Home > 106th Congressional Bills > H.R. 2418 (ih) To amend the Public Health Service Act to revise and extend programs relating to organ procurement and transplantation. [Introduced in House] ...

H.R. 2418 (ih) To amend the Public Health Service Act to revise and extend programs relating to organ procurement and transplantation. [Introduced in House] ...

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  2d Session
                                H. R. 2418


                                 AN ACT

 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,


    This Act may be cited as the ``Organ Procurement and 
Transplantation Network Amendments of 2000''.


    (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 was established in the private sector 
        pursuant to a contract awarded by the Federal Government, 
        should continue to be operated by a nonprofit private entity 
        pursuant to a contract with the Federal Government.
            (3) The Federal Government should continue to provide 
        Federal oversight of and financial assistance for the services 
        provided 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 assist the efforts of the 
        Network to serve patient 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 the Congress Regarding Family Discussions of Organ 
Donations.--The Congress recognizes the importance of families pledging 
to each other to share their lives as organ and tissue donors and 
acknowledges the importance of discussing organ and tissue donation as 
a family.
    (c) Sense of the Congress Regarding Living Donations of Organs.--
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.


    (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 continuing operation of an Organ Procurement and 
Transplantation Network (in this section referred to as the `Network'), 
which contract shall be awarded to a nonprofit private entity that has 
expertise and experience in organ procurement and transplantation. The 
Network shall meet the following requirements:
            ``(1) The Network shall be an independent, nonprofit 
        private entity that is a separate legal entity from the entity 
        to which such contract is awarded.
            ``(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 
            ``(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 
                    ``(C) The Board shall have an executive committee, 
                and such other committees as the Board determines to be 
                    ``(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 
        listing patients and 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 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 
            ``(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.
            ``(10) The Network shall recognize the differences in 
        health and in organ transplantation issues between children and 
        adults throughout the system and adopt criteria, policies, and 
        procedures that address the unique health care needs of 
    ``(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 annually 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 
                            ``(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).
                    ``(E) Information under this paragraph shall be 
                updated not less frequently than once a year.
            ``(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, and among children.
            ``(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; Monitoring of Network Participants.--The 
Network shall monitor the operations of Network participants to the 
extent appropriate for determining whether the participants are 
maintaining compliance with criteria under subsection (b)(3). In 
monitoring a Network participant under the preceding sentence, the 
Network shall inform the participant of any findings indicating 
noncompliance by the participant.
    ``(g) Quality Assurance; Peer Review Proceedings.--
            ``(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 

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