[Senate Hearing 105-700]
[From the U.S. Government Publishing Office]
S. Hrg. 105-700
ORGAN DONATIONS
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HEARINGS
before a
SUBCOMMITTEE OF THE
COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE
ONE HUNDRED FIFTH CONGRESS
SECOND SESSION
__________
SPECIAL HEARINGS
__________
SEPTEMBER 10, 1998--WASHINGTON, DC
SEPTEMBER 12, 1998--SCRANTON, PA
__________
Printed for the use of the Committee on Appropriations
Available via the World Wide Web: http://www.access.gpo.gov/congress/
senate
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COMMITTEE ON APPROPRIATIONS
TED STEVENS, Alaska, Chairman
THAD COCHRAN, Mississippi ROBERT C. BYRD, West Virginia
ARLEN SPECTER, Pennsylvania DANIEL K. INOUYE, Hawaii
PETE V. DOMENICI, New Mexico ERNEST F. HOLLINGS, South Carolina
CHRISTOPHER S. BOND, Missouri PATRICK J. LEAHY, Vermont
SLADE GORTON, Washington DALE BUMPERS, Arkansas
MITCH McCONNELL, Kentucky FRANK R. LAUTENBERG, New Jersey
CONRAD BURNS, Montana TOM HARKIN, Iowa
RICHARD C. SHELBY, Alabama BARBARA A. MIKULSKI, Maryland
JUDD GREGG, New Hampshire HARRY REID, Nevada
ROBERT F. BENNETT, Utah HERB KOHL, Wisconsin
BEN NIGHTHORSE CAMPBELL, Colorado PATTY MURRAY, Washington
LARRY CRAIG, Idaho BYRON DORGAN, North Dakota
LAUCH FAIRCLOTH, North Carolina BARBARA BOXER, California
KAY BAILEY HUTCHISON, Texas
Steven J. Cortese, Staff Director
Lisa Sutherland, Deputy Staff Director
James H. English, Minority Staff Director
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Subcommittee on Departments of Labor, Health and Human Services, and
Education, and Related Agencies
ARLEN SPECTER, Pennsylvania, Chairman
THAD COCHRAN, Mississippi TOM HARKIN, Iowa
SLADE GORTON, Washington ERNEST F. HOLLINGS, South Carolina
CHRISTOPHER S. BOND, Missouri DANIEL K. INOUYE, Hawaii
JUDD GREGG, New Hampshire DALE BUMPERS, Arkansas
LAUCH FAIRCLOTH, North Carolina HARRY REID, Nevada
LARRY E. CRAIG, Idaho HERB KOHL, Wisconsin
KAY BAILEY HUTCHISON, Texas PATTY MURRAY, Washington
TED STEVENS, Alaska ROBERT C. BYRD, West Virginia
(Ex officio) (Ex officio)
Majority Professional Staff
Bettilou Taylor
Mary Dietrich
Minority Professional Staff
Marsha Simon
Administrative Support
Jim Sourwine and Jennifer Stiefel
C O N T E N T S
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Page
Thursday, September 10, 1998
Opening remarks of Senator Arlen Spector......................... 1
Prepared statement........................................... 1
Prepared statement of Senator Wendell Ford....................... 2
Prepared statement of Senator J. Robert Kerrey................... 3
Prepared statement of Representative Ron Klink................... 4
Opening remarks of Senator Rick Santorum......................... 5
Division of opinion.............................................. 7
Statement of Donna Shalala, Secretary of Health and Human
Services, Office of the Secretary, Department of Health and
Human Services................................................. 7
Prepared statement........................................... 10
Remarks of Senator Robert Torricelli............................. 15
Prepared statement........................................... 16
Nationwide distribution of organs................................ 17
Statement of Ronald W. Busuttil, M.D., president-elect, American
Society of Transplant Surgeons................................. 20
Prepared statement........................................... 22
Statement of Craig J. Irwin, president, National Transplant
Action Committee............................................... 26
Prepared statement........................................... 27
Statement of Charles M. Miller, M.D., director, Recanati-Miller
Transplant Institute........................................... 31
Prepared statement........................................... 33
Statement of Dr. William W. Pfaff, president, United Network for
Organ Sharing.................................................. 35
Prepared statement........................................... 36
Sickest patients................................................. 37
Remarks of Senator Lauch Faircloth............................... 39
Prepared statement........................................... 39
Remarks of Senator Patty Murray.................................. 40
Prepared statement........................................... 41
National system.................................................. 42
Additional committee questions................................... 43
Questions submitted by Senator Specter........................... 43
Responses of Dr. Charles M. Miller........................... 43
Responses of Dr. William W. Pfaff............................ 45
Material Submitted Subsequent to Conclusion of Hearing
Prepared statement of the University of Pittsburgh Medical Center 57
Prepared statement of Howard M. Nathan, executive director,
Delaware Valley Transplant Program............................. 60
Prepared statement of Alan P. Brownstein, MPH, president and
chief executive officer, American Liver Foundation............. 61
Prepared statement of Joseph L. Brand, chairman, National Kidney
Foundation..................................................... 64
Prepared statement of John H. Fitch, director of government
relations, National Funeral Directors Association.............. 65
Prepared statement of the Patient Access to Transplantation
Coalition...................................................... 66
Letter from Senator Daniel K. Inouye and Senator Daniel K. Akaka. 70
Saturday, September 12, 1998
Opening remarks of Senator Specter............................... 71
Statement of Hon. Robert P. Casey, former Governor of the
Commonwealth of Pennsylvania................................... 72
Organ donor families............................................. 77
Tissue........................................................... 78
Statement of Robert Solfanelli, heart and lung transplant
recipient...................................................... 82
Standardized medical criteria.................................... 83
Prepared statement of Robert Solfanelli.......................... 85
Heart and lung transplant........................................ 87
Travel costs..................................................... 89
Prepared statement of Elmeretta B. Lecrone, heart transplant
recipient...................................................... 89
Other transplant beneficiaries................................... 90
Statement of Valarie Reiley, Harrisburg, PA, liver transplant
recipient...................................................... 91
Statement of Diane Zapolski, Brooklyn, PA, liver transplant
recipient...................................................... 91
Statement of Mary Angeli, Old Forge, PA, liver transplant
recipient...................................................... 92
ORGAN DONATIONS
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THURSDAY, SEPTEMBER 10, 1998
U.S. Senate,
Subcommittee on Labor, Health and Human
Services, and Education, and Related Agencies,
Committee on Appropriations,
Washington, DC.
The subcommittee met at 10 a.m., in room SD-138, Dirksen
Senate Office Building, Hon. Arlen Specter (chairman)
presiding.
Present: Senators Specter, Faircloth, and Murray.
Also present: Senators Santorum and Torricelli.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
STATEMENT OF DONNA SHALALA, SECRETARY OF HEALTH AND
HUMAN SERVICES
OPENING REMARKS OF SENATOR ARLEN SPECTER
Senator Specter. Good morning, ladies and gentlemen. It is
precisely 10 o'clock, and we will begin this hearing of the
Subcommittee on Labor, Health and Human Services, and Education
of the Appropriations Committee.
Without objection, since I am the only Senator here, except
for our witness, my full statement will be placed in the
record. We have a very tight timetable and have to be concluded
by 11 o'clock.
Our subject matter today is the issue of organ transplants,
and we are dealing here with a regulation issued by the
Department of Health and Human Services, which would
essentially establish priority based on need without regard to
geography.
prepared statement
We have a provision in the House of Representatives
Appropriation Committee report--it has not reached the House
floor yet--which would delay that for a year. The subcommittee,
which was marked up in the full committee on the Senate side,
has no such limitations.
[The statement follows:]
Prepared Statement of Senator Arlen Specter
The subcommittee will come to order. Today the Labor-HHS
subcommittee convenes this special hearing to discuss the
proposal by the Department of Health and Human Services to
change the prioritization system that determines which patients
on a waiting list would receive a donated organ.
This has been an important issue on this bill. The House
included language in the fiscal year 1998 supplemental bill to
delay implementation of these changes until October 1, 1998. In
their version of the fiscal year 1999 Labor-HHS appropriations
bill, the House included language to further delay the changes
until November 1, 1999.
Because of a chronic shortage of available organs, these
decisions are critical to those who may have only days or even
hours to live unless an organ is found, as well as to those who
suffer from a chronic but no less debilitating illness. It has
been estimated that 57,000 people are on an organ donor waiting
list somewhere in this country and that 500 new patients are
added to the lists each month. In contrast there were only
5,400 donors in 1996.
Managing a shortage of this magnitude causes great anxiety
among patients, their families, and their doctors. It is a
zero-sum situation--giving to one takes away from another. A
central answer to this dilemma is to increase the numbers of
individuals who choose to be a donor. Because of the urgency to
increase donations, the Senate version of the appropriations
bill triples funding for organ donation activities from $2.8
million last year to $10 million. That more than doubles the
administration's budget request for this program.
In the meantime, Secretary Shalala has the difficult task
of proposing a fair method to deal with the shortage. This
hearing will examine the underlying reasons and assumptions of
the proposal and its implications for patients and their
families.
Today we will have two panels, the first one with Donna
Shalala, distinguished Secretary of the Department of Health
and Human Services. The second panel includes: Mr. Craig Irwin
of the National Transplant Action Committee, Dr. Charles Miller
of the Mount Sinai Medical Center, Dr. Ronald Busuttil of the
American Society of Transplant Surgeons, and Dr. William Pfaff
of the United Network for Organ Sharing.
The subcommittee will also be holding a field hearing on
this topic in Scranton, Pennsylvania this Saturday. We will
have former Governor Bob Casey, a transplant recipient himself,
and two other patients as witnesses who can testify in personal
terms about waiting for a donated organ.
Before Secretary Shalala begins her opening statement, the
subcommittee will hear brief statements from Senator Robert
Torricelli of New Jersey and Congressman Ron Klink from
Pittsburgh.
Senator Torricelli, you may begin.
To ensure that we have sufficient time for questions and
answers, we ask that each witness limit their opening remarks
to 5 minutes. Your full statement will be included in their
entirety in the appropriate place in the record.
additional prepared statements
Senator Specter. Senator Ford, Senator Kerrey, and
Congressman Klink were unable to attend the hearing today, they
have submitted statements which we will insert into the record
at this point.
[The statements follow:]
Prepared Statement of Senator Wendell Ford
Let me begin by thanking you for the opportunity to express
the Kentucky transplants community's concerns in today's
hearing. I know that everyone here is equally concerned with
assuring that liver transplant patients are treated with
fairness and dignity.
Unfortunately, today's hearing and the motivation behind
the hearing have sent up a red flag in much of the transplant
community. With good reason, they are concerned this hearing
will add fuel to an emotional issue drawing attention away from
what should be everyone's main concern--patients. A battle
between HHS and Congress over who ultimately decides transplant
policy places patients and the UNOS process in jeopardy.
Many of us are very concerned that in an effort to review
policy and nationalize the organ allocation system, HHS will
decrease the access to transplant centers around the country.
I certainly understand the position of larger centers who
have seen their performance levels drop. But their drop in
numbers has a positive side to it. It means that medium and
smaller transplant centers across the country have developed
the knowledge and expertise to treat the medically underserved
in their area.
In fact, that change has made a tremendous impact on states
like my own. Only 13 Kentuckians underwent liver
transplantation in 1988 as compared to 38 performed through
August of this year. This represents nearly a 300-percent
increase. Yet, it does not represent either a population
explosion or a sudden increase in the incidence of liver
disease. We've saved more Kentucky lives because of the
increased accessibility to transplant centers located in the
Commonwealth as well as the centers' own efforts to increase
organ donations. The Commonwealth is proof of the success of
local primacy in organ donations and allocation.
Most of the patients undergoing transplantation at our
local centers are indigent. They do not have the means nor the
ability to travel with their families to a large metropolitan
area. This is compounded by the fact that transplantation often
requires spending months at the location before and after
transplantation. Increasing the number of transplant centers
has removed what were once daunting obstacles for many
patients.
HHS's recent proposal will have a far reaching effect on
the organ program in this country. It's imperative that HHS
recognize and listen to the transplant community before a
national organ allocation policy is established.
I have heard from many of my constituents including Cheryl
Geiger, a transplant patient, who wrote: ``* * * how are
patients and their families supposed to pay for the costs
associated with having to travel to a transplant center in
another state? This policy change favors the wealthy. People
who cannot afford to travel to distant transplant centers will
end up foregoing the opportunity.'' She is not alone, Alice
Melkovitz was listed 3 times at a Pittsburgh facility, but was
sent home because of problems with her insurance.
In a recent letter to Members and again in her statements
during the Joint Congressional hearing on June 18th, Secretary
Shalala stated, ``the medium waiting times for the two major
liver transplant centers in Kentucky were vastly different--38
days at one center, 226 at the other.'' According to the
University of Kentucky Medical Center this information is
outdated and incorrect. Recent statistics indicate that the
waiting time between the two programs is two days; 154 days in
one and 156 days in the other.
Secretary Shalala has yet to respond to my letter disputing
her comments. But it is my strong belief that inaccurate
information makes it difficult to determine what impact the HHS
regulation will have on smaller and medium transplant centers.
By all means review. But don't jeopardize a system that has
grown over the past 10 years into a generally successful,
responsive and most importantly, equitable service for
thousands of Americans.
I believe Secretary Shalala has done an excellent job in
leading HHS. However, I do not believe there is justification
for changing the organ allocation policy. Everyone in the
transplant community has a common goal--to save lives. Our top
priority should be to increase the number of organ donations.
To do that, we need to be sure any policy changes and tinkering
with the system doesn't end up having a negative impact on this
shared goal.
In closing, let me say that until we have as many organ
donors as we have needs, the system will not be perfect. But
regardless of how good HHS's intentions might be, preemptive
federal action may have the undesirable effect of not only
undermining UNOS efforts on behalf of liver transplantations,
but for other types of organs as well.
Thank you.
------
Prepared Statement of Senator J. Robert Kerrey
Mr. Chairman, I welcome the opportunity to share my views
on organ allocation. I am pleased that this Committee is
contributing to public debate on this important issue.
It is obvious to me that our current organ allocation
system does not work. Our transplant centers have established
an enviable list of success stories, but the approximately
4,000 people who die each year waiting for an available organ
are not able to share in this success. I am particularly
troubled by the geographic disparities in waiting times, which
range from five months to twenty-eight months for white liver
recipients. This variation means that whether you live or die
can be determined by where you live, or where you list, not by
your medical need or your prospects for a successful
transplant.
Transplant recipients are our children, our neighbors and
our friends. I want to briefly share two Nebraska transplant
stories with you--one long-delayed success, and one tragic
death.
First, Shante Smith is a four-year-old Nebraskan who loves
to dance and eat pizza and onion rings. She has also had two
small bowel transplants at the University of Nebraska Medical
Center. Between her two transplants, Shante waited a total of
634 days for a small bowel donor. She is now recovering after
her latest transplant.
Next, I want to highlight Justin Parker, an Illinois baby
who died at UNMC while waiting for a liver and small bowel
transplant. Justin's irreversible liver damage was a
complication of other health problems he encountered early in
life. Last December, when he was 17 months old, he was
classified as a Status 1 patient. From December through April,
Justin was ``re-extended'' as a Status 1 patient seventeen
times; although these high-priority patients supposedly receive
a transplant in two to six days, Justin spent 133 days as a
Status 1 candidate. He died two months ago, still waiting for a
liver--and we know that during his wait, less-critically ill
patients received livers instead of Justin because they waited
closer to a donor.
We all know that patients must wait for organs, in part,
because demand exceeds supply. But this scarcity demands that
we develop allocation policies that ensure the fair and
efficient distribution of organs to patients whose lives depend
on a transplant.
To be clear, I support the Secretary's regulations. These
regulations are a positive step towards ensuring that all
patients, regardless of where they live, have the best possible
chance of getting the care they need and deserve. The
Department of Health and Human Services has struck an
appropriate balance between governmental leadership and the
transplant community's technical expertise. The regulations
articulate broad performance goals and empower UNOS to
establish the specific policies and medical criteria necessary
to achieve these goals. If UNOS meets these goals--developing
standard criteria for listing patients and determining medical
status, as well as creating allocation policies that give
priority to the most urgent medical needs--we will have made
enormous progress towards a more equitable allocation system.
We can and must improve the availability and accessibility
of transplant services for all Americans--and these regulations
establish the firm foundation we need to achieve these goals.
Thank you.
------
Prepared Statement of Representative Ron Klink
I applaud the new regulation to fix the problems with the
current system for organ sharing and urge the members of this
committee to let it be implemented because it will save lives.
Regrettably, there has been more misinformation than
information about what this regulation actually says. Let me
outline why I think it should be implemented immediately.
Organ sharing is a matter of life and death. The problem is
that every year people die unnecessarily because the current
organ allocation system is broken. We can do better and I urge
you to not let parochial interests get in the way of fixing the
problem.
Whether or not you get the organ that will save your life
should not depend on where you live. Organs do not and should
not belong to any geographical or politick entity. 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 waiting for a
transplant.
The most difficult organ to transplant is the liver.
Pioneered at the University of Pittsburgh, upwards of 90
percent of all the liver transplant surgeons today were either
trained at Pittsburgh or by doctors who were trained there. Yet
facilities like Pittsburgh, Mt. Sinai, Cedars-Sinai, and
Stanford and other highly regarded transplant centers which
take on the most difficult and riskiest transplant patients are
struggling with the longest waiting times in the country.
While these centers are highly regarded, many of their
patients do not come to them because of their reputations. The
fact is that many of their patients only seek them out after
having been turned down by their local transplant centers.
There is 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 reputations should they not be successful.
Currently there are patients from at least 31 states
awaiting organs at the University of Pittsburgh, all of whom
are dependent on an organ becoming available in Western
Pennsylvania or West Virginia. Is it any wonder that our
waiting lists are longer than almost anywhere else in the
country. Obviously, this is not an issue that impacts people in
one particular geographical region, but it affects everyone who
is waiting for an organ no matter what state or congressional
district they come from.
This isn't right. Whether you live or die should not depend
on where you live.
This debate is not about pitting big transplant centers
against small ones, or about pitting one region against
another. It is about making sure that the gift of life goes to
the person who needs it the most rather than someone who
happens to have the good fortune to live in the right state,
county, or city. Its about helping at least 300 people each
year to continue to live.
The fact is that the current system discriminates against
people who live near the highly regarded centers with the
longer waiting lists. It's not their fault that their local
center is willing to take the harder and sicker patients when
other centers avoid the sicker patients in favor of patients
who may be still able to work, go to school, or even play golf
while patients elsewhere are near death without any opportunity
to receive that organ because they have the misfortune of being
on the wrong side of the Pennsylvania-Ohio line.
The worst thing about this whole debate is that the
organization that is under contract with the Department of
Health and Human Services (HHS) to run the national organ
procurement transplant network, the United Network for Organ
Sharing (UNOS), is the biggest opponent of any change. Sadly,
UNOS is spending upwards of $1 million of patient fees to lobby
against HHS making the system more fair.
All HHS wants to do is: (1) require UNOS to develop
policies that would standardize its criteria for listing
patients and for determining their medical status, and (2)
ensure that medical urgency, not geography, is the main
determinant for allocating organs.
HHS should be allowed to proceed. The longer we delay the
more lives are at risk. In this day of modern air travel and
communications there is no good reason for an organ to stop at
the border. There is no good reason why if I passed away while
attending the Superbowl in New Orleans that my liver should go
to a golfer in Louisiana when I may have a loved one who is in
desperate need of a transplant at home.
People are dying because they happen to live in the wrong
ZIP Code and because States do not want to share their organs.
Nowhere else in society would we allow a monopoly like this to
continue. We must put an end to this craziness. There is no
room in this country for politics to affect who lives and who
dies. The patients who need the organs the most should get
them. Period.
opening remarks of senator rick santorum
Senator Specter. We have my distinguished colleague,
Senator Santorum here. And I thank you for promptness, Senator
Santorum, and the floor is yours.
Senator Santorum. I thank you, my dear colleague from
Pennsylvania, and congratulate you on holding this hearing on
what I think is really one of the most important issues that we
can deal with here, an issue of life and death and an issue
that we have to deal with. It is under our purview.
We set out the statute in the first place as to how this
allocation system would work, we have taken on that
responsibility, and now we have to, I think, carry forward in
making sure that the public trust is kept.
I would just say, the reason we are having the hearing and
the reason that these regulations are necessary is simply
because of one simple fact, we do not have enough organs that
are being donated.
And so anything that this subcommittee can do and the
Congress can do to further publicize the need for organ
donation, to encourage organ donation, to make it a much more
acceptable practice I think is very, very important. And I
would commend to you and to your staff whatever has been done
on States levels.
I know lots of States have done some things. I am an organ
donor. I have a Pennsylvania driver's license. Right under my
picture there, it says organ donor. We do that in Pennsylvania.
I know other States have done it.
It is important that we continue to try to publicize as
much as possible the need for organs and make it politically
desirable, politically correct, if you will, or politically
incorrect not to be an organ donor. And to the extent----
Senator Specter. We are joined by the distinguished
Secretary of Health and Human Services.
Madame Secretary, if you would come up and sit next to
Senator Santorum, we welcome you here.
Senator Santorum. That is the first issue. Second, as the
Senator from Pennsylvania knows, Pennsylvania has 14 transplant
hospitals. It is not an easy issue for us in Pennsylvania.
There are large centers and there are small hospitals that do
this, and they are on both sides of this issue.
So I come to this not as someone who is trying to represent
a parochial interest in Pennsylvania, but someone who is trying
to do what I believe is best for patients. And I believe what
is best for patients is to allocate organs to the patients who
can best utilize those organs, who are in the greatest need,
irrespective of where they live.
I can tell you, as I said, I am an organ donor. And when I
die, I do not care if my organs go to people in Pittsburgh or
they go to people in Pennsylvania. I hope they go to someone
who can use them best, who needs them the most.
And I think that is the way most Americans feel, and I
think that is the way most organ donors feel. I think to have a
different kind of approach--frankly, I know several States have
taken the position--and Louisiana is one of them, and I know
Mr. Livingston is from Louisiana and he is representing the
views, at least, of his States legislature and Governor. But
the idea of States protections is as parochial and as
distasteful an action as I can possibly think. If in fact they
really cared about the people in Louisiana or States like
Wisconsin or others who have done so, or States like New Jersey
that are considering them, then they should pass a law that
says that organs should go to people who are Louisiana
residents.
But they do not do that. They pass a law that says an organ
has to stay within the States, whether the recipient is a
Louisiana resident or not.
If you look at the State of New Jersey, two-thirds of the
people in New Jersey who have organ transplants do not have
them in New Jersey. Yet if they pass a law that says they have
to keep the organs in New Jersey, two-thirds of the people in
New Jersey who get organ transplants will not get organs from
their own States, because they are having most of these done in
New York and Pennsylvania.
So if these are truly humanitarian efforts on the parts of
the States to take care of people within their borders, then
they would have very different laws. But the laws are passed to
protect economic interests within their States. And let us be
very clear about it. They protect hospitals and doctors and
practices for those particular reasons, for economic purposes.
We should not be allocating organs for economic purposes.
We should do it because we care about the lives of patients who
are in need of these organs.
The final point I would like to make is, there is a lot of
debate, and will be a lot of debate, over the next several
weeks on a bill that I know the Secretary and I disagree on, on
the issue of HMO's. We need to maximize patient choice and
quality and access. And a lot will be made as to all these
restrictions on people being able to choose their doctor or go
and get the procedure they need.
And yet the very same people who argue against the HMO's
and against the procedures they use will argue that we should
limit people's choices of what hospital they go to to get the
transplant that they believe they need from the people who they
think are the best to do it.
I come from Pittsburgh, where the waiting time is 800 days,
800 days, well over twice the national average. To limit
people's choices of what center they go to, where they believe
their best chance of survival is, to limit their choices,
because of the limitation on the organs going to that center,
is arguing against everything that they argue for in their HMO
protection bill.
So if they are going to argue patient choice, patient
quality, patient access, then be consistent when it comes to
the area of transplants. And they are not. And I hope that this
committee and the Senate will resist the efforts to place a
moratorium on these regulations.
They are sound regulations. They are balanced regulations.
And they are first and foremost on behalf of the patients and
the patients' interests in this country.
Thank you.
division of opinion
Senator Specter. Thank you very much, Senator Santorum. You
accurately state the division of opinion in your State, my
State, Pennsylvania, where we have hospitals and constituents
on both sides of this issue. And I concur with your views and
the views of the secretary, that this ought to be a medical
decision and not one governed by economics or regionalism.
summary statement of hon. donna shalala
Senator Specter. Well, we are pleased to have the
distinguished Secretary of Health and Human Services, Secretary
Shalala, to testify on this issue. This is a matter that the
Secretary and I have discussed on a number of occasions. And
what we need to do now is to focus the considerations and the
arguments to see if we cannot come to a conclusion, proper
conclusion, with our colleagues on the House side.
And we welcome you here, Madam Secretary.
Secretary Shalala. Thank you very much, Senator Specter,
Mr. Chairman.
And let me associate myself with Senator Santorum's
comments about this rule. I appreciate having the opportunity
to be here today. As the leadership of our authorizing and
Appropriations Committee requested, we have worked very hard to
clarify the goals and the responsibilities of both the
department, as well as the transplant community and understand
what responsibilities that the Congress of the United States
gave us.
We believe that it is essential that we now go forward so
that the doctors and the patients in the transplant community
can establish equitable policies that are based on sound
medical criteria. And I think that is the point of the rule
that the Department has put forward, that these decisions ought
to be in the hands of doctors and patients.
I do not think I have ever testified on a subject so
suggestive of lessons from biblical teaching or mythology,
lessons that tell how humanity is given a great gift and learns
to use that gift wisely for the benefit of all or loses the
gift when jealously and self-dealing replace equity and
fairness.
In the case of the gift of life provided by organ
transplantation, the lessons of the Bible are indeed important.
We are witnessing States trying to withhold organs from other
States. We are seeing transplant centers hiring lobbyists to
influence Federal policy as part of a competition for scarce
organs. Patients are pitted against patients.
I remind you that self-interest, exemplified by buying and
selling of organs, is what led the Congress to the passage of
the National Organ Transplant Act in the first place. The act
now requires the Organ Procurement and Transplant Network
[OPTN], to assist organ procurement organizations in the
nationwide distribution of organs equitably among transplant
patients.
The network's primary goal is to make sure that Americans
who need an organ have an equal opportunity to receive one,
consistent with sound medical judgment and without regard to
who they are or where they are listed.
I emphasize this last point, because, as I will explain in
a moment, I have a deep concern that people are dying in this
country not because they lacked health insurance or access to
care, but simply because of where they list.
We believe that medical necessity, not geography, should be
the No. 1 criterion for who receives organs for
transplantation. And we believe that most Americans would be
shocked to find out that under our current system, if they or a
loved one needs a transplant, that they could lose out to a
less sick patient just across the State line.
Patients in some parts of the country can wait as much as
five times longer than patients in other parts of the country
who have the same severity of illness. Less ill patients
receive transplants, while more severely ill patients, perhaps
only a few miles away, die.
We need a level playing field so that the same medical
criteria are used for all patients, so that organs are
allocated according to medical need. And that is why we issued
our April 2 rule.
It calls on the OPTN and our contractor, the United Network
for Organ Sharing [UNOS], which operates the network, to
develop allocation policies that will reduce these inequities.
That is, we called on them to design the allocation policies.
Let me repeat that. The April 2 rule contains no allocation
policy. It calls on UNOS to develop a policy that will bring
this fragmented and irrational system to an end.
The rule contains three common sense approaches for
improving fairness and relying on medical criteria for
allocating organs. First, the criteria for placing patients on
waiting lists are to be standardized and based on objective
medical criteria. UNOS actually agrees with this goal.
Second, the criteria for determining the medical status of
patients are to be standardized and based on objective
criteria. Again, UNOS agrees.
Third, medical urgency is to be main criterion for
allocating organs, and organs are not to be confined to the
artificial geographical areas that have no medical rationale.
As you know, the April 2 patient fairness rule has been
controversial. An earlier appropriations bill delayed the
implementation of the rule until October 1. Subsequently, in
addition to suspending the organ donation rule, the House
Appropriations Committee also included language in the fiscal
1995 appropriations bill to delay our patient fairness
regulation by another year.
I deeply respect the views of those in Congress who seek to
delay the patient fairness rule. And I believe they have the
best interests of patients at heart. However, I am deeply
concerned that opposition to the rule is based on
misinformation generated by political lobbying by UNOS that has
mischaracterized the Department's intent and the meaning of the
patient fairness regulation.
So we appreciate the opportunity to set the record
straight. And if I might shorten my testimony, Senator, let me
simply go through a series of claims and finish my summary.
First, UNOS has claimed that the rule creates a single
national waiting list that would result in more deaths and
longer waits for patients across the country. This is false.
The rule asks UNOS to develop the allocation policy and does
not require a national waiting list. What the rule calls for is
fairness. And it emphasizes medical criteria over nonmedical
criteria.
UNOS claims that the rule will force doctors to transplant
livers into the very sickest patients, contrary to sound
medical judgment. Again, this is not true. Our regulation
explicitly says the opposite. We believe that transplants
should be performed on the basis of medical urgency, consistent
with sound medical judgment. We specifically direct that
allocation policies should not require transplantation in
futile cases and should not waste organs.
UNOS claims that the rule will force transplant centers to
close. This, too, is false. If anything, a fairer distribution
of organs should enhance the ability of all centers to have
better access to matching organs.
UNOS claims that the organ procurement areas with excellent
donation rates will lose organs to areas with poorer donation
rates. Once again, false. Already 33 percent of donated organs
are used outside the local area. And broader sharing will mean
patients will benefit from a wider pool of organs.
UNOS has even gone so far as to claim that the Federal
Government should have no voice in these issues. That is simply
nonsensical. The transplant network is operated on a day-to-day
basis by a private sector organ network. Our regulation
protects that structure.
But the law also demands that the organ network be
accountable. And my Department has a clear responsibility to
ensure the purposes of the act are carried out. And keep in
mind that Medicare alone pays for 50 percent of the transplants
performed in this country.
During the past several months, the HHS staff and UNOS
representatives began a series of discussions about transplant
policies and the meaning of the rule. During these lengthy
discussions, we clarified several issues that had been most
concerned to UNOS.
At several points, it appeared that there was broad
agreement between the two parties on the clarifications made by
our staff. At one point, they removed their legislative action
kit from its Internet site, although UNOS would not publicly
correct the misinformation that had been spread throughout the
transplant community and the Congress.
I understand that at the last meeting between HHS and UNOS
the respective parties in the room concurred on draft language
that both sides felt could form the basis for a mutual
understanding. In the end, though, they would not agree to that
language.
UNOS has informed HHS that it will not correct the record
unless the Department agrees in advance to change the
regulation. It is the UNOS record, I believe, that has resulted
in widespread misunderstanding of the patient fairness rule.
Members of this subcommittee have expressed reservations about
the April 2 rule. I have taken these concerns seriously.
I also know that Members of Congress are fair and want a
debate that is based on facts and what is best for patients. I
appreciate the tough questions that Members have asked and the
examination of the regulation from every angle.
We purposely delayed the implementation of the rule so that
there would be time for additional comment and for Congress to
hold hearings on these issues. And as I said earlier, we have
worked hard to clarify the scope and intent of the rule. And I
believe that any further delay would be counterproductive.
prepared statement
I hope that you will conclude, as I have, that the April 2
rule is our best chance of meeting the goals of the National
Organ Transplant Act and of protecting patients.
Thanks for the opportunity to set the record straight.
Senator Specter. Thank you very much, Madam Secretary.
[The statement follows:]
Prepared Statement of Hon. Donna Shalala
Chairman Specter, Senator Harkin, distinguished members of
the Subcommittee, I appreciate having the opportunity to be
here today to testify about our regulatory guideline designed
to ensure a fair organ transplantation network for patients. At
the request of you and Chairman Livingston, and the leadership
of our authorizing committees, we have worked hard to clarify
the goals and responsibilities of both HHS and the transplant
community. We believe it is essential that we now go forward so
that doctors and patients in the transplant community can
establish equitable policies that are based on sound medical
criteria.
Mr. Chairman, without a doubt, organ transplantation is one
of the wondrous medical developments of the century. Organ
transplant surgery has given life where death was once a
certainty for tens of thousands of chronically ill Americans.
Every patient who survives transplant surgery to lead a
productive life has been touched by a miracle.
I also want to reiterate our strong commitment to
increasing organ donations, in particular the regulation we
issued earlier this year to strengthen hospital participation
in the organ procurement process.
But like all miracles, these are in short supply. Every
day, eleven Americans whose lives could be saved by
transplantation die because there are not enough organs for
everyone who needs them. Increasing organ donation rates must
be our number one priority.
Unfortunately, only 5,500 cadaveric donors, about one half
to one third of all potential donors, contribute organs for
transplantation. While the number of cadaveric organ donors has
increased by 30 percent, the number of deaths on the waiting
lists has also grown, by nearly 177 percent.
Last December, the Department of Health and Human Services
announced a nationwide initiative to increase organ donations.
A national partnership of public, private and volunteer
organizations is working together to identify and overcome
known barriers to organ donation. The centerpiece of the
initiative is a new regulation, which took effect August 21,
that we believe will increase organ donation by 20 percent
within two years. This regulation requires hospitals
participating in Medicare or Medicaid to report all deaths to
organ procurement organizations so that medically suitable
donors can be more readily identified. The rule is based on the
effective Pennsylvania state law that requires the reporting of
deaths to state organ procurement organizations.
Regrettably, the House fiscal year 1999 Labor-HHS-Education
appropriations bill was amended with language that would
suspend implementation of this important rule. We hope members
of both Houses will agree to omit this language from the final
bill. This proposal, which has strong support from doctors and
patients in the transplant community, could save thousands of
lives.
Increasing organ donation is our most important transplant
policy goal, but not the only one. We also must do a much
better job of meeting the central mandate of the National Organ
Transplant Act: to ensure an equitable nationwide system for
the distribution of transplantable organs. Under existing
policies, where a patient lives and which transplant hospital a
patient chooses are often the primary determinants of whether
the patient receives an organ. In other words, where you live
and where you list can determine whether you live or die.
Medical urgency--how badly a patient needs the transplant
and his or her chances of survival- is not always the main
factor in deciding who lives and who dies. I believe that the
emphasis on geography instead of medical judgment is the reason
that patients in one part of the country wait as much as five
times longer than patients in other parts of the country who
have the same severity of illness. Policies of the Organ
Procurement and Transplantation Network should be based on
medical criteria, as developed by the transplant community
itself.
Non-medical criteria, such as geography, should not drive
allocation decisions. A person's wealth should not drive
allocation decisions. A patient's celebrity should not drive
allocation decisions. Politics should not drive allocation
decisions. We want allocation decisions to be based on medical
criteria.
Allocating scarce organs to patients on the basis of
geography is fundamentally unfair. Not only is current
allocation policy inequitable, existing allocation boundaries
simply do not make sense. The transplant network is using
boundaries that were designed for organ procurement. These
boundaries are not based on medical criteria and I believe it
would be a mistake to continue using them for allocation
purposes.
Transplant centers have adapted to the current system, and
in fact, have proliferated under it. But patients have not.
Regardless of any economic gains for local transplant centers,
the system is bad for patients. Improving the system for
patients is the reason the Department issued a regulation April
2 that asks the Organ Procurement and Transplantation Network
to develop fairer policies that are based on medical criteria.
As you know, the April 2 patient fairness rule has been
controversial. An earlier appropriations rider delayed
implementation of the rule until October 1. Subsequently, in
addition to suspending the organ donation rule, the House
Appropriations Committee also included language in the fiscal
year 1999 appropriations bill to delay our patient fairness
regulation by another year.
I respect the views of those in Congress who seek to delay
the patient fairness rule, and I believe they have the best
interests of patients at heart. However, I am concerned that
opposition to the rule is based on misinformation generated by
a political lobbying campaign that has mischaracterized the
Department's intent and the meaning of the patient fairness
regulation.
In 1991, the HHS Inspector General found that the national
Organ Procurement and Transplantation network was inequitable,
particularly with respect to race and geography, and that it
did not meet the intent of the 1984 Act. Earlier this year, a
House panel examining this issue asked the Inspector General to
update its findings. The Inspector General issued its updated
report in June, which found that the inequities identified in
1991 remain in the network, and in some cases have worsened,
particularly for African Americans. Let me read you the
conclusion reached by the Inspector General two months ago:
Our brief review of these data lead us to reaffirm the
importance of the central message we presented in our 1991
report--that the national organ allocation system should focus
on equity among patients, not among transplant centers, and on
common medical criteria, not the circumstances of a patient's
residence or transplant center affiliation. We continue to
believe that the April 2, 1998 HHS rule moves in that
direction.
Under the current policy, patients who are less ill receive
transplants while more severely ill patients, perhaps only a
few miles away, die. We all have friends and relatives who live
in different parts of the country. Should any one of them have
a better chance of living than the other if they needed an
organ transplant? Is it fair that patients with virtually
identical medical needs are treated differently solely because
of where they live?
The unfairness exists, not only between different parts of
the country, but even within states. For example, the median
waiting times for the two major liver transplant centers in the
State of Kentucky are vastly different. One recent report found
that the median waiting times for livers at one of the centers
was 38 days while it was 226 days at another. In Louisiana, the
median waiting time at one center was 18 days, while it was 262
days at a different center. In Michigan, one center had a
waiting time of 161 days while another major center in the
State had a waiting time of 401 days. And so it goes across the
country, inequity within states, and unfairness from one state
to another.
These waiting list disparities are the most visible
shortcoming of the current system. Less visible are the
resulting inequities among those who receive organs. Where
waiting times are the shortest, organs may go to patients who
are less ill; while at the same moment, in areas where patients
wait longer, organs often are not offered to patients with
greater medical need. In the worst cases, patients die in areas
where waiting times are long, while, at the same time, organs
are being made available to patients who are less ill in areas
with shorter waiting times.
The April 2 rule does not impose an allocation policy.
Instead, it calls on the contractor that administers the
network, the United Network for Organ Sharing, or UNOS, to
develop an allocation policy that will reduce current
inequities in the network. I want to be clear about this,
because there appears to be misunderstanding about the rule.
The April 2 rule contains no allocation policy. It calls on
UNOS to develop the policy. The rule is consistent with the
Department's long-standing position that the development of any
policies requiring medical judgment be left to the transplant
community. We will rely on the judgment of transplant
professionals to establish policy reforms. And they will have
broad latitude to develop policy within the parameters of the
regulation.
The rule contains three common sense goals that are
consistent with the equity requirements of the National Organ
Transplant Act. The first goal requires that criteria for
placing patients on waiting lists be standardized and be based
as much as possible on objective medical criteria. The network
cannot be truly fair if the standards for placing patients on
waiting lists differ across the country. UNOS agrees with this
goal and is working toward it.
The second goal requires that criteria for determining the
medical status of patients be standardized, again on the basis
of objective criteria. Uniform criteria for determining medical
status will prevent gaming of the system. UNOS also agrees with
this goal and is working toward its accomplishment.
The third goal requires that medical urgency, not
geography, be the main criterion--not the sole criterion--for
allocating organs. This goal also meets the intent of the Organ
Transplant Act for an equitable nationwide organ transplant
network. UNOS objects to this goal, and if their position
prevails, the current inequitable system will be maintained
There is a central purpose to the performance goals, which
is to ensure, to the maximum extent possible, that all
patients, regardless of where they live, are treated the same.
Because there are not yet enough organs to save everyone on the
waiting lists, I believe we must, at a minimum, guarantee
fairness, while we continue to strive to increase donation.
I recognize that there are legitimate diverse views in the
transplant community about the third performance goal, which
requires reform of allocation policies. Small transplant
centers worry they will be swallowed by large transplant
centers. Organ Procurement Organizations that have worked hard
to obtain transplantable organs are concerned that organs will
flow from their state, leaving a shortage. Such concerns must
be debated by the transplant community and they should strive
to reach consensus on the best policies for patients.
Unfortunately, to this point, UNOS has failed to seize the
opportunity offered by the rule to develop consensus about
policy improvements. In fact, UNOS has gone to great lengths to
preserve the current unfair system. It has launched a political
lobbying campaign against the April 2 rule. This campaign has
been characterized by misinformation. The essence of the UNOS
campaign has been to create phantom policies and use scare
tactics that have hospital administrators and patients around
the country up in arms. UNOS has made available form letters,
part of a self-described ``legislative action kit,'' to
surgeons and patients across the country.
I am deeply concerned about these efforts to misrepresent
the provisions of the regulation. I have received numerous
letters from Members of Congress, transplant professionals,
patients, and the public that reflect inaccuracies published by
UNOS. I am especially distressed that UNOS is needlessly
frightening transplant patients.
UNOS has claimed that the rule creates a single national
waiting list for patients that would result in more patients'
deaths and longer waits for all patients across the country.
This claim is completely false. As I have said, the rule asks
UNOS to develop the allocation policy. There is no requirement
for a national waiting list anywhere in the rule. The rule
calls for fairness. How the fairness is achieved in terms of
allocation policy is primarily up to UNOS. Leading members of
the transplant community have presented proposals to UNOS to
remedy the current system's unfairness with very little, if
any, adverse impact on local transplant centers. There have
been several experiments in allocation policies involving
broader sharing of organs that have been sanctified by UNOS.
These experiments are interesting and worthy of consideration.
But instead of consideration, UNOS has resorted to frightening
patients and surgeons. The scare tactic of the national waiting
list is a central theme of the phantom policy created by UNOS.
I reiterate that the Department does not have a
preconceived notion of any allocation policies. We are relying
on the transplant community to develop the policy. Any policy
that is sensible, is based on sound medical judgment, and
reduces geographic inequity, will be taken seriously by the
Department.
UNOS has claimed that the rule will force doctors to
transplant livers into the very sickest patients, contrary to
sound medical judgment. This claim also is false. We know that
transplanting the very sickest patient is not always the best
course. We believe that transplants should be performed on the
basis of medical urgency, the definition of which includes
viability and chances of survival. Further, it is up to UNOS to
develop policies on medical urgency.
UNOS claims the rule will force transplant centers to
close. There is nothing in the regulation that would force any
centers to close. On the contrary, a fairer distribution of
organs should enhance the ability of all centers to have better
access to matching organs for transplantation.
UNOS has claimed that organ procurement areas with
excellent donation rates will lose organs to areas with poorer
donation records. This is another false assertion. Already,
over 35 percent of donated organs are used outside the local
area. Our organ donation initiative should result in increased
organs for every procurement area. Also, broader sharing will
mean that patients will benefit from a wider pool from which to
draw.
I think the most outrageous UNOS claim is that the
regulation would hurt minorities and the poor. In the first
place, the current system is not fair to minorities, as the
Inspector General has reported. Minorities can only benefit
from the fairer policies the regulation attempts to encourage.
As for UNOS claims about the poor, the truth is that Americans
who cannot afford to pay for transplant surgery do not even get
on the waiting list. So the opposite of UNOS's allegation is
true: it is the current unfair system that has negative
consequences for minorities and the poor. We are trying to
change the system. UNOS is trying to preserve it.
Finally, I would like to comment on the UNOS claim that the
Department lacks the authority to issue any rules governing the
Organ Procurement and Transplantation Network. As I have said,
the National Organ Transplant Act gives the Department the
authority to oversee the network. The primary reason the Act
was passed in the first place was because the unregulated
network was rife with abuses. Also, the Department, through
Medicare and Medicaid, pays for more than half the transplant
surgeries in the United States. We pay for most of the listing
fees charged by UNOS. To say we have no basis to issue
regulations when our authority is clear is a disservice to
Congress, which created the network, and to the patients, whose
transplant bills we pay.
I regret that UNOS has frightened patients and perhaps
jeopardized organ donation in some areas of the country. Only a
year ago, a former President of UNOS, Dr. James Burdick, warned
against such scare tactics. Dr. Burdick sent a statement to all
UNOS members. It said:
``* * * the community must generally understand the likely
impact of a new or revised policy. In recent months, there have
been conflicting accounts in the news media of the potential
effects of revisions to liver allocation policy. While diverse
views are held within the community, we must realize that
contradictory or inaccurate statements about the policy's
effect can needlessly confuse or frighten those with the most
at stake--patients desperately awaiting transplants.''
What has been the response to Dr. Burdick's warning? There
have been charges that the April 2 rule will kill people. There
have been charges that the April 2 regulation discriminates
against minorities. There have been charges that patients will
have to travel great distances for transplants. There have been
charges that transplant centers will be shut down. All these
charges come from UNOS and all of them are false. Dr. Burdick's
responsible policy was flatly rejected.
On June 18, the Senate Labor and Human Resources Committee
and the House Commerce Committee conducted a joint hearing
about the April 2 patient fairness rule. Members of the
Committees urged HHS and UNOS to put aside their differences
and work out a mutual understanding of policy that would
benefit patients. We agreed with the Members. Beginning the
very next day, HHS and UNOS began a series of discussions about
transplant policies and the meaning of the rule. The
Administrative Procedures Act prevented any actual negotiation
about the regulation. Any changes in the rule, if necessary,
will result from the public comment process, and UNOS has
offered comments as part of that process that we will seriously
consider.
During the lengthy discussions with UNOS, HHS staff
clarified several issues that had been of most concern to UNOS:
specifically, allocation policies will be developed by UNOS,
not the Department. HHS emphasized that the regulation does not
require a national list, and that it would be up to UNOS to
develop an allocation policy that results in broader sharing.
The key goals for any policy developed by UNOS must be to
benefit patients and improve the current system.
HHS reiterated that there should not be an arbitrary policy
requiring that only the sickest patients be transplanted, but
that the patients with the greatest medical urgency, based on
sound medical judgment, not geography, should be transplanted.
HHS made it clear to UNOS that it should not develop policies
that adversely affect small transplant centers or unduly
benefit large transplant centers.
In fact, HHS would reject any policies that would result in
the wastage of organs.
At several points in these lengthy discussions, it appeared
that there was broad agreement between the two parties on the
clarifications made by HHS staff. At one point, UNOS removed
its legislative action kit from its Internet site, although it
would not publicly correct the misinformation that had been
spread throughout the transplant community and the Congress. I
understand that at the last meeting between HHS and UNOS, the
respective parties in the room concurred on draft language that
both sides felt could form the basis for a mutual
understanding. In the end, UNOS would not agree to the
language. It seems that UNOS believes its political interests
are best served by suspension of the patient fairness
regulation and continuation of the current system. UNOS has
informed HHS that it will not correct the record unless the
Department agrees in advance to change the regulation. It is
the UNOS record, I believe, that has resulted in widespread
misunderstanding of the patient fairness rule.
Many of Members of Congress have expressed reservations
about the April 2 rule. I know their concerns are sincere and I
take them very seriously. I want to respond to every one of
them. I know that you are fair and agree that the debate should
be based on facts and what is best for patients.
My fervent hope is that the polarization created by the
UNOS lobbying campaign is the result of a misunderstanding of
the rule and its intent. I say this because I believe that all
of us--the Department, UNOS, and Members of Congress, want what
is best for patients.
I want you to ask me the tough questions and examine the
regulation from every angle. One of the reasons we initially
delayed the implementation of the rule ourselves, prior to the
action by Congress, is so that there would be time for
additional public comment as well the opportunity for Congress
to have hearings on these issues. As I said earlier, we have
worked hard to clarify the scope and intent of the rule and
believe that any further delay would be counterproductive. I am
hopeful that you will conclude, as I do, that the April 2 rule
is our best chance of meeting the goals of the National Organ
Transplant Act.
Thank you for the opportunity to testify and set the record
straight. I will be happy to answer any questions that you may
have.
remarks of senator robert torricelli
Senator Specter. Senator Torricelli has arrived. And if you
would wait, Madam Secretary----
Secretary Shalala. I would be happy to.
Senator Specter. Questions are going to be limited. As I
said at the outset, we are going to have to conclude the
hearing by 11 o'clock. But I think it would be useful to have
Senator Torricelli's views, which I think are in opposition to
your position. And we can then perhaps have a brief three-way
discussion.
Secretary Shalala. They are, but I should note that we are
good friends.
Senator Specter. Well, I am sure that will prevail,
notwithstanding the discussions.
Welcome, Senator Torricelli.
Senator Torricelli. Thank you, Mr. Chairman, very much, and
Madam Secretary.
Senator Specter. The floor is yours under the 5-minute time
rule.
Senator Torricelli. Thank you very much for the
opportunity.
Mr. Chairman, with much being said today about our national
organ transplantation program in our various States, this much
should be clear to all of us: This program has been an
extraordinary success. In 15 years over 200,000 Americans have
received an organ.
Not only is the technology working, there are people who
are living and breathing as a result of the cooperation and the
generous gifts of those in the last moments of their life. The
problem that remains is simply that not enough Americans are
donating their organs. Less than 1 percent of deaths result in
organ donation with 4,000 Americans dying every year, waiting
for an organ donation.
This is the problem, not the fact that the individual
States have initiated their own systems for distributing the
organs. The new HHS proposal may be well intentioned, but I,
along with 26 of our colleagues in the Senate, are concerned
that by removing geographic criteria, the proposal will not
improve overall levels of donation and transplantation, but
will rather shift donations and transplantations along
different regions of the country and impose great new costs.
Our belief is that under this scenario the number of actual
donations and transplants will not increase. We will only have
new burdens.
Transplant programs across the Nation including those in
States represented by members of this subcommittee. Wisconsin,
South and North Carolina, Washington, and Missouri have
repeated the warning that centralizing the system will shift
organs away from local facilities.
As organs begin to flow to large transplant centers, these
community-based centers will be forced to close, because they
will be unable to maintain the volume necessary to operate. The
consequences will be felt most greatly among our nation's most
disadvantaged patients, the poor and minorities, many of whom
will be unable to bear the expense of travel.
Over 23 percent of the transplant patients nationwide rely
on Medicaid, which does not provide coverage for travel
expenses. In addition, I fear that large centers may refuse to
serve uninsured patients, many of whom are minorities, because
of the increased pool of insured patients for them to pick
from. A recent study of the largest transplant centers
indicated that only 7 percent of liver transplant patients were
minorities, which is 23 percent nationally.
In my State, we are very proud of our locally based organ
donation system. A citizen of New Jersey waits only 26 days for
a liver transplant. We have an active system to encourage our
citizens to donate their organs. We maintain a list, and it has
resulted in one of the lowest, or the lowest, waiting periods
in the Nation.
A citizen of the United States can be expected to wait 250
days, on average if they live in other States. That is not
because our State is not meeting its responsibility or many
other States. The answer is not to nationalize the system and
destroy a system that is working. The answer is for other
States to do what we have done.
Our fear is that the smaller centers that now exist in our
State will not be able to compete and will no longer exist if
this system is nationalized. Not only have we reduced the
waiting period in New Jersey with what is a model program, but
we have ensured that based on race and income that no one is
disadvantaged.
Fully one-third of the people receiving transplants in our
State do not even have private health insurance, but they are
protected. Under the system being proposed in nationalizing
this process, the question arises: How will the poor be
protected? How will they travel hundreds or even thousands of
miles with their families, wait for transplants and bear those
costs?
prepared statement
That is the risk of nationalizing a system and ending the
statewide systems, which I believe are working and can be made
to work so very well. That, Mr. Chairman, I believe is the
reason why the House of Representatives appears on the verge of
imposing a year wait before nationalizing a system and why 26
of our colleagues, including 4 members of this subcommittee,
have joined in my legislation for a 1-year moratorium to ensure
that we understand the consequences on the poor, on the
uninsured, on waiting periods and what it would mean to
compromise or end these various State systems, which we believe
are working so well.
[The statement follows:]
Prepared Statement of Senator Robert G. Torricelli
Thank you Chairman Specter for holding this hearing and for
the opportunity to testify. The issue of the proposed HHS organ
donation regulations and its impact on our organ donation and
allocation system is one of the most pressing before Congress.
This debate has re-focused national attention on our organ
donation system. Among the great successes of the last decade
has been the successful development of community-based systems
of organ donation. In the last 15 years, nearly 200,000
Americans have received an organ. Last year alone, 20,000
Americans received a donated organ.
Notwithstanding this success, the program is still
struggling to provide organs for all those who need them. With
organs being donated in less than one percent of deaths, 4,000
Americans die every year waiting for organs in the U.S. Today,
tens of thousands of names wait for new organs on Regional and
State lists for new organs and a new name is added every 16
minutes.
Clearly we must improve the current system to encourage
more individuals to donate and to facilitate the accessibility
of donated organs to those in need. However, while the new HHS
proposal is well-intentioned, I am concerned that by removing
geographic criteria, the proposal will not improve overall
levels of donation and transplantation but rather will shift
donations and transplantations among different regions of the
country.
Under this scenario, the number of actual donations and
transplants will not increase. The only thing that will change
is who receives and who performs the donations. Transplant
programs across the nation including those in States
represented by members of the Subcommittee in Wisconsin, South
Carolina, North Carolina, Washington, and Missouri have
repeated the warning that centralizing the system will shift
donated organs away from community based facilities to a
handful of large transplant centers that have the longest
waiting lists.
As organs begin to flow to large transplant centers, many
community based centers will be forced to close because they
will be unable to maintain the volume necessary to operate.
When locally-based transplant centers are closed, patients and
their families will be forced to travel to other states at
their own financial expense and medical risk.
The consequences of this will be felt most greatly among
our nation's most disadvantaged patients, the poor and
minorities, many of whom will be unable to bear the expense of
travel. Over 23 percent of transplant patients nationwide rely
on Medicaid, which does not provide coverage for traveling
expenses. In addition, I fear that larger centers may refuse to
serve uninsured patients, many of whom are minorities, because
of the increased pool of insured patients for them to pick
from. A recent study of the nations largest transplant centers
show that, in 1996, only 7 percent of their liver transplant
patients were minorities versus 23 percent nationally.
In my State, we are proud of our locally based organ
donation system. It actively promotes organ donation within our
communities and serves the sickest patients first, close to
their homes. It has resulted in shorter waiting periods,
increased donations, and healthier patients. A person in New
Jersey need wait only 26 days on average for an organ, compared
to a 250-day national waiting period.
Our system also ensures that all of our citizens, including
the poor, will be accommodated. Fully 30 percent of patients in
New Jersey have no access to private insurance, but, through
our system of charity care, we're insuring that regardless of
income, people can receive donations.
Mr. Chairman, the potential consequences of the HHS
proposal on local centers and their patients are too great for
us to act in haste. I understand that for several months, HHS
and the United Network of Organ Sharing (UNOS) have been in
confidential discussions to address the concerns raised by many
members of Congress and the transplant community. However, the
October 1 deadline is rapidly approaching. It would be tragic
if we were to allow a lack of time to prevent a successful
culmination to these efforts.
As I am sure the Chairman knows, I have introduced
legislation that now has 25 bi-partisan cosponsors, including
several members of this Subcommittee that would delay for one
year the regulations while HHS conducts a study to determine
their impact. I am confident that with greater time to consult
with the medical community, particularly those serving low-
income patients, HHS will be able to develop new regulations
that will raise the overall level of organ donation system.
Again, thank you for the opportunity to be here today.
nationwide distribution of organs
Senator Specter. Senator Torricelli, let me start with a
question on a subject raised by the Secretary. And that is,
from the existing legislation, which provides assist organ
procurement organizations in the nationwide distribution of
organs equitably among transplant patients.
Does not the articulation of a policy for nationwide
distribution of organs equitably among transplant patients
really resolve the issue on existing policy?
Senator Torricelli. Mr. Chairman, I believe that there is a
misconception in our State policies that there is not a
national distribution. Forty percent, for example, of the
organs donated in New Jersey go into a national pool. There is
national distribution. The States simply are allocating them
locally first.
But where there are successful statewide programs, there
are an abundance of organs that are going to those States that
do not have these programs.
Senator Specter. Well, that is an interesting answer,
Senator, but I do not think you can have it both ways. When you
discuss smaller centers and their ability to compete, that is
really an effort, as are some of the other efforts, that I
understand your point, but that is to protect New Jersey. That
is not to have a national system.
And with all respect, it really is not a question of
whether centers can compete. It is a question of whether needy
people can obtain organs.
Senator Torricelli. That is exactly the question. I would
not defend a local hospital's interest if it meant that a
single citizen would have a better access to organ donation.
But I think the facts speak for themselves.
We have a system where the people of our State, and of many
other States, including one-half the members of this committee,
are meeting their local responsibilities. Our systems are
working. Our citizens are getting these transplants. And indeed
so successfully that we are able to export almost one-half of
the organs donated in our State.
But we are doing it in hospitals where people, including
poor people, one-third of them with no insurance, can drive to
their local centers, not fly to Chicago, Nebraska, or
Pittsburgh. Their families can be----
Senator Specter. How about Philadelphia? It is very close.
[Laughter.]
Senator Torricelli. For Philadelphia, we have a special
place in our hearts. [Laughter.]
Senator Specter. Be careful on your testimony. You may want
to go to Jefferson one day, and this is all recorded.
[Laughter.]
Senator Torricelli. But, Mr. Chairman, there is a real
problem since so many of the people who receive this care are
indigent. And as I suggested, in our State 30 percent have no
health insurance. And the Federal Government is not providing
transportation costs.
The question arises, if a poor person who lives in Newark
or any other major city in the country even has an organ
donated, how do they deal with the cost of going to Chicago?
And how about their families? And how about the long period
they have to remain there?
Senator Specter. But what reason do you have to assert, as
you have on a couple of occasions, with reference to minorities
and poor people--and I share your concern there--that they will
be treated any worse under a national system?
Senator Torricelli. Well, under our----
Senator Specter. If you make a determination as to who
needs it the most, is that not really the best assurance that
there will not be a determination by who has the ability of pay
or who may have a preferential status, not being poor, not
being a minority?
Senator Torricelli. There is if someone is paying the
bills. In our system, under indigent care in our States and in
many other States that have these model programs, we ensure
that a person who has an organ being donated is treated
financially no different, is put in our system of indigent care
in our State and the bills are paid.
We are concerned that if our system now is superseded by a
national system, that that will no longer be available. And all
of a sudden, cost will become a major obstacle to the indigent.
Senator Specter. Senator Torricelli, let me raise a legal
issue. You are a noted constitutional scholar.
Senator Torricelli. Only by you, but thank you for noting
that. [Laughter.]
Senator Specter. Well, no; I think that ``Fox News Sunday''
recognized you as a national scholar this week and ``Meet the
Press'' and others, Senator Lautenberg and others.
Is there not a real constitutional issue here about having
States enact legislation to limit organs to their home State
under the commerce clause and also under the supremacy clause
with the Federal policy being that which I just read to you?
Senator Torricelli. Well, I will admit to you, Senator,
this is my first appearance on behalf of States' rights in my
long service in the U.S. Congress. [Laughter.]
It is not a cause of which I usually have sympathy. I do
think, however, in the traditional role of the States, both in
ensuring health care and providing indigent care and in the
regulation of health care industries within our States, which
traditionally have had a strong or even a dominant State role,
this is not unusual.
But indeed, I would be less troubled if I saw the Federal
Government duplicating State by State what we are doing in our
individual States than by the program that is being proposed. I
do not think we are simply nationalizing what has been a series
of State successes. I think we are compromising what has been a
series of State successes.
Senator Specter. Well, thank you, Senator Torricelli. We
have a tough issue here.
Madam Secretary, I am going to give you the last word on
the panel. We have a tough, tough matter here. When Senator
Torricelli refers to members of this subcommittee, there was no
effort made to insert a clause similar to that in the House
bill.
So I think that--and in the full committee, as well, that
we are satisfied. What we will do on the floor, I do not know.
But we have a very tough bill, which we have to get out.
One of the concerns that I have is with so many collateral
issues. One of my colleagues said that all the air is going to
be sucked out of every room in Washington now that we have the
Starr report out. And I think we have to focus on the important
work of September, which is the appropriation process.
We have a lot of big matters: The NIH funding, and Head
Start, labor safety, et cetera. And I do not want to see us
bogged down over riders. And this is a big one. So we are going
to have to figure out a way, and I am prepared to work with
you, Madam Secretary, to find the answer here, which does not
start another civil war over States' rights.
New Jersey is a little far to the north, but I hear
secession.
Secretary Shalala. Thank you very much, Senator. I would
urge Senator Torricelli to look at the inspector general's
report on the issue of racial disparities. She has suggested
that in fact his description of poor people and minorities
being taken care of under the current system is exactly the
opposite, that racial disparities have actually increased over
the years as this system has evolved, and that a correction of
the system is necessary to protect the rights of low-income
people and of minorities.
Second, I would simply say to Senator Torricelli that one-
half the people in New Jersey now go outside the State to get
an organ, that one-half clearly stay in the State. And a fairer
system will protect both the people of New Jersey, whether they
are rich or poor, as well as the people of Pennsylvania.
Senator Specter. All right. Thank you very much. We could
go on at some considerable more detail. But as I say, we have
to conclude by 11 o'clock.
We thank you very much, Madam Secretary.
And thank you, Senator Torricelli.
Senator Specter. We will now call Dr. Bennett, Mr. Irwin,
Dr. Miller, Dr. Pfaff. If you would step forward promptly,
please.
We had talked about limiting the--if we can have order in
the hearing room, so that we can proceed, please.
We had talked about limiting the statements from 5 to 3
minutes. But we will maintain the statements at 5 minutes. But
we are going to insist that we stay right on time, because, to
repeat, we have to conclude the hearing by 11 o'clock.
STATEMENT OF RONALD W. BUSUTTIL, M.D., PRESIDENT-ELECT,
AMERICAN SOCIETY OF TRANSPLANT SURGEONS
Senator Specter. We begin with Dr. Busuttil, president-
elect of the American Society of Transplant Surgeons and
director of the Dumont-UCLA Transplant Center. Welcome, Dr.
Busuttil, and the floor is yours.
Dr. Busuttil. Thank you, Senator Specter, and thank the
committee for allowing me to make this presentation.
I am Dr. Ronald Busuttil, professor of surgery and chief of
the Division of Liver and Pancreas Transplantation at the UCLA
School of Medicine. The UCLA liver transplant program is one of
the larger programs in the country. In fact, it is the most
active transplant program in the world, performing close to 300
liver transplants per year.
I am here today testifying as a transplant surgeon and as
president-elect of the American Society of Transplant Surgeons.
I will be brief. And I would like to emphasize several key
points in my oral testimony today.
First, the two aspects of the proposed rule which surgeons
most strongly and uniformly support are standardized listing
criteria and standardized criteria for determining the medical
status of patients awaiting a transplant. These criteria are
already being used by liver transplant programs in the United
States.
When I testified before a joint Senate and House hearing on
the OPTN rule almost 3 months ago, I suggested that the same
criteria used by all transplant centers, coupled with better
enforcement, might go a long way toward resolving the concerns
of those who have focused on perceived geographic differences
and waiting times for the most seriously ill patients awaiting
liver transplants.
I also suggested at that time that in fact waiting times
had already become relatively equal throughout the country for
the most critically ill patients. Today with data for 1998,
through the month of August, which is now available, I would
like to call the committee's attention to the fact that for
status one patients, the most critically ill, the mean waiting
time for a transplant across the country is 4 days, with not a
great deal of regional variation.
For example, the mean waiting time in my State, California,
during this period was 2 days. The mean waiting time in
Pennsylvania was 5 days. The mean waiting time in New York was
2 days; in Florida, 3 days; and in Texas, 2 days.
Let me additionally say, as I emphasized in my June 18
testimony, that many of us in the transplant community do not
believe that time on the waiting list is necessarily the best
indicator of a fair organ allocation system, because there are
so many clinical variables that go into determining waiting
time.
But even if waiting time were the crux of the issue, I
would suggest that the rationale for rushing this rule into
effect would seem to have disappeared.
This brings me to my second point. We have for some time
now been trying to point out that the Department's apparent
determination earlier this year to give priority to sickest
patients first without geographic consideration would in fact
be detrimental to the goal of providing the most Americans with
life-saving transplants.
This policy, which has been modeled for liver
transplantation, has actually been shown to have significant
disadvantages to alternative systems, including the current
one. That is not to say that the current one is the best. And
clearly we believe that some modifications are in order.
However, giving priority to sickest first over broad
geographic areas would be wasteful and dangerous, resulting in
fewer patients transplanted, increased death rates, increased
retransplantation due to poor organ function--and I would like
to emphasize that point--and increased overall cost of
transplantation.
Senator Specter. Dr. Busuttil, your yellow light is on, so
I am going to ask you to summarize before the red light
appears.
Dr. Busuttil. One additional problem with requiring broad
geographic transportation of organs is that it would curtail
the use of the new split liver technique, in which a single
organ is divided to provide transplants for two recipients. And
full utilization of this technique will allow an additional
1,000 donors per year.
I would like to make a final point before concluding my
oral testimony. When I appeared before Congress on June 18, I
made it clear that our Society of Transplant Surgeons was
prepared to work as intensively as possible with the Department
of Health and Human Services to resolve our concerns.
To date, we have received no indication from them that they
wish to address the concerns that we achieved. Based on this--
--
prepared statement
Senator Specter. Dr. Busuttil, your time is up. We are on a
very tight time schedule. I am not going to stop you in
midsyllable like they do in the Supreme Court to me, but we are
going to have to stick within the time.
Dr. Busuttil. I would like to conclude by saying that we
urge the committee to block the implementation of this rule as
it now stands.
Thank you, and I apologize for going over.
Senator Specter. Thank you very much, Dr. Busuttil.
[The statement follows:]
Prepared Statement of Ronald W. Busuttil, M.D., Ph.D., F.A.C.S.
I am Dr. Ronald Busuttil, Professor of Surgery and Chief of
the Division of Liver and Pancreas Transplantation at the UCLA
School of Medicine. The UCLA liver transplant program is the
most active transplant program in the world, performing close
to 300 liver transplants per year.
I am here today as President-elect of the American Society
of Transplant Surgeons (ASTS) and as a transplant surgeon
representing the transplant programs of the University of
California system at Davis, Irvine, Los Angeles, and San Diego,
but most importantly as a patient advocate to testify about
Final Rule regarding the Organ Procurement and Transplantation
Network (OPTN).
The ASTS is a medical society of close to 700 transplant
surgeons whose members perform the vast majority of organ
transplants in the U.S. The ASTS has developed a consensus
position on the OPTN regulation that is included in my written
testimony. There are some important aspects of the regulation
which ASTS strongly supports, but there are others that we feel
do not benefit the patients we serve.
There are several key points that I would like to emphasize
in my oral testimony today.
1. The two aspects of the proposed rule which surgeons most
strongly and uniformly support--standardized listing criteria
and standardized criteria for determining the medical status of
patients awaiting a transplant--are already being used by all
liver transplant programs in the United States.
When I testified before a Joint Senate-House hearing on the
OPTN rule almost three months ago, I suggested that seeing that
the same criteria ARE being used by ALL transplant centers--
coupled with better enforcement--might go a long way toward
resolving the concerns of those who have focused on perceived
geographic differences in waiting times for the most seriously
ill patients awaiting liver transplants.
I suggested on June 18th that in fact, it might well
already be the case that waiting times had already become
relatively equal throughout the country for our most critically
ill patients.
Today, with data for 1998 through the month of August now
available, I would like to call the Committee's attention to
the fact that for Status One patients, the most critically ill,
the mean waiting time for a transplant--across the country--now
is running four days, with not a great deal of regional
variation. For example, the mean waiting time in my state,
California, during this period was two days. The mean waiting
time in Pennsylvania was five days. The mean waiting time in
New York was two days. The mean waiting time in Florida was
three days. The mean waiting time in Texas was two days.
Let me additionally say that many of us in the transplant
community do not believe that time on a waiting list is
necessarily the best indicator of a fair organ allocation
system. But the Department of Health and Human Services--while
privately conceding to us that waiting times might not be the
best proxy for fairness--has made it clear that they intend to
stick to this rationale for implementing a rule that would
dramatically restructure organ allocation policy.
Well, that being the case, I would suggest that the
rationale for rushing this rule into effect may largely have
disappeared.
That brings me to my second point.
2. We have for some time now been trying to point out that
the Department's apparent determination earlier this year to
give priority to sickest patients first--without geographic
consideration--would in fact be detrimental to the goal of
providing the most Americans with life-saving transplants.
This policy, which has been modeled for liver
transplantation, has actually been shown to have significant
disadvantages to alternate systems, including the current one.
Giving priority to sickest first over broad geographic areas
would be wasteful and dangerous, resulting in fewer patients
transplanted, increased death rates, increased
retransplantation due to poor organ function, and increased
overall cost of transplantation.
The Department in subsequent discussions with our society
has told us that in fact, giving priority to sickest patients
first--in effect, creating a single national waiting list--is
not the intent of the rule. Nevertheless, they have not changed
the rule to make it clear that it would not require
transporting organs across broad geographic areas.
One additional problem with requiring broad geographic
transportation of organs is that it would curtail the use of
the new split-liver technique, in which a single organ is
divided to provide transplants for two recipients. Full
utilization of this split-liver procedure would potentially
increase available donor livers by close to 1,000 per year in
the U.S.
Just this summer, I have performed 10 split-liver
transplants--providing a new chance at life to 5 additional
Californians who otherwise would undoubtedly still be lingering
on the waiting list.
This is not to say that alternatives to the current
allocation policy should not be considered. We wish to
emphasize that this is exactly the process for the OPTN, namely
to thoughtfully reevaluate the existing policy as new data
becomes available.
I would like to make a final point before concluding my
oral testimony.
When I appeared before Congress on June 18th, I made it
clear that our Society of transplant surgeons was prepared to
work as intensively as possible with the Department of Health
and Human Services to resolve our concerns--which are
enumerated in our position paper, and many of which I have not
discussed in my oral testimony--if the Department's objective
remained to put a new OPTN rule into effect on October 1.
After communicating to them our concerns, we have waited
quietly--not taking our story to the media; not taking our
story to Members of Congress--while talks took place between
the Department and UNOS which we hoped would result in a
satisfactory resolution of these important issues.
Now, almost three months later, and only days before the
rule is scheduled to take effect, we have not been informed of
any specific proposed chances in the OPTN rule that would
address areas of critical importance to ASTS.
In the final analysis, the surgeons who are members of our
society are the medical professionals who took the vow to
First, Do No Harm. We believe the OPTN rule, as it stands,
would harm a system which we have tried to make as fair as
humanly possible.
We have serious concerns about the language in the rule as
it now stands which--in the final analysis--would permit
substitution of the Secretary's judgment on organ allocation
for the judgment of medical professionals. We do not believe
this is what was intended by Congress when it enacted NOTA, and
we urge the Committee to block implementation of the rule as it
now stands.
------
American Society of Transplant Surgeons--Position Paper
Introduction
On April 2, 1998, the Secretary of the Department of Health and
Human Services issued a final rule governing the Organ Procurement and
Transplantation Network (OPTN). The American Society of Transplant
Surgeons (ASTS) has discussed the merits of this final rule among its
members and council, and has formulated a position on these
regulations. There are areas of agreement, as well as disagreement,
with the rule as written. We believe that our collective experience as
transplant surgeons, involved and committed to the care of the
transplant patients, qualifies us to comment with perspective on these
regulations because of their direct impact on our patients' lives. ASTS
wishes to participate in constructive dialogue, and is appreciative
that Congress has extended the comment period until August 31, 1998 and
delayed implementation of the regulations until October 1, 1998. We are
hopeful that modifications to the final rule can be agreed upon by all
concerned parties prior to any implementation so that our patients can
best be served.
It is the goal of ASTS, first and foremost, to see that as many as
possible of the growing number of patients waiting to benefit from a
transplant actually receive this opportunity for a new chance at life.
As long as there continue to be fewer organs available than there are
patients awaiting a transplant, the ASTS believes public transplant
policies should support the primary goals of: (1) expanding and
enhancing organ donation throughout the United States through education
and legislative initiatives, and (2) insuring that the precious organs
presently available provide the maximum benefit to the maximum number
of Americans in an equitable fashion.
It is the consensus of ASTS that the rule issued by HHS should be
more definitively clarified to address these two issues since it may
unintentionally work against these national goals.
Organ allocation policy development
ASTS would first like to emphasize that we 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. To that end, the current OPTN contract holder, the United
Network for Organ Sharing (UNOS), has established clearly defined roles
and responsibilities that involve a broadly representative group of
individuals with expertise and interest in transplantation and the
patients we serve. For the most part, ASTS believes this system has
succeeded and ASTS supports the system. But ASTS also believes that
UNOS' performance as the OPTN contract holder requires continuous re-
examination and refinement. ASTS agrees that the HHS, as the grantor of
the OPTN contract, has oversight responsibilities, but ASTS believes
that HHS should not attempt to dictate medical practice. As discussed
in more depth in this document, ASTS does not believe HHS should be
involved in making, modifying, or vetoing organ allocation policy
unless directed to do so by law.
Allocation of organs
The HHS final rule sets three broad performance goals for organ
allocation including: (1) standardized listing criteria for placing
patients on waiting lists using objective and measurable medical
criteria; (2) standardized criteria for determining medical status
using objective and measurable medical criteria that will differentiate
patients from the least to the most medically urgent; and (3) organ
allocation policies that give priority to those whose needs are most
urgent with the result that differences in waiting times for patients
in the same medical status category will be reduced.
Standardized listing criteria
ASTS strongly agrees with the provision calling for standardized
listing criteria. It should also call for standardized de-listing
criteria. Only when standardized listing and de-listing criteria, and
standardized criteria for determining medical status, are universally
applied by all centers will waiting times become more interpretable
over time as one measure of equity of allocation policy. In fact, ASTS,
UNOS and its Board and committees, and the transplant community have
already recognized the need for standardized criteria and have acted
appropriately. In order to equitably allocate and distribute the scarce
organs, a well-defined procedure for entry to and exit from the waiting
list is required. Standardized listing criteria are in place for heart
and kidney recipients. Standardized listing criteria for liver
transplant recipients were developed by the Liver and Intestinal Organ
Transplantation Committee of UNOS and subsequently approved by the UNOS
Board. These criteria were implemented in 1997 and are currently
assumed to be in use by all liver transplant programs in the U.S.
Monitoring of this should be taking place even now. If non-compliance
is determined, enforcement by appropriate sanctions should be
recommended by UNOS and implemented by HHS.
These standardized listing criteria will need ongoing refinement as
medical practices change and more data on patient survival becomes
available. The ASTS is supportive of the process by which these
criteria are developed and modified, and supports the development of
standardized listing criteria for all transplanted organs.
Standardized criteria for determining medical status
The ASTS agrees that the same objective medical criteria should be
utilized by all transplant centers to determine the severity of a
patient's illness, and that the status classification scheme should be
as unambiguous as possible. There has been an ongoing effort within
UNOS to refine the medical status categories for liver transplant
candidates as the field of transplantation has evolved. Even further
refinement of this process is to be anticipated. We would support a
rapid review system whereby all patients being listed at any status
would need approval, and an appeal process for controversial patients
should be available.
Organ allocation policies that give priority to those whose needs
are most urgent. There have been different and conflicting conclusions
drawn about approaches to organ allocation, depending on favored
theoretical modeling systems, that cannot truly take into account
progress in this rapidly evolving field. There has been general
consensus in UNOS based on such modeling, but there have also been
outspoken minority viewpoints. We believe the allocation policy for
livers needs continuous evolution based on the most current knowledge,
which can only be reflected by the expertise of those deeply involved
in the field.
Based on this expertise, we do not believe that a single national
list of liver distribution is realistic or necessary to achieve an
equitable distribution system. Furthermore, we do not believe it is in
our patients' best interest. As it now stands, ASTS believes that a
single national list giving priority to ``sickest first'' would be
wasteful and dangerous, resulting in fewer patients transplanted,
increased death rates, increased re-transplantation due to poor organ
function, and increased overall costs of transplantation.
On the other hand, there are alternative distribution systems to be
examined that may enhance distribution equity. ASTS also recognizes
that within regions, there are issues of inequity that UNOS should have
the will and authority to address and facilitate correction. These are
issues that should be continuously re-examined by UNOS. We wish to
express our willingness and desire to be involved in this process.
Until the organ supply meets the organ demand, no perfect solution will
ever be achieved that will provide access to organs for all patients
who need them.
Transition to new policies
ASTS agrees with the Secretary that when the OPTN revises
allocation policies, provisions must be made to ensure that patients
already on the waiting list for transplantation are not disadvantaged
by the new policy.
OPTN Board composition
The final rule mandates an OPTN Board size of at least 30 members,
and specifically requires that 4 of these members be transplant
surgeons or transplant physicians.
We have always supported the inclusion of transplant recipients,
donor families and other members of the general public on the OPTN
Board. As you know, this is already the case. However, ASTS
respectfully submits that because of the technical and scientific as
well as ethical and social problems continuously presented by this
field, transplant surgeons and transplant physicians should constitute
no more nor less than 50 per cent of this Board. The final regulation
simply does not allow for this in a practical way.
On a related note, we wish to observe that ASTS considers it
essential for HHS officials and the OPTN to develop a closer working
relationship. While this need not be viewed as requiring a government
representative on the OPTN Board, it probably does mean that senior HHS
representatives should regularly attend OPTN meetings and maintain a
constructive dialogue with the OPTN Board and staff.
Public access to data
ASTS agrees with the Secretary that physicians, patients, and the
public should have access to accurate, understandable, and timely
information regarding transplant center performance. We believe that
data should be collected annually, and be made available to HHS and the
public within one-year after the period to which they apply. We agree
that these data should include general transplant center and program
information, actuarial patient and graft survival rates, re-transplant
rates, waiting times, rates of non-acceptance of organs, and other data
that would be helpful for physicians, patients, and their families in
making transplant decisions. The transplant community must be given the
opportunity to review and present the data in such a way as to avoid
misinterpretation, and the Secretary should provide assurances that any
release of data conforms to the laws and regulations governing the OPTN
and that patient confidentiality will be preserved.
Secretarial oversight
ASTS would be pleased to work with the Secretary to develop a
process that would preserve the Secretary's legitimate oversight role
while allowing a reasonable level of input by various stakeholders,
specifically including surgeons, other physicians, and patients
actively involved in transplantation. In suggesting this, however, we
wish to stress our view that organ allocation and other OPTN policies
should generally, if not always, be developed through an ongoing
consensus process under which the relevant scientific, clinical, and
ethical factors are considered.
Review and evaluation
ASTS strongly agrees that allocation and other policies, such as
standardized listing criteria, must be enforced. The regulation notes
(in section 121.10) that enforcement 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 of Medicaid. We believe that
the regulation should provide an opportunity for due process and
corrective action, and the initial use of time-limited intermediate
sanctions, prior to the imposition of severe sanctions such as
withdrawal of center Medicare and Medicaid reimbursement.
Reducing socioeconomic inequities
ASTS certainly believes that medical criteria should be the sole
determinant of access to transplantation. Section 121.4 of the final
rule requires the OPTN to develop policies that reduce inequities
resulting from socioeconomic status. We recognize that many Americans
lack health insurance coverage. Nevertheless, we view this as a
societal issue rather than one that can easily or independently be
addressed by the OPTN, or by individual transplant centers and
professionals.
Promoting organ donation
Finally, ASTS wishes to emphasize that the true solution to this
ethical and medical dilemma lies in increasing the supply of these
life-saving organs in our country. We strongly believe that this is
possible through just legislation and through devotion of additional
resources which, to date, have not been forthcoming. We believe it is
in this area that the ASTS can be most helpful and wish to express our
eagerness to carry this initiative forward.
STATEMENT OF CRAIG J. IRWIN, PRESIDENT, NATIONAL
TRANSPLANT ACTION COMMITTEE
Senator Specter. We now turn to Mr. Craig Irwin, president
of the National Transplant Action Committee.
Mr. Irwin. Thank you, Mr. Chairman.
In 1996, this body stated, the original intent of the
National Organ Transplant Act was to assure patients that no
matter who they were or where they lived, they would have a
fair chance for receiving an organ transplant.
Today the sense of the Senate as embodied in those words is
not being carried out. In fact, accidents of geography account
more for who receives a transplant than medical necessity.
Mr. Shay Colamarski from Spokane, WA, was a working and
productive young man when he found out he had hepatitis B and
needed a liver transplant. He was denied a transplant in
Washington and had to go to San Francisco, where he waited for
nearly 2 years. The waiting time in Washington was only about 9
months.
Mr. Colamarski received his transplant 1 year ago last week
and is with me today. Ask him if the system is fair to
patients.
Jordan Rosebar was not so fortunate. On June 1 she was
listed at hospitals in Pennsylvania and Florida in the most
urgent category, status 1. Two organs were found that evening.
One stayed in Louisiana. The other went to healthier patient in
a different Florida hospital. Jordan died early the next
morning. She was only 18 months old.
Each of these stories help illustrate the problems with the
current organ allocation system. Like Mr. Colamarski, about one
in four patients travel outside of their State for a
transplant. Even though patients migrate, our current system of
allocation is based upon local first.
As a result, patients are not treated fairly. Their chance
to receive an organ varies dramatically from city to city and
from State to State. The medical concept of triage is an
important one. Those who can benefit the most from health care
receive priority treatment.
But as young Jordan Rosebar's case illustrates, geography,
not medical urgency, is the key factor in the current organ
allocation system. Clearly, the OPTN is not working. The system
is not fair.
For nearly 6 years the allocation debate has raged within
the transplant community. Unfortunately, the welfare of
patients waiting for transplants have been largely ignored in
this debate. And so significant improvements have not been made
in the system.
However, at the same time, HHS has been working on final
rules governing the OPTN. The rules set clear performance
objectives for the OPTN that will promote equity and are
consistent with the medical principle of triage.
Once again, the Senate stated the United States should have
a consistent and fair system of organ allocation and move away
from the persistent fragmentation and inconsistency that may
have evolved despite the National Organ Transplant Act.
The Secretary's regulation does exactly that. While
negotiating on one hand, UNOS is fighting the regulations on
the other. While this debate rages, patients are dying
needlessly. The system is not fair.
UNOS serves two masters, profits for its members and the
needs of patients. HHS has only one, the needs of patients.
UNOS lacks the resolve to address these problems, instead
putting profits ahead of patients. These regulations cannot be
delayed any longer.
prepared statement
Once again, Mr. Chairman, I conclude citing the Senate's
own words, It is time for the final rule to be issued. The
final rule is viewed by the Senate to be of highest priority. I
hope these words still ring today.
Thank you.
Senator Specter. Thank you very much, Mr. Irwin.
[The statement follows:]
Prepared Statement of Craig Irwin
The National Transplant Committee [NTAC] respectfully submits its
comments to the Senate Appropriations Committee, on its hearing
concerning the governance of the U.S. Organ Procurement and
Transplantation Network [OPTN]. NTAC is a consumer advocacy
organization with approximately 1500 members across the United States,
NTAC was founded 1992 by organ transplant patients and advocates
interested in public policy issues ant decisions that impact organ
transplant patients and their families. NTAC is not directly affiliated
with any transplant centers or professional organizations.
NTAC and its principals have a long history of involvement with the
National Organ Transplant Act [NOTA] and federal organ transplant
policy. One of the current NTAC directors was involved with the
original 1983 Congressional hearts that eventually led to the
establishment of the OPTN. Since then, NTAC officers and directors have
testified at Congressional hearings in 1990, 1993, and 1995. In 1995,
NTAC was the only transplant patient advocacy organization invited to
testify at hearings on NOTA before the Senate Committee on Labor and
Human Resources.
NTAC has also closely monitored and participated in the development
of the Final Rule on the OPEN that is the subject of today's hearing.
NTAC submitted a comment on the proposed rule in 1994 and participated
in hearings conducted by the Department of Health and Human Services in
December 1996. In addition, we have also participated in deliberations
conducted by the OPTN contractor pertaining to the allocation of organs
for transplantation. In September 1996 NTAC participated in a forum
conducted by the OPTN contractor on the allocation of livers for
transplantation
NTAC supports the final OPTN rules as published by HHS. We believe
that the rules arc consistent with the intent of NOTA and that they
serve the best interest of the public health, organ transplant
patients, and organ donor families.
While supporting the final rule, NTAC also has grave concerns about
the misinformation and lobbing activities conducted by many doctors and
professionals in the transplant industry as well as the OPTN
contractor. We feel that these activities have needlessly inflamed and
frightened transplant patients and their families. The contractor's
efforts to stop or delay the implementation of these rules is
reprehensible and should be a factor considered by the Congress in any
future deliberations regarding the OPTN contractor and contract.
hhs authority to oversee the optn
NOTA was enacted by Congress in 1984 in order to establish a
national system, based upon medical criteria, of matching organ donors
and patients needing transplants. Although NOTA mandated that the OPTN
operate under the management of a ``private, non-profit organization.''
the act also requires the Secretary to maintain a unit within the
Public Health Service to ``administer [the act].''
Because of the role given to the private contractor under NOTA,
some have argued that the intent of Congress was to create an
independent private network free of government intervention. In 1990,
Congress amended the act in order to provide the Secretary with greater
flexibility in contracting for the operation of the OPTN. This
amendment clearly places greater responsibility and authority within
HHS to oversee the operation of the OPTN. NTAC believes that there is
an important role for the Secretary and the Department of Health and
Human Services in the operation of the OPTN and that the Final Rule is
consistent with the Congressional intent of NOTA.
Although Congress has not amended NOTA since 1990, in 1996 the U.S.
Senate, under the leadership of Senators Frist and Kennedy, unanimously
passed the Organ Transplant Reauthorization Act of 1996. As part of its
report, the Senate stated that ``It is the committee's belief that a
portion of the public distrust [of the organ transplant network] is an
indirect result of the failure of the government to issue final rules
governing the policies and procedures for organ transplantation. Else
committee believes that it is time for the final rule to be issued and
that the call for final rules, which has spanned more than 6 years,
needs to be brought to closure. The ``final rule'' is viewed by the
committee to be of highest priority.''
NTAC believes that HHS serves a vital role in organ transplant
policy in the United States. Congress has also stipulated a clearly
defined role for HHS. We believe that the rules now under consideration
are consistent with NOTA and serve the best interest of transplant
patients and the public.
specific provisions of the regulations
Section 121.3.--The OPTN
NTAC supports all the provisions of this section of the regulation
and especially those sections pertaining to the composition of the
board and qualifications for membership in the OPTN.
NTAC has long held the view that there is a great measure of
conflict among all board members of the OPTN between their personal/
institutional interests and those of the transplant patients. As stated
in the preamble of the rule, organ transplantation has become a $3
billion industry in the United States. Organ transplant centers,
physicians and surgeons all have a vested financial stake in the public
policies developed by the OPTN. These decisions can translate into
millions of dollars for a single institution. In addition, a health
care facility's ability to maintain a viable organ transplant program
can also translate into millions of additional dollars through other
grants and contracts.
These financial incentives to maintain a viable transplant program
can bias critical public policy decisions. Since its inception, the
OPTN has maintained a board of directors made up predominantly of
physicians and surgeons in the transplant industry. We believe that the
OPTN board composition hinders thoughtful public policy. Nowhere has
this been more evident than in OPTN policies governing organ
allocation.
NTAC supports section 121.3(a) in its entirety. The inclusion of
six members of the general public on the OPTN board of directors
(paragraph (a)(1)(iv)) will ensure that the policies of the OPTN will
continue to serve the public's health care interest. Furthermore,
limiting surgeon and physician membership on the board to 50 percent
combined with a minimum requirement that 25 percent of the board
consist of patients, donors, and families members, will help protect
the interests of the transplant patients.
It has been argued that patients, donors and family members already
represent more than 25 percent of the OPTN board. Although this may be
true, it is also true that oftentimes these ``public'' members of the
board have been medical doctors or had some additional professional
interest in organ transplantation. It has also been argued that a high
degree of professional and medical expertise on the OPTN is necessary
in order to effectively deal with the complex medical decisions
required of the OPTN board of directors. In truth many of the issues
facing the OPTN board involve broad public policy decisions where a
medical background and education is not critical. A framework to
provide medical guidance and input to the board of directors is
sufficient to assist the board with understanding the medical factors
that impact their public policy decisions
In addition to the overwhelming influence of medical professionals
on the OPTN board, the OPTN membership is also strongly biased toward
transplant professionals. At present there are fewer than 10 ``general
public members'' of the OPTN contractor. Section 121.3(c)(2)(iii) will
provide any interested parties with an opportunity to become a member
of and participate in the OPTN. This will result in broader
participation in the selection of OPTN board members and provide
protections that the policies of the OPTN will serve the public health
care interest without the influence of financial conflict or bias.
Section 121.11.--Record maintenance and reporting requirements
There are many factors that impact the likelihood of receiving and
saving an organ transplant. Among these are the experience and
historical performance of the transplant center, the acceptance and
turn down rate of donated organs, as well as the length of an
institution's waiting list. NTAC believes that there is a broad range
of critical data that must be made available to the public and to
transplant patients. This information must be timely and accurate.
Also, it is important that the public be able to evaluate and
monitor the impact of public policy decisions on organ transplant
patients as well as assess the performance of the OPTN contractor. This
requires access to a wide range of critical data.
The current OPTN contractor's system of record maintenance and
reporting is insufficient to meet the critical needs of patients, the
public, and those with an interest in the public policies of the OPTN.
It has been our experience that important data is often withheld
without good reason. The current OPTN contractor has used arguments
such as ``patient confidentiality'' and ``the data has not been
verified'' to defend its refusal to make available critical data.
However, it is our belief that these ``defenses'' have been nothing
more than a tool to guard the OPTN contractor or individual OPTN
members from scrutiny or criticism.
The OPTN last published the center specific survival report in
1997. The data used in the analysis only included transplants performed
through 1993. As a result, the report included many qualifying letters
from transplant centers providing their most recent patient survival
results. Unfortunately, these updates are meaningless unless they are
reported in the risk-adjusted format of the center specific report
itself and in a manner that enables individuals to compare transplant
performance in some meaningful way. What makes this matter even more
critical is the fact that it is oftentimes transplant centers with
poorer outcomes that use these ``updates'' to report more recent and
more favorable results.
NTAC believes that maintaining patient confidentiality is important
and is confident that HHS will ensure that the individual privacy and
confidentiality of transplant recipients will be protected under the
rule's expanded reporting requirements. The OPTN rule would ensure that
critical data be made available to patients, families, advocates, and
other interested parties. The availability of this data will make it
possible for patients to be better informed about transplant centers
and possible options at the time of transplant. Furthermore, the rules
will facilitate the appropriate monitoring of the transplant system as
a whole.
Section 121.8.--Organ allocation
Over the past two decades, organ transplantation has proven to be
an effective means of treating patients with end stage organ failure.
Unfortunately, there are not enough organs to save everyone. Despite
efforts within the transplant community to increase donation, the
number of organs available has grown only about 1 to 2 percent per
year. In the meantime, the number of Americans waiting for organ
transplants is now approaching 60,000.
NOTA was enacted so that ``an equitable policy and system [would
exist] so that individuals throughout our country can have access to
organ transplantation when appropriate and necessary.'' Congress
created the National Task Force on Organ Procurement and
Transplantation whose responsibility it was to develop recommendations
that would lead to a ``truly national, coordinated mechanism for
efficient distribution of all available organs.'' (Senate Report No.
98-382 and House Conference Report No. 98-1127, U.S. Code Cong. And
Adm. News, p. 3975)
In its report, the Task Force recommended that ``donated organs be
considered a national resource to be used for the public good.'' The
Task Force also recommended that ``selection of patients both for
waiting lists and for allocation of organs be based upon medical
criteria that are publicly stated and fairly applied.''
However, there is a growing list of publications and reports that
have all concluded that the nation's organ allocation system is not
fair and that standards other than medical criteria often decide who
receives an organ transplant. According to the most recent reports, the
system takes its biggest toll on minorities and children.
On June 1, Jordan Rosebar was listed in the most urgent category,
Status I, at a hospital in Pittsburgh, PA. In a desperate measure,
surgeons also listed her at the University of Miami Medical Center in
Florida. Within hours, two sets of organs were known to be available
from the organ procurement organization serving the Miami region. No
one was more critical than Jordan was. But, because she was physically
in Pittsburgh, the current system prohibited those organs from being
shipped to save Jordan. However, one organ stayed in Louisiana while
the other was to be transplanted into a patient in the lowest priority
category at a Florida hospital. Jordan died early the next morning.
Jordan Rosebar was 18 months old.
NTAC enthusiastically supports Section 121.8 of the rule governing
organ allocation. The rule establishes a public policy objective in
lieu of proscribing a specific organ allocation model. We believe that
the HHS rule establishes an appropriate public policy while allowing
medical professionals to develop the necessary medical criteria for
organ allocation. Also, the HHS rule provides flexibility so that organ
allocation policies may quickly be modified to meet any future changes
in medical technology.
The objectives stated in the rule will not only improve the equity
of the system consistent with the intent of Congress and the National
Task Force; it will also save lives in two important regards. First,
computer simulation modeling has illustrated that a system of improved
equity based upon medical standards will result in patient's living
longer lives. Second, the results of a poll completed for NTAC by the
Gallup Organization found that nearly 1 in 3 Americans would be more
willing to consent to organ donation if they knew that the organs would
go to the patients who needed them the most regardless of where they
lived. The HHS rule will foster greater public confidence and support
in the nation's transplant system.
We believe the rule to be in the best interest of transplant
patients and the American public. It concerns us that many
professionals in the transplant community have attempted to inflame
transplant patients and the public through misleading statements. Their
goal is to maintain a system that serves many transplant programs well
while serving the public health care interest poorly.
Opponents have charged that the rule will result in the closure of
transplant centers and harm patient access to transplantation. There is
no evidence to support this. Using UNOS modeling data, NTAC has
examined the net impact of greater organ sharing and greater equity in
liver allocation. We have found that there will be minimal impact, if
any, on patient access to transplants. The majority of the transplant
centers will continue to be those that annually perform 25 to 100
transplants.
Opponents have also argued that broader organ sharing will have an
adverse impact on organ donation. In a poll conducted for NTAC by the
Gallup Organization 83 percent of those who responded agreed that
organs ``should go to the sickest patient in the U.S. no matter where
they live.'' Also, 32 percent said that they would be more likely to
donate an organ if they knew that the organ recipient was the sickest
person, regardless of location.'' NTAC believes that the HHS rule will
have a positive impact on organ donation by fostering greater
confidence in the organ allocation system.
Opponents have argued that more patients would die if there were
greater organ sharing to create equity. The bulk of the evidence
supports just the opposite. Currently, ``healthier'' patients on the
waiting list often receive transplants while sicker patients wait and
die. For healthier patients, there are other health care options that
can prolong life, improve a patient's quality of life, and delay the
need for an organ transplant. For the sickest patients--there is no
other option but transplantation.
Although we are supportive of the allocation section of the rule,
we have concerns over the enforcement of the public policy directive.
The current OPTN contractor has shown a resistance to positive changes
in the organ allocation system despite growing evidence that the
current system is not fair and despite pleas from patient support
groups for change. It is our hope that the Secretary and the Department
will aggressively enforce the organ allocation policy established in
the rule and ensure that the OPTN contractor complies with the rule as
published.
We believe that the organ allocation policy established by HHS will
serve patients well and foster the development of a system that is fair
and equitable to all Americans needing organ transplants.
summary
The rule making process has extended a number of years. NTAC
believes that the resulting rule is the result of a great deal of
research and thought on the part of the Department of Health and Human
Services. The policies established by HHS will provide a strong voice
for patients and the public in this very important sector of the health
care industry while still providing doctors and other medical
professionals the needed flexibility to make health care decisions in
consultation with their patients.
The regulations will also ensure the national system of organ
allocation and transplantation that was envisioned by Congress in 1984
and is still the goal today.
The original intent of the National Organ Transplant Act was to
assure patients that no matter who they were or where they lived, they
would have a fair chance of receiving an organ transplant. It is the
belief of the committee that the United States should adopt a
consistent and fair system of allocation and move away from the
persistent fragmentation and inconsistency that may have evolved
despite the National Organ Transplant Act.''
``It is the committee's belief that a portion of the public
distrust [of the organ transplant network] is an indirect result of the
failure of the government to issue final rules governing the policies
and procedures for organ transplantation. The committee believes that
it is time for the final rule to be issued and that the call for final
rules, which has spanned more than 6 years, needs to be brought to
closure. The ``final rule'' is viewed by the committee to be of highest
priority.''
National Transplant Action Committee supports the OPTN Rule and
looks forward to working with the Department of Health and Human
Services toward its successful implementation. We hope that the
Congress will allow the current process to move forward so that all
Americans' regardless of who they are or where they live, will have a
fair and equitable opportunity to find a donor when they need an organ
transplant.
STATEMENT OF CHARLES M. MILLER, M.D., DIRECTOR, THE
RECANATI-MILLER TRANSPLANTATION INSTITUTE
Senator Specter. We now turn to Dr. Charles Miller,
director of the Recanati-Miller Transplant Institute, Mount
Sinai Hospital, New York.
Welcome, Dr. Miller. The floor is yours.
Dr. Miller. Good morning and thank you, Mr. Chairman, for
the opportunity to address the committee.
Today, based on my 15 years of experience as a transplant
surgeon, I would like to give you my personal view of these
complex issues in transplantation, voice my strong support for
the rule issued by HHS, and convince the committee that it
should be implemented without delay.
The rule states, ``Geography cannot remain a primary
criteria in organ allocation. Where you live cannot determine
whether you live or die.''
Presently, there are 63 areas served by local organ
procurement organizations. And the boundaries that these make
make our organ allocation system inequitable, because medical
urgency and length of time waiting are rendered less important
than where the organ is procured.
Livers, for instance, are preferentially given to local
patients, even if there are sicker patients just across an OPO
border in a neighboring community. For example, a liver in New
Jersey, where I live, parenthetically, might be used in Newark
for a patient waiting comfortably at home while a patient
across the river in New York is dying in the ICU. And vice
versa. Such accidents of geography should not continue.
The link between organ distribution and OPO boundaries
dates from the infancy of transplantation, when organ
preservation techniques did not allow safe distance sharing of
organs.
Today there is no logic in remaining confined to local
distribution areas. We need to bring our system up to our
science. By sharing organs beyond where they are procured, the
playing field will be leveled for patients and fairness
achieved.
Now, broad sharing in a national system is not the same as
a single national waiting list. A single list is just one type
of national system. While it ensures equity, it would also
require the most extreme change, from these 63 subsystems to
just 1. And the transplant community, and I agree with Dr.
Busuttil, agrees that a single national list is not necessary
to achieve reasonable equity.
The systems based on population densities or larger super
regions would provide for more flexibility, economies of scale
and community acceptance. Any such potential system is possible
under the new rule, as it does not mandate any specific system.
It merely makes equity for patients the primary objective.
What about the concept of caring for the sickest patient
first? Now some opponents of the new rule claim that the
concept portends utilitarian disaster, that fewer lives will be
saved.
But caring for the sickest first does not mean wasting
scarce organs, because the new rule also demands utility to
minimize organ wastage. It calls for a system to discourage
transplantation of patients with no reasonable hope of
survival.
Interestingly, each OPO already employs a sickest first
policy. And our ability to care for transplant candidates and
to identify patients with no reasonable chance of survival has
improved dramatically in recent years.
UNOS has already instituted, and we must continue to
refine, specific criteria for placing patients on or removing
them from the waiting list and for prioritizing them according
to medical urgency. Employing such criteria many more lives
will be saved with broader sharing and timely transplantation
of the neediest patients.
Two other commonly expressed fears regarding the new rule
are that smaller transplants will have to close and that organ
donations will decrease. But there is no evidence, no evidence,
to support either of these concerns. With respect to small
centers, there is actually some evidence that they will do
better.
It is much more likely that transplant centers will open or
close on the basis of factors other than allocation, including
reimbursement issues, quality issues, institutional support,
and local competition for patients.
prepared statement
I also believe that the HHS rule will actually lead to
increased organ donation, as the public begins to trust that
organs will be dispensed fairly. Three opinion polls have
clearly shown that donor families want organs to go to patients
who need them the most, and they do not care----
Senator Specter. Your red light is about to go on. Would
you summarize, please, Dr. Miller?
Dr. Miller. Yes, sir.
In summary, the HHS rule is a flexible, patient-sensitive
plan. The long debate over organ allocation has outlived its
useful. Let us enfranchise the public and save more lives by
allowing the rule to be implemented without delay.
Thank you.
Senator Specter. Thank you very much, Dr. Miller.
[The statement follows:]
Prepared Statement of Dr. Charles M. Miller
Good morning. Thank you for the opportunity to address the
committee. My name is Charles Miller. I am a transplant
surgeon. I am also the physician-in-chief of transplantation
services at the Mount Sinai Hospital in New York City, and
Director of the Transplantation Institute at the Mount Sinai
Medical Center. I have been part of the national discussion
regarding organ donation and organ allocation for over seven
years. As a member of UNOS, I have served on its many
committees, including its organ allocation committee, for over
five years. From 1994 to 1996, I was a member of the UNOS board
of directors. In addition, I have been a member of the American
Society of Transplant Surgeons for more than 10 years, and I
have worked within that organization to help formulate a
rational and balanced position on these issues. At the request
of Barbara DeBono, New York State's Commissioner of Health, I
have also chaired, for the past year, the State's task force to
increase organ donation.
Today I'd like to give my personal view on the complex
issues of allocation and donation, voice my strong support for
the rule issued by Secretary Shalala, and convince you that her
thoughtfully conceived plan should be implemented without
delay.
In general, I see little need for governmental intervention
in our field. However, I am troubled by our community's lack of
success in developing a fair allocation system, despite in-
depth analysis and computer modeling, and I am concerned about
the destructive publicity that the debate has caused and its
negative effect on organ donation. For over seven years now,
the transplant community has struggled unsuccessfully to
develop a system for allocating organs that is fair to all
patients. We have made some progress, but unfortunately we have
not resolved one of the most fundamental questions: Are donated
organs a local commodity or a national treasure to be
distributed based on patient need?
The dispute within the transplant community has reached the
point where governmental input and mediation is required, to
establish and confirm that the prime consideration in organ
allocation is not where one lives but rather one's medical need
and reasonable chance for survival.
Secretary Shalala wrote, ``Geography cannot remain a
primary criteria in organ allocation. Where you live cannot
determine whether you live or die.'' Illness knows no
geographic boundaries. Neither should organ allocation.
Presently, however, organ allocation is based primarily on
narrow geographic boundaries--the 63 areas served by local
Organ Procurement Organizations [OPO]. These boundaries make
our organ allocation system inequitable, because medical
urgency and length of time waiting are rendered less important
than where an organ is procured. Livers are preferentially
given to local patients, even if there are sicker patients
across an OPO border in a neighboring community. For instance,
a liver in New Jersey might be used in Newark for a patient
waiting at home, while a patient across the river in New York
is dying in the ICU. Or vice versa. Such ``accidents of
geography'' happen all the time without our knowing it, because
there are almost always local patients who can use an organ,
and the system does not in the first instance look for
recipients outside of the local area. The link between organ
distribution and OPO boundaries dates from the infancy of
transplantation, when organ preservation techniques did not
allow safe, distant sharing of organs. Today, there is no logic
in remaining confined to local distribution areas. We need to
bring our system up to our science. Once the primacy of
geography is nullified by the new rule, we have the ingenuity
and ability to develop equitable formulas for allocation. By
sharing organs beyond where they are procured, the playing
field will be leveled for patients with equivalent disease
severity across the entire country.
I would also like to briefly discuss several other issues
raised by the final rule that are causing concern in the
transplant community.
I want to emphasize that broadening sharing in a rational
national system is not the same as having a single national
waiting list. Why are the terms ``single national list'' and
``national system'' different? A single national list is but
one type of national system. For any organ, it is important to
understand that broadened sharing in a national system is not
the same as a single national waiting list. A single national
list would provide the most pure form of equity, but it would
also require the most extreme change, from 63 subsystems to 1.
For many good reasons, there is broad consensus within the
transplant community--with which I agree--that a single
national list is not necessary to achieve reasonable equity and
is in other ways undesirable. Systems based on population or
organ donor densities or large super-regions would provide for
more flexibility, economies of scale, and community acceptance.
Any such potential system is possible under the new rule, as it
does not mandate a specific distribution or allocation
algorithm; it merely makes equity the primary objective. What
the new rule does mandate, however, is that we finally begin
the hard work of designing a new, fair and modern system.
What about the concept of ``caring for the sickest patient
first?'' Some opponents of the new rule claim that this concept
portends utilitarian disaster--that fewer lives will be saved
and organs will be wasted. But ``caring for the sickest first''
does not mean wasting scarce organs. The new rule also demands
utility, to minimize organ wastage. It calls for a system that
discourages transplantation of patients with no reasonable hope
of survival. Interestingly, each OPO already employs a
``sickest first'' policy. Our ability to care for transplant
candidates and to identify those patients who have no
reasonable chance of survival has improved dramatically over
recent years. UNOS has already instituted, and we must continue
to refine, specific criteria for placing patients on or
removing them from the waiting list and for prioritizing them
according to medical urgency. Employing such criteria, many
more lives could be saved with broader sharing and timely
transplantation of the sickest patients. And it is critical
that decisions requiring medical judgment, including such
criteria, be made by physicians, not by bureaucratic or
political decree.
Two other commonly expressed fears regarding the new rule
are that smaller transplant centers will have to close, and
that organ donation will decrease. There is no evidence to
support either of these concerns. With respect to the question
of center closures, I believe that the new rule will be neutral
in terms of its impact. If a wider sharing system were
instantly enacted, it might temporarily shift organs away from
centers with shorter waiting lists toward centers with longer
lists, where patients have long waiting times--but in time, as
the playing field became level, new patients at small centers
would accrue waiting times that were equivalent to those of
patients at larger centers. Advocates for some small centers
are concerned, however, that the temporary downturn in volume
would be so severe that they would not be able to maintain
financial or operational viability. This fear is unfounded,
because the new rule demands that new policies be put into
effect with ``transition protections'' to assure that patients
who are already listed will not be disadvantaged by any new
system. During a transition period, centers can adapt in order
to remain competitive. It is much more likely that transplant
centers will open or close on the basis of factors other than
allocation, including reimbursement issues, quality issues,
institutional support, and local and regional competition for
patients.
In contrast to the oft-stated rhetoric that organ donation
will suffer, I believe that the HHS rule will lead to increased
organ donation as the public begins to trust that organs will
be dispensed fairly. Three opinion polls have clearly shown
that donor families want organs to go to patients who need them
the most, and that they don't care about geographic boundaries.
The real benefit to the donor family is the opportunity to
transform, at least in part, a terrible tragedy into a chance
for life for another person, in a process that is still
considered by many to be mysterious and miraculous. They feel
that the meaning and value of their gift is maximized by making
sure that the neediest patients are transplanted first, no
matter where they might be.
In summary, our organ allocation system continues to put
geographic primacy above patient need. You or I, our spouses or
members of our families, could someday be one of these severely
ill people. Illness knows no geographic boundaries. Neither
should organ allocation.
Secretary Shalala's rule is a courageous, flexible, and
patient-sensitive plan that allows for improved cooperation
between the government and the transplant community. The long
debate over organ allocation has outlived its usefulness.
Enough is enough. Let's enfranchise the public, by allowing the
rule to be implemented without delay.
STATEMENT OF WILLIAM PFAFF, M.D., PRESIDENT, UNITED
NETWORK FOR ORGAN SHARING
Senator Specter. We now turn to Dr. William Pfaff,
president of the United Network for Organ Sharing.
Thank you for joining us, Dr. Pfaff. And the floor is
yours.
Dr. Pfaff. Chairman Specter, members of the subcommittee,
good morning. I am Dr. William Pfaff, the emeritus professor of
surgery at the University of Florida College of Medicine and
the current president of the United Network for Organ Sharing.
It is an honor and privilege to be here this morning to testify
about organ donation and allocation issues that, unfortunately,
have become very, very controversial.
Senator Faircloth. Doctor, would you pull the microphone
closer, please?
Dr. Pfaff. Thank you, sir.
We at UNOS are troubled by this current controversy and,
like all of you, wish it to end and focus what we need to do
best and what do most; that is, working to ensure that organ
donation increases and as many patients as possible have access
to life-saving transplants.
No discussion of allocation can be complete without
mentioning donations. So let me commend HHS and Congress for
their recent commitments and efforts to increase organ
donation. The Health Care Finance Administration recently
issued a regulation requiring all hospitals participating in
the Medicare system to follow similar procedures, as have the
recent State legislations in Pennsylvania and Maryland. UNOS'
board of directors unanimously voted to support the HHS
regulation.
As we exist today, UNOS, by its design and in its role as
the organ procurement and transplant network contractor, has
developed a consensus-based policymaking process that is
intended to continually evolve and innovate in response to
technological advances, changes in donation rates, and other
developing circumstances. We provide a national forum for
establishing sound consensus-based medical guidelines for
transplantation and distribution of organs.
Organ procurement distribution policies are continually
challenged and verified within this process to ensure that most
is made of the scarce and precious resource or donor organs.
The transplant community's policies are published for public
comment and are ultimately reviewed and approved by HHS.
At issue here is the April 2, 1998, Department of Health
and Human Services regulation governing the activities of the
transplant network and laying out a framework for a new organ
allocation system and processes by which transplant policy is
made.
To summarize our concerns, UNOS believes, No. 1, the
regulation, as written, is subject to misunderstanding and
conflicting interpretations and could potentially cause harm to
patients.
No. 2, clarification by Congress is needed to resolve the
possible conflicts between the regulation and the National
Organ Transplant Act, as highlighted by the AMA in its written
comments to the Department.
No. 3, the regulation must reflect the intent of NOTA that
OPTN governance and policy issues be determined by the OPTN
with oversight by HHS.
No. 4, we think the regulation should be delayed until it
is rewritten to clarify the Department's intent and make other
necessary changes.
Since the June 18 joint meeting, we have had five
productive meetings with top HHS and HRSA officials to discuss
a number of our specific concerns, including the intent of some
of the language which appears in the regulation. We were
pleased, for example, to learn that the Department does not
intend to require a national sickest patient first allocation
system. But we continue to be concerned that this
interpretation is not adequately reflected in writing within
the regulation.
Our meetings have been fruitful in clarifying the
Department's intent and interpretation with regard to other
specific aspects of the regulation. However, these discussions
have not been completed.
prepared statement
UNOS firmly believes that all clarifying interpretations
must be reflected within the regulation. Without such changes,
the transplant community, patients and donor families are left
wondering and worrying about fundamental components of organ
procurement and allocation policy. We are hopeful that
continued discussions with HHS will bring our resolved issues
to resolution.
So on behalf of HHS, we thank you for inviting us to
participate in the hearing today. I would be happy to answer
any of your questions.
Senator Specter. Thank you very much, Dr. Pfaff.
[The statement follows:]
Prepared Statement of Dr. William W. Pfaff
Chairman Specter, members of the Subcommittee, good morning. I am
Dr. William Pfaff, Professor Emeritus of Surgery at the University of
Florida College of Medicine and current President of the United Network
for Organ Sharing (UNOS). It is an honor and a privilege to be here
this morning to testify on organ donation and allocation issues that
have unfortunately become controversial. We at UNOS are troubled by
this current controversy, and like all of you, wish to end it and focus
on doing what is needed most--working to ensure that organ donation
increases and as many patients as possible have access to life saving
transplants.
Donation and the current system
No discussion of organ allocation can be complete without
mentioning donation. So, let me first commend HHS and Congress for
their recent commitments and efforts aimed at increasing organ
donation.
We face a critical shortage of donated organs in this country. The
list of patients waiting to receive life saving organ transplants grows
dramatically each day. Since 1988, the organ transplant waiting list
has quadrupled, with nearly 61,000 men, women and children waiting for
a transplant today. Yet, the number of individuals who have chosen to
give the gift of life has not grown commensurately.
Many states are recognizing this problem and are implementing new
laws to encourage and facilitate organ donation. For example,
Pennsylvania and Maryland have passed laws that require hospitals to
contact their Organ Procurement Organization (OPO) whenever a fatality
occurs so that the OPO can make a preliminary decision to pursue
donation of either organs or tissues. In addition, the Health Care
Financing Administration recently issued a regulation requiring all
hospitals participating in the Medicare system to follow similar
procedures. UNOS' Board of Directors unanimously voted to support this
regulation.
Obviously, the difficult decisions about organ allocation would be
made infinitely easier if there were simply more organs available to
those in need. Accordingly, we appreciate the Department's efforts
toward this end and we stand ready to work with the Secretary and
Congress on additional initiatives that will help promote organ
donation. In fact, just yesterday we sent to every office on Capitol
Hill some important information about organ donation including an organ
donor card and we encourage you today to sign those cards and become a
potential donor.
UNOS, and its predecessor organization the South-Eastern Organ
Procurement Foundation (SEOPF), have been involved in human organ
procurement and distribution for more than 20 years. We are a
membership organization that seeks to improve transplantation through
self-governance for the benefit of patients with organ failure. UNOS
members represent the breadth and depth of the transplant community and
are transplant centers, OPO's, patients, recipients, donor families,
physicians, surgeons, scientists, health organizations and the public.
UNOS was the first and has subsequently been the only private
corporation to hold the Federal contract to operate the OPTN. We have
now enjoyed the honor of operating the OPTN for more than 12 years.
As we exist today, UNOS, by its design, and in its role as OPTN
contractor, has developed a consensus based policy-making process that
is intended to continually evolve and innovate in response to
technological advances, changes in donation rates and other developing
circumstances. We provide a national forum for establishing sound,
consensus-based medical guidelines for transplantation and the
distribution of organs. Organ procurement and distribution policies are
continually challenged and verified within this process to ensure the
most is being made of the scarce and precious resource of donor organs.
UNOS uses state-of-the-art computer technology and the best talents of
the transplant community to bring the most efficient and equitable
organ allocation system to patients who depend on it. The transplant
community's policies are published for public comment and are
ultimately reviewed and approved by HHS.
The OPTN regulation
At issue here today is the April 2, 1998 Department of Health and
Human Services (HHS) Regulation governing the activities of the OPTN
and laying out a framework for a new organ allocation system and
process by which transplant policy is made. In testimony before a joint
hearing earlier this year, my predecessor detailed UNOS' concerns with
the April 2 Regulation. We have submitted detailed comments on this
Regulation to HHS. I can provide both documents for the record if you
would like. To summarize for you today, however, UNOS believes that:
(1) the Regulation as written is subject to misunderstanding and
conflicting interpretations and could potentially cause harm to
patients, (2) clarification by Congress is needed to resolve the
possible conflicts between the Regulation and the National Transplant
Act (NOTA) (as highlighted by the AMA in its written comments to the
Department), (3) the Regulation must reflect the intent of NOTA that
OPTN governance and policy issues be determined by the OPTN with
oversight by HHS and, (4) the Regulation should be delayed until it is
rewritten to clarify the Departments intent and make other necessary
changes.
Since the June 18th joint hearing, we have had five productive
meetings with top HHS and HRSA officials to discuss a number of our
specific concerns including the intent of some of the language which
appears in the Regulation. We are pleased, for example to learn that
the Department does not intend to require a ``national sickest patient
first'' allocation system, but we continue to be concerned that this
interpretation is not adequately reflected in writing within the
Regulation. Our meetings thus far have been fruitful in clarifying the
Department's intent and interpretation with regard to other specific
aspects of the Regulation, however these discussions are not completed.
UNOS firmly believes, that all clarifying interpretations must be
reflected within the Regulation. Without such changes, the transplant
community, patients and donor families are left wondering and worrying
about fundamental components of organ procurement and allocation
policy. We are hopeful that continued discussions with HHS will bring
our unresolved issues to resolution.
On behalf of UNOS, thank you again for inviting us to participate
in this hearing today and I would be happy to answer any of your
questions.
sickest patients
Senator Specter. As I said, we are going to have to
conclude at 11 o'clock or as close to that as we can. We have
had others join us on the panel. We are going to have a single
round of 4 minute questions.
And let me begin with you, Dr. Busuttil. In your oral
statement and writing, you have said that to give priority to
sickest patients first without geographic consideration would
in fact be detrimental to the goal of providing the most
Americans with life-saving transplants.
I have read the statement. By the way, all statements will
be made a part of the record in full. Aside from the issue of
providing transplants to people who are moribund, which will
not be done according to the Secretary, what is your reasoning
which says that giving it to sickest patients first without
geographical consideration would be detrimental to providing
Americans with life-saving transplants?
Dr. Busuttil. A couple of reasons, Senator. First of all,
if we have no geographic considerations, organs will be flying
long distances. When the organs fly long distances, they have a
long ischemia time. The chances of those organs not working is
increased. And that is even augmented when you put those organs
in patients who are critically ill.
Senator Specter. Is that in fact true? I am told that with
the modern technological--well, never mind what I am told.
Dr. Miller, do you agree with that?
Dr. Miller. Well, I do not agree, with all due respect to
Ron, who has tremendous experience as well----
Senator Specter. Well, without respect, get to the point.
Does geographical distribution pose a medical problem?
Dr. Miller. I think in a full national system it might, but
anything less than that probably would not.
Senator Specter. Well, how would it? That is a pretty
important point. In a full national system, how would the
organs be injured?
Dr. Miller. Well, it depends on which organ you are talking
about, No. 1. I think shipping----
Senator Specter. Which organs would be injured?
Dr. Miller. Well, hearts could definitely be injured. So
you really--you do not want to really preserve a heart more
than 4 to 6 hours. And I think getting that across the country
really could be detrimental----
Senator Specter. How many hours did you say?
Dr. Miller. 4 to 6.
Senator Specter. Can any other organs be injured?
Dr. Miller. But, you know--but the liver can oftentimes
make it across the country safely. But you can probably----
Senator Specter. Can any other organs be injured? I want to
come back to Dr. Busuttil. He is shaking his head no with
livers. Any other organs injured from a national distribution?
Dr. Miller. Probably the lung, but----
Senator Specter. Probably?
Dr. Miller. The lung.
Senator Specter. The lung?
Dr. Miller. Yes.
Senator Specter. Would all of you gentlemen give us a
written answer to that question, which is a very core question?
Dr. Miller. Sure.
Senator Specter. Dr. Busuttil, you were shaking your head
no. Do you want----
Dr. Busuttil. Well, we have looked at this.
Senator Specter. Excuse me. The question--I am not
finished. Do you, just to sharpen the focus, do you want to
disagree with Dr. Miller on the issue of livers being shipped
nationally?
Dr. Busuttil. Yes, sir; if you transport a liver for 1,000
miles or more, the likelihood of getting that liver into the
recipient within 12 hours is not--you usually will get it in
within about 12 hours.
Beyond 12 hours of ischemia time, the chances of the livers
not working increases. Therefore, if you are going from coast
to coast, there is a higher incidence of nonfunction of that
organ. And I think every transplant surgeon would agree with
that.
remarks of senator faircloth
Senator Specter. Senator Faircloth.
Senator Faircloth. Thank you, Mr. Chairman, and thank you
for holding this meeting.
How long will a heart last? I mean, it might vary from a
super well heart to one that was not so well. But how long, if
you take one out of a patient in New York, how quick does it
have to be back in a patient in somewhere? How long? Either
one.
Dr. Busuttil. Well, usually, as Charlie said, usually 4 to
6 hours is what most centers will allow the ischemia time of
the heart.
Senator Faircloth. Well, 4 to 6 hours does not get you
very far around the country, because you have to get it back
into the patient. There is more time than just the flight time.
Dr. Busuttil. That is correct. That was the point I was
making.
Dr. Miller. But, you know, I looked at how long it took us
to get livers in in our institution, about 1,000 different
livers. And I found there was no difference in ischemia time
from the ones we had just in our local area from ones that we
had taken as far away as Denver, CO. There are lots of
reasons----
Senator Faircloth. There was no difference in time?
Dr. Miller. No difference, no. Because basically, if you
get it in in under 12 hours, it works just perfectly, actually
probably 14.
Senator Faircloth. A liver.
Dr. Miller. Yes.
Senator Faircloth. But a heart not.
Dr. Miller. Not a heart.
Senator Faircloth. But a liver has a longer shelf life.
Dr. Miller. Kidneys last----
Senator Faircloth. A longer shelf left. [Laughter.]
Dr. Miller. And kidneys even longer.
Senator Faircloth. All right. I am through. Thank you.
prepared statement
Senator Specter. Thank you very much, Senator Faircloth.
Your full statement will be inserted into the record at this
point.
[The statement follows:]
Prepared Statement of Senator Lauch Faircloth
If ever there was an issue deserving of considerable public
debate, it's the issue of our Nation's policies regarding organ
donation.
We're awed by the science that allows us to take organs
from one person and put them successfully into another. We've
all but eliminated the earlier problems of organ rejection,
thanks to the new drugs we've developed.
Science is bringing us to a point where we can grow new
organs from just a few cells, or even doing successful trans-
species transplants.
But as the science progresses, we find waiting lists for
organs growing longer and longer. People are confused,
frustrated and anguished as loved ones wait for the organ that
will restore them to a healthy life.
As they wait, questions abound about our National organ
allocation policies.
Why do we have different policies for different organs?
Why are the rules regarding livers different from those
regarding kidneys--especially in this day of Federal Express
overnight deliveries?
And we can't overlook the role money plays in getting an
organ.
If you can afford to pay the fee to be on a waiting list in
every part of the country, you're likely to get an organ
faster. Is this fair? Obviously not.
Why are Americans in North Carolina waiting for organs when
enterprising surgeons in Oklahoma are bringing in rich folks
from other parts of the World for American organ transplants.
Is this right?
These are the things that beg healthy public discussion and
oversight, which we're doing today. Now I know that some folks
feel strongly about this and feel we've waited long enough--
that we need to act.
I don't disagree we need to make improvements, but we need
to include everyone. Having the Department of Health and Human
Services try to jam final regulations down our throats isn't
going to help if they're not willing to recognize the role that
Congress plays in this process.
Now I'm an organ donor. If there's anything left that
someone needs, I'm happy to be a donor. We need to do all we
can to increase the number of folks willing to do this. I'm
glad to see that we're going to be addressing this very
important subject today. Thank you.
remarks of senator murray
Senator Specter. Senator Murray.
Senator Murray. Thank you, Mr. Chairman, for holding this
hearing on obviously a very difficult subject. I do have a
statement I would like to submit for the record and some
questions I would like to submit for Secretary Shalala to
answer.
Let me just ask one question of the panel. I have heard a
lot from surgeons. I have heard a lot from patients in my
State. But I have not heard very much about the impact of the
current structure or the proposed regulations on children from
low income families, not necessarily those without insurance,
but those who have kids with other kids at home that cannot
travel from center to center. Perhaps both parents have to
work.
If any of you could comment on that, I would appreciate it.
Mr. Irwin. Senator, if I might comment on that, I think
that the system can really be toughest on children, not just
low income children, but all children. Being from the Pacific
Northwest myself, I know that there are limited opportunities
for transplantation for children in our area.
As a result, they oftentimes have to go to cities like San
Francisco or Omaha, where they face long waiting lists. And
unfortunately, because of the way the current system works, a
pediatric organ that is found in our area would first, because
of the allocation system, be offered to an adult at a local
transplant center before offered to a child somewhere else,
even though that child might be from our own community.
And there was an interesting report that was presented at a
conference of pediatric surgeons recently that talked about how
devastating on a national level that this is for children.
So this is a real problem in the system that I do not think
we can ignore. And it is not just low income children; it is
all children that are suffering under the system.
Senator Murray. Does anybody else want to comment?
Dr. Pfaff. Well, let me comment, Senator. Actually, there
are an awful lot of systems that are points, particular efforts
to give particular advantage to children so that children
awaiting a kidney transplant have remarkable priority. So half
the children are transplanted each year, as opposed to about
4\1/2\ percent of all patients who are on dialysis.
For livers and hearts, provisions have been made in each
circumstance to try and hasten the pace of transplantation with
greatest priority. And that has occurred through the community
system. We were painted earlier as a unitarian group. In
actuality, it is whole bunch of entities perhaps not too much
like Congress in that it is run in a democratic fashion.
Dr. Busuttil. Senator Murray, I would like to make one
brief comment. We have a very active pediatric transplant
program. I transplant about 50 babies a year. Over one-half of
those babies are indigent babies. They are either from single
family parents--there is a real problem in how these people are
able to take care of those babies and how we are able to get
support for those families.
And clearly, it would be almost unheard of for these--they
would not be able to get a transplant if they had to travel
long distances away from our center.
prepared statement
Senator Murray. Thank you, Mr. Chairman. I know we are on a
short timeframe.
Senator Specter. Thank you very much, Senator Murray.
[The statement follows:]
Prepared Statement of Senator Patty Murray
Today's hearing, unlike some of the hearings we have here
in Congress, is truly about life or death. The issues
surrounding organ procurement and allocation are by far the
most difficult for us as legislators to address. We make public
policy not medical decisions.
I have heard from many constituents about the new proposed
regulations issued by HHS. I have heard from surgeons concerns
about the transplant center at the University of Washington and
I have heard from patients concerned that they will face
additional delays in receiving an organ.
Because of the emotional and difficult issues surrounding
current policy and the proposed changes, it has become almost
impossible to charter an acceptable course for this debate.
I have some real concerns about the impact of the proposed
regulations, especially in the Northwest, but I am not sure
that the current structure is acceptable either. Currently,
Washington state residents have a 241-day waiting period for a
new liver. While this is below some regions of the country it
is not a great situation.
I have read through much of the testimony of today's
witnesses and am hopeful that working together we can find an
acceptable structure based on fairness and equity, not
politics. We need a system that is more uniformed and were
everyone, rich or poor, young or old, black or white has the
same chance of receiving the true gift of life.
I have supported a delay in the regulations in order to
give all interested parties the opportunity to review the
current structure as well as the proposed reforms called for by
HHS. I also think that the additional time will give Members of
Congress the opportunity to review the data and make more
informed decisions based on facts, not emotions.
I thank the Chairman for scheduling this hearing and I
thank the witnesses for their willingness to testify.
national system
Senator Specter. Dr. Miller, with respect to a national
system, would that be helpful with respect to heart
transplants?
Dr. Miller. Again, as I stated in my opening testimony, a
national system does not necessarily mean a single national
list. So what you really need to----
Senator Specter. Well, what would the advantage be of a
national system with respect to hearts, which cannot last
longer than 4 to 6 hours on transplant?
Dr. Miller. Well, I think a national system, where the
country was broken up into a number of smaller regions, where
the organs would be able to be transported within the framework
of those----
Senator Specter. Well, what would the advantage then be of
a national system? Would a regional system be adequate?
Dr. Miller. Well, I think a national system can be a system
of a few regions, but not 63----
Senator Specter. Well, what would be the advantage of
having a national system? If you have a national system and you
are talking about heart transplants, what would be the
advantage? How big would the region and how far can you move
with a heart?
Dr. Miller. Right.
Senator Specter. You send these commercially? You send
these by special charter? How do you send these organs?
Dr. Miller. Well, the hearts--it varies from the organs.
Hearts are usually procured by the home center. And, you know,
we have flown down to Louisiana, about 1,500 miles, to get
hearts. So that is a long ways. And that is within the safe
procurement distance.
Senator Specter. 1,500 miles to Louisiana and then 1,500--
and how far back? How do you do that within 4 to 6 hours?
Dr. Miller. You only have to get it back. You go down there
and you take it out and you just bring it back. And you can
get----
Senator Specter. Why Louisiana?
Dr. Miller. Why----
Senator Specter. Why do you illustrate with Louisiana? Do
they have an abundance of organs?
Dr. Miller. They may, but that is not why I did. I just----
Senator Specter. You just picked Louisiana at random.
Dr. Miller. Actually, it is the one I remember going to.
Maybe they do.
Senator Specter. Is there something special about Louisiana
for organs? [Laughter.]
Dr. Miller. There are a lot of things special about
Louisiana.
Senator Specter. I ask that because Congressman Livingston
is raising the issue on the House side.
Dr. Miller. Right. Well, I think----
Senator Specter. Run me through this as to how a national
system would help with heart transplants.
Dr. Miller. Well, I think again a national system can be--
it does not necessarily mean a single national list.
Senator Specter. Broken up into regions. Now work through a
regional approach.
Dr. Miller. So, let us see. If we want to transport 4 to 6
hours, we can fly 1,500 miles. Maybe 3 regions would do a good
job. Three regions is really a national system.
Senator Specter. 1,500 miles?
Dr. Miller. Let us say a 1,500 mile radius from anywhere
from a donor. Just track out 1,500 miles and see who is the
neediest. That could work.
Senator Specter. And you could get a heart in 4 hours to be
on the conservative side, 1,500 miles.
Dr. Miller. Oh yes; all you have to do is----
Senator Specter. Do you transport these by charter jet?
Dr. Miller. Yes; the team is transported down and
transported back by charter jet.
Now livers, there is less stringent requirements. We can--I
mean, I have sent Dr. Busuttil livers.
Dr. Busuttil. They never work.
Dr. Miller. Why?
Senator Specter. What do they----
Dr. Busuttil. The ones you send me----
Senator Specter. Give me the other organs. You can talk
later. Give me the other organs and the timespan. What other
organs are acceptable for transplants and how long will they
last?
Dr. Miller. Well, the lung is also limited, like to about 4
hours. But the liver much longer. The kidney is often flown
around the country for a variety of different regions.
Senator Specter. How long can you have a kidney in transit?
Dr. Miller. 24 to 36 hours.
Senator Specter. Any other organs?
Dr. Miller. Pancreas I would say about 12 hours.
Senator Specter. Any other organs?
Dr. Miller. We are not transplanting any other ones than
that at this point.
additional committee questions
Senator Specter. Well, what I would ask you gentlemen to do
is to comment on this critical issue of how long the organs
last and how it works.
And Mr. Irwin and Dr. Miller, how would it function, if you
moved from a national system to a regional system? And what is
the scientific evidence that you have as to how long the liver
will last? And the same thing for Dr. Busuttil and Dr. Pfaff
with a response to that.
Because if the medical science does not hold up on time,
that is obviously a very, very big factor. Or with the
limitations of time, what are the other advantages which would
be present from a national system?
[The following are written responses to Senator Specter's
questions asked at the hearing.]
Questions Submitted by Senator Arlen Specter
Responses of Dr. Charles M. Miller
At the hearing today on organ transplantation, questions were
raised about the maximum viable ischemic times for each organ (i.e.,
the time that an organ can remain outside the human body and still be
viable for transplantation). It was suggested that the HHS Final Rule
compromises patient outcomes by needlessly prolonging ischemic times.
The opposite is true. The HHS Final Rule calls for the OPTN to develop
allocation policies that meet performance criteria that specifically
incorporates the consideration of factors such as the ischemic times.
Specifically, the HHS Final Rule mandates that the OPTN consider
medical criteria, including ischemic times, for each type of donated
organ in developing organ allocation proposals. Section 121.8(a)(3)
requires that all organ allocation policies be designed using ``sound
medical judgment'' and ``to avoid wasting organs'' (63 FR. 16335). In
the Preamble to the Final Rule, HHS discusses at length the issue of
ischemic time limits and the transportation of organs at 63 FR. 16314-
16315. The essence of the HHS discussion can be summarized in this
sentence from the Preamble: ``The performance goals are designed to
allow (and require) the OPTN to craft policies tailored to each organ
transplant type that are workable, feasible, and avoid organ wastage.''
Copies of the relevant portions of the Preamble are attached (Appendix
A).
With respect to your inquiry on ischemic times for specific organs,
transplant professionals generally agree that current, safe ischemic
time limits for specific organs are as follows:
Ischemic times for specific organs
Organs Hours Hours
Hearts......................... 4 to 6 Kidneys........ 24 to 36
Lungs.......................... 6 to 8 Pancreas....... 18 to 24
Livers......................... 13 to 16
For each organ, the ischemic time begins during the operation to
remove the donor's organs, when blood flow to the organ is interrupted,
just prior to removal from the body. The ischemic time ends when the
organ has been transplanted into the recipient and blood again flows
through the organ. An organ remains safe, healthy and viable when
transplanted within the above times, regardless of the distance the
organ travels.
I hope this has appropriately and completely addressed your
questions. If you have any further questions regarding this or any
other issue, please do not hesitate to call.
______
Appendix A--63 FR 16314-16315
We are reminded that there are practicalities involved, including
especially transportation. The problem is not occasional cross-
continental shipping from one large city to another, which is
relatively straightforward. Instead, however, there can be severe
logistical problems with frequent shipping of organs (often preceded by
a special team that travels to retrieve the organ and return with it),
or with moving organ among relatively transportation-disadvantaged
areas, even within the same State. The performance goals are designed
to allow (and require) the OPTN to craft policies tailored to each
organ transplant type that are workable, feasible, and avoid organ
wastage.
Many commenters urged that the Secretary require rational sharing
of organs, without any role for geographic factors. Others urged
regional sharing. We prefer the performance goal approach. Achieving
the goal will certainly require greater geographic sharing and will
probably require national sharing for sorry organs for patients with
specified medical conditions. Indeed, regional sharing is already a
prominent feature of heart allocation, and national sharing a prominent
feature of kidney allocation. However, we believe that any simple
formulation would inhibit the ability of the OPTN to craft the most
sensible policies that achieve practical as well as ethical results,
and we wish to encourage change over time as medical science and
medical criteria improve. Therefore, we are at this time using the
performance goal approach for all organs (with an accelerated schedule
for the initial revision of policies for liver allocation).
The Secretary appreciates that there are many factors that can
contribute to achieving the geographic equity goal. For example, if the
Departments organ donation initiative were to achieve a high rate of
success, then fewer organs would need to be shared. Improved listing
criteria and medical status categories will reduce measured inequities.
Nonetheless, within foreseeable parameters, we see no basis to expect
that inequities can be eliminated for any major organ category without
broader geographic organ sharing, on at least a broad regional basis
for all patients with high levels of urgency.
We also require the OPTN to take into account key constraints on
organ allocation. There are patients with urgent need for whom
transplantation is futile. Organs cannot be used without an assessment
of the immune system and other physical conditions of patients. Broad
geographic sharing should not come at the expense of wasting organs
through excessive transportation times. Efficient management of organ
allocation will sometimes dictate less transportation when the highest
ranking patient can wait a day or two for the next available organ.
Sound medical judgment must be exercised before a final decision on
whether to transplant a particular organ into a particular patient. Our
goals allow for these factors to affect transplantation outcomes. For
example, 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 medial criteria and allocation policies.
______
Responses of Dr. William W. Pfaff
On behalf of the United Network for Organ Sharing (UNOS), I am
providing you the additional information requested at your September
10, 1998, hearing on organ donation and allocation. Attached you will
find the most current data available that demonstrates the probable
effect of ischemic time (or time a donated organ can survive without a
blood supply) on organ graft survival for kidney, liver, pancreas,
heart, and lungs.
In addition to our data analysis I am also providing you with UNOS'
current allocation policies for each organ. As you will undoubtedly
note, these policies take into consideration the medical impact of
ischemic time. You raised an important point during the hearing that
needs to be emphasized in the discussion of the implementation of the
April 2 regulation: a system for sharing donated organs nationally is
not currently medically feasible for every organ type. The undisputed
biological consequences of increased ischemic time on organ graft
survival make it wholly inadequate to expect, for example, hearts or
lungs to survive cross-country sharing.
As I hope you will also note from this data, while younger donor
organs do indeed have stronger resistance to the effects of ischemia,
the percentage of older donors has increased substantially in recent
years (with the overall number of donors remaining constant).
Therefore, it is fundamentally important that allocation policies
particularly for livers, pancreas, kidneys and lungs recognize this
factor as well.
We appreciate the opportunity to share this information with you
and hope that it is useful as you consider the impact of the April 2
regulation. We would be pleased to share additional information with
you or to answer any questions you might have about the data we are
presenting. Thank you for your interest in this important issue.
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the impact of cold ischemia time on graft survival: a unos analysis of
optn and scientific registry data
The impact of ischemia time (the time between organ retrieval and
transplantation) on organ survival following transplantation has been
well-documented (Appendix 1). Ischemic injury results from prolonged
lack of blood flow and, at some point, affects organ function following
transplantation. The amount of ischemia required to compromise organ
function differs by organ type and for most organs, by donor age.
To quantify the effect of cold ischemia time (CIT) on graft
survival using national data, we analyzed all cadaveric heart, liver,
lung, kidney, and pancreas transplants performed between April 1, 1994,
and December 31, 1995. The distribution of CIT for these transplants is
shown in Appendix 2. The accompanying graphs show for each organ type
various lengths of CIT and the associated probabilities of graft
failure within the first week after transplant, as CIT has been shown
to have an effect on early transplant outcomes.
Many factors determine how well and how long a graft will function
after transplant. For example, the graft survival rate is affected by
CIT, and for most organs, by donor age. For that reason, the
accompanying data show the effect of CIT on the probability of graft
failure for various donor ages. In the case of hearts, donor age did
not have a significant impact on the probability of graft failure
within one week. Therefore, for the heart analysis, we examined the
effect of CIT on the probability of graft failure based on the
recipient's respiratory status (on mechanical ventilation or not) at
the time of transplant, since this factor does have an impact on graft
survival. The effect of CIT shown here reflects the results of a
multivariate analysis, which controlled for the effects of other donor
and recipient risk factors (Appendix 3).
Organ types differ in their ability to tolerate CIT. At 6 hours of
CIT, all organs except for heart and pancreas showed a 1 to 4 percent
probability of failure depending upon the donor's age. In these cases,
organs from older donors had a higher probability of graft failure than
organs from younger donors. Pancreas transplants with as few as 6 hours
of cold time already showed a 5 percent probability of failure within
one week, regardless of donor age. Beyond 6 hours, pancreas transplants
from older donors were more severely compromised by CIT than those from
younger donors. During the time period examined in this analysis, 5
percent of pancreases were transplanted within less than 6 hours
(Appendix 2).
With 6 hours of CIT, heart transplants showed a 3 to 8 percent
probability of failure at one week, depending upon the ventilatory
status of the patient. Because hearts are so sensitive to CIT, heart
candidates are prioritized, in part, according to their distance from
available donors, using a system of concentric circles, in the center
of which is the donor hospital (see attached allocation policy
summaries). By 8 hours of CIT, the probability of heart graft failure
increased by at least 50 percent over the failure probability at 6
hours. This was also true for lungs at 8 hours. Among the lungs
transplanted during the study period, fewer than 5 percent accumulated
more than 8 hours of CIT. Fewer than 5 percent of hearts accumulated
more than 5 hours.
Kidneys demonstrated the most tolerance to CIT. The probability of
graft failure did not show a 50 percent increase until about 36 hours
of CIT. Currently, only 5 percent of kidneys accrue more CIT than 36
hours. Even though kidneys can tolerate relatively long ischemia times,
kidney recipients can rarely be selected at long distances from the
donor, because of a laboratory test (crossmatch test) that must be done
using serum from the patient and cells from the kidney donor. Often
done before other organ transplants as well, this test absolutely must
be done before kidney transplantation. The test rules out the
possibility that the patient already has antibodies that would destroy
the kidney being offered.
For livers, regardless of donor age, the probability of early
failure increased by almost 25 percent by 10 hours of CIT. The
probability increased by almost 50 percent by 15 hours. Under the
current allocation system, which distributes livers locally first,
about 35 percent of livers accrue 10-15 hours of CIT. Any system of
broader sharing will increase this percentage and the associated
probability of early failure.
It is important to note that an ever-increasing percentage of the
donor population consists of those older than the age of 50 (see
Appendix 4). In view of the finding that older donor organs are more
vulnerable to ischemic injury, allocation policy revisions resulting in
longer ischemia times should be undertaken with full understanding of
the implications for future graft failure and retransplant rates, organ
availability, and an exacerbation of the current organ shortage.
______
Appendix 1.--Partial Reference List for the Impact of Ischemia Time on
Survival Following Transplantation
Heart
Bourge, R.C., Naftel, D.C., Costanza-Nordin, M.R., Kirklin, J.K.,
Young, J.B., Kubo, S.H., Olivari, M.T., Kasper, E.K. Pretransplantation
Risk Factors for Death after Heart Transplantation: A Multi-
institutional Study. Journal of Heart and Lung Transplantation 12: 549-
562, 1993.
Hosenpud J.D., Bennett L., Keck B. Fiol B., Boucek M., Novick R.
The Registry of the International Society for Heart and Lung
Transplantation: Fifteenth Official Report-1998. Journal of Heart and
Lung Transplantation 17: 656-668, 1998.
Liver
Furukawa, H., Todo, S., Imventarza, O., Casavilla, A., Wu, Y.M.,
Scotti-Foglieni, C., Broznick, B., Bryant, J., Day, R., Starzl, T.E.,
Effect of Cold Ischemia Time on the Early Outcome of Human Hepatic
Allografts Preserved with UW Solution. Transplantation 51: 1000-1004,
1991.
Adam, R., Sanchez, C., Astarcioglu, I., Bismuth, H., Deleterious
Effect of Extended Cold Ischemia Time on the Post-transplant Outcome of
Aged Livers. Transplantation Proceedings 27: 1181-1193, 1995.
Deschenes M., et al. Early allograft dysfunction after liver
transplantation: a definition and predictors of outcome. National
Institute of Diabetes and Digestive and Kidney Diseases Liver
Transplantation Database. Transplantation 66: 302-310, 1998.
Kidney
Troppmann, C., Gillingham, K.J., Benedetti, E., Almond, P.S.,
Gruessner, R.W.G., Najarian, J.S., Matas, A.J., Delayed Graft Function,
Acute Rejection, and Outcome after Cadaver Renal Transplantation.
Transplantation 59: 962-968, 1995.
Ojo, A.O., et al. Delayed graft function: risk factors and
implications for renal allograft survival. Transplantation 63: 968-974,
1997.
Terasaki, P.I., et al. Significance of the donor age effect on
kidney transplants. Clin. Transplant. 11: 366-372, 1997.
Heaf, J.G., et al. Hyperfiltration, creatinine clearance and
chronic graft loss. Clin. Transplant. 12: 11--18, 1998.
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Brief Summary of UNOS Organ Allocation Policies
organ distribution
All potential recipients of organ transplants must be registered on
the UNOS computer system waiting list. Information on all cadaveric
organ donors must be entered on the UNOS computer as soon as possible
before organ allocation, and for kidneys within 15 hours after organ
retrieval. Transplant candidates are permitted to register at more than
one transplant center; however, transplant centers may not list the
same patient on more than one OPO's patient waiting list. When a
transplant candidate receives an organ, that patient must be removed
from all organ waiting lists. With approval of the applicable UNOS
Regions, appropriate UNOS committees and the Board of Directors,
transplant centers and OPO's may develop inter- and intra-regional
organ sharing arrangements. In addition, upon approval of the
appropriate UNOS committees and the Board of Directors, a transplant
center or an OPO may adopt alternative point assignments to the organ
distribution criteria other than those points specified in the UNOS
policies. Allocation criteria applicable to each type of organ are
listed below:
kidney allocation
The sharing of zero-antigen mismatched kidneys is mandatory with
the exception of a simultaneous kidney-extrarenal organ transplant.
Also, blood type O kidneys shall be transplanted only into blood type O
patients. Kidneys shall be allocated locally first, then regionally,
and then nationally to patients in descending point sequence as
determined by the following criteria:
Waiting time.--A kidney transplant candidate's waiting time begins
when the patient is registered on the UNOS patient waiting list. One
point is assigned to the candidate waiting for the longest time with
fractions of points assigned proportionately to all other patients who
have waited a shorter time. For each full year of waiting time a
patient accrues, an additional 1 point will be assigned to that
patient.
Quality of match.--Points are assigned based on the number of
mismatches between the transplant candidate's antigens and the donor's
antigens. Quality of match points are assigned as follows:
--7 points if there are no B or DR mismatches;
--5 points if there is one B or DR mismatch;
--2 points if there is a total of 2 mismatches at the B and DR loci.
Panel reactive antibody.--Candidates who are incompatible with 80
percent or more of a randomly selected panel are considered highly
sensitized. Highly sensitized kidney transplant candidates that have a
preliminary negative crossmatch with a donor are assigned 4 points.
Medical urgency.--Points are not assigned for medical urgency to
candidates on a regional or national waiting list. For candidates on a
local waiting list, the physician may use his/her medical judgment in
assigning medical urgency points if there is only one kidney transplant
center. When there is more than one local kidney transplant center, a
cooperative medical decision is required prior to assignment of medical
urgency points.
Pediatric patients.--Candidates who are less than 11 years old are
assigned 4 additional points for kidney allocation. Candidates who are
11 years old or older but less than 18 years old are assigned 3
additional points for kidney allocation.
Donation status.--A kidney transplant candidate is assigned 4
points if he or she has donated for transplantation within the United
States his or her vital organ or a segment of a vital organ (i.e.,
kidney, liver segment, lung segment, partial pancreas, small bowel
segment).
Payback of shared kidneys.--When a kidney is shared for a zero-
antigen mismatch, a combined kidney-extrarenal organ transplant, or for
a highly sensitized recipient, the OPO receiving the kidney shall offer
through the UNOS Organ Center a kidney from the next suitable donor of
the same blood type as the donor from whom the shared kidney was
retrieved.
liver allocation
Livers shall be allocated locally first, then regionally, and then
nationally to liver transplant candidates based on the following
criteria:
Preliminary stratification.--For every potential liver recipient,
the acceptable donor size must be determined by the responsible
surgeon. The UNOS Match System only will consider potential liver
recipients who are an acceptable size for a particular donor liver.
Blood type similarity points.--Liver candidates with the same blood
type as the donor receive 10 points. Candidates with compatible but not
identical blood types receive 5 points, and those with incompatible
types do not receive any points. Blood type O transplant candidates who
will accept a liver from an A2 blood type donor receive 5 points for
incompatible matching. Blood type O livers shall not be transplanted to
Status 2b or 3 candidates who are not a blood type 0.
Waiting time.--A candidate's waiting time begins at the time the
candidate is registered on the UNOS patient waiting list. Ten points
are assigned to the candidate waiting for the longest period and
proportionately fewer points are assigned to patients who have waited a
shorter time. For example, if there are 75 candidates on the liver
waiting list, the patient waiting the longest would be assigned 10
points (75/75 10). A candidate whose rank order was 60 would
be assigned 2 points ((75 -60)/75 10 = 2).
Status 1 and 2A liver patients.--Time of waiting will be calculated
for Status 1 and Status 2A liver patients from the time the patient is
listed as a Status 1 or 2A and will only include time listed as a
Status 1 or 2A.
Degree of medical urgency.--Each candidate is assigned a status
code which corresponds to how medically urgent it is that the candidate
receive a liver transplant. Medical urgency is defined differently for
adult versus pediatric candidates.
Medical urgency is assigned to adult liver transplant candidates
(age greater than or equal to 18 years of age) as follows:
--Status 1.--A candidate with fulminant liver failure with a life
expectancy without a liver transplant of less than 7 days;
fulminant liver failure is defined as meeting at least one of
four specific medical criteria (refer to UNOS Policy 3.6 for
complete details).
--Status 2A.--A candidate who is in the hospital's critical care unit
due to chronic liver failure with a life expectancy without a
liver transplant of less than 7 days, and has a long-term
prognosis with a successful liver transplant equivalent to that
of a patient with fulminant liver failure. The patient also has
a Child-Turcotte-Pugh (CTP) score greater than or equal to 10
and meets at least one of four specific medical criteria that
indicate that the patient has experienced a severe
decompensating event (for details, refer to UNOS Policy 3.6).
The CTP score is a standard scoring system used to assess
severity of liver disease.
--Status 2B.--A candidate with a CTP score greater than or equal to
10, or a CTP score or equal to 7 and meets at least one of four
specific medical criteria that indicate that the patient has
experienced a severe decompensating event (for details, refer
to UNOS Policy 3.6).
--Status 3.--Continuous medical care with a CTP score greater than or
equal to 7.
--Status 7.--Temporarily Inactive.
Medical urgency is assigned to pediatric liver transplant
candidates (age less than 18 years of age) as follows:
--Status 1.--A candidate with in the hospital's Intensive Care Unit
(ICU) due to chronic or acute liver failure with a life
expectancy without a liver transplant of less than 7 days who
meets at least one of ten specific medical criteria that
indicate extreme medical urgency (refer to UNOS Policy 3.6 for
details).
--Status 2B.--A candidate meets at least one of seven specific
medical criteria (refer to UNOS Policy 3.6 for details).
--Status 3.--A candidate who has met the inclusion criteria to be
listed for pediatric liver transplantation and requires
continuous medical care.
--Status 7.--Temporarily Inactive.
UNOS Policy also makes special provision for pediatric patients
with Ornithine Transcarbamylase Deficiency (OTC) or Crigler-Najjar
Disease Type I, and adult patients with Hepatocellular Carcinoma (HCC).
In exceptional cases, patients who do not meet the specified medical
criteria for a particular urgency status could be assigned that status
upon application and justification by the transplant center to its
Regional Review Board. In many regions, the Regional Review Board also
reviews new patient registrations and status upgrades to determine
eligibility based on UNOS Minimum Liver Patient Listing Criteria and
the status code criteria listed above.
Please refer to UNOS Policy 3.6 for a complete description of all
medical urgency status codes, the CTP scoring system, and specific
definitions of qualifying medical events. These can be found on the
UNOS Web Site at WWW.UNOS.ORG
After preliminary stratification and point assignments based on
blood type similarity and time waiting, livers are offered to potential
recipients in the following sequence:
Local:
--1. Status 1 patients in descending point order.
--2. Status 2A patients in descending point order.
--3. Status 2B patients in descending point order.
--4. Status 3 patients in descending point order.
Regional:
--1. Status 1 patients in descending point order.
--2. Status 2A patients in descending point order.
--3. Status 2B patients in descending point order.
--4. Status 3 patients in descending point order.
National:
--1. Status 1 patients in descending point order.
--2. Status 2A patients in descending point order.
--3. Status 2B patients in descending point order.
--4. Status 3 patients in descending point order.
allocation of hearts, lungs, and heart-lung combinations
Thoracic organ allocation utilizes a hierarchical system rather
than a point system for prioritizing transplant candidates. Candidates
are prioritized based on the following criteria:
Medical urgency.--There are two urgency categories for heart
allocation. The urgent Status 1 candidate is defined as a patient who
requires cardiac and/or pulmonary assistance with one or more of the
following devices in place: total artificial heart, left or right
ventricular assistance system, intra-aortic balloon pump, or a
ventilator. If the candidate does not have one of these devices in
place, he/she still may qualify as Status 1 if the candidate is located
in an intensive care unit and requires inotropic agents to maintain
adequate cardiac output, or the candidate is less than 6 months old.
The Status 2 category includes all other candidates who do not meet the
Status 1 criteria. There are no medical urgency criteria for lung and
heart-lung candidates.
ABO typing.--All blood type matches are considered equally and
identical matches are not given priority over compatible matches. For
organ allocation to Status 2 heart candidates and candidates awaiting a
lung or heart-lung combination, candidates with a blood type that is
identical to the donor have priority over candidates with compatible
blood types.
Waiting time.--Except for Status 1 heart candidates, calculation of
the time a patient has been waiting for a thoracic organ transplant
begins at the date and time the patient is first registered as active
on the UNOS patient waiting list. When waiting time is used for organ
allocation, a patient with more waiting time will receive a preference
over other patients who have accumulated less time within the same
status category. Waiting time for Status 1 heart candidates will begin
from the moment a patient is registered as a Status 1 and only include
the amount of time the patient is listed as a Status 1.
Following these criteria, heart and heart-lung combinations are
allocated as follows:
--For every thoracic organ donor allocated locally, the choice will
be made by the transplant program whether to use the heart for
an isolated heart (without lung) transplant for a Status 1
candidate, or for a combined heart-lung transplant. If the
heart is used for an isolated heart transplant, the organ will
be allocated first to Status 1 candidates according to length
of time waiting. If the heart is not allocated to a Status 1
patient, then the organ will be allocated to other local
candidates in the following sequence based on the candidate's
length of time waiting:
--Heart-lung candidates with a blood type that is identical to the
organ donor; then
--Heart-lung candidates with a blood type that is compatible to the
organ donor; then
--Status 2 isolated heart candidates with a blood type that is
identical to the organ donor; then
--Status 2 isolated heart candidates with a blood type that is
compatible to the organ donor.
After local allocation, thoracic organs are allocated based upon
the distance of the recipient hospital from the donor hospital.
Concentric circles of 500- and 1,000-mile radii define three zones with
the donor hospital as the center. Zone A extends to 500 miles, Zone B
is from 500 to 1,000 miles, and Zone C is beyond 1,000 miles. Thoracic
organs are allocated within each zone in the following sequence based
on the candidate's length of time waiting:
--Status 1, isolated heart candidates in Zone A;
--Identical blood type heart-lung candidates in Zone A;
--Compatible blood type heart-lung candidates in Zone A;
--Status 1, isolated heart candidates in Zone B; Identical blood type
heart-lung candidates followed by compatible blood type heart-
lung candidates in Zones B and C;
--Status 2, identical blood type isolated heart candidates in Zone A;
--Status 2, compatible blood type isolated heart candidates in Zone
A;
--Status 2, identical blood type isolated heart candidates in Zone B;
--Status 2, compatible blood type isolated heart candidates in Zone
B;
--Status 1, isolated heart candidates in Zone C;
--Status 2, identical blood type isolated heart candidates in Zone C;
--Status 2, compatible blood type isolated heart candidates in Zone
C.
Lungs are allocated only after the heart has been allocated. If one
lung is accepted for single lung transplantation, the remaining lung
will be offered for other single lung candidates in descending order on
the waiting list.
Lungs are allocated to local candidates first, followed by
candidates in Zone A, then to candidates in Zone B. and finally to
candidates in Zone C. In each zone, lungs will be allocated to
candidates who have a blood type that is identical to the donor
followed by candidates with compatible blood types. Recipient selection
within each group will be based on length of time waiting.
Lung candidates with idiopathic pulmonary fibrosis.--Lung
transplant candidates diagnosed with idiopathic pulmonary fibrosis are
assigned 90 days of additional waiting time when registered on the UNOS
patient waiting list.
pancreas and pancreatic islet allocation
Pancreata are allocated locally first, followed by regionally and
then nationally. For local allocation, the transplant center may select
recipients from candidates awaiting an isolated pancreas, kidney-
pancreas combination, or a combined solid organ-islet transplant from
the same donor. Within each patient waiting list, pancreata are
allocated to patients according to blood type compatibility and the
length of time waiting. For combined kidney-pancreas candidates, blood
type O kidneys must be transplanted only into blood type O recipients.
If a pancreas is not allocated locally for an isolated or combined
whole organ transplant, or a combined solid organ-islet transplant, the
pancreas shall be allocated regionally and then nationally in the
following sequence with recipient selection in each category based on
blood type compatibility and length of time waiting:
--Isolated pancreas candidates with O A, B. DR antigen mismatches;
then
--Isolated pancreas candidates with 1 A, B. DR antigen mismatches;
then
--Isolated pancreas candidates with 2 A, B. DR antigen mismatches;
then
--Combined kidney-pancreas candidates if the kidney is available.
Blood type O kidneys must be transplanted into blood type O
recipients and the kidney must be paid back; then
--Isolated pancreas candidates with 3 or more A, B. and DR antigen
mismatches.
Mandatory sharing of zero-antigen mismatch pancreata.--If there is
a candidate for whom there is a zero-antigen mismatch with the donor,
the pancreas from that donor shall be offered to the candidate waiting
for a combined kidney/pancreas transplant with a zero-antigen mismatch
first locally, then regionally, and then nationally, based on time
waiting, and then to a candidate waiting for an isolated pancreas
transplant with a zero-antigen mismatch, first locally, then
regionally, and then nationally, based on time waiting.
If a suitable recipient for a whole pancreas is not identified,
then the Host OPO shall offer the pancreas locally for clinical islet
transplantation. If the organ is not used locally, the Host OPO shall
offer the pancreas regionally and then nationally for clinical islet
transplantation.
At the regional and national levels, islet allocation is based on
HLA matching, medical urgency, and time waiting. Three points are
assigned to candidates with 0 HLA mismatches. Candidates with 1
mismatch receive 2 points. Candidates with 2 mismatches receive 1 point
and candidates with 3 or more mismatches receive 0 points. The medical
urgency criteria for islet allocation consist of two status categories.
The higher priority Status 1 designation is limited to patients who
have already received an islet transplant at least three weeks prior to
the current allocation. These recipients are considered in urgent need
because the typical islet recipient requires subsequent transplants
involving multiple islets from additional donors within a short time in
order for the procedure to be effective. Islet candidates awaiting
their initial transplant are assigned to Status 2. One point is
assigned to the candidate with the longest waiting time with a fraction
of a point assigned to candidates who have waited a shorter time. For
example, if there are 75 candidates awaiting islet transplantation, the
candidate waiting the longest will receive 1 point (75/75 1 =
1). The candidate with the 60th longest waiting time would be assigned
0.2 points (75 -60)/75 1 = 0.2).
intestinal organ allocation
Intestinal organ transplantation may include the stomach, small
and/or large intestine, or any portion of the gastro-intestinal tract
as determined by the medical needs of individual patients. Following a
local-regional-national hierarchy of distribution, recipient selection
for an intestinal organ at each level is based on medical urgency and
waiting time. Intestinal organs are allocated first to transplant
candidates who are size compatible and have a blood type that is
identical to that of the organ donor. These patients are followed by
candidates who have a blood type that is compatible to that of the
organ donor. The medical urgency criteria consist of 2 status
categories. The urgent Status 1 designation includes candidates whose
liver function is abnormal and/or no longer have vascular access for
intravenous feeding. Candidates who do not meet these criteria are
assigned to Status 2. The sequence for allocation of intestinal organs
is as follows:
--Local Status 1 patients; then
--Local Status 2 patients; then
--Status 1 patients in the Host OPO's region; then
--Status 2 patients in the Host OPO's region; then
--Status 1 patients in all other regions; then
--Status 2 patients in all other regions.
organ allocation to candidates awaiting a multiple-organ transplant
Candidates for a multiple-organ transplant where one of the
required organs is a heart or liver shall be placed on the individual
UNOS waiting list for each organ. When the candidate is eligible to
receive a heart or liver based upon the existing UNOS allocation policy
for either organ type, or an approved variance to these policies, the
second required organ shall be allocated to the multiple-organ
candidate from the same donor if the donor is located within the same
local organ distribution unit where the multiple-organ candidate is
registered. If the multiple-organ candidate is on a waiting list
outside the local organ distribution unit where the donor is located,
voluntary sharing of the second organ is recommended. When the second
organ is shared, the same organ of an identical blood type shall be
paid back to the Host OPO from the next acceptable donor recovered by
the recipient OPO.
subcommittee recess
Senator Specter. Thank you all very much for being here,
that concludes our hearing. The subcommittee will stand in
recess subject to the call of the Chair.
[Whereupon, at 11:08 a.m., Thursday, September 10, the
subcommittee was recessed, to reconvene subject to the call of
the Chair.]
Material Submitted Subsequent to Conclusion of Hearing
[Clerk's note.--The following statements and letter, were
received subsequent to conclusion of the hearing. The
statements and letter will be inserted into the record at this
point.]
Prepared Statement of the University of Pittsburgh Medical Center
The University of Pittsburgh Medical Center (UPMC)
respectfully submits to the Senate Appropriations Committee the
following comments to evidence our general support for the
Final Rule (63 FR 16296) governing the U.S. Organ Procurement
and Transplantation Network (OPTN) issued by Secretary Shalala
on April 2, 1998. We do not believe there should be any more
delay in implementation of the Final Rule.
At the outset we must note that UPMC has advocated a
position that goes further than that adopted in the Final Rule:
i.e., that the Secretary should adopt specific allocation
policies for donated organs. We did so based on our belief that
the development of national organ allocation policy is a
decision that should not be left solely to a non-governmental
body. Our position was also influenced by the fact that the
current OPTN contractor has not shown any inclination to
respond to the evident inequities in the current national organ
allocation system, as characterized in the 1994 proposed rule
and as evidenced by the results of a number of analyses
presented in reports by government agencies, including GAO and
OIG, and by the contractor's own analyses and data.
Nevertheless, UPMC understands the position taken by the
Secretary in the Final Rule, which is to allow the transplant
community to exercise medical judgment within policy parameters
set by the Final Rule and implemented through the OPTN
contract, to develop organ allocation systems that meet
specific performance guidelines.
We note that since the publication of the Final Rule, the
OPTN contractor and others in the transplant community have
engaged in a concerted effort to discredit the Final Rule and
its performance standards by offering a ``parade of horribles''
that will purportedly result from implementation of the Final
Rule. These false predictions contradict the views and
judgments voiced by an overwhelming number of patients and
patient groups, including Transplant Recipients International
Organization, the American Liver Foundation, the Minority Organ
and Tissue Transplantation Education Project, and the National
Transplant Action Committee, which all support the Final Rule.
The voices of the patients have been drowned out by the wails
of protestations arising from transplant programs, transplant
surgeons, and representatives of organ procurement
organizations (OPO's), who have focused primarily on protecting
a monopoly of donated organs which they believe belongs to
them. (In fact, the National Organ Transplant Act (NOTA) was
purposely written to prevent such monopolies.) Yet, it is those
patients' voices that should be heard.
Of course, not all transplant programs, transplant
professionals, and OPOs have taken such parochial views
regarding the allocation of lifesaving donated organs. Some in
the transplant community understand organs are a gift from the
donors to the transplant community for the sole purpose of
saving the lives of those patients who are otherwise about to
die. A growing number of transplant programs and transplant
surgeons recognize, notwithstanding the anti-regulation
hyperbole, that the performance guidelines and other
requirements of the Final Rule represent sound policy
decisions, do not infringe upon the medical judgment of the
transplant doctors, and most importantly, will make a more
equitable system for Americans who are awaiting organ
transplantation.
Liver allocation policies developed pursuant to the Final
Rule will not result in an immediate and large diversion of
donated livers from small and medium-sized transplant centers
to a few large transplant centers such as UPMC, the University
of California, and others.
At the outset, the Final Rule itself does not specify any
organ allocation policy, but will simply guide the OPTN
contractor to develop new allocation policies for donated
livers and other donated organs over a specified time. In
addition, the Final Rule requires the OPTN to consider adoption
of transition procedures to be put into effect with the
implementation of each new organ allocation policy ``that would
treat people on the national list and awaiting transplantation
prior to the adoption or effective date of the revised policies
no less favorably than they would have been treated under the
previous policies.'' (Regs. section 121.8(a)(5)(i)). Further,
the OPTN is mandated to develop such a transition procedure to
be implemented simultaneously with a revised liver allocation
system. (Regs. section 121.8(a)(5)(ii)). Thus, those currently
listed and waiting for organ transplants will not be treated
any less favorably by a new OPTN system than under the current
system.
In fact, UNOS's newly proposed system for heart allocation
contains such a ``grandfather'' provision. There is no ``hue
and cry'' from UNOS or heart surgeons that the change of status
definitions will harm patients on the heart waiting list at
small transplant programs.
Critics argue that, over time, most of the donated livers
will go to a few large transplant centers because such centers
currently have the sickest patients. However, the large numbers
of very sick patients currently on the waiting lists at the
larger centers is a direct result of the inequities in the
current allocation policy and the current long waiting times at
those centers. For example, very few patients enter the liver
waiting list in Status 1 or Status 2A, the most urgent
categories. Most patients enter the liver waiting list as
Status 3 or Status 2B. Because of the long waiting times at the
larger centers (generally more than 1 year), the medical
condition of the patients there eventually deteriorates until
they are in the most medically urgent health status categories.
Patients who enter the waiting list at transplant programs with
short waiting times are able to receive a donated liver while
they still are relatively healthy. In the future, under a
revised allocation policy based upon the performance guidelines
in the Final Rule, it can reasonably be anticipated that all
patients in similar medical condition will have comparable
waiting times, independent of the size of the transplant
program where they are waiting for transplantation.
The important benefit that critics ignore is that under an
allocation policy which complies with the Final Rule
performance guidelines, no patient has an advantage over other
patients based solely on location. Each new registrant will
have an approximately equal opportunity to receive a donated
organ as any other waiting list patient in the same status
category regardless of the hospital where each patient is
listed. Under such rules, it is logical that a new registrant,
especially a very sick patient may well choose to stay close to
home rather than travel to a larger center unless there is a
compelling reason for such travel, such as insurance company
requirements or special treatment capabilities at the distant
center, or a high mortality rate at the local transplant
center. Currently, UNOS data show that about 25 percent of all
transplant recipients already travel outside their home state
to be listed for transplantation.
If one removes the ``organ lottery'' (whereby a patient can
receive a donated organ quickest) as a consideration when
patients are choosing a transplant program, then patients and
their physicians will presumably choose a program based on
medical considerations and the needs of the patient, and when
necessary, insurance company requirements. The resulting organ
transplant system will thus increase patients' options for
choosing the transplant program that they and their physicians
think will provide the best medical care.
A new, more equitable liver allocation policy will not
cause the closure of small or ``local'' transplant centers due
to a lack of available organs. Under a new liver allocation
system developed pursuant to the performance guidelines of the
Final Rule, newly registered patients at each transplant
hospital will have an approximately equal opportunity to
receive a compatible organ as patients in similar medical
circumstances anywhere and everywhere in the country. There is
no reason why any single transplant program should close if
their patients wait the same time for transplantation as all
other patients in the country. Each transplant program will be
able to attract patients (or not attract patients) based on
criteria such as: patient mortality rates; cost of
transplantation; the ability of the program to treat difficult
cases or certain types of liver disease; and the listing
criteria of the center with regard to medically urgent
patients, highly sensitized patients, or patients with little
or no ability to pay.
Every transplant program will still have the advantage of
``proximity'' to local patients as an attraction. For example,
Alabama, Arizona, Iowa, Kansas, Nebraska, New Jersey, Oklahoma,
Oregon, South Carolina, and Utah are states with only one
active liver transplant center, but each program performs more
than thirty liver transplants per year. Residents of those
states and possibly neighboring states who require a liver
transplant will still be inclined to choose such ``local''
centers, unless the ``local'' center will not accept them, or
their insurance company requires them to travel to another
center, or they need specialized treatment at another center.
Thus, such programs are not likely to close as a result of
broader geographic sharing of organs.
It is possible that a few liver transplant programs around
the country may close if a liver allocation system meeting the
performance guidelines in the Final Rule is implemented, if
patients no longer choose to list at these programs. The
transplant center, however, would continue to perform other
transplants. But there is no evidence to indicate a wholesale
closing of liver transplant programs. For example, according to
the 1997 OPTN Annual Report, there were six liver transplant
programs in the state of Louisiana in 1996, two of which
regularly performed more than twenty transplants per year and
four of which performed seven or less per year. One large liver
program is located in New Orleans and the other is in
Shreveport. It is possible that some of those four small liver
transplant programs in Louisiana may close, depending on their
ability to attract patients; however patients who wished to
stay in-state clearly would still have the option to do so.
It is important to note that under the Final Rule medical
judgments are not ``being supplanted by bureaucrats,'' as
opponents of the Rule have argued. The current system, based on
consensus medical judgment within the transplant community, is
to treat the ``sickest first'' and that concept is merely
carried forward into the performance guidelines of the Final
Rule. The current liver allocation policy places candidates
into various medical urgency categories depending upon the
severity of their illness and how long they can expect to
survive without transplantation. Available organs are then
allocated among those patients, with the sickest patients being
the first patients offered an available, compatible donated
organ. In fact, UNOS recently revised the heart allocation
system to give priority to patients with life expectancy of
less than one month.
Under the current liver allocation policy, however, the
medical urgency of many patients is overridden by the non-
medical consideration of geography. That is, a very sick
patient in Dallas may die even though a compatible liver is
available in Fort Worth or Oklahoma City (forty minutes away by
air) because the compatible donated organ goes to a much less
sick patient who is in the ``local'' Fort Worth or Oklahoma
City area. This may happen even when the medical community
agrees that the Dallas patient is more medically needy than the
Fort Worth or Oklahoma City patient, and it is a prime example
of the unfairness of the current liver allocation policy. The
performance guidelines, therefore, correctly provide that the
non-medical considerations of place of residence or place of
listing shall not be major determinants of access to an organ
transplant. The medical urgency status of the patient is the
most important factor.
We would also note that the requirement for standardized,
objective, listing criteria for transplant candidates, which
will provide safeguards against potential abuses of any
allocation policy, is to be developed by the transplant
community. The transplant community has recognized for some
time the need for standardized listing criteria, which include
not only objective and standardized criteria for placing a
patient on the national list, but also objective and
standardized criteria for moving patients from one status to
another on the list, and standardized and objective criteria
for determining when patients must be removed from the list
because they are too sick or otherwise not suitable for a
transplant. The Final Rule requires that such criteria be
developed and implemented by the OPTN, and in fact, the OPTN
has already made progress in developing objective listing
criteria and medical urgency categories.
The Final Rule properly permits transplant professionals to
exercise their medical judgment, within certain broad non-
medical parameters, to determine when a patient should properly
be considered for a transplant, and when a patient should no
longer be eligible to receive an organ transplant. Under the
current liver allocation system, patients are often temporarily
removed to Health Status 7 (inactive and not considered
eligible for a transplant) or otherwise permanently removed
from consideration for transplantation, because medical
judgments are made that transplants for such patients would be
futile. The Final Rule does not change this practice.
Organ donation should not suffer if organs are sent to
seriously ill patients who are out-of-state. In a recent public
opinion poll entitled ``Adults' Opinions Concerning Organ
Allocation Policies and Their Effects on Organ Donation,'' the
Gallup Organization stated the following in the Summary of
Survey Findings:
``A majority of adults agree with the statement, `an organ
from a donor should go to the sickest patient in the U.S. no
matter where they live.' A third (33 percent) of all adults
strongly agree with the statement and 50 percent agree. Asked
the extent to which they agreed with the statement, `an organ
from a donor should go to a sick patient in the donor's local
area rather than a sicker person elsewhere in the U.S.' most
adults say they disagree--18 percent strongly disagree and 55
percent disagree.''
These findings are consistent with the study results cited
in the 1990 OIG report in which more than 75 percent of
respondents disagreed with the statement that ``donor organs
should go to someone in the area where the donor lived'' and a
1994 UNOS poll in which more than half of the respondents gave
the highest priority to giving organs to the most critically
ill patient.
The prevailing view of organ donor families can be seen in
the testimony of a registered nurse at the hearings before the
House Government Reform and Oversight Committee on Human
Resources on April 8, 1998. In describing her decision to
donate her deceased husband's organs, she wrote:
``I didn't ask or care if Jim's organs went north, south,
east or west or stayed here in Wisconsin. My intent was that
someone was to be given another chance to live.'' (p. 2)
The gift of another chance to live is the reason behind the
enactment of NOTA; it is the hope of every patient on the
national waiting list; and it is the focus of the performance
guidelines in the Final Rule.
conclusion
It is UPMC's belief that the Final Rule provides
appropriate guidelines for the development of new allocation
policies for donated livers and other donated organs, and that
there are a number of alternative liver allocation systems that
have been discussed within the transplant community over the
last four years that would meet these goals and provide for a
fairer system for those patients awaiting transplants. Indeed,
as the Final Rule contemplated, some of these policies are
being debated within the Liver and Intestine Committee of the
OPTN, which has been charged with identifying those policies
that meet the performance guidelines of the Final Rule.
We urge that you not delay the effective date of the Final
Rule and allow the transplant community to develop the
allocation policies that can provide greater benefits to the
transplant patients of America.
------
Prepared Statement of Howard M. Nathan, Director, Delaware Valley
Transplant Program
I am Howard M. Nathan, Executive Director of the Delaware
Valley Transplant Program [DVTP]. DVTP is the nonprofit organ
procurement organization [OPO] serving the eastern half of
Pennsylvania, southern New Jersey, and Delaware. DVTP currently
serves a population of 10 million people, with nearly 3,000 of
those being patients awaiting life-saving organ transplants at
12 regional transplant hospitals. DVTP consistently has been
recognized as one of the nation's top performing OPOs. In 1997,
DVTP was the most active OPO in the country, coordinating a
national record number of organ donors (291) for any OPO
service area in the United States, resulting in 917 organ
transplants. I appear today to comment on DVTP's position on
recent actions taken by the United States Department of Health
and Human Services (``HHS'') regarding organ donation and
allocation.
1. DVTP Endorses the August 21, 1998 Medicare and Medicaid
Conditions of Participation for Hospitals.
DVTP endorses the recently implemented Medicare and
Medicaid Conditions of Participation for Hospitals, which
require the referral of all patient deaths in hospitals to the
area OPO, and which require the OPO or other specially trained
individuals to inform families of the option to donate and
request consent to donation. These rules, modeled on DVTP's
experience in the eastern half of Pennsylvania, should
positively impact on the underlying problem, the donor
shortage. We urge Congress and HHS to maintain the Conditions
of Participation that went into effect on August 21, 1998 and
continue to focus efforts on increasing organ donation.
2. DVTP Opposes the Implementation of the Federal Rules for
the Organ Procurement Transplantation Network (the ``OPTN'')
Published by HHS on April 2, 1998 (the ``OPTN Rules'').
DVTP opposes implementing the OPTN Rules as published
because those Rules vest in the Secretary of HHS the unilateral
power to develop and implement policies on organ allocation.
While the OPTN Rules do not dictate the content of the policies
the OPTN must adopt regarding allocation and patient listing,
they do grant wide latitude to the Secretary of HHS. DVTP is
concerned that policy could be dictated solely by the
Secretary, rather than be developed through the OPTN
contractor, currently the United Network for Organ Sharing
(UNOS), utilizing a process that reflects and balances the
views of the transplant community at large.
Until the organ shortage that exists in this country can be
fully eliminated, there will continue to be patients awaiting
transplant who will die. The issue of organ allocation, and the
attendant issues of who will receive organ transplants and who
will not, are complicated ones that require a balanced review
and consensus by those who are affected: members of the public
and members of the medical community. Such a review has not yet
been taken; such a consensus has not yet been reached.
DVTP supports delaying the implementation of the OPTN Rules
for at least one year. This time should allow all of the
constituent groups not only to reach consensus on the content
of the Rules, but more importantly, to reach consensus on the
content of any policies governing allocation.
3. DVTP Supports the Commitment of Additional Monies to
Public Education Programs.
DVTP applauds the proposal of the U.S. Senate
Appropriations Committee to commit 10 million dollars for organ
donation and urges using a significant portion of those monies
to support donor awareness efforts through public education
programs. Financial support must be dedicated to strengthening
the nation's understanding of the options families face when
their loved ones die. At least five million dollars a year for
at least four years should be directed to a national public
education campaign such as the Coalition on Donation's campaign
``Share Your Life, Share Your Decision,'' which was adopted by
HHS for use in its national public education initiative.
Only by increasing the number of organs donated can we as a
nation save the thousands of individuals who daily await
lifesaving transplant operations. Initiatives such as the
August 21, 1998, Conditions of Participation and national
public education campaigns are critical to addressing our organ
shortage crisis.
Attached are DVTP's more specific comments on the Medicare
and Medicaid Conditions of Participation and the OPTN Rules.
Thank you for this opportunity to comment on the Conditions
of Participation and the OPTN Rules.
------
Prepared Statement of Alan P. Brownstein, MPH, President and Chief
Executive Officer, American Liver Foundation
Chairman Specter and Senator Harkin, thank you for giving the
American Liver Foundation the opportunity to testify today on the
Department of Health and Human Services' Final Rule on Organ Allocation
announced by the Department on March 26, 1998.
The American Liver Foundation (ALF) is a national voluntary health
organization dedicated to the prevention, treatment and cure for
hepatitis and other liver diseases through research and education. ALF
has 26 Chapters nationwide and provides information to 200,000 patients
and families. Over 70,000 physicians, including primary care
practitioners and liver specialists and scientists also receive regular
information through the ALF scientific newsletter, Liver Update. ALF
was founded 22 years ago by the American Association for the Study of
Liver Diseases. In recent years ALF has provided over $6 million to
support liver research with guidance from our medical advisors.
Mr. Chairman, the Final Rule on Organ Allocation represents an
exceedingly important issue and the American Liver Foundation
appreciates your willingness to call this very timely hearing. Our
position on the Final Rule has been developed with much thought and
deliberation. Very active in our discussions have been the following
physician and non-physician ALF Members: Rocco F. Andriola. Esq., Bruce
R. Bacon, MD, Eugene Feingold, Ph.D., Louise M. Jacobbi, Russell H.
Wiesner, MD, John Lake, MD, Ronald J. Sokol, MD, Lewis W. Teperman, MD,
and John M. Vierling, MD.
The new rule for organ allocation
As stated by the Department of Health and Human Services, the rule
does not prescribe specific allocation policies, but sets forth
performance goals and a process by which to design and review these
policies. The broad performance goals require standardized medical
criteria for determining the placement of patients on waiting lists and
the status of their illness. The rule also requires medical urgency and
length of waiting time to be taken into account, with medical judgment
the final determinant as to how organs can best be used. By creating
performance goals that will minimize waiting time disparities across
the country this rule will help make the Nation's transplant system
more equitable for patients.
ALF supports this new rule and notes that much of what is called
for has been accomplished by UNOS serving under contract as the Organ
Procurement and Transplantation Network (OPTN). More specifically, the
new rule calls on the OPTN, the private sector system created by the
National Organ Transplant Act of 1984, to develop revised organ
allocation policies that will reduce the current geographic disparities
in the amount of time patients wait for an organ. The rule also calls
on the OPTN to develop uniform criteria for determining a patient's
status and eligibility for placement on a waiting list. The criteria
will be aimed at assuring that patients with greatest medical need will
receive scarce organs based on medical judgment and common medical
criteria, no matter where they live or in what transplant center they
are awaiting treatment.
Liver allocation must be fair and equitable
ALF supports a system of organ allocation that most benefits
patients. Allocation of organs should be based on sound medical
considerations, taking into account medical urgency, practicality and
sound medical judgment. This may require changing local organ
procurement organization operating principles and expanding geographic
areas for organ sharing. The creation of a ``national list'' may
present risks of organ wastage and unfavorable outcomes regarding
patient and graft survival.
Urgent need to explore third party conflict resolution intervention
ALF strongly believes that extensive analysis and careful
consideration of any policy change must ensure that those changes
improve and increase a patient's access to care and patient and graft
survival. In short, the policy must benefit the patients it covers. ALF
believes that the growing controversy surrounding proposed changes to
OPTN policy has undermined the public's confidence and has had a
negative influence on a perceived or real fairness of the system. ALF
believes that this may be having an adverse effect on organ donation.
For these reasons, ALF is asking that all parties, representing
different points of view, come together to develop a consensus on this
urgent matter. The ALF calls upon government, medical and non-profit
leaders to explore the feasibility of initiating a formal conflict
resolution process to assist in this matter.
The ultimate solution to the problem of scarce organs is to increase
the number of donated organs
Today there are more than 55,990 people on the UNOS list waiting
for a donated organ and every 18 minutes another person is added to the
waiting list for organs. In contrast to the numbers on the waiting
list--and about 500 people are added to the list each month--only
slightly more than 19,400 Americans each year receive an organ
transplant.
More resources are needed to support public-private partnerships to
promote organ donor awareness. This is critical because increased organ
donation will help resolve the inequities in organ allocation.
Currently, slightly more than 19,400 Americans each year receive an
organ transplant in contrast to the over 58,000 on the UNOS list
waiting for a transplant. As a result about 4,000 people die in the
United States each year while waiting for an organ transplant. This
means that more than 10 people die each day while waiting for an organ.
Thus, for liver transplantation in 1997, 10,000 people were on the
waiting list for a liver; 4,000 received transplants; and, nearly 1,000
died while waiting.
The Health Resources and Services Administration, the Division of
Transplantation has only approximately $700,000 in its fiscal year 1998
budget for public awareness efforts to increase the rate of organ
donation. The ALF believes these amounts need to be increased
substantially and sustained for a decade or more to have the intended
effect of changing public attitudes and behaviors to increase the rate
of organ donation.
Biomedical research focused on transplantation issues should be
increased to multiply the success and effectiveness of the system.
The ALF strongly believes that significant improvements in the
outcome of organ transplants and significant progress to address the
organ shortage can be made by expanding transplantation research at the
National Institute of Health.
In the fiscal year 1997, 13 of the NIH Institutes and Centers spent
$266.8 million on transplantation research; in fiscal year 1998 the
total increased to $274.9 million, or an increase of only 3 percent.
The ALF strongly recommends that the Congress increase NIH
transplantation research.
conclusion
Once again, we would like to thank Chairman Specter and Senator
Harkin for inviting the American Liver Foundation to testify today. You
have an important role to play in insuring that this debate is resolved
in a timely manner. There are a number of other important areas in the
Rule that are not commented on in this statement as the ALF elected to
comment only on the areas considered by ALF to be of highest priority.
Mr. Chairman, attached to this testimony is the ALF position
statement on the Final Rule as adopted by the ALF Board of Directors.
______
Position on Liver Allocation: the HHS Rule for Organ Allocation
Announced March 26, 1998
The ``final'' rule by the Secretary of Health and Human Service
calls on the Organ Procurement and Transplant Network (OPTN), the
private sector system created by the National Organ Transplant Act of
1984, to develop revised organ allocation policies that will reduce the
current geographic disparities in the amount of time patients wait for
an organ transplant. The rule also calls on the OPTN to develop uniform
criteria for determining a patient's status and eligibility for
placement on the waiting list. The criteria will be aimed at assuring
that patients with the greatest medical need will receive scarce organs
based on medical judgment and common medical criteria, no matter where
they live or in what transplant center they are awaiting treatment. ALF
support this new rule, and notes that much of what is called for has
been accomplished by UNOS serving under contract as the OPTN.
Liver Allocation Must be Fair and Equitable.--ALF supports a system
of organ allocation that most benefits patients. Allocation of organs
should be based on sound medical considerations, taking into account
medical urgency, practicality and sound medical judgment. This may
require changing local organ procurement organization operating
principles and expanding geographic areas for organ sharing. The
creation of a ``national list'' may present risks of organ wastage and
unfavorable outcomes regarding patient and graft survival.
Urgent Need to Explore Third Party Conflict Resolution
Intervention.--ALF strongly believes that extensive analysis and
careful consideration of any policy change must ensure that those
changes improve and increase a patient's access to care and patient and
graft survival. In short, the policy must benefit the patients it
covers. ALF believes that the growing controversy surrounding proposed
changes to OPTN policy has undermined the public's confidence and has
had a negative influence on a perceived or real fairness of the system.
ALF believes that this may be having an adverse effect on organ
donation. For these reasons, ALF is asking that all parties,
representing different points of view, come together to develop a
consensus on this urgent matter. The ALF calls upon government, medical
and non-profit leaders to explore the feasibility of initiating a
formal conflict resolution process to assist in this matter.
The Ultimate Solution to the Problem of Scarce Organs is to
Increase the Number of Organs Available for Transplant.--More resources
are needed to support public-private partnerships to promote organ
donor awareness. This is critical because increased organ donation will
help resolve the inequities in organ allocation. Currently, slightly
more than 19,400 Americans each year receive an organ transplant in
contrast to the over 58,000 on the UNOS list waiting for a transplant.
As a result, about 4,000 people die in the United States each year
while waiting organ transplantation. This means that 10 people die each
day while waiting for an organ. Thus, for liver transplantation in
1997, 10,000 people were on the waiting list for a liver; 4,000
received transplants; and nearly 1,000 died while waiting.
Biomedical research focused on transplantation issues should be
increased to multiply the success and effectiveness of this system.
The American Liver Foundation acknowledges the following
individuals for the assistance they provided in preparing this position
statement: Rocco F. Andriola, Esq.; John Lake, MD; Bruce R. Bacon, MD;
Ronald J. Sokol, MD; Eugene Feingold, Ph.D.; Lewis W. Teperman, MD;
Louise M. Jacobbi; John M. Vierling, MD; and Russell H. Wiesner, MD.
______
Prepared Statement of Joseph L. Brand, Chairman, the National Kidney
Foundation
organ allocation regulations
The National Kidney Foundation (NKF) appreciates the opportunity to
provide testimony for the written record regarding the Administration's
April 1998 regulations for organ allocation policy under the Organ
Procurement and Transplant Network (OPTN). NKF is the nation's leading
voluntary health organization dedicated to the prevention and treatment
of diseases of the kidney and urinary tract and we provide assistance
to individuals through programs of research and training support,
patient services, and public and professional education. Our membership
consists of 30,000 volunteers, including physicians, scientists,
nurses, social workers, renal dietitians, kidney patients and their
families, and concerned members of the lay public.
The mission of the 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. The 1998 U.S. Transplant Games, which were held in
Columbus, Ohio in August, were a testament to the NKF's commitment to
organ donation and transplantation. More than 1,500 athletes from all
ages from across the country competed in 13 Olympic-style events,
helping to celebrate the second chance at life by bringing together
recipients of organ transplants of every type.
As the world's largest voluntary health organization promoting
organ and tissue donation, NKF is dedicated to increasing the
availability of organs to advance the health of those who need the
``Gift of Life.'' With the transplant waiting list growing every year,
new efforts are required to increase the number of organ donors. As
such, we are supportive and appreciative of recent efforts by the
Administration in this regard, including the requirement that hospitals
that participate in Medicare and Medicaid refer all deaths to organ
procurement organizations (OPO's) for potential organ donation.
Because the OPTN regulations call for such sweeping changes in
organ procurement and distribution, NKF urges a delay in their
implementation so as to afford the transplant community and government
agencies the opportunity to fully assess their potential impact on
patient outcomes, organ donation and the cost of transplantation.
Furthermore, the policy goals upon which the regulations are based
cannot be achieved unless uniform listing criteria are determined,
accepted and implemented.
Despite many efforts of the Administration, NKF, and other
organizations, the organ shortage is expected to remain constant, if
not increase, as medical advances make organ transplantation an option
for more individuals. Therefore, there is a crucial need to address the
issue of organ supply. Nevertheless, NKF believes that the
Administration's organ allocation rules for the OPTN could result in a
decrease in the availability of organs for transplantation in this
country. It should be noted that this conclusion was reached only after
extensive consultation and input from the NKF constituency, including a
survey of our 51 affiliates and discussions with our constituent
councils: the Patient and Family Council, the National Donor Family
Council, and the transAction Council.
Organ donation efforts are more successful in certain geographical
areas than in others in part because of the effectiveness of certain
OPO's and because of community spirit energized by local transplant
centers. As a result of the new regulations, some transplant centers
may be forced to close. This may reduce the propensity to donate organs
in the parts of the United States served by those centers. Another
consequence of the regulation is that there would be little incentive
for OPO's to improve performance. Rather than attempting to equalize
the distribution of scarce organs, greater emphasis should be placed on
the evaluation and improvement of individual OPO performance. Finally,
our affiliates are concerned that a policy of allocating organs to
those with the greatest medical urgency could increase the number of
transplant rejections and increase the need for second transplants,
thus reducing the availability of organs for individuals on waiting
lists who may be better recipients so far as their potential organ
survival after transplantation.
National policy for organ procurement and distribution should be
based upon principles of maximizing graft survival, balanced by
equitable allocation. We are concerned that the effort to equalize
waiting times for organs may give rise to additional inequities. For
example, as noted above, if smaller transplant centers are forced to
close as a result of the exportation of organs, members of lower
socioeconomic groups--many of whom are minorities--may find it
difficult to afford the costs associated with travel to distant
transplant centers (including travel for post transplant care).
Although the goal is to ``level the playing field'' for transplant
candidates, the new regulation would have the effect of barring certain
potential transplant recipients based on ability to pay. Finally,
because of the availability of dialysis as an alternative to renal
transplantation, medical urgency should not be a factor in determining
priority for allocation of kidneys.
We are concerned also about the impact the new allocation
regulation would have on the costs of transplantation. A national
allocation system would result in increased costs for either the
transport of patients or the retrieval and shipment of donated organs.
We urge Congress to give careful consideration to improving access
to transplantation by expanding organ donation.
______
Prepared Statement of John H. Fitch, Director of Government Relations,
National Funeral Directors Association
On behalf of the National Funeral Directors Association (NFDA), I
am pleased to submit the following testimony for the record on the
Subcommittee's September 10 hearing on Organ Donations. NFDA was
founded in 1882 and is the largest funeral service organization in the
world. NFDA members provide services to families across the United
States. The average funeral home conducts approximately 160 services
per year. Eighty-five percent of the funeral homes in America are
family owned and operated businesses and have served their communities
for three and four generations.
NFDA embraces the Subcommittee's commitment to increase organ
donation and to oversee HHS' policies in this area. NFDA's members
strongly support efforts to encourage individuals to donate healthy and
usable organs. To this end, many funeral directors have publicly
supported organ donation efforts sponsored by various groups and
organizations.
The U.S. Department of Health and Human Services has recently
issued two rules which are intended to increase the number of organ
donations. Specifically, HHS has issued a final rule on the Organ
Procurement and Transplantation Network (OPTN) requiring the OPTN Board
to develop policies standardizing the criteria for organ
transplantation. HHS has also issued a rule modifying the conditions of
participation for hospitals in the Medicare and Medicaid programs
regarding organ and tissue donation and transplantation. Under this
rule, hospitals must implement written protocols that incorporate the
following elements related to organ donation and transplantation: (1)
hospitals must notify Organ Procurement Organizations (OPO's) of
imminent and actual deaths; (2) OPO's must notify the family of every
potential donor of its option to donate organs and/or tissue; and (3)
OPO's must review death records to assure medically suitable organs
were not overlooked.
Implementation of these rules and the general increase in the
number of donations occurring in the United States will present
challenges to the funeral service industry. NFDA would like to take
this opportunity to highlight these challenges for the Subcommittee and
to briefly note some of the ramifications of organ donation on family
burial decisions.
While NFDA believes many families support increasing donations to
help other families, NFDA encourages educational efforts to better
inform families of the process and its implication for funeral
arrangements. Most families are not fully aware of these implications.
Family understanding of these issues is also complicated by the fact
that the decision to donate organs and/or tissue is often made at a
time of emotional distress. For example, it is our experience that the
actual organ and tissue retrieval is often more extensive and lengthy
than the family may have expected. The process of identifying a
recipient for the organs, and the subsequent retrieval of organs and
tissues is complex and time-consuming. Such retrievals may delay the
family's funeral and burial arrangements and certain wishes of the
family regarding viewing.
NFDA believes that potential organ donors and families of organ
donors need to be aware of the possible implications of organ/tissue
donation including the effect on embalming, the time associated with
reconstructing the vascular system which is oftentimes damaged during
harvesting and related damage, and the impact on viewing. To encourage
these educational efforts, NFDA has initiated discussions with the
American Association of Tissue Banks and the American Organ Procurement
Organization. NFDA is also working with these and other relevant
organizations to consider how to develop policies to address these and
related issues.
In closing, NFDA believes that the disclosure of all relevant
information surrounding organ donation, procurement, and harvesting as
well as appropriate and ethical practices in this area are issues that
should be considered as organ procurement efforts are increased. We
encourage the Subcommittee to review these important concerns.
Thank you in advance for your time and consideration of our
comments. I look forward to working with you, your staff, and the
Subcommittee on this issue.
______
Prepared Statement of the Patient Access to Transplantation Coalition
This statement is submitted on behalf of the Patient Access to
Transplantation (PAT) Coalition, an independent and informal coalition
of transplant centers and other medical institutions which provide
nationally recognized excellence in patient care. The PAT Coalition is
comprised of 28 transplant centers located in 18 states across the
nation.
Baylor College of Medicine
Emory University
Henry Ford Health System
Hermann Hospital (Houston, TX)
Inova Health System (Fairfax, VA)
Jewish Hospital (Louisville, KY)
Louisiana State University
Medical University of South Carolina
Memorial Medical Center (New Orleans, LA)
Methodist Hospital (Houston, TX)
Ochsner Medical Institutions
Ohio State University
Oregon Health Sciences University
St. Louis University Hospital
St. Luke's Hospital (Houston, TX)
Tulane University
University Hospitals of Cleveland
University of Alabama at Birmingham
University of Florida/Shands Hospital
University of Kansas
University of Kentucky
University of Medicine and Dentistry of New Jersey
University of Michigan
University of Virginia
University of Washington
University of Wisconsin at Madison
Virginia Commonwealth University
Wake Forest University
introduction
Each year the number of individuals in need of an organ transplant
grows at a far more rapid pace than the number of organ donors. The
situation is now critical, with almost 60,000 patients on the waiting
list nationwide. As transplant centers striving to save as many of our
patients as possible, we know that the best and only solution to this
crisis is to increase organ donation. Until there no longer is a
shortage of organs, the transplant community will be forced to make
difficult choices about how these scarce but precious resources should
be allocated.
We believe that, in its April 2, 1998 final rule, the Department of
Health and Human Services (HHS) removes these choices from the private-
sector transplant community. It puts bureaucrats at the bedside and
directs physicians and transplant centers to carry out HHS policy
directives rather than following the collective medical wisdom of the
transplant community. We strongly believe that these difficult and
important decisions should be left, as Congress intended, to the
transplant community.
Although the new HHS allocation policy may make superficial sense,
it does not stand the test of reason. It focuses on the needs of the
few to the detriment of the many. Remarkably, HHS admits that its
chosen policy will reduce survival rates, reduce the number of patients
transplanted, and increase the number of individuals on the waiting
list as well as overall waiting time. Equity--defined primarily as the
elimination of geographical disparities in waiting times--carries a
heavy price which will be paid with patients' lives.
We are also very concerned about the impact of this policy on
patient access to affordable transplantation services. The development
of newer transplant centers with local and regional service areas has
allowed patients from all walks of life to be transplanted. Data relied
upon by HHS reveals that its allocation policy will distribute organs
away from small and mid-size transplant centers to a few large centers
with a high percentage of hospitalized patients. This may force some of
these small and mid-size centers, which traditionally serve larger
numbers of minority and low-income patients, to close.
For the sake of the 60,000 Americans who are currently waiting to
receive the gift of life, we hope that Congress will ensure that this
ill-advised policy does not go into effect. We urge Members to enact
legislation to impose a moratorium on the regulations and to
reauthorize the National Organ Transplant Act (NOTA) to clarify
Congress' intent that these important medical and ethical issues be
decided by the transplant community rather than HHS.
current allocation policy
The OPTN Contractor, the United Network for Organ Sharing (UNOS),
has established various allocation systems for cadaveric kidneys,
livers, thoracic organs, pancreas and intestinal organs, as well as a
separate system for organs not specifically addressed. Under the
current liver allocation policy (which will first be impacted by HHS'
new regulations), UNOS keeps a list of every patient in the United
States waiting for a transplant. When an organ becomes available, it is
generally offered first to the sickest patients (ranked ``Status 1'')
within the local Organ Procurement Organization's (OPO's) service area.
If the organ cannot be used by a Status 1 patient on the local list, it
is then offered to the remaining patients on the list (ranked by
severity of illness as Status 1, 2A, 2B or 3). If no match for the
donated organ can be found on the local list, it is then offered to
patients in the multi-state OPTN region, again prioritized by severity
of illness. In the absence of a regional match, the donated organ is
offered to patients nationwide, with priority again given to the
sickest patients.
The current policy was developed by the transplant community to
achieve the maximum benefit for the maximum number of individuals in an
equitable fashion. Because Status 1 patients are more likely to die
than those whose needs are less medically urgent, the current system
gives them first priority in obtaining local organs. However, because
many patients in lower status categories also will die while waiting,
and are more likely to survive surgery without requiring
retransplantation, the current system next offers locally procured
organs to these patients before offering them to patients within the
surrounding region. When viewed as a group, transplant candidates are
best served by a system which ensures the highest survival rates
possible. This reduces the number of transplants which fail and require
retransplantation, thereby denying another patient the chance for a
transplant because there simply are not enough organs available for
everyone on the waiting list.
summary of the hhs final rule
The final rule establishes three broad ``performance goals to be
achieved by the OPTN'' in developing organ allocation policy. See 63
Fed. Reg. 16296 (1998) (to be codified at 42 U.S.C. part 121). The
performance goals require the OPTN to establish: (1) minimum listing
criteria to be used by transplant centers in determining whether a
patient is suitable to be listed for a transplant; (2) status
categories based on ``objective medical criteria to be used nationwide
in determining the medical status of those awaiting transplantation'';
and (3) equitable allocation policies ``that provide organs to those
with the greatest medical urgency, in accordance with sound medical
judgment,'' and direct organs ``so as to equalize waiting times,
especially for those with greatest medical need.'' Id. at 16296-7.
problems with hhs' organ allocation policy
1. The policy places bureaucrats at patients' bedside
Although we recognize that HHS has oversight responsibility for the
OPTN under NOTA, we believe that a direct, substantive role for the
Department in developing organ allocation policies conflicts with both
the letter and the spirit of the law. Under NOTA, Congress established
the OPTN as a private-sector entity which, under contact with the
government, assists organ procurement organizations in the equitable,
nationwide distribution of organs among transplant patients. See 42
U.S.C. section 274(b)(2)(D).
Seizing on the words ``nationwide'' and ``equitable,'' HHS goes far
beyond its oversight role to mandate the establishment of organ
allocation policy. Both the preamble and the text of the rule clearly
evidence the agency's policymaking agenda. See 63 Fed. Reg. at 16311
(``[T]he OPTN must be primarily responsible for * * * developing
equitable allocation policies that reflect the Secretary's policies, as
expressed in this regulation.''); id. at 16334 (``[T]he Secretary may *
* * direct the OPTN to adopt a policy; or, may develop a policy that
the OPTN must follow.'').
The ``discretion'' granted by HHS is illusory. It is as if the
agency is telling the OPTN to bake a chocolate cake, but allowing it to
pick the recipe. Do federal policymakers really know better than
transplant physicians and surgeons what is best for their patients? We
think not--and strongly believe that these issues should be left, as
Congress intended, to the transplant community representatives,
including patients, who comprise the OPTN.
2. It will reduce survival rates and the number of individuals
transplanted
When asked during a national conference call whether the new policy
would yield the greatest benefit for the greatest number of patients,
HRSA Administrator Dr. Claude Fox admitted that the new rule favors
equity over utility. Indeed, the preamble to the rule states that
survival rates will decrease with priority to the most urgent patients.
Id. at 16325. Moreover, HHS explicitly recognizes that transplanting
sicker patients will result in additional retransplantations because
very sick patients are more likely to experience graft rejection. Id.
This means that fewer individuals would be transplanted under the new
policy.
The HHS policy appears to be based on the erroneous assumption that
only hospitalized patients are sick enough to require transplantation.
Although not hospitalized, many patients on the waiting list are
homebound or bedridden. They are extremely sick, and getting sicker.
Why should the government force them to wait until they are as sick as
possible before they can receive a transplant? Indeed, of the 953
patients who died last year while waiting for a liver transplant,
almost 60 percent were not hospitalized.
Rather than seeking to benefit transplant candidates as a group,
HHS looks only at the interests of the most desperately ill patients.
In so doing, the agency fails to consider the needs of the vast
majority of patients waiting for organ transplants, thereby sentencing
them to lower survival chances and more time on the waiting list.
3. The HHS policy will increase the number of patients on the waiting
list, as well as waiting times
HHS mandates the OPTN to implement new organ allocation policies
``to equalize waiting times, especially for those with greatest medical
needs.'' 63 Fed. Reg. at 16297. However, there is little regional
variation in waiting times for Status 1 and Status 2 patients--a fact
which Administrator Fox admitted during a March 26 HRSA-sponsored
conference call.
It is true that the length of time that lower-status patients spend
on waiting lists may vary greatly from region to region, and even
within regions. However, HHS admits that waiting time variations are
not reliable indicators of medical status since aggressive listing and
accelerating hospitalization may artificially inflate patient waiting
times and status, Id., at 16311-12. Indeed, the Department admits that
``current measures of waiting time disparities are weak because the
lack of listing standards does not create uniform, status-related
measures.'' Id., at 16327. Yet, eliminating these disparities is the
hallmark of its proposed organ allocation policy.
It is also important to note that other factors, such as local
organ donation rates, influence how long patients must wait to receive
a donor organ. A recent UNOS study (McBride, et al., 1997) found that
the two OPTN regions with the longest waiting times for less urgent
patients had the highest ratios of patients waiting to the number of
organs donated and transplanted. HHS itself admits that there are
``great disparities'' in the production of donor organs and that ``the
productivity of the local OPO directly impacts the number of
transplants done in the OPO service area.'' 63 Fed. Reg. at 16314.
The fundamental flaw underlying the Secretary's approach is that it
equates waiting time equality with equity. We strongly disagree. It is
not equitable to take organs from regions that have successfully
reduced waiting times through effective, locally-based procurement
programs and give them to regions with longer-than-average waiting
times.
Moreover, because geographical disparities exist only with respect
to patients in less medically urgent status categories, a ``sickest
first'' policy will only reduce disparities by forcing patients in some
regions to wait longer as organs that would have been offered to them
are transported to patients in other regions. Data relied on by the
Secretary indicates that broader sharing will only ``equalize'' waiting
times by forcing patients in some regions to wait up to 82 days longer
for transplants to reduce waiting times in other regions by, at most, 8
days. 63 Fed. Reg. at 16327 (Table 12). In fact, HHS admits that
overall patient waiting time--and therefore the number of individuals
on the waiting list--will actually increase under the new allocation
scheme. Id. at 16324-25.
While organs remain scarce, as is currently but unfortunately the
case, allocation policy must take into account considerations of
utility as well as equity. The new policy promulgated by HHS values
``equity,'' defined according to waiting times, without regard to
utility, thereby prolonging waiting times, decreasing the efficacy of
transplants and wasting valuable organs.
4. The HHS policy will impair patient access to transplantation
services, especially for low-income and minority recipients
Lack of access to organs may drive some regional transplant centers
out of business, inflicting a fundamental blow to patient access. Data
cited in the preamble to the rule indicates that large centers would
perform 30 percent more transplants under the new allocation scheme,
while small and mid-size centers will experience 19 percent and 25
percent reductions, respectively. Id. at 16331 (Table 15). Our research
suggests that the impact on small and mid-size centers may be even more
severe. If these centers close, patients will be forced to travel
longer distances at greater expense, and will be separated from their
family members when they most need them.
The preamble concludes, without citing any supporting evidence,
that ``this concern over local access and increased travel only affects
a small number of patients.'' Id. at 16303. However, according to UNOS
data, 70 percent of the patients who received liver transplants in 1996
were transplanted at centers in the OPO service area in which they
resided.
Because Medicaid patients often are unable to obtain transplants
outside their home states, they will be sharply disadvantaged under the
Secretary's national allocation policy. The preamble to the rule
brushes off the arguments that higher travel costs and lack of health
insurance will effectively exclude low-income individuals from the
opportunity to receive an organ, labeling these concerns as
``speculative.'' Id. at 16303. However, UNOS data indicates that almost
one in five kidney and liver transplant candidates nationwide are on
Medicaid.
A new allocation policy which could eliminate access to financing
for one in five transplant candidates certainly does not seem
equitable.
Many local and regional centers have been serving significantly
higher-than-average proportions of minority patients. UNOS data
regarding the percentage of minority patients served by several OPOs is
illustrative:
Mississippi: 82.4 percent and 30.8 percent African-American kidney
and heart recipients, respectively.
New Mexico: 72.7 percent minority liver recipients and 70.9 percent
minority kidney recipients.
South Carolina: Kidney recipients were 63.8 percent minority and
56.9 percent African American, while 41.7 percent of heart recipients
were minorities.
By contrast, one of the major centers which supports the HHS rule
performed only 7.3 percent of its liver transplants on minorities in
1996 (compared to the national average of 23.1 percent), and just 16.4
percent of its kidney recipients were minorities (versus 44.9 percent
nationally). We are extremely concerned that the HHS policy would
impair minority access to transplant services by shifting organs away
from regional centers to a few large national centers which
historically have served fewer minority patients.
5. The HHS policy will harm local organ donation efforts
The establishment of transplant programs serving local, state and
regional areas has resulted in a marked increase in the total number of
annual transplants in the United States. We firmly believe that the
presence of a transplant program in a community or state provides a
context and a focus for efforts to increase organ donation. Indeed, if
centers are forced to close, their transplant teams will no longer be
available to recover organs in the surrounding area, further hurting
donation efforts.
HHS contends that it has seen ``no credible evidence that local
performance encourages donation.'' 63 Fed. Reg. at 16304. However, this
ignores the testimony of numerous expert witnesses who expressed this
sentiment to HHS during its December 1996 public hearing--as well as
the opinion of HHS' own hearing chairman. After the hearing, Assistant
Secretary for Health Phil Lee stated on national television that ``when
you have a local area with a local transplant center that vigorously
educates the public in the area * * * you have a higher level of
donation. That's what we were told in the hearings.''
The public relations efforts mounted in support of the HHS rule
contend that donated organs are a ``national resource'' subject to
federal regulations and control. However, organ donation occurs
locally, not nationally, and involves donor families, physicians,
hospitals and organ procurement organizations, all working closely
together within a local setting.
We are concerned that the ``nationalization'' of donated organs
would, over time, undermine these relationships and reduce the
incentives for vigorous, community-based efforts to increase organ
donations. Rather than micromanaging organ allocation, HHS should be
seeking to increase organ donation through education and legislative
initiatives. Only by increasing the number of families who consent to
donate their loved ones' organs can we eliminate the shortage now
forcing us to make these difficult allocation decisions.
______
Letter From Senator Daniel K. Inouye and Senator Daniel K. Akaka
U.S. Senate,
Washington, DC, June 17, 1998.
Hon. Bill Frist,
Chairman, Subcommittee on Public Health and Safety, Committee on Labor
and Human Resources, U.S. Senate, Washington, DC.
Dear Mr. Chairman: This letter is in response to Secretary
Shalala's proposed final ruling on organ donation and transplantation.
We applaud the Secretary's intent to increase equity among transplant
candidates. However, there may be circumstances where geographic areas
are unable to comply with the ruling or where compliance would cause
significant hardship to a patient population. Therefore, we encourage
the Congress to ensure that the Organ Procurement and Transplantation
Network (OPTN) includes a mechanism for exemption from the final
ruling.
The final rule emphasizes the importance of both maintaining high
quality of organs to be transplanted and reducing organ wastage. Unlike
any other transplant center in the United States, because of Hawaii's
geographical isolation, it would be nearly impossible for us to comply
with the rules. Organs would have to travel at least 2,300 miles or 5
to 6 hours just to get to the west coast. These figures do not include
travel time to and from airports, flight availability, connecting
flights to other cities, differing time zones, or unforeseen delays. It
should be noted that times would be further increased if the organs
were allocated to another area of the United States.
In a recent Honolulu case (May 2, 1998), the heart, kidneys, liver,
and pancreas were recovered from a 29-year-old female. The pancreas was
placed for transplant in Sacramento, California, and the organs shipped
to the airport in a timely manner. Unfortunately, due to mechanical
difficulty, the flight was delayed. Alternate transportation, including
a private charter, was not available and, ultimately, the pancreas was
wasted. It should also be noted that there are no flights leaving
Hawaii after 10:40 p.m. Organs recovered late in the day could not be
shipped until the next morning, adding significantly to ischemic time.
Additionally, organs being allocated to Hawaii's sickest patients might
also end up with unnecessary increases in ischemic times due to the
flight arrangements from the mainland to the Hawaiian islands. This
would dramatically reduce the quality of organs allocated to our
transplant recipients to the point of endangering their lives.
We believe that Hawaii's transplant candidates would suffer
tremendous hardship under the proposed ruling. If organs are allocated
to the sickest patients first, the viability of our sole transplant
center is at risk, eliminating reasonable access to treatment for many
Hawaii residents related to their inability to travel long distances
and the associated financial hardship. Thus, the ruling will
unintentionally result in the creation of a two-tiered health care
system, with transplantation only for the wealthy. These patients will
also lose their support system during their extended treatment and
recovery period. Many patients report that they cannot travel to the
mainland and will then choose not to be listed as transplant
candidates.
Last, Hawaii's population includes significant numbers of people of
Asian and Pacific Island descent, as well as an indigenous culture.
This population provides unique opportunities and challenges for the
health care delivery system. We are a culturally diverse population on
a small group of islands, and we maintain strong bonds to family and
friends. Traditional beliefs surrounding medical care and end-of-life
practices all influence participation in ``western'' medical care, as
well as attitudes toward donation. While national surveys may predict
no decrease in donation if organs are to be shared nationally, when
offered the option of donation, most of our families ask where the
organs will be used. To promote organ donation in Hawaii, we need to be
able to inform these families that they are providing for their
community.
For these reasons, we encourage the Congress to ensure that the
OPTN includes a mechanism for exemptions to the final ruling.
Sincerely,
Daniel K. Inouye,
U.S. Senator.
Daniel K. Akaka,
U.S. Senator.
ORGAN DONATIONS
----------
SATURDAY, SEPTEMBER 12, 1998
U.S. Senate,
Subcommittee on Labor, Health and Human
Services, and Education, and Related Agencies,
Committee on Appropriations,
Scranton, PA.
The subcommittee met at 10:20 a.m., at the Lackawanna
County Courthouse, Scranton, PA, Hon. Arlen Specter (chairman)
presiding.
Present: Senator Specter.
NONDEPARTMENTAL WITNESSES
STATEMENT OF HON. ROBERT P. CASEY, FORMER GOVERNOR OF
THE COMMONWEALTH OF PENNSYLVANIA
opening remarks of senator specter
Senator Specter. Good morning ladies and gentlemen. We will
now convene the field hearing for the Senate Appropriations
Subcommittee on Labor, Health and Human Services, and
Education. One of the critical issues facing the Congress in
its current session is the issue of how to deal with organ
transplants, a very important subject which really means life
or death for so many Americans who need an organ transplant.
The Department of Health and Human Services has promulgated
regulations which would establish a national system on the
basis of need and there has been an effort made in the House of
Representatives to delay the implementation of this regulation
in order to allow the localities which have a different system
for organ transplants to take effect.
We are privileged this morning to have the distinguished
former Governor of the Commonwealth, the Honorable Robert P.
Casey, as a witness to testify. I have known Governor Casey for
many many years going back to 1966. We have served together and
apart as public officials. Governor Casey has special insights
into this very important issue because he has been the
recipient of a double transplant.
On a personal note, the Governor had his operation on June
14, 1993, which coincidentally was the same day that I had
brain surgery. Governor Casey was in the hospital at Pittsburgh
and I was in the hospital in Philadelphia. The next day the
Philadelphia Daily News had a front page picture of Governor
Casey looking in one direction and me looking in the other
direction. So we were sort of facing each other on the separate
pictures. The big headline said, ``anguish.'' The newspaper
relayed the stories about how we both had very serious
operations on the same day. As soon as the word reached
Harrisburg, governmental officials suspended all operations. I
am not sure out of concern for Bob Casey and Arlen Specter as
much as that of concern to figure out who would replace the
Governor and who would replace the Senator, who would replace
the man who replaced the Senator, who would replace the man who
replaced the Governor. It is a complex issue of domino falling
which is not typical and so it is understandable. Governor
Casey and I were laughing about that a few weeks ago when I had
occasion to visit him in his home here in Scranton.
summary statement of hon. robert casey
Well, Governor, we welcome you here. We understand that it
is an easier trip for me to come to Scranton than it is for you
to come to Washington. I had the opportunity to attend the Race
for the Cure, incidentally, for a few minutes. So we are just a
couple of minutes late in starting. But I am delighted to see
you looking so well. I thank you for offering your insights and
testimony on this very important issue of public concern. The
floor is yours, Governor.
Mr. Casey. Thank you very much, Senator Specter. I
appreciate your coming to Scranton to this hearing and giving
me the opportunity to share my thoughts on the new organ
allocation and donation rules issued by Secretary Donna
Shalala.
And I speak not just for myself but for those others who
will be here today, other transplant recipients. Robert
Solfanelli whom we met and there was a wonderful story that had
a very happy ending, unlike many of these stories which do not
have happy endings. And I will talk about that in a few
minutes. And Mrs. Lecrone who is also an organ recipient and
will testify as well.
I will start by saying that my purpose in coming today is
to urge you to support the regulation issued by Secretary
Shalala and move toward its implementation as soon as possible.
It is important there not be any delay. I know that there is
opposition in the House of Representatives and some of the
States to the implementation, but there is also a collateral
move to delay the implementation.
We know that the first priority on the regs is liver in
terms of the chronology of how this will work out. But I would
say that because 10 people die everyday because they cannot get
organs. And, in many cases, due to the current inequitable
allocation policy, which I will address in a minute, every day
we delay means more people will have to face death because they
cannot get an organ. So I hope that the committee will bear
that in mind in weighing the course that you are going to take
with respect to this very, very important matter.
Obviously, those of us who have been through this
experience and our families have a special, very personal
attitude toward it because it resulted in the saving of our
lives. And, of course, each transplant recipient has a story.
Now, my story is fairly well known. On June 14, as you pointed
out, the same day that you were hospitalized, I received a
heart and a liver transplant at the University of Pittsburgh
Medical Center. A very rare procedure, one that has been done
just a few times in this country. And it was very risky but it
was the only alternative I had to save my life. It was made
possible by transplant pioneer Dr. Thomas Starzl, University of
Pittsburgh Medical Center.
The way it developed was incredibly unique, I think. In a
chance conversation I mentioned my illness and he said he could
treat me with a liver transplant. And I had been 2 years into
this illness and I had been told that there was no cure and no
treatment. When it came time for me to face this issue, I was
incredibly blessed by the generosity of a woman in Monessen,
PA. Her name is Frances Lucas, whose son had been killed, by a
man in a case of mistaken identity, in her own front yard.
Beaten senseless, never regained consciousness, 34 years of
age, an African-American young man who had been subject to all
the travails and difficulties of modern life. And his life was
taken and mine was saved because of the generosity of this
woman who had lost another son to violence, her older son,
Eugene, shot in the back. So two sons lost to violence. And the
man whose organs I carry in my body today, William Michael
Lucas, a 34-year-old young man from Monessen, PA, is the reason
why I am able to come to this table and talk this morning.
You know, we have all heard the Biblical expression,
``greater love than this no man hath than a man lay down his
life for a friend.'' Well, I was saved by strangers, not
friends, people I never met. This incredibly generous woman
whose son had just been taken from her by violence, you know,
she could have said, well, do not bother me. I am grieving. My
son is dead. But she did not say that. She said, my son had a
good heart and it is right that someone else ought to have it.
So if you change that Biblical quotation and just
substitute one word, ``greater love than this no man hath than
a man lay down his life for a stranger,'' how much more power.
I was saved by strangers; a 34-old-year African-American young
man, his mother; a surgical team at the University of
Pittsburgh from all over the world, Japan; a Chinese-American;
the Vietnamese doctor; a doctor from Ecuador; a doctor who was
an American citizen who grew up and was born in Russia, his
father was a diplomat, Dr. John Armitage; seven of them. And
they saved my life.
And just parenthetically, when people talk about the
immigration rules, we have got to keep certain people out of
this country. That strikes a very personal chord with me. I
think the greatest thing about this country is its diversity.
And there you had my body on that table, there because of the
Lucas family, being saved by seven surgeons, including an
American surgeon from Nashville, people I had never met before,
and they saved my life.
And my life was saved because at that point in time there
was a rule, a regulation which said that we have a separate
waiting list in the Pittsburgh region for multiple organ
recipients. There was a separate list for heart and liver. It
is such a rare procedure, there has possibly only been a few
done since I had mine done, maybe a handful. I read in the
Inquirer some months ago, the first one was done in
Philadelphia about a year ago, heart/liver in Philadelphia.
When I went to Pitt, University of Pittsburgh, they were
not doing them anyplace in the country. If I had not gone to
that institution and met that doctor, Doctor Starzl, there
would have been no hope for me. So I mention these details
because every transplant recipient has a story, a very personal
story. And there is nothing more real than what we are talking
about here today.
I mean, you and I have considered all public issues of
great moment, great complexity, great importance to the
country. But none is more real than this one. I mean, this
brings you face to face with the essence of life, what life is
all about, the value of life and the fragility of life. And
that is why it is so important. These regulations have the
awesome power to say you shall live and you shall die. And that
is the effect of what we are talking about here today.
It is essential that these rules be fair and open and
understood and uniform and communicated to people who are
facing these decisions. The present system is a patchwork
quilt, as you know, from State to State or region to region,
and we have regions, as you know, for allocation of organs. But
from region to region, different waiting lists, different
criteria for getting on the list, different criteria for
determining medical status with respect to the urgency of the
need for the organ. And it is all different. And you have got
these poor people who cannot afford it, scouring every last
avenue where they can find a transplant center where the
waiting list is shorter so they can have a chance to live. And
that is not right. It is not right.
As the current regulations mandate that the primary factor
is the geographic location of where the organ is developed or
where the organ originates. And that is as arbitrary as it can
be. The defense for that position, I know it is couched in very
idealistic terms. But I have to tell you, and I talk to people
every week from all over the country, several people every week
on the telephone. I call them, they call me and we talk.
It is my belief that this geographic limitation, if you
will, is dictated by economic necessity from the point of view
of transplant centers, small centers. You cannot transplant
organs if you do not have organs. And so there is this
parochial turf battle, if you will, in which the organs are
first given to people in the locality. And I know you have
testimony and you know that so many people go out of State for
their transplants, an average of 25 percent. You heard
testimony recently, I understand, in New Jersey, 64 percent of
the people leave New Jersey and go to other States. And so the
geographic rule in New Jersey can work against New Jersey
citizens.
Talk about the law of unintended consequences. You can have
a transplant recipient go from Newark to Philadelphia and have
an organ that shows up in New Jersey a week later and because
of this rule the Jersey resident in Philadelphia can be at
death's door but that organ will go to someone in New Jersey,
in all likelihood, who is less sick then the New Jersey
resident in Philadelphia across the river. Now, that does not
make any sense. The priority ought to hinge on medical
necessity and sound medical judgment. I know the rules say that
the geography can be taken into account but now it is the No. 1
factor.
And so much has happened since 1984 when the National Organ
Transplant Act was put into effect, as you know. The ischemic
life of organs is much longer now. They can transport them
longer distances. You can even probably go coast to coast, I
would think, with most organs, although it is not uniform.
But I am advocating today a position in which the sickest
people get the priority based on medical need and medical
urgency. You know, it is a very simple illustration. If you
come on an accident scene and there are five people injured,
two of them critical and three less so, you do not take the
ones that are not badly injured to the hospital first. You take
the critical ones first. That is what medical ethics requires.
The American Medical Association has said that, that it is
unethical to prohibit the transportation of organs unless the
life of the organ will not permit the transportation. But
otherwise it is unethical. So what we are advocating today is
not only morally right but it is right in terms of the ethics
of the profession.
When I had my transplant, first I met with my doctors and
said, look, there are certain rules that apply to this
procedure. And I want you to all look me right in the eye and
tell me that you are going to follow the rules in my case to
the letter. OK. We got that clear? And they did, to the letter.
I mean, I want fairness for myself and I want fairness for
everybody else, too. And it is high time for this system is
changed so that fairness was the rule of the day. Fairness
predicated on medical urgency and medical necessity, not to
arbitrary accident of where the person lives or where the
person is listed for transplant or where the organ originated.
That is a self-serving rule designed to protect parochial
interests.
In this system, the patient should be first, not transplant
center, not transplant doctors, not the cash flow of some new
transplant center that needs organs to survive. That is not the
criteria. They are important considerations. I do not diminish
them. But the No. 1 priority has got to be what is best for the
patient. How can we save more lives? How can we make the system
more fair and demonstratively fair so that people can look at
it and say, this is a fair system, I want to donate my organs
to that system because it will be handled correctly?
And studies have been made that show that people do not
care about geography when they donate organs. They do it as a
living memory of their loved ones and to save the life of the
recipient. And, you know, every organ that is donated can save
numerous lives. I will read something to you in a minute that
touches on that. But fairness is something that has got to be
the touchstone. Equal opportunity, and allocation policies
which put a patient's location and the origin of the donated
organ on a higher priority than the patient's medical need and
medical status are simply wrong. They are unjust, and in my
judgment, they ought to be changed. It has got to be fair to
all patients, no matter where they are listed, no matter where
they live.
On the average, 25 percent of all transplant patients
travel outside of their home States for their transplant
medical care. That is the first point I want to make.
Allocation based on medical need and urgency.
The second point goes to the question of notification when
a person is deceased, so there can be a dialog between the
organ procurement organization in that local area and the
family of the decedent. And of course, it is obviously very
helpful if the decedent, during his or her lifetime, indicates
a desire to have the organs donated. That simplifies the
process considerably.
But, as you know, in 1995 in Pennsylvania I signed Act 102
which requires that the organ procurement organization be
notified of the death of the decedent to give professionals,
trained people, an opportunity to consult with the family and
explain to the family the importance of this. And it is a very,
very difficult and sensitive thing because they are in
bereavement. They are in shock. But people in their infinite
goodness can rise above their grief and their shock and the
tendency we all have to be selfish and be generous. And believe
me, that is God's work in a very literal sense.
So the organ notification law went into effect in
Pennsylvania in 1995. In the southeastern part of our State
under the leadership of Howard Nathan, whom you know, and who
has worked very hard in this area, one of the representatives
here today, organ donation in the eastern half of the State in
the last 3 years has increased 40 percent. Transplantation has
increased 50 percent. Now, when you translate that into organs
and people, you are talking about hundreds of lives being saved
just in the eastern half of one State. Imagine if that rule
were in effect nationwide. It is fair to say that thousands of
people would be saved.
For the life of me, I cannot understand why the House of
Representatives, which I understand has been dealt this case,
put a rider on this appropriation bill that you have before
your committee which struck that notification provision. What
reason can be imagined for such a change? Why would anyone want
to do that? I mean, it just defies comprehension because it is
so demonstratively efficacious and effective. It does not cost
any money. It is a simple thing to do. But it is working in
Pennsylvania. And it is being modeled and followed in at least
four other States in the country.
And as you know, the language in this regulation, there was
a White House ceremony not too long ago where the new
allocation policy of the Federal Government under Secretary
Shalala's direction was announced and they said specifically in
that proceeding in that public event that they were following
the model of Pennsylvania law.
So I mean, empirically it is working. And it will work
nationwide. And that is the second point that I would make. We
now have something like 55,000 people each year who receive
these organs. I think something like 4,000 die because they
cannot get organs, 10 every day. And I think that is something,
I think, that has to command the attention of all of us.
And by the way, if you are comparing the purposes, Howard
Nathan's group advises me that while organ donation in the
eastern half of Pennsylvania was going up 40 percent, the rest
of the country went up 6 percent. So you get some sense of the
magnitude of the difference.
organ donor families
I served for a year as the president of an organization
called Transplant Recipients International Organization [TRIO].
This is the only organization, to my knowledge, in this country
which is dedicated exclusively to the advocacy of patients,
transplant patients, those on waiting lists, organ donor
families who have donated organs. And after all the organ donor
families are the ones that make it all possible. But this
organization called TRIO advocates on behalf of all of them, a
nonprofit organization, not for transplant centers, not for
transplant physicians, not for organ procurement organizations.
We have a system now, which you know, an organization
called the United Network on Organ Sharing [UNOS]. Well, it is
delegated by the Congress after the 1984 National Organ
Transplant Act, with the responsibility for running this
system. It is a private organization funded with some public
money but also funded with the fees that patients pay to get on
the transplant list. It costs something like $357 to get on the
transplant list. Those fees, as you know, go to UNOS.
This organization has enormous power. No one votes for
them. There is very little, as far as I can see,
accountability. And I want to urge you in the strongest
possible terms to raise the Congress to be active in its
oversight of this organization. It has enormous power. I am
told that hospitals cannot get reimbursed unless they are
approved by UNOS. So they have, in effect, rulemaking and
legislative power.
Oversight is badly needed because all of the members of
that organization, and there are some wonderful people in the
organization, but they have their own interests, their own
professional and economic interests, which has to be taken into
account in deciding on the fairness of what they do. So
oversight is essential.
I would like to read something from the TRIO newsletter,
which came out this month, in September. And I quote, ``more
than 60,000 Americans are awaiting transplants.'' This number
is climbing weekly. Meanwhile, there are only about 5,000
donors annually and this number is stagnant. We have this
situation in which the demand is escalating enormously and the
donation of organs is flat. So the problem gets worse with each
passing week.
Back to the direct quote from TRIO. About one-third of the
potential donors are never even approached about their options
at the time of death of a loved one. Continuing the quote,
``organs from one donor can help up to 50 others.'' So even
small increases in donation have huge and beneficial
consequences. And there, I think just parenthetically, they
must be talking about tissue as organs, it would seem to me.
And by the way, UNOS has testified before your subcommittee
in favor of the Shalala allocation rule and the Shalala rule on
notification, the entire regulation, again, on the basis of
fairness.
All transplant patients understand the concern of fairness.
What they do not understand is why a donated organ will go
first to a less ill patient in the area where it is generated
rather than to a patient from a neighboring area who is at
death's door. That they do not understand.
I will conclude now, Mr. Chairman, and I apologize for
probably going longer than I should have, but this is a very
personal issue to all of us and we think about it a lot. And
because of the grace of the Lord and the expertise of my
surgeons and the people of this State, I am still around. And I
got to finish my Governorship and got a second chance at life.
I got to see a lot of my grandchildren I was not supposed to
see back in 1993. But I have seen them, thank God. And I want
all transplant candidates to have that opportunity to have a
new, healthier life because that is what the system should be
all about.
So I urge you in the strongest possible terms to, as I hope
you will, because I know you are a fighter, this is something
worth fighting for. And I appreciate very much the chance to be
here today to talk to you.
Senator Specter. Thank you very much, Governor Casey. I
think it was entirely fitting that at this stage of your career
you have another cause, you have another public service issue.
You have been in public service for a long time, as a State
senator, and auditor general and Governor and I think that it
is very appropriate that you have another cause. And your
testimony was not at all too long. It is to the point and it is
cogent and it is very important.
I think your example as a recipient of organ transplants
has done a great deal to notify Americans that organs need to
be available to be transplanted. And I think this hearing today
will focus a good bit of public attention, again, on the issue
of organ transplants and the personal plea, which I echo, that
you have made that people should make their organs available.
It is of no harm to the individual who is gone and the organs
may be used for others.
And I think it is very poignant, as you have commented,
that your life was saved, you could finish your term as
Governor and you could see more of your grandchildren. When I
visited you, Mr. Casey, you commented that you expected No. 27
on Labor Day?
Mr. Casey. He has arrived.
Senator Specter. Wonderful. Wonderful. The Casey family is
a national, international model, 8 children, 27 grandchildren.
It is wonderful.
Governor, just a question to you on amplification. I said
at the outset that I agree with you that the rule promulgated
by the Department of Health and Human Services ought to be
carried out and it ought to be medical necessity, which all
together, we will be fighting to try to get that done. And you
may rest assured that I will be quoting you extensively. And I
will, in fact, make your testimony available to the other
members of the committee, starting with the chairman,
Congressman Livingston, who takes a concurrent position.
You have testified that one donor can help many. I would be
interested in your amplification of that, if I understood you
correctly.
tissue
Mr. Casey. Yes; well, in my case, I do not know this
officially, but I believe that my donor saved at least three
other people besides me. In other words, I received his heart
and liver. But you have the pancreas, you have other organs
that can be utilized. And then, of course, when you add the
tissue aspect to it, that expands the----
Senator Specter. You say add tissue?
Mr. Casey. The tissue. In other words, you can donate
tissue as well as organs. And I think that is probably where
the No. 50 came from. But I know in the case of organs,
certainly--for example, I know at the University of Pittsburgh
Medical Center they have had transplants procedures where the
entire stomach has been replaced, seven, eight organs. But
normally they are given to individuals so you can have multiple
beneficiaries of just one donation procedure.
Senator Specter. You had commented on the circumstances,
Mrs. Frances Lucas made available the organs form her son,
William Michael Lucas. If you know, what was the time period
between the death of Mr. Lucas and the time that the organs
were transplanted into your body?
Mr. Casey. It was very short because of the fact that at
that time they had a separate list for heart and liver
transplant recipients. My name was the only name on the list.
In addition to that, under the criteria, if you are dying, and
my doctors told me when I walked in the University of
Pittsburgh Medical Center they took some preliminary tests,
Doctor Starzl came to my room and said, you could die at any
moment. Because I had developed--after I got to the hospital,
in addition to the other residual problems that were in my
system because of the disease that I had, I developed what is
called atrial fibrillation. President Bush had the same thing,
if you recall. But it has to do with the electrical system in
the heart. And mine was about to----
Senator Specter. Who did you say had the same thing?
Mr. Casey. President Bush had atrial fibrillation. And
depending on its severity, it can be fatal. So my doctors told
me, just as I told you, you could die at any moment. Now, if
that is the case, we talk about medical urgency, that is what
we are talking about. So the closer to death the person is, the
higher in priority they go. So that combination of medical
urgency and that the fact that at that time there was a
separate list for heart and liver--it is a very rare procedure.
I was the only name on the list and I was at death's door. So
those two criteria made it possible for me to get the organs
quickly.
Senator Specter. You commented that you met Doctor Starzl
and up to that time you had been informed there was no cure for
your situation. Could you amplify how you happened to meet
Doctor Starzl and the conversation which ensued?
Mr. Casey. Yes; I had a disease called familial
amyloidosis, which is a mouthful. But when you have that
disease, the liver is not diseased but it produces an abnormal
protein. The liver is the protein factory of the human body. If
you have familial amyloidosis, the liver produces too much
protein and it destroys organs and the strain that I had
destroys the heart. Other strains attack other parts of the
body.
But Doctor Starzl is who I called. In direct response to
your question, I called him because he sent me a copy of his
book. This is now May 1993. I had gone 2 years with this
disease. And I was told flatly that there was no cure, no
treatment and I just had to live with that. And I was going
down physically with each passing day and I knew it.
But I called him not to talk about my condition but just to
thank him for sending me a copy of his book. And I said at the
end of the conversation just on the spur of the moment, I don't
know why I said it to him. Thank God I did because it saved my
life. I said, ``by the way, what do you know about
amyloidosis?'' He said, ``I will call you back in 5 minutes.''
I hung the phone up and I sat there for about 5 minutes the
phone rang. Governor, Tom Starzl. I can cure you with a liver
transplant.
Senator Specter. What took him so long to find out?
Mr. Casey. Well, you have a lot of experience with doctors.
It was not on the one hand or the other hand, you know, medical
probability, blah, blah, blah. It was, I can cure you. That is
the verb he used, cure. And I said, you are my man, let's go.
And I went to that hospital and they were going to take a
battery of tests and they said, we do not have to see anything
else, we know enough, your heart is just barely functioning.
Senator Specter. So that was in May and then you got----
Mr. Casey. Well, now we are in June. May was when I talked
to him for the first time and I had, of course, made
arrangements to leave the Governorship. And it was an
incredible year because, you will recall that Senator Frank
Lynch passed away in Philadelphia. And our budget was early
that year. We got it May 30. If we had not gotten an early
budget, I probably would not be around. It normally goes to
July 1, the beginning of the fiscal year. But I made
arrangements to go to Pittsburgh quickly. We had a press
conference in Harrisburg with Doctor Starzl and Doctor John
Fong and saved my life.
Senator Specter. Then you went to Pittsburgh to await the
availability of the organs?
Mr. Casey. I went there for testing because they thought I
needed a liver transplant. When I went out there, within a day
they determined I needed a heart and liver because the heart
had been destroyed.
Senator Specter. Had there been a previous liver, joint--
double liver transplant operation before yours?
Mr. Casey. There had been four or five, I think, in the
country, most of which had been performed at the University of
Pittsburgh Medical Center and all of those persons had died.
Senator Specter. So yours was the first successful liver--
--
Mr. Casey. I believe that to be a fact. There was only one
other man in the world at that point, if my memory serves me
correctly, in Great Britain who had amyloidosis and a heart/
liver transplant.
Senator Specter. Now, that ailment was the same ailment
which Mayor Caligiuri had or Mayor Tullio of Erie had?
Mr. Casey. Same name but very different in kind. They had
what is called primary amyloidosis, which is a disease of a
totally different order. It has a much quicker----
Senator Specter. Is there a special susceptibility for
elected officials for this ailment?
Mr. Casey. Is there what?
Senator Specter. A special susceptibility of elected
officials? [Laughter.]
Mr. Casey. It might be the water or the air. But Mayor
Tullio, whom you knew, and Dick Caligiuri, whom you knew, both
had primary amyloidosis. And at that point a liver transplant
would not have helped them because their problem was not
abnormal protein. It was a different systemic disease. I think
it was more of a form of cancer. But they have the same name so
when I got sick, people figured that he has got the same thing
that the other two people--gentlemen had. But it is very
different, essentially different in the sense that by getting a
new liver you develop--you get the protein deposition
characteristics of the new liver, not of the liver that caused
the problem initially.
And Doctor Starzl was smart enough to figure out that this
procedure was not medically different in its essence, than
procedures that had been going on for a long time in which
livers had been transplanted to cure abnormality. For example,
one of the best examples of that was the Stormy Jones case whom
Doctor Starzl did the surgery. Stormy Jones was a young child
from Texas whose liver produced an abnormal cholesterol as
opposed to an abnormal protein, which is what amyloidosis does.
Stormy Jones had a cholesterol reading that was off the charts.
Her organs were clogged with cholesterol. But essentially it
was the same medical challenge. Doctor Starzl gave her a new
liver and she was cured. I am sorry. He gave her a new heart
and liver, identical to mine in terms of the impact of the
disease. A completely different disease, but still essentially
the same in the sense that by replacing the heart and the
liver, the characteristics that produced the illness are
eliminated.
Stormy Jones lived for 7 or 8 years and her heart rejected
and she died. If she were alive today, she probably would not
experience rejection because we now have better immuno-
suppression medication and she probably could have been saved.
But Doctor Starzl knew the Stormy Jones case. And my case,
that's why he went to the book for a minute. He wanted to see
the nature of the strain that I had. Once he determined that,
he knew essentially by replacing my liver, just as he replaced
Stormy Jones' liver, my condition could be cured if I could
live that long. And the question then was, can the heart
sustain the insult or the trauma of the liver transplant
because when they unhook your liver, they unhook every blood
vessel in your body.
And when they put the new liver in and hook it up, it is a
very meticulous process of sewing it back together. When they
put the blood back in that liver it is such a shock to your
system, you must have a strong heart to withstand that initial,
what the doctors call insult, to the heart.
Senator Specter. So they did the heart transplant first,
gave you a new heart?
Mr. Casey. First.
Senator Specter. How long did the operation take?
Mr. Casey. Well, I think it was 10 or 11 hours, 12 hours,
something like that. I know I came out of it sooner then they
expected me to, but you know, it is incredible. If someone
could explain to me how they can sedate you with drugs and put
you under for 13 hours and then bring you back to life. I do
not understand that. I mean, that in itself is a miracle to me
but they did it.
But, you know, my story is not unique. Bobby Solfanelli and
the others you will hear today, everybody has a story. And you
know, it is a real life story. And it affects not only the
person involved in the procedure but the whole family, before,
during and after, it is a family thing.
But when I look back on the improbability of all of these
circumstances coming together, an early budget, the fact that I
called this man by coincidence really on a totally unrelated
matter, and there is more to it which I will not go into other
details because I have already gone too long. But I drew the
long straw, obviously. And I am very grateful for that.
Senator Specter. Well, you are a great example in many
ways, Governor Casey. And we will circulate your testimony. I
think it will be very influential and we will be fighting to
keep the Senate position and to have Secretary Shalala's ruling
go into effect.
And it is a question of medical necessity and fairness to
the patients and not a matter of dollars and cents or a matter
of geography or a matter of parochial interest. It is a matter
of doing what is right for the patients. So we thank you very
much for coming.
Mr. Casey. Thank you, Senator Specter.
Senator Specter. Thank you, Bob.
[A brief recess was taken.]
STATEMENT OF ROBERT SOLFANELLI, HEART AND LUNG
TRANSPLANT RECIPIENT
ACCOMPANIED BY:
JOSEPH SOLFANELLI
NATALIE SOLFANELLI
Senator Specter. We will resume our hearing. And we are
pleased to have with us Mr. Robert Solfanelli, who is a native
of Scranton, graduated from Attica Heights High School. At the
age of 3 he was diagnosed with pulmonary hypertension that got
progressively worse until he received a double lung transplant
in Scranton's Mercy Hospital in 1995.
After his transplant he enrolled at the University of
Virginia where he received the Paul Berringer Scholarship for
academic achievement and received his bachelor's degree this
May. His mother, Natalie, founded a local coalition on organ
and tissue donation to promote public awareness and increase
the number of those willing to donate. I would very much
welcome you here and look forward to your testimony.
Mr. Robert Solfanelli. Thank you. As you said, my name is
Bob Solfanelli. I am now 24 years old and a recipient of a
double lung and heart transplant. I am honored to be here this
morning to share my thoughts with you. I am sure I cannot speak
as eloquently as Governor Casey but I came here to give you my
thoughts and my opinions on your proposal.
It is evident to everyone, especially those of us in the
transplant community, that the laws governing organ donor
allocation are critical and should always be the subject of
very careful consideration. The significance of policy
regarding organ allocation and patient listing is immeasurable
to the 60,000 plus people currently on the transplant waiting
lists in the United States.
The most important element of our Nation's organ
procurement and transplantation system is that it operates for
the greatest benefit of transplant patients. On the whole, I am
very happy and impressed with the key principles of the current
proposal and it is some of these same goals upon which I would
like to place special emphasis today.
STANDARDIZED MEDICAL CRITERIA
This proposal specifically calls for the establishment of
standardized medical criteria used to determine the status of a
person's illness and when the person can be placed on a waiting
list. Although this might, at first, sound like a basic element
of this proposal, it is actually a very delicate issue in and
of itself. Not only will this criteria be used to determine who
is sick enough to be placed on a transplant list, but it also
will determine who might be too sick to be listed. Certainly,
in many cases, the medical professionals associated with this
procedure can determine a patient's chances of post-transplant
survival. But there will also be patients who are borderline,
those whose chances of survival hover somewhere around 50-50.
It is impossible for doctors to predict the outcome of any
transplant, but in these cases it is especially difficult to
guess. No one can say which is the greater loss, the patient
who might have made a successful transplant recovery but did
not meet the criteria to be placed on the list, or the healthy
graft that was lost to a gamble on a patient with a weak heart
but a strong will to live. As I said, no one can predict the
outcome. But we must be very careful when determining the
standard by which transplant candidates are judged.
Another major component of this proposal calls for an
effort to level the playing field in organ allocation. The idea
is to move away from the current regional waiting list into a
larger national waiting list. To do this, special status or
priority must be given to those patients who are most ill. This
is already being done, for example, in the case of heart
patients as those who are labeled status 1 are moved to the top
of the waiting lists. With other waiting lists, however, like
those for patients in need of a lung transplant, there is no
way to give priority to the sickest patients.
Allocation is determined solely by time on the waiting
list, regardless of medical urgency. Once criteria are in place
to categorize the immediacy of a patient's need, I think that
the patient of higher medical status should be able to receive
a donated organ from another geographic location before a
patient with a less urgent need who happens to be closer to the
organ donor. For this reason, the move to a national organ
waiting list seems to be a great idea.
However, this issue, like the others, has more factors to
consider. Most organs are viable for transplantation only for a
limited period of time after being harvested. Because of this,
the feasibility of a single, nationwide, need-based waiting
list becomes questionable. Transportation time and resources
must also be considered to avoid wasted organs.
Each of these points to which I have made reference played
some part in my own transplant history. I was first evaluated
and placed on the waiting list for a double lung transplant in
January 1994 at Barnes Hospital in St. Louis. At the time I was
told that the average waiting list there was about 7 months and
as my name moved to the top of the list I would have to
relocate to St. Louis while I waited for my organs.
Well, I decided that I wanted to stay home in Pennsylvania
where I could be with my friends and my family. So I moved my
name to a waiting list in Philadelphia. Once on that list,
those 7 months came and went with no potential donors for me.
My condition continued to get worse during this time and I
could actually feel my life slipping away from me. The next
thing I knew, a year had gone by since I was first listed for
my transplant and I began to wonder if I would even live to see
the inside of the operating room.
After 13 months on the waiting list for a double lung
transplant, my pulmonary condition had put such a strain on my
heart that my doctors determined that I needed a new heart as
well as the lungs. Not only did this force me to switch
transplant centers, because the one I was at did perform lung
transplants but not heart-lung transplants, this also meant
that I had to be put on a different waiting list, a list which
reflected no accrual of my previous 13 months.
Once listed for the heart, however, I met the criteria for
the highest priority and was able to move up the list under
those circumstances. By this time, I had grown so sick that I
had to move to the hospital as I continued to wait and to hope
for the organs that I needed.
Some 4 months after being placed on the list for the heart
and lungs, I finally received my transplant. What made my
transplant even more unique is the fact that my organs came
from a donor in Michigan, an area from which, due to the
current allocation system, it is very rare that they have
organs in my region. I was extremely fortunate and I cannot
express my gratitude for that gift and for that stroke of luck.
My story raises a lot of questions concerning organ
allocation procedures. Why did I face a longer waiting time in
Pennsylvania than I did in St. Louis? Why is there, at this
time, no way on waiting lists for some organs to give priority
to those patients with the most immediate need? With such
provisions, perhaps I would have received my transplant sooner
and would never have needed a heart as well as lungs. That
would have been one more organ to save one more dying person.
And when is a patient too sick to be a candidate for a
transplant? I am sure that, in the last few months before my
transplant, some doctors would have thought that I was too sick
to survive the transplant. Yet my condition had only
deteriorated that far after nearly 1\1/2\ years on the waiting
list for lungs which I never received. Fortunately, I had a
strong will to live and doctors who believed in my
determination who had hope for me. But what if I had not gotten
those organs from outside of my region? I probably would not be
alive to speak to you today. But mine is just one story, 1
story out of over 60,000 out there right now.
The only real way to eliminate many of the dilemmas
associated with organ allocation in this country is to increase
the number of organ donors. With enough donors, long waiting
lists would be eliminated, more transplants would be performed
and thousands more lives would be saved.
It is my understanding that the proposed rules would allot
more money for the promotion of public awareness to the need
for organ donors in the United States. As Governor Casey
stressed, this new rule would also require that organ
procurement organizations are notified of the deaths of
potential donors.
For this reason, many more lives could be saved as these
potential donor families are approached by trained
professionals who can understand their grieving but still help
them to determine whether or not they want to make that
precious gift.
No one knows the benefits of an organ transplant better
than I do. No longer does walking a distance of 30 feet feel
like running a marathon. I can now think about my future
without wondering if it is too short to consider. In the 3
years since my transplant, I have done many things that once
seemed impossible for me. The first thing I did was learn to
rollerblade about a month after my transplant. Since then I
have seen new places and made new friends. I spent a month last
summer studying in London and, most recently, in May I
graduated from the University of Virginia. Every day now is a
reason for me to smile.
With all of this in mind, I welcome and support the current
proposal concerning the allocation of donor organs for
transplantation. It is my hope that these rules will address
these issues and achieve their goals, thereby making it
possible for more people to have a second chance that I have
been so lucky to enjoy. Transplants should not be about waiting
lists and accidents of geography. They should be about hopes,
fears, and dreams. Thank you all for your time.
Senator Specter. Thank you very much, Mr. Solfanelli. Your
parents are here today?
Mr. Robert Solfanelli. Yes; they are.
prepared statement
Senator Specter. Thank you very much for joining us. Your
sister is here as well?
Mr. Robert Solfanelli. She was not able to make it.
Senator Specter. She was not able to make it. Well, She was
an intern with our office here and we thank her for her help.
[The statement follows:]
Prepared Statement of Robert Solfanelli
Good morning. My name is Bob Solfanelli, I am 24 years old,
and the recipient of a heart and double lung transplant just
over 3 years ago. I am honored to be here today to discuss the
proposed policies concerning organ donor allocation. The
testimony that I submit to you today is based solely on my
knowledge of the current proposal, and my own opinions formed
from my experiences as a transplant patient.
It is evident to everyone, especially those of us in the
transplant community, that the laws governing organ donor
allocation are critical and should always be the subject of
very careful consideration. The significance of policy
regarding organ allocation and patient listing is immeasurable
to the 60,000+ people currently on transplant waiting lists in
the U.S. The most important element of our Nation's organ
procurement and transplantation system is that it operates for
the greatest benefit of transplant patients. On the whole, I am
very happy and impressed with the key principles of the current
proposal, and it is some of these same goals upon which I would
like to place special emphasis.
This proposal specifically calls for the establishment of
standardized medical criteria used to determine the status of a
person's illness and when the person can be placed on a waiting
list. Although this might, at first, sound like a basic element
of this proposal, it is actually a very delicate issue in and
of itself. Not only will this criteria be used to determine who
is sick enough to be placed on a transplant waiting list, but
could also dictate which patients are too sick to be listed.
Certainly, in many cases, the medical professionals associated
with this procedure can determine a patient's chances of post-
transplant survival. But there will also be patients who are
borderline--those whose chances of survival hover somewhere
around 50/50. It is impossible for doctors to predict the
outcome of any transplant, but in these cases, it is especially
difficult to guess. No one can say which is the greater loss--
the patient who might have made a successful transplant
recovery, but did not meet the criteria to be placed on the
list, or the healthy graft that was lost to a gamble on a
patient with a weak heart, but a strong will to live. As I
said, no one can predict the outcome, but we must be very
careful when determining the standard by which transplant
candidates are judged.
Another major component of this proposal calls for an
effort to ``level the playing field'' in organ allocation. The
idea is to move away from the current regional waiting lists to
a larger, national waiting list for those patients with the
most serious and immediate need for a transplant. To do this,
special status or priority must be given to those patients who
are most ill. This is already being done, for example, in the
case of heart patients as those who are labeled ``status 1''
are moved to the top of the waiting lists (although still on a
regional level). With other waiting lists however, like those
for patients in need of lung transplants, there is no way to
give priority to the sickest patients. Allocation is determined
by amount of time on the waiting list, regardless of medical
urgency. Once criteria is in place to categorize the immediacy
of a patient's need, I think that a patient of higher medical
status should be able to receive a donated organ from another
geographic location before a patient with a less urgent need,
who happens to be closer to the donor. For this reason, the
move to a national organ waiting list seems to be a great idea.
However, this issue, like the others, has more factors to
consider. Most organs are only viable for transplantation for a
limited period of time after being harvested from the donor.
Because of this, the feasibility a single, nationwide, need-
based waiting list becomes questionable. Transportation time
and resources must also be considered to avoid wasted organs.
Each of these points to which I have made reference played
some part in my own transplant history. I was first evaluated
and placed on the waiting list for a double lung transplant in
January 1994 at Barnes Hospital in St. Louis. I was told that,
at the time, the average wait for lungs was approximately seven
months, and that I would have to move to St. Louis once I moved
near the top of that list. Shortly thereafter, I transferred my
name to a list in Pennsylvania so I could remain at home with
my family and friends as I waited for a donor to become
available. Those first seven months came and went with no
potential donors for me. My condition continued to get worse
during this time, and I could actually feel my life slipping
away from me. The next thing I knew, a year had gone by since I
was first listed for my transplant, and I began to wonder if I
would even live to see the inside of the operating room.
After thirteen months on the waiting list for a double lung
transplant, my pulmonary condition had put such strain on my
heart that my doctors determined that I needed a new heart as
well as the lungs for which I had been waiting. Not only did
this force me to switch transplant centers (the one I was
listed at performed lung transplants, but not heart-lungs), but
this also meant that I had to be put on a different waiting
list, a list which reflected no accrual of my previous thirteen
months. Once listed for the heart however, I met the criteria
for the highest priority and was able to move up the list under
those circumstances. By this time, I had grown so sick that I
had to move into the hospital as I continued to wait and to
hope for the organs I needed.
Four months after being placed on the list for the heart
and lungs, I finally received my transplant. What made my
transplant even more unique is the fact that my organs came
from a donor in Michigan, an area from which, due to the
current allocation system, my region rarely received organs. I
was extremely fortunate, and I can not express my gratitude for
that gift and for that stroke of luck.
My story raises a lot of questions concerning organ
allocation procedures. Why did I face a longer waiting time in
Pennsylvania than I did in St. Louis? Why is there, at this
time, no way, on the waiting lists for some organs, to give
priority to those patients with the most immediate need for
transplant? With such provisions, perhaps I would have received
my transplant sooner, and would never have needed a heart as
well as lungs--that would have been one more organ to give
another dying patient. And when is a patient too sick to be a
candidate for a transplant? I'm sure that, in the last few
months before my transplant, some doctors would have thought I
was too sick to survive. Yet my condition had only deteriorated
that far after nearly a year and a half on transplant waiting
lists. Fortunately, I had a strong will to live, and doctors
who believed in my determination and who had hope for me. But
what if I had not gotten those organs from outside of my
region? I probably would not be alive to speak to you today.
But mine is just one story--one out of more than 60,000 out
there right now.
The only real way to eliminate many of the dilemmas
associated with organ allocation in this country is to increase
the number of organ donors. With enough donors, long waiting
lists would be eliminated, more transplants would be performed,
and thousands of more lives could be saved. It is my
understanding that the proposed rules would allot more money
for the promotion of public awareness to the need for organ
donors in the U.S. In my opinion, this is the best way to
increase the number of lives saved through organ transplants.
No one knows the benefits of an organ transplant better
than I do. No longer does walking a distance of thirty feet
feel like running a marathon. I can now think about my future
without wondering if it is too short to consider. In the three
years since my transplant, I have done many things that once
seemed impossible for me. I learned how to Rollerblade, I have
seen new places and made new friends, I spent a month last
summer studying in London, and, most recently, I graduated from
college at the University of Virginia. Every day now is a
reason to smile.
With all of this in mind, I welcome and support the current
proposal concerning the allocation of donor organs for
transplantation. It is my hope that these rules will address
these issues and achieve their goals, thereby making it
possible for more people to have the second chance that I have
been so lucky to enjoy. Transplants should not be about waiting
lists and accidents of geography--they should be about hopes,
fears, and dreams. Thank you very much for your time.
heart and lung transplant
Senator Specter. In your testimony you mention your heart
as well as lungs. Did you have a heart transplant as well?
Mr. Robert Solfanelli. I did. I had heart and double lung
transplant.
Senator Specter. You had a heart and double lung
transplant. And that was done all at the same time?
Mr. Robert Solfanelli. It was all done at the same time in
August 1995.
Senator Specter. And the donor was from Michigan.
Mr. Robert Solfanelli. That is correct.
Senator Specter. For all the organs?
Mr. Robert Solfanelli. All the organs.
Senator Specter. The heart and the double lungs?
Mr. Robert Solfanelli. That is correct.
Senator Specter. Do you know how long much time elapsed
between the death of the donor and the time the organs were
transplanted into your body?
Mr. Robert Solfanelli. I am not sure of the exact time. I
know that every resource was used to transport those organs as
quickly as possible. But luckily I was in Pittsburgh so I was
not as far from Michigan as I would have been if I were still
in Philadelphia.
Senator Specter. One of the issues which has arisen is the
length of time which the organs can last and we had a hearing
in Washington earlier this week. And we were told that with
respect to the heart that it is a 4- to 6-hour interval.
Mr. Robert Solfanelli. That is correct. That is once it is
harvested from the donor.
Senator Specter. I am sorry. I cannot hear you.
Mr. Robert Solfanelli. As I understand it, that is 4 to 6
hours after that organ is harvested from the donor.
Senator Specter. Yes.
Mr. Robert Solfanelli. So once the organ is harvested, it
is important to get out the door and enroute to the waiting
recipient.
Senator Specter. Do you know if in your case it was by jet,
charter jet?
Mr. Robert Solfanelli. It was either by jet or helicopter.
Senator Specter. Jet or helicopter. Well, from Michigan it
would probably be by jet. It is a little far to come by
helicopter.
Mr. Robert Solfanelli. Actually, I believe it was a
combination.
Senator Specter. What was your period of recuperation like?
How fast did you recuperate?
Mr. Robert Solfanelli. I was on my feet and walking around
about 4 days after my transplant.
Senator Specter. And when did you start the rollerblading?
Mr. Robert Solfanelli. I got home about a month after my
surgery and it was the first thing I wanted to do.
Senator Specter. And you graduated with academic
achievement this past May?
Mr. Robert Solfanelli. That is correct.
Senator Specter. And how do you feel?
Mr. Robert Solfanelli. I feel terrific.
Senator Specter. When did you first find out that you
needed this transplant?
Mr. Robert Solfanelli. I first found out late in 1993. I
had been at Lehigh University. I began my studies there. In
Bethlehem the campus is built into a mountainside. And I was
there, I began to notice getting around that campus became more
and more difficult for me. I finally realized that this was
because my condition was getting worse and I went to discuss
this problems with my doctor. It was at that time we first
decided to look into the possibility of a transplant.
Senator Specter. I would be interested to know, and I do
not mean to press you on anything that you choose not to answer
as to the financing, how expensive was it, how it was paid for.
You would have to refer to your father for that?
Mr. Robert Solfanelli. I would have to refer to my parents
for that.
Senator Specter. May I ask the parents to come forward, if
you would not mind answering that question? What is your first
name, Mr. Solfanelli?
Mr. Joseph Solfanelli. Joseph.
Senator Specter. And may the record show that Mr.
Solfanelli appears in a Race for the Cure emblem.
Mrs. Solfanelli. I will attest to that.
Mr. Joseph Solfanelli. Natalie is also a breast cancer
survivor.
Senator Specter. Well, you are very lucky parents and you
are a very lucky young man, Robert, to have this complex
medical procedure. Mrs. Solfanelli, do you have other children?
Mrs. Solfanelli. Yes; we have two other children. We have a
son, David, who is a Scranton policeman. And we have a
daughter, Sarah, who is a senior at the College of William and
Mary, who worked in your office last summer.
Senator Specter. Well, I know she was an intern and I thank
her for that. I would be interested to know, and I think my
colleagues would, too, if you would be willing to say the cost
and the payment for this. Obviously, it is a very expensive
proposition.
Mrs. Solfanelli. A very expensive proposition. Fortunately,
we have excellent medical insurance which covered most of the
medical costs. The really very pressing cost, Senator, was all
the peripheral things that go along with it, the travel costs.
As Bob mentioned, he was first listed at St. Louis at Barnes
Hospital where they pioneered lung transplants.
travel costs
The travel cost, the cost of the family to be near him, the
housing that would have been required if he had had to move to
St. Louis to wait for his transplant there. And, of course, the
housing that we had to arrange for while we waited with him in
Pittsburgh and various trips to doctors. And it was quite
expensive, although, the actual medical costs were pretty much
covered by insurance. I have to say, we were fortunate in that
regard.
Senator Specter. Mr. Solfanelli, what line of work are you
in?
Mr. Joseph Solfanelli. I am an attorney, general counsel
for a bank.
Senator Specter. Well, thank you very much for your support
in the past and for your being here today and good luck to you,
Bob.
Mr. Robert Solfanelli. Thank you very much.
prepared statement of elmeretta b. lecrone, heart transplant recipient
Senator Specter. We had another--a third witness listed,
Ms. Elmeretta Lecrone, a resident of Luzerne County who
underwent a heart transplant at Temple University in 1994. She
called a little bit before 10 o'clock this morning to say she
had been traveling back from Newark, NJ, and her car broke down
and had to be towed. So she is unable to be with us today. We
have received her statement which we will insert into the
record at this point.
[The statement follows:]
Prepared Statement of Elmeretta B. Lecrone
improving fairness and effectiveness in allocating organs for
transplantation
My thanks to Senator Specter and this Committee for giving
me the opportunity to present these comments. As a heart
transplant recipient (Temple University Hospital 1994) and as
member of a donor family (1996) I have been personally involved
in the organ donation and allocation processes.
One of the most critical factors in organ donation is
community awareness. We cannot do enough to expand public
knowledge of the realities of organ donation and
transplantation. The recent ``Share Your Life, Share Your
decision'' campaign and the National Donor Card Act of 1997
have been very positive initiatives. I believe it is crucial to
allocate significant public moneys to support donor awareness
through public education programs. The key to saving lives
through organ transplantation is in increasing the number of
donated organs. More families must come to recognize organ
donation as an option when faced with the death of a loved one.
It its imperative that people realize this decision is one that
is more easily made before tragedy strikes.
The Medicare and Medicaid Conditions of Participation for
hospitals, should have a big impact on relieving the donor
shortage. They require the referral of all patient deaths to
the local Organ Procurement Organization (OPO), and that the
OPO or a trained person inform the families of the option to
donate and to request consent to do so. The experience in
eastern Pennsylvania has suggested that this procedure
significantly increases organ donations. I would encourage
Congress and HHS to keep these conditions in place in
conjunction with increased efforts to continue to expand public
education programs.
The Implementation of Federal Rules for the Organ
Procurement Transplantation Network, (the Rule) published by
HHS in April 1998 raises many questions. I am not a medical
professional and I have read a summary of this document, not
the document in its entirety. There are some positive ideas
expressed, for example the need to standardize the medical and
status reporting terminology in the transplant arena. The issue
of organ allocation is very complex, and attempts at a solution
should involve representation of all the various positions in
the transplant community. Decisions such as content of policies
that must be adopted concerning organ allocation and patient
listing require a formulation process that balances the views
of all. I question the capability of a government agency to
unilaterally make and/or oversee these decisions alone.
Thinking about ``The Rule'' really causes more questions
than answers to emerge. Some organs, hearts, for example, have
an optimum preservation time of 4 to 6 hours. Would a national
listing for organs with these shorter preservation times really
be practical? Present medical practice allows the organ
recipient to be in the operating room prepped and ready for
surgery, waiting for the donated organ to arrive. No incision
is made until the new organ is in the operating room. Time is
crucial. As the preservation time of an organ is lengthened the
chances of success of the surgery decline. A regional
allocation system is clearly preferable in this type of
situation.
``The Rule'' indicates that patients should have equal
chances to receive an organ based on medical need, not the
accident of geography. Waiting times do not always depend on
medical need alone. Blood type, body size, the condition of the
patient, the availability of the physician--all are
contributing factors. Speaking of geography, would a national
list really address that problem or would it end up
discriminating against those who live in sparsely populated
areas? How would placing people on a national list affect the
cost and rate of success of transplants? If only the sickest
people were transplanted, the rate of success would probably go
down. The costs for transplantation would likely go up. The
longer one waits, the poorer health becomes. According to ``The
Rule,'' I would have probably died before I received a
transplant. Though I was able to survive without
hospitalization, my heart would have just stopped beating from
weakness and deterioration. Because I was not in the hospital,
I was not a status 1. On a national list I would have been a
nobody. In a regional situation I was able to have the surgery
that enabled me to be alive, and to become a productive member
of society again. Had I been forced to wait a longer time for
my transplant, it is doubtful that I could have resumed such an
active life because my condition was deteriorating rapidly and
blood was not reaching all bodily areas. Most likely, I would
have died with a few weeks.
Perhaps for organs that have a long preservation time it is
feasible to have a national list for the sickest patients, but
for other organs a regional system would function best due to
time restrictions. Other than the very sickest patients, it
would seem to me to be very difficult to deal with thousands of
people en masse. Even with computers, it would eat up an
inordinate amount of valuable time to rank, sort and select
candidates, and perhaps some organs would deteriorate past the
point of use while we searched through thousands of names. If
the name that finally came up was on the other coast it might
be too late to send the organ there. Then what?
I would urge this committee to delay the implementation of
``The Rule'' until allocation policies can be more thoroughly
examined. Life is not always fair, as much as we might try to
make it so. It is not always possible for us to really know
what constitutes fairness. The best way to ensure that more
people get lifesaving transplants is to make it a top priority
to encourage and support the donation of more organs.
other transplant beneficiaries
Senator Specter. I am told that there are others in the
audience who are beneficiaries of heart transplants. Would you
mind standing?
Ms. Reiley. I am a liver transplant.
Senator Specter. Would you mind stepping forward and just
give us your name for the record? Have a chair. I do not expect
the questioning to be more than a half hour for each of you.
[Laughter.]
Mr. Joseph Solfanelli. I may add before these young ladies
speak, I do not think about it very often. But when it crosses
my mind, it causes me to pause. I am a recipient of two cornea
transplants. I had a cornea transplant in my right eye and my
left eye, one at Wills and one at Johns Hopkins. If it were not
for those transplants I would not have my vision today. I would
not be able to see my son recover. So it touches my family in a
big way. And I think it affects a number of families throughout
this country. It is a family issue and it just changes the
whole life of every family.
Senator Specter. Thank you very much, Mr. Solfanelli.
STATEMENT OF VALARIE REILEY, HARRISBURG, PA
Senator Specter. Would you identify yourself, please, the
lady on her right?
Ms. Reiley. My name is Valarie Reiley and I come from
Harrisburg, PA. And I had my liver transplant in 1989. And it
was done at Pittsburgh, Doctor Starzl's team, and Dr. John Fong
was on there, too, with Dr. Louis Milais. And I have a disease
called hemochromatosis, which has too much iron in your blood
and it is also familial.
And I did not know I had it until it was too late that
there is therapy for it. The therapy is to withdraw blood from
your system periodically until they get the overload from your
system. The overload causes cirrhosis of the liver. And
fortunately I had wonderful doctors in Hershey Medical Center
who believed in me and wanted me to live and worked very hard
with Pittsburgh to get----
Senator Specter. And how have you been feeling?
Ms. Reiley. Wonderful. I was always tired all my life.
Senator Specter. And you had the transplant in 1989?
Ms. Reiley. 1989. And my twin died 2 years later because it
was too late for her.
Senator Specter. Your twin died 2 years later?
Ms. Reiley. From the same disease.
Senator Specter. Did she need a transplant?
Ms. Reiley. She would have had to have one but she was so
sick with a disease, arthritis, osteoporosis from that same
disease.
Senator Specter. Were you identical twins?
Ms. Reiley. No; we were fraternal twins. But she was not
going to the same doctor as I was in Hershey. And I think that
physicians make a lot of difference. I was very, very lucky. I
have a lot of faith in God and getting to Pittsburgh by jet is
how I got through emergency. I only had 5 months to live when I
was told that I had this disease and there is nothing they
could do about it.
Senator Specter. Five months to live?
Ms. Reiley. Yes.
Senator Specter. Thank you very much.
STATEMENT OF DIANE ZAPOLSKI, BROOKLYN, PA
Senator Specter. Would you identify yourself, ma'am?
Ms. Zapolski. My name is Diane Zapolski and I had a liver
transplant in 1990 at Pittsburgh with Doctor Starzl and Doctor
Fong. I had what they called chronic atherotoxic hepatitis
caused by chemicals that I worked with. I have done great since
my transplant. They told my family at the time of my surgery--
--
Senator Specter. Where do you live?
Ms. Zapolski. I live in Brooklyn, PA.
Senator Specter. How far is that from here?
Ms. Zapolski. About 45 minutes.
Senator Specter. Well, thank you for coming over today.
STATEMENT OF MARY ANGELI, OLD FORGE, PA
Senator Specter. Ma'am, would you identify yourself?
Ms. Angeli. Yes; I am Mary Angeli. I had my transplant in
1984. I had Berkiar's syndrome. And I live here in Old Forge,
PA. And I was probably one of the sickest people--I was the
sickest person at that time. I was not on a waiting list.
Senator Specter. And what did you have a transplant of?
Ms. Angeli. Liver.
Senator Specter. Liver transplant.
Ms. Angeli. But I was not on a waiting list. And that goes
to show you, I went to the top of the list. I was not sick with
liver disease. I just got sick in a week or two and I had my
transplant.
conclusion of hearings
Senator Specter. Well, thank you very much, ladies, for
being willing to share with us that bit of information. We will
put that on the record. It will be useful. Thank you very much
for coming and that concludes our hearing.
That concludes our hearings, the subcommittee will recess
and reconvene subject to the call of the Chair.
[Whereupon, at 11:35 a.m., Saturday, September 12, the
hearings were concluded, and the subcommittee was recessed, to
reconvene subject to the call of the Chair.]
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