‘‘(C) With respect to the patient involved,
the information shall (taking into account pa-
tients in similar medical circumstances) include
the following as applied to specific transplant
centers:
‘‘(i) The probability of receiving an
organ transplant.
‘‘(ii) The length of time that similarly
situated patients have waited historically to
receive a transplant.
‘‘(iii) Medical outcomes for similarly
situated patients, which information shall
be adjusted to reflect the medical risk fac-
tors for such patients.
‘‘(D) With respect to the patient involved,
the information shall include the information
described in subparagraph (C) as applied to the
service areas of specific qualified organ procure-
ment organizations (other than such areas in
which there is only one transplant center).
‘‘(3) ANNUAL PUBLIC REPORT.—The Network
shall annually make available to the public a report
on the overall status of organ procurement and
transplantation.
‘‘(4) CONFIDENTIALITY.—Except for the re-
lease of information that is authorized under para-
graph (2) or (3) by the Network, neither the Net-
work nor the Secretary has authority to release the
following information (unless authorized in writing
by the patient or other entity with which the data
is concerned):
‘‘(A) Information that permits direct or in-
direct identification of any patient who is wait-
ing for a transplant, or who is an organ trans-
plant patient or recipient of an organ.
‘‘(B) Information that permits direct or in-
direct identification of any potential or actual
organ donors.
‘‘(C) Information that permits direct or in-
direct identification of participants in Network
deliberations or determinations related to prac-
titioner or institutional qualifications, due proc-
ess proceedings or peer review activities, except
for information announcing final decisions of
the Network.
This paragraph may not be construed as prohibiting
the disclosure of information within the Network, in-
cluding information disclosed in the course of inter-
active organ sharing operations within the Network.
‘‘(e) STUDIES.—
‘‘(1) IN GENERAL.—The Network shall carry
out studies and demonstration projects for the pur-
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.
‘‘(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.—
‘‘(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).
‘‘(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
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.
‘‘(g) 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
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-
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 1999, 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-
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 six-month period beginning on the
date on which the notice is so published.
‘‘(h) 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—
‘‘(1) conducting public hearings and receiving
from interested persons comments regarding criteria
of the Network and critical comments relating to the
manner in which the Network is carrying out its du-
ties under this section;
‘‘(2) providing such comments to the Network
and receiving responses from the Network; and
‘‘(3) the consideration by the Secretary of such
comments.
‘‘(i) EVALUATIONS BY GENERAL ACCOUNTING OF-
FICE.—
‘‘(1) IN GENERAL.—The Comptroller General of
the United States shall periodically conduct evalua-
tions of the Network, including the structure and
function of the Network and the relationship be-
tween the Secretary and the nonprofit private entity
that under subsection (a) operates the Network. The
first such evaluation shall be completed not later
than one year after the date of the enactment of the
Organ Procurement and Transplantation Network
Amendments of 1999, and such an evaluation shall
be completed not later than every third year there-
after.
‘‘(2) INPUT FROM FIELD.—In conducting eval-
uations under paragraph (1), the Comptroller Gen-
eral shall consult with experts in the field of organ
transplantation, including organizations that rep-
resent transplant surgeons, transplant physicians,
transplant centers, and qualified organ procurement
organizations.
‘‘(3) PROCEDURES
OF
NETWORK.—The Net-
work shall establish procedures for coordinating with
the Comptroller General for purposes of evaluations
under paragraph (1).
‘‘(4) REPORTS
TO
CONGRESS.—The Comp-
troller General shall prepare reports describing the
findings of evaluations under paragraph (1) and
shall submit such reports to the Committee on Com-
merce of the House of Representatives and the Com-
mittee on Health, Education, Labor, and Pensions
of the Senate.’’.
(b) RULE
OF CONSTRUCTION.—The amendments
made by this Act may not be construed as affecting the
duration of the contract under section 372 of the Public
Health Service Act that was in effect on the day before
the date of the enactment of this Act.
SEC. 4. ADDITIONAL AMENDMENTS.
(a) IN GENERAL.—Part H of title III of the Public
Health Service Act (42 U.S.C. 273 et seq.) is amended—
(1) by striking section 373;
(2) in section 374—
(A) in subsection (b)(1), by inserting after
‘‘organization’’ the following: ‘‘and other orga-
nizations for the purpose of increasing the sup-
ply of transplantable organs’’;
(B) in subsection (c), by striking ‘‘or 373’’
each place such term appears; and
(C) in subsection (d), by amending para-
graph (2) to read as follows:
‘‘(2) The term ‘‘organ’’, with respect to trans-
plantation into humans, means the human or other
animal kidney, liver, heart, lung, pancreas, and any
other organ (other than human corneas and eyes)
specified by the Secretary by regulation. For pur-
poses of section 372(c), such term includes bone
marrow.’’;
(3) in section 375—
(A) in paragraph (1), by striking ‘‘this
part’’ and inserting ‘‘this section’’; and
(B) in paragraph (4)—
(i) by redesignating clauses (i) and
(ii) as subparagraphs (A) and (B), respec-
tively; and
(ii) in subparagraph (B) (as so redes-
ignated), by striking ‘‘comparative costs
and patient outcomes’’ and inserting ‘‘com-
parative patient outcomes’’;
(4) in section 376—
(A) by striking ‘‘the Secretary’’ and insert-
ing ‘‘the Organ Procurement and Transplan-
tation Network under section 372’’; and
(B) by striking ‘‘Committee on Energy and
Commerce’’ and inserting ‘‘Committee on Com-
merce’’; and
(5) by striking section 377.
(b) REDESIGNATIONS.—Part H of title III of the
Public Health Service Act, as amended by subsection (a)
of this section, is amended by redesignating sections 374
through 376 as sections 373 through 375, respectively.