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Statement of the University of Pittsburgh Medical Center on U.S. District Court Decision on Transplant Regulation

PITTSBURGH, September 30, 1998 — The University of Pittsburgh Medical Center (UPMC) is not surprised by the decision of the U.S. District Court in Baton Rouge to grant a temporary injunction preventing a U.S. Department of Health and Human Services (HHS) regulation from going into effect as scheduled tomorrow, Oct. 1. The matters before the court require careful review. The UPMC is confident that after the court weighs the arguments from both sides, the determination will be made that the regulation overseeing the Organ Procurement and Transplantation Network (OPTN) should indeed go into effect without any further delays.

The HHS rule will make the system more fair for all patients, including those from Louisiana, many of whom travel to other states for transplants. Once all provisions of the rule are fully in place, the rule is expected to save significantly more lives.

The Louisiana suit claims that patients will suffer immediate and irreparable harm when the regulation goes into effect. The rule will not cause immediate harm to patients. Patients currently listed for transplantation are protected under a provision in the rule that requires a "grandfathering" clause to assure that patients who are currently waiting are "treated no less favorably under new allocation policies than they would have been under current allocation policies." Since no particular policy is specified in the rule, it is impossible to project the negative consequences purported by the plaintiffs. The rule leaves it up to the OPTN to rely on its medical expertise and judgment to devise allocation policies that meet the rule’s performance goals. Once the rule goes into effect, the transplant community has 60 days to determine fair liver allocation policies and one year to determine policies for all other organs.

Louisiana’s interest in this suit is the desire of its transplant centers and organ procurement organization to preserve the status quo, whereby donated organs are preferentially allocated to patients listed at local centers, even if there may be a sicker patient elsewhere. The suit also seeks to preserve Louisiana state law, which requires donated organs to be offered to patients listed in state first. Because many patients are required to travel to other states for transplantation, the plaintiffs in this case do not necessarily represent the interests of all Louisiana residents.

With the temporary injunction, other aspects of the regulation that are uniformly supported by those in the transplant community also will be affected. These include provisions to provide greater participation by patients and family members in policy-making decisions and provisions to allow the release of timely and useful transplant data to patients and the general public to assist in their health care choices.

 

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