest in this area and has resisted 
attempts to obtain vital information. In 1997 a request for data on 
organs turned down by transplant centers was made available only after 
an exhaustive process that culminated in a Freedom of Information Act 
request. Only then did UNOS make the data available. In its attempt to 
block the information UNOS used similar defenses to those proposed in 
HR 2418. However, no patients were ever identified, directly or 
indirectly, as a result of the data release. Information currently 
available with respect to center specific performance and OPO 
performance is outdated when it is published. The current HHS 
regulations would require the OPTN contractor to update its data every 
six months.
    The UNOS governance and policy setting process is highly 
politically charged and greatly influenced by transplant center self 
interest. There is no opportunity given for public testimony at UNOS 
board meetings or committee meetings. Public members and patient 
advocates are excluded from participating in UNOS because of their 
viewpoints. Recently, the UNOS patient affairs committee attempted to 
censure a UNOS public member because his positions and public 
statements were critical of the organization.
    Not only is the UNOS policy setting process corrupted, its 
enforcement of policies is based upon political expedience and 
appeasement. Recently, the UNOS board of directors implemented a policy 
to create regional sharing for liver transplant candidates in the most 
urgent health care status. However, transplant centers in Wisconsin 
refused to abide by the new policy, adversely affecting patients in 
nearby Illinois. UNOS currently has at its disposal some of the same 
penalties available to it that are created in HR 2418. However, instead 
of enforcing its policy, UNOS opted to endorse a special agreement 
insisted on by the Wisconsin transplant centers.
    However, the most critical decisions impacting organ transplant 
patients center on the allocation of donated organs. As stated in a 
Congressional conference report ``The Organ Procurement and 
Transplantation Network (OPTN) was created by the 1984 Act in order to 
facilitate an equitable allocation of organs among patients.'' ``The 
allocation of organs may well be a life-or-death decision for 
patients.'' (Senate Report 100-310, P.L. 100-607). In 1990 UNOS changed 
liver allocation rules to eliminate the priority status given to the 
most medically urgent patients on the national waiting list. The policy 
was enacted before public comment was sought. Since then, organ 
allocation has been hotly debated in the organ transplant community.
    The organ allocation issue is exacerbated by the fact that there 
are approximately 65,000 patients on the national waiting list and the 
number of transplants has continued to hover around only 20,000. Over 
ten patients die each day waiting for organs.
    The manner in which UNOS has managed the policy setting process in 
this critical illustrates the shortcomings of the current system and 
UNOS's ability to promulgate policies that serve the public interest. 
After exhaustive debate and efforts on the part of patients and the 
public UNOS began considering the liver allocation issue. The result 
was a policy where patients with chronic liver diseases would be 
eliminated from the highest priority status. It was only after HHS 
intervention and overwhelming public outcry at a three-day hearing that 
the policy was reversed. Recommendations made by the UNOS Liver and 
Intestine Committee to expand liver allocation in order to improve 
equity were ignored by the UNOS board, which focused on regional and 
local interests instead of promulgating a fair public policy. In the 
meantime, patients have needlessly died as a result of UNOS's failure 
to act in a responsible manner.
    These issues highlight the grave concerns with the function of the 
OPTN and the manner in which UNOS has managed the transplant network. 
Throughout the years, Congress has acted to limit the authority of the 
OPTN contractor, attempted to improve the internal operation and 
management of UNOS, and has called upon HHS to exert greater authority 
of the Act and the OPTN to protect the public interest. In 1990 
Congress eased the minimum qualifications that must be met by deleting 
a prior requirement that an entity seeking the OPTN contract must not 
be engaged in any activity unrelated to organ procurement. The 
Committee Report stated ``By modifying this requirement, the Committee 
intends to provide the Secretary with the opportunity to seek out the 
best possible potential applicants for this critical role.'' The 
Committee went on to state ``This change, along with changes the 
Committee has made in the OPTN board of directors, reflect deep concern 
on the part of the Committee in the manner in which the OPTN has 
functioned.'' The Congress should continue to be concerned.
    It is in this context that NTAC opposes the proposed OPTN 
reauthorization bill. We believe that UNOS has failed to carry out the 
mandates of the National Organ Transplant Act and that undue political 
influence and rampant self-interest characterize the UNOS process. The 
welfare of patients should be at the forefront of the OPTN policy 
setting process but that is not the case.
    In lieu of HR 2418, we believe that the Committee should give 
serious consideration to the recent report of the Institute of Medicine 
on Organ Procurement and Transplantation. Congress requested the report 
as part of a one-year delay in the HHS regulations.
    The IOM has emerged from its deliberations in support of the final 
rule which, together with its own recommendations, ``could go a long 
way toward facilitating the development of improved principles of 
[organ] allocation and improving what everyone agrees should be a 
patient-centered system.''
                highlights of the iom committee report:
1. Impact of the Final Rule on Access
    The IOM Committee found that the Final Rule would not adversely 
impact patient access to organ transplantation. It has been claimed 
that small transplant centers would close as a result of changes to the 
nation's organ allocation system imposed by the Final Rule. ``The 
committee was not persuaded'' by the arguments stated by the opponents 
of the Final Rule. In fact, the IOM report states that, ``there is some 
preliminary information that counters the argument that broader sharing 
[of organs] under the Final Rule would adversely affect small 
transplant centers.'' ``Broader organ sharing may well increase the 
prospects that a patient listed at a low-volume transplant center will 
obtain a suitable matching organ.''
    The committee also examined the impact of the Final Rule on 
minorities and low-income populations. The committee found that 
``African Americans do not receive kidney transplants as quickly as 
whites'' and that the rule would not exacerbate this problem. The 
committee also found that ``broader sharing of organs resulting from 
implementation of the Final Rule is not likely to have a significant 
adverse effect on those who are dependent on Medicaid for their health 
care.''
2. Impact of the Final Rule on Organ Donation
    The IOM committee found no evidence to support claims that organ 
donation rates would decrease as a result of the Final Rule, stating 
that ``the committee found no convincing evidence to support the claim 
that broader sharing would adversely affect donation rates or that 
potential donors would decline to donate because an organ might be used 
outside the immediate geographic area. In fact, there is some evidence 
suggesting that broader sharing is associated with increased rates of 
donation.''
3. Analysis of Waiting Times
    Disparities in waiting times for liver transplant candidates have 
been at the center of a heated debate over the allocation of scarce 
donor organs. Therefore, the Committee concentrated its research on the 
current liver allocation policies. The IOM Committee concluded that 
aggregate-waiting time is not a good measurement of the equity and 
effectiveness of the transplant system. However, the Committee made 
other key observations about the transplant system.
    a. The system is basically fair for the sickest patients (Status 
1). However, the IOM Committee recommends improvements: ``Although the 
current system appears equitable, with respect to status 1 patients 
receiving transplants at similar rates among OPOs and having similar 
mortality and outcomes, the equity of the current system might be 
improved for all patients if it were possible to identify a minimum OPO 
population size or transplant volume that would promote both greater 
consistency in transplantation rates across OPOs and a higher rate of 
transplantation for needier patients.''
    b. Some of the healthier patients on the waiting list do not die 
while on the list nor do they move up in priority, suggesting that some 
patients are inappropriately put on the list for a liver transplant. 
The IOM found that there are patients on the waiting list who ``have 
little likelihood of receiving a transplant and are also at little risk 
of dying.''
    c. More ``healthier'' patients die on the waiting list in OPOs with 
smaller transplant centers. ``Of concern was evidence of a 
statistically significant increase in the risk of pretransplant 
mortality in those OPOs with smaller transplant volumes.'' Relatively 
healthy patients in small-volume OPOs ``had a significantly increased 
risk of pretransplant mortality while on the waiting list.''
    d. Larger OPOs transplant the sickest patients while smaller OPOs 
and transplant centers transplant a greater percentage of healthier 
patients. The IOM concluded that ``smaller OPOs, by generally 
transplanting more status 2B and 3 patients than larger OPOs, may 
contribute to a situation in which more severely ill patients are 
required to wait longer for organs at increased risk of death.''
    e. There are fewer patients waiting in smaller OPOs so that they 
can transplant healthier patients. ``Although smaller OPOs have lower 
transplantation rates than larger OPOs, their listing rates are even 
further reduced relative to larger OPOs.'' ``This means that smaller 
OPOs are able to allocate organs to patients farther down their shorter 
waiting lists than are larger OPOs.''
    f. Increased sharing of organs would save more lives. ``A 
reasonable improvement in the current allocation scheme could be 
achieved by creating allocation areas of sufficient size to shift some 
of the transplants from status 3 to statuses 1 and 2.'' ``It seems 
apparent that patients on liver transplant waiting lists will be better 
served by an allocation system that facilitates broader sharing within 
larger populations.'' Greater sharing will have the effect of 
``increasing transplantation rates for status 1 patients, decreasing 
pretransplantation mortality for status 2B patients, and decreasing 
transplantation rates for status 3 patients without increasing 
mortality.'' The net effect is that more lives would be saved through 
broader sharing of donor organs to those patients with the greatest 
need.
4. Patient survival
    The IOM found that the medically acceptable ischemic time (time 
that organs can travel without a blood supply) for donated livers was 
12 hours. However, more significantly, the IOM Committee found that 
larger transplant centers had better patient survival rates than 
smaller centers, despite the fact that larger centers also transplant 
the sickest patients. ``Patients located in smaller-volume OPOs had 
increased risk of posttransplant mortality relative to those in larger-
volume OPOs.'' In reviewing UNOS data the IOM Committee found that 
``several of the transplant centers doing 25 or fewer liver transplants 
had 1-year graft survival rates significantly lower than expected, 
given the health status of their patients.''
5. Costs
    The IOM Committee concluded that increased sharing would have a 
slight increase in the overall costs of liver transplantation. However, 
the committee stated ``The committee was unable to estimate the 
magnitude of the increase, but believes that it would be marginal 
compared to the total expenditures for transplantation. The committee 
also believes the health benefits of implementing broader sharing will 
be substantial and outweigh any net increase in expenditures.''
6. Federal Oversight
    The report of the IOM Committee supports the HHS Final Rule, ``In 
the end, the committee emerged from its deliberations generally 
supportive of the Final Rule.'' In addition, the committee called for 
more, not less, federal government oversight of the nation's organ 
transplant system. ``Weak [government] 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.''
    The report recommends that HHS ``should exercise the legitimate 
oversight responsibilities assigned to it by the National Organ 
Transplant Act in order to manage the system of organ procurement and 
transplantation in the public interest.'' Furthermore, the committee 
recommended ``a process for periodic, independent and comprehensive 
review by a body reporting to the Secretary and not affiliated with the 
OPTN contractor is needed to help provide objective information and 
advise for the future directions of the system.'' The board would 
include ``a broad spectrum of medical and scientific experts, including 
epidemiologists and health services researchers, as well as 
representatives from the community of transplant patients and donor 
families.''
                               conclusion
    National Transplant Action Committee opposes HR 2418 and hopes that 
the Committee will not vote in favor of legislation which we believe 
will have a devastating impact on organ transplant patients throughout 
the United States. We encourage the Committee to focus on sound public 
policies as opposed to parochial self-interests. We hope that the HHS 
regulations will be permitted to move forward and that a fair and 
equitable system soon becomes established for the 65,000 Americans 
currently waiting for transplants in our nation's hospitals.

    Mr. Bilirakis. Thank you, Mr. Irwin. Dr. Rabkin.

                   STATEMENT OF JOHN M. RABKIN

    Mr. Rabkin. Mr. Chairman, distinguished members of the 
committee, I am John Rabkin. I am a surgeon and the Chief of 
Liver Transplantation at the Oregon Health Sciences University. 
I am here today on behalf of the 31 organ transplant programs 
and 1,300 patients that currently make up the Patient Access to 
Transplantation or the PAT Coalition. I respectfully request 
submission into the hearing record along with my testimony the 
August 28, 1998, PAT Coalition comments on the health and human 
services final rule and a recent PAT Coalition policy paper 
from this September which delineates our views on several 
critical issues in the legislative and regulatory debate.
    The PAT Coalition strongly supports H.R. 2418, the Organ 
Procurement and Transplantation Amendments of 1999, the 
reauthorization of the National Organ Transplant Act, or NOTA, 
introduced by Representatives Bilirakis, Pallone and Green. We 
appreciate their commitment to this issue and that of Commerce 
Committee Chairman Tom Bliley and other members of this 
committee.
    The PAT Coalition urges Congress to pass this legislation 
because we feel strongly that enactment of this bill is the 
best way to settle controversy over organ transplantation 
resulting from the HHS rulemaking. Moreover, we think it is 
imperative to stem the erosion of public faith in the 
transplant system which has occurred since HHS issued its 
controversial rule in April 1998.
    We believe that the current organ transplant system is fair 
and that it does a good job of acquiring and allocating organs 
for transplantation. We all must recognize the extremely 
dynamic aspects of the transplant system as medical 
developments occur on practically a daily basis. Like any 
system, there is and always will be room for ongoing 
improvement and this is how our current system operates. A 
recent study by the Institute of Medicine came to the same 
conclusion, ``The committee found that the current system is 
reasonably equitable for the most severely ill status 1 liver 
patients since the likelihood of receiving a transplant is 
similar across organ procurement organizations, or OPOs, for 
these patients.''
    The IOM study contradicted the underlying rationale for the 
controversial final rule on organ allocation proposed by the 
Department of Health and Human Services. In an analysis of 
68,000 liver patient records, the IOM panel said, ``The overall 
median waiting time that patients wait for organs, the issue 
that seems to have brought the committee to the table in the 
first place, is not a useful statistic for comparing access to 
or equity of the current system of liver transplantation, 
especially when aggregated across all categories of liver 
transplant patients.''
    HHS always maintained that reducing these regional 
differences in waiting time was the primary goal of the rule on 
organ allocation. The PAT Coalition has actively supported the 
two moratoriums on the HHS final rule implemented by Congress 
because we think that the final rule usurps the authority of 
the transplant community under NOTA to determine organ 
transplant policy. Stated most simply, Congress in NOTA vests 
the private sector OPTN with the authority to determine organ 
allocation policy.
    We strongly support this NOTA directive and agree with 
Congress that the private sector entity is far better equipped 
than the government to make medical policy judgments and adapt 
to changing technological developments and scientific and 
medical advances.
    NOTA simply does not provide the Secretary with authority 
to substitute her judgment if she or her staff disagree with a 
medical transplant community with respect to policymaking, yet 
the Secretary's final rule usurps this authority by regulatory 
fiat and claims the ability to reverse OPTN policy.
    Among our other concerns we also recognize that the 
transplant policy suggested in the final rule would result in 
more of our patients dying while waiting for transplant and a 
significantly higher rate of retransplantation and possible 
organ wastage. We are also concerned that the core HHS policy 
is a design to direct more organs to a few larger transplant 
centers, which would result in a loss of access to 
transplantation services for those patients who could not 
travel long distances for financial or family reasons.
    The rule itself applies to all organs and cannot withstand 
medical scrutiny. For example, another serious effect of this 
policy would be to increase the cold ischemic time, or the time 
that organs are stored outside of the body, since organs would 
travel farther to the large centers. The IOM study pointed out, 
``That a 4.2 percent reduction in retransplantation by using 
livers with lower ischemic times would necessitate less 
retransplantation and would mean that 170 additional patients 
could receive a liver transplant.''
    The HHS policy is also short sighted in its wholesale 
preemption of State laws regarding organ transplantation. Many 
of the beneficial policies that have served to improve organ 
procurement and donation were based on State laws such as the 
organ donor checkoff on driver's licenses. The HHS preemption 
fails to recognize that fact. In addition, this preemption 
clearly exceeds the authority granted by Congress.
    During the moratorium period we have worked actively with 
the transplant community to try to form a consensus on how best 
to deal with the HHS position. We have been involved in 
discussions with HHS officials who have promised the transplant 
community a revised proposal that would take into consideration 
our objections to the final rule. We are still waiting for a 
response from HHS as the clock ticks down on the current 
moratorium scheduled to expire October 21.
    We are also still waiting for the HHS to publish an 
analysis of the thousands of public comments filed in response 
to the final rule. We understand that more than 85 percent of 
these comments stated strong opposition or concerns about the 
rule.
    The best solution to the problem is for Congress to 
reiterate the long-held statutory premise that organ transplant 
policy should be left to the private sector transplant 
community through passage of new authorizing legislation. Short 
of that, Congress should continue the moratorium until a new 
authorization bill can be passed.
    H.R. 2418 recognizes that scientific and medical decisions 
about organ transplant policy should be left to the private 
sector transplant community rather than to the Federal 
Government bureaucracy, a concept that the PAT Coalition 
enthusiastically supports. The legislation's construct has 
worked successfully historically and we continue to believe 
that the private sector is better equipped than the government 
to sort through the complex medical, specific, and ethical 
challenges presented by organ transplantation.
    H.R. 2418 correctly places a strong emphasis on the real 
solution to the organ shortage problem, which is increasing 
organ donation. With your permission, Mr. Chairman, I would 
like to submit a report of Kansas State University researcher 
and professor of psychology James Shanteau's recent summary of 
research on what motivates people to donate organs and a press 
release article which expressed serious concern that the HHS 
new organ policy may result in a donation decline.
    Mr. Bilirakis. Without objection, that is made a part of 
the record Dr. Rabkin. Proceed.
    Mr. Rabkin. Thank you, Mr. Chairman. Most importantly, H.R. 
2418 would restore the public's confidence in the transplant 
system. Congress should expeditiously take this positive step 
forward building on a truly unique and successfully working 
transplant system and pass H.R. 2418, the organ procurement and 
transplantation network amendments of 1999. We appreciate the 
opportunity to testify here today. Thank you.
    [The prepared statement of John M. Rabkin follows:]
Prepared Statement of John M. Rabkin, Oregon Health Sciences University 
      representing the Patient Access to Transplantation Coalition
    Mr. Chairman, distinguished Members of the Committee, I am John M. 
Rabkin, M.D., a surgeon and Chief of Liver Transplantation at the 
Oregon Health Sciences University.
    I am here today on behalf of the 31 organ transplant programs and 
1300 patients that currently make up the Patient Access to 
Transplantation (PAT) Coalition. I respectfully request submission into 
the hearing record, along with my testimony, a recent PAT Coalition 
policy paper (September 1999) which delineates our views on several 
critical issues in the legislative and regulatory debate.
    The Patient Access to Transplantation (PAT) Coalition supports H.R. 
2418, the ``Organ Procurement and Transplantation Network Amendments of 
1999,'' the re-authorization of the National Organ Transplant Act 
(NOTA), introduced by Reps. Bilirakis, Pallone, and Green. We 
appreciate their commitment to this issue and that of Commerce 
Committee Chairman Tom Bliley, and other Members of this Committee.
    The PAT Coalition urges Congress to pass this legislation because 
we feel strongly that enactment of this bill is the best way to settle 
the controversy over organ transplantation resulting from the HHS 
rulemaking. Moreover, we think it is imperative to stem the erosion of 
public faith in the transplant system that has occurred since HHS 
issued its controversial Rule in April 1998.
    We believe the current organ transplant system is fair and does a 
good job of acquiring and allocating organs for transplantation. We all 
must recognize the extremely dynamic aspects of the transplant system 
as medical developments occur on practically a daily basis. Like any 
system, there is, and will always be, room for ongoing improvement, and 
there are several proposals that the PAT Coalition supports to increase 
the numbers of transplants.
    A recent study by the Institute of Medicine came to the same 
conclusion: ``The committee found that the current system is reasonably 
equitable for the most severely ill (Status 1) liver patients, since 
the likelihood of receiving a transplant is similar across organ 
procurement organizations (OPOs) for these patients.''
    The IOM study contradicted the underlying rationale for the 
controversial Final Rule on organ allocation proposed by the Department 
of Health and Human Services. In an analysis of 68,000 liver patient 
records, the IOM panel said ``the `overall median waiting time' that 
patients wait for organs--the issue that seems to have brought the 
committee to the table in the first place--is not a useful statistic 
for comparing access to or equity of the current system of liver 
transplantation, especially when aggregated across all categories of 
liver transplant patients.'' HHS always maintained that reducing 
regional differences in waiting times was the primary goal of the rule 
on organ allocation.
    The panel also found that enlarging the current organ allocation 
areas--a broader, regional sharing concept that the PAT Coalition 
generally supports--would improve the chances of Status 1 and 2 
patients being transplanted.
    The PAT Coalition has actively supported the two moratoriums on the 
HHS Final Rule implemented by Congress because we think that the Final 
Rule usurps the authority of the transplant community under NOTA to 
determine organ transplant policy. Stated most simply, Congress in NOTA 
vests the private sector OPTN with the authority to determine organ 
allocation policy. We strongly support this NOTA directive and agree 
with Congress that the private sector entity is far better equipped 
than the government to make medical policy judgments and adapt to 
changing technological developments and scientific and medical 
advances. NOTA simply does not provide the Secretary with authority to 
substitute her judgment if she or her staff disagree with the medical 
transplant community with respect to policymaking--yet the Secretary's 
Final Rule usurps this authority by regulatory fiat and claims the 
ability to reverse OPTN policy.
    Among our other concerns, we also recognize that the transplant 
policy suggested in the Final Rule would result in more of our patients 
dying while waiting for a transplant, and a significantly higher rate 
of retransplantation and possible organ wastage. We are also concerned 
that the core HHS policy is a design to direct more organs to a few 
larger transplant centers, which would result in a loss of access to 
transplantation services for those patients who could not travel long 
distances for financial or family reasons.
    The Rule itself applies to all organs and cannot withstand medical 
scrutiny. For example, another serious effect of this policy would be 
to increase the ``cold ischemic time'' for organs since organs would 
travel farther to the large centers. The IOM study pointed out that ``a 
4.2 percent reduction in re-transplantation . . . by using livers with 
lower ischemic times would necessitate less re-transplantation and 
would mean that 170 additional patients could receive a liver 
transplant.''
    The HHS policy is also shortsighted in its wholesale preemption of 
state laws regarding organ transplantation. Many of the beneficial 
policies that have served to improve organ procurement and donation are 
based on state laws, such as the organ donor check-off on driver's 
licenses. The HHS preemption fails to recognize that fact. In addition, 
this preemption clearly exceeds the authority granted by Congress.
    During the moratorium period, we have worked actively with the 
transplant community to try to form a consensus on how best to deal 
with the HHS position. We have been involved in discussions with HHS 
officials who have promised the transplant community a revised proposal 
that would take into consideration our objections to the Final Rule. We 
are still waiting for a response from HHS as the clock ticks down on 
the current moratorium scheduled to expire October 21, 1999. We also 
are still waiting for HHS to publish an analysis of the thousands of 
public comments filed in response to the Final Rule. We understand that 
more than 85% of these comments stated strong opposition or concerns 
about the Rule.
    The best solution to the problem is for Congress to reiterate the 
long held statutory premise that organ transplant policy should be left 
to the private sector transplant community through passage of new 
authorizing legislation. And, short of that, Congress should continue 
the moratorium until a new authorization bill can be passed.
    H.R. 2418, the ``Organ Procurement and Transplantation Network 
Amendments Act of 1999'' recognizes that scientific and medical 
decisions about organ transplant policy should be left to the private 
sector transplant community rather than to the federal government 
bureaucracy, a concept that the PAT Coalition enthusiastically 
supports. The legislation's construct has worked successfully 
historically, and we continue to believe that the private sector is 
better equipped than the government to sort through the complex 
medical, scientific, and ethical challenges presented by organ 
transplantation.
    H.R. 2418 correctly places a strong emphasis on the real solution 
to the organ shortage problem: increasing organ donation.
    But most importantly, this bill would restore the public's 
confidence in the transplant system and would serve to recognize the 
contributions made by the donors, patients, OPOs, doctors and 
volunteers who have actively participated in the development of a 
transplant system that results in 21,000 life-saving transplants each 
year.
    Since the passage of NOTA in 1984, the number of people receiving 
organs has increased annually and survival rates are steadily 
improving.
    Congress should expeditiously take a positive step forward, 
building on a truly unique and successfully working transplant system, 
and pass H.R. 2418, the ``Organ Procurement and Transplantation Network 
Amendments of 1999''.
    We appreciate the opportunity to testify here today.
    Thank you.
              Patient Access to Transplantation Coalition
                              policy paper
                             September 1999
    The Patient Access to Transplantation (PAT) Coalition supports an 
organ allocation system that balances fairly ``equity'' with 
``utility.'' Organ allocation policy must seek to achieve the greatest 
good for the greatest number of people. Organ allocation policy must 
avoid futile transplantation, excessive retransplantation, decreased 
viability of organs and other waste adversely affecting the supply of 
organs.
    Local access to transplantation must be preserved both for the sake 
of patients nationwide, especially minorities and medically underserved 
populations, and in order to improve donation.
                                  nota
    The PAT Coalition strongly supports NOTA's current delineation of 
authority. The National Organ Transplant Act (NOTA), as initially 
passed by Congress and as amended, establishes and clearly delegates 
policymaking authority to the Organ Procurement Transplantation Network 
(OPTN), a private sector entity comprised of physicians, patients and 
other transplant community representatives.

 NOTA's legislative history explicitly provides that the 
        private sector OPTN should decide medical criteria for 
        allocating organs, and should resolve issues regarding the fair 
        distribution of organs.
 NOTA grants the Secretary oversight authority. Under NOTA, the 
        Secretary is responsible for contracting with the OPTN and for 
        soliciting comments on the OPTN's performance of its duties.
 The PAT Coalition strongly supports retention of medical 
        decisionmaking in the private sector, and opposes HHS' 
        involvement in developing, modifying or vetoing organ 
        allocation policy unless specifically directed under statute.
                               preemption
    NOTA currently does not contain federal preemption statutory 
language. The Secretary's Final Rule should avoid any attempt to 
preempt by regulation authority of the states or authority in the area 
of organs which the Congress has not granted explicitly to the 
Department. The federal preemption issue should be reserved for NOTA 
reauthorization. Otherwise, HHS invites a lawsuit on the preemption 
issue.
                                hhs role
    The Pat Coalition supports a strong federal leadership role in 
organ donation. Intractable problems in allocation can never be fully 
resolved as long as the dire shortage of available organs remains and 
we urge the federal government to assume affirmative responsibility and 
make this its highest and primary priority. To that end the PAT 
Coalition supports:

 Substantial increases in federal funding available for organ 
        donation initiatives, including a national educational campaign 
        which covers living donor organ donation as well.
 Direct financial support and matching grants to states who are 
        willing to mount donor education and awareness campaigns within 
        their states, establish donor registration programs, and test 
        other innovative approaches such as contributions for funeral 
        expenses.
 Substantial increases in the National Institutes of Health 
        (NIH) budget for targeted institute intramural and extramural 
        research initiatives directed at increasing donations and 
        making scientific and medical progress in organ transplantation 
        (e.g., NIDDK, NHLBI, etc.).
 Continual expansion of the HRSA extramural research support 
        funding to test, evaluate and replicate creative research 
        projects developed nationwide, including a directive to cover 
        living donation initiatives.
 Seed money to explore the feasibility and logistics of 
        establishing a national organ donor registry.
    The PAT Coalition supports the oversight role given to the 
Secretary of Health and Human Services in the National Organ 
Transplantation Act (NOTA) regarding oversight of the Organ Procurement 
Transplantation Network (OPTN). HHS has no policy role in organ 
allocation.

 The PAT Coalition supports strong enforcement of OPTN policies 
        by the OPTN. The Department may exercise its oversight 
        responsibilities to seek input on the OPTN's exercise of this 
        authority.
 Any independent review board created to assist or advise the 
        Secretary (as suggested by the IOM) must be fully autonomous 
        and independent. The appointment, composition and 
        responsibilities of any such group must be wholly independent 
        of any political process and the Department and Administration. 
        We do not support using the Federal Advisory Committee Act 
        (``FACA'') construct because it would vest the Secretary with 
        appointment authority and the role of a committee or advisory 
        board chartered under this authority would be advisory and non-
        binding. This review group should not be charged with any 
        policymaking responsibilities which belong in the private 
        sector OPTN.
                     listing criteria and practices
    The PAT Coalition believes that the private sector medical 
community, including surgeons, transplant physicians and scientists, 
should be solely responsible for development and ongoing refinement, 
where appropriate, of organ-specific listing and de-listing criteria 
based on standardized medical assessments.

 In balancing equity and utility considerations, the PAT 
        Coalition recognizes that transplantation of the ``sickest'' 
        patient is not always the best or most appropriate use of an 
        organ, given higher survival rates and lower retransplantation 
        rates of less sick patients.
 The PAT Coalition supports an independent process of 
        prospective and ongoing concurrent review of patient status and 
        application of medical listing and delisting criteria through 
        chart review of all transplant centers within a given region.
 The PAT Coalition supports imposition of significant monetary 
        penalties by the OPTN to enforce standardized listing and de-
        listing practices, and adherence to OPTN policy.
                            regional sharing
    The PAT Coalition supports broader regional sharing of organs based 
on private sector initiatives and arrangements. The PAT Coalition 
supports flexibility in the size of the population base utilized to 
achieve broader regional sharing, such as a population range of 6-11 
million lives. Working relationships and arrangements between and among 
transplant centers in specific regions must drive the development of 
broader sharing. We do not perceive a ``cookie cutter'' approach to 
broader sharing will succeed because successful sharing must be based 
on relationships, which reflect regional considerations and 
availability of transplant centers and other resources within these 
regions. The PAT Coalition opposes development of a national waiting 
list and any centralized allocation system administered or structured 
by the federal government.
                       importance of local access
 The PAT Coalition continues to believe that the policy 
        mandated by HHS will impair access to transplantation services, 
        especially for low-income and minority patients. Lack of access 
        to organs may drive some regional transplant centers out of 
        business, inflicting a fundamental blow to patient access and 
        patient choice. Any Final Rule adopted by HHS must ensure 
        access to transplantation and prevent unnecessary transplant 
        center closings. The OPTN must assure that allocation policies 
        developed will not harm patient access to local transplantation 
        services.
 The PAT Coalition concurs with the independent research 
        finding that for a significant number of individuals, there is 
        a greater willingness of people to donate if they can be 
        assured that their organs will remain in their own local 
        community or at least in their state (source: 12 years of 
        independent research conducted by Kansas State University 
        researcher James Shanteau).
                          additional concerns
 OPO performance and effectiveness must be measured in a more 
        meaningful way. HHS should develop alternative and outcome 
        performance measures for OPOs as recommended by the General 
        Accounting Office and endorsed by the Institute of Medicine.
 The Medicare and Medicaid statutes should be amended to ensure 
        coverage to transplantation for beneficiaries who are 
        uninsured. Such costs should not be borne by transplant 
        centers.
 Models should be developed and disseminated nationally from 
        careful screening of procurement and utilization practices and 
        subsequent clinical outcomes.
                        congressional oversight
    The PAT Coalition supports strong Congressional oversight of both 
the federal Department of Health and Human Services and the Organ 
Procurement Transplantation Network (OPTN). To that end, the General 
Accounting Office (GAO) should be charged with periodic oversight 
reviews of both the Health Resources Services Administration (HRSA) and 
Health Care Financing Administration (HCFA) program responsibilities 
and the OPTN contractor.

    Mr. Bilirakis. Thank you very much, Doctor. There is a 
package here, testimony of the National Kidney Foundation and 
various letters--Shands Health Care and University of Texas, et 
cetera, which has been handed to the minority, and I would ask 
unanimous consent that it may be made a part of the record. 
Without objection. That will be the case.
    I very much appreciate Dr. Rabkin emphasizing so very much 
the donation area, because without adequate organs being 
donated we can have all the allocation systems in the world, 
change this, change that, and it is just not adequate.
    And that is what concerns me an awful lot. Granted we are 
concerned about allocation and that sort of thing. And Mr. 
Barrett said it as--I am not going to paraphrase and I may even 
be wrong in paraphrasing, but he referred to the people in his 
area wanting to know basically who was getting the organ and at 
least that there would be an easier donation type of a 
situation if they knew that it was sort of local, if you will, 
or at least regional. And I have made those comments before and 
I feel very strongly about that.
    I don't have any trouble putting myself in the shoes of the 
public back in my region in terms of--and we do well, 
particularly in Florida, we do well as far as donations are 
concerned. And someone said something about if it ain't broke 
don't fix it, and that concerns me.
    I want that to be a part of the record because I know Mr. 
Irwin referred to prior comments on my prior positions on my 
part.
    But I will tell you and anyone who says differently is 
lying in my opinion, that we are, as I said earlier, parochial. 
We have to be. We represent people in our congressional 
district. And I dare say that if the University of Pittsburgh 
were not at the forefront of this national allocation system, 
that some of the people in Pennsylvania and eastern Ohio might 
maybe not change their positions but at least look at it a 
little more objectively. And the same thing is true if Florida 
and the University of Florida and Miami and whatnot had a 
different position, that certainly would have an effect on me, 
and I am going to be the first one to admit that.
    But we are concerned about equitable--to use the terms that 
I think Mr. Irwin used--equitable allocation. And we are 
concerned about the sickest receiving the organs as against 
those who are not in that category.
    I understand that the IOM report concluded the current 
system of liver allocation is not only fair for the sickest 
patients, but to everyone in urgent need of a transplant 
receives--and I believe Dr. Rabkin touched on this--receives 
one, status 1 and 2A.
    And if that is the case, it makes me wonder, Secretary 
Shalala in a January 20, 1999, press release said: ``These 
findings make clear that changes are urgently needed to produce 
better and fairer outcomes for our Nation's organ transplant 
patients'' and that, ``further delay can only needlessly injure 
patients.''
    And yes, the IOM, which has been quoted so very much by the 
administration and by others and certainly has made the news, 
basically is being held out as having said that unfairness 
exists and that sort of thing. So Dr. Gibbons, would you care 
to expand?
    Mr. Gibbons. Love to. Let me first state that there is a 
difference between equitable and optimal.
    Mr. Bilirakis. Equitable and?
    Mr. Gibbons. And optimal.
    Mr. Bilirakis. Okay.
    Mr. Gibbons. Our findings were that the status 1 patients 
were treated equitably in the sense that there was not 
significant variability across the organ procurement 
organization for those status 1 patients, meaning that the 
rates of transplantation were fairly similar and there weren't 
these large geographic heterogeneous distributions. This was 
not true for the status 2B and 3 patients. There was 
considerable variability from one OPO to the other and beyond 
just that, the smaller OPOs were transplanting large numbers 
more of these less severely ill patients relative to the larger 
organ procurement organizations.
    Mr. Bilirakis. Are the sickest patients receiving the 
organs even though--I mean, and if that is the case, are some 
of those organs, many of those organs, whatever the proper term 
is, coming from outside of those regions?
    Mr. Gibbons. That is an excellent point. First of all, all 
status 1 patients are not receiving organs. By our comments 
about it being equitable it means that the rates are fairly 
similar, but only 54 percent of the status 1 patients are ever 
receiving an organ across the country.
    Now, what happens to the other 46 percent, which is a very 
important question? 8 percent of those status 1 patients die 
while waiting for an organ. Again, those rates are comparable 
across the system.
    Mr. Bilirakis. Doctor, forgive me, are you saying that 
appropriate organs are available in other regions and that they 
are being used for people who are nowhere near as sick and for 
that reason these category 1 people are not receiving the 
organs?
    Mr. Gibbons. That is one of the reasons, yes, sir.
    Mr. Bilirakis. That is one of the reasons.
    Mr. Gibbons. Absolutely.
    Mr. Bilirakis. And you pointed--you have detailed that in 
your report in terms of evidence of that and that sort? I am 
not trying to be difficult, don't get me wrong, I just want to 
be sure. I know that you have used terms like ``inconclusive'' 
and that sort of thing, and I just want to know is this 
conclusive? I am assured in Florida particularly, Mr. Miller 
can speak to this--nobody is under oath here--but I am assured 
that many organs are shipped, if that is the proper term, out 
of the State to be used by recipients who are sicker. Is this 
true, Mr. Miller? If it is not true, please feel free----
    Mr. Miller. Well, it just so happens that we have a very, 
very busy transplant program in Florida, many status 1 
patients. So if I were to say what the net would be, the 
balance of trade for status 1s would probably be into the 
State. On the other hand, were there a status 1, let's say, in 
Emory in Atlanta, and we have the donor in Miami, that status 1 
would be sent to Atlanta.
    As a matter of fact, Dr. Payne just testified that the new 
algorithm for status 1 sharing was already in the pipeline as 
the Institute of Medicine was deliberating. So there was a more 
broader sharing of status 1s----
    Mr. Bilirakis. You said that. I suspect that Dr. Payne said 
that, too, and I apologize for not hearing his testimony. But 
Dr. Gibbons heard that. Is that true, were these changes in the 
pipeline during the times that you were deliberating and 
working up your report?
    Mr. Gibbons. There were changes that were made during the 
course of--towards the end of our report that were to some 
degree consistent with our recommendations. Our recommendations 
were broader sharing all across the board, not just for status 
1 patients.
    Also, what you are saying and what Dr. Miller is saying is 
completely consistent with our findings; that is, those States 
and those regions that started to institute broader sharing of 
one form or another had an increase, a statistically 
significant increase, in the overall transplantation rates of 
status 1 patients, making it more optimal, despite the fact 
that it was already quite equitable. There are status 1 
patients who are not receiving organs, and there are small 
organ procurement organizations in existence that are 
transplanting much higher rates of 2Bs and 3s that could 
ultimately go to status 1 patients in other organ procurement 
organizations within the limits of cold ischemic time.
    Mr. Bilirakis. My time is well up. We might--depending on 
how many more people return, we might go a second round here.
    Mr. Brown.
    Mr. Brown. Thank you, Mr. Chairman.
    Dr. Rabkin, in your testimony you said that the organ 
transplant policy should be left to the private sector 
transplant community. You basically argue, if I understand 
transplantation, communities should make virtually all or 
basically all allocation distribution decisions, correct?
    Mr. Rabkin. I think if you define the transplant community 
as it is currently structured, the answer yes would be correct.
    Mr. Brown. How would you define it?
    Mr. Rabkin. Well, the transplant community currently 
doesn't just consist of transplant surgeons and transplant 
physicians. It includes, most importantly, patients, patient 
families, donor families. It includes members of the community. 
So I think it is a very broad net. But I think all of these 
individuals have an interest and a knowledge and a commitment 
to the transplantation process. They understand the nuances, 
and they therefore--what has historically happened is they have 
derived an allocation policy that has been very effective and 
has brought transplantation to the point that it is today. It 
is a dynamic process, continuously evolving and improving.
    Mr. Brown. If those transplants are paid by Medicare or 
Medicaid, FEHP, the Federal health system, does that change the 
position that you take in terms of who should make these 
decisions?
    Mr. Rabkin. By the same token that we don't discriminate on 
a payor to decide who gets a transplant. It doesn't matter who 
is paying for it who should be making the decision on who 
should get a transplant.
    The answer is no. We are trying to help as many patients as 
we can with the limited resources that we have available.
    Mr. Brown. So with these decisions, spending taxpayer 
dollars, there should be no real public role of government and 
of representing taxpayers when taxpayers are paying huge 
amounts of money in a very profitable system, a system that has 
huge--all kinds of for-profit entities in this system, from 
doctors being very well paid to hospitals using it as profit 
centers, for-profit hospitals and in some cases not-for-profit 
hospitals, for other kinds of people in this allocation system 
which you describe very well. There should be no role for 
taxpayer government involvement in these decisions?
    Mr. Rabkin. No. That is not, in fact, what we believe. 
There is a role for government oversight.
    What I stated was that the allocation policy is a medical 
decisionmaking policy. It is similar to all other policies that 
take place currently in other medical fields. There is not a 
government bureaucracy deciding necessarily who gets treated 
with a particular illness and in what fashion. I think that 
there is a level of decisionmaking and oversight that does take 
place at the Federal level, but the allocation policy per se 
needs to be in the hands of the transplant community.
    Mr. Brown. Even though the allocation decisions affect 
large numbers of people, even people that--affects large 
numbers of people beyond perhaps what you very narrowly define 
as the transplant community, those decisions shouldn't be 
overseen by the HHS or shouldn't be formed or formulated in any 
way by HHS?
    Mr. Rabkin. I am not sure I really understand your 
question. I think that I have stated as best I can state that I 
try to segregate what we feel ought to be left in the hands of 
the transplant community, which is really the medical 
decisionmaking involved, as opposed to some of the----
    Mr. Brown. Let me take another direction for a moment. 
Adding that UNOS in this bill has an appropriation of $6 
million, so there is always government involvement when it 
comes to paying for it, the section, page 15 of the bill, this 
is my concern. I don't disagree with you in terms of the 
medical decisions. Clearly, the physicians and the nurses and 
the hospitals and the transplant--the patients all should have 
major roles in all of this. But on page 15, there is a section 
on gifts. ``this section does not prohibit the network from 
accepting gifts of money or services including gifts to carry 
out activities to provide for increase in organ donation.''
    On page 20 of the bill, ``Prohibition against organ 
purchases,'' insert after, ``does not include--does not 
include''--inserting after, ``does not include the following: A 
benefit, the exchange of which is expressly contemplated by 
organ distribution policies, demonstration projects.'' it goes 
on and on and on.
    My concern and a concern of a lot of us on both sides is 
the enormous profits that come from the terrific services that 
you as surgeons and the people that work with you--enormous 
profits generated in many cases. What drives this whole issue 
in part, I am not sure that we--I am not sure that we have 
protected the public when things like gifts are expressly 
allowed. Those gifts could take the form--some cases a gift to 
encourage people to donate perhaps, but in other cases gifts to 
steer people into major centers or to encourage--maybe if I am 
a wealthy potential beneficiary, recipient of a transplant, 
then I make a gift to a hospital and get moved up on the list, 
or my family does. We have to be extremely careful that--while 
you certainly want to do the right thing from your testimony, 
all of you do, that are physicians and nonphysicians alike, we 
need to be especially careful to not allow the for-profit drive 
in this to overwhelm what should become good public policy.
    Did you want to say something, Mr. Irwin, just a minute 
ago?
    Mr. Irwin. I just wanted to comment that I believe there 
are two levels of decisionmaking that go on here, or policy 
setting. One certainly is medical. From our perspective I don't 
think that we have an issue with that. For the most part, the 
medical allocation policies that distinguish status 1 patients 
from 2As, 2Bs, and 3s we feel is pretty well thought out. The 
problem is the public policy issue. With that medical criteria, 
how big of an attachment area do you use?
    The problem with the system today is you have--because of a 
varying number of factors, you have relatively small allocation 
areas where relatively healthy patients are being transplanted, 
where sicker patients are not being transplanted in fairly 
close proximity, which really is contrary to the medical 
allocation decision that the sickest patients should be given 
priority.
    The other concern that we have in our experience is just 
the way these decisions are made by the OPTN contractors' 
board. There seems to be a lot of self-interest that comes out 
in the discussions at the board level to the point where 
sometimes recommendations from committees that explore this 
issue are overlooked or overruled despite the fact from our 
perspective they make pretty good sense from a public policy 
perspective.
    Mr. Brown. Thank you, Mr. Chairman.
    Mr. Bilirakis. I thank the gentleman.
    Mr. Bryant.
    Mr. Bryant. Thank you, Mr. Chairman. I apologize to this 
panel for being a little bit late. We were involved in another 
committee, and I have missed some of the testimony. For that 
reason I would ask Mr. Irwin, if you have a microphone handy 
there, you represent NTAC. Is that the correct----
    Mr. Irwin. Yes, the National Transplant Action Committee.
    Mr. Bryant. Does NTAC in any way coordinate its activities 
with the University of Pittsburgh?
    Mr. Irwin. Mr. Bryant, we coordinate our activities with a 
lot of institutions and patients around the country. We have--
we speak with and work with Mount Sinai Medical Center, with 
the University of North Carolina. We have received a 
contribution last year from Jackson Memorial Hospital in Miami. 
I work with Stanford and University of California, San 
Francisco. And yes, we coordinate our activities with all of 
these institutions, including the University of Pittsburgh.
    Mr. Bryant. Thank you.
    Mr. Chairman, if I could, with unanimous consent I have a 
six-page document that is various memoranda from the University 
of Pennsylvania and a one-sheet, two-sided letter from Mr. 
Livingston, our former Member, former Chairman of the 
Appropriations Committee. I would like to----
    Mr. Bilirakis. Is that University of Pennsylvania or 
Pittsburgh?
    Mr. Bryant. It could be Pennsylvania, UPMC. I think that is 
University of Pittsburgh.
    Mr. Bilirakis. Okay. In any case, without objection, but 
that is a part--well, I am not sure. Anyhow, that is part of 
the record.
    Mr. Bryant. Thank you.
    [The information referred to follows:]
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    Mr. Bryant. The concern I had, quite frankly, Mr. Irwin, is 
that in this confidential memorandum, it is discussing various 
strategies in lobbying Congress and getting people to write 
letters, which I assume would be taking a position consistent 
with the University of Pittsburgh.
    It mentions that Charlie and Craig mentioned it is more 
critical than ever for legislators to hear from their 
constituents. And then Craig and Charlie have identified the 
following members of the House and Senate Appropriations 
Committees as initial targets because of their views in the 
district.
    So it looks to me like you have been coordinating 
strategies that I assume would make NTAC consistent with taking 
the position consistent with the University of Pittsburgh?
    Mr. Irwin. Certainly, Mr. Bryant. The same thing is 
happening on the other side of this issue with the opposition.
    Mr. Bryant. I have no doubt. I just want to be transparent.
    Mr. Irwin. In addition, I would like to state that we do 
have membership around this country, and we rely on volunteers 
and that membership to also help us in a variety of areas.
    Mr. Bryant. Does--do you--you are an active lobbyist for 
the year 1998. During this particular year, and including the 
year that you wrote the letter about former Chairman 
Livingston, were you officially lobbying? Were you registered 
as a lobbyist in 1998?
    Mr. Irwin. The National Transplant Action Committee has not 
filed as a lobbyist. The work that I do I do through a private 
company. And as directed by law, this is a company that I 
started with Mr. Charlie Fisk that does a variety of services 
in the transplant field. As appropriate, we have filed papers 
with respect to the lobbying act.
    Mr. Bryant. For year 1998?
    Mr. Irwin. Mr. Bryant, off the top of my head, I can't tell 
you exactly. I think we filed in 1997 because we did have some 
considerable expenditures, but I know in the last year I can't 
tell you whether or not we met the criteria or not.
    Mr. Bryant. Could you tell me if either you or Mr. Fisk are 
being paid by the University of Pittsburgh to testify?
    Mr. Irwin. No. I have never been paid by the University of 
Pittsburgh to testify.
    Mr. Bryant. And Mr. Fisk?
    Mr. Irwin. No.
    Mr. Bryant. Dr. Raub, if I might ask you some questions 
also. At last year's hearing there was a great deal of concern 
that the regulations would force the closure or have a severe 
negative impact or small and medium-size transplant centers who 
are performing these vital services. The Secretary at that time 
assured this committee that she would make certain that 
regulation would not have that effect. Specifically, the 
Secretary was asked by Senator Frist, ``Would you be willing to 
provide assurances and regulation if possible that you are not 
asking the UNOS or whoever the contracting agency might be for 
a policy that would result in the center's closing,'' end of 
question.
    The Secretary responded, ``The answer is yes. As best I can 
tell, the IOM report was less than convincing that these 
regulations would not have such an impact citing conflicting 
studies.''
    My question is are you willing to give this subcommittee 
the same assurances that the Secretary did last year?
    Mr. Raub. Sir, the final rule as published in April 
includes the provision that, when the OPTN develops the 
proposed allocation policies, it take into account and make an 
assessment of the likely impact on those small centers. The 
basis of that provision is to fulfill the Secretary's 
assurance. It is not our desire to close small centers.
    Mr. Bryant. That would be then--you feel that would 
adequately protect the small centers?
    Mr. Raub. We do, sir.
    Mr. Bryant. Mr. Chairman, is my time up?
    Mr. Bilirakis. It is. If you would like an extra minute or 
so, with unanimous consent, we will be glad to grant it. I do 
want to finish. Hopefully, we will finish up before the vote 
comes up on the last amendment on this particular bill on the 
floor. Please proceed if you would like.
    Mr. Bryant. If I could have unanimous consent for one 
additional question?
    Mr. Bilirakis. Without objection.
    Mr. Bryant. Dr. Raub, we are all aware of the substantial 
debate generated by the Department's April 2, 1998, final rule. 
I understand that you have conducted a series of meetings with 
the transplant community aimed at identifying a reasonable 
compromise all parties can live with. It is also my 
understanding that as part of the process, the Department has 
indicated on several occasions its intent to reissue 
modifications to the April 2, 1998, final rule, but has not yet 
actually done so. Specifically, your letter of August 30, 1999, 
to the transplant community stated that ``I intend to move 
vigorously in cooperation with the transplant community to put 
a modified final rule in place--''and this is important--``and 
to bring about the changes in the regulation that could and 
should be made.''
    Why then, when we find ourselves less than 1 month from the 
expiration of the current moratorium, has the Department not 
yet issued anything in writing to indicate the proposed 
modifications of the final rule? Are we running out of time?
    Mr. Raub. Sir, in considering the public comment, the IOM 
report, and the meetings with the representatives of the 
transplant community, the Department has made several 
determinations. One is that the core principles and provisions 
as embodied in the rule are sound. Second, these interactions 
have helped us identify a number of areas where some refinement 
or revision or other clarification in the rule would make it 
better and would be responsive to many of the concerns. I 
indicate two examples in my prepared testimony.
    Third, the intent of the Department, by the time of the 
date of the end of the moratorium, is to have those revisions 
in place and be prepared for that revised rule to go forward.
    Mr. Bryant. If I might follow up, on a time line, when 
would we see this?
    Mr. Raub. I can't state a precise time line other than that 
our intent is to meet the end of the moratorium and to have 
these revisions in place at that time.
    Mr. Bryant. Can you identify for this subcommittee those 
aspects of the rule that you plan to change?
    Mr. Raub. Just elaborating on one of the examples in the 
testimony, both the IOM report and a number of the public 
comments indicate a desirability of some sort of scientific 
expert independent advisory panel. We believe that is an 
intriguing idea. We are considering the number of variants that 
have been proposed for that. We are looking at that in the 
context of the Federal Advisory Committee Act. That is an area 
that we are pursuing very seriously.
    Also, our colleagues on the outside have pointed to the 
various sentences in either the rule or the preamble that have 
caused them to conclude, incorrectly, that the rule calls for a 
national list, that it overrides the decisions of physicians 
with respect to which patients to transplant. We are looking 
hard at that language. That was not the intent of it. To the 
extent that we identify an ambiguity and can clarify that, we 
will do so.
    Mr. Bryant. Thank you, Mr. Chairman.
    Mr. Rabkin. Mr. Chairman, would it be out of order for me 
to just ask a question?
    Mr. Bilirakis. Who asked that? A question of whom, of Dr. 
Raub?
    Mr. Rabkin. Yes.
    Mr. Barrett. Mr. Chairman, there is 10 minutes until the 
next vote.
    Mr. Bilirakis. If you are going to ask questions, sir, 
without--this is out of the ordinary, but do it quickly. And 
respond to very----
    Mr. Barrett. I would like to object until we are done with 
our questioning, if I could.
    Mr. Bilirakis. Okay. The objection is heard, so you can't 
do it.
    Mr. Barrett.
    Mr. Barrett. Thank you, Mr. Chairman. I don't mean to be 
rude. If we have time, I would be happy to let you do it.
    Mr. Irwin, you begin your testimony by saying you are a 
consumer advocate of the National Transplant Action Committee 
as a consumer advocacy organization; is that correct?
    Mr. Irwin. Yes.
    Mr. Barrett. What percentage of your funds comes from 
consumers?
    Mr. Irwin. Off the top of my head, I couldn't tell you.
    Mr. Barrett. Would it be fair to say that over 90 percent 
comes from hospitals?
    Mr. Irwin. Not that much.
    Mr. Barrett. Can you give me a ballpark figure?
    Mr. Irwin. It is like moving--a moving target. What I can 
tell you is we recently did a fund-raiser in our community with 
about 200 volunteers that raised about $30,000. I would say 
maybe 60 percent.
    Mr. Barrett. Dr. Rabkin, the Patient Access Coalition, I 
assume the lion's share of your money comes from hospitals as 
well?
    Mr. Rabkin. That is correct.
    Mr. Barrett. I say that because we are all on our best 
behavior, and we are all trying to be nice to each other, but 
we are fighting about money, and we shouldn't forget that.
    I would like to sort of invite you in and have you sit with 
me and pretend for a moment that I am a hospital administrator 
that is affected by this rule. We have been spending $200,000 
on an organ procurement outreach network in our community. This 
new rule comes down that says from here on in the organs will 
not stay in our region, they will be shipped across the 
country. Correct me if I am wrong, but as I am sitting here 
with my surgeons, my nurses, and my other hospital 
administrators, I am going to say, zero out that $200,000 in 
organ procurement, that is no longer a priority. Put that 
$200,000 into developing a waiting list of the most critical 
patients. Won't I do that, Dr. Raub?
    Mr. Raub. I see that as a possible decision, sir, but I 
couldn't state it with certainty that it would or wouldn't be.
    Mr. Barrett. Dr. Gibbons, what would you do if you were 
administrator of that hospital? Would you put money into organ 
procurement, or would you put it into developing a waiting 
list, if you were running a hospital?
    I am asking what you would do. Data shmata. What would you 
do?
    Mr. Gibbons. I only do data, sir.
    Mr. Barrett. You look remarkably like a human being, so I 
am asking you what you would do if you were the hospital 
administrator.
    Mr. Gibbons. If I were the hospital administrator, sir, I 
would note that increased broader sharing has actually 
increased donation rates, and that to ship an organ across the 
country doesn't make an awful lot of sense given cold ischemic 
times and the----
    Mr. Barrett. $200,000, where would you put that money, 
putting patients on a waiting list or procuring organs that 
might by shipped across the country?
    Mr. Gibbons. I would put it into procuring organs because I 
don't believe that those organs would be shipped across the 
country. I think broader sharing is a good thing, and 9 million 
people is not so large that it reaches----
    Mr. Barrett. Okay. Mr. Gibbons.
    Mr. Gibbons. That is me.
    Mr. Barrett. Mr. Irwin, what would you do?
    Mr. Irwin. It doesn't make sense to try to buildup your 
waiting list if you don't have the donors to service it.
    Mr. Barrett. But aren't we putting together a beautiful 
system for a free rider in pure economic terms, someone who 
says, well, I am not going to worry about organ procurement 
because I gain nothing. I gain nothing from organ procurement--
in the most selfish way. Maybe in the global picture we do, but 
I am concerned about my center here. And so the ticket to 
success under this system is to develop a waiting list.
    Wouldn't we agree with that, the ticket to guaranteeing 
patients under this new system--guaranteeing patients under 
this new system is not getting organs, the ticket is getting 
sick patients. So if I am a rational economic actor, I am going 
to be putting my effort into getting sick patients. I think 
that has a devastating impact on the supply of organs.
    Mr. Irwin. If you still want to hear from me, let me make a 
couple of comments.
    First of all, organ donation rates certainly vary 
throughout the country. I don't see any evidence that 
transplant centers or OPOs with larger waiting lists are less 
aggressive or more aggressive in trying to find donors. I think 
everybody in this system works hard to maximize organ donation.
    Second of all, I think you will find that in many cases 
patients who do end up--who are sick patients who end up in a 
larger center, they are there because they are turned down by 
another center who doesn't have the expertise or the 
willingness to transplant them.
    Third of all, I think if you look at the data, transplant 
centers that do transplant fairly sick patients in many cases 
have survival rates that are on a par or even better than 
transplant centers that transplant healthy patients.
    Mr. Barrett. If I may, Mr. Chairman, I know that time is 
short. I also want to make this point. This is from Mr. Irwin's 
testimony commenting on the IOM study. Quoting, ``Broader 
sharing of organs resulting from implementation of the final 
rule is not likely to have a significant adverse effect on 
those who depend on Medicaid for their health care.''
    I don't read that as a ringing endorsement that we are 
going to improve access to the poor. That is one of the things 
that we have had discussions here. To say that it is not going 
to have a significant adverse effect certainly leaves the door 
open that it is going to have an adverse effect. With 
minorities in particular, the committee found, ``that African-
Americans do not receive kidney treatments as quickly as 
whites,'' and that the Department's rule would not exacerbate 
this problem. It doesn't say it will improve the problem, it 
simply says it is not going to make the problem worse.
    So again, I think as we talk about minorities, about the 
underserved, that no one should leave this room thinking that 
the Department's rule is somehow helping minorities and the 
poor based on IOM's own statement.
    I would yield back the balance of my time.
    Mr. Bilirakis. Mr. Green.
    Mr. Green. Thank you, Mr. Chairman, and I will be as quick 
as I can.
    My first question is for Dr. Miller and Dr. Payne. I am 
concerned that OPOs have not shown a willingness to share 
organs with other OPOs or States within their closed region 
unless they do not have any match within their own area. This 
practice is--the Institute of Medicine found it could have a 
negative impact on all patients who may lose the opportunity to 
receive a life-saving organ based solely on their location.
    In your testimony, you mentioned that the OPTN had already 
begun to implement some of the IOM recommendations as they 
relate to organ sharing. Would you comment in greater detail on 
the steps that have been taken? Are there plans to take or 
encourage or require broader sharing of organs by OPOs within 
reasonable geographic boundaries?
    Remember, I am from Texas. We are pretty big. We have three 
OPOs in our own State, and geographically there is no relation 
to their areas.
    Mr. Miller. Dr. Payne is going to be able to do this better 
than I. I would like to comment, though, if I might. The reason 
is he is the president of UNOS this year. I think that is 
important. That is where this process occurs.
    However, we have felt the impact and are going to feel more 
of this impact because of broader sharing, and it has to do 
with the most urgently ill patients needing it. It is going to 
be regionalized rather than localized so that in a region--for 
instance, we are in a very large region in Florida that 
consists of Florida, Alabama, Georgia, Louisiana, Mississippi. 
We are talking about a large region that has much more than 9 
million people. That region has developed methodologies now to 
attempt to share status 1--liver status 1 patients.
    May I make one comment about this local effect on organ 
donation, because there has been actually statements made by 
both the esteemed Congressmen here as well as some of my 
colleagues at this table that have actually put words into the 
IOM's mouth, so to speak. IOM came out with a statement that 
was very perceptively stated by Congressman Bilirakis, our 
chairman, that said that it was inconclusive as to whether 
there would be an effect or not on local organ retrieval or 
closure of local programs. Inconclusive. They did not say that 
there would not be an effect.
    Now, if you were to ask experts in this field, the majority 
of the American Society of Transplant Surgeons feel that there 
would be an effect. We came out with a white paper about that. 
That word is very important because it is a word that is used 
by--if you will forgive me--statisticians who do not wish to 
make mistakes. It is very important that they don't.
    Mr. Bilirakis. Doctor, would you submit that white paper 
for the record?
    Mr. Miller. It has been submitted, and we will do so again. 
It was our first paper on this when the----
    Mr. Bilirakis. Please do so. The staff is not certain.
    [The information referred to follows:]
   Prepared Statement of the American Society of Transplant Surgeons
 on efforts to resolve the controversy over the organ procurement and 
                        transplantation network
Introduction:
    On October 21, 1998, a Congressionally ordered moratorium went into 
effect on implementation by the U.S. Department of Health and Human 
Services (DHHS) of the Final Rule published by HHS Secretary Donna 
Shalala in the Federal Register on April 2, 1998 (42 CFR Part 121). 
This one-year moratorium is scheduled to end on October 21, 1999 unless 
further extended by the U.S. Congress. In imposing the moratorium, 
Congress asked the Institute of Medicine (IOM) and the General 
Accounting Office to conduct a study of current policies of the Organ 
Procurement and Transplantation Network (OPTN) and the potential impact 
of the Final Rule. An IOM Committee was formed to conduct this study in 
early 1999, and it published a report, entitled ``Organ Procurement and 
Transplantation: Assessing Current Policies and the Potential Impact of 
the DHHS Final Rule,'' on July 20, 1999.
    The American Society of Transplant Surgeons (ASTS), as the 
professional organization representing the surgeons, physicians and 
scientists who lead the transplant programs at the major medical 
centers across the United States, is committed to the continuing 
refinement of organ allocation policies to meet the needs of our 
patients. During the past 18 months, we have expressed both strong 
support for and strong opposition to various aspects of the Final Rule. 
We have met repeatedly with leaders of DHHS, have testified on this 
subject at hearings conducted by the U.S. Senate and the U.S. House of 
Representatives, and have both testified before and provided voluminous 
written information to the Institute of Medicine during its 
deliberations in the spring of 1999.
    We believe, based on numerous conversations, that an increasingly 
broad consensus exists among members of the transplant professional 
community on many of the most contentious aspects of the Final Rule. We 
believe if a new Final Rule were to be published today, it would not 
contain some of the elements that ASTS has most vigorously opposed. 
DHHS itself has stated that it intends to publish some number of 
unspecified changes to the Final Rule at some unspecified time prior to 
implementation. We are increasingly apprehensive, however, that the 
transplant community--and Members of the U.S. Congress, which is 
concluding its 1999 Session--will not see the proposed changes in a 
timeframe that would enable Congress to again legislatively defer 
implementation of the Final Rule if the changes are not found to be 
sufficiently responsive to our concerns.
    While we do not propose in this position paper to repeat all of the 
points ASTS has made in published position statements and testimony, we 
would like to highlight the major concerns we have been discussing with 
DHHS--and our views on recommendations of the IOM Committee. We also 
urge Secretary Shalala to immediately publish the changes she proposes 
to make in the Final Rule. Given that the one-year moratorium is near 
an end and we still have not seen any proposed changes, we believe that 
when publication of changes by DHHS finally does occur, a reasonable 
period of time for consideration of, and reaction to, these changes by 
the transplant community--and Members of Congress--prior to 
implementation is both fair and essential.
NOTA and Secretarial Authority:
    The most difficult area to resolve in our discussions with 
representatives of DHHS has been the question of Secretarial authority. 
We strongly believe the National Organ Transplant Act (NOTA), which was 
passed by Congress in 1984 and established the OPTN in the private 
sector under government contract, intended for the OPTN to make organ 
allocation policy based on sound medical principles and scientific data 
independent of political influence. This important principle is 
reaffirmed in the NOTA reauthorization legislation introduced this 
summer in the U.S. House by Chairman Michael Bilirakis and we hope that 
the legislative consideration of NOTA Reauthorization will move forward 
in the coming year.
    Let us be clear that ASTS supports preservation of the Secretary's 
legitimate oversight role. Three of the five specific recommendations 
included in the IOM Committee's report addressed the area of oversight 
and review. The committee concluded that ``oversight and review of the 
nation's organ procurement and transplantation system needs to be 
enhanced to improve the system's accountability to the public and to 
ensure that it operates effectively in the public interest.'' We 
endorse Recommendation 8.1 (Exercise Federal Oversight) and we stand 
ready to assist DHHS in defining and updating performance standards for 
the OPTN, OPOs and transplant centers.
    We simultaneously recognize and support the responsibility of the 
OPTN to make specific organ allocation policy based on sound medical 
principles and scientific data. We have expressed to DHHS our concerns 
that sections 121.4 (b) and (d) could be interpreted as setting the 
stage for the Secretary of DHHS to make specific allocation policy, and 
have suggested changes in these sections to clarify the respective 
roles. DHHS's oversight responsibility should be to ensure that the 
policies that guide the operation of the system are equitable, based on 
sound medical science, and are adhered to. However, the Secretary must 
not dictate specific transplant practices or medical judgments. The 
OPTN's responsibility is to make specific policy concerning allocation 
and to modify that policy on the basis of sound medical science and 
developing medical practices.
Independent Scientific Review:
    We believe IOM Recommendation 8.2, that the Department ``establish 
an external independent, multidisciplinary scientific review board,'' 
has great merit. We agree with the committee that the organ allocation 
system should be reviewed periodically by an independent body separate 
from the OPTN. Obviously, a number of key issues remain to be 
addressed, including the makeup of this board, how members would be 
appointed, and what issues the board would review.
    To be truly independent, we believe it important that the 
independent scientific review panel not be appointed at the sole 
discretion of the Secretary, and since this panel will be reviewing 
issues of medical judgment, we believe it imperative that this panel 
consist of not more nor less than 50 per cent transplant surgeons and 
physicians active in the field of transplantation. We believe an 
appropriately composed body could bring medically sound resolution to 
difficult or contentious problems through careful objective review. We 
would then expect the Secretary and the OPTN to work together to 
develop solutions based upon recommendations of this body. We are 
prepared to suggest appropriate scientific experts to participate in 
these reviews.
Standardized listing and de-listing criteria:
    The transplant community currently recognizes the need for 
standardized listing criteria, de-listing criteria and criteria for 
determining medical status. It is clearly within the purview of the 
OPTN to develop these criteria, and to continually refine them based 
upon changes in clinical care resulting from advances in medical 
science. We believe the Final Rule should instruct the OPTN to develop 
standardized listing and de-listing criteria, and to develop a process 
for both prospective and retrospective review for compliance. It should 
also provide a mechanism for funding prospective review, such as an 
increase in listing fees. In this area, we would expect that DHHS would 
be in a position of enforcing sanctions for non-compliance, and we urge 
that the language of the Final Rule be changed to clearly reflect this.
Evaluation and Enforcement:
    We totally agree that allocation and other policies, such as 
standardized listing and de-listing criteria, must be enforced. 
However, as noted in section 121.10, the only enforcement currently 
specified would involve relatively harsh penalties, including 
termination of a transplant hospital's participation in Medicare or 
Medicaid, or termination of a transplant hospital's reimbursement under 
Medicare or Medicaid.
    We believe the Rule should direct the OPTN to make recommendations 
on graduated enforcement options, and work with DHHS to develop a 
process for corrective action prior to imposition of severe sanctions. 
Among the issues to be addressed is due process, including at what 
level of enforcement Secretarial approval is required prior to 
imposition of penalties.
Organ specific allocation policies:
    We have previously emphasized the important principle that 
different organ transplants require different allocation policies. The 
IOM report is careful to make recommendations about liver 
transplantation only. Objective criteria of disease severity may be 
relevant to organs in which there is no suitable life support system, 
such as livers or hearts. These types of criteria may have no relevance 
to other organ transplants, such as kidneys or pancreata, for which 
there are suitable support techniques. We urge the Secretary to review 
the Final Rule and indicate that other principles may apply to such 
organs.
Reducing Socio-Economic inequities:
    We are encouraged by the IOM report's conclusion that ``the most 
important predictors of equity in access to transplant services lie 
outside the transplantation system--that is, access to health insurance 
and high-quality health care services. Thus we are concerned that 
Section 121.4, subsection (3) of the final rule may seem to place a 
too-heavy burden on transplant hospitals and OPOs. Specifically, we 
propose that subsection (3) be changed to: ``(i) Ensuring that patients 
in need of transplant are listed without regard to source of payment. 
(ii) Procedures for transplant hospitals to make reasonable efforts to 
obtain from other sources . . .''
OPTN Board Composition:
    The final rule in Section 121.3 mandates an OPTN Board with a 
minimum of 30 members. Two seats are specifically allocated to 
transplant surgeons and two to transplant physicians. It provides that 
``transplant candidates, transplant recipients, organ donors and family 
members'' shall comprise ``at least 25 percent'' of Board members; and 
that transplant surgeons and transplant physicians shall comprise ``no 
more than 50 percent.'' We strongly believe that because of the 
technical and scientific as well as ethical and social problems 
continuously occurring in this field, transplant physicians and 
surgeons should comprise no more nor less than 50 percent of the 
membership of the Board.
Allocation of Organs:
    In 1998, DHHS contended that differences in the median time that 
patients spent waiting for a transplant at various centers demonstrated 
a fundamental unfairness of the current allocation system, and argued 
on that basis for immediate implementation of the Final Rule.
    ASTS has always taken the position that waiting times as used by 
DHHS were not a good indicator of fairness, and totally agree with the 
data analysis performed by the IOM Committee which clearly indicates 
that waiting time is not a reasonable measure of equity of allocation 
for patients nor is the disparity of overall median waiting time a 
reasonable measure of fairness of the current system.
    But while we do not believe that waiting times as currently used 
are an appropriate performance measure, we are not--in the absence of a 
better methodology--prepared to totally endorse the IOM Recommendation 
to ``discontinue use of waiting time as an allocation criterion for 
patients in Status 2B and 3.'' We believe waiting times might continue 
to be one consideration in the triage of liver patients in Status 2b 
and 3 when all other medical criteria are equal.
    Thus, we recommend that certain sections of 121.8 be revised. As we 
have previously stated, neither time waiting nor medical urgency can be 
considered absolute measures of equity for allocation of all types of 
organs for transplantation. For these reasons, we would suggest that 
the final rule contain general principles of equity, and suggest that 
it be left to the OPTN to develop the specific policies that achieve 
equity.
Record Maintenance and Reporting Requirements:
    We endorse IOM Recommendations 8.3 (Improve Data Collection and 
Dissemination). We strongly agree that physicians, patients and the 
public should have access to accurate, understandable, and timely 
information regarding performance of the OPTN, OPOs and transplant 
centers. However, the provisions in Section 121.11 mandating that 
updated data be made available to the public ``no less frequently than 
every six months . . . and shall be presented no more than six months 
later than the period to which they apply'' are not currently 
realistic. We propose that data be collected annually. The one-year 
border will likely lead to more accurate and efficient reporting. We 
also propose that data made available within one year after the period 
to which it applies, but that it be made available more quickly at a 
time when implementation of improved systems make this possible. Within 
two years of the date of implementation of the Final Rule, we believe 
it should be possible to make data available no more than six months 
later than the period to which the data applies.
    It is extremely important that the Secretary assure that any 
release of data be done in a manner that preserves the confidentiality 
of individual patients and donors. Understanding that organ 
transplantation is performed infrequently even in the busiest centers, 
identification of the date and location of a procedure could 
simultaneously identify the donor and recipient. Thus, in some 
circumstances, appropriate coding of some information may be necessary.
Organ Allocation Units:
    We believe that Recommendation 1 (Establish Organ Allocation Areas 
for Livers) is deserving of further study and would urge the 
Secretary--even prior to issuance of the Final Rule--to direct the OPTN 
to present an analysis on those areas where broader geographic sharing 
is now in effect and possibly even conduct tests in certain geographic 
areas based on this recommendation. Although the report of the IOM 
committee found no evidence that supports the concerns that wider 
sharing--or disassociating organ retrieval from organ allocation--would 
lead to decreased donation or closure of small programs, further study 
is required before such a conclusion can be drawn. There is no question 
that several OPOs serving relatively small population areas have 
achieved some of the best donation rates, while other OPOs do not have 
comparable rates of donation. This would suggest that local factors may 
well influence organ donation, a very complex and delicate system, and 
that changes should be made with extreme care. Therefore, to the extent 
that steps are taken either to broaden organ allocation areas or 
disassociate organ retrieval from organ donation, we recommend that any 
change in policy be reviewed by the OPTN within one year, and at yearly 
thereafter, for its impact on patient outcomes, organ donation rates 
and transplant center volumes. We suggest that the OPTN might also 
undertake studies to determine whether the same principle of 
population-based allocation areas might improve the system of 
allocation of other organs.
DHHS and OPTN:
    The report of the IOM committee clearly supports complementary 
roles of DHHS and the OPTN in the transplant system. Unfortunately, a 
variety of issues have led to substantial discord between the two 
organizations. While we understand the positions of the two parties and 
have commented on them previously, we believe it is critical to the 
transplant community that these disputes be ended. We are encouraged by 
Secretary Shalala's announcement that DHHS is prepared to make 
alterations in the Final Rule, and urge her to publish those changes 
for consideration by the transplant community and the U.S. Congress at 
the earliest possible date.

September 16, 1999

    Mr. Bilirakis. Please proceed, Mr. Green. I am sorry for 
interrupting.
    Mr. Green. Dr. Payne?
    Mr. Payne. My comments regarding wider sharing----
    Mr. Green. Wider sharing within the region. I am not 
familiar with southeast Texas, but I am in the Southeast of the 
United States but understand Texas and sharing within the 
region, if not nationally.
    Mr. Payne. If I could just preface the answer with a little 
explanation about OPO boundaries, because I would hate for UNOS 
to be saddled with the present OPO boundaries. Those boundaries 
were established by HHS at the point that they were established 
through HCFA. They were approved by HCFA. So those OPO 
boundaries were out of the purview of UNOS at the time.
    Mr. Green. My concern, though, is that the goal, I think, 
was to regionalize it; not nationalize it, but regionalize it.
    Mr. Payne. One of the first policies that UNOS adopted that 
extended sharing beyond OPO boundaries was that of identically 
matched kidneys. That truly is a national program where if a 
kidney is made available anywhere in the country, and it is a 
so-called perfect match with anybody on the waiting list, every 
effort is made to get it to that particular patient. If more 
than one patient is identified, the patient waiting the longest 
gets that organ. That is a long-standing program that is 
available and takes it--expands all OPOs in the country. That 
is an extraregional sharing agreement.
    Mr. Green. That is for kidneys. That sounds like what HHS 
might be wanting to do. I am a cosponsor of the bill, and I am 
concerned about what may happen in my own State.
    Mr. Payne. The point there is that there is efficacy in 
doing that. There is demonstrated improvement in outcome, so 
there is an effort made to do that, plus it is possible to do 
that with kidney transplants because the cold ischemic time 
that we heard about is not as critical in kidneys. They can go 
longer, so you have the time to do it. In a liver transplant, 
it is much more difficult to set up some sort of that broad 
sharing scheme.
    So there have been stepwise attempts in regions around the 
country to broaden sharing agreements across OPOs. Many of 
them, they have been permitted by UNOS. Now, most recently the 
policy that has been put in place nationally is that it will 
mandate regional sharing, meaning the 11 UNOS administrative 
regions for status 1 liver transplant recipients. Again, that 
is because of the effectiveness of that for that particular 
patient population. Those patients have a demonstrated benefit.
    Earlier on, Dr. Gibbons was talking about the differences 
between equity and effectiveness, and in that case there is a 
real effective change in going from that 4 days that people 
average down to 2 days. Everybody moves together. There is no 
change in equity. Everybody waits the same amount of time, but 
everybody wins in terms of effectiveness in terms of that 
patient.
    Mr. Green. Thank you, Mr. Chairman. I see my light on. 
Since we haven't had a call for a vote, I have one question----
    Mr. Bilirakis. Without objection, I have no problem with 
you asking that additional question.
    Mr. Green. Thank you, Mr. Chairman.
    Dr. Raub, you mentioned that proposed provisions, we won't 
have to wait much longer. But again, this legislation and 
Congress is going to have to act before October. It concerns me 
that we don't have those revisions now so that we can look at 
them and see what may need to be done. But that leads into, 
both for the administration and UNOS and the rest of the panel, 
that we have been dealing with this in delaying the 
effectiveness of the final rule. There has been--in earlier 
hearings there was effort to have both sides sit down and work 
together to see how we could come up with something that would 
be, and to this date I guess we haven't.
    Has there been efforts between the administration and HHS 
and UNOS and the various groups to actually sit down and see 
how this could be worked out?
    Mr. Raub. Sir, repeated discussions and meetings have been 
held with both oral and written comments. As I indicated in my 
testimony, the Department has considered very seriously all of 
those comments and has identified some areas where, while not 
modifying the core principles or provisions of the rule, we 
think some refinements would improve it. And we are working 
hard to get those formulated before the moratorium date ends.
    Mr. Green. Thank you, Mr. Chairman. Any other comments 
from--everyone else has a dog in the fight, so to speak.
    Mr. Miller. The American Society of Transplant Surgeons has 
met with the Department very recently. My colleague, the 
president of the society, Dr. Busuttil, met with Dr. Fox.
    We are concerned that we will not see this rule until the 
very last minute. There may be language in the rule that still 
might be improved upon. This is of great concern to us.
    Mr. Rabkin. Mr. Green, I would like to echo that thought 
and say that after having such a long period where we have had 
an opportunity to meet with the HHS and failed up to this date 
to have any concrete proposal for change, it troubles us as 
well in the PAT Coalition that we will not have the opportunity 
to weigh in and make suggestions for refinement. As an example, 
Dr. Raub pointed out that the IOM suggested an independent 
panel to be set up to look at some of these issues. In fact, 
then he went on to mention implementing the Federal Advisory 
Committee Act.
    Well, the problem that we would immediately recognize is 
that under that act it is directly under the Secretary's 
discretion, it is advisory, and, frankly, we don't understand 
how that would add any benefit if it is not an independent 
panel. I think if you read the IOM report, they are very 
explicit, it needs to be an independent panel. So again, as an 
example, if the HHS comes forward at the 11th hour with a 
proposal, but has these nuances of the interpretation that it 
would be put forward in policy, that would be clearly 
objectionable to the members of the PAT Coalition.
    Mr. Green. Thank you, Mr. Chairman.
    Mr. Bilirakis. Well, Mr. Green, you brought up a point 
certainly that I have been concerned with. We had all hoped--
again, we are an ivory tower here. We use that term an awful 
lot, but it is true. We are required to make these tough 
choices and these tough decisions when, in fact, people are 
better capable of doing it than we are.
    So this is why we had hoped that the transplant surgeons, 
HHS would get together and work something out, and you haven't. 
I haven't been privy to those conversations, but frankly, in my 
mind, I really wonder whether HHS is willing to bend at all or 
just dead set on their ways. Again, I am not trying to belittle 
any efforts that HHS made in trying to work out these things 
and not resolving it and not having to pass legislation to do 
something that you all should be able to do, particularly when 
we hear of a bending on the part of UNOS in terms of some of 
these areas that have been pointed out.
    Can you, Dr. Raub--would you furnish to the committee a 
copy of those areas that you are contemplating changing that 
Mr. Bryant went into that somewhat? Will do you that?
    Mr. Raub. Yes, sir.
    Mr. Bilirakis. Can do you that within the next couple of 
days?
    Mr. Raub. I will do it as soon as we can, sir.
    Mr. Barrett. Mr. Chairman, just for my education, the 1-
year moratorium, when does that expire? Do we know the day that 
expires?
    Mr. Bilirakis. October 21.
    Mr. Barrett. I just want to say that I share the concern 
that we are going to see that about the same time we saw the 
Department's testimony.
    Mr. Bilirakis. Well, Dr. Raub, you indicated you have been 
working on this. Is there any reason why you can't furnish at 
least where you are at this point within the next few days? You 
will furnish it when you can. That might not be until late 
October.
    Mr. Raub. Some of the items are still in the early stages 
of crafting.
    Mr. Bilirakis. The moratorium is almost over, and they are 
still in the early stages of drafting. I sometimes wonder if--
well, sir, we need that information. I frankly think that the 
industry out there, the transplant industry, needs that 
information, and I think they need it long before to give them 
an opportunity--I mean, I don't think that they should be left 
with what we have been here today, not having seen the 
testimony until an hour before the hearing started.
    I say that with all due respect, but you should also 
realize that--well, I am going to ask that that information, 
whatever is available--and whatever isn't available, I guess 
you can't furnish--be submitted to this committee within--let's 
say within 7 days of today?
    Need 48 hours? Why?
    I am told that you have that information, and you are--all 
right, 48 hours. I am going to ask that it be furnished in 48 
hours. I don't think that we should have to go through any 
legal proceedings or whatnot in order to get that.
    Can you do that, what you have?
    Mr. Raub. I will convey that request, sir.
    Mr. Bilirakis. Please, Dr. Raub, do that. We want to do 
this the right way, the nice way.
    All right. A vote is being called on the floor. We have a 
number of questions--oh, yes. A statement here submitted by 
Charles Fisk; a statement here by Bruce Weir, Transplant 
Recipients International Organization, Inc., and a statement by 
Congressman Pete Stark. I would ask as the Chair unanimous 
consent those be made a part of the record.
    There are a number of questions as per always, as per usual 
that have not been asked, and we would like to furnish those to 
you in writing and request that you respond to them as quickly 
as you can, because, again, we are trying to do the right 
thing. I know there has been more adversarial taking place at 
that table there than frankly usually takes place up here, but 
believe it or not, we are trying to do the right thing. 
Whatever information you furnish to us could be helpful.
    The hearing is adjourned.Thank you. Thank you for your 
patience.
    [Whereupon, at 5:45 p.m., the subcommittee was adjourned.]
    [Additional material submitted for the record follows:]
    Prepared Statement of Charles Fiske, UNOS General Public Member
    Mr. Chairman and Members of the Subcommittee: Thank you for 
allowing me to submit written testimony on the reauthorization of the 
National Organ Transplant Act. I came before this committee in April of 
1990 and also April of 1993 to address issues about the national 
transplant system. My involvement in organ transplantation began in 
1982 when my then nine-month old daughter, Jamie needed a liver 
transplant. At that time there was not much of a system in place for 
matching donors with recipients. In addition liver transplants had not 
been performed on anyone as young as Jamie and since there were only 
two liver transplant centers in the country our family faced a 
difficult ordeal. Jamie was successfully transplanted in November at 
age eleven months at the University of Minnesota Hospital.
    The following Spring (April 1983) we came before then, Congressman 
Al Gore who was conducting hearing on the problems transplant patients 
faced. In the fall of that year Senator Orrin Hatch held hearings to 
learn of the ordeals that we and other families encountered while 
waiting for an organ to be found in time. Senator Hatch was familiar 
with Jamie's situation since the donated liver came from Jesse Bellon 
of Alpine, Utah. In 1984, President Reagan signed the National 
Transplant Act calling for a Task Force to study the issue. The task 
force concluded that a single national system would ensure that these 
national resources--donated organs--could be effectively allocated 
fairly to all needing an organ transplant. Since then, I have been 
actively involved in the issue and served on the UNOS (United Network 
for Organ Sharing--the federal contractor) Board of Directors for four 
years. Currently, I am one of only nine UNOS general public members. My 
observations and conclusions today are similar in some respects to my 
testimony previously presented before this same committee. We've come 
far but still have a long way to go to encourage the transplant system 
to be responsive to patients no matter who they are or where they live. 
The implementation of the HHS transplant regulations will take the care 
of patients to the next level. Passage of H.R. 2418 will be a step 
backwards in this process and should not be passed. Congress has 
directed that the single national system be response to all medically 
urgent patients especially those with the least access.
    Congress must again encourage and demand that the National 
Transplant System reflect the needs of the patient population first 
before serving the unique interests of any transplant center. I've 
always advocated that the system be fair so that those patients who are 
medically most urgent receive first attention. Patients should not have 
to chase organs but rather be assured that when their time comes for 
transplantation they, given their medical status, will have a fair 
chance of receiving an organ. Currently the system is based on local 
preference so that the available organ is given locally even if there 
is another more medically urgent patient in the next local area. If the 
organ can't be used it is distributed regionally and then nationally. 
Recently UNOS passed a resolution to have organs shared with status one 
patients (most medically urgent with seven days to live) within each of 
the eleven regions in the country. This is a good first step. 
Allocation determined primarily through geographic boundaries rather 
than medical urgency makes little sense especially if those organs can 
be safely transported greater distances. The wider allocation of organs 
needs to be expanded to include status 2A and 2B patients as well. 
There has been a marked increase in the number of transplant centers. 
As a result, with more patients needing transplantation the supply of 
available organs cannot meet the current demand.
    Congress needs to require that the national transplant system take 
the following steps:
    1) There should be greater oversight on the system to protect 
patients from the self-interests of transplant centers. The UNOS Board 
is comprised of many individuals who represent various transplant 
centers throughout the country. Often they are voting on policies that 
directly affect the financial interests of their own institutions. On 
the one hand the contractor is a membership organization and on the 
other a regulatory body. Over the course of years this has been a 
difficult task for the contractor. Greater oversight would assure the 
general public that the system is in operating the best interest of all 
patients whether they lived in New England or on the West Coast. That 
oversight involves the establishment of specific standards that not 
only protect the public but also assure the transplant community that 
there is a mechanism in place to encourage compliance with public 
policy directives. Only the Secretary can issue public policy that has 
the effect of law. Much of current debate over the NOTA reauthorization 
has to do with the confusion between the development of public policy 
and the practice of medicine. The current contractor and a number of 
transplant centers have determined that all transplant issues are 
considered the practice of medicine and are unwilling to respond 
positively to standards that have been established for the public 
policy purposes. Much energy has been spent circling the wagons to keep 
the Department at bay when in reality the public strongly supports a 
system that meets the needs of its most medically urgent. The 
transplant system is not the private domain of a certain select group 
within the transplant community but directly connected to all our 
citizens on whom we depend for organ donation. It is the general public 
through its patient registration fees and tax dollars that is fueling 
the system. To suggest that the National System can fairly operate on 
its own is both unrealistic and shortsighted. The recent border war 
over organ allocation between Wisconsin and Illinois is a prime example 
of special interests winning out over patients' interests.
    2) The most medically urgent patients must receive organs first. 
Distribution for organs for the most urgent category could be 
realistically done beyond the boundaries of our current systems at both 
the local level and the regional level. The recently completed 
Institute of Medicine studies found that the current system now 
operating could be greatly improved so that organs may be reaching to 
most medically urgent. The Institute of Medicine did find that the less 
urgent patients (Status 3) were being transplanted at the expense of 
those who are most medically urgent (Status 1)
    3) Data should be made available in a timely fashion. This data is 
not the private property of the federal contract and should be 
accessible to physicians and patients who make decisions on which 
center to approach for treatment. Data must be used to help drive 
public policy decisions so that parochial interests of the various 
transplant centers cannot come before the interests of patients.
    4) Patient registration fees should reflect the cost of helping run 
the transplant system rather that fuels the special interest and lobby 
efforts of the contractor.
    5) Greater steps need to be taken so that the ``green screen'' (no 
dollars, no transplant) affect is adequately understood as a major 
impediment preventing some patients from receiving care.
    Congress has the ability to require this be done. The public needs 
to have confidence in the system so that when organs are distributed 
each patient can receive an organ in a timely fashion when their turn 
becomes available.
    I'll submit copies of my prior testimonies from 1990 and 1993. 
Issues that were raised then are yet to be resolved. I would urge this 
Committee to look forward not only in fully supporting the HHS 
regulations but also encouraging the current contractor to take the 
immediate steps necessary to put an allocation system in place that is 
responsive to current needs of the general public. The clear and astute 
recommendations that have come forward from the recently published 
Institute of Medicine report on the transplant system have supported 
the Department's efforts to encourage the contractor to be more 
responsive to the needs of patients. Once the changes have been enacted 
a full reauthorization of NOTA is in order. A more comprehensive bill 
to include the recommendations of the IOM report, the OIG report 
(August 1999) and the April 1998 HHS regulations should be considered 
in the spring of 2000.
    Again I thank the Committee for the opportunity to present this 
information and I am available at anytime to review this matter with 
you.
                                 ______
                                 
  Prepared Statement of Bruce Weir, President, Transplant Recipients 
                    International Organization, Inc.
    I am submitting this testimony today on behalf of a vital segment 
of the national transplant system that has been, and still is, quite 
under-represented . . . the patients.
    In April of 1998, the Secretary of the Health and Human Services 
(HHS) issued a ``Final Rule'' that addressed certain areas in the 
present system that need improvement (allocation of organs, oversight 
of the system, to name a couple).
    United Network of Organ Sharing (UNOS), who holds the contract of 
the Organ Procurement and Transplant Network (OPTN), decided to fight 
these changes and the two sides became polarized. No gain for either 
side; and even worse . . . the patients lost. Many of the changes would 
have helped a patient's chances of being transplanted sooner. When 
things got to an impasse, UNOS then successfully lobbied Congress to 
issue a moratorium for one year, asking the Institute of Medicine (IOM) 
to study the Rule and the issues having been raised to see if the Rule 
had any merit. The IOM Report was issued on July 20, 1999 and generally 
supported the reasons the ``Final Rule'' was issued and debunked the 
untruths spread by its opponents. The moratorium expires October 21, 
1999.
    The very Congress that ordered the moratorium, not having yet 
studied or evaluated the IOM report, is now embarking on a mission to 
rewrite the law that established the OPTN, how it operates and what, if 
any oversight and authority the Secretary of HHS might or should have 
over the national organ transplant system.
    What I have seen of the proposed changes only heightens my 
concerns. This bill is greatly skewed in favor of OPTN and lessens the 
power and authority of HHS. There needs to be balance. This bill would 
create imbalance.
    I urge you all to seriously consider whether this is the time to 
even consider such changes. Transplant centers may feel these changes 
are necessary to help insure their future. This is not the time for 
patients--for while they are waiting, they have no future.
                                 ______
                                 
  Prepared Statement of Hon. Pete Stark, a Representative in Congress 
                      from the State of California
    Mr. Chairman: Thank you for holding this hearing today which will 
help educate Members concerning the need for a more effective and fair 
system of organ allocation.
    Every day 10 people die in this country waiting for an organ 
transplant. At least 65,000 Americans are currently awaiting an organ 
transplant. There is no disagreement about the problem--there aren't 
enough organs to meet the needs of patients. This Congress, I 
introduced legislation, H.R. 941, the ``Gift of Life Congressional 
Medal Act of 1999.'' This legislation encourages donations thereby 
making more organs available for potential donation. I hope Members 
would consider this effort to increase donations.
    In April of last year, after extensive public debate, the 
Department of Health and Human Services issued regulations intended to 
provide oversight for the nation's organ transplant system and to help 
guide the transplant community to create a fairer transplant system. 
The FY '99 Appropriations bill included a moratorium on the regulations 
until October 21 of this year. Congress also directed the Institute of 
Medicine (IoM) to report on the current organ allocation system.
    The Secretary's regulation will let medical people make medical 
decisions about the best way to allocate the limited number of donated 
organs within a framework that, as set forth by the IoM, will improve 
the function of the system. The Secretary's regulation is urgently 
needed by patients across the country.
    I believe there is a great deal of evidence of the need for timely 
implementation of the Secretary's regulations concerning organ 
allocation policies.
    For example, a recent report from the HHS Office of Inspector 
General found that the Secretary's new transplant rules would not 
impose new hardships on patients from small communities who need 
transplants. According to the OIG, most transplant centers are 
clustered around major cities and it is a ``myth'' that most Americans 
now have access to transplants virtually in their backyard. Thus the 
regulation won't hurt ``local access'' because such local access 
doesn't truly exist.
    Also, the Institute of Medicine has issued its report with 
conclusions that are very supportive of the Department's regulations. 
The IoM supports having the Federal government exercise its legitimate 
oversight responsibilities under the National Organ Transplant Act, 
instead of allowing a federal contractor essentially make the rules. 
The report also declares that the current system would be significantly 
enhanced if the allocation of scarce organs were done over larger 
populations than is now the case.
    The IoM report stated that ``Vigilant and conscientious oversight 
and review of programs . . . are critically important to ensuring 
accountability on the part of the OPTN and other participants in the 
organ procurements and transplantation system.'' The report also 
concluded that the Department's Final Rule appropriately places 
oversight responsibility with the federal government. Yet H.R. 2418 
would set allocation policies different than those contained in the 
Department's regulations.
    Among other flaws, H.R. 2418 provides unreasonable protections for 
the current contractor (UNOS), removes the Secretary's legitimate 
oversight authority over the program, while simultaneously making data 
less available to the public. It is a significant step backward from 
even current law. And, in its delegation of power to private parties, 
it is probably unconstitutional.
    I can think of no better way to put patients first than to make the 
system fair for all. This issue is about putting patients first--not 
putting transplant bureaucracies first.
    Mr. Chairman, armed with the strong support of the IoM report, 
Congress should oppose another moratorium and should not enact H.R. 
2418.
                                 ______
                                 
          Prepared Statement of the National Kidney Foundation
    On behalf of the thousands of individuals who are on waiting lists 
for an organ transplant, we wish to thank you for introducing 
legislation to reauthorize the National Organ Transplant Act (NOTA). 
The Mission of the National Kidney Foundation (NKF) is to prevent 
kidney and urinary tract diseases, improve the health and well-being of 
individuals and families affected by these diseases and increase the 
availability of all organs for transplantation. NKF represents 30,000 
lay and professional volunteers from all walks of life and every part 
of the country.
    The NKF has long held that NOTA should be reauthorized in an effort 
to expand organ donation and we are pleased that H.R. 2418 addresses 
the problem of the shortage of organs available for transplant in this 
country. In addition, we are supportive of the effort to clarify the 
responsibility for developing, establishing, and maintaining medical 
criteria and standards for organ procurement and transplantation as a 
function of the OPTN. Further, we believe that the transplant community 
at large should play an integral role in the development of these 
policies. The NKF agrees that the OPTN shall make available timely 
information on outcomes at specific transplant centers, as you have 
provided for in Sec. 3(d)(2), so as to help transplant candidates make 
informed choices.
    Research supported by the NKF Council of Nephrology Social Workers 
shows that unreimbursed expenses serve as a disincentive to living 
organ donation. As such, we are very appreciative and supportive of 
Sec. 5 of H.R. 2418, ``Payment of Travel and Subsistence Expenses 
Incurred Toward Living Organ Donation.'' However, we urge you to remove 
the provision that the donor must reside in a different State than the 
recipient. Certain expenses, such as the need for temporary day care, 
are incurred regardless of where the donor resides and a transplant 
center instate could be at a greater distance from the donor than one 
in a State different from that in which the donor lives. We also urge 
you to remove the provision that restricts payments to situations in 
which the annual income of the organ recipient is less than $35,000. It 
is our belief that it is more appropriate for States, transplant 
centers, organ procurement organizations and voluntary health agencies 
to determine who should be eligible for assistance in each particular 
instance. Furthermore, any means test might be more appropriate for the 
donor rather than the recipient. We also believe Sec. 4(c) will be 
useful toward increasing organ donation, specifically as this would 
facilitate demonstration projects on the efficacy and acceptability of 
financial incentives to families for cadaveric organ donation.
    We have additional specific suggestions regarding H.R. 2418. With 
regards to the composition of the OPTN Board of Directors (Sec. 3(a)), 
we believe a more specific designation is warranted for transplant 
recipients, candidates for transplants, donors and donor families, 
rather than the ``reasonable proportion'' cited in the bill language, 
and we recommend that transplant surgeons and transplant physicians 
should comprise not more than 50% of the members of the OPTN Board. We 
also suggest that ``transplant patients'' be added in the list of 
groups with which the Comptroller General be required to consult in 
preparation of the General Accounting Office's evaluation of the 
Network (Sec. 3(i)(2)).
    Thank you for holding this hearing and for the opportunity to 
provide written testimony. We look forward to working with you to 
improve the efficiency and effectiveness of our nation's organ 
procurement and transplant system.
                                 ______
                                 
          Louisiana State University Medical Center
                                   Office of the Chancellor
                                                 September 21, 1999
The Honorable Thomas J. Bliley, Jr.
Chairman
House Commerce Committee
2125 Rayburn House Office Building
Washington, D.C. 20515-0106
    Dear Chairman Bliley: I am writing on behalf of the Louisiana State 
University Health Sciences Center to express my deep concern that 
implementation of the DHHS Final Rule regarding organ allocation will 
jeopardize access to life-saving organ transplants needed by 
Louisiana's working poor and indigent. These are the very patients most 
dependent upon our institution's organ transplantation programs. 
However, H.R. 2418, the ``Organ Procurement and Transplantation Network 
Amendments of 1999'' appears to be in the best interest of these 
patients as it would provide them with continued access to organ 
transplantation. Introduced by Chairman Michael Bilirakis of the Health 
and Environment Subcommittee, Congressman Gene Green and Congressman 
Frank Pallone, H.R. 2418 is supportive not only of the organ 
transplantation programs at the LSU Health Sciences Centers in New 
Orleans and Shreveport, but also of most other medical centers across 
the country. For example, the bill specifies that functions 
``scientific, clinical or medical in nature'' are within the ``sole 
discretion'' of the Organ Procurement and Transplantation Network 
(OPTN). Further, it restricts the Secretary of the Department of Health 
and Human Services from using provisions in the Social Security Act to 
exert broad oversight authority relative to the OPTN. These two 
provisions would effectively prevent DHHS from going forward with its 
OPTN Final Rule which, as I have stated, is not in the best interest of 
many of our patients.
    As you know, Congress, through the appropriations process, thus far 
has blocked DHHS from implementing the Final Rule. However, on October 
21, 1999, the current congressional moratorium will expire. My 
colleagues and I feel it is imperative for the future well-being of our 
patients that H.R. 2418 be considered by the appropriate authorizing 
committees in Congress.
            Sincerely,
             John C. McDonald, M.D., Professor and Chairman
       Department of Surgery, LSU Health Sciences Center-Shreveport
        Philip Boudreaux, M.D., Professor of Surgery, LSUMC
Division of Transplantation, President, Louisiana Organ Procurement 
                                                             Agency
cc: Louisiana Congressional Delegation
   The Honorable Richard Ieyoub
   Mervin L. Trail, M.D.
   Bonnie J. Hymel
                                 ______
                                 
   University of Medicine & Dentistry of New Jersey
                               Office of the Vice President
                                                 September 20, 1999
The Honorable Thomas J. Bliley, Jr.
Chairman, House Commerce Committee
2125 Rayburn House Office Building
Washington, DC 20515-0106
    Dear Chairman Bliley: As Acting Chief Executive Officer of UMDNJ-
University Hospital in Newark, New Jersey, I am writing to lend my 
institution's strong support to the passage of H.R. 2418, the ``Organ 
Procurement and Transplantation Network Amendments of 1999.'' 
Introduced by Chairman Michael Bilirakis of the Health and Environment 
Subcommittee and cosponsored by Congressman Frank Pallone of New 
Jersey, this legislation supports the interests of New Jersey's sole 
transplant program and other programs throughout the country. 
Provisions contained within the bill would effectively prevent DHHS 
from going forward with its OPTN Final Rule, which we strongly oppose 
as it threatens the continued viability of our outstanding liver 
transplant program.
    As you know, the moratorium blocking DHHS from implementing the 
final rule is scheduled to expire on October 21 without any measure of 
compromise or consensus having been reached between the transplant 
community and the Administration. We believe that a strong show of 
support for H.R. 2418 in the House will send still another clear signal 
to the Secretary and the Administration that the Final Rule as written 
is not acceptable and that DHHS should seek to accommodate the concerns 
held by most transplant centers throughout the nation.
    Accordingly, I urge you to support H.R. 2418 and ask that you 
encourage your colleagues to do the same.
            Sincerely,
                               Daniel L. Marcantuono, FACHE
                                     Acting Chief Executive Officer
                                 ______
                                 
                                             Clarian Health
                                                 September 22, 1999
The Honorable Thomas J. Bliley, Jr.
Chairman
House Commerce Committee
2125 Rayburn House Office Building
Washington, D.C. 20515-0106
    Dear Chairman Bliley: On behalf of Clarian Health Partners located 
in Indianapolis, Indiana, I am writing in support of H.R. 2418, the 
``Organ Procurement and Transplantation Network Amendments of 1999.'' 
Introduced by Chairman Michael Bilirakis of the Health and Environment 
Subcommittee, along with Congressmen Gang Green and Frank Pallone, this 
legislation is supportive of the interests of the organ transplantation 
programs at Clarian Health Partners and at most other medical centers 
across the country. For example, the bill specifies that those 
functions that are ``scientific, clinical or medical in nature'' are 
within the ``sole discretion' of the Organ Procurement and 
Transplantation Network (OPTN). Further, it restricts the Secretary of 
the Department of Health and Human Services from using provisions in 
the Social Security Act to exert broad oversight authority relative to 
the OPTN. These two previsions would effectively prevent DHHS from 
going forward with its OPTN Final Rule, which Clarian Health and others 
strongly oppose.
    As you know, Congress through the appropriations process has thus 
far blocked DHHS from implementing the Final Rule. However, on October 
21, 1999, the current congressional moratorium will expire, and we feel 
it is imperative that this legislation be afforded the opportunity to 
be considered in the appropriate authorizing committees in Congress. We 
believe a strong show of support for H.R. 2518 in the House will send a 
clear signal to the Administration that the Final Rule is not 
acceptable and that DHHS should seek to accommodate the concerns held 
by most transplant centers by modifying the regulations. Accordingly, I 
would urge you to support H.R. 2418, and also ask that you encourage 
your colleagues to do the same.
    Thank you for your consideration.
            Sincerely,
                                          Bruce M. Melchert
                                 Vice President, Government Affairs
                                 ______
                                 
            The University of Alabama at Birmingham
                                    Office of the President
                                                 September 20, 1999
The Honorable Thomas J. Bliley, Jr.
Chairman
House Commerce Committee
2125 Rayburn House Office Building
Washington, D.C. 205OS15-0106
    Dear Chairman Bliley: On behalf of the University of Alabama at 
Birmingham (UAB), I am writing in support of H.R. 2418, the ``Organ 
Procurement and Transplantation Network Amendments of 1999'' introduced 
by your colleague Michael Bilirakis, Chairman of the Health and 
Environment Subcommittee. As you know, this legislation is supportive 
of the interests of the organ transplantation programs at UAB and at 
most other medical centers across the country. It specifies that those 
functions that are ``scientific, clinical or ethical in nature'' are 
within the `sole discretion'' of the Organ Procurement and 
Transplantation Network (OPTN). Further, it restricts the Secretary of 
the Department of Health and Human Services from using provisions in 
the Social Security Act to exert broad oversight authority relative to 
the OPTN. These two provisions would effectively prevent DHHS from 
going forward with its OPTN Final Rule, which we and others strongly 
oppose.
    As you know, Congress through the appropriations process has thus 
far blocked DHHS from implementing the Final Rule. However, on October 
21, 1999, the current congressional moratorium will expire, and we feel 
it is imperative that this legislation be afforded the opportunity to 
be considered in the appropriate authorizing committees in Congress. 
Accordingly, I would urge you to lend your strong support to H.R. 2418. 
In this regard, I am pleased to report that we anticipate all of the 
House members from Alabama will be supportive of this important 
legislation.
            Sincerely,
                                            W. Ann Reynolds
                                                          President
                                 ______
                                 
                            The University of Texas
                       Health Science Center at San Antonio
                                                  September 2, 1999
The Honorable Joe Barton
2264 Rayburn HOB
Washington, DC 20515-4306
    Dear Representative Barton: I am writing to request that you become 
a co-sponsor of Representative Michael Bilirakis's bill, H.R. 2418, 
which relates to transplant oversight by the Secretary of Health. I 
feel strongly that the government should have oversight of this 
process, but should not dictate the process as is suggested in the 
final rule, written by Secretary Shalala. I also feel that a dramatic 
overhaul of the current system is not in the interest of patients 
waiting for implantation in the United States. The current system works 
well. It can be improved upon, and UNOS has been taking progressive 
steps, including the recent sharing of organs, regionally for Status I 
patients, which are consistently improving the system.
    The recent Institute of Medicine study indicated the current system 
was a good system, and suggested small changes to modify it, rather 
than a traumatic change, which in my opinion would be a total disaster. 
Most of Secretary Shalala's effort to change the system his been based 
on the political consideration of the inequality of waiting times, and 
the Institute of Medicine's study clearly concluded that waiting times 
should not be a measure of transplant equity. Therefore, I urge you to 
please not support the final rule, which is supported by Secretary 
Shalala, and I request that you call Representative Bilirakis's office, 
202-225-5735 to add your name as a cosponsor on this bill.
            Best regards,
                                      Glenn Halff, M.D.    
                                Associate Professor of Surgery,    
                        Director, Division of Organ Transplantation
                                 ______
                                 
                                          Shands HealthCare
                                                 September 21, 1999
The Honorable Thomas J. Bliley, Jr.
Chairman
House Commerce Committee
2125 Rayburn House Office Building
Washington, D.C. 20515-01066
    Dear Chairman Bliley: On behalf of Shands HealthCare at the 
University of Florida, I am writing in support of H.R. 2418, the 
``Organ Procurement and Transplantation Network Amendments of 1999.'' 
Introduced by Chairman Michael Bilirakis of the Health and Environment 
Subcommittee, along with Congressmen Gene Green and Frank Pallone, this 
legislation is supportive of the interests of the organ transplantation 
programs at Shands and at most other medical centers across the 
country. For example, the bill specifies that those functions that are 
``scientific, clinical or medical in nature'' are within the ``sole 
discretion'' of the Organ Procurement and Transplantation Network 
(OPTN). Further, it restricts the Secretary of the Department of Health 
and Human Services from using provisions in the Social Security Act to 
exert broad oversight authority relative to the OPTN. These two 
provisions would effectively prevent DHHS from going forward with its 
OPTN Final Rule, which Shands and others strongly oppose.
    As you know, Congress through the appropriations process has thus 
far blocked DHHS from implementing the Final Rule. However, on October 
21, 1999, the current congressional moratorium will expire, and we feel 
it is imperative that this legislation be afforded the opportunity to 
be considered in the appropriate authorizing committees in Congress. We 
believe a strong show of support for H.R. 2418 in the House will send a 
clear signal to the Administration that the Final Rule is not 
acceptable and that DHHS should seek to accommodate the concerns held 
by most implant centers by modifying the regulations. Accordingly, I 
would urge you to support H.R. 2418, and also ask that you encourage 
your colleagues to do the same.
            Sincerely,
                                  J. Richard Gaintner, M.D.
                                            Chief Executive Officer
                                 ______
                                 
                            Saint Louis University Hospital
                                                 September 21, 1999
The Honorable Thomas J. Bliley, Jr.
Chairman
House Commerce Committee
2125 Rayburn House Office Building
Washington, D.C. 20515-0106
    Dear Chairman Bliley: On behalf of Saint Louis University Hospital, 
I am writing in support of H.R. 2418, the ``Organ Procurement and 
Transplantation Network Amendments of 1999.'' Introduced by Chairman 
Michael Bilirakis of the Health and Environment Subcommittee, along 
with Congessmen Gene Green and Frank Pallone, this legislation is 
supportive of the interests of the or,an transplantation programs at 
Saint Louis University Hospital and at most other medical centers 
across the country. For example, the bill specifies that those 
functions that are ``scientific, clinical or medical in nature'' are 
within the ``sole discretion'' of the Organ Procurement and 
Transplantation Network (OPTN). Further, it restricts the Secretary of 
the Department of Health and Human Services from using provisions in 
the Social Security Act to exert broad oversight authority relative to 
the OPTN. These two provisions would effectively prevent DHHS from 
going forward with its OPTN Final Rule, which Saint Louis University 
Hospital and others strongly oppose.
    As you know, Congress through the appropriations process has thus 
far blocked DHHS from implementing the Final Rule. However, on October 
21, 1999, the current congressional moratorium will expire, and we fell 
it is imperative that this legislation be afforded the opportunity to 
be considered in the appropriate authorizing committees in Congress.
    We believe a strong show of support for H.R. 2418 in the House will 
send a clear signal to the Administration that the Final Rule is not 
acceptable and that DHHS should seek to accommodate the concerns held 
by most transplant centers by modifying the regulations. Accordingly, I 
would urge you to support H.R. 2418, and also ask that you encourage 
your colleagues to do the same.
            Sincerely,
                                              Jan Blomfield
     Administrator for Transplant Services, Saint Louis University 
                                                           Hospital
                                 ______
                                 
                                                 LifeCenter
                                                     August 6, 1999
Representative Rob Portman
United States Representative, Ohio
238 Cannon Building
Washington, DC 20515

RE: NOTA Reauthorization

    Dear Representative Portman, I am the Executive Director of Ohio 
Valley LifeCenter (LifeCenter). LifeCenter is the federally designated, 
non-profit organ procurement organization serving the Cincinnati area. 
Recently, Congressmen Bilirakis, Pallone, and Green introduced a bill 
to reauthorize the National Organ Transplant Act (NOTA). I would like 
to bring to your attention the importance of this bill to the Greater 
Cincinnati area. As you are aware, there has been considerable focus on 
the issue of organ allocation in the United States. At the heart of the 
matter is who is most capable of deciding national implant policy: 
those involved in the field or the federal government
    The bill has several key components:

 Increase organ donation.
 Reaffirm that authority for transplant policy decisions and 
        medical/scientific judgment/decision-making reside in the 
        transplant community, with the government's role being one of 
        oversight.
 Preserves the Organ Procurement Transplant Network (OPTN) as a 
        private entity.
 Requires that administrative/procedural functions of the OPTN 
        be established by mutual agreement through a contract between 
        the OPTN and HHS.
 Updates NOTA to reflect recent medical advances in the field 
        of transplantation.
    LifeCenter fully supports this bill. I would request that you 
consider being a cosponsor of this much-needed legislation.
    Last year, Congress enacted a one-year moratorium on the organ 
allocation regulations proposed by the Department of Health and Human 
Services. This moratorium expires in October. This would be to the 
detriment of those Greater Cincinnati residents awaiting a life-saving 
organ transplant. The expiration of this moratorium heightens the need 
for NOTA reauthorization or, at the very least, an extension of the 
moratorium.
    Please feel free to contact me, if I can provide additional 
information or assistance.
            Sincerely,
                                             David D. Lewis
                                                 Executive Director
                                 ______
                                 
                                                 LifeCenter
                                                     August 6, 1999
Representative John A. Boehner
United States Representative, Ohio
1011 Longworth HOB
Washington, DC 20515

RE: NOTA Reauthorization

    Dear Representative Boehner, I am the Executive Director of Ohio 
Valley LifeCenter (LifeCenter). LifeCenter is the federally designated, 
non-profit organ procurement organization serving the Cincinnati area. 
Recently, Congressmen Bilirakis, Pallone, and Green introduced a bill 
to reauthorize the National Organ Transplant Act (NOTA). I would like 
to bring to your attention the importance of this bill to the Greater 
Cincinnati area. As you are aware, there has been considerable focus on 
the issue of organ allocation in the United States. At the heart of the 
matter is who is most capable of deciding national implant policy: 
those involved in the field or the federal government
    The bill has several key components:

 Increase organ donation.
 Reaffirm that authority for transplant policy decisions and 
        medical/scientific judgment/decision-making reside in the 
        transplant community, with the government's role being one of 
        oversight.
 Preserves the Organ Procurement Transplant Network (OPTN) as a 
        private entity.
 Requires that administrative/procedural functions of the OPTN 
        be established by mutual agreement through a contract between 
        the OPTN and HHS.
 Updates NOTA to reflect recent medical advances in the field 
        of transplantation.
    LifeCenter fully supports this bill. I would request that you 
consider being a cosponsor of this much-needed legislation.
    Last year, Congress enacted a one-year moratorium on the organ 
allocation regulations proposed by the Department of Health and Human 
Services. This moratorium expires in October. This would be to the 
detriment of those Greater Cincinnati residents awaiting a life-saving 
organ transplant. The expiration of this moratorium heightens the need 
for NOTA reauthorization or, at the very least, an extension of the 
moratorium.
    Please feel free to contact me, if I can provide additional 
information or assistance.
            Sincerely,
                                             David D. Lewis
                                                 Executive Director
                                 ______
                                 
                                                 LifeCenter
                                                     August 6, 1999
Representative Steve Chabot
United States Representative, Ohio
129 Cannon Building
Washington, DC 20515

RE: NOTA Reauthorization

    Dear Representative Chabot, I am the Executive Director of Ohio 
Valley LifeCenter (LifeCenter). LifeCenter is the federally designated, 
non-profit organ procurement organization serving the Cincinnati area. 
Recently, Congressmen Bilirakis, Pallone, and Green introduced a bill 
to reauthorize the National Organ Transplant Act (NOTA). I would like 
to bring to your attention the importance of this bill to the Greater 
Cincinnati area. As you are aware, there has been considerable focus on 
the issue of organ allocation in the United States. At the heart of the 
matter is who is most capable of deciding national implant policy: 
those involved in the field or the federal government
    The bill has several key components:

 Increase organ donation.
 Reaffirm that authority for transplant policy decisions and 
        medical/scientific judgment/decision-making reside in the 
        transplant community, with the government's role being one of 
        oversight.
 Preserves the Organ Procurement Transplant Network (OPTN) as a 
        private entity.
 Requires that administrative/procedural functions of the OPTN 
        be established by mutual agreement through a contract between 
        the OPTN and HHS.
 Updates NOTA to reflect recent medical advances in the field 
        of transplantation.
    LifeCenter fully supports this bill. I would request that you 
consider being a cosponsor of this much-needed legislation.
    Last year, Congress enacted a one-year moratorium on the organ 
allocation regulations proposed by the Department of Health and Human 
Services. This moratorium expires in October. This would be to the 
detriment of those Greater Cincinnati residents awaiting a life-saving 
organ transplant. The expiration of this moratorium heightens the need 
for NOTA reauthorization or, at the very least, an extension of the 
moratorium.
    Please feel free to contact me, if I can provide additional 
information or assistance.
            Sincerely,
                                             David D. Lewis
                                                 Executive Director
                                 ______
                                 
                                                 LifeSource
                                                      July 29, 1999
The Honorable Bill Luther
House of Representatives
Washington, DC 20510
    Dear Representative Luther: On behalf of LifeSource, the Organ 
Procurement Organization serving Minnesota, I am writing to ask your 
support for legislation re-authorizing the National Organ Transplant 
Act (NOTA). This bill, H.R. 2418, was introduced on July 1, 1999. Your 
leadership in signing on as a co-sponsor of this legislation is 
important in maintaining the organ procurement and transplantation 
system.
    The bill seeks to increase organ donation, and it reaffirms that 
authority for transplant policy decisions and medical/scientific 
decision-making will reside in the transplant community. This will 
maintain the appropriate administrative oversight of the Department of 
Health and Human Services while allowing the patients and medical 
professional to develop appropriate donation and allocation policies. 
The bill will also maintain the Organ Procurement and Transplantation 
Network's (OPTN) status as a private entity and will update NOTA to 
reflect medical advances in the field of transplantation. NOTA has not 
been re-authorized since 1990.
    I also anticipate that additional language will be proposed via 
amendment which will address the process for designation and 
certification of Organ Procurement Organizations by the Health Care 
Financing Administration. LifeSource and other members of the OPO 
community, supported by findings of the General Accounting Office, 
believe that the current process and standards used to assess OPO 
performance are flawed and should be discontinued until a new process 
is developed. I am enclosing a letter to Jeffrey L. Kang, M.D., M.P.H., 
HCFA, from the Association of Organ Procurement Organizations which 
further outlines OPO concerns.
    We believe it is vitally important that the NOTA reauthorization 
move forward at this time and encourage you to sign on as a cosponsor. 
Please do not hesitate to contact me if I can provide any additional 
information.
            Sincerely,
                                            Susan Gunderson
                                            Chief Executive Officer
                                 ______
                                 
                              University of Florida
                                        College of Medicine
                                                    August 11, 1999
The Honorable Karen Thurman
440 Cannon HOB
Washington DC 20515
ATTN: Jeff Cohen

RE: Institute of Medicine Report
    Dear Congresswoman Thurman: I have reviewed Congressman William 
Coyne's letter dated July 29, 1999 that he sent to his colleagues in 
Congress regarding his interpretation of the Institute of Medicine's 
(IOM) report on organ allocation. Congressman Coyne's interpretation of 
the report is a rather limited one and does not, in the opinion of most 
transplant professionals, truly represent the content of that report. I 
thought it might be helpful to you and your staff to clarify some of 
these issues.
    The most important point that Congressman Coyne fails to understand 
is that the IOM determined that geographic differences and waiting 
times are ``not an appropriate measure of the fairness of the system.'' 
The claims made by the proponents of the HHS regulation are that 
waiting times vary from region to region. While this is true, it 
reflects the listing practices of centers in those regions and not the 
availability of organs. In fact, the waiting time for liver 
transplantation for all Status 1 patients is remarkably similar in 
every UNOS Region across the country (two to four days). The IOM 
clearly recommends that the use of waiting time as an allocation 
criterion for statuses 2B and 3 be discontinued. The IOM noted that the 
heavy emphasis placed on waiting times by HHS created the perception 
that the system was unfair.
    The IOM report does not, as Congressman Coyne states, suggest that 
the Health and Human Services (HHS) regulations should be implemented. 
The IOM in fact determined that the liver organ allocation system is 
``reasonably effective and equitable'' and that no system will ever 
function perfectly when the need for organs vastly exceeds the demands. 
The IOM does suggest that sharing of livers for the Status 1 (sickest 
patient) Category be done over areas consisting of approximately 
9,000,000 people. This is, however, similar to the geographically based 
system already in place. In fact, all of the UNOS Regions currently 
share livers for this patient status category. No changes need to be 
effected in order to fulfill this recommendation.
    Congressman Coyne neglected to mention that the IOM found that the 
institution of these regulations would increase the overall cost of 
transplantation. Congressman Coyne's letter states that the IOM 
concluded that the new regulations would not cause small transplant 
centers to close or negatively impact access for minority populations. 
The IOM was unable to come up with any firm evidence based conclusions 
regarding these issues, but they did recognize that a consensus existed 
in the transplant community that the implementation of these 
regulations would lead to these problems.
    In summary, the findings of the IOM challenge the medical basis of 
the regulations suggested by the HHS. While they do endorse a note for 
federal oversight, I do not believe that it is their intention that 
anyone other than the medical community determine the rules for organ 
allocation.
    I do not believe that Congressman Coyne's interpretation of the IOM 
report accurately reflects the content of that report. I hope that this 
letter is helpful and I would be happy to discuss this with you at your 
leisure.
    Thank you for your ongoing concern regarding the organ allocation 
issue.
            Sincerely,
                                              Alan Reed, MD
                                     Associate Professor of Surgery
                                 ______
                                 
                          University Hospitals of Cleveland
                                                    26 August, 1999
Congressman Thomas C. Sawyer, Ohio
1414 Longworth House Office Building
Washington, DC 20515
    Dear Congressman Sawyer: I am writing you to urge you to extend the 
moratorium on the HHS Organ Procurement and Transplantation Network 
Final Rule.
    As you know Secretary Shalala and HHS have repeatedly sought to 
implement rules that would effectively nationalize organ acquisition. 
While effectively spun as a means to equalize access and ameliorate 
regional inequities, the real purpose of the proposed rule is to 
restore oligopoly in transplantation to a few centers, such as The 
University of Pittsburgh, which have seen volume disappear, have 
suffered financially, and which seek to repair that damage through use 
of friends and lobbyists to obtain governmental relief. The citizens of 
Ohio among others will see access to transplantations reduced as a 
result and those without means may lose it altogether.
    The Institute of Medicine was asked to provide an evaluation of 
this controversial issue, and issued their report earlier this month.
    Recently a letter from Secretary Shalala to Members of Congress 
cast the Institute of Medicine report--a neutral assessment of the 
problem--as an endorsement of her position.
    It is nothing of the sort. In fact the IOM report is evenhanded. It 
notes that there are no real differences in waiting limes for the 
sickest liver patents--the core argument of the Secretary's position 
and the casus belli of the dispute--but that there are differences 
among less ill patents, and that these could be erased by establishing 
catchment areas of 9 million or so. This is similar to what we have 
already in Ohio, and we can live with it. But it is not an endorsement 
for the very broad catchment areas necessary to afford the few HHS-
favored centers what they seek. What the Secretary wants on their 
behalf is in effect a private bill.
    Failure to extend the moratorium is certain to lead to a massive 
export of organs, recipients and ultimately skilled professionals from 
Ohio to other states. I cannot see how this pernicious policy change is 
in the interest of Ohioans and I think it both unwise and unfair.
            Sincerely,
   D. Allan Gray, Senior Vice President and General Manager
       Medical/Surgical Services, University Hospitals of Cleveland
                                 ______
                                 
                    Mississippi Organ Recovery Agency, Inc.
                                                      July 14, 1999
Representative Chip Pickering
427 Cannon House Office Bldg.
Washington, D.C. 20515

Re: Organ Procurement and Transplantation Network Amendments of 1999

    Dear Rep. Pickering: As you are aware over the last two years there 
has been much discussion of the organ allocation process and who 
determines distribution of this scarce resource. Since the inception of 
the Organ Procurement and Transplant Network (OPTN), the United Network 
for Organ Sharing (UNOS) has been charged with overseeing allocation of 
organs for transplant in the United States. UNOS has done an excellent 
job over the years dealing with the very difficult task of determining 
how the precious gift of life of an organ transplant should optimally 
be shared to ensure maximal lives saved.
    Currently Representative Michael Bilirakis (FL), Chair of the 
Subcommittee on Health and the Environment of the House Commerce 
Committee, is looking for cosponsors for legislation he is introducing 
to ensure that efforts continue to allocate organs optimally. This 
legislation will ensure that Mississippians will continue to have fair 
and equitable access to transplantation. If this legislation is not 
passed, many Mississippians may die of organ failure and never get the 
opportunity of transplant, particularly minority Mississippians and 
those in the lower socioeconomic strata.
    Please support this legislation that should enable every 
Mississippian in need access to transplantation.
    Please call if we can be of any further service or answer any 
questions.
            Sincerely,
                                               Kevin Stump,
                                                 Executive Executor
                                 Shirley Schlessinger, M.D.
                                                   Medical Director
                                 ______
                                 
                           Center for Donation & Transplant
                                                 September 16, 1999
Hon. Michael R. McNulty
House of Representatives.
2161 Rayburn
Washington, DC 20515
    Dear Congressman McNulty: I am writing to ask for your support in 
cosponsoring the National Organ Transplant Reauthorization Bill, H.R. 
2418. It is my understanding that there will be a hearing on this bill 
on September 22. For additional information or to be added as a 
cosponsor, the contact person in Congressman Bilirakis's office is 
Michael Reilly. The phone number is 202-225-5755.
    As in the past, thank you for your support.
            Sincerely,
                                                 Frank Taft
                                                           Director
                                 ______
                                 
                               Tennessee Transplant Society
                                                     August 2, 1999
The Honorable Bill Frist
SD-567 Dirksen Senate Office Building
Washington, DC 20510-4205
    Dear Senator Frist: The Tennessee Transplant Society (TTS) consists 
of all seven transplant centers, all of the transplant professionals 
(physicians, nurses, transplant coordinators), and all organ 
procurement organizations within the state of Tennessee. At the July 26 
meeting of the TTS, there was a vote taken following discussion of the 
Institute of Medicine (IOM) Report and the continuing saga of the HHS 
final rule regarding the allocation of organs for transplant. The IOM 
report did not support the basic premise of the HHS rule, that is, 
waiting times for patients needing transplant are valid measure and 
should be equalized.
    The Tennessee Transplant Society unanimously requests you to 
cosponsor Congressman Billrakis' Bill H.R. 2418 ``Organ Procurement and 
Transplantation Network Amendments of 1999.'' Additionally, if it does 
not look like H.R. 2418 is gong to pass in this session of Congress, we 
would strongly encourage you to support an extension of the moratorium 
on the implementation of the HHS final rule (current effective date 10/
1/99) while we study the ideas brought forward in the IOM report.
            Sincerely yours,
                             C. Wright Pinson, M.D., M.B.A.
                                                          President
                                 ______
                                 
                             Jacksonville Transplant Center
                                                      July 26, 1999
The Honorable Corrine Brown
2444 Rayburn House Office Building
Independence Ave. and S. Capitol St., SW
Washington, DC 20510
    Dear Representative Brown: I write regarding H.R. 2418 (Organ 
Procurement and Transplant Patient Network amendments of 1999), a Bill 
before the House of Representatives. Since I serve patients in your 
District, I encourage your support of this Bill.
    H.R. 2418 allows for the general functions of day-to-day organ 
donation and transplantation to continue throughout America. It 
maintains the truly excellent administrative structure and self 
governance of the Organ Procurement and Transplantation Network. 
Important in the latter is the fact that the Board governing the 
Network is inclusive not just of medical professionals, but of patients 
and public members. Further, the Bill establishes a workable and 
reasonable relationship of oversight between the Secretary of Health 
and Human Services and the Network contractor.
    Important new features of the Bill relate to access to 
transplantable organs and tissues, recognition that organs and tissues 
from certain animal sources may soon be applied to human disease, and 
enabling sections on provision of benefits for cadaveric organ donation 
should demonstration projects to increase organ donation be developed 
around survivor benefits. Finally, an important aspect of the Bill is 
that expenses of living organ donors be reimbursed through mechanisms 
similar to other aspects of organ transplant reimbursement.
    May I thank you in advance for considering support of this 
important Bill which may so positively affect your constituents and my 
patient.
            Sincerely,
                                     Thomas G. Peters, M.D.
          Clinical Professor of Surgery, University of Florida HSCJ
                                 ______
                                 
                             Jacksonville Transplant Center
                                                      July 26, 1999
The Honorable Charles T. Canady
2432 Rayburn House Office Building
Independence Ave. and S. Capitol St., SW
Washington, DC 20510
    Dear Representative Canady: I write regarding H.R. 2418 (Organ 
Procurement and Transplant Patient Network amendments of 1999), a Bill 
before the House of Representatives. Since I serve patients in your 
District, I encourage your support of this Bill.
    H.R. 2418 allows for the general functions of day-to-day organ 
donation and transplantation to continue throughout America. It 
maintains the truly excellent administrative structure and self 
governance of the Organ Procurement and Transplantation Network. 
Important in the latter is the fact that the Board governing the 
Network is inclusive not just of medical professionals, but of patients 
and public members. Further, the Bill establishes a workable and 
reasonable relationship of oversight between the Secretary of Health 
and Human Services and the Network contractor.
    Important new features of the Bill relate to access to 
transplantable organs and tissues, recognition that organs and tissues 
from certain animal sources may soon be applied to human disease, and 
enabling sections on provision of benefits for cadaveric organ donation 
should demonstration projects to increase organ donation be developed 
around survivor benefits. Finally, an important aspect of the Bill is 
that expenses of living organ donors be reimbursed through mechanisms 
similar to other aspects of organ transplant reimbursement.
    May I thank you in advance for considering support of this 
important Bill which may so positively affect your constituents and my 
patient.
            Sincerely,
                                     Thomas G. Peters, M.D.
          Clinical Professor of Surgery, University of Florida HSCJ
                                 ______
                                 
                             Jacksonville Transplant Center
                                                      July 26, 1999
The Honorable Tillie Fowler
106 Cannon House Office Building
Independence Ave. and S. Capitol St., SW
Washington, DC 20510
    Dear Representative Fowler: I write regarding H.R. 2418 (Organ 
Procurement and Transplant Patient Network amendments of 1999), a Bill 
before the House of Representatives. Since I serve patients in your 
District, I encourage your support of this Bill.
    H.R. 2418 allows for the general functions of day-to-day organ 
donation and transplantation to continue throughout America. It 
maintains the truly excellent administrative structure and self 
governance of the Organ Procurement and Transplantation Network. 
Important in the latter is the fact that the Board governing the 
Network is inclusive not just of medical professionals, but of patients 
and public members. Further, the Bill establishes a workable and 
reasonable relationship of oversight between the Secretary of Health 
and Human Services and the Network contractor.
    Important new features of the Bill relate to access to 
transplantable organs and tissues, recognition that organs and tissues 
from certain animal sources may soon be applied to human disease, and 
enabling sections on provision of benefits for cadaveric organ donation 
should demonstration projects to increase organ donation be developed 
around survivor benefits. Finally, an important aspect of the Bill is 
that expenses of living organ donors be reimbursed through mechanisms 
similar to other aspects of organ transplant reimbursement.
    May I thank you in advance for considering support of this 
important Bill which may so positively affect your constituents and my 
patient.
            Sincerely,
                                     Thomas G. Peters, M.D.
          Clinical Professor of Surgery, University of Florida HSCJ
                                 ______
                                 
                             Jacksonville Transplant Center
                                                      July 26, 1999
The Honorable Cliff Stearns
2227 Rayburn House Office Building
Independence Ave. and S. Capitol St., SW
Washington, DC 20510
    Dear Representative Stearns: I write regarding H.R. 2418 (Organ 
Procurement and Transplant Patient Network amendments of 1999), a Bill 
before the House of Representatives. Since I serve patients in your 
District, I encourage your support of this Bill.
    H.R. 2418 allows for the general functions of day-to-day organ 
donation and transplantation to continue throughout America. It 
maintains the truly excellent administrative structure and self 
governance of the Organ Procurement and Transplantation Network. 
Important in the latter is the fact that the Board governing the 
Network is inclusive not just of medical professionals, but of patients 
and public members. Further, the Bill establishes a workable and 
reasonable relationship of oversight between the Secretary of Health 
and Human Services and the Network contractor.
    Important new features of the Bill relate to access to 
transplantable organs and tissues, recognition that organs and tissues 
from certain animal sources may soon be applied to human disease, and 
enabling sections on provision of benefits for cadaveric organ donation 
should demonstration projects to increase organ donation be developed 
around survivor benefits. Finally, an important aspect of the Bill is 
that expenses of living organ donors be reimbursed through mechanisms 
similar to other aspects of organ transplant reimbursement.
    In your capacity as a member of the Commerce Committee, may I ask 
that you especially regard this Bill as an important step in serving 
patients in need of an organ transplant. I stand ready to provide 
further information or assistance to your office should that be 
necessary. May I thank you in advance for positively considering H.R. 
2418.
            Sincerely,
                                     Thomas G. Peters, M.D.
          Clinical Professor of Surgery, University of Florida HSCJ
                                 ______
                                 
                                    The University Hospital
                                                  September 3, 1999
The Honorable Steve Chabot
United States Representative, Ohio
129 Cannon Building
Washington, DC 20515

RE: House Bill: H.R. 2418

    Dear Representative Chabot: I am the Administrator of Transplant 
Services at The Health Alliance of Greater Cincinnati. Recently, 
Congressmen Bilirakis, Pallone, and Green introduced House Bill H.R. 
2418 to reauthorize the National Organ Transplant Act (NOTA). I would 
like to bring to your attention the importance of this bill to the 
Greater Cincinnati area. As you are aware, there has been considerable 
focus on the issue of organ allocation in the United States. At the 
heart of the matter is who is most capable of deciding national 
transplant policy: those involved in the field or the federal 
government?
    The bill has several key components:

 Increase organ donation.
 Decrease disincentives for living organ donation.
 Reaffirm that authority for transplant policy decisions and 
        medical/scientific judgment/decision-making resides in the 
        transplant community with the government's role being one of 
        oversight.
 Preserves the Organ Procurement Transplant Network (OPTN) as a 
        private entity.
 Requires that administrative/procedural functions of the OPTN 
        be established by mutual agreement through a contract between 
        the OPTN and HHS.
 Updates NOTA to reflect recent medical advances in the field 
        of transplantation.
    Last year, Congress imposed a one-year moratorium on the organ 
allocation regulations proposed by the Department of Health and Human 
Services. This moratorium expires October 21, 1999. Enactment of the 
HHS organ allocation regulation would be detrimental to the Greater 
Cincinnati residents awaiting a life-saving organ transplant. The 
expiration of this moratorium heightens the need for NOTA 
reauthorization or, at the very least, an extension of the moratorium.
    I fully support the House Bill H.R. 2418. I am requesting that you 
consider being a cosponsor of this important and critical legislation.
    Please contact me for additional information or assistance at (513) 
584-1811.
            Sincerely,
                                    Edward Y. Zavia, M.B.A.
                                 Administrator, Transplant Services
                                 ______
                                 
                                 405 Owendale Drive
                                          Antioch, TN 37013
                                                      June 24, 1999
The Hon. Ed Bryant
408 Cannon House Office Bldg
Washington, D.C. 20515
    Dear Mr. Bryant, I am writing to you today concerning important 
pending legislation which will affect organ and tissue transplantation 
policy in the United States for years to come. I speak from the 
perspective of a donor father (both of my sons were organ donors 
following tragic accidents in 1990-91) and as the spouse of a kidney 
recipient in 1994. Tragically, my wife has since passed away, but I 
have been so energized by her determination and courage throughout her 
wait of over 25 months for an organ that I have been actively involved 
in organ donation matters since that date. Specifically, I have been a 
member of the national Board of Directors of Transplant Recipients 
International Organization (TRIO) and also the President of the Music 
City (Nashville area) TRIO local chapter. In addition, I have worked 
extensively with Rotary International, the National Kidney Foundation 
(NKF), Tennessee Donor Services (TDS), the Minority Organ Tissue 
Transplant Education Program (MOTTEP) and several other organizations 
to promote increased organ donation awareness.
    I provide you with this detailed background information so that you 
can understand the depth of my frustration concerning the ongoing 
debate in the Congress over national transplantation policy. While 
there is general agreement that the existing policies developed by the 
National Organ and Transplant Act during the mid-80's are not perfect, 
it is the feeling of most of the ``non-professionals'' within the 
transplant community (recipients, donor families, and those currently 
waiting) that the system in operation today has served us well. It has 
proven to be remarkably adaptive to changing conditions as medical 
advances have taken place, and has resulted in a transplantation record 
that is the envy of the world. This has taken place primarily because 
of the wisdom of the Congress to establish a private partnership 
between the medical community and the patient population which is 
independent from undue political interference by government operatives, 
however well intentioned. Difficult decisions involving the allocation 
of scarce organ resources have been made by this informed private 
partnership, rather than by a corps of government attorneys and 
bureaucrats.
    I do not want to sound harsh in the above assessment, but it is 
imperative that you understand that the current system has indeed 
served us well, and that any improvements should be made on the margins 
by legislation to strengthen, rather than dismember, the Organ 
Procurement Transplant Network (OPTN). This really should not become a 
partisan issue, as both sides should have an intense interest in 
insulating the organ transplant process from the political whims of 
whichever party is in control of the Executive Branch or the Congress. 
It is critical that you insist that the current ``firewall'' be 
maintained so that transplantation policies are predictable, just, and 
institutionally immune from political tampering.
    I would also like to address comments which have been made publicly 
by those purporting to represent all transplant patients and donor 
families. This is simply a myth. There are, in fact, many different 
viewpoints throughout this large and diverse community. As you can 
imagine, there are some who view the current system as ``unfair'' and 
in need of massive government intervention, if not outright total 
control. It is my experience that these folks, however vocal, are in a 
distinct minority, but their opinions are nonetheless real.
    What I see is a vast majority of those Americans who are interested 
in transplant matters wanting the existing partnership of medical 
professionals and transplant patients to remain in charge of transplant 
policy. Those who argue otherwise as ``spokespersons'' for transplant 
groups simply do not represent the views of the majority of their 
membership. I say this with absolute certainty in the case of 
Transplant Recipients International Organization (TRIO), because as a 
Board member I asked repeatedly that our entire membership be polled on 
this key issue, and such never happened.
    When we did poll our local chapter here in Tennessee, the results 
were overwhelming in support of the current non-political, private 
partnership (the OPTN). [The actual vote was 131-4]. In speaking with 
other TRIO chapter Presidents, I noted differing levels of support due 
to local factors, but the overall fact is that there is NOT unanimity 
in support of either side. Some of the other organizations which 
purport to speak for the transplant community (e.g., National 
Transplant Action) are simply ad hoc ``fronts'' which have been 
chartered by interested parties to lobby for passage of proposed HHS 
regulations which will financially favor them. The bottom line is that 
no one speaks for the entire transplant community and that there are 
mixed feelings about the issue throughout the U.S. I can report, 
however, that the vast majority of the TRIO members to whom I have 
personally spoken are opposed to government intervention and want the 
existing system to have simple improvements.
    There is also a fear that large transplant centers with political 
clout will monopolize transplantation procedures by manipulating 
proposed rules dictated by FMS personnel. Opponents may dismiss such 
concerns as paranoia, but these worries are indeed genuine and have 
been supported by the monopolistic track record of certain large 
centers. Those of us who have had the opportunity to experience the 
expertise of some of the smaller, regional transplant centers 
understand first hand the excellence and talent available in many 
locations throughout the country. The benefit, which I have seen 
countless times, is that under the existing system families are able to 
provide local support for patients who do not have to travel long 
distances to receive life saving transplant operations.
    As a two-time donor father I would like to comment personally on 
one aspect of organ donation which is frequently misstated by 
proponents of a ``national'' system. It is often stated by these people 
that donor families ``do not care where organs of their loved ones 
go.'' This may be correct in some cases, but I can report to you that 
many of us who have been in this most difficult situation have been 
acutely concerned that hope be provided first to those in need in our 
local region. We do not want these precious gifts to be treated as just 
some other government owned part shipped cross country to a large 
center currently in favor with federal rulemakers.
    Obviously there are many other issues which are associated with 
this pending legislation, but I encourage you to focus on one thought: 
patients do not want a working, viable process with a proven track 
record to be dismembered and displaced by policies dictated by 
government bureaucrats subject to political pressure. Keep 
transplantation a predominantly medical issue with rules established by 
the existing partnership of medical experts, patients, and donor 
families.
            Sincerely,
                                                 Thomas L. Meredith
                                 ______
                                 
                                    Tennesee Donor Services
                                                 September 21, 1999
The Honorable Ed Bryant
United States Representative
408 Cannon House Office Building
Washington, DC 20515-4207

Attention: Carrie Dawson, Legislative Aide

    Dear Representative Bryant: Tennessee Donor Services (TDS) is the 
federally designated Organ Procurement Organization (OPO) serving the 
vast majority of Tennessee. On September 22, 1999 the House Commerce 
Committee will conduct hearings on H.R. 2418, the National Organ 
Transplant Act (NOTA) Reauthorization Bill. The bill has a significant 
number of bipartisan sponsors,
    Last year, Congress extended a moratorium on the implementation of 
a federal rule that would have had a serious negative impact on the 
centers and patients we serve. This moratorium is set to expire October 
21, 1999. On behalf of transplant centers, transplant physicians, donor 
families, and recipients that we serve, I request your support and urge 
you to cosponsor H.R. 2418, ``Organ Procurement and Transplantation 
Network Amendments of 1999.''
    H.R. 2418 protects the integrity of organ procurement organizations 
and transplant centers all across the country. It reiterates the 
original intent of the National Organ Transplant Act of 1984 which was 
to create a national system that promotes and supports a central 
network in the private sector serving all of the citizens of the United 
States,
    H.R. 2418 is unanimously supported by all Tennessee OPOs and ten 
transplant centers. In the area served by TDS, H.R. 2418 has the 
support of Vanderbilt University Medical Center, St. Thomas Hospital, 
Centennial Medical Center/Parkview, UT Medical Center, Johnson City 
Medical Center and Erlanger. H.R. 2418 is also unanimously supported by 
Mid-South Transplant Foundation and its affiliated centers.
    We also encourage you to send a letter to the Secretary of HHS 
asking that the final rule be withdrawn in the meantime. If the 
Secretary fails to do so, we urge you to extend the moratorium until 
such time as a solution in the best interests of the patients we serve 
can be achieved.
    Please contact Michael Reilly with Congressman Bilirakis' office at 
(202) 225-5755 to be added as a cosponsor, I thank you for your support 
of H.R. 2418. You may contact me at (615) 327-2247, if you have any 
questions or need additional information.
            Sincerely,
                                        Lawrence D. Cochran
                                                 Executive Director
                                 ______
                                 
                          University of Illinois at Chicago
                                                  Chicago, Illinois
The Honorable Diana DeGette
1339 Longworth Building
U.S. House of Representatives
Washington, DC 20515-0601
    Dear Congresswoman DeGette: Thank you for your letter requesting 
additional information in connection with the testimony I gave recently 
at a hearing of the Subcommittee on Health and the Environment relating 
to organ procurement and transplantation. I apologize for not getting 
back to you sooner; however, I have moved offices and mail has been 
delayed in reaching me.
    You asked several questions relating to liver transplantation for 
pediatric patients, particularly in response to recent studies done by 
researchers at Pittsburgh Children's Hospital and the Medical 
University of South Carolina. Those studies apparently raised questions 
whether pediatric patients are receiving appropriate access to donated 
livers.
    The Institute of Medicine Committee that prepared the report 
``Organ Procurement and Transplantation'' was not specifically 
requested to investigate the issue of pediatric patients' access to 
transplantation and we did not do so. We did not have copies of the 
research you cite and I have not read them. Some of our analysis of 
transplant waiting times and mortality does, however, bear on one of 
the points raised in your letter and I am happy to share that with you.
    According to your letter, the research studies you cited found that 
children are ``55% more likely to die waiting for an organ transplant 
than adults.'' (Presumably this refers to liver transplants.) Our 
analysis yielded somewhat different conclusions. Although the most 
severely ill (status 1) children, aged 0-5, had a significantly lower 
rate of transplantation than status 1 adults, they also had a lower 
rate of pretransplant mortality. This finding suggests young children 
in status 1 are capable of living longer than adults in this status as 
they wait on the list. Less severely ill (status 2B) children (aged 0-
5) actually had a higher rate of transplantation than status 2B adults 
and the least severely ill (status 3) children in all ages (aged 0-17) 
had transplantation rates that were significantly higher than adults. 
In both of these status groups, there was no difference between 
children and adults in their pretransplant mortality rates. In 
addition, age was not a significant determinant of post-transplantation 
mortality.
    There could be a variety of reasons why our findings differ from 
those cited in your letter, but without having read those studies I 
cannot pinpoint what they might be. The time period covered by the 
data, the comprehensiveness of the data, and whether patients were 
classified by severity of illness would be some of the things to look 
at. Our analysis reflects the experience of all liver transplant 
patients who were on waiting lists anywhere in the nation from the 
start of 1998 through the first quarter of 1999 and we stratified these 
patients by severity of illness (status level).
    Finally, I would note that the recommendation of the IOM Committee 
that donated livers be allocated over larger populations would appear 
to improve the likelihood that a suitable organ would be found for a 
child awaiting a transplant. Furthermore, the Committee's 
recommendation to eliminate waiting time as a criterion for allocating 
organs to status 2B and status 3 patients and to substitute more 
medically relevant criteria to bring about a better match (e.g. 
pediatric versus adult) would also appear to benefit children.
    I hope this information is useful to you in your review of this 
important issue.
            Sincerely,
          Robert D. Gibbons, Professor of Biostatistics    
                              University of Illinois at Chicago    
         IOM Organ Procurement and Transplantation Committee Member
cc: The Honorable Michael Bilirakis
                                 ______
                                 
 Responses of William F. Raub, Deputy Assistant Secretary for Planning 
and Evaluation/Science Policy, Department of Health and Human Services, 
                   to Questions of Hon. Diana DeGette
    Question: Recent studies by researchers at Pittsburgh Children's 
Hospital and the Medical University of South Carolina reveal some 
rather disturbing trends with respect to pediatric transplantation. The 
studies indicate that: Two-thirds of liver donations by children go to 
adults; and Pediatric liver donations have increased through the 
1990's. And yet--The number of children who received a donated liver 
from another child decreased dramatically from 1990 to 1996; and, 
Children are 55% more likely to die while waiting for an organ 
transplant than adults.
    According to American Medical News, ``Europe has virtually 
eliminated deaths of children while on liver waiting lists by giving 
them priority over adults for pediatric organs . . .''
    The Administration's Final Rule, H.R. 2418, and the IOM report all 
fail to directly address this issue.
    To all the members of the panel, what are we as a nation doing to 
address this growing and unacceptable problem for children in need of 
organ transplantations and what additional steps need to be taken to 
reduce pediatric mortality rates?
    Response: The current liver allocation conventions of the Organ 
Procurement and Transplantation Network (OPTN) give priority to 
children 18 years of age and under, who account for 10 percent of 
transplant candidates. The 1998 HHS regulation made clear that the 
Department intended the OPTN to address the special needs of children 
as it developed fairer allocation policies:
        ``. . . current OPTN policies take into account the special 
        medical needs of children. The Secretary endorses this approach 
        and expects that the OPTN will continue to take these needs 
        into account as it develops new medical criteria and allocation 
        policies.'' (63 FR 16315; also discussed at 63 FR 16304)
    The recent amendments to that regulation reaffirm this intention:
        ``The Department wishes to emphasize, however, that these 
        changes are not intended to limit the ability of the OPTN to 
        address special situations such as the unique needs of young 
        children.'' (64 FR 56657)
    Based on the OPTN's actions, the guidance provided in the HHS 
regulations, and our expectations for continued improvement in split-
liver techniques (whereby an adult donor liver that is too large for a 
child can be divided surgically to transplant two individuals in need 
of a smaller liver), the Department is optimistic that children will 
have a growing new source of opportunities for transplantation.
    Children have the following outcomes under current OPTN liver 
allocation policies: they receive liver transplants at a higher rate 
(60%) than do adults (45%); their survival at one year with or without 
transplant (21%) is similar to all other age groups; and they die 
awaiting a transplant at a slightly lower rate (12.5%) than do adults 
on the waiting lists (14%).
    Despite these generally favorable data, room remains for 
improvement. The Department--through its efforts to increase organ 
donation generally (its National Organ and Tissue Donor Initiative), 
its research to improve transplantation procedures, and its oversight 
of the OPTN--will continue to strive to meet the needs of children 18 
years of age and under who are candidates for liver or other organ 
transplantation. The Department intends to highlight this issue as it 
seeks comments from the public and advice from the Advisory Committee 
on Organ Transplantation on new allocation policies developed in 
response to the amended HHS regulation.
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