‘‘(C) has an agreement with the Secretary
to be reimbursed under title XVIII of the Social
Security Act for the procurement of kidneys;
‘‘(D) notwithstanding any other provision
of law, has met the other requirements of this
subsection and has been certified or recertified
by the Secretary as meeting the performance
standards to be a qualified organ procurement
organization through a process which—
‘‘(i) granted certification or recertifi-
cation within the previous 4 years with
such certification in effect as of October 1,
2000, and remaining in effect through the
earlier of—
‘‘(I) January 1, 2002; or
‘‘(II) the completion of recertifi-
cation under the requirements of
clause (ii); or
‘‘(ii) is defined through regulations
promulgated by the Secretary not later
than January 1, 2002, which—
‘‘(I) require recertification of
qualified organ procurement organiza-
tions not more frequently than once
every 4 years;
‘‘(II) rely on performance meas-
ures that are based on empirical evi-
dence of organ donor potential and
other related factors in each service
area of the qualified organ procure-
ment organizations;
‘‘(III) provide for the filing and
approval of a corrective action plan by
a qualified organ procurement organi-
zation that fails to meet the perform-
ance standards and a grace period of
not less than 2 years during which
such organization can implement the
corrective action plan without risk of
decertification; and
‘‘(IV) provide for a qualified
organ procurement organization to
appeal a decertification to the Sec-
retary on substantive and procedural
grounds;
‘‘(E) has procedures to obtain payment for
nonrenal organs provided to transplant centers;
‘‘(F) has a defined service area that is of
sufficient size to assure maximum effectiveness
in the procurement of organs;
‘‘(G) has a director and other such staff,
including the organ donation coordinators and
organ procurement specialists necessary to ef-
fectively obtain organs from donors in its serv-
ice area; and
‘‘(H) has a board of directors or an advi-
sory board which—
‘‘(i) is composed of—
‘‘(I) members who represent hos-
pital administrators, intensive care or
emergency room personnel, tissue
banks, and voluntary health organiza-
tions in its service area;
‘‘(II) members who represent the
public residing in such area;
‘‘(III) a physician with knowl-
edge, experience, or skill in the field
of histocompatibility or an individual
with a doctorate degree in biological
science with knowledge, experience, or
skill in the field of histocompatibility;
‘‘(IV) a physician with knowledge
or skill in the field of neurology; and
‘‘(V) from each transplant center
in its service area, a member who is
a surgeon who has practicing privi-
leges in such center and who performs
organ transplant surgery;
‘‘(ii) has the authority to recommend
policies for the procurement of organs and
the other functions described in paragraph
(2); and
‘‘(iii) has no authority over any other
activity of the organization.
‘‘(2) 
An 
organ 
procurement 
organization
shall—
‘‘(A) have effective agreements, to identify
potential organ donors, with all of the hospitals
and other health care entities in its service area
which have facilities for organ donation;
‘‘(B) conduct and participate in systematic
efforts, including professional education, to ac-
quire all usable organs from potential donors;
‘‘(C) arrange for the acquisition and pres-
ervation of donated organs and provide quality
standards for the acquisition of organs which
are consistent with the standards adopted by
the Organ Procurement and Transplantation
Network under section 372(b)(2)(E), including
arranging for testing with respect to preventing
the acquisition of organs that are infected with
the etiologic agent for acquired immune defi-
ciency syndrome;
‘‘(D) arrange for the appropriate tissue
typing of donated organs;
‘‘(E) have a system to distribute organs
equitably among transplant patients according
to the requirements established by the Organ
Procurement and Transplantation Network,
and approved by the Secretary, under section
372(c);
‘‘(F) provide or arrange for the transpor-
tation of donated organs to transplant centers;
‘‘(G) have arrangements to coordinate its
activities with transplant centers in its service
area;
‘‘(H) participate in the Organ Procure-
ment and Transplantation Network established
under section 372;
‘‘(I) have arrangements to cooperate with
tissue banks for the retrieval, processing, pres-
ervation, storage, and distribution of tissues as
may be appropriate to assure that all usable tis-
sues are obtained from potential donors;
‘‘(J) evaluate annually the effectiveness of
the organization in acquiring potentially avail-
able organs; and
‘‘(K) assist hospitals in establishing and
implementing protocols for making routine in-
quiries about organ donations by potential do-
nors.’’.
SEC. 4. ORGAN PROCUREMENT AND TRANSPLANTATION
NETWORK.
Section 372 of the Public Health Service Act (42
U.S.C. section 274) is amended to read as follows:
‘‘SEC. 372. ORGAN PROCUREMENT AND TRANSPLANTATION
NETWORK.
‘‘(a) CONTRACT AUTHORITY OF SECRETARY.—The
Secretary shall by contract provide for the establishment
and operation of an Organ Procurement and Transplan-
tation Network which meets the requirements of sub-
section (b) of this section.
‘‘(b) FUNCTIONS.—
‘‘(1) The Organ Procurement and Transplan-
tation Network shall carry out the functions de-
scribed in paragraph (2) and shall—
‘‘(A) be operated by a private nonprofit en-
tity that has an expertise in organ procurement
and transplantation; and
‘‘(B) have a board of directors—
‘‘(i) that includes representatives of
organ procurement organizations (includ-
ing organizations that have received grants
under section 371), transplant centers, vol-
untary health associations, transplant re-
cipients or their family members, donor
family members, and the general public;
and
‘‘(ii) that shall establish an executive
committee and other committees, whose
chairpersons shall be selected to ensure
continuity of the board.
‘‘(2) The Organ Procurement and Transplan-
tation Network shall—
‘‘(A) establish in one location—
‘‘(i) a national list of individuals who
need organs; and
‘‘(ii) a national system, through the
use of computers and in accordance with
established medical criteria, to match or-
gans and individuals included on the list,
especially—
‘‘(I) individuals whose immune
system makes it difficult for them to
receive organs; and
‘‘(II) individuals considered to
have the highest medical urgency;
‘‘(B) establish membership criteria for hos-
pitals and other health care entities performing
organ transplants;
‘‘(C) maintain a twenty-four-hour tele-
phone service to facilitate matching organs with
individuals included in the list;
‘‘(D) assist organ procurement organiza-
tions in the nationwide distribution of organs
equitably among transplant patients;
‘‘(E) adopt and use standards of quality
for the acquisition and transportation of do-
nated organs, including standards for pre-
venting the acquisition of organs that are in-
fected with the etiologic agent for acquired im-
mune deficiency syndrome;
‘‘(F) prepare and distribute, on a national
basis, samples of blood sera from individuals
who are included on the list and whose immune
system makes it difficult for them to receive or-
gans, in order to facilitate matching the com-
patibility of such individuals with organ donors;
‘‘(G) coordinate, as appropriate, the trans-
portation of organs from organ procurement or-
ganizations to transplant centers;
‘‘(H) provide information to physicians and
other health professionals regarding organ do-
nation;
‘‘(I) collect, analyze, and publish data con-
cerning organ donation and transplants;
‘‘(J) carry out studies and demonstration
projects for the purpose of improving proce-
dures for organ procurement and allocation;
‘‘(K) work actively to increase the supply
of donated organs;
‘‘(L) submit to the Secretary an annual re-
port containing information on the comparative
costs and patient outcomes at each transplant
center affiliated with the organ procurement
and transplantation network; and
‘‘(M) submit to the Secretary an annual
report containing such financial information, as
determined by the Secretary, to be necessary to
evaluate the cost of operating the Organ Pro-
curement and Transplantation Network.
‘‘(c) ORGAN ALLOCATION.—
‘‘(1) The Organ Procurement and Transplan-
tation Network shall develop organ specific policies
(including combinations of organs, such as for kid-
ney-pancreas transplants), subject to the review of
the Secretary, for the equitable allocation of
cadaveric organs to individuals on the national wait-
ing list.
‘‘(2) Standardized minimum listing criteria for
including individuals on the national list shall be es-
tablished and, to the extent possible, shall—
‘‘(A) contain explicit thresholds for listing
a patient;
‘‘(B) include thresholds to avoid futile
transplants or the wasting of organs;
‘‘(C) be expressed through objective and
measurable medical criteria; and
‘‘(D) be reviewed periodically and revised
as appropriate.
‘‘(3) Where appropriate for the specific organ,
transplant candidates shall—
‘‘(A) be grouped by status categories from
most to least medically urgent with—
‘‘(i) sufficient categories to avoid
grouping together individuals with substan-
tially different medical urgency;
‘‘(ii) explicit thresholds for differen-
tiating among patients; and
‘‘(iii) explicit standards for the move-
ment of individuals among the status cat-
egories;
‘‘(B) be expressed through objective and
measurable medical criteria; and
‘‘(C) be reviewed periodically and revised
as appropriate.
‘‘(4) Organ allocation policies and procedures
shall be established in accordance with sound med-
ical judgment and shall—
‘‘(A) be designed and implemented to allo-
cate organs among transplant candidates—
‘‘(i) in order of decreasing medical ur-
gency status;
‘‘(ii) over the largest geographic area
so that neither place of residence nor place
of listing shall be a major determinant;
and
‘‘(iii) so as to maintain organ viability
and avoid organ wastage; and
‘‘(B) be reviewed periodically and revised
as appropriate.
‘‘(5) Where medical urgency is not an appro-
priate measurement for organ allocation, policies
and procedures shall be established in accordance
with sound medical judgment and shall be designed
and implemented—
‘‘(A) to allocate organs among individuals
on the waiting list based upon their time on the
waiting list; and
‘‘(B) to reduce the inter-transplant pro-
gram waiting time variance to be as small as
possible.
‘‘(d) AUTHORITY OF THE SECRETARY.—The policies
and rules established by the Organ Procurement and
Transplantation Network shall be subject to review and
approval by the Secretary. The Secretary shall—
‘‘(1) in consultation with the Organ Procure-
ment and Transplantation Network, develop mecha-
nisms to promote and review compliance with the re-
quirements of this section;
‘‘(2) establish and approve all fees, dues, or
similar costs charged in the operation of the Organ
Procurement and Transplantation Network;
‘‘(3) establish procedures for receiving from in-
terested persons critical comments relating to the
manner in which the Organ Procurement and Trans-
plantation Network is carrying out the duties of the
Network under subsection (b) of this section; and
‘‘(4) take such action, as determined by the
Secretary, to enforce the requirements of this section
as well as the requirements under title XVIII of the
Social Security Act.
‘‘(e) NATIONAL TRANSPLANT ADVISORY BOARD.—
‘‘(1) The Secretary shall provide for the estab-
lishment of a National Organ Transplant Advisory
Board (referred to in this subsection as the ‘Board’).
‘‘(2) The National Organ Transplant Advisory
Board shall carry out the functions described in
paragraph (3) and shall be comprised of individuals
that—
‘‘(A) include a broad spectrum of rep-
resentatives of the medical and scientific com-
munity, including epidemiologists and health
service researchers, as well as representatives
from organ procurement organizations and the
community of transplant patients, family mem-
bers and donor families;
‘‘(B) are selected by the Secretary in con-
sultation with the Organ Procurement and
Transplantation Network; and
‘‘(C) serve terms of not less than three
years.
‘‘(3) The National Organ Transplant Advisory
Board shall assist the Secretary in ensuring that the
Organ Procurement and Transplantation Network is
grounded on the best available medical science and
is effective and equitable as possible and shall—
‘‘(A) at the request of the Secretary, re-
view the policies and rules of the Organ Pro-
curement and Transplantation Network;
‘‘(B) at the request of the Secretary, re-
view and consider policies and regulations af-
fecting organ transplantation developed by the
Secretary;
‘‘(C) advise and propose to the Secretary
policies, rules, and regulations affecting organ
procurement and transplantation;
‘‘(D) advise the Secretary with respect to
comments received by the Secretary under sec-
tion 372(d)(3) of this title;
‘‘(E) meet at the request of the Secretary,
but not less than two times every year; and
‘‘(F) elect a Chairperson and Vice-chair-
person as well as any other officers as deter-
mined by the Board.
‘‘(4) For the purpose of carrying out this sub-
section, there are authorized to be appropriated
$500,000 for each of the fiscal years 2000 through
2005.’’.
SEC. 5. SCIENTIFIC REGISTRY.
Section 373 of the Public Health Service Act (42
U.S.C. 274a) is amended to read as follows:
‘‘SEC. 373. SCIENTIFIC REGISTRY.
‘‘The Secretary shall, by grant or contract, develop
and maintain a scientific registry of the recipients of organ
transplants. The registry shall include such information
respecting patients and transplant procedures as the Sec-
retary deems necessary to an ongoing evaluation to the
scientific and clinical status of organ transplantation. The
registry shall also include such information respecting
both donors and patients in transplants involving living
donors. The Secretary shall prepare for inclusion in the
report under section 376 an analysis of information de-
rived from the registry.’’.
SEC. 6. ADMINISTRATION.
Section 375 of the Public Health Service Act (42
U.S.C. section 274c) is amended to read as follows:
‘‘SEC. 375. ADMINISTRATION.
‘‘The Secretary shall designate and maintain an iden-
tifiable administrative unit in the Public Health Service
to—
‘‘(1) administer this part and coordinate with
organ procurement activities under title XVIII of the
Social Security Act;
‘‘(2) administer and coordinate programs, as
determined by the Secretary, to increase organ dona-
tion rates;
‘‘(3) provide technical assistance to organ pro-
curement organizations, the Organ Procurement and
Transplantation Network established under section
372, and other entities in the health care system in-
volved in organ donations, procurements, and trans-
plants; and
‘‘(4) provide information—
‘‘(A) to patients, their families, and their
physicians about transplantation; and
‘‘(B) to patients and their families about
resources available nationally and in each State,
and the comparative costs and patient outcomes
at each transplant center affiliated with the
organ procurement and transplantation net-
work, in order to assist the patients and fami-
lies with the costs associated with transplan-
tation.’’.
SEC. 7. ADDITIONAL AMENDMENTS.
(a) PART H.—Part H of title III of the Public Health
Service Act (42 U.S.C. 273 et seq.) is amended—
(1) in section 374—
(A) in subsection (b)(1), by striking all
after ‘‘organization’’ and inserting the fol-
lowing: ‘‘and other organizations for the pur-
pose of increasing the supply of transplantable
organs.’’; and
(B) in subsection (b)(2), by striking all
after ‘‘two years.’’;
(2) in section 376, by striking ‘‘Committee on
Energy and Commerce’’ and inserting ‘‘Committee
on Commerce’’; and
(3) by striking section 377.
(b) PART J.—Part J of title III of the Public Health
Service Act (42 U.S.C. 274k et seq.) is amended by redes-
ignating sections 379 through 379(a) as sections 380
through 380(a).
SEC. 8. PAYMENT OF TRAVEL AND SUBSISTENCE EXPENSES
INCURRED TOWARD LIVING ORGAN DONA-
TION.
Part H of title III of the Public Health Service Act
is amended by inserting after section 376 the following
section:
‘‘SEC. 377. TRAVEL AND SUBSISTENCE PAYMENTS FOR LIV-
ING ORGAN DONATION.
‘‘(a) IN GENERAL.—The Secretary may make awards
of grants or contracts to States, transplant centers, quali-
fied organ procurement organizations under section 371,
or other public or private entities for the purpose of—
‘‘(1) providing for the payment of travel and
subsistence expenses incurred by individuals toward
making living donations of their organs (in this sec-
tion referred to as ‘donating individuals’); and
‘‘(2) in addition, providing for the payment of
such incidental nonmedical expenses that are so in-
curred as the Secretary determines by regulation to
be appropriate.
‘‘(b) ELIGIBILITY.—
‘‘(1) IN GENERAL.—Payments under subsection
(a) may be made for the qualifying expenses of a do-
nating individual only if—
‘‘(A) the State in which the donating indi-
vidual resides is a different State than the
State in which the intended recipient of the
organ resides; and
‘‘(B) the annual income of the intended re-
cipient of the organ does not exceed $35,000
(as adjusted for fiscal year 2002 and subse-
quent fiscal years to offset the effects of infla-
tion occurring after the beginning fiscal year
2001).
‘‘(2) CERTAIN
CIRCUMSTANCES.—Subject to
paragraph (1), the Secretary may in carrying out
subsection (a) provide as follows:
‘‘(A) The Secretary may consider the term
‘donating individuals’ as including individuals
who in good faith incur qualifying expenses to-
ward the intended donation of an organ but
with respect to whom, for such reason as the
Secretary determines to be appropriate, no do-
nation of the organ occurs.
(B) The Secretary may consider the term
‘qualifying expenses’ as including the expenses
of having one or more family members of do-
nating individuals accompany the donating indi-
viduals for purposes of subsection (a) (subject
to making payment for only such types of ex-
penses as are paid for donating individuals).
‘‘(c) LIMITATION ON AMOUNT OF PAYMENT.—
‘‘(1) IN GENERAL.—With respect to the geo-
graphic area to which a donating individual travels
for purposes of section (a), if such area is other than
the covered vicinity for the intended recipient of the
organ, the amount of qualifying expenses for which
payments under such subsection are made may not
exceed the amount of such expenses for which pay-
ment would have been made if such area had been
the covered vicinity for the intended recipient, taking
into account the costs of travel and regional dif-
ferences in the cost of living.
‘‘(2) COVERED VICINITY.—For purposes of this
section, the term ‘covered vicinity’ with respect to an
intended recipient of an organ from a donating indi-
vidual, means the vicinity of the nearest transplant
center to the residence of the intended recipient that
regularly performs transplants of that type of organ.
‘‘(d) RELATIONSHIP TO PAYMENTS UNDER OTHER
PROGRAMS.—An award may be made under subsection (a)
only if the applicant agrees that the award will not be ex-
pended to pay the qualifying expenses of a donating indi-
vidual to the extent that payment has been made, or can
reasonably be expected to be made, with respect to such
expenses—
‘‘(1) under any State compensation program,
under an insurance policy, or under any Federal or
State health benefits program; or
‘‘(2) by an entity that provides health services
on a prepaid basis.
‘‘(e) DEFINITIONS.—For purposes of this section:
‘‘(1) The term ‘covered vicinity’ has the mean-
ing given such term in subsection (c)(2).
‘‘(2) The term ‘donating individual’ has the
meaning indicated for such term in subsection
(a)(1), subject to subsection (b)(2)(A).
‘‘(3) The term ‘qualifying expenses’ means the
expenses authorized for purposes of subsection (a),
subject to subsection (b)(2)(B).
‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—For the
purpose of carrying out this section, there is authorized
to be appropriated $5,000,000 for each of fiscal years
2000 through 2005.’’.
SEC. 9. PROGRAMS AND DEMONSTRATION PROJECTS TO
INCREASE ORGAN DONATION.
Part H of title III of the Public Health Service Act
is amended by inserting after section 377 the following
section:
‘‘SEC. 378. INITIATIVES TO INCREASE ORGAN DONATION.
‘‘(a) PUBLIC AWARENESS.—The Secretary shall (di-
rectly or through grants or contracts) carry out a program
to educate the public with respect to organ donation.
‘‘(b) STUDIES
AND DEMONSTRATIONS.—The Sec-
retary may make grants to public and nonprofit entities
for the purpose of carrying out studies and demonstration
projects with respect to increasing rates of organ donation.
The Secretary shall—
‘‘(1) give priority to those studies and dem-
onstration projects that are founded upon a ‘best
practices’ approach to increasing organ donation
consent rates;
‘‘(2) give priority to those geographic areas
with lower organ donation consent rates, especially
among minorities;
‘‘(3) provide assistance to qualified organ pro-
curement organizations described under section 371
to implement programs and projects, that as deter-
mined by Secretary through studies and demonstra-
tion projects, have proven to be effective in increas-
ing organ donation rates; and
‘‘(4) provide assistance to the study and consid-
eration of ‘presumed consent’ as an opportunity to
increase organ donation rates.
‘‘(c) GRANTS TO STATES.—The Secretary may make
grants to states for the purpose of carrying out public edu-
cation and outreach programs designed to increase the
number of organ donors within the state. To be eligible,
each state shall—
‘‘(1) submit an application to the Secretary, in
such form as prescribed by the Secretary; and
‘‘(2) establish yearly benchmarks for improve-
ment in organ donation rates in the State.
‘‘(d) CONGRESSIONAL MEDAL.—
‘‘(1) The Secretary shall design a bronze medal
with suitable emblems, devices, and inscriptions, to
be determined by the Secretary, to commemorate
organ donors and their families.
‘‘(2) Any organ donor, or the family of any
organ donor, shall be eligible for a medal.
‘‘(3) The Secretary shall direct the Organ Pro-
curement and Transplantation Network, established
under section 372, to—
‘‘(A) establish an application procedure re-
quiring the relevant organ procurement organi-
zations, described in section 371 of this title,
through which an individual of their family
made an organ donation, to submit documenta-
tion supporting the eligibility of that individual
or their family to receive a medal.
‘‘(B) determine through the documentation
provided, and, if necessary, independent inves-
tigation, whether the individual or family is eli-
gible to receive a medal.
‘‘(4) The Secretary shall make suitable arrange-
ments as necessary with the Secretary of the Treas-
ury to strike and deliver the medals described in
paragraph (3).
‘‘(5) The Secretary shall provide for the presen-
tation to the relevant organ procurement organiza-
tions all medals struck pursuant to this section to
individuals or families that, in accordance with para-
graph (3), the Organ Procurement and Transplan-
tation Network has determined eligible to receive
medals.
‘‘(6)(A) Except as provided in subparagraph
(B), only 1 medal may be presented to a family
under paragraph (5). Such medal shall be presented
to the donating family member, or in the case of a
deceased donor, the family member who signed the
consent form authorizing, or who otherwise author-
ized, the donation of the organ involved.
‘‘(B) In the case of a family in which more than
1 member is an organ donor, an additional medal
may be presented to each such organ donor or their
family.
‘‘(7) The Secretary or the Organ Procurement
and Transplantation Network may provide dupli-
cates of a medal—
‘‘(A) to any recipient of a medal under
subsection (4) under such regulation as the
Secretary may issue; and
‘‘(B) the cost of which shall be sufficient
to cover the costs of such duplicates.
‘‘(8) The medals struck pursuant to the section
are national medals for purposes of section 5111 of
title 31, United States Code.
‘‘(9) No provision of law governing procurement
or public contracts shall be applicable to the pro-
curement of goods or services necessary for carrying
out the provisions of this section.
‘‘(10)(A) The Secretary of the Treasury may
enter into an agreement with the Organ Procure-
ment and Transplantation Network to collect funds
to offset expenditures relating to the issuance of
medals authorized under this section.
date of enactment of this section from funds re-
ceived under this subsection.
‘‘(11) For the purposes of this section, the term
‘‘organ’’ means the human kidney, liver, heart, lung,
pancreas, and any other human organ (other than
corneas and eyes) specified by regulation by the Sec-
retary.
‘‘(12) This section shall be effective for the 5-
year period beginning on the date of the enactment
of this section.
‘‘(e) ANNUAL REPORT
TO CONGRESS.—The Sec-
retary shall submit to the Congress a report on the activi-
ties carried out under this section, including provisions de-
scribing the extent to which the activities have affected
the rate of organ donation.
‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—
‘‘(1) IN
GENERAL.—For the purpose of car-
rying out this section, there are authorized to be ap-
propriated $10,000,000 for fiscal year 2000, and
such sums as may be necessary for each of the fiscal
years 2001 through 2005. Such authorization of ap-
propriations is in addition to any other authoriza-
tions of appropriations that are available for such
purpose.
‘‘(2) PUBLIC AWARENESS.—Of the amounts ap-
propriated under paragraph (1) for a fiscal year, the
Secretary may not obligate more than $2,000,000
for carrying out subsection (a).’’.
SEC. 10. AUTHORIZATION OF APPROPRIATIONS
Part H of title III of the Public Health Service Act
is amended by inserting after section 378 the following
section:
‘‘SEC. 379. AUTHORIZATION OF APPROPRIATIONS FOR
ORGAN 
PROCUREMENT 
AND 
TRANSPLAN-
TATION NETWORK.
‘‘For the purpose of providing for the Organ Procure-
ment and Transplantation Network under section 372,
and for the Scientific Registry under section 373, there
are authorized to be appropriated $4,000,000 for fiscal
year 2000, and such sums as may be necessary for each
of fiscal years 2001 through 2005.’’.
SEC. 11. EFFECTIVE DATE.
The amendments made by this Act take effect Octo-
ber 1, 2000, or upon the date of enactment of this Act,
whichever occurs later.
Æ