Comments on the U.S. Department of Health and Human Services (HHS) proposed rules for the Organ Procurement and Transplantation Network (OPTN)

To: Judith B. Braslow - Director, Division of Organ Transplantation, HHS
From: Thomas A. Gonwa, MD, FACP - President, ASTP
Date: October 26, 1994

Date posted on the Web: July 25, 1996

Dear Ms. Braslow:

On behalf of the American Society of Transplant Physicians I would like to compliment the Department of Health and Human Services on publication of the proposed rules for the Organ Procurement and Transplantation Network (OPTN) in the Federal Register, Volume 59, Number 173, Page 46482. The A.S.T.P. has long felt that the OPTN rules should be confirmed on the federal law books in order to insure smooth functioning and compliance with the rules of the OPTN. As such, the A.S.T.P. is in full support of the regulations published and wish to make comment on two areas.

1. COMPOSITION OF THE BOARD OF THE OPTN. Under part 121.3.A.1, the regulations state the composition of the board. It is stated that there are two members each from and elected by the associations representing transplant coordinators, the association representing organ procurement organizations, and the association representing histocompatibility experts. The regulations then go on to state that individuals are elected by a majority vote of the voting OPTN membership, which include two representatives who are transplant physicians. As the major organization representing transplant physicians in the United States, we feel that the A.S.T.P. should have the right to elect transplant physicians members to the board in a manner similar to N.A.T.C.O. A.O.P.O., and A.S.H.I. We would strongly recommend that the proposed rules be modified to allow the A.S.T.P. to elect two representatives to the O.P.T.N. board representing transplant physicians.
2. ORGAN ALLOCATION. The A.S.T.P. has long been active in the area of organ allocation. We have made specific recommendations in the past regarding equitable organ allocation and, most recently, modification of the donor kidney allocation scheme in effect for U.N.O.S. I enclose for you two documents which outline these positions. The first one dated January 7, 1994 to Douglas J. Norman, the then president of U.N.O.S. outlines the A.S.T.P.'s position on the U.N.O.S. statement of principles and objectives of equitable organ allocation. The A.S.T.P. will be glad to elaborate on any of the points in this letter as your request. The second letter dated October 17, 1994 to Margaret D. Allen, M.D., the current president of U.N.O.S., outlines the A.S.T.P.'s recommendations for changes in the donor kidney allocation scheme. Again, the A.S.T.P. will be glad to elaborate on these positions at any time.

The A.S.T.P. firmly believes that an O.P.T.N. directed by both transplant professionals and the general public will help provide superb access to improvement in transplantation for all citizens of the United States. We are concerned, however, that there are a few topics which need to be addressed. I would, once again, like to raise the issue of a consensus conference co-sponsored by the Department of Transplantation and the A.S.T.P. to cover three of these topics. These are:

1. Definition of suitability of patients for transplant with establishment of standard listing criteria for each organ;
2. Definition of severity of illness and its role in determining priority for transplant; and
3. Definition of standards for offering retransplantation of the same organ.

Thank you for allowing the A S.T.P. to comment on the proposed rules for the O.P.T.N.

Sincerely yours,

THOMAS A. GONWA, M.D., F.A.C.P. President

cc:
ASTP Executive Committee
ASTP Public Policy Committee
Mr. Charles Plante, CLP Associates

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