[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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