[United States Statutes at Large, Volume 118, 108th Congress, 2nd Session]
[From the U.S. Government Publishing Office, www.gpo.gov]

118 STAT. 584

Public Law 108-216
108th Congress

An Act


 
To amend the Public Health Service Act to promote organ donation, and
for other purposes. NOTE: Apr. 5, 2004 -  [H.R. 3926}

Be it enacted by the Senate and House of Representatives of the
United States of America in Congress NOTE: Organ Donation and Recovery
Improvement Act. assembled,

SECTION 1. NOTE: 42 USC 201 note. 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 recognizes the
importance of families pledging to each other to share their lives as
organ and tissue donors and acknowledges the importance 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
subsistence 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.

[[Page 585]]
118 STAT. 585

``(b) Preference.--The Secretary shall, in carrying out subsection
(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, accompany 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
subsection (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. NOTE: Grants. Contracts. 42 USC 274f-1. PUBLIC
AWARENESS; STUDIES AND DEMONSTRATIONS.

``(a) Organ Donation Public Awareness Program.--The Secretary 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

[[Page 586]]
118 STAT. 586

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) NOTE: Reports. 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 assessment 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
awareness efforts, information dissemination, activities
pertaining to the State donor registry, and other innovative
donation specific 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 professionals and other
appropriate professionals in issues surrounding organ, tissue, and eye
donation including evidence-based proven methods to approach patients
and their families, cultural sensitivities, 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 appropriations that are
available for such purpose.

``SEC. 377B. NOTE: 42 USC 274f-2. 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
coordinated 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
significant trauma care, or a hospital or consortium of
hospitals that serves a population base of not fewer than
200,000 individuals.

``(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.

[[Page 587]]
118 STAT. 587

``(c) Requirements.--Each entity receiving a grant under subsection
(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
performance 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 NOTE: Deadline. 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 determine 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. NOTE: 42 USC 274f-3. STUDIES RELATING TO ORGAN DONATION
AND THE RECOVERY, PRESERVATION, AND TRANSPORTATION OF
ORGANS.

``(a) Development of Supportive Information.--The Secretary, 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
donation 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;

[[Page 588]]
118 STAT. 588

``(3) ensure that scientific evidence of the research and
other activities undertaken under this section is readily
accessible 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. NOTE: 42 USC 274f-4. REPORT RELATING TO ORGAN DONATION
AND THE RECOVERY, PRESERVATION, AND TRANSPORTATION OF
ORGANS.

``(a) In General.--Not NOTE: Deadline. later than December 31,
2005, and every 2 years thereafter, the Secretary shall report to the
appropriate 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

[[Page 589]]
118 STAT. 589

``(B) the most effective donation and recovery
practices.
``(2) An evaluation of living donation practices and
procedures. 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 conducted 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 Federal 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
appropriate, 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. NOTE: 42 USC 273a. 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. NOTE: Deadline. Reports. 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.

[[Page 590]]
118 STAT. 590

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.

LEGISLATIVE HISTORY--H.R. 3926:
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CONGRESSIONAL RECORD, Vol. 150 (2004):
Mar. 23, 24, considered and passed House.
Mar. 25, considered and passed Senate.