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Testimony on Organ Donation Allocation by The Honorable Donna E. Shalala
U.S. Department of Health and Human Services

Before the Senate Labor and Human Resources Committee and also before the House Committee on Commerce
June 18, 1998

Good Morning, Chairmen Jeffords and Bliley, Senators Kennedy and Frist, Representatives Dingell, Bilirakis, Brown, and other distinguished members, it is an honor to appear today before this joint hearing of the Senate Labor and Human Resources and House Commerce Committees . My testimony concerns one of the most important medical breakthroughs of the century, and perhaps the most wondrous: organ transplantation. Until the first half of the century, people routinely died of diseases of the liver, heart, lungs, kidneys and pancreas. The notion that patients with such diseases could be saved by transplanting organs from one human being to another was once beyond our imagination. In the short span of our lifetimes, organ transplantation has evolved from the impossible, to the conceptual, to the experimental, and now, nearly to the routine.

It is an odd notion, thinking of miracles as routine, yet the stunning survival rates of transplant recipients show that extraordinary surgical outcomes are a regular event. These successes are made possible by courageous and dedicated surgeons, physicians and nurses. A member of this heroic profession, one of America's great transplant surgeons, Senator Bill Frist, is cochairing this hearing.

There is much to celebrate about organ transplantation. There is much to celebrate because individuals like Senator Frist did not give up in the face of adversity. As a result of their tenacity and flexibility, the biggest obstacles to successful organ transplant surgery were gradually overcome. Today, donated organs can be preserved for longer periods of time, tissue typing is more accurate and immunosuppressant drugs are much more effective.

We must also remember the patients. Many of them, long forgotten except by friends and family, died during the evolution of transplant surgery. Because of their sacrifices, thousands more live today.

Just as medical professionals struggle to perfect transplant surgery, Federal policymakers also must grapple with difficult issues. These include finding new methods to increase organ donation and balancing our reliance on the medical judgment of the transplant community with statutory requirements to ensure fairness for transplant patients.

There was a time that transplant surgery was grossly unfair. Organs were sold to the highest bidder, often a wealthy foreign national. There were few transplant centers, with loose affiliations, which operated without national standards. As surgical accomplishments mounted, so did abuses and excesses. Eventually Congress intervened by passing the National Organ Transplant Act of 1984.

The Act made the buying and selling of organs a criminal offense. It created the Organ Procurement and Transplantation Network, commonly known as the OPTN. The Act now requires the OPTN to "assist organ procurement organizations in the nationwide distribution of organs equitably among transplant patients." Congress charged the Department of Health and Human Services with implementation of the Act.

We have come a long way from the pioneering days of organ transplantation. The Organ Transplant Act, and related changes to the Medicare law, provided for national policies and required transplant hospitals to abide by the rules of the national network. The network's primary goal is to ensure that all Americans in need have an equal opportunity to receive an organ transplant, consistent with sound medical judgment, regardless of who they are or where they live and choose to list.

Just as the pioneers of transplant surgery had to change their techniques and tinker with their approaches before they reached their goals, we must be prepared to adjust Federal policies to meet the intent of the Organ Transplant Act. Organ transplant policies are not yet fair to all Americans, and there is much that must be done before that aim is achieved.

There are about 55,000 people on waiting lists for organ transplants. Every day, more than ten of them die. They die because of a shortage of organs, and as the gap between the demand and supply of available organs grows, they may die in even greater numbers.

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, 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 during the same period.

Increasing organ donations must be our number one policy priority. Last December, we 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 was proposed in December and issued in final form yesterday. This regulation requires hospitals participating in Medicare or Medicaid to report to organ procurement organizations all deaths 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. Our goal is for the new rule, combined with other work being accomplished by the partnership, to result in a twenty percent increase in organ donation within two years.

Increasing organ donation is our most important policy goal, but not the only one. We also must do a much better job of meeting the central goal of the National Organ Transplant Act, which is 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 - 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 policy anymore than a person's wealth, celebrity or religion ethnicity or race should be a factor.

The current policies appear to be particularly unfair to minorities, many of whom wait on lists at large urban transplant hospitals that have long waiting lists. African Americans wait twice as long as white Americans for kidney transplants. Certainly, part of the reason for this inequity has to do with biological matching factors. But I am convinced that geographic inequities also have a role in the disparity.

The National Organ Transplant Act was intended to reduce such inequities. The law's insistence on fairness is echoed by the American Medical Association's Code of Medical Ethics, which states:

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 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. As you know, the Office of Inspector General is an independent organization. Earlier this year, a House panel examining this issue asked the Inspector General to update its findings. Last week, the Inspector General issued its updated report, 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 last week:

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, less ill patients 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 less ill patients in areas with shorter waiting times.

The April 2 rule does not actually contain any allocation policy. Instead, it calls on an HHS contractor, 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.

The rule contains three common sense goals which 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 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. In disregard of the Act, UNOS insists on maintaining the current inequitable system.

There is a central purpose to the performance goals, which is to ensure, to the maximum possible extent, 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 cynical political lobbying campaign against the April 2 rule. This campaign has been characterized by misinformation and outright falsehoods. 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 sent form letters, part of a self-described "legislative action kit," to surgeons and patients across the country. UNOS has been loud and vociferous in its lobbying and is working with some of the highest priced public relations and lobbying firms in town. As a result of their slick lobbying campaign, you are hearing protests about the April 2 rule.

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. I appreciate having the opportunity today to set the record straight about the intent and effect of this important rule.

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 is also false. We know that transplanting the 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. Again, UNOS will set the policy.

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 regulations attempt 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. Taxpayers 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 are paid by taxpayers.

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.

Many of you have expressed reservations about the April 2 rule. I know your concerns are legitimate and I take them very seriously. I want to respond to every one of them. I know that members of both committees, and the Congress in general, 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. Department representatives met with UNOS before the rule was issued to explain our intent. Meetings have occurred since the rule's publication and I hope that we will continue to meet so that UNOS has a complete understanding of the rule and what the Department hopes to accomplish.

I want you to ask the Department tough questions and examine the regulation from every angle. One of the reasons we delayed the implementation of the rule is so that there would be time for additional public comment as well the opportunity for Congress to have hearings on these issues. 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.

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