Congressional critics of new HHS regulations that will overhaul the nation's system for allocating organs for transplant have backed down, clearing the way for sweeping changes to take effect next year.
The shift, championed by HHS Secretary Donna Shalala, will lead to geographically broader sharing of organs, particularly livers, and will favor sicker patients regardless of how long they have been waiting for a transplant.
The regulations, published in final form Oct. 20, will also give HHS a more direct role in setting transplant policies. Under current federal law, the organ sharing system is administered by an independent contractor governed by the transplant community.
Under an agreement reached last week between the administration and congressional leaders, the regulations will take effect late this year or in early 2000. The timing is tied to enactment of the HHS spending bill for fiscal 2000, expected this week. After a three-week public comment period and a subsequent three-week HHS review, the regulation will be in force.
However, clinical practice probably won't change before late winter or early spring, when the nuts-and-bolts details for liver sharing are produced to comply with the regulation.
Originally, the new regulation was slated to take effect this week. Congressional opponents, however, sought a moratorium that could have delayed the makeover indefinitely (Oct. 25, p. 12).
Fighting over the regulations now appears to be over.
"We're going to be moving forward on the issue," said Bob Spieldenner, spokesman for the United Network for Organ Sharing. The private contractor, based in Richmond, Va., is responsible for developing and implementing organ policy and had strenuously opposed the regulation.
This week, UNOS' board of directors will meet in Baltimore and chart the organization's course for implementing the new regulations, Spieldenner said.
Organ policy, and who controls it, is likely to remain a hot topic on Capitol Hill, however. The 1984 law underpinning the nation's transplant system is up for reauthorization, and changes in the law could undo the new regulations.
"The fundamental issue is who has final authority to make these decisions," said Evan Knisely, spokesman for Patient Access to Transplantation Coalition, a group of more than 30 transplant centers opposed to the changes and HHS' intervention in transplant policy. "Congress said in 1984 that the transplant community does, and we expect they will again," he said.