New National Organ Transplant Rules to Take Effect Soon
Oct. 18, 1999 (Washington) -- The government has released a retooled version of national organ transplant regulations that it plans to implement before the end of the year. The plan would establish dramatically new standards for transplant centers.
The regulations would require that centers develop consistent medical criteria for patients seeking transplants. "Physicians and transplant centers need to be using uniform criteria for placing patients on the waiting list and defining their medical urgency," Health and Human Services (HHS) official Kevin Thurm told reporters Monday.
Transplant centers would be responsible for crafting the criteria, although HHS would approve them. The centers would also have an enforcement role under the rules. According to Thurm, "This means working toward a prospective as well as retrospective review to make sure misallocation is not occurring."
The government rules notes that using the amount of time a patient has been waiting for an organ as an allocation criterion can be inequitable, because it can allow less sick patients to get organs sooner than those in dire need.
Under the new rules, centers are also to share organs over a broader geographic area, although national sharing would not be required. HHS believes that broader sharing is essential to ensure that the sickest, not just the closest, patients get access to a center's organs. In 1998, the government notes, 71% of livers were transplanted to patients in the least urgent medical status categories.
Claude Fox, MD, who heads the HHS Health Resources and Services Administration, said that the rules would positively impact transplant patients. "We think this is going to improve survival overall," he told reporters.
Thurm said, "The [government] does not seek to interfere with the practice of medicine ? but to assume ? the appropriate responsibility for ensuring that the system as a whole operates in the public interest."
Key voices in the transplant community disagree. "The bottom line is that the [government] continues to insist on having the final word on decisions relating to the allocation of organs to transplant patients," said American Society of Transplant Physicians President Ronald Busuttil, MD. "These are medical decisions."
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.