[House Hearing, 106 Congress]
[From the U.S. Government Publishing Office]
ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK AMENDMENTS OF 1999
=======================================================================
HEARING
before the
SUBCOMMITTEE ON
HEALTH AND ENVIRONMENT
of the
COMMITTEE ON COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED SIXTH CONGRESS
FIRST SESSION
on
H.R. 2418
__________
SEPTEMBER 22, 1999
__________
Serial No. 106-75
__________
Printed for the use of the Committee on Commerce
------------------------------
U.S. GOVERNMENT PRINTING OFFICE
59-992CC WASHINGTON : 1999
COMMITTEE ON COMMERCE
TOM BLILEY, Virginia, Chairman
W.J. ``BILLY'' TAUZIN, Louisiana JOHN D. DINGELL, Michigan
MICHAEL G. OXLEY, Ohio HENRY A. WAXMAN, California
MICHAEL BILIRAKIS, Florida EDWARD J. MARKEY, Massachusetts
JOE BARTON, Texas RALPH M. HALL, Texas
FRED UPTON, Michigan RICK BOUCHER, Virginia
CLIFF STEARNS, Florida EDOLPHUS TOWNS, New York
PAUL E. GILLMOR, Ohio FRANK PALLONE, Jr., New Jersey
Vice Chairman SHERROD BROWN, Ohio
JAMES C. GREENWOOD, Pennsylvania BART GORDON, Tennessee
CHRISTOPHER COX, California PETER DEUTSCH, Florida
NATHAN DEAL, Georgia BOBBY L. RUSH, Illinois
STEVE LARGENT, Oklahoma ANNA G. ESHOO, California
RICHARD BURR, North Carolina RON KLINK, Pennsylvania
BRIAN P. BILBRAY, California BART STUPAK, Michigan
ED WHITFIELD, Kentucky ELIOT L. ENGEL, New York
GREG GANSKE, Iowa THOMAS C. SAWYER, Ohio
CHARLIE NORWOOD, Georgia ALBERT R. WYNN, Maryland
TOM A. COBURN, Oklahoma GENE GREEN, Texas
RICK LAZIO, New York KAREN McCARTHY, Missouri
BARBARA CUBIN, Wyoming TED STRICKLAND, Ohio
JAMES E. ROGAN, California DIANA DeGETTE, Colorado
JOHN SHIMKUS, Illinois THOMAS M. BARRETT, Wisconsin
HEATHER WILSON, New Mexico BILL LUTHER, Minnesota
JOHN B. SHADEGG, Arizona LOIS CAPPS, California
CHARLES W. ``CHIP'' PICKERING,
Mississippi
VITO FOSSELLA, New York
ROY BLUNT, Missouri
ED BRYANT, Tennessee
ROBERT L. EHRLICH, Jr., Maryland
James E. Derderian, Chief of Staff
James D. Barnette, General Counsel
Reid P.F. Stuntz, Minority Staff Director and Chief Counsel
______
Subcommittee on Health and Environment
MICHAEL BILIRAKIS, Florida, Chairman
FRED UPTON, Michigan SHERROD BROWN, Ohio
CLIFF STEARNS, Florida HENRY A. WAXMAN, California
JAMES C. GREENWOOD, Pennsylvania FRANK PALLONE, Jr., New Jersey
NATHAN DEAL, Georgia PETER DEUTSCH, Florida
RICHARD BURR, North Carolina BART STUPAK, Michigan
BRIAN P. BILBRAY, California GENE GREEN, Texas
ED WHITFIELD, Kentucky TED STRICKLAND, Ohio
GREG GANSKE, Iowa DIANA DeGETTE, Colorado
CHARLIE NORWOOD, Georgia THOMAS M. BARRETT, Wisconsin
TOM A. COBURN, Oklahoma LOIS CAPPS, California
Vice Chairman RALPH M. HALL, Texas
RICK LAZIO, New York EDOLPHUS TOWNS, New York
BARBARA CUBIN, Wyoming ANNA G. ESHOO, California
JOHN B. SHADEGG, Arizona JOHN D. DINGELL, Michigan,
CHARLES W. ``CHIP'' PICKERING, (Ex Officio)
Mississippi
ED BRYANT, Tennessee
TOM BLILEY, Virginia,
(Ex Officio)
(ii)
------------------------------
C O N T E N T S
__________
Page
Testimony of:
Gibbons, Robert D., Professor of Biostatistics, School of
Medicine, Department of Psychiatry, University of Illinois
at Chicago, accompanied by Mitchell W. Spellman, Professor
of Surgery Emeritus and Dean of Medical Services Emeritus,
Harvard Medical School, and Susanne Stoiber, Executive
Officer, Institute of Medicine............................. 31
Irwin, Craig, President, National Transplant Action Committee 45
Miller, Joshua, Division of Transplantation, Department of
Surgery, University of Miami School of Medicine............ 40
Payne, William, Director, Liver Transplant Program, Fairview
Medical Center............................................. 26
Rabkin, John M., Chief, Liver/Pancreas Transplantation
Heptobiliary Surgery, Oregon Health Sciences University.... 51
Raub, William F., Deputy Assistant Secretary for Planning and
Evaluation/Science Policy, Department of Health and Human
Services................................................... 20
Material submitted for the record by:
Center for Donation and Transplant, letter dated September
16, 1999, to Hon. Michael R. McNulty....................... 94
Clarian Health, letter dated September 22, 1999, to Hon.
Thomas J. Bliley, Jr....................................... 87
Fiske, Charles, prepared statement of........................ 82
Gibbons, Robert D., Professor of Biostatistics, School of
Medicine, Department of Psychiatry, University of Illinois
at Chicago, letter to Hon. Diana DeGette, enclosing
response for the record.................................... 99
Jacksonville Transplant Center:
Letter dated July 26, 1999, to Hon. Corrine Brown........ 94
Letter dated July 26, 1999, to Hon. Charles T. Canady.... 95
Letter dated July 26, 1999, to Hon. Tillie Fowler........ 95
Letter dated July 26, 1999, to Hon. Cliff Stearns........ 96
LifeCenter:
Letter dated August 6, 1999, to Hon. Rob Portman......... 89
Letter dated August 6, 1999, to Hon. John A. Boehner..... 90
Letter dated August 6, 1999, to Hon. Steve Chabot........ 91
LifeSource, letter dated July 29, 1999, to Hon. Bill Luther.. 91
Louisiana State University Medical Center, letter dated
September 21, 1999, to Hon. Thomas J. Bliley, Jr........... 86
Meredith, Thomas L., letter dated June 24, 1999, to Hon. Ed
Bryant..................................................... 97
Mississippi Organ Recovery Agency, Inc., letter dated July
14, 1999, to Hon. Chip Pickering........................... 93
National Kidney Foundation, prepared statement of............ 85
Raub, William F., Deputy Assistant Secretary for Planning and
Evaluation/Science Policy, Department of Health and Human
Services, responses to questions of Hon. Diana DeGette..... 100
Saint Louis University Hospital, letter dated September 21,
1999, to Hon. Thomas J. Bliley, Jr......................... 89
Shands HealthCare, letter dated September 21, 1999, to Hon.
Thomas J. Bliley, Jr....................................... 88
Stark, Hon. Pete, a Representative in Congress from the State
of California, prepared statement of....................... 84
Tennessee Donor Services, letter dated September 21, 1999, to
Hon. Ed Bryant............................................. 98
Tennessee Transplant Society, letter dated August 2, 1999, to
Hon. Bill Frist............................................ 94
University Hospital, The, letter dated September 3, 1999, to
Hon. Steve Chabot.......................................... 96
University Hospitals of Cleveland, letter dated August 26,
1999, to Hon. Thomas C. Sawyer............................. 93
University of Alabama at Birmingham, letter dated September
20, 1999, to Hon. Thomas J. Bliley, Jr..................... 87
University of Florida, letter dated August 11, 1999, to Hon.
Karen Thurman.............................................. 92
University of Medicine and Dentistry of New Jersey, letter
dated September 20, 1999, to Hon. Thomas J. Bliley, Jr..... 86
University of Texas, letter dated September 2, 1999, to Hon.
Joe Barton................................................. 88
Weir, Bruce, President, Transplant Recipients International
Organization, Inc., prepared statement of.................. 84
(iii)
ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK AMENDMENTS OF 1999
----------
WEDNESDAY, SEPTEMBER 22, 1999
House of Representatives,
Committee on Commerce,
Subcommittee on Health and Environment,
Washington, DC.
The subcommittee met, pursuant to notice, at 10 a.m., in
room 2322, Rayburn House Office Building, Hon. Michael
Bilirakis (chairman) presiding.
Members present: Representatives Bilirakis, Burr, Bilbray,
Ganske, Coburn, Bryant, Brown, Waxman, Pallone, Green, Barrett,
and Eshoo.
Also present: Representative Klink.
Staff present: Marc Wheat, majority counsel; Clay Alspach,
legislative clerk; and John Ford, minority counsel.
Mr. Bilirakis. The hearing will come to order. Good
afternoon. I am pleased to convene this hearing on H.R. 2418,
the Organ Procurement and Transplantation Network Amendment of
1999. I was pleased to introduce this bipartisan legislation
with my colleague, Gene Green of Texas.
Last summer this subcommittee held a joint hearing with the
Senate Labor Committee to review our Nation's system for organ
allocation, and more specifically the changes proposed by the
Department of Health and Human Services. The Department's
proposed changes to the Organ Procurement and Transplantation
Network and the policies that it sets for all patients have
been, to say the very least, as we all know, controversial. A
majority of the comments received by the Department were very
critical of the regulation, and certainly we in Congress have
heard from many experts in the field about the consequences,
unintended or otherwise, of the Department's regulations.
We will have the opportunity to hear a range of views on
these issues generally and H.R. 2418 in particular from our
witnesses today.
Of course, many of us have already heard directly from our
constituents. Recently, I received a letter from Kathy Gibson,
a 49-year-old constituent who received two kidney transplants
within the past year. The second transplant, which was a
success, followed an unsuccessful first transplant using her
husband's kidney. Kathy received her second kidney through Life
Link Foundation, a nonprofit community service entity in Tampa
that operates four of the Nation's 62 organ procurement
organizations. She wrote to tell me how grateful she was for
Life Link's assistance saying, ``I have nothing but good things
to say regarding my transplant team from Tampa General Hospital
and Life Link Transplant Institute. They found me the gift of
life.''
H.R. 2418 was drafted with people like Kathy Gibson in
mind. The bill recognizes the decisions regarding organ
procurement and transplantation are best left to the medical
community, as Congress intended in passing the National Organ
Transplant Act of 1984. Those experts at the forefront of
changes in the medical profession are best suited to adjust
policies in light of new technology and new medical
understanding.
H.R. 2418 also addresses the underlying problem of an
inadequate organ supply by promoting incentives to increase
organ donation. For example, the bill includes innovative
provisions to help reduce the financial burden on living
donors. As the National Kidney Foundation has noted, these
provisions will help increase the supply of organs needed for
many men and women waiting for a matching organ to be
transplanted.
I want to welcome all of our witnesses. I appreciate their
time and effort in joining us and look forward to hearing their
testimony. As you know, we changed the time for this from 2 to
2:30 for a very good reason. I appreciate your understanding in
that regard.
I will now recognized the ranking member Mr. Brown for an
opening statement.
Mr. Brown. Thank you, Mr. Chairman. I would like to also
thank today's witnesses for joining us and a special thank you
to Representative Klink, who has joined us. He is not a member
of the subcommittee, but he has a special interest and
knowledge of this issue, especially in this western end of his
State and his district.
I would like to commend you, Mr. Chairman, for bringing
increased attention to a process within our health care system
that is critical to the lives of so many Americans, the process
of allocating an obviously scarce number of donated organs for
those individuals throughout the country waiting for and
praying for them. Your bill is intended to correct some
important problems and forestall others. It addresses the lack
of enforcement mechanisms to ensure that network participants
comply with quality standards. It reflects a view I believe
that we all share; that is, organ allocation decisions be
shielded from political bias.
However, Mr. Chairman, I am concerned that in an effort to
wall off organ donation allocation decisions from political
influence, H.R. 2418 also shields the organ allocation
contractor from the accountability and subordination to the
public that it should have. The bill appears to deny the
Secretary of Health and Human Services the right to exert any
authority over any allocation decisions that are scientific,
clinical or medical in nature. The private contractor that
coordinates the organ allocation could not be challenged on
decisions of that nature. Since no legitimate organ allocation
decisions are made outside the context of scientific, clinical
and medical considerations, this effectively undercuts the
Secretary's oversight of the contractor's activities. The
Secretary, charged with representing the public and the public
interest, would be unable to hold the organ allocation
contractor to its contract.
Let's explore a scenario, one we certainly hope would never
happen. Let's say a private contractor hired to allocate
donated organs determines, based on scientific and medical
data, that malnourished children should be the last to receive
donor organs because malnourishment is correlated with the
rejection of donor organs. Even if that decision reflects the
best science that medicine has to offer, is it the right thing
to do from a public policy perspective? Obviously not.
Malnourishment is not just correlated with rejecting donor
organs, it is also correlated, obviously, with poverty, with
the public agreeing to choose which child's life to save based
on family income.
As I read it, under H.R. 2418 the public would in the end
have no say in that matter. The organ allocation contractor
could implement the rule without--regardless of public policy
implications and without any public input. I am concerned that
the organ allocation contractor would have more power than the
entity it contracts with, particularly when the entity speaks
on behalf of the public. I question the wisdom of setting a
precedent like this when, for government contractor
relationships, it advocates the government's responsibility and
alleviates the contractor of accountability.
Mr. Chairman, I support the goal of ensuring an allocation
system free of political bias and designed to deter internal
breaches of quality. But the system as a whole and those who
administer it must also be held accountable. The Institute of
Medicine made a recommendation that I think would reconcile the
need for public accountability and the importance of keeping
politics out of organ allocation decisions. They recommended
the establishment of an external independent scientific review
board that would be charged with periodically assessing the
organ allocation system. Starting there we can achieve our
goals without compromising the integrity of the government/
contractor relationship.
I look forward to hearing our witnesses' perspectives on
this issues. I would like again to express my appreciation to
the chairman for his efforts.
Mr. Bilirakis. I thank the gentlemen.
Dr. Ganske for an opening statement?
Mr. Ganske. Thank you, Mr. Chairman. In the interest of
hearing testimony from our first panel, I just want to say I
appreciate you having the hearing, and I look forward to the
testimony. Thanks.
Mr. Bilirakis. Mr. Waxman, opening statement?
Mr. Waxman. Thank you very much, Mr. Chairman. Only 5
months have passed since our last hearing on organ allocation,
but a great deal has changed. For some time I have been deeply
troubled by the debate over the Department's final rule. I have
heard outright misrepresentations and gross misinformation
aimed at scaring patients, communities of color and the poor
into believing that the administration wanted to make it harder
for them to obtain organ transplants. UNOS has spent nearly $1
million lobbying Congress, dollars which should have gone
toward saving lives.
Today we finally have the cure for this lobbying and
rhetorical excess. The Institute of Medicine has provided us
with a blueprint for a more equitable and efficient organ
allocation system. They have reminded us that we must put
patients, not UNOS, not transplant centers, not transplant
surgeons, first. The IOM concluded that the final rule should
be implemented. They concluded that HHS should exercise
legitimate oversight responsibilities articulated in the final
rule. They documented how weak oversight has compromised
accountability at all levels, and they found that broader
sharing of organs won't hurt donation rates or close small
transplant centers.
The IOM report reveals a national organ allocation system
badly in need of reform, but H.R. 2418 ignores the IOM report.
Patients across the country say that this bill would only make
things or change things for the worse. It would strip the
Secretary of her oversight authority over UNOS. It would
insulate UNOS from competition and accountability. It would
grant sole authority over life-and-death decisions to an
organization that has fought to keep patient outcome data
secret, shielded its decisionmaking from public input, and
enforced its policies in a politically expedient manner.
Today a patient seeking a transplant has practically no
idea how well our transplant centers are performing. The data
is hidden somewhere in UNOS. After years of resistance, UNOS
has finally made some patient outcome data available, but that
data is for the years 1988 to 1994. That means that patients
are still in the dark about the centers' current performance.
Yesterday at our request the Department provided myself,
Mr. Dingell, Mr. Klink, and Mr. Stark with patient outcome data
for every transplant center in the country. This data is up-to-
date and was obtained under congressional mandate from UNOS.
This data shows that a patient's chances of survival depends
very much on where you get your transplant. Depending on the
transplant center, a patient's likelihood of getting a liver
transplant within a year of listing can range anywhere from 25
to 70 percent. Depending on the transplant center, if you are
waiting for a liver transplant, your likelihood of dying within
a year of listing can range from 7 to 22 percent.
This new data would help transplant patients make better
decisions, but this data is blinded and the transplant centers
are only identified by number. This afternoon I will formally
request that the Department provide us with the identities of
the transplant centers. When we receive this information, we
will provide transplant patients with all of this recent
information about every transplant center in the country,
information which UNOS should have made public a long time ago.
I want to thank you, Mr. Chairman, for holding this
hearing. I look forward to this afternoon's testimony.
Mr. Bilirakis. I thank the gentleman.
Dr. Coburn for an opening statement.
Mr. Coburn. Thank you, Mr. Chairman. I am not going to be
able to stay for the whole hearing because of other
obligations, but I wanted to make a couple points as we talked
about the IOM study. The IOM study, the Institute of Medicine,
is the same institute that said we shouldn't track HIV by
partner notification. They are the same people who
underestimated the sexually transmitted disease epidemic in
this country. Although they are valuable in their input, what
they say, in this physician's eyes, is not always 100 percent
accurate. I think that needs to be said without demeaning or
taking discredit for the efforts of those in the Institute of
Medicine.
The second thing that I would say and offer is my own State
has done a great job in terms of increasing the number of
transplant organs available. I have a great deal of difficulty
thinking that if families in Oklahoma have a loved one who
lives in Oklahoma, and Oklahoma is working hard in their one
good transplant center to perfect and improve survivability,
that Big Brother should not have the right to tell Oklahomans
that they can't direct an organ for their own State brothers
and sisters.
That is what we are really talking about here. There is a
States rights issue and a personal issue that has been ignored
in this process. I raise that because it is a concern to me. I
am not sure that it will be heated, but it is an important
thing if we really want States to be active. And should all
organ transplants be run by the Federal Government? That is
where we are headed, and I am not sure that is a great idea. I
am not sure it is great for innovation. I am not sure it is
great for patient longevity. I am not sure it is great for
people who are receiving transplants.
As a physician, I know transplant centers when they start
don't have good rates. As they perfect and get better, they
improve. So I would just hope that we would consider those
thoughts as we hear this testimony and ask the questions. With
that, I yield back and thank you, Mr. Chairman, for this
hearing.
Mr. Bilirakis. I thank the gentleman.
Mr. Green, for an opening statement.
Mr. Green. Thank you, Mr. Chairman, for scheduling this
hearing on H.R. 2418 today. I am pleased to be an original
cosponsor because I believe it ensures that medicine and
science instead of Federal employees will develop our Nation's
organ transplant policy.
The Department of Health and Human Services released their
final rule on organ transplantation last year. They did so to
equalize the waiting time differences for sicker patients
around the country. They claim that a national waiting list
would reduce some of the differences, which admittedly can be
too long, and make the organ transplantation process fair.
However, a recent Institute of Medicine report found that the
current system is equitable for the most severely ill patients.
While their report also found that broader sharing between OPOs
and States in regions would be better, it is important to note
that this initiative is already being implemented within the
transplant community.
I agree with the intent of the promulgated HHS regulation.
However, I believe that the regulation would leave small and
medium-size transplant centers at a significant operating
disadvantage, which would ultimately cause them to shut their
doors, leaving thousands of needy patients with few options.
The problem with organ allocation policy is not the way
they are allocated, but the number we have to allocate. Instead
of trying to force new regulations on a transplant community
that has nearly unanimously rejected them because they could
harm patients, we need to focus on ways to encourage more
people to donate healthy organs. I support creating the fair
organ allocation system, not one that so many patient groups,
transplant surgeons, and organ procurement organizations
believe would do more harm than good. I believe any policy
needs to be dictated by the true experts in this issue, the
transplant community. That is why I am proud to be a cosponsor.
I would hope the administration recognizes the shortfall of
their rule and would reach out to the transplant community and
reach a compromise. Short of that, we have no choice but to
pass legislation.
Again, Mr. Chairman, I appreciate your willingness to
address this issue in a timely and equitable manner. I believe
many of today's witnesses will express many concerns raised to
me by both the Houston medical community and the Texas Medical
Center in Houston. Thank you.
Mr. Bilirakis. I thank the gentleman.
Mr. Bryant.
Mr. Bryant. Thank you, Mr. Chairman, and I thank you for
convening this hearing. I, too, am proud to be a cosponsor of
H.R. 2418 because I believe it is a good bill and the right way
to handle this matter. I think we are here today because--in
large part because of HHS's final rule on Organ Procurement and
Transplantation Network, which was published in April.
Obviously, this has been a controversial issue since the
beginning. In fact, we have as a Congress placed a 1-year
moratorium on this. The moratorium is about to expire.
I think many of us do have serious concerns about this rule
for several reasons; I think particularly its effect, potential
effect, on local transplantation and small transplant centers.
I think that we could go on, but I did want to incorporate as
part of my statement and I will at this time ask unanimous
consent to put the full letter that I am about to read a
portion of----
Mr. Bilirakis. Without objection, so ordered.
Mr. Bryant. [continuing] as well as the letter from the
Tennessee Transplant Society, dated August 2, 1999.
Mr. Bilirakis. Without objection.
Mr. Bryant. This is a letter--again, I will just take
portions out--from a gentleman who has a great deal of
credibility in this area. He is a donor father. His wife also
was a kidney recipient. He has been on numerous organizations
involving transplants, most particular a member of the national
board of TRIO. He states in a quite lengthy letter that the
policies that have come out of the National Organ and
Transplant Act back in the mid-1980's, while not perfect, are
good. He congratulates us or commends Congress on our wisdom,
primarily because ``it established a private partnership
between the medical community and the patient population which
is independent from undue political influence by government
operatives however well they might be intended. Difficult
decisions involving the allocation of scarce organ resources
have been made by informed private partnership rather than by a
core of government attorneys and bureaucrats.''
It goes on to say that there is a fear that a large
transplant center with political clout would monopolize
transplantation procedures by manipulating proposed rules
dictated by HHS personnel. Proponents may dismiss such concerns
as paranoia, but these worries are indeed genuine and have been
supported by the monopolistic track record of certain large
centers. Those of us who have had the opportunity to experience
that could tell you that some of the smaller regional
transplant centers understand firsthand the excellence and
talent available in many locations throughout the country. The
benefit which I have seen countless times is under the existing
system, families are able to provide local support for patients
that do not have to travel long distances to receive life-
saving transplant operations.
He goes on, if I might add, to say that ``I can report to
you that many of us who have been in the most difficult
situation have been acutely concerned that hope be provided
first to those in need in our local region. We do not want
these precious gives to be treated as just some other
government-owned part, shipped across country to a large center
currently in favor with Federal rulemakers.''
He closes by, ``Keep transplantation a predominantly
medical issue with rules established by the existing
partnership of medical experts, patients, and donor families.''
I agree with the sentiments of my constituent and would
tell you further that I do look forward to the witnesses that
we have here today. Like Dr. Coburn, I have another hearing
that I have to jump back and forth between, so I apologize. I
may not be here for your full testimony, I am going to try to
come back and forth, but I would like to make that my way of
explanation.
Again, Mr. Chairman, thank you for what you are doing in
this area.
Mr. Bilirakis. I thank you, sir.
Mr. Pallone for an opening statement.
Mr. Pallone. Thank you, Mr. Chairman. The National Organ
Transplant Act reauthorization is long overdue. Increasing the
supply of organs for transplantation is a critical policy issue
in this Nation and an acute problem in my home State of New
Jersey. The Federal Government can help realize this goal in
two broad ways. First, it must maintain an equitable organ
allocation system, and second, it must develop a new and
improved process for evaluating the Nation's organ procurement
program. In my opinion, H.R. 2418 of which I am a cosponsor
along with the chairman and Mr. Green, ensures both of these
points.
We must move swiftly to reauthorize the National Organ
Transplant Act, and as we do so, however, we must keep some
basic principles in mind. The recently completed Institute of
Medicine report recommends creation of organ allocation areas
independent of the current organ procurement organization
population structure. An optimal population size of
approximately 9 million is suggested for the organ allocation
areas. They should be accomplished through new regional sharing
agreements, not through consolidation of OPOs. The report notes
that achieving optimum results and procuring organs for
transplants is highly dependent on good working relationships
at the local level among hospitals, OPOs, transplant centers
and on others. The committee does not want its recommendations
to detract from or interfere with present operations where they
are working effectively.
I want to say that New Jersey's 6 transplant centers which
service approximately 8.5 million residents already fits this
model.
Congress specifically charged the Institute of Medicine
with the review of access to transplantation services for low-
income populations and racial and ethnic minority groups. This
review included an examination of the impact of State policies
regarding payments for services for patients outside of the
States in which the patients reside. The report states the most
important predictors of equity in access to transplant services
lie outside the transplantation system; that is, access health
insurance and high-quality health care services. The fact is
that many minority and ethnic groups and low-income groups do
not have access to health insurance and high-quality health
care services. This fact of life cannot be divorced from a the
review of how well organ donation transplantation works. This
critical area must be given as much consideration and note as
policies regarding allocations, or we will produce a caste
system for organ transplantation with only the rich being able
to afford transplants.
The IOM report noted that Federal oversight of the national
transplant system is useful in some areas. I feel strongly that
the medical community must be free to make critical clinical
decisions regarding transplants, but I welcome Federal
oversight in the area of appeals, enforcement of national organ
transplantation policy, and imposition of sanctions when deemed
necessary to further the operation of the national transplant
system.
I have learned from constituents in my area that many
variables affect organ donor rates. The current performance
standards used by the Federal Government do not accurately
assess OPO performance because they are based on total
population and not the number of potential donors. In New
Jersey, for example, the number of potential donors is
significantly reduced by the State's high incidence of cancer
and AIDS. The diverse nature of New Jersey's people also make
organ donation education and procurement particularly
challenging.
Adherence to the current performance standards without
regard to these operations which occur from one area of the
country to another may needlessly lead to the termination of
OPOs with strong relationships in their communities which are
addressing their coverage area donor potential in an effective
manner.
Organ procurement organizations cannot fully concentrate on
programs to increase the supply of organs when they are
burdened by the mandate to meet unpredictable national average
performance standards over a 2-year period. Such a short cycle
does not help. OPOs implement best practices to increase the
organ supply. The population-based performance measures used by
HCFA has been widely criticized by the Institute of Medicine,
the GAO, the Harvard School of Public Health and others as
being significantly flawed for assessing OPO performance. Mr.
Chairman, unless overturned, these inappropriate measures may
very well result in the decertification of OPOs that are
actually excellent performers. To that end I support the
inclusion of language in the reauthorization calling on HHS to
suspend the current OPO recertification process until a fair
process that relates to true performance are developed in
cooperation with the OPO community.
I believe that H.R. 2418 will allow organ procurement
organizations the freedom to do their good work of educating
and procuring precious organs in an efficient manner, and
therefore I look forward to working with you, Mr. Chairman, to
directly help those Americans in need of transplantation by
passing this good bill. Thank you.
Mr. Chairman, could I ask, I would like to ask unanimous
consent to submit for the record a statement by Peggy Dreker of
Kearny, New Jersey. Ms. Dreker is the cofounder of the New
Jersey chapter of the Transplant Recipients International
Organization. Her testimony recounts the hardship she and her
family experienced when their 2-year-old son needed a liver
transplant. And he had--both she and her husband had to travel
back and forth to Pittsburgh for 3 years to save their son's
life. No offense to my friend from Pennsylvania, Pittsburgh is
actually a nice place, but it is unfortunate they had to travel
back and forth to Pittsburgh during this time. Their testimony
illustrates why we need to pass H.R. 2418, and I would ask that
it be included in the record.
Mr. Bilirakis. Without objection that is part of the
record.
[The prepared statement of Peggy Dreker follows:]
Prepared Statement of Peggy Dreker, New Jersey Chapter, Transplant
Recipients International Organization
Good Morning, I am Peggy Dreker. I live in Kearny, New Jersey which
is located about 15 miles outside of New York City. I am the co-founder
of the New Jersey Chapter of TRIO, Transplant Recipients International
Organization. I serve on the Board of Directors of the New Jersey Organ
and Tissue Sharing Network, the organ procurement agency in New Jersey,
and I am currently the Treasurer of that board. I am here today in
another role, that of a Mom who would like to share my experience with
the transplant community. I am also here because I am concerned that
part of the new HHS regulations will hurt many potential recipients and
many New Jersey residents. I am concerned that these changes will limit
patient access to transplant services which can add a tremendous
financial and family burden to the transplant patient. I am also here
today to tell you that the NJ chapter of TRIO strongly supports HR 2418
sponsored by Congressman Bilirakis and cosponsored by New Jersey's
Congressman Pallone.
I would like to share with you my story which is typical of many
families that have had family members transplanted and therefore, the
tremendous need for local services.
In December of 1984, when taking my six week old son Daniel, for a
regular check up, the pediatrician pointed out that he was bit
jaundiced and recommended that he have blood work done. He referred us
to a pediatric gastroenterologist, Dr. Lucy McLoughlin at United
Hospital in Newark, New Jersey. Daniel was hospitalized immediately on
Christmas Eve. One week later on new Year's Eve, Daniel was diagnosed
as having liver disease. In my mind I thought, OK, they know what the
problem is and we are in a children's hospital, let's get this thing
fixed quickly. I was in for a rude awakening when Dr. McLoughlin
informed us that the only way to ``fix'' Daniel's problem was through a
liver transplant. In 1985, I considered this just another thing that
needed to be done. Imagine my shock and surprise when I discovered that
an organ would not be available ``on demand'' just because my son
needed it. I was appalled, and shocked but mostly scared. During this
time we began a relationship with the physicians and nurses that so
lovingly cared for my son and in turn for me. I was glad we had this
relationship with the staff of the hospital knowing a liver transplant
would mean a long hospital stay. That's when the final blow came. The
doctor informed us the closest place for Daniel to receive his
transplant was Children's Hospital at the University of Pittsburgh. I
was shocked that as a life-long New Jersey resident, my husband and I
both worked in New Jersey and yet health care was not available in the
State for my son. I immediately wrote to the Commissioner of Health in
New Jersey who informed me that transplant services were only available
regionally and we were fairly lucky that Pittsburgh wasn't too far away
from New Jersey.
While trying to deal with a sick infant in the intensive care unit,
the real world also went on. I decided to resign from my position
working for the County. My employer had been very generous extending my
maternity leave but I felt I could not ask for an indefinite leave.
This also meant that I would lose my medical coverage. We had just
purchased a home and were counting on our two incomes to pay the
mortgage. This plan was shot. We also realized that many of Daniel's
expenses were not being covered by our insurance which we always
thought was so inclusive.
When Daniel was two months old he was placed on the national
transplant list from Children's Hospital in Pittsburgh. Daniel weighed
under eight pounds and was literally starving to death. He was on a
constant feeding tube and his color was changing from a glow in the
dark yellow to a sallow shade of green.
Getting a bit desperate, I decided to call the White House seeking
help for Daniel. We were referred to the Transplant Office headed by
Michael Batten. The local media in New Jersey/New York picked up on
this correspondence and within two days of Daniel's arrival home we
were besieged by the media. We decided to go along with this attention
hoping that it would raise awareness for Daniel's plight. A reporter
from the New York Times followed us around for a week trying to put a
diary together of what it was like waiting to get a transplant. The
local communities in the area rallied together to raise funds and
awareness for Daniel. This was a wonderful thing but it did take away
from our privacy and family life. Little did we know how important
those funds would become.
In August of 1985, we received a call saying there was an organ
available for Daniel. This was after a false alarm in June where we
used up all our favors of a free plane ride, ambulance and police
escorts. In 1985, time was of the essence getting to the transplant
center. Within one hour, my husband arrived home for work, we begged
cash from anyone who had it, contacted the airline to get on a regular
scheduled flight to Pittsburgh, and packed clothing for all of us not
sure how long we would be gone. We made arrangements with the local
police department and the State Police since we had under one hour to
get to Newark Airport. All of this while handling a sick infant who was
still on a feeding pump, special formula and who cried constantly. By
the time we left our home, it finally dawned on me that we were leaving
a lot more than a house; I would have no family, no friends, no
familiar physicians and nurses and no husband who would have to come
back home shortly to return to work. I would be handling Daniel's
health on my own. My first view of the city of Pittsburgh was strapped
on a stretcher in the back of speeding ambulance with my tiny son on my
chest sleeping.
On August 5, 1985 my son Daniel received the gift of life from a
total stranger, another infant who had died. Daniel's surgery lasted
well over 10 hours as we were left standing in the waiting room of the
hospital with everything we owned and no place to stay. We ended up
showering at the University of Pittsburgh dorms. Daniel was blessed
with the best medical and nursing care. Unfortunately, within three
days it was determined that Daniel would need another liver. By this
time my husband had returned to work in New Jersey. My family drove the
eight hours out to Pittsburgh to locate a cheap furnished apartment for
me to live. Paying rent is not covered under your insurance. The
community fund-raising money came in handy for this. Daniel was
hospitalized in Pittsburgh from August 5, 1985 through April 10, 1986
before he was released with the knowledge that a second transplant was
still needed. During this time, I would stay with Daniel in the
hospital six days and nights a week. On Saturday morning, my husband
would fly out to Pittsburgh and stay about 24 hours before returning
back home. Daniel did not recognize him and would cry whenever he
walked into the room. The total feeling of isolation was relieved only
by the wonderful nursing staff who quickly became my new family. During
this long period of hospitalization we developed a dependence on the
physicians, as they developed a familiarity with my son on a daily
basis. Six months later, when my son was finally discharged, the sense
of anxiety of leaving the transplant center was upsetting. We were now
back to using our original physicians back home in New Jersey. At the
time, my son was the first and only transplant patient Dr. McLoughlin
cared for. As of today, she cares for 40 post transplant children.
For the next 18 months, Daniel and I would fly back to Pittsburgh
every three weeks or so because of the tubes that were left in him
while he was waiting for another liver. Imagine if you can, traveling
with a baby with a liver drain coming out the right side, a feeding
tube coming out of his nose and a broviac catheter coming from his
neck. I would leave the plane in Pittsburgh airport, put Daniel in the
stroller, put the feeding pump on my shoulder, drag a set of luggage
wheels with a suitcase and a baby walker, and carry a pack with diaper,
bottles and supplies I needed if one of his tubes happened to break
loose, which they frequently did. That was just to get through the
airport before I could hail a cab. I would then pack this into the cab
and head to the hospital. Thirty dollars later we arrived at the
hospital. By this time, Daniel was screaming and I had reached my wits
end. This procedure went on for the next year or more.
On October 26, 1987 we received a call that a second liver was
available for Daniel. This time all the commercial flights from the
three surrounding airports had stopped for the evening. We ended up
chartering a small private plane from a friend of a friend that we had
never even met. We again packed up our things and tried to put our
lives on hold.
Daniel had been blessed with this second gift of life. Surgery went
well. We quickly reverted back to our hospital routine as my husband
left us again in Pittsburgh to go back to work. We used the money
raised by the communities to pay the rent on our apartment so we still
had that. Daniel spent about eight weeks in the hospital and another
month in Pittsburgh before he was sent home on Christmas Eve 1987--
three years after the original diagnosis.
Since Daniel's ordeal, New Jersey has worked very hard establishing
quality transplant programs for its residents. The thought of returning
back to a time where accessibility to a transplant center could impede
a person getting a transplant is appalling. The three years that my son
and I lived away from home hurt my family, my marriage, my finances and
ended my career.
Today, Daniel is a healthy fifteen year old. In the last 15 years a
lot has changed in New Jersey.
There are now more transplant centers and pediatric transplant
programs are available. Someone in my position would not have to leave
the state to get medical care for a child.
I fear that the new HHS regulations on organ allocation will send
us back to 1985, back to a time when there was not easy access to
transplants for many people. In New Jersey the state has allowed more
transplant centers to open, but only when there is a proven need. So
there are not too many centers and they all have reasonable waiting
lists. We also have worked hard at the New Jersey Organ and Tissue
Sharing Network to increase the number of organs procured. The New
Jersey Organ and Tissue Sharing Network does an excellent job in
procuring organs and its potential yield from New Jersey's population
is very high. We need to continue this, please don't let it be taken
away by regulations that threaten transplant services to New Jersey
residents and unfair federal agency review regulations that fail to
take into consideration population characteristics that inhibit
donation. It just doesn't make sense to me to destroy a system that
works so well, a system that provides good outcomes and that so many
people rely on. People need transplant services in their states like
they need cardiac services, obstetric services and cancer care. Don't
set policy that consolidated transplant services to regional areas.
Americans will suffer.
I am not the only one who feels this way. I am surrounded by people
at the Sharing Network and organizations like TRIO where people, like
me, have experienced what it is like to have to go out of state. We are
appalled by the HHS regulations and strongly support HR 2418. In fact,
the New Jersey Chapter of TRIO has actively opposed the HHS
regulations, as have Arkansas, Ohio, Louisiana, New Mexico, Hawaii,
Memphis/Nashville, South West Florida, Main and Rhode Island Chapters
of TRIO. We support Congressmen Bilirakis and Pallone's legislation
that will further enhance organ donation and transplantation for all
Americans.
I know that the current system is not perfect and I think there are
some aspects of the new regulations that are good that have been
incorporated in HR 2418. We can not allow the unbridled hunger for
organs by mega transplant centers to dictate organ allocation schemes.
It is the responsibility of the federal government to support policy
that encourages the decentralization of transplant services so that
Americans in need do not have to experience the hardships I endured
with Daniel. Regular people like me need access to transplants,
preferably close to home. HR 2418 supports this policy.
Thank you.
Mr. Bilirakis. I might add at this point the opening
statement of all members of the subcommittee will made a part
of the record, and would now recognize Ms. Eshoo for an opening
statement.
Ms. Eshoo. Thank you, Mr. Chairman. I can't help but think
of the joint hearing on this very issue that this committee had
with our Senate counterparts a year ago this last June, June
18, 1998. So I want to thank you and salute you for having yet
another hearing on this issue. It is a very important one. It
is one of literally life and death for people in our country,
and it is a difficult issue to take on, but one that deserves
the kind of examination that you are giving to it. So I thank
you for having the hearing.
Very recently--my staff didn't put this in the written open
commentary, but I can't help but think of it. Very recently a
company, I think within the boundary of my congressional
district, had online the sale or the posting of an organ
online. It is a company that does essentially public auctions.
Now, the response to that was absolutely extraordinary and
overwhelming. The company did say out of respect, please don't
bid on this. But I think if we were to peel away some of the
veil of that in terms of its high profile in terms of the news,
what it underscores is not only the demand, but the urgency.
Any one of us that would need to have an organ replaced in
order to live--just imagine that--would want to have that organ
available right now. So what we are dealing with is how best
and how fairly to do this. As we speak, I am sure that people
are going to think, well, this one is from such and such a
district, this is what they have in their district, that is why
they are saying it. We need to rise above that because the
American people obviously deserve to have a system that is
going to speak to the urgency at hand. In fact, if this hearing
lasts 2 hours, someone will die waiting for an organ. That,
too, underscores the urgency. A mere one-third of the more than
60,000 Americans now on waiting lists will receive a donated
organ this year. With today's technology, really, people
shouldn't be dying because they can't get an organ in time. We
know that the system can't feed the demand, so we have more to
do than what we are just dealing with here.
But of those organ that are donated, what is the best
system, how should they be disbursed, so to speak. I don't want
to sound cold or bureaucratic about this, because we are
talking about human beings' lives.
Last Congress we enacted a 1-year moratorium on the HHS
proposed rule so that the Institute of Medicine, the IOM, could
study its potential effect. That study, released in July,
resoundingly supported HHS's proposed rule. They concluded
that, ``broader sharing is likely to result in more of the most
medically urgent patients receiving first attention when
waiting for donated livers.''
The IOM study goes on to refute many of the criticisms that
were raised about final rule. Broader sharing of organs does
not require a national waiting list. Treating more medically
urgent patients first does not mean wasting organs on patients
too sick to benefit from a transplant. Broader sharing does not
mean reduced services to minorities or closure of smaller
transplant centers. The substantial health benefits of broader
sharing would outweigh the marginal effects of cost.
We have the medical knowledge to do successful organ
transplants. We need to make sure that we have in place a
system, match that, and have a record that we have a system
that makes the most of available organs.
Let me just close by saying the following: In the aftermath
of the joint hearing that we had with the Senate, I was a
fairly new member of the committee. And the message that went
out across the country, the impact of just having the hearing,
really astounded me. It was yet another underscoring of the
need to do better.
Some have heavily criticized the organization that is in
place and how they do their work. That is not what I am here
for. I think that all of us together, wherever we come from,
whatever we have in our districts, whatever take we have on
this, have to really at the end of the day be devoted to
filling any kind of gap that exists. So I am looking forward to
hearing from the panelists today.
What I drew out of that hearing was that we do have some
shortcomings. It is not for a committee or organization to do--
it is not good enough. I used to say when I was in local
government, don't tell me about your organization, tell me how
effective your organization is for the people I represent.
So with that, Mr. Chairman, I hope that the people that
testify will inform and enlighten us as to the results of the
study and how they can direct themselves toward what is being
proposed. I think they are steps in the right direction myself,
and I appreciate your having this hearing. I think it is timely
and critical. Thank you.
Mr. Bilirakis. I thank the gentlelady.
Mr. Barrett.
Mr. Barrett. Thank you, Mr. Chairman. I thank you also for
holding this very important hearing.
This is an issue that I think combines so many different
human elements and so many economic elements together at the
same time that it is bound to raise emotions on all sides. As
Ms. Eshoo said, I think all of us look at this issue a little
differently depending upon where we come from, whether we have
a large center, small center, no center, or how close we are to
a center.
But I look at the issue, and notwithstanding all of the
emotions, health issues, the urgency issues, I think frankly
what we are talking about here is very much an economic issue.
These centers are big money-makers. And each one of us who has
a center wants for economic reasons to maintain the economic
resource that we have located in our own communities. There is
nothing wrong with that. For those people who represent large
centers, I understand where they are coming from. From people
like myself, who come from mid-sized centers, I trust that the
people who represent the large centers also understand where we
are coming from.
In the end, of course, we want to do what is right for the
patient. But there is no correct answer written in the back of
the book as to what is the right answer for the patient.
The part of the country that I represent, the upper
Midwest, does very, very well in producing several things.
Ironically, we are dealing with one on the floor right now. We
do very well in producing milk in the State of Wisconsin, as
does Minnesota. There is another product that we do very well
in the Midwest, and that is organs. For whatever reason, the
people in our part of the country are very generous when it
comes to giving organs. I would like to think that it is
because we have this down-to-earth group of people who care
about other people and society and are willing to make that
sacrifice. Others might have other explanations as to why that
occurs, but the fact is that if you look at Wisconsin and
Minnesota in particular, we remain relatively high in the
number of organs we produce. Correspondingly, we have health
care centers and transplant centers that use some of these
organs.
I get back to the economic argument because I look at the
report from the Office of the Inspector General fostering
equity in patient access to transplantation, local access to
liver transplantation, where the inspector general says that 80
percent of the liver transplants are done in 35 cities in this
country. So right now people are traveling to cities, 35
different cities, to get organ transplants. Now we are going to
fight about which city they go to.
I am obviously of the school of thought to say, well, if we
want regions of the country to continue putting their emphasis
on procuring organs, it makes sense not to penalize those
regions of the country that do a good job of procuring organs.
We could have taken another approach in our part of the country
and instead of trying to harvest organs, we could have tried to
harvest a waiting list and get as many people as we could on a
waiting list so that there would be a lot of sick patients that
would be on our waiting list. I personally think that that in
the big picture is counterproductive. To say that what we
should be doing is having the transplant centers put all of
their emphasis on developing waiting lists, I think, is
inevitably going to mean is they are going to put less emphasis
on recruiting new organs.
I certainly heard--or rather the analysis that said that
people don't care whether they know who the person is who is
receiving the organ, that it doesn't make any difference to
them. Again, I might be living in not exactly in Garrison
Keillor country, but close to it, where it does matter to
people if they know somebody. We have stories in our community
about somebody who donated this organ marrying someone who
donated that organ, and there is this nice little storybook
ending from people who have met through this network.
So it is not big east coast stuff, it is not big west coast
stuff, it is corny Midwest stuff, but I think it works.
I think what happens is that we should be putting more
emphasis on increasing the supply of organs and stop fighting
over where people are going to go, because again, as the
inspector general's report says, 80 percent of the people are
traveling. Let's not fight among the hospitals to develop
waiting lists. Let's work together to get more people to give
organs.
I would yield back the balance of my time.
Mr. Bilirakis. I thank the gentleman for his remarks.
Mr. Klink is not a member of this subcommittee, and that is
the only reason that we passed over him in his opening
statement. The rules state that I must do that. But in any
case, he has a great interest in this subject, as he does in
most health care subjects, and the Chair is pleased to invite
him to make an opening statement if he wishes.
Mr. Klink. I certainly thank the chairman for his courtesy.
He has always been very courteous. Even in this case where he
knows that he and I come down on different sides of this issue,
he has gone out of his way to allow my voice to be heard, and I
appreciate that.
If ever there was an issue that deserves to be protected
from political maneuvering, it is indeed the issue of organ
allocation. This is one of the few issues that we in Congress
will deal with where there is no doubt about it, it is life or
death. If you are the one that is waiting for the organ, you
either get the organ, or you die. There is nothing abstract
about it.
Regardless of how each of us approaches this issue, I hope
that all of us agree the best thing for everyone is to get this
dispute out of the annual appropriations process by for once
and all establishing the rules for how our organ network should
operate.
As I have seen this and I have studied it, there are two
issues that are before us today: One, how do we make the
allocation system fair and equitable; and, two, who should be
responsible for setting and enforcing the policies for sharing
organs? Should it be HHS or a government contractor?
While the bill before us today is a sincere attempt by two
of my dearest friends in the legislative body here to rewrite
those rules, I must respectfully speak against H.R. 2418
because it does nothing, I think, to make the system more
equitable because it delegates too much policymaking authority
to a largely unaccountable government contractor. The fact is
that every year people die unnecessarily because the current
organ allocation system is broken. Whether or not you get an
organ that can save your life will depend on where you live.
But under the current system, depending on where the organ was
harvested, it could be given to someone with years to live
while someone in the next town across the wrong border may die
while waiting for a transplant.
One of the most difficult organs to transplant is the
liver. Pioneered at the University of Pittsburgh, upwards to 90
percent of all of the liver transplant surgeons today were
either trained at the University of Pittsburgh or by doctors
who were trained there. Yet facilities like Pittsburgh and
other highly regarded transplant centers which take on the most
difficult and riskiest transplantations are struggling because
they have the longest transplant list in the country.
While these centers are highly regarded, many of their
patients don't come to them because of their reputation. The
fact is that many of the patients come there and only seek them
out after they have been turned down by their local transplant
centers. There is very strong evidence to suggest that many
smaller transplant centers avoid the riskier transplants on the
sicker patients because they are more difficult and would
adversely impact their reputation should they not be
successful. Without national standards for how people get
listed or how organs should be shared, the organs do not follow
the people that need them. This is not right, and it should be
fixed.
Ever since the rule was announced last April, its
proponents have argued that the Secretary should not be allowed
to set organ allocation policy because it involves a medical
question that should best be left to medical professionals in
the transplant community. I have to tell my colleagues that
this argument causes me great difficulty when I know that if we
share organs more broadly, lives would be saved.
I agree with the views of those in the transplant community
should be given great weight, but I disagree with the notion in
this bill that the Secretary should totally refer to a
contractor on questions that are, ``scientific, clinical, or
medical in nature.'' The biggest opponent of any change and the
proponent of this bill is the OPTN contractor, UNOS, who has a
vested interest in not having the Department of Health and
Human Service looking over their shoulders. Sadly, UNOS has
budgeted upwards to $1 million of patients' fees to lobby
against the proposed changes. That is money that should have
been spent saving lives.
The argument that the Secretary is unqualified to deal with
medical questions causes me great difficulty when I know that
every year Medicare and Medicaid pay for more than 50 percent
of the transplants in this country. I think it would be highly
irresponsible for us as taxpayers to pay for those transplants
without making sure that the money is spent equitably. Not only
would we be delegating sole authority over allocation policy to
a private contractor, which I think would be an
unconstitutional delegation of legislative authority, but as
the agency that oversees most of our health policy, I don't
understand how the Secretary becomes less qualified to deal
with allocation policy than she is in making scientific,
clinical, or medical decisions as she oversees, Medicare,
Medicaid, NIH, or the FDA. As the ranking Democrat on Oversight
and Investigation, I fully agree with the Institute of Medicine
that says ``vigilant and conscientious oversight and the review
of programs and policies are critically important to ensuring
accountability on the part of the OPTN, and that the HHS final
rule appropriately places this responsibility with the Federal
Government.''
Again, I would close by saying that I must oppose H.R. 2418
as it is currently written because I feel it fails to improve
the allocation system, and it gives too much policy-setting
authority to an unaccountable Federal contractor while severely
restricting the Secretary's authority to oversee the transplant
network. People are dying because they happen to live in the
wrong zip code and because States don't want to share their
organs. Nowhere else in society would we allow a monopoly like
this to continue. We have to put an end to this craziness. The
No. 1 priority of organ allocation has to be medical necessity,
not geography, period.
Mr. Chairman, again, I thank you so much. I yield back my
time, and I ask unanimous consent, to not prolong your hearing,
I would like to submit questions for the witness in writing.
Mr. Bilirakis. Without objection that will be the case. Of
course, written questions are always provided to the witnesses
to be responded to.
[Additional statements submitted for the record follow:]
Prepared Statement of Hon. Barbara Cubin, a Representative in Congress
from the State of Wyoming
Thank you, Mr. Chairman, for holding this important and timely
hearing on organ allocation. I think many people, myself included, are
happy to see legislation introduced that will address the problems
associated with the 1998 proposed rule on a new organ allocation
policy.
I have grave concerns about Secretary Shalala's proposed rule. The
``sickest-patient-first'' standard, applied on a national basis, would
result in more deaths and fewer successful transplants.
In rural states, where most of the population is spread over large
areas and many people live in rural communities, the number of
transplants would drop, decreasing access to care if the ``sickest-
patient-first'' standard were applied.
A national list would give transplant programs in high-population
areas access to more organs. Regions with small populations would have
fewer. The northwestern region's success in supplying quality, cost-
effective transplants to all regions of the country could be reversed
under this standard.
I believe that decisions regarding organ procurement and
transplantation policy are best left to the medical community,
patients, and donor families. Local and regional distribution areas
have many advantages including giving people local access to
transplantation and shorter distances to travel with the transplant
organ. Our current allocation system achieves a balanced and fair
distribution of organs for all who await a life saving transplant.
I would like to commend the chairman, the subcommittee, and those
involved in the drafting of H.R. 2418. This bill recognizes the
importance of maintaining the regional boundaries in the current organ
allocation system, and ensuring that medical experts ultimately make
the decisions regarding organ transplantation.
I would like to thank our witnesses for appearing here today, and
look forward to hearing their testimony. Thank you, Mr. Chairman.
______
Prepared Statement of Hon. Tom Bliley, Chairman, Committee on Commerce
Thank you, Chairman Bilirakis, for convening this afternoon's
hearing on H.R. 2418, the Organ Procurement and Transplantation Network
Amendments of 1999.
It has been well over a year since the Administration issued its
regulation on the Organ Procurement and Transplantation Network. Some
claim that the regulation changed the HHS Secretary's oversight
authority into a policy-making authority. Policy control of the Network
is not what Congress intended, and that is not what the law permits.
The Organ Procurement and Transplantation Network was authorized by
Congress to make decisions without political interference. The
decisions they make safeguard the interests of not just those who are
presently on a waiting list, but those unknown persons who will be
placed on a waiting list in the future.
Mr. Chairman, your bill would safeguard the independence of the
Network. It also would increase the level of accountability of the
Network by mandating timely reports on the performance of transplant
centers within the Network. The bill includes an innovative enforcement
mechanism that would mandate the payment of liquidated damages by
transplant centers that try to cheat under the Network rules. You are
also to be applauded for the provision that would offer assistance for
living donors seeking to donate an organ to someone in another state.
It is evident that a great deal of work and consultation went into
this bill, Mr. Chairman, and I congratulate you for bringing H.R. 2418
to this stage in the authorizing process. I support your bill, Mr.
Chairman, and I look forward to the testimony this afternoon and to a
mark-up in the near future.
______
Prepared Statement of Hon. John D. Dingell, a Representative in
Congress from the State of Michigan
Mr. Chairman, a hearing on the subject of organ allocation is
timely and I thank you for scheduling it. I know that we have many
other issues to discuss and hopefully resolve before this session ends.
Mr. Chairman, there are a lot of reasons why we must reach some
kind of collective and durable agreement on the future course of organ
allocation policy. Let me name a few. First, patients need and deserve
an allocation program that is efficient and equitable. The ongoing
struggle over the current organ allocation system is discouraging and
harmful to the many persons across this country who are in need of an
organ transplant. Second, the professional transplant community
consists of talented and dedicated professionals. Their views and
concerns are important and need to be weighed in any organ allocation
policy we develop. Third, the public has an important interest in organ
allocation policy. I think the point is sometimes overlooked that when
we speak of the proper role of the Secretary, we are ultimately
speaking of the public's interest in this matter. The Secretary is a
steward of the public interest and is accountable as such. In my view,
this is more so when we note the fact that a third or more of all organ
transplants are paid for with taxpayer-funded health insurance programs
such as Medicare and Medicaid.
Some will argue that organ allocation is purely a matter of
medicine and science and that public officials have no business in such
matters. This is a curious argument. We debate public policies on such
medical and scientific issues as limits on stem cell and cloning
research, pain management, the scope and direction of public research
funded by the NIH, availability of FDA approved pharmaceutical
products, reimbursement for medical procedures, protection of human
research subjects, and so on. The argument that medicine and science
are not proper areas for public scrutiny is a dangerous notion and
therefore should be rejected.
Let me be specific. H.R. 2418 divorces the operations of a
government contractor from any meaningful oversight by or
accountability to the Department of Health and Human Services, the
agency from which the contractor derives its authority to operate an
organ allocation system. Without that government contract, the Organ
Procurement and Transplantation Network would have no authority to
operate. As I have already noted, my concerns in this area are
amplified by the fact that Medicare and Medicaid pay for a substantial
percentage of all organ transplants. There simply must be greater
accountability of the Network to the Secretary than H.R. 2418 would
provide.
I am also concerned that H.R. 2418 does not do enough to alleviate
the shortage of organs. One example that comes to mind is the cost of
immunosuppressive drugs. A major reason for long term failure of
transplants is a lack of compliance with the life long drug therapy
that is required for transplant patients. The major reason for a lack
of compliance with immunosuppressive drug therapy is the lack of
resources to pay for them. The result is that the organ fails and
another is needed. We should examine this question and determine
whether providing drug coverage for those who need it would be cost
effective and help reduce the shortage of organs.
We should also take a look at other ways to encourage donations.
These include, for living donors, extended leave, expanded
reimbursement for costs beyond that proposed in H.R. 2418, and expanded
insurance coverage. More aggressive outreach by medical, educational,
and legal professionals, as well as other community leaders, to promote
awareness of the need for donations is also desirable.
Mr. Chairman, I support the concept of engaging in an effort aimed
at trying to resolve the issues that have been so divisive. I see
encouraging signs of movement from almost every direction. HHS has
indicated that it is willing to repropose its allocation regulation in
an effort to deal with some of the criticisms leveled against its
earlier version. The study by the Institute of Medicine, particularly
with respect to the role of waiting times, may also have had an
influence on the Department's thinking. The transplant community, for
its part, has in some cases shown a recognition of the merit of broader
regions for sharing organs. There is not a complete meeting of the
minds yet, but I sense that the differences may be smaller than a year
ago.
I am certainly willing to work with you and my colleagues on this.
I thank the witnesses for appearing here today, and look forward to
continued progress in increasing the supply of organs and making their
allocation more equitable.
______
Prepared Statement of Hon. Nathan Deal, a Representative in Congress
from the State of Georgia
Thank you, Mr. Chairman for holding this important hearing
regarding H.R. 2418, the Organ Procurement and Transplantation Network
Amendments of 1999. As a cosponsor of this legislation, I appreciate
your efforts in addressing this issue and encourage the subcommittee to
support this bill which is important to my constituents and the State
of Georgia.
As you know, this legislation reinforces the original intent of the
National Organ Transplant Act of 1984 that is responsible for
developing and maintaining the medical criteria and standards for organ
procurement and transplantation resting with the medical community. It
is my belief that properly trained physicians should be responsible for
transplant issues, and we must ensure that these functions remain the
sole discretion of the Organ Procurement and Transplantation Network
(OPTN).
Furthermore, it is vital that we increase the supply of donated
organs around the country so that more people may receive transplants
and we can achieve a just and equitable allocation system. To that end,
H.R. 2418 includes provisions that require the OPTN to actively
increase the supply of donated organs and authorize the Secretary of
Health and Human Services to award grants related to increasing organ
donation. Finally, the bill strengthens patient confidentiality
safeguards and mandates that transplant centers provide specific
information to the patients.
If implemented, the Department of Health and Human Services' Final
Rule on this matter will harm the state of Georgia. Currently,
Georgians employ one of the best organ procurement systems in the
country that results in better access to transplants. I fear that
Georgians will no longer be as likely to donate their organs if the
Final Rule is implemented and find it troubling that my state would be
punished for our successful organ procurement program.
Again, I appreciate your efforts in introducing this legislation. I
look forward to hearing from our witnesses and recommend that the
subcommittee move ahead in this process to pass H.R. 2418.
Mr. Bilirakis. The Chair calls the panel forward. Please
come forward.
Dr. William Raub is the Deputy Assistant Secretary for
Planning and Evaluation/Science Policy with the Department of
Health and Human Services. Dr. William Payne is the director of
the liver transplant program, Fairview Medical Center,
Minneapolis, Minnesota. Dr. Robert G. Gibbons, professor of
biostatistics, School of Medicine, Department of Psychiatry,
University of Illinois, Chicago; Dr. Joshua Miller, Division of
Transplantation, Department of Surgery, University of Miami
School of Medicine; Mr. Craig Irwin, president of the National
Transplant Action Committee out of Portland, Oregon; and Dr.
John M. Rabkin, chief of liver transplantation, Oregon Health
Sciences University, Portland, Oregon.
Gentlemen, the committee welcomes you. Before we hear from
the first witness, I unfortunately have a negative statement to
make. I want to remind our witnesses, not only here but
forevermore, that the committee expects to receive testimony 2
days prior to the hearing. The purpose of this rule, I think it
is kind of obvious, is to allow members and their staffs
sufficient time to review the statements and educate themselves
on the testimony that will be at the hearing.
The testimony from the administration was not received
until 1 p.m. Today. Now, anyone tell me that that is unfair.
That is unacceptable, and it shows, I think, blatant disrespect
for the members of the subcommittee. And I know that the
administration had to be aware that a hearing like this was
going to take place because of the controversy that is
involved.
The committee noticed this hearing 1 week prior to the
hearing date, providing ample time for invited witnesses to
produce testimony. And please, Dr. Raub, this is certainly no
reflection upon you personally, but I appreciate it if you
would maybe pass the word on to the Department to give us the
courtesy of submitting their testimony at least 2 days prior to
the hearing. We have gotten complaints from the minority, too,
in this regard so it doesn't come just from the majority. I
think that you can understand that.
Mr. Brown, did you have anything that you wanted to comment
in this regard?
Mr. Brown. Only that I agree with your assessment, Mr.
Chairman.
Mr. Bilirakis. All right. The committee ordinarily gives
the administration witness 10 minutes to testify and the others
5 minutes. But I am going to--you are all busy people, have
taken time away from your schedules to be here. Anywhere
between 5 and 10 minutes would be appreciated because I know
that you have an awful lot of valuable things to say to us.
Dr. Raub, we would ask you to kick it off, sir.
STATEMENTS OF WILLIAM F. RAUB, DEPUTY ASSISTANT SECRETARY FOR
PLANNING AND EVALUATION/SCIENCE POLICY, DEPARTMENT OF HEALTH
AND HUMAN SERVICES; WILLIAM PAYNE, DIRECTOR, LIVER TRANSPLANT
PROGRAM, FAIRVIEW MEDICAL CENTER; ROBERT D. GIBBONS, PROFESSOR
OF BIOSTATISTICS, SCHOOL OF MEDICINE, DEPARTMENT OF PSYCHIATRY,
UNIVERSITY OF ILLINOIS AT CHICAGO, ACCOMPANIED BY MITCHELL W.
SPELLMAN, PROFESSOR OF SURGERY EMERITUS AND DEAN OF MEDICAL
SERVICES EMERITUS, HARVARD MEDICAL SCHOOL, AND SUSANNE STOIBER,
EXECUTIVE OFFICER, INSTITUTE OF MEDICINE; JOSHUA MILLER,
DIVISION OF TRANSPLANTATION, DEPARTMENT OF SURGERY, UNIVERSITY
OF MIAMI SCHOOL OF MEDICINE; CRAIG IRWIN, PRESIDENT, NATIONAL
TRANSPLANT ACTION COMMITTEE; AND JOHN M. RABKIN, CHIEF, LIVER/
PANCREAS TRANSPLANTATION HEPTOBILIARY SURGERY, OREGON HEALTH
SCIENCES UNIVERSITY
Mr. Raub. Thank you, Mr. Chairman. Good afternoon, Chairman
Bilirakis, Congressman Brown, other members of the
subcommittee. I am William Raub, Deputy Assistant Secretary for
Science Policy at the Department of Health and Human Services.
I appreciate your invitation to testify.
I will discuss H.R. 2418 and also will testify in general
about national organ transplantation policies and the
constructive discussions we have had with our colleagues in the
transplant community about those policies. With your
permission, I will submit my full statement for the record.
Thanks in part to the passage of NOTA in 1984, organ
transplantation now is a routine and widely endorsed procedure.
Many organizations and individuals deserve high praise for this
achievement: The United Network for Organ Sharing; surgeons,
physicians, nurses and other health professional who have
committed themselves to the practice of transplantation
medicine; laboratory and clinical scientists who continue to
generate new knowledge and technology that drives
transplantation medicine to ever greater success; the staff of
organ procurement organizations who work so diligently to
acquire and transport organs to transplant programs; patients
who provide invaluable insights as to how OPTN processes might
be improved; and most of all, organ donors and their loved one
whose decisions to share the gift of life enable
transplantation medicine to flourish.
Through the efforts of the Organ Procurement
Transplantation Network, organ transplantation has become
available to more and more chronically ill patients. Last year
more than 21,000 Americans received organ transplants, but more
than 4,000 people on transplant waiting lists died because of
the scarcity of donated organs. As these lists grow, many more
will die as the system continues to strain under the demand for
organs.
In light of this demand, we in the administration believe
that our first priority must be to increase organ donation. To
that end, in December 1997, the Department launched its organ
and tissue donation initiative to foster partnerships between
public and private-sector organizations, to enhance public
education about the need for donation, and to recruit potential
donors. We believe that we must work to ensure that the OPTN
operates equitably and provides the best possible outcomes for
patients.
This role for the Federal Government was recently affirmed
by the Institute of Medicine, ``The Federal Government as well
as the transplantation community has a legitimate and
appropriate role to play in assuring that the organ procurement
and transplantation system serves the public interest,
especially the needs and concerns of patients, donors, and
families affected by it. The IOM learned of numerous instances
in which weak governance tends to undermine the effectiveness
of the system. Weak oversight has compromised accountability at
all levels, permitted poor procedures for data collection and
analysis to persist, and allowed the system to operate without
adequate assessment of performance.''
Thus, in commending the OPTN for its accomplishments, we
cannot ignore the persistent flaws and unfairness in the
system. The most medically urgent patients do not always
receive priority. Patients with similar levels of disease may
have different outcomes depending on where they live or list.
Distrust among transplant surgeons and hospital administrators
sometimes impedes broader sharing of organs. True measures of
equity to judge the OPTN do not exist.
In recognition of a need for public sector oversight of the
OPTN, and in response to provisions of the Consolidated Omnibus
and Emergency Supplemental Appropriations Act of 1999, the
Department has increased its efforts to assess the performance
of transplant programs. With the assistance of staff from UNOS,
the contractor for both the OPTN and the scientific registry,
the Department staff analyzed OPTN outcome data for liver and
heart transplants with respect to three critical issues: One,
the likelihood that, having been listed as a transplant
candidate, a patient would receive an organ within 1 year; two,
the likelihood that a patient will die within 1 year of listing
while awaiting transplantation; and three, the likelihood that
a patient would still be alive 1 year after listing
irrespective of whether he or she underwent a transplant
procedure.
After risk adjustment, that is adjustment for differences
in the mix of patients' health status from program to program,
the analysis revealed substantial differences in outcome from
one transplant program to another. These findings warrant
attention by the OPTN. In the course of performing these
analyses, the Department staff identified gaps in the data
currently collected by the scientific registry; for example,
additional clinical details about patients' condition at the
time of listing, which could improve risk adjustment, and
additional data on clinical complications, which could help in
assessing quality of life following transplantation.
The Department intends to encourage UNOS in its management
of the OPTN and its operation of the scientific registry to
broaden the scope of data collection and make increased use of
program-specific performance analyses.
Many of the flaws in the OPTN are addressed in the final
rule issued by the Department in April, 1998, after extensive
public comment and 3 days of public hearings.
The rule requires the OPTN to develop policies that will
result in standard listing practices and medically based
definitions of patient status categories. The rule also
requires policies that will encourage broader geographic
sharing of organs so that the most medically urgent patients
receive transplants based on sound medical judgment. The rule
leaves the policy decisions to the OPTN with oversight by the
Department.
I again quote from the IOM report: ``Vigilant and
conscientious oversight and review of program policies are
critically important to ensuring accountability on the part of
the OPTN and other participants in the organ procurement and
transplantation system. The final rule appropriately places
this responsibility with the Federal Government. The IOM
believes that this is an important aspect of the final rule and
charge that should be pursued by the Federal Government in
close cooperation with the full range of participants in the
transplant community.''
The Department concurs with the IOM. This is the balance we
sought in the rule.
Mr. Chairman, we have taken very seriously the charge we
were given by the Congress last year to work cooperatively with
the transplant community to clarify the intent and the effect
of the rule. We very much appreciate the many hours that those
in the community have spent meeting with us and their
constructive approach in identifying apparent problems and
potential solutions through oral and written comments. In
addition, we have carefully reviewed the IOM report and
recommendations and have met with representatives of the IOM
expert committee on two separate occasions. Also we are
fortunate to have additional data pursuant to the study
provisions of the omnibus bill.
In response to these helpful comments and discussions, we
have committed to revise the rule in important areas. For
example, we intend to clarify the rule so that there is no
doubt that the OPTN will develop allocation policies. We intend
to ease any lingering concerns of the transplant community
about the Secretary's regulatory authority by instituting an
independent advisory committee, as recommended by IOM, to
review major differences between the Secretary and OPTN on
policy matters.
Other areas of potential clarification or revision have
been discussed in detail with transplant community
representatives. I believe our revisions will address the major
concerns we have heard from the transplant community, yet
maintain the essential framework of the rule requiring
standardization of certain practices and encouraging broader
geographic sharing of organs.
Consistent with the law, it is our intent that the rule
once revised go forward to address inequities in the system
identified by the Department and IOM. However, congressional
review of the OPTN is essential; and the Department looks
forward to working together with you, Mr. Chairman, and other
Members of the Congress to develop legislation to reauthorize
NOTA. Reauthorization should primarily address the needs of
patients and also maintain the requirement of NOTA that there
be a national, equitable system of organ allocation in the
United States. We recommend that reauthorization reinforce the
role of the Federal Government in overseeing the OPTN in
accordance with the IOM recommendations and that the statute
continue to leave management and policy development of the OPTN
in the private sector.
The Department is concerned that H.R. 2418 does not do
enough to preserve and strengthen many of the attributes of the
OPTN that have placed transplantation firmly within the medical
mainstream. Indeed in some instances the bill takes a step
backward. The Department therefore opposes H.R. 2419 in its
current form. My full statement contains comments on specific
provisions.
In summation, Mr. Chairman and members of the subcommittee,
the Department is committed to working with you and the members
of the transplant community to create policies that improve the
quality of care and the equity of our organ allocation system.
While we have had our differences, our recent discussions with
the transplant community have been quite promising. We hope
that this spirit of cooperation can extend to our discussions
on reauthorization of NOTA as well. Thank you for the
opportunity to testify today.
[The prepared statement of William F. Raub follows:]
Prepared Statement of William F. Raub, Deputy Assistant Secretary for
Science Policy, Office of the Assistant Secretary for Planning and
Evaluation, Office of the Secretary, Department of Health and Human
Services
Good afternoon, Chairman Bilirakis, Congressman Brown, and other
members of the Subcommittee. I am William Raub, Deputy Assistant
Secretary for Science Policy at the Department of Health and Human
Services. I appreciate your invitation to be here today to discuss H.R.
2418, a bill to reauthorize the National Organ Transplant Act (NOTA). I
also will testify in general about national organ transplantation
policies and the constructive discussions we have had with our
colleagues in the transplant community about those policies.
Thanks in large part to the passage of NOTA in 1984, the transplant
network is very different from the system that existed then. Organ
transplantation is no longer experimental; it is routine. The
figurative handful of centers comprising the network in 1984 has grown
into an enterprise of 891 organ-specific transplant programs.
Technological advances allow excised organs to last much longer and to
be transported much farther than they could fifteen years ago.
In many respects, NOTA and the transplant network it spawned have
served patients well. We have an organized national system requiring a
structured approach to organ transplantation that did not previously
exist. Allocation of scarce organs is done more cooperatively than in
the past. Advances in drugs for immuno-suppression and techniques for
lengthening cold ischemic time have resulted in high survival rates for
transplant patients.
Many organizations and individuals deserve high praise for the
achievements of the Organ Procurement and Transplantation Network
(OPTN): the United Network for Organ Sharing (UNOS); surgeons,
physicians, nurses, and other health professionals who have committed
themselves to the practice of transplantation medicine; laboratory and
clinical scientists who continue to generate new knowledge and
technology that drives transplantation medicine to ever-greater
success; staff of the Organ Procurement Organizations (OPOs), who work
so diligently to acquire and transport organs to transplant programs;
patients, who provide invaluable insights as to how OPTN processes
might be improved; and, most of all, organ donors and their loved ones,
whose decisions to share the gift of life enable transplantation
medicine to flourish.
Their efforts have made organ transplantation available to more and
more chronically ill patients. Last year more than 21,000 Americans
received organ transplants. But more than 4,000 people on transplant
waiting lists died because of the scarcity of donated organs. As these
lists grow, many more will die as the system continues to strain under
the demand for organs.
We in the Administration believe that our first priority must be to
increase organ donation. To that end, in December 1997, the Department
launched its National Organ and Tissue Donation Initiative to foster
partnerships between public- and private-sector organizations to
enhance public education about the need for donation and to recruit
potential donors. The centerpieces of this initiative are a rule,
modeled upon legislation in Pennsylvania, requiring hospitals
participating in Medicare to expand their reporting of imminent deaths
and deaths to OPOs and a new $5 million grant program to learn more
about what works in organ donation. We are pleased to report that organ
donation increased by more than 5 percent last year as a result of our
collective efforts, and we are hopeful that the upward trend will
continue. Nevertheless, we recognize that the need for transplantation
is growing faster than the supply of organs and that continued emphasis
on both organ donation and equitable organ allocation is necessary.
A second priority for the Administration is to ensure that the OPTN
established by NOTA works equitably and provides the best possible
outcomes for patients. The role of the federal government in this area
was recently affirmed by the Institute of Medicine (IOM), which was
directed by Congress last year to study the national organ
transplantation network. Two months ago, IOM reported that:
The federal government, as well as the transplantation
community, has a legitimate and appropriate role to play in
ensuring that the organ procurement and transplantation system
serves the public interest, especially the needs and concerns
of patients, donors, and families affected by it. The [IOM]
learned of numerous instances in which weak governance tends to
undermine the effectiveness of the system . . . Weak oversight
has compromised accountability at all levels, permitted poor
procedures for data collection and analysis to persist, and
allowed the system to operate without adequate assessment of
performance.
As I said, the OPTN should be commended for its wonderful
accomplishments. Nevertheless, we cannot ignore the persistent flaws
and unfairness in the system. The most medically urgent patients do not
always receive priority. Patients with similar levels of disease may
have different outcomes, depending on where they live or list. Distrust
among transplant surgeons and hospital administrators sometimes impedes
broader sharing of organs. True measures of equity to judge the OPTN do
not exist.
In recognition of the need for public-sector oversight of the OPTN
and in response to provisions of the Consolidated Omnibus and Emergency
Supplemental Appropriations Act of 1999, the Department has increased
its efforts to assess the performance of transplant programs. With the
assistance of staff from UNOS, the contractor for both the OPTN and the
Scientific Registry, Department staff analyzed OPTN patient outcome
data for liver and heart transplants with respect to three critical
issues:
the likelihood that, having been listed as a transplant candidate, a
patient will receive a organ within one year;
the likelihood that a patient will die within one year of listing
while awaiting transplantation; and
the likelihood that a patient will still be alive one year after
listing, irrespective of whether he or she underwent a
transplant procedure.
After risk adjustment (i.e., adjustment for differences in the mix
of patients' health status from program to program), the analyses
revealed substantial differences in outcomes from one transplant
program to another. The principal findings for liver transplants
illustrate this:
ten percent of the programs have a risk-adjusted rate of
transplantation within one year of listing of 71 percent or
more; whereas, for another ten percent of the programs, the
rate is 25 percent or less;
the likelihood of dying within one year of listing while awaiting a
transplant ranges from less than 8 percent to more than 22
percent; and
the likelihood of surviving one year after listing as a transplant
candidate or a recipient ranges from approximately 65 percent
to almost 86 percent.
The analogous values for heart transplants are 36-72 percent
(transplantation within one year of listing), 9-23 percent (death
within one year of listing while awaiting a transplant), and 67-84
percent (survival for one year after listing irrespective of whether
transplanted or not).
In the course of performing these analyses, Department staff
identified gaps in the data currently collected by the Scientific
Registry--e.g., additional clinical details about patients' conditions
at the time of listing (which could improve risk adjustment) and
additional data on clinical complications (which could help in
assessing quality of life following transplantation). The Department
intends to encourage UNOS, in its management of the OPTN and its
operation of the Scientific Registry, to broaden the scope of data
collection and make increased use of program-specific performance
analyses.
Although these findings warrant further study to determine the
precise reasons for such variances in patient outcomes, one thing is
clear. Where a patient lives or lists often does more to determine
whether he or she gets a transplant than do medical considerations.
Patients in like circumstances are being treated differently, in clear
contradiction of the premise of NOTA that we have an equitable national
system of organ transplantation in the United States.
Many of the flaws that I have discussed are addressed in the final
rule for the OPTN that was issued by the Department in April, 1998,
after extensive public comment and three days of public hearings. The
rule requires the OPTN to develop policies that will result in standard
listing practices and medically based definitions of patient status
categories. The rule also requires policies that will encourage broader
geographic sharing of organs so that the most medically urgent patients
receive transplants, based on the sound medical judgment of physicians
under this general rubric. The rule leaves the policy decisions to the
OPTN with oversight by the Department.
In reference to the final rule, I again quote from the IOM report:
Vigilant and conscientious oversight and review of programs and
policies are critically important to ensuring accountability on
the part of the OPTN and other participants in the organ
procurement and transplantation system. The Final Rule
appropriately places this responsibility with the federal
government. The [IOM] believes that this is an important aspect
of the Final Rule and charge that should be pursued by the
federal government in close cooperation with the full range of
participants in the transplant community.
The Department clearly concurs with the IOM. There should be
vigilant government oversight and close cooperation with the transplant
community. This is the balance we sought in the HHS rule.
Mr. Chairman, we have taken very seriously the charge we were given
by the Congress last year to work collaboratively with the transplant
community to clarify the intent and effect of the rule. We very much
appreciate the many hours that those in the community have spent
meeting with us and their constructive approach in identifying apparent
problems and potential solutions through oral and written comments. In
addition, we have carefully reviewed the IOM report and recommendations
and have met with representatives of the IOM committee on two separate
occasions. As I have indicated, we are also fortunate to have
additional data pursuant to the study provisions in the omnibus bill.
In response to these helpful comments and discussions, we have
committed to revise the rule in important areas. For example, we intend
to clarify the rule so there is no doubt that the OPTN will develop
allocation policies. We intend to ease any lingering concerns of the
transplant community about the Secretary's regulatory authority by
instituting an independent advisory committee--as recommended by IOM--
to review major differences between the Secretary and OPTN on policy
matters. Other areas of potential clarification or revision have been
discussed in detail with transplant community representatives. I
believe our revisions will address the major concerns we have heard
from the transplant community yet maintain the essential framework of
the rule requiring standardization of certain practices and encouraging
broader geographic sharing of organs.
Consistent with the law, it is our intent that the rule, once
revised, go forward to address inequities in the system identified by
the Department and IOM. However, congressional review of the OPTN is
essential, and the Department looks forward to working together with
you, Mr. Chairman, and other members of Congress to develop legislation
to reauthorize NOTA. Reauthorization should primarily address the needs
of patients and also maintain the requirement of NOTA that there be a
national, equitable system of organ transplantation in the United
States. We recommend that reauthorization reinforce the role of the
federal government in overseeing the OPTN, in accordance with the IOM
recommendations, and that the statute continue to leave management and
policy development of the OPTN in the private sector.
The Department is concerned that H.R. 2418 does not do enough to
preserve and strengthen many of the attributes of the OPTN that have
placed transplantation firmly within the medical mainstream. Indeed, in
some instances, the bill takes a step backward. The Department,
therefore, opposes H.R. 2418 in its current form. The following
paragraphs describe our principal concerns.
While calling for a national system to match organs and
individuals who need organ transplants, the bill does nothing
to decrease the reliance on arbitrary geographic boundaries and
the inequities that result. Commenting specifically on
allocation of livers, IOM concluded that ``the fairness of the
organ procurement and transplantation system, and its
effectiveness in meeting its stated goals, would be
significantly enhanced if the allocation of scarce donated
livers were done over larger populations than is now the
case.'' Medical outcomes, waiting time and the possibility of
fatality should not depend on the geographic location of a
transplant program at which a patient is wait-listed.
H.R. 2418 does not ensure that patients and referring
physicians can obtain the kinds of program-specific information
they need to make decisions about whether, when, and where to
seek transplantation. Although H.R. 2418 provides for program-
specific data on such items as the probability of receiving an
organ transplant, the waiting time for similarly situated
patients, and the medical outcomes for similarly situated
patients, the bill does not specify that this information also
be timely and easy to use. Out-of-date information can lead
referring physicians and patients to make less than optimal
decisions.
H.R. 2418 would erode the role of the federal government in
providing oversight of the OPTN. The OPTN, by its structure, is
not able to incorporate into its activities the public policy
considerations that underpin the NOTA. The Department believes
that it must continue to be an active partner with the private-
sector in striving to fulfill the goals of the OPTN. Indeed,
the overarching purpose of the OPTN rule is to clarify the
nature and extent of oversight by the Department while ensuring
a continued prominent role for transplantation professionals,
patients / patient-advocates, and other organizations and
individuals in the private sector.
As you know, under the U.S. Constitution, a private entity
cannot perform functions inherent to the federal government.
Yet the bill does not stipulate that binding policies for the
OPTN be approved by the federal government.
Although H.R. 2418 requires that the Board of the OPTN have
physician representation of no less than 50 percent, it makes
no such percentage requirements for patients and donor
families, who we believe should have a significant
representation on the Board.
In summation, Mr. Chairman and members of the Subcommittee, the
Department is committed to working with you and the members of the
transplant community to create policies that improve the quality of
care and the equity of our organ allocation system. While we have had
our differences, our recent discussions with the transplant community
have been quite promising. We hope that this spirit of cooperation can
extend to our discussions on reauthorization of NOTA as well. Thank you
for the opportunity to testify today.
Mr. Ganske [presiding]. Thank you, Mr. Raub. By the way,
why was your testimony so late?
Mr. Raub. Sir, the invitation to the Department, as I
understand it, arrived at the end of last week. We worked very
hard over the----
Mr. Ganske. The invitation I am told arrived last Tuesday.
Mr. Raub. That is not my knowledge, sir, but I have no
reason to dispute your statement.
Mr. Ganske. Okay. If it arrived last Tuesday, why did we
not receive your testimony until today? Will you take personal
responsibility and find out what the delay was?
Mr. Raub. Yes, sir, I will.
Mr. Ganske. Thank you. Dr. Payne?
STATEMENT OF WILLIAM PAYNE
Mr. Payne. Thank you, Mr. Chairman and distinguished
members of the committee. It is an honor to testify today as
the current President of UNOS, the United Network for Organ
Sharing. I am Bill Payne, a liver transplant surgeon and
Director of the Liver Transplant Program at the University of
Minnesota.
On behalf of UNOS I will be speaking in support of H.R.
2418. First, however, I would like to provide a brief report on
three major improvements made since we last appeared before
you.
In June, the UNOS board of directors voted to institute a
major change to the liver allocation policy by establishing
region-wide sharing for the most urgent patients. This new
policy, which has been in development for several years,
addresses many of the concerns that have been raised with
regard to allocation over the last year.
Each year more than 4,000 people die needlessly because of
the organ shortage. I am pleased to report that UNOS recently
completed a pilot test of its new critical pathway for organ
donor management developed under our contract with HRSA. The
study revealed a 10.4 percent increase in the number of organs
recovered per donor at pilot sites.
This is extremely important news. The organ supply has
remained roughly the same for years despite everyone's best
efforts. As this new organ recovery technique is implemented
nationally we expect a 10 percent increase, the largest in a
decade.
Finally, UNOS recently unveiled an impressive array of new
on-line data for patients and the public. By updating our
Internet site we have an all new section called ``Transplant
Patient Data Source.'' we are now providing the latest
statistics on survival rates on every transplant program in the
country, the size of waiting lists and waiting times at each
center and OPO, and the supply of donated organs nationally by
State and by transplant center.
This unique research tool offers patients the critical
information they need to evaluate transplant centers in a user
friendly format. Consumer information and scientific data of
this kind is unprecedented, available nowhere else in medicine.
In fact, we recently asked Arthur Andersen to conduct a study
to evaluate the data published by leading major health
organizations. Arthur Andersen polled 40 Federal public health
agencies and national private health care organizations and
found that other than the small bone marrow transplant
registry, none of the organizations polled collects or analyzes
center-specific data or health care-related outcome data and
makes it available to the public to the extent that UNOS does.
With regard to H.R. 2418, I am proud to represent the UNOS
membership in strongly supporting this legislation. Mr.
Chairman, we very much appreciate your leadership on this issue
and commend you for your hard work and the truly bipartisan
support for this legislation. We support this bill for many
reasons.
First, the bill reinforces the original intent of NOTA. It
was Chairman Bliley and other members of this committee who
designed the current public-private structure that keeps the
delicate medical decisionmaking with doctors and the medical
community. H.R. 2418 preserves the original intent of NOTA by
restating that the responsibility for developing, establishing
and maintaining medical criteria and standards for organ
procurement and transplantation rests in the private sector and
the medical community.
This inclusive and democratic policymaking process ensures
that transplantation policy reflects the consensus of the
community while addressing the issues facing practitioners and
patients every day.
Second, the bill also updates NOTA by providing new
direction in important areas such as enforcement,
accountability, and patient confidentiality. It provides
several new means by which the network can enforce its
policies. It also includes new requirements improving the
network's public accountability. Specific and detailed data
reporting requirements will now be mandated by law. The bill
also provides for a new periodic evaluation of the network's
performance by the GAO to be submitted to Congress for review.
UNOS strongly endorses these new oversight measures.
The bill also ensures that in an effort to provide more
information to the public, the confidentiality of patients pre
and post transplant will not be compromised. We wholeheartedly
support this important protection for patients.
Finally and perhaps most importantly, the bill provides new
incentives for donation. Simply put, too few people give the
gift of life. The medical community struggles daily with
families torn with grief over the loss of a loved one who
through fear or mistrust choose not to allow organs to live on.
This bill represents further commitment by Congress to help us
increase donation.
Mr. Chairman, we believe all of these provisions are great
improvements to NOTA and that a reauthorization is timely and
necessary. We urge the committee to pass it, and again thank
you for the opportunity to appear before you today. I would be
happy to answer any questions you may have.
[The prepared statement of William Payne follows:]
Prepared Statement of William Payne, President, United Network for
Organ Sharing
Mr. Chairman, distinguished members of the Committee, it is an
honor to be here today to testify as the current President of the
United Network for Organ Sharing, or UNOS. My name is Bill Payne, and I
am a liver transplant surgeon currently serving as Chief of Staff at
Fairview University Medical Center in Minneapolis, Minnesota, where I
also am Director of the Liver Transplant Program.
UNOS members elect a new president each June, and my predecessors
have appeared before you in the past. Therefore, you know that UNOS has
been the Organ Procurement and Transplantation Network--the OPTN, or
Network--since the passage of NOTA in 1986, and continues to operate
this national Network under contract with the Department of Health and
Human Services. Because we have testified before you in the past, I
will only briefly recount who UNOS is and what we do.
As a private membership organization, UNOS includes every
transplant center and organ procurement organization in the United
States. The corporation qualifies under federal law as a charitable,
tax-exempt scientific and educational organization. Although we employ
almost 200 full-time staff, the important clinical and scientific work
of UNOS, as well as the critical establishment of national transplant
standards and policies, is accomplished by thousands of volunteers.
UNOS incorporates and embodies the entire organ transplant
community in this country. It comprises surgeons, physicians, nurses,
ethicists, and allied health professionals, as well as patients,
patient advocates, and donor family members, all of whom have dedicated
hundreds of thousands of hours to the operation of this critical life-
saving Network.
It has been a year since UNOS last appeared before this Committee
to testify on issues relating to organ transplantation. And, as you
know, much has happened since then. I want to take this opportunity to
inform you of several significant changes that have been made since we
appeared last. In the last year, UNOS has:
Implemented new liver allocation policies;
Increased the supply of organs; and
Published new, extensive data for patients and the public.
new unos initiatives
New Liver Allocation Policy
Today's liver allocation policy is significantly different than
when this issue was last before the Committee. In June, the UNOS Board
of Directors voted to institute a dramatic change to the liver
allocation policy that has been in development for several years. The
new policy establishes region-wide sharing for the most urgent
patients--the subset of patients doctors agree have the best chance of
a successful transplant. This policy is founded on broad community
consensus because it achieves the benefits of broader sharing while
avoiding the problems that many think are inherent in the distribution
of livers over excessively large areas, such as increased retransplants
or decreased access at smaller centers. This action is a major step
toward the goal of broader sharing of livers and addresses many of the
concerns that have been raised with regard to allocation over the last
year.
This new sharing policy is also consistent with the Institute of
Medicine's (IOM) recent recommendation that livers be shared in areas
with a base population of 9 million versus the much smaller organ
procurement organization (OPO) service areas. Since UNOS' 11 regions
range in population from 10 million to 40 million, these areas are
significantly larger than those recommended by the IOM. Needless to
say, we will still be examining the IOM's recommendations to determine
its advantages or disadvantages over the current system.
Increasing the Organ Supply
Regarding organ donation, I am pleased to report that UNOS has
developed a new technique that has the potential to increase the
overall number of transplantable organs by more than 10 percent. As you
know, the organ supply has remained roughly the same for years, despite
the best efforts of everyone involved in transplantation. UNOS recently
completed a pilot test of the new UNOS Critical Pathway for organ donor
management developed under our contract with the Health Resources and
Services Administration (HRSA).
The study revealed that use of this new protocol resulted in a 10.4
percent increase in the number of organs recovered per donor at the
test sites. The study also demonstrated that use of the Pathway reduced
costs and did not increase the time spent in donor management. As the
Pathway is implemented across the country, we expect to see a
nationwide increase in the organ supply on the order of 10 percent, the
largest increase in more than a decade.
New Data Available for Patients
Another significant change that has taken place since we were
before the Committee last involves new information and data that we
have made available to the public. Two weeks ago, UNOS unveiled an
online resource to provide the transplant community and the public with
unprecedented access to organ transplant information by utilizing the
latest in Internet technology.
Available on our web site (www.unos.org/patients), Transplant
Living is a new site offering patients and their families a single,
comprehensive source for everything they want and need to know to
handle the often tough decisions involved in obtaining an organ
transplant. It is designed to help those who have just discovered they
need a transplant better understand the process, and help them feel
they are making the best choices for their care.
Among its many resources, the web site features Transplant 101,
designed to be a step-by-step guide for patients and their families for
every stage of the organ transplant process. There is helpful
information on financing transplants, local support groups,
instructions on how to get on waiting lists, as well as past
experiences from transplant recipients, professionals and family
members of organ donors
The UNOS Internet site has been updated with a new section called,
Transplant Patient DataSource. This part of our web site provides the
latest statistics on:
Survival rates for every transplant program in the country;
The size of waiting lists and waiting times at each center and
OPO; and
The supply of donated organs, nationally, by state, and by
transplant center.
This unique research tool offers patients the critical information
they need to evaluate transplant centers when making decisions about
obtaining a life-saving organ. This kind of consumer information and
scientific data is unprecedented because nowhere else in medicine is
this level of detailed, institution-specific data available.
UNOS is extremely proud to have been able to step into this
leadership role in medicine, not only for the United States, but for
the entire world. Through our partnership with HHS, under our contracts
with HRSA, and through other funding arrangements, we have been able to
provide more extensive data for patients and the public than any other
public or private institution in medicine.
Ask yourself this question: If your doctor told you today that you
had a life-threatening condition, could you find information about
where you could receive treatment, and the track record at each
hospital where it is provided? Could you learn the number of similar
cases and the results at each of those centers, including every
center's survival rate?
Unless the treatment you need is an organ or bone marrow
transplant, the answer is no.
Arthur Andersen Study
We recently asked the world's leading information and management
consulting firm, Arthur Andersen, LLP, to conduct a study to evaluate
the extent to which leading major health organizations collect outcomes
data and provide center-specific information to the public.
Arthur Andersen polled 40 federal public health agencies and
national private health care organizations and found that other than
the bone marrow transplant registry, none of the organizations polled
collect or analyze center-specific data or healthcare-related outcome
data, or make it available to the public to the extent that UNOS does.
Three of the organizations noted that they make efforts to track other
types of data, e.g. number of cases, case demographics, etc., but that
the data is not made publicly available.
We believe the findings of this survey by Arthur Andersen confirm
the unique and unprecedented depth of information UNOS now makes
available to anyone interested in organ transplants.
UNet
Beyond the new, improved outreach to patients and their families,
UNOS is launching a similar, but secure, Internet-based transplant
information resource to help doctors and the transplant community match
donors to recipients faster and more efficiently. UNETsm
replaces an older, less user-friendly computer system, and should
eliminate many of the time-consuming telephone calls and faxes required
to coordinate the donation, allocation, and transplantation of life
saving organs. UNETsm is scheduled to go online next week,
offering physicians and organ centers unprecedented, real-time access
to the latest organ transplant information.
Both of these Internet-based efforts are a direct response to
feedback and suggestions from UNOS' network of patients, families,
doctors and medical professionals. With its lifesaving charter, UNOS
continually evaluates different ways to improve the system and help
make donation and transplant data readily available.
nota reauthorization
With regard to H.R. 2418, the bill that is before the Committee
today, I am proud to represent the UNOS membership in strongly
supporting this legislation. As I stated in my July 14, 1999 letter to
you, Mr. Chairman, we very much appreciate your leadership on this
issue and commend you for your hard work in developing this legislation
and the bipartisan support it has received.
Since 1990, when NOTA was last reauthorized, many of us in the
transplant community have been anxious about the state of
transplantation, and the Federal government's commitment to the public-
private partnership established in NOTA. We are enthusiastic about the
prospect of NOTA reauthorization and the opportunity to update and
strengthen current law. Specifically, we support H.R. 2418 for the
following reasons.
H.R. 2418 Reinforces the Original Intent of NOTA
It was Chairman Bliley and other members of this Committee who
designed the current public-private partnership that we now know as the
Organ Procurement and Transplantation Network. The beauty of this
structure is that it keeps delicate and informed medical decision
making in the medical and transplant community and out of the political
realm.
We at UNOS, as the Network contractor since its inception, believe
that the vision of NOTA's original authors has been a successful model
of great service to patients. The current system serves as a check and
balance system, producing the best medical decisions and the best
transplant policies for current and potential organ donors and
recipients.
H.R. 2418 preserves the original intent of NOTA by restating that
the responsibility for developing, establishing and maintaining medical
criteria and standards for organ procurement and transplantation rests
in the private sector and the medical community. With doctors,
patients, donor families, procurement coordinators, ethicists,
government officials, and others participating in a democratic policy
making process, transplantation policy can reflect a consensus of the
community while addressing the issues facing practitioners and patients
every day.
H.R. 2418 Creates New Enforcement and Accountability Requirements
Within the framework of the original NOTA, H.R. 2418 updates NOTA
by providing new direction in important areas such as enforcement,
accountability, and patient confidentiality.
Enforcement: Over the years, the transplant community has been
concerned that the Network lacked any real mechanisms to enforce its
policies. H.R. 2418 provides for several actions that the Network may
take in this regard. This approach is contrasted with what many have
regarded as the only enforcement mechanism available to the Network
under current law: the severe penalty of a hospital or OPO losing its
eligibility to be a Medicare provider (so severe a penalty that it is
unlikely to ever be invoked). The bill's proposed intermediate actions
include:
Payment of damages by Network participants who are found to be
non-compliant with Network policies through a peer review
process;
Suspension of a transplant program's ability to receive organs
for transplantation; and
Public designation as a member not in good standing.
Accountability: In addition to new enforcement mechanisms, H.R.
2418 includes new important requirements designed to make the Network
more accountable to Congress, the Secretary of Health and Human
Services and the public. For the first time, specific and detailed data
reporting requirements will be mandated by law. This ensures that the
extensive data that UNOS has recently made available to the public will
always be available in the future. The bill also provides for a new
periodic evaluation of the Network's performance by the Comptroller
General of the United States, which shall be submitted to Congress for
its review. Never before have such oversight measures been required by
law, and we support them.
Patient Confidentiality: As a significant new addition to NOTA,
H.R. 2418 contains a specific provision to protect patient
confidentiality. This provision ensures that, in an effort to provide
more information to the public regarding transplant hospital waiting
lists and outcomes, the confidentiality of patients--pre- and post-
transplant--will be protected. Many people do not realize the depth of
information that patients must disclose to be placed on a waiting list
to receive an organ transplant. As with any medical information,
disclosure of this information--even if unintended--can have
devastating effects on people lives. We wholeheartedly support this
important protection for patients.
H.R. 2418 Provides New Incentives for Donation
Perhaps most important are the bill's provisions aimed at
increasing donation. All of us involved in organ transplantation
struggle regularly with our frustration over the shortage of donor
organs. Each year, nearly 4,000 people die needlessly because too few
people give the gift of life. The medical community struggles daily
with families torn with grief over the loss of a loved one, who,
through fear or mistrust, choose not to allow organs to live on.
We know that Congress is committed to helping us bridge the gap.
There have been several recent steps taken such as the passage of the
Organ Donor Leave Act. For the past several years, Congress has also
been generous in appropriating more funds dedicated to educating people
about organ donation. This bill continues that trend.
The bill also provides resources to HHS to seek out the ``best
practices'' in organ procurement so they can be duplicated around the
country. I, for example, come from a state that has a great success
rate in recovering organs. These funds could help facilitate
information sharing and training between OPOs, hospital personnel and
others around the country, allowing for the best and most successful
ideas to be replicated.
Summary
Mr. Chairman, we believe all of these provisions are great
improvements to NOTA and that a reauthorization is timely and
necessary. We support the bill and urge the Committee to pass it.
Again, thank you for the opportunity to appear before you today.
Mr. Ganske. Thank you. Mr. Gibbons?
STATEMENT OF ROBERT D. GIBBONS
Mr. Gibbons. Good afternoon, Mr. Chairman and members of
the committee. My name is Robert Gibbons and I am a professor
of biostatistics at the University of Illinois in Chicago, and
also a member of the Institute of Medicine's Committee on Organ
Procurement and Transplantation. With me today is another
member from the IOM committee, Dr. Mitchell Spellman, who is
Professor of Surgery Emeritus and also Dean of Medical Services
Emeritus for Harvard University Medical School. And also with
me is Susanne Stoiber, the Executive Officer of the Institute
of Medicine.
We are pleased to have this opportunity on behalf of our
fellow committee members and the Institute of Medicine to talk
to you about our report on organ procurement and
transplantation. Copies of the report's executive summary have
been submitted for the record and preliminary print of the full
report has been available to members of this subcommittee.
The IOM was asked by Congress to review the regulation
published by the Department of Health and Human Services in
April 1998. Congress asked IOM to review its potential effect
on access to transplantation services, organ donation rates,
waiting times, survival rates and cost of organ transplantation
services.
Much of the public debate that led up to Congress asking
for our report centered on the observation that the time it
takes to receive a liver transplant varies greatly depending on
the location of the transplant center where the patient was
placed on the waiting list; namely, geographic heterogeneity.
Our committee quickly discerned that on the one hand this claim
was highly overstated, but on another it diverted attention
from very real and very important issues.
The reason this view is misleading is that it aggregated
data across all the levels of severity of patients. Patients in
liver Transplantation are broken down into four status groups
depending on the severity of their condition. The most severely
ill patients, which are called status 1 patients, have a life
expectancy of approximately a week. By contrast, the less
severely ill patients, status 3 patients and sometimes status
2B patients, may wait months or even years for a transplant.
Among the status 1 patients, the severely ill patients,
there is very little variation in waiting time. On average
these patients who do get transplanted do so within 4 days.
This is not the case for the less severely ill patients who can
wait months or possibly years based on differing policies and
practices among the transplant centers on when these patients
are placed on the list.
It is these listing practices that gave the overall
impression that there were large heterogeneity in the median
waiting times. Important to note is that more than 50 percent
of the patients are, in fact, status 3 patients accounting for
the variation in the median.
In terms of our analysis, for a variety of reasons the IOM
committee focused its attention on livers. We reviewed over
68,000 liver transplant records for every liver transplant
patient on the list from 1995 through 1999. This was a huge
data base.
Attached to my testimony is a map showing the configuration
of the 63 organ procurement organizations, which I will call
OPOs from here on, covering the U.S. and its territories. The
populations covered by these OPOs varied from 1 million to 12
million people.
We determined in an important finding that OPOs serving
larger populations are associated with improved access overall
for those patients most in need of a transplant. The committee
found specifically that for status 1 patients, those most
severely ill patients most in need of a transplant, they would
receive transplants--they wait a comparable period of time
across the country, about 4 days on average. However,
transplantation rates do vary for patients who are not as ill,
with smaller OPOs having a larger proportion of status 2B and
status 3 patients receiving transplants relative to the larger
OPOs. Consequently patients who are less ill sometimes receive
transplants before more severely ill patients who are served by
a different organ procurement organization.
Based on the data available and our analysis, these
differences begin to disappear when the population served by
the OPO reached 9 million people or more. For that reason, and
because the probability of a suitable match between a donated
liver and a status 1 patient increases as the size of the
population covered increases, we concluded that liver
allocation areas should be established to cover an area large
enough to serve at least 9 million people.
There were many other findings by the committee, but I will
highlight a couple. Our analyses indicated that the longer that
status 2B and status 3 patients are on the list, the lower
their likelihood is that they will die or receive a transplant.
This finding also led the committee to the conclusion that the
time on the waiting list is not an appropriate criterion for
allocating organs among the less severely ill patients.
Finally, we also looked at existing sharing arrangements
and we found that the existing sharing arrangements did, as we
would expect, increase status 1 transplantation rates and
decrease the rate of transplantation of the less severely ill
patients without increasing their pretransplantation mortality
rates.
There were several concerns expressed about the notion of
broader sharing. The first was whether or not there would be a
limitation on minority access or access to low-income patients.
The committee did not find any evidence in support of these
concerns.
Information available to the committee indicated that the
smallest transplant centers are not a major source of access
for racial and ethnic minorities. Moreover, we found the
evidence that small centers would be forced to close under
broader sharing arrangements to be inconclusive.
We also heard concern that distributing organs across a
wider area would discourage donation and again we found no
evidence in support of this idea.
Finally, we also found that broader sharing would
significantly increase the cost of transplantation and although
it will increase the cost, only marginally compared to the
total expenditures for transplantations.
Finally, the committee concluded that achieving the goals
of the National Organ Transplant Act requires an active Federal
role in review and oversight and this should be done in
collaboration with representatives of those involved in
transplantation, including patients, donor families,
physicians, nurses, OPOs and transplant centers. At the heart
of this there should be an independent scientific review board
that should assist with policies and procedures, making sure
that they are well grounded in medical science; that there is a
cohesive and strategic approach to the entire transplantation
system; that the interests of transplant patients and donor
families are given paramount concern; and credibility and trust
are maintained with patients in the transplant community and
the general public.
Thank you.
[The prepared statement of Robert D. Gibbons follows:]
Prepared Statement of Robert D. Gibbons, Professor of Biostatistics,
University of Illinois at Chicago
Good afternoon Mr. Chairman and members of the Committee. My name
is Robert D. Gibbons. I am a Professor of Biostatistics at the
University of Illinois at Chicago and a member of the Institute of
Medicine (IOM) Committee on Organ Procurement and Transplantation
Policy. With me is another member of the IOM committee, Mitchell W.
Spellman, M.D., Ph.D. Dr. Spellman is professor of surgery, emeritus,
and dean for medical services, emeritus, at the Harvard Medical School.
[Also with me is Ms. Susanne Stoiber, the Executive Officer for the
IOM.]
We are pleased to have this opportunity--on behalf of our fellow
committee members and the Institute of Medicine--to talk about our
report on organ procurement and transplantation. Copies of the report's
Executive Summary have been submitted for the record, and a preliminary
print of the full report has been available to the members of this
Subcommittee. I have a short oral statement and Dr. Spellman and I [OR,
the three of us] will be pleased to answer any questions you may have
about the report.
the committee's assignment
The IOM was asked by the Congress to review a regulation published
by the Department of Health and Human Services (DHHS) in April 1998.
That regulation set forth various requirements and procedures to be
followed by the Organ Procurement and Transplantation Network (OPTN) in
carrying out its responsibilities under the National Organ Transplant
Act (NOTA). The Congress suspended implementation of the regulation and
asked the IOM to review its potential effect on several important
issues, including:
Access to transplantation services by low-income populations
and racial and ethnic minorities;
Organ donation rates;
Waiting times for organ transplants;
Patient survival rates and organ failure rates; and
Costs of organ transplantation services.
Our report examines each of these issues, and sets forth several
conclusions and recommendations.
the initial public debate
Much of the public debate, leading up to the Congress asking for
our report, centered on the observation that the time it takes to
receive a liver transplant varies greatly, depending upon the location
of the transplant center where the patient has been placed on the
waiting list. This geographic inequity was put forward as evidence that
the current system is grossly inequitable. Our Committee quickly
discerned, however, that this was not the best way to evaluate the
data. One the one hand, it overstated the inequities, for reasons I
will briefly explain; but on the other hand, it diverted attention from
some very real and very important issues. The reason this view was
misleading is that it aggregated the data for all patients awaiting a
liver transplant, instead of breaking the data down into the four
status groups into which patients are classified, depending on the
severity of their condition. The most severely ill patients--those
having a life expectancy of a week or less--are in status 1. There is
very little variation in the waiting time for these patients; it is a
matter of a few days for those who receive a transplant. The least
severely ill patients-- those in status 3--may wait months or even
years for a transplant. Since more than half of all patients on the
waiting lists are in status 3, the data for these patients are what
determines the overall variation in median waiting times used in the
arguments noted above. But this tells us very little about the equity
or effectiveness of the system, since differing policies and practices
among transplant centers on when status 3 patients should be placed on
a waiting list means that these patients form a very heterogeneous
group.
the committee's analysis
For a variety of reasons, the IOM Committee focused its attention
on livers. In order to review the issues in greater depth, the
Committee obtained, from the OPTN, approximately 68,000 records
covering all the patients awaiting a liver transplant during the period
from 1995 to 1999. Of particular interest were the consequences of the
current OPTN policies on allocating donated organs among patients, and
the likely consequences of the changes in those policies called for by
the DHHS regulation.
Organ Procurement Organizations (OPOs) are statutorily created
entities responsible for the procurement of donated organs and for
coordinating the allocation of those organs among patients on the
waiting lists of transplant centers. Attached to my testimony is a map,
showing the configuration of the 63 OPOs covering the U.S. and its
territories. At the present time, with a few important exceptions, when
these OPOs obtain an organ donated for transplantation, they seek to
allocate it to a patient located within their own defined geographical
area. Only if they cannot find a suitable patient within their own area
do they seek to find a patient located in one of the other--typically
adjacent--OPO areas. The populations covered by these OPO areas vary
from approximately 1 million to about 12 million. We determined that
OPOs serving larger populations are associated with improved access for
those patients most in need of a transplant.
The Committee found that status 1 patients (those with the highest
medical urgency for a transplant) who receive transplants wait for a
comparable period of time all across the country--about 4 days on
average. Moreover, the transplantation rates and the pre-
transplantation mortality rates for status 1 patients do not vary
significantly from one OPO to another, despite substantial variations
in the size of the OPOs. (Size of OPO was defined either by the size of
the population served or the number of transplants performed within the
OPO service area.) However, only about one-half of the patients listed
as status 1 receive a transplant.
Transplantation rates do vary for patients who are not as ill, with
smaller OPOs having a larger proportion of status 2B and status 3
patients receiving transplants than larger OPOs. Consequently, patients
who are less ill sometimes receive transplants before more severely ill
patients who are served by a different organ procurement organization.
Based on the data available to the Committee, these differences begin
to disappear when the population served by the OPO reaches 9 million or
more.
For that reason, and because the probability of a suitable match
between a donated liver and a status 1 patient increases as the size of
the population covered increases, we concluded that liver allocation
areas should be established to cover an area large enough to serve at
least 9 million people. Nine million is as far as our available data
could take us. Logic suggests that larger areas would be even more
effective in arranging a suitable match. These areas, however, should
not be so geographically broad as to pose difficulties or delays in
transporting organs, which could threaten the viability of the organ
and the success of transplantation. The allocation areas for organs
other than livers will differ depending on how long they can survive
outside the body.
It is important to note that improvements in the rates of
transplantation for status 1 patients do not appear to come at the
expense of other patients. Our analysis indicated that the longer
status 2B and status 3 patients are on the waiting list, the lower is
the likelihood that they will either die or receive a transplant. This
finding also lead the Committee to the conclusion that time on the
waiting list is not an appropriate criterion for allocating organs
among status 2B and status 3 patients.
There are currently in effect several arrangements under which two
or more OPOs share donated organs on a statewide or regional basis, at
least for status 1 patients. The Committee could make only a
preliminary analysis of the data available for such sharing
arrangements, but that analysis tends to confirm the Committee's view
that broader sharing is beneficial. The analysis shows that that such
sharing: (1) increases status 1 transplantation rates; (2) decreases
status 2B pre-transplantation mortality rates; and (3) decreases the
rate of transplantation of status 3 patients without increasing their
pre-transplantation mortality rates.
concerns expressed about broader organ sharing
The Committee heard some people in the transplant community express
concern that broader sharing of organs might reduce access to organs
for minorities and low-income patients. This would be true, they
stated, if broader sharing resulted in the closure of some of the
smaller transplant centers.
The Committee did not find any evidence to support these concerns.
For low-income patients, regardless of their racial and ethnic
backgrounds, there is an appropriate concern that they may not be
referred to a transplant center for an evaluation for transplantation.
This is because appropriate referral depends in large part on whether
they have access to health insurance and high-quality health services.
Once patients are referred for an organ transplant--again regardless of
their race or ethnicity--there appear to be no significant disparities
either in their placement on a waiting list or in access to
transplantation.
Information available to the Committee indicated that the smallest
transplant centers are not a major source of access for racial and
ethnic minorities. Moreover, we found the evidence that small centers
would be forced to close under broader organ sharing to be
inconclusive.
The Committee also heard concern that distributing organs across a
wider geographic area would discourage donation and drive down organ
donation rates. Organ donation rates are affected by many variables,
including cultural attitudes about donation and transplantation, the
age and race of the potential donor, the progression of illness in the
potential donor, the manner in which families of potential donors are
approached, and the various policies and practices of hospital staff
and OPOs. The biggest shortcoming at present appears to be that many
potential donors are not identified and their families not approached
about the possibility of donation. The Committee found little
evidence--if any--to support the notion that families would decline to
donate, or that health professionals involved in organ procurement
would be less diligent in their efforts, if they knew a donated organ
would be used outside the donor's immediate geographic area. The
Committee believes current efforts to increase donation should be
sustained and that broader allocation arrangements should be made in a
way that does not undermine current effective working relationships
between OPOs and hospitals.
Another concern expressed to the Committee was that broader sharing
would significantly increase the cost of transplantation. Based on data
provided to the Committee by the General Accounting Office (GAO), as
well as the published literature, the Committee concluded that total
expenditures associated with organ procurement and transplantation are
likely to increase as a result of broader sharing. OPOs and transplant
teams may both experience higher transportation costs. In addition, a
larger number of sicker patients will receive transplants and there
will likely be more re-transplants' both of which would increase costs.
The Committee was unable to estimate the magnitude of the increase, but
believes it would be marginal compared to the total expenditures for
transplantation
federal oversight and review
The Committee believes that, when Congress passed the National
Organ Transplant Act, it intended for there to be a cohesive, well-
coordinated system encompassing all aspects of transplantation. The
Committee also believes that we do not have such a system at this time
and that we cannot have such a system without effective, comprehensive
oversight. We therefore concluded that achieving the goals of the
National Organ Transplant Act requires an active federal role in review
and oversight, and that this should be in collaboration with
representatives from all those involved in transplantation, including
patients, donor families, physicians and nurses, OPOs, and transplant
centers. The federal government, as well as the transplantation
community, has a legitimate and appropriate role to play in ensuring
that the organ procurement and transplantation system serves the public
interest, especially the needs and concerns of patients, donors, and
families affected by it.
At the present time, responsibilities are dispersed throughout the
system, creating impediments to oversight and review, permitting poor
procedures for data analysis and dissemination to persist, and allowing
the system to operate without adequate assessment of performance. The
Committee acknowledges that many aspects of organ procurement and
transplantation require effective arrangements and decision making at a
local level. However, a more centralized mechanism for oversight and
review would improve the quality assurance that donors and recipients
deserve. This is not to say that the federal government should be
making medical judgments regarding individual patients, but rather that
its responsibility is to ensure that the policies that guide the
operation of the system are equitable and well-grounded in medical
science. Vigilant and conscientious oversight and review of programs
and policies are critically important to ensuring accountability on the
part of the OPTN and other participants in the organ procurement and
transplantation system.
To assist in this activity, there needs to be independent
scientific review. The Committee recommends that an independent,
multidisciplinary advisory board be appointed to assist in the
oversight of the program. Such a board could help to assure that: (1)
policies and procedures are well grounded in medical science: (2) there
is a cohesive, strategic approach to the entire transplantation system:
(3) the interests of transplant patients and donor families are given
paramount concern: and (4) credibility and trust are maintained with
patients, the transplantation community and the general public.
In addition, the Committee concluded that better performance
measures should be developed for each of the components of the
transplantation system, and that data about the system should be
reliably and regularly gathered, independently assessed, and made
widely available. The Committee's concerns about oversight and review
cut across the individual issues specified in its charge and relate in
general to all organ transplantation, not just liver transplantation.
committee recommendations
Based on its review and analysis of the data and information
available to it, the Committee reached the following recommendations:
Recommendation 1: Establish Organ Allocation Areas for Livers
The committee recommends that the DHHS Final Rule be
implemented by the establishment of Organ Allocation Areas
(OAAs) for livers--each serving a population base of at least 9
million people (unless such area exceeds the limits of
acceptable cold ischemic time). OAAs should generally be
established through sharing arrangements among organ
procurement organizations to avoid disrupting effective current
procurement activities.
Recommendation 2: Discontinue Use of Waiting Time as an Allocation
Criterion for Patients in Statuses 2B and 3
The heterogeneity and wide range of severity of illness in
statuses 2B and 3 make waiting time misleading within these
categories. For this reason, waiting time should be
discontinued as an allocation criterion for status 2B and 3
patients. An appropriate medical triage system should be
developed to ensure equitable allocation of organs to patients
in these categories. Such a system may, for example, be based
on a point system arising out of medical characteristics and
disease prognoses rather than waiting times.
Recommendation 3: Exercise Federal Oversight
The Department of Health and Human Services should exercise the
legitimate oversight responsibilities assigned to it by the
National Organ Transplant Act, and articulated in the Final
Rule, in order to manage the system of organ procurement and
transplantation in the public interest. This oversight should
include greater use of patient-centered, outcome-oriented
performance measures for OPOs, transplant centers, and the
OPTN.
Recommendation 4: Establish Independent Scientific Review
The Department of Health and Human Services should establish an
external, independent, multidisciplinary scientific review
board responsible for assisting the Secretary in ensuring that
the system of organ procurement and transplantation is grounded
on the best available medical science and is as effective and
as equitable as possible.
Recommendation 5: Improve Data Collection and Dissemination
Within the bounds of donor and recipient confidentiality and
sound medical judgment, the OPTN contractor should improve its
collection of standardized and useful data regarding the system
of organ procurement and transplantation and make it widely
available to independent investigators and scientific reviewers
in a timely manner. DHHS should provide an independent,
objective assessment of the quality and effectiveness of the
data that are collected and how they are analyzed and
disseminated by the OPTN.
References:
DHHS (U.S. Department of Health and Human Services). 1998b. Organ
Procurement and Transplantation Network; Final Rule (42 CFR Part 121).
Federal Register 63(63):16296-16338.
GAO (U.S. General Accounting Office). 1997. Report to the ranking
minority member, Committee on Labor and Human Resources, U.S. Senate.
Organ Procurement Organizations: Alternatives Being Developed to More
Accurately Assess Performance. GAO/HEHS-98-26. Washington, D.C.: GAO.
IOM (Institute of Medicine). 1999. Organ Procurement and
Transplantation Policy. Washington, D.C.: National Academy Press.
UNOS (United Network for Organ Sharing) 1999. Available at:
www.unos.org. Accessed July 1, 1999.
Committee on Organ Procurement and Transplantation Policy
EDWARD D. PENHOET (Chair), Dean, School of Public Health,
University of California at Berkeley
NAIHUA DUAN, Statistics Group, RAND Corporation, Santa Monica
(until May 6, 1999)
NANCY Neveloff DUBLER, Director, Division of Bioethics, Montefiore
Medical Center, Professor of Bioethics, Albert Einstein College of
Medicine, New York
CHARLES K. FRANCIS, President, Charles R. Drew University of
Medicine and Science, Los Angeles
ROBERT D. GIBBONS, Professor of Biostatistics, Departments of
Biostatistics and Psychiatry, University of Illinois at Chicago
BARBARA GILL, Clinical Nurse Specialist, Abilene Cardiothoracic and
Vascular Surgery of Texas, Abilene
EVA GUINAN, Associate Professor of Pediatrics, Harvard Medical
School, Boston
MAUREEN HENDERSON, Professor Emeritus of Epidemiology and Medicine,
University of Washington, Seattle
SUZANNE T. ILDSTAD, Director, Institute for Cellular Therapeutics,
University of Louisville
PATRICIA A. KING, Carmack Waterhouse Professor of Law, Medicine,
Ethics, and Public Policy, Georgetown University, Washington, D.C.
MANUEL MARTINEZ-MALDONADO, Vice Provost for Research and Professor
of Medicine, Oregon Health Sciences University, Portland
GEORGE E. MCLAIN, Assistant Chief of Anesthesiology, Martin
Memorial Medical Center, Stuart, Florida
DAVID MELTZER, Assistant Professor, Section of General Internal
Medicine, Department of Economics, and Harris School of Public Policy
Studies, University of Chicago
JOSEPH E. MURRAY, Professor of Surgery, Emeritus, Harvard Medical
School, Boston
DOROTHY NELKIN, University Professor, New York University
Department of Sociology and School of Law, New York
MITCHELL W. SPELLMAN, Director of Academic Alliances and
International Exchange Programs, Harvard Medical International, Harvard
Medical School, Boston
[GRAPHIC] [TIFF OMITTED] T9992.001
Mr. Bilirakis. Thank you very much. Dr. Miller, when did
you arrive? I was able to escape late yesterday after that
storm which swerved from dead on Pinellas County down to your
area.
Mr. Miller. We ducked and it missed us. It went around the
south tip of the State, so we were all fortunate.
Mr. Bilirakis. They are crazy, aren't they? In any case,
sir, you are welcome. Please proceed.
STATEMENT OF JOSHUA MILLER
Mr. Miller. I appreciate the opportunity to testify at this
hearing on the important legislation that you have introduced,
Mr. Chairman, which would reauthorize programs relating to
organ procurement and transplantation. I am Dr. Joshua Miller,
Codirector of the Division of Transplantation at the University
of Miami School of Medicine in Miami, Florida. I am appearing
today as the immediate past President of the American Society
of Transplant Surgeons, the ASTS, a professional organization
of surgeons, physicians and scientists who during the past 25
years of our existence have pioneered and continue to advance
the frontiers of life-sustaining organ transplantation.
ASTS members have the responsibility for directing
transplantation clinical and research programs at America's
major medical centers. As part of this responsibility, we
helped forge the National Organ Transplant Act, NOTA, into law
in partnership with the U.S. Congress over a decade and a half
ago.
We were instrumental in conceiving an organ procurement and
distribution network and, in partnership with the Health Care
Finance Administration of the Department of Health and Human
Services, helped to organize it and to put it into action
during the same period.
We are here now 15 years later to work with you in
reauthorizing NOTA and providing a clear congressional
guideline for how that network can provide the maximum benefit
to our patients as we move into the 21st century.
Because of the explosive success of organ transplantation
in the latter part of the 20th century there are now more than
65,000 Americans, an additional 3,000 since I last testified
before your subcommittee in April, Mr. Chairman, with end-stage
failure of hearts, livers, lungs, pancreases, and kidneys
awaiting life-saving and life-sustaining transplants. This is a
potentially explosive situation because as the number of
patients on waiting lists climbs inexorably toward 100,000,
concern and frustration over the allocation of these scarce
organs is bound to grow. Our fear is that this mounting public
concern is leading to increased efforts to politicize what is
and ought to remain a medical decisionmaking process.
We strongly believe that Congress in enacting NOTA and
establishing the Organ Procurement and Transplantation Network,
the OPTN, in the private sector under government contract
intended for this highly specialized and expert OPTN to make
organ allocation policy based on sound medical and ethical
principles and scientific data independent of political
influence, and that is how it has essentially operated these
past 15 years.
But as you are aware, Mr. Chairman, several sections of the
final rule governing the OPTN published by the Secretary of
Health and Human Services a year ago April could be interpreted
as setting the stage for the Secretary of DHHS to make specific
allocation policy. This effort by the Department was the result
of the fairly recent intense criticism by a vocal minority of
one very specialized aspect of the OPTN, liver allocation. We
have repeatedly expressed our concerns to DHHS in the course of
a number of meetings this past summer. We have suggested
changes in a rule that we largely agree with, this rule that we
largely agree with, changes designed to prevent the baby that
we jointly conceived from being thrown out with the bath water,
changes that among other things would clarify that the
Secretary must not dictate specific transplantation practices
or medical judgments. We were also greatly concerned that the
rule might unwittingly tamper with the very delicate but very
real local influences on organ donation that we discussed in my
last appearance before your committee.
We believe the legislation you have drafted makes it clear
that there is a most legitimate oversight role for DHHS in
ensuring that the policies which guide the operation of the
system are adhered to, and we support that oversight role for
DHHS.
We would also like to submit for the record a white paper
our society issued just last Friday summarizing our views on
the issues that we have been discussing with DHHS and on some
of the recommendations included in the report delivered to
Congress in midsummer by the Institute of Medicine. We know
Members of Congress have been provided with a variety of
interpretations of this IOM report both by DHHS and by the OPTN
contractor, UNOS, generally claiming vindications for their
positions. And as is so often the case, we believe the truth
falls somewhere in between.
I would like to just mention two important points that the
IOM report makes what I believe go to the heart of our concern
over leaving medical decisions in the hands of medical
professionals.
Throughout 1998 and right up through this summer, DHHS, in
urging Congress to allow the final rule to be imposed without
delay, contended that significant regional differences in the
length of time patients spend on waiting lists for livers
demonstrated a fundamental unfairness of the current system.
The ASTS testified before Congress more than a year ago as we
repeatedly informed the Department that there really were only
small differences in waiting times for patients in the most
urgent categories and that median waiting times for all liver
patients as used by the Department were really not a good
measure of fairness.
The Institute of Medicine after analyzing data, and as was
just mentioned, ``Overall median waiting time, which has
dominated the policy debate, is a poor measure of differences
in access to transplantation.''
It further suggested that differences in waiting time for
less urgent patients are so, ``misleading''--that was the word
that the IOM used, misleading--that it proposed waiting time no
longer be an allocation criteria in less urgent categories of
liver patients.
The public focus on waiting time as the driver of the need
for quick fix, quick change in the allocation of livers is
exactly the kind of politicization of the medical
decisionmaking process that concerns us.
And I would like to touch briefly on one other
recommendation of the IOM that we move toward a system of
broader sharing of livers for patients in most urgent need
because we do believe that this recommendation has merit. In
fact, less than a month after the IOM issued its report the
OPTN put into effect a new policy of broader regional sharing
for status 1 liver patients, the most urgent category, and this
was already in the due process pipeline. This policy will
hopefully ensure that those most critical liver patients to the
best of our medical ability today have access to life-saving
organs. This I believe is indicative that the establishment of
allocation policies by the OPTN is a dynamic process through
which change does take place in response to new information and
analysis. Could this change have occurred earlier? Probably.
Does the current system function perfectly? Of course not. Is
there room for improvement in the performance of the current
contractor? Absolutely. There is always room for improvement in
the operation of the network through refinements like those
suggested in our legislation.
Our society's interests lie in the structure and operation
of the network and its relationship to DHHS. Our interest is
not to be specifically protective of the incumbent contractor
that is operating the network. We also very much believe that
the OPTN should be responsive to independent external review
and assessment. We would favor strengthening the section you
already included in the legislation relative to General
Accounting Office evaluations of the network.
We have a small number of other changes we would be pleased
to discuss with you, Mr. Chairman, which we believe would
further strengthen the NOTA reauthorization effort. But again
let me conclude my prepared remarks by thanking you for the
leadership you have demonstrated sponsoring this most important
piece of legislation, and I would welcome any questions that I
might be able to answer.
Thank you.
[The prepared statement of Joshua Miller follows:]
Prepared Statement of Joshua Miller, American Society of Transplant
Surgeons
I appreciate the opportunity to testify at this hearing on the
important legislation that you have introduced, Mr. Chairman, which
would reauthorize programs relating to organ procurement and
transplantation.
I am Dr. Joshua Miller, Professor of Surgery, Microbiology ,
Immunology and Pathology, and Chief of the Division of Kidney and
Pancreas Transplantation, at the University of Miami School of Medicine
in Miami, Florida.
I am appearing today as the Immediate Past President of the
American Society of Transplant Surgeons (the ASTS), the professional
organization of Surgeons, Physicians, and Scientists who, during the
past 25 years of our existence, have pioneered and continued to advance
the frontiers of life-sustaining organ transplantation. ASTS members
have the responsibility for directing transplantation clinical and
research programs at America's major medical centers.
As part of this responsibility we helped forge the National Organ
Transplant Act into law in partnership with the United States Congress
over a decade and a half ago. We conceived of an organ procurement and
distribution network, and, in partnership with the Health Care
Financing Administration of the Department of Health and Human
Services, helped organize it and put it into action during the same
period.
Now, we are here--15 years later--to work with you in reauthorizing
NOTA and providing clear Congressional guidelines for how that network
can provide the maximum benefit to the maximum number of patients as we
move into the 21st Century.
Because of the explosive success of organ transplantation in the
latter half of the 20th century, there are now more than 65,000
patients--an additional three thousand since I last testified before
your Subcommittee in April--with end-stage failure of hearts, livers,
lungs, pancreases, and kidneys awaiting life-saving transplants.
This is a potentially explosive situation, Mr. Chairman, because as
the number of patients on waiting lists climbs inexorably toward and
passes 100,000 Americans, concern and frustration over the allocation
of these scarce organs is bound to grow. Our fear is that, inevitably,
this mounting public concern over who-gets-an-organ-and-when will lead
to increased efforts to politicize what is, and ought to remain, a
medical decision-making process.
We strongly believe that Congress, in enacting NOTA and
establishing the Organ Procurement and Transplantation Network in the
private sector under government contract, intended for the OPTN to make
organ allocation policy based on sound medical principles and
scientific data independent of political influence. And that is how it
has operated these past 15 years.
But as you are aware, Mr. Chairman, several sections of the Final
Rule governing the OPTN published by Secretary of Health and Human
Services Donna Shalala a year ago April could be interpreted as setting
the stage for the Secretary of DHHS to make specific allocation policy.
We have repeatedly expressed our concerns over this to DHHS, in the
course of a number of meetings this past summer. We have suggested
changes that, among other things, would clarify that the Secretary must
not dictate specific transplant practices or medical judgments.
We believe the legislation you have drafted, Mr. Chairman, makes it
clear there is a legitimate oversight role for DHHS in ensuring that
the policies which guide the operation of the system are equitable,
based on sound medical science, and are adhered to. We support that
oversight role for DHHS.
But we do want to again express our appreciation to you, Mr.
Chairman, for making it clear in this legislation that the
responsibility for ``developing, establishing, and maintaining medical
criteria, and standards,'' and policy concerning allocation, belongs
with the Network. And those policies should be modified by the Network,
as necessary, on the basis of sound medical science and developing
medical practices.
We would also like to submit for the record, along with these
remarks Mr. Chairman, a white paper our society issued just last Friday
summarizing our views on a variety of the issues we have been
discussing with DHHS. It also contains our views on some of the
recommendations included in the report delivered to Congress in
midsummer by a Committee of the Institute of Medicine.
We know Members of Congress have been provided with a variety of
interpretations of this IOM report, both by DHHS and by the OPTN
contractor, the United Network for Organ Sharing, among others,
generally claiming vindication for their positions. As is so often the
case, we believe the truth falls somewhere between.
I would like to just mention a couple of important points that the
IOM report makes, however, that I believe go to the heart of our
concern over leaving medical decisions in the hands of medical
professionals.
Throughout 1998 and right up through this summer, DHHS--in urging
Congress to allow the Final Rule to be imposed without delay--contended
that significant regional differences in the length of time patients
spend on waiting lists for livers demonstrate a fundamental unfairness
of the current system.
We suggested in testimony before Congress more than a year ago--as
we repeatedly suggested to the Department--there really were only small
differences in waiting time for patients in the most urgent categories,
and that median waiting times for all liver patients, as used by the
Department, were really not a good measure of fairness.
The Institute of Medicine--after analyzing years of data--
concluded, and I quote: ``Overall median waiting time, which has
dominated the policy debate, is a poor measure of differences in access
to transplantation.'' It further suggested that differences in waiting
time for less urgent patients are so ``misleading''--that was the word
the IOM used-that it proposed waiting time no longer be an allocation
criterion in less urgent categories of liver patients.
The public focus on waiting times as the driver of the need for
quick change in the allocation of livers is exactly the kind of
politicization of the medical decision-making process that concerns us.
I would also like to touch briefly on another recommendation by the
Institute of Medicine--that we move toward a system of broader regional
sharing of livers for patients in most urgent need--because we do
believe that this recommendation has a great deal of merit.
The IOM committee concluded, after crunching the data, that the
most urgent liver patients--Status 1 patients--would be more likely to
receive an organ expeditiously if contiguous OPOs were grouped into
what it called Organ Allocation Areas each serving a population base
greater than nine million.
Less than a month after the IOM issued its report, the OPTN put
into effect a new policy of broader regional sharing for Status 1 liver
patients--the most urgent category--which hopefully will insure that
these most critical liver patients have access to a life-saving organ
sooner than might have been the case.
I believe this is indicative, Mr. Chairman, of the fact that the
establishment of allocation policies by the OPTN is a dynamic process
through which change does take place in response to new information and
analysis, and changes in medical science and medical practice.
Could this change have occurred earlier? Probably. Does the current
system function perfectly? Of course not. Is there room for improvement
in the performance of the current contractor? Absolutely.
There is always room for improvement in the operation of the
network through refinements, like some suggested in your legislation.
And I might add that our Society's interests lie in the structure
and operation of the network, the composition of the network and its
relationship to DHHS, and the composition and authority of the network
board of directors and committees, which establish policy for the
network. Our interest is not to be specifically protective of the
incumbent contractor that operates the network.
We also very much believe that the OPTN should be responsive to
independent external review and assessment. We would favor
strengthening the section you already included in the legislation, Mr.
Chairman, relative to General Accounting Office evaluations of the
network.
We have a small number of other changes we would be pleased to
discuss with you, Mr. Chairman, which we believe would further
strengthen the NOTA reauthorization effort. But again, let me conclude
my prepared remarks by thanking you for the leadership you have
demonstrated in sponsoring this most important piece of legislation.
Thank you.
Mr. Bilirakis. Thank you, Mr. Miller. You heard the bells,
and the bad news is that there is no good news. The bad news is
that we have a 15-minute vote followed by two 5-minute votes,
so we are talking probably 35, 40 minutes. I would have liked
to have been able to get through at least the witnesses, but we
just won't really have time to do that because I hate to cut
you off at 5 minutes. So I am just going to have to ask you to
be as patient--continue to be as patient as you have been. We
are going to break probably until about 4:30 or shortly
thereafter.
Mr. Ganske. Mr. Chairman?
Mr. Bilirakis. Yes?
Mr. Ganske. I ask unanimous consent for 1 minute.
Mr. Bilirakis. One true 1 minute? Without objection.
Mr. Ganske. Thank you, Mr. Chairman. As probably one of the
few Congressmen who has scrubbed with Dr. Starzl and also did
my general surgical training at the University of Oregon Health
Sciences Center, I have some understanding of this issue.
I am disturbed with the administration on this. I think you
have put your foot in a tar baby where you shouldn't be. Mr.
Chairman, I see that on your bill you have cosponsors Gene
Green, Bill Jefferson, Ken Bentsen, Peter Deutsch, Carlos
Romero-Barcelo, Ralph Hall, Bart Gordon, David Wu, Jim Clyburn,
Frank Pallone, Martin Frost, Sheila Jackson Lee, Jerry Kleczka,
Peter DeFazio, Maurice Hinchey, Earl Hilliard, Tammy Baldwin,
and a whole bunch of Republicans, and guess what, Mr. Chairman?
You can now put my name on your cosponsor list. Thank you very
much.
Mr. Bilirakis. I thank the gentleman and I believe that
there are some that are probably not on that list.
Thank you for that. Dr. Gibbons, you have heard some of the
comments made by Mr. Miller. I know that Dr. Payne, I am sorry
I was called out by a large group of people that wanted to see
me about another matter. That is the life up here but hopefully
you all can talk about some of the comments that you have
heard. We are trying to do the right thing. Granted, there is
parochialism here. There is no question about it. But at the
same time I think for the most part we do want to do what is
right.
Well, anyhow, maybe you can have a little bit of interplay
among yourself until we return. Thank you.
[Brrief recess.]
Mr. Bilirakis. We are back. Mr. Irwin, President of the
National Transplant Action Committee. By the way, thanks again
for your patience and your understanding. Please proceed, sir.
STATEMENT OF CRAIG IRWIN
Mr. Irwin. Thank you, Mr. Chairman. I am here today
speaking on behalf of not only The National Transplant Action
Committee but also TRIO, Transplant Recipients International
Organization, and MOTTEP, the Minority Organ Transplant and
Tissue Education Program. Collectively we represent thousands
of transplant patients throughout the United States.
Unfortunately, Dr. Clyde Calendar of MOTTEP nor Mr. Bruce
Weir, President of TRIO, were able to be here today but I am
joined by Lisa Kory, President of TRIO.
I am here to speak in opposition to H.R. 2418, the Organ
Procurement and Transplantation Network Amendments of 1999.
This legislation comes amid considerable debate over the rules
promulgated by the Department of Health and Human Services last
year. Those rules are scheduled to go into effect on October
21.
Our three organizations believe that transplant patients
and their families must be the focus of our public policy in
this area of health care. Patients should be able to access
critical information about the transplant system and the
quality of care in our Nation's transplant hospitals. Patients
deserve to be treated fairly by the organ allocation system.
Some patients have choices among transplant centers, however,
many don't. A patient's chance of finding a suitable donor
shouldn't be a matter of who you are or where you live. And
patients and their families either directly or through HHS
deserve to have a significant role in the development of public
policies impacting the Nation's transplant system.
These beliefs are consistent with the goals and intent of
the National Organ Transplant Act. To quote the intent of
Congress: The organ procurement and transplantation network was
created in order to facilitate an equitable allocation of
organs among patients. The OPTN's responsibilities are great
and the purpose of the act will be served only if the policies
of the OPTN are sound and are soundly developed. The allocation
of organs may well be a life or death decision for patients.
And although the act gives the contractor authority to
develop medical policies regarding the safe allocation and
transportation of organs, it does not give the contractor
public policy authority. Instead it gives administrative
authority to the Secretary.
Unfortunately, what has evolved is a patchwork system of
organ allocation designed to meet the expectations and needs of
transplant centers instead of the patients. Many patients and
advocates who have worked hard to help others and have much to
offer are often left out of the OPTN policy setting process
because of their views. And critical data is often difficult to
obtain and is often old and useless.
I am pleased to hear of Mr. Waxman's remarks regarding the
availability of comprehensive data, and we look forward to
reviewing that data and making it available to patients around
the country.
These problems have continued to surface throughout the
years. The concerns of patients have been echoed by the
Congress and reflected by changes to the act in 1988 and 1990.
In 1990, Congress eased the minimum qualifications that
must be met by an entity seeking the OPTN contract stating
that, ``By modifying this requirement, the committee intends to
provide the Secretary with the opportunity to seek out the best
possible potential applicants for this critical role.''
This change along with changes the committee has made to
the OPTN board of directors reflect deep concern on the part of
the committee in the manner in which the OPTN has functioned.
That same year, Congress amended the act to mandate that the
OPTN assist organ procurement organizations in the nationwide
distribution of organs equitably among transplant patients.
The bill now before this committee represents a complete
reversal from these patient-driven policies and statements.
H.R. 2418 would make dramatic changes to the manner in which
organs are allocated to patients on the waiting list. New
factors could now be considered in addition to equity. Fairness
would no longer be the benchmark. Secretarial oversight would
essentially be eliminated with no recourse to change or amend
policies which might be detrimental to patients. The right of
patients and the public to become members of the OPTN would be
eliminated. There would be no further competition for the OPTN
contract. UNOS would be the only organization meeting the
contract criteria.
H.R. 2418 contradicts the past actions by this committee.
The bill also ignores the recommendations of the recent report
by the Institute of Medicine, which was required by Congress,
submitted to this committee. The report contains key
recommendations impacting transplant patients. The IOM calls
for more oversight, not less, of the OPTN. In addition, the
report calls for independent comprehensive review by a body
reporting to the Secretary and not affiliated with the OPTN
contractor.
The IOM concluded that broader sharing as called for by the
regulation would have the net effect of saving more lives by
increasing transplantation rates for those with the greatest
risk of dying, decreasing pre-transplant mortality rates for
the next level of patients on the waiting list and decreasing
the number of the healthiest patients transplanted without
increasing their risk of dying.
Finally, the report dispels the many myths promoted by the
opponents of the regulation, many of which we have heard today.
Paramount is the myth that minorities would be hurt by the
regulations.
Although the IOM found that there is essentially parity and
equity in liver allocation, the report also concluded that
minorities would not be hurt by the regulations. The HHS
regulations will move the system toward greater fairness and a
more patient-driven system. H.R. 2418 will move us in the
opposite direction.
Mr. Chairman, when the committee last took up the
reauthorization in 1993, you took exception to the full
committee's desire to simply call for a study of organ
allocation. You were quite eloquent in recognizing that sick
people will continue to die merely because of UNOS-created
geographic boundaries. You asked the Secretary to do what the
committee would not, operate the program closer to the original
congressional intent when the act was passed in 1984.
Mr. Chairman, you were right then. Your conclusions apply
equally today and your views have been validated by the IOM. On
behalf of the 65,000 patients now waiting for transplants in
the United States, we ask that you not change directions now.
Thank you.
[The prepared statement of Craig Irwin follows:]
Prepared Statement of Craig Irwin, President, National Transplant
Action Committee
National Transplant Action Committee (NTAC) is a consumer advocacy
organization founded in 1992. We currently have approximately 1500
members across the United States. NTAC has been a leading advocate for
organ transplant patients and their families as directed by our Patient
Public Policy Committee.
analysis and comment on hr 2418
NTAC strongly opposes HR 2418, the ``Organ Procurement and
Transplantation Network Amendments of 1999. The bill now before the
Committee would make drastic changes to the National Organ Transplant
Act (NOTA) and the management of the nation's Organ Procurement and
Transplantation Network (OPTN).
1. The bill establishes the private contractor as an ``independent
partner'' with the federal government. It requires the Department of
Health and Human Services (HHS) to ``cooperate'' with the contractor as
well as eliminates the oversight role of HHS. It reduces the role of
the Secretary to taking and reviewing comments but grants no authority
to HHS to protect or promote the public health interest through an
administrative role.
2. Eliminates the independent Scientific Registry
3. Gives the OPTN contractor greater authority over which
information is released to patients and the public. Grants the
contractor new ``authority'' by which to withhold vital information
from the public.
4. Excludes members of the public and patients from being members
of the OPTN. Membership is only permitted to ``entities'' in the
transplant field.
5. The bill would eliminate the release of center specific data and
replace it with less helpful OPO specific data.
6. Gives the contractor broad judicial authority and the right to
penalize transplant centers. Such penalties may include the withholding
of organs from transplant centers that do not adhere to network rules.
7. Administrative and procedural activities between the Secretary
and the contractor would now have to be conducted on a mutually
consensual basis. Gives the contractor sole discretion over
``scientific, clinical, and medical decisions'' regardless of the
impact of such decisions on the public health interest.
8. Any subsequent contractor must be approved by the OPOs and
transplant centers. Requires the OPTN contractor to have ``experience''
in organ transplantation.
9. Changes the criteria for the allocation of donated organs.
Expands consideration of allocation policies to include issues of
equity and ethics. It also eliminates the requirement that organs be
distributed on a ``nationwide'' basis ``equitably among patients on the
waiting list.''
NTAC believes that each one of these provisions would have an
adverse impact on organ transplant patients and the public's health
care interest. We support the current National Organ Transplant Act and
the Final Rule promulgated by HHS governing the OPTN. We are concerned
that HR 2418 is aimed at derailing the HHS rules before they go into
effect on October 21, 1999.
The OPTN is currently operated by the United Network for Organ
Sharing (UNOS) based in Richmond, VA. UNOS has operated the network
since its inception in 1986. HR 2418 as written would eliminate the
Secretary's discretion to contract with the best possible candidate to
operate the OPTN. Under the Bill, UNOS could essentially operate the
OPTN without regard to the public health interest and without oversight
by HHS and still not jeopardize its standing as the OPTN contractor.
Throughout the years, patients, transplant centers, the
Administration, and the public have raised concerns about the manner in
which UNOS has operated the OPTN. These concerns have been echoed by
Congress and reflected in amendments to the National Organ Transplant
Act in 1988 and 1990. Although the Act has not been formally amended
since 1990 congressional hearings in 1993 and 1995 have resulted in
similar actions attempting to address troubling concerns over UNOS
activities.
Timely, accurate, and useful information is critical to the public,
policy makers, and especially transplant patients. UNOS has shown a
blatant disregard for the public interest in this area and has resisted
attempts to obtain vital information. In 1997 a request for data on
organs turned down by transplant centers was made available only after
an exhaustive process that culminated in a Freedom of Information Act
request. Only then did UNOS make the data available. In its attempt to
block the information UNOS used similar defenses to those proposed in
HR 2418. However, no patients were ever identified, directly or
indirectly, as a result of the data release. Information currently
available with respect to center specific performance and OPO
performance is outdated when it is published. The current HHS
regulations would require the OPTN contractor to update its data every
six months.
The UNOS governance and policy setting process is highly
politically charged and greatly influenced by transplant center self
interest. There is no opportunity given for public testimony at UNOS
board meetings or committee meetings. Public members and patient
advocates are excluded from participating in UNOS because of their
viewpoints. Recently, the UNOS patient affairs committee attempted to
censure a UNOS public member because his positions and public
statements were critical of the organization.
Not only is the UNOS policy setting process corrupted, its
enforcement of policies is based upon political expedience and
appeasement. Recently, the UNOS board of directors implemented a policy
to create regional sharing for liver transplant candidates in the most
urgent health care status. However, transplant centers in Wisconsin
refused to abide by the new policy, adversely affecting patients in
nearby Illinois. UNOS currently has at its disposal some of the same
penalties available to it that are created in HR 2418. However, instead
of enforcing its policy, UNOS opted to endorse a special agreement
insisted on by the Wisconsin transplant centers.
However, the most critical decisions impacting organ transplant
patients center on the allocation of donated organs. As stated in a
Congressional conference report ``The Organ Procurement and
Transplantation Network (OPTN) was created by the 1984 Act in order to
facilitate an equitable allocation of organs among patients.'' ``The
allocation of organs may well be a life-or-death decision for
patients.'' (Senate Report 100-310, P.L. 100-607). In 1990 UNOS changed
liver allocation rules to eliminate the priority status given to the
most medically urgent patients on the national waiting list. The policy
was enacted before public comment was sought. Since then, organ
allocation has been hotly debated in the organ transplant community.
The organ allocation issue is exacerbated by the fact that there
are approximately 65,000 patients on the national waiting list and the
number of transplants has continued to hover around only 20,000. Over
ten patients die each day waiting for organs.
The manner in which UNOS has managed the policy setting process in
this critical illustrates the shortcomings of the current system and
UNOS's ability to promulgate policies that serve the public interest.
After exhaustive debate and efforts on the part of patients and the
public UNOS began considering the liver allocation issue. The result
was a policy where patients with chronic liver diseases would be
eliminated from the highest priority status. It was only after HHS
intervention and overwhelming public outcry at a three-day hearing that
the policy was reversed. Recommendations made by the UNOS Liver and
Intestine Committee to expand liver allocation in order to improve
equity were ignored by the UNOS board, which focused on regional and
local interests instead of promulgating a fair public policy. In the
meantime, patients have needlessly died as a result of UNOS's failure
to act in a responsible manner.
These issues highlight the grave concerns with the function of the
OPTN and the manner in which UNOS has managed the transplant network.
Throughout the years, Congress has acted to limit the authority of the
OPTN contractor, attempted to improve the internal operation and
management of UNOS, and has called upon HHS to exert greater authority
of the Act and the OPTN to protect the public interest. In 1990
Congress eased the minimum qualifications that must be met by deleting
a prior requirement that an entity seeking the OPTN contract must not
be engaged in any activity unrelated to organ procurement. The
Committee Report stated ``By modifying this requirement, the Committee
intends to provide the Secretary with the opportunity to seek out the
best possible potential applicants for this critical role.'' The
Committee went on to state ``This change, along with changes the
Committee has made in the OPTN board of directors, reflect deep concern
on the part of the Committee in the manner in which the OPTN has
functioned.'' The Congress should continue to be concerned.
It is in this context that NTAC opposes the proposed OPTN
reauthorization bill. We believe that UNOS has failed to carry out the
mandates of the National Organ Transplant Act and that undue political
influence and rampant self-interest characterize the UNOS process. The
welfare of patients should be at the forefront of the OPTN policy
setting process but that is not the case.
In lieu of HR 2418, we believe that the Committee should give
serious consideration to the recent report of the Institute of Medicine
on Organ Procurement and Transplantation. Congress requested the report
as part of a one-year delay in the HHS regulations.
The IOM has emerged from its deliberations in support of the final
rule which, together with its own recommendations, ``could go a long
way toward facilitating the development of improved principles of
[organ] allocation and improving what everyone agrees should be a
patient-centered system.''
highlights of the iom committee report:
1. Impact of the Final Rule on Access
The IOM Committee found that the Final Rule would not adversely
impact patient access to organ transplantation. It has been claimed
that small transplant centers would close as a result of changes to the
nation's organ allocation system imposed by the Final Rule. ``The
committee was not persuaded'' by the arguments stated by the opponents
of the Final Rule. In fact, the IOM report states that, ``there is some
preliminary information that counters the argument that broader sharing
[of organs] under the Final Rule would adversely affect small
transplant centers.'' ``Broader organ sharing may well increase the
prospects that a patient listed at a low-volume transplant center will
obtain a suitable matching organ.''
The committee also examined the impact of the Final Rule on
minorities and low-income populations. The committee found that
``African Americans do not receive kidney transplants as quickly as
whites'' and that the rule would not exacerbate this problem. The
committee also found that ``broader sharing of organs resulting from
implementation of the Final Rule is not likely to have a significant
adverse effect on those who are dependent on Medicaid for their health
care.''
2. Impact of the Final Rule on Organ Donation
The IOM committee found no evidence to support claims that organ
donation rates would decrease as a result of the Final Rule, stating
that ``the committee found no convincing evidence to support the claim
that broader sharing would adversely affect donation rates or that
potential donors would decline to donate because an organ might be used
outside the immediate geographic area. In fact, there is some evidence
suggesting that broader sharing is associated with increased rates of
donation.''
3. Analysis of Waiting Times
Disparities in waiting times for liver transplant candidates have
been at the center of a heated debate over the allocation of scarce
donor organs. Therefore, the Committee concentrated its research on the
current liver allocation policies. The IOM Committee concluded that
aggregate-waiting time is not a good measurement of the equity and
effectiveness of the transplant system. However, the Committee made
other key observations about the transplant system.
a. The system is basically fair for the sickest patients (Status
1). However, the IOM Committee recommends improvements: ``Although the
current system appears equitable, with respect to status 1 patients
receiving transplants at similar rates among OPOs and having similar
mortality and outcomes, the equity of the current system might be
improved for all patients if it were possible to identify a minimum OPO
population size or transplant volume that would promote both greater
consistency in transplantation rates across OPOs and a higher rate of
transplantation for needier patients.''
b. Some of the healthier patients on the waiting list do not die
while on the list nor do they move up in priority, suggesting that some
patients are inappropriately put on the list for a liver transplant.
The IOM found that there are patients on the waiting list who ``have
little likelihood of receiving a transplant and are also at little risk
of dying.''
c. More ``healthier'' patients die on the waiting list in OPOs with
smaller transplant centers. ``Of concern was evidence of a
statistically significant increase in the risk of pretransplant
mortality in those OPOs with smaller transplant volumes.'' Relatively
healthy patients in small-volume OPOs ``had a significantly increased
risk of pretransplant mortality while on the waiting list.''
d. Larger OPOs transplant the sickest patients while smaller OPOs
and transplant centers transplant a greater percentage of healthier
patients. The IOM concluded that ``smaller OPOs, by generally
transplanting more status 2B and 3 patients than larger OPOs, may
contribute to a situation in which more severely ill patients are
required to wait longer for organs at increased risk of death.''
e. There are fewer patients waiting in smaller OPOs so that they
can transplant healthier patients. ``Although smaller OPOs have lower
transplantation rates than larger OPOs, their listing rates are even
further reduced relative to larger OPOs.'' ``This means that smaller
OPOs are able to allocate organs to patients farther down their shorter
waiting lists than are larger OPOs.''
f. Increased sharing of organs would save more lives. ``A
reasonable improvement in the current allocation scheme could be
achieved by creating allocation areas of sufficient size to shift some
of the transplants from status 3 to statuses 1 and 2.'' ``It seems
apparent that patients on liver transplant waiting lists will be better
served by an allocation system that facilitates broader sharing within
larger populations.'' Greater sharing will have the effect of
``increasing transplantation rates for status 1 patients, decreasing
pretransplantation mortality for status 2B patients, and decreasing
transplantation rates for status 3 patients without increasing
mortality.'' The net effect is that more lives would be saved through
broader sharing of donor organs to those patients with the greatest
need.
4. Patient survival
The IOM found that the medically acceptable ischemic time (time
that organs can travel without a blood supply) for donated livers was
12 hours. However, more significantly, the IOM Committee found that
larger transplant centers had better patient survival rates than
smaller centers, despite the fact that larger centers also transplant
the sickest patients. ``Patients located in smaller-volume OPOs had
increased risk of posttransplant mortality relative to those in larger-
volume OPOs.'' In reviewing UNOS data the IOM Committee found that
``several of the transplant centers doing 25 or fewer liver transplants
had 1-year graft survival rates significantly lower than expected,
given the health status of their patients.''
5. Costs
The IOM Committee concluded that increased sharing would have a
slight increase in the overall costs of liver transplantation. However,
the committee stated ``The committee was unable to estimate the
magnitude of the increase, but believes that it would be marginal
compared to the total expenditures for transplantation. The committee
also believes the health benefits of implementing broader sharing will
be substantial and outweigh any net increase in expenditures.''
6. Federal Oversight
The report of the IOM Committee supports the HHS Final Rule, ``In
the end, the committee emerged from its deliberations generally
supportive of the Final Rule.'' In addition, the committee called for
more, not less, federal government oversight of the nation's organ
transplant system. ``Weak [government] oversight has compromised
accountability at all levels, permitted poor procedures for data
collection and analysis to persist, and allowed the system to operate
without adequate assessment of performance.''
The report recommends that HHS ``should exercise the legitimate
oversight responsibilities assigned to it by the National Organ
Transplant Act in order to manage the system of organ procurement and
transplantation in the public interest.'' Furthermore, the committee
recommended ``a process for periodic, independent and comprehensive
review by a body reporting to the Secretary and not affiliated with the
OPTN contractor is needed to help provide objective information and
advise for the future directions of the system.'' The board would
include ``a broad spectrum of medical and scientific experts, including
epidemiologists and health services researchers, as well as
representatives from the community of transplant patients and donor
families.''
conclusion
National Transplant Action Committee opposes HR 2418 and hopes that
the Committee will not vote in favor of legislation which we believe
will have a devastating impact on organ transplant patients throughout
the United States. We encourage the Committee to focus on sound public
policies as opposed to parochial self-interests. We hope that the HHS
regulations will be permitted to move forward and that a fair and
equitable system soon becomes established for the 65,000 Americans
currently waiting for transplants in our nation's hospitals.
Mr. Bilirakis. Thank you, Mr. Irwin. Dr. Rabkin.
STATEMENT OF JOHN M. RABKIN
Mr. Rabkin. Mr. Chairman, distinguished members of the
committee, I am John Rabkin. I am a surgeon and the Chief of
Liver Transplantation at the Oregon Health Sciences University.
I am here today on behalf of the 31 organ transplant programs
and 1,300 patients that currently make up the Patient Access to
Transplantation or the PAT Coalition. I respectfully request
submission into the hearing record along with my testimony the
August 28, 1998, PAT Coalition comments on the health and human
services final rule and a recent PAT Coalition policy paper
from this September which delineates our views on several
critical issues in the legislative and regulatory debate.
The PAT Coalition strongly supports H.R. 2418, the Organ
Procurement and Transplantation Amendments of 1999, the
reauthorization of the National Organ Transplant Act, or NOTA,
introduced by Representatives Bilirakis, Pallone and Green. We
appreciate their commitment to this issue and that of Commerce
Committee Chairman Tom Bliley and other members of this
committee.
The PAT Coalition urges Congress to pass this legislation
because we feel strongly that enactment of this bill is the
best way to settle controversy over organ transplantation
resulting from the HHS rulemaking. Moreover, we think it is
imperative to stem the erosion of public faith in the
transplant system which has occurred since HHS issued its
controversial rule in April 1998.
We believe that the current organ transplant system is fair
and that it does a good job of acquiring and allocating organs
for transplantation. We all must recognize the extremely
dynamic aspects of the transplant system as medical
developments occur on practically a daily basis. Like any
system, there is and always will be room for ongoing
improvement and this is how our current system operates. A
recent study by the Institute of Medicine came to the same
conclusion, ``The committee found that the current system is
reasonably equitable for the most severely ill status 1 liver
patients since the likelihood of receiving a transplant is
similar across organ procurement organizations, or OPOs, for
these patients.''
The IOM study contradicted the underlying rationale for the
controversial final rule on organ allocation proposed by the
Department of Health and Human Services. In an analysis of
68,000 liver patient records, the IOM panel said, ``The overall
median waiting time that patients wait for organs, the issue
that seems to have brought the committee to the table in the
first place, is not a useful statistic for comparing access to
or equity of the current system of liver transplantation,
especially when aggregated across all categories of liver
transplant patients.''
HHS always maintained that reducing these regional
differences in waiting time was the primary goal of the rule on
organ allocation. The PAT Coalition has actively supported the
two moratoriums on the HHS final rule implemented by Congress
because we think that the final rule usurps the authority of
the transplant community under NOTA to determine organ
transplant policy. Stated most simply, Congress in NOTA vests
the private sector OPTN with the authority to determine organ
allocation policy.
We strongly support this NOTA directive and agree with
Congress that the private sector entity is far better equipped
than the government to make medical policy judgments and adapt
to changing technological developments and scientific and
medical advances.
NOTA simply does not provide the Secretary with authority
to substitute her judgment if she or her staff disagree with a
medical transplant community with respect to policymaking, yet
the Secretary's final rule usurps this authority by regulatory
fiat and claims the ability to reverse OPTN policy.
Among our other concerns we also recognize that the
transplant policy suggested in the final rule would result in
more of our patients dying while waiting for transplant and a
significantly higher rate of retransplantation and possible
organ wastage. We are also concerned that the core HHS policy
is a design to direct more organs to a few larger transplant
centers, which would result in a loss of access to
transplantation services for those patients who could not
travel long distances for financial or family reasons.
The rule itself applies to all organs and cannot withstand
medical scrutiny. For example, another serious effect of this
policy would be to increase the cold ischemic time, or the time
that organs are stored outside of the body, since organs would
travel farther to the large centers. The IOM study pointed out,
``That a 4.2 percent reduction in retransplantation by using
livers with lower ischemic times would necessitate less
retransplantation and would mean that 170 additional patients
could receive a liver transplant.''
The HHS policy is also short sighted in its wholesale
preemption of State laws regarding organ transplantation. Many
of the beneficial policies that have served to improve organ
procurement and donation were based on State laws such as the
organ donor checkoff on driver's licenses. The HHS preemption
fails to recognize that fact. In addition, this preemption
clearly exceeds the authority granted by Congress.
During the moratorium period we have worked actively with
the transplant community to try to form a consensus on how best
to deal with the HHS position. We have been involved in
discussions with HHS officials who have promised the transplant
community a revised proposal that would take into consideration
our objections to the final rule. We are still waiting for a
response from HHS as the clock ticks down on the current
moratorium scheduled to expire October 21.
We are also still waiting for the HHS to publish an
analysis of the thousands of public comments filed in response
to the final rule. We understand that more than 85 percent of
these comments stated strong opposition or concerns about the
rule.
The best solution to the problem is for Congress to
reiterate the long-held statutory premise that organ transplant
policy should be left to the private sector transplant
community through passage of new authorizing legislation. Short
of that, Congress should continue the moratorium until a new
authorization bill can be passed.
H.R. 2418 recognizes that scientific and medical decisions
about organ transplant policy should be left to the private
sector transplant community rather than to the Federal
Government bureaucracy, a concept that the PAT Coalition
enthusiastically supports. The legislation's construct has
worked successfully historically and we continue to believe
that the private sector is better equipped than the government
to sort through the complex medical, specific, and ethical
challenges presented by organ transplantation.
H.R. 2418 correctly places a strong emphasis on the real
solution to the organ shortage problem, which is increasing
organ donation. With your permission, Mr. Chairman, I would
like to submit a report of Kansas State University researcher
and professor of psychology James Shanteau's recent summary of
research on what motivates people to donate organs and a press
release article which expressed serious concern that the HHS
new organ policy may result in a donation decline.
Mr. Bilirakis. Without objection, that is made a part of
the record Dr. Rabkin. Proceed.
Mr. Rabkin. Thank you, Mr. Chairman. Most importantly, H.R.
2418 would restore the public's confidence in the transplant
system. Congress should expeditiously take this positive step
forward building on a truly unique and successfully working
transplant system and pass H.R. 2418, the organ procurement and
transplantation network amendments of 1999. We appreciate the
opportunity to testify here today. Thank you.
[The prepared statement of John M. Rabkin follows:]
Prepared Statement of John M. Rabkin, Oregon Health Sciences University
representing the Patient Access to Transplantation Coalition
Mr. Chairman, distinguished Members of the Committee, I am John M.
Rabkin, M.D., a surgeon and Chief of Liver Transplantation at the
Oregon Health Sciences University.
I am here today on behalf of the 31 organ transplant programs and
1300 patients that currently make up the Patient Access to
Transplantation (PAT) Coalition. I respectfully request submission into
the hearing record, along with my testimony, a recent PAT Coalition
policy paper (September 1999) which delineates our views on several
critical issues in the legislative and regulatory debate.
The Patient Access to Transplantation (PAT) Coalition supports H.R.
2418, the ``Organ Procurement and Transplantation Network Amendments of
1999,'' the re-authorization of the National Organ Transplant Act
(NOTA), introduced by Reps. Bilirakis, Pallone, and Green. We
appreciate their commitment to this issue and that of Commerce
Committee Chairman Tom Bliley, and other Members of this Committee.
The PAT Coalition urges Congress to pass this legislation because
we feel strongly that enactment of this bill is the best way to settle
the controversy over organ transplantation resulting from the HHS
rulemaking. Moreover, we think it is imperative to stem the erosion of
public faith in the transplant system that has occurred since HHS
issued its controversial Rule in April 1998.
We believe the current organ transplant system is fair and does a
good job of acquiring and allocating organs for transplantation. We all
must recognize the extremely dynamic aspects of the transplant system
as medical developments occur on practically a daily basis. Like any
system, there is, and will always be, room for ongoing improvement, and
there are several proposals that the PAT Coalition supports to increase
the numbers of transplants.
A recent study by the Institute of Medicine came to the same
conclusion: ``The committee found that the current system is reasonably
equitable for the most severely ill (Status 1) liver patients, since
the likelihood of receiving a transplant is similar across organ
procurement organizations (OPOs) for these patients.''
The IOM study contradicted the underlying rationale for the
controversial Final Rule on organ allocation proposed by the Department
of Health and Human Services. In an analysis of 68,000 liver patient
records, the IOM panel said ``the `overall median waiting time' that
patients wait for organs--the issue that seems to have brought the
committee to the table in the first place--is not a useful statistic
for comparing access to or equity of the current system of liver
transplantation, especially when aggregated across all categories of
liver transplant patients.'' HHS always maintained that reducing
regional differences in waiting times was the primary goal of the rule
on organ allocation.
The panel also found that enlarging the current organ allocation
areas--a broader, regional sharing concept that the PAT Coalition
generally supports--would improve the chances of Status 1 and 2
patients being transplanted.
The PAT Coalition has actively supported the two moratoriums on the
HHS Final Rule implemented by Congress because we think that the Final
Rule usurps the authority of the transplant community under NOTA to
determine organ transplant policy. Stated most simply, Congress in NOTA
vests the private sector OPTN with the authority to determine organ
allocation policy. We strongly support this NOTA directive and agree
with Congress that the private sector entity is far better equipped
than the government to make medical policy judgments and adapt to
changing technological developments and scientific and medical
advances. NOTA simply does not provide the Secretary with authority to
substitute her judgment if she or her staff disagree with the medical
transplant community with respect to policymaking--yet the Secretary's
Final Rule usurps this authority by regulatory fiat and claims the
ability to reverse OPTN policy.
Among our other concerns, we also recognize that the transplant
policy suggested in the Final Rule would result in more of our patients
dying while waiting for a transplant, and a significantly higher rate
of retransplantation and possible organ wastage. We are also concerned
that the core HHS policy is a design to direct more organs to a few
larger transplant centers, which would result in a loss of access to
transplantation services for those patients who could not travel long
distances for financial or family reasons.
The Rule itself applies to all organs and cannot withstand medical
scrutiny. For example, another serious effect of this policy would be
to increase the ``cold ischemic time'' for organs since organs would
travel farther to the large centers. The IOM study pointed out that ``a
4.2 percent reduction in re-transplantation . . . by using livers with
lower ischemic times would necessitate less re-transplantation and
would mean that 170 additional patients could receive a liver
transplant.''
The HHS policy is also shortsighted in its wholesale preemption of
state laws regarding organ transplantation. Many of the beneficial
policies that have served to improve organ procurement and donation are
based on state laws, such as the organ donor check-off on driver's
licenses. The HHS preemption fails to recognize that fact. In addition,
this preemption clearly exceeds the authority granted by Congress.
During the moratorium period, we have worked actively with the
transplant community to try to form a consensus on how best to deal
with the HHS position. We have been involved in discussions with HHS
officials who have promised the transplant community a revised proposal
that would take into consideration our objections to the Final Rule. We
are still waiting for a response from HHS as the clock ticks down on
the current moratorium scheduled to expire October 21, 1999. We also
are still waiting for HHS to publish an analysis of the thousands of
public comments filed in response to the Final Rule. We understand that
more than 85% of these comments stated strong opposition or concerns
about the Rule.
The best solution to the problem is for Congress to reiterate the
long held statutory premise that organ transplant policy should be left
to the private sector transplant community through passage of new
authorizing legislation. And, short of that, Congress should continue
the moratorium until a new authorization bill can be passed.
H.R. 2418, the ``Organ Procurement and Transplantation Network
Amendments Act of 1999'' recognizes that scientific and medical
decisions about organ transplant policy should be left to the private
sector transplant community rather than to the federal government
bureaucracy, a concept that the PAT Coalition enthusiastically
supports. The legislation's construct has worked successfully
historically, and we continue to believe that the private sector is
better equipped than the government to sort through the complex
medical, scientific, and ethical challenges presented by organ
transplantation.
H.R. 2418 correctly places a strong emphasis on the real solution
to the organ shortage problem: increasing organ donation.
But most importantly, this bill would restore the public's
confidence in the transplant system and would serve to recognize the
contributions made by the donors, patients, OPOs, doctors and
volunteers who have actively participated in the development of a
transplant system that results in 21,000 life-saving transplants each
year.
Since the passage of NOTA in 1984, the number of people receiving
organs has increased annually and survival rates are steadily
improving.
Congress should expeditiously take a positive step forward,
building on a truly unique and successfully working transplant system,
and pass H.R. 2418, the ``Organ Procurement and Transplantation Network
Amendments of 1999''.
We appreciate the opportunity to testify here today.
Thank you.
Patient Access to Transplantation Coalition
policy paper
September 1999
The Patient Access to Transplantation (PAT) Coalition supports an
organ allocation system that balances fairly ``equity'' with
``utility.'' Organ allocation policy must seek to achieve the greatest
good for the greatest number of people. Organ allocation policy must
avoid futile transplantation, excessive retransplantation, decreased
viability of organs and other waste adversely affecting the supply of
organs.
Local access to transplantation must be preserved both for the sake
of patients nationwide, especially minorities and medically underserved
populations, and in order to improve donation.
nota
The PAT Coalition strongly supports NOTA's current delineation of
authority. The National Organ Transplant Act (NOTA), as initially
passed by Congress and as amended, establishes and clearly delegates
policymaking authority to the Organ Procurement Transplantation Network
(OPTN), a private sector entity comprised of physicians, patients and
other transplant community representatives.
NOTA's legislative history explicitly provides that the
private sector OPTN should decide medical criteria for
allocating organs, and should resolve issues regarding the fair
distribution of organs.
NOTA grants the Secretary oversight authority. Under NOTA, the
Secretary is responsible for contracting with the OPTN and for
soliciting comments on the OPTN's performance of its duties.
The PAT Coalition strongly supports retention of medical
decisionmaking in the private sector, and opposes HHS'
involvement in developing, modifying or vetoing organ
allocation policy unless specifically directed under statute.
preemption
NOTA currently does not contain federal preemption statutory
language. The Secretary's Final Rule should avoid any attempt to
preempt by regulation authority of the states or authority in the area
of organs which the Congress has not granted explicitly to the
Department. The federal preemption issue should be reserved for NOTA
reauthorization. Otherwise, HHS invites a lawsuit on the preemption
issue.
hhs role
The Pat Coalition supports a strong federal leadership role in
organ donation. Intractable problems in allocation can never be fully
resolved as long as the dire shortage of available organs remains and
we urge the federal government to assume affirmative responsibility and
make this its highest and primary priority. To that end the PAT
Coalition supports:
Substantial increases in federal funding available for organ
donation initiatives, including a national educational campaign
which covers living donor organ donation as well.
Direct financial support and matching grants to states who are
willing to mount donor education and awareness campaigns within
their states, establish donor registration programs, and test
other innovative approaches such as contributions for funeral
expenses.
Substantial increases in the National Institutes of Health
(NIH) budget for targeted institute intramural and extramural
research initiatives directed at increasing donations and
making scientific and medical progress in organ transplantation
(e.g., NIDDK, NHLBI, etc.).
Continual expansion of the HRSA extramural research support
funding to test, evaluate and replicate creative research
projects developed nationwide, including a directive to cover
living donation initiatives.
Seed money to explore the feasibility and logistics of
establishing a national organ donor registry.
The PAT Coalition supports the oversight role given to the
Secretary of Health and Human Services in the National Organ
Transplantation Act (NOTA) regarding oversight of the Organ Procurement
Transplantation Network (OPTN). HHS has no policy role in organ
allocation.
The PAT Coalition supports strong enforcement of OPTN policies
by the OPTN. The Department may exercise its oversight
responsibilities to seek input on the OPTN's exercise of this
authority.
Any independent review board created to assist or advise the
Secretary (as suggested by the IOM) must be fully autonomous
and independent. The appointment, composition and
responsibilities of any such group must be wholly independent
of any political process and the Department and Administration.
We do not support using the Federal Advisory Committee Act
(``FACA'') construct because it would vest the Secretary with
appointment authority and the role of a committee or advisory
board chartered under this authority would be advisory and non-
binding. This review group should not be charged with any
policymaking responsibilities which belong in the private
sector OPTN.
listing criteria and practices
The PAT Coalition believes that the private sector medical
community, including surgeons, transplant physicians and scientists,
should be solely responsible for development and ongoing refinement,
where appropriate, of organ-specific listing and de-listing criteria
based on standardized medical assessments.
In balancing equity and utility considerations, the PAT
Coalition recognizes that transplantation of the ``sickest''
patient is not always the best or most appropriate use of an
organ, given higher survival rates and lower retransplantation
rates of less sick patients.
The PAT Coalition supports an independent process of
prospective and ongoing concurrent review of patient status and
application of medical listing and delisting criteria through
chart review of all transplant centers within a given region.
The PAT Coalition supports imposition of significant monetary
penalties by the OPTN to enforce standardized listing and de-
listing practices, and adherence to OPTN policy.
regional sharing
The PAT Coalition supports broader regional sharing of organs based
on private sector initiatives and arrangements. The PAT Coalition
supports flexibility in the size of the population base utilized to
achieve broader regional sharing, such as a population range of 6-11
million lives. Working relationships and arrangements between and among
transplant centers in specific regions must drive the development of
broader sharing. We do not perceive a ``cookie cutter'' approach to
broader sharing will succeed because successful sharing must be based
on relationships, which reflect regional considerations and
availability of transplant centers and other resources within these
regions. The PAT Coalition opposes development of a national waiting
list and any centralized allocation system administered or structured
by the federal government.
importance of local access
The PAT Coalition continues to believe that the policy
mandated by HHS will impair access to transplantation services,
especially for low-income and minority patients. Lack of access
to organs may drive some regional transplant centers out of
business, inflicting a fundamental blow to patient access and
patient choice. Any Final Rule adopted by HHS must ensure
access to transplantation and prevent unnecessary transplant
center closings. The OPTN must assure that allocation policies
developed will not harm patient access to local transplantation
services.
The PAT Coalition concurs with the independent research
finding that for a significant number of individuals, there is
a greater willingness of people to donate if they can be
assured that their organs will remain in their own local
community or at least in their state (source: 12 years of
independent research conducted by Kansas State University
researcher James Shanteau).
additional concerns
OPO performance and effectiveness must be measured in a more
meaningful way. HHS should develop alternative and outcome
performance measures for OPOs as recommended by the General
Accounting Office and endorsed by the Institute of Medicine.
The Medicare and Medicaid statutes should be amended to ensure
coverage to transplantation for beneficiaries who are
uninsured. Such costs should not be borne by transplant
centers.
Models should be developed and disseminated nationally from
careful screening of procurement and utilization practices and
subsequent clinical outcomes.
congressional oversight
The PAT Coalition supports strong Congressional oversight of both
the federal Department of Health and Human Services and the Organ
Procurement Transplantation Network (OPTN). To that end, the General
Accounting Office (GAO) should be charged with periodic oversight
reviews of both the Health Resources Services Administration (HRSA) and
Health Care Financing Administration (HCFA) program responsibilities
and the OPTN contractor.
Mr. Bilirakis. Thank you very much, Doctor. There is a
package here, testimony of the National Kidney Foundation and
various letters--Shands Health Care and University of Texas, et
cetera, which has been handed to the minority, and I would ask
unanimous consent that it may be made a part of the record.
Without objection. That will be the case.
I very much appreciate Dr. Rabkin emphasizing so very much
the donation area, because without adequate organs being
donated we can have all the allocation systems in the world,
change this, change that, and it is just not adequate.
And that is what concerns me an awful lot. Granted we are
concerned about allocation and that sort of thing. And Mr.
Barrett said it as--I am not going to paraphrase and I may even
be wrong in paraphrasing, but he referred to the people in his
area wanting to know basically who was getting the organ and at
least that there would be an easier donation type of a
situation if they knew that it was sort of local, if you will,
or at least regional. And I have made those comments before and
I feel very strongly about that.
I don't have any trouble putting myself in the shoes of the
public back in my region in terms of--and we do well,
particularly in Florida, we do well as far as donations are
concerned. And someone said something about if it ain't broke
don't fix it, and that concerns me.
I want that to be a part of the record because I know Mr.
Irwin referred to prior comments on my prior positions on my
part.
But I will tell you and anyone who says differently is
lying in my opinion, that we are, as I said earlier, parochial.
We have to be. We represent people in our congressional
district. And I dare say that if the University of Pittsburgh
were not at the forefront of this national allocation system,
that some of the people in Pennsylvania and eastern Ohio might
maybe not change their positions but at least look at it a
little more objectively. And the same thing is true if Florida
and the University of Florida and Miami and whatnot had a
different position, that certainly would have an effect on me,
and I am going to be the first one to admit that.
But we are concerned about equitable--to use the terms that
I think Mr. Irwin used--equitable allocation. And we are
concerned about the sickest receiving the organs as against
those who are not in that category.
I understand that the IOM report concluded the current
system of liver allocation is not only fair for the sickest
patients, but to everyone in urgent need of a transplant
receives--and I believe Dr. Rabkin touched on this--receives
one, status 1 and 2A.
And if that is the case, it makes me wonder, Secretary
Shalala in a January 20, 1999, press release said: ``These
findings make clear that changes are urgently needed to produce
better and fairer outcomes for our Nation's organ transplant
patients'' and that, ``further delay can only needlessly injure
patients.''
And yes, the IOM, which has been quoted so very much by the
administration and by others and certainly has made the news,
basically is being held out as having said that unfairness
exists and that sort of thing. So Dr. Gibbons, would you care
to expand?
Mr. Gibbons. Love to. Let me first state that there is a
difference between equitable and optimal.
Mr. Bilirakis. Equitable and?
Mr. Gibbons. And optimal.
Mr. Bilirakis. Okay.
Mr. Gibbons. Our findings were that the status 1 patients
were treated equitably in the sense that there was not
significant variability across the organ procurement
organization for those status 1 patients, meaning that the
rates of transplantation were fairly similar and there weren't
these large geographic heterogeneous distributions. This was
not true for the status 2B and 3 patients. There was
considerable variability from one OPO to the other and beyond
just that, the smaller OPOs were transplanting large numbers
more of these less severely ill patients relative to the larger
organ procurement organizations.
Mr. Bilirakis. Are the sickest patients receiving the
organs even though--I mean, and if that is the case, are some
of those organs, many of those organs, whatever the proper term
is, coming from outside of those regions?
Mr. Gibbons. That is an excellent point. First of all, all
status 1 patients are not receiving organs. By our comments
about it being equitable it means that the rates are fairly
similar, but only 54 percent of the status 1 patients are ever
receiving an organ across the country.
Now, what happens to the other 46 percent, which is a very
important question? 8 percent of those status 1 patients die
while waiting for an organ. Again, those rates are comparable
across the system.
Mr. Bilirakis. Doctor, forgive me, are you saying that
appropriate organs are available in other regions and that they
are being used for people who are nowhere near as sick and for
that reason these category 1 people are not receiving the
organs?
Mr. Gibbons. That is one of the reasons, yes, sir.
Mr. Bilirakis. That is one of the reasons.
Mr. Gibbons. Absolutely.
Mr. Bilirakis. And you pointed--you have detailed that in
your report in terms of evidence of that and that sort? I am
not trying to be difficult, don't get me wrong, I just want to
be sure. I know that you have used terms like ``inconclusive''
and that sort of thing, and I just want to know is this
conclusive? I am assured in Florida particularly, Mr. Miller
can speak to this--nobody is under oath here--but I am assured
that many organs are shipped, if that is the proper term, out
of the State to be used by recipients who are sicker. Is this
true, Mr. Miller? If it is not true, please feel free----
Mr. Miller. Well, it just so happens that we have a very,
very busy transplant program in Florida, many status 1
patients. So if I were to say what the net would be, the
balance of trade for status 1s would probably be into the
State. On the other hand, were there a status 1, let's say, in
Emory in Atlanta, and we have the donor in Miami, that status 1
would be sent to Atlanta.
As a matter of fact, Dr. Payne just testified that the new
algorithm for status 1 sharing was already in the pipeline as
the Institute of Medicine was deliberating. So there was a more
broader sharing of status 1s----
Mr. Bilirakis. You said that. I suspect that Dr. Payne said
that, too, and I apologize for not hearing his testimony. But
Dr. Gibbons heard that. Is that true, were these changes in the
pipeline during the times that you were deliberating and
working up your report?
Mr. Gibbons. There were changes that were made during the
course of--towards the end of our report that were to some
degree consistent with our recommendations. Our recommendations
were broader sharing all across the board, not just for status
1 patients.
Also, what you are saying and what Dr. Miller is saying is
completely consistent with our findings; that is, those States
and those regions that started to institute broader sharing of
one form or another had an increase, a statistically
significant increase, in the overall transplantation rates of
status 1 patients, making it more optimal, despite the fact
that it was already quite equitable. There are status 1
patients who are not receiving organs, and there are small
organ procurement organizations in existence that are
transplanting much higher rates of 2Bs and 3s that could
ultimately go to status 1 patients in other organ procurement
organizations within the limits of cold ischemic time.
Mr. Bilirakis. My time is well up. We might--depending on
how many more people return, we might go a second round here.
Mr. Brown.
Mr. Brown. Thank you, Mr. Chairman.
Dr. Rabkin, in your testimony you said that the organ
transplant policy should be left to the private sector
transplant community. You basically argue, if I understand
transplantation, communities should make virtually all or
basically all allocation distribution decisions, correct?
Mr. Rabkin. I think if you define the transplant community
as it is currently structured, the answer yes would be correct.
Mr. Brown. How would you define it?
Mr. Rabkin. Well, the transplant community currently
doesn't just consist of transplant surgeons and transplant
physicians. It includes, most importantly, patients, patient
families, donor families. It includes members of the community.
So I think it is a very broad net. But I think all of these
individuals have an interest and a knowledge and a commitment
to the transplantation process. They understand the nuances,
and they therefore--what has historically happened is they have
derived an allocation policy that has been very effective and
has brought transplantation to the point that it is today. It
is a dynamic process, continuously evolving and improving.
Mr. Brown. If those transplants are paid by Medicare or
Medicaid, FEHP, the Federal health system, does that change the
position that you take in terms of who should make these
decisions?
Mr. Rabkin. By the same token that we don't discriminate on
a payor to decide who gets a transplant. It doesn't matter who
is paying for it who should be making the decision on who
should get a transplant.
The answer is no. We are trying to help as many patients as
we can with the limited resources that we have available.
Mr. Brown. So with these decisions, spending taxpayer
dollars, there should be no real public role of government and
of representing taxpayers when taxpayers are paying huge
amounts of money in a very profitable system, a system that has
huge--all kinds of for-profit entities in this system, from
doctors being very well paid to hospitals using it as profit
centers, for-profit hospitals and in some cases not-for-profit
hospitals, for other kinds of people in this allocation system
which you describe very well. There should be no role for
taxpayer government involvement in these decisions?
Mr. Rabkin. No. That is not, in fact, what we believe.
There is a role for government oversight.
What I stated was that the allocation policy is a medical
decisionmaking policy. It is similar to all other policies that
take place currently in other medical fields. There is not a
government bureaucracy deciding necessarily who gets treated
with a particular illness and in what fashion. I think that
there is a level of decisionmaking and oversight that does take
place at the Federal level, but the allocation policy per se
needs to be in the hands of the transplant community.
Mr. Brown. Even though the allocation decisions affect
large numbers of people, even people that--affects large
numbers of people beyond perhaps what you very narrowly define
as the transplant community, those decisions shouldn't be
overseen by the HHS or shouldn't be formed or formulated in any
way by HHS?
Mr. Rabkin. I am not sure I really understand your
question. I think that I have stated as best I can state that I
try to segregate what we feel ought to be left in the hands of
the transplant community, which is really the medical
decisionmaking involved, as opposed to some of the----
Mr. Brown. Let me take another direction for a moment.
Adding that UNOS in this bill has an appropriation of $6
million, so there is always government involvement when it
comes to paying for it, the section, page 15 of the bill, this
is my concern. I don't disagree with you in terms of the
medical decisions. Clearly, the physicians and the nurses and
the hospitals and the transplant--the patients all should have
major roles in all of this. But on page 15, there is a section
on gifts. ``this section does not prohibit the network from
accepting gifts of money or services including gifts to carry
out activities to provide for increase in organ donation.''
On page 20 of the bill, ``Prohibition against organ
purchases,'' insert after, ``does not include--does not
include''--inserting after, ``does not include the following: A
benefit, the exchange of which is expressly contemplated by
organ distribution policies, demonstration projects.'' it goes
on and on and on.
My concern and a concern of a lot of us on both sides is
the enormous profits that come from the terrific services that
you as surgeons and the people that work with you--enormous
profits generated in many cases. What drives this whole issue
in part, I am not sure that we--I am not sure that we have
protected the public when things like gifts are expressly
allowed. Those gifts could take the form--some cases a gift to
encourage people to donate perhaps, but in other cases gifts to
steer people into major centers or to encourage--maybe if I am
a wealthy potential beneficiary, recipient of a transplant,
then I make a gift to a hospital and get moved up on the list,
or my family does. We have to be extremely careful that--while
you certainly want to do the right thing from your testimony,
all of you do, that are physicians and nonphysicians alike, we
need to be especially careful to not allow the for-profit drive
in this to overwhelm what should become good public policy.
Did you want to say something, Mr. Irwin, just a minute
ago?
Mr. Irwin. I just wanted to comment that I believe there
are two levels of decisionmaking that go on here, or policy
setting. One certainly is medical. From our perspective I don't
think that we have an issue with that. For the most part, the
medical allocation policies that distinguish status 1 patients
from 2As, 2Bs, and 3s we feel is pretty well thought out. The
problem is the public policy issue. With that medical criteria,
how big of an attachment area do you use?
The problem with the system today is you have--because of a
varying number of factors, you have relatively small allocation
areas where relatively healthy patients are being transplanted,
where sicker patients are not being transplanted in fairly
close proximity, which really is contrary to the medical
allocation decision that the sickest patients should be given
priority.
The other concern that we have in our experience is just
the way these decisions are made by the OPTN contractors'
board. There seems to be a lot of self-interest that comes out
in the discussions at the board level to the point where
sometimes recommendations from committees that explore this
issue are overlooked or overruled despite the fact from our
perspective they make pretty good sense from a public policy
perspective.
Mr. Brown. Thank you, Mr. Chairman.
Mr. Bilirakis. I thank the gentleman.
Mr. Bryant.
Mr. Bryant. Thank you, Mr. Chairman. I apologize to this
panel for being a little bit late. We were involved in another
committee, and I have missed some of the testimony. For that
reason I would ask Mr. Irwin, if you have a microphone handy
there, you represent NTAC. Is that the correct----
Mr. Irwin. Yes, the National Transplant Action Committee.
Mr. Bryant. Does NTAC in any way coordinate its activities
with the University of Pittsburgh?
Mr. Irwin. Mr. Bryant, we coordinate our activities with a
lot of institutions and patients around the country. We have--
we speak with and work with Mount Sinai Medical Center, with
the University of North Carolina. We have received a
contribution last year from Jackson Memorial Hospital in Miami.
I work with Stanford and University of California, San
Francisco. And yes, we coordinate our activities with all of
these institutions, including the University of Pittsburgh.
Mr. Bryant. Thank you.
Mr. Chairman, if I could, with unanimous consent I have a
six-page document that is various memoranda from the University
of Pennsylvania and a one-sheet, two-sided letter from Mr.
Livingston, our former Member, former Chairman of the
Appropriations Committee. I would like to----
Mr. Bilirakis. Is that University of Pennsylvania or
Pittsburgh?
Mr. Bryant. It could be Pennsylvania, UPMC. I think that is
University of Pittsburgh.
Mr. Bilirakis. Okay. In any case, without objection, but
that is a part--well, I am not sure. Anyhow, that is part of
the record.
Mr. Bryant. Thank you.
[The information referred to follows:]
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Mr. Bryant. The concern I had, quite frankly, Mr. Irwin, is
that in this confidential memorandum, it is discussing various
strategies in lobbying Congress and getting people to write
letters, which I assume would be taking a position consistent
with the University of Pittsburgh.
It mentions that Charlie and Craig mentioned it is more
critical than ever for legislators to hear from their
constituents. And then Craig and Charlie have identified the
following members of the House and Senate Appropriations
Committees as initial targets because of their views in the
district.
So it looks to me like you have been coordinating
strategies that I assume would make NTAC consistent with taking
the position consistent with the University of Pittsburgh?
Mr. Irwin. Certainly, Mr. Bryant. The same thing is
happening on the other side of this issue with the opposition.
Mr. Bryant. I have no doubt. I just want to be transparent.
Mr. Irwin. In addition, I would like to state that we do
have membership around this country, and we rely on volunteers
and that membership to also help us in a variety of areas.
Mr. Bryant. Does--do you--you are an active lobbyist for
the year 1998. During this particular year, and including the
year that you wrote the letter about former Chairman
Livingston, were you officially lobbying? Were you registered
as a lobbyist in 1998?
Mr. Irwin. The National Transplant Action Committee has not
filed as a lobbyist. The work that I do I do through a private
company. And as directed by law, this is a company that I
started with Mr. Charlie Fisk that does a variety of services
in the transplant field. As appropriate, we have filed papers
with respect to the lobbying act.
Mr. Bryant. For year 1998?
Mr. Irwin. Mr. Bryant, off the top of my head, I can't tell
you exactly. I think we filed in 1997 because we did have some
considerable expenditures, but I know in the last year I can't
tell you whether or not we met the criteria or not.
Mr. Bryant. Could you tell me if either you or Mr. Fisk are
being paid by the University of Pittsburgh to testify?
Mr. Irwin. No. I have never been paid by the University of
Pittsburgh to testify.
Mr. Bryant. And Mr. Fisk?
Mr. Irwin. No.
Mr. Bryant. Dr. Raub, if I might ask you some questions
also. At last year's hearing there was a great deal of concern
that the regulations would force the closure or have a severe
negative impact or small and medium-size transplant centers who
are performing these vital services. The Secretary at that time
assured this committee that she would make certain that
regulation would not have that effect. Specifically, the
Secretary was asked by Senator Frist, ``Would you be willing to
provide assurances and regulation if possible that you are not
asking the UNOS or whoever the contracting agency might be for
a policy that would result in the center's closing,'' end of
question.
The Secretary responded, ``The answer is yes. As best I can
tell, the IOM report was less than convincing that these
regulations would not have such an impact citing conflicting
studies.''
My question is are you willing to give this subcommittee
the same assurances that the Secretary did last year?
Mr. Raub. Sir, the final rule as published in April
includes the provision that, when the OPTN develops the
proposed allocation policies, it take into account and make an
assessment of the likely impact on those small centers. The
basis of that provision is to fulfill the Secretary's
assurance. It is not our desire to close small centers.
Mr. Bryant. That would be then--you feel that would
adequately protect the small centers?
Mr. Raub. We do, sir.
Mr. Bryant. Mr. Chairman, is my time up?
Mr. Bilirakis. It is. If you would like an extra minute or
so, with unanimous consent, we will be glad to grant it. I do
want to finish. Hopefully, we will finish up before the vote
comes up on the last amendment on this particular bill on the
floor. Please proceed if you would like.
Mr. Bryant. If I could have unanimous consent for one
additional question?
Mr. Bilirakis. Without objection.
Mr. Bryant. Dr. Raub, we are all aware of the substantial
debate generated by the Department's April 2, 1998, final rule.
I understand that you have conducted a series of meetings with
the transplant community aimed at identifying a reasonable
compromise all parties can live with. It is also my
understanding that as part of the process, the Department has
indicated on several occasions its intent to reissue
modifications to the April 2, 1998, final rule, but has not yet
actually done so. Specifically, your letter of August 30, 1999,
to the transplant community stated that ``I intend to move
vigorously in cooperation with the transplant community to put
a modified final rule in place--''and this is important--``and
to bring about the changes in the regulation that could and
should be made.''
Why then, when we find ourselves less than 1 month from the
expiration of the current moratorium, has the Department not
yet issued anything in writing to indicate the proposed
modifications of the final rule? Are we running out of time?
Mr. Raub. Sir, in considering the public comment, the IOM
report, and the meetings with the representatives of the
transplant community, the Department has made several
determinations. One is that the core principles and provisions
as embodied in the rule are sound. Second, these interactions
have helped us identify a number of areas where some refinement
or revision or other clarification in the rule would make it
better and would be responsive to many of the concerns. I
indicate two examples in my prepared testimony.
Third, the intent of the Department, by the time of the
date of the end of the moratorium, is to have those revisions
in place and be prepared for that revised rule to go forward.
Mr. Bryant. If I might follow up, on a time line, when
would we see this?
Mr. Raub. I can't state a precise time line other than that
our intent is to meet the end of the moratorium and to have
these revisions in place at that time.
Mr. Bryant. Can you identify for this subcommittee those
aspects of the rule that you plan to change?
Mr. Raub. Just elaborating on one of the examples in the
testimony, both the IOM report and a number of the public
comments indicate a desirability of some sort of scientific
expert independent advisory panel. We believe that is an
intriguing idea. We are considering the number of variants that
have been proposed for that. We are looking at that in the
context of the Federal Advisory Committee Act. That is an area
that we are pursuing very seriously.
Also, our colleagues on the outside have pointed to the
various sentences in either the rule or the preamble that have
caused them to conclude, incorrectly, that the rule calls for a
national list, that it overrides the decisions of physicians
with respect to which patients to transplant. We are looking
hard at that language. That was not the intent of it. To the
extent that we identify an ambiguity and can clarify that, we
will do so.
Mr. Bryant. Thank you, Mr. Chairman.
Mr. Rabkin. Mr. Chairman, would it be out of order for me
to just ask a question?
Mr. Bilirakis. Who asked that? A question of whom, of Dr.
Raub?
Mr. Rabkin. Yes.
Mr. Barrett. Mr. Chairman, there is 10 minutes until the
next vote.
Mr. Bilirakis. If you are going to ask questions, sir,
without--this is out of the ordinary, but do it quickly. And
respond to very----
Mr. Barrett. I would like to object until we are done with
our questioning, if I could.
Mr. Bilirakis. Okay. The objection is heard, so you can't
do it.
Mr. Barrett.
Mr. Barrett. Thank you, Mr. Chairman. I don't mean to be
rude. If we have time, I would be happy to let you do it.
Mr. Irwin, you begin your testimony by saying you are a
consumer advocate of the National Transplant Action Committee
as a consumer advocacy organization; is that correct?
Mr. Irwin. Yes.
Mr. Barrett. What percentage of your funds comes from
consumers?
Mr. Irwin. Off the top of my head, I couldn't tell you.
Mr. Barrett. Would it be fair to say that over 90 percent
comes from hospitals?
Mr. Irwin. Not that much.
Mr. Barrett. Can you give me a ballpark figure?
Mr. Irwin. It is like moving--a moving target. What I can
tell you is we recently did a fund-raiser in our community with
about 200 volunteers that raised about $30,000. I would say
maybe 60 percent.
Mr. Barrett. Dr. Rabkin, the Patient Access Coalition, I
assume the lion's share of your money comes from hospitals as
well?
Mr. Rabkin. That is correct.
Mr. Barrett. I say that because we are all on our best
behavior, and we are all trying to be nice to each other, but
we are fighting about money, and we shouldn't forget that.
I would like to sort of invite you in and have you sit with
me and pretend for a moment that I am a hospital administrator
that is affected by this rule. We have been spending $200,000
on an organ procurement outreach network in our community. This
new rule comes down that says from here on in the organs will
not stay in our region, they will be shipped across the
country. Correct me if I am wrong, but as I am sitting here
with my surgeons, my nurses, and my other hospital
administrators, I am going to say, zero out that $200,000 in
organ procurement, that is no longer a priority. Put that
$200,000 into developing a waiting list of the most critical
patients. Won't I do that, Dr. Raub?
Mr. Raub. I see that as a possible decision, sir, but I
couldn't state it with certainty that it would or wouldn't be.
Mr. Barrett. Dr. Gibbons, what would you do if you were
administrator of that hospital? Would you put money into organ
procurement, or would you put it into developing a waiting
list, if you were running a hospital?
I am asking what you would do. Data shmata. What would you
do?
Mr. Gibbons. I only do data, sir.
Mr. Barrett. You look remarkably like a human being, so I
am asking you what you would do if you were the hospital
administrator.
Mr. Gibbons. If I were the hospital administrator, sir, I
would note that increased broader sharing has actually
increased donation rates, and that to ship an organ across the
country doesn't make an awful lot of sense given cold ischemic
times and the----
Mr. Barrett. $200,000, where would you put that money,
putting patients on a waiting list or procuring organs that
might by shipped across the country?
Mr. Gibbons. I would put it into procuring organs because I
don't believe that those organs would be shipped across the
country. I think broader sharing is a good thing, and 9 million
people is not so large that it reaches----
Mr. Barrett. Okay. Mr. Gibbons.
Mr. Gibbons. That is me.
Mr. Barrett. Mr. Irwin, what would you do?
Mr. Irwin. It doesn't make sense to try to buildup your
waiting list if you don't have the donors to service it.
Mr. Barrett. But aren't we putting together a beautiful
system for a free rider in pure economic terms, someone who
says, well, I am not going to worry about organ procurement
because I gain nothing. I gain nothing from organ procurement--
in the most selfish way. Maybe in the global picture we do, but
I am concerned about my center here. And so the ticket to
success under this system is to develop a waiting list.
Wouldn't we agree with that, the ticket to guaranteeing
patients under this new system--guaranteeing patients under
this new system is not getting organs, the ticket is getting
sick patients. So if I am a rational economic actor, I am going
to be putting my effort into getting sick patients. I think
that has a devastating impact on the supply of organs.
Mr. Irwin. If you still want to hear from me, let me make a
couple of comments.
First of all, organ donation rates certainly vary
throughout the country. I don't see any evidence that
transplant centers or OPOs with larger waiting lists are less
aggressive or more aggressive in trying to find donors. I think
everybody in this system works hard to maximize organ donation.
Second of all, I think you will find that in many cases
patients who do end up--who are sick patients who end up in a
larger center, they are there because they are turned down by
another center who doesn't have the expertise or the
willingness to transplant them.
Third of all, I think if you look at the data, transplant
centers that do transplant fairly sick patients in many cases
have survival rates that are on a par or even better than
transplant centers that transplant healthy patients.
Mr. Barrett. If I may, Mr. Chairman, I know that time is
short. I also want to make this point. This is from Mr. Irwin's
testimony commenting on the IOM study. Quoting, ``Broader
sharing of organs resulting from implementation of the final
rule is not likely to have a significant adverse effect on
those who depend on Medicaid for their health care.''
I don't read that as a ringing endorsement that we are
going to improve access to the poor. That is one of the things
that we have had discussions here. To say that it is not going
to have a significant adverse effect certainly leaves the door
open that it is going to have an adverse effect. With
minorities in particular, the committee found, ``that African-
Americans do not receive kidney treatments as quickly as
whites,'' and that the Department's rule would not exacerbate
this problem. It doesn't say it will improve the problem, it
simply says it is not going to make the problem worse.
So again, I think as we talk about minorities, about the
underserved, that no one should leave this room thinking that
the Department's rule is somehow helping minorities and the
poor based on IOM's own statement.
I would yield back the balance of my time.
Mr. Bilirakis. Mr. Green.
Mr. Green. Thank you, Mr. Chairman, and I will be as quick
as I can.
My first question is for Dr. Miller and Dr. Payne. I am
concerned that OPOs have not shown a willingness to share
organs with other OPOs or States within their closed region
unless they do not have any match within their own area. This
practice is--the Institute of Medicine found it could have a
negative impact on all patients who may lose the opportunity to
receive a life-saving organ based solely on their location.
In your testimony, you mentioned that the OPTN had already
begun to implement some of the IOM recommendations as they
relate to organ sharing. Would you comment in greater detail on
the steps that have been taken? Are there plans to take or
encourage or require broader sharing of organs by OPOs within
reasonable geographic boundaries?
Remember, I am from Texas. We are pretty big. We have three
OPOs in our own State, and geographically there is no relation
to their areas.
Mr. Miller. Dr. Payne is going to be able to do this better
than I. I would like to comment, though, if I might. The reason
is he is the president of UNOS this year. I think that is
important. That is where this process occurs.
However, we have felt the impact and are going to feel more
of this impact because of broader sharing, and it has to do
with the most urgently ill patients needing it. It is going to
be regionalized rather than localized so that in a region--for
instance, we are in a very large region in Florida that
consists of Florida, Alabama, Georgia, Louisiana, Mississippi.
We are talking about a large region that has much more than 9
million people. That region has developed methodologies now to
attempt to share status 1--liver status 1 patients.
May I make one comment about this local effect on organ
donation, because there has been actually statements made by
both the esteemed Congressmen here as well as some of my
colleagues at this table that have actually put words into the
IOM's mouth, so to speak. IOM came out with a statement that
was very perceptively stated by Congressman Bilirakis, our
chairman, that said that it was inconclusive as to whether
there would be an effect or not on local organ retrieval or
closure of local programs. Inconclusive. They did not say that
there would not be an effect.
Now, if you were to ask experts in this field, the majority
of the American Society of Transplant Surgeons feel that there
would be an effect. We came out with a white paper about that.
That word is very important because it is a word that is used
by--if you will forgive me--statisticians who do not wish to
make mistakes. It is very important that they don't.
Mr. Bilirakis. Doctor, would you submit that white paper
for the record?
Mr. Miller. It has been submitted, and we will do so again.
It was our first paper on this when the----
Mr. Bilirakis. Please do so. The staff is not certain.
[The information referred to follows:]
Prepared Statement of the American Society of Transplant Surgeons
on efforts to resolve the controversy over the organ procurement and
transplantation network
Introduction:
On October 21, 1998, a Congressionally ordered moratorium went into
effect on implementation by the U.S. Department of Health and Human
Services (DHHS) of the Final Rule published by HHS Secretary Donna
Shalala in the Federal Register on April 2, 1998 (42 CFR Part 121).
This one-year moratorium is scheduled to end on October 21, 1999 unless
further extended by the U.S. Congress. In imposing the moratorium,
Congress asked the Institute of Medicine (IOM) and the General
Accounting Office to conduct a study of current policies of the Organ
Procurement and Transplantation Network (OPTN) and the potential impact
of the Final Rule. An IOM Committee was formed to conduct this study in
early 1999, and it published a report, entitled ``Organ Procurement and
Transplantation: Assessing Current Policies and the Potential Impact of
the DHHS Final Rule,'' on July 20, 1999.
The American Society of Transplant Surgeons (ASTS), as the
professional organization representing the surgeons, physicians and
scientists who lead the transplant programs at the major medical
centers across the United States, is committed to the continuing
refinement of organ allocation policies to meet the needs of our
patients. During the past 18 months, we have expressed both strong
support for and strong opposition to various aspects of the Final Rule.
We have met repeatedly with leaders of DHHS, have testified on this
subject at hearings conducted by the U.S. Senate and the U.S. House of
Representatives, and have both testified before and provided voluminous
written information to the Institute of Medicine during its
deliberations in the spring of 1999.
We believe, based on numerous conversations, that an increasingly
broad consensus exists among members of the transplant professional
community on many of the most contentious aspects of the Final Rule. We
believe if a new Final Rule were to be published today, it would not
contain some of the elements that ASTS has most vigorously opposed.
DHHS itself has stated that it intends to publish some number of
unspecified changes to the Final Rule at some unspecified time prior to
implementation. We are increasingly apprehensive, however, that the
transplant community--and Members of the U.S. Congress, which is
concluding its 1999 Session--will not see the proposed changes in a
timeframe that would enable Congress to again legislatively defer
implementation of the Final Rule if the changes are not found to be
sufficiently responsive to our concerns.
While we do not propose in this position paper to repeat all of the
points ASTS has made in published position statements and testimony, we
would like to highlight the major concerns we have been discussing with
DHHS--and our views on recommendations of the IOM Committee. We also
urge Secretary Shalala to immediately publish the changes she proposes
to make in the Final Rule. Given that the one-year moratorium is near
an end and we still have not seen any proposed changes, we believe that
when publication of changes by DHHS finally does occur, a reasonable
period of time for consideration of, and reaction to, these changes by
the transplant community--and Members of Congress--prior to
implementation is both fair and essential.
NOTA and Secretarial Authority:
The most difficult area to resolve in our discussions with
representatives of DHHS has been the question of Secretarial authority.
We strongly believe the National Organ Transplant Act (NOTA), which was
passed by Congress in 1984 and established the OPTN in the private
sector under government contract, intended for the OPTN to make organ
allocation policy based on sound medical principles and scientific data
independent of political influence. This important principle is
reaffirmed in the NOTA reauthorization legislation introduced this
summer in the U.S. House by Chairman Michael Bilirakis and we hope that
the legislative consideration of NOTA Reauthorization will move forward
in the coming year.
Let us be clear that ASTS supports preservation of the Secretary's
legitimate oversight role. Three of the five specific recommendations
included in the IOM Committee's report addressed the area of oversight
and review. The committee concluded that ``oversight and review of the
nation's organ procurement and transplantation system needs to be
enhanced to improve the system's accountability to the public and to
ensure that it operates effectively in the public interest.'' We
endorse Recommendation 8.1 (Exercise Federal Oversight) and we stand
ready to assist DHHS in defining and updating performance standards for
the OPTN, OPOs and transplant centers.
We simultaneously recognize and support the responsibility of the
OPTN to make specific organ allocation policy based on sound medical
principles and scientific data. We have expressed to DHHS our concerns
that sections 121.4 (b) and (d) could be interpreted as setting the
stage for the Secretary of DHHS to make specific allocation policy, and
have suggested changes in these sections to clarify the respective
roles. DHHS's oversight responsibility should be to ensure that the
policies that guide the operation of the system are equitable, based on
sound medical science, and are adhered to. However, the Secretary must
not dictate specific transplant practices or medical judgments. The
OPTN's responsibility is to make specific policy concerning allocation
and to modify that policy on the basis of sound medical science and
developing medical practices.
Independent Scientific Review:
We believe IOM Recommendation 8.2, that the Department ``establish
an external independent, multidisciplinary scientific review board,''
has great merit. We agree with the committee that the organ allocation
system should be reviewed periodically by an independent body separate
from the OPTN. Obviously, a number of key issues remain to be
addressed, including the makeup of this board, how members would be
appointed, and what issues the board would review.
To be truly independent, we believe it important that the
independent scientific review panel not be appointed at the sole
discretion of the Secretary, and since this panel will be reviewing
issues of medical judgment, we believe it imperative that this panel
consist of not more nor less than 50 per cent transplant surgeons and
physicians active in the field of transplantation. We believe an
appropriately composed body could bring medically sound resolution to
difficult or contentious problems through careful objective review. We
would then expect the Secretary and the OPTN to work together to
develop solutions based upon recommendations of this body. We are
prepared to suggest appropriate scientific experts to participate in
these reviews.
Standardized listing and de-listing criteria:
The transplant community currently recognizes the need for
standardized listing criteria, de-listing criteria and criteria for
determining medical status. It is clearly within the purview of the
OPTN to develop these criteria, and to continually refine them based
upon changes in clinical care resulting from advances in medical
science. We believe the Final Rule should instruct the OPTN to develop
standardized listing and de-listing criteria, and to develop a process
for both prospective and retrospective review for compliance. It should
also provide a mechanism for funding prospective review, such as an
increase in listing fees. In this area, we would expect that DHHS would
be in a position of enforcing sanctions for non-compliance, and we urge
that the language of the Final Rule be changed to clearly reflect this.
Evaluation and Enforcement:
We totally agree that allocation and other policies, such as
standardized listing and de-listing criteria, must be enforced.
However, as noted in section 121.10, the only enforcement currently
specified would involve relatively harsh penalties, including
termination of a transplant hospital's participation in Medicare or
Medicaid, or termination of a transplant hospital's reimbursement under
Medicare or Medicaid.
We believe the Rule should direct the OPTN to make recommendations
on graduated enforcement options, and work with DHHS to develop a
process for corrective action prior to imposition of severe sanctions.
Among the issues to be addressed is due process, including at what
level of enforcement Secretarial approval is required prior to
imposition of penalties.
Organ specific allocation policies:
We have previously emphasized the important principle that
different organ transplants require different allocation policies. The
IOM report is careful to make recommendations about liver
transplantation only. Objective criteria of disease severity may be
relevant to organs in which there is no suitable life support system,
such as livers or hearts. These types of criteria may have no relevance
to other organ transplants, such as kidneys or pancreata, for which
there are suitable support techniques. We urge the Secretary to review
the Final Rule and indicate that other principles may apply to such
organs.
Reducing Socio-Economic inequities:
We are encouraged by the IOM report's conclusion that ``the most
important predictors of equity in access to transplant services lie
outside the transplantation system--that is, access to health insurance
and high-quality health care services. Thus we are concerned that
Section 121.4, subsection (3) of the final rule may seem to place a
too-heavy burden on transplant hospitals and OPOs. Specifically, we
propose that subsection (3) be changed to: ``(i) Ensuring that patients
in need of transplant are listed without regard to source of payment.
(ii) Procedures for transplant hospitals to make reasonable efforts to
obtain from other sources . . .''
OPTN Board Composition:
The final rule in Section 121.3 mandates an OPTN Board with a
minimum of 30 members. Two seats are specifically allocated to
transplant surgeons and two to transplant physicians. It provides that
``transplant candidates, transplant recipients, organ donors and family
members'' shall comprise ``at least 25 percent'' of Board members; and
that transplant surgeons and transplant physicians shall comprise ``no
more than 50 percent.'' We strongly believe that because of the
technical and scientific as well as ethical and social problems
continuously occurring in this field, transplant physicians and
surgeons should comprise no more nor less than 50 percent of the
membership of the Board.
Allocation of Organs:
In 1998, DHHS contended that differences in the median time that
patients spent waiting for a transplant at various centers demonstrated
a fundamental unfairness of the current allocation system, and argued
on that basis for immediate implementation of the Final Rule.
ASTS has always taken the position that waiting times as used by
DHHS were not a good indicator of fairness, and totally agree with the
data analysis performed by the IOM Committee which clearly indicates
that waiting time is not a reasonable measure of equity of allocation
for patients nor is the disparity of overall median waiting time a
reasonable measure of fairness of the current system.
But while we do not believe that waiting times as currently used
are an appropriate performance measure, we are not--in the absence of a
better methodology--prepared to totally endorse the IOM Recommendation
to ``discontinue use of waiting time as an allocation criterion for
patients in Status 2B and 3.'' We believe waiting times might continue
to be one consideration in the triage of liver patients in Status 2b
and 3 when all other medical criteria are equal.
Thus, we recommend that certain sections of 121.8 be revised. As we
have previously stated, neither time waiting nor medical urgency can be
considered absolute measures of equity for allocation of all types of
organs for transplantation. For these reasons, we would suggest that
the final rule contain general principles of equity, and suggest that
it be left to the OPTN to develop the specific policies that achieve
equity.
Record Maintenance and Reporting Requirements:
We endorse IOM Recommendations 8.3 (Improve Data Collection and
Dissemination). We strongly agree that physicians, patients and the
public should have access to accurate, understandable, and timely
information regarding performance of the OPTN, OPOs and transplant
centers. However, the provisions in Section 121.11 mandating that
updated data be made available to the public ``no less frequently than
every six months . . . and shall be presented no more than six months
later than the period to which they apply'' are not currently
realistic. We propose that data be collected annually. The one-year
border will likely lead to more accurate and efficient reporting. We
also propose that data made available within one year after the period
to which it applies, but that it be made available more quickly at a
time when implementation of improved systems make this possible. Within
two years of the date of implementation of the Final Rule, we believe
it should be possible to make data available no more than six months
later than the period to which the data applies.
It is extremely important that the Secretary assure that any
release of data be done in a manner that preserves the confidentiality
of individual patients and donors. Understanding that organ
transplantation is performed infrequently even in the busiest centers,
identification of the date and location of a procedure could
simultaneously identify the donor and recipient. Thus, in some
circumstances, appropriate coding of some information may be necessary.
Organ Allocation Units:
We believe that Recommendation 1 (Establish Organ Allocation Areas
for Livers) is deserving of further study and would urge the
Secretary--even prior to issuance of the Final Rule--to direct the OPTN
to present an analysis on those areas where broader geographic sharing
is now in effect and possibly even conduct tests in certain geographic
areas based on this recommendation. Although the report of the IOM
committee found no evidence that supports the concerns that wider
sharing--or disassociating organ retrieval from organ allocation--would
lead to decreased donation or closure of small programs, further study
is required before such a conclusion can be drawn. There is no question
that several OPOs serving relatively small population areas have
achieved some of the best donation rates, while other OPOs do not have
comparable rates of donation. This would suggest that local factors may
well influence organ donation, a very complex and delicate system, and
that changes should be made with extreme care. Therefore, to the extent
that steps are taken either to broaden organ allocation areas or
disassociate organ retrieval from organ donation, we recommend that any
change in policy be reviewed by the OPTN within one year, and at yearly
thereafter, for its impact on patient outcomes, organ donation rates
and transplant center volumes. We suggest that the OPTN might also
undertake studies to determine whether the same principle of
population-based allocation areas might improve the system of
allocation of other organs.
DHHS and OPTN:
The report of the IOM committee clearly supports complementary
roles of DHHS and the OPTN in the transplant system. Unfortunately, a
variety of issues have led to substantial discord between the two
organizations. While we understand the positions of the two parties and
have commented on them previously, we believe it is critical to the
transplant community that these disputes be ended. We are encouraged by
Secretary Shalala's announcement that DHHS is prepared to make
alterations in the Final Rule, and urge her to publish those changes
for consideration by the transplant community and the U.S. Congress at
the earliest possible date.
September 16, 1999
Mr. Bilirakis. Please proceed, Mr. Green. I am sorry for
interrupting.
Mr. Green. Dr. Payne?
Mr. Payne. My comments regarding wider sharing----
Mr. Green. Wider sharing within the region. I am not
familiar with southeast Texas, but I am in the Southeast of the
United States but understand Texas and sharing within the
region, if not nationally.
Mr. Payne. If I could just preface the answer with a little
explanation about OPO boundaries, because I would hate for UNOS
to be saddled with the present OPO boundaries. Those boundaries
were established by HHS at the point that they were established
through HCFA. They were approved by HCFA. So those OPO
boundaries were out of the purview of UNOS at the time.
Mr. Green. My concern, though, is that the goal, I think,
was to regionalize it; not nationalize it, but regionalize it.
Mr. Payne. One of the first policies that UNOS adopted that
extended sharing beyond OPO boundaries was that of identically
matched kidneys. That truly is a national program where if a
kidney is made available anywhere in the country, and it is a
so-called perfect match with anybody on the waiting list, every
effort is made to get it to that particular patient. If more
than one patient is identified, the patient waiting the longest
gets that organ. That is a long-standing program that is
available and takes it--expands all OPOs in the country. That
is an extraregional sharing agreement.
Mr. Green. That is for kidneys. That sounds like what HHS
might be wanting to do. I am a cosponsor of the bill, and I am
concerned about what may happen in my own State.
Mr. Payne. The point there is that there is efficacy in
doing that. There is demonstrated improvement in outcome, so
there is an effort made to do that, plus it is possible to do
that with kidney transplants because the cold ischemic time
that we heard about is not as critical in kidneys. They can go
longer, so you have the time to do it. In a liver transplant,
it is much more difficult to set up some sort of that broad
sharing scheme.
So there have been stepwise attempts in regions around the
country to broaden sharing agreements across OPOs. Many of
them, they have been permitted by UNOS. Now, most recently the
policy that has been put in place nationally is that it will
mandate regional sharing, meaning the 11 UNOS administrative
regions for status 1 liver transplant recipients. Again, that
is because of the effectiveness of that for that particular
patient population. Those patients have a demonstrated benefit.
Earlier on, Dr. Gibbons was talking about the differences
between equity and effectiveness, and in that case there is a
real effective change in going from that 4 days that people
average down to 2 days. Everybody moves together. There is no
change in equity. Everybody waits the same amount of time, but
everybody wins in terms of effectiveness in terms of that
patient.
Mr. Green. Thank you, Mr. Chairman. I see my light on.
Since we haven't had a call for a vote, I have one question----
Mr. Bilirakis. Without objection, I have no problem with
you asking that additional question.
Mr. Green. Thank you, Mr. Chairman.
Dr. Raub, you mentioned that proposed provisions, we won't
have to wait much longer. But again, this legislation and
Congress is going to have to act before October. It concerns me
that we don't have those revisions now so that we can look at
them and see what may need to be done. But that leads into,
both for the administration and UNOS and the rest of the panel,
that we have been dealing with this in delaying the
effectiveness of the final rule. There has been--in earlier
hearings there was effort to have both sides sit down and work
together to see how we could come up with something that would
be, and to this date I guess we haven't.
Has there been efforts between the administration and HHS
and UNOS and the various groups to actually sit down and see
how this could be worked out?
Mr. Raub. Sir, repeated discussions and meetings have been
held with both oral and written comments. As I indicated in my
testimony, the Department has considered very seriously all of
those comments and has identified some areas where, while not
modifying the core principles or provisions of the rule, we
think some refinements would improve it. And we are working
hard to get those formulated before the moratorium date ends.
Mr. Green. Thank you, Mr. Chairman. Any other comments
from--everyone else has a dog in the fight, so to speak.
Mr. Miller. The American Society of Transplant Surgeons has
met with the Department very recently. My colleague, the
president of the society, Dr. Busuttil, met with Dr. Fox.
We are concerned that we will not see this rule until the
very last minute. There may be language in the rule that still
might be improved upon. This is of great concern to us.
Mr. Rabkin. Mr. Green, I would like to echo that thought
and say that after having such a long period where we have had
an opportunity to meet with the HHS and failed up to this date
to have any concrete proposal for change, it troubles us as
well in the PAT Coalition that we will not have the opportunity
to weigh in and make suggestions for refinement. As an example,
Dr. Raub pointed out that the IOM suggested an independent
panel to be set up to look at some of these issues. In fact,
then he went on to mention implementing the Federal Advisory
Committee Act.
Well, the problem that we would immediately recognize is
that under that act it is directly under the Secretary's
discretion, it is advisory, and, frankly, we don't understand
how that would add any benefit if it is not an independent
panel. I think if you read the IOM report, they are very
explicit, it needs to be an independent panel. So again, as an
example, if the HHS comes forward at the 11th hour with a
proposal, but has these nuances of the interpretation that it
would be put forward in policy, that would be clearly
objectionable to the members of the PAT Coalition.
Mr. Green. Thank you, Mr. Chairman.
Mr. Bilirakis. Well, Mr. Green, you brought up a point
certainly that I have been concerned with. We had all hoped--
again, we are an ivory tower here. We use that term an awful
lot, but it is true. We are required to make these tough
choices and these tough decisions when, in fact, people are
better capable of doing it than we are.
So this is why we had hoped that the transplant surgeons,
HHS would get together and work something out, and you haven't.
I haven't been privy to those conversations, but frankly, in my
mind, I really wonder whether HHS is willing to bend at all or
just dead set on their ways. Again, I am not trying to belittle
any efforts that HHS made in trying to work out these things
and not resolving it and not having to pass legislation to do
something that you all should be able to do, particularly when
we hear of a bending on the part of UNOS in terms of some of
these areas that have been pointed out.
Can you, Dr. Raub--would you furnish to the committee a
copy of those areas that you are contemplating changing that
Mr. Bryant went into that somewhat? Will do you that?
Mr. Raub. Yes, sir.
Mr. Bilirakis. Can do you that within the next couple of
days?
Mr. Raub. I will do it as soon as we can, sir.
Mr. Barrett. Mr. Chairman, just for my education, the 1-
year moratorium, when does that expire? Do we know the day that
expires?
Mr. Bilirakis. October 21.
Mr. Barrett. I just want to say that I share the concern
that we are going to see that about the same time we saw the
Department's testimony.
Mr. Bilirakis. Well, Dr. Raub, you indicated you have been
working on this. Is there any reason why you can't furnish at
least where you are at this point within the next few days? You
will furnish it when you can. That might not be until late
October.
Mr. Raub. Some of the items are still in the early stages
of crafting.
Mr. Bilirakis. The moratorium is almost over, and they are
still in the early stages of drafting. I sometimes wonder if--
well, sir, we need that information. I frankly think that the
industry out there, the transplant industry, needs that
information, and I think they need it long before to give them
an opportunity--I mean, I don't think that they should be left
with what we have been here today, not having seen the
testimony until an hour before the hearing started.
I say that with all due respect, but you should also
realize that--well, I am going to ask that that information,
whatever is available--and whatever isn't available, I guess
you can't furnish--be submitted to this committee within--let's
say within 7 days of today?
Need 48 hours? Why?
I am told that you have that information, and you are--all
right, 48 hours. I am going to ask that it be furnished in 48
hours. I don't think that we should have to go through any
legal proceedings or whatnot in order to get that.
Can you do that, what you have?
Mr. Raub. I will convey that request, sir.
Mr. Bilirakis. Please, Dr. Raub, do that. We want to do
this the right way, the nice way.
All right. A vote is being called on the floor. We have a
number of questions--oh, yes. A statement here submitted by
Charles Fisk; a statement here by Bruce Weir, Transplant
Recipients International Organization, Inc., and a statement by
Congressman Pete Stark. I would ask as the Chair unanimous
consent those be made a part of the record.
There are a number of questions as per always, as per usual
that have not been asked, and we would like to furnish those to
you in writing and request that you respond to them as quickly
as you can, because, again, we are trying to do the right
thing. I know there has been more adversarial taking place at
that table there than frankly usually takes place up here, but
believe it or not, we are trying to do the right thing.
Whatever information you furnish to us could be helpful.
The hearing is adjourned.Thank you. Thank you for your
patience.
[Whereupon, at 5:45 p.m., the subcommittee was adjourned.]
[Additional material submitted for the record follows:]
Prepared Statement of Charles Fiske, UNOS General Public Member
Mr. Chairman and Members of the Subcommittee: Thank you for
allowing me to submit written testimony on the reauthorization of the
National Organ Transplant Act. I came before this committee in April of
1990 and also April of 1993 to address issues about the national
transplant system. My involvement in organ transplantation began in
1982 when my then nine-month old daughter, Jamie needed a liver
transplant. At that time there was not much of a system in place for
matching donors with recipients. In addition liver transplants had not
been performed on anyone as young as Jamie and since there were only
two liver transplant centers in the country our family faced a
difficult ordeal. Jamie was successfully transplanted in November at
age eleven months at the University of Minnesota Hospital.
The following Spring (April 1983) we came before then, Congressman
Al Gore who was conducting hearing on the problems transplant patients
faced. In the fall of that year Senator Orrin Hatch held hearings to
learn of the ordeals that we and other families encountered while
waiting for an organ to be found in time. Senator Hatch was familiar
with Jamie's situation since the donated liver came from Jesse Bellon
of Alpine, Utah. In 1984, President Reagan signed the National
Transplant Act calling for a Task Force to study the issue. The task
force concluded that a single national system would ensure that these
national resources--donated organs--could be effectively allocated
fairly to all needing an organ transplant. Since then, I have been
actively involved in the issue and served on the UNOS (United Network
for Organ Sharing--the federal contractor) Board of Directors for four
years. Currently, I am one of only nine UNOS general public members. My
observations and conclusions today are similar in some respects to my
testimony previously presented before this same committee. We've come
far but still have a long way to go to encourage the transplant system
to be responsive to patients no matter who they are or where they live.
The implementation of the HHS transplant regulations will take the care
of patients to the next level. Passage of H.R. 2418 will be a step
backwards in this process and should not be passed. Congress has
directed that the single national system be response to all medically
urgent patients especially those with the least access.
Congress must again encourage and demand that the National
Transplant System reflect the needs of the patient population first
before serving the unique interests of any transplant center. I've
always advocated that the system be fair so that those patients who are
medically most urgent receive first attention. Patients should not have
to chase organs but rather be assured that when their time comes for
transplantation they, given their medical status, will have a fair
chance of receiving an organ. Currently the system is based on local
preference so that the available organ is given locally even if there
is another more medically urgent patient in the next local area. If the
organ can't be used it is distributed regionally and then nationally.
Recently UNOS passed a resolution to have organs shared with status one
patients (most medically urgent with seven days to live) within each of
the eleven regions in the country. This is a good first step.
Allocation determined primarily through geographic boundaries rather
than medical urgency makes little sense especially if those organs can
be safely transported greater distances. The wider allocation of organs
needs to be expanded to include status 2A and 2B patients as well.
There has been a marked increase in the number of transplant centers.
As a result, with more patients needing transplantation the supply of
available organs cannot meet the current demand.
Congress needs to require that the national transplant system take
the following steps:
1) There should be greater oversight on the system to protect
patients from the self-interests of transplant centers. The UNOS Board
is comprised of many individuals who represent various transplant
centers throughout the country. Often they are voting on policies that
directly affect the financial interests of their own institutions. On
the one hand the contractor is a membership organization and on the
other a regulatory body. Over the course of years this has been a
difficult task for the contractor. Greater oversight would assure the
general public that the system is in operating the best interest of all
patients whether they lived in New England or on the West Coast. That
oversight involves the establishment of specific standards that not
only protect the public but also assure the transplant community that
there is a mechanism in place to encourage compliance with public
policy directives. Only the Secretary can issue public policy that has
the effect of law. Much of current debate over the NOTA reauthorization
has to do with the confusion between the development of public policy
and the practice of medicine. The current contractor and a number of
transplant centers have determined that all transplant issues are
considered the practice of medicine and are unwilling to respond
positively to standards that have been established for the public
policy purposes. Much energy has been spent circling the wagons to keep
the Department at bay when in reality the public strongly supports a
system that meets the needs of its most medically urgent. The
transplant system is not the private domain of a certain select group
within the transplant community but directly connected to all our
citizens on whom we depend for organ donation. It is the general public
through its patient registration fees and tax dollars that is fueling
the system. To suggest that the National System can fairly operate on
its own is both unrealistic and shortsighted. The recent border war
over organ allocation between Wisconsin and Illinois is a prime example
of special interests winning out over patients' interests.
2) The most medically urgent patients must receive organs first.
Distribution for organs for the most urgent category could be
realistically done beyond the boundaries of our current systems at both
the local level and the regional level. The recently completed
Institute of Medicine studies found that the current system now
operating could be greatly improved so that organs may be reaching to
most medically urgent. The Institute of Medicine did find that the less
urgent patients (Status 3) were being transplanted at the expense of
those who are most medically urgent (Status 1)
3) Data should be made available in a timely fashion. This data is
not the private property of the federal contract and should be
accessible to physicians and patients who make decisions on which
center to approach for treatment. Data must be used to help drive
public policy decisions so that parochial interests of the various
transplant centers cannot come before the interests of patients.
4) Patient registration fees should reflect the cost of helping run
the transplant system rather that fuels the special interest and lobby
efforts of the contractor.
5) Greater steps need to be taken so that the ``green screen'' (no
dollars, no transplant) affect is adequately understood as a major
impediment preventing some patients from receiving care.
Congress has the ability to require this be done. The public needs
to have confidence in the system so that when organs are distributed
each patient can receive an organ in a timely fashion when their turn
becomes available.
I'll submit copies of my prior testimonies from 1990 and 1993.
Issues that were raised then are yet to be resolved. I would urge this
Committee to look forward not only in fully supporting the HHS
regulations but also encouraging the current contractor to take the
immediate steps necessary to put an allocation system in place that is
responsive to current needs of the general public. The clear and astute
recommendations that have come forward from the recently published
Institute of Medicine report on the transplant system have supported
the Department's efforts to encourage the contractor to be more
responsive to the needs of patients. Once the changes have been enacted
a full reauthorization of NOTA is in order. A more comprehensive bill
to include the recommendations of the IOM report, the OIG report
(August 1999) and the April 1998 HHS regulations should be considered
in the spring of 2000.
Again I thank the Committee for the opportunity to present this
information and I am available at anytime to review this matter with
you.
______
Prepared Statement of Bruce Weir, President, Transplant Recipients
International Organization, Inc.
I am submitting this testimony today on behalf of a vital segment
of the national transplant system that has been, and still is, quite
under-represented . . . the patients.
In April of 1998, the Secretary of the Health and Human Services
(HHS) issued a ``Final Rule'' that addressed certain areas in the
present system that need improvement (allocation of organs, oversight
of the system, to name a couple).
United Network of Organ Sharing (UNOS), who holds the contract of
the Organ Procurement and Transplant Network (OPTN), decided to fight
these changes and the two sides became polarized. No gain for either
side; and even worse . . . the patients lost. Many of the changes would
have helped a patient's chances of being transplanted sooner. When
things got to an impasse, UNOS then successfully lobbied Congress to
issue a moratorium for one year, asking the Institute of Medicine (IOM)
to study the Rule and the issues having been raised to see if the Rule
had any merit. The IOM Report was issued on July 20, 1999 and generally
supported the reasons the ``Final Rule'' was issued and debunked the
untruths spread by its opponents. The moratorium expires October 21,
1999.
The very Congress that ordered the moratorium, not having yet
studied or evaluated the IOM report, is now embarking on a mission to
rewrite the law that established the OPTN, how it operates and what, if
any oversight and authority the Secretary of HHS might or should have
over the national organ transplant system.
What I have seen of the proposed changes only heightens my
concerns. This bill is greatly skewed in favor of OPTN and lessens the
power and authority of HHS. There needs to be balance. This bill would
create imbalance.
I urge you all to seriously consider whether this is the time to
even consider such changes. Transplant centers may feel these changes
are necessary to help insure their future. This is not the time for
patients--for while they are waiting, they have no future.
______
Prepared Statement of Hon. Pete Stark, a Representative in Congress
from the State of California
Mr. Chairman: Thank you for holding this hearing today which will
help educate Members concerning the need for a more effective and fair
system of organ allocation.
Every day 10 people die in this country waiting for an organ
transplant. At least 65,000 Americans are currently awaiting an organ
transplant. There is no disagreement about the problem--there aren't
enough organs to meet the needs of patients. This Congress, I
introduced legislation, H.R. 941, the ``Gift of Life Congressional
Medal Act of 1999.'' This legislation encourages donations thereby
making more organs available for potential donation. I hope Members
would consider this effort to increase donations.
In April of last year, after extensive public debate, the
Department of Health and Human Services issued regulations intended to
provide oversight for the nation's organ transplant system and to help
guide the transplant community to create a fairer transplant system.
The FY '99 Appropriations bill included a moratorium on the regulations
until October 21 of this year. Congress also directed the Institute of
Medicine (IoM) to report on the current organ allocation system.
The Secretary's regulation will let medical people make medical
decisions about the best way to allocate the limited number of donated
organs within a framework that, as set forth by the IoM, will improve
the function of the system. The Secretary's regulation is urgently
needed by patients across the country.
I believe there is a great deal of evidence of the need for timely
implementation of the Secretary's regulations concerning organ
allocation policies.
For example, a recent report from the HHS Office of Inspector
General found that the Secretary's new transplant rules would not
impose new hardships on patients from small communities who need
transplants. According to the OIG, most transplant centers are
clustered around major cities and it is a ``myth'' that most Americans
now have access to transplants virtually in their backyard. Thus the
regulation won't hurt ``local access'' because such local access
doesn't truly exist.
Also, the Institute of Medicine has issued its report with
conclusions that are very supportive of the Department's regulations.
The IoM supports having the Federal government exercise its legitimate
oversight responsibilities under the National Organ Transplant Act,
instead of allowing a federal contractor essentially make the rules.
The report also declares that the current system would be significantly
enhanced if the allocation of scarce organs were done over larger
populations than is now the case.
The IoM report stated that ``Vigilant and conscientious oversight
and review of programs . . . are critically important to ensuring
accountability on the part of the OPTN and other participants in the
organ procurements and transplantation system.'' The report also
concluded that the Department's Final Rule appropriately places
oversight responsibility with the federal government. Yet H.R. 2418
would set allocation policies different than those contained in the
Department's regulations.
Among other flaws, H.R. 2418 provides unreasonable protections for
the current contractor (UNOS), removes the Secretary's legitimate
oversight authority over the program, while simultaneously making data
less available to the public. It is a significant step backward from
even current law. And, in its delegation of power to private parties,
it is probably unconstitutional.
I can think of no better way to put patients first than to make the
system fair for all. This issue is about putting patients first--not
putting transplant bureaucracies first.
Mr. Chairman, armed with the strong support of the IoM report,
Congress should oppose another moratorium and should not enact H.R.
2418.
______
Prepared Statement of the National Kidney Foundation
On behalf of the thousands of individuals who are on waiting lists
for an organ transplant, we wish to thank you for introducing
legislation to reauthorize the National Organ Transplant Act (NOTA).
The Mission of the National Kidney Foundation (NKF) is to prevent
kidney and urinary tract diseases, improve the health and well-being of
individuals and families affected by these diseases and increase the
availability of all organs for transplantation. NKF represents 30,000
lay and professional volunteers from all walks of life and every part
of the country.
The NKF has long held that NOTA should be reauthorized in an effort
to expand organ donation and we are pleased that H.R. 2418 addresses
the problem of the shortage of organs available for transplant in this
country. In addition, we are supportive of the effort to clarify the
responsibility for developing, establishing, and maintaining medical
criteria and standards for organ procurement and transplantation as a
function of the OPTN. Further, we believe that the transplant community
at large should play an integral role in the development of these
policies. The NKF agrees that the OPTN shall make available timely
information on outcomes at specific transplant centers, as you have
provided for in Sec. 3(d)(2), so as to help transplant candidates make
informed choices.
Research supported by the NKF Council of Nephrology Social Workers
shows that unreimbursed expenses serve as a disincentive to living
organ donation. As such, we are very appreciative and supportive of
Sec. 5 of H.R. 2418, ``Payment of Travel and Subsistence Expenses
Incurred Toward Living Organ Donation.'' However, we urge you to remove
the provision that the donor must reside in a different State than the
recipient. Certain expenses, such as the need for temporary day care,
are incurred regardless of where the donor resides and a transplant
center instate could be at a greater distance from the donor than one
in a State different from that in which the donor lives. We also urge
you to remove the provision that restricts payments to situations in
which the annual income of the organ recipient is less than $35,000. It
is our belief that it is more appropriate for States, transplant
centers, organ procurement organizations and voluntary health agencies
to determine who should be eligible for assistance in each particular
instance. Furthermore, any means test might be more appropriate for the
donor rather than the recipient. We also believe Sec. 4(c) will be
useful toward increasing organ donation, specifically as this would
facilitate demonstration projects on the efficacy and acceptability of
financial incentives to families for cadaveric organ donation.
We have additional specific suggestions regarding H.R. 2418. With
regards to the composition of the OPTN Board of Directors (Sec. 3(a)),
we believe a more specific designation is warranted for transplant
recipients, candidates for transplants, donors and donor families,
rather than the ``reasonable proportion'' cited in the bill language,
and we recommend that transplant surgeons and transplant physicians
should comprise not more than 50% of the members of the OPTN Board. We
also suggest that ``transplant patients'' be added in the list of
groups with which the Comptroller General be required to consult in
preparation of the General Accounting Office's evaluation of the
Network (Sec. 3(i)(2)).
Thank you for holding this hearing and for the opportunity to
provide written testimony. We look forward to working with you to
improve the efficiency and effectiveness of our nation's organ
procurement and transplant system.
______
Louisiana State University Medical Center
Office of the Chancellor
September 21, 1999
The Honorable Thomas J. Bliley, Jr.
Chairman
House Commerce Committee
2125 Rayburn House Office Building
Washington, D.C. 20515-0106
Dear Chairman Bliley: I am writing on behalf of the Louisiana State
University Health Sciences Center to express my deep concern that
implementation of the DHHS Final Rule regarding organ allocation will
jeopardize access to life-saving organ transplants needed by
Louisiana's working poor and indigent. These are the very patients most
dependent upon our institution's organ transplantation programs.
However, H.R. 2418, the ``Organ Procurement and Transplantation Network
Amendments of 1999'' appears to be in the best interest of these
patients as it would provide them with continued access to organ
transplantation. Introduced by Chairman Michael Bilirakis of the Health
and Environment Subcommittee, Congressman Gene Green and Congressman
Frank Pallone, H.R. 2418 is supportive not only of the organ
transplantation programs at the LSU Health Sciences Centers in New
Orleans and Shreveport, but also of most other medical centers across
the country. For example, the bill specifies that functions
``scientific, clinical or medical in nature'' are within the ``sole
discretion'' of the Organ Procurement and Transplantation Network
(OPTN). Further, it restricts the Secretary of the Department of Health
and Human Services from using provisions in the Social Security Act to
exert broad oversight authority relative to the OPTN. These two
provisions would effectively prevent DHHS from going forward with its
OPTN Final Rule which, as I have stated, is not in the best interest of
many of our patients.
As you know, Congress, through the appropriations process, thus far
has blocked DHHS from implementing the Final Rule. However, on October
21, 1999, the current congressional moratorium will expire. My
colleagues and I feel it is imperative for the future well-being of our
patients that H.R. 2418 be considered by the appropriate authorizing
committees in Congress.
Sincerely,
John C. McDonald, M.D., Professor and Chairman
Department of Surgery, LSU Health Sciences Center-Shreveport
Philip Boudreaux, M.D., Professor of Surgery, LSUMC
Division of Transplantation, President, Louisiana Organ Procurement
Agency
cc: Louisiana Congressional Delegation
The Honorable Richard Ieyoub
Mervin L. Trail, M.D.
Bonnie J. Hymel
______
University of Medicine & Dentistry of New Jersey
Office of the Vice President
September 20, 1999
The Honorable Thomas J. Bliley, Jr.
Chairman, House Commerce Committee
2125 Rayburn House Office Building
Washington, DC 20515-0106
Dear Chairman Bliley: As Acting Chief Executive Officer of UMDNJ-
University Hospital in Newark, New Jersey, I am writing to lend my
institution's strong support to the passage of H.R. 2418, the ``Organ
Procurement and Transplantation Network Amendments of 1999.''
Introduced by Chairman Michael Bilirakis of the Health and Environment
Subcommittee and cosponsored by Congressman Frank Pallone of New
Jersey, this legislation supports the interests of New Jersey's sole
transplant program and other programs throughout the country.
Provisions contained within the bill would effectively prevent DHHS
from going forward with its OPTN Final Rule, which we strongly oppose
as it threatens the continued viability of our outstanding liver
transplant program.
As you know, the moratorium blocking DHHS from implementing the
final rule is scheduled to expire on October 21 without any measure of
compromise or consensus having been reached between the transplant
community and the Administration. We believe that a strong show of
support for H.R. 2418 in the House will send still another clear signal
to the Secretary and the Administration that the Final Rule as written
is not acceptable and that DHHS should seek to accommodate the concerns
held by most transplant centers throughout the nation.
Accordingly, I urge you to support H.R. 2418 and ask that you
encourage your colleagues to do the same.
Sincerely,
Daniel L. Marcantuono, FACHE
Acting Chief Executive Officer
______
Clarian Health
September 22, 1999
The Honorable Thomas J. Bliley, Jr.
Chairman
House Commerce Committee
2125 Rayburn House Office Building
Washington, D.C. 20515-0106
Dear Chairman Bliley: On behalf of Clarian Health Partners located
in Indianapolis, Indiana, I am writing in support of H.R. 2418, the
``Organ Procurement and Transplantation Network Amendments of 1999.''
Introduced by Chairman Michael Bilirakis of the Health and Environment
Subcommittee, along with Congressmen Gang Green and Frank Pallone, this
legislation is supportive of the interests of the organ transplantation
programs at Clarian Health Partners and at most other medical centers
across the country. For example, the bill specifies that those
functions that are ``scientific, clinical or medical in nature'' are
within the ``sole discretion' of the Organ Procurement and
Transplantation Network (OPTN). Further, it restricts the Secretary of
the Department of Health and Human Services from using provisions in
the Social Security Act to exert broad oversight authority relative to
the OPTN. These two previsions would effectively prevent DHHS from
going forward with its OPTN Final Rule, which Clarian Health and others
strongly oppose.
As you know, Congress through the appropriations process has thus
far blocked DHHS from implementing the Final Rule. However, on October
21, 1999, the current congressional moratorium will expire, and we feel
it is imperative that this legislation be afforded the opportunity to
be considered in the appropriate authorizing committees in Congress. We
believe a strong show of support for H.R. 2518 in the House will send a
clear signal to the Administration that the Final Rule is not
acceptable and that DHHS should seek to accommodate the concerns held
by most transplant centers by modifying the regulations. Accordingly, I
would urge you to support H.R. 2418, and also ask that you encourage
your colleagues to do the same.
Thank you for your consideration.
Sincerely,
Bruce M. Melchert
Vice President, Government Affairs
______
The University of Alabama at Birmingham
Office of the President
September 20, 1999
The Honorable Thomas J. Bliley, Jr.
Chairman
House Commerce Committee
2125 Rayburn House Office Building
Washington, D.C. 205OS15-0106
Dear Chairman Bliley: On behalf of the University of Alabama at
Birmingham (UAB), I am writing in support of H.R. 2418, the ``Organ
Procurement and Transplantation Network Amendments of 1999'' introduced
by your colleague Michael Bilirakis, Chairman of the Health and
Environment Subcommittee. As you know, this legislation is supportive
of the interests of the organ transplantation programs at UAB and at
most other medical centers across the country. It specifies that those
functions that are ``scientific, clinical or ethical in nature'' are
within the `sole discretion'' of the Organ Procurement and
Transplantation Network (OPTN). Further, it restricts the Secretary of
the Department of Health and Human Services from using provisions in
the Social Security Act to exert broad oversight authority relative to
the OPTN. These two provisions would effectively prevent DHHS from
going forward with its OPTN Final Rule, which we and others strongly
oppose.
As you know, Congress through the appropriations process has thus
far blocked DHHS from implementing the Final Rule. However, on October
21, 1999, the current congressional moratorium will expire, and we feel
it is imperative that this legislation be afforded the opportunity to
be considered in the appropriate authorizing committees in Congress.
Accordingly, I would urge you to lend your strong support to H.R. 2418.
In this regard, I am pleased to report that we anticipate all of the
House members from Alabama will be supportive of this important
legislation.
Sincerely,
W. Ann Reynolds
President
______
The University of Texas
Health Science Center at San Antonio
September 2, 1999
The Honorable Joe Barton
2264 Rayburn HOB
Washington, DC 20515-4306
Dear Representative Barton: I am writing to request that you become
a co-sponsor of Representative Michael Bilirakis's bill, H.R. 2418,
which relates to transplant oversight by the Secretary of Health. I
feel strongly that the government should have oversight of this
process, but should not dictate the process as is suggested in the
final rule, written by Secretary Shalala. I also feel that a dramatic
overhaul of the current system is not in the interest of patients
waiting for implantation in the United States. The current system works
well. It can be improved upon, and UNOS has been taking progressive
steps, including the recent sharing of organs, regionally for Status I
patients, which are consistently improving the system.
The recent Institute of Medicine study indicated the current system
was a good system, and suggested small changes to modify it, rather
than a traumatic change, which in my opinion would be a total disaster.
Most of Secretary Shalala's effort to change the system his been based
on the political consideration of the inequality of waiting times, and
the Institute of Medicine's study clearly concluded that waiting times
should not be a measure of transplant equity. Therefore, I urge you to
please not support the final rule, which is supported by Secretary
Shalala, and I request that you call Representative Bilirakis's office,
202-225-5735 to add your name as a cosponsor on this bill.
Best regards,
Glenn Halff, M.D.
Associate Professor of Surgery,
Director, Division of Organ Transplantation
______
Shands HealthCare
September 21, 1999
The Honorable Thomas J. Bliley, Jr.
Chairman
House Commerce Committee
2125 Rayburn House Office Building
Washington, D.C. 20515-01066
Dear Chairman Bliley: On behalf of Shands HealthCare at the
University of Florida, I am writing in support of H.R. 2418, the
``Organ Procurement and Transplantation Network Amendments of 1999.''
Introduced by Chairman Michael Bilirakis of the Health and Environment
Subcommittee, along with Congressmen Gene Green and Frank Pallone, this
legislation is supportive of the interests of the organ transplantation
programs at Shands and at most other medical centers across the
country. For example, the bill specifies that those functions that are
``scientific, clinical or medical in nature'' are within the ``sole
discretion'' of the Organ Procurement and Transplantation Network
(OPTN). Further, it restricts the Secretary of the Department of Health
and Human Services from using provisions in the Social Security Act to
exert broad oversight authority relative to the OPTN. These two
provisions would effectively prevent DHHS from going forward with its
OPTN Final Rule, which Shands and others strongly oppose.
As you know, Congress through the appropriations process has thus
far blocked DHHS from implementing the Final Rule. However, on October
21, 1999, the current congressional moratorium will expire, and we feel
it is imperative that this legislation be afforded the opportunity to
be considered in the appropriate authorizing committees in Congress. We
believe a strong show of support for H.R. 2418 in the House will send a
clear signal to the Administration that the Final Rule is not
acceptable and that DHHS should seek to accommodate the concerns held
by most implant centers by modifying the regulations. Accordingly, I
would urge you to support H.R. 2418, and also ask that you encourage
your colleagues to do the same.
Sincerely,
J. Richard Gaintner, M.D.
Chief Executive Officer
______
Saint Louis University Hospital
September 21, 1999
The Honorable Thomas J. Bliley, Jr.
Chairman
House Commerce Committee
2125 Rayburn House Office Building
Washington, D.C. 20515-0106
Dear Chairman Bliley: On behalf of Saint Louis University Hospital,
I am writing in support of H.R. 2418, the ``Organ Procurement and
Transplantation Network Amendments of 1999.'' Introduced by Chairman
Michael Bilirakis of the Health and Environment Subcommittee, along
with Congessmen Gene Green and Frank Pallone, this legislation is
supportive of the interests of the or,an transplantation programs at
Saint Louis University Hospital and at most other medical centers
across the country. For example, the bill specifies that those
functions that are ``scientific, clinical or medical in nature'' are
within the ``sole discretion'' of the Organ Procurement and
Transplantation Network (OPTN). Further, it restricts the Secretary of
the Department of Health and Human Services from using provisions in
the Social Security Act to exert broad oversight authority relative to
the OPTN. These two provisions would effectively prevent DHHS from
going forward with its OPTN Final Rule, which Saint Louis University
Hospital and others strongly oppose.
As you know, Congress through the appropriations process has thus
far blocked DHHS from implementing the Final Rule. However, on October
21, 1999, the current congressional moratorium will expire, and we fell
it is imperative that this legislation be afforded the opportunity to
be considered in the appropriate authorizing committees in Congress.
We believe a strong show of support for H.R. 2418 in the House will
send a clear signal to the Administration that the Final Rule is not
acceptable and that DHHS should seek to accommodate the concerns held
by most transplant centers by modifying the regulations. Accordingly, I
would urge you to support H.R. 2418, and also ask that you encourage
your colleagues to do the same.
Sincerely,
Jan Blomfield
Administrator for Transplant Services, Saint Louis University
Hospital
______
LifeCenter
August 6, 1999
Representative Rob Portman
United States Representative, Ohio
238 Cannon Building
Washington, DC 20515
RE: NOTA Reauthorization
Dear Representative Portman, I am the Executive Director of Ohio
Valley LifeCenter (LifeCenter). LifeCenter is the federally designated,
non-profit organ procurement organization serving the Cincinnati area.
Recently, Congressmen Bilirakis, Pallone, and Green introduced a bill
to reauthorize the National Organ Transplant Act (NOTA). I would like
to bring to your attention the importance of this bill to the Greater
Cincinnati area. As you are aware, there has been considerable focus on
the issue of organ allocation in the United States. At the heart of the
matter is who is most capable of deciding national implant policy:
those involved in the field or the federal government
The bill has several key components:
Increase organ donation.
Reaffirm that authority for transplant policy decisions and
medical/scientific judgment/decision-making reside in the
transplant community, with the government's role being one of
oversight.
Preserves the Organ Procurement Transplant Network (OPTN) as a
private entity.
Requires that administrative/procedural functions of the OPTN
be established by mutual agreement through a contract between
the OPTN and HHS.
Updates NOTA to reflect recent medical advances in the field
of transplantation.
LifeCenter fully supports this bill. I would request that you
consider being a cosponsor of this much-needed legislation.
Last year, Congress enacted a one-year moratorium on the organ
allocation regulations proposed by the Department of Health and Human
Services. This moratorium expires in October. This would be to the
detriment of those Greater Cincinnati residents awaiting a life-saving
organ transplant. The expiration of this moratorium heightens the need
for NOTA reauthorization or, at the very least, an extension of the
moratorium.
Please feel free to contact me, if I can provide additional
information or assistance.
Sincerely,
David D. Lewis
Executive Director
______
LifeCenter
August 6, 1999
Representative John A. Boehner
United States Representative, Ohio
1011 Longworth HOB
Washington, DC 20515
RE: NOTA Reauthorization
Dear Representative Boehner, I am the Executive Director of Ohio
Valley LifeCenter (LifeCenter). LifeCenter is the federally designated,
non-profit organ procurement organization serving the Cincinnati area.
Recently, Congressmen Bilirakis, Pallone, and Green introduced a bill
to reauthorize the National Organ Transplant Act (NOTA). I would like
to bring to your attention the importance of this bill to the Greater
Cincinnati area. As you are aware, there has been considerable focus on
the issue of organ allocation in the United States. At the heart of the
matter is who is most capable of deciding national implant policy:
those involved in the field or the federal government
The bill has several key components:
Increase organ donation.
Reaffirm that authority for transplant policy decisions and
medical/scientific judgment/decision-making reside in the
transplant community, with the government's role being one of
oversight.
Preserves the Organ Procurement Transplant Network (OPTN) as a
private entity.
Requires that administrative/procedural functions of the OPTN
be established by mutual agreement through a contract between
the OPTN and HHS.
Updates NOTA to reflect recent medical advances in the field
of transplantation.
LifeCenter fully supports this bill. I would request that you
consider being a cosponsor of this much-needed legislation.
Last year, Congress enacted a one-year moratorium on the organ
allocation regulations proposed by the Department of Health and Human
Services. This moratorium expires in October. This would be to the
detriment of those Greater Cincinnati residents awaiting a life-saving
organ transplant. The expiration of this moratorium heightens the need
for NOTA reauthorization or, at the very least, an extension of the
moratorium.
Please feel free to contact me, if I can provide additional
information or assistance.
Sincerely,
David D. Lewis
Executive Director
______
LifeCenter
August 6, 1999
Representative Steve Chabot
United States Representative, Ohio
129 Cannon Building
Washington, DC 20515
RE: NOTA Reauthorization
Dear Representative Chabot, I am the Executive Director of Ohio
Valley LifeCenter (LifeCenter). LifeCenter is the federally designated,
non-profit organ procurement organization serving the Cincinnati area.
Recently, Congressmen Bilirakis, Pallone, and Green introduced a bill
to reauthorize the National Organ Transplant Act (NOTA). I would like
to bring to your attention the importance of this bill to the Greater
Cincinnati area. As you are aware, there has been considerable focus on
the issue of organ allocation in the United States. At the heart of the
matter is who is most capable of deciding national implant policy:
those involved in the field or the federal government
The bill has several key components:
Increase organ donation.
Reaffirm that authority for transplant policy decisions and
medical/scientific judgment/decision-making reside in the
transplant community, with the government's role being one of
oversight.
Preserves the Organ Procurement Transplant Network (OPTN) as a
private entity.
Requires that administrative/procedural functions of the OPTN
be established by mutual agreement through a contract between
the OPTN and HHS.
Updates NOTA to reflect recent medical advances in the field
of transplantation.
LifeCenter fully supports this bill. I would request that you
consider being a cosponsor of this much-needed legislation.
Last year, Congress enacted a one-year moratorium on the organ
allocation regulations proposed by the Department of Health and Human
Services. This moratorium expires in October. This would be to the
detriment of those Greater Cincinnati residents awaiting a life-saving
organ transplant. The expiration of this moratorium heightens the need
for NOTA reauthorization or, at the very least, an extension of the
moratorium.
Please feel free to contact me, if I can provide additional
information or assistance.
Sincerely,
David D. Lewis
Executive Director
______
LifeSource
July 29, 1999
The Honorable Bill Luther
House of Representatives
Washington, DC 20510
Dear Representative Luther: On behalf of LifeSource, the Organ
Procurement Organization serving Minnesota, I am writing to ask your
support for legislation re-authorizing the National Organ Transplant
Act (NOTA). This bill, H.R. 2418, was introduced on July 1, 1999. Your
leadership in signing on as a co-sponsor of this legislation is
important in maintaining the organ procurement and transplantation
system.
The bill seeks to increase organ donation, and it reaffirms that
authority for transplant policy decisions and medical/scientific
decision-making will reside in the transplant community. This will
maintain the appropriate administrative oversight of the Department of
Health and Human Services while allowing the patients and medical
professional to develop appropriate donation and allocation policies.
The bill will also maintain the Organ Procurement and Transplantation
Network's (OPTN) status as a private entity and will update NOTA to
reflect medical advances in the field of transplantation. NOTA has not
been re-authorized since 1990.
I also anticipate that additional language will be proposed via
amendment which will address the process for designation and
certification of Organ Procurement Organizations by the Health Care
Financing Administration. LifeSource and other members of the OPO
community, supported by findings of the General Accounting Office,
believe that the current process and standards used to assess OPO
performance are flawed and should be discontinued until a new process
is developed. I am enclosing a letter to Jeffrey L. Kang, M.D., M.P.H.,
HCFA, from the Association of Organ Procurement Organizations which
further outlines OPO concerns.
We believe it is vitally important that the NOTA reauthorization
move forward at this time and encourage you to sign on as a cosponsor.
Please do not hesitate to contact me if I can provide any additional
information.
Sincerely,
Susan Gunderson
Chief Executive Officer
______
University of Florida
College of Medicine
August 11, 1999
The Honorable Karen Thurman
440 Cannon HOB
Washington DC 20515
ATTN: Jeff Cohen
RE: Institute of Medicine Report
Dear Congresswoman Thurman: I have reviewed Congressman William
Coyne's letter dated July 29, 1999 that he sent to his colleagues in
Congress regarding his interpretation of the Institute of Medicine's
(IOM) report on organ allocation. Congressman Coyne's interpretation of
the report is a rather limited one and does not, in the opinion of most
transplant professionals, truly represent the content of that report. I
thought it might be helpful to you and your staff to clarify some of
these issues.
The most important point that Congressman Coyne fails to understand
is that the IOM determined that geographic differences and waiting
times are ``not an appropriate measure of the fairness of the system.''
The claims made by the proponents of the HHS regulation are that
waiting times vary from region to region. While this is true, it
reflects the listing practices of centers in those regions and not the
availability of organs. In fact, the waiting time for liver
transplantation for all Status 1 patients is remarkably similar in
every UNOS Region across the country (two to four days). The IOM
clearly recommends that the use of waiting time as an allocation
criterion for statuses 2B and 3 be discontinued. The IOM noted that the
heavy emphasis placed on waiting times by HHS created the perception
that the system was unfair.
The IOM report does not, as Congressman Coyne states, suggest that
the Health and Human Services (HHS) regulations should be implemented.
The IOM in fact determined that the liver organ allocation system is
``reasonably effective and equitable'' and that no system will ever
function perfectly when the need for organs vastly exceeds the demands.
The IOM does suggest that sharing of livers for the Status 1 (sickest
patient) Category be done over areas consisting of approximately
9,000,000 people. This is, however, similar to the geographically based
system already in place. In fact, all of the UNOS Regions currently
share livers for this patient status category. No changes need to be
effected in order to fulfill this recommendation.
Congressman Coyne neglected to mention that the IOM found that the
institution of these regulations would increase the overall cost of
transplantation. Congressman Coyne's letter states that the IOM
concluded that the new regulations would not cause small transplant
centers to close or negatively impact access for minority populations.
The IOM was unable to come up with any firm evidence based conclusions
regarding these issues, but they did recognize that a consensus existed
in the transplant community that the implementation of these
regulations would lead to these problems.
In summary, the findings of the IOM challenge the medical basis of
the regulations suggested by the HHS. While they do endorse a note for
federal oversight, I do not believe that it is their intention that
anyone other than the medical community determine the rules for organ
allocation.
I do not believe that Congressman Coyne's interpretation of the IOM
report accurately reflects the content of that report. I hope that this
letter is helpful and I would be happy to discuss this with you at your
leisure.
Thank you for your ongoing concern regarding the organ allocation
issue.
Sincerely,
Alan Reed, MD
Associate Professor of Surgery
______
University Hospitals of Cleveland
26 August, 1999
Congressman Thomas C. Sawyer, Ohio
1414 Longworth House Office Building
Washington, DC 20515
Dear Congressman Sawyer: I am writing you to urge you to extend the
moratorium on the HHS Organ Procurement and Transplantation Network
Final Rule.
As you know Secretary Shalala and HHS have repeatedly sought to
implement rules that would effectively nationalize organ acquisition.
While effectively spun as a means to equalize access and ameliorate
regional inequities, the real purpose of the proposed rule is to
restore oligopoly in transplantation to a few centers, such as The
University of Pittsburgh, which have seen volume disappear, have
suffered financially, and which seek to repair that damage through use
of friends and lobbyists to obtain governmental relief. The citizens of
Ohio among others will see access to transplantations reduced as a
result and those without means may lose it altogether.
The Institute of Medicine was asked to provide an evaluation of
this controversial issue, and issued their report earlier this month.
Recently a letter from Secretary Shalala to Members of Congress
cast the Institute of Medicine report--a neutral assessment of the
problem--as an endorsement of her position.
It is nothing of the sort. In fact the IOM report is evenhanded. It
notes that there are no real differences in waiting limes for the
sickest liver patents--the core argument of the Secretary's position
and the casus belli of the dispute--but that there are differences
among less ill patents, and that these could be erased by establishing
catchment areas of 9 million or so. This is similar to what we have
already in Ohio, and we can live with it. But it is not an endorsement
for the very broad catchment areas necessary to afford the few HHS-
favored centers what they seek. What the Secretary wants on their
behalf is in effect a private bill.
Failure to extend the moratorium is certain to lead to a massive
export of organs, recipients and ultimately skilled professionals from
Ohio to other states. I cannot see how this pernicious policy change is
in the interest of Ohioans and I think it both unwise and unfair.
Sincerely,
D. Allan Gray, Senior Vice President and General Manager
Medical/Surgical Services, University Hospitals of Cleveland
______
Mississippi Organ Recovery Agency, Inc.
July 14, 1999
Representative Chip Pickering
427 Cannon House Office Bldg.
Washington, D.C. 20515
Re: Organ Procurement and Transplantation Network Amendments of 1999
Dear Rep. Pickering: As you are aware over the last two years there
has been much discussion of the organ allocation process and who
determines distribution of this scarce resource. Since the inception of
the Organ Procurement and Transplant Network (OPTN), the United Network
for Organ Sharing (UNOS) has been charged with overseeing allocation of
organs for transplant in the United States. UNOS has done an excellent
job over the years dealing with the very difficult task of determining
how the precious gift of life of an organ transplant should optimally
be shared to ensure maximal lives saved.
Currently Representative Michael Bilirakis (FL), Chair of the
Subcommittee on Health and the Environment of the House Commerce
Committee, is looking for cosponsors for legislation he is introducing
to ensure that efforts continue to allocate organs optimally. This
legislation will ensure that Mississippians will continue to have fair
and equitable access to transplantation. If this legislation is not
passed, many Mississippians may die of organ failure and never get the
opportunity of transplant, particularly minority Mississippians and
those in the lower socioeconomic strata.
Please support this legislation that should enable every
Mississippian in need access to transplantation.
Please call if we can be of any further service or answer any
questions.
Sincerely,
Kevin Stump,
Executive Executor
Shirley Schlessinger, M.D.
Medical Director
______
Center for Donation & Transplant
September 16, 1999
Hon. Michael R. McNulty
House of Representatives.
2161 Rayburn
Washington, DC 20515
Dear Congressman McNulty: I am writing to ask for your support in
cosponsoring the National Organ Transplant Reauthorization Bill, H.R.
2418. It is my understanding that there will be a hearing on this bill
on September 22. For additional information or to be added as a
cosponsor, the contact person in Congressman Bilirakis's office is
Michael Reilly. The phone number is 202-225-5755.
As in the past, thank you for your support.
Sincerely,
Frank Taft
Director
______
Tennessee Transplant Society
August 2, 1999
The Honorable Bill Frist
SD-567 Dirksen Senate Office Building
Washington, DC 20510-4205
Dear Senator Frist: The Tennessee Transplant Society (TTS) consists
of all seven transplant centers, all of the transplant professionals
(physicians, nurses, transplant coordinators), and all organ
procurement organizations within the state of Tennessee. At the July 26
meeting of the TTS, there was a vote taken following discussion of the
Institute of Medicine (IOM) Report and the continuing saga of the HHS
final rule regarding the allocation of organs for transplant. The IOM
report did not support the basic premise of the HHS rule, that is,
waiting times for patients needing transplant are valid measure and
should be equalized.
The Tennessee Transplant Society unanimously requests you to
cosponsor Congressman Billrakis' Bill H.R. 2418 ``Organ Procurement and
Transplantation Network Amendments of 1999.'' Additionally, if it does
not look like H.R. 2418 is gong to pass in this session of Congress, we
would strongly encourage you to support an extension of the moratorium
on the implementation of the HHS final rule (current effective date 10/
1/99) while we study the ideas brought forward in the IOM report.
Sincerely yours,
C. Wright Pinson, M.D., M.B.A.
President
______
Jacksonville Transplant Center
July 26, 1999
The Honorable Corrine Brown
2444 Rayburn House Office Building
Independence Ave. and S. Capitol St., SW
Washington, DC 20510
Dear Representative Brown: I write regarding H.R. 2418 (Organ
Procurement and Transplant Patient Network amendments of 1999), a Bill
before the House of Representatives. Since I serve patients in your
District, I encourage your support of this Bill.
H.R. 2418 allows for the general functions of day-to-day organ
donation and transplantation to continue throughout America. It
maintains the truly excellent administrative structure and self
governance of the Organ Procurement and Transplantation Network.
Important in the latter is the fact that the Board governing the
Network is inclusive not just of medical professionals, but of patients
and public members. Further, the Bill establishes a workable and
reasonable relationship of oversight between the Secretary of Health
and Human Services and the Network contractor.
Important new features of the Bill relate to access to
transplantable organs and tissues, recognition that organs and tissues
from certain animal sources may soon be applied to human disease, and
enabling sections on provision of benefits for cadaveric organ donation
should demonstration projects to increase organ donation be developed
around survivor benefits. Finally, an important aspect of the Bill is
that expenses of living organ donors be reimbursed through mechanisms
similar to other aspects of organ transplant reimbursement.
May I thank you in advance for considering support of this
important Bill which may so positively affect your constituents and my
patient.
Sincerely,
Thomas G. Peters, M.D.
Clinical Professor of Surgery, University of Florida HSCJ
______
Jacksonville Transplant Center
July 26, 1999
The Honorable Charles T. Canady
2432 Rayburn House Office Building
Independence Ave. and S. Capitol St., SW
Washington, DC 20510
Dear Representative Canady: I write regarding H.R. 2418 (Organ
Procurement and Transplant Patient Network amendments of 1999), a Bill
before the House of Representatives. Since I serve patients in your
District, I encourage your support of this Bill.
H.R. 2418 allows for the general functions of day-to-day organ
donation and transplantation to continue throughout America. It
maintains the truly excellent administrative structure and self
governance of the Organ Procurement and Transplantation Network.
Important in the latter is the fact that the Board governing the
Network is inclusive not just of medical professionals, but of patients
and public members. Further, the Bill establishes a workable and
reasonable relationship of oversight between the Secretary of Health
and Human Services and the Network contractor.
Important new features of the Bill relate to access to
transplantable organs and tissues, recognition that organs and tissues
from certain animal sources may soon be applied to human disease, and
enabling sections on provision of benefits for cadaveric organ donation
should demonstration projects to increase organ donation be developed
around survivor benefits. Finally, an important aspect of the Bill is
that expenses of living organ donors be reimbursed through mechanisms
similar to other aspects of organ transplant reimbursement.
May I thank you in advance for considering support of this
important Bill which may so positively affect your constituents and my
patient.
Sincerely,
Thomas G. Peters, M.D.
Clinical Professor of Surgery, University of Florida HSCJ
______
Jacksonville Transplant Center
July 26, 1999
The Honorable Tillie Fowler
106 Cannon House Office Building
Independence Ave. and S. Capitol St., SW
Washington, DC 20510
Dear Representative Fowler: I write regarding H.R. 2418 (Organ
Procurement and Transplant Patient Network amendments of 1999), a Bill
before the House of Representatives. Since I serve patients in your
District, I encourage your support of this Bill.
H.R. 2418 allows for the general functions of day-to-day organ
donation and transplantation to continue throughout America. It
maintains the truly excellent administrative structure and self
governance of the Organ Procurement and Transplantation Network.
Important in the latter is the fact that the Board governing the
Network is inclusive not just of medical professionals, but of patients
and public members. Further, the Bill establishes a workable and
reasonable relationship of oversight between the Secretary of Health
and Human Services and the Network contractor.
Important new features of the Bill relate to access to
transplantable organs and tissues, recognition that organs and tissues
from certain animal sources may soon be applied to human disease, and
enabling sections on provision of benefits for cadaveric organ donation
should demonstration projects to increase organ donation be developed
around survivor benefits. Finally, an important aspect of the Bill is
that expenses of living organ donors be reimbursed through mechanisms
similar to other aspects of organ transplant reimbursement.
May I thank you in advance for considering support of this
important Bill which may so positively affect your constituents and my
patient.
Sincerely,
Thomas G. Peters, M.D.
Clinical Professor of Surgery, University of Florida HSCJ
______
Jacksonville Transplant Center
July 26, 1999
The Honorable Cliff Stearns
2227 Rayburn House Office Building
Independence Ave. and S. Capitol St., SW
Washington, DC 20510
Dear Representative Stearns: I write regarding H.R. 2418 (Organ
Procurement and Transplant Patient Network amendments of 1999), a Bill
before the House of Representatives. Since I serve patients in your
District, I encourage your support of this Bill.
H.R. 2418 allows for the general functions of day-to-day organ
donation and transplantation to continue throughout America. It
maintains the truly excellent administrative structure and self
governance of the Organ Procurement and Transplantation Network.
Important in the latter is the fact that the Board governing the
Network is inclusive not just of medical professionals, but of patients
and public members. Further, the Bill establishes a workable and
reasonable relationship of oversight between the Secretary of Health
and Human Services and the Network contractor.
Important new features of the Bill relate to access to
transplantable organs and tissues, recognition that organs and tissues
from certain animal sources may soon be applied to human disease, and
enabling sections on provision of benefits for cadaveric organ donation
should demonstration projects to increase organ donation be developed
around survivor benefits. Finally, an important aspect of the Bill is
that expenses of living organ donors be reimbursed through mechanisms
similar to other aspects of organ transplant reimbursement.
In your capacity as a member of the Commerce Committee, may I ask
that you especially regard this Bill as an important step in serving
patients in need of an organ transplant. I stand ready to provide
further information or assistance to your office should that be
necessary. May I thank you in advance for positively considering H.R.
2418.
Sincerely,
Thomas G. Peters, M.D.
Clinical Professor of Surgery, University of Florida HSCJ
______
The University Hospital
September 3, 1999
The Honorable Steve Chabot
United States Representative, Ohio
129 Cannon Building
Washington, DC 20515
RE: House Bill: H.R. 2418
Dear Representative Chabot: I am the Administrator of Transplant
Services at The Health Alliance of Greater Cincinnati. Recently,
Congressmen Bilirakis, Pallone, and Green introduced House Bill H.R.
2418 to reauthorize the National Organ Transplant Act (NOTA). I would
like to bring to your attention the importance of this bill to the
Greater Cincinnati area. As you are aware, there has been considerable
focus on the issue of organ allocation in the United States. At the
heart of the matter is who is most capable of deciding national
transplant policy: those involved in the field or the federal
government?
The bill has several key components:
Increase organ donation.
Decrease disincentives for living organ donation.
Reaffirm that authority for transplant policy decisions and
medical/scientific judgment/decision-making resides in the
transplant community with the government's role being one of
oversight.
Preserves the Organ Procurement Transplant Network (OPTN) as a
private entity.
Requires that administrative/procedural functions of the OPTN
be established by mutual agreement through a contract between
the OPTN and HHS.
Updates NOTA to reflect recent medical advances in the field
of transplantation.
Last year, Congress imposed a one-year moratorium on the organ
allocation regulations proposed by the Department of Health and Human
Services. This moratorium expires October 21, 1999. Enactment of the
HHS organ allocation regulation would be detrimental to the Greater
Cincinnati residents awaiting a life-saving organ transplant. The
expiration of this moratorium heightens the need for NOTA
reauthorization or, at the very least, an extension of the moratorium.
I fully support the House Bill H.R. 2418. I am requesting that you
consider being a cosponsor of this important and critical legislation.
Please contact me for additional information or assistance at (513)
584-1811.
Sincerely,
Edward Y. Zavia, M.B.A.
Administrator, Transplant Services
______
405 Owendale Drive
Antioch, TN 37013
June 24, 1999
The Hon. Ed Bryant
408 Cannon House Office Bldg
Washington, D.C. 20515
Dear Mr. Bryant, I am writing to you today concerning important
pending legislation which will affect organ and tissue transplantation
policy in the United States for years to come. I speak from the
perspective of a donor father (both of my sons were organ donors
following tragic accidents in 1990-91) and as the spouse of a kidney
recipient in 1994. Tragically, my wife has since passed away, but I
have been so energized by her determination and courage throughout her
wait of over 25 months for an organ that I have been actively involved
in organ donation matters since that date. Specifically, I have been a
member of the national Board of Directors of Transplant Recipients
International Organization (TRIO) and also the President of the Music
City (Nashville area) TRIO local chapter. In addition, I have worked
extensively with Rotary International, the National Kidney Foundation
(NKF), Tennessee Donor Services (TDS), the Minority Organ Tissue
Transplant Education Program (MOTTEP) and several other organizations
to promote increased organ donation awareness.
I provide you with this detailed background information so that you
can understand the depth of my frustration concerning the ongoing
debate in the Congress over national transplantation policy. While
there is general agreement that the existing policies developed by the
National Organ and Transplant Act during the mid-80's are not perfect,
it is the feeling of most of the ``non-professionals'' within the
transplant community (recipients, donor families, and those currently
waiting) that the system in operation today has served us well. It has
proven to be remarkably adaptive to changing conditions as medical
advances have taken place, and has resulted in a transplantation record
that is the envy of the world. This has taken place primarily because
of the wisdom of the Congress to establish a private partnership
between the medical community and the patient population which is
independent from undue political interference by government operatives,
however well intentioned. Difficult decisions involving the allocation
of scarce organ resources have been made by this informed private
partnership, rather than by a corps of government attorneys and
bureaucrats.
I do not want to sound harsh in the above assessment, but it is
imperative that you understand that the current system has indeed
served us well, and that any improvements should be made on the margins
by legislation to strengthen, rather than dismember, the Organ
Procurement Transplant Network (OPTN). This really should not become a
partisan issue, as both sides should have an intense interest in
insulating the organ transplant process from the political whims of
whichever party is in control of the Executive Branch or the Congress.
It is critical that you insist that the current ``firewall'' be
maintained so that transplantation policies are predictable, just, and
institutionally immune from political tampering.
I would also like to address comments which have been made publicly
by those purporting to represent all transplant patients and donor
families. This is simply a myth. There are, in fact, many different
viewpoints throughout this large and diverse community. As you can
imagine, there are some who view the current system as ``unfair'' and
in need of massive government intervention, if not outright total
control. It is my experience that these folks, however vocal, are in a
distinct minority, but their opinions are nonetheless real.
What I see is a vast majority of those Americans who are interested
in transplant matters wanting the existing partnership of medical
professionals and transplant patients to remain in charge of transplant
policy. Those who argue otherwise as ``spokespersons'' for transplant
groups simply do not represent the views of the majority of their
membership. I say this with absolute certainty in the case of
Transplant Recipients International Organization (TRIO), because as a
Board member I asked repeatedly that our entire membership be polled on
this key issue, and such never happened.
When we did poll our local chapter here in Tennessee, the results
were overwhelming in support of the current non-political, private
partnership (the OPTN). [The actual vote was 131-4]. In speaking with
other TRIO chapter Presidents, I noted differing levels of support due
to local factors, but the overall fact is that there is NOT unanimity
in support of either side. Some of the other organizations which
purport to speak for the transplant community (e.g., National
Transplant Action) are simply ad hoc ``fronts'' which have been
chartered by interested parties to lobby for passage of proposed HHS
regulations which will financially favor them. The bottom line is that
no one speaks for the entire transplant community and that there are
mixed feelings about the issue throughout the U.S. I can report,
however, that the vast majority of the TRIO members to whom I have
personally spoken are opposed to government intervention and want the
existing system to have simple improvements.
There is also a fear that large transplant centers with political
clout will monopolize transplantation procedures by manipulating
proposed rules dictated by FMS personnel. Opponents may dismiss such
concerns as paranoia, but these worries are indeed genuine and have
been supported by the monopolistic track record of certain large
centers. Those of us who have had the opportunity to experience the
expertise of some of the smaller, regional transplant centers
understand first hand the excellence and talent available in many
locations throughout the country. The benefit, which I have seen
countless times, is that under the existing system families are able to
provide local support for patients who do not have to travel long
distances to receive life saving transplant operations.
As a two-time donor father I would like to comment personally on
one aspect of organ donation which is frequently misstated by
proponents of a ``national'' system. It is often stated by these people
that donor families ``do not care where organs of their loved ones
go.'' This may be correct in some cases, but I can report to you that
many of us who have been in this most difficult situation have been
acutely concerned that hope be provided first to those in need in our
local region. We do not want these precious gifts to be treated as just
some other government owned part shipped cross country to a large
center currently in favor with federal rulemakers.
Obviously there are many other issues which are associated with
this pending legislation, but I encourage you to focus on one thought:
patients do not want a working, viable process with a proven track
record to be dismembered and displaced by policies dictated by
government bureaucrats subject to political pressure. Keep
transplantation a predominantly medical issue with rules established by
the existing partnership of medical experts, patients, and donor
families.
Sincerely,
Thomas L. Meredith
______
Tennesee Donor Services
September 21, 1999
The Honorable Ed Bryant
United States Representative
408 Cannon House Office Building
Washington, DC 20515-4207
Attention: Carrie Dawson, Legislative Aide
Dear Representative Bryant: Tennessee Donor Services (TDS) is the
federally designated Organ Procurement Organization (OPO) serving the
vast majority of Tennessee. On September 22, 1999 the House Commerce
Committee will conduct hearings on H.R. 2418, the National Organ
Transplant Act (NOTA) Reauthorization Bill. The bill has a significant
number of bipartisan sponsors,
Last year, Congress extended a moratorium on the implementation of
a federal rule that would have had a serious negative impact on the
centers and patients we serve. This moratorium is set to expire October
21, 1999. On behalf of transplant centers, transplant physicians, donor
families, and recipients that we serve, I request your support and urge
you to cosponsor H.R. 2418, ``Organ Procurement and Transplantation
Network Amendments of 1999.''
H.R. 2418 protects the integrity of organ procurement organizations
and transplant centers all across the country. It reiterates the
original intent of the National Organ Transplant Act of 1984 which was
to create a national system that promotes and supports a central
network in the private sector serving all of the citizens of the United
States,
H.R. 2418 is unanimously supported by all Tennessee OPOs and ten
transplant centers. In the area served by TDS, H.R. 2418 has the
support of Vanderbilt University Medical Center, St. Thomas Hospital,
Centennial Medical Center/Parkview, UT Medical Center, Johnson City
Medical Center and Erlanger. H.R. 2418 is also unanimously supported by
Mid-South Transplant Foundation and its affiliated centers.
We also encourage you to send a letter to the Secretary of HHS
asking that the final rule be withdrawn in the meantime. If the
Secretary fails to do so, we urge you to extend the moratorium until
such time as a solution in the best interests of the patients we serve
can be achieved.
Please contact Michael Reilly with Congressman Bilirakis' office at
(202) 225-5755 to be added as a cosponsor, I thank you for your support
of H.R. 2418. You may contact me at (615) 327-2247, if you have any
questions or need additional information.
Sincerely,
Lawrence D. Cochran
Executive Director
______
University of Illinois at Chicago
Chicago, Illinois
The Honorable Diana DeGette
1339 Longworth Building
U.S. House of Representatives
Washington, DC 20515-0601
Dear Congresswoman DeGette: Thank you for your letter requesting
additional information in connection with the testimony I gave recently
at a hearing of the Subcommittee on Health and the Environment relating
to organ procurement and transplantation. I apologize for not getting
back to you sooner; however, I have moved offices and mail has been
delayed in reaching me.
You asked several questions relating to liver transplantation for
pediatric patients, particularly in response to recent studies done by
researchers at Pittsburgh Children's Hospital and the Medical
University of South Carolina. Those studies apparently raised questions
whether pediatric patients are receiving appropriate access to donated
livers.
The Institute of Medicine Committee that prepared the report
``Organ Procurement and Transplantation'' was not specifically
requested to investigate the issue of pediatric patients' access to
transplantation and we did not do so. We did not have copies of the
research you cite and I have not read them. Some of our analysis of
transplant waiting times and mortality does, however, bear on one of
the points raised in your letter and I am happy to share that with you.
According to your letter, the research studies you cited found that
children are ``55% more likely to die waiting for an organ transplant
than adults.'' (Presumably this refers to liver transplants.) Our
analysis yielded somewhat different conclusions. Although the most
severely ill (status 1) children, aged 0-5, had a significantly lower
rate of transplantation than status 1 adults, they also had a lower
rate of pretransplant mortality. This finding suggests young children
in status 1 are capable of living longer than adults in this status as
they wait on the list. Less severely ill (status 2B) children (aged 0-
5) actually had a higher rate of transplantation than status 2B adults
and the least severely ill (status 3) children in all ages (aged 0-17)
had transplantation rates that were significantly higher than adults.
In both of these status groups, there was no difference between
children and adults in their pretransplant mortality rates. In
addition, age was not a significant determinant of post-transplantation
mortality.
There could be a variety of reasons why our findings differ from
those cited in your letter, but without having read those studies I
cannot pinpoint what they might be. The time period covered by the
data, the comprehensiveness of the data, and whether patients were
classified by severity of illness would be some of the things to look
at. Our analysis reflects the experience of all liver transplant
patients who were on waiting lists anywhere in the nation from the
start of 1998 through the first quarter of 1999 and we stratified these
patients by severity of illness (status level).
Finally, I would note that the recommendation of the IOM Committee
that donated livers be allocated over larger populations would appear
to improve the likelihood that a suitable organ would be found for a
child awaiting a transplant. Furthermore, the Committee's
recommendation to eliminate waiting time as a criterion for allocating
organs to status 2B and status 3 patients and to substitute more
medically relevant criteria to bring about a better match (e.g.
pediatric versus adult) would also appear to benefit children.
I hope this information is useful to you in your review of this
important issue.
Sincerely,
Robert D. Gibbons, Professor of Biostatistics
University of Illinois at Chicago
IOM Organ Procurement and Transplantation Committee Member
cc: The Honorable Michael Bilirakis
______
Responses of William F. Raub, Deputy Assistant Secretary for Planning
and Evaluation/Science Policy, Department of Health and Human Services,
to Questions of Hon. Diana DeGette
Question: Recent studies by researchers at Pittsburgh Children's
Hospital and the Medical University of South Carolina reveal some
rather disturbing trends with respect to pediatric transplantation. The
studies indicate that: Two-thirds of liver donations by children go to
adults; and Pediatric liver donations have increased through the
1990's. And yet--The number of children who received a donated liver
from another child decreased dramatically from 1990 to 1996; and,
Children are 55% more likely to die while waiting for an organ
transplant than adults.
According to American Medical News, ``Europe has virtually
eliminated deaths of children while on liver waiting lists by giving
them priority over adults for pediatric organs . . .''
The Administration's Final Rule, H.R. 2418, and the IOM report all
fail to directly address this issue.
To all the members of the panel, what are we as a nation doing to
address this growing and unacceptable problem for children in need of
organ transplantations and what additional steps need to be taken to
reduce pediatric mortality rates?
Response: The current liver allocation conventions of the Organ
Procurement and Transplantation Network (OPTN) give priority to
children 18 years of age and under, who account for 10 percent of
transplant candidates. The 1998 HHS regulation made clear that the
Department intended the OPTN to address the special needs of children
as it developed fairer allocation policies:
``. . . current OPTN policies take into account the special
medical needs of children. The Secretary endorses this approach
and expects that the OPTN will continue to take these needs
into account as it develops new medical criteria and allocation
policies.'' (63 FR 16315; also discussed at 63 FR 16304)
The recent amendments to that regulation reaffirm this intention:
``The Department wishes to emphasize, however, that these
changes are not intended to limit the ability of the OPTN to
address special situations such as the unique needs of young
children.'' (64 FR 56657)
Based on the OPTN's actions, the guidance provided in the HHS
regulations, and our expectations for continued improvement in split-
liver techniques (whereby an adult donor liver that is too large for a
child can be divided surgically to transplant two individuals in need
of a smaller liver), the Department is optimistic that children will
have a growing new source of opportunities for transplantation.
Children have the following outcomes under current OPTN liver
allocation policies: they receive liver transplants at a higher rate
(60%) than do adults (45%); their survival at one year with or without
transplant (21%) is similar to all other age groups; and they die
awaiting a transplant at a slightly lower rate (12.5%) than do adults
on the waiting lists (14%).
Despite these generally favorable data, room remains for
improvement. The Department--through its efforts to increase organ
donation generally (its National Organ and Tissue Donor Initiative),
its research to improve transplantation procedures, and its oversight
of the OPTN--will continue to strive to meet the needs of children 18
years of age and under who are candidates for liver or other organ
transplantation. The Department intends to highlight this issue as it
seeks comments from the public and advice from the Advisory Committee
on Organ Transplantation on new allocation policies developed in
response to the amended HHS regulation.