[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 376 Introduced in Senate (IS)]







108th CONGRESS
  1st Session
                                 S. 376

 To amend the Public Health Service Act to promote organ donation and 
    facilitate interstate linkage and 24-hour access to State donor 
                  registries, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           February 12, 2003

  Mr. Durbin 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 
    facilitate interstate linkage and 24-hour access to State donor 
                  registries, 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 Donor Outreach, Network, and Timely 
Exchange Act'' or the ``DONATE Act''.

SEC. 2. AMENDMENT TO THE PUBLIC HEALTH SERVICE ACT.

    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 ORGAN AND TISSUE DONOR REGISTRY RESOURCE CENTER.

    ``(a) In General.--The Secretary, acting through the Administrator 
of the Health Resources and Services Administration, shall establish a 
National Organ and Tissue Donor Registry Resource Center (referred to 
in this section as the `Center').
    ``(b) Duties.--The Center established under subsection (a) shall--
            ``(1) advance the development, expansion, and evaluation of 
        State donor registries;
            ``(2) facilitate timely access to and exchange of accurate 
        donor information between State registries on a 24-hour a day 
        basis;
            ``(3) develop consensus guidelines on a standard registry 
        model, including whether or not such registries should include 
        living donor information, that represents best practices, 
        including--
                    ``(A) the core functions and content of a registry;
                    ``(B) clear legal and ethical standards for minimum 
                levels of information necessary to establish informed 
                consent;
                    ``(C) standardized, legally verifiable consent 
                documentation;
                    ``(D) privacy protections, including guidelines for 
                accessing the registry database;
                    ``(E) data exchange protocols and standards; and
                    ``(F) methods to legally enforce the wishes of the 
                donor;
            ``(4) provide technical assistance to the States for the 
        establishment and operation of State registries, including 
        assistance in developing model legislation for State 
        registries; and
            ``(5) maintain a registry information clearinghouse to 
        collect, synthesize, and disseminate best practices information 
        about donor registries, including maintaining a web site.
    ``(c) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, $5,000,000 for each of the 
fiscal years 2004 through 2008.

``SEC. 371B. GRANTS FOR STATE ORGAN AND TISSUE DONOR REGISTRIES.

    ``(a) Program Authorized.--The Secretary shall award grants or 
cooperative agreements to eligible entities to support the development, 
enhancement, expansion, and evaluation of State organ and tissue donor 
registries.
    ``(b) Eligible Entity.--In this section, the term `eligible entity' 
means a State.
    ``(c)  Use of Funds.--An eligible entity that receives a grant or 
cooperative agreement under subsection (a) shall--
            ``(1) provide for authorization under State law of the 
        registry;
            ``(2) establish benchmarks for improvement in organ 
        donation in the State;
            ``(3) at a minimum, make registries available to organ 
        procurement organizations and to other State agencies 24 hours, 
        7 days a week and without a fee;
            ``(4) include provisions that protect the privacy of 
        donors; and
            ``(5) include legal protections for individuals complying 
        with the law, including those who carry out advance directives 
        and organ, tissue, and eye procurement.
    ``(d) Application.--An entity that desires a grant or cooperative 
agreement under subsection (a) shall submit an application to the 
Secretary at such time, in such manner, and containing such information 
as the Secretary may reasonably require.
    ``(e) Report.--An eligible entity that receives a grant or 
cooperative agreement under subsection (a) shall prepare and submit a 
report to the Secretary that describes the manner in which such entity 
has used amounts received through a grant under this section and 
assesses initiatives that may be replicated in other States.
    ``(f) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, $10,000,000 for each of the 
fiscal years 2004 through 2008.

``SEC. 371C. ADVISORY TASK FORCE.

    ``(a) In General.--The Secretary shall establish an advisory task 
force to study State registries and make recommendations to Congress 
regarding such registries.
    ``(b) Membership.--The task force 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 
        procurement;
            ``(3) at least 2 members shall be representatives of 
        organizations with experience conducting national awareness 
        campaigns and donor outreach;
            ``(4) at least 2 members shall be representatives of States 
        with existing donor registries;
            ``(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) Term.--Members shall be appointed for 3-year rotating terms. 
Any vacancy in the task force shall not affect its powers, but shall be 
filled in the same manner as the original appointment.
    ``(d)  Initial Meeting.--Not later than 30 days after the date on 
which all members of the task force have been appointed, the task force 
shall hold its first meeting.
    ``(e) Meetings.--The task force shall meet at the call of the 
Chairman who shall be selected by the Secretary.
    ``(f) Compensation.--Each member of the task force shall not 
receive compensation for services provided under this section.
    ``(g) Travel Expenses.--The members of the task force 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 
task force.
    ``(h) Administrative Support.--The Secretary shall ensure that the 
task force is provided with administrative support or any other 
technical assistance that such task force needs in carrying out its 
duties.
    ``(i) Permanent Committee.--Section 14 of the Federal Advisory 
Committee Act shall not apply to the task force established under this 
section.
    ``(j) Report.--Not later than 1 year after the date of enactment of 
this section, and in the subsequent year as well, the task force 
established under subsection (a) shall prepare and submit to Congress a 
report regarding the status of State registries, current best 
practices, recommendations to increase the number and quality of State 
registries, and recommendations regarding the merits of a national 
database or ways to improve linkages between State registries and 
consider and make recommendations regarding whether any Federal funds 
for the establishment of new registries should be limited to State 
agency processes that are linked to the ability to make a legally 
binding gift.

``SEC. 371D. EXPENSES INCURRED TOWARD LIVING ORGAN DONATION.

    ``(a) In General.--The Secretary may award grants to eligible 
entities to pay for travel, subsistence, and other necessary nonmedical 
miscellaneous expenses related to living organ donation by any donating 
individual.
    ``(b) Definitions.--In this section:
            ``(1) Donating individual.--The term `donating individual' 
        means any individual who is making, or in good faith plans to 
        make, a living donation of his or her organs.
            ``(2) Eligible entity.--The term `eligible entity' means a 
        State, transplant center, qualified organ procurement 
        organization under section 371, or other public or private 
        entity.
            ``(3) Necessary nonmedical miscellaneous expenses.--The 
        term `necessary nonmedical miscellaneous expenses' means such 
        necessary nonmedical miscellaneous expenses as the Secretary 
        deems appropriate.
    ``(c) Preference.--Preference shall be given to intended recipients 
or donors of organs with incomes not exceeding $60,000 (as adjusted for 
fiscal year 2004 and subsequent fiscal years to offset the effects of 
inflation occurring after the beginning of fiscal year 2003).
    ``(d) Use of Funds.--
            ``(1) In general.--An eligible entity that receives a grant 
        under subsection (a) shall use funds received through such 
        grant to pay for travel, subsistence, and other necessary 
        nonmedical miscellaneous expenses of any donating individual.
            ``(2) Family.--An eligible entity that receives a grant 
        under subsection (a) may use funds received through such grant 
        to pay for travel, subsistence, and other necessary nonmedical 
        miscellaneous expenses of 1 or more family members of any 
        donating individual to accompany the donating individual in 
        making the living donation.
            ``(3) Prohibition.--An eligible entity shall not pay the 
        travel, subsistence, and other necessary nonmedical 
        miscellaneous expenses of a donating individual if payment has 
        been made, or can reasonably be expected to be made, with 
        respect to such expenses--
                    ``(A) under any State compensation program, under 
                an insurance policy, or under any Federal or State 
                health benefits program;
                    ``(B) by an entity that provides health services on 
                a prepaid basis; or
                    ``(C) by the recipient of the organ.
    ``(e) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, $15,000,000 for fiscal year 
2004, and such sums as may be necessary for each of the fiscal years 
2005 through 2008.

``SEC. 371E. ORGAN DONATION PUBLIC AWARENESS PROGRAM.

    ``(a) National Program.--The Secretary shall establish a public 
education program to increase awareness about organ donation and the 
need to provide for an adequate rate of such donations.
    ``(b) Grants to Entities.--The Secretary may award grants to public 
and nonprofit private entities to carry out studies and demonstration 
projects with respect to providing for an adequate rate of organ 
donation.
    ``(c) Grants to States.--
            ``(1) In general.--The Secretary may award grants to States 
        to establish programs designed to increase awareness regarding 
        organ donation and the number of organ donors within the State, 
        including living donors.
            ``(2) Use of funds.--A State that receives a grant under 
        paragraph (1) may use funds received through such grant to--
                    ``(A) work in a partnership with other public 
                agencies or private sector institutions for education 
                and awareness efforts, information dissemination, 
                activities pertaining to the State organ donor 
                registry, and other innovative donation specific 
                initiatives, including living donation;
                    ``(B) establish yearly benchmarks for improvement 
                in organ donation rates in the State; and
                    ``(C) develop, enhance or expand a State donor 
                registry, which shall be available to organ procurement 
                organizations and other State agencies upon a search 
                request 24 hours, 7 days a week.
            ``(3) Application.--A State shall submit an application at 
        such time, in such manner, and containing such information as 
        the Secretary may reasonably require.
            ``(4) Report.--A State that receives a grant under 
        paragraph (1) shall prepare and submit to the Secretary a 
        report on an annual basis that describes the State's use of 
        funds received under this subsection, and assesses the use of 
        such funds and any initiatives for potential replication in 
        other States.
    ``(d) Report.--The Secretary shall annually submit to the Congress 
a report on the activities carried out under this section, including 
provisions describing the extent to which the activities have affected 
the rate of organ donation.
    ``(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. 3. CONGRESSIONAL MEDAL.

    (a) In General.--The Secretary of the Treasury shall design and 
strike a bronze medal with suitable emblems, devices, and inscriptions, 
to be determined by the Secretary of the Treasury, to commemorate organ 
donors and their families.
    (b) Eligibility.--Any organ donor, or the family or family member 
of any organ donor, shall be eligible for a medal described in 
subsection (a).
    (c) Documentation.--The Secretary of Health and Human Services 
shall direct the entity holding the Organ Procurement and 
Transplantation Network (hereafter in this Act referred to as ``OPTN'') 
to contract to--
            (1) establish an application procedure requiring the 
        relevant organ procurement organization, as described in 
        section 371(b)(1) of the Public Health Service Act (42 U.S.C. 
        273(b)(1)), through which an individual or their family made an 
        organ donation, to submit to the OPTN contractor documentation 
        supporting the eligibility of that individual or their family 
        to receive a medal described in subsection (a); and
            (2) determine, through the documentation provided, and, if 
        necessary, independent investigation, whether the individual or 
        family is eligible to receive a medal described in subsection 
        (a).
    (d) Delivery to the Secretary of Health and Human Services.--The 
Secretary of the Treasury shall deliver medals struck pursuant to this 
Act to the Secretary of Health and Human Services.
    (e) Delivery to Eligible Recipients.--The Secretary of Health and 
Human Services shall direct the OPTN contractor to arrange for the 
presentation to the relevant organ procurement organization all medals 
struck pursuant to this Act to individuals or families that the OPTN 
contractor has determined to be eligible to receive medals under this 
Act.
    (f) Limitation.--
            (1) In general.--Except as provided in paragraph (2), only 
        1 medal may be presented to a family under subsection (b). Such 
        medal shall be presented to the donating family member, or in 
        the case of a deceased donor, the family member who signed the 
        consent form authorizing, or who otherwise authorized, the 
        donation of the organ involved.
            (2) Exception.--In the case of a family in which more than 
        1 member is an organ donor, the OPTN contractor may present an 
        additional medal to each such organ donor or their family.
    (g) Duplicate Medals.--
            (1) In general.--The Secretary of Health and Human Services 
        or the OPTN contractor may provide duplicates of the medal 
        described in subsection (a) to any recipient of a medal under 
        subsection (e), under such regulations as the Secretary of 
        Health and Human Services may issue.
            (2) Limitation.--The price of a duplicate medal shall be 
        sufficient to cover the cost of such duplicates.
    (h) National Medals.--The medals struck pursuant to this section 
are national medals for purposes of section 5111 of title 31, United 
States Code.
    (i) General Waiver of Procurement Regulations.--No provision of law 
governing procurement or public contracts shall be applicable to the 
procurement of goods or services necessary for carrying out the 
provisions of this Act.
    (j) Solicitation of Donations.--
            (1) In general.--The Secretary of the Treasury may enter 
        into an agreement with the OPTN contractor to collect funds to 
        offset expenditures relating to the issuance of medals 
        authorized under this section.
            (2) Payment of funds.--
                    (A) In general.--Except as provided in subparagraph 
                (B), all funds received by the Organ Procurement and 
                Transplantation Network under paragraph (1) shall be 
                promptly paid by the Organ Procurement and 
                Transplantation Network to the Secretary of the 
                Treasury.
                    (B) Limitation.--Not more than 5 percent of any 
                funds received under paragraph (1) shall be used to pay 
                administrative costs incurred by the OPTN contractor as 
                a result of an agreement established under this 
                section.
            (3) Numismatic public enterprise fund.--Notwithstanding any 
        other provision of law--
                    (A) all amounts received by the Secretary of the 
                Treasury under paragraph (2)(A) shall be deposited in 
the Numismatic Public Enterprise Fund, as described in section 5134 of 
title 31, United States Code; and
                    (B) the Secretary of the Treasury shall charge such 
                fund with all expenditures relating to the issuance of 
                medals authorized under this section.
            (4) Start-up costs.--A 1-time amount not to exceed $55,000 
        shall be provided to the OPTN contractor to cover initial 
        start-up costs. The amount will be paid back in full within 3 
        years of the date of the enactment of this Act from funds 
        received under paragraph (1).
            (5) No net cost to the government.--The Secretary of the 
        Treasury shall take all actions necessary to ensure that the 
        issuance of medals authorized under subsection (a) results in 
        no net cost to the Government.
    (k) Definitions.--In this section:
            (1) Organ.--The term ``organ'' means the human kidney, 
        liver, heart, lung, pancreas, and any other human organ (other 
        than corneas and eyes) specified by regulation of the Secretary 
        of Health and Human Services or the OPTN contractor.
            (2) Organ procurement and transplantation network.--The 
        term ``Organ Procurement and Transplantation Network'' means 
        the Organ Procurement and Transplantation Network established 
        under section 372 of the Public Health Service Act (42 U.S.C. 
        274).
    (l) Sunset Provision.--This section shall be effective during the 
5-year period beginning on the date of the enactment of this Act.

SEC. 4. IOM REPORT.

    (a) 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 that have achieved a higher than 
average organ donation rate.
    (b) Barriers.--In conducting the evaluation under subsection (a), 
the Institute of Medicine shall examine existing barriers to organ 
donation.
    (c) Report.--Not later than 18 months after the date of enactment 
of this section, the Institute of Medicine shall submit to the 
Secretary of Health and Human Services a report concerning the 
evaluation conducted under this section. 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 procurement 
rates.

SEC. 5. ESTABLISHMENT OF PROGRAM OF GRANTS REGARDING HOSPITAL ORGAN 
              DONATION COORDINATORS.

    Part H of title III of the Public Health Service Act (42 U.S.C. 273 
et seq.) is amended by inserting after section 374 the following:

``SEC. 374A. GRANTS REGARDING HOSPITAL ORGAN DONATION COORDINATORS.

    ``(a) In General.--
            ``(1) In general.--The Secretary may award grants to 
        qualifying organ donation entities to establish programs 
        coordinating organ donation activities of eligible hospitals, 
        including coordinating with 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 public or nonprofit private hospital 
        that performs significant trauma care, or a public or nonprofit 
        private hospital or consortium of such hospitals that serves a 
        population base of not fewer than 200,000 individuals.
            ``(3) Qualifying organ donation entity.--In this section, 
        the term `qualifying organ donation entity' means--
                    ``(A) an eligible hospital; or
                    ``(B) a qualified organ procurement organization 
                under section 371.
    ``(b) Preference in Making Grants.--In making grants under 
subsection (a), the Secretary shall give preference to an applicant if 
the Secretary determines that the probable result of such a grant would 
be a significant increase in the rate of organ donation for the 
eligible hospital involved.
    ``(c) 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.
    ``(d) Evaluations; Report to Congress.--
            ``(1) Evaluations.--The Secretary shall, directly or 
        through contracts with public or private entities, provide for 
        annual evaluations 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.
            ``(2) Report.--Not later than 1 year after the date on 
        which amounts are first appropriated pursuant to subsection 
        (f), and annually thereafter, the Secretary shall submit to the 
        appropriate committees of the Congress a report that summarizes 
        evaluations under paragraph (1).
    ``(e) 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 make available (directly or through donations from public or 
private entities) non-Federal contributions in an amount equal to 30 
percent of the grant awarded to such entity.
    ``(f) Funding.--
            ``(1) Authorization of appropriations.--For the purpose of 
        carrying out this section, there are authorized to be 
        appropriated $3,000,000 for fiscal years 2004 through 2007.
            ``(2) Allocation.--Of the amounts appropriated under 
        paragraph (1) for a fiscal year, the Secretary shall reserve 50 
        percent for grants under subsection (a) to qualifying organ 
        donation entities described in paragraph (3)(A) of such 
        subsection and 50 percent for grants under subsection (a) to 
        qualifying organ donation entities described in paragraph 
        (3)(B) of such subsection.''.

SEC. 6. LIMITATION.

    Nothing in this Act shall affect organ and tissue allocation. 
Standard State and national practices that determine the appropriate 
procurement organization for obtaining consent for an individual organ 
or tissue donation shall continue to apply to such determinations.
                                 <all>