New National Organ Transplant Rules to Take Effect Soon
HHS put out similar rules in 1998 but outraged transplant centers, and their umbrella group, the United Network for Organ Sharing (UNOS), successfully petitioned Congress to block them.
"We've kept to principles we started out with," HHS Secretary Donna Shalala told reporters. "We have followed the [Institute of Medicine (IOM)] report very closely." As ordered by Congress, the IOM reviewed the transplant system and issued recommendations this summer. Included in those recommendations is a call for "independent scientific review" to assist the government in organ allocation policy. The revamped HHS rules would establish a government-appointed outside advisory committee.
That isn't acceptable to transplant physicians. "To attempt now to pass this off as somehow being the 'independent' review board contemplated by the IOM simply is not at all what we were talking about," Busuttil said. He noted that the advisory committee would have no binding authority over HHS.
Government officials stressed that they have extensively consulted with the transplant community in developing their new rules. "I can't tell you how exhaustive the number of meetings has been with the transplant community," Shalala told reporters.
The new rules would go into effect 30 days from their date of official publishing, which will occur in about a week.
But in its end-of-session free-for-all, Congress may move again to block the regulations from taking effect. Just last week, the House Commerce Committee approved legislation that would grant UNOS more independence.
According to UNOS President William Payne, MD, the bill reinforces the intent of the nation's organ transplant system. "Responsibility for developing, establishing, and maintaining medical criteria and standards ? rests in the private sector and the medical community," he said in congressional testimony last month.
The Clinton Administration strongly opposes the legislation, which it claims would weaken the system's accountability and likely be unconstitutional.
But UNOS believes that the legislation should move forward quickly, spokesman Al Hinman tells WebMD. He says that the group applauds the government for listening to the concerns and recommendations of transplant centers and doctors.