PITTSBURGH, September 29, 1998 — Not until a new federal regulation goes into effect will the national organ transplant network be accountable for its policies and will there be assurances that changes are made that make the system more fair for all patients. But eleventh-hour efforts by those opposed to government intervention threaten to prevent the U.S. Department of Health and Human Services(HHS) rule from being implemented as scheduled on Thursday, Oct. 1.
"Every day the new rule is delayed means that more patients will be disadvantaged by the current organ distribution system and that more patients will die unnecessarily," says John J. Fung, M.D., Ph.D., chief of the division of transplant surgery at the University of Pittsburgh Medical Center (UPMC).
"Actions being taken to derail the government’s attempts to restore fairness, such as the lawsuit filed by the centers in Louisiana, are nothing more than abhorrent. We have to look beyond our own self-interests and embrace what is best for patients everywhere," adds Dr. Fung.
The UPMC has long advocated for reforms of the current system that is characterized by gross geographic disparities in waiting times and access to donated organs. It has voiced support of the HHS regulation, as have a number of patient advocacy groups and other transplant centers.
But lobbying spearheaded by the United Network for Organ Sharing (UNOS), which holds the federal contract to operate the Organ Procurement and Transplantation Network (OPTN), has been aimed at questioning HHS’s authority. Even though the National Organ Transplant Act (NOTA) of 1984 established the OPTN to operate a fair and equitable national system under authority of the Secretary of Health, UNOS believes it has authority to set life and death public policy, not HHS.
"UNOS has really mischaracterized what the HHS rule says. It does not dictate a specific policy. It simply asks the transplant community to use its expertise to make improvements to the current organ allocation system so that patients are treated equitably, according to the mandates set by NOTA," says Dr. Fung.
The regulation sets performance goals to guide the OPTN as it devises new policies. These goals include minimizing geographic disparities in waiting times, standardizing listing and medical status criteria, and assuring medical urgency takes precedence over geographic considerations, so that patients in the most need are offered organs before less sick patients.
Lobbying has already resulted in the regulation’s delay to Oct. 1. It had been scheduled to go into effect July 1, but Congressman Bob Livingston (R-La.) attached a rider to an emergency spending bill last spring, changing the date. He is expected to try to delay the rule another year with language inserted into the Labor, HHS, and Education appropriations bill, which must pass Congress before Oct. 9. Now a federal lawsuit filed by his state and Louisiana’s transplant centers and organ procurement organization seeks a preliminary injunction with the ultimate goal of stopping the regulation altogether. A ruling is expected this week.
While the suit echoes the same misleading claims made by UNOS and other opponents to the rule, the lawsuit also attempts to preserve a Louisiana state law that assures organs donated there are offered first to its local centers before being offered to patients elsewhere, even if these patients are in greater need.
"Such laws are perverse because they do not serve patients. While they may serve local transplant centers, they do not serve all residents of the state. In Louisiana, for instance, more than 30 percent go out-of-state for liver transplants, some to programs where access to donated organs is severely limited. Nationally, 25 percent travel out of their home states for life-saving transplants.
"The new rule will help all patients, Louisiana patients included," asserts Dr. Fung.
The date the regulation goes into effect sets the clock for UNOS to develop policies that meet the rule’s performance standards. For liver allocation policies, UNOS is given 60 days, and for all other organs, the contractor has one year to identify new policies.
In order to meet the rule’s requirements, UNOS will most likely need to adopt policies that involve broader sharing of organs. Computer simulation models performed by CONSAD Research Corporation, a consultant to the UPMC, have identified a number of policies that would reduce the disparities in the current system and save significantly more lives. Results of new projections are expected to be released by CONSAD soon.