Requires the President's Council on Bioethics to evaluate and report to the Secretary on the ethical implications of reducing economic barriers to organ donation.
Authorizes the Secretary to award grants: (1) to qualified organ procurement organizations to establish programs to coordinate their efforts with hospitals; and (2) for reimbursement of travel and subsistence expenses incurred by individuals toward making living organ donations.
Directs the Secretary, acting through the Administrator of the Health Resources and Services Administration and the Director of the Agency for Healthcare Research and Quality, to: (1) develop scientific evidence supporting increased donation and improved recovery, preservation, and transportation of donated organs and tissues; and (2) support efforts to develop a uniform clinical vocabulary and technology and to enhance the skills of the organ procurement workforce.
Directs the Secretary to contract with the Institute of Medicine to evaluate: (1) existing organ donation practices; and (2) living donation practices and procedures.
Requires the Secretary to establish: (1) an advisory committee to study and report to Congress on existing organ donor registries; and (2) and maintain a registry of living organ donors.
[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[S. 1949 Introduced in Senate (IS)]
107th CONGRESS
2d Session
S. 1949
To amend the Public Health Service Act to promote organ donation, and
for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
February 14, 2002
Mr. Frist (for himself, Mr. Dodd, Mr. Hutchinson, Mr. Jeffords, 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 378G; 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.--The task force shall be composed of--
``(1) the Surgeon General, who shall serve as the
chairperson;
``(2) 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);
``(3) a representative from the Department of
Transportation;
``(4) a representative from the Department of Defense;
``(5) a representative from the Department of Veterans
Affairs;
``(6) a representative from the Office of Personnel
Management; and
``(7) 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.
Such projects may include projects to remove financial disincentives to
organ donation and research on issues relating to presumed consent.
``(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; and
``(B) hospital- or other health care-facility based
chaplains; and
``(C) emergency medical personnel.
``(d) Limited Demonstration Projects.--
``(1) In general.--Notwithstanding section 301 of the
National Organ Transplant Act (42 U.S.C. 274e), the Secretary
may conduct up to 3 demonstration projects to examine methods
to reduce economic barriers to organ donation,
including demonstration projects to increase cadaveric donation.
``(2) Duration.--Each project shall last no more than 3
years, and shall be conducted in a limited number of sites or
areas.
``(3) 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 (1).
``(4) Reports.--
``(A) Council's report.--The President's Council on
Bioethics, created under Executive Order 13237 (66 Fed.
Reg. 59851; relating to the Council's creation), shall
submit a report to the Secretary evaluating the ethical
implications of methods to reduce economic barriers to
organ donation, including demonstration projects to
increase cadaveric donation.
``(B) Secretary's report.--The Secretary shall
review such report submitted by the Council and submit
a report to the appropriate committees of Congress that
describes the review provided by the Secretary under
paragraph (3) and evaluates the Council's report
submitted under this paragraph.
``(e) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section, $5,000,000 for fiscal year
2002, and such sums as may be necessary for each of the fiscal years
2003 through 2006.
``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 2002, and
such sums as may be necessary for each of fiscal years 2003 through
2006.''.
SEC. 103. STUDIES RELATING TO ORGAN AND TISSUE DONATION AND THE
RECOVERY, PRESERVATION, AND TRANSPORTATION OF ORGANS AND
TISSUES.
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 AND TISSUE DONATION AND THE
RECOVERY, PRESERVATION, AND TRANSPORTATION OF ORGANS AND
TISSUES.
``(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 and tissue donation and improve the recovery,
preservation, and transportation of organs and tissues.
``(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 and tissue 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 2002, and such sums as may be necessary for each of
fiscal years 2003 through 2006.''.
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; 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.
``(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.''.
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 for Lower-Income Donors.--The Secretary shall, in
carrying out subsection (a), give preference to lower-income donors.
``(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 2002, and such sums as may be necessary for each of fiscal
years 2003 through 2006.''.
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>
Introduced in Senate
Sponsor introductory remarks on measure. (CR S857-858)
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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