[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2418 Introduced in House (IH)]







106th CONGRESS
  1st Session
                                H. R. 2418

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              July 1, 1999

   Mr. Bilirakis (for himself, Mr. Green of Texas, and Mr. Pallone) 
 introduced the following bill; which was referred to the Committee on 
                                Commerce

_______________________________________________________________________

                                 A BILL


 
 To amend the Public Health Service Act to revise and extend 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 Procurement and 
Transplantation Network Amendments of 1999''.

SEC. 2. FINDINGS.

    (a) In General.--The Congress finds as follows:
            (1) It is in the public interest to maintain and improve a 
        system for promoting and supporting a central network in the 
        private sector to assist organ procurement organizations and 
        transplant centers in the distribution of organs among 
        transplant patients and the provision of organ transplantation 
        services, and to assure quality and facilitate collaboration 
        among network members and individual medical practitioners 
        participating in network activities.
            (2) The Organ Procurement and Transplantation Network 
        (``Network''), which is in the private sector, exists because 
        of a partnership between public and private enterprise. A 
        nonprofit private entity established the Network pursuant to a 
        contract awarded by the Federal Government, and that same 
        entity has operated the Network since the Network was 
        established.
            (3) It is desirable to continue this partnership, and the 
        Federal Government should continue to provide Federal oversight 
        of and financial assistance for the services performed by the 
        Network.
            (4) The responsibility for developing, establishing, and 
        maintaining medical criteria and standards for organ 
        procurement and transplantation belongs in the private sector 
        and is a function of the Network.
            (5) The Federal Government should cooperate with the 
        Network to assist its efforts to serve patients and donor 
        families in procuring and distributing organs.
            (6) The Federal Government should carry out programs to 
        educate the public with respect to organ donation, including 
        the need to provide for an adequate rate of such donations.
    (b) Sense of Congress.--The Congress--
            (1) recognizes the generous contribution made by each 
        living individual who has donated an organ to save a life; and
            (2) acknowledges the advances in medical technology that 
        have enabled organ transplantation with organs donated by 
        living individuals to become a viable treatment option for an 
        increasing number of patients.

SEC. 3. ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK.

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

            ``organ procurement and transplantation network

    ``Sec. 372. (a) In General.--The Secretary shall by contract 
provide for the establishment and operation of an Organ Procurement and 
Transplantation Network (in this section referred to as the `Network') 
that meets the following requirements:
            ``(1) The Network shall be an independent, nonprofit 
        private entity that has expertise and experience in organ 
        procurement and transplantation.
            ``(2) The Network shall in accordance with criteria under 
        subsection (b)(3) include as members qualified organ 
        procurement organizations (as described in section 371(b)), 
        transplant centers, and other entities that have a demonstrated 
        interest in the fields of organ donation or transplantation. 
        (Such members are in this section referred to as `Network 
        participants'.)
            ``(3) The Network shall have a board of directors (in this 
        section referred to as the `Board'). The Board shall, after 
        consultation with Network participants, establish the policies 
        for carrying out the functions described in this section for 
        the Network.
            ``(4) The Board shall be in accordance with the following:
                    ``(A) The Board shall include representatives of 
                qualified organ procurement organizations, transplant 
                centers, voluntary health associations, and the general 
                public, including a reasonable proportion of the 
                members of the Board who are patients awaiting a 
                transplant or transplant recipients or individuals who 
                have donated an organ or family members of patients, 
                recipients or donors.
                    ``(B) The Board shall establish membership 
                categories and qualifications with respect to serving 
                on the Board, and shall have exclusive authority to 
                admit individuals to membership on the Board. 
                Transplant surgeons and transplant physicians shall 
                comprise not less than 50 percent of the membership of 
                the Board. The Board shall be limited to a total of 42 
                members.
                    ``(C) The Board shall have an executive committee, 
                and such other committees as the Board determines to be 
                appropriate.
                    ``(D) The chair of each such committee shall be 
                selected so as to ensure the continuity of leadership 
                for the Board.
    ``(b) General Functions.--The following applies to the Network:
            ``(1) The Network shall establish and operate a national 
        system to match organs and individuals who need organ 
        transplants, especially individuals whose immune system makes 
        it difficult for them to receive organs.
            ``(2) The national system shall maintain one or more lists 
        of individuals who need organ transplants, shall be operated in 
        accordance with established medical criteria, shall be operated 
        through the use of computers, and may function on a 
        regionalized basis.
            ``(3) The Network shall establish criteria for being a 
        Network participant, shall establish medical criteria for 
        allocating organs, and shall provide to members of the public 
        an opportunity to comment with respect to such criteria.
            ``(4) The Network shall maintain a twenty-four-hour 
        telephone and computer service to facilitate matching organs 
        with individuals included in the list.
            ``(5) The Network shall assist organ procurement 
        organizations in the local, regional, and nationwide 
        distribution of organs. The distribution of organs shall be 
        based on medical criteria established by the Network, and also 
        shall be based on equity and ethics without regard to economic 
        status of those awaiting organ transplants and without 
        political control or influence.
            ``(6) The Network shall adopt and use standards of quality 
        for the acquisition and transportation of donated organs, 
        including standards regarding the transmission of infectious 
        diseases.
            ``(7) The Network shall prepare and distribute, on a 
        regionalized basis (and, to the extent practicable, among 
        regions or on a national basis), samples of blood sera from 
        individuals who are included on the list and whose immune 
        system makes it difficult for them to receive organs, in order 
        to facilitate matching the compatibility of such individuals 
        with organ donors.
            ``(8) The Network shall coordinate, as appropriate, the 
        transportation of organs from organ procurement organizations 
        to transplant centers.
            ``(9) The Network shall work actively to increase the 
        supply of donated organs.
    ``(c) Scientific Registry.--
            ``(1) In general.--The Network shall maintain a scientific 
        registry of patients awaiting organ transplantation, persons 
        from whom organs are removed for transplantation, and organ 
        transplant recipients for the ongoing evaluation of the 
        scientific and clinical status of organ transplantation.
            ``(2) Reports.--The Network shall prepare for inclusion in 
        the report under section 375 an analysis of scientifically and 
        clinically valid information derived from the scientific 
        registry under paragraph (1).
    ``(d) Information and Data.--
            ``(1) In general.--The Network shall--
                    ``(A) provide information to physicians and other 
                health professionals regarding organ donation and 
                transplantation; and
                    ``(B) collect, analyze, and publish data concerning 
                organ donation and transplantation.
            ``(2) Information for patients and general public.--The 
        Network shall make available to patients in need of organ 
        transplants information in accordance with the following:
                    ``(A) The information shall be transplant-related 
                information specific to transplant centers that are 
                Network participants, which information has been 
                determined by the Network to be scientifically and 
                clinically valid.
                    ``(B) The information shall be designed to assist 
                patients and referring physicians in choosing a 
                transplant center, including information on the supply 
                of and demand for organs.
                    ``(C) With respect to the patient involved, the 
                information shall (taking into account patients in 
                similar medical circumstances) include the following as 
                applied to specific transplant centers:
                            ``(i) The probability of receiving an organ 
                        transplant.
                            ``(ii) The length of time that similarly 
                        situated patients have waited historically to 
                        receive a transplant.
                            ``(iii) Medical outcomes for similarly 
                        situated patients, which information shall be 
                        adjusted to reflect the medical risk factors 
                        for such patients.
                    ``(D) With respect to the patient involved, the 
                information shall include the information described in 
                subparagraph (C) as applied to the service areas of 
                specific qualified organ procurement organizations 
                (other than such areas in which there is only one 
                transplant center).
            ``(3) Annual public report.--The Network shall annually 
        make available to the public a report on the overall status of 
        organ procurement and transplantation.
            ``(4) Confidentiality.--Except for the release of 
        information that is authorized under paragraph (2) or (3) by 
        the Network, neither the Network nor the Secretary has 
        authority to release the following information (unless 
        authorized in writing by the patient or other entity with which 
        the data is concerned):
                    ``(A) Information that permits direct or indirect 
                identification of any patient who is waiting for a 
                transplant, or who is an organ transplant patient or 
                recipient of an organ.
                    ``(B) Information that permits direct or indirect 
                identification of any potential or actual organ donors.
                    ``(C) Information that permits direct or indirect 
                identification of participants in Network deliberations 
                or determinations related to practitioner or 
                institutional qualifications, due process proceedings 
                or peer review activities, except for information 
announcing final decisions of the Network.
        This paragraph may not be construed as prohibiting the 
        disclosure of information within the Network, including 
        information disclosed in the course of interactive organ 
        sharing operations within the Network.
    ``(e) Studies.--
            ``(1) In general.--The Network shall carry out studies and 
        demonstration projects for the purpose of improving procedures 
        for organ procurement and allocation, including but not limited 
        to projects to examine and attempt to increase transplantation 
        among populations with special needs or limited access to 
        transplantation.
            ``(2) Certain technologies.--The Network may study the 
        impact of possible transplantation of animal organs 
        (xenotransplantation) and other technologies to determine the 
        impact upon, and prevent negative effects on, the fair and 
        effective use of human allograft organs.
    ``(f) Quality Assurance.--
            ``(1) In general.--The Network shall develop a peer review 
        system for assuring that members of the Network comply with 
        criteria under subsection (b)(3).
            ``(2) Noncompliance.--
                    ``(A) Payment of damages.--The Network shall 
                require that, as a condition of being a Network 
                participant, each such participant agree that the 
                Network may, through a peer review proceeding under 
                paragraph (1), require the participant to pay damages 
                for the failure of the participant to comply with 
                criteria under subsection (b)(3). The Network shall 
                establish procedures to ensure that such proceedings 
                are conducted in an impartial manner, with adequate 
                opportunity for the Network participant involved to 
                receive a hearing. The Network shall identify various 
                types of violations of such criteria and specify the 
                maximum amount of damages that the Network may under 
                this subparagraph require a Network participant to pay 
                for the type of violation involved.
                    ``(B) Restricting access to allocation system.--If 
                under subparagraph (A) it has been determined that a 
                Network participant has engaged in substantial 
                violations of criteria under subsection (b)(3), the 
                Network may restrict the extent to which such 
                participant is permitted to receive allocations of 
                organs through the Network.
                    ``(C) Status of network participants with respect 
                to violations.--Subject to paragraph (3), the Network 
                may take actions to make the public aware of the extent 
                to which a Network participant has been required to pay 
                damages under subparagraph (A) or has been the subject 
                of restrictions under subparagraph (B).
            ``(3) Confidentiality.--With respect to a peer review 
        proceeding under paragraph (1), neither the Network nor the 
        Secretary has authority to release data or information to the 
        public relating to the proceedings without the written 
        permission of all the parties involved, except that if damages 
        under paragraph (2) are required to be paid, the requirement 
        may be publicly announced after the conclusion of the 
        proceeding.
    ``(g) Administrative Provisions.--
            ``(1) Limitation on amount of contract.--The amount 
        provided under a contract under subsection (a) in any fiscal 
        year may not exceed $6,000,000 for the operation of the 
        Network, including the scientific registry under subsection 
        (c). Such limitation does not apply to amounts provided under 
the contract for increasing organ donation and procurement.
            ``(2) Relationship between secretary and network.--The 
        administrative and procedural functions described in this 
        section for the Network shall be carried out in accordance with 
        the mutual agreement of the Secretary and the Network. For 
        purposes of the preceding sentence, functions that are 
        scientific, clinical, or medical in nature are not 
        administrative or procedural functions and are within the sole 
        discretion of the Network. With respect to the programs under 
        titles XVIII and XIX of the Social Security Act, this section 
        may not be construed as having any legal effect on such 
        programs, except to the extent that section 1138 of such Act, 
        or any other provision of such Act, provides otherwise.
            ``(3) Nonfederal assets of network.--
                    ``(A) In general.--No assets in the possession of 
                the Network or revenues collected by the Network, other 
                than amounts appropriated under section 378, shall be 
                considered or be treated as Federal property, Federal 
                revenues, or program funds pursuant to a Federal 
                contract, nor shall such assets, revenues, or 
                nonappropriated funds be subject to restriction or 
                control by the Secretary, nor shall any member of the 
                Network be required by the Secretary to pay any fees to 
                the Network, nor shall the Secretary be authorized to 
                collect or authorize collection of service fees with 
                respect to the Network or the scientific registry under 
                subsection (c).
                    ``(B) Gifts.--This section does not prohibit the 
                Network from accepting gifts of money or services, 
                including gifts to carry out activities to provide for 
                an increase in the rate of organ donation.
            ``(4) Community endorsement of contract recipient.--In the 
        case of any contract under subsection (a) that is awarded after 
        the date of the enactment of the Organ Procurement and 
        Transplantation Network Amendments of 1999, the Secretary shall 
        select an applicant to receive the contract from among 
        applicants that have the written endorsement of a majority of 
        the combined total number of transplant centers and qualified 
        organ procurement organizations that are Network participants 
        (without regard to whether such centers or organizations 
        endorse more than one applicant for the contract).
            ``(5) Change in contract recipient.--With respect to the 
        expiration of the period during which a contract under 
        subsection (a) is in effect, if the Secretary makes a 
        determination to award the contract to a different entity than 
        the entity to which the previous contract under such subsection 
        was awarded, the Secretary shall publish in the Federal 
        Register a notice that such change in the administration of the 
        Network will take place, and the change may not take effect any 
        sooner than the expiration of the six-month period beginning on 
        the date on which the notice is so published.
    ``(h) Additional Procedures Regarding Oversight and Public 
Accountability.--For purposes of providing oversight of and public 
accountability for the operation of the Network, the Secretary shall 
establish procedures for--
            ``(1) conducting public hearings and receiving from 
        interested persons comments regarding criteria of the Network 
        and critical comments relating to the manner in which the 
        Network is carrying out its duties under this section;
            ``(2) providing such comments to the Network and receiving 
        responses from the Network; and
            ``(3) the consideration by the Secretary of such comments.
    ``(i) Evaluations by General Accounting Office.--
            ``(1) In general.--The Comptroller General of the United 
        States shall periodically conduct evaluations of the Network, 
        including the structure and function of the Network and the 
        relationship between the Secretary and the nonprofit private 
        entity that under subsection (a) operates the Network. The 
        first such evaluation shall be completed not later than one 
        year after the date of the enactment of the Organ Procurement 
        and Transplantation Network Amendments of 1999, and such an 
        evaluation shall be completed not later than every third year 
        thereafter.
            ``(2) Input from field.--In conducting evaluations under 
        paragraph (1), the Comptroller General shall consult with 
        experts in the field of organ transplantation, including 
        organizations that represent transplant surgeons, transplant 
        physicians, transplant centers, and qualified organ procurement 
        organizations.
            ``(3) Procedures of network.--The Network shall establish 
        procedures for coordinating with the Comptroller General for 
        purposes of evaluations under paragraph (1).
            ``(4) Reports to congress.--The Comptroller General shall 
        prepare reports describing the findings of evaluations under 
        paragraph (1) and shall submit such reports to the Committee on 
        Commerce of the House of Representatives and the Committee on 
        Health, Education, Labor, and Pensions of the Senate.''.
    (b) Rule of Construction.--The amendments made by this Act may not 
be construed as affecting the duration of the contract under section 
372 of the Public Health Service Act that was in effect on the day 
before the date of the enactment of this Act.

SEC. 4. ADDITIONAL AMENDMENTS.

    (a) In General.--Part H of title III of the Public Health Service 
Act (42 U.S.C. 273 et seq.) is amended--
            (1) by striking section 373;
            (2) in section 374--
                    (A) in subsection (b)(1), by inserting after 
                ``organization'' the following: ``and other 
                organizations for the purpose of increasing the supply 
                of transplantable organs'';
                    (B) in subsection (c), by striking ``or 373'' each 
                place such term appears; and
                    (C) in subsection (d), by amending paragraph (2) to 
                read as follows:
            ``(2) The term ``organ'', with respect to transplantation 
        into humans, means the human or other animal kidney, liver, 
        heart, lung, pancreas, and any other organ (other than human 
        corneas and eyes) specified by the Secretary by regulation. For 
        purposes of section 372(c), such term includes bone marrow.'';
            (3) in section 375--
                    (A) in paragraph (1), by striking ``this part'' and 
                inserting ``this section''; and
                    (B) in paragraph (4)--
                            (i) by redesignating clauses (i) and (ii) 
                        as subparagraphs (A) and (B), respectively; and
                            (ii) in subparagraph (B) (as so 
                        redesignated), by striking ``comparative costs 
                        and patient outcomes'' and inserting 
                        ``comparative patient outcomes'';
            (4) in section 376--
                    (A) by striking ``the Secretary'' and inserting 
                ``the Organ Procurement and Transplantation Network 
                under section 372''; and
                    (B) by striking ``Committee on Energy and 
                Commerce'' and inserting ``Committee on Commerce''; and
            (5) by striking section 377.
    (b) Redesignations.--Part H of title III of the Public Health 
Service Act, as amended by subsection (a) of this section, is amended 
by redesignating sections 374 through 376 as sections 373 through 375, 
respectively.
    (c) Prohibition Against Organ Purchases.--Section 301(c)(2) of the 
National Organ Transplant Act (42 U.S.C. 274e(c)(2)) is amended by 
inserting after ``does not include'' the following: ``a benefit, the 
exchange of which is expressly contemplated by organ distribution 
policies, demonstration projects, or programs duly established or 
sanctioned by the board of directors of the Organ Procurement and 
Transplantation Network under section 372 of the Public Health Service 
Act, or''.

SEC. 5. PAYMENT OF TRAVEL AND SUBSISTENCE EXPENSES INCURRED TOWARD 
              LIVING ORGAN DONATION.

    Part H of title III of the Public Health Service Act, as amended by 
section 4(b) of this Act, is amended by inserting after section 375 the 
following section:

  ``payment of travel and subsistence expenses incurred toward living 
                             organ donation

    ``Sec. 376. (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 (in this section referred 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 2001 and subsequent fiscal years to offset 
                the effects of inflation occurring after the beginning 
                of fiscal year 2000).
            ``(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 reasons 
                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 subsection 
        (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 costs 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 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; or
            ``(2) by an entity that provides health services on a 
        prepaid basis.
    ``(e) Definitions.--For purposes of this section:
            ``(1) The term `covered vicinity' has the meaning given 
        such term in subsection (c)(2).
            ``(2) The term `donating individuals' has the meaning 
        indicated for such term in subsection (a)(1), subject to 
        subsection (b)(2)(A).
            ``(3) 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 the fiscal years 2000 through 2005.''.

SEC. 6. PUBLIC AWARENESS; STUDIES AND DEMONSTRATIONS.

    Part H of title III of the Public Health Service Act, as amended by 
section 5 of this Act, is amended by inserting after section 376 the 
following section:

             ``public awareness; studies and demonstrations

    ``Sec. 377. (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, including the need to provide for an 
adequate rate of such donations.
    ``(b) Studies and Demonstrations.--The Secretary may make grants to 
public and nonprofit private entities for the purpose of carrying out 
studies and demonstration projects with respect to providing for an 
adequate rate of organ donation. Such a grant may be made to an entity 
only if the entity has a demonstrated history and involvement in organ-
donation activities.
    ``(c) Annual Report to Congress.--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.
    ``(d) 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 is available for such purpose.
            ``(2) Studies and demonstrations.--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 (b).''.

SEC. 7. AUTHORIZATION OF APPROPRIATIONS.

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

      ``authorization of appropriations for organ procurement and 
                        transplantation network

    ``Sec. 378. (a) Operation of Network.--For the purpose of providing 
for the Organ Procurement and Transplantation Network under section 
372, including the scientific registry, there are authorized to be 
appropriated $6,000,000 for fiscal year 2000, and such sums as may be 
necessary for each of the fiscal years 2001 through 2005.
    ``(b) Increasing Organ Donation and Procurement.--For the purpose 
of increasing organ donation and procurement through the Organ 
Procurement and Transplantation Network under section 372, there are 
authorized to be appropriated such sums as may be necessary for each of 
the fiscal years 2000 through 2005. Such authorization of 
appropriations is with respect to such purpose in addition to the 
authorization of appropriations established in subsection (a).''.

SEC. 8. EFFECTIVE DATE.

    The amendments made by this Act take effect October 1, 1999, or 
upon the date of the enactment of this Act, whichever occurs later.
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