H. R. 3926

One Hundred Eighth Congress

of the

United States of America

AT THE SECOND SESSION

Begun and held at the City of Washington on Tuesday,

the twentieth day of January, two thousand and four

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 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.
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‘‘(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. 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
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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 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. 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.
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‘‘(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 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. 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;
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‘‘(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. 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 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
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‘‘(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. 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.
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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).

Speaker of the House of Representatives.

Vice President of the United States and

President of the Senate.