IIB
106TH CONGRESS
2D SESSION
H. R. 2418
IN THE SENATE OF THE UNITED STATES
APRIL 5, 2000
Received; read twice and referred to the Committee on Health, Education,
Labor, and Pensions
AN ACT
To amend the Public Health Service Act to revise and extend
programs relating to organ procurement and transplantation.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
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SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Organ Procurement
and Transplantation Network Amendments of 2000’’.
SEC. 2. FINDINGS.
(a) IN GENERAL.—The Congress finds as follows:
(1) It is in the public interest to maintain and
improve a system for promoting and supporting a
central network in the private sector to assist organ
procurement organizations and transplant centers in
the distribution of organs among transplant patients
and the provision of organ transplantation services,
and to assure quality and facilitate collaboration
among network members and individual medical
practitioners participating in network activities.
(2) The Organ Procurement and Transplan-
tation Network (‘‘Network’’), which was established
in the private sector pursuant to a contract awarded
by the Federal Government, should continue to be
operated by a nonprofit private entity pursuant to a
contract with the Federal Government.
(3) The Federal Government should continue to
provide Federal oversight of and financial assistance
for the services provided by the Network.
(4) The responsibility for developing, estab-
lishing, and maintaining medical criteria and stand-
ards for organ procurement and transplantation be-
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longs in the private sector and is a function of the
Network.
(5) The Federal Government should assist the
efforts of the Network to serve patient and donor
families in procuring and distributing organs.
(6) The Federal Government should carry out
programs to educate the public with respect to organ
donation, including the need to provide for an ade-
quate rate of such donations.
(b) SENSE OF THE CONGRESS REGARDING FAMILY
DISCUSSIONS OF ORGAN DONATIONS.—The Congress rec-
ognizes the importance of families pledging to each other
to share their lives as organ and tissue donors and ac-
knowledges the importance of discussing organ and tissue
donation as a family.
(c) SENSE OF THE CONGRESS REGARDING LIVING
DONATIONS OF ORGANS.—The Congress—
(1) recognizes the generous contribution made
by each living individual who has donated an organ
to save a life; and
(2) acknowledges the advances in medical tech-
nology that have enabled organ transplantation with
organs donated by living individuals to become a via-
ble treatment option for an increasing number of pa-
tients.
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SEC. 3. ORGAN PROCUREMENT AND TRANSPLANTATION
NETWORK.
(a) IN GENERAL.—Section 372 of the Public Health
Service Act (42 U.S.C. 274) is amended to read as follows:
‘‘ORGAN PROCUREMENT AND TRANSPLANTATION
NETWORK
‘‘SEC. 372. (a) IN GENERAL.—The Secretary shall
by contract provide for the continuing operation of an
Organ Procurement and Transplantation Network (in this
section referred to as the ‘Network’), which contract shall
be awarded to a nonprofit private entity that has expertise
and experience in organ procurement and transplantation.
The Network shall meet the following requirements:
‘‘(1) The Network shall be an independent,
nonprofit private entity that is a separate legal enti-
ty from the entity to which such contract is award-
ed.
‘‘(2) The Network shall in accordance with cri-
teria under subsection (b)(3) include as members
qualified organ procurement organizations (as de-
scribed in section 371(b)), transplant centers, and
other entities that have a demonstrated interest in
the fields of organ donation or transplantation.
(such members are in this section referred to as
‘Network participants’).
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‘‘(3) The Network shall have a board of direc-
tors (in this section referred to as the ‘Board’). The
Board shall, after consultation with Network partici-
pants, establish the policies for carrying out the
functions described in this section for the Network.
‘‘(4) The Board shall be in accordance with the
following:
‘‘(A) The Board shall include representa-
tives of qualified organ procurement organiza-
tions, transplant centers, voluntary health asso-
ciations, and the general public, including a
reasonable proportion of the members of the
Board who are patients awaiting a transplant
or transplant recipients or individuals who have
donated an organ or family members of pa-
tients, recipients or donors.
‘‘(B) The Board shall establish member-
ship categories and qualifications with respect
to serving on the Board, and shall have exclu-
sive authority to admit individuals to member-
ship on the Board. Transplant surgeons and
transplant physicians shall comprise not less
than 50 percent of the membership of the
Board. The Board shall be limited to a total of
42 members.
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‘‘(C) The Board shall have an executive
committee, and such other committees as the
Board determines to be appropriate.
‘‘(D) The chair of each such committee
shall be selected so as to ensure the continuity
of leadership for the Board.
‘‘(b) GENERAL FUNCTIONS.—The following applies
to the Network:
‘‘(1) The Network shall establish and operate a
national system to match organs and individuals
who need organ transplants, especially individuals
whose immune system makes it difficult for them to
receive organs.
‘‘(2) The national system shall maintain one or
more lists of individuals who need organ transplants,
shall be operated in accordance with established
medical criteria, shall be operated through the use of
computers, and may function on a regionalized
basis.
‘‘(3) The Network shall establish criteria for
being a Network participant, shall establish medical
criteria for listing patients and for allocating organs,
and shall provide to members of the public an oppor-
tunity to comment with respect to such criteria.
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pose of improving procedures for organ procurement
and allocation, including but not limited to projects
to examine and attempt to increase transplantation
among populations with special needs or limited ac-
cess to transplantation, and among children.
‘‘(2) CERTAIN TECHNOLOGIES.—The Network
may study the impact of possible transplantation of
animal organs (xenotransplantation) and other tech-
nologies to determine the impact upon, and prevent
negative effects on, the fair and effective use of
human allograft organs.
‘‘(f) QUALITY ASSURANCE; MONITORING OF NET-
WORK PARTICIPANTS.—The Network shall monitor the
operations of Network participants to the extent appro-
priate for determining whether the participants are main-
taining compliance with criteria under subsection (b)(3).
In monitoring a Network participant under the preceding
sentence, the Network shall inform the participant of any
findings indicating noncompliance by the participant.
‘‘(g) QUALITY ASSURANCE; PEER REVIEW PRO-
CEEDINGS.—
‘‘(1) IN GENERAL.—The Network shall develop
a peer review system for assuring that members of
the Network comply with criteria under subsection
(b)(3).
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‘‘(2) NONCOMPLIANCE.—
‘‘(A) PAYMENT OF DAMAGES.—The Net-
work shall require that, as a condition of being
a Network participant, each such participant
agree that the Network may, through a peer re-
view proceeding under paragraph (1), require
the participant to pay damages for the failure
of the participant to comply with criteria under
subsection (b)(3). The Network shall establish
procedures to ensure that such proceedings are
conducted in an impartial manner, with ade-
quate opportunity for the Network participant
involved to receive a hearing. The Network shall
identify various types of violations of such cri-
teria and specify the maximum amount of dam-
ages that the Network may under this subpara-
graph require a Network participant to pay for
the type of violation involved.
‘‘(B) RESTRICTING
ACCESS
TO
ALLOCA-
TION SYSTEM.—If under subparagraph (A) it
has been determined that a Network participant
has engaged in substantial violations of criteria
under subsection (b)(3), the Network may re-
strict the extent to which such participant is
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permitted to receive allocations of organs
through the Network.
‘‘(C) STATUS OF NETWORK PARTICIPANTS
WITH
RESPECT
TO
VIOLATIONS.—Subject to
paragraph (3), the Network may take actions to
make the public aware of the extent to which a
Network participant has been required to pay
damages under subparagraph (A) or has been
the subject of restrictions under subparagraph
(B).
‘‘(3) CONFIDENTIALITY.—With respect to a
peer review proceeding under paragraph (1), neither
the Network nor the Secretary has authority to re-
lease data or information to the public relating to
the proceedings without the written permission of all
the parties involved, except that if damages under
paragraph (2) are required to be paid, the require-
ment may be publicly announced after the conclusion
of the proceeding.
‘‘(h) ADMINISTRATIVE PROVISIONS.—
‘‘(1) LIMITATION ON AMOUNT OF CONTRACT.—
The amount provided under a contract under sub-
section (a) in any fiscal year may not exceed
$6,000,000 for the operation of the Network, includ-
ing the scientific registry under subsection (c). Such
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limitation does not apply to amounts provided under
the contract for increasing organ donation and pro-
curement.
‘‘(2) RELATIONSHIP BETWEEN SECRETARY AND
NETWORK.—The 
administrative 
and 
procedural
functions described in this section for the Network
shall be carried out in accordance with the mutual
agreement of the Secretary and the Network. For
purposes of the preceding sentence, functions that
are scientific, clinical, or medical in nature are not
administrative or procedural functions and are with-
in the sole discretion of the Network. With respect
to the programs under titles XVIII and XIX of the
Social Security Act, this section may not be con-
strued as having any legal effect on such programs,
except to the extent that section 1138 of such Act,
or any other provision of such Act, provides other-
wise.
‘‘(3) NONFEDERAL ASSETS OF NETWORK.—
‘‘(A) IN GENERAL.—No assets in the pos-
session of the Network or revenues collected by
the Network, other than amounts appropriated
under section 378, shall be considered or be
treated as Federal property, Federal revenues,
or program funds pursuant to a Federal con-
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tract, nor shall such assets, revenues, or non-
appropriated funds be subject to restriction or
control by the Secretary, nor shall any member
of the Network be required by the Secretary to
pay any fees to the Network, nor shall the Sec-
retary be authorized to collect or authorize col-
lection of service fees with respect to the Net-
work or the scientific registry under subsection
(c).
‘‘(B) GIFTS.—This section does not pro-
hibit the Network from accepting gifts of money
or services, including gifts to carry out activities
to provide for an increase in the rate of organ
donation.
‘‘(4) COMMUNITY ENDORSEMENT OF CONTRACT
RECIPIENT.—In the case of any contract under sub-
section (a) that is awarded after the date of the en-
actment of the Organ Procurement and Transplan-
tation Network Amendments of 2000, the Secretary
shall select an applicant to receive the contract from
among applicants that have the written endorsement
of a majority of the combined total number of trans-
plant centers and qualified organ procurement orga-
nizations that are Network participants (without re-
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gard to whether such centers or organizations en-
dorse more than one applicant for the contract).
‘‘(5) CHANGE IN CONTRACT RECIPIENT.—With
respect to the expiration of the period during which
a contract under subsection (a) is in effect, if the
Secretary makes a determination to award the con-
tract to a different entity than the entity to which
the previous contract under such subsection was
awarded, the Secretary shall publish in the Federal
Register a notice that such change in the adminis-
tration of the Network will take place, and the
change may not take effect any sooner than the ex-
piration of the 6-month period beginning on the date
on which the notice is so published. Such a change
does not affect the membership status of any Net-
work participant, or the membership status of any
individual who serves on the Board (other than any
membership position that is predicated solely on
being a representative of the current contractor
under subsection (a)).
‘‘(i) ADDITIONAL PROCEDURES REGARDING OVER-
SIGHT AND PUBLIC ACCOUNTABILITY.—For purposes of
providing oversight of and public accountability for the op-
eration of the Network, the Secretary shall establish pro-
cedures for—