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







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, and Mr. Enzi) introduced the 
 following bill; which was read twice and referred to the Committee on 
                 Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 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,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Organ Donation and Recovery 
Improvement Act''.

                  TITLE I--ORGAN DONATION AND RECOVERY

SEC. 101. INTERAGENCY TASK FORCE ON ORGAN DONATION.

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

``SEC. 378. INTER-AGENCY TASK FORCE ON ORGAN DONATION AND RESEARCH.

    ``(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--
            ``(1) federally supported or conducted organ donation 
        efforts and policies; and
            ``(2) federally supported or conducted basic, clinical and 
        health services research (including research on preservation 
        techniques and organ rejection and compatibility).
    ``(b) Composition.--
            ``(1) In general.--The task force shall be composed of--
                    ``(A) the Surgeon General, who shall serve as the 
                chairperson; and
                    ``(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).
            ``(2) Other ex officio members.--The Secretary shall invite 
        the following individuals to serve as ex officio members of the 
        task force:
                    ``(A) A representative from the Department of 
                Transportation.
                    ``(B) A representative from the Department of 
                Defense.
                    ``(C) A representative from the Department of 
                Veterans Affairs.
                    ``(D) A representative from the Office of Personnel 
                Management.
                    ``(E) A physician representative from the board of 
                directors of the Organ Procurement and Transplantation 
                Network.
                    ``(F) Representatives of other Federal agencies or 
                departments as determined to be appropriate by the 
                Secretary.
    ``(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).
    ``(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.''.

SEC. 102. DEMONSTRATION PROJECTS, EDUCATION, AND PUBLIC AWARENESS.

    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:

``SEC. 378A. DEMONSTRATION PROJECTS, EDUCATION, AND PUBLIC AWARENESS.

    ``(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.
    ``(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.
    ``(c) Development of Curricula and Other Education Activities.--
            ``(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.
            ``(2) Health care professionals.--For purposes of 
        subparagraph (A), the term `health care professionals' 
        includes--
                    ``(A) medical students, residents and fellows, 
                attending physicians (through continuing medical 
                education courses and other methods), nurses, social 
                workers, and other allied health professionals;
                    ``(B) hospital- or other health care-facility based 
                chaplains; and
                    ``(C) emergency medical personnel.
    ``(d) Limited Demonstration Projects.--
            ``(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.
            ``(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.
            ``(3) Duration.--Each project shall last no more than 3 
        years, and shall be conducted in a limited number of sites or 
        areas.
            ``(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).
    ``(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.

``SEC. 378B. GRANTS REGARDING HOSPITAL ORGAN DONATION COORDINATORS.

    ``(a) Authority.--
            ``(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.
            ``(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) 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.
    ``(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.
    ``(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.''.

SEC. 103. 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 378B, as added by 
section 102, the following:

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

    ``(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.
    ``(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, 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--
            ``(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 $5,000,000 
for fiscal year 2004, and such sums as may be necessary for each of 
fiscal years 2005 through 2008.''.

SEC. 104. REPORTS.

    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:

``SEC. 378D. REPORTS.

    ``(a) IOM Report on Best Practices.--
            ``(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.
            ``(2) Considerations.--In conducting the evaluation under 
        paragraph (1), the Institute of Medicine shall examine--
                    ``(A) existing barriers to organ donation, 
                including among minority populations; and
                    ``(B) best donation and recovery practices, 
                including--
                            ``(i) mandated choice and presumed consent;
                            ``(ii) organ procurement organization and 
                        provider consent practices (including consent 
                        best practices);
                            ``(iii) the efficacy and reach of existing 
                        State routine notification laws with respect to 
                        organ procurement organizations;
                            ``(iv) the impact of requests for consent 
                        in States where registry registration 
                        constitutes express consent under State law; 
                        and
                            ``(v) recommendations with respect to 
                        achieving higher donation rates, including 
                        among minority populations.
            ``(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.
    ``(b) IOM Report on Living Donations.--
            ``(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).
            ``(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.
    ``(c) Report on Donation and Recovery Activities.--
            ``(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.
            ``(2) Requirements.--To the extent practicable, each 
        evaluation submitted under paragraph (1) shall--
                    ``(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
                    ``(B) assess organ donation and recovery activities 
                that are recently completed, ongoing, or planned.''.

SEC. 105. TECHNICAL AMENDMENT CONCERNING ORGAN PURCHASES.

    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.''.

                   TITLE II--LIVING DONATION EXPENSES

SEC. 201. 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 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 
        such types of expenses as are paid for 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) 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.''.

                      TITLE III--ORGAN REGISTRIES

SEC. 301. ADVISORY COMMITTEE.

    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. ADVISORY COMMITTEE.

    ``(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.
    ``(b) Membership.--The committee shall be composed of 10 members of 
whom--
            ``(1) at least 1 member shall be a physician with 
        experience performing transplants;
            ``(2) at least 1 member shall have experience in organ 
        recovery;
            ``(3) at least 1 member shall be representative of an 
        organization with experience conducting national awareness 
        campaigns and donor outreach;
            ``(4) at least 1 member shall be representative of a State 
        with an existing donor registry;
            ``(5) at least 1 member shall have experience with national 
        information systems where coordination occurs with State-based 
        systems; and
            ``(6) at least 1 member shall represent donor families, 
        transplant recipients, and those awaiting transplantation.
    ``(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.
    ``(d) Meetings.--The committee shall meet at the call of the 
Chairman who shall be selected by the Secretary.
    ``(e) Compensation.--Each member of the committee shall not receive 
compensation for services provided under this section.
    ``(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.
    ``(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.
    ``(h) Permanent Committee.--Section 14 of the Federal Advisory 
Committee Act shall not apply to the committee established under this 
section.
    ``(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.
    ``(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.''.

SEC. 302. NATIONAL LIVING DONOR REGISTRY.

    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:

``SEC. 371B. NATIONAL LIVING DONOR REGISTRY.

    ``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.''.

SEC. 303. 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).
                                 <all>