Chairman Spector, 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 the 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 U.S. 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 FY 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 FY 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
judgement be left to the transplant community. We will rely on the
judgement 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.
