```

[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3926 Enrolled Bill (ENR)]

        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.
    ``(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 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.
    ``(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;
        ``(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
            ``(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.

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.
```