Organ Procurement and Transplantation Network Amendments of 1999

H.R. 2418 overturns the principles which have governed the Nation’s organ allocation system for fifteen years. The bill raises fatal constitutional concerns and irresponsibly inverts the roles of the Federal government and its contractor. In the end, H.R. 2418 poses a threat to the hopes and health of transplant patients and their families.

The National Organ Transplant Act of 1984 (NOTA) created the Organ Procurement and Transplantation Network (OPTN), a national organ allocation system overseen by the Secretary of Health and Human Services. Congress created the OPTN because "[a]n equitable policy and system is necessary so that individuals throughout our country can have access to organ transplantation when appropriate and necessary."

Since 1984, Congress has emphasized repeatedly that the OPTN should serve all Americans as equitably as possible. The Organ Transplant Amendments Act of 1987 recognized that the OPTN was created "in order to facilitate an equitable allocation of organs" across the country. In the Transplant Amendments Act of 1990, Congress stressed that the OPTN was to assist "in the nationwide distribution of organs equitably among transplant patients." In 1996, the Senate passed a bipartisan NOTA reauthorization bill by unanimous consent, only to have this Committee fail to act on this important legislation. The Senate advised this Committee —

"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."

In furthering the goal of a "consistent and fair system of allocation," the Secretary published the Final Rule governing the OPTN on April 2, 1998. Because of the OPTN’s failure to remedy geographical and ethnic inequities across the country, the Final Rule calls for more equitable sharing of organs and for uniform, objective criteria for patient listing. As the Final Rule states, it "does not establish specific allocation policies, but instead looks to the organ transplant community to take action to meet the performance goals."

We believe this approach to be wholly consistent with the intent of Congress. Allocation policies must be developed "bottom up" through the expertise and experience of patients and practitioners. But the Secretary is given oversight authority to ensure those policies reflect the public interest. When those policies fail to achieve the ends envisioned by Congress, as they are failing today, the Secretary plays an indispensable role in correcting these failures.

The Final Rule has been supported by the major transplant patient organizations, including the American Liver Foundation, Transplant Recipients International Organization and the National Transplant Action Committee. But the efforts of the current OPTN contractor, the United Network for Organ Sharing (UNOS), to derail the Final Rule have had a corrosive effect on public confidence in the organ allocation system. Misinformation has been spread to frighten patients, communities of color, and the poor. Patient listing fees which should have been expended on health care have been squandered on a lobbying and public relations campaign.

The result has been genuine harm to the public health. The organ allocation system is an inequitable patchwork of ad hoc sharing or parochial hoarding. Patients live or die based on where they live– not on how sick they are. African Americans and the poor continue to face disproportionate barriers to referrals, waiting lists, and transplants. Most recently, states including Louisiana, Texas and Wisconsin have enacted hoarding laws intended to impede organ sharing. And to crown this dismal record, a one-year moratorium on the Final Rule’s implementation was enacted in the Omnibus Appropriations Act of 1999 (P.L. 105-277).

The provision which blocked the Final Rule also mandated an Institute of Medicine (IOM) study of the organ procurement and transplantation system. The study advocates major changes in the organ allocation system and endorses active oversight by the Secretary. The IOM "recommends that the DHHS Final Rule be implemented" because broader sharing "will result in more opportunities to transplant sicker patients without adversely affecting less sick patients." The study dismisses claims that donation rates would suffer or small transplant centers would close under the Final Rule.

Perhaps most importantly, the IOM cites the need for strong federal oversight of the allocation system, concluding—

"The Department of Health and Human Services should exercise the legitimate oversight responsibilities assigned to it by the National Organ Transplant Act, and articulated in the Final Rule, to manage the system of organ procurement and transplantation in the public interest."

In contrast, H.R. 2418 completely eliminates meaningful oversight of the OPTN. It divests the Secretary of any authority to require anything of the OPTN. Functions of a "scientific, clinical, or medical" nature would be in the "sole discretion" of the OPTN. As the bill’s sponsors readily acknowledge, this encompasses practically everything of meaning, including the Nation’s organ allocation and transplantation policies.

Moreover, any changes to those few minor "administrative and procedural functions" remaining under the Secretary’s purview would require the "mutual agreement" of the Secretary and the OPTN. H.R. 2418 advances the absurd proposition that the OPTN should exercise an absolute veto over any proposed changes to the organ allocation system, whether they affect the number of organs it allocates or the number of paper clips it purchases. Indeed, were H.R. 2418 to become law, nothing short of an act of Congress would serve to alter the nation’s organ allocation system in the absence of the OPTN’s autocratic consent.

The fallacy of shielding the OPTN from accountability and oversight by the Secretary is compounded, in the view of the Department of Justice, by "significant constitutional concerns involving the separation of powers." In creating an unregulated monopoly affecting the lives and health of Americans, the Department regards H.R. 2418 as an unconstitutional delegation of authority to a private entity because it "goes beyond... permissible forms of legislation by actually giving to a private organization regulatory authority unfettered by executive involvement."

Were H.R. 2418 to become law and somehow survive constitutional challenge, it would fail to accomplish what its sponsors claim they desire — insulate the organ allocation system from politics and bureaucrats. By eliminating Secretarial oversight, H.R. 2418 simply invests private bureaucrats with absolute life-and-death authority and the freedom to exercise it in settling their institutional disputes or professional rivalries.

H.R. 2418 is also silent regarding state laws. The sponsors acknowledge that a state law would prevail in a conflict with the OPTN’s policies— ensuring inevitable conflicts with state hoarding laws and other statutes affecting the availability of organs. But in liberating the OPTN from what the sponsors perceive to be the burden of Secretarial oversight, they condemn it to a certain ‘death of a thousand cuts’ from conflicting state mandates.

The bill would exacerbate a perennial problem with UNOS. Public knowledge about the performance of the OPTN has been limited because of restrictions UNOS placed on access to essential patient outcome data. For many years, the Department faced fierce resistance to its efforts to obtain such data from its own contractor. Only in the past few weeks did UNOS make five-year old, transplant center-specific data available to the public.

This week, at the request of members of this Committee, the Department released a report providing up-to-date patient outcome data for the first time on more than 100 transplant centers across the country. The data revealed "a wide variation in center-specific outcomes," including a three-fold difference in the chances of getting a liver or heart transplant at centers farthest from the national average. The odds of dying while on the waiting list varied by 300 percent for liver patients and 250 percent for heart patients.

Such data should have already been available to the public. But in order to compel UNOS to disclose the data analyzed by the Department, Congress had to enact a law at the time the moratorium on the Final Rule was enacted. Under H.R. 2418, however, such data would only be available to a narrow category of listed patients – not to the public or the Secretary. The bill would thus enable the OPTN to conceal vital data from public scrutiny.

H.R. 2418 is also laden with measures blatantly intended to protect UNOS, the incumbent contractor, from competition. For example, the bill provides that a new contractor selected by the Secretary must also meet with the "written endorsement of a majority" of the OPTN’s members. Such a requirement makes a mockery of bidding out an essential government contract, and is inconsistent with the Federal Acquisition Regulation, which mandates competition in all government contracts.

H.R. 2418 has other serious substantive flaws, but of those remaining, the most troubling must be the manner in which it opens the organ allocation system to potential financial abuses. Donated organs are the ‘gift of life,’ not commodities. Yet the bill as introduced would have emasculated our country’s long-standing ban on the sale of organs.

The bill also dispenses with any limits to the OPTN’s "accepting gifts of money or services." It is silent about what potential influence such gifts might have on a patient’s status on a waiting list. It fails to bar preferential treatment on the basis of such gifts. While "economic status" is a prohibited factor in allocation decisions, "gifts" are not.

Finally, H.R. 2418 includes an additional carve-out of the OPTN’s finances from Secretarial oversight. Nonappropriated revenue, such as patient listing fees, would be free from "restriction or control by the Secretary." Patients have no choice in paying the listing fees. If they do not, they have no chance of receiving a transplant. The bill would allow UNOS or its successor to set those fees as high as they wished, and use those monies for any purpose, including lobbying or other political activities. Under H.R. 2418, the Secretary and the public would be unable to stop this misuse of funds.

Despite its many flaws and unsound foundation, H.R. 2418 is most dangerous as a blunt political instrument, not as prospective law. The Secretary of Health and Human Services has already written this Committee that she would recommend the President veto the bill in its present form. The Department of Justice has written of its profound constitutional defects. Instead, H.R. 2418 is primarily intended to provide momentum to the legislative effort to extend a moratorium on the Final Rule.

On October 18 the Secretary fulfilled her commitment to revise the Final Rule to account for many of the concerns raised by the IOM report, UNOS and other stakeholders. We believe that implementation of the revised regulation should be allowed to proceed. We are ever hopeful that a variety of factors will come together and compromise will be achieved. The moratorium will expire imminently. Even UNOS has adopted broader organ sharing policies, albeit in an effort to preempt the Final Rule. Our hope is that such progress will benefit patients and simply render the extreme provisions of H.R. 2418 irrelevant.

JOHN D. DINGELL
RON KLINK
BOBBY L. RUSH
EDOLPHUS TOWNS
HENRY A. WAXMAN
ALBERT R. WYNN
TED STRICKLAND
SHERROD BROWN
TOM SAWYER
EDWARD J. MARKEY