[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 573 Reported in Senate (RS)]






                                                       Calendar No. 410
108th CONGRESS
  1st Session
                                 S. 573

 To amend the Public Health Service Act to promote organ donation, and 
                          for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 6, 2003

    Mr. Frist (for himself, Mr. Dodd, Mr. Enzi, Mr. Fitzgerald, Mr. 
 Bennett, and Mr. Hatch) introduced the following bill; which was read 
 twice and referred to the Committee on Health, Education, Labor, and 
                                Pensions

                           November 24, 2003

                Reported by Mr. Gregg, with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 A BILL


 
 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,

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``Organ Donation and Recovery 
Improvement Act''.</DELETED>

        <DELETED>TITLE I--ORGAN DONATION AND RECOVERY</DELETED>

<DELETED>SEC. 101. INTERAGENCY TASK FORCE ON ORGAN DONATION.</DELETED>

<DELETED>    Part H of title III of the Public Health Service Act (42 
U.S.C. 273 et seq.) is amended--</DELETED>
        <DELETED>    (1) by redesignating section 378 (42 U.S.C. 274g) 
        as section 378E; and</DELETED>
        <DELETED>    (2) by inserting after section 377 (42 U.S.C. 
        274f) the following:</DELETED>

<DELETED>``SEC. 378. INTER-AGENCY TASK FORCE ON ORGAN DONATION AND 
              RESEARCH.</DELETED>

<DELETED>    ``(a) In General.--The Secretary shall establish an inter-
agency task force on organ donation and research (referred to in this 
section as the `task force') to improve the coordination and evaluation 
of--</DELETED>
        <DELETED>    ``(1) federally supported or conducted organ 
        donation efforts and policies; and</DELETED>
        <DELETED>    ``(2) federally supported or conducted basic, 
        clinical and health services research (including research on 
        preservation techniques and organ rejection and 
        compatibility).</DELETED>
<DELETED>    ``(b) Composition.--</DELETED>
        <DELETED>    ``(1) In general.--The task force shall be 
        composed of--</DELETED>
                <DELETED>    ``(A) the Surgeon General, who shall serve 
                as the chairperson; and</DELETED>
                <DELETED>    ``(B) representatives to be appointed by 
                the Secretary from relevant agencies within the 
                Department of Health and Human Services (including the 
                Health Resources and Services Administration, Centers 
                for Medicare & Medicaid Services, National Institutes 
                of Health, and Agency for Healthcare Research and 
                Quality).</DELETED>
        <DELETED>    ``(2) Other ex officio members.--The Secretary 
        shall invite the following individuals to serve as ex officio 
        members of the task force:</DELETED>
                <DELETED>    ``(A) A representative from the Department 
                of Transportation.</DELETED>
                <DELETED>    ``(B) A representative from the Department 
                of Defense.</DELETED>
                <DELETED>    ``(C) A representative from the Department 
                of Veterans Affairs.</DELETED>
                <DELETED>    ``(D) A representative from the Office of 
                Personnel Management.</DELETED>
                <DELETED>    ``(E) A physician representative from the 
                board of directors of the Organ Procurement and 
                Transplantation Network.</DELETED>
                <DELETED>    ``(F) Representatives of other Federal 
                agencies or departments as determined to be appropriate 
                by the Secretary.</DELETED>
<DELETED>    ``(c) Annual Report.--In addition to activities carried 
out under subsection (a), the task force shall support the development 
of the annual report under section 378D(c).</DELETED>
<DELETED>    ``(d) Termination.--The task force may be terminated at 
the discretion of the Secretary following the completion of at least 2 
annual reports under section 378D(c). Upon such termination, the 
Secretary shall provide for the on-going coordination of federally 
supported or conducted organ donation and research 
activities.''.</DELETED>

<DELETED>SEC. 102. DEMONSTRATION PROJECTS, EDUCATION, AND PUBLIC 
              AWARENESS.</DELETED>

<DELETED>    Part H of title III of the Public Health Service Act (42 
U.S.C 273 et seq.) is amended by inserting after section 378, as added 
by section 101, the following:</DELETED>

<DELETED>``SEC. 378A. DEMONSTRATION PROJECTS, EDUCATION, AND PUBLIC 
              AWARENESS.</DELETED>

<DELETED>    ``(a) Grants To Increase Donation Rates.--The Secretary 
shall award peer-reviewed grants to public and non-profit private 
entities, including States, to carry out studies and demonstration 
projects to increase organ donation and recovery rates, including 
living donation.</DELETED>
<DELETED>    ``(b) Organ Donation Public Awareness Program.--The 
Secretary shall 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.</DELETED>
<DELETED>    ``(c) Development of Curricula and Other Education 
Activities.--</DELETED>
        <DELETED>    ``(1) In general.--The Secretary, in coordination 
        with the Organ Procurement and Transplantation Network and 
        other appropriate organizations, shall support the development 
        and dissemination of model curricula to train health care 
        professionals and other appropriate professionals (including 
        religious leaders in the community, funeral directors, and law 
        enforcement officials) in issues surrounding organ donation, 
        including methods to approach patients and their families, 
        cultural sensitivities, and other relevant issues.</DELETED>
        <DELETED>    ``(2) Health care professionals.--For purposes of 
        subparagraph (A), the term `health care professionals' 
        includes--</DELETED>
                <DELETED>    ``(A) medical students, residents and 
                fellows, attending physicians (through continuing 
                medical education courses and other methods), nurses, 
                social workers, and other allied health 
                professionals;</DELETED>
                <DELETED>    ``(B) hospital- or other health care-
                facility based chaplains; and</DELETED>
                <DELETED>    ``(C) emergency medical 
                personnel.</DELETED>
<DELETED>    ``(d) Limited Demonstration Projects.--</DELETED>
        <DELETED>    ``(1) Reports.--Not later than 1 year after the 
        date of enactment of this section, the Secretary shall prepare 
        and submit to the appropriate committees of Congress a report 
        evaluating the ethical implications of proposals for 
        demonstration projects to increase cadaveric 
        donation.</DELETED>
        <DELETED>    ``(2) Authority.--Notwithstanding section 301 of 
        the National Organ Transplant Act (42 U.S.C. 274e), upon the 
        submission of and consistent with the report by the Secretary 
        under paragraph (1), the Secretary may conduct up to 3 
        demonstration projects to increase cadaveric 
        donation.</DELETED>
        <DELETED>    ``(3) Duration.--Each project shall last no more 
        than 3 years, and shall be conducted in a limited number of 
        sites or areas.</DELETED>
        <DELETED>    ``(4) Review.--The Secretary shall provide for the 
        ongoing ethical review and evaluation of such projects to 
        ensure that such projects are administered effectively as 
        possible and in accordance with the stated purpose of this 
        subsection under paragraph (2).</DELETED>
<DELETED>    ``(e) Authorization of Appropriations.--There is 
authorized to be appropriated to carry out this section, $5,000,000 for 
fiscal year 2004, and such sums as may be necessary for each of the 
fiscal years 2005 through 2008.</DELETED>

<DELETED>``SEC. 378B. GRANTS REGARDING HOSPITAL ORGAN DONATION 
              COORDINATORS.</DELETED>

<DELETED>    ``(a) Authority.--</DELETED>
        <DELETED>    ``(1) In general.--The Secretary may award grants 
        to qualified organ procurement organizations 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.</DELETED>
        <DELETED>    ``(2) Eligible hospital.--For purposes of this 
        section, an eligible hospital is 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.</DELETED>
<DELETED>    ``(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--</DELETED>
        <DELETED>    ``(1) by representatives from the eligible 
        hospital and the qualified organ procurement organization with 
        respect to which the grant is made; and</DELETED>
        <DELETED>    ``(2) by such other entities as the 
        representatives referred to in paragraph (1) may 
        designate.</DELETED>
<DELETED>    ``(c) 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. Such evaluation shall 
include recommendations on whether the program should be expanded to 
include other grantees, such as hospitals.</DELETED>
<DELETED>    ``(d) 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.</DELETED>
<DELETED>    ``(e) Funding.--For the purpose of carrying out this 
section, there are authorized to be appropriated $3,000,000 for fiscal 
year 2004, and such sums as may be necessary for each of fiscal years 
2005 through 2008.''.</DELETED>

<DELETED>SEC. 103. STUDIES RELATING TO ORGAN DONATION AND THE RECOVERY, 
              PRESERVATION, AND TRANSPORTATION OF ORGANS.</DELETED>

<DELETED>    Part H of title III of the Public Health Service Act (42 
U.S.C. 273 et seq.) is amended by inserting after section 378B, as 
added by section 102, the following:</DELETED>

<DELETED>``SEC. 378C. STUDIES RELATING TO ORGAN DONATION AND THE 
              RECOVERY, PRESERVATION, AND TRANSPORTATION OF 
              ORGANS.</DELETED>

<DELETED>    ``(a) Development of Supportive Information.--The 
Secretary, acting through the Administrator of the Health Resources and 
Services Administration and 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.</DELETED>
<DELETED>    ``(b) Activities.--In carrying out subsection (a), the 
Secretary shall--</DELETED>
        <DELETED>    ``(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;</DELETED>
        <DELETED>    ``(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;</DELETED>
        <DELETED>    ``(3) ensure that scientific evidence of the 
        research and other activities undertaken under this section is 
        readily accessible by the organ procurement workforce; 
        and</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(c) Research, Demonstrations, and Training.--The 
Secretary, acting through the Administrator of the Health Resources and 
Services Administration and the Director of the Agency for Healthcare 
Research and Quality, as appropriate, shall provide support for 
research, demonstrations, and training as appropriate, to--</DELETED>
        <DELETED>    ``(1) develop a uniform clinical vocabulary for 
        organ recovery;</DELETED>
        <DELETED>    ``(2) apply information technology and 
        telecommunications to support the clinical operations of organ 
        procurement organizations;</DELETED>
        <DELETED>    ``(3) enhance the skill levels of the organ 
        procurement workforce in undertaking quality improvement 
        activities; and</DELETED>
        <DELETED>    ``(4) assess specific organ recovery, 
        preservation, and transportation technologies.</DELETED>
<DELETED>    ``(d) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be appropriated 
$5,000,000 for fiscal year 2004, and such sums as may be necessary for 
each of fiscal years 2005 through 2008.''.</DELETED>

<DELETED>SEC. 104. REPORTS.</DELETED>

<DELETED>    Part H of title III of the Public Health Service Act (42 
U.S.C. 273 et seq.) is amended by inserting after section 378C, as 
added by section 103, the following:</DELETED>

<DELETED>``SEC. 378D. REPORTS.</DELETED>

<DELETED>    ``(a) IOM Report on Best Practices.--</DELETED>
        <DELETED>    ``(1) In general.--The Secretary shall enter into 
        a contract with the Institute of Medicine to conduct an 
        evaluation of the organ donation practices of organ procurement 
        organizations, States, other countries, and other appropriate 
        organizations.</DELETED>
        <DELETED>    ``(2) Considerations.--In conducting the 
        evaluation under paragraph (1), the Institute of Medicine shall 
        examine--</DELETED>
                <DELETED>    ``(A) existing barriers to organ donation, 
                including among minority populations; and</DELETED>
                <DELETED>    ``(B) best donation and recovery 
                practices, including--</DELETED>
                        <DELETED>    ``(i) mandated choice and presumed 
                        consent;</DELETED>
                        <DELETED>    ``(ii) organ procurement 
                        organization and provider consent practices 
                        (including consent best practices);</DELETED>
                        <DELETED>    ``(iii) the efficacy and reach of 
                        existing State routine notification laws with 
                        respect to organ procurement 
                        organizations;</DELETED>
                        <DELETED>    ``(iv) the impact of requests for 
                        consent in States where registry registration 
                        constitutes express consent under State law; 
                        and</DELETED>
                        <DELETED>    ``(v) recommendations with respect 
                        to achieving higher donation rates, including 
                        among minority populations.</DELETED>
        <DELETED>    ``(3) Report.--Not later than 18 months after the 
        date of enactment of this section, the Institute of Medicine 
        shall submit to the Secretary a report concerning the 
        evaluation conducted under this subsection. Such report shall 
        include recommendations for administrative actions and, if 
        necessary, legislation in order to replicate the best practices 
        identified in the evaluation and to otherwise increase organ 
        donation and recovery rates.</DELETED>
<DELETED>    ``(b) IOM Report on Living Donations.--</DELETED>
        <DELETED>    ``(1) In general.--The Secretary shall enter into 
        a contract with the Institute of Medicine to conduct an 
        evaluation of living donation practices and procedures. Such 
        evaluation shall include, but is not limited to an assessment 
        of issues relating to informed consent and the health risks 
        associated with living donation (including possible reduction 
        of long-term effects).</DELETED>
        <DELETED>    ``(2) Report.--Not later than 18 months after the 
        date of enactment of this section, the Institute of Medicine 
        shall submit to the Secretary a report concerning the 
        evaluation conducted under this subsection.</DELETED>
<DELETED>    ``(c) Report on Donation and Recovery Activities.--
</DELETED>
        <DELETED>    ``(1) In general.--The Secretary as part of the 
        report specified in 274d shall submit an evaluation concerning 
        federally supported or conducted organ donation and recovery 
        activities, including donation and recovery activities 
        evaluated or conducted under the amendments made by the Organ 
        Donation and Recovery Improvement Act to increase organ 
        donation and recovery rates.</DELETED>
        <DELETED>    ``(2) Requirements.--To the extent practicable, 
        each evaluation submitted under paragraph (1) shall--</DELETED>
                <DELETED>    ``(A) evaluate the effectiveness of 
                activities, identify best practices, and make 
                recommendations regarding the adoption of best 
                practices with respect to organ donation and recovery; 
                and</DELETED>
                <DELETED>    ``(B) assess organ donation and recovery 
                activities that are recently completed, ongoing, or 
                planned.''.</DELETED>

<DELETED>SEC. 105. TECHNICAL AMENDMENT CONCERNING ORGAN 
              PURCHASES.</DELETED>

<DELETED>    Section 301(c)(2) of the National Organ Transplant Act (42 
U.S.C. 274e(c)(2)) is amended by adding at the end the following: 
``Such term does not include familial, emotional, psychological, or 
physical benefit to an organ donor, recipient, or any other party to an 
organ donation event.''.</DELETED>

         <DELETED>TITLE II--LIVING DONATION EXPENSES</DELETED>

<DELETED>SEC. 201. REIMBURSEMENT OF TRAVEL AND SUBSISTENCE EXPENSES 
              INCURRED TOWARD LIVING ORGAN DONATION.</DELETED>

<DELETED>    Section 377 of the Public Health Service Act (42 U.S.C. 
274f) is amended to read as follows:</DELETED>

<DELETED>``SEC. 377. REIMBURSEMENT OF TRAVEL AND SUBSISTENCE EXPENSES 
              INCURRED TOWARD LIVING ORGAN DONATION.</DELETED>

<DELETED>    ``(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--</DELETED>
        <DELETED>    ``(1) providing for the reimbursement of travel 
        and subsistence expenses incurred by individuals toward making 
        living donations of their organs (in this section referred as 
        `donating individuals'); and</DELETED>
        <DELETED>    ``(2) providing for the reimbursement of such 
        incidental nonmedical expenses that are so incurred as the 
        Secretary determines by regulation to be appropriate.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(c) Certain Circumstances.--The Secretary may, in 
carrying out subsection (a), consider--</DELETED>
        <DELETED>    ``(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</DELETED>
        <DELETED>    ``(2) the term `qualifying expenses' as including 
        the expenses of having relatives or other individuals, not to 
        exceed 2, who accompany or assist the donating individual for 
        purposes of subsection (a) (subject to making payment for only 
        such types of expenses as are paid for donating 
        individual).</DELETED>
<DELETED>    ``(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--</DELETED>
        <DELETED>    ``(1) under any State compensation program, under 
        an insurance policy, or under any Federal or State health 
        benefits program;</DELETED>
        <DELETED>    ``(2) by an entity that provides health services 
        on a prepaid basis; or</DELETED>
        <DELETED>    ``(3) by the recipient of the organ.</DELETED>
<DELETED>    ``(e) Authorization of Appropriations.--For the purpose of 
carrying out this section, there is authorized to be appropriated 
$5,000,000 for fiscal year 2004, and such sums as may be necessary for 
each of fiscal years 2005 through 2008.''.</DELETED>

             <DELETED>TITLE III--ORGAN REGISTRIES</DELETED>

<DELETED>SEC. 301. ADVISORY COMMITTEE.</DELETED>

<DELETED>    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:</DELETED>

<DELETED>``SEC. 371A. ADVISORY COMMITTEE.</DELETED>

<DELETED>    ``(a) In General.--Not later than 6 months after 
enactment, the Secretary shall establish an advisory committee to study 
existing organ donor registries and make recommendations to Congress 
regarding the costs, benefits, and expansion of such 
registries.</DELETED>
<DELETED>    ``(b) Membership.--The committee shall be composed of 10 
members of whom--</DELETED>
        <DELETED>    ``(1) at least 1 member shall be a physician with 
        experience performing transplants;</DELETED>
        <DELETED>    ``(2) at least 1 member shall have experience in 
        organ recovery;</DELETED>
        <DELETED>    ``(3) at least 1 member shall be representative of 
        an organization with experience conducting national awareness 
        campaigns and donor outreach;</DELETED>
        <DELETED>    ``(4) at least 1 member shall be representative of 
        a State with an existing donor registry;</DELETED>
        <DELETED>    ``(5) at least 1 member shall have experience with 
        national information systems where coordination occurs with 
        State-based systems; and</DELETED>
        <DELETED>    ``(6) at least 1 member shall represent donor 
        families, transplant recipients, and those awaiting 
        transplantation.</DELETED>
<DELETED>    ``(c) Initial Meeting.--Not later than 30 days after the 
date on which all members of the committee have been appointed, the 
committee shall hold its first meeting.</DELETED>
<DELETED>    ``(d) Meetings.--The committee shall meet at the call of 
the Chairman who shall be selected by the Secretary.</DELETED>
<DELETED>    ``(e) Compensation.--Each member of the committee shall 
not receive compensation for services provided under this 
section.</DELETED>
<DELETED>    ``(f) Travel Expenses.--The members of the committee shall 
be allowed travel expenses, including per diem in lieu of subsistence, 
at rates authorized for employees of agencies under subchapter I of 
chapter 57 of title 5, United States Code, while away from their homes 
or regular places of business in the performance of services for the 
committee.</DELETED>
<DELETED>    ``(g) Administrative Support.--The Secretary shall ensure 
that the committee is provided with administrative support or any other 
technical assistance that such committee needs in carrying out its 
duties.</DELETED>
<DELETED>    ``(h) Permanent Committee.--Section 14 of the Federal 
Advisory Committee Act shall not apply to the committee established 
under this section.</DELETED>
<DELETED>    ``(i) Report.--Not later than 1 year after the date on 
which the committee is established under subsection (a), the committee 
shall prepare and submit to Congress a report regarding the status of 
organ donor registries, current best practices, the effect of organ 
donor registries on organ donation rates, the merits of expanding organ 
donor registries, issues relating to consent, the efficacy of current 
privacy protections, potential forms of technical assistance, and 
recommendations regarding improving the effectiveness and establishing 
formal linkages between organ donor registries.</DELETED>
<DELETED>    ``(j) Definition.--In this section, the term `organ donor 
registry' means a listing of individuals who have indicated their 
desire to donate their organs and tissue upon their death through 
driver's license preferences or other formal mechanisms.''.</DELETED>

<DELETED>SEC. 302. NATIONAL LIVING DONOR REGISTRY.</DELETED>

<DELETED>    Part H of title III of the Public Health Service Act (42 
U.S.C. 273 et seq.), as amended by section 301, is further amended by 
inserting after section 371A the following:</DELETED>

<DELETED>``SEC. 371B. NATIONAL LIVING DONOR REGISTRY.</DELETED>

<DELETED>    ``The Secretary shall by contract establish and maintain a 
registry of individuals who have served as living organ donors for the 
purpose of evaluating the long-term health effects associated with 
living organ donations.''.</DELETED>

<DELETED>SEC. 303. QUALIFIED ORGAN PROCUREMENT ORGANIZATIONS.</DELETED>

<DELETED>    Section 371(a) of the Public Health Service Act (42 U.S.C. 
273(a)) is amended by striking paragraph (3).</DELETED>

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, who 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 2004 through 2008.''.

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 or contracts to 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.--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. To be eligible, each State shall--
            ``(1) submit an application to the Department in the form 
        prescribed;
            ``(2) establish yearly benchmarks for improvement in organ 
        donation rates in the State; and
            ``(3) report to the Secretary on an annual basis a 
        description and assessment of the State's use of these grant 
        funds, accompanied by an assessment of initiatives for 
        potential replication in other States.
Funds 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 2004, and such sums as may be necessary for each of the 
fiscal years 2005 through 2008. 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, an 
        eligible hospital is 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 2004, and 
such sums as may be necessary for each of fiscal years 2005 through 
2008.''.

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 2004, and such sums as may be necessary for each of 
fiscal years 2005 through 2008.''.

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)(4).
    ``(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 an 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 is authorized to 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).




                                                       Calendar No. 410

108th CONGRESS

  1st Session

                                 S. 573

_______________________________________________________________________

                                 A BILL

 To amend the Public Health Service Act to promote organ donation, and 
                          for other purposes.

_______________________________________________________________________

                           November 24, 2003

                       Reported with an amendment