[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.

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     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]
BILLING CODE 4160-15-M