[Federal Register Volume 61, Number 220 (Wednesday, November 13, 1996)]
[Proposed Rules]
[Pages 58158-58160]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-29145]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
42 CFR Part 121
Organ Procurement and Transportation Network; Organ Allocation
Policies
AGENCY: Health Resources and Services Administration, DHHS.
ACTION: Request for additional public comment on proposed rule; notice
of public hearings.
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SUMMARY: This document announces that the Secretary of Health and Human
Services is formally inviting additional
[[Page 58159]]
public comment on the Notice of Proposed Rulemaking (NPRM) published on
September 8, 1994, to establish rules governing the operation of the
Organ Procurement and Transportation Network (OPTN). The Secretary is
seeking additional comments on policies affecting the allocation of
human livers for transplantation. In addition, this document announces
that a public hearing will be held at which interested individuals may
submit oral comments regarding such policies as well as regarding
methods to increase organ donation.
DATES:
Hearing: The hearing will be held on December 10-11, 1996,
beginning at 9 a.m. each day. Requests to testify must be submitted by
December 2, 1996.
Comments: For those who choose to send written comments only,
comments must be submitted by December 13, 1996 in order to ensure full
consideration. Because the issue of organ donation is not part of the
rulemaking process, we will accept comments and suggestions on this
issue at any time.
ADDRESSES: Written requests to testify and written comments on
allocation policies should be transmitted to: Ms. Judith Braslow,
Director, HRSA Division of Transplantation, Room 7-29, 5600 Fishers
Lane, Rockville, Maryland 20857.
In light of the short period for submitting requests to testify,
such requests may also be submitted by telefax to Ms. Braslow at (301)
594-6095.
Comments will be available for public inspection three business
days after their receipt in Room 7-29, Parklawn Building, 5600 Fishers
Lane, Rockville, Maryland, Monday through Friday of each week from 8:00
a.m. to 4:30 p.m. To view public comments in Washington, D.C., call
(202) 690-7890 to make an appointment for inspection in Room 309 G of
the Hubert Humphrey Building, 200 Independence Avenue, S.W.
The hearing will be held at the Natcher Center on the National
Institutes of Health campus in Bethesda, Maryland.
FOR FURTHER INFORMATION CONTACT:
Ms. Braslow at the address listed above. Telephone: (301) 443-7577.
SUPPLEMENTARY INFORMATION: Allocation of human livers for
transplantation has been debated within the transplant community for
several years. On September 8, 1994, the Department published an NPRM
to establish rules governing the operation of the OPTN (59 FR 46482-
99). The public comment period expired on December 7, 1994, although
additional comments were received and accepted after that date.
As part of the preamble to the NPRM, the Department solicited
comments on the organ-allocation policies used to distribute organs by
the OPTN (59 FR 46487). Since that time, the OPTN has undertaken a
major review of its policies governing the allocation of livers, and
the Board of Directors of the OPTN has proposed a revised policy to
allocate livers. The revisions proposed by the Board have generated
considerable controversy within the transplant community. In view of
sections 372-375 of the Public Health Service Act, 42 U.S.C. 274-274c,
which vest responsibility in the Secretary of Health and Human Services
for oversight of the OPTN, the Department has concluded that further
public participation in the development of allocation policies related
to livers is desirable. Accordingly, we have decided to seek additional
comments on the NPRM and to accept oral testimony and written comments
on liver allocation policies and the processes by which they may be
developed.
In addition, we recognize that the difficult issues associated with
establishing allocation policies stem from a central problem: the
medical need for organs far exceeds organs donated. Accordingly, we
have decided to use a public hearing as an opportunity to solicit
public comments on methods to increase organ donation and general
awareness of organ transplantation as a therapeutic alternative for
end-stage organ disease.
Participants in the hearing will be limited to ten minutes per
individual (or institution). Those requesting to testify should
indicate whether their comments will address allocation policies, organ
donation, or both. We are particularly interested in comments
addressing the following issues:
1. Allocation of Human Livers for Transplantation
The Organ Procurement and Transplantation Network (OPTN) currently
allocates human livers for transplantation in accordance with the
following policy:
To local Status 1 patients first in descending point order; then
to
local Status 2 patients in descending point order; then to
all other local patients in descending point order; then to
Status 1 patients in the Host OPO's (organ procurement
organization) region in descending point order; then to Status 2
patients in that region in descending point order; then to
all other regional patients in descending point order; then to
Status 1 patients in all other regions in descending point
order; then to
Status 2 patients in all other regions in descending point
order; and finally to
all other patients in all other regions in descending point
order.
The Status definitions, in pertinent part, are as follows:
A patient listed as Status 1 is in a hospital's Intensive Care
Unit (ICU) due to acute or chronic liver failure with a life
expectancy without a liver transplant of less than 7 days.
A patient listed as Status 2 is continuously hospitalized in an
acute care bed for at least five days, or is ICU bound.
A patient listed as Status 3 requires continuous medical care.
A patient listed as Status 4 is at home and functioning
normally.
A patient listed as Status 7 is temporarily inactive--patients
who are temporarily unsuitable for transplant are listed as Status
7.
The OPTN Board's proposed policy would revise the definitions of
several of the status groups and would revise the ``local'' area which
constitutes the first allocation area. In seeking additional comment,
the Secretary invites comments on the following questions:
a. Does the OPTN Board's policy achieve the best outcome that can
reasonably be expected for the patients of America? If not, what
revisions to the policy, alternative policy, or combination of policies
would yield a superior result?
Please present data and other information that support your view;
for example, success measures or factors mentioned in the NPRM which
include (1) equitable distribution of organs; (2) improvement in graft
and patient survival, and (3) enhanced patient choice among transplant
programs. In particular, please indicate the measures you considered
most important in assessing the relative efficacy of various policy
options.
b. Would changes in other OPTN policies related to liver
allocation, such as those noted below, yield a better outcome for the
patients of America than the present system? Should such changes be
implemented in addition to a change in the OPTN Board's allocation
policy or phased in with a change?
Criteria for entering patients on the waiting list for
liver transplant.
Definition of the status categories for patients on the
waiting list for liver transplant.
Procedures for ensuring compliance with OPTN policies
affecting liver allocation.
[[Page 58160]]
Use of performance measures, e.g., quality of transplant
outcomes and annual number of transplants performed, in determining the
eligibility of transplant centers to receive donor livers.
2. Donation of Organs for Transplantation
The medical need for livers and other human organs for
transplantation continues to exceed the number of donor organs by a
considerable margin. No organ allocation policies, no matter how well
crafted or effectively implemented, can be expected to compensate for
serious short-falls in the supply of organs relative to the demand.
a. What are the major impediments to organ donation?
b. How can the Department, organ procurement organizations,
hospitals, and other entities improve current efforts to promote organ
donation?
c. Where and to what extent are further initiatives necessary to
ensure that members of racial and ethnic minority groups are
appropriately apprised regarding such matters as the role of organ
transplantation within the health-care system, the unique health
benefits that can ensue from successful transplantation, the
limitations associated with transplant procedures, and the challenges
involved in recruiting organ donors?
Dated: November 6, 1996.
Ciro V. Sumaya,
Administrator.
Approved: November 7, 1996.
Donna E. Shalala,
Secretary.
[FR Doc. 96-29145 Filed 11-8-96; 10:52 am]
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