Organ Procurement and Transportation Network; Organ Allocation Policies

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.

-----------------------------------------------------------------------

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]

BILLING CODE 4160-15-M