Organ Donation and Recovery Improvement Act
PL 108-216 (H.R.3926), enacted 04/05/2004

118 STAT. 584
PUBLIC LAW 108–216—APR. 5, 2004
Public Law 108–216
108th Congress
An Act
To amend the Public Health Service Act to promote organ donation, and for other
purposes.
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Organ Donation and Recovery
Improvement Act’’.
SEC. 2. SENSE OF CONGRESS.
(a) PUBLIC AWARENESS OF NEED FOR ORGAN DONATION.—It
is the sense of Congress that the Federal Government should carry
out programs to educate the public with respect to organ donation,
including the need to provide for an adequate rate of such donations.
(b) FAMILY DISCUSSIONS OF ORGAN DONATIONS.—Congress rec-
ognizes the importance of families pledging to each other to share
their lives as organ and tissue donors and acknowledges the impor-
tance of discussing organ and tissue donation as a family.
(c) LIVING DONATIONS OF ORGANS.—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 technology that
have enabled organ transplantation with organs donated by
living individuals to become a viable treatment option for an
increasing number of patients.
SEC. 3. REIMBURSEMENT OF TRAVEL AND SUBSISTENCE EXPENSES
INCURRED TOWARD LIVING ORGAN DONATION.
Section 377 of the Public Health Service Act (42 U.S.C. 274f)
is amended to read as follows:
‘‘SEC. 377. REIMBURSEMENT OF TRAVEL AND SUBSISTENCE EXPENSES
INCURRED TOWARD LIVING ORGAN DONATION.
‘‘(a) IN GENERAL.—The Secretary may award grants to States,
transplant centers, qualified organ procurement organizations
under section 371, or other public or private entities for the purpose
of—
‘‘(1) providing for the reimbursement of travel and subsist-
ence expenses incurred by individuals toward making living
donations of their organs (in this section referred to as ‘donating
individuals’); and
‘‘(2) providing for the reimbursement of such incidental
nonmedical expenses that are so incurred as the Secretary
determines by regulation to be appropriate.
42 USC 201 note.
Organ Donation
and Recovery
Improvement
Act.
Apr. 5, 2004
[H.R. 3926}
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118 STAT. 585
PUBLIC LAW 108–216—APR. 5, 2004
‘‘(b) PREFERENCE.—The Secretary shall, in carrying out sub-
section (a), give preference to those individuals that the Secretary
determines are more likely to be otherwise unable to meet such
expenses.
‘‘(c) CERTAIN CIRCUMSTANCES.—The Secretary may, in carrying
out subsection (a), consider—
‘‘(1) the term ‘donating individuals’ as including individuals
who in good faith incur qualifying expenses toward the intended
donation of an organ but with respect to whom, for such reasons
as the Secretary determines to be appropriate, no donation
of the organ occurs; and
‘‘(2) the term ‘qualifying expenses’ as including the expenses
of having relatives or other individuals, not to exceed 2, accom-
pany or assist the donating individual for purposes of subsection
(a) (subject to making payment for only those types of expenses
that are paid for a donating individual).
‘‘(d) RELATIONSHIP TO PAYMENTS UNDER OTHER PROGRAMS.—
An award may be made under subsection (a) only if the applicant
involved agrees that the award will not be expended to pay the
qualifying expenses of a donating individual 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;
‘‘(2) by an entity that provides health services on a prepaid
basis; or
‘‘(3) by the recipient of the organ.
‘‘(e) DEFINITIONS.—For purposes of this section:
‘‘(1) The term ‘donating individuals’ has the meaning
indicated for such term in subsection (a)(1), subject to sub-
section (c)(1).
‘‘(2) The term ‘qualifying expenses’ means the expenses
authorized for purposes of subsection (a), subject to subsection
(c)(2).
‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of
carrying out this section, there is authorized to be appropriated
$5,000,000 for each of the fiscal years 2005 through 2009.’’.
SEC. 4. PUBLIC AWARENESS; STUDIES AND DEMONSTRATIONS.
Part H of title III of the Public Health Service Act (42 U.S.C.
273 et seq.) is amended by inserting after section 377 the following:
‘‘SEC. 377A. PUBLIC AWARENESS; STUDIES AND DEMONSTRATIONS.
‘‘(a) ORGAN DONATION PUBLIC AWARENESS PROGRAM.—The Sec-
retary shall, directly or through grants or contracts, establish a
public education program in cooperation with existing national
public awareness campaigns to increase awareness about organ
donation and the need to provide for an adequate rate of such
donations.
‘‘(b) STUDIES AND DEMONSTRATIONS.—The Secretary may make
peer-reviewed grants to, or enter into peer-reviewed contracts with,
public and nonprofit private entities for the purpose of carrying
out studies and demonstration projects to increase organ donation
and recovery rates, including living donation.
‘‘(c) GRANTS TO STATES.—
‘‘(1) IN
GENERAL.—The Secretary may make grants to
States for the purpose of assisting States in carrying out organ
Grants.
Contracts.
42 USC 274f–1.
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118 STAT. 586
PUBLIC LAW 108–216—APR. 5, 2004
donor awareness, public education, and outreach activities and
programs designed to increase the number of organ donors
within the State, including living donors.
‘‘(2) ELIGIBILITY.—To be eligible to receive a grant under
this subsection, a State shall—
‘‘(A) submit an application to the Department in the
form prescribed;
‘‘(B) establish yearly benchmarks for improvement in
organ donation rates in the State; and
‘‘(C) report to the Secretary on an annual basis a
description and assessment of the State’s use of funds
received under this subsection, accompanied by an assess-
ment of initiatives for potential replication in other States.
‘‘(3) USE OF FUNDS.—Funds received under this subsection
may be used by the State, or in partnership with other public
agencies or private sector institutions, for education and aware-
ness efforts, information dissemination, activities pertaining
to the State donor registry, and other innovative donation spe-
cific initiatives, including living donation.
‘‘(d) EDUCATIONAL ACTIVITIES.—The Secretary, in coordination
with the Organ Procurement and Transplantation Network and
other appropriate organizations, shall support the development and
dissemination of educational materials to inform health care profes-
sionals and other appropriate professionals in issues surrounding
organ, tissue, and eye donation including evidence-based proven
methods to approach patients and their families, cultural sensitivi-
ties, and other relevant issues.
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of
carrying out this section, there are authorized to be appropriated
$15,000,000 for fiscal year 2005, and such sums as may be necessary
for each of the fiscal years 2006 through 2009. Such authorization
of appropriations is in addition to any other authorizations of appro-
priations that are available for such purpose.
‘‘SEC. 377B. GRANTS REGARDING HOSPITAL ORGAN DONATION
COORDINATORS.
‘‘(a) AUTHORITY.—
‘‘(1) IN
GENERAL.—The Secretary may award grants to
qualified organ procurement organizations and hospitals under
section 371 to establish programs coordinating organ donation
activities of eligible hospitals and qualified organ procurement
organizations under section 371. Such activities shall be coordi-
nated to increase the rate of organ donations for such hospitals.
‘‘(2) ELIGIBLE HOSPITAL.—For purposes of this section, the
term ‘eligible hospital’ means a hospital that performs signifi-
cant trauma care, or a hospital or consortium of hospitals
that serves a population base of not fewer than 200,000 individ-
uals.
‘‘(b) ADMINISTRATION OF COORDINATION PROGRAM.—A condition
for the receipt of a grant under subsection (a) is that the applicant
involved agree that the program under such subsection will be
carried out jointly—
‘‘(1) by representatives from the eligible hospital and the
qualified organ procurement organization with respect to which
the grant is made; and
‘‘(2) by such other entities as the representatives referred
to in paragraph (1) may designate.
42 USC 274f–2.
Reports.
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118 STAT. 587
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‘‘(c) REQUIREMENTS.—Each entity receiving a grant under sub-
section (a) shall—
‘‘(1) establish joint organ procurement organization and
hospital designated leadership responsibility and accountability
for the project;
‘‘(2) develop mutually agreed upon overall project perform-
ance goals and outcome measures, including interim outcome
targets; and
‘‘(3) collaboratively design and implement an appropriate
data collection process to provide ongoing feedback to hospital
and organ procurement organization leadership on project
progress and results.
‘‘(d) RULE OF CONSTRUCTION.—Nothing in this section shall
be construed to interfere with regulations in force on the date
of enactment of the Organ Donation and Recovery Improvement
Act.
‘‘(e) EVALUATIONS.—Within 3 years after the award of grants
under this section, the Secretary shall ensure an evaluation of
programs carried out pursuant to subsection (a) in order to deter-
mine the extent to which the programs have increased the rate
of organ donation for the eligible hospitals involved.
‘‘(f) MATCHING REQUIREMENT.—The Secretary may not award
a grant to a qualifying organ donation entity under this section
unless such entity agrees that, with respect to costs to be incurred
by the entity in carrying out activities for which the grant was
awarded, the entity shall contribute (directly or through donations
from public or private entities) non-Federal contributions in cash
or in kind, in an amount equal to not less than 30 percent of
the amount of the grant awarded to such entity.
‘‘(g) FUNDING.—For the purpose of carrying out this section,
there are authorized to be appropriated $3,000,000 for fiscal year
2005, and such sums as may be necessary for each of fiscal years
2006 through 2009.’’.
SEC. 5. STUDIES RELATING TO ORGAN DONATION AND THE RECOVERY,
PRESERVATION, AND TRANSPORTATION OF ORGANS.
Part H of title III of the Public Health Service Act (42 U.S.C.
273 et seq.) is amended by inserting after section 377B, as added
by section 4, the following:
‘‘SEC. 377C. STUDIES RELATING TO ORGAN DONATION AND THE
RECOVERY, PRESERVATION, AND TRANSPORTATION OF
ORGANS.
‘‘(a) DEVELOPMENT
OF SUPPORTIVE INFORMATION.—The Sec-
retary, acting through the Director of the Agency for Healthcare
Research and Quality, shall develop scientific evidence in support
of efforts to increase organ donation and improve the recovery,
preservation, and transportation of organs.
‘‘(b) ACTIVITIES.—In carrying out subsection (a), the Secretary
shall—
‘‘(1) conduct or support evaluation research to determine
whether interventions, technologies, or other activities improve
the effectiveness, efficiency, or quality of existing organ dona-
tion practice;
‘‘(2) undertake or support periodic reviews of the scientific
literature to assist efforts of professional societies to ensure
that the clinical practice guidelines that they develop reflect
the latest scientific findings;
42 USC 274f–3.
Deadline.
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118 STAT. 588
PUBLIC LAW 108–216—APR. 5, 2004
‘‘(3) ensure that scientific evidence of the research and
other activities undertaken under this section is readily acces-
sible by the organ procurement workforce; and
‘‘(4) work in coordination with the appropriate professional
societies as well as the Organ Procurement and Transplantation
Network and other organ procurement and transplantation
organizations to develop evidence and promote the adoption
of such proven practices.
‘‘(c) RESEARCH
AND DISSEMINATION.—The Secretary, acting
through the Director of the Agency for Healthcare Research and
Quality, as appropriate, shall provide support for research and
dissemination of findings, to—
‘‘(1) develop a uniform clinical vocabulary for organ
recovery;
‘‘(2) apply information technology and telecommunications
to support the clinical operations of organ procurement
organizations;
‘‘(3) enhance the skill levels of the organ procurement
workforce in undertaking quality improvement activities; and
‘‘(4) assess specific organ recovery, preservation, and
transportation technologies.
‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of
carrying out this section, there are authorized to be appropriated
$2,000,000 for fiscal year 2005, and such sums as may be necessary
for each of fiscal years 2006 through 2009.’’.
SEC. 6. REPORT RELATING TO ORGAN DONATION AND THE RECOVERY,
PRESERVATION, AND TRANSPORTATION OF ORGANS.
Part H of title III of the Public Health Service Act (42 U.S.C.
273 et seq.) is amended by inserting after section 377C, as added
by section 5, the following:
‘‘SEC. 377D. REPORT RELATING TO ORGAN DONATION AND THE
RECOVERY, PRESERVATION, AND TRANSPORTATION OF
ORGANS.
‘‘(a) IN GENERAL.—Not later than December 31, 2005, and
every 2 years thereafter, the Secretary shall report to the appro-
priate committees of Congress on the activities of the Department
carried out pursuant to this part, including an evaluation describing
the extent to which the activities have affected the rate of organ
donation and recovery.
‘‘(b) REQUIREMENTS.—To the extent practicable, each report
submitted under subsection (a) shall—
‘‘(1) evaluate the effectiveness of activities, identify effective
activities, and disseminate such findings with respect to organ
donation and recovery;
‘‘(2) assess organ donation and recovery activities that are
recently completed, ongoing, or planned; and
‘‘(3) evaluate progress on the implementation of the plan
required under subsection (c)(5).
‘‘(c) INITIAL REPORT REQUIREMENTS.—The initial report under
subsection (a) shall include the following:
‘‘(1) An evaluation of the organ donation practices of organ
procurement organizations, States, other countries, and other
appropriate organizations including an examination across all
populations, including those with low organ donation rates,
of—
‘‘(A) existing barriers to organ donation; and
Deadline.
42 USC 274f–4.
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‘‘(B) the most effective donation and recovery practices.
‘‘(2) An evaluation of living donation practices and proce-
dures. Such evaluation shall include an assessment of issues
relating to informed consent and the health risks associated
with living donation (including possible reduction of long-term
effects).
‘‘(3) An evaluation of—
‘‘(A) federally supported or conducted organ donation
efforts and policies, as well as federally supported or con-
ducted basic, clinical, and health services research
(including research on preservation techniques and organ
rejection and compatibility); and
‘‘(B) the coordination of such efforts across relevant
agencies within the Department and throughout the Fed-
eral Government.
‘‘(4) An evaluation of the costs and benefits of State donor
registries, including the status of existing State donor registries,
the effect of State donor registries on organ donation rates,
issues relating to consent, and recommendations regarding
improving the effectiveness of State donor registries in
increasing overall organ donation rates.
‘‘(5) A plan to improve federally supported or conducted
organ donation and recovery activities, including, when appro-
priate, the establishment of baselines and benchmarks to
measure overall outcomes of these programs. Such plan shall
provide for the ongoing coordination of federally supported or
conducted organ donation and research activities.’’.
SEC. 7. NATIONAL LIVING DONOR MECHANISMS.
Part H of title III of the Public Health Service Act (42 U.S.C.
273 et seq.) is amended by inserting after section 371 the following:
‘‘SEC. 371A. NATIONAL LIVING DONOR MECHANISMS.
‘‘The Secretary may establish and maintain mechanisms to
evaluate the long-term effects associated with living organ donations
by individuals who have served as living donors.’’.
SEC. 8. STUDY.
Not later than December 31, 2004, the Secretary of Health
and Human Services, in consultation with appropriate entities,
including advocacy groups representing those populations that are
likely to be disproportionately affected by proposals to increase
cadaveric donation, shall submit to the appropriate committees
of Congress a report that evaluates the ethical implications of
such proposals.
Deadline.
Reports.
42 USC 273a.
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118 STAT. 590
PUBLIC LAW 108–216—APR. 5, 2004
LEGISLATIVE HISTORY—H.R. 3926:
CONGRESSIONAL RECORD, Vol. 150 (2004):
Mar. 23, 24, considered and passed House.
Mar. 25, considered and passed Senate.
SEC. 9. QUALIFIED ORGAN PROCUREMENT ORGANIZATIONS.
Section 371(a) of the Public Health Service Act (42 U.S.C.
273(a)) is amended by striking paragraph (3).
Approved April 5, 2004.
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