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Testimony on Organ Transplant Policy by The Honorable Donna Shalala
U.S. Department of Health and Human Services

Before the Senate Committee on Appropriations, Subcommittee on Labor, HHS and Education
September 10, 1998

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.

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