Mr. Chairman and members of the Subcommittee, thank you for inviting the Department of
Health and Human Services to participate in this very important hearing on national organ
transplantation policy. I am Doctor Claude Earl Fox, Acting Administrator of the Health
Resources and Services Administration. I am accompanied by Doctor William Raub, the
Secretary's Science Advisor and Marc Smolonsky, Senior Policy Advisor in the Office of
the Assistant Secretary for Legislation.
We are delighted to be here in Wisconsin, a State with an outstanding record of organ donation.
Wisconsin has some of the finest transplant surgeons in the country. And one of the great
breakthroughs in transplant technology, the Belzar UW solution, was developed in Wisconsin.
This is an appropriate issue for discussion here or anywhere else in the United States, because
organ transplantation policy affects all Americans, regardless of where they live.
As you know, the National Organ Transplant Act of 1984 created the national Organ
Procurement and Transplantation Network, commonly known by its acronym, OPTN. The
OPTN is managed under a contract with the Department by the United Network for Organ
Sharing, or UNOS. The Act was amended twice, in 1988 and 1990, each time with language
clarifying that the OPTN should direct an equitable nationwide distribution of organs. In the
construction of a national organ allocation network, Congress recognized that there is a
shortage of organs available for transplantation, and that the shortage was likely to continue into
the foreseeable future. Congress further recognized that medical urgency and equity should be
the main criteria for access to available organs and that no one should be allowed to unfairly
game the system.
Prior to passage of the National Organ Transplant Act, the distribution of organs was often
unfair. Wealthy people or persons with special connections reportedly were able to manipulate
the system so that they received organ transplants instead of people who were sicker and had
been waiting far longer. Patients from foreign countries sometimes received life-saving
transplants while Americans died. After hearings and media reports had confirmed many of these
allegations, Congress acted swiftly to establish a national system.
HHS has the responsibility to oversee the OPTN to ensure that its policies conform to
technological advances and are consistent with the intent of the statute. Our reviews indicate that
there are still many challenges to optimal patient care. The greatest challenge is the shortage of
organs available for transplantation. About 4,000 people died in 1996 while waiting for a
transplant that probably would have saved their lives. The gap between the demand and supply of
available organs for transplantation is growing, and will continue to expand as medical
innovations make transplantation an option for more and more patients.
Approximately 10,000 to 15,000 deaths in the United States each year could result in viable
organ donation. But only 5,500 cadaveric donors, one half to one third of potential organ donors,
contribute organs for transplantation. While the number of cadaveric organ donors has increased,
from 4,084 in 1988 to 5,417 in 1996, the number of deaths among people on organ transplant
waiting lists has also grown. There were 1,507 deaths on the waiting list in 1988, a number that
jumped to 4,022 in 1996.
Some 20,000 Americans received organ transplants in 1996, but more than 55,000 people were
on the waiting lists. Of those on the waiting lists, ten people will die every day, mainly because
there are not enough organs to meet their needs.
The Nation's failure to obtain optimal donation rates for transplantable organs is unquestionably
the biggest problem facing the transplant community. Addressing the shortage of organs is a
priority of this Administration. Last December, the Vice President announced a nationwide
initiative to increase organ donations. The initiative is focused on known barriers to donation by
creating a national partnership of public, private and volunteer organizations. The partnership
emphasizes the need to share personal decisions on organ donation with one's family. Even if an
individual agrees during his or her lifetime to be an organ donor, the agreement is not always
honored without family consent. As part of the initiative, HHS convened a conference on best
practices last week, with experts from throughout the country discussing successful solutions for
increasing organ donations.
The initiative also includes proposed Medicare regulations designed to ensure that deaths are
reported to organ procurement organizations whenever there is potential for donation. HHS is
working with providers, consumers, organ procurement organizations, eye and tissue banks and
hospitals to develop a final regulation. The proposal is based on approaches that have
been successful in other areas. For example, organ donations increased dramatically in
Pennsylvania as the result of a state law that requires the reporting of deaths to organ
procurement organizations. The Department estimates that the number of donors nationwide
could increase by 20 percent within two years of the publication of a final rule.
Organ procurement is one of the most sensitive issues in American society. Asking a family to
donate an organ from a loved one who just died is a wrenching task, which is done most
effectively by people who are trained organ procurement specialists. There are many heroic
individuals who are in the business of saving lives every day by convincing people to donate
organs. But as a nation, we must do a better job.
Although the country's mixed record on organ donation is our primary concern, there are other
problems that pose vexing questions for the Department. How do we ensure that organs are
allocated fairly and with sufficient efficiency that available organs are used to prolong the lives
of people in the greatest need? How do we guarantee that the OPTN operates primarily in the
interests of patients? Our best answers to these questions are contained in the new regulations for
the OPTN, which were published last week.
Six principles underlie the regulations:
- Transplant patients are best served by an organ allocation
system that functions equitably on a nationwide basis.
- The Secretary of Health and Human Services should represent
the public interest by setting broad goals for the OPTN and by
overseeing OPTN policy development and operations with a view
toward ensuring that the goals are being addressed in a
reasonable manner.
- The OPTN must exercise leadership in performing its
responsibilities under the National Organ Transplant Act, in
particular by devising the specific policies assigned under the
regulations, and by adapting its policies and procedures to
changes in medical science and technology.
- Organs should be equitably allocated to all patients, giving
priority to those patients in most urgent medical need of
transplantation, in accordance with sound medical judgment.
- Thorough, timely, and easy to use information about transplant
centers, including center-specific performance data, is essential
for measuring quality of care and should be readily available to
help patients and physicians in choosing among transplant
centers.
- Potential conflicts of interest should be minimized for those
who are responsible for operation of the OPTN.
The statute that created the OPTN requires the Secretary of Health and Human Services to
provide timely information to patients, their families, and physicians about transplantation.
Current OPTN policies make it impossible to fulfill this requirement because the Department has
been denied current and thorough information. Under existing policies, for example, we cannot
provide Americans with the current one-year survival rates of patients and organ grafts. We
cannot compare the performance of transplant programs. Data available to patients today is four
years old, so it is out of date. Given that the data made public is outdated and incomplete,
patients cannot review the performance of respective transplant programs. We find this situation
unacceptable and seek to obtain timely useful data for patients through the pending regulation.
The pending regulation also addresses the issue of the broader sharing of organs and intends to
spur debate within the OPTN about the suitability of the current local-first policy for the
allocation of organs. We believe there is solid evidence that the current system is unfair and that
patients may be dying unnecessarily because they happen to live in the wrong place
at the wrong time. Secretary Shalala believes that everyone in need of a transplant should have
equal access to an organ, regardless of where they live or list.
We believe broader sharing of organs will reduce current geographic inequities in the OPTN. Our
view is supported by numerous prominent medical authorities and experts who have proposed
broader sharing of donated organs. For example, Dr. Lawrence Hunsicker, the current President
of the United Network for Organ Sharing, said in 1986:
In principle, and to the extent technically and practically
achievable, any citizen or resident of the United States in need
of a transplant should be considered as a potential recipient of
each retrieved organ on a basis equal to that of a patient who
lives in the area where the organs or tissues are retrieved.
Organs and tissues ought to be distributed on the basis of
objective priority criteria, and not on the basis of accidents of
geography.
According to the American Medical Association's Code of Medical Ethics:
Organs should be considered a national, rather than a local or
regional resource. Geographical priorities in the allocation of
organs should be prohibited except when transportation of organs
would threaten their suitability for transplantation.
In 1991, the HHS Inspector General reached the following conclusion:
...current organ distribution practices fall short of
congressional and professional expectations, and that there has
been substantial progress in developing a national organ
distribution system grounded in uniform policies and standards.
However, organ distribution remains...confined primarily within
the individual service areas of the...Organ Procurement
Organizations.
In passing the National Organ Transplant Act, Congress clearly intended that the OPTN act as a
nationwide system, free of geographic bias. In 1990, when Congress amended the statute to
emphasize the importance of a truly national allocation system, the Senate reported, because the
demand for transplantable organs is expected to continue to be considerably greater than the
supply, a fair and equitable organ sharing system is critical to the future of a national transplant
program that the public will support.
The OPTN has not met the mandate of the statute that created it. The allocation system is not
fair, nor is it a national network. By allocating organs primarily at the local level, OPTN policies
give the sickest patients a substantially lower chance of being promptly matched to a
suitable organ. Current OPTN policies create enormous geographic disparities in the time
patients must wait to receive transplants. For example, based on the latest data, if you live in
New England and need a kidney transplant, you will wait as long as three years. But in the upper
portion of the southeast, a patient in need of a kidney transplant will wait as little as 231 days.
We find the disparity in waiting times across the country to be unacceptable. Americans in need
of organ transplants will live or die on the basis of where they live. The policy that allows this to
happen is contrary to the intent of Congress and in violation of the American Medical
Association's Code of Ethics.
It would be illegal to deny an organ to patients solely because of their race, gender, or age. Yet
organs are denied to patients because of where they live. Geographic discrimination is no better
than any other sort of discrimination. It is flat out wrong and should no longer be tolerated.
The Department recognizes that there is tremendous controversy over the subject of organ
allocation. We understand that there is division in the transplant community about the
distribution of organs, and that while many want the current system changed, others do not. The
OPTN must not be so paralyzed by controversy and division that it does not act to change a
system that is unfair to patients, and that may be allowing patients to die unnecessarily. Through
the pending regulation, the Department is putting patients first. What is best for patients, in our
view, overrides concerns about the individual needs of transplant centers, whether they be large
or small.
In its pursuit of justice for patients, the Department does not intend to substitute its own medical
judgment for the judgment of members of the OPTN-. Although the pending regulation requires
changes in current allocation policy, the regulation does not contain a specific policy. The
regulation leaves it to the OPTN to reform the policy and present its recommendations to the
Secretary. I reiterate, HHS will not be setting any new allocation policy; it is up to the medical
experts of the OPTN to set the new policy. We ask only that the policy conform to three basic
performance goals: One, that criteria for placing patients on waiting lists be standardized; two,
that criteria for determining medical status of patients be standardized; and three, that medical
urgency, not geography, be the main criterion for allocating organs.
The OPTN agrees with the first two performance goals. In fact, the network is already working
toward those aims. It is the third performance goal, the one that is designed to end discrimination
in the allocation system, with which the OPTN is struggling. But I am confident that if the OPTN
puts patients first, it will accomplish this goal as well.
I have described what the pending regulation will do. Now let me tell you what it will not do.
The regulation will not adversely affect patients who are on waiting lists at the time it takes
effect. The regulation states that no one currently on a waiting list will be disadvantaged by
changes in the allocation policy. The regulation will not deprive any locality of organs. Broader
sharing will mean that patients have more access to organs, not less. Our goal is that all patients
be better off as a result of policy reforms.
I will conclude by saying that the Department has solicited widespread public comment on this
regulation. It was published as an NPRM in 1994, and we received extensive public comments in
response. In December 1996, the Department conducted three days of public hearings on issues
pertaining to the regulation. Everyone connected to the transplant community, from
patients to surgeons, was invited to testify. The pending regulation has a 60-day public comment
period and a delayed effective date. Should the Department learn anything during the public
comment period that requires change, the effective date of the regulation can be delayed further
to accommodate the changes. We encourage public debate on the regulation, whether it be at a
hearing like this one or within the confines of the OPTN.
Thank you for the opportunity to testify. I will be pleased to answer any questions you may have.
