Memorandum
TO: ASTP Membership
FROM: Tom Gonwa, M.D.
ASTP Public Policy Committee Chair
DATE: March 27, 1998
RE: Publication of final rule to govern the operation of the Organ Procurement
and Transplantation Network (OPTN)
On March 26, 1998, Health and
Human Services Secretary Donna E. Shalala announced the publication
of the final rule to govern the operation of the OPTN. The
regulations will appear in the Federal Register dated April
2, 1998 and there will be a 60-day comment period. The effective
date for the regulation is 90 days after its publication
in the Federal Register. All of the time frames mentioned
in the regulation flow from the effective date. The regulation
address the following areas:
1) The OPTN in regard to:
A) the composition of the Board of Directors;
B) the duties of the Board of Directors, including:
1) the Executive Committee;
2) the Executive Director; and
3) The Committees of the OPTN.
C) the Membership of the OPTN; and
D) The Corporate Status of the OPTN.
2) OPTN Policies: Secretarial
Review and Appeals:
A) Policies to achieve the mission of the OPTN; and
B) Policies to meet the Secretary's contract for the operation of the OPTN,
including:
1) Policies for the equitable allocation of the cadaveric organs;
2) Policies, consistent with CDC recommendations, for the testing
of organ donors and follow-up to prevent the transmission of infectious disease;
3) Policies that reduce inequities resulting from socio-economic
status;
4) Policies regarding the training and experience of transplant
surgeons and transplant physicians in designated transplant programs;
5) Policies for nominating officers and members of the Board of
Directors; and
6) A policy on such other matters as the Secretary directs.
As the Board of Directors of the
OPTN is responsible for developing these policies, the regulations
set forth requirements for the Board regarding input from
the OPTN membership and other interested parties on policies
it creates. Also, the Board must provide, at least 30 days
prior to there proposed implementation, the Secretary of
HHS the opportunity to comment and/ or to provide objections
within a reasonable time. Furthermore, the Secretary will
have the option of publishing the policies in the Federal
Register to receive public comment. If the Secretary provides
objections and the directs the OPTN Board to revise the policy(s)
and the OPTN does not revise the policy in a timely manner,
the Secretary may take such actions as the Secretary determines
necessary.
Also, under this section of the
regulation, there is a process defined for individuals or
entities to submit appeals to the Secretary regarding policies
created by the OPTN or the Secretary.
3) Listing Requirements:
A) Individuals may only be listed for a designated transplant program;
B) Individuals are placed on a national list as soon as they are determined
to be candidates for transplant; and
C) An OPTN member shall pay a registration fee to the OPTN for each transplant
candidate it places on the national list. The amount of the fee shall be
determined by the OPTN with the approval of the Secretary. The regulation
discusses the process for approval.
4) Organ Procurement:
The regulation addresses the criteria for the suitability of organs for
transplantation
5) Identification of Organ Recipient:
A) List of potential transplant recipients discusses OPTN computer match
program, rank order of potential recipients, and when the donor or
donor organ does not meet a transplant program's donor acceptance criteria;
B) Offering of organ for potential recipients - This section defines when
an offer can be made.
C) Transportation of the organ to the potential recipient - This section
defines who is responsible for transportation, documentation and packaging.
D) Receipt of the organ - This section defines responsibility for the organ
upon receipt.
E) Wastage
6) Allocation of Organs: The policies
to be developed by the OPTN for organ allocation for the
equitable allocation. Such policies should meet the following
requirements:
A) Minimum listing criteria for the national list should be standardized;
B) Transplant candidates shall be grouped by status categories ordered
from most to least medically urgent;
C) Organ allocation policies and procedures shall be in accordance with
sound medical judgment;
D) The development of performance indicators;
E) Transition - including the process and timing for the review of the
organ allocation policies by the Secretary;
F) Variances; and
G) Directed Donation.
7) Designated Transplant Program
Requirements - This section states the requirements for a
hospital to be a designated transplant program and the rules
that a member of the OPTN should abide by. Please note that
one of the requirements is a transplant physician must be
on site.
8) Reviews, Evaluation, and Enforcement
- This section states the process for review and evaluation
by the Secretary, the review and evaluation by the OPTN,
and the enforcement of the OPTN Rules. Under the enforcement
section, it provides for enforcement of the OPTN recommendations
and it provides for Secretarial action.
9) Record Maintenance and Reporting
Requirements - This section includes requirements for information
gathered by the OPTN, the Scientific Registry, and the OPOs.
In the past, the release of information that has been collected
through the OPTN has been a source of contention. This section
of the regulation addresses these past situations.
10) Preemption - No state or local
governing entity shall establish or continue in effect any
law, rule, or regulation, or other requirement that would
restrict an entity from comply with the organ allocation
policies of the OPTN or other policies of the OPTN that have
been approved by the Secretary.
This memorandum provides an overview
of the sections of the regulation. Please review the regulation
text that is attached to this memorandum. There are many
fine points under each section that need to be considered.
The ASTP would appreciate receiving written comments, either
by fax, (202) 857-1115 or by e-mail: at ast@ahint.com by
April 24, 1998. Your comments will be reviewed by the ASTP
Board of Directors as the craft the official ASTP response
to this regulation. Thank you in advance for your work on
this issue. If you have any questions, please do not hesitate
to call ASTP Washington Representative, Jill Rathbun, at
(202) 857-1898.
