HHS RULE CALLS FOR ORGAN ALLOCATION BASED ON MEDICAL CRITERIA, NOT GEOGRAPHY

Calls on Private Transplant Network to Develop Policies

HHS Secretary Donna E. Shalala today announced a new regulation to improve the nation's organ transplantation system, to assure that allocation of scarce organs will be based on common medical criteria, not accidents of geography.

The new rule calls on the Organ Procurement and Transplantation Network, the private sector system created by the National Organ Transplant Act of 1984, to develop revised organ allocation policies that will reduce the current geographic disparities in the amount of time patients wait for an organ. The rule also calls on the OPTN to develop uniform criteria for determining a patient's medical status and eligibility for placement on a waiting list. The criteria will be aimed at assuring that patients with greatest medical need will receive scarce organs based on medical judgment and common medical criteria, no matter where they live or in what transplant center they are awaiting treatment.

"Patients who need an organ transplant should not have to gamble that an organ will become available in their local area, nor should they have to travel to transplant centers far from home simply to improve their chances of getting an organ," Secretary Shalala said. "Instead, patients everywhere in the country should have an equal chance to receive an organ, based on their medical condition and the judgment of their physicians."

"HHS does not want to choose which patients receive scarce organs. Those choices must be made by transplant professionals," she said. "But this regulation will help assure that organs are allocated on the basis of medical need, and that availability of organs will not be impeded by arbitrary geographic lines."

In addition to today's action, the Clinton Administration last year launched a new National Organ and Tissue Donation Initiative with public and private sector partners, aimed at increasing organ donation by 20 percent within two years.

"The real answer to the problem of scarce organs is to increase the number of organ donations," Secretary Shalala said. "Our national initiative is a serious new effort to bring about more organ donation."

Under the regulation announced today, performance goals would be established to guide the OPTN as it modifies existing organ allocation policies. Under the current policies, matching organs are usually made available to all listed patients in a local organ procurement area before they are made available to other patients outside the area. This means less ill patients in the local procurement may receive a transplant while patients with more urgent medical need in another area continue to wait.

Under today's regulation, three new sets of criteria for organ allocation would be developed by the OPTN. Development of the criteria would include public input and comment and final HHS approval. Secretary Shalala emphasized that the regulation looks to transplant professionals in the OPTN to develop the revised policies. "We are not substituting our judgment for the judgment of medical professionals," she said. "We are asking them to make the system fairer, and we are setting clear performance goals to guide their work." The criteria to be developed by the OPTN are:

- Criteria aimed at allocating organs first to those in the highest medical urgency status, with reduced reliance on geographical factors. This should reduce disparities in waiting times for patients at different transplant centers in different areas of the country. Today, there is a wide variation in waiting times, with patients in some areas waiting five times longer or more for an organ than in other areas. The new criteria would provide for wider sharing to assure organs were made available to patients with greatest medical need.

- Criteria to be followed in deciding when to place patients on the waiting list for an organ. Today, each transplant center establishes its own criteria, with the result that patients listed at one center may not be as ill as patients not yet listed at another center with more stringent medical listing criteria. Under the regulation, the OPTN would develop medically objective criteria to be used by all transplant centers.

- Criteria for determining the status of patients who are listed. Medically objective, uniform criteria would help ensure a "level playing field" in selecting among patients and determining which have the greatest medical need. The OPTN is already developing uniform criteria of this kind.

The final rule includes a new 60-day comment period, and becomes effective 90 days after publication in the Federal Register. The OPTN would have another 60 days to propose new criteria for livers, and a year for development of criteria for other organs.

"Together, these new uniform criteria will add up to a fairer and more understandable system, which will serve both patients and the transplant system better," Shalala said.

Other provisions of today's regulation include enhanced access to center-specific data about transplant centers, measuring outcomes and helping patients and physicians to choose among transplant centers; a broad definition of the composition of the OPTN membership and board of directors; the process for HHS review of OPTN policies before they become mandatory for OPTN members; and approval authority over the fees charged for registration on the OPTN waiting list (currently $357, usually paid by an insurer, most often Medicare or Medicaid.)

In 1996, some 20,000 Americans - about 55 each day - gained a new lease of a better life through transplantation. However, more than 55,000 people are on the transplant waiting list nationwide, and some 4,000 people - 10 every day - die in the U.S. while awaiting a donated organ.

The OPTN includes transplant centers and organ procurement organizations, as well as other public, medical and professional organizations

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Note: HHS press releases are available on the World Wide Web at: http://www.hhs.gov.

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