Pub.L. 108-217 To provide for an additional temporary extension of programs under the Small Business Act and the Small Business Investment Act of 1958 through June 4, 2004, and for other purposes. <> ...

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               ORGAN DONATION AND RECOVERY IMPROVEMENT ACT

[[Page 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 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 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 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 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 

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