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



 
  PUTTING PATIENTS FIRST: INCREASING ORGAN SUPPLY FOR TRANSPLANTATION

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

                                HEARING

                               before the

                            SUBCOMMITTEE ON
                         HEALTH AND ENVIRONMENT

                                 of the

                         COMMITTEE ON COMMERCE
                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED SIXTH CONGRESS

                             FIRST SESSION

                               __________

                             APRIL 15, 1999

                               __________

                           Serial No. 106-14

                               __________

            Printed for the use of the Committee on Commerce

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

                     U.S. GOVERNMENT PRINTING OFFICE
57-607 CC                    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:
    Brand, Joseph L., Chairman, Office of Scientific and Public 
      Policy, National Kidney Foundation.........................    45
    Burton, Jamar, Organ Transplant Recipient, State of Tennessee    10
    Campbell, John R., Executive Director, Lifelink Foundation...    13
    Guillemin, Cynthia, Organ Transplant Recipient, State of 
      Florida....................................................    10
    Higgins, Robert S.D., Director, Thoracic Organ 
      Transplantation, Henry Ford Hospital.......................    35
    Johnston, Abbey Lynn, Organ Transplant Recipient, State of 
      Ohio.......................................................    11
    Marcos, Amadeo, Assistant Professor of Surgery, Medical 
      College of Virginia........................................    21
    Metzger, Robert A., Medical Director, Transplant Physician, 
      TransLife at Florida Hospital..............................    29
    Miller, Joshua, President, American Society of Transplant 
      Surgeons, Department of Surgery, University of Miami School 
      of Medicine................................................    41
    Nathan, Howard M., President, Coalition on Donation, Delaware 
      Valley Transplant Program..................................    17
    Neylan, John F., American Society of Transplantation.........    25
    Thio, Kara Grace, Organ Transplant Recipient, State of North 
      Carolina...................................................    11
Material submitted for the record by:
    Brand, Joseph L., Chairman, Office of Scientific and Public 
      Policy, National Kidney Foundation, letter dated May 5, 
      1999, enclosing response for the record....................    67
    Campbell, John R., Executive Director, Lifelink Foundation, 
      letter dated May 4, 1999, enclosing response for the record    64
    Higgins, Robert S.D., Director, Thoracic Organ 
      Transplantation, Henry Ford Hospital, response for the 
      record.....................................................    70
    Hoffmann-La Roche, prepared statement of.....................    59
    Marcos, Amadeo, Assistant Professor of Surgery, Medical 
      College of Virginia, letter dated April 27, 1999, enclosing 
      response for the record....................................    77
    Metzger, Robert A., Medical Director, Transplant Physician, 
      TransLife at Florida Hospital, letter dated May 5, 1999, 
      enclosing response for the record..........................    61
    Miller, Joshua, President, American Society of Transplant 
      Surgeons, Department of Surgery, University of Miami School 
      of Medicine, letter dated May 5, 1999, enclosing response 
      for the record.............................................    73
    Nathan, Howard M., President, Coalition on Donation, Delaware 
      Valley Transplant Program, letter dated May 18, 1999, 
      enclosing response for the record..........................    83
    Neylan, John F., American Society of Transplantation, letter 
      dated April 30, 1999, enclosing response for the record....    79

                                 (iii)

  


  PUTTING PATIENTS FIRST: INCREASING ORGAN SUPPLY FOR TRANSPLANTATION

                              ----------                              


                        THURSDAY, APRIL 15, 1999

                  House of Representatives,
                             Committee on Commerce,
                    Subcommittee on Health and Environment,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 10:07 a.m., in 
room 2123, Rayburn House Office Building, Hon. Michael 
Bilirakis (chairman) presiding.
    Members present: Representatives Bilirakis, Upton, 
Greenwood, Burr, Bilbray, Whitfield, Ganske, Coburn, Cubin, 
Bryant, Brown, Waxman, Pallone, Green, DeGette, and Barrett.
    Staff present: Marc Wheat, majority counsel; Patrick 
Morrisey, majority counsel; Penn Crawford, clerk; and John 
Ford, minority counsel.
    Mr. Bilirakis. The hearing will come to order. I am sure we 
all admire the patience of the children, particularly, but I do 
not think we ought to make them wait any longer.
    I am pleased to convene this hearing on increasing the 
supply of organs available for transplantation. The 
subcommittee's review of these issues is timely because, as we 
know, next week is National Organ and Tissue Donor Awareness 
Week.
    Last year, 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. Despite strong 
differences of opinion, all of the witnesses recognize the 
severe shortage of organs for transplantation. The question 
before us now, as then, is what the Federal Government can and 
should do to improve this situation.
    This year, 20,000 people will receive organ transplants, 
but 40,000 will not. In the last decade alone, the waiting list 
for transplants grew by over 300 percent. Much of this increase 
is due to improvements in medical treatments for transplant 
patients. However, the gap between organ supply and demand 
remains enormous.
    As we consider these issues, we should remember that many 
successful programs to encourage organ donation have been 
developed at the State level. In my home State of Florida, the 
organ procurement program operated by LifeLink has increased 
donations by 46 percent in the past 3 years alone. Today, John 
Campbell will describe the innovative strategies LifeLink has 
employed to increase organ supplies in Florida and Georgia.
    This is literally a matter of life and death for tens of 
thousands of Americans each year. Given the enormity of these 
issues, we have an obligation to work together to address these 
concerns on a bipartisan basis. However, the solution to this 
problem, I am sure we all agree, is not entirely legislative.
    By working to increase public awareness about the need for 
organ donations, we can all save lives. My wife and I were 
proud to sign the First Family Pledge, which encourages 
families to talk about the importance of organ and tissue 
donation, and are hopeful that most of the Congress, if not all 
of it, will follow suit. Many already have, obviously.
    Our first witnesses today are young people who participated 
in the First Family Pledge Congress, which was held yesterday. 
Their lives were saved by an organ transplant and they will 
provide a firsthand perspective on these issues. Their stories 
should motivate us to redouble our efforts to increase organ 
donations.
    Our second panel of experts will focus on methods being 
used to increase organ donation and expand organ supply. They 
will also discuss the reasons why demand greatly exceeds supply 
in certain areas of the country.
    I again want to welcome all of our witnesses and especially 
our young heroes. I appreciate their time and effort in joining 
us, and I look forward to hearing their testimony. I will allow 
the panel to make their opening statements at this time, but I 
would hope that they could be curtailed in the interest of not 
extending the patience of the young people on the first panel.
    Mr. Brown is recognized for an opening statement.
    Mr. Brown. Thank you, Mr. Chairman. I welcome all of our 
witnesses. Thank you for coming today and being with us.
    I would like to take this opportunity to commend my 
colleague, Mr. Stark, for introducing the Gift of Life 
Congressional Medal Act, legislation that recognizes the 
compassion, humanitarianism, and courage of organ donor 
families. I am proud to be a cosponsor of this bill.
    I am particularly pleased, Mr. Chairman, to welcome our 
first panel. I understand that Abbey, and it says in front of 
her name Ms. Johnston, is from Napoleon, Ohio. I live in 
Lorain, not very far from you, about 100 miles away from you. 
Welcome to you and to your three friends on the panel. Thank 
you for coming.
    The four of you coming to talk to us today is a better 
advertisement for organ donation than any billboard or 
television commercial or long-winded speech that could ever be. 
Meeting you and hearing your stories makes the need for 
increased organ donation more real for all of us.
    I looked at my own district to get a better sense of the 
donation shortfall. At any given time last year, more than 
1,100 people in Northeast Ohio were waiting for a transplant. 
Over the same period, there were only 86 organ donors and 231 
tissue donors. That is a tremendous gap. Fortunately, there are 
actions we can take to reduce this critical shortfall.
    The U.S. population is increasing but the number of organ 
donors, unfortunately, is not. As a matter of fact, there has 
not been a significant increase in the number of organ donors 
since 1986. At the same time, the number of patients waiting 
for donated organs has grown dramatically, driven in part by 
medical advances and changes in the Nation's demographics.
    Research shows we can improve this situation by focusing on 
two key areas, becoming more diligent in identifying and 
referring potential organ donors and learning better ways to 
help families negotiate the difficult emotions around organ 
donation. Experts believe more than a quarter of medically 
suitable organ donors go unrecognized. Based on this figure, 
each year, we forsake thousands--thousands--of critical 
opportunities to help patients.
    But this is not the most common reason that medically 
suitable organs are not recovered. Family refusal to provide 
consent for donation is. These families face an untenable 
decision at a crisis point in their lives. But researchers 
believe we can encourage more families to consider organ 
donation by adopting outreach and support models that have met 
with particular success. According to these researchers, there 
are fertile opportunities to identify and apply best practices 
to organ donation, and by doing so we can increase organ 
donation rates. It will not be easy, but together, we can do 
it.
    Organ donation is such an amazing act of giving, one that 
delivers hope, health, and time to thousands of patients each 
year. I look forward to learning more about this issue from our 
four panelists. Thank you for joining us again.
    Mr. Bilirakis. I thank the gentleman.
    Mr. Bryant, for an opening statement.
    Mr. Bryant. Thank you, Mr. Chairman. I am happy to be here 
today to learn more about organ donation and transplantation. 
With all the recent discussions in the medical and health 
policy communities about how best to allocate the number of 
donated organs, I am glad that we are choosing to focus today's 
hearing on the root problem, the shortage of organs available 
for transplant. Finding ways to increase organ supply is really 
the best, most direct way to help thousands of patients 
currently waiting for a transplant and those who will need 
organs in the future.
    I would like to take this opportunity to welcome this most 
distinguished panel of witnesses. I appreciate each of you 
taking your time to be here today. I want to particularly 
welcome Mr. Burton, who is a good volunteer from the State of 
Tennessee. He lives just outside my district, up around 
Nashville, but I thank him for being here and I know that you 
will help us better understand the nature of the problem and 
how we in Congress can assist you in your efforts.
    As a result of you being here and testifying today, all of 
you, I am going to look at supporting the pledge you have asked 
us to support regarding organ donations and discussing those, 
and I will make that commitment to you today, especially for my 
good volunteer, Mr. Burton.
    Thank you, Mr. Chairman and Mr. Brown, for holding these 
hearings and I yield back.
    Mr. Bilirakis. Thank you, sir.
    Mr. Pallone, for an opening statement.
    Mr. Pallone. Thank you, Mr. Chairman. Let me say that I do 
think this is a very important hearing and I want to thank you 
and Mr. Brown for holding it this morning.
    Increasing the supply of organs for transplantation is a 
critical public policy issue in this Nation and an acute 
problem in my own State of New Jersey and I am grateful for the 
opportunity to hear from today's witnesses, particularly the 
first panel here. They look about the age of some of my 
children.
    I want to articulate some of the concerns I have with the 
impact the current system is having on the ability of organ 
procurement organizations to focus all of their energies on 
their mission. New Jersey has one of the finest organ 
procurement systems in the country and New Jersey's largest 
organ procurement organization, the New Jersey Organ and Tissue 
Sharing Network, does an excellent job in organ donation 
education and in meeting the needs of New Jersey's transplant 
centers.
    One particularly noteworthy aspect of the New Jersey Organ 
and Tissue Sharing Network's efforts is its work in assisting 
minority and indigent care communities. New Jersey's network 
has been recognized nationally for its work in these areas.
    My State was also one of the first to pass routine referral 
legislation and help set the standard that the Federal 
Government eventually followed, and I am very pleased to note 
that since the enactment of that legislation, New Jersey has 
seen a 20 percent increase in donation. Despite this increase, 
however, there are still flaws in the system that are 
obstructing the effort to increase organ donation. Like every 
OPO in the Nation, New Jersey's sharing network must meet HCFA 
recertification standards every 2 years or face termination.
    Mr. Chairman, I wanted to say I am extremely concerned 
about the unpredictability of the recertification process and 
the impact it has on the ability of OPOs to focus their energy 
on increasing organ donations. OPOs must conform to performance 
thresholds that may have no direct correlation to the OPO 
service population characteristics and, therefore, no real 
connection to the actual performance of the OPO.
    The recertification process, moreover, allows no time for 
OPOs to respond to HCFA's findings. Sometimes they are notified 
only a month or 2 before the recertification deadline, by which 
time it is too late to address identified problems. HCFA's 
regulations allow no corrective action plan for the OPOs to 
improve donation services. In other words, either you meet the 
arbitrary requirements or you fail. There is no second chance.
    Organ procurement organizations are on the front lines of 
public education efforts and the existence of a performance 
review process that removes established organizations without 
due process, or at least an attempt to deal with local 
demographic realities, is of great concern to me. Organ 
procurement organizations cannot concentrate fully 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, and such a short cycle simply 
does not help OPOs implement the best practices to increase the 
organ supply.
    This system is clearly not good for areas with diverse 
populations and areas with high cancer, HIV, and HVC rates that 
adversely impact the supply of organs, and accordingly, I would 
like to see HCFA suspend the certification process so new and 
better data from hospital death records and other sources can 
be studied. Study of new information will allow for a 
certification process that better reflects actual organ 
donation potential to be implemented.
    My State and other areas with diverse populations and high 
incidences of disease cannot tolerate the biannual threats to 
their existence. The system obstructs the access my 
constituents have to organ donation and transplantation 
services and this flaw must be addressed, and I am hopeful that 
today's hearing will move us closer to this goal. Thank you 
again.
    Mr. Bilirakis. I thank the gentleman.
    Mr. Greenwood, for an opening statement.
    Mr. Greenwood. Thank you, Mr. Chairman, and thank you for 
holding this hearing. I think our patients are well named 
because they are very patient while these Congressmen drone on 
here.
    Over the last 10 years, the number of transplants performed 
in the country increased by about 56 percent while the number 
of patients on the waiting list grew by about 316 percent. Some 
people estimate that less than one-third of the potential 
donors in America actually contribute. But according to some 
researchers, it may be possible to increase by 80 percent the 
number of organ donations in the United States through 
incentive programs and public education.
    In my State of Pennsylvania, we have passed what we call 
routine notification requirements, that all deaths or imminent 
deaths be reported to the local OPO. After we did that, within 
3 years of doing that, organ donations were up 43 percent in 
Pennsylvania.
    In addition, Pennsylvania offers a $300 contribution toward 
funeral expenses to families of organ donors as part of a 3-
year pilot program. The money is given directly to the funeral 
home. Because the program does not give money directly to the 
donor, it is not considered a direct financial incentive, which 
is banned under Federal law. The whole question of financial 
incentives as a methodology of increasing organ donor supply is 
controversial and raises a variety of ethical questions.
    In the audience is a friend of mine and a constituent. His 
name is Gene Epstein. He has been promoting an idea in which 
the Federal Government would issue a $10,000 life insurance 
policy with benefits payable upon donation and transplantation 
of the deceased's organs. Mr. Epstein has been working with Dr. 
Alan Bozeman, a liver transplant recipient, to develop public 
support for this idea. Dr. Bozeman and Mr. Epstein estimate 
that if all potential organs were transplanted successfully, 
the only remaining patients waiting for an organ would be new 
listees.
    This is an intriguing idea. We would have to look at how it 
would be financed, and I welcome his insights and ask my 
colleagues to examine his ideas. I also ask unanimous consent 
that his proposal, entitled ``Project Donor,'' be inserted into 
the record.
    Mr. Bilirakis. Without objection.
    [The Proposal appears at pg. 87.]
    Mr. Greenwood. Mr. Epstein has also brought with him a 
check for $100,000 payable to the United States Treasury in a 
gesture to kick-start such a program if the U.S. Congress 
thought we ought to put it into law. I look forward to today's 
discussion. Thank you, Mr. Chairman.
    Mr. Bilirakis. That is some kind of motivation for it.
    I might add that in the many discussions that we have had 
regarding the proper method of organ allocation, Mr. Greenwood 
constantly reminded us that as important as that was, organ 
supply or having proper organ supply was just as significant. 
So this hearing is really somewhat of a testimonial, if you 
will, to Mr. Greenwood, I would say, more than anything else.
    Mr. Barrett, for an opening statement.
    Mr. Barrett. Thank you, Mr. Chairman. Good morning, girls 
and boys. It is a pleasure to have you here. As adults, we will 
spend a lot of time talking about how organs should be 
distributed and what we can do to increase the supply, but in 
case we are going to have to give you a recess before we 
actually get to hear your testimony, I just want to thank you 
for being here and I very much look forward to hearing what you 
have to say. Thank you, Mr. Chairman.
    Mr. Bilirakis. Thank you so much.
    Mr. Whitfield, for an opening statement.
    Mr. Whitfield. Mr. Chairman, thank you very much. Like the 
others on this panel, it is seldom that we have such a 
distinguished group of young witnesses and I know all of us are 
looking forward to hearing their testimony because they have 
the firsthand experience of what transplants are really all 
about, so I look forward to their testimony and thank you for 
holding this hearing.
    Mr. Bilirakis. Thank you. I appreciate that. These young 
people have been sitting here for quite some time. They are 
very, very patient, much more so than any of us could be, and 
so I have asked for brevity in the opening statements.
    Mr. Waxman? I do not necessarily intend that to reflect on 
you.
    Mr. Waxman. No, I understand. I thank you very much, Mr. 
Chairman, and I thank the young people for their patience. This 
is an important hearing and I am glad you have called it. I am 
really pleased that we have these witnesses here today to talk 
to us.
    It is obvious that unless people have organs for 
transplantation, some people are unfortunately going to die, 
which means that we have got to have more organs. I am pleased 
that the Clinton administration has started a new initiative to 
get people to be aware of these facts so if an occasion arises, 
they will either donate their own organs or respond to the call 
from members of their family, if they suffer a sudden death.
    But there is another point. I have been excited at the 
possibility of stem cell research at UCLA and other places 
where there is talk that they can develop organs that can be 
used for transplantation. I would just want to emphasize that 
we should not do anything to stop this kind of research. We 
should not let politics get in the way of this research because 
it holds an enormous amount of promise for the future.
    Mr. Chairman, I thank you for this chance to say a few 
words and to welcome our witnesses today and I want to tell you 
how much I think it is important that we are holding this 
hearing and I thank you for it.
    Mr. Bilirakis. Thank you, sir.
    Dr. Ganske, for an opening statement.
    Mr. Ganske. Thanks, Mr. Chairman. I will be brief. I was 
just thinking that back in 1976, 1977, 1978, I worked with a 
lot of children who had biliary atresia and would have 
benefited from transplantation surgery. As I am looking at our 
first panel here, I was just thinking about the advances that 
have been made in transplant surgery and we should try to do 
everything we can to make those benefits available to as many 
people as possible, and I yield back.
    Mr. Bilirakis. Thank you, Doctor.
    Mr. Green?
    Mr. Green. Thank you, Mr. Chairman. I will put my full 
statement in the record, but I want to, like my colleagues, 
thank Jamar, Abbey Lynn, Cynthia, and Kara Grace and say that I 
was at the press conference yesterday over on the Senate side 
and saw some constituents there and I am proud to have made the 
pledge.
    The problem, like my colleague from Pennsylvania said, we 
have 66,000 people on waiting lists and 20,000 transplants 
available, so we have to do better to develop the transplants. 
Coming from Texas, we have a State program that has implemented 
a number of things to try and increase, and it has worked, and 
I encourage us to look at that, Mr. Chairman.
    [The prepared statement of Hon. Gene Green follows:]
  Prepared Statement of Hon. Gene Green, a Representative in Congress 
                        from the State of Texas
    Last year the administration made a good faith effort to reduce 
waiting times for patients who need an organ transplant. Unfortunately, 
what their plan did not recognize is that merely re-allocating organs 
under today's levels of supply and demand would save few lives.
    The reality is, when you have 66,000 people on waiting lists and 
only approximately 20,000 transplants, our federal resources would be 
better spent supporting programs to increase donation rather than to 
force changes to existing allocation policies.
    If we are serious about making a difference, we have to be serious 
about increasing the number of organ donors.
    In most cases, finding the solution to a problem is the hardest 
part. But in this instance, we know what we need to do, we just don't 
know the best way to do it.
    Fortunately, many states around the country, including my home 
state of Texas, are starting to figure it out.
    For example, within the past few years, Texas has implemented a 
series of programs to help increase organ donation. These include: 1) 
Increasing community participation in increasing donor awareness; 2) 
increasing family consent for donation; and 3) increasing hospital 
referrals of potential organ donors to the OPO.
    While these programs may seem obvious, they resulted in a 12% 
increase in Texas organ donation last year alone.
    Other states have similar programs and have also had excellent 
results. Now we must join the states and the administration in support 
of existing programs and do everything possible to encourage other 
states to initiate new programs.
    I look forward to hearing from our witnesses to learn more about 
what other states are doing, so we can see what is working.
    Thank you Mr. Chairman.

    Mr. Bilirakis. I thank the gentleman.
    Dr. Coburn, do you have an opening statement?
    Mr. Coburn. Thank you, Mr. Chairman. I am extremely 
interested in this issue. I have had three of my own pediatric 
patients transplanted in Oklahoma and three transplanted 
outside of Oklahoma. I understand the organ availability issue. 
Oklahoma has worked hard to improve that and increase it, and 
we have. I think our goal ought to be to find out what we can 
find during these hearings and then we ought to make sure that 
we implement any policy that will increase the available number 
of organs, regardless of where they are transplanted, and I 
just want to thank everybody's effort in bringing this issue to 
the forefront and you for having this hearing. I yield back.
    Mr. Bilirakis. Thank you, sir.
    Ms. DeGette?
    Ms. DeGette. Thank you, Mr. Chairman. I, too, would like to 
thank these guys for coming today. It is nice to see all of you 
here to testify and to tell us about organ transplants.
    Just to add a slightly different perspective, I spent some 
time during the recess up at the Joslin Diabetes Center at 
Harvard University learning about efforts to improve patient 
tolerance of transplanted organs. In addition to the many, many 
people who are on waiting lists right now for organ donations, 
as Congressman Waxman said, there is enormous potential in 
years to come for islet cell transplantation.
    We have 16 million people in the United States right now 
who have diabetes. Many of those people, if we could perfect 
organ transplantation, and tolerance to these transplants, 
would benefit from pancreatic transplantation and also islet 
cell transplantation. It could literally cure their diabetes. 
But in order to do that, we have to improve our transplantation 
program in this country because we do not even have enough 
pancreases or other organs for people who are currently on 
waiting lists.
    So I appreciate you holding this hearing, Mr. Chairman, and 
I yield back the balance of my time.
    Mr. Bilirakis. Thank you.
    Mr. Upton?
    Mr. Upton. Thank you, Mr. Chairman. If there is not a 
better reason to reauthorize this law, it is the four wonderful 
kids that are sitting at that table. I have signed the donor 
pledge. I look forward to working with you to get the job done, 
and we appreciate the patience of our witnesses. And with that, 
I will cut short my statement. Thank you.
    Mr. Bilirakis. I thank the gentleman.
    [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 hearing on how 
to best increase the organ supply for those patients in need of 
transplantation.
    Almost one year ago I, along with other Members of Congress who 
represent the Northwestern part of the U.S., wrote a strongly worded 
letter to Secretary of Health Shalala asking that she reconsider the 
controversial proposed rule on a new organ allocation policy.
    In part, the letter pointed out that the ``sickest-patient-first'' 
standard, applied on a national basis, would result in more deaths and 
fewer successful transplants.
    In our mostly 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-
density areas access to more organs. Regions with smaller 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.
    We pointed out that the Organ Procurement and Transplantation 
Network (OPTN), a consensus based organization of transplant 
professionals, transplant recipients, organ donors and family members, 
rejected the ``sickest-first'' standard because it would not work to 
ensure the greatest benefit from available organs.
    Although I disagreed with much of Secretary's work in this regard, 
I was very pleased to see that the Department of Health and Human 
Services has made it a priority for hospitals that participate in the 
Medicaid and Medicare Programs to implement ``routine notification'' 
policies as they relate to organ donations, transplantations, and 
allocations.
    It really is an important step in allowing for better 
communications among the providers, hospitals and organ procurement 
organizations (OPOs).
    There are many factors that affect the donation of organs, many of 
which the federal government would have no control over. However, if 
there is a role that the federal government can play to ensure that 
those who need an organ transplant receive one in a speedy and 
dependable manner we need to do that immediately.
    I look forward to hearing from the witnesses today to see what 
their suggestions are in this regard.
    Thank you, Mr. Chairman. I yield back the balance of my time.
                                 ______
                                 
 Prepared Statement of Hon. Tom Bliley, Chairman, Committee on Commerce
    Thank you, Chairman Bilirakis for holding this hearing today on a 
topic that is literally vital: finding lifesaving solutions to the 
problem of a short supply of organs available for transplants for 
Americans in need.
    Our first panel of witnesses are all experts in the field of 
pediatric transplantation. Each of these experts is between the ages of 
seven and ten years old, and each of them has had at least one organ 
transplant. Their young and precious lives illustrate why we should do 
our very best to increase the supply of organs for transplant. Their 
testimony this morning should remind us in the months ahead, as we 
consider the reauthorization of the National Organ Transplant Act, that 
the closure of regional transplant centers cannot occur.
    Our second panel of witnesses, or what we will refer to today as 
the ``grown-ups' table,'' represents those who have dedicated their 
lives and imaginations to saving the lives of thousands of people each 
year. It is this panel, in regional transplant centers and organ 
procurement organizations where innovation and enterprise of the 
highest order is being carried out.
    We will learn of breakthrough treatments from Dr. Marcos at the 
Medical College of Virginia, where living donors actually donate part 
of their livers to help someone in need, most often a child. The 
Medical College of Virginia has had great success in this area, 
employing exciting procedures where the liver tissue regenerates in 
both donor and recipient. This procedure promises to free up more 
donated livers for others, thus easing the pressure on those facing 
long and life-endangering illnesses. The Medical College of Virginia 
has performed 25 living donations since the beginning of 1998, and 
performs more adult-to-adult procedures than any center in the country. 
Every week, MCV performs about four adult-to-child living donor 
transplants a week, helping guarantee more birthday parties and summer-
time ice cream socials for these children and their families.
    Other witnesses we will hear from today will describe ideas put 
into action by centers which are increasing donation rates and 
extending supplies throughout the Nation. I ask my colleagues to work 
with me through the authorization process to encourage the Organ 
Procurement and Transplantation Network that is increasing the supply 
of organs, rather than pursue an experimental redistribution program 
that would result in the closure of regional transplant centers.
    Thank you, again, Chairman Bilirakis for calling this hearing, and 
I look forward to the testimony of our witnesses.

    Mr. Bilirakis. Our first panel is, of course, the very 
significant panel of true heroes. Ms. Emily Joan Mahon from the 
State of Wisconsin was to be a part of the panel, but I 
understood she took ill this morning and is not able to appear. 
But we do have Mr. Jamar Burton from the State of Tennessee, 
Ms. Cynthia Guillemin from my State of Florida, Ms. Kara Grace 
Thio from the State of North Carolina, and Ms. Abbey Lynn 
Johnston from the State of Ohio.
    Kids, I know you all have a written opening statement that 
is a part of the record. You are welcome to read that or just 
speak on your own. Just tell us basically about your 
experience, whatever you think is going to be very helpful to 
us as we confront this problem.
    Jamar, why do we not start off with you.

 STATEMENTS OF JAMAR BURTON, ORGAN TRANSPLANT RECIPIENT, STATE 
 OF TENNESSEE; CYNTHIA GUILLEMIN, ORGAN TRANSPLANT RECIPIENT, 
STATE OF FLORIDA; KARA GRACE THIO, ORGAN TRANSPLANT RECIPIENT, 
    STATE OF NORTH CAROLINA; AND ABBEY LYNN JOHNSTON, ORGAN 
              TRANSPLANT RECIPIENT, STATE OF OHIO

    Mr. Burton. I am Jamar Burton from Antioch, Tennessee. I am 
10 years old and I am a kidney transplant recipient. I would 
like to thank the members of this committee for giving me the 
opportunity to speak about the importance of organ donation.
    I have two donors to thank for the miracle that lets me sit 
here today. The first is my mother, who donated one of her 
kidneys to me when I was a baby. Unfortunately, a bad case of 
chicken pox when I was just starting school damaged that 
kidney, so I needed a second transplant. I was blessed. I got a 
second kidney in 1995, and now I am doing fine.
    But many people are not so blessed. Today, more than 700 
people from my State, Tennessee, are waiting for organs. All of 
them and all of their families are hoping an organ will be 
available in time, but some of them will be disappointed.
    These people do not make the decision to get a transplant 
by themselves. I know from my own experience, they make the 
decision with their families. It is a matter that affects the 
entire family. So why should people make the decision to be an 
organ donor by themselves? People should discuss organ donation 
with their family, too.
    That is why I think the First Family Pledge idea, getting 
families to all agree to be organ donors, is the best hope for 
the thousands of people waiting. I would like to thank all of 
the Members of Congress, particularly Senator Frist and 
Congressmen Tanner and Ford, for supporting the First Family 
Pledge. Thank you.
    Mr. Bilirakis. Thank you so much, Jamar.
    Cynthia, you are up.

                 STATEMENT OF CYNTHIA GUILLEMIN

    Ms. Guillemin. I am Cynthia Guillemin from Miami, Florida. 
My doctor calls me Madeline, like in the story book, because I 
lived in France when I was really little. I am 7 years old and 
my mommy gave me her kidney when I was 6. I would like to thank 
all you important people for letting me speak to you today.
    Just 1 year ago, I was on a kidney machine for a long, long 
time because my kidneys did not work. My mommy was really nice, 
kind, to give me one of hers. Many kids like me cannot get this 
present because their mommies and daddies cannot give it to 
them. I was very lucky. Many people need to get this gift of 
life from other families.
    Today, more than 1,000 mommies and daddies in Florida who 
cannot give such presents are waiting for their kids to maybe 
get them from other families. I say families because when a kid 
like me, or a mommy or a daddy or a brother or a sister, needs 
a transplant, they do not wait by themselves. Their whole 
family hopes and prays for them.
    When this present is given, the whole family is happy. The 
miracle is a family miracle, so we should thank the families 
who made it happen. If families talk about both parts of this 
miracle, the giving and receiving of transplants, then 
everybody will know it is the right thing to do.
    That is why I thank you for the First Family Pledge. I 
would like to thank everybody here, especially Mr. Bilirakis, 
for signing the First Family Pledge. Thank you. And thank you 
also to my favorite Dr. Miller who operated me.
    Mr. Bilirakis. She did considerably better with my name 
than I did with hers, did she not? Thank you, Cynthia.
    Kara Grace?

                  STATEMENT OF KARA GRACE THIO

    Ms. Thio. I am Kara Grace Thio from Cary, North Carolina. I 
am 7 years old. I am a liver transplant recipient. I would like 
to thank this committee for letting me speak today.
    I received the gift of life when I was 8 months old. Since 
then, my mother and I are doing all we can to encourage organ 
and tissue donation.
    More than 2,000 people from North Carolina are waiting for 
an organ to be available. Some will be lucky and get a new 
chance, like me. Some will be disappointed. I think all of them 
should have the chance for a transplant.
    Yesterday, 200 children like me came to Washington to show 
Congress how transplants changed our lives. Lots of family 
members came, too, because transplants change the lives of 
entire families.
    Families should discuss the miracle of transplants. If a 
member of my family needed a transplant, we all would hope they 
would get an organ. So should not families all also agree to be 
organ donors?
    It is also important for family members to know about each 
other's desires to be organ donors because it is the family 
members who are the ones who make sure that their loved one's 
wish to be an organ donor gets fulfilled.
    That is why we support the First Family Pledge idea. I 
would like to thank the Members of Congress, particularly 
Congressman Burr, who is on the Commerce Committee, Senators 
Helms and Edwards, and Congress members Myrick, Clayton, Watt, 
Pomeroy, Price, and Jones for supporting the First Family 
Pledge. Thank you.
    Mr. Bilirakis. Last, but far from least, Abbey Lynn.

                STATEMENT OF ABBEY LYNN JOHNSTON

    Ms. Johnston. I am Abbey Lynn Johnston from Napoleon, Ohio. 
I am 10 years old and I am a liver transplant recipient. I 
would like to thank the members of this committee for giving me 
the opportunity to speak today about the importance of 
increasing the availability of organs for transplantation.
    It sometimes is hard for me to realize today how sick I was 
when I was a baby, not even 2 years old, and in desperate need 
of a new liver. I am sure my family has very clear memories of 
their worries and their hopes and their prayers.
    Fortunately, the gift of life was available for me, but 
more than 1,000 residents of Ohio are waiting right now for a 
transplant, not knowing whether the gift of life is going to be 
available for them. Can you imagine how the families of all 
these people must feel?
    We have great medical centers in Ohio. In Cincinnati, where 
I got my transplant, at Ohio State in Columbus, in Cleveland, 
transplant surgeons at these Ohio centers perform this miracle 
operation every day. The doctors are available. The organs are 
not.
    If every Ohio family talked about the miracle of 
transplantation, they all obviously would hope an organ would 
be available if one of them needed it. Well, the Golden Rule 
says it is better to give than to receive. The two parts, 
giving and receiving, are linked. Every family might be in a 
position some day where it would be hoping to receive. Every 
family ought to be willing to give.
    I think the First Family Pledge idea, getting families to 
all talk about the miracle of transplantation and to all agree 
as a family to be organ donors, is the best hope for the 
thousands of people waiting. I would like to thank all the 
Members of Congress, especially Congressmen Brown and 
Strickland, who are members of the subcommittee, and 
Congressmen Oxley and Sawyer, who are members of the full 
Commerce Committee, and Senators DeWine and Voinovich, and a 
half a dozen other members of the Ohio Congressional delegation 
who are supporting the First Family Pledge. Thank you.
    Mr. Bilirakis. Thank you so much. I think if every American 
had the privilege to hear your story the way we do, virtually 
all would be taking the First Family Pledge. Of course, we take 
the pledge, but we also have to follow up and do what we have 
pledged to do, and that is something that is so important.
    I just have one question very quickly. We do not want to 
keep you much longer. Do any of you know other children, 
friends or other children who will need a transplant or who 
need a transplant? Do you know any, Cynthia?
    Ms. Guillemin. No.
    Mr. Bilirakis. No, you do not know any. What would you tell 
them if you knew, if one of your friends, one of your 
neighbors, needed a transplant? What would you tell those 
children? How would you make them feel good? Do any of you have 
an answer to that? Abbey Lynn, Cynthia, Jamar? No? Okay. It is 
not the first time I have raised a question from up here and 
not gotten an answer.
    Mr. Bilirakis. Any further questions from members of the 
subcommittee?
    [No response.]
    Mr. Bilirakis. Thank you so very much. You are real heroes 
in our eyes.
    You are excused. Thank you. Good luck to you.
    The next panel consists of Mr. John Campbell, Executive 
Director of LifeLink; Mr. Howard M. Nathan, President of the 
Coalition on Donation; Dr. Amadeo Marcos, Assistant Professor 
of Surgery, Medical College of Virginia--I wish you would all 
come forward as we call your names--Dr. Joshua Miller, 
President of the American Society of Transplant Surgeons, 
University of Miami School of Medicine; Dr. John F. Neylan, 
American Society of Transplantation; Dr. Robert A. Metzger, 
Medical Director and Transplant Physician, Translife at Florida 
Hospital in Orlando; Dr. Robert S.D. Higgins, Director of 
Thoracic Organ Transplantation, Henry Ford Hospital, Detroit, 
Michigan; and Mr. Joseph L. Brand, Chairman of the National 
Kidney Foundation, Office of Scientific and Public Policy, 
Arlington, Virginia.
    Gentlemen, your submitted written statements are a part of 
the record. I understand the green light does not go on, but 
the red light does, so I will turn on the 5-minute clock, and 
hopefully you will stay as close to that 5 minutes as you can. 
I do not want you to cutoff right in the middle of a thought, 
however.
    I might add that the opening statements of all members of 
the subcommittee are a part of the record, without objection.
    We will kick it off with Mr. Campbell, if you would pull 
the microphone over, John, closer to you.

 STATEMENTS OF JOHN R. CAMPBELL, EXECUTIVE DIRECTOR, LIFELINK 
FOUNDATION; HOWARD M. NATHAN, PRESIDENT, COALITION ON DONATION, 
 DELAWARE VALLEY TRANSPLANT PROGRAM; AMADEO MARCOS, ASSISTANT 
  PROFESSOR OF SURGERY, MEDICAL COLLEGE OF VIRGINIA; JOHN F. 
NEYLAN, AMERICAN SOCIETY OF TRANSPLANTATION; ROBERT A. METZGER, 
 MEDICAL DIRECTOR, TRANSPLANT PHYSICIAN, TRANSLIFE AT FLORIDA 
    HOSPITAL; ROBERT S.D. HIGGINS, DIRECTOR, THORACIC ORGAN 
TRANSPLANTATION, HENRY FORD HOSPITAL; JOSHUA MILLER, PRESIDENT, 
AMERICAN SOCIETY OF TRANSPLANT SURGEONS, DEPARTMENT OF SURGERY, 
 UNIVERSITY OF MIAMI SCHOOL OF MEDICINE; AND JOSEPH L. BRAND, 
  CHAIRMAN, OFFICE OF SCIENTIFIC AND PUBLIC POLICY, NATIONAL 
                       KIDNEY FOUNDATION

    Mr. Campbell. Thank you, Mr. Chairman. Thank you, ladies 
and gentlemen. I am John Campbell and I am here on behalf of 
LifeLink Foundation, which operates four of the Nation's 62 
organ procurement organizations, LifeLink of Florida, LifeLink 
of Southwest Florida, LifeLink of Georgia, and LifeLink of 
Puerto Rico.
    In the last 10 years, LifeLink's programs have experienced 
success in increasing organ donation which is far greater than 
the national average. We believe the success is due to unique 
programs at LifeLink which could be exported to other areas of 
the country to increase organ donation and save lives.
    This year, LifeLink of Florida procured transplantable 
organs from 40 donors per million population, the highest rate 
in the Nation. This is the standard by which OPOs are currently 
judged. The national average is some 20 donors per million 
population.
    We are not here to say that LifeLink's programs can double 
the supply of organ donors in this country, but we are here to 
say and to report on the increases in donations that were 
achieved with LifeLink's programs and to briefly identify those 
programs.
    First, about those successes. In 1989, 63 organ donors were 
procured in Tampa at LifeLink of Florida. The next year, we 
implemented new programs designed to increase organ donation. 
In 3 years, organ donation increased by 46 percent. Last year, 
112 organ donors were procured at LifeLink of Florida, a 78 
percent increase over 1989. Over that 10-year period, then, 943 
more organs were made available for transplant than if these 
increases had not occurred.
    But in trying to export these programs, in 1993, the 
program was implemented in most of the State of Georgia. As of 
last year, the LifeLink of Georgia program had increased 
donation by 94 percent, from 67 donors to 130 donors. More 
importantly, in 1996, LifeLink of Georgia was awarded the 
service area that was formerly served by the Medical College of 
Georgia, which had been decertified for failing to meet the 
minimum criteria established by HCFA. In 1 year, this area of 2 
million persons in eastern Georgia went from 22 organ donors to 
42 organ donors, a 91 percent increase. Last year, the increase 
was 118 percent, to 48 donors.
    In brief, LifeLink's program consists of three strategies. 
We first simplify the donation process. LifeLink and its eye 
and tissue bank partners have always employed a unified 
approach to donor referral with a 24-hour shared in-house 
operator system, whereby only one agency contacts the hospital. 
HCFA deserves credit for implementing some of these changes as 
one of the Medicare conditions of participation last year.
    Also, there is virtually no competition for tissue and eye 
donors in LifeLink's hospitals. We believe that the current 
state of aggressive competition among eye and tissue banks in 
many parts of the country may decrease organ and tissue 
donation. We took the extraordinary step at LifeLink of giving 
up our eye bank to a competing agency for no remuneration so 
there would be only one eye, tissue, and organ bank in our 
Florida service area. It may be that exclusive service areas 
for eye and tissue banks should be awarded as they are to organ 
procurement agencies.
    Second, we increased our responsibility for hospital 
contact and donor consent rates. LifeLink has had required 
referral in our hospitals for many years, and this has also 
become part of the new HCFA COP and has already increased organ 
donation this year. But we also implemented the system of 
designated requestors, employees highly skilled in meeting the 
needs of donor families when requesting organ donations. Our 
consent rates are among the Nation's highest.
    Also, in Georgia, we created the Minority Donation 
Education Project to address the low consent rate among African 
Americans. LifeLink's minority consent rate has become nearly 
50 percent, which we believe is significant.
    Third, we established a strong hospital liaison and organ 
procurement organization management program. We focused on a 
service-oriented approach to hospital development and hired 
applicants with communications and public relations 
backgrounds. But most importantly, we hired significant numbers 
of these employees. We have in the State of Georgia 20 full-
time hospital development employees for the 7 million persons 
in that State. We have six full-time hospital development 
employees for the 2.8 million people in our Florida service 
area. We do not believe any organ procurement organization in 
the United States staffs at near these levels.
    And last, LifeLink is independent of its transplant centers 
in Georgia, Florida, and Puerto Rico. Although we have the 
appropriate and required transplant center representation on 
our governing and advisory boards, a majority of our board 
members come from the community. In this way, LifeLink is free 
to establish reasonable programs to increase organ donation 
without undue concern about the financial impact of these 
programs on its transplant centers.
    In conclusion, our professional education and hospital 
service programs have allowed LifeLink to meet the needs of 
donor and recipient families in our service area. We provide a 
large number of organs for transplant in Florida, but 
significantly, also for the rest of the country. We would be 
glad to share our program with any agency, if that would help 
achieve a similar increase in donation. Thank you, Mr. 
Chairman.
    [The prepared statement of John R. Campbell follows:]
 Prepared Statement of John R. Campbell, Senior Vice President/General 
                      Counsel, LifeLink Foundation
    My name is John Campbell, and I am here on behalf of LifeLink 
Foundation, which operates four of the nation's 62 Organ Procurement 
Organizations (OPOs), LifeLink of Florida, LifeLink of Southwest 
Florida, LifeLink of Georgia, and LifeLink of Puerto Rico. Along with 
my employers and co-workers, I have helped to manage these programs for 
the last ten years. In those ten years, LifeLink's programs have 
experienced success in increasing organ donation that is far greater 
than the national average. We believe this success is due to unique 
circumstances and unique programs at LifeLink, circumstances and 
programs which could be exported to other areas of the country to 
significantly increase organ donation and save lives.
    Ladies and gentlemen, you are aware of the dilemma we face: 65,000 
Americans wait to receive a life-saving gift from some 5,400 organ 
donors this year. Those donors produce some 20,000 transplants, leaving 
45,000 Americans to wait their turn, and many to die waiting. 
Unfortunately, the number of organ donors has not significantly 
increased in the last decade. However, LifeLink has experienced 
significant increases in organ, tissue, and eye donation in its service 
areas. These increases are tied to programs of management, hospital 
education, public education, and community involvement.
                   successes of the lifelink program
    This year, LifeLink procured transplantable organs from 40 donors 
per million population, the highest rate in the nation. (See 
Attachment). This is the standard by which OPOs are currently judged. 
The national average is some 20 donors per million population. We are 
not here to say that this means LifeLink's programs can double the 
supply of organ donors in this country. The number of potential organ 
donors is fixed, and all we can do is increase our efficiencies of 
identifying and medically managing such cases, as well as optimizing 
our consent rates. We are here to report on the increases in donation 
that were achieved with LifeLink's programs, and to briefly identify 
those programs.
    In 1989, 63 organ donors were procured in Tampa, at LifeLink of 
Florida. The next year, we implemented certain programs designed to 
increase organ donor identification and organ donation, which are 
described below. In 3 years, organ donor referrals increased by 400%, 
and organ donors increased by 46% to 92. Last year, 112 organ donors 
were procured at LifeLink of Florida, a 78% increase over 1989. And, 
over that 10 year period, 943 more organs were made available for 
transplant than if these increases had not occurred. It is important to 
note that LifeLink was already one of the top performing OPOs when this 
process started.
    In 1993, the program was implemented in most of Georgia, including 
Atlanta. From 67 organ donors in 1992, the LifeLink of Georgia program 
increased to 130 donors in 1998, an increase of 94%. More importantly, 
in 1996 LifeLink of Georgia was awarded the territory of Eastern 
Georgia, which had been decertified for failing to meet the minimum 
criteria established by HCFA. In the first full year of operation, this 
area of two million persons went from 22 organ donors to 42 organ 
donors, a 91% increase. In 1998, this area produced 48 organ donors.
    In addition to the increases in organ donation noted above, 
LifeLink has experienced significant increases in eye and tissue 
donation with our tissue banking partners, to some of the highest 
levels reported in the country.
                   structure of the lifelink program
    LifeLink's program has been shared with any OPO or agency with an 
interest, here and with visitors from Asia, India, South America and 
England. In brief, it consists of three key strategies which we hope 
can be replicated in other agencies and other states:
1. Simplify the Donation Process
 For many years, LifeLink and its eye and tissue bank partners 
        have employed a unified approach to referral in all hospitals. 
        Our approach uses a 24-hour shared; single, in-house transplant 
        operator system, whereby only one agency contacts the hospital. 
        The Health Care Financing Administration (HCFA) deserves credit 
        for implementing some of these changes as one of the Medicare 
        Conditions of Participation (COP) last August.
 LifeLink believes that there should be no competition for 
        tissue and eye donors in hospitals, and that the current state 
        of aggressive competition in many parts of the country may 
        decrease donation. We took the extraordinary step of giving up 
        our eye bank to a competing agency, for no remuneration, so 
        there would be only one eye, tissue, and organ bank in our 
        Florida service area.
 If exclusive service areas for eye and tissue banks were 
        assigned and awarded as they are to organ procurement agencies, 
        we believe far less confusion and negative incidents would 
        result.
2. Accept the Responsibility of Contact and Consent
 LifeLink implemented Required Referral in 97 percent of our 
        hospitals. This has also become part of the new HCFA COP.
 LifeLink implemented a system of ``designated requestors,'' 
        employees highly skilled in meeting the needs of donor families 
        when making the request for organ donation. Our consent rates 
        for tissue and organ donation are among the highest in the 
        nation.
 In Georgia, LifeLink created the Minority Donation Education 
        Project (M.D.E.P.) to address the low consent rate among 
        African-Americans through the education of health care workers 
        about donation. LifeLink is also a local contractor with the 
        Minority Organ and Tissue Transplant Education Program 
        (MOTTEP), which provides public education about donation to 
        minority communities. LifeLink's minority consent rate is 
        nearly 50 percent, which we believe is significant.
 LifeLink has instituted a chaplain's program, with on-staff 
        clergy who are active in our community churches and with 
        hospital based chaplains to educate them about organ and tissue 
        donation.
Establish a Strong Liaison and Management Program
 LifeLink focused on a service-oriented approach to hospital 
        development and medical examiner development, and hired 
        applicants with communications and public relations 
        backgrounds. Most importantly, we have significant numbers of 
        these employees, and we have expended the resources required to 
        ensure the optimal amount of hospital referrals and feedback. 
        We have 20 Full Time Employees for the 7 million people in 
        Georgia (including our MDEP staff), and 6 Full Time Employees 
        for the 2.8 million people in our Florida service area. We do 
        not believe any OPO in the country staffs at this level of FTEs 
        per million population.
 LifeLink hospital development staff follow-up at the staff 
        level in person on virtually all referrals, encouraging greater 
        participation by nurses and physicians.
 We instituted administrative call, requiring the executive 
        director to be on call 24-hours a day, and to be contacted on 
        every organ and tissue donor to provide continuity and quality. 
        Our Risk manager is also on call 24-hours a day, to provide 
        input on more difficult, single organ, or ``marginal'' donors.
 LifeLink is independent of its transplant centers in Georgia, 
        Florida, and Puerto Rico. Although we have appropriate and 
        required transplant center representation on our governing and 
        advisory boards, a majority of our board members represent the 
        community. In this way, LifeLink is free to establish 
        reasonable programs to increase organ donation, without undue 
        concern about the financial impact of these programs on its 
        transplant centers.
                               conclusion
    Our professional education program and comprehensive service system 
have positively impacted LifeLink's ability to meet the needs of 
families in our service area. We provide a large number of organs for 
transplant centers in Florida, and around the country. LifeLink exports 
a significant percentage of organs, as does the state of Florida, so 
our efforts help increase transplantation around the country, not just 
in our service area. We would be delighted to share our program with 
any agency or state to help them achieve a similar increase in needed 
organ donations.
                               Attachment

                              AOPO OPO Voluntary Survey--January 1998-December 1998
                                                 [Updated Final]
----------------------------------------------------------------------------------------------------------------
                                                                                                         Donors
                  UNOS Code                                OPO Name             Population    Total       per
                                                                                 Reported     Donors    Million
----------------------------------------------------------------------------------------------------------------
FLWC.........................................  LifeLink of Florida............         2.8        112      40.00
FLUF.........................................  University of Florida..........         2.4         78      32.50
FLFH.........................................  TransLife......................         2.4         78      32.50
NVLV.........................................  Nevada Donor Network...........         1.0         31      31.00
PADV.........................................  Delaware Valley Trans..........         9.9        298      30.10
MOMA.........................................  Mid-America Transplant Assoc...         4.2        124      29.52
TNMS.........................................  Mid-South Trans. Foundation....         1.7         49      28.82
WISE.........................................  Wisconsin Donor Network........         2.2         63      28.64
WNCP.........................................  Lifesource-Upper Midwest OPO...         6.1        174      28.52
WIUW.........................................  University of Wisconsin........         3.1         87      28.06
  National Average...........................  ...............................  ..........  .........      21.70
----------------------------------------------------------------------------------------------------------------


    Mr. Bilirakis. Thank you so much, Mr. Campbell.
    Mr. Nathan?

                  STATEMENT OF HOWARD M. NATHAN

    Mr. Nathan. Good morning, Mr. Chairman. Thank you for 
holding these hearings. It is an important topic.
    My name is Howard Nathan. I am the Executive Director of 
Delaware Valley Transplant Program, the regional nonprofit 
organization in the eastern half of Pennsylvania, southern New 
Jersey, and Delaware. I am also President of the Coalition on 
Donation, which is a national alliance of all the transplant 
community focusing on grassroots, primary education, public 
education about organ and tissue donations.
    I will first talk about my experience as an organ 
procurement organization executive director. My organization 
represents 3,200 people waiting for transplants in our region 
at 12 hospitals in the greater Philadelphia area. In 1997 and 
1998, DVTP was the most active OPO in the United States, 
coordinating a record number of organ donors, resulting in 
1,844 life-saving transplants.
    The Coalition on Donation, through its world class talents 
from advertising and communications, including the Ad Council, 
has communicated its message throughout the country so that 
more and more people are signing organ donor cards and has 
cooperated with many national organizations in partnership to 
increase organ donation.
    One of the things that I would like to talk about today, 
which Congressman Greenwood referred to, was the law that was 
passed in Pennsylvania in 1994. It was called Act 102. It was 
the most comprehensive law on organ donations, to encourage 
organ donations. The first part of it, called routine referral, 
was enacted and cooperation occurred with all the hospitals in 
Pennsylvania, resulting in a 43 percent increase in organ 
donations and a 53 percent increase in transplants, compared to 
the year prior to its implementation. It has now been 
implemented nationally through the Medicare conditions of 
participation of hospitals and preliminary data shows that a 
5.5 percent increase in donations have occurred since its 
implementation as recorded by the number of organ donors last 
year.
    Equally important are not only systems in hospitals but 
providing public education to increase the awareness of the 
donor option.
    One of the other conditions of the Pennsylvania law was the 
Organ Donor Awareness Trust Fund, which raised voluntary 
contributions from driver's license contributions to increase 
public education initiatives. Congressman Greenwood indicated 
that one of those provisions, which was released yesterday in 
the media, aids organ donor families for funeral expenses. It 
has not been implemented yet. It will be implemented in the 
fall.
    In addition, there is a computerized registry that 
registers people's wishes through their driver's license 
program, and since 1995, more than 3 million Pennsylvanians 
have been registered, which allows the organ procurement 
organization access to this information 24 hours a day.
    Increasing consent rates is the key now, once we have the 
systems in place to hear about all potential donors from 
hospitals. That is why I have taken the Presidency of the 
Coalition on Donation for the past several years, to increase 
this message, the ``share your life, share your decision'' 
message to the country. There are many examples of cooperation 
and partnerships with organizations throughout the country. It 
is supported by the United Network for Organ Sharing. The 
transplant community has funded this effort, but more funding 
is needed to communicate this message to the public.
    The Ad Council is one of our partners and has communicated 
this message to 30,000 media outlets each year for the past 4 
years. The James Redford Institute for Transplant Awareness, 
led by Jamie Redford, a liver transplant recipient, created two 
films that will be distributed this year to educate kids about 
organ transplantation and donation, which will be distributed 
by the Coalition.
    One of the more visible campaigns was the Michael Jordan 
campaign, with which many of you are probably familiar. More 
than 12 million organ donor cards with Michael Jordan's picture 
have been distributed nationwide and more than a million 
posters have been distributed to kids throughout the country.
    So it is a combination of these two factors, organ 
procurement efficiency, as my colleague, Mr. Campbell, talked 
about, cooperation with hospitals in each State, and making 
sure that every family is offered that option and hopefully 
that they are predisposed by having the discussion while they 
are alive and well at the dinner table to talk about this 
``share your life, share your decision'' message.
    Ongoing public education is the key to increasing organ 
donation. We need more of a commitment to moneys to public 
education to make sure that this message is carried out in 
every American household. Additionally, suggestions for 
geographic centralization of donor information, such as a 
driver's license registry, would be

very helpful in making sure that people's wishes are 
registered, but most importantly, to make sure that then they 
follow up with the discussion with their family.
    Thank you very much, and I appreciate the opportunity.
    [The prepared statement of Howard M. Nathan follows:]
  Prepared Statement of Howard M. Nathan on Behalf of Delaware Valley 
              Transplant Program and Coalition on Donation
    I am Howard M. Nathan, the Executive Director of Delaware Valley 
Transplant Program (``DVTP''). DVTP is the nonprofit organ procurement 
organization (``OPO'') that serves patients and hospitals in Eastern 
Pennsylvania, Southern New Jersey, and Delaware and has a population 
base of 9.8 million. For 25 years, DVTP has served more than 160 acute 
care hospitals in the greater Philadelphia region; it has been 
certified by the Health Care Financing Administration (``HCFA'') since 
1988 as the OPO for its service area and has been a Medicare provider 
since 1979, when HCFA assigned DVTP independent OPO provider status for 
reimbursement purposes. DVTP currently serves nearly 3,200 patients 
awaiting life-saving organ transplants at 12 regional transplant 
hospitals. In addition, it has cooperative relationships with 4 
regional eye banks and 3 tissue banks. DVTP consistently has been 
recognized as one of the nation's top performing OPOs. In 1997 and 
1998, DVTP was the most active OPO in the U.S., coordinating a national 
record number of organ donors (291 and 298 respectively) for any OPO 
service area in the United States resulting in 1,844 life saving 
transplants.
    I am also appearing today as President of the national Coalition on 
Donation (``Coalition''). The Coalition is an alliance of the entire 
transplant community, including 48 national organizations and 50 local 
grassroots coalitions with the primary mission of educating the public 
about organ and tissue donations and creating a willingness to donate. 
You may be familiar with the Coalition's unified national message, 
``Share Your Life, Share Your Decision'' which was developed by the Ad 
Council and utilized in the Coalition's highly visible Michael Jordan 
public education campaign, as well as the Ad Council campaigns on organ 
and tissue donation. Numerous partnerships with world class talents 
from other advertising and media agencies have been formed so that all 
organizations in the Coalition have the opportunity to utilize these 
talents and deliver a common message to the public. Another such 
example, supported by Congress' efforts in enacting the National Donor 
Card Insert Act, the Coalition worked with the U.S. Department of 
Treasury and Department of Health & Human Services in 1997 to provide 
70 million people the opportunity to indicate their wish to become 
organ or tissue donors by including donor cards in the envelopes that 
contained IRS tax refunds.
    My other experiences in transplantation include past President of 
the Association of Organ Procurement Organizations (``AOPO'') and 3 
times elected to the Board of the current Organ Procurement and 
Transplantation Network (``OPTN'') contractor, the United Network for 
Organ Sharing (``UNOS'').
    Working with DVTP and our elected representatives, as well as other 
organizations, such as the Coalition on Donation, ``OPO, and UNO'' for 
more than 20 years, has granted me the opportunity to work closely not 
only with transplant hospitals and OPOs, but with donor families and 
transplant recipients at both the local and national levels. I 
understand that a single unified message regarding donation must be 
communicated through comprehensive public education initiatives. This 
in conjunction with providing all potential donor families with the 
donor option is critical to combating the organ donor shortage.
  i. routine referral--ensuring all families are advised of the donor 
                                 option
DVTP's Experience with Pennsylvania's Routine Referral Law Resulted in 
        a Dramatic Increase in Organ Donation.
    In 1994, Pennsylvania enacted Routine Referral legislation which 
provides (i) for the routine referral of all hospital patients' deaths 
to the OPO in order to determine suitability for anatomical donation, 
and (ii) for OPO initiation of and participation in the family 
discussion regarding the donor option. Implementation of this law 
resulted in unprecedented growth in the number of organ donors in 
DVTP's Pennsylvania service area. Just 4 years after enactment of the 
law, the number of donors that DVTP coordinated in its Pennsylvania 
service area increased by 43%. Similarly, the number of actual organ 
transplants that DVTP coordinated in 1998 was 53% greater than the 
number DVTP coordinated in 1994. This growth occurred at a time when 
organ donations nationally increased an average of less than 2-3% a 
year.
Routine Referral is Being Implemented Nationally.
    The Pennsylvania Routine Referral Law and DVTP's partnership with 
the health care community in Pennsylvania served as a national model 
for Routine Referral rules that were promulgated and applied nationally 
to all Medicare and Medicaid participating hospitals as of August, 
1998. Those rules, which members of Congress, including members of this 
Committee chose to have implemented last year (notwithstanding 
Congress' decision to delay the implementation of rules regarding the 
organ procurement and transplantation network) are already having an 
effect.
    Preliminary data reveals that national organ donation rates for 
calendar year 1998 are approximately 5.5% higher than the donation 
rates for calendar year 1997. The most significant increases appear to 
have occurred the last four months of 1998; the four months following 
the effective date of the federal Routine Referral rules. I anticipate 
that just as DVTP's Pennsylvania donation rates have continued to rise, 
the national rates will continue to rise with Congress' full support of 
this federal Routine Referral standard and the continued cooperation of 
the medical community.
    The 1994 Pennsylvania Routine Referral law went beyond advising 
families of the donor option at the time of a loved one's death. 
Equally significant, it recognized the critical issue of providing 
public education and increasing awareness of the donor option. That law 
provided for the establishment of an Organ Donor Trust Fund. The Trust 
Fund monies, funded through voluntary contributions made by residents 
through state tax refunds, as well as check offs on drivers' license 
and motor vehicle registration applications, are committed to public 
education initiatives.
    Finally, the Pennsylvania law established a central computerized 
registry of individuals who have elected to have the organ donor 
designation included on their driver's license. This enables the OPO to 
have immediate confidential access to information regarding a patient's 
own wishes regarding donation. Since January 1995, over 3 million 
Pennsylvanians have designated their wishes regarding donation on their 
drivers' licenses and that information is included in the central 
registry. Several other states, including Delaware Florida, Georgia, 
Illinois, Louisiana, Maryland and Missouri have similar registries.
         ii. increasing awareness will increase organ donation
    Increasing consent rates requires significant public education and 
information. This process of disseminating information must take place 
well before the tragic event which may result in a loved one's death. 
Education and discussions regarding the gift of life must occur at a 
time when the individual has the opportunity to make this decision 
regarding him or herself. Congress and this nation have supported 
patient autonomy and decision making. The optimal time to make 
decisions regarding donation is in the home, outside the hospital 
setting and well before traumatic end of life decisions are required to 
be made. The decision regarding organ donation is one that can easily 
be made if individuals have accurate information about donation. It is 
a decision that simply requires thoughtful consideration of the issues 
and a designation on a driver's license or donor card. Although it 
requires no further legal action by the donor, it is imperative that 
the wishes of the individual be clearly communicated to his or her next 
of kin so that they will be knowledgeable about the choice that has 
been made.
    The Coalition on Donation was created in 1993 by the transplant 
community to bring the issue of donation to the forefront and to 
provide a unified message to the public regarding organ donation. The 
single message ``Share Your Life, Share Your Decision'' provides the 
action steps needed for an individual to make a decision and share it 
with his or her loved ones. The literature demonstrates that ongoing 
public education does bring organ donation into the mainstream and 
families are more comfortable discussing their wishes regarding 
donation now that donation is no longer shrouded in myth. It is an 
option embraced by the various cultural and religious groups and is 
supported because donation does save lives.
    The Coalition on Donation serves as an example at many levels for 
the type of collaborative relationship that is critical if we as a 
nation are to successfully combat the donor organ shortage.

 The United Network for Organ Sharing (``UNOS'') has 
        collaborated since the Coalition's inception. UNOS and the 
        transplant community have supported the Coalition and its 
        educational campaigns by providing funding for the Coalition's 
        staff and through the voluntary assessment of UNOS members and 
        the transplant community.
 The Ad Council, in conjunction with its tremendous talent and 
        more than 50 years of communication expertise, has created four 
        campaigns that have been distributed to more than 30,000 media 
        outlets in the past six years.
 The James Redford Institute for Transplant Awareness developed 
        a film to educate teens about donation and transplantation and 
        has partnered with the Coalition to distribute the film 
        nationwide for the 1999-2000 school year.
 Through the Coalition, Congress and the transplant community 
        successfully partnered to distribute more than 60 million donor 
        cards in 1997 as provided by the National Donor Card Insert 
        Act.
 The Coalition and UNOS' public education campaigns were 
        considered so essential to overcoming the organ donor shortage 
        that the federal government also adopted the Coalition's 
        ``Share Your Life. Share Your Decision.'' Michael Jordan public 
        education campaign.
 The U.S. Postal Service working with the Coalition to promote 
        the issuance of and distribution of an organ donor awareness 
        stamp in 1998.
 More recently, after considering numerous national charitable 
        organizations, a major motion picture studio will soon announce 
        it has chosen UNOS and the Coalition as recipients of a PSA 
        competition, which included high profile ad agencies to develop 
        public education pieces on organ donation and transplantation.
    The health care community must also continue to receive updated 
information on donation and transplantation advancement and 
initiatives. One example of a jointly developed educational tool for 
the medical community is the recently published Journal of the 
Association of Critical Care Nurses. That Journal edition supported by 
both UNOS and the Critical Care Nurses Association reports on the 
medical advancements regarding the medical suitability of potential 
organ donors after cardiac death being made which allow a greater 
number of families to be offered the donor option.
 iii. partnering for the future--action plan to reduce the organ donor 
                                shortage
    These historical collaborative efforts demonstrate that steps to 
decrease the gap between the number of available organs and the number 
of people on the waiting lists can be undertaken. A comprehensive 
national approach to educating and informing the public must be 
supported. We need to give Americans the ability to easily designate 
their wishes without burdening the decision-maker. In all hospitals, we 
must support Routine Referral to ensure that all potential donor 
families have considered the donor option at or near the time of the 
death of a loved one.
    This comprehensive approach must include:

1. A system of efficiently operating OPOs given the responsibility of 
        discussing the donor option with families at or near the time 
        of death of a loved one.
2. Ongoing public education and awareness programs designed to inform 
        families about organ and tissue donation and to encourage 
        decision-making long before the family must deal with the 
        traumatic circumstances surrounding a loved one's death. The 
        donor decision is best decided by the individual in the light 
        of life, not by the family in the darkness surrounding death.
3. The ongoing commitment of monies to public education efforts. This 
        can be accomplished through a variety of mechanisms, including 
        a voluntary contribution made by taxpayers of a portion of any 
        federal tax refund. Similar to the Pennsylvania law, these 
        funds could be earmarked for specific public education and 
        awareness programs designed to promote organ and tissue 
        donation.
4. Support of the geographic centralization of donor information that 
        is immediately available to the OPO. The establishment of state 
        registries or regional will ensure that the wishes of a 
        decedent as designated on a drivers license or other 
        registration are known and honored. This can be accomplished 
        through central state registries such as the ones supported by 
        Pennsylvania, Delaware, Florida, Georgia, Illinois, Louisiana, 
        Maryland and Missouri.
    It is through initiatives such as those described above that we can 
expect to combat the organ shortage.
    Thank you for allowing me to provide testimony to this Committee.

    Mr. Bilirakis. Thank you, Mr. Nathan.
    Dr. Marcos?

                   STATEMENT OF AMADEO MARCOS

    Mr. Marcos. Thank you. Mr. Chairman, members of the 
committee, on behalf of the Virginia Commonwealth University 
Medical College of Virginia, I would like to talk to you today 
about the topic of living donor liver transplants. The waiting 
list, as you all know, has grown out of proportion----
    Mr. Bilirakis. Would you pull the microphone closer to you, 
Dr. Marcos? Thank you.
    Mr. Marcos. The waiting list has grown out of proportion. 
Up to April 1999, 12,648 patients were waiting for livers. 
Despite the significant efforts to increase awareness and need 
for donation, the number of donors for livers remains static, 
with around 4,000 cadaveric livers available, which will mean 
that 10 to 15 percent of the patients waiting on that list are 
going to die within a year.
    Transplant decisions have come with strategies to aim and 
to resolve this problem. Some solutions have been reducing the 
size of the liver, splitting the livers, and the one I am going 
to talk to you about today, which is the living donor liver 
transplant. This technique was started in the 1980's in an 
effort to alleviate the shortage of organs at that time for 
pediatric recipients. The main disadvantage of this operation 
is putting a healthy donor at risk, which will always be an 
ethical concern.
    But besides the availability, which is the main advantage 
of this technique, the biggest constraints imposed by cadaveric 
donation is time. Despite advances in organ preservation, the 
viability of the liver decreases or declines after procurement 
and it is seriously compromised after 12 hours. This, of 
course, is a good advantage of the living donor.
    The living donor permits to screen and do more tests on the 
donors which has no limited time and rule out 100 percent 
infectious diseases like HIV and hepatitis. The psychological 
advantages of a living donor transplant, although they are 
difficult to quantitate, are undoubtedly significant. The 
opportunity to help save the life of a loved one gives donors a 
great deal of personal satisfaction and some degree of control 
over a situation that would otherwise be left entirely to 
chance. Recipients take comfort in the fact that the organs 
come from a loved one or a known one and this could translate 
into better care of those organs.
    Finally, our preliminary figures show that living donation 
may actually be more cost effective than cadaveric donation.
    While this technique has significantly impacted on 
pediatric transplantation, its use for adults has been limited. 
Surgeons in Japan at the beginning of the 1990's started doing 
right lobe living donor transplants with very good results.
    Ourselves, at the Medical College of Virginia, started 
doing this technique about a year ago and since have performed 
about 22 adult-to-adult right lobe living donor transplants. 
The main driving force behind us has been the dramatic decrease 
of cadaveric organs in our organ procurement organization, OPO, 
by 40 percent from the previous year. Twenty percent of this 
reduction was a result of sending organs for sharing within our 
region to other OPOs. As new laws for organ allocation and the 
development of new liver programs in the region could 
potentially increase this reduction of cadaveric offers, the 
living donor becomes a significant life-saving option for our 
patients. Nowadays, 45 percent of patients that get transplants 
at the Medical College of Virginia do so through a living 
donor.
    Although long-term results and follow-up is lacking, our 
initial results are extremely promising. Most importantly, 
there have been no complications on the donors. They all have 
left the hospital within a week and returned back to their own 
activities. When asked if they would do it again, they all say 
yes. The recipients also have had good results and we have 
performed this procedure both in high urgency or elective 
circumstances with excellent results.
    The number of patients awaiting liver transplantation is 
likely to continue to increase, at least over the next decade. 
While the incidence of many liver diseases is expected to be 
stable, the incidence of hepatitis is increasing dramatically. 
A significant number of patients infected with hepatitis B and 
C will go on to develop end-stage liver disease, requiring 
transplantation. Current data also suggests that early stage 
cancer can be treated with transplantation, which in itself 
will shorten the availability of organs.
    In summary, the waiting lists will continue to increase. 
The number of cadaveric donations has been relatively static, 
leaving a significant number of people to die each year while 
waiting for transplantation. Living donor liver transplantation 
has been widely accepted by the transplant community and 
general population as an appropriate means of expanding the 
donor pool for pediatric recipients. Early data suggests that 
this technology can be safely performed in adult recipients, 
although continued critical review of the results is warranted. 
For every patient that receives a liver from a living donor, a 
cadaveric organ can become available for a patient waiting on 
the list.
    I want to thank the Commerce Committee and the Institute of 
Medicine for the opportunity to participate in this hearing. 
Thank you.
    [The prepared statement of Amadeo Marcos follows:]
    Prepared Statement of Amadeo Marcos, Medical College of Virginia
    Good Morning Chairman Bilirakis and Members of the Subcommittee on 
Health and Environment. It is indeed a pleasure for me to be here with 
you to share the successes that we, at Virginia Commonwealth 
University's Medical College of Virginia, have had in the area of organ 
transplantation. Specifically, I would like to focus on the living-
liver transplant program.
    Diseases of the liver are diverse and indiscriminately affect 
people of all ages and races. Most conditions are unfortunately, 
progressive and almost uniformly fatal. Because the liver serves so 
many indispensable functions, medical management of the complications 
of end stage liver disease is complex and ultimately fails, resulting 
in death of the patient unless the process is interrupted by 
transplantation.
    Significant advances in the field of organ transplantation over the 
last few decades have resulted in dramatic improvements in survival and 
quality of life following transplantation. As a result of these 
innovations, early transplantation has become the treatment of choice 
for most acute and chronic liver diseases and a variety of genetic 
disorders.
    With this success, the waiting list has grown far out of proportion 
to the number of organ donations. There were 12,648 patients listed for 
liver transplantation by April 1999. Despite significant efforts to 
increase awareness of the need for organ donation, the numbers have 
been relatively static for several years. Only about 4000 cadaveric 
livers become available for transplantation each year, leaving as many 
as 10 to 15% of the waiting list to die before an organ becomes 
available.
    The function, vascular supply, and anatomical position of the liver 
impose significant limitations on the size of the donor organ that can 
be transplanted. The liver must be large enough to meet the early post-
operative needs of the recipient to overcome the results that result 
from the process of transplantation. Unlike the kidney or the pancreas, 
the specialized function and blood supply to the liver necessitate its 
transplantation into its natural anatomic position, limiting a graft to 
the size of the cavity. The size limitation has been particularly 
problematic for infants and children needing transplants, as most 
cadaveric donors are adults.
    Organs for pediatric recipients have always been relatively scarce, 
and several innovative surgical techniques were developed in response. 
Size reduction involves ``trimming'' an adult size liver down to an 
appropriate size for a child, while the remnant is discarded. Though 
this wastes a portion of the viable organ, it is an option if another 
organ of appropriate size is unavailable. Split liver transplantation 
divides the organ into two smaller segments, potentially doubling the 
number of patients that benefit from single cadaveric organ. Donor 
organs for splitting must possess certain characteristics that are, 
unfortunately, all too rare. Rather than significantly increasing the 
availability of organs, split liver transplantation effectively diverts 
the supply from adults in need of organs to children.
    Living donor transplantation was developed in the late 1980's in an 
effort to definitively alleviate the shortage of organs for pediatric 
recipients without contributing to the shortage for adults. Using 
surgical techniques similar to those for resection of liver tumors, a 
segment of the liver is removed from a willing donor, usually a parent, 
and transplanted into the recipient. This technique has been widely 
applied to the pediatric population over the last decade with over one 
thousand successful procedures reported to date. With refinements in 
surgical techniques, living donor transplantation actually results in 
better patient and graft survival. The safety of the donor has been 
well established for the type of resection generally employed for 
pediatric recipients, with only one death and a handful of potentially 
life threatening complications reported worldwide.
    The main disadvantage of using a living donor is the ethical 
problem of subjecting a healthy donor to a surgical procedure of 
significant magnitude. When compared with cadaveric donation it may 
pose some advantages.
    Besides availability, one of the biggest constraints imposed by 
cadaveric donation is time. Despite advances in organ preservation, the 
viability of the liver declines immediately following procurement and 
is seriously compromised after 12 hours, limiting screening of donors 
and preparation of recipients. The use of living donors essentially 
removes this time constraint.
    The immediate and long term function of transplanted livers is 
directly related to ``cold storage'' time. Organs from living donors 
are transplanted almost immediately, essentially eliminating ``cold 
storage'', thereby optimizing function. The recovery time, number of 
post operative complications, and chances of survival following liver 
transplantation are also related to the preoperative condition of the 
recipient. Significant decompensation adversely impacts recovery and 
long term survival. Organs from living donors are available at the time 
transplantation is medically indicated, without further deterioration 
of the recipient waiting for a cadaveric liver. This has been the main 
advantage of this technique.
    Although screening tests for viral infectious diseases are 
remarkably accurate and there have been relatively few reports of 
transmission of the more serious diseases in recent years, there are 
false negatives and early infections which may not be detected by 
standard tests. More meticulous testing for infectious diseases, 
including HIV and hepatitis, is impractical for cadaveric donors and 
information regarding their lifestyle is generally lacking. More 
sensitive testing and screening can be performed with living donors, at 
least theoretically decreasing the risk of transmission of these 
diseases. Subclinical bacteria and fungal infections are relatively 
common in cadaveric donors, contributing to post transplant 
complications. Living donors are unlikely to harbor a subclinical 
infection and transplantation could be delayed pending resolution.
    The psychological advantages of living donor transplantation, 
although difficult to quantitate, are undoubtedly significant. The 
opportunity to help save the life of a loved one gives donors a great 
deal of personal satisfaction and some degree of control over a 
situation that would otherwise be left entirely to chance. Recipients 
take comfort in the fact that the source of their graft is a trusted 
friend or relative and a new bond is undoubtedly created between donor 
and recipient that could translate into better care of the given organ.
    Finally, our preliminary figures suggest that living donation may 
actually be more cost effective than cadaveric donation.
    While this technique has had significant impact on pediatric 
transplantation, its application to adults in need of transplantation 
has been limited by size of the segment of liver that is obtained. The 
original technique involves resection of only a small portion of the 
left side of the liver, inadequate for transplantation into adults. We 
knew from the trauma of cancer literature that resection of up to 80% 
of liver mass is well tolerated by otherwise healthy individuals and is 
technically feasible. The liver, unlike other solid organs, is uniquely 
able to regenerate to a predetermined size, making these extensive 
resections possible without significant risk of liver failure. There 
has been hesitation to perform these more extensive procedures, 
however, because of the higher potential for complications in donors, 
including bleeding, infection, and cardiac and pulmonary events. 
Surgeons in Japan, where cadaveric donation was not an option until 
recently, were the first to report donor resections of the entire right 
side of the liver, representing approximately 60% of liver mass, in the 
early 1990's. The initial procedures, despite being performed in 
desperation, gave good results with minimal donor complications.
    The living donor liver transplant program at the Medical College of 
Virginia Hospitals was started just over one year ago. We have since 
performed 22 adult-to-adult right lobe living donor transplants. The 
main driving force behind this has been the dramatic decrease of 
cadaveric organs in our Organ Procurement Organization (OPO) by 40% 
from the previous year. 20% of this reduction was a result of sending 
organs for sharing from our OPO to others within our region. As new 
laws for organ allocation and the development of new liver programs in 
the region could potentially increase this reduction in cadaveric 
offers, the living donor becomes a significant life saving option for 
adult patients on our waiting list. Living donor transplants now 
represent almost 45% of all the liver transplants we perform at the 
Medical College of Virginia.
    Although long-term follow up is lacking, our initial results are 
extremely promising. Most importantly, there have been no serious donor 
complications. None have required transfusion of banked blood and all 
have been discharged from the hospital within 10 post-operative days. 
None have required reoperation or readmission to the hospital, and all 
promptly returned to their previous activity level. Imaging of their 
livers has confirmed rapid regeneration to its previous size. No one 
has expressed regret for having undergone surgery.
    The results in recipients have also been excellent. We have 
performed these procedures in both high urgency and more elective 
circumstances with outcomes similar to those obtained from cadaveric 
transplantation. All of the grafts have functioned well after 
transplant. Survival is comparable to cadaveric transplantation with 
only 3 deaths occurring in patients who were seriously decompensated 
prior to transplantation. All of the deaths were attributable to 
infectious complications rather than surgical or graft specific 
factors. A majority of recipients were discharged within two weeks of 
surgery.
    The number of patients awaiting liver transplantation is likely to 
continue to increase, at least over the next few decades. While the 
incidence of many liver diseases is expected to be stable, the 
incidence of hepatitis infections is increasing dramatically.
    A significant number of patients infected with hepatitis B and C 
will go on to develop end stage liver disease requiring 
transplantation. Current data also suggests that early stage liver 
cancer can be effectively treated by transplantation. The development 
of more effective screening methods may result in extending the 
indications for liver transplantation to include more cancer patients.
    In summary, the waiting list for liver transplantation has expanded 
out of proportion to the number of cadaveric donations and will likely 
continue to grow for at least the next decade. The number of cadaveric 
donations has been relatively static, leaving a significant number of 
people to die each year while awaiting transplantation. Living donor 
transplantation has been widely accepted by the transplant community 
and general population as an appropriate means of expanding the donor 
pool for pediatric recipients. Early data suggests that this technology 
can be safely extended to meet the needs of adult recipients, although 
continued critical review of the results is warranted.
    For every patient that receives a liver from a living donor, a 
cadaveric organ can be made available for the next person on the 
waiting list.

    Mr. Bilirakis. Thank you very much, Dr. Marcos.
    Dr. Neylan?

                   STATEMENT OF JOHN F. NEYLAN

    Mr. Neylan. Thank you, Mr. Chairman. I am John Neylan and I 
am Medical Director of Kidney Transplantation at Emory 
University and I am President of the American Society of 
Transplantation.
    The AST, which has no government support, was established 
in 1982 and our membership, now over 1,400 members strong, is 
comprised of physicians, surgeons, and scientists actively 
engaged in the research and practice of transplantation 
medicine and immunobiology. As such, the AST represents the 
majority of professionals in the field of transplantation in 
the United States today.
    Over the last 30 years, transplantation of solid organs has 
moved from experimental to accepted therapy, with over 20,000 
performed in 1998 alone. The success of this procedure has 
improved greatly over the last few years, with almost all solid 
organ recipients now enjoying an 83 to 97 percent survival rate 
at 1 year.
    Much of this success can be attributed to research in 
immunosuppression and basic science that has been funded 
through Federal appropriations. Our better understanding of the 
body's response to foreign proteins has led to countless other 
breakthroughs throughout all areas of medical science. However, 
this success has brought with it some new challenges.
    More and more individuals are agreeing to be placed on the 
waiting list for an organ transplant, and as a result, the list 
has increased in size by 255 percent in the last 10 years. It 
is an unfortunate and absolutely unnecessary fact for those in 
need of a transplant to go without the gift of life. There is 
an insufficient supply of available donors, which is far less 
than the growing demand.
    I would like to focus my testimony on the most important 
issue facing the transplant community today, providing 
transplantable organs for patients in need. Even as we in the 
transplant community continue the deliberate and at times 
difficult discussions that surround the process of determining 
the optimal means for allocating a precious, though numerically 
inadequate, resource, we must never forget the crux of the 
problem and the real solution, increasing organ donation.
    During the next hour, four new names will join those 58,000 
individuals in this country waiting for a solid organ 
transplant, and by the time I get home to Atlanta this evening, 
10 individuals will have died because the wait for a transplant 
was just too long. It is an unfortunate and absolutely 
unnecessary fact that we as a Nation are not living up to our 
potential. Too many families are turning down the option of 
organ donation.
    But, Mr. Chairman, with increased education and improved 
coordination among the public and private sectors, we can 
improve donation rates and thus make the gift of life a reality 
for thousands of Americans. The AST believes strongly that 
Federal and State governments, providers, and the patient 
community need to establish a working compact directed at 
translating the extremely high public awareness about the value 
of the gift of life into a proactive national effort to 
actually increase organ donation. Only by working collectively 
with all the stakeholders involved can we successfully address 
this critical issue.
    In addition, the AST strongly supports Congressional 
reauthorization of the National Organ Transplant Act, which was 
last reauthorized in 1990. Such reauthorization undoubtedly 
will help to enhance support for organ donation initiatives.
    In my own State of Georgia, there are numerous examples of 
such good works. Many communities have rallied financial 
support for someone amongst them in need of a liver transplant. 
Through these efforts, socio-economically disadvantaged 
patients have received the fruits of this life-saving but 
costly medical miracle.
    On another level, we have within our State a charitable 
organization entitled the Carlos and Marguerite Mason Fund, 
which has so far provided millions of dollars for transplant 
research, patient support, and also organ donation initiatives. 
An example of the latter is an ongoing minority outreach 
program which seeks through multiple interventions to enhance 
donation within the African American community.
    At the State level, Georgia has clearly demonstrated a real 
and tangible financial support for organ donation by providing 
a discounted driver's license renewal fee to those who 
designate their personal support to the cause of organ 
donation.
    Last year, the AST worked closely with Congressman Elijah 
Cummings to introduce and pass in the House of Representatives 
legislation to increase the amount of leave time available to 
Federal employees serving as donors. In the past, a lack of 
leave time has served as a significant impediment and a 
disincentive for individuals willing otherwise to share the 
gift of life. The legislation has been reintroduced into the 
106th Congress and is strongly supported by our Society.
    AST believes that targeted initiatives, such as Congressman 
Cummings' Congressional legislation, can collectively make a 
difference, especially those initiatives which support living 
donation. Indeed, programs that enhance living donation may be 
among the most immediate, the most effective, and the least 
expensive activities available to our Nation today.
    As we all know, organ donation is the real answer to 
dealing with the dilemma of allocating and distributing this 
inadequate supply. In addition to our own efforts and those of 
the greater transplant community, the AST has consistently 
urged the Federal Government to take on a continued and greater 
leadership role in this most important component of the problem 
through increased research funding, increased public education 
and awareness campaigns, and through the implementation of the 
hospital participation in Medicare and Medicaid regulations.
    A year and a half ago, the administration moved forward 
with a national organ and tissue donation initiative to 
encourage more families to discuss and understand their loved 
ones' wishes in regard to donation. Most recently, these 
activities have included a national donor day, and this week, a 
national donor recognition ceremony, to honor those individuals 
who have given the ultimate gift, the gift of life. These 
important initiatives serve to raise the national awareness and 
educate the public regarding the importance and critical need 
of their participation in the process. Such activities are 
helpful in the reduction of family refusal, which is the No. 1 
cause of loss of potential donors today.
    We all know and understand that increasing our Nation's 
supply of organs is the real answer to our current dilemma. You 
cannot put a price tag in human terms on such a gift. Yes, a 
transplant procedure and follow-up is expensive, but relative 
to the lost productivity, the impact on the quality of life, 
and the cost of living with end-stage heart or renal disease, 
transplantation is, indeed, very cost effective.
    Mr. Bilirakis. Dr. Neylan, forgive me, but if you could 
summarize.
    Mr. Neylan. I will be happy to. And also, it may be the 
only hope, not just for improved survival but for a full and 
healthy life for these individuals and their families. Through 
better education and awareness campaigns, we can win this 
important battle together.
    Thank you, Mr. Chairman.
    [The prepared statement of John F. Neylan follows:]
 Prepared Statement of John F. Neylan, President, American Society of 
                            Transplantation
    Mr. Chairman and Members of the Subcommittee, thank you for the 
opportunity to present testimony on behalf of the American Society of 
Transplantation (AST).
    I am John F. Neylan, M.D., Medical Director of Kidney 
Transplantation at Emory University and I am President of the American 
Society of Transplantation (AST). The AST, which has no governmental 
support, was established in 1982. Our membership, now over 1,400 
members strong, is comprised of physicians, surgeons, and scientists 
actively engaged in the research and practice of transplantation 
medicine and immunobiology. As such, AST represents the majority of 
professionals in the field of transplantation in the United States.
    Over the last 30 years, transplantation of solid organs has moved 
from experimental to accepted therapy, with over 20,000 performed in 
1998 alone. The success of this procedure has improved greatly over the 
last few years with almost all solid organ recipients enjoying an 83-
97% survival rate at one year. Much of this success can be attributed 
to research in immunosuppression that has been funded by previous 
federal appropriations. Our better understanding of the body's response 
to foreign proteins has led to countless other breakthroughs in all 
areas of medical science. However, this success has brought with it new 
challenges.
    More and more individuals are agreeing to be placed on waiting 
lists for an organ transplant, and as a result the list has increased 
in size by 255 percent in the last ten years. It is unfortunate and 
absolutely unnecessary for those in need of a transplant to go without 
the ``Gift-of-Life.'' This happens because the supply of available 
donors is far less that the demand.
    I would like to focus my testimony on the most important issue 
facing the transplant community today, providing transplantable organs 
for patients in need. Even as we in the transplant community continue 
the deliberate and at times difficult process of determining the 
optimal means to allocate a precious though numerically inadequate 
resource, we must never forget the ``crux'' of the problem and the real 
solution . . . increasing organ donation.
    During the next hour, four new names will join those 58,000 
individuals in this country waiting for a solid organ transplant. And 
by the time I get home to Atlanta this evening, 10 individuals will 
have died because the wait for a transplant was just too long. It is 
unfortunate and absolutely unnecessary, but the sad fact is that we as 
a nation are not living up to our potential. Too many families are 
turning down the option of organ donation.
    But, Mr. Chairman, with increased education and improved 
coordination among the public and private sectors, we can improve 
donation rates and thus make the gift-of-life a reality for thousands 
of Americans. The AST believes strongly that federal and state 
governments, providers, and the patient community need to establish a 
working compact directed at translating the extremely high public 
awareness of the ``gift-of-life'' into a pro-active national effort to 
increase organ donation. Only by working collectively as the transplant 
community, with all stakeholders involved, can we successfully address 
the issue of donation. In addition, the AST strongly supports 
Congressional reauthorization of the National Organ Transplant Act, 
which was last reauthorized in 1990, to enhance support for organ 
donation initiatives.
    In my own state of Georgia, there are numerous examples of such 
good works. Many communities have rallied financial support for someone 
amongst them in need of a liver transplant. Through these efforts, 
socioeconomically disadvantaged patients have received the fruits of 
this life-saving but costly medical miracle. On another level, we have 
within our state a charitable organization entitled the Carlos and 
Marguerite Mason Fund which has provided millions of dollars for 
transplant research, patient support and also organ donation 
initiatives. An example of the latter is an ongoing minority outreach 
program which seeks through multiple interventions to enhance donation 
within the African-American community. And at the state level, Georgia 
has clearly demonstrated a real and tangible financial support for 
organ donation by providing a discounted driver's license renewal fee 
to those who designate their personal support to the cause of organ 
donation.
    Last year, the AST worked closely with Congressman Elijah Cummings 
to introduce and pass, in the House of Representatives, legislation 
(H.R. 2943), to increase the amount of leave time available to Federal 
employees serving as donors. In the past, a lack of leave time has 
served as a significant impediment and disincentive for individuals 
willing to share the gift-of-life. The legislation has been 
reintroduced in the 106th and strongly supported by our Society. AST 
believes that targeted initiatives such as Congressman Cummings 
legislation can collectively make a difference, especially those 
initiatives which support living donation. Indeed, programs that 
enhance living donation may be among the most immediate, most effective 
and least expensive activities available to our nation today.
    As we all know, organ donation is the real answer to dealing with 
the dilemma of allocating and distributing an inadequate supply of 
organs. In addition to our own efforts, and those of the greater 
transplant community, the AST has consistently urged the Federal 
Government to continue to take on a greater leadership role in this 
most important component of the problem through increased research 
funding, public education and awareness campaigns, and through the 
implementation of the hospital participation in Medicare and Medicaid 
regulations requiring notification of potential donors to the organ 
procurement organizations (OPO).
    A year and half ago, the Administration moved forward with a 
national organ and tissue donation initiative to encourage more 
families to discuss and understand there loved ones' wishes in regard 
to donation. Most recently, these activities have included a National 
Donor Day, and this week, a National Donor Recognition Ceremony to 
honor those individuals who have given the ultimate gift . . . the 
gift-of-life. These important initiatives serve to raise national 
awareness and educate the public regarding the importance and critical 
need of their participation in the organ donation process. Such 
activities are helpful in the reduction of family refusal, which is the 
number one cause of loss of potential donors today. As a result, the 
AST has advocated and strongly urged, through testimony before the 
House and Senate Appropriations Committees, that increased funding be 
provided to the Division of Transplantation, located in the Health 
Resources and Services Administration with additional funds for FY 
2000. Such funding will help to insure the success of these and other 
programs federally initiated to enhance donor awareness and improve the 
public trust in the process.
    We all know and understand that increasing our nations supply of 
organs is the real answer to our current dilemma. You can't put a price 
tag in human terms of such a gift. Yes, a transplant procedure and 
follow-up care is expensive. But, relative to the lost productivity, 
the impact on quality of life, and the cost of living with end stage 
heart or renal disease, transplantation is very cost effective. Also, 
it may be the only hope not just for improved survival, but for a full 
and healthy life for many individuals and their families. Through 
better education and awareness campaigns, we can win this important 
battle.
    Thank you.

    Mr. Bilirakis. Thank you very much.
    Dr. Metzger?

                 STATEMENT OF ROBERT A. METZGER

    Mr. Metzger. Mr. Chairman, members of the subcommittee, my 
name is Robert Metzger and I am the Medical Director of both 
the Translife Organ Procurement Organization and the kidney 
transplant program at Florida Hospital Medical Center in 
Orlando, Florida. I also serve as the incoming medical advisor 
of the Association of Organ Procurement Organizations, or AOPO, 
the membership organization that represents all 62 organ 
procurement organizations in the Nation. I am also the Vice 
Chairman of the Council for Organ Availability at UNOS. I would 
like to thank the committee for providing this important forum 
on the national shortage of organs for transplantation.
    In brief, as you have heard, our dilemma is that we simply 
do not have enough organs to satisfy the demand. While there 
will always be a need for allocating organs, reaching agreement 
on such a plan would be much easier if we could expand the 
supply of available organs. It is here that I will focus my 
remarks today.
    Five thousand potential recipients will die awaiting 
transplantation this year, although over the past decade the 
number of donor organs recovered has increased somewhat. The 
increases come about in three major ways.
    First, there has been a steady increase in the number of 
donors coming from the older age groups, especially 65 and 
above. Unfortunately, these organs function less well.
    Second, there are more living donors, especially from 
genetically unrelated spouses and friends. With reimbursement 
of personal expenses, I feel this pool could increase 
substantially.
    Third, efficiency in organ procurement has increased with 
more solid organs procured per donor. Developments in utilizing 
non-heartbeating donors and split livers and lungs offers some 
promise for expanding this procurement efficiency.
    Important initiatives have been taken to enhance OPO 
effectiveness. The range is broad, including the establishment 
of continued quality improvement teams, the conduct of general 
public awareness campaigns, targeted community outreach to 
ethnic and racial populations, school education programs, and 
special emphasis on donor families.
    Increasing donation is not an easy task. The challenge is 
compounded by the fact that we have poor knowledge of how 
effective we are in recovering organs. The primary reason for 
this is that we do not have a good measurement of OPO 
efficiency and the HCFA standards currently used to measure 
this are woefully inadequate. Unless we develop an accurate 
knowledge of the actual donor potential in our region, it 
remains impossible to assess our effectiveness.
    Fortunately, new methodologies spearheaded by AOPO's death 
record review study is addressing this issue. More than half of 
the Nation's OPOs are participating in this study and the 
preliminary results indicate that only about 40 percent of 
potential donors actually become donors. Of the remainder, most 
were either not identified or referred as potential donors or 
the family declined to consent to donation. Yet approximately 
75 percent of Americans surveyed in public opinion polls say 
that they would support organ donation for themselves. A window 
of opportunity clearly exists.
    Over the past 15 years, a number of State and voluntary 
efforts have resulted in increased hospital referral rates to 
the OPO community. Based on this success, HCFA promulgated new 
Medicare hospital conditions of participation last August that 
mandate all in-hospital deaths be referred in a timely way to 
the local OPO so that a determination can be made if the 
patient is a potential organ donor. The regulations also 
specify that only expert requestors, that is, OPO staff or 
hospital staff specifically trained to request organ and tissue 
donation in an appropriate manner, are permitted to approach 
families.
    Although it is too early to judge the effectiveness of this 
rule, it does address the two major deficiencies noted above 
and we are seeing significant increases in referral calls made 
to many local OPOs as well as improved hospital cooperation.
    In the context of reviewing barriers to organ donation, a 
critical issue that has a clear impact on the effort to 
increase organ supply is the turmoil created by the current 
practice of OPO recertification and performance evaluation. The 
current OPO certification process, which occurs every 2 years, 
has perhaps unintendedly created the strange result of 
introducing major distractions and, indeed, disruptions to the 
mission of OPOs to increase the supply of organs. Unlike 
hospitals, for example, the certification period for OPOs is 
much shorter, the criteria for evaluation do not measure OPO 
performance or capability, is without due process for resolving 
deficiencies, contains no corrective action clause, and OPOs 
found deficient are directed to close their doors. Although the 
current measures have been in use by both the government and 
industry, there is widespread agreement that these measures are 
not meaningful for judging or improving performance.
    With the new conditions of participation in place and 
giving the compelling results of recent empirical work, the 
time is ripe for placing a moratorium on the current 
certification process and supporting a collaborative industry-
government examination of alternative OPO performance measures.
    In closing, I do want to commend the committee again for 
convening this brief examination today on organ supply. I would 
encourage, furthermore, that consideration be given to 
reauthorization of the National Organ and Transplantation Act 
and the provision of a broader forum to revisit these issues.
    Thank you again for this opportunity to testify today.
    [The prepared statement of Robert A. Metzger follows:]
Prepared Statement of Robert Metzger, Medical Director, TransLife Organ 
                        Procurement Organization
    My name is Robert Metzger and I am the Medical Director of the 
TransLife Organ Procurement Organization, at Florida Hospital Medical 
Center in Orlando, Florida, and also am Medical Director of the 
TransLife Transplant Program. I am boarded in the Internal Medicine 
subspecialty of Nephrology and have had a career covering practice, 
education, research, and administrative aspects of medicine. I also 
serve as the Medical Advisor-Elect of the Association of Organ 
Procurement Organizations (AOPO), the membership organization that 
represents all 62 organ procurement organizations (OPO) in the nation, 
with its collective goal of maximizing the number and quality of organs 
(and tissues) available for transplant. In addition, I am currently the 
Co-Chair of the Council for Organ Availability of the United Network 
for Organ Sharing (UNOS).
    Today, I am here in my Medical Director capacity with the TransLife 
Organ Procurement Organization and Transplant Program, but am prepared 
to respond to questions regarding the focus of both AOPO and the UNOS 
Council for Organ Availability. I would like to thank the Committee for 
providing this important forum to address the matter of our continuing 
national shortage of organs for transplantation, and the opportunity 
given me to comment on key issues regarding the inadequate supply of 
organs and the role of OPOs.
    Organ transplantation is a unique part of American medicine. While 
there are many areas in which medical care is rationed implicitly, 
transplantation is the only one where we must do so explicitly. We 
simply do not have enough organs to satisfy the demand, so we must 
develop complicated systems of allocation. While there will always be a 
need for some system of establishing priority for a scarce resource, 
reaching agreement on such a plan would be much easier if we could 
expand the supply of available organs. It is here that I will focus my 
remarks today.
    At the outset, I would like to briefly comment on what an organ 
procurement organization (OPO) is, and how it is central to the general 
topic of today's proceeding. In brief, OPOs are organizations that are 
the captains of the supply side of the industry. They are the experts 
when it comes to talking about supply availability.
    In coordinating activities relating to organ procurement in a 
designated service area, OPOs are the professionals who evaluate 
potential donors, discuss donation with family members, and arrange for 
the surgical removal of donated organs. It is the OPOs who are the 
experts responsible for preserving the organs and making arrangements 
for their distribution according to national organ sharing policies. 
These organizations, furthermore, provide information and education to 
medical professionals and the general public to encourage organ and 
tissue donation, and increase the availability of organs for 
transplantation. The OPOs are federally certified by the Health Care 
Financing Administration (HCFA). The new web page of AOPO (http://
www.aopo.org) provides a complete listing of the OPOs in the nation.
    The service population of OPOs varies across the nation from a low 
of about one million to a high of nearly twelve million people. 
TransLife has a service population of 2.4 million people covering ten 
counties in east Central Florida.
    As you know, our continuing national crisis is real. Of the more 
than 60,000 patients currently waiting for an organ transplant in this 
country, about 20,000 will receive a transplant, 35,000 will continue 
waiting while the disease progresses, and 5,000 will die. It has been 
estimated that an increase in organs of around 18,000 to 20,000 would 
be required to conform demand (as measured by the addition of new 
patients to the waiting lists, deaths, and removal from the lists due 
to advanced disease) with supply (as measured by the number of 
transplants performed.)
    Over the past decade, the number of donors recovered in the nation 
has increased somewhat. At TransLife, 78 donors were recovered this 
past year, compared to 74 in 1997 and 69 in 1996. Although that 
corresponds to over 32 donors per million population and ranks near the 
top by current HCFA standards for OPOs, you will see shortly that we 
don't really know what that standard means. The national increase to 
date has come about in three major ways. First, most of the change in 
the number of organ donors has come from the older age groups, 
especially 65 and above. Criteria for accepting cadaver donors have 
begun to be liberalized and expanded. In addition to increasing age, 
larger numbers of donors are occurring with diabetes, hypertension, 
some infections, and other conditions. Unfortunately, there is a trade 
off in poorer graft function in these expanded criteria donors.
    Second, there are more living donors. There were over 4100 living-
donor transplants in the United States in 1998 up from 3905 in 1997 and 
3690 in 1996. Of note is the fact that from 1996 to 1998, the 
percentage of spouses and friends who were emotionally, as opposed to 
genetically, related donors increased from 3.9% to 12.5%, significantly 
contributing to the overall improvement. Third party living donors, 
neither genetically or emotionally related, but altruistically 
motivated, are being considered in some programs. I feel living donors 
would be even more plentiful if Medicare and other third party payers 
would reimburse these individuals for their out of pocket expenses and 
the lost wages associated with this heroic act.
    Third, efficiency in organ procurement has increased, with more 
solid organs procured (and transplanted) per donor. Although this 
donor-transplant ratio has risen substantially since the late 1980's, 
much of the improvement through 1996 was recorded in the earlier part 
of the period.
    Other developments such as the revisited interest in non-heart 
beating donors and medical advances in split livers and lungs are among 
important areas that show promise for expanding the organ pool. Non-
heart beating donors, donors in whom the family requests that life 
support be withdrawn but may not yet be clinically brain dead, could 
add substantially to the pool of kidney and liver organs. However the 
procurement of organs from these donors is labor intensive and yet to 
be fully embraced by the organ procurement and transplant community. 
The Institute of Medicine's ongoing evaluation of this issue is 
awaited. Split liver and lung techniques may also increase in the 
future in both living and cadaver donors and I would be happy to 
comment on these developments.
    Across the organ procurement community, a number of examples can be 
cited of important initiatives that have been taken to enhance OPO 
effectiveness. For example, TransLife developed ``Tiger Teams'' at 
three of our major donor hospitals. These are organizations of health 
care professionals who are committed to supporting and promoting organ 
donation. The multidisciplinary teams include representatives from 
Nursing, Hospital Administration, Clergy, the Medical Examiner's office 
and Social Services. The teams meet on a monthly basis to discuss donor 
activity and consent rates; conduct case reviews and assist the OPO in 
planning education. They keep donation at the forefront of their 
respective facilities. LifeNet, based in Virginia Beach, Virginia, 
enlisted hospital administrators from every hospital in its service 
area to send representatives to form an OPO liaison council that would 
help to develop and implement new strategies. This LifeNet Liaison 
Council contributed to improved hospital relations leading to the 
successful initiation of voluntary routine referral of potential organ 
donors in all their facilities.
     The range of successful initiatives among OPOs is broad and 
includes the following: 1) establishment of continuous quality 
improvement teams, 2) the conduct of general public awareness 
campaigns, 3) targeted community outreach to ethnic and racial 
populations, 4) school education programs and curriculum development, 
5) special emphases on donor families and bereavement counseling 
services, and 6) other focused programs to work collaboratively with 
local hospitals.
    Increasing donation is not an easy task. A lot of smart, dedicated, 
hard-working professionals in the nation's 62 OPOs, and many others, 
have spent much time, energy and money tackling this problem. The 
challenge before us is compounded by the fact that we really don't know 
whether we are being more or less efficient in our recovery of organs. 
The reason is that we don't have a good understanding of the underlying 
potential for brain-dead, heart-beating (that is, ``standard'') organ 
donors, and how it is changing from year to year.
    As we struggle to eradicate the organ shortage, two of the most 
limiting factors in organ donation come into focus: (1) failure to 
determine which patients are potential organ donors and the lack of 
referral of these patients to OPOs; and (2) the refusal of patients' 
families to consent to donation.
    Without knowing the denominator in the organ procurement equation, 
it is impossible to tell if we are increasing the percentage of 
potential donors converted into actual donors. It may be, as many 
suspect, that the donor pool is actually shrinking through a decline in 
deaths from traumatic causes--motor vehicle accidents, homicides, 
suicides, etc. This traditionally has been a major source of organ 
donors. If this is true, than the increase in donors may be more 
significant than it might otherwise appear.
    The need to understand the size and nature of the potential organ 
donor pool, and how it varies from region to region, was the impetus 
several years ago for AOPO to begin a detailed examination of this 
issue. More than half of the nation's OPOs now are participating in 
this study, which employs a standard methodology to retrospectively 
review hospital medical records. From these data, the number and 
distribution of potential donors can be determined, and the efficiency 
in converting potential into actual donors can be measured.
    The UNOS Council for Organ Availability, which I Co-Chair, is very 
interested in monitoring the progress of this study as it continues in 
to its second phase. Indeed, our Council is charged with developing 
information on best practices among the more effective OPOs in the 
nation. The initial challenge for us, ironically, is to identify the 
more effective OPOs. Standard measures used to date for assessing OPO 
performance, are clearly inadequate and can be quite misleading, a 
point I will return to later. The availability of alternative measures, 
such as looking at OPO performance in the context of potential donors, 
offers great promise in giving us a better profile for our charge.
    Preliminary results of the AOPO study indicate that only about 40 
percent of the potential donors actually became donors. Of those who 
were not donors, most were identified as potential donors, but the 
family declined to consent; and in some cases the family was never 
asked. Yet over 75 percent of Americans surveyed in public opinion 
polls say that they would support organ donation for themselves. 
Therefore if we can assure 100 percent identification of potential 
donors in a timely way, and we can have a trained, expert requester 
approaching families at the right time, with the right information, we 
ought to be able to move the donor conversion rate from 40 percent to 
something much higher.
    A sobering statistic underlying concerns with the referral of 
potential organ donors is the estimate that 27 percent of the medically 
suitable organ donors in the US are never recognized as potential 
donors. As highlighted in the current issue of Critical Care Nurse, 
which provides special attention to clinical dimensions of organ 
donation, ``reasons why hospital staff do not recognize which patients 
are potential organ donors and refer these patients to the OPO include 
lack of knowledge about the criteria for organ donation, reluctance to 
spend the time to get the OPO involved, and uncertainty about how to 
initiate the donor referral process.''
    Over the past fifteen years, a number of efforts have been 
undertaken in different parts of the country to increase hospital 
referral rates to the OPO community. In recent years, the more 
prominent legislative efforts have taken the form of ``routine 
notification'' legislation passed in a number of States, which required 
that all deaths or deaths that are imminent within a hospital be 
referred to the Medicare-certified OPO. Based largely on the 
experiences in these States (Pennsylvania being the most notable), HCFA 
promulgated the new Medicare Hospital Conditions of Participation last 
August. These regulations, which are only now being implemented, 
mandate that all in hospital deaths be referred in a timely way to the 
local OPO so that a determination can be made if a patient is a 
potential organ donor. The regulations also specify that only expert 
requesters--that is, OPO staff or hospital staff specifically trained 
to request organ and tissue donation--are permitted to approach 
families.
    There have been early implementation difficulties. These include 
the absence of an age cut off for death referral calls, questions 
regarding how and whom to train on the hospital staff, especially 
physicians, problems occasioned by some hospitals asking patients about 
organ donation upon admission, and referrals to and conflicts with and 
among tissue banks. Overall, however, the regulation has made important 
inroads towards improving the percentage of potential donors, improving 
the timeliness of referrals to the OPO, and improving the effectiveness 
of the consent process.
    Already we are seeing significant increases in referral calls made 
to local OPOs, unless the OPOs and hospitals are in settings where 
either legislated or voluntary routine referral was in place before the 
federal rules were promulgated. In some instances, calls have increased 
from 50 per month to nearly 2,000. Given the fact that there currently 
is no age limit on the referral calls, it is clear that most of these 
calls do not involve potential donors for solid organ recovery. The 
largest increases are occurring in tissue donor referrals. Nonetheless, 
earlier State experiences with routine referral laws have translated 
into increases in organ donation. When fully implemented next August 
and in subsequent years, we expect that the federal regulations will 
produce similar results.
    Failure to obtain request for consent represents an equally 
important limiting factor to achieve greater success in organ 
availability. Estimates suggest that around one-third of the medically 
suitable organ donors in the US do not donate because the family of the 
potential donor refuses to consent to donation.
    Research regarding the consent process has indicated critical 
ingredients for dramatically increasing success in obtaining consent. 
First, it is important to de-couple discussions about brain death and 
discussions about organ donation. Second, private discussions are best. 
And, third, OPO participation with hospital staff is advantageous. 
Although these methods are not uniformly understood or practiced, the 
recently promulgated Medicare Conditions of Participation do strengthen 
these dimensions by specifically stating that families must be 
approached in a sensitive and caring fashion by OPO staff members or by 
designated requesters who complete OPO training requirements. Early 
returns on implementation of these regulations, furthermore, do suggest 
that the hospital and organ procurement industries are moving ahead 
collaboratively to make this work.
    In the context of reviewing barriers to organ donation, a critical 
issue that has a clear impact on the effort to increase organ supply is 
the turmoil created by the current practice of OPO recertification and 
performance evaluation.
    The current OPO certification process, which occurs every two 
years, has perhaps unintendedly created the strange result of 
introducing major distractions and indeed disruptions to the mission of 
OPOs to increase the supply of organs. Unlike hospitals, for example, 
the certification period for OPOs is much shorter, the criteria for 
evaluation do not measure OPO performance or capability, a clearly 
defined due process component for resolving complaints does not exist, 
no corrective action plans are included, and OPOs that are found 
deficient by the current measures simply are directed to close their 
doors.
    The OPO certification process sets an arbitrary population-based 
performance standard for certification of OPOs based on donors per 
million of population (DPMP). It sets a standard for acceptable 
performance based on five criteria: donors recovered per million, 
kidneys recovered per million, kidneys transplanted per million, extra-
renal organs recovered per million, and extra-renal organs transplanted 
per million. These current measures of performance do not adequately 
distinguish among OPOs and do not necessarily correlate with actual 
donor potential and OPO efficiency. A very effective OPO that is 
getting a high yield from potential donors may look terrible because 
they have a lot of AIDS, older people, minorities and other risk 
factors in the population. At the same time, a very ineffective OPO may 
look good because they have a population with a high proportion of 
potential donors.
    Under current regulatory practice, OPOs are decertified if they 
fail to meet the 75th percentile of the national means on 4 of the 5 
performance measures. Service areas are reassigned to another OPO whose 
performance is greater than the 75th percentile of the national mean. 
Therefore, it is a mathematical certainty that some of the OPOs must 
fail each cycle--no matter how much they individually improve.
    From the perspective of OPOs, the process is like musical chairs. 
Every two years, you take two chairs away, with no real rhyme or 
reason. Unfortunately, worrying about the dance has often diverted 
enormous energy on the part of the OPO community from our primary 
mission of increasing organ supply. Particularly distressing is that 
this do or die approach, based on measures that offer no real 
stimulation to do a better job, may very well undermine the time and 
effort needed to enhance the positive objectives of the new Conditions 
of Participation.
    A critical need exists to know the expected performance of OPOs 
based on their potential. It is hard to improve what you can't measure 
accurately.
    Although the population-based measures have been in use by both the 
government and industry, it is important to note that there is 
widespread agreement that these measures are not meaningful for 
improving performance. In 1997, for example, the General Accounting 
Office issued a report concluding that the existing standards of 
performance are not valid measures for determining OPO performance and 
that a new system should be developed which takes into consideration 
each OPO's particular service area and the potential of that service 
area. Indeed, it is possible that efficient OPOs have been shut down 
based on these criteria with disruption of an effective donation 
process in areas served by what seems to be poorly performing OPOs.
    In recent months, some important new data has been developed, 
shared with HHS and GAO officials, which has significant policy 
implications for considering alternative OPO performance measures. 
Specifically, AOPO has made significant progress on its major death 
record review study, which includes an unprecedented amount of quality 
data collected on donor potential. The study recently produced 
preliminary results from its major death record review, which indicates 
poor correlation between OPO potential and the current population 
standards. A Harvard School of Public health study recently reported 
similar results from a mathematical model for calculating organ donor 
potential in OPO territories as did a report from the United States 
Renal Data System (USRDS) published recently in the journal 
Transplantation. Members of the Committee might find presentations 
regarding these efforts to be of particular assistance in additional 
deliberations regarding this area.
    In order to stabilize organ procurement and focus on improving our 
performance in increasing the supply, we need the following:

 An immediate moratorium to the current recertification process 
        and the use of the current performance measurements. HCFA can 
        do this administratively by extending the certification process 
        from 2 to 4 years as they were directed in the Balanced Budget 
        Act of 1997. The moratorium should last until there is a new 
        process in place.
 Support for a collaborative effort among HCFA, IOM, GAO, and 
        the Industry to develop better measures of OPO performance--
        measures that can determine potential and will focus OPOs 
        effectively on increasing the supply of organs.
 Negotiated rule making with HCFA and the Industry to design a 
        new recertification and performance measurement process.
 The new process should include a longer time between 
        recertifications; due process for plans that fail; an 
        opportunity for a corrective action plan.
    In closing, I do want to commend the Committee again for convening 
this brief examination today of the issues around increasing the 
nation's supply of organs. Given the urgency of these matters, I would 
encourage, furthermore, that consideration is given by the Committee 
this session to reauthorize the National Organ and Transplantation Act 
(NOTA), amended to include:

 Financial reimbursement for lost wages and personal expenses 
        for all living donors.
 Research funding to further explore and define factors 
        resulting in improved consent for donation.
 Further emphasis to the general public that organ donation 
        saves lives.
    Thank you again for the opportunity to testify today. I will be 
happy to answer any questions.

    Mr. Bilirakis. Thank you so much, Dr. Metzger.
    Dr. Higgins?

                STATEMENT OF ROBERT S.D. HIGGINS

    Mr. Higgins. Thank you. Mr. Chairman and members of the 
committee, thank you for this opportunity to submit testimony 
on increasing organ supply for organ transplantation. My name 
is Robert Higgins. I am a surgeon and physician and director of 
the heart and lung transplant program at Henry Ford Hospital in 
Detroit, Michigan. I serve as the Region X, which includes 
Michigan, Indiana, and Ohio, thoracic organ transplant 
committee representative for the United Network for Organ 
Sharing, or UNOS.
    I am here today representing Henry Ford Hospital and the 
Patient Access to Transplantation Coalition, or PAT. Formed in 
June 1998, the Patient Access to Transplantation Coalition is 
an independent and informal coalition of 31 transplant centers 
and other medical institutions which provide local access to 
nationally recognized excellence in transplant care. Although 
our membership is diverse, one aspect of our mission is clear. 
We work to ensure that more organs are available to more 
patients. The PAT Coalition believes that, in reality, donation 
occurs locally and not nationally and involves donor families, 
physicians, hospitals, and organ procurement organizations all 
working closely together within a local setting.
    As physicians, we are thrilled with the advancements that 
allow us to help more and more patients. We are also deeply 
concerned that the supply of organs limits this field of life-
giving therapy. We applaud you, Mr. Chairman, for scheduling 
this crucial hearing to discuss ways we can work together to 
increase organ donation. In the next few minutes, I would like 
to share with you main strategies which we have employed to 
increase the availability of organs. These include public 
awareness and education to encourage families and individuals 
to consider donation, improving ways to work with patients and 
families at the decision point when organ donation is offered, 
and increasing the supply through techniques such as split 
liver procedures that benefit two recipients instead of one and 
increasing the use of living donors.
    In the State of Michigan, there are eight transplant 
centers, with the Henry Ford Hospital and the University of 
Michigan Health System accounting for 40 percent of the organ 
transplants performed in the State. The Transplantation Society 
of Michigan serves as the federally designated organ 
procurement agency for the entire State and allocates organs 
for each transplant center.
    Henry Ford Hospital is serving a population in southeast 
Michigan of over 800,000 aligned patients, including large 
Medicare, Medicaid, and managed care populations. Over the past 
30 years, more than 1,700 patients have received an organ 
transplant at Henry Ford Hospital, giving patients a second 
lease on life. Southeast Michigan is home to a large African 
American population, which experiences a higher than average 
incidence of hypertension, diabetes, chronic kidney disease, 
and other chronic illnesses which often leads to the need for 
transplantation services.
    Our transplant program is located in the city of Detroit, 
where approximately 75 percent of residents are African 
American. The recent development of transplant centers in urban 
centers, such as the Henry Ford Health System, provides local 
access for patients from all walks of life. Without a 
geographically accessible program in the vicinity, costs to 
patients' families and those with limited financial resources 
may be prohibitive.
    Nationwide, over 62,000 patients await life-saving or life-
enhancing organ transplants. In the kidney failure population, 
as I am sure you will hear, close to 40 percent of those are 
African American. Transplant programs at institutions such as 
the Henry Ford Hospital serve predominately urban populations 
and provide critical access to transplant programs in the 
region. Among the patients served by our hospital, more than 40 
percent are covered either by Medicare or Medicaid.
    Historically, African Americans have donated less 
frequently than others. A number of reasons have been 
identified, including a lack of information about 
transplantation, religious beliefs, fear of premature death, 
and mistrust of the medical community. The Henry Ford Health 
System has developed critical partnerships with a number of 
organizations, such as the Patient Access to Transplantation 
Coalition, to address many of these issues.
    We have also developed partnerships with the National 
Minority Organ Tissue Transplant Education Program, or MOTTEP, 
which is designed to educate minorities on the facts about 
organ and tissue transplantation and to increase the number of 
persons who actually become donors. It delivers a culturally 
sensitive message by ethnically similar messengers within 
minority communities. MOTTEP has been effective in advancing 
the goal of improving organ donation rates in our African 
American community.
    Last year, the PAT Coalition worked actively with the 
Appropriations Committee to achieve substantially increased 
Federal dollars directed toward organ donation. We commend 
Congress for appropriating these funds. We also take great 
pride in the leadership of the Michigan delegation, who in 1996 
supported a campaign to increase organ donation rates in the 
United States through legislation that allowed information on 
organ donation to be included in IRS refunds.
    In the State of Michigan, the Secretary of State, Candace 
Miller, has recently implemented an organ donor registry 
through legislation approved by the Michigan legislature and 
this has increased donors by 140 percent since 6 months after 
its implementation. The law requires the Secretary of State to 
provide ID and driver's license applicants information about 
Michigan's organ procurement agency as well as explanations of 
what an anatomic gift is. Since the Michigan organ donor 
registry started, approximately 2,000 names have been added 
each week to the list of potential donors. The number of 
registered potential organ donors has increased from 16,000 in 
July 1998 to approximately 40,000 names today.
    Henry Ford Hospital has also embraced additional strategies 
to alleviate the organ shortage. Living related kidney donation 
is a very powerful tool to increase the number of organ donors. 
In 1997, an African American man in his mid-40's needed a 
kidney transplant. None of his family members were found to be 
a suitable match. In the absence of an available cadaveric 
donor, an alternative means was needed. A close friend and 
coworker, who happened to be white, offered to be tested. As it 
turned out, the friend was a perfect match and our first cross-
racial living organ donation surgery took place. Both patients 
recovered well and continued their friendship. Our community 
rallied behind the cross-racial living organ donation and 
celebrated both the medical and community triumph. Living 
related organ donations now comprise approximately 50 percent 
of the Henry Ford Hospital kidney transplant patients.
    Another innovative approach to alleviate the shortage is 
the split liver transplant procedure, where two recipients 
receive a donor organ when clinically appropriate. We performed 
our first split liver transplant for two female patients in 
1997. These donations can be particularly important to 
children, who account for approximately 10 percent of those 
waiting for a liver transplant. Many physicians feel the split 
liver procedure can be an effective strategy to address the 
organ donor shortage in pediatric populations, and as more 
transplant centers become comfortable with this procedure 
nationwide, it may have a significant impact.
    Congress has a unique opportunity to provide legislative 
leadership in refocusing the national organ debate on donation 
and the PAT Coalition urges the Commerce Committee to lead on 
this issue by supporting legislation which gives the public 
genuine motivation and incentives to be aware and willing to 
become organ donors. Specific areas which may be considered 
include creating travel and subsistence incentives for those 
who want to donate in living related transplant procedures, 
creating a national registry for organ donors, and continuing 
expansion of the new HRSA organ donation extramural research 
program.
    In closing, I applaud the involvement of Congress in 
initiatives to put patients and families first and to increase 
the organ supply for transplantation. As we move forward with 
new procedures and technology, we must also continue our 
efforts to raise public awareness and work with our communities 
to donate the precious scarce resource of organs. Thank you for 
your efforts.
    [The prepared statement of Robert S.D. Higgins follows:]
 Prepared Statement of Robert S.D. Higgins, Director of Thoracic Organ 
 Transplantation, Henry Ford Hospital, on Behalf of the Patient Access 
                      to Transplantation Coalition
    Mr. Chairman and Members of the Committee, thank you for this 
opportunity to submit testimony on increasing organ supply for organ 
transplantation. My name is Robert Higgins. I am a physician and 
Director of Thoracic Organ Transplantation at Henry Ford Hospital in 
Detroit, Michigan. I serve as the Region 10 (Michigan, Indiana and 
Ohio) Thoracic Organ Transplant Committee Representative for the United 
Network for Organ Sharing (UNOS). I am here today representing Henry 
Ford Hospital and the Patient Access to Transplantation (PAT) 
Coalition.
    As we enter into a new millennium, our nation can point with pride 
to many miraculous medical technological breakthroughs, including 
remarkable advances in transplantation services. Improvements in drugs, 
practices and technology in the transplant field have enabled doctors 
to perform more life saving procedures, with better results than ever 
before. The organ shortage is really a hallmark of this success. With 
improvements in transplantation science and technology, the number of 
patients who can benefit has increased dramatically, outstripping the 
supply of organs. This is the real story. As physicians engaged with 
our patients in one of the most sensitive areas of medicine, we are 
thrilled with the advancements that allow us to help more and more 
patients. We are also deeply concerned that the supply of organs limits 
this field of life giving therapy.
    We see our patients as mothers, fathers and children in the context 
of a family and community that benefits from their ability to live and 
carry out their responsibilities. We are able to provide stabilization 
care and hold out the promise of a continued active life through 
transplantation. To many of us, the only barrier appears to be lack of 
available organs. Waiting times do vary across regions of the nation 
and unfortunately, as many as 13 people die in our nation every day 
while waiting for an organ transplant because of the shortage of 
organs. We applaud you, Mr. Chairman, for scheduling this crucial 
hearing to discuss ways we can work together to increase organ 
donation.
    What I will cover with you are the main strategies we employ for 
increasing the availability of organs. These are:

 Public awareness and education to encourage families and 
        individuals to consider donating healthy organs in the event of 
        imminent death;
 Improving ways to work with patients and families at the 
        decision point where donation is to be considered;
 New procedures and technology that improves the success rate 
        for transplantation services. This includes better selection 
        criteria of patients most likely to benefit, improved 
        techniques for maintaining the viability of the donated organ 
        until it can be placed, and improvements in drugs and other 
        therapies to reduce rejection rates; and
 Increasing the supply through techniques such as split liver 
        procedures that benefit two receiving patients instead of just 
        one, and the increased use of living donors.
    It is important to keep in mind, however, that the number of organs 
needed to fill demand will always be a moving target. This is because 
technology also helps to continuously expand the number of patients 
that can benefit from transplantation.
Public Awareness and Public Education
    More than 62,000 patients currently await organ transplants. Last 
year the PAT Coalition worked actively with the Appropriations 
Committees to achieve substantially increased federal dollars directed 
at organ donation. We commend Congress for appropriating $5.9 million 
above the Administration's budget request. We also take great pride in 
the leadership of the Michigan delegation who in 1996 supported a 
campaign to increase organ donation rates in the U.S. through 
legislation that allowed information on organ donation to be included 
with IRS refunds. We appreciate this and other wonderful efforts of 
Congress, such as this hearing, to focus public attention and create 
awareness about the need for organ donation.
    In Michigan, Secretary of State Candice Miller recently announced 
that registry legislation which the Michigan Legislature passed last 
year already has increased the number of organ donors by about 140% 
since the program began operating six months ago.
    The Michigan law requires the Secretary of State to provide ID and 
driver's license applicants information about Michigan's organ 
procurement agency, as well as an explanation of what an anatomical 
gift is. The law also established a registry of names of persons 
willing to be an organ and tissue donor. Licenses and ID cards now 
contain a statement that the licensee is an organ and tissue donor, 
which can be honored by hospitals, physicians and family.
    Since the Michigan organ donor registry started, approximately 
2,000 names have been added each week to the list of potential donors. 
The number of registered potential organ donors has increased from 
16,387 in July 1998 to approximately 40,000 names today.
    Historically, African Americans have donated less frequently than 
others. A number of reasons have been identified, including a lack of 
information about transplantation, religious beliefs, fear of premature 
death, and mistrust of the medical community. The National Minority 
Organ Tissue Transplant Education Program (MOTTEP) is designed to 
educate minorities on the facts about organ and tissue transplantation 
and to increase the number of persons who actually become donors. We in 
Michigan perceive that it delivers a culturally sensitive message by 
ethnically similar messengers within the minority communities. MOTTEP 
has been extremely effective in advancing the goal of improving 
donation rates in our African American community. The Transplantation 
Society of Michigan and Henry Ford Hospital have been partners with 
MOTTEP since its arrival in Detroit in 1995 and have provided 
administrative and professional guidance to this very important 
program.
Working with Families and Patients
    Under a voluntary system, such as we have in the U.S., permission 
of the donor patient and/or family is required. For the most part, the 
voluntary system relies on hospitals and doctors to work with families 
to get the necessary permission. One of our strongest tools in this 
process is helping the giving family to understand the good that will 
come from the organ donation.
    Let me walk you through the process of asking a family for an organ 
donation from their loved one. Generally, the injured or sick patient 
who arrives at the hospital was fine before the admission, and families 
are in shock at the life-threatening condition. The patient frequently 
has suffered a catastrophic brain injury from a stroke, aneurysm, care 
accident, gunshot, and other traumatic event. A social worker or other 
family support person is contacted to work with the family. Our 
LifeShare coordinator will assist by calling other family members, 
making sure the family understands what is happening with their loved 
one, and ensuring that everyone understands what the physicians and 
nurses have explained about the medical condition of the patient.
    If the patient fails to respond to treatment and has been declared 
brain dead by two physicians, our LifeShare coordinator consoles the 
family, and asks if organ donation had ever been discussed. The answer 
is usually, ``No.'' We explain that this could be an opportunity to 
give life to someone else who is very sick.
    Families will ask two main questions about donating: ``Where will 
the organ go?'' and ``Who is the recipient--can we meet him/her?'' We 
find that our families are reassured about the organ donation process 
when they are told organs are distributed locally first, then 
regionally, and then nationwide if a local match is not found. Families 
also like to know who the recipient is. This is often done through an 
anonymous letter writing process. Since there is great interest in 
meeting the organ recipient, this can be arranged if the families are 
locally based. This process has the effect of bringing closure to the 
grieving family and offering some consolation for their loss. It is a 
good process and reinforces deep human values for both the donor and 
the receiving patient.
Living Donors
    Henry Ford Hospital has embraced additional strategies to help 
alleviate the organ shortage. Living related kidney donation is a very 
powerful tool to increase the number of organ donors available. I would 
like to share with you one case in particular at our institution. In 
1997, an African American man in his mid 40's needed a kidney 
transplant. None of his family members were found to be a suitable 
match for his blood type and tissue type. In the absence of an 
available cadaveric donor, an alternative means was needed. A close 
friend and co-worker at General Motors who happened to be white, 
offered to be tested. As it turned out, the friend was a perfect match 
and our first cross racial living organ donation surgery took place. 
Both patients recovered well and continue their friendship. Our 
community rallied behind this cross racial living organ donation, and 
celebrated both the medical and community triumph. Living related organ 
donations now comprise approximately 50% of our Henry Ford Hospital 
kidney transplant patients.
Split Liver Transplants
    Another innovative approach to alleviating the organ donor shortage 
is to split a single liver between two recipients when clinically 
appropriate. In 1997, we performed our first split liver transplant for 
two female patients who received the gift of life from a single donor. 
Split liver donations can be particularly important for children, who 
account for approximately 10% of those waiting for a liver transplant. 
Split liver procedures often involve one adult and one child because 
the smaller liver lobe is suitable for pediatric patients. The 
procedure has to be done by surgery teams that can handle both patients 
at the same time. Many physicians feel that the split liver procedure 
can be an effective strategy to address organ shortage for pediatric 
populations. As more transplant centers nationwide become comfortable 
with this technically challenging procedure, it may have a significant 
impact on alleviating the overall organ shortage.
Michigan Perspective
    In the state of Michigan there are eight transplant centers, with 
Henry Ford Hospital and the University of Michigan Health System 
accounting for 40% of the organ transplants performed in the state. The 
Transplantation Society of Michigan serves as the federally designated 
organ procurement organization (OPO) for the entire State and is 
authorized to allocate organs among transplant centers in Michigan and 
qualified transplant centers nationwide under the Organ Procurement 
Transplantation Network (OPTN).
    Henry Ford Hospital serves a population in southeast Michigan of 
more than 800,000 aligned patients, including large Medicare, Medicaid 
and managed care populations. Our transplant program began with corneal 
transplants in the 1960s. In 1968, the hospital's first kidney 
transplant was performed. Since then, our multi-organ transplant 
program has grown to include heart, liver, lungs, pancreas, kidney, 
autologous and allogeneic bone marrow transplantation. In 1998, 139 
organ transplantations were performed at Henry Ford Hospital. Over the 
last 30 years, more than 1,700 patients have received an organ 
transplant at Henry Ford Hospital, giving patients a second lease on 
life.
    Southeast Michigan is home to a large African American population 
which experiences a higher than average incidence of hypertension, 
diabetes, chronic kidney disease and other chronic illnesses which 
often leads to the need for transplantation services. Our transplant 
program is located in the City of Detroit, where approximately 75% of 
residents are African American.
    The relatively recent development of transplant centers in urban 
centers across this country is an important improvement in our Health 
Care System, because it provides local access for patients from all 
walks of life. Without a geographically accessible program in the 
vicinity, costs to patients, families and those with limited financial 
resources can be prohibitive.
    Nationwide, over 62,000 patients await life saving or life 
enhancing organ transplants. In the kidney failure population, close to 
40% of those patients are African American. Transplant programs at 
institutions such as Henry Ford Hospital, which serve predominately 
urban populations, provide critical access to transplant programs in 
the region. Among the patients served by Henry Ford Hospital, more than 
40% are covered by Medicare and Medicaid. Over 25% of the population we 
serve earns an economic income less than 100% of the Federal Poverty 
Level.
    Formed in June 1988, the Patient Access to Transplantation (PAT) 
Coalition is an independent and informal coalition of transplant 
centers and other medical institutions which provide local access to 
nationally-recognized excellence in patient care. The PAT Coalition 
membership today consists of 31 transplant centers of varied size 
located in 21 states nationwide. Although our membership is diverse, 
one aspect of our mission is clear: ensuring that more organs are 
available to more patients.
    The PAT Coalition believes that, in reality, donation occurs 
locally, not nationally, and involves donor families, physicians, 
hospitals and organ procurement organizations, all working closely 
together within a local setting.
    The PAT Coalition and other private sector national organizations 
recognize that the establishment of transplant programs serving local, 
state, and regional areas has resulted in a marked increase in the 
total number of annual transplants in the United States, and firmly 
believes that the presence of a transplant program in a community or 
state provides a context and a focus for efforts to increase organ 
donation. Indeed, if centers are no longer able to operate in urban 
communities across this great nation, their transplant teams will no 
longer be available to recover organs in the surrounding area, further 
hurting donation efforts.
    Congress has a unique opportunity to provide legislative leadership 
in refocusing the national organ debate on donation, and the PAT 
Coalition urges the Commerce Committee to lead on this issue by 
supporting legislation which gives the public genuine motivation and 
incentives to be aware and willing to become organ donors. Specific 
areas that should be considered in legislation include: creating travel 
and subsistence incentives for those who want to donate or receive 
organs, creating a national registry of organ donors, and continued 
expansion of the new HRSA organ donation extramural research program. 
Donation represents the arena in which all transplant interests can 
unite and work together.
    In closing, I applaud the involvement of Congress in initiatives to 
put patients and families first and increase the organ supply for 
transplantation. Until we are personally touched by a tragic 
circumstance that revolves around organ transplantation, we cannot 
fully appreciate the value to our community of donors who give a second 
chance at life to so many sick individuals. As we move forward with new 
procedures and technology, so must we also continue our efforts to 
raise public awareness and work with our communities to donate the 
precious, scarce resource of organs. Thank you for your efforts.

    Mr. Bilirakis. Thank you so much, Dr. Higgins.
    Dr. Miller?

                   STATEMENT OF JOSHUA MILLER

    Mr. Miller. Representative Bilirakis and members of the 
committee, thank you very much for the opportunity to testify 
today. 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, Miami, Florida, in Jackson Memorial 
Hospital. I happen to be Cynthia Guillemin's transplant 
surgeon, but I have to admit that her last statement was not in 
the prepared thing that I read, so you will have to pardon 
that.
    I am appearing today as the President this year of the 
American Society of Transplant Surgeons, the ASTS, which is the 
leadership 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. Our Society has taken the field from 
experimental trials to highly developed treatment modalities 
that increasingly offer thousands of men, women, and children a 
new chance at an ever longer and healthier life. ASTS members 
have the responsibility for directing clinical and research 
transplantation 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 
U.S. Congress over 15 years ago. We conceived of an organ 
procurement and distribution network. And in partnership with 
the Health Care Finance Administration of the Department of 
Health and Human Services, helped organize it and put it into 
action during the same period.
    Because of the explosive success of organ transplantation 
in the latter half of the 20th century--you have heard the 
numbers. There are 62,000 patients with end-stage failure of 
hearts, livers, lungs, pancreases, kidneys awaiting life-saving 
transplants this year, and probably fewer than 5,000 cadaver 
organ donors will provide us with only about 18,000 organs that 
can be used. Even with approximately 3,000 organs from living 
donors, the total number available does not begin to keep pace 
with the growing demand, so unless more organs become 
practically available for transplantation in the near future, 
the number waiting will forseeably pass 100,000.
    How can we improve organ availability? Members of the ASTS 
are continuously working in the trenches with our patients and 
also in investigational laboratories seeking, one, innovative 
methods of improving the availability and quality of organs for 
transplantation; two, ways to more successfully preserve 
transplantable organs outside the human body; three, safer and 
medically acceptable ways to transplant from living donors 
kidneys, lungs, livers, and pancreatic segments; four, methods 
of safely splitting organs from cadaver organ donors; five, 
hastening the day when animal cells and organs will be 
available to replace their human counterparts using molecular 
technology; and six, working to advance our understanding of 
the human immune system.
    We have extended our most recent initiative this year into 
operational practices and improving organ availability, and in 
a most important component, education of the American public, 
and these initiatives have taken two major directions.
    Operationally, with our colleagues in the organ procurement 
organizations of America, we are already adapting novel 
approaches to improve the identification of organ donors in 
donor hospitals and in their physiologic maintenance in order 
to significantly increase organ availability, and this includes 
practical approaches now in operation in Spain and other 
practices in operation in Great Britain on donor maintenance. 
We did this after a week-long fact-finding tour in these 
countries last October and our working group then organized 
plans to set similar practices in place in demonstration 
regions in the United States.
    We feel that there is the potential of actually doubling 
the number of heart transplants available to Americans with 
these particular practices. There also could be an improvement 
in overall organ donation in our country by at least 50 
percent. That would enable us to provide a new chance at life 
to an additional 10,000 American men, women, and children each 
year, and I am pleased to provide two reports outlining 
progress in these initiatives for your detailed study.
    The second major initiative is one of public education now 
10 months into operation and it is called the First Family 
Pledge campaign. It was launched by the ASTS last May and has 
as its honorary co-chairs Reg and Maggie Green, who donated 
their 7-year-old son Nicholas's organs and tissues after he was 
murdered in Italy in 1994. The First Family Pledge campaign now 
has the support of all of the organizations involved in 
increasing organ and tissue donation in America, who several 
years ago, as you heard, formed the Coalition for Donation.
    The whole concept of organ donation has not been well 
defined because the thoughts behind the process have not been 
clearly dissected and portrayed by us who know what we see in 
the trenches when consent for donation is requested and when 
organ transplants are performed. Organ donation and life-saving 
transplants are not merely individual acts. They require the 
participation and support of loved ones, the families close to 
the potential recipient who might die without the transplant, 
and the family of the potential cadaver organ donor, who must 
be included in this process in order that they understand the 
opportunity of saving lives of many after the tragic but 
inevitable death of their loved one. In fact, we could not 
proceed without family consent.
    In any family's time of need, all family members obviously 
hope a life-saving organ will become available in time, and if 
we dare hope for this gift of life for our family, how can we 
do less than make a commitment in return, a family commitment 
to be there for them if the circumstances ever arise to save a 
life in other families, the lives of their loved ones through 
the reciprocal act of organ donation.
    More than 250 Members of Congress publicly endorsed this 
initiative. This heartening surge in leadership support was 
demonstrated yesterday by the First Family Pledge Congress, in 
which many of the Members of Congress attended. I include an 
informational packet about this initiative for your perusal and 
would be happy to answer any questions about organ donation 
that I can. Thank you.
    [The prepared statement of Joshua Miller follows:]
  Prepared Statement of Joshua Miller, President, American Society of 
                          Transplant Surgeons
    I appreciate the opportunity to testify at this hearing on Putting 
Patients First: Increasing the Organ Supply for 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 President this year of the American 
Society of Transplant Surgeons (the ASTS) the leadership 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. Our Society has taken the 
field from experimental trials to highly developed treatment modalities 
that increasingly offer thousands of men, women, and children a new 
chance of an ever longer and healthier life. 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 15 years 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.
    Because of the explosive success of organ transplantation in the 
latter half of the 20th century, there are now 62,000 patients with 
end-stage failure of hearts, livers, lungs, pancreases, and kidneys 
awaiting life-saving transplants. This year, fewer than 5,000 cadaver 
organ donors will provide us with only about 18,000 organs that can be 
used, applying current methodology.
    Even with approximately 3,000 organs from living donors, the total 
number available does not begin to keep pace with growing demand. So, 
unless more organs become practically available for transplantation, 
the number waiting will probably pass 100,000 in the not too distant 
future.
    How can we improve organ availability? Members of ASTS are 
continuously working in the trenches with our patients and also in 
investigational laboratories seeking:

 Innovative methods of improving the availability and quality 
        of organs for transplantation;
 Ways to more successfully preserve transplantable organs 
        outside the human body;
 Safer and medically acceptable ways to transplant from living 
        donors kidneys, lungs, and liver and pancreatic segments;
 Methods of safely splitting organs from cadaver donors;
 Hastening the day when animal cells and organs will be 
        available to replace their human counterparts using molecular 
        technology;
 Working to advance our understanding of the human immune 
        system.
    We have already done some of this, in part, in using porcine heart 
valve replacement and skin for dressings for extensive burn coverage in 
critically ill patients.
    We have extended our most recent initiatives this year into 
operational practice, in improving organ availability and in the most 
important component, education of the American public. These 
initiatives have taken two major directions.
    Operationally, with our paramedical assistants and colleagues who 
have developed and administered the Organ Procurement Organizations in 
America, represented by the Association of Organ Procurement 
Organizations (AOPO), we are already adapting novel approaches to 
improve the identification of organ donors in donor hospitals, and in 
their physiologic maintenance, in order to significantly increase organ 
availability. This includes increasing consent rates by families of the 
donors using the practical approaches now in operation in Spain, as 
well as the organizational structure and practice in operation in Great 
Britain.
    We did this after a week-long fact-finding tour of these countries 
last October. Our delegates--Dr. John Roberts of the University of 
California at San Francisco, Dr. Bruce Rosengard and Dr. Avi Shaked of 
the University of Pennsylvania in Philadelphia--worked with OPO 
representatives from Massachusetts, Minnesota, Florida, and California, 
as well as a representative of the former Partnership For Organ 
Donation. This working group then organized plans to adapt the 
application of these novel systems of organ donation and maintenance 
that had been in practice in these countries for the past several 
years, to set similar practices in place in demonstration regions in 
the United States.
    We sought at the outset, and several times since, to involve the 
Department of Health and Human Services in these efforts. While they 
expressed interest, they thus far, for ill-defined administrative 
reasons, have been unable to help with the seed funding of the 
projects, which continue to develop with an enthusiastic response of 
our professionals.
    We feel the potential exists to actually double the number of heart 
transplants available to Americans. There also could be an improvement 
in overall organ donation in our country by these activities from a 
rate of 19 donors per million to over 30 donors per million--a 50 
percent increase that would enable us to provide a new chance at life 
to an additional 10,000 American men, women and children each year. I 
am pleased to provide formal reports outlining our progress in these 
two initiatives for your detailed study.
    The second initiative is one of public education, now ten months 
into operation, and it is called the First Family Pledge Campaign. It 
was launched by ASTS last May and has as its honorary co-chairs Reg and 
Maggie Green, who donated their 7-year-old son Nicholas' organs and 
tissue after he was murdered in Italy in 1994.
    The First Family Pledge Campaign now has the support of all of the 
organizations involved in increasing organ and tissue donation in 
America, who several years ago formed the Coalition for Donation. The 
whole concept of organ donation has not been well-defined, because the 
thoughts behind the process have not been clearly dissected and 
portrayed by us who know what we see in the trenches when consent for 
donation is requested and when life-saving organ transplants are 
performed.
    Organ donation and transplantation are not, and should not be, 
individual acts.
    They require the participation and support of the loved ones, the 
family close to the potential recipient who might die without the 
transplant, and the family of the potential cadaver organ donor, who 
must be included in this process, in order that they understand the 
opportunity of saving lives of many after the tragic, but inevitable, 
death of their loved one.
    It is a family-to-family act of Americans who understand that we 
all ultimately are part of one human family.
    In any family's time of need, all family members obviously hope a 
life-saving organ will become available in time. If we dare hope for 
this gift of life, how can we do less than make a family commitment, in 
return, to our brethren--to be there for them, if the circumstances 
ever arise, to save the life of their loved ones through the reciprocal 
act of organ donation.
    We think this powerful concept--a family pledge, far better than 
the solitary, individual act of signing an organ donor card--has 
enormous potential.
    Already, the First Family Pledge approach has resulted in more than 
twice as many Members of Congress publicly endorsing organ and tissue 
donation as ever before--a heartening surge in leadership support 
demonstrated yesterday by the First Family Pledge Congress which many 
Members attended.
    This First Family Pledge activity is rapidly growing nationwide, 
and will continue with the help of yourselves as examples of First 
Families, pledging, if catastrophe ever occurred to your loved ones, 
organ donation, to fulfill the life-saving needs of others. First 
Family Pledge activities are now being organized in many American 
cities and communities, with the help of their mayors, and county 
executives, and city council leaders --their First Families. I also 
include an informational packet about this initiative for your perusal 
and would be happy to answer any questions that I can about organ 
donation in America.
    Thank you.

    Mr. Bilirakis. Thanks so much, Dr. Miller. Your emotions 
serve you well on this subject.
    Mr. Brand?

                  STATEMENT OF JOSEPH L. BRAND

    Mr. Brand. Thank you, Mr. Chairman. Mr. Chairman, members 
of the committee, my name is Joe Brand. I am the volunteer 
Chairman of the National Kidney Foundation. The National Kidney 
Foundation is the world's largest private organization 
representing organ donors, transplant recipients, and 
candidates for transplantation. We speak for the more than 
4,000 constituents of our National Donor Family Council who 
have had the personal experience of the gift of life and the 
more than 3,000 members of the NKF TransAction Council who have 
benefited from life-saving organ transplant.
    Every other year, thousands of recipients of all solid 
organ transplants compete in the U.S. transplant games 
sponsored by the National Kidney Foundation. Finally, a large 
portion of the almost 10,000 members of the National Kidney 
Foundation Patient and Family Council are on the transplant 
waiting list. In all, the National Kidney Foundation represents 
30,000 lay and professional volunteers from every walk of life 
and every part of the United States.
    Mr. Chairman, you have already heard from Dr. Neylan that 
before the day is over, ten Americans will die for want of a 
transplant. We, the National Kidney Foundation, therefore 
salute this Subcommittee on Health and Environment of the 
Commerce Committee for its decision to put patients first and 
rally national attention to the need to increase the supply of 
organs available for transplantation.
    Living organ donation is a bright chapter in the organ 
donation story. While the number of cadaveric organ donors 
increased by 33 percent between 1996 and 1998, the number of 
living donors grew by 95 percent during that same time period. 
The National Kidney Foundation believes that we have only begun 
to tap the potential of living donations.
    Therefore, we are planning many new programs, including 
one, for example, called ``Do You Have a Donor?'' This program 
will reach out to patients when they are first diagnosed with 
chronic renal insufficiency which may eventually necessitate 
transplantation. It will present early on the option for many 
patients of a living related donation. It is designed to 
prepare the potential recipient and the potential donors for 
the process of considering a living donation.
    This kind of private sector initiative offers a great deal 
of promise. Nevertheless, there are barriers to living 
donations which an organization like the National Kidney 
Foundation is not able to address. For instance, there are 
financial disincentives to living donations. Living donors are 
faced with a loss of income attributable to the time from work 
needed for evaluation, surgery, and recovery. There are also 
costs associated with their donation which are not 
reimbursable, for example, travel, lodging, meals, and child 
care.
    Two seminal studies sponsored by the National Kidney 
Foundation's Council of Nephrology Social Workers shed some 
light on the extent of the problem of financial disincentives. 
In a survey involving more than 500 living related donors at 
nine geographically dispersed centers, almost 25 percent of the 
respondents reported that donation had caused a financial 
hardship. Another such study by the National Kidney 
Foundation's Council of Nephrology Social Workers was the first 
to explore financial issues at the time of the transplant. 
Approximately one quarter of the family members surveyed 
indicated that financial issues kept them from being donors.
    The National Kidney Foundation encourages legislation to 
address the financial disincentives to living donation. We 
understand that Congressman Karen Thurman is working on such a 
measure. If Federal funds were available to remove financial 
disincentives to living donations, the superior graft survival 
rates associated with living donation would justify the 
expenditure. Furthermore, such payments are explicitly exempted 
from the prohibitions in Title III of the National Organ 
Transplant Act of 1984.
    I would like to leave you with one final message. The 
availability of organs for transplantation would be enhanced if 
we could reduce the need to repeat transplants. At least one-
eighth of cadaveric kidney transplant recipients have had a 
previous transplant and more than a fifth of the candidates for 
a kidney transplant have had one or more transplants already.
    One reason why transplant recipients lose their grafts is 
that they cannot afford to pay for anti-rejection drugs after 
Medicare payment for these drugs ceases during the 3-year post-
transplant period. The National Kidney Foundation, therefore, 
emphatically supports H.R. 1115, which would extend these 
Medicare benefits indefinitely and which was referred to your 
committee on April 7, 1999. I am very pleased to note that of 
the 82 cosponsors, many of your subcommittee members are on 
that list.
    Mr. Chairman and members of the committee, I thank you for 
the opportunity to testify on behalf of the 30,000 people we 
represent, each one of whom has a vital interest in the subject 
matter before you. Thank you.
    [The prepared statement of Joseph L. Brand follows:]
Prepared Statement of Joseph L. Brand on Behalf of The National Kidney 
                               Foundation
    Mr. Chairman and members of the committee: I am Joseph L. Brand, 
chairman of the National Kidney Foundation, the world's largest private 
organization representing organ donors, transplant recipients and 
candidates for transplantation. The Mission of the National Kidney 
Foundation 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. In particular, the 4,229 constituents of our National 
Donor Family Council have had the personal experience of giving the 
``Gift of Life'' and the 3, 317 members of the NKF transAction Council 
have benefitted from a life-saving organ transplant. In alternate years 
thousands of recipients of all solid organ transplants compete in the 
US Transplant Games sponsored by the National Kidney Foundation. 
Finally, a large proportion of the 9,354 members of the National Kidney 
Foundation Patient and Family Council are on transplant waiting lists. 
In all, NKF represents 30,000 lay and professional volunteers from 
every walk of life and every part of the United States.
    Mr. Chairman, before the day is over ten Americans will die for 
want of an organ transplant. The National Kidney Foundation, therefore, 
salutes the Subcommittee on Health and Environment of the Commerce 
Committee for its decision to ``Put Patients First'' and rally national 
attention to the need to increase the supply of organs available for 
transplantation. For its part the National Kidney Foundation is 
redoubling its efforts to increase organ donation by establishing a new 
supporting organization, ``Transplant America,'' which will be a 
vehicle for a new focused effort to more effectively bring our 
resources to bear in a serious and thoughtful way on the terrible organ 
shortage we face.
    Living organ donation is a bright chapter in the organ donation 
story. While the number of cadaveric organ donors increased by 33% 
between 1988 and 1996, the number of living donors grew by 95% during 
that same time period. That National Kidney Foundation believes that we 
have only begun to tap the potential of living donation. Therefore, NKF 
and Transplant America are planning many new programs, including one, 
for example, called ``Do You Have A Donor?'' This program will reach 
out to patients when they are first diagnosed with chronic renal 
insufficiency which may eventually necessitate transplantation. It will 
present early-on the option, for many patients, of a living related 
donation. It is designed to prepare the potential recipient and the 
potential donors for the process of considering a living donation. It 
also raises the issue in an up-front and honest manner so that living 
donation can be considered by more potential donors and recipients.
    This kind of private sector initiative offers a great deal of 
promise. Nevertheless, there are barriers to living donation which an 
organization like the National Kidney Foundation is not able to 
address. For instance, there are financial disincentives to living 
donation. Living donors are faced with loss of income attributable to 
the time away from work needed for evaluation, surgery and recovery. 
There are also costs associated with their donation which are not 
reimbursable, for example, travel, lodging, meals, child care, etc. Two 
seminal studies sponsored by the National Kidney Foundation Council of 
Nephrology Social Workers shed some light on the extent of the problem 
of financial disincentives. In a survey involving more than 500 living-
related donors at nine geographically dispersed centers, almost 25% of 
the respondents reported that donation had caused a financial hardship. 
Another CNSW study was the first to explore financial issues at the 
time of the transplant. Approximately one quarter of the family members 
surveyed indicated that financial issues kept them from being donors. 
In this study the University of North Carolina Transplant Program 
contacted 124 patients and 108 family members over a one year period. 
The National Kidney Foundation encourages legislation to address the 
financial disincentives to living donation. We understand that 
Congresswoman Karen Thurman is working on such a measure. If federal 
funds were available to remove financial disincentives to living 
donation, the superior graft survival rates associated with living 
donation would justify the expenditure. Furthermore, such payments are 
explicitly exempted from the prohibitions in Title III of the National 
Organ Transplant Act of 1984.
    There are other disincentives to living donation which are perhaps 
less well documented. For example, there is anecdotal information 
indicating that living donors may experience discrimination in 
obtaining health and life insurance. We need to determine the degree to 
which these are access problems and to explore ways to address these 
barriers.
    I would like to leave you with one final message. The availability 
of organs for transplantation would be enhanced if we could reduce the 
need for repeat transplants. At least one-eighth of cadaveric kidney 
transplant recipients have had a previous transplant and more than a 
fifth of the candidates for a kidney transplant have had one or more 
transplants already. One reason why transplant recipients lose their 
grafts is that they cannot afford to pay for anti-rejection drugs after 
Medicare payment for these drugs ceases three years post-transplant. 
The National Kidney Foundation emphatically supports H.R. 1115, that 
would extend these Medicare benefits indefinitely and which was 
referred to your committee on April 7, 1999.
    Mr. Chairman and Members of the Committee, I hope that our 
testimony has provided a new perspective on the problem of the supply 
of organs for transplantation in the United States. I would be pleased 
to answer any questions you may have or to provide any additional 
information that the committee may request. Thank you for the 
opportunity to testify here today.

    Mr. Bilirakis. Thank you so much, Mr. Brand.
    We have heard testimony this morning about a myriad of 
programs in effect in States to increase the supply of organs. 
We have heard testimony that there has been a lot of progress 
made, far from enough, to be sure, but progress has been made. 
We have heard testimony more recently from Mr. Brand and others 
about incentives for people to donate their kidneys, and some 
incentives in Pennsylvania and other States.
    Things are nowhere near where they should be, and there is 
a role that Congress should be playing. We have to figure out 
what that role is or what that role should be and take into 
consideration so many factors.
    I just worry that since there is progress, if we make any 
great changes in the current picture, what that might do. So 
the question is, if we were to move to a national waiting list 
system, which, as you know, the administration is proposing, 
would we be destroying the incentives that States have crafted 
policies to increase organ supplies? I think that is critical. 
We are concentrating now on finding ways to better that supply. 
But no matter what we come up with, if it is set back because 
we change the current system of allocation, then we are right 
back where we started from or maybe even worse off.
    Mr. Campbell, those of you who talked about what is 
happening in the particular States, if you have been in the 
audience when we have had organ allocation discussions, you 
know that I have raised that as my biggest concern about 
change. Florida, for instance, now has a pretty good record in 
this regard. The State would be conceivably losing its 
incentive to do even better if this national waiting system 
were to go into effect. I would like to hear from all of you. 
Yes, Dr. Miller?
    Mr. Miller. Congressman Bilirakis, I happen to agree with 
you. There are certain improvements and this will be the 
subject for an intense discussion tomorrow at the Institute of 
Medicine that Dr. Ronald Busuttil will be representing our 
Society, directing the largest liver transplant program in the 
United States. He is our President-elect.
    But there are certain problems that will be brought up with 
a national list that I think I can speak to that have to do 
with the disincentives that were not mentioned in the OPTN rule 
and they have to do with the fact that professionals in organ 
donation are very frequently motivated by local factors, by the 
success rate of their own transplant programs and those close 
to them, by the pressures put upon them by the transplant 
professionals in those centers. They get to know their own 
organ transplant potential recipients. They get to know them 
very well. There are these local factors that have to be taken 
into account. To nationalize this whole system is not to think 
of it in specifics but in generalities, and that is dangerous.
    Mr. Bilirakis. Thank you, sir. Any further comments, as 
briefly as you can because I would like to hear from as many of 
you as I can within my period of time. Mr. Campbell?
    Mr. Campbell. I would agree with Dr. Miller. A number of us 
have said this morning that organ donation is a local 
phenomenon. It is a community phenomenon, and to a large 
degree, it is a personal phenomenon. LifeLink definitely feels 
that a process such as has been contemplated of complete 
national sharing would be a disincentive to the kind of efforts 
that have increased organ donation so dramatically in the State 
of Florida.
    Mr. Bilirakis. Dr. Marcos, I know you are anxious to 
comment.
    Mr. Marcos. Yes. I think we are the living proof of what 
surgeons have to do to meet this shortage of organs. A program 
like ours, if new rules come around, will mean even less organs 
for our region. Doing a living donor liver is a major, major 
surgical procedure, putting a healthy donor at risk. So I speak 
for my program and I think that any changes, like you say, in 
the current allocation of organs might jeopardize at least the 
citizens in our State.
    Mr. Bilirakis. Thank you. Dr. Neylan, do you have any 
comment?
    Mr. Neylan. As I said in my testimony, I think the issues 
surrounding allocation are extremely difficult. This has been a 
deliberate process which has engaged the transplant community, 
broadly defined, and I think it is a process which has to 
continue in that manner.
    The allocation of this scarce resource for the various 
types of organs is far from perfect, but it is, nonetheless, 
the best system we have so far. We continue to look very 
carefully, all of us in every part of the country, to address 
the concerns that have been raised, concerns about inequities 
in waiting times, concerns about whether patients just across 
the river have a better access to an organ than on the other 
side of the river.
    These are very important issues, but these are issues that 
have to be entertained by the transplant community in 
partnership with the Federal Government, State government, and 
all the other parties that are a part of this process. So I 
would continue to reiterate, as I believe the others have said 
before me, that that process needs to go forward in that manner 
and that spirit.
    Mr. Bilirakis. Dr. Metzger?
    Mr. Metzger. Mr. Chairman, I could only second what Dr. 
Miller and Mr. Campbell said. In Florida, we have five of the 
most successful organ procurement organizations in the country 
and each of them developed with an individual transplant 
program, illustrating the successful efforts that can be made 
when that is a local issue and the programs are working 
together to provide the organs for their patients.
    Mr. Bilirakis. Mr. Nathan, I did not mean to skip you. I 
did not know whether you had anything to offer.
    Mr. Nathan. Well, those of us in the organ donor field feel 
very stressed by the fact that this has become a public issue, 
in that the whole system is based on public trust. The 
transplant community has, as Dr. Neylan said, really debated 
this in an imperative way. In other words, we get data, we look 
at it, and we relook at the allocation process. But to come in 
and sort of mandate a one-size-fits-all type of policy is very 
scary to those of us in the community, and I think secondarily, 
perhaps disrupting this public trust by publicizing this 
debate.
    Mr. Bilirakis. I appreciate the indulgence of the 
subcommittee. I have gone over my time, but this is really a 
very important point, I think, for all of us. I know, Dr. 
Higgins, you would like to be heard very briefly.
    Mr. Higgins. Just very briefly, in my opinion. We serve a 
large African-American community and we are concerned that any 
change in the allocation scheme which advantages local centers 
may, in fact, disadvantage African-Americans or socio-
economically disadvantaged people by sending organs away from 
local centers.
    So I think it is a real concern for us in Detroit. We 
transplant 20 percent of our patients, the recipients are 
African-American. They may not have access to adequate high-
quality transplant procedures if the organ allocation system 
shifts organs away from local medium-sized and small centers to 
large regional centers. I know that most of our patients could 
not get up and fly to a large center and be able to be on the 
list and sit there and wait. So I think it is a major issue 
from that standpoint.
    Mr. Bilirakis. Mr. Brand, do you have anything you want to 
offer?
    Mr. Brand. Yes, Mr. Chairman, if I might. Our organization 
represents both donors and transplant recipients and we 
recently polled them as to how they view this issue. 
Essentially, they prefer the local issue, the local option. We 
await the Institute of Medicine study on it, but that is the 
view of the people who----
    Mr. Bilirakis. I am not going to ask you to respond to 
this, but I have to wonder. You are all leaders in the field 
here and I know that there are others, too, who have different 
opinions. I just would hope that you have made your opinions 
known to the administration and particularly to your Members of 
Congress, your Representatives. That is just very critical 
because we can be spending so much time up here coming up with 
new ideas and then get actually set back rather than continue 
to go forward.
    Mr. Brown?
    Mr. Brown. Thank you. First, I would like to ask unanimous 
consent that the record be held open for written comments to 
the witnesses from any members and opening statements, and 
there is a statement, also, if I could make this request even 
longer, from Congressman Stark to be entered into the record.
    Mr. Bilirakis. Without objection.
    Mr. Brown. Thank you.
    [The prepared statement of Hon. Pete Stark follows:]
  Prepared Statement of Hon. Pete Stark, a Representative in Congress 
                      from the State of California
    Mr. Chairman, I wish to commend you for convening this essential 
hearing on organ donation and thank you for allowing me to enter this 
statement.
    As you are well aware, there is a serious shortage of viable organs 
for transplant. Over 50,000 people are currently waiting for a 
transplant operation. Because of low donor rates, over 4,000 people die 
each year for lack of a suitable organ.
    We need to use every possible means to increase the number of 
donated organs for all Americans. Earlier this year, I introduced the 
``Gift of Life Congressional Medal Act of 1999'' (H.R. 941). Senator 
Frist introduced the same legislation in the Senate. This legislation 
sends a clear message that donating one's organs is a selfless act that 
should receive the profound respect of the Nation.
    This legislation would allow the Health and Human Service's Organ 
Procurement Organization (OPO) and the Organ Procurement and 
Transplantation Network to establish a nonprofit fund to design, 
produce, and distribute the Gift of Life Congressional Medal. Funding 
would come solely from charitable donations.
    The donor or a surviving family member would have the option of 
receiving the medal.
    Families would also be able to request that a Member of Congress, 
state or local official, or community leader award the medal to the 
donor or donor's survivors.
    According to the United Network for Organ Sharing (UNOS), an 
average of 5,300 donations per year was made between 1994 and 1996. 
Research points to a clear need for incentive programs and public 
education on organ donation. These efforts can increase the number of 
organ donations by more than 80%.
    This legislation contributes one solution to a complex problem. 
Creating the Gift of Life Congressional Medal establishes in 
unambiguous terms the importance of organ donation. In addition, the 
medal represents this Nation's profound those who actions save the 
lives of others. By appropriately acknowledging the importance of organ 
donation, we anticipate greater levels of participation in donation 
programs. This noncontroversial, nonpartisan legislation will do much 
to increase organ donation. Therefore, I ask each of you to help 
support this legislation.
    I hope that your deliberations will be productive and identify 
additional ways of increasing the availability of organs for 
transplant.

    Mr. Brown. Mr. Nathan, you said something a moment ago 
about the government being involved in this. I would ask you 
just one question about that. Understanding that doctors and 
hospitals want to make these decisions but government pays for 
roughly half the cost, I believe nationally, of transplants, 
does the Louisiana State law, or the organ hoarding law that 
they have, disturb you as much as the Federal HHS getting 
involved in this issue?
    Mr. Nathan. Well, I do not want to comment necessarily on 
Louisiana. I do not know the state of that situation.
    Mr. Brown. But you do know that they have a State law that, 
as much as possible, keeps their organs in-State, although they 
do not seem to mind people in their State getting organs from 
other States.
    Mr. Nathan. Right. Just so you know, where I am coming from 
is that I represent a large regional program and we advocate 
sharing. The question that lies is to what extent. At what 
point do you share organs? In other words, is it for the 
sickest patient 3,000 miles away? Is it for someone who has 
been on the list an hour longer? These are sort of the problems 
that occur when you start trying to mandate a national sharing 
system. And I do not think many of us at the table are beyond 
sharing, because there are a lot of sharing systems. Florida, 
for example, has a State-wide sharing system.
    So my point is that I do not advocate State laws that keep 
organs within a State. I do not think that is a good policy, 
particularly one who works within three States. But I think the 
reality is that they are complex and the fear is that for the 
government to mandate a system, and knowing how long sometimes 
it takes for things to change, this is a very interactive 
process. It changes on a 6-month basis and the system may need 
to change quicker and respond to patients' needs quicker than 
perhaps some sort of policy like that. I think that is the fear 
that everybody at this table has.
    Mr. Brown. Okay.
    Mr. Nathan. Did that make sense to you?
    Mr. Brown. Yes, it makes sense. I think we temper that by 
understanding that taxpayers are paying for a lot of this and 
that our health care system, to sort of allow doctors and 
transplant centers and hospitals to sort of unilaterally make 
these decisions without some sort of public involvement is not 
right, either, and that we need to come to some understanding 
that there needs to be a consensus and a sharing there of 
decisionmaking.
    Mr. Nathan. I think I totally agree with that and I think 
the idea is that it is trying to build consensus, but it is a 
very difficult issue to mandate some sort of policy that may 
affect local programs. I think the biggest fear is not knowing 
the outcome.
    I have advocated--I actually wrote testimony last June to 
this subcommittee to basically say that I thought the best way 
to handle this is to suggest some changes and try a pilot 
program for 3 years and then look at the information, because 
one of the problems in modeling is you cannot feel the outcome. 
I think if people knew there was a limit to testing a new 
sharing procedure, that may help alleviate some fears.
    Mr. Brown. Okay. Dr. Metzger?
    Mr. Metzger. Congressman Brown, I would just like to make a 
comment regarding the taxpayers' payments. There is no doubt 
that if you increase sharing, you increase a number of things 
that increase cost. All of us voluntarily share when it is very 
appropriate to do so and beneficial for our patients and that 
has been an ongoing thing in transplantation.
    When you share across longer geographic areas, the cold 
ischemic time goes up dramatically, and Dr. Mark Schintzler, 
who you may want to get testimony from at some time, at Barnes 
Hospital in St. Louis has excellent data combining the USRDS 
and UNOS data systems, showing that for every hour of cold 
ischemic time, you increase the cost of transplantation for 
that patient $100 per year per patient life. So increasing cold 
ischemic time is very bad. Nationally right now, it is about 5 
hours' difference between local and sharing programs, and so 
that is $500 per patient per year in costs that the taxpayer 
has to pay when you go to a more nationwide sharing system.
    Mr. Brown. Let me shift. Can I have another couple of 
minutes, Mr. Chairman? That is a pretty quick 5 minutes.
    Mr. Bilirakis. Yes.
    Mr. Brown. Thank you. Dr. Marcos and Dr. Higgins, if I 
could ask you something totally off of what I just mentioned. I 
am sorry I did not hear your testimony, Dr. Marcos. I read your 
testimony. I had a high school group out in the hall that I had 
to talk to you. Both of you, and Dr. Higgins, you mentioned in 
your oral testimony about pediatric recipients and trimming 
down and splitting and what you can do with that. Could you, 
and I hate to make it this quick, but could you just sort of 
run through sort of what all of that means in terms of which 
kidneys you can do that and understanding difference in size 
with children and with adults? Could you kind of run through 
that briefly, each of you?
    Mr. Marcos. Yes. We are talking about livers. In the 
beginning, the problem was to get organs for pediatrics, for 
kids. So surgeons started cutting down livers to accommodate 
those small bodies and the rest of the liver was thrown out and 
wasted. Therefore, you are only benefiting one patient.
    Then this new technique, splitting the liver came, in which 
you cut the liver in two, you put the biggest part on the adult 
and then the smallest, because the liver is not a symmetrical 
organ, the smallest goes to another pediatric or very small 
adult. So that is splitting of organs. You are benefiting two 
recipients out of a single organ, though it is very hard to do. 
Maybe Dr. Busuttil, who has a lot of experience, is here today 
with us, but it is very hard to do and all the counties that we 
do it and maybe a community hospital in the middle of the 
night. But anyway, that solved that problem.
    Nowadays, it is the adult, the recipient that is suffering 
from the shortage of organs. The pediatric recipients are more 
or less covered, mostly from living donors. That is done in a 
lot of centers in America. Then came the idea of living donor 
from adult to adult in which you take a big portion of the 
liver, the right side, from a living donor to a recipient.
    So those are the three techniques that surgeons have been 
forced to, because if we had organs, we would rather take a 
cadaveric organ of the same size and put it into the recipient. 
We do not, so those are the three techniques that we presented 
or talked about today.
    Mr. Brown. Is there anything you want to add to that, or 
does that cover it?
    Mr. Higgins. That basically covers it, I think, but it is 
only for livers that this technique could theoretically be 
utilized. You cannot do it for the heart.
    Mr. Brown. Thank you.
    Mr. Bilirakis. Mrs. Cubin?
    Mrs. Cubin. Thank you, Mr. Chairman. I do have a statement 
to submit for the record.
    Mr. Bilirakis. Without objection, we have already gone 
through that.
    Mrs. Cubin. Thank you.
    I am married to a physician and probably have more 
experience in dealing, or at least in knowing about 
transplantation, both patients and donors, than a lot of 
people. As a matter of fact, when I was in the State 
legislature some 10 or 12 years ago, the very first month I was 
there, a woman came to the legislature with her 14-year-old 
daughter that needed a kidney transplant, asking the 
legislature to pay for that transplant because her daughter 
would die. That was a real eye opener. We checked into the 
number of people in Wyoming who were waiting for transplants. 
There were 17, and had we financed all of them, it would have 
literally bankrupted all at once our entire Medicaid budget. It 
was very difficult at that time.
    Having said that, it seems to me that, really, one of the 
biggest problems, or at least a big problem in getting an 
adequate number of organ donors is education, public education. 
I right now have no idea--I mean, I would be glad to give 
anybody anything I have got when I do not need it, but I have 
no idea if any of my organs, at my age, in my physical 
condition, would even be desirable to someone, and I think that 
a lot of people, once they get over the age of 40--I know you 
cannot believe I am over 40----
    Mr. Bilirakis. That is correct.
    Mrs. Cubin. Do not laugh. But I think a lot of people 
really do not know that. And so public education, in my mind, 
is very lacking as far as organ donors. Who do you think should 
be responsible for that public education, at what level? Should 
it be in the local community? I can see going into high 
schools, to colleges. My son when he was in high school said, 
``No way would I ever want any of my organs to be donated.'' 
Now he is in college and he says, ``Yes, that would be great.'' 
Who should take the lead in educating the public about organ 
donation? Dr. Miller?
    Mr. Miller. I have just a few comments. I totally empathize 
and sympathize with what you have just said. It is fascinating 
because the public in general believes that if they sign an 
organ donor card, that means that their organs are going to be 
taken. It is impossible to do. That is why we took it as an 
initiative to start this First Family Pledge campaign because 
it is a family to-family thing.
    But the educational process, if this is going to become 
part of the American culture, to be an automatic in our 
thinking, something very simple, we are organ donors, it has to 
be done from the lower school grades upwards. There has to be 
institution in our formal educational schooling that organ 
donation is part of what we do in life. That requires State, 
Federal, local. Who does it? Lots of people do it. Can it be 
better organized? You bet.
    Mrs. Cubin. Mr. Nathan?
    Mr. Nathan. That is a very good question because the answer 
is you have to do it all, and the concept of creating a 
Coalition on Donation, which represents both public and private 
organizations, is to get each of their organizations to promote 
organ and tissue donation. So the Federal Government has 
adopted the Coalition on Donations ``share your life, share 
your decision'' initiative. The Coalition has partnered with 
the Ad Council to do public service announcements. Michael 
Jordan volunteered his image to reach children and sports fans.
    So the answer is, you have to put the message in every 
level of society. Some State programs, for example, like in 
Pennsylvania, where I am from, we are putting the message into 
secondary schools, so that we are taking some of these creative 
tools that were created by these national groups and then 
implementing them at the local level. So it is a top-down, 
bottom-up approach.
    Mrs. Cubin. Just to get my opinion on the record about the 
national waiting list, I know in all the communities in 
Wyoming, if someone thinks that their organ or their family's 
organ will go to someone in the Rocky Mountain State, they are 
much more likely to help their neighbor or someone in their 
community. They are much more likely to go that far than to 
think that it might go someplace in New York, because, you 
know, if you are from Wyoming, you think everybody from New 
York is a little weird anyway. You are not even sure your liver 
would fit.
    I have one question. This is just curiosity. When you are 
talking about dividing a liver between an adult and a child and 
the smaller portion being transplanted into the child, then 
does that liver grow with the child as the child grows?
    Mr. Marcos. Yes. And, actually, in adults, too, we have 
proven that within around 7 to 14 days after transplant, the 
liver grows back to the full size, which makes living donation 
of livers such an important fact. If you donate a kidney from a 
living donor, the kidney does not grow back. The liver does, 
and it does pretty fast, and as those kids you saw this 
morning, today, it will grow with them. It is a wonderful 
organ.
    Mrs. Cubin. And how about the pancreas?
    Mr. Marcos. There has been some experience with living 
donor pancreas, though that has not been well established. The 
organs usually do not increase in size. The kidneys do suffer 
some hypertrophy in function but do not do the same phenomenon 
as livers do.
    Mr. Miller. You are really dealing with a very dynamic 
field here. Things have even changed in the past few years. 
There is so much in the way of scientific or medical advances. 
When you ask a question about can a pancreas increase in size, 
what one is dealing with in a pancreas is transplantation to 
replace the need for insulin in diabetics, which is such a 
devastating disease.
    There are ways now of culturing the islets of langerhans, 
which make insulin. There are ways perhaps of even introducing 
growth factors into this culture so that these cells can 
enlarge and proliferate. This is all dynamic. Were you to ask 
this question 3 or 4 years from now, you would probably get a 
different answer.
    Mrs. Cubin. Thank you, Mr. Chairman.
    Mr. Brown. Mr. Chairman, I would like to just comment. I 
was saying to the chairman, and this may sound a bit 
inappropriate, but my friend from Wyoming saying that a Wyoming 
person may not be so predisposed toward donating an organ to 
someone from New York, would someone from Wyoming be happy to 
receive an organ from someone in New York if it came to that? I 
just am not sure I believe----
    Mrs. Cubin. I did not say that they would not want to do 
that. I am saying that they would be more likely to want to 
give it to someone if they thought it would be in their 
community, in their area, that there would be an emotional 
desire, just a feeling of community.
    You know, I am absolutely convinced that the old barn 
raising mentality that we still have in the West, where 
neighbors help neighbors, people in communities build 
communities instead of having the government do it. I am 
absolutely convinced that that is what will save this country, 
and I think it is that attitude.
    You start with your family, your city, your county, your 
State, and you go out as far as you can and be as generous as 
you can with the resources that you have. But I just think 
instinctively that if I knew or if someone knew it was going to 
go to someone in their area, they would be more likely to do 
it, thus having more organs available. But certainly the 
country is part of our community, and I did not mean to be 
disparaging that way.
    Mr. Brown. No. I----
    Mrs. Cubin. I just think it is more likely that people 
would donate if they thought it would go to their community.
    Mr. Brown. Do you think that is largely regional or part 
racial or do you think that going to Cheyenne is okay, but 
Denver is not, or Chicago is too far, or----
    Mrs. Cubin. I think it has something to do with--pardon me?
    Mr. Brown. Cheyenne is okay if you live in Casper, but 
Denver is not, or maybe Denver is and Chicago is not?
    Mrs. Cubin. No. No. I think anyplace in the Rocky Mountain 
region. It depends at how big you look at your community. But 
it does not matter if you live in Casper and the organ is 
needed in Cheyenne or Denver or New York if the donor is not 
going to give it. It does not matter.
    Mr. Bilirakis. Mr. Greenwood?
    Mr. Greenwood. Thank you. One thing we would never want to 
see is a Republican organ donated to a Democrat. That would be 
beyond the pale. I think we should separate them that way 
first.
    First off, I apologize for being absent for some of your 
testimony. One of the rites of spring here in Washington is 
that the school groups come down and they expect you to go see 
them, and so Mr. Brown and I, at least, and others have to run 
out and do that from time to time.
    But it was illustrative as I was talking to the students 
about what I do and I was telling them that I was at a 
committee hearing about organ donation and I tried to outline 
the problem a little bit to them, three interesting responses. 
One student said, well, is it not true that if you sign up as 
an organ donor, they will not save your life in the hospital? 
So I tried to disabuse her of that information. Then one of the 
fathers proudly pulled out his Pennsylvania driver's license 
and showed that he was an organ donor. Then one of the students 
said, well, they wanted an extra dollar to do that and I did 
not have the dollar so I did not sign up to be an organ donor.
    That raises the issue of we know, and we have known for a 
long time that there is this tremendous differential between 
the demand and the supply of organs. We have tried a variety of 
things, and you gentlemen have all been terrific at making your 
recommendations and I have looked at your testimony.
    The question of financial incentives has always been sort 
of a very hard, bright ethical line that is drawn, that you do 
not want to tie any financial incentives, to create an 
incentive using financial means. And yet there has been some 
inching across of that line. In Pennsylvania, as I mentioned, I 
think that with the $1 that goes to the driver's license, there 
is a fund, and now we pay $300 toward the funeral arrangements 
for a donor. I do not know if anybody has ever donated an organ 
for the $300 that might go to their funeral. I would be 
surprised, but maybe they do.
    When HCFA creates a condition of participation in Medicare 
and Medicaid, that is a huge financial incentive. I mean, make 
no mistake about it, you will do this or we will withhold maybe 
millions of dollars from you. So that is certainly the use of a 
financial incentive.
    As I mentioned in my opening statement, my constituent, Mr. 
Epstein, who has been sitting patiently here, he believes that 
what we should do is that the Federal Government should, as a 
matter of law, essentially create an insurance policy, in his 
proposal, $10,000, that would go to the family of anyone who 
donated their organs. He thinks that that is benign, that no 
harm can come from that and that, in fact, a tremendous good 
could come of that, that that would be the level of financial 
incentive that would wake a lot of people up and say, hey, 
$10,000 to my family is a significant chunk of money. He 
believes that if the Federal Government were involved in that 
kind of a financial incentive program that, in fact, we would 
save a lot of money because we would save a lot of payments of 
Medicaid and perhaps Medicare payments that are made to 
hospitals for people who wait for organs.
    I would like each of you in the time that remains to give 
me your thoughts about financial incentives in general or the 
specific program that I have set forth in specific. Just jump 
in. I will start with my regional guy, Mr. Nathan.
    Mr. Nathan. It is good to see you. You know, when this was 
proposed in Pennsylvania in 1994, it sort of had no debate at 
all. I mean, it just sort of snuck through to become law and it 
has taken this much time to buildup these funds to this point 
where we can just give this nominal amount of money toward 
funeral expenses. It was really directed by a legislator who 
came to the point where families that he knew felt that they 
would not have money to bury someone and if there were a 
donation involved, an organ donation, maybe there was a way for 
them to benefit. It was a very sort of innocent thing that was 
thrown in at the last hour in this law.
    What is interesting about it, when this hit the newspapers 
yesterday, we had calls from all over the country because it is 
a novel idea. The biggest fear, I think, that transplanters 
have, and there are certainly a lot of people at the table who 
can comment, is crossing that line from true altruism--it has 
always been called the gift of life--to that which folks 
concerned that organs, would be bought and sold, in essence.
    That is not the idea here. I do not think it is Mr. 
Epstein's idea to do that, either. The idea is for folks to 
have some small benefit, and again, I do not know how large 
that benefit should be, whether it is Mr. Epstein's plan or 
whether it is this small funeral expense. I do not know.
    The reason why I think the question has to be asked is 
because we have never answered the question, and that is why 
this pilot program, I think, will be very important, to 
determine if it has any influence not only on donors but people 
who did not donate, to see if it had any fact at all in their 
decision.
    So I think the question has been asked and now it is going 
to be tested. Certainly, other people can comment on the 
rationale behind not wanting it in the transplant community.
    Mr. Greenwood. Mr. Brand?
    Mr. Brand. We have looked at this issue with our 
constituents and the bottom line is, we would support at least 
a pilot study on financial incentives. When I became the 
volunteer Chairman of the National Kidney Foundation 18 months 
ago, I convened a group of outside business people and said, 
here is the problem. Cadaveric donations are flat. Demand is 
going like this. We have been in this business 50 years. One of 
our mandates has been public education. Guess what? If we were 
in business, we would have to commit bankruptcy right now 
because we just have not changed the numbers. I have not heard 
a bad idea here today. Every one of these ideas is a very good 
idea, I think. The problem is implementation.
    What we decided was we had to focus. We had to raise a pile 
of money, set up a foundation within our foundation focused 
only on changing the numbers. We are committing to do that in 5 
years. We are trying to raise $25 million to implement a lot of 
the programs. The Pennsylvania law that Dr. Nathan has talked 
about has been now transplanted itself to Maryland, Texas, 
elsewhere. It certainly is working. We ought to have a model 
law for all 50 States doing that. Financial incentives, if we 
have any data that says they are working, we ought to try them 
elsewhere. So we certainly would support that.
    Mr. Greenwood. Thank you.
    Mr. Neylan. I would like to speak to that, as well. I guess 
partly from my scientific training, I look at the idea of 
piloting as a natural methodology, that, indeed, as we take on 
these new ideas, we should test them, and we should test them 
in a small and controlled fashion. That is No. 1.
    But two, after we have tested them, let us look at them 
critically and let us compare them with other experiments. If 
there is good news there, let us expand it. Let us support it 
and let us develop it further.
    The Pennsylvania law of $1 going to a fund--great idea. 
Georgia took a slightly different idea. They said, let us take 
$2 off. Anyone that wants to be an organ donor can get their 
renewed driver's license for $2 less. That is the same thing, 
really. The State is still supporting this financially. It 
sends a good message. It is early. We cannot really speak to 
the results yet. But it is a pilot and we are looking at it. We 
need to learn from these things.
    I think our message today ought to be that we need to be 
creative in the approach to organ donation. We need to be open, 
even to the idea of financial incentives, but it needs to be 
done carefully.
    Relating to financial incentives, let us turn that on its 
ear. What about disincentives? Again, in my testimony, I 
mentioned our support of Congressman Cummings' bill which would 
extend the Federal leave for Federal employees who are organ 
donors. There is a real financial disincentive to being a 
living donor. As Mr. Brand has suggested, if we can do more to 
remove those disincentives, we will also, I believe, encourage 
perhaps one of the most effective and cost effective means of 
increasing organ donation today, that is, increasing the living 
donors.
    Mr. Bilirakis. Very briefly, Dr. Miller. I do not mean to 
cut you off, but we need to wrap up.
    Mr. Miller. The only point I wanted to make was that we are 
again dealing within a changing world. If you would have asked 
this question 25 years ago when transplantation was still in 
its heyday, it would have been an absolute no. The ethics would 
have forbidden it. Well, I do not know if ethics change, but 
somehow or other culture and outlooks change, and now we know 
that it is better for our society to have more organ donors.
    So I would echo everything that has been spoken here, but I 
think you have got to look at this again and again and again, 
and that is why something that is just going to be stamped as a 
great leveling, as a generalization, cannot be written in 
stone. It has got to be continuously reexamined, and that is 
what all of us are doing.
    Mr. Greenwood. Thank you all.
    Mr. Bilirakis. Dr. Coburn?
    Mr. Coburn. Mr. Chairman, I have nine questions and there 
is no way I am going to get all these gentlemen to answer them. 
I would like permission to submit those and ask if you would 
please answer in writing these questions that I have. They have 
to deal with local transplant sites, they have to do with organ 
availability, they have to do with the new Federal guidelines, 
and I would like your expert opinion on each of them.
    Mr. Bilirakis. Yes. We always ask the panel if they are 
willing to receive written questions and respond in writing. 
You have nothing else at this point?
    Mr. Coburn. No.
    Mr. Bilirakis. I guess that finishes up. This is a 
fascinating subject, a very, very significant one, obviously. 
It is life or death. I was just telling Mr. Brown a few minutes 
ago how I just wish we could focus on things up here, but you 
do not have that kind of a luxury, unfortunately. You have got 
to go from one problem to another to another to another.
    Your being here today has been a tremendous help and I 
would request that you not only, of course, be available to 
answer written questions in writing, but additionally, if you 
have anything additional you want to offer us, additional ideas 
on how maybe we can attack this problem in addition to what you 
have already told us, which has been so valuable, please do not 
hesitate. We would be very receptive to it.
    Thank you so very much for being here. God bless you for 
your great work.
    The subcommittee is adjourned.
    [Whereupon, at 12:15 p.m., the subcommittee was adjourned.]
    [Additional material submitted for the record follows:]
                Prepared Statement of Hoffmann-La Roche
    In recent years, demand for organs has increased as the medical 
community has developed new and better ways to treat transplant 
patients. However, organ donation rates have not kept pace with demand, 
leading to a national shortage of organs available for donation. 
According to UNOS, there has been no change in donation rates between 
1996 and 1998. At the same time, the number of individuals on the organ 
waiting list increased by 13 percent between 1996 and 1997. More than 
4,000 patients died while on the waiting list in 1997. As of June 1998, 
56,222 individuals were awaiting an organ. Of the 2.1 million people 
who die in the U.S. each year, 12,000-15,000 could potentially be organ 
donors.
    The causes of the organ shortage are multiple and varied. Barriers 
to donation include public misconception regarding the donation process 
and the definition of brain death, and the failure of potential donors 
to communicate their wishes to their families. A 1993 Gallup Survey 
sponsored by the Harvard School of Public Health, the Partnership for 
Organ Donation and 17 Organ Procurement Organizations (OPOs) showed 
that the majority of those polled would donate a relative's organs if 
they knew of the individual's wish to be a donor. However, relatively 
few individuals have informed their families of their desire to be a 
donor. It is for this reason that Roche supports the American Society 
of Transplant Surgeons (ASTS) First Family Pledge. This effort to 
encourage community leaders, such as members of Congress, to commit to 
be an organ donor and to discuss this commitment with their families 
can only serve to raise the issue of organ donation and the importance 
of sharing one's wishes.
    A related barrier is that hospital workers are not often trained in 
the sensitivities needed when approaching grieving families about 
donation. Unless the families of potential donors are approached in a 
sensitive, caring way, they will be more likely to reject the donation 
option. The Department of Health and Human Services (HHS) issued a rule 
on June 17, 1998 requiring that all individuals in a hospital setting 
requesting organ donation be trained through a certified program 
administered by their local OPO. In addition, the rule requires 
hospitals participating in the Medicare program to report all deaths 
and impending deaths to the OPOs and eye/tissue banks. This rule is 
modeled after legislation enacted in Pennsylvania, which state 
officials estimate has increased organ donation rates in the state by 
40 percent. HHS officials hope that the new rule will increase organ 
donation rates by 20 percent nationally. However, under current law 
hospitals participating in Medicare are already required to inform all 
families of the organ donation option. Some transplant experts believe 
that, unless HHS actively enforces this new rule, hospitals simply will 
not comply with the requirement. In addition, merely complying with the 
requirement does not ensure that appropriate techniques will be 
employed. A commitment on the part of hospitals and adequate training 
of personnel are essential to realization of this goal.
    Another barrier to donation is individuals' misconception of their 
church's attitude toward organ donation. Many people believe that their 
faith opposes organ donation. However, a recent publication by UNOS and 
the South-Eastern Organ Procurement Foundation (SEOPF) shows that the 
major U.S. religious denominations either support organ donation or 
leave the decision to the individual.
    These varied issues suggest that numerous initiatives need to be 
developed to try to increase the supply of organs for transplant. In 
addition, mechanisms for measuring the effectiveness of these 
initiatives should be developed. This is important for the purpose of 
justifying the expenses associated with efforts to increase donation 
and for the purpose of duplicating and expanding these initiatives. For 
example, numerous States and OPOs have developed innovative strategies 
for increasing organ donation, but in some cases there have been 
implementation problems or a failure to duplicate successful programs.
    Not only are innovative efforts to increase donation needed, but we 
must caution against actions which could inadvertently result in fewer 
donations. One such issue is the recent HHS rule regarding the 
allocation of organs. Organ allocation is a uniquely complex matter, 
encompassing medical, economic and ethical issues. Given this 
complexity, we urge that any proposal affecting the current allocation 
system be grounded in the patient's best interest. Accordingly, the 
transplant community should be full participants in any decisions 
regarding the allocation of organs. Ultimately, it is the 
transplantation community, patients and their families that truly can 
make the most equitable determination regarding the distribution of the 
short supply of organs.
    The Institute of Medicine (IOM) has been directed by Congress to 
examine both the current Organ Procurement and Transplantation Network 
(OPTN) policies and the HHS rule. The IOM must evaluate the impact of 
the OPTN policies and the HHS rule on: access to transplantation 
services by low-income and minority populations, organ donation rates, 
the ability of OPOs to sustain donation rates, waiting times for organ 
transplants, patient survival, and the cost of transplantation 
services. Further action on this issue should await the IOM report and 
recommendations. We look forward to the IOM analysis.
    In addition to expanding organ donation, efforts must be taken to 
maximize the quality of life of individuals who have received a 
transplant. Currently, Medicare covers immunosuppressives, following a 
Medicare-covered transplant, for three years. In 1986, Congress enacted 
Part B coverage of immunosuppressives for one year. The Omnibus Budget 
Reconciliation Act of 1993 (OBRA 93), extended this coverage to three 
years. Transplant recipients must take immunosuppressive medication 
every day for the rest of their lives. Failure to take these 
medications significantly increases the risk of the transplanted organ 
being rejected. According the United States Renal Data System, Medicare 
spending for dialysis patients average $49,000 per year. First-year 
expenses associated with a kidney transplant average more than 
$100,000. Medicare pays for the majority of kidney transplants 
performed in the country (more than 8,000 of the approximately 11,000 
in 1995, according to HCFA). Elimination of the time limitation for 
immunosuppressive coverage will further protect this enormous 
investment already made by Medicare.
    Transplant recipients have faced an anxious ordeal as their disease 
progressed and they waited for a suitable donor organ. These 
individuals should not have to experience the ordeal of how to pay for 
their medications in order to sustain their organ and lead a productive 
life. Successful transplants are important not only to the recipients 
but to donor families as well. Taking efforts to ensure that transplant 
recipients lead long and productive lives with their new organs 
recognizes the generosity of those donors and their families who have 
given the gift of life. The inability of transplant recipients to 
maintain their organs, resulting in multiple transplants, could 
negatively impact the effort to increase organ donation.
    For all these reasons, Hoffmann-La Roche is one of the founding 
members of the Immunosuppressive Drugs Coverage Coalition whose goal is 
to support legislation to eliminate the three-year limit on Medicare 
coverage of immunosuppressive drugs. The Coalition strongly supports 
legislation introduced in the House by Representatives Canady (R-FL) 
and Thurman (D-FL), H.R. 1115, and legislation introduced in the Senate 
by Senator DeWine (R-OH), S. 631. We encourage the Committee to pass 
this legislation this year.
    Roche is a leading research-intensive pharmaceutical company that 
discovers, develops, manufactures and markets numerous prescription 
drugs that improve, prolong and save the lives of patients with serious 
illnesses. Transplantation is among the company's many areas of 
therapeutic interest. Roche provides a wide range of medications 
through its marketing and sales subsidiary, Roche Laboratories Inc.
    We look forward to working with Congress, the Administration, and 
the transplant community to increase organ donation rates.
                                 ______
                                 
                                                  TransLife
                                                        May 5, 1999
The Honorable Michael Bilirakis
Chairman
Subcommittee on Health and Environment
Committee on Commerce
U.S. House of Representatives
Room 2125, Rayburn House Office Building
Washington, D.C. 20515-6115
    Dear Congressman Bilirakis: It was my pleasure to offer testimony 
on improving the supply of organs for transplantation to your 
subcommittee on April 15, 1999. I will now take the opportunity to 
respond to the questions in your letter of April 25,1999.
    Question 1. At the hearing, witnesses testified about numerous 
state programs to increase organ supplies. If Congress were to move to 
a national waiting list system, how would that impact existing state 
policies designed to increase organ supplies?
    Response 1. The Florida Statewide Coalition on Donation, a 
subsidiary of the National Coalition on Donation, was formed to 
coordinate public education and statewide public service announcements 
promoting organ donation. The Florida legislature provided some funding 
for this. Other states are also organizing similar efforts, and like 
Florida, are funding electronic donor registries within their states. 
Local OPOs provide the Coalition with the personnel and energy to move 
forward with these campaigns. Many of the participants are local 
recipients and donor family members and bring a community effort to the 
programs. Many of us feel that this community identity does enhance 
donation and the effort our staffs put forward on its behalf. A 
movement to a national waiting list could dampen this enthusiasm and 
lead to fewer donations.
    Question 2. Pennsylvania has instituted a program that pays 
families of organ donors $300 in state contributions for the donor's 
funeral expenses, starting this July. What is your opinion on this type 
of program?
    Response 2. The Pennsylvania initiative to contribute $300 to 
funeral expenses for the donor explores the issue of financial 
incentives and I support it as a pilot study addressing this issue. 
Pilot studies evaluating other incentives such as a paid up insurance 
policy should also be evaluated. However, a careful analysis of these 
studies should be done before extending this to the entire donor 
network. My personal feeling is that financial incentives will be 
beneficial but only in special subgroups of the population.
    Question 3. The proposed HHS regulations to reallocate organs state 
that ``the OPTN is required to develop equitable allocation policies 
that provide organs to those with the greatest medical urgency, in 
accordance with sound medical judgment.'' When President Clinton signed 
H.R. 3579, the Supplemental Appropriations and Rescissions Act, on May 
1, 1998, which extended the public comment period and implementation 
deadline for the HHS OPTN regulations, he issued a written statement in 
opposition to extending the comment period on the rule. In stating his 
reasons for opposing the extension, President Clinton stated that ``The 
final rule would ensure that organs are allocated to the sickest 
candidates first.'' What would be the supply-side effects of a policy 
where organs were to be allocated to ``the sickest candidates first''?
    Response 3. UNOS modeling of a ``sicker patient first'' policy 
indicates that more organs would be wasted and fewer patients 
transplanted with poorer overall results. Unfortunately, sicker 
patients are more likely to die or lose their transplants to post 
operative complications. My experience in the private practice of 
medicine for over 25 years, taught me early on that I couldn't ``cure'' 
everyone; that, unfortunately, not everyone would ever have equal 
access to medical care, and one had to learn to deal with ``the hand 
you were dealt''. It is, and always will be, an imperfect world.
    Question 4. How do we increase the consent rates for families to 
donate organs? What recommendation would you offer to increase the 
number of individuals willing to donate their organs?
    Response 4. Only hard work and more understanding of the ``consent 
process'' will resolve this problem. Fortunately, some scientific 
approaches are now underway to do so. UNOS has a study to look at 
several procurement coordinators who have exceptionally high consent 
rates and to try to identify the characteristics that make them 
successful. Hopefully, these traits can be transferred to others. The 
Southeastern Organ Procurement Foundation (SEOPF) has a study 
evaluating the process (called the trans-theoretical model of behavior 
modification) that moves someone along the path of making a positive 
response to donation. We should have some outcome data in 12-18 months.
    Question 5. In your estimation, how would the Department of Health 
and Human Services regulations published April 2, 1998, affect your 
patients and your ability to provide the highest quality of medical 
care for them? What impact will this rule have on local access to 
transplant services nationwide?
    Response 5. The Health and Human Services rule that would mandate 
``broader'' sharing would result in increased waiting times for Florida 
recipients as our patients currently have shorter waiting times when 
compared to the national averages. This could potentially lead to 
further deterioration in their health prior to transplantation. Local 
access to local organs, the optimal transplant situation, would occur 
less frequently.
    Question 6. Could you please explain to the Committee why some 
areas of the country have much higher rates of organ donation than 
others?
    Response 6. As mentioned in my written testimony, differences in 
population demographics may play a role in the variations in organ 
donation in some areas of the country. If an area has a high population 
of the elderly; of HIV positive individuals or other transmissible 
diseases (hepatitis, cancer); or minorities, who consent less 
frequently; donation rates /million population will be low. Some OPOs, 
though, may be inefficient due to inadequate budgeting for donation 
activities or have ineffective personnel. We won't know this until we 
can confidently measure an OPOs true donor potential and compare it to 
their actual donation rates.
    Question 7. As you know, the Department of Health and Human 
Services regulations have created quite an intense debate about the 
allocation of organs for transplantation. Some suggest, however, that 
the debate would be more constructive if it revolved around organ 
donation instead. What is your opinion?
    Response 7. I believe too much energy is being expended on the 
allocation issues and more needs to be focused on donation. In some 
OPOs, some transplant programs put little, if any, effort on the 
donation side. Often the recipient's attending physician is the one 
most critical of allocation discrepancies but feels ``too busy'' to get 
involved in activities to increase donation. That is not to say that 
allocation issues aren't real, but increasing the supply of donor 
organs can only solve it.
    Question 8. As the number of transplant programs across the country 
has grown, has the number of transplant procedures grown also? Can you 
elaborate on the estimated number of procedures which will be performed 
within the next five years?
    Response 8. The opening of new transplant programs does seem to 
increase donation activity and enthusiasm in those local areas. 
However, only if actual donation increases, does the number of 
transplants increase. Otherwise, one simply changes the address for the 
transplant. We have seen an increase in transplant programs and an 
increase in transplant procedures this past decade but many factors 
came into play such as medical advances (splitting organs, unrelated 
living donors, and expanded donors) that cloud the issue in this 
relationship. Optimistically, I am hoping for an annual 10% increase in 
the number of transplants per year over the next 5 years. This is based 
on increasing the consent rate for donation and improving the 
efficiency of the various OPOs.
    Question 9. In your opinion, does an active local transplant 
program stimulate organ donation?
    Response 9. Yes. It definitely increases local awareness and 
donation activities as mentioned above. The local procurement staffs 
may also be more enthusiastic when they can see the results of their 
difficult labor expressed in transplant recipients they can both see 
and touch. After all, they have the most difficult job in this 
profession.
    Question 10. What would you define as an appropriate role for the 
federal government in the formulation of transplant policy?
    Response 10. The federal government, in its role of oversight of 
the Organ and Transplant Network, should strive to be responsive to the 
needs of the transplant community. It should assure that a democratic 
process that includes all members of the transplant community, 
including recipient and donor families, is utilized in the rule making 
for the OPTN. It should be in the forefront of passing legislation that 
will provide adequate funding for the OPTN and its policies as well as 
demonstrating that the federal government strongly supports organ 
donation as a proper behavior for all its citizens.
    Question 11. Your written testimony stated that there were 4,100 
living donors last year, up from 3,905 the previous year and 3,690 the 
year before that. To what do you ascribe the increase?
    Response 11. The increase seen in living donation is related to 
several factors. The improved results in these kidney recipients versus 
cadaver transplants have prompted more transplant professionals to 
emphasize living donation. New surgical techniques for segmental lung 
and liver transplants have added these organs to the pool in some 
centers. The expansion of living donation to the biologically unrelated 
donor (spouses, friends, and now, altruistically motivated strangers) 
has made the biggest impact; especially in kidney transplants.
    Question 12. How long is the recovery for a living donor? Are there 
new surgical procedures that cut the recovery time? How might this 
affect supplies of organs?
    Response 12. Using the standard donor operation, most donors are 
out of the hospital in 4-5 days, driving a car in 2-3 weeks and 
returning to work in 3-6 weeks, depending on the job. New procedures, 
although a little more risky and difficult, utilizing laproscopic 
techniques, allow the donor to return home in 48 hours and return to 
work in 1-2 weeks. As this technique is more broadly utilized, it could 
attract donors who previously feared the standard procedure and could 
not afford the costs and the time to donate. Its impact is unknown but 
could be substantial. It does require extra training and experience for 
the surgeons to master this technique.
    Question 13. How do these patients handle the loss of income in 
that time period? Are you aware of any companies or insurance policy 
that would help compensate for this time lost from a job?
    Response 13. Most living donors save up their vacation time to 
cover the time away from work. A small number may have short-term 
disability plans at work. Often other members of the extended family 
will contribute financially to help out. Many just suffer the loss and 
take gratification from their sacrifice. I am not aware of any 
insurance plans, other than an occasional short-term disability policy, 
that covers the donor's economic losses. Most don't even cover the 
medical costs but Medicare or the recipient's insurer then will.
    Question 14. In your testimony, you indicated that the current OPO 
certification process distracts OPOs from actually increasing their 
organ supplies. Can you elaborate on that comment? Can you recommend an 
alternative regulatory approach which accurately measures an OPOs 
performance, yet allows it to maintain its focus on increasing organ 
supplies?
    Response 14. The current certification process with its 2 year 
cycle, no due process or corrective action plans allowed and based on 
questionable performance criteria, pressures many OPOs to focus on the 
certification process itself rather than activities and methods to 
increase donation. Rather than worrying if their jobs still exist, the 
personnel can be evaluating and implementing activities that would 
improve their performance and increase donation.
    This past year, HCFA promulgated new rules mandating hospitals to 
work more closely with OPOs. This development promises to make a 
significant positive impact on organ donation across the nation. The 
time has never been better to focus the energies of the organ 
procurement community and others to increasing organ availability, and 
not be distracted by certification processes that tend to be more 
disruptive than supportive or valid for promoting OPO effectiveness and 
holding them accountable.
    The current do-or-die certification process, based on flawed 
population measures, distracts OPOs forced to compete under an 
imperfect grading system, with no guarantee of a fair appraisal based 
on individual improvement in effectiveness. It is impossible for OPOs 
not to be distracted when their future may largely be determined by 
events out of their control.
    HCFA should currently extend the certification of all OPOs while 
still monitoring performance using the current standards in order to 
provide data to OPOs on relative performance. During the extension, a 
collaborative industry-government examination of alternative OPO 
performance measures should be conducted. All parties should agree upon 
the new process, one similar to that for hospital accreditation. The 
certification cycle should be 4 years, have a mechanism for responding 
to and correcting perceived deficiencies, and performance should be 
measured on the basis of actual donation rates compared to the number 
of potential donors measured from that service area. This alternative 
to the current approach would provide a more supportive framework for 
promoting organ donation and focus OPO efforts more directly on 
individual improvement.
    Question 15. In your oral testimony, you mentioned a study by Dr. 
Mark Schintler of Washington University in St. Louis which indicated 
that every hour of cold ischemic time increases patient costs by $100 
per year. Can you please provide a copy of that study for the record? 
What implications does this study have for a national system of organ 
allocation?
    Response 15. I have enclosed with this response, a pre-publication 
copy of Dr. Mark Schintzler's economic analysis of the allocation 
process, ``The Economics of HLA Matching in Cadaveric Renal 
Transplantation'' that he has co-authored with others. His address and 
phone number are included on the title page. His data indicate that a 
broader shipping of organs to the ``sicker patients'' resulting in 
longer cold ischemic times before the organs are transplanted would be 
more expensive and produce poorer results. A worse case scenario would 
occur if no attempt were made to place the organs to the ``best'' match 
but simply to the sickest patient regardless of matching. His analysis 
suggests that the local transplantation of organs allowing shorter cold 
ischemic times along with an algorithm that would provide for better 
local matches would be optimal. His analysis only evaluates kidney 
transplants at this time but some of his principles will likely relate 
to the other organs also.
    Again, I would like to thank you for the privilege of testifying 
before your Subcommittee and for the opportunity to provide this 
additional response.
            Sincerely,
                                    Robert A. Metzger, M.D.
                                                   Medical Director
                                 ______
                                 
                                        LifeLink Foundation
                                                        May 4, 1999
Michael Bilirakis
Chairman
Subcommittee on Health and Environment
U.S. House of Representatives
Committee on Commerce
Room 2125, Rayburn House Office Building
Washington, D.C. 20515-6115
    Dear Mr. Chairman: Thank you for your leadership in addressing the 
proposed changes to our nation's organ allocation system. We are very 
appreciative of your efforts. Enclosed are my responses to the 
questions that resulted from the April 15, 1999 hearing, ``Putting 
Patients First: Increasing Organ Supply for Transplantation.'' Again, 
thank you for the opportunity to testify about LifeLink's success.
    Question 1. At the hearing, witnesses testified about numerous 
state programs to increase organ supplies. If Congress were to move to 
a national waiting list system, how would that impact existing state 
policies designed to increase organ supplies?
    Response. Florida's success has come about because of dedicated 
work by organ procurement agencies, and by the state in promoting and 
regulating organ and tissue donation, at great cost to the state and 
the local organ and tissue donation centers. Florida has enacted 
numerous statutes to support this work. For example: creating oversight 
by The Florida Statewide Organ and Tissue Procurement Advisory Board; 
regulating organ and tissue procurement agencies; establishing an organ 
donor registry tied to the Department of Motor Vehicles driver license 
program, which registry can be accessed by hospitals and Organ 
Procurement Agencies (``OPOs''); enacting an unusual version of the 
Uniform Anatomical Gift Act, which allows OPOs to approach the courts 
in cases which do not fit the traditional family model for consent; and 
other laws. This state work, in partnership with the independent 
efforts of Florida Hospitals and OPOs, has produced a level of organ 
donation in Florida that is the highest in the nation. It is also 
dramatically higher than the level of donation in most other places.
    The State of Florida, during the 1998 Legislative Session, passed a 
law mandating that organs recovered in the State should be offered to 
transplant centers in Florida with potential recipients who would 
benefit from the organ first. Essentially, generous Floridians who 
consent to organ donation would benefit other Floridians first, keeping 
them healthy, and getting them back to work when appropriate. If a 
national waiting list were implemented, preemption of State law would 
occur, thus ignoring the will of the people of Florida, and sending a 
precious gift to out-of-state transplant centers which have not worked 
to develop the donation system in their state. Even so, it is important 
to note that Florida already supplies a very large number of organs to 
other states under this current system, a large number of organs which 
are available for export because of the work of the State and the 
people of Florida.
    Question 2. Pennsylvania has instituted a program that pays 
families of organ donors $300 in state contributions for the donor's 
funeral expenses, starting this July. What is your opinion on this type 
of program?
    Response. We believe this will provide the organ donation and 
transplantation community an opportunity to view Pennsylvania as a 
pilot state for the rest of the nation. We will have the opportunity to 
observe their results, and determine if the stipend for funeral 
expenses caused an increase in organ donation. If rates of donation 
increase, we may want to consider a similar initiative. However, we are 
concerned about the possibility that any incentive system will be 
viewed by potential donor families as inappropriate when these families 
consider giving the priceless gift of life. We believe other programs, 
such as LifeLink's, have been shown to be effective without stipends.
    Question 3. What would be the supply-side effects of a policy where 
organs were to be allocated to ``the sickest candidates first?''
    Response. The supply-side effects would result from the increased 
transplant of sicker patients, at great distance from the location of 
the donation. First, costs will dramatically increase, because of the 
required private jet transportation of hearts and livers. Second, 
``warm'' time, or the time from organ procurement to implantation, will 
increase, and thereby decrease the function of the organs. This will 
also increase costs. The patients at the ``top'' of the transplant list 
are very sick, and do not do as well with their transplants as other 
patients. Therefore, retransplants will increase because very sick 
patients are more likely to experience rejection of the organ, and 
transplant hospital stays will increase. Data indicates that a new 
allocation scheme would substantially increase organ wastage. Also, in 
States like Florida, the hard work and dramatic success of our local 
and state organ donation partnership will be diluted by siphoning 
organs to out-of-state transplant centers. We believe donor families 
are more likely to donate knowing that the organs will benefit their 
local community. But we also believe that the staff responsible for 
acquiring consent and arranging the logistics of organ donation are 
also motivated by the knowledge that patients in their community are 
being helped by their hard work. The immediate results are apparent to 
everyone involved, and give them the greatest incentive to work at 
their maximum efficiency.
    Question 4. How do we increase the consent rates for families to 
donate organs? What recommendations would you offer to increase the 
number of individuals willing to donate their organs?
    Response. As I stated in my testimony, there are proven key 
strategies that can help increase organ donation. They include: a 
simplified referral process; elimination of competition among tissue 
and eye banks; the use of designated requestors; a focused education 
program throughout minority communities; a significant hospital 
development program; and independent organ procurement organizations 
and transplant centers. However, once consistent referral of all 
potential donors is achieved, increases can only occur through improved 
consent. Only persons who have demonstrated substantial skill in 
appropriate donor family interactions should be allowed to panic' ate 
in the consent process. Preferably, these persons should be full-time, 
although that may not be possible.
    Nationally, donor consent is at perhaps 48%. LifeLink's consent 
rate is 75% if hospital approaches to donor families are included, 
above 85% if they are not. The national ``conversion'' rate (medically 
suitable referrals which become donors) is perhaps 40%. LifeLink's 
conversion rate is 58%. We believe this increased conversion rate, and 
the increased consent rate, flows from having extremely skilled 
``requestors'', and very motivated employees involved in every other 
aspect of donation.
    Question 5. In your estimation, how would the Department of Health 
and Human Services regulations published April 2, 1998 affect your 
patients and your ability to provide the quality of medical care for 
them? What impact will this rule have on local access to transplant 
services nationwide?
    Response. We believe that our local transplant center patients will 
be significantly and negatively impacted, as will the vast majority of 
the country's 120 liver transplant centers. Donated livers will be sent 
from Florida to a half dozen urban regional transplant centers--none of 
which are in the southeast. Our community will be deprived of this 
life-saving resource, a resource which our local citizens and the 
community have developed together. Highly skilled doctors and nurses 
will no longer perform the same number of transplants. Local centers 
may be forced to close their doors.
    In addition, access for low-income patients may be decreased. 
Medicaid patients may be unable to obtain transplants outside their 
home state, and other patient families may not be able to accompany 
their loved one to support them at a faraway transplant center. Also, 
organ donation will be affected. Many donor families have stated that a 
key factor in their decision to donate was the knowledge that they 
would be helping someone within their community.
    Eliminating this motivation may substantially reduce voluntary 
organ donation nationwide.
    Question 6. Could you please explain to the Committee why some 
areas of the country have much higher rates of organ donation than 
others?
    Response. Some organ procurement organizations, such as LifeLink, 
have invested the resources necessary to educate hospital staff; 
nurses, physicians, and administrators, about donation so that the 
referrals will be provided to the organ procurement organization in a 
timely and well received manner. For example, LifeLink has 21 full-time 
persons working in the State of Georgia alone in hospital and minority 
education.
    Public education programs have also been established to provide an 
overall awareness about the need for organ donors. Quite simply, some 
organizations have not invested the necessary resources to make an 
impact on the donor shortage. In addition, some transplant centers have 
grown their list so heavily that the rate of donation in those 
communities can never serve the needs of those patients. It is 
important to note that this phenomena is in part a result of managed 
care programs forcing patients to be listed at transplant centers 
because of favorable contracts. These lists become unmanageably long, 
and out strip the supply of local organs.
    Question 7. As you know, the Department of Health and Human 
Services regulations have created quite an intense debate about the 
allocation of organs for transplantation. Some suggest, however, that 
the debate would be more constructive if it revolved around organ 
donation instead. What is your opinion?
    Response. We believe increasing organ donation is the number one 
challenge we face, and presenters at the April 15th hearing provided 
constructive methods for accomplishing that. There is, if current 
numbers are accurate, the potential for actually acquiring up to 4,000 
more organ donors each year nationally, by increasing consent rates to 
75-80%, acquiring virtually all suitable donor referrals, and 
maximizing the donor potential from those referrals. At over three 
organs per donor, 12,000 more organs each year could reduce the 
existing list to a manageable number soon. However, until this year's 
approximately 5% increase in organ donors, the national figures have 
remained virtually stagnant.
    Question 8. As the number of transplant programs across the country 
has grown, has the number of transplant procedures grown also? Can you 
elaborate on the estimated number of procedures that will be performed 
within the next five years?
    Response. Yes, the number of transplant procedures has grown, but 
this number is dwarfed by the increase in the patient waiting list. The 
increase in local transplant centers has more equitably spread the 
number of procedures from large urban transplant centers to local 
centers, whose surgeons previously trained at the large urban centers. 
Access to transplant centers in the local community allows patients to 
receive care close to home, with the support of family and friends. 
This is a positive phenomenon. However, without an increase in the 
number of available organ donors, the number of transplants cannot 
dramatically increase. The proposed change in allocation policy can 
only redistribute organs and change the addresses of those patients who 
do not receive organs and will die as a result.
    Only an increase in organ donation can save lives, and that is 
where we should be directing our national efforts.
    Question 9. In your opinion, does an active local transplant 
program stimulate organ donation?
    Response. Absolutely! The sense of identification with local 
patients, and with the patients across an OPO's home state, is integral 
to the success of an organ donor program. Of course OPO staff want to 
help any patient in need, but the drive that is needed to perform this 
kind of heart-wrenching work day after day is further fueled by knowing 
the names and identities of those local patients who wait. The energy 
to take all appropriate steps to locate organ donors is increased when 
the individual efforts of these employees sometimes save the life of 
someone the coordinator knows. Also, active local transplant centers 
increase awareness in the community about organ donation and educate 
the public about organ donation by their very presence.
    Question 10. What would you define as an appropriate role for the 
federal, government in the formulation of transplant policy?
    Response. The Federal government should ensure that proper minimal 
performance standards are set, and met, and that organizations which do 
not meet these standards are removed. However, when it comes to 
policies regarding distribution of organs, the Federal Government 
should allow the scientific and medical community, with proper non-
political oversight, to enact and enforce rules designed to maximize 
organ usage and patient survival. This process is a fast moving, fluid 
one, as is transplantation itself, and is not the appropriate place for 
regulation by the law-making process, which is slow and subject to 
political influence.
    Question 11. What are some of the key elements in helping LifeLink 
achieve recognition for the highest number of transplantable organs in 
the nation? What are some of your practices in identification and organ 
donation that other organ procurement organizations are not using?
    Response. The key elements that have helped LifeLink achieve the 
highest rate in the nation include: a simplified referral process; the 
elimination of competition among tissue and eye banks; the use of 
specially trained designated requestors; a focus on the minority 
community; a significant hospital development program; and an 
independence from the transplant centers we serve.
    Many organ procurement organizations have not invested in the 
hospital development program, or helped to eliminate competition among 
eye and tissue banks. Many OPO executive directors, when asked why they 
have not implemented and fully funded hospital development programs, or 
designated requestor or minority education/requestor programs, respond 
that their board members would not approve of the necessary increase in 
charges. Under the current system, many, if not most, of an OPO's board 
members are transplant center representatives, and have a conflict of 
interest when such issues are raised.
    Recognizing this problem, LifeLink is structured to meet government 
advisory board composition criteria, while keeping its governing board 
representative of the community.
    Please contact me if additional information is required. It has 
been a pleasure working with your staff members Todd Tuten and Mark 
Wheat.
            Sincerely,
                               John R. Campbell, P.A., J.D.
                              Senior Vice President/General Counsel
                                 ______
                                 
                         National Kidney Foundation
                     Office of Scientific and Public Policy
                                                        May 5, 1999
The Honorable Michael Bilirakis
Chairman, Subcommittee on Health and Environment
U.S. House of Representatives
Committee on Commerce
Room 2125, Rayburn House Office Building
Washington, DC 20515-6115
    Dear Chairman Bilirakis: Thank you for your letter of April 21, 
1999. On behalf of the National Kidney Foundation (NKF) I wish to 
express again our appreciation for the privilege of presenting the NKF 
perspective on ``Putting Patients First: Increasing Organ Supply for 
Transplantation,'' at the Subcommittee hearing on April 15, 1999. We 
also appreciate the opportunity for additional input on the issues 
which were raised during the hearing by responding to the questions 
posed in your recent letter.
    Question 1. At the hearing, witnesses testified about numerous 
state programs to increase organ supplies. If Congress were to move to 
a national waiting list system, how would that impact existing state 
policies designed to increase organ supplies?
    Response. We are concerned that states may have less incentive to 
continue to develop innovative programs to increase the supply of 
organs available for transplantation if Congress were to move to a 
national waiting list system. Furthermore, state legislatures could be 
less likely to support funding for such innovative programs if there 
were a national waiting list.
    Question 2. Pennsylvania has instituted a program that pays 
families of organ donors $300 in state contributions for the donor's 
funeral expenses, starting this July. What is your opinion on this type 
of program?
    Response. The National Kidney Foundation has long called for 
demonstration projects to determine the impact of programs which would 
assist donor families in paying for funeral or burial expenses, based 
upon the recommendations of our consensus conference, ``Controversies 
in Organ Donation,'' which was held in 1991.
    Question 3. The proposed HHS regulations to reallocate organs state 
that ``the OPTN is required to develop equitable allocation policies 
that provide organs to those with the greatest medical urgency, in 
accordance with sound medical judgement.'' When President Clinton 
signed H.R. 3579, the Supplemental Appropriations and Rescissions Act, 
on May 1, 1998, which extended the public comment period and 
implementation deadline for the HHS OPTN regulations, he issued a 
written statement in opposition to extending the comment period on the 
rule. In stating his reasons for opposing the extension, President 
Clinton stated that ``The final rule would ensure that organs are 
allocated to the sickest candidates first.'' What would be the supply-
side effects of a policy where organs were to be allocated to ``the 
sickest candidates first''?
    Response. We believe that less patients would receive liver 
transplants if the OPTN were required to develop policies where organs 
are allocated to the sickest candidates first. Such candidates are 
likely to have poor outcomes and require repeat transplants, thus 
reducing the number of organs available for other candidates. 
Furthermore, NYF has maintained that a ``sickest first'' policy should 
not be applied to renal transplantation because of the availability of 
dialysis as an altemative therapy.
    Question 4. How do we increase the consent rates for families to 
donate organs? What recommendations would you offer to increase the 
number of individuals willing to donate their organs?
    Response. To respond to this question, it is necessary to 
differentiate between cadaveric organ donation and living organ 
donation.
    The experience in Pennsylvania indicates that cadaveric organ 
donation could be increased through implementation of the ``required 
referral'' provision in the new HCFA Conditions of Participation for 
hospitals. This puts individuals trained in the consent process at the 
bedside of potential donors. Registries which track individuals who 
have executed organ donation directives might also be helpful in the 
consent process since they give the donor family indisputable evidence 
of the wishes of the decedent. As indicated in our testimony, removing 
the disincentives for living donation, including financial 
disincentives, could increase the number of individuals who are willing 
to donate.
    Question 5. In your estimation, how would the Department of Health 
and Human Services regulations published April 2, 1998, affect your 
patients and your ability to provide the highest quality of medical 
care for them? What impact will this rule have on local access to 
transplant services nationwide?
    Response. We are concerned that the April 2, 1998 regulations have 
politicized the organ donation/organ allocation process since they give 
the DHHS Secretary veto power over OPTN policy. Transplantation should 
be based upon medical science, not politics. We are concerned that the 
rule may cause some local transplant centers to close and that would 
make it difficult for low income transplant candidates to receive a 
transplant. Such candidates may not be able to afford to travel to 
distant transplant centers for evaluation, the transplant itself and 
post-operative care and testing.
    Question 6. Could you please explain to the Committee why some 
areas of the country have much higher rates of organ donation than 
others?
    Response. There are many factors that influence organ donor rates 
in different parts of the country. The ethnic/racial/cultural mix of 
the community where individual organ procurement organizations operate 
is an important variable. Some groups have traditionally been more 
likely to donate than others. Also, a high incidence/prevalence of HIV 
infection in a community is a contraindication for organ donation. 
Finally, there is variance in the performance of the organ procurement 
agencies themselves.
    Question 7. As you know, the Department of Health and Human 
Services regulations have created quite an intense debate about the 
allocation of organs for transplantation. Some suggest, however, that 
the debate would be more constructive if it revolved around organ 
donation instead. What is your opinion?
    Response. The National Kidney Foundation firmly believes that the 
focus of the debate in Congress should move from organ allocation to 
organ donation and we are very pleased that your Subcommittee has held 
a hearing to begin that process. In particular, provisions to increase 
the supply of organs available for transplantation should be included 
in the re-authorization of the National Organ Transplant Act of 1984. A 
change in allocation policy fails to address the larger issue-the 
growing transplant waiting list.
    Question 8. As the number of transplant programs across the country 
has grown, has the number of transplant procedures grown also? Can you 
elaborate on the estimated number of procedures which will be performed 
within the next five years?
    Response. Extrapolating from the current experience, Thomas Gonwa, 
M.D., chairman of the NKF Council on Transplantation, provided the 
following estimates for the number of transplants which will be 
performed in the next five years:

Kidney...............................................      60,000-80,000
Liver................................................      30,000-35,000
Heart................................................      10,000-15,000
Lung.................................................              5,000
Kidney/Pancreas......................................              4,000


    The number of those procedures will be largely influenced by trends 
in organ donation. However, developments in science and changes in 
policy also have a role to play. Science can contribute to the 
availability of organs for transplantation by finding new ways to 
prevent graft loss and thus reduce the need for second and third 
transplants. Another example of the role of science is in split liver 
and partial lung transplants which multiply the use of organs which are 
donated. The promise of required referral is that it could increase 
organ donation by 20%. Finally, reimbursement policy has a role to play 
to the extent that extending the period of time during which Medicare 
pays for anti-rejection drugs could reduce the need for second and 
third transplants. For this reason, the NKF is a strong advocate of 
H.R. 1115 and S. 631, legislation that would eliminate the current 36-
month time limitation for Medicare coverage of immunosuppressive 
medications for transplant recipients.
    Question 9. In your opinion, does an active local transplant 
program stimulate organ donation?
    Response. It is the opinion of the National Kidney Foundation that 
an active local transplant program stimulates organ donation.
    Question 10. What would you define as an appropriate role for the 
federal government in the formulation of transplant policy?
    Response. The federal government should assist in the formulation 
of transplant policy by facilitating and funding demonstration projects 
as well as by supporting basic and clinical research on 
transplantation. It should also establish reimbursement policy (for 
Medicare and Medicaid and as a model for private third party payers) 
which a) is consistent with transplant science, b) promotes the welfare 
of transplant candidates and transplant recipients and c) maximizes 
utilization of organs which are donated.
    Question 11. I was very pleased to learn that the number of living 
organ donors increased by 95% over the period from 1988 to 1996. What 
accounts for this increase in donations? How can we continue to 
replicate its success?
    Response. The number of living donations has grown as transplant 
centers have developed programs to tap the potential of living 
transplantation. This could further increase as more centers are 
encouraged to develop such programs and guidelines are developed to 
improve the information provided to potential donors. Additionally, the 
potential of living organ donation could be enhanced by protocols 
permitting emotionally related donation and paired donation. As noted 
above, eliminating the financial disincentives for living donation 
would help to maintain the momentum.
    As stated in our testimony for the hearing, living organ donation 
is a priority for the National Kidney Foundation. In the coming year 
NKF will sponsor a consensus conference to explore ways to increase 
living organ donation and better serve living organ donors.
    Question 12. You indicated that a survey conducted by the National 
Kidney Foundation found that a majority of respondents indicated that 
they would prefer that donated organs be used locally. Could you 
provide the Committee a copy of the survey for the record? In your 
opinion, how would a national waiting list affect donations?
    Response. By way of background you should know that the NKF is a 
federation of 52 local kidney foundations, known as ``Affiliates,'' and 
that the NKF umbrella includes three ``constituent'' councils (the 
National Donor Family Council, the Patient and Family Council and the 
transaction Council), seven ``scientific'' councils and three 
``professional'' councils (among the latter are the Council on 
Transplantation and the Council of Nephrology Social Workers). The 
4,229 constituents of our National Donor Family Council have had the 
personal experience of giving the ``Gift of Life'' and the 3,317 
members of the NKF transaction Council have benefitted from a life-
saving organ transplant. In all, NKF represents 30,000 lay and 
professional volunteers from every walk of life and every part of the 
United States.
    In response to the April 2, 1998 regulations, three conference 
calls were convened to survey the NKF constituent councils concerning 
the new policy during the week of April 13, 1998. The views of the 
members of the Executive Committees of the National Donor Family 
Council, the transaction Council and the Patient and Family Council, 
respectively, were elicited during those conference calls. Throughout 
the month of May 1998, NKF sought input on the regulations from our 
Affiliates. A questionnaire was distributed by fax and a second copy of 
that instrument was mailed to every Affiliate office.
    The National Kidney Foundation is grateful to be able to serve as a 
resource as Congress debates the future of organ donation and 
transplantation. We have helped to shape public policy in this area for 
more than 30 years and stand ready to provide any additional 
information or assistance that the subcommittee might find useful at 
this point in time.
            Sincerely,
                                            Joseph L. Brand
                                                           Chairman
                                 ______
                                 
 Responses for the Record of Dr. Robert Higgins, Director of Thoracic 
               Organ Transplantation, Henry Ford Hospital
    Question 1. At the hearing, witnesses testified about numerous 
state programs to increase organ supplies. If Congress were to move to 
a national waiting list system, how would that impact existing state 
policies designed to increase organ supplies?
    Response 1. A national waiting list with no preference for local 
patients would negate the incentive for potential donors to donate an 
organ that could benefit someone in their local community, state or 
region. OPO, hospital and medical personnel feel strongly that donor 
families are impacted by first-hand accounts of organ donation success 
stories and local media coverage about transplant recipients. Organ 
donation is a local phenomenon and as such is impacted by cultural and 
religious beliefs that are difficult to understand or respond to on a 
``one size fits all'' basis.
    Issues related to death and dying have traditionally been the 
responsibility of the states and issues related to organ donation and 
disposition are covered under state law. Under the Uniform Anatomical 
Gift Act, which is the model donation statute for all states, 
responsibility for organ donation efforts such as drivers license check 
off, the legal definition of who is a donor and who is a donee, as well 
as other legal issues are addressed. A national system would break up 
these traditional responsibilities and relationships that support organ 
donation in the states as defined in the Uniform Anatomical Gift Act 
and would essentially be a federal over-reach into an area which has 
traditionally been the prerogative of the states.
    Question 2. Pennsylvania has instituted a program that pays 
families of organ donors $300 in state contributions for the donor's 
funeral expenses, starting this July. What is your opinion on this type 
of program?
    Response 2. The issue of financial incentives for organ donation is 
a complex moral and ethical question which has been debated for some 
time. As it stands now, economic incentives for organ donation are 
illegal based upon the National Organ Transplantation Act of 1984 
(Public Law 98-507).
    We question the advisability of tying financial incentives to a 
system which has been based upon altruism and voluntary donations of 
organs. Families are already apprehensive about donating a loved one's 
organs due to a lack of information, superstitions, religious beliefs, 
and culturally driven attitudes about death, often mixed with a feeling 
that the hospital, health plan, or medical staff may not perform all 
possible interventions on the patient so that the organs can be used 
elsewhere. The ``who'', ``how'', and ``why'' of donating organs are 
unclear to many, and adding a new dimension with monetary incentives 
may cloud or create even more suspicion during the sensitive decision 
making period by family members.
    The potential for coercive economic incentives that may undercut 
the altruistic nature of donation and create questionable motivation 
for donation, in particular for those who are in financial need, is a 
significant concern.
    Thus, prior to formalizing any kind of system of remuneration, 
diligent consultation with the medical profession, medical ethicists 
and legal experts should be secured. In addition, we are a society that 
is grappling with issues of assisted suicide and the right of patients 
and families to terminate treatment, all of which introduce 
opportunities to make tragic mistakes in decisions relating to 
financial incentives for organ donations.
    If Congress or state governments decide to proceed with even small 
monetary incentives, such as payment for funeral costs, we strongly 
recommend close supervision, public disclosure and tight controls over 
the way the program is implemented. Even small amounts begin the danger 
of starting down a slippery slope that can lead to the dangers of a 
payment system for organs. We acknowledge, however, that clearly 
defined financial incentives such a ``rewarded gifting'' in the form of 
modest sums of money paid to a family to defray costs of funeral 
expenses may benefit individual transplant recipients and the society 
at large. These kinds of initiatives, of course, would have to be 
carefully delineated, so as not to be construed as a payment system for 
organs.
    Question 3. The proposed HHS regulations to reallocate organs state 
that ``the OPTN is required to develop equitable allocation policies 
that provide organs to those with the greatest medical urgency, in 
accordance with sound medical judgment.'' When President Clinton signed 
H.R. 3579, the Supplemental Appropriations and Rescissions Act, on May 
1, 1998, which extended the public comment period and implementation 
deadline for the HHS OPTN regulations, he issued a written statement in 
opposition to extending the comment period on the rule. In stating his 
reasons for opposing the extension, President Clinton stated that ``The 
final rule would ensure that organs are allocated to the sickest 
candidates first.'' What would be the supply-side effects of a policy 
where organs were to be allocated to ``the sickest candidates first''?
    Response 3. A ``sickest first'' policy would increase the number of 
re-transplants as more patients experience graft rejection, and thus 
reduce the number of organs available for transplantation overall. 
Patients would have to become ``sicker'' in order to receive a 
transplant, thus reducing their chance for survival. This would be 
completely counter-productive and result in increased cost with reduced 
success.
    Question 4. How do we increase the consent rates for families to 
donate organs? What recommendation would you offer to increase the 
number of individuals willing to donate their organs?
    Response 4. The key to overcoming donor families reluctance to 
consent is twofold: 1) better educational programs to increase the 
knowledge about organ donation and transplantation including involving 
religious and community leaders, and 2) a ``best practices'' approach 
in terms of asking for family consent that could be implemented in 
every hospital. Mandatory referral by the hospital to the OPO is also 
an important part of increasing organ donation.
    Question 5. In your estimation, how would the Department of Health 
and Human Services regulations published April 2, 1998, affect your 
patients and your ability to provide the highest quality of medical 
care for them? What impact will this rule have on local access to 
transplant services nationwide?
    Response 5. A national list coupled with a sickest first policy 
would make it all but impossible for my patients and in particular 
patients everywhere that are poor or minority patients, to receive a 
transplant. From a physician's point of view, without available organs, 
there is nothing I can do to help my patients over the longer term. If 
the rule were in effect today, the federal government would essentially 
be denying the benefits of organ transplantation to a broader number of 
patients.
    Question 6. Could you please explain to the Committee why some 
areas of the country have much higher rates of organ donation than 
others?
    Response 6. Many factors come into play. Areas that do not have a 
transplant center generally do not have a well-developed organ donation 
infrastructure and the associated outreach programs in place. In some 
areas, there is clearly a need for increased efforts while in other 
areas, because of population, economic or cultural reasons, efforts to 
increase donation will have a limited effect.
    Question 7. As you know, the Department of Health and Human 
Services regulations have created quite an intense debate about the 
allocation of organs for transplantation. Some suggest, however, that 
the debate would be more constructive if it revolved around organ 
donation instead. What is your opinion?
    Response 7. I absolutely agree. The real solution to the problem is 
to focus our efforts on ways to increase organ donation. We are 
currently reaching only about 35% of potential donors and getting 
consent from only about 50% of those we do reach. If we increased the 
organ donation rate for livers from 21 donors per million, which is the 
current average, to 30 donors per million, the waiting time for a liver 
transplant would be less than 20 days for all patients in all regions 
of the country.
    A recent Associated Press analysis of the 63 organ procurement 
organizations across the country concluded that 2000 more transplants 
could be performed each year if each below-average organ bank performed 
up to the median level.
    Question 8. As the number of transplant programs across the country 
has grown, has the number of transplant procedures grown also? Can you 
elaborate on the estimated number of procedures which will be performed 
within the next five years?
    Response 8. As the number of transplant programs across the country 
has grown, there has been a corresponding increase in the number of 
transplant procedures. Though there has been no extensive scientific 
study undertaken to determine this, UNOS data clearly shows that 
between 1988 and 1995, the number of liver transplant centers in the 
U.S. grew from 70 to 119, a 70% increase. During the same time period, 
as transplantation became a reality for many without the means to 
travel, the number of liver transplants grew from 1,713 to 3,923, an 
increase of 129%. Transplantation is a reality today for more people 
than ever before, and we must recognize that it has evolved in the 
context of the consensus-oriented process developed by the OPTN--not by 
a federal directive.
    Question 9. In your opinion, does an active local transplant 
program stimulate organ donation?
    Response 9. In my opinion, an active local transplant program does 
indeed stimulate organ donation. My experience has taught me that when 
a community can relate to the miracle of transplantation, often through 
knowing someone or reading about someone whose life was saved, 
increased awareness and participation are the result. If 
transplantation were a phenomenon that ``happened somewhere else,'' 
local communities would have a more difficult time engaging people in 
the process of organ donation. People must be able to feel the positive 
impact of transplantation in their community in order to achieve the 
maximum level of participation and awareness.
    Question 10. What would you define as an appropriate role for the 
federal government in the formulation of transplant policy?
    Response 10. The appropriate role for the federal government in the 
formulation of transplant policy has been clearly defined by the 
National Organ Transplant Act of 1984 (NOTA). This is the position with 
which I am aligned. NOTA very explicitly states that the OPTN, which 
consists of not only surgeons, but patients, donor families, and OPO 
representatives, shall be primarily responsible for the development and 
implementation of sound transplant policies, while the Secretary of the 
Department of Health and Human Services exists in an oversight 
capacity. The appropriate role, therefore, is for the federal 
government to ensure the implementation of sound transplant policy as 
developed by the medical experts and consumers involved in 
transplantation every day. The federal government should not be in the 
position of proposing transplant policy. The transplant community feels 
very strongly that we--the surgeons, donors, donor families, patients, 
and OPOs--must continue to develop transplant policy in a consensus-
driven process that is able to respond to the latest advances in 
medical technology, while simultaneously ensuring the maximum level of 
access to transplantation for all patients.
    Question 11. Why have donation rates among minorities been so low?
    Response 11. Donation rates among minorities have been low for 
several reasons. The most glaring shortfall has been in the African-
American population, where donation rates had been 7% only a few years 
ago. It is now running closer to 15% which is commensurate with the 
percentage of African-Americans in the general population. Clearly we 
have begun making progress, but there remains significant room for 
improvement. In my opinion, this problem stems mainly from the issue of 
access to transplantation and other medical services. Minority 
populations have historically suffered from inadequate access to 
quality medical care. This has bred a distrust of the ``medical 
establishment'' as minorities tend to view medicine with suspicion and 
apprehension. This has resulted in a hesitancy to donate, with patients 
believing their organs will not be utilized to benefit minority 
patients, but go to ``white'' patients who are able to afford them. 
There is also a fear that the ``medical establishment'' will not do 
everything possible to save their life if they have indicated they 
intend to donate their organs. These concerns are not founded, and must 
be countered with outreach efforts in minority communities.
    There have also been religious concerns raised, with patients 
expressing the need to ``go to heaven whole.'' Community churches must 
undertake efforts to ensure patients are educated about the benefits of 
transplantation.
    Question 12. What are some of the strategies to increase organ 
donation that have worked best in minority communities?
    Response 12. MOTTEP--The Minority Organ Tissue Transplantation 
Education Program, headed by Dr. Clive Callender, has made tremendous 
inroads into this problem. The program is grassroots and seeks to 
educate the public not only about organ and tissue donation but also 
health care issue as well (e.g., avoiding salt and fried foods, regular 
checkups, etc)
    This program has been instrumental in raising organ donation rates 
among minorities in or region. Moreover, I believe it has been a big 
reason why donation rates have increased nationally.
    Also, the use of minority coordinators who speak with potential 
donor families has improved consent rates. This strategy helps assuage 
concerns that the ``establishment'' is only after their loved one's 
organs and allows the family to grieve with someone of the same 
ethnicity who would potentially understand their concerns better.
    The MOTTEP paradigm could and should be used nationally. Their 
philosophy can be easily transferred to the general public; however, it 
will take substantial backing by the government to fund these education 
programs on a national basis. MOTTEP works because people go to 
churches, schools, malls, and wherever people might be. It is very 
labor intensive but it is the only way to answer questions. Having 
advertisements with Michael Jordan are well intentioned but unless 
people can see the direct benefits and ask questions first hand, no 
major dent in the donation rate will be seen.
    Question 13. In your testimony, you discussed the increasing 
prevalence of living organ donations. How would you reassure a 
potential living donor about the safety and viability of the procedure?
    Response 13. The physician or staff involved with the procedure are 
typically responsible for educating and explaining the risk of any 
surgical procedure. It is incumbent upon the physician to fully 
disclose the status of living donor transplantation. For example, data 
should be shared related to patient risk and outcomes so that patients 
can make informed decisions about whether to proceed.
                                 ______
                                 
                    American Society of Transplant Surgeons
                                                        May 5, 1999
The Honorable Michael Bilirakis
Chairman
Subcommittee on Health and Environment
U.S. House of Representatives
Committee on Commerce
Room 2125, Rayburn House Office Building
Washington, DC 20515-6115
    Dear Chairman Bilirakis: It was an honor to appear as a witness on 
April 15, 1999 before the Subcommittee on Health and Environment under 
your leadership. As you know, I represent the American Society of 
Transplant Surgeons (ASTS) and offered our testimony on increasing the 
organ supply for transplantation. The following are follow-up answers 
to the questions you posed in your letter to me of April 21, 1999.
    Question 1. At the hearing, witnesses testified about numerous 
state programs to increase organ supplies. If Congress were to move to 
a national waiting list system, how would that impact existing state 
policies designed to increase organ supplies?
    Answer. First of all, the term ``national waiting list'' is a 
misnomer in that it no longer characterizes what is being proposed by 
the Department of Health and Human Services (DHHS). All parties 
including DHHS now appear to recognize that a unified national 
allocation scheme--which routes organs to the next name on the list 
without regard to where the organ was retrieved or where the patient is 
located--is not a practical possibility, particularly given the 
importance of minimizing cold ischemic time, at the current state of 
organ preservation technology.
    But DHHS certainly is proposing to move away from the current 
system of allocation to a system of broader geographic sharing. We 
acknowledge that certain artificial boundaries have been established in 
the designation of UNOS regions, and in the creation of Organ 
Procurement Organization (OPO) territories (the latter, approved and 
designated by the Health Care Finance Administration), that have 
created inequities in distribution in certain areas of this country. In 
several cases, reliance on rivers, state lines, and even city limits to 
define distribution areas aggravates some inequities. These should be 
specifically addressed and remedied. But there certainly are no 
persistent glaring national injustices that necessitate the type of 
radical change of distribution policies proposed by DHHS, which we 
believe would have a strong negative impact on states that have more 
effective organ donor programs.
    For instance, in our own state of Florida, population clusters are 
fairly evenly geographically distributed and far enough away from the 
neighboring states of Georgia and Alabama that state boundaries cannot 
play an adverse role in general in distribution. If one looks at New 
York and New Jersey, the perspective is entirely different. Louisiana 
also has population centers in general away from the population centers 
with transplant programs of other states. The case is similar in 
California, but contrasts to the situation presented in some state 
pairs such as Wisconsin and Illinois.
    The complexity increases when one considers that, as mentioned in a 
succeeding question, some states indeed have more effective organ donor 
programs (as we are blessed with here in Florida) than other states. 
There is no simple explanation or solution to this phenomenon. Pockets 
of our populace still do not have cadaver organ donation in their 
cultural mores, such as Orientals in population centers on the West 
Coast. This is also true in some cities where massive population growth 
has been fueled by refugees from countries in which organ donation is 
less-advanced, such as those from Central America, Mexico, and the 
Caribbean.
    With this background, the answer to your question is that moving to 
a national list would indeed have a negative impact on organ donation 
in a number of states. We would hope Congress would recognize that the 
current system--constantly modified by experts on the preservation of 
specific organs and their transplantation--has been most effective in 
the equitable distribution of all organs for the years of its 
existence. It recognizes that organ donation to not-fully-appreciated 
extent is a local phenomenon, for a variety of social as well as 
geographic reasons. OPOs function most effectively when driven by their 
transplant surgeons and by the needs of their local patients. Such is 
the motivation that breeds success in organ retrieval. The current 
system may need further fine-tuning, but it is NOT broken.
    Question 2. Pennsylvania has instituted a program that pays 
families of organ donors $300 in state contributions for the donor's 
funeral expenses starting this July. What is your opinion on this type 
of program?
    Answer. I personally see no ethical issue. Other incentives might 
be even serve as more of a motivation to increase donation, but I view 
this as an interesting effort and we will obviously be interested to 
see if it has an impact on the donation rate.
    Question 3. The proposed HHS regulations to reallocate organs state 
that ``the OPTN is required to develop equitable allocation policies 
that provide organs to those with the greatest medical urgency, in 
accordance with sound medical judgment.'' When President Clinton signed 
H.R. 3579, the Supplemental Appropriations and Rescissions Act, on May 
1, 1998, which extended the public comment period and implementation 
deadline for the HHS OPTN regulations, he issued a written statement in 
opposition to extending the comment period on the rule. In stating his 
reasons for opposing the extension, President Clinton stated that ``The 
final rule would ensure that organs are allocated to the sickest 
candidates first.'' What would be the supply-side effects of a policy 
where organs were to be allocated to ``the sickest candidates first''?
    Answer: The ASTS has made it clear that we believe the impact of 
such a ``sickest first'' policy would be contrary to our goal of 
insuring that the precious organs presently available provide the 
maximum benefit to the maximum number of Americans in an equitable 
fashion. This point was made in testimony presented at two previous 
Congressional hearings by Dr. Ronald W. Busuttil, President-elect of 
the Society and director of the world's most active liver transplant 
center in UCLA, and I am submitting copies of his testimony with this 
response. I also include a copy of our written testimony to the 
Institute of Medicine, presented by Dr. Busuttil on April 16th, which 
expands on these points.
    Unfortunately, critical care medicine and vital organ 
transplantation is not an exact science. That is why a significant 
number of Status 3 liver patients, those thought to be the least sick, 
die while in that status. We urge the Congress to leave decisions of 
this kind in the hands of the medical professionals--who battle these 
life-and-death issues with their patients every day--and not permit 
them to be imposed by governmental authority far from the trenches 
where life and death is played out.
    The simple answer is that there are some changes that must evolve 
in the distribution of life-saving organs for transplantation, as they 
have evolved in the past. This can be accomplished with the help of the 
federal government, but not with the implementation of a radically new 
OPTN rule which with its current inferences, language, and preamble has 
resulted in sound-bites such as ``sickest patients first.''
    Question 4. How do we increase the consent rates for families to 
donate organs? What recommendation would you offer to increase the 
number of individuals willing to donate their organs?
    Answer: For one thing, the ASTS itself has launched a very logical 
public educational campaign--The First Family Pledge Campaign--that has 
as a general concept (to be accepted by the general public, as it has 
been by our congressional leaders) discussion of organ donation as a 
family event. I include information on this campaign and express our 
gratitude to you for your participation and your leadership in it.
    There are some additional simple points that should be stated 
relative to public support for organ donation. The acceptance of 
seatbelts by the American public was a generation in coming. I, myself, 
must confess that I did not use them until five years ago when shamed 
into doing so by my five year-old grandchild. He learned it in school. 
The importance of organ and tissue donation must be ingrained into our 
American culture from early grade school onward, together with the 
Pledge of Allegiance and the multiplication tables. Organ donation must 
come to be viewed as part of our American way of life. The First Family 
Pledge is really no more than an extension of the Golden Rule.
    There are additionally several other specific operational 
initiatives that I refer to in my testimony being implemented by the 
ASTS and its co-partners this year. These initiatives would be helped 
by some minimal underwriting from either HCFA or HRSA. I would be most 
happy to discuss them in more detail with you or your staff as well.
    Question 5. In your estimation, how would the Department of Health 
and Human Services regulations published April 2, 1998, affect your 
patients and your ability to provide the highest quality of medical 
care for them? What impact will this rule have on local access to 
transplant services nationwide?
    Answer: In general the rule as currently written will impact 
negatively upon patients nationwide. I personally work in a large 
transplant center, one of the five largest in the world, and am proud 
of our record over the years. I also have been proud of our organ 
procurement agency, the University of Miami OPO. This has repeatedly 
over the years had one of the most enviable records nation- and 
worldwide in organ retrieval for life-saving transplantation. This is 
due to our local OPO Director, Les Olson, with whom I have had the 
privilege of working for 30 years, first in Minnesota, and then for 
over 20 years in South Florida. Please make no mistake. Organ donation 
is a local phenomenon dependant on the expertise of professional 
personnel. That also accounts for the great records in organ retrieval 
of Lifelink in West Florida, for Translife in Central Florida, and for 
the University of Florida OPOs. How could those who drafted the OPTN 
rule not acknowledge this? Some of the language in the OPTN rule also 
will have a negative impact on local access to service. I can expand on 
this, but I refer you to comments already made by our ASTS (enclosed). 
It is also worth noting that the vast majority of the written comments 
on the rule, collected by DHHS and not yet described by the Department, 
are understood to have been negative.
    Question 6. Could you please explain to the Committee why some 
areas of the country have much higher rates of organ donation than 
others?
    Answer: In brief, the variables are: (1) The expertise of OPO 
personnel and their motivation; (2) Cultural and ethnic pockets of 
population with a more negative view of the process; (3) The failure to 
appreciate the extent to which the driving force attaining high rates 
of organ donation are the transplant professionals involved in the act 
of transplantation, led by transplant surgeons.
    Question 7. As you know, the Department of Health and Human 
Services regulations have created quite an intense debate about the 
allocation of organs for transplantation. Some suggest, however, that 
the debate would be more constructive if it revolved around organ 
donation instead. What is your opinion?
    Answer: I agree totally with this statement. The problem of 
allocation will not be ``solved'' until we increase the organ donation 
rate in a way that allows any patient in need of an organ to benefit 
from this new chance at life. The government certainly should be 
focusing its attention on increasing public support for donation, and 
leaving the triage of complex medical conditions to the ``docs,'' where 
it belongs.
    Question 8. As the number of transplant programs across the country 
has grown, has the number of transplant procedures grown also? Can you 
elaborate on the estimated number of procedures which will be performed 
within the next five years?
    Answer: The number of transplant procedures has certainly grown, 
and will continue to grow. The estimated number to be performed in the 
next five years is truly limited by the availability of donor organs. 
The number of potential recipients has grown, conservatively, by about 
10% per year for the last three or four years, and could continue to do 
so for the next five years. In fact, when one considers the future need 
for liver transplantation in light of the epidemic of hepatitis C, 
which is now occurring in the United States, an even greater number of 
transplants may be required. It has been estimated that within 10 years 
there will be a 61 per cent increase in cirrhosis, and a 529 per cent 
increase in the need for liver transplantation due to Hepatitis C. 
Furthermore, the technology of improved organ preservation, 
xenografting, and even organ cloning may well impact these numbers 
within the first decade of the new millennium.
    Question 9. In your opinion, does an active local transplant 
program stimulate organ donation?
    Answer: Yes, for reasons previously described, organ donation is 
very much driven by active, aggressive, and respected local transplant 
surgeons and other expert professionals, and vice versa.
    Question 10. What would you define as an appropriate role for the 
federal government in the formulation of transplant policy?
    Answer: The federal government should assist the professionals by 
providing enforcement of the regulations generated by the OPTN, UNOS. 
The federal government has the responsibility for oversight of the 
OPTN, and the implementation of NOTA. NOTA begs to be reauthorized with 
the firm principle clearly established that the final responsibility 
for the life and death medical decisions inherent in organ allocation 
and distribution should repose with medical professionals, and be made 
on the basis of scientific fact and not potential political influence. 
We, as physicians, hold this task as the highest motivational force in 
our lives and our professional careers. We took an oath. The final 
responsibility for medical decisions should lie with the medical 
community, and not with the Secretary of Health and Human Services. 
That is what this is all about.
    Question 11. Can you discuss the progress of efforts to 
successfully preserve transplantable organs outside the body?
    Answer: Progress in this particular field may not appear to be 
steady, and by no means is it expanding geometrically as in other areas 
of transplantation. It is one of our most limiting variables in organ 
availability. However, strides are being made in cryopreservation of 
cells, tissues, and even complex organs that deal with the 
susceptibility of subcellular structures to crystallization, so as to 
freeze them for prolonged periods. Also, tissue culture technology has 
seen more remarkable advances with the identification and molecular 
generation of growth factors for certain types of tissue, and the 
maintenance of cells, tissues and even of organs ex vivo, possibly even 
of their generation in tissue culture. The practical implementation of 
such technology is difficult to predict. But, there are indicators that 
significant applicable progress will be made in the next ten years, 
provided the funds for underwriting the research continue to be 
available.
    Question 12. In your testimony, you mentioned initiatives underway 
to increase consent rates in Great Britain and Spain. Can you elaborate 
on those approaches and what we can learn from them?
    Answer: The ASTS has already performed site visits to the programs 
in these countries working with individual OPOS, and is working in 
partnership with the American Organization of Procurement Organizations 
(AOPO) to implement that which we have learned.
    1.) In the national initiative from Great Britain, the improved 
identification and maintenance of suitable donors for heart and lung 
transplantation has the potential for doubling the number of donors 
available for such transplants in our country. This involves new 
intensive care monitoring techniques that are being described in a 
grant application to the National Heart, Lung and Blood Institute of 
the NIH. Further information can be provided by Dr. Bruce Rosengard of 
our ASTS, who is the Director of Cardiac Transplantation at the 
University of Pennsylvania in Philadelphia.
    2.) In adapting some of the Spanish practices, we have begun, with 
the help of individuals previously with an organization called The 
Partnership For Organ Donation, to initiate demonstration projects in 
certain OPOs to amplify incentives in the hospitals in their areas to 
identify and maintain potential organ donors, an essential component of 
this model.
    Reinforcement by HRSA and funding for both of these projects would 
aid them greatly. (We are proceeding independently with departmental 
knowledge and acquiescence, but not thus far with their financial 
help.) In any event, we expect these to demonstrate a positive impact 
within the next two years.
    It was a privilege to appear before your Subcommittee. The bottom 
line of my message to you on behalf of the ASTS is that (1) we urge the 
Congress of the United States to reenact the National Organ Transplant 
Act (NOTA) to send a clear message as to its implementation by the 
Department of Health and Human Services. The message is that the 
decisions of organ allocation to save lives by transplantation must in 
the final analysis be under the responsibility and aegis of surgeons 
and physicians empowered to do so by law. (2) There must be sanctions 
applied by HCFA when rules promulgated by these surgeons, physicians, 
and their lay peers, i.e., the OPTN contractees, are not adhered to, to 
ensure optimum usage of these organs according to the highest medical 
and ethical precepts. This is the manner in which implementation of 
NOTA by the Executive Branch should occur. (3) Operational and 
educational initiatives to increase organ donations could well be 
incorporated into the law by a collaborative participation of our 
medical and paramedical experts with the help and direction of the 
Congressional leadership.
    We indeed would welcome the opportunity to work closely with you in 
achieving these goals.
            Sincerely yours,
                        Joshua Miller, M.D., President,    
                       American Society of Transplant Surgeons,    
                             University of Miami School of Medicine
Enc.
                                 ______
                                 
                                Medical College of Virginia
                                                     April 27, 1999
The Honorable Michael Bilirakis
Committee on Commerce
U.S. House of Representatives
2125 Rayburn House Office Building
Washington, D.C. 20515
    Dear Mr. Bilirakis, per your request, I am answering the questions 
listed below.
    Question 1. At the hearing, witnesses testified about numerous 
state programs to increase organ supplies. If Congress were to move to 
a national waiting list system, how would that impact existing state 
policies designed to increase organ supplies?
    Response. A national waiting list would seriously undermine 
existing state policies designed to increase organ supplies. Organ 
donation appears to be a relatively regionally driven phenomenon. Areas 
where there is an active transplant center have historically had the 
highest organ donation rates. The idea that organs recovered in one 
area would be shipped across the country, I believe, would negatively 
impact that particular area's motivation to donate organs for 
transplantation. The most populated and urbanized states also have the 
largest numbers of patients needing liver transplantation. A 
nationalized waiting list would divert organs to the most seriously ill 
patients. Statistically, the majority of the organs that become 
available will, then, go to the centers with the largest numbers of 
patients. This would have several implications for centers in less 
heavily populated regions. Very few organs will become available for 
these centers and many would be forced to stop offering this service to 
their patients. Liver transplant recipients need not only intensive 
preoperative and immediate post operative care but also require 
skilled, continued follow up care. It is not cost effective to provide 
these specialized services for only a small number of patients. 
Patients would be forced away from their homes and families in order to 
receive life saving medical care. A nationalized waiting list would 
also shift the responsibility of instituting measures to increase the 
supply of organs away from the individual states and regions. The needs 
of the individual regions may be very different and nationalized 
policies may not serve them well.
    Question 2. Pennsylvania has instituted a program that pays 
families of organ donors $300.00 in state contributions for the donor's 
funeral expenses, starting this July. What is your opinion on this type 
of program?
    Response. I agree. $300.00 is not likely to spark too much more 
organ donation but it is a step in the right direction. We are not 
suggesting that cadaveric organ donors get paid per se, but there needs 
to be some incentive. The process of organ donation can interrupt the 
mourning process and delay funeral proceedings. While $300.00 does not 
begin to pay the entire bill, it can make up for the slight 
inconvenience imposed by organ donation. Limited life insurance 
policies is another good suggestion. We at the Medical College of 
Virginia are the leading center on living donor adult to adult liver 
transplantation. Even though the donor operation is included in the 
cost of the recipient operation, nevertheless, donors have to come back 
to the hospital for medical check ups, lab work as a normal post 
operative period after a very delicate surgery. They need to stay out 
of work for at least three weeks to one month. We can see in this field 
that reimbursement for the lost time at work and in other expenses 
associated with living donor organ donation is also a reasonable 
incentive.
    Question 3. The proposed HHS regulations to reallocate organs state 
that ``the OPTN is required to develop equitable allocation policies 
that provide organs to those with the greatest medical urgency, in 
accordance with sound medical judgement.'' When President Clinton 
signed H.R. 3579, the Supplemental Appropriations and Rescissions Act, 
on May 1, 1998, which extended the public comment period and 
implementation deadline for the HHS OPTN regulations, he issued a 
written statement in opposition to extending the comment period on the 
rule. In stating his reasons for opposing the extension, President 
Clinton stated that ``The final rule would ensure that organs are 
allocated to the sickest candidates first.'' What would be the supply 
side effects of a policy where organs were to be allocated to ``the 
sickest candidates first''?
    Response. This has been discussed in detail by PAT Coalition. 
Allocation to the ``sickest first'' on a national level will increase 
wait list mortalities, waste organs, increase retransplantation rates, 
disadvantage medically and economically disenfranchised segments of the 
population by limiting access to transplantation for indigent patients 
as smaller centers are forced to close their doors. The organs would be 
diverted to the most critically ill patients first, regardless of their 
location. While this may sound like a fair and reasonable way to 
allocate organs, a policy such as this may actually result in lost 
lives. The immediate and long term survival of liver transplant 
recipients is directly dependent on their preoperative condition, with 
significant decompensation adversely affecting survival. Blindly 
applied legislation may mean that a significant number of organs are 
given to people with little chance of survival. Organs may not become 
available for others until they too are critically ill with little 
chance of survival.
    Question 4. How do we increase the consent rates for families to 
donate organs? What recommendations would you offer to increase the 
number of individuals willing to donate their organs?
    Response. Making drivers license decision a legally binding 
document (which it actually is in the state of Virginia, by the way) 
and limiting liability and exposure of OPO's with respect to families 
of individuals who have designated themselves donors on their license. 
Public education and education of medical community involved in 
identifying and deciding brain dead patients. ``Required request'' has 
already led to some increase. Further study of states/countries where 
``presumed consent'' is operational is warranted.
    Question 5. In your estimation, how would the Department of Health 
and Human Services regulation published April 2, 1998, affect your 
patients and your ability to provide the highest quality of medical 
care for them? What impact will this rule have on local access to 
transplant services nationwide?
    Response. The portion of the April 2 HHS rule which would create a 
national wait list will severely limit access to transplantation for 
the indigent population by forcing small and moderately sized centers 
to close their doors. This concept is designed to support only a select 
few very large transplant centers, which would regionalize access to 
transplantation to only a few places in the entire country. It is 
obvious that moderately sized centers, such as our own, not only can 
provide high quality transplant patient services, but also provide the 
innovative driving force required to develop something like a ``living 
donor adult-to-adult right lobe'' liver transplant program, etc.
    Question 6. Could you please explain to the Committee why some 
areas of the country have much higher rates of organ donation than 
others?
    Response. In general, areas involved with a regional or local 
transplant center have the highest donation rates. Other factors 
include the socioeconomic and religious fabric of the regional culture, 
organization and effectiveness of OPO's, etc.
    Question 7. As you know, the Department of Health and Human 
Services regulations have created quite an intense debate about the 
allocation of organs for transplantation. Some suggest, however, that 
the debate would be more constructive if it revolved around organ 
donation instead. What is your opinion?
    Response. Very definitely organ donation is the problem, with 
allocation a distant secondary problem. Primary effort should be 
directed to increasing the number of organs available for 
transplantation. The present allocation scheme, although not perfect, 
should not be completely discarded, since it is working pretty well. 
Analysis of waiting time differences between regions in the country 
will need to await data generated AFTER uniform listing and medical 
urgency criteria have been in effect for some time, since to do so now 
is to compare apples to oranges.
    Question 8. As the number of transplant programs across the country 
has grown, has the number of transplant procedures grown also? Can you 
elaborate on the estimated number of procedures which will be performed 
with the next five years?
    Response. The number of procedures will continue to increase, but 
slowly, until or unless there is a major increase in supply of 
available transplantable organs either by increase in cadaveric donors, 
living donors, or xenotransplantation comes of age. Cadaveric donors 
are slowly increasing, and this slight increase is due to the 
willingness of transplant physicians and patients to consider organs 
from donors that in the past would have been not used due to the age of 
the donor or the events that surrounded the donors death. This is the 
so called ``marginal'' donor and it is through the use of the marginal 
donor that this increase has come about. The living donor is an 
excellent source of organs and since for every liver that is obtained 
from a living donor a patient on the waiting list that does not happen 
to be fortunate enough of having a living donor will automatically move 
up one step in the waiting list. Techniques like splitting livers can 
potentially double the number of organs available. Although it is 
important to know that splitting the liver will still only benefit one 
adult for every single liver that is procured. Therefore, with this 
technique, the shortage of organs for adults which is the main problem 
in America, can not be solved.
    Question 9. In your opinion, does an active local transplant 
program stimulate organ donation?
    Response. Very definitely so!!!
    Question 10. What would you define as an appropriate role for the 
federal government in the formulation of transplant policy?
    Response. Federal government should act as an oversight group for 
policies generated by National Transplant Community, as it has since 
NOTA was first enacted in 1984, and UNOS has administered the OPTN 
contract.
    Question 11. Dr. Marcos, you were recently quoted in an interesting 
article entitled ``Increasing Split Livers Will Decrease Organ 
Shortage,'' published in the American Medical News, on the importance 
of developing living donor transplants. You state in this article that 
45% of the transplants you do are living donor transplants. What do you 
think the upper bound limit of living donor transplants is?
    Response. 45% living donor livers in our program over the past year 
is a function of decline in cadaveric donors! It is hard to say what 
the upper limit is, but it will never fulfill the need for people on 
the wait list. Hepatitis C is epidemic, for example, and thus we might 
expect a large increase in end stage liver disease requiring liver 
transplant in the near future. As more organs become available through 
a living donor, patients that were not considered for transplantation 
in the past due to the shortage of organs, this being the case of 
patients with cancer of the liver, can be considered for living donor 
liver transplantation under very rigorous protocols.
    Question 12. Given the severe shortage of livers available for 
transplantation, how prevalent do you foresee split liver transplants 
becoming within the next few years? How will the more frequent use of 
split liver transplants affect the length of the waiting list?
    Response. Split livers only benefits one adult per liver. The other 
beneficiary will be a pediatric recipient. The pediatric shortage of 
organs has decreased significantly with the excellent use of the living 
donor adult to child liver transplant which has been happening all over 
the world. They per se are not the group of the population that is in 
desperate need of organs. Not only does splitting the liver offers one 
liver per adult, if any problems may arise from the use of the liver it 
will mean that it could potentially take at least two livers to benefit 
a single adult. Which would be working against the adults on the 
waiting list.
    Question 13. I understand that the UNOS committee with 
responsibility for this area is recommending a rule that would increase 
the supply of livers by dividing them and encouraging greater sharing. 
When do you anticipate this new rule will go into effect?
    Response. Ask UNOS. It seems to be too soon. I don't think it will 
be particularly effective. Splits have many more complications. 
Splitting livers can potentially increase the shortage for adult organs 
benefitting only pediatric recipients.
    I hope I have successfully answered your questions. If you have any 
questions or concerns, please do not hesitate to contact me.
            Sincerely Yours,
          Amadeo Marcos, Assistant Professor of Surgery    
                     Director of the Living Donor Liver Program    
                                        Division of Transplantation
                                 ______
                                 
                        American Society of Transplantation
                                                     April 30, 1999
The Honorable Michael Bilirakis
Chairman, Subcommittee on Health and Environment
U.S. House of Representatives
Committee on Commerce
Room 2125, Rayburn House Office Building
Washington, D.C. 20515-6115
    Dear Mr. Bilirakis: Thank you for allowing me to testify on behalf 
of the American Society of Transplantation (AST) before the 
Subcommittee on Health and Environment for the April 15, 1999 hearing 
entitled, ``Putting Patients First: Increasing Organ Supply for 
Transplantation.'' The AST is strongly supportive of your leadership in 
advancing solutions to enhance organ donation, the most critical issue 
facing patients in need of organ transplantation.
    At your request, I am here responding to the 14 questions you sent 
subsequent to the hearing.
    Question 1. At the hearing, witnesses testified about numerous 
state programs to increase organ supplies. If Congress were to move to 
a national waiting list system, how would that impact existing state 
policies designed to increase organ supplies?
    Response. It is not evident that a national waiting list system 
would have any impact at all on existing state policies designed to 
increase organ supplies. Indeed, it is important that we do not get 
caught in the trap of confusing donation efforts with allocation. Any 
program that supports donation is valuable, but it should not be 
directly tied to allocation.
    The congressionally mandated Organ Procurement and Transplant 
Network (OPTN) operates as a national waiting list system, coordinating 
the placement of organs throughout the country according to national, 
regional and local algorithms. This should not be confused with a 
single national waiting list, an artificially constructed proposed 
national sharing arrangement for a single pool of organ recipients, 
which is in fact, not endorsed by the OPTN contractor, UNOS, the 
Secretary of Health, or the AST.
    While many groups have worked hard to increase donation, including 
the national and local governments, UNOS, professional societies, 
patient groups, etc, there should be agreement that the 62 organ 
procurement organizations (OPOs) form the local nucleus of organ 
donation and recovery. We hope that State efforts work in concert with 
the local OPOs that have responsibility for organ donation and recovery 
in their states to ensure maximum yield. So too, must national and 
state policies work hand in hand to promote the optimal donation, 
recovery and transplantation of these precious organs. Certainly, a 
national policy of organ distribution should be fashioned, to the 
extent possible, in a manner which will enhance organ recovery in the 
states and not discourage it in any way.
    Question 2. Pennsylvania has instituted a program that pays 
families of organ donors $300 in state contributions for the donor's 
funeral expenses, starting this July. What is your opinion on this type 
of program?
    Response. We support carrying out creative pilot studies to explore 
the possibility that quite modest financial supports may enhance organ 
donation, such as the one in Pennsylvania. In my testimony, I also 
mentioned the support currently being provided to organ donation by the 
state of Georgia. In the Georgia program, driver's license renewal fees 
are discounted by $2.00 for those who designate their wishes to be 
organ and tissue donors. These experiments should be carried out under 
carefully controlled conditions, and their results should be thoroughly 
examined. If such programs are successful, opportunities for broader 
application should be sought. However, with any and all such efforts, 
we must respect and preserve the basic underlying altruism and public 
trust, which is the foundation of organ donation.
    Question 3. The proposed HHS regulations to reallocate organs state 
that ``the OPTN is required to develop equitable allocation policies 
that provide organs to those with the greatest medical urgency, in 
accordance with sound medical judgement.'' When President Clinton 
signed H.R.3579, the Supplemental Appropriations and Rescissions Act, 
on May 1, 1998, which extended the public comment period and 
implementation deadline for the HHS OPTN regulations, he issued a 
written statement in opposition to extending the comment period on the 
rule. In stating his reasons for opposing the extension, President 
Clinton stated that, ``The final rule would ensure that organs are 
allocated to the sickest candidates first.'' What would be the supply-
side effects of a policy where organs were to be allocated to ``the 
sickest candidates first''?
    Response. We must first understand that medical urgency is most 
suitably applied to the instance of life-saving organ transplants such 
as the heart or liver and only more selectively to life-enhancing organ 
transplants like the kidney or pancreas. In the case of hearts and 
livers, the present system of allocation is strongly weighted toward 
the sickest patients with the greatest medical urgency, and in fact 
because of broader regional sharing for such organs, the waiting times 
for these ``Status 1'' patients are quite similar throughout the 
nation. Importantly, we must also continue to balance practical 
concerns for utility, especially for the majority of potential organ 
recipients so that overall results are optimized. It can be argued that 
reserving the allocation of organs to only the sickest candidates may 
decrease the overall good that can come from these organs. This is 
because the sickest candidates, even if transplanted, are more likely 
to die than are transplant recipients who are less ill. Put another 
way, policies that increase the number of organs that are allocated to 
the sickest will likely reduce the total number of individuals who live 
with functioning transplants. Of course, all of this results from a 
donor shortage that forces us to explicitly ration organs one way or 
the another.
    Question 4. How do we increase the consent rates for families to 
donate organs? What recommendation would you offer to increase the 
number of individuals willing to donate their organs?
    Response. Family refusal is a major impediment to organ donation 
despite the fact that national public opinion polls have demonstrated 
that more than 75% of individuals profess to be supportive. Clearly we 
must find new ways to better translate this public awareness into 
action with higher consent rates. We must work diligently to solve this 
problem through research efforts, epidemiological studies, and public 
awareness campaigns. We must better define those factors characterizing 
the most successful OPOs and support the appropriate extension of 
effective strategies to other areas of the country. We must also be 
willing to support and study innovative local/state initiatives to 
increase organ donation. Indeed, it is encouraging that the Division of 
Transplantation, located in the Health Resources and Services 
Administration has recently issued a request for proposals (RFP) to 
increase organ and tissue donation. By identifying and understanding 
the fundamental characteristics of successful strategies, we will 
become more successful and more cost-effective in our future efforts.
    Question 5. In your estimation, how would the Department of Health 
and Human Services regulations published April 2, 1998, affect your 
patients and your ability to provide the highest quality of medical 
care for them? What impact will this rule have on local access to 
transplant services nationwide?
    Response. The impact of these regulations on the quality of medical 
care would depend upon the formulation of the policies of allocation by 
the OPTN. Those allocation policies will determine who gets 
transplanted but should not affect the care provided by physicians to 
transplant recipients. There is no evidence that broad sharing will 
diminish local access. In fact, there are data that demonstrate that 
new local programs flourish in areas that have broad sharing.
    Question 6. Could you please explain to the Committee why some 
areas of the country have much higher rates of organ donation than 
others?
    Response. According to the current measure of donation rates 
(donors per million base populations), there is significant variation 
in the performance of OPOs. Many factors play a role in the variation 
in organ donation rates, such as the characteristics of the local 
population and the commitment of resources provided by the local OPOs. 
However, it is also broadly recognized that this measure (donors per 
million base populations) is flawed and does not provide accurate data. 
Newer measures, such as donors/1000 deaths or conversion rates of 
acceptable donors may be better measures. An ongoing Association of 
Organ Procurement Organization (AOPO) study has already shown that OPOs 
that appear to be functioning poorly by one measure may be outstanding 
by another. Until there is clearer agreement on appropriate outcome 
measures, we can't fully answer this question. Nevertheless, it is 
probable that some OPOs are more successful in converting potential 
donors into actual donors, and we should attempt to identify 
explanations. Ultimately, if we can identify reasons for differences in 
retrieval rates, then we may be able to exploit this knowledge to 
improve the performance of all OPOs.
    Question 7. As you know, the Department of Health and Human 
Services regulations have created quite an intense debate about the 
allocation of organs for transplantation. Some suggest, however, that 
the debate would be more constructive if it revolved around organ 
donation instead. What is your opinion?
    Response. These are two separate issues, each requiring careful 
consideration. If we had a sufficient supply of transplantable organs, 
the allocation questions could be more easily addressed. However, with 
our current serious shortage, the allocation debate tends to drown out 
discussions about donation, as UNOS and most OPOs have discovered. This 
is unfortunate as indeed, both are critically important, and both must 
be addressed separately.
    Question 8. As the number of transplant programs across the country 
has grown, has the number of transplant procedures grown also? Can you 
elaborate on the estimated number of procedures which will be performed 
within the next five years?
    Response. It is impossible to say for certain whether increases in 
the number of transplant programs has increased the number of 
procedures, or has only shifted procedures to other centers. However, 
given the reality of the present donor shortage, it is unlikely that 
further expanding the number of transplant centers will significantly 
increase the number of transplants performed. The number of donors 
inevitably limits the number of transplants.
    The number of transplants has increased modestly because of 
innovative techniques to increase the number of grafts per donor (e.g., 
split livers, transplanting two halves of a liver into two patients), 
decreasing organ ``wastage'' through the increased use of ``extended 
donors,'' and increased numbers of living donors for kidney and liver 
transplantation. At our current rate of donation, approximately one 
hundred thousand organ transplants are likely to be performed over the 
next five years. Unfortunately, this number will provide for less than 
25% of those on the waiting list.
    Question 9. In your opinion, does an active local transplant 
program stimulate organ donation?
    Response. In the early years of development of transplantation 
science and clinical practice, transplant programs and organ 
procurement programs were tightly linked. The activity of one was 
inexorably tied to the other. In the current era, transplant centers 
and OPOs are quite often separate and independent. Some have speculated 
that even in the present day, the activity of a local transplant 
program enhances local efforts to procure transplantable organs, though 
there are no data that substantiate this hypothesis. It is possible, 
for example, that interest stimulated by press reports of local 
transplant efforts could stimulate local organ donation. The argument 
can be made that individuals who read about others in their community 
receiving transplants may be more likely to sign a donor card, etc. 
However, we are not aware of any studies showing that there has been a 
greater-than-expected increase in local donation when a new transplant 
program opens. The recently implemented federal rule of required 
referral as a condition of participation in Medicare will likely 
diminish this influence if it does exist in any locales.
    Local transplant programs should be encouraged, first and foremost, 
when their presence provides improved access to care. If they also 
increase donation, that is an added bonus. Current experience 
demonstrates that local programs do thrive in areas with wide sharing.
    Question 10. What would you define as an appropriate role for the 
federal government in the formulation of transplant policy?
    Response. The transplant community should create through consensus 
and scientific research, the policies, which provide for organ 
transplantation in this nation. The federal government should provide 
appropriate oversight and authority to such policies so that they may 
be effectively implemented.
    Question 11. You stated in your testimony that a lack of leave time 
has served as a significant barrier and disincentive for individuals 
willing to share the gift-of-life. What are the recovery times for 
kidney and liver donors?
    Response. Living donation is currently under utilized. It is 
important to identify and alleviate any and all disincentives to this 
important altruistic behavior. Part of that process is the recognition 
that kidney donors typically require 4-6 weeks of recovery and time 
away from work. For liver donors, this is typically in the range of 6-8 
weeks.
    Question 12. From 1988 to 1997, the annual number of kidneys 
donated by living persons rose 104 percent, from 1,812 to 3,705. What 
brought about this increase?
    Response. It is likely that the recent increase in living donors, 
including biologically unrelated donors, has been due to a combination 
of factors. Living donors have been strongly motivated to donate 
because of the increasing waiting times for cadaveric donors. In 
addition, altruism has increased with the demonstrated success of the 
procedure. It is also now recognized that the success of living donor 
transplants, including living unrelated kidneys, is better than that of 
cadaver organs.
    Question 13. As transplant centers use new techniques to cut 
recovery times, will that have the effect of increasing donation? Can 
you comment on the new surgical procedure at Johns Hopkins that is 
cutting the recovery time of kidney donors?
    Response. While it appears that only a small percentage of 
potential living kidney donors are dissuaded to donate simply because 
of the concern for morbidity with the standard surgical techniques, 
many transplant centers around the nation are now or soon will be 
utilizing the laparascopic approach to donor nephrectomy as an elective 
alternative. The early results of this experience suggest that although 
hospital lengths of stay and donor recovery times are slightly shorter, 
other complications can arise. More research is necessary before 
concluding whether such techniques will appreciably enhance living 
donation.
    Question 14. Your written testimony requested that ``increased 
funding be provided to the Division of Transplantation, located in the 
Health Resources and Services Administration (``HRSA'') with additional 
funds for FY2000.'' My understanding is that Congress gave $5.9 million 
above the President's request for the ``Extramural Support Program to 
Increase Organ and Tissue Donation'' for Fiscal Year 1999, and the 
Administration's request for proposals was just published on April 5, 
1999. Can you explain why the Health Resources and Services 
Administration only recently requested this additional funding?
    Response. It is not unusual that several months are required to 
develop an adequate RFP and review process when a new competitive 
contract is announced. We are confident that there will be many 
applicants for these contracts and that the money will be awarded in FY 
99.
    Thank you again for the opportunity to provide testimony. The AST 
stands ready to assist you and your committee in any way that we can to 
enhance the opportunities for patients in need of organ 
transplantation.
            Sincerely,
                                        John F. Neylan M.D.
                     President, American Society of Transplantation
                                 ______
                                 
                                 Gift of Life Donor Program
                                                       May 18, 1999
Michael Bilirakis, Chairman
Subcommittee on Health and Environment
U.S. House of Representatives
Committee on Commerce
Room 2125
Rayburn House Office Building
Washington, DC 20515-6115
    Dear Representative Bilirakis: I am writing in response to your 
April 21, 1999 request in follow up to my April 15 appearance before 
the Subcommittee on Health and Environment on Putting Patients First: 
Increasing Organ Supply for Transplantation. Just as I testified on 
April 18, I am responding as President and CEO of Gift of Life Donor 
Program (formerly Delaware Valley Transplant Program [``DVTP'']) and 
President of the Coalition on Donation.
    The number of each item corresponds with the number in your April 
21 letter:
    Question 1.At the hearing, witnesses testified about numerous state 
programs to increase organ supplies. If Congress were to move to a 
national waiting list system, how would this impact existing state 
policies designed to increase organ supplies?
    Response. There are no current state policies/ laws in 
Pennsylvania, New Jersey or Delaware that address organ allocation. We 
follow national policies and guidelines for the allocation of all 
organs. I do not believe that allocation should be restricted in any 
way by state law; this would go against the intent of the existing 
statutory model which provides for a national transplant system.
    The existing state organ donor laws address programs to increase 
organ and tissue donations. As you are aware, the ``Routine Referral'' 
law passed in Pennsylvania in 1994 has resulted in significant 
increases in organ donations. We anticipate that additional steps 
forward in reducing the organ shortage will occur with the 
implementation of the ``Routine Referral'' standard for Medicare and 
Medicaid participating hospitals.
    By and large, we believe that the greatest impact of the current 
debate and attempts to mandate change in the allocation of a scarce 
national resource has been to harm public trust in the organ donation 
and transplant system. The current system has been characterized as 
being broken and unfair to most patients. That simply is not true.
    While historically there have been discrepancies in waiting times 
by region, those discrepancies are in large part based on a system of 
organ allocation that no longer exists. Major changes to the liver and 
heart allocation policies have been instituted during the past two 
years to ensure that the sickest patients receive priority to the 
extent medically feasible. I believe that today's data would reveal 
very different results than data from 1996 upon which the current organ 
allocation debate is framed.
    Question 2. Pennsylvania has instituted a program that pays 
families of organ donors $300 in state contributions for the donor's 
funeral expenses, starting this July. What is your opinion on this type 
of program?
    Response. In 1994, the Pennsylvania legislature enacted a 
comprehensive law promoting organ donation in the Commonwealth. This 
pioneer legislation included the Routine Referral standard that has 
become a national model. The legislature recognized that in order to 
effectively combat the organ shortage, an effective public education 
and awareness campaign had to be instituted. This included the 
establishment of an Organ Donation Awareness Trust Fund which has among 
its stated purposes the financial support of organ donation awareness 
programs. Included in the legislation was the mandate for development 
of a pilot program such as the Voluntary Death Benefit Program which 
will allow limited reimbursement (directly to the provider, such as the 
funeral home) of certain donor family expenses. Under the guidance of a 
Organ Donation Advisory Committee, and various state agencies, along 
with involved legislators and citizens, the Commonwealth is seeking to 
implement the pilot Voluntary Death Benefit Program provided for under 
the legislation. The Voluntary Death Benefit Program has not yet been 
instituted. Final recommendations for this program will be made on June 
9 to the Secretary of the Pennsylvania Department of Health and then to 
Pennsylvania Governor Tom Ridge. This program is but one component of a 
comprehensive approach to increasing organ donations in the state.
    In the context of Pennsylvania's overall organ donor law, we 
believe that the pilot Benefit program should be tried and that it may 
impact donation rates by providing another contact with families so 
that they can receive information regarding organ donation. We are 
doubtful that the ``benefit'' (which is anticipated to be no more than 
$300 and which will paid directly to the funeral to reimburse for 
costs) will have an immediate or noticeable impact on consent rates. 
However, over time, the discussion regarding the availability of the 
benefit may lead more people to be familiar with the concept of organ 
donation.
    Question 3. The proposed HHS regulations to reallocate organs state 
that ``the OPTN is required to develop equitable allocation policies 
that provide organs to those with the greatest medical urgency, in 
accordance with sound medical judgment.'' When President Clinton signed 
H.R. 3579, the Supplemental Appropriations and Rescissions Act, on May 
1, 1998 which extended the public comment period and implementation 
deadline for the HHS OPTN regulations, he issued a written statement in 
opposition to extending the comment period on the rule. In stating his 
reasons for opposing the extension, President Clinton stated that ``The 
final rule would ensure that organs are allocated to the sickest 
candidates first. What would be the supply-side effects of a policy 
where organs were to be allocated to the ``sickest candidates first?''
    Response. We believe that the current system of policy development 
is sound. It is based on consensus building and medical judgement. 
Major changes to the liver and heart allocation policies have been 
instituted during the past two years by the Organ Procurement and 
Transplantation Network (``OPTN'') contractor, the United Network for 
Organ Sharing (``UNOS''). This includes standardized listing criteria 
for patients and changes to the status designations for liver and heart 
patients. We believe that the current system, while not perfect, is 
designed to ensure that the sickest patient is offered the organ first. 
We know in our region that the vast majority of patients receiving 
heart and liver transplants are transplanted at the highest level of 
acuity and are the sickest patients in our region.
    We believe that further changes to mandate a single national list 
for allocation, may lead to organs being wasted and potential donors 
lost given the attendant medical and social issues.
    Question 4. How do we increase the consent rates for families to 
donate organs? What recommendations would you offer to increase the 
number of individuals willing to donate their organs?
    Response. There is no one answer to the issue of increasing consent 
rates. Expanded public education programs combined with best-
demonstrated practices in hospitals can lead to increased consent 
rates.
    National public education campaigns such as those conducted by the 
national Coalition on Donation can, over time, impact public opinion 
and encourage people to take action. The major limitation to public 
services campaigns and initiatives is funding. Although the Coalition 
campaign is the major public education initiative in the United States, 
it receives no grant money or funding from the Federal Government.
    Other initiatives that should be explored include the creation of 
statewide registries or a national registry of organ donors.
    Pennsylvania's Drivers License Donor registry is now the second 
largest in the nation (Illinois has the largest). The Pennsylvania 
Drivers License Donor registry provides an important opportunity to 
educate citizens and to record their decisions about organ donation. In 
addition to Pennsylvania and Illinois, Florida, Delaware, Georgia, 
Louisiana, Maryland and Missouri have similar registries. Additionally, 
as stated in my April 15 testimony:

The Ad Council, in conjunction with its tremendous talent and more than 
        50 years of communication expertise, has created four campaigns 
        that have been distributed to more than 30,000 media outlets in 
        the past six years.
The James Redford Institute for Transplant Awareness developed a film 
        to educate teens about donation and transplantation and has 
        partnered with the Coalition to distribute the film nationwide 
        for the 1999-2000 school year.
Through the Coalition, Congress and the transplant community 
        successfully partnered to distribute more than 60 million donor 
        cards in 1997 as provided by the National Donor Card Insert 
        Act.
The U.S. Postal Service working with the Coalition to promote the 
        issuance of and distribution of an organ donor awareness stamp 
        in 1998.
Significant also is the anticipated announcement by a major motion 
        picture studio that it will create a new public service 
        campaign for UNOS and the Coalition. This will include the 
        development of public education pieces on organ donation and 
        transplantation by a number of nationally recognized ad 
        agencies.
    We believe that on-going focused public awareness initiatives are 
critical to addressing the organ shortage.
    Question 5. In your estimation, how would the Department of Health 
and Human Services regulations published April 2, 1998, affect your 
patients and your ability to provide the highest quality of medical 
care for them? What impact will this rule have on local access to 
transplant services nationwide?
    Response. Mandating a national allocation system for all organs is 
likely to spur growth at a few large centers in the country but may 
impact the viability of smaller programs. This may have the effect of 
reducing or inhibiting access to services by those recipients and their 
families who are not able to travel to large centers due to economic 
and other barriers. Additionally, mandating a national allocation 
system of organs will eliminate the concept of local neighbor helping 
neighbor. Complete elimination of the concept of neighbor helping 
neighbor may adversely impact donation. Finally, a national allocation 
system disregards differences in medical judgment and opinion. It also 
disregards the practices of transplant surgeon who perform the organ 
recovery and view the organ in the donor patient and evaluate biopsy 
results (for livers) in order to evaluate suitability for transplant 
generally, as well as suitability for a specific recipient.
    Question 6. Could you please explain to the Committee why some 
areas of the country have much higher rates of organ donation than 
others?
    Response. This is a complex question. Donation rates are a 
combination of level of public support, hospital participation, 
demographics of the local population, performance of organ procurement 
organizations and willingness of transplant surgeons to use expanded 
donors and non-heart beating cadaver donors.
    Our organization commits significant resources to grass roots 
public education. We also have extensive hospital development and 
education programs. We have very strong relationships with key 
physicians and health care professionals in our hospitals and are 
largely viewed as an extension of the hospital's care team. These 
partnering relationships enable our staff, who are specially trained in 
the process of interacting with grieving families regarding donation, 
to play a leading role in the consent discussion with families. Many 
OPOs, quite simply, do not have the same collaborative relationships 
with their regional hospitals and health care professionals. These 
relationships are critical to assuring that families are advised of the 
donor option in a sensitive and caring manner and are provided with all 
of the information needed in order to make a decision regarding 
donation.
    Question 7. As you know, the Department of Health and Human 
Services regulations have created quite an intense debate about the 
allocation of organs for transplantation. Some suggest, however, that 
the debate would be more constructive if it revolved around organ 
donation instead. What is your opinion?
    Response. We agree with this statement. As we have stated in 
numerous public forums it is only by implementing measures that 
increase the number of organs donated that our nation can address the 
critical organ shortage that exists in this country. Rather than 
completely overhauling a system that has had much success, attention 
must be focused on donation. The Routine Referral laws which have been 
enacted must be fully implemented along with comprehensive donor 
education programs. We urge Congress and HHS to support donor awareness 
efforts through public education programs. Financial support must be 
committed to strengthening the nation's understanding of the options 
families face when their loved ones die.
    We also believe that the public debate over allocation during the 
past few years has adversely impacted the public's view of the donation 
process. Any debate regarding allocation must be conducted in a 
thoughtful and responsible manner so that those who have donated 
understand the positive impact of their gifts.
    Question 8. As the number of transplant programs across the country 
has grown, has the number of transplant procedures grown also? Can you 
elaborate on the estimated number of procedures which will be performed 
within the next five years?
    Response. We believe that the data demonstrates that more people 
who are medically suitable candidates for transplantation will undergo 
transplantation if the services are available in local communities. 
Citizens and community doctors have become well educated about the 
success of transplantation and the availability of services in local 
communities.
    Question 9. In your opinion, does an active local transplant 
program stimulate organ donation?
    Response. We believe that active local transplant programs heighten 
the public's awareness and understanding of the issues surrounding 
donation and transplantation. By virtue of the fact that more members 
of the local community are involved in donation and transplantation 
issues, the organ donor shortage is a prominent and well publicized 
issue in the media in our communities.
    Question 10. What would you define as an appropriate role for the 
federal government in the formulation of transplant policy?
    Response. The Federal Government's primary objective should be to 
maximize and encourage organ donation through appropriate public policy 
initiatives and with funding programs for education.
    Question 11. How do you expect the supply shortages to be impacted 
by the implementation of routine notification policies? In 
Pennsylvania, we saw substantial increase in organ donation after the 
program took effect. Are we likely to see similar increases nationally 
as a result of the new Conditions of Participation for Medicare and 
Medicaid?
    Response. We believe our experiences in Pennsylvania can and will 
be replicated in other parts of the country. As I testified on April 
15, in just four years after enactment of the law, the number of donors 
that our program coordinated in its Pennsylvania service area increased 
by 43%. Similarly, the number of actual organ transplants that we 
coordinated in 1998 was 50% greater than the number we coordinated in 
1994. This growth occurred at a time when organ donations nationally 
increased an average of less than 2-3% a year.
    Preliminary data reveals that national organ donation rates for 
calendar year 1998 are approximately 5.5% higher than the donation 
rates for calendar year 1997. The most significant increases appear to 
have occurred the last four months of 1998; the four months following 
the effective date of the federal Routine Referral rules. I anticipate 
that just as our donation rates have continued to rise, the national 
rates will continue to rise with Congress' full support of this federal 
Routine Referral standard and the continued cooperation of the medical 
community.
    Question 12. Is the National Donor Card Insert Act succeeding in 
its goal of increasing organ supplies?
    Response. The National Donor Card Insert Act was a one-time program 
to distribute cards with income tax refunds. We believe that any method 
of distributing donor cards and information to millions of Americans is 
worthwhile. This program is worth repeating. Given the appropriate time 
and financial resources, the Coalition could develop enhanced programs 
for evaluating programs like this one.
    Thank you for the opportunity to provide additional information. 
Please do not hesitate to contact me at 215-557-8090 if you have any 
questions.
            Sincerely,
    Howard M. Nathan, President and Chief Executive Officer
                               and President, Coalition on Donation
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