[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[S. 2398 Introduced in Senate (IS)]







106th CONGRESS
  2d Session
                                S. 2398

    To amend the Public Health Service Act to revise and extend the 
      programs relating to organ procurement and transplantation.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             April 11, 2000

Mr. Fitzgerald (for himself, Mr. Schumer, Mr. Durbin, Mr. Santorum, Mr. 
  Specter, Ms. Mikulski, Mr. Sarbanes, and Mr. Kerrey) 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 revise and extend the 
      programs relating to organ procurement and transplantation.

    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 Transplantation Fairness Act 
of 2000''.

SEC. 2. FINDINGS.

    (a) In General.--Congress makes the following findings:
            (1) It is in the public interest to maintain and 
        continually improve a national network to ensure the fair and 
        effective distribution of organs among patients on the national 
        waiting list irrespective of their place of residence or the 
        location of the transplant program with which they are listed, 
        and to ensure quality and facilitate collaboration among 
        network members and individual medical practitioners 
        participating in the network activities.
            (2) The Organ Procurement and Transplantation Network 
        (referred to in this section as the ``Network'') was created in 
        1984 by the National Organ Transplant Act (Public Law 98-507) 
        in order to facilitate an equitable allocation of organs among 
        all patients on a national basis.
            (3) The Federal Government should continue to provide 
        Federal oversight of the Network and is responsible for 
        protecting the public's health care interest and ensuring that 
        the policies of the Network meet the goals established by this 
        Act.
            (4) The responsibility for developing, establishing, and 
        maintaining medical criteria and standards for organ 
        procurement and transplantation should be a function of the 
        Network, and the Secretary of Health and Human Services should 
        provide oversight to ensure compliance with this Act and other 
        applicable laws.
            (5) The network should be operated by a private 
        organization under contract with the Department of Health and 
        Human Services.
            (6) The Federal Government is responsible for ensuring that 
        the efforts of the Network serve patients and donor families in 
        the procurement and distribution of organs.
            (7) The Federal Government should take immediate action to 
        improve organ donation rates and increase the number of organs 
        available for transplantation.
            (8) There is a significant disparity between the number of 
        organ donors and the number of individuals waiting for organ 
        transplants, and it is in the public's best interest to have a 
        system of organ allocation that ensures that transplant 
        candidates with similar severity of illness have similar 
        likelihood of transplantation irrespective of their place of 
        residence or the location of the transplant program with which 
        they are listed.
    (b) Sense of Congress Regarding Organ Donation.--It is the sense of 
Congress that--
            (1) the factors that impact organ donation rates are 
        complex and require a multifaceted approach to increase organ 
        donation rates;
            (2) the Federal Government should lead the national effort 
        to increase organ donation and develop programs with the 
        transplant community to research and implement a best practices 
        approach to increasing organ donation; and
            (3) a generous contribution has been made by each 
        individual who has donated an organ to save a life.

SEC. 3. ORGAN PROCUREMENT ORGANIZATIONS.

    Section 371 of the Public Health Service Act (42 U.S.C. 273) is 
amended to read as follows:

``SEC. 371. ORGAN PROCUREMENT ORGANIZATIONS.

    ``(a) Authority of the Secretary.--The Secretary may make grants 
to, and enter into contracts with, qualified organ procurement 
organizations described in subsection (b), and other nonprofit private 
entities, for the purpose of carrying out special projects designed to 
increase the number of organ donors.
    ``(b) Qualified Organizations.--
            ``(1) Requirements.--A qualified organ procurement 
        organization for which grants may be made under subsection (a) 
        is an organization that, as determined by the Secretary, will 
        carry out the functions described in paragraph (2), and that--
                    ``(A) is a nonprofit entity;
                    ``(B) has accounting and other fiscal procedures 
                (as specified by the Secretary) necessary to ensure the 
                fiscal stability of the organization;
                    ``(C) has an agreement with the Secretary to be 
                reimbursed under title XVIII of the Social Security Act 
                for the procurement of kidneys;
                    ``(D) notwithstanding any other provision of law, 
                has met the other requirements of this subsection and 
                has been certified or recertified by the Secretary as 
                meeting the performance standards to be a qualified 
                organ procurement organization through a process that--
                            ``(i) granted certification or 
                        recertification within the previous 4 years 
                        with such certification in effect as of October 
                        1, 2000, and remaining in effect through the 
                        earlier of--
                                    ``(I) January 1, 2002; or
                                    ``(II) the completion of 
                                recertification under the requirements 
                                of clause (ii); or
                            ``(ii) is set forth in regulations 
                        prescribed by the Secretary not later than 
                        January 1, 2002, that--
                                    ``(I) require recertifications of 
                                qualified organ procurement 
                                organizations not more frequently than 
                                once every 4 years;
                                    ``(II) rely on outcome and process 
                                performance measures that are based on 
                                available, practical empirical evidence 
                                of organ donor potential or other 
                                related factors in each service area of 
                                qualified organ procurement 
                                organizations;
                                    ``(III) use multiple outcome 
                                measures as part of the certification 
                                process;
                                    ``(IV) provide for the filing and 
                                approval of a corrective action plan by 
                                a qualified organ procurement 
                                organization if the Secretary notifies 
                                the organ procurement organization that 
                                it has failed to meet the performance 
                                measures after the first 2 years of the 
                                4 year certification period, which 
                                corrective action plan shall apply for 
                                the 3 years following approval of such 
                                plan;
                                    ``(V) provide for a qualified organ 
                                procurement organization to appeal a 
                                decertification to the Secretary on 
                                substantive and procedural grounds;
                    ``(E) has procedures to obtain payment for nonrenal 
                organs provided to transplant centers;
                    ``(F) has a defined service area that is of 
                sufficient size to assure maximum effectiveness in the 
                procurement of organs;
                    ``(G) has a director and other such staff, 
                including the organ donation coordinators and organ 
                procurement specialists necessary to effectively obtain 
                organs from donors in its service area; and
                    ``(H) has a board of directors or an advisory board 
                that--
                            ``(i) is composed of--
                                    ``(I) members who represent 
                                hospital administrators, intensive care 
                                or emergency room personnel, tissue 
                                banks, and voluntary health 
                                organizations in its service area;
                                    ``(II) members who represent the 
                                public residing in such area;
                                    ``(III) a physician with knowledge, 
                                experience, or skill in the field of 
                                histocompatibility or an individual 
                                with a doctorate degree in biological 
                                science with knowledge, experience, or 
                                skill in the field of 
                                histocompatibility;
                                    ``(IV) a physician with knowledge 
                                or skill in the field of neurology; and
                                    ``(V) from each transplant center 
                                in its service area, a member who is a 
                                surgeon who has practicing privileges 
                                in such center and who performs organ 
                                transplant surgery;
                            ``(ii) has the authority to recommend 
                        policies for the procurement of organs and the 
                        other functions described in paragraph (2); and
                            ``(iii) has no authority over any other 
                        activity of the organization.
            ``(2) Functions.--An organ procurement organization shall--
                    ``(A) have effective agreements, to identify 
                potential organ donors, with all of the hospitals and 
                other health care entities in its service area that 
                have facilities for organ donation;
                    ``(B) conduct and participate in systematic 
                efforts, including professional education, to acquire 
                all usable organs from potential donors;
                    ``(C) arrange for the acquisition and preservation 
                of donated organs and provide quality standards for the 
                acquisition of organs which are consistent with the 
                standards adopted by the Organ Procurement and 
                Transplantation Network under section 372(b)(2)(F), 
                including arranging for testing with respect to 
                preventing the acquisition of organs that are infected 
                with the etiologic agent for acquired immune deficiency 
                syndrome;
                    ``(D) arrange for the appropriate tissue typing of 
                donated organs;
                    ``(E) assist the Organ Procurement and 
                Transplantation Network in the equitable distribution 
                of organs among patients on a national basis;
                    ``(F) provide or arrange for the transportation of 
                donated organs to transplant centers;
                    ``(G) have arrangements to coordinate its 
                activities with transplant centers in its service area;
                    ``(H) participate in the Organ Procurement and 
                Transplantation Network established under section 372;
                    ``(I) have arrangements to cooperate with tissue 
                banks for the retrieval, processing, preservation, 
                storage, and distribution of tissues as may be 
                appropriate to assure that all usable tissues are 
                obtained from potential donors;
                    ``(J) evaluate annually the effectiveness of the 
                organization in acquiring potentially available organs; 
                and
                    ``(K) assist hospitals in establishing and 
                implementing protocols for assuring that all deaths and 
                imminent deaths are reported to the appropriate organ 
                procurement organization.''.

SEC. 4. ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK.

    Section 372 of the Public Health Service Act (42 U.S.C. 274) is 
amended to read as follows:

``SEC. 372. ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK.

    ``(a) In General.--The Secretary shall by regulation provide for 
the establishment and operation of an Organ Procurement and 
Transplantation Network that meets the requirements of subsection (b).
    ``(b) Requirements.--
            ``(1) In general.--The Organ Procurement and 
        Transplantation Network shall carry out the functions described 
        in paragraph (2) and shall--
                    ``(A) be operated by a private entity under 
                contract with the Department of Health and Human 
                Services; and
                    ``(B) have a board of directors--
                            ``(i) not more than 50 percent of which 
                        members are transplant surgeons or transplant 
                        physicians;
                            ``(ii) at least 25 percent of which members 
                        are transplant candidates, transplant 
                        recipients, organ donors, and family members; 
                        and
                            ``(iii) that includes representatives of 
                        organ procurement organizations, voluntary 
                        health associations, and the general public; 
                        and
                            ``(iv) that shall establish an executive 
                        committee and other committees, whose 
                        chairpersons shall be selected to ensure 
                        continuity of the board.
            ``(2) Functions.--The Organ Procurement and Transplantation 
        Network shall--
                    ``(A) establish and maintain one or more lists 
                derived from a national list of individuals who need 
                organ transplants;
                    ``(B) establish a national system, through the use 
                of computers and in accordance with established medical 
                criteria, to match organs and individuals included on 
                such lists;
                    ``(C) establish membership criteria for hospitals, 
                for performing organ transplants, and for individual 
                members;
                    ``(D) maintain a 24-hour telephone service to 
                facilitate matching organs with individuals included in 
                such lists;
                    ``(E) allocate organs so that transplant candidates 
                with similar severity of illness have similar 
                likelihood of receiving a transplant irrespective of 
                their place of residence or the location of the 
                transplant program with which they are listed;
                    ``(F) adopt and use standards of quality for the 
                acquisition and transportation of donated organs, 
                including standards for preventing the acquisition of 
                organs that are infected with the etiologic agent for 
                acquired immune deficiency syndrome;
                    ``(G) prepare and distribute, on a national basis, 
                samples of blood sera from individuals who are included 
                on such lists in order to facilitate matching the 
                compatibility of such individuals with organ donors;
                    ``(H) coordinate, as appropriate, the 
                transportation of organs from organ procurement 
                organizations to transplant centers;
                    ``(I) provide information to physicians and other 
                health professionals and the general public regarding 
                organ donation;
                    ``(J) collect, analyze, and publish data concerning 
                organ donation and transplants;
                    ``(K) provide data to the Secretary in order to 
                permit the Secretary to carry out the Secretary's 
                responsibilities under this part, and to the Scientific 
                Registry maintained pursuant to section 373;
                    ``(L) respond in a timely fashion and to the extent 
                permitted, to requests for data from researchers and 
                investigators;
                    ``(M) carry out studies and demonstration projects 
                for the purpose of improving procedures for organ 
                procurement and allocation;
                    ``(N) work actively to increase the supply of 
                donated organs;
                    ``(O) submit to the Secretary an annual report 
                containing information on the comparative costs and 
                patient outcomes at each transplant center affiliated 
                with the Organ Procurement and Transplantation Network; 
                and
                    ``(P) submit to the Secretary an annual report 
                containing such financial information, as determined by 
                the Secretary, to be necessary to evaluate the cost of 
                operating the Organ Procurement and Transplantation 
                Network.
            ``(3) Availability of patient listing fees and 
        participation fees.--
                    ``(A) In general.--Any fees described in 
                subparagraph (B) that are collected by the Organ 
                Procurement and Transplantation Network--
                            ``(i) shall be available to the Organ 
                        Procurement and Transplantation Network, 
                        without fiscal year limitation, for use in 
                        carrying out the functions of the Organ 
                        Procurement Transplantation Network under this 
                        section; and
                            ``(ii) shall not be used for any activity 
                        (including lobbying or other political 
                        activity) that is not authorized under this 
                        section.
                    ``(B) Covered fees.--Subparagraph (A) applies with 
                respect to the following:
                            ``(i) Listing fees.
                            ``(ii) Fees imposed as a condition of being 
                        a participant in the Organ Procurement and 
                        Transplantation Network.
                    ``(C) Construction.--No provision of this paragraph 
                may be construed to prohibit the Organ Procurement and 
                Transplantation Network from--
                            ``(i) collecting fees other than the fees 
                        described in subparagraph (B); or
                            ``(ii) using fees covered by clause (i) for 
                        an activity covered by subparagraph (A)(ii) or 
                        other activity.
    ``(c) Organ Allocation.--
            ``(1) Development of policies.--The Organ Procurement and 
        Transplantation Network shall develop organ-specific policies 
        (including combinations of organs, such as for kidney-pancreas 
        transplants), subject to the review of and approval by the 
        Secretary, for the equitable allocation of cadaveric organs to 
        individuals on the national waiting list.
            ``(2) Listing criteria.--Standardized minimum listing 
        criteria for including individuals on the national list shall 
        be established and, to the extent possible, shall--
                    ``(A) contain explicit thresholds for the listing 
                of a patient;
                    ``(B) avoid futile transplants or the wasting of 
                organs;
                    ``(C) be expressed through objective and measurable 
                medical criteria; and
                    ``(D) be reviewed periodically and revised as 
                appropriate.
            ``(3) Requirements relating to transplant candidates.--
        Where appropriate for the specific organ, transplant candidates 
        shall--
                    ``(A) be grouped by status categories from most to 
                least medically urgent with--
                            ``(i) sufficient categories to avoid 
                        grouping together individuals with 
                        substantially different medical urgency;
                            ``(ii) explicit thresholds for 
                        differentiating among patients; and
                            ``(iii) explicit standards for the movement 
                        of individuals among the status categories;
                    ``(B) be expressed through objective and measurable 
                medical criteria; and
                    ``(C) be reviewed periodically and revised as 
                appropriate.
            ``(4) Requirements for allocation policies and 
        procedures.--Organ allocation policies and procedures shall be 
        established in accordance with sound medical judgment and 
        shall--
                    ``(A) be designed and implemented to allocate 
                organs among transplant candidates--
                            ``(i) in order of decreasing medical 
                        urgency status;
                            ``(ii) over the largest geographic area 
                        practicable in a manner consistent with organ 
                        viability so that neither place of residence 
                        nor place of listing shall be a major 
                        determinant; and
                            ``(iii) so as to maintain organ viability 
                        and avoid organ wastage; and
                    ``(B) be reviewed periodically and revised as 
                appropriate.
            ``(5) Policies where medical urgency is not an appropriate 
        measurement.--Where medical urgency is not an appropriate 
        measurement for organ allocation, policies and procedures shall 
        be established in accordance with sound medical judgment.
    ``(d) Authority of the Secretary.--The policies and rules 
established by the Organ Procurement and Transplantation Network that 
are to be enforceable shall be subject to review and approval by the 
Secretary. The Secretary shall--
            ``(1) in consultation with the Organ Procurement and 
        Transplantation Network, develop mechanisms to promote and 
        review compliance with the requirements of this section;
            ``(2) establish and approve all fees, dues, or similar 
        costs charged to support the operation of the Organ Procurement 
        and Transplantation Network;
            ``(3) establish procedures for receiving from interested 
        persons critical comments relating to the manner in which the 
        Organ Procurement and Transplantation Network is carrying out 
        the duties of the Network under subsection (b); and
            ``(4) take such action, as determined by the Secretary, to 
        enforce the requirements of this section as well as the 
        requirements under title XVIII of the Social Security Act.
            ``(5) if the Organ Procurement and Transplantation Network 
        fails to submit a policy on a matter which the Secretary 
        determines should be enforced under this section or section 
        1138 of the Social Security Act, or the Organ Procurement and 
        Transplantation Network submits a policy that the Secretary 
        determines is inconsistent with the goals of this Act, submit 
        to the board of directors or advisory board of the Organ 
        Procurement and Transplantation Network the Secretary's version 
        of such policy.
    ``(e) National Transplant Advisory Board.--
            ``(1) Establishment.--The Secretary shall, by regulation, 
        provide for the establishment of a National Organ Transplant 
        Advisory Board (referred to in this subsection as the `Board').
            ``(2) Membership.--The Board shall carry out the functions 
        described in paragraph (3) and shall be comprised of 
        individuals that--
                    ``(A) include a broad spectrum of representatives 
                of the medical and scientific community, including 
                transplant surgeons, transplant physicians, 
                epidemiologists, and health service researchers, as 
                well as representatives from organ procurement 
                organizations and the community of transplant patients, 
                family members and donor families;
                    ``(B) are selected by the Secretary;
                    ``(C) serve terms of not less than 3 years.
            ``(3) Functions.--The Board shall assist the Secretary in 
        ensuring that the Organ Procurement and Transplantation Network 
        is grounded on the best available medical science and is 
        effective and equitable as possible and shall--
                    ``(A) at the request of the Secretary, review the 
                policies and rules of the Organ Procurement and 
                Transplantation Network;
                    ``(B) advise and propose to the Secretary policies, 
                rules, and regulations affecting organ procurement and 
                transplantation;
                    ``(C) at the request of the Secretary, review and 
                consider policies and regulations affecting organ 
                transplantation developed by the Secretary;
                    ``(D) advise the Secretary with respect to comments 
                received by the Secretary under subsection (d)(3);
                    ``(E) meet at the request of the Secretary, but not 
                less than 2 times each year; and
                    ``(F) elect a Chairperson and Vice-chairperson as 
                well as any other officers as determined appropriate by 
                the Board.
            ``(4) Authorization of appropriations.--For the purpose of 
        carrying out this subsection, there are authorized to be 
        appropriated $1,000,000 for each of the fiscal years 2000 
        through 2005.''.

SEC. 5. SCIENTIFIC REGISTRY.

    Section 373 of the Public Health Service Act (42 U.S.C. 274a) is 
amended to read as follows:

``SEC. 373. SCIENTIFIC REGISTRY.

    ``The Secretary shall, by grant or contract, develop and maintain a 
scientific registry of the recipients of organ transplants. The 
registry shall include such information concerning patients and 
transplant procedures as the Secretary determines to be necessary to an 
ongoing evaluation to the scientific and clinical status of organ 
transplantation. The registry shall also include such information 
concerning both donors and patients in transplants involving living 
donors. The Secretary shall prepare for inclusion in the report under 
section 376 an analysis of information derived from the registry.''.

SEC. 6. ADMINISTRATION.

    Section 375 of the Public Health Service Act (42 U.S.C. 274c) is 
amended to read as follows:

``SEC. 375. ADMINISTRATION.

    ``The Secretary shall designate and maintain an identifiable 
administrative unit in the Public Health Service to--
            ``(1) administer this part and coordinate with organ 
        procurement activities under title XVIII of the Social Security 
        Act;
            ``(2) administer and coordinate programs, as determined by 
        the Secretary, to increase organ donation rates;
            ``(3) provide technical assistance to organ procurement 
        organizations, the Organ Procurement and Transplantation 
        Network established under section 372, and other entities in 
        the health care system involved in organ donations, 
        procurements, and transplants; and
            ``(4) provide information--
                    ``(A) to patients, their families, and their 
                physicians about transplantation; and
                    ``(B) to patients and their families about 
                resources available nationally and in each State, and 
                the comparative costs and patient outcomes at each 
                transplant center affiliated with the Organ Procurement 
                and Transplantation Network, in order to assist the 
                patients and families with the costs associated with 
                transplantation.''.

SEC. 7. ADDITIONAL AMENDMENTS.

    Part H of title III of the Public Health Service Act (42 U.S.C. 273 
et seq.) is amended--
            (1) in section 374 (42 U.S.C. 274b)--
                    (A) in subsection (b)(1), by striking ``and may not 
                exceed $100,000'' and inserting ``and other 
                organizations for the purpose of increasing the supply 
                of transplantable organs''; and
                    (B) in subsection (b)(2), by striking the second 
                sentence;
            (2) in section 376 (42 U.S.C. 274d), by striking 
        ``Committee on Energy and Commerce'' and inserting ``Committee 
        on Commerce''; and
            (3) by striking section 377 (42 U.S.C. 274f).

SEC. 8. PAYMENT OF TRAVEL AND SUBSISTENCE EXPENSES INCURRED TOWARD 
              LIVING ORGAN DONATION.

    Part H of title III of the Public Health Service Act (42 U.S.C. 273 
et seq.) is amended by inserting after section 376 the following 
section:

``SEC. 376A. TRAVEL AND SUBSISTENCE PAYMENTS FOR LIVING ORGAN DONATION.

    ``(a) In General.--The Secretary may make awards of grants or 
contracts 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 payment of travel and subsistence 
        expenses incurred by individuals toward making living donations 
        of their organs (referred to in this section as `donating 
        individuals'); and
            ``(2) in addition, providing for the payment of such 
        incidental nonmedical expenses that are so incurred as the 
        Secretary determines by regulation to be appropriate.
    ``(b) Eligibility.--
            ``(1) In general.--Payments under subsection (a) may be 
        made for the qualifying expenses of a donating individual only 
        if--
                    ``(A) the State in which the donating individual 
                resides is a different State than the State in which 
                the intended recipient of the organ resides; and
                    ``(B) the annual income of the intended recipient 
                of the organ does not exceed $35,000 (as adjusted for 
                fiscal year 2002 and subsequent fiscal years to offset 
                the effects of inflation occurring after the beginning 
                fiscal year 2001).
            ``(2) Certain circumstances.--Subject to paragraph (1), the 
        Secretary may in carrying out subsection (a) provide as 
        follows:
                    ``(A) The Secretary may consider 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 reason 
                as the Secretary determines to be appropriate, no 
                donation of the organ occurs.
                    (B) The Secretary may consider the term `qualifying 
                expenses' as including the expenses of having one or 
                more family members of donating individuals accompany 
                the donating individuals for purposes of subsection (a) 
                (subject to making payment for only such types of 
                expenses as are paid for donating individuals).
    ``(c) Limitation on Amount of Payment.--
            ``(1) In general.--With respect to the geographic area to 
        which a donating individual travels for purposes of section 
        (a), if such area is other than the covered vicinity for the 
        intended recipient of the organ, the amount of qualifying 
        expenses for which payments under such subsection are made may 
        not exceed the amount of such expenses for which payment would 
        have been made if such area had been the covered vicinity for 
        the intended recipient, taking into account the costs of travel 
        and regional differences in the cost of living.
            ``(2) Covered vicinity.--For purposes of this section, the 
        term `covered vicinity' with respect to an intended recipient 
        of an organ from a donating individual, means the vicinity of 
        the nearest transplant center to the residence of the intended 
        recipient that regularly performs transplants of that type of 
        organ.
    ``(d) Relationship to Payments Under Other Programs.--An award may 
be made under subsection (a) only if the applicant 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; or
            ``(2) by an entity that provides health services on a 
        prepaid basis.
    ``(e) Definitions.--In this section:
            ``(1) Covered vicinity.--The term `covered vicinity' has 
        the meaning given such term in subsection (c)(2).
            ``(2) Donating individual.--The term `donating individual' 
        has the meaning indicated for such term in subsection (a)(1), 
        subject to subsection (b)(2)(A).
            ``(3) Qualifying expenses.--The term `qualifying expenses' 
        means the expenses authorized for purposes of subsection (a), 
        subject to subsection (b)(2)(B).
    ``(f) Authorization of Appropriations.--For the purpose of carrying 
out this section, there is authorized to be appropriated $5,000,000 for 
each of fiscal years 2000 through 2005.''.

SEC. 9. PROGRAMS AND DEMONSTRATION PROJECTS TO INCREASE ORGAN DONATION.

    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. INITIATIVES TO INCREASE ORGAN DONATION.

    ``(a) Public Awareness.--The Secretary shall (directly or through 
grants or contracts) carry out a program to educate the public with 
respect to organ donation.
    ``(b) Studies and Demonstrations.--The Secretary may make grants to 
public and nonprofit entities for the purpose of carrying out studies 
and demonstration projects with respect to increasing rates of organ 
donation. The Secretary shall--
            ``(1) give priority to those studies and demonstration 
        projects that are founded upon a best practices approach to 
        increasing organ donation consent rates;
            ``(2) give priority to those geographic areas with lower 
        organ donation consent rates, especially among minorities;
            ``(3) provide assistance to qualified organ procurement 
        organizations described under section 371 to implement programs 
        and projects, that as determined by Secretary through studies 
        and demonstration projects, have proven to be effective in 
        increasing organ donation rates; and
            ``(4) provide assistance to the study and consideration of 
        presumed consent as an opportunity to increase organ donation 
        rates.
    ``(c) Grants to States.--The Secretary may make grants to states 
for the purpose of carrying out public education and outreach programs 
designed to increase the number of organ donors within the State. To be 
eligible, each State shall--
            ``(1) submit an application to the Secretary, in such form 
        as prescribed by the Secretary; and
            ``(2) establish yearly benchmarks for improvement in organ 
        donation rates in the State.
    ``(d) Congressional Medal.--
            ``(1) Design.--The Secretary shall design a bronze medal 
        with suitable emblems, devices, and inscriptions, to be 
        determined by the Secretary, to commemorate organ donors and 
        their families.
            ``(2) Eligibility.--Any organ donor, or the family of any 
        organ donor, shall be eligible for a medal under this 
        subsection.
            ``(3) Requirements.--The Secretary shall direct the Organ 
        Procurement and Transplantation Network, established under 
        section 372, to--
                    ``(A) establish an application procedure requiring 
                the relevant organ procurement organizations, described 
                in section 371, through which an individual or their 
                family made an organ donation, to submit documentation 
                supporting the eligibility of that individual or their 
                family to receive a medal; and
                    ``(B) determine through the documentation provided, 
                and, if necessary, independent investigation, whether 
                the individual or family is eligible to receive a 
                medal.
            ``(4) Delivery.--The Secretary shall make suitable 
        arrangements as necessary with the Secretary of the Treasury to 
        strike and deliver the medals described in paragraph (3).
            ``(5) Presentation.--The Secretary shall provide for the 
        presentation to the relevant organ procurement organizations 
        all medals struck pursuant to this section to individuals or 
        families that, in accordance with paragraph (3), the Organ 
        Procurement and Transplantation Network has determined eligible 
        to receive medals.
            ``(6) Limitation.--
                    ``(A) in general.--Except as provided in 
                subparagraph (B), only 1 medal may be presented to a 
                family under paragraph (5). 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.
                    ``(B) Additional medals.--In the case of a family 
                in which more than 1 member is an organ donor, an 
                additional medal may be presented to each such organ 
                donor or their family.
            ``(7) Duplicates.--The Secretary or the Organ Procurement 
        and Transplantation Network may provide duplicates of a medal--
                    ``(A) to any recipient of a medal under paragraph 
                (4) under such regulation as the Secretary may issue; 
                and
                    ``(B) the cost of which shall be sufficient to 
                cover the costs of such duplicates.
            ``(8) National medals.--The medals struck pursuant to this 
        subsection are national medals for purposes of section 5111 of 
        title 31, United States Code.
            ``(9) Applicability of provisions.--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 subsection.
            ``(10) Funding.--
                    ``(A) Agreements.--The Secretary of the Treasury 
                may enter into an agreement with the Organ Procurement 
                and Transplantation Network to collect funds to offset 
                expenditures relating to the issuance of medals 
                authorized under this subsection.
                    ``(B) Payment and limitation.--
                            ``(i) Payment.--Except as provided in 
                        clause (ii), all funds received by the Organ 
                        Procurement and Transplantation Network under 
                        this paragraph shall be promptly paid to the 
                        Secretary of the Treasury.
                            ``(ii) Limitation.--Not more than 5 percent 
                        of any funds received under this paragraph may 
                        be used to pay administrative costs incurred by 
                        the Organ Procurement and Transplantation 
                        Network as a result of an agreement established 
                        under this subsection.
                    ``(C) Deposits and expenditures.--Notwithstanding 
                any other provision of law--
                            ``(i) all amounts received by the Secretary 
                        of the Treasury under paragraph (10)(A)(i) 
                        shall be deposited in the Numismatic Public 
                        Enterprise Fund, as described in section 5134 
                        of title 31, United States Code; and
                            ``(ii) the Secretary of the Treasury shall 
                        charge such fund with all expenditures relating 
                        to the issuance of medals authorized under this 
                        subsection.
                    ``(D) Start-up costs.--A one-time amount of not to 
                exceed $55,000 shall be provided by the Secretary to 
                the Organ Procurement and Transplantation Network to 
                cover initial start-up costs to be paid back in full 
                within 3 years of the date of enactment of this section 
                from funds received under this subsection.
            ``(11) Definition.--For the purposes of this section, the 
        term `organ' means the human kidney, liver, heart, lung, 
        pancreas, and any other human organ (other than corneas and 
        eyes) specified by regulation by the Secretary.
            ``(12) Effective date.--This subsection shall be effective 
        for the 5-year period beginning on the date of the enactment of 
        this section.
    ``(e) Annual Report to Congress.--The Secretary shall submit to the 
Congress an annual 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.
    ``(f) Authorization of Appropriations.--
            ``(1) In general.--For the purpose of carrying out this 
        section, there are authorized to be appropriated $10,000,000 
        for fiscal year 2000, and such sums as may be necessary for 
        each of the fiscal years 2001 through 2005. Such authorization 
        of appropriations is in addition to any other authorizations of 
        appropriations that are available for such purpose.
            ``(2) Public Awareness.--Of the amounts appropriated under 
        paragraph (1) for a fiscal year, the Secretary may not obligate 
        more than $2,000,000 for carrying out subsection (a).''.

SEC. 10. AUTHORIZATION OF APPROPRIATIONS.

    Section 378 of the Public Health Service Act (42 U.S.C. 274g) is 
amended to read as follows:

``SEC. 378. AUTHORIZATION OF APPROPRIATIONS FOR ORGAN PROCUREMENT AND 
              TRANSPLANTATION NETWORK.

    ``For the purpose of providing for the Organ Procurement and 
Transplantation Network under section 372, and for the Scientific 
Registry under section 373, there are authorized to be appropriated 
$4,000,000 for fiscal year 2000, and such sums as may be necessary for 
each of fiscal years 2001 through 2005.''.

SEC. 11. PREEMPTION.

    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 the following:

``SEC. 378A. PREEMPTION.

    ``No State or political subdivision of a State shall establish or 
continue in effect any law, rule, regulation, or other requirement that 
would restrict in any way the ability of any transplant hospital, organ 
procurement organization, or other entity to comply with the organ 
allocation policies of the Network under this part.''.

SEC. 12. EFFECTIVE DATE.

    The amendments made by this Act shall take effect on October 1, 
2000, or upon the date of enactment of this Act, whichever occurs 
later.
                                 <all>