[House Report 106-429]
[From the U.S. Government Publishing Office]



106th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES
 1st Session                                                    106-429

======================================================================



 
    ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK AMENDMENTS OF 1999

                                _______
                                

November 1, 1999.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

  Mr. Bliley, from the Committee on Commerce, submitted the following

                              R E P O R T

                             together with

                            DISSENTING VIEWS

                        [To accompany H.R. 2418]

      [Including cost estimate of the Congressional Budget Office]

  The Committee on Commerce, to whom was referred the bill 
(H.R. 2418) to amend the Public Health Service Act to revise 
and extend programs relating to organ procurement and 
transplantation, having considered the same, report favorably 
thereon with an amendment and recommend that the bill as 
amended do pass.

                                CONTENTS

                                                                   Page
Amendment........................................................     2
Purpose and Summary..............................................     9
Background and Need for Legislation..............................     9
Hearings.........................................................    18
Committee Consideration..........................................    19
Committee Votes..................................................    19
Committee Oversight Findings.....................................    23
Committee on Government Reform Oversight Findings................    23
New Budget Authority, Entitlement Authority, and Tax Expenditures    23
Committee Cost Estimate..........................................    23
Congressional Budget Office Estimate.............................    23
Federal Mandates Statement.......................................    25
Advisory Committee Statement.....................................    25
Constitutional Authority Statement...............................    25
Applicability to Legislative Branch..............................    25
Section-by-Section Analysis of the Legislation...................    25
Changes in Existing Law Made by the Bill, as Reported............    31
Dissenting Views.................................................    45

                               Amendment

  The amendment is as follows:
  Strike out all after the enacting clause and insert in lieu 
thereof the following:

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 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 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 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.

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 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 
        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 
        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 
        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.
          ``(10) The Network shall establish criteria, policies, and 
        procedures to address the disparity in mortality rates between 
        children and adults while waiting for organ transplants.
  ``(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 
                        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).
                  ``(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 
                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.
  ``(h) 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. Such a change 
        does not affect the membership status of any Network 
        participant, or the membership status of any individual who 
        serves on the Board (other than any membership position that is 
        predicated solely on being a representative of the current 
        contractor under subsection (a)).
  ``(i) 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.
  ``(j) 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 second year 
        thereafter.
          ``(2) Input from field.--In conducting evaluations under 
        paragraph (1), the Comptroller General shall consult with 
        organizations that represent transplant surgeons, transplant 
        physicians, transplant centers, and qualified organ procurement 
        organizations, and with other experts in the field of organ 
        transplantation, including experts who are not members of the 
        Board of the Network or of the executive structure of the 
        contractor under subsection (a) .
          ``(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.--
                  ``(A) Comptroller general.--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. The Comptroller 
                General shall provide a copy of each such report to the 
                Network.
                  ``(B) Network.--Not later than 180 days after the 
                date on which a report is submitted under subparagraph 
                (A), the Network shall submit to each of the committees 
                specified in such subparagraph a report describing any 
                actions the Network has taken in response to the report 
                under subparagraph (A).''.
  (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) Performance Standards.--Section 371(b)(1) of the Public Health 
Service Act (42 U.S.C. 273(b)(1)) is amended--
          (1) by redesignating subparagraphs (D) through (G) as 
        subparagraphs (E) through (H), respectively;
          (2) by moving subparagraph (F) (as so redesignated) two ems 
        to the left; and
          (3) by inserting after subparagraph (C) the following:
          ``(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 which--
                  ``(i) granted certification or recertification within 
                the previous 4 years with such certification in effect 
                as of October 1, 1999, 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 defined through regulations promulgated by 
                the Secretary not later than January 1, 2002, which--
                          ``(I) require recertifications of qualified 
                        organ procurement organizations not more 
                        frequently than once every 4 years;
                          ``(II) rely on performance measures that are 
                        based on empirical evidence of organ donor 
                        potential and other related factors in each 
                        service area of qualified organ procurement 
                        organizations;
                          ``(III) provide for the filing and approval 
                        of a corrective action plan by a qualified 
                        organ procurement organization that fails to 
                        meet the performance standards and a grace 
                        period of not less than 3 years during which 
                        such organization can implement the corrective 
                        action plan without risk of decertification; 
                        and
                          ``(IV) provide for a qualified organ 
                        procurement organization to appeal a 
                        decertification to the Secretary on substantive 
                        and procedural grounds;''.

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.
  ``(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.

                          Purpose and Summary

    H.R. 2418, the Organ Procurement and Transplantation 
Network Amendments of 1999, ensures that decision making with 
regard to organ transplantation remains, as originally intended 
under the National Organ Transplant Act of 1984 (NOTA) (Public 
Law 98-507), in the transplant community.
    The bill also requires that new, timely, and transplant 
center-specific information be made available to the public. 
The bill provides statutory requirements for the dissemination 
of this material to avoid reliance upon administrative 
mechanisms, as is currently the case.
    H.R. 2418 also creates new incentives for people to become 
organ donors and provides for studies to discover who has the 
most innovative and successful approaches to organ recovery and 
donation around the country.

                  Background and Need for Legislation

    Solid organ transplantation is perhaps the most uniquely 
complex medical and surgical procedure performed in the modern 
era of medicine. It is unique in that transplantation depends 
entirely on the supply of donor organs, which is a product of 
the generosity of the American people. However, that supply 
continues to be tragically short of the need for 
transplantation among patients with end-stage organ disease and 
organ failure. Every year the number of patients who die while 
waiting for a transplant increases, as does the national 
waiting list, which now exceeds 65,000 patients waiting for 
kidney, liver, heart, lung, pancreas, and intestine 
transplants.
    For these compelling reasons, and to insulate organ 
transplantation from political control or interference, 
Congress established a structure in the private sector to 
encourage and facilitate the effort of organ procurement and 
transplantation throughout the country. In doing so, Congress 
has consistently recognized that the management and formulation 
of policies applicable to this field of medicine is best left 
in the expert hands of the medical community, the patients, and 
donor families who are most directly affected. The role of the 
Federal government in this network has been carefully 
restricted by statute to providing technical assistance to the 
private sector together with appropriate oversight of Federal 
funding.
    On April 2, 1998, the Secretary of Health and Human 
Services (the Secretary) issued a Final Rule regarding 
implementation of the NOTA (42 U.S.C. 274), which contained 
provisions that ran counter to fifteen years of Congressional 
legislation relating to NOTA. The April 2, 1998, Final Rule 
drew immediate and widespread criticism throughout the 
transplant community of transplant surgeons and physicians, 
affiliated healthcare professionals, patients, donors and their 
families, and State and local governments. H.R. 2418 responds 
to Secretarial claims made in the regulation, amends and 
restates provisions of the NOTA to clarify and reaffirm the 
Act's existing provisions, and where necessary, adds new 
provisions to address concerns raised in Committee hearings.

History of the organ procurement and transplantation network, 
        scientific registry, and organ allocation

    Establishment of the Organ Procurement and Transplantation 
Network. In an effort to assist transplant centers to 
facilitate the sharing of organs through a clearinghouse of 
similar institutions, the National Organ Transplant Act of 1984 
directed the Secretary of the Department of Health and Human 
Services (HHS or the Department) to establish by contract the 
Organ Procurement and Transplantation Network (OPTN or the 
Network), which would establish the policies to govern 
allocation of organs throughout the country. NOTA also 
established the Task Force on Organ Transplantation for the 
purpose of conducting a comprehensive study on medical, social, 
economic, and ethical issues related to organ transplantation. 
The Task Force on Organ Transplantation published a report in 
1986 (Organ Transplantation: Issues and Recommendations) 
offering recommendations including a call for the establishment 
of a national system or network for matching organ donors with 
organ transplant recipients. The Task Forcerecommended, among 
other things, that members of the OPTN adopt uniform policies for the 
OPTN and improve efforts in public education to increase organ 
donation. On September 30, 1986, HHS awarded the contract to establish 
and run the OPTN to the United Network for Organ Sharing (UNOS), a 
private, nonprofit corporation.
    One recommendation the Task Force made to Congress in 1986 
is that information be published annually to inform the public 
of the status of organ transplant activity at each transplant 
center. Subsequently, section 373 of NOTA established the 
Scientific Registry. The purpose of the Scientific Registry is 
to maintain information on patients and transplants and 
transplant procedures for assessing the scientific and clinical 
status of organ transplantation. Currently, the Scientific 
Registry maintains a data request system and produces an annual 
statistical report for the public and a report on patient 
survival rates. UNOS also competed for and won the contract 
from HHS to operate the Scientific Registry.
    Perhaps the most important provision of NOTA was the 
establishment of the principle that the Network would be a 
private sector entity, and that the Federal government would 
encourage and assist by providing contract funding. NOTA was 
very specific in this regard. It stated that ``[T]he Secretary 
shall by contract provide for the establishment and operation 
of an organ procurement and transplantation network * * *'' (42 
U.S.C. 274; emphasis added). Indeed, the accompanying 
legislative history made it clear that the Secretary was not 
authorized to establish and operate the Network within the 
government. The report reinforced NOTA's basic premise that the 
role of the Secretary was that of providing funding by contract 
for the establishment and operation of the Network in the 
private sector. In the report, the Senate Committee on Labor 
and Human Resources found:

          * * * sufficient cause to believe that the national 
        coordinating effort, while stimulated by the federal 
        government and this legislation, should nonetheless be 
        located in the private sector rather than in 
        government. In this regard, the Committee is aware and 
        encourages the very worthwhile effort, established in 
        the private sector with the assistance of the Federal 
        Government through the office of the Surgeon General of 
        the United States, to provide a cohesive and united 
        policy for organ transplantation. (Senate Report No. 
        98-382, Apr. 6, 1984)

    NOTA provided that the Network was to be a private 
nonprofit entity with a board of directors which includes 
representatives of organ procurement organizations, transplant 
centers, voluntary health associations, and the general public. 
NOTA also described the duties to be performed by the Network 
in achieving its mission of enhancing the effectiveness and 
efficiency of the national organ procurement and 
transplantation effort. These duties included the creation of a 
national list of patients waiting for a transplant and a 
national system using computers to match donated organs with 
patients on the list in accordance with established medical 
criteria. The Network was to have a 24-hour telephone service 
to facilitate matching, help Organ Procurement Organizations 
(OPOs) distribute organs that could not be placed within the 
OPOs' service areas, and assist in coordinating the 
transportation of organs from OPOs to transplant centers. The 
Network was also given the responsibility for collecting, 
analyzing, and publishing data concerning organ donation and 
transplantation and for providing information to physicians and 
other health professionals regarding organ donation.
    Federal Oversight and Authority. By defining the 
relationship between the Secretary and the Network as 
contractual in nature, the Congress established a mechanism 
that gave the Federal government effective oversight of the 
expenditure of appropriated funds through the enormous body of 
Federal contract law and regulation. This approach ensured that 
the Network only conducted those activities authorized by law 
and agreed to by the Secretary under contract. The Network is 
therefore fully accountable to the Secretary and the public 
through this oversight mechanism, and the Secretary has the 
power to prevent implementation by the Network of anything 
deemed to be harmful to the public.
    NOTA also required that the Secretary designate and 
maintain a unit in the Public Health Service to administer part 
H of the Public Health Service Act, dealing with organ 
allocation, and to provide assistance to organ procurement 
organizations, the Organ Procurement and Transplant Network, 
and the Scientific Registry, and provide technical assistance 
to organ procurement organizations receiving grants and 
contracts for organ transplant activities. In addition, current 
law requires the Secretary to conduct public education programs 
that (1) aim to increase the donation of organs; (2) provide 
information to patients, their families, and their physicians; 
and (3) provide technical assistance to the OPTN, organ 
procurement organizations, and others involved in the donation, 
procurement, and transplantation of organs. The Secretary is 
given no authority to supplant the policymaking role of the 
OPTN.
    NOTA did not authorize the Secretary to establish medical 
criteria or policies for the Network. Such authority was 
expressly left to the private sector. Nor did NOTA authorize 
the Secretary to impose fees, require payments from those 
obtaining Network services, exercise control over private funds 
or assets obtained by the Network or the Network contractor, or 
regulate the field of organ transplantation beyond any 
authority established otherwise under law.
    Since 1986, UNOS has competed for and been awarded the 
contract to operate the OPTN. Current law requires that the 
OPTN have a board of directors that includes representatives of 
organ procurement organizations, transplant centers, voluntary 
health associations, and the general public. The board of 
directors for the OPTN comprises 38 members who represent the 
perspectives of physicians, surgeons, patients, patient 
advocates, organ procurement organizations, organ donors, 
transplant recipients and their families, patient advocates, 
histocompatibility (tissue-typing) laboratories, transplant 
coordinators, bioethicists, the general public, and others. A 
total of 434 transplant-related organizations (such as 
transplant hospitals, laboratories, and organ procurement 
organizations) comprise the membership of the OPTN.
    In 1986, Section 1138 of the Social Security Act was 
amended (Omnibus Budget Reconciliation Act of 1986, Public Law 
99-509) to require that transplant centers and organ 
procurement organizations who are members of the OPTN abide by 
the rules and policies of the OPTN. That requirement became a 
condition of participation in the Federally supportedMedicare 
and Medicaid programs. In 1994, Congress further amended section 1138 
of the Social Security Act (Social Security Act Amendments of 1994, 
Public Law 103-432) to require that transplant hospitals establish 
written agreements with organ procurement organizations for the purpose 
of identifying potential organ donors in designated service areas.
    1986 Omnibus Budget Reconciliation Act. In the 1986 Omnibus 
Budget Reconciliation Act (1986 OBRA), Congress amended the 
Social Security Act by adding a new provision to section 1138, 
which required that:

          The Secretary shall provide that a hospital meeting 
        the requirements of title XVIII or XIX may participate 
        in the program established under such title only if * * 
        * in the case of a hospital in which organ transplants 
        are performed, the hospital is a member of, and abides 
        by the rules and requirements of, the Organ Procurement 
        and Transplantation Network * * *
          The Secretary shall provide that payment may be made 
        under title XVIII or XIX with respect to organ 
        procurement costs attributable to payments made to an 
        organ procurement agency only if the agency * * * is a 
        member of, and abides by the rules and requirements of, 
        the Network; allocates organs, within its service area 
        and nationally, in accordance with medical criteria and 
        the policies of the Network.

    Nothing in this OBRA provision was intended to change the 
basic nature of the Network or the relationship between the 
Federal government and the Network as specified in the 
Transplant Act. However, due to this new condition for 
participation in Medicare and Medicaid, concerns were expressed 
about the propriety of a Federal law requiring membership in a 
private organization and adherence to such organization's rules 
and requirements. Therefore, Congress made several changes to 
the National Organ Transplant Act in 1988 to address such 
concerns.
    1988 Transplant Act Amendments. The 1988 amendments did not 
alter the original concept of a private sector Network but 
added requirements for the Network's adoption of membership 
criteria and policies. The approach prescribed by those 
amendments substantively addressed the same issues as the 
Administrative Procedures Act (APA) for the adoption of Federal 
rules, which includes giving the public notification of, and an 
opportunity to comment on, proposed policies. The 1988 
amendments required the private sector Network to formally 
adopt and publish its membership criteria and the medical 
criteria for organ allocation and to provide members of the 
public the opportunity to comment on them.
    The 1988 amendments enhanced the Secretary's oversight role 
by requiring that the Secretary ``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 * * * and the 
consideration by the Secretary of such comments.''
    In addressing the provisions in the 1986 OBRA, the 1988 
amendments of NOTA ensured that there was adequate governmental 
oversight of the Network to avoid any problems regarding 
improper delegation of authority. The Network was given only 
the power to establish such criteria as are permitted under the 
Secretary's contract, and the Secretary has the authority to 
ensure that the Network cannot act without Federal oversight. 
By addressing the substantive public policy issues that the APA 
seeks to address, and by giving the Secretary authority to seek 
public comments as well, the 1988 amendments adequately 
addressed these concerns.
    NOTA was amended in 1988 and 1990 to modify requirements in 
the roles for and functions of the OPTN and, among other 
things, requirements for the OPTN to assist in organ 
allocation. In 1988, Congress enacted the Health Programs 
Extension of 1988 (Public Law 100-607) to (1) establish a grant 
program for organ procurement organizations and encourage the 
increased donation of organs, (2) require that organ 
procurement organizations and hospitals cooperate in 
establishing and implementing routine referral and inquiry 
protocols for organ donations, (3) require the Secretary to 
establish procedures for receiving and considering comments 
critical of the OPTN, and (4) require the Secretary to work 
with the OPTN to resolve issues about the OPTN.
    The Transplant Amendments Act of 1990 (Public Law 101-616) 
made significant revisions in the operation and management of 
the OPTN, and placed public policy restraints on the OPTN board 
to guide its actions. The law (1) required that organs be 
distributed equitably among patients; (2) modified requirements 
in the OPTN's board of directors; (3) required the Secretary to 
establish performance standards to increase the effectiveness 
and efficiency of organ procurement organizations in the 
procurement and equitable distribution of organs; and (4) 
required that transplant center-specific information about 
survival rates, outcomes, and costs be made available to the 
public.

Policy issues and reauthorization of the OPTN

    Organ Allocation. The allocation process for organs is 
predicated on scientific and medical judgment. One premise for 
the successful transplantation of organs is the relative 
genetic or medical histocompatibility shared by the organ donor 
and recipient. This compatibility, which is expressed in the 
unique characteristics or qualities of the tissue that makes up 
the organ, is assessed by using a series of tests for 
establishing a medical match. Organ procurement organizations 
and transplant hospitals evaluate tissue matching along with 
other medical criteria in their decisions to allocate an organ 
consistent with OPTN policies.
    Medical criteria constitute a critical first step in the 
distribution of organs. The medical criteria seek to optimize 
the level of biologic and genetic similarities shared by a 
donor and host to minimize the possibility of graft rejection. 
The greater the medical compatibility, the greater the chances 
for a successful transplant operation and long-term survival. 
The medical criteria establish the scientific basis for 
matching organs. Other criteria include the likelihood of graft 
and host survival, medical status, and length of time spent in 
the intensive care unit. However, it should be noted that for 
each organ, the OPTN has articulated an organ allocation policy 
thatpermits transplant centers to consider different criteria 
for transplantation such as a patient's age, the availability of 
alternative therapies, or history of repeat transplantation.
    Relationship of the Secretary to the OPTN. The Secretary 
has an administrative and oversight function in the activities 
of the OPTN, and the Secretary articulated that role in the 
April 2, 1998, final rule (63 Fed. Reg. 16296 (1998)). However, 
the Secretary's interpretation of the extent to which the 
Secretary should be involved in OPTN policy-making was a source 
of considerable debate throughout 1998 and 1999. Physicians, 
transplant surgeons, and some patient advocacy groups testified 
before the House Committee on Commerce on June 18, 1998, in 
favor of Congressional clarification of the role of the 
Secretary as the administrator of the OPTN with oversight 
responsibilities, but without any direct role in the 
scientific, medical, or policy-making activities of the OPTN 
(Serial No. 105-107).
    Role of Organ Procurement Organizations. The Committee 
recognizes the need to increase organ donation within the 
United States, and the important role of OPOs in that effort. 
The current process for certification and recertification of 
OPOs has created a level of uncertainty that is interfering 
with OPO effectiveness in raising the level of donation. The 
General Accounting Office (GAO), the Institute of Medicine 
(IOM), and a number of private organizations have identified 
substantial limitations of the current OPO certification and 
recertification process conducted by HHS. These limitations 
include the use of current population-based performance 
measures to certify OPOs that do not result in improved 
performance and accountability for OPOs. The process has been 
criticized also for decertifying OPOs solely on the basis of 
these measures without the opportunity for corrective action or 
due process.
    In the Balanced Budget Act of 1997 (Public Law 105-33), 
Congress intended to reduce the uncertainty of OPO 
recertification by granting authority to the Department of 
Health and Human Services to extend the period for 
recertification of all OPOs from two (2) to four (4) years. The 
Committee intends that the Department will now extend the 
recertification period for all OPOs to four years, and will use 
this extended period to substantially revise the process and 
criteria for certification to solve the problems that have been 
identified with the process. The Committee does not intend that 
the Department will reverse or alter any certification or 
recertification decision made by the Department prior to the 
date this provision was approved by the Committee. The 
Committee also does not intend to prevent the Department from 
decertifying in the future an OPO for failure to meet any of 
the OPOs standards created by this section or any other 
applicable statute other than the performance standards 
addressed in this subsection.
    The Committee intends that the Department will work 
collaboratively with the organ procurement community in the 
effort to revise the current OPO certification and 
recertification process. The Department will collaborate on a 
review of alternative approaches to performance measurement, 
including those suggested by the GAO, the IOM, and the Harvard 
School of Public Health, and will design new performance 
measures that would take into account process variables and 
donor potential within an OPO service area. The Committee 
intends that the Department will revise the certification 
process to reduce the uncertainty and randomness of the current 
process by providing OPOs with appropriate safeguards such as 
an appropriate grace period to file corrective action plans and 
other due process rights. The Committee intends that currently 
certified OPOs will continue to meet the requirements of this 
subsection until the alternative performance standards 
described in this subsection have been promulgated by the 
Department and the performance of each of the OPOs has been 
reviewed in relation to these alternative standards.
    Does the Sick Chicken Case Still Rule the Roost? At the 
Full Committee markup, the Committee also considered whether 
Schechter Poultry Corp. v. United States (295 U.S. 495 (1935)) 
still serves as a barricade to Congressional delegation of 
policy-making authority to private-sector entities like the 
Organ Procurement and Transplantation Network. The Schechter 
case, along with Carter v. Carter Coal Co., 298 U.S. 238 
(1936), proved to be the last constitutional barrier to the 
implementation of the New Deal over the question of the 
delegation doctrine.
    While the Supreme Court has continued to state that 
congressional delegations to private parties are disfavored, 
the High Court has not, in fact, struck down any such 
enactments in the ensuing years. As Justice Marshall wrote, 
``The notion that the Constitution narrowly confines the power 
of Congress to delegate authority to administrative agencies, 
which was briefly in vogue in the 1930's, has been virtually 
abandoned by the Court for all practical purposes * * *.'' FPC 
v. New England Power Co., 415 U.S. 345, 352-3 (1974) (Marshall, 
J., concurring and dissenting). This reticence has occurred in 
the face of numerous instances in which Congress has 
specifically included private parties in the implementation of 
Federal legislation.
    In 1936, the Supreme Court struck down provisions of the 
Bituminous Coal Conservation Act of 1935, which delegated to 
certain producers and miners the power to fix maximum labor 
hours and minimum wages. The Court categorically stated that 
``a statute which attempts to confer such power undertakes an 
intolerable and unconstitutional interference with personal 
liberty and private property.'' Carter v. Carter Coal Co., 298 
U.S. 238, 311 (1936). The Court relied upon its earlier case, 
Schechter Poultry Corporation v. United States, wherein it had 
invalidated provisions relating to codes of fair competition, 
authorized to be approved by the President in his discretion 
``to effectuate the policy'' of the Act. This delegation of 
law-making responsibility to private groups was found to be 
``unknown to our law and * * * utterly inconsistent with the 
constitutional prerogatives and duties of Congress.'' Schechter 
Poultry Corp., at 537.
    Nevertheless, expansion of private participation in the 
implementation of Federal legislation has occurred since the 
1930's, and numerous examples may be cited wherein Congress has 
chosen to delegate responsibilities to private parties in all 
areas of powers that may be entrusted to the executive branch. 
Early examples of congressional delegations upheld by the High 
Court include Currin v. Wallace, 306 U.S. 1 (1939), wherein the 
Court sustained the constitutionality of a provision of the 
Tobacco Inspection Act of 1935 that denied judicial review of 
marketing orders adopted with the consent of handlers and 
farmers. The Court held that therewas no unconstitutional 
delegation of power because ``Congress ha[d] merely placed a 
restriction upon its own regulation by withholding its operation as to 
a given market `unless two-thirds of the growers voting favor it.' '' 
(See id. at 15-16. Similarly, in Wickard v. Filburn, 317 U.S. 111, 115-
116 (1942), wheat and tobacco growers were empowered through referenda 
to accept or reject quotas or market designations). Under the 
Agricultural Marketing Agreement Act of 1937, Congress conditioned the 
effectiveness of the orders of the Secretary of Agriculture fixing the 
prices that handlers must pay to dairy farmers for milk products upon 
the approval in referenda by prescribed majorities of the handlers and 
producers in given areas. These provisions were sustained in United 
States v. Rock Royal Cooperative, 307 U.S. 533, 577-578 (1939) and H.P. 
Hood & Sons v. United States, 307 U.S. 588, 599-603 (1939).
    The line of cases permitting delegations to private parties 
continues into modern times. Under the Beef Promotion and 
Research Act, as amended, an assessment is placed on cattle 
producers and importers, and the funds are turned over to a 
Cattlemen's Beef Promotion and Research Board and a Beef 
Promotion Operating Committee, which are charged with 
implementing the program. The Secretary of Agriculture selects 
members of the Board from lists furnished him by the designated 
units of producers and importers throughout the country, and 
the Committee is composed of ten members designated by the 
board and ten members from State beef councils, that is, 
entities organized pursuant to State statutes. All the programs 
are dependent upon referenda approval for their validity, and 
once approved, are binding on everyone, not just those who 
agree to participate. This scheme was upheld in United States 
v. Frame, 885 F.2d 1119 (3d Cir. 1989), cert. den., 1168 
(1990).
    Under the Occupational Safety and Health Act, Congress 
directed the Secretary of Labor to adopt interim occupational 
health and safety standards in particular areas developed by 
standards-producing private organizations, 29 U.S.C. 
Sec. Sec. 652(9), 655(a), a delegation that was upheld in 
Noblecraft Industries v. Secretary of Labor, 614 F.2d 199 (9th 
Cir. 1980). A provision in the Medicare statute providing that 
hearings on disputed claims for Medicare payments be conducted 
by private insurance carriers, without a further right of 
appeal, was sustained in Schweiker v. McClure, 456 U.S. 188 
(1982). A three-judge court upheld a congressional mandate in 
another portion of the Medicare statute that incorporated 
private professional standards review organizations into the 
process for denying reimbursements to providers where services 
are claimed to be ``medically unnecessary.'' This delegation to 
the private organizations was upheld in Association of American 
Physicians & Surgeons v. Weinberger, 395 F. Supp. 125 
(N.D.Ill.), aff'd. per curiam, 423 U.S. 975 (1975). See also 
Corum v. Beth Israel Medical Center, 373 F. Supp. 550, 551-553 
(S.D.N.Y. 1974) (where the district court held that it was not 
unconstitutional for Congress to give veto power over the 
Secretary of Health, Education and Welfare's rulemaking 
authority to a now-defunct private entity called ``the Federal 
Hospital Council.'')
    More recently, patients in a psychiatric hospital whose 
Medicare and Medicaid benefits were terminated when the 
hospital lost its accreditation by a private organization, and 
thus was de-certified by the Secretary of HHS under the 
Medicare and Medicaid programs, challenged the delegation of 
the accreditation responsibility to the private organization. 
The Third Circuit Court of Appeals found that the Secretary 
retained sufficient ultimate authority over decertification 
decisions resulting from loss of accreditation by a private 
entity to view the delegation as constitutional. Cospito v. 
Heckler, 742 F.2d 72 (3d Cir. 1984), cert. den., 471 U.S. 1131 
(1985). This authority appeared to result from the Secretary's 
inherently broad discretion to adopt rules regarding 
psychiatric hospitals under the Medicare program. Thus, even 
though the statute defined inpatient psychiatric hospital 
services as ``inpatient services which are provided in an 
institution which is accredited as a psychiatric hospital by 
the [Joint Commission on Accreditation of Hospitals],'' the 
court held ``that the Secretary has the authority to make 
findings regarding the adequacy of a psychiatric hospital 
independent of the JCAH, and also has the authority to 
establish his own general standards by which those 
determinations are made.'' Id. at 89. In effect, the court 
viewed the actions of the private accreditation entity as 
subject to review by a public official under a Federal statute, 
and hence there was no impermissible delegation of legislative 
authority to a private party. See Todd & Co., v. SEC, 557 F.2d 
1008 (3d Cir. 1977) (in which the court found no 
unconstitutional delegation where the actions of private 
organizations were ultimately subject to review by a public 
agency.)
    An unbroken line of precedents since the mid-1930's 
supports the conclusion that Congress may empower private-
sector institutions to carry out functions under Federal law. 
While such delegations may not exist without some oversight by 
the executive branch, the non-delegation doctrine, per se, does 
not pose a bar to the inclusion of private parties in the 
execution of Federal legislation.

                                Hearings

    The Subcommittee on Health and Environment held a 
legislative hearing on H.R. 2418, the Organ Procurement and 
Transplantation Network Amendments of 1999, on September 22, 
1999. The Subcommittee received testimony from: Dr. William 
Raub, Deputy Assistant Secretary for Planning and Evaluation/
Science Policy, Department of Health and Human Services; Dr. 
William Payne, Director, Liver Transplant Program, Fairview 
Medical Center, Minneapolis, Minnesota; Dr. Robert D. Gibbons, 
Professor of Biostatistics, School of Medicine, Department of 
Psychiatry, University of Illinois at Chicago; Dr. Joshua 
Miller, Division of Transplantation, Department of Surgery, 
University of Miami School of Medicine, Miami, Florida; Mr. 
Craig Irwin, President, National Transplant Action Committee, 
Portland, Oregon; Dr. John M. Rabkin, Chief, Liver/Pancreas 
Transplantation Hepatobiliary Surgery, Oregon Health Sciences 
University, Portland, Oregon.
    The Subcommittee on Health and Environment held a hearing 
entitled ``Putting Patients First: Increasing Organ Supply for 
Transplantation,'' on April 15, 1999. The Subcommittee received 
testimony from Mr. Jamar Burton, Organ Transplant Recipient, 
State of Tennessee; Ms. Abbey Lynn Johnston, Organ Transplant 
Recipient, State of Ohio; Ms. Cynthia Guillemin, Organ 
Transplant Recipient, State of Florida; and Ms. Kara Grace 
Thio, Organ Transplant Recipient, State of North Carolina. 
Additional witnesses included Mr. John R. Campbell, Executive 
Director, LifeLink Foundation; Mr. Howard M. Nathan, President, 
Coalition on Donation, Delaware Valley Transplant Program, 
Philadelphia, Pennsylvania; Dr. AmadeoMarcos, Assistant 
Professor of Surgery, Medical College of Virginia, Richmond, Virginia; 
Dr. Joshua Miller, Division of Transplantation, Department of Surgery, 
University of Miami School of Medicine, Miami, Florida; Dr. John F. 
Neylan, President, American Society of Transplantation; Dr. Robert A. 
Metzger, Medical Director, Transplant Physician, Translife at Florida 
Hospital, Orlando, Florida; Dr. Robert S. D. Higgins, Director, 
Thoracic Organ Transplantation, Henry Ford Hospital, Detroit, Michigan; 
and Mr. Joseph L. Brand, Chairman, National Kidney Foundation, Office 
of Scientific and Public Policy, Arlington, Virginia.
    On June 18, 1998, the House Subcommittee on Health and 
Environment and the Senate Committee on Labor and Human 
Resources held a joint hearing entitled ``Putting Patients 
First: Resolving Allocation of Transplant Organs.'' The 
Committees received testimony from The Honorable Robert G. 
Torricelli, U.S. Senator, State of New Jersey; The Honorable 
Louis Stokes, U.S. Representative, 11th Congressional District, 
State of Ohio; The Honorable Rick Santorum, U.S. Senator, 
Commonwealth of Pennsylvania; The Honorable Leonard L. Boswell, 
U.S. Representative, 3rd Congressional District, State of Iowa; 
The Honorable J. Robert Kerrey, U.S. Senator, State of 
Nebraska; The Honorable Karen Thurman, U.S. Representative, 5th 
Congressional District, State of Florida; The Honorable Ernest 
F. Hollings, U.S. Senator, State of South Carolina; The 
Honorable Bob Inglis, U.S. Representative, 4th Congressional 
District, State of South Carolina; The Honorable Thomas M. 
Barrett, U.S. Representative, 5th Congressional District State 
of Wisconsin; The Honorable Donna E. Shalala, Secretary, 
Department of Health and Human Services; Mr. Bruce Weir, 
President, Transplant Recipients International Organization, 
Inc.; Mr. Tom Meredith, Private Citizen, Antioch, Tennessee; 
Ms. Peggy Dreker, Private Citizen, Kearny, New Jersey; Dr. 
Lawrence G. Hunsicker, President, United Network for Organ 
Sharing, and Medical Director, Transplantation, University of 
Iowa Hospital and Clinic, Iowa City, Iowa; Dr. James F. 
Childress, Edwin B. Kyle Professor of Religious Studies and 
Medical Education, University of Virginia; Dr. Jorge D. Reyes, 
Director, Pediatric Transplantation Surgery, University of 
Pittsburgh Medical Center; Dr. Ron Busuttil, DuMont UCLA 
Transplant Center, UCLA Medical Center; Dr. Hector C. Ramos, 
Director of Liver Transplantation, Lifelink Transplant 
Institute, Tampa, Florida; Dr. Jeffrey C. Reese, Assistant 
Professor of Surgery, Director of Kidney-Pancreas 
Transplantation, University of Vermont; Dr. Clive O. Callender, 
Director, Howard University Transplant Center, Washington, 
D.C.; and Dr. William E. Harmon, Chief, Division of Nephrology, 
The Children's Hospital, Boston, Massachusetts.

                        Committee Consideration

    On September 30, 1999, the Subcommittee on Health and 
Environment met in open markup session and approved H.R. 2418, 
the Organ Procurement and Transplantation Network Amendments of 
1999, for Full Committee consideration, amended, by a voice 
vote. On October 13, 1999, the Committee on Commerce met in 
open markup session and ordered H.R. 2418 reported to the 
House, amended, by a voice vote, a quorum being present.

                            Committee Votes

    Clause 3(b) of rule XIII of the Rules of the House requires 
the Committee to list the record votes on the motion to report 
legislation and amendments thereto. The following are the 
recorded votes on the motion to report H.R. 2418 and on 
amendments offered to the measure, including the names of those 
Members voting for and against.


                      Committee Oversight Findings

    Pursuant to clause 3(c)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee held legislative and 
oversight hearings and made findings that are reflected in this 
report.

           Committee on Government Reform Oversight Findings

    Pursuant to clause 3(c)(4) of rule XIII of the Rules of the 
House of Representatives, no oversight findings have been 
submitted to the Committee by the Committee on Government 
Reform.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    In compliance with clause 3(c)(2) of rule XIII of the Rules 
of the House of Representatives, the Committee finds that H.R. 
2418, the Organ Procurement and Transplantation Network 
Amendments of 1999, would result in no new or increased budget 
authority, entitlement authority, or tax expenditures or 
revenues.

                        Committee Cost Estimate

    The Committee adopts as its own the cost estimate prepared 
by the Director of the Congressional Budget Office pursuant to 
section 402 of the Congressional Budget Act of 1974.

                  Congressional Budget Office Estimate

    Pursuant to clause 3(c)(3) of rule XIII of the Rules of the 
House of Representatives, the following is the cost estimate 
provided by the Congressional Budget Office pursuant to section 
402 of the Congressional Budget Act of 1974:

                                     U.S. Congress,
                               Congressional Budget Office,
                                  Washington, DC, October 21, 1999.
Hon. Tom Bliley,
Chairman, Committee on Commerce,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for H.R. 2418, the Organ 
Procurement and Transplantation Network Amendments of 1999.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contacts are Cyndi 
Dudzinski (for federal costs), and Leo Lex (for the state and 
local impact), and Jennifer Bullard (for the private-sector 
impact).
            Sincerely,
                                          Barry B. Anderson
                                    (For Dan L. Crippen, Director).
    Enclosure.

H.R. 2418--Organ Procurement and Transplantation Network Amendments of 
        1999

    Summary: H.R. 2418 would amend the National Organ 
Transplant Act of 1984 and reauthorize the Organ Procurement 
and Transplantation Network activities administered by the 
Health Resources and Services Administration (HRSA). In 1999, a 
total of $10 million was appropriated for the organ procurement 
and transplant network, for the scientific registry, and for 
the purpose of increasing organ donation and procurement. In 
2000, this legislation would authorize the appropriation of $6 
million for the network and the registry and such sums as may 
be necessary for increasing organ donation and procurement. It 
would also authorize $5 million in new funding for travel and 
subsistence expenses incurred during living organ donation and 
$10 million for a program to educate the public and for studies 
and demonstrations designed to increase the rate of organ 
donation. It would authorize such sums as may be necessary for 
all these activities for 2001 through 2005.
    Assuming appropriations of the necessary amounts, CBO 
estimates that implementing H.R. 2418 would cost $8 million in 
2000 and a total of $101 million from 2000 through 2004, 
without adjusting for inflation, and $108 million if inflation 
adjustments are included. The legislation would not affect 
direct spending or receipts; therefore, pay-as-you-go 
procedures would not apply.
    H.R. 2418 contains no private-sector or intergovernmental 
mandates as defined in the Unfunded Mandates Reform Act (UMRA). 
The bill would provide grants to states and other public and 
private entities that provide assistance to individuals for 
travel and subsistence expenses associated with the donation of 
living organs.
    Estimated cost to the Federal Government: The estimated 
budgetary impact of H.R. 2418 is shown in the following table. 
The costs of this legislation fall within budget function 550 
(health).

----------------------------------------------------------------------------------------------------------------
                                                                 By fiscal years, in millions of dollars--
                                                          ------------------------------------------------------
                                                              2000       2001       2002       2003       2004
----------------------------------------------------------------------------------------------------------------
                                  CHANGES IN SPENDING SUBJECT TO APPROPRIATION

                                        Without Adjustments for Inflation

Estimated Authorization Level............................         26         26         26         26         26
Estimated Outlays........................................          8         19         24         25         25
                                          With Adjustment for Inflation

Estimated Authorization Level............................         26         27         27         28         28
Estimated Outlays........................................          8         19         24         27         27
----------------------------------------------------------------------------------------------------------------

    Basis of estimate: For purposes of this estimate, CBO 
assumes that the bill will be enacted early in fiscal year 2000 
and that outlays will follow historical spending rates for 
these activities. Where specified, CBO assumes the authorized 
and estimated amounts would be appropriated. The bill does not 
contain a specific authorization level for increasing organ 
donation and procurement, but instead would authorize the 
appropriation of such sums as may be necessary for 2000 through 
2005. Based on the amount spent in the past for this activity, 
CBO estimates an authorization level of $5 million for 2000. 
The table shows two alternative spending paths: one assuming no 
increases to account for anticipated inflation, and one with 
annual inflation adjustments.
    Pay-as-you-go considerations: None.
    Intergovernmental and private-section impact: H.R. 2418 
contains no private-sector or intergovernmental mandates as 
defined in UMRA. The bill would provide grants to states and 
other public and private entities that provide assistance to 
individuals for travel and subsistence expenses associated with 
the donation of living organs.
    Estimate prepared by: Federal Costs: Cyndi Dudzinski. 
Impact on State, local, and tribal governments: Leo Lex. Impact 
on the private sector: Jennifer Bullard.
    Estimate approved by: Peter H. Fontaine, Deputy Assistant 
Director for Budget Analysis.

                       Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

                      Advisory Committee Statement

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act were created by this 
legislation.

                   Constitutional Authority Statement

    Pursuant to clause 3(d)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee finds that the 
Constitutional authority for this legislation is provided in 
Article I, section 8, clause 3, which grants Congress the power 
to regulate commerce with foreign nations, among the several 
States, and with the Indian tribes.

                  Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

             Section-by-Section Analysis of the Legislation


Section 1. Short title

    Section 1 establishes the short title of the bill as the 
``Organ Procurement and Transplantation Network Amendments of 
1999.''

Section 2. Findings

    Section 2 reports findings of the Congress related to the 
importance of the Organ Procurement and Transplantation Network 
(the Network) and the role of the Network in allocating scarce 
organs while promoting donation to increase organ supply.

Section 3. Organ Procurement and Transplantation Network

    Section 3 amends section 372 of the Public Health Service 
Act (PHSA) to establish general and specific requirements for 
operating the Network.
    Section 372(a) specifies requirements for continuing 
operation of the Network. Specifically, the Network must: (1) 
be a legal entity that is separate from the contracting 
organization; (2) include as its members organ procurement 
organizations, transplant centers, and other entities 
affiliated with organ donation and transplantation; and (3) 
have a Board of Directors (Board) that consults with Network 
participants to carry out its statutory responsibilities.
    Section 372(a)(4)(A) requires the Network to include on its 
Board representatives of qualified organ procurement 
organizations, transplant centers, voluntary health 
associations, and members of the general public. A reasonable 
proportion of the Board membership must include patients who 
are on the waiting list to receive a transplant, or transplant 
recipients, or individuals who have donated an organ, or family 
members of patients, recipients, or donors.
    Section 372(a)(4)(B) requires that the Board establish 
membership categories and qualifications for service on the 
Board, and authorizes the Board to have exclusive authority to 
admit individuals to its membership. Transplant surgeons and 
transplant physicians must comprise at least 50 percent of the 
membership of the Board. The Board is limited to a total of 42 
members.
    Section 372(a)(4)(C) requires that the Board have an 
executive committee and other appropriate committees.
    Section 372(a)(4)(D) requires that the Board select the 
chair of each committee to ensure that there is continuity of 
leadership for the Board.
    Section 372(b) establishes requirements for general 
functions of the Network. The Network must: (1) establish and 
operate a national system to match organs and individuals who 
need transplants, especially those individuals whose immune 
system makes it difficult for them to receive organs; (2) 
maintain one or more lists of patients who need organ 
transplants and operate the national system according to 
established medical criteria; (3) establish membership criteria 
for Network participants and medical criteria for listing 
patients and for allocating organs, and provide the public with 
an opportunity to comment on such criteria; (4) maintain the 
national system on a 24-hour basis using telephones and 
computers to facilitate organ matching among individuals on the 
waiting list; (5) assist organ procurement organizations in 
organ allocation, basing allocation on medical criteria 
established by the Network, and equity and ethics without 
regard to the economic status, political control, or influence 
of those awaiting an organ; (6) adopt quality standards for the 
acquisition and transportation of donated organs, including 
standards for preventing the transmission of infectious 
diseases; (7) prepare and distribute samples of blood sera from 
individuals who are included on the list and whose immune 
system makes it difficult for them to receive organs; (8) 
coordinate the transportation of organs from organ procurement 
organizations to transplant centers; (9) work actively to 
increase organ donations; and (10) establish criteria, policies 
and procedures to address the disparity in mortality rates 
between children and adults while waiting for transplants.
    Section 372(c) establishes requirements for the Scientific 
Registry.
    Section 372(c)(1) requires that the Network maintain a 
scientific registry of patients who are waiting for an organ 
transplant, individuals who donate organs, and patients who 
receive organs for the purpose of an ongoing evaluation of the 
scientific and clinical status of organ transplantation. 
Section 372(c)(2) requires the Network to use scientific and 
clinical data from the Scientific Registry to publish a report 
on the status of organ transplantation (as required in section 
375).
    Section 372(d) introduces new requirements related to the 
disclosure of information to Network participants and the 
general public.
    Regarding requirements for information disclosure, section 
372(d)(1) requires the Network to: (1) provide information to 
physicians and other health professionals on organ donation and 
transplantation; and (2) collect, analyze, and publish data on 
an annual basis on organ donation and transplantation.
    Section 372(d)(2) describes the types of information that 
the Network must make available to patients. The Network must 
provide to patients information that is: (1) transplant-
related, specific to transplant centers, and scientifically and 
clinically valid; (2) designed to assist patients and referring 
physicians in choosing a transplant center, including 
information on the supply of and demand for organs; and (3) 
with respect to the patient involved, include specific details 
about the transplant center, such as the probability of 
receiving an organ transplant at the center, the historical 
waiting time for receiving an organ transplant at the center, 
and the medical outcomes or survival rates for patients with 
similar medical conditions. In addition, subparagraph (D) 
requires the Network to provide information to patients by 
service areas, as defined by organ procurement organizations. 
In accordance with subparagraph (E) this information must be 
updated at least once a year.
    Section 372(d)(3) requires that the Network publish and 
make available to the public an annual report on the overall 
status of organ procurement and transplantation.
    Section 372(d)(4) prohibits the Network from releasing 
information, except for that authorized in paragraph (2) or 
(3). Unless authorized to do so by the patient or other entity 
in writing, the Network is prohibited from releasing 
information that permits: (1) the direct or indirect 
identification of persons on a waiting list for a transplant, 
organ transplant patients, donors or recipients; (2) the direct 
or indirect identification of any potential or actual organ 
donors; or (3) direct or indirect identification of 
participants in Network deliberations related to practitioner 
or institutional qualifications, due process proceedings or 
peer review activities. Exceptions to this prohibition apply to 
the release of 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.
    Section 372(e) requires that the Network carry out studies 
and demonstration projects.
    Section 372(e)(1) requires that the Network carry out 
studies and projects designed to explore means for improving 
the process by which organs are procured and allocated, as well 
as ways to increase transplantation among populations with 
special needs or limited access, and among children.
    Section 372(e)(2) directs the Network to consider a study 
on the transplantation of animal organs into humans 
(xenotransplantation) including the impact of applying 
alternate technologies for human transplantation.
    Section 372(f) requires that the Network monitor the 
operations of Network participants in order to determine 
whether the Network participants are in compliance with 
statutory requirements for establishing medical criteria for 
organ allocation (required under subsection (b)(3)).
    Section 372(g) establishes new requirements for peer review 
proceedings within the Network.
    Section 372(g)(1) requires that the Network develop a peer 
review system for assuring that members of the Network comply 
with quality assurance criteria under subsection (b)(3).
    Section 372(g)(2) mandates that the Network require as a 
condition of participation each Network participant to agree 
that the Network may, through a peer review process, require 
the participant to pay damages for the failure of the 
participant to comply with the criteria in subsection (b)(3). 
The Network must establish procedures to ensure that peer 
review proceedings are conducted in an impartial manner, with 
adequate opportunity for the Network participant to receive a 
hearing. The Network must identify various types of violations 
of such criteria and specify the maximum amount of damages that 
the Network may require a Network participant to pay for 
violations.
    Section 372(g)(2)(B) permits the Network to restrict access 
to allocations of organs, if a Network participant has engaged 
in substantial violations of organ allocation criteria under 
subsection(b)(3).
    Section 372(g)(2)(C) permits the Network to take actions to 
make the public aware of the extent to which a Network 
participant has been required to pay damages or has been the 
subject of restrictions in activities in organ allocation.
    Section 372(g)(3) places restrictions on the release of 
data or information by the Network or the Secretary without the 
written permission of all parties involved if such data or 
information is related to peer review proceedings. If damages 
are required to be paid under paragraph (2) then the 
requirement may be publicly announced after the conclusion of 
the proceeding.
    Section 372(h) establishes administrative provisions and 
procedural functions for the Network.
    Section 372(h)(1) states that the amount of the contract 
for operating the Network, including the Scientific Registry, 
in any fiscal year may not exceed $6 million. The limitation 
does not apply to amounts provided for increasing organ 
donations.
    Section 372(h)(2) clarifies the relationship between 
Secretary and the Network. The administrative and procedural 
functions of the Network are to be carried out in accordance 
with the mutual agreement of the Secretary and the Network. 
Functions that are scientific, clinical, or medical in nature 
are not administrative or procedural functions and are within 
the sole discretion of the Network. This section may not be 
construed as having any legal effect on the Medicare or 
Medicaid programs, except to the extent that section 1138 of 
the Social Security Act, or any other provision of such Act, 
provides otherwise.
    Section 372(h)(3) establishes policy for non-Federal assets 
of the Network.
    Section 372(h)(3)(A) states that no assets in the 
possession of the Network or revenues collected by the Network, 
other than amounts appropriated for the Network, 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 non-appropriated funds be subject to 
restriction or control by the Secretary. In addition, no member 
of the Network shall 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.
    Section 372(h)(3)(B) allows the Network to accept gifts of 
money or services for carrying out activities related to organ 
procurement and transplantation.
    Section 372(h)(4) states that if any contract for the 
Network is awarded after the date of enactment, the Secretary 
must 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.
    Section 372(h)(5) states that if the Secretary makes a 
determination to award the contract to a different contractor 
than the existing one, the Secretary must publish a notice to 
that effect in the Federal Register. The change can take effect 
no earlier than six months from the date of the notice. Such a 
change does not affect the membership status of any Network 
participant, or the membership status of any individual who 
serves on the Board.
    Section 372(i) establishes requirements for additional 
procedures for oversight and public accountability. The 
Secretary must establish procedures for: (1) conducting public 
hearings and receiving comments from the public 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) considering the 
public comments.
    Section 372(j) includes requirements for evaluations by the 
Comptroller General of the United States.
    Section 372(j)(1) directs the Comptroller to periodically 
conduct evaluations of the Network, including its structure and 
function and the relationship between the Secretary and the 
Network. The first evaluation must be completed no later than 
one year after enactment. Thereafter, periodical evaluations 
are due every second year.
    Section 372(j)(2) requires that the Comptroller General, in 
conducting evaluations under paragraph (1), must consult with 
organizations that represent transplant surgeons, transplant 
physicians, transplant centers, organ procurement 
organizations, and other experts in the field of organ 
transplantation.
    Section 372(j)(3) requires that the Network establish 
procedures for coordinating with the Comptroller General to 
carry out required evaluations.
    Section 372(j)(4) requires that the Comptroller General 
report to Congress.
    Section 372(j)(4)(A) requires that the Comptroller General 
prepare reports describing the findings of evaluations and 
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.
    Section 372(j)(4)(B) requires that the Network respond to 
the report of the Comptroller General, within 180 days of its 
publication, on actions it has taken in response to the 
evaluation issued by the Comptroller General.
    Section 372(b) provides a rule of construction stating that 
the Act does not affect the duration of the existing contract 
that was in effect on the date of enactment of the Act.

Section 4. Additional amendments

    Section 4 makes technical and conforming amendments to Part 
H of title III of the Public Health Service Act.

Section 5. Payment of travel and subsistence expenses incurred toward 
        living organ donation

    Section 5 establishes new section 376 in Part H of title 
III of the Public Health Service Act, as amended by 4(b) of 
this Act.
    Section 376(a) permits the Secretary to make awards or 
grants for: (1) the payment of travel and expenses incurred by 
living organ donors; and (2) the payment of incidental non-
medical expenses that the Secretary determines appropriate.
    Section 376(b)(1) provides that the Secretary may make 
payments to living organ donors only if (1) the organ donor 
resides in a different State from that of the intended 
recipient, and (2) the annual income of the intended recipient 
does not exceed $35,000 (to be updated for inflation beginning 
in Fiscal Year 2001).
    Section 376(b)(2) authorizes the Secretary to make 
exceptions to the eligibility requirements specified above. The 
Secretary may provide payment of travel and expenses for 
individuals who in good faith intend to, but do not, donate an 
organ. Also, the Secretary may provide for the expenses of one 
or more family members who accompany the organ donor.
    Section 376(c)(1) requires that payment be limited to 
reasonable expenses that would be expected to travel to the 
vicinity of the transplant center nearest to the intended 
recipient.
    Section 376(c)(2) defines the term, ``covered vicinity'' as 
the vicinity of the nearest transplant center to the residence 
of the intended recipient that regularly performs transplants 
of that type of organ.
    Section 376(d) provides that the award made under 
subsection (a) will not be used to pay for the same expenses 
that have been paid for, or can reasonably be expected to be 
made by (1) any State compensation plan or Federal or State 
health benefits program, or (2) an entity that provides health 
services on a prepaid basis.
    Section 376(e) makes reference to sections in the bill that 
define the terms, ``covered vicinity,'' ``donating 
individual,'' and ``qualifying expenses.''
    Section 376(f) authorizes to be appropriated for this 
section a total of $5 million for each of Fiscal Years 2000 
through 2005.

Section 6. Public awareness; studies and demonstrations

    Section 6 adds new section 377 to Part H of title III of 
the Public Health Service Act.
    Section 377(a) requires that the Secretary carry out a 
program to educate the public on organ donation, including the 
need to provide for an adequate rate for such donations.
    Section 377(b) authorizes the Secretary to make grants to 
public and nonprofit private entities in order to carry out 
studies and demonstration projects for increasing organ 
donation.
    Section 377(c) requires that the Secretary submit to 
Congress an annual report on public awareness activities, 
including observations about the extent to which the activities 
have affected organ donation.
    Section 377(d)(1) authorizes to be appropriated a total of 
$10,000,000 for Fiscal Year 2000, and such sums as may be 
necessary for each of the Fiscal Years 2001 through 2005 for 
activities in section (6). The Secretary may not, for any one 
fiscal year, obligate more $2,000,000 for studies and 
demonstrations.

Section 7. Authorization of appropriations

    Section 378(a) authorizes to be appropriated a total of $6 
million for operation of the Network, including the Scientific 
Registry, for Fiscal Year 2000, and such sums as may be 
necessary for Fiscal Years 2001 through 2005.
    Section 378(b) authorizes such sums as necessary for 
programs to increase organ donation and procurement as required 
in section 372 of the Act for each of the Fiscal Years 2000 
through 2005.

Section 8. Effective date

    Section 8 states that provisions of the Act become 
effective on the date of enactment.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italic, existing law in which no change is 
proposed is shown in roman):

                      PUBLIC HEALTH SERVICE ACT

           *       *       *       *       *       *       *



        TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH

           *       *       *       *       *       *       *



                       Part H--Organ Transplants


                    organ procurement organizations

  Sec. 371. (a) * * *
  (b)(1) A qualified organ procurement organization for which 
grants may be made under subsection (a) is an organization 
which, as determined by the Secretary, will carry out the 
functions described in paragraph (2) and--
          (A) * * *

           *       *       *       *       *       *       *

          (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 
        which--
                  (i) granted certification or recertification 
                within the previous 4 years with such 
                certification in effect as of October 1, 1999, 
                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 defined through regulations 
                promulgated by the Secretary not later than 
                January 1, 2002, which--
                          (I) require recertifications of 
                        qualified organ procurement 
                        organizations not more frequently than 
                        once every 4 years;
                          (II) rely on performance measures 
                        that are based on empirical evidence of 
                        organ donor potential and other related 
                        factors in each service area of 
                        qualified organ procurement 
                        organizations;
                          (III) provide for the filing and 
                        approval of a corrective action plan by 
                        a qualified organ procurement 
                        organization that fails to meet the 
                        performance standards and a grace 
                        period of not less than 3 years during 
                        which such organization can implement 
                        the corrective action plan without risk 
                        of decertification; and
                          (IV) provide for a qualified organ 
                        procurement organization to appeal a 
                        decertification to the Secretary on 
                        substantive and procedural grounds;
          [(D)] (E) has procedures to obtain payment for non-
        renal organs provided to transplant centers,
          [(E)] (F) has a defined service area that is of 
        sufficient size to assure maximum effectiveness in the 
        procurement and equitable distribution of organs, and 
        that either includes an entire metropolitan statistical 
        area (as specified by the Director of the Office of 
        Management and Budget) or does not include any part of 
        the area,
          [(F)] (G) has a director and such other staff, 
        including the organ donation coordinators and organ 
        procurement specialists necessary to effectively obtain 
        organs from donors in its service area, and
          [(G)] (H) has a board of directors or an advisory 
        board which--
                  (i) * * *

           *       *       *       *       *       *       *


             [organ procurement and transplantation network

  [Sec. 372. (a) The Secretary shall by contract provide for 
the establishment and operation of an Organ Procurement and 
Transplantation Network which meets the requirements of 
subsection (b). The amount provided under such contract in any 
fiscal year may not exceed $2,000,000. Funds for such contracts 
shall be made available from funds available to the Public 
Health Service from appropriations for fiscal years beginning 
after fiscal year 1984.
  [(b)(1) The Organ Procurement and Transplantation Network 
shall carry out the functions described in paragraph (2) and 
shall--
          [(A) be a private nonprofit entity that has an 
        expertise in organ procurement and transplantation, and
          [(B) have a board of directors--
                  [(i) that includes representatives of organ 
                procurement organizations (including 
                organizations that have received grants under 
                section 371), transplant centers, voluntary 
                health associations, and the general public; 
                and
                  [(ii) that shall establish an executive 
                committee and other committees, whose 
                chairpersons shall be selected to ensure 
                continuity of leadership for the board.
  [(2) The Organ Procurement and Transplantation Network 
shall--
          [(A) establish in one location or through regional 
        centers--
                  [(i) a national list of individuals who need 
                organs, and
                  [(ii) a national system, through the use of 
                computers and in accordance with established 
                medical criteria, to match organs and 
                individuals included in the list, especially 
                individuals whose immune system makes it 
                difficult for them to receive organs,
          [(B) establish membership criteria and medical 
        criteria for allocating organs and provide to members 
        of the public an opportunity to comment with respect to 
        such criteria,
          [(C) maintain a twenty-four-hour telephone service to 
        facilitate matching organs with individuals included in 
        the list,
          [(D) assist organ procurement organizations in the 
        nationwide distribution of organs equitably among 
        transplant patients,
          [(E) 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,
          [(F) 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,
          [(G) coordinate, as appropriate, the transportation 
        of organs from organ procurement organizations to 
        transplant centers,
          [(H) provide information to physicians and other 
        health professionals regarding organ donation,
          [(I) collect, analyze, and publish data concerning 
        organ donation and transplants,
          [(J) carry out studies and demonstration projects for 
        the purpose of improving procedures for organ 
        procurement and allocation, and
          [(K) work actively to increase the supply of donated 
        organs. \1\
          [(L) 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.
  [(c) The Secretary shall establish procedures for--
          [(1) 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
          [(2) the consideration by the Secretary of such 
        critical comments.]

             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 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 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 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.
          (10) The Network shall establish criteria, policies, 
        and procedures to address the disparity in mortality 
        rates between children and adults while waiting for 
        organ transplants.
  (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 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).
                  (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 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.
  (h) 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. Such a change does not affect the membership 
        status of any Network participant, or the membership 
        status of any individual who serves on the Board (other 
        than any membership position that is predicated solely 
        on being a representative of the current contractor 
        under subsection (a)).
  (i) 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.
  (j) 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 
        second year thereafter.
          (2) Input from field.--In conducting evaluations 
        under paragraph (1), the Comptroller General shall 
        consult with organizations that represent transplant 
        surgeons, transplant physicians, transplant centers, 
        and qualified organ procurement organizations, and with 
        other experts in the field of organ transplantation, 
        including experts who are not members of the Board of 
        the Network or of the executive structure of the 
        contractor under subsection (a) .
          (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.--
                  (A) Comptroller general.--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. The Comptroller General 
                shall provide a copy of each such report to the 
                Network.
                  (B) Network.--Not later than 180 days after 
                the date on which a report is submitted under 
                subparagraph (A), the Network shall submit to 
                each of the committees specified in such 
                subparagraph a report describing any actions 
                the Network has taken in response to the report 
                under subparagraph (A).

                          [scientific registry

  [Sec. 373. 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 
respecting patients and transplant procedures as the Secretary 
deems necessary to an ongoing evaluation of the scientific and 
clinical status of organ transplantation. The Secretary shall 
prepare for inclusion in the report under section 376 an 
analysis of information derived from the registry.]

           general provisions respecting grants and contracts

  Sec. [374.] 373. (a) * * *
  (b)(1) A grant for planning under section 371(a)(1) may be 
made for one year with respect to any organ procurement 
organization and other organizations for the purpose of 
increasing the supply of transplantable organs and may not 
exceed $100,000.

           *       *       *       *       *       *       *

  (c)(1) The Secretary shall determine the amount of a grant or 
contract made under section 371 [or 373]. Payments under such 
grants and contracts may be made in advance on the basis of 
estimates or by the way of reimbursement, with necessary 
adjustments on account of underpayments or overpayments, and in 
such installments and on such terms and conditions as the 
Secretary finds necessary to carry out the purposes of such 
grants and contracts.
  (2)(A) Each recipient of a grant or contract under section 
371 [or 373] shall keep such records as the Secretary shall 
prescribe, including records which fully disclose the amount 
and disposition by such recipient of the proceeds of such grant 
or contract, the total cost of the undertaking in connection 
with which such grant or contract was made, and the amount of 
that portion of the cost of the undertaking supplied by other 
sources, and such other records as will facilitate an effective 
audit.
  (B) The Secretary and the Comptroller General of the United 
States, or any of their duly authorized representatives, shall 
have access for the purpose of audit and examination to any 
books, documents, papers, and records of the recipient of a 
grant or contract under section 371 [or 373] that are pertinent 
to such grant or contract.
  (d) For purposes of this part:
          (1) The term ``transplant center'' means a health 
        care facility in which transplants of organs are 
        performed.
          [(2) The term ``organ'' means the human kidney, 
        liver, heart, lung, pancreas, and any other human organ 
        (other than corneas and eyes) specified by the 
        Secretary by regulation and for purposes of section 
        373, such term includes bone marrow.]
          (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.

                             administration

  Sec. [375.] 374. The Secretary shall designate and maintain 
an identifiable administrative unit in the Public Health 
Service to--
          (1) administer this [part] section and coordinate 
        with the organ procurement activities under title XVIII 
        of the Social Security Act,

           *       *       *       *       *       *       *

          (4) provide information--
                  [(i)] (A) to patients, their families, and 
                their physicians about transplantation; and
                  [(ii)] (B) to patients and their families 
                about the resources available nationally and in 
                each State, and the [comparative costs and 
                patient outcomes] comparative patient outcomes 
                at each transplant center affiliated with the 
                organ procurement and transplantation network, 
                in orderto assist the patients and families 
with the costs associated with transplantation.

                                 report

  Sec. [376.] 375. Not later than February 10 of 1991 and of 
each second year thereafter, [the Secretary] the Organ 
Procurement and Transplantation Network under section 372 shall 
publish, and submit to the [Committee on Energy and Commerce] 
Committee on Commerce of the House of Representatives and the 
Committee on Labor and Human Resources of the Senate, a report 
on the scientific and clinical status of organ transplantation. 
The Secretary shall consult with the Director of the National 
Institutes of Health and the Commissioner of the Food and Drug 
Administration in the preparation of the report.

[SEC. 377. STUDY BY GENERAL ACCOUNTING OFFICE.

  [(a) In General.--The Comptroller General of the United 
States shall conduct a study for the purpose of determining--
          [(1) the extent to which the procurement and 
        allocation of organs have been equitable, efficient, 
        and effective;
          [(2) the problems encountered in the procurement and 
        allocation; and
          [(3) the effect of State required-request laws.
  [(b) Report.--Not later than January 7, 1992, the Comptroller 
General of the United States shall complete the study required 
in subsection (a) and submit to the Committee on Energy and 
Commerce of the House of Representatives, and to the Committee 
on Labor and Human Resources of the Senate, a report describing 
the findings made as a result of the study.]


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.


              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.
  (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. 378. AUTHORIZATION OF APPROPRIATIONS.

  [For the purpose of carrying out this part, there are 
authorized to be appropriated $8,000,000 for fiscal year 1991, 
and such sums as may be necessary for each of the fiscal years 
1992 and 1993.]


       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).

           *       *       *       *       *       *       *


                            DISSENTING VIEWS

    H.R. 2418 overturns the principles which have governed the 
Nation's organ allocation system for fifteen years. The bill 
raises fatal constitutional concerns and irresponsibly inverts 
the roles of the Federal government and its contractor. In the 
end, H.R. 2418 poses a threat to the hopes and health of 
transplant patients and their families.
    The National Organ Transplant Act of 1984 (NOTA) created 
the Organ Procurement and Transplantation Network (OPTN), a 
national organ allocation system overseen by the Secretary of 
Health and Human Services. Congress created the OPTN because 
``[a]n equitable policy and system is necessary so that 
individuals throughout our country can have access to organ 
transplantation when appropriate and necessary.''
    Since 1984, Congress has emphasized repeatedly that the 
OPTN should serve all Americans as equitably as possible. The 
Organ Transplant Amendments Act of 1987 recognized that the 
OPTN was created ``in order to facilitate an equitable 
allocation of organs'' across the country. In the Transplant 
Amendments Act of 1990, Congress stressed that the OPTN was to 
assist ``in the nationwide distribution of organs equitably 
among transplant patients.'' In 1996, the Senate passed a 
bipartisan NOTA reauthorization bill by unanimous consent, only 
to have this Committee fail to act on this important 
legislation. The Senate advised this Committee--

          The original intent of the National Organ Transplant 
        Act was to assure patients that no matter who they were 
        or where they lived, they would have a fair chance of 
        receiving an organ transplant. It is the belief of the 
        committee that the United States should adopt a 
        consistent and fair system of allocation and move away 
        from the persistent fragmentation and inconsistency 
        that may have evolved despite the National Organ 
        Transplant Act.

    In furthering the goal of a ``consistent and fair system of 
allocation,'' the Secretary published the Final Rule governing 
the OPTN on April 2, 1998. Because of the OPTN's failure to 
remedy geographical and ethnic inequities across the country, 
the Final Rule calls for more equitable sharing of organs and 
for uniform, objective criteria for patient listing. As the 
Final Rule states, it ``does not establish specific allocation 
policies, but instead looks to the organ transplant community 
to take action to meet the performance goals.''
    We believe this approach to be wholly consistent with the 
intent of Congress. Allocation policies must be developed 
``bottom up'' through the expertise and experience of patients 
and practitioners. But the Secretary is given oversight 
authority to ensure those policies reflect the public interest. 
When those policies fail to achieve the ends envisioned by 
Congress, as they are failing today, the Secretary plays an 
indispensable role in correcting these failures.
    The Final Rule has been supported by the major transplant 
patient organizations, including the American Liver Foundation, 
Transplant Recipients International Organization and the 
National Transplant Action Committee. But the efforts of the 
current OPTN contractor, the United Network for Organ Sharing 
(UNOS), to derail the Final Rule have had a corrosive effect on 
public confidence in the organ allocation system. 
Misinformation has been spread to frightenpatients, communities 
of color, and the poor. Patient listing fees which should have been 
expended on health care have been squandered on a lobbying and public 
relations campaign.
    The result has been genuine harm to the public health. The 
organ allocation system is an inequitable patchwork of ad hoc 
sharing or parochial hoarding. Patients live or die based on 
where they live--not on how sick they are. African Americans 
and the poor continue to face disproportionate barriers to 
referrals, waiting lists, and transplants. Most recently, 
states including Louisiana, Texas and Wisconsin have enacted 
hoarding laws intended to impede organ sharing. And to crown 
this dismal record, a one-year moratorium on the Final Rule's 
implementation was enacted in the Omnibus Appropriations Act of 
1999 (P.L. 105-277).
    The provision which blocked the Final Rule also mandated an 
Institute of Medicine (IOM) study of the organ procurement and 
transplantation system. The study advocates major changes in 
the organ allocation system and endorses active oversight by 
the Secretary. The IOM ``recommends that the DHHS Final Rule be 
implemented'' because broader sharing ``will result in more 
opportunities to transplant sicker patients without adversely 
affecting less sick patients.'' The study dismisses claims that 
donation rates would suffer or small transplant centers would 
close under the Final Rule.
    Perhaps most importantly, the IOM cites the need for strong 
federal oversight of the allocation system, concluding--

          The Department of Health and Human Services should 
        exercise the legitimate oversight responsibilities 
        assigned to it by the National Organ Transplant Act, 
        and articulated in the Final Rule, to manage the system 
        of organ procurement and transplantation in the public 
        interest.

    In contrast, H.R. 2418 completely eliminates meaningful 
oversight of the OPTN. It divests the Secretary of any 
authority to require anything of the OPTN. Functions of a 
``scientific, clinical, or medical'' nature would be in the 
``sole discretion'' of the OPTN. As the bill's sponsors readily 
acknowledge, this encompasses practically everything of 
meaning, including the Nation's organ allocation and 
transplantation policies.
    Moreover, any changes to those few minor ``administrative 
and procedural functions'' remaining under the Secretary's 
purview would require the ``mutual agreement'' of the Secretary 
and the OPTN. H.R. 2418 advances the absurd proposition that 
the OPTN should exercise an absolute veto over any proposed 
changes to the organ allocation system, whether they affect the 
number of organs it allocates or the number of paper clips it 
purchases. Indeed, were H.R. 2418 to become law, nothing short 
of an act of Congress would serve to alter the nation's organ 
allocation system in the absence of the OPTN's autocratic 
consent.
    The fallacy of shielding the OPTN from accountability and 
oversight by the Secretary is compounded, in the view of the 
Department of Justice, by ``significant constitutional concerns 
involving the separation of powers.'' In creating an 
unregulated monopoly affecting the lives andhealth of 
Americans, the Department regards H.R. 2418 as an unconstitutional 
delegation of authority to a private entity because it ``goes beyond * 
* * permissible forms of legislation by actually giving to a private 
organization regulatory authority unfettered by executive 
involvement.''
    Were H.R. 2418 to become law and somehow survive 
constitutional challenge, it would fail to accomplish what its 
sponsors claim they desire--insulate the organ allocation 
system from politics and bureaucrats. By eliminating 
Secretarial oversight, H.R. 2418 simply invests private 
bureaucrats with absolute life-and-death authority and the 
freedom to exercise it in settling their institutional disputes 
or professional rivalries.
    H.R. 2418 is also silent regarding state laws. The sponsors 
acknowledge that a state law would prevail in a conflict with 
the OPTN's policies--ensuring inevitable conflicts with state 
hoarding laws and other statutes affecting the availability of 
organs. But in liberating the OPTN from what the sponsors 
perceive to be the burden of Secretarial oversight, they 
condemn it to a certain `death of a thousand cuts' from 
conflicting state mandates.
    The bill would exacerbate a perennial problem with UNOS. 
Public knowledge about the performance of the OPTN has been 
limited because of restrictions UNOS placed on access to 
essential patient outcome data. For many years, the Department 
faced fierce resistance to its efforts to obtain such data from 
its own contractor. Only in the past few weeks did UNOS make 5-
year-old, transplant center-specific data available to the 
public.
    This week, at the request of members of this Committee, the 
Department released a report providing up-to-date patient 
outcome data for the first time on more than 100 transplant 
centers across the country. The data revealed ``a wide 
variation in center-specific outcomes,'' including a three-fold 
difference in the chances of getting a liver or heart 
transplant at centers farthest from the national average. The 
odds of dying while on the waiting list varied by 300 percent 
for liver patients and 250 percent for heart patients.
    Such data should have already been available to the public. 
But in order to compel UNOS to disclose the data analyzed by 
the Department, Congress had to enact a law at the time the 
moratorium on the Final Rule was enacted. Under H.R. 2418, 
however, such data would only be available to a narrow category 
of listed patients--not to the public or the Secretary. The 
bill would thus enable the OPTN to conceal vital data from 
public scrutiny.
    H.R. 2418 is also laden with measures blatantly intended to 
protect UNOS, the incumbent contractor, from competition. For 
example, the bill provides that a new contractor selected by 
the Secretary must also meet with the ``written endorsement of 
a majority'' of the OPTN's members. Such a requirement makes a 
mockery of bidding out an essential government contract, and is 
inconsistent with the Federal Acquisition Regulation, which 
mandates competition in all government contracts.
    H.R. 2418 has other serious substantive flaws, but of those 
remaining, the most troubling must be the manner in which it 
opens the organ allocation system to potential financial 
abuses. Donated organs are the `gift of life,' not commodities. 
Yet the bill as introduced would have emasculated our country's 
long-standing ban on the sale of organs.
    The bill also dispenses with any limits to the OPTN's 
``accepting gifts of money or services.'' It is silent about 
what potential influence such gifts might have on a patient's 
status on a waiting list. It fails to bar preferential 
treatment on the basis of such gifts. While ``economic status'' 
is a prohibited factor in allocation decisions, ``gifts'' are 
not.
    Finally, H.R. 2418 includes an additional carve-out of the 
OPTN's finances from Secretarial oversight. Nonappropriated 
revenue, such as patient listing fees, would be free from 
``restriction or control by the Secretary.'' Patients have no 
choice in paying the listing fees. If they do not, they have no 
chance of receiving a transplant. The bill would allow UNOS or 
its successor to set those fees as high as they wished, and use 
those monies for any purpose, including lobbying or other 
political activities. Under H.R. 2418, the Secretary and the 
public would be unable to stop this misuse of funds.
    Despite its many flaws and unsound foundation, H.R. 2418 is 
most dangerous as a blunt political instrument, not as 
prospective law. The Secretary of Health and Human Services has 
already written this Committee that she would recommend the 
President veto the bill in its present form. The Department of 
Justice has written of its profound constitutional defects. 
Instead, H.R. 2418 is primarily intended to provide momentum to 
the legislative effort to extend a moratorium on the Final 
Rule.
    On October 18 the Secretary fulfilled her commitment to 
revise the Final Rule to account for many of the concerns 
raised by the IOM report, UNOS and other stakeholders. We 
believe that implementation of the revised regulation should be 
allowed to proceed. We are ever hopeful that a variety of 
factors will come together and compromise will be achieved. The 
moratorium will expire imminently. Even UNOS has adopted 
broader organ sharing policies, albeit in an effort to preempt 
the Final Rule. Our hope is that such progress will benefit 
patients and simply render the extreme provisions of H.R. 2418 
irrelevant.

                                   John D. Dingell.
                                   Ron Klink.
                                   Bobby L. Rush.
                                   Edolphus Towns.
                                   Henry A. Waxman.
                                   Albert R. Wynn.
                                   Ted Strickland.
                                   Sherrod Brown.
                                   Tom Sawyer.
                                   Edward J. Markey.

                                  
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