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[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[S. 2366 Reported in Senate (RS)]

                                                       Calendar No. 509

106th CONGRESS

  2d Session

                                S. 2366

_______________________________________________________________________

                                 A BILL

To amend the Public Health Service Act to revise and extend provisions 
     relating to the Organ Procurement and Transplantation Network.

_______________________________________________________________________

                             April 13, 2000

                       Reported with an amendment

                                                       Calendar No. 509
106th CONGRESS
  2d Session
                                S. 2366

To amend the Public Health Service Act to revise and extend provisions 
     relating to the Organ Procurement and Transplantation Network.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                             April 5, 2000

    Mr. Frist (for himself, Mr. Jeffords, Mr. Gregg, Mr. Enzi, Mr. 
 Hutchinson, Ms. Collins, Mr. Brownback, Mr. Hagel, Mr. Sessions, Mr. 
  Nickles, and Mr. Feingold) introduced the following bill; which was 
 read twice and referred to the Committee on Health, Education, Labor, 
                              and Pensions

                             April 13, 2000

              Reported by Mr. Jeffords, with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 A BILL

 
To amend the Public Health Service Act to revise and extend provisions 
     relating to the Organ Procurement and Transplantation Network.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

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

<DELETED>SEC. 2. ORGAN PROCUREMENT AND TRANSPLANTATION 
              NETWORK.</DELETED>

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

<DELETED>``SEC. 372. ORGAN PROCUREMENT AND TRANSPLANTATION 
              NETWORK.</DELETED>

<DELETED>    ``(a) Establishment of Network.--</DELETED>
        <DELETED>    ``(1) In general.--An Organ Procurement and 
        Transplantation Network (in this section referred to as the 
        `Network' or the `OPTN') is established as a private network 
        and shall operate under this section.</DELETED>
        <DELETED>    ``(2) Requirements.--The Network shall--</DELETED>
                <DELETED>    ``(A) in accordance with criteria 
                developed under subsection (c)(1)(B), include as 
                members of the Network 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 shall be referred to 
                in this section as `Network participants'); 
                and</DELETED>
                <DELETED>    ``(B) have a policy board (referred to in 
                this section as the `OPTN Board') that meets the 
                requirements of subsection (b).</DELETED>
<DELETED>    ``(b) OPTN Policy Board.--</DELETED>
        <DELETED>    ``(1) Composition.--The OPTN Board shall be 
        composed of not more than 36 voting members to be elected under 
        paragraph (2) and 5 nonvoting, ex officio members appointed 
        under paragraph (3).</DELETED>
        <DELETED>    ``(2) Elected members.--</DELETED>
                <DELETED>    ``(A) In general.--The voting members of 
                the OPTN Board shall be elected by the members of the 
                Network described in subsection (a)(2)(A), from among 
                the nominees submitted under subparagraph (B), through 
                a fair and open process.</DELETED>
                <DELETED>    ``(B) Nominating committee.--The 
                nominating committee established under paragraph (5) 
                shall, prior to each election of OPTN Board members 
                under this paragraph, develop a list of nominees for 
                such election. Such list shall reflect the diversity of 
                Network members described in subsection (a)(2)(A), 
                including factors such as program type and size and 
                geographic location. Recommendations may be submitted 
                to the nominating committee by the Secretary, the 
                members of the Network described in subsection 
                (a)(2)(A), or the general public.</DELETED>
                <DELETED>    ``(C) Qualifications.--The OPTN Board 
                shall be composed of--</DELETED>
                        <DELETED>    ``(i) transplant surgeons and 
                        transplant physicians;</DELETED>
                        <DELETED>    ``(ii) representatives of 
                        qualified organ procurement organizations, 
                        transplant centers, voluntary health 
                        associations, or the general public, including 
                        patients awaiting a transplant or transplant 
                        recipients or individuals who have donated an 
                        organ, or the family members of such patients, 
                        recipients or donors; and</DELETED>
                        <DELETED>    ``(iii) individuals distinguished 
                        in the fields of ethics, basic, clinical and 
                        health services research, biostatistics, health 
                        care policy, or health care economics or 
                        financing.</DELETED>
                <DELETED>    ``(D) Representation requirement.--The 
                OPTN Board shall be structured to ensure that--
                </DELETED>
                        <DELETED>    ``(i) at least 50 but not more 
                        than 55 percent of the members elected under 
                        this paragraph are transplant surgeons and 
                        transplant physicians; and</DELETED>
                        <DELETED>    ``(ii) at least 20 but not more 
                        than 25 percent of the members elected under 
                        this paragraph are transplant candidates, 
                        transplant recipients, organ donors and family 
                        members of such individuals.</DELETED>
                <DELETED>Nothing in this subparagraph shall be 
                construed to preclude an individual voting member of 
                the OPTN Board from being a representative described in 
                each of clauses (i) and (iii) or (ii) and (iii) of 
                subparagraph (C) so long as the limitation described in 
                clause (i) of this subparagraph is complied 
                with.</DELETED>
        <DELETED>    ``(3) Appointed members.--</DELETED>
                <DELETED>    ``(A) In general.--The Secretary shall 
                appoint as ex officio, nonvoting members of the OPTN 
                Board, 1 representative from each of the 
                following:</DELETED>
                        <DELETED>    ``(i) The Health Resources and 
                        Services Administration.</DELETED>
                        <DELETED>    ``(ii) The National Institutes of 
                        Health.</DELETED>
                        <DELETED>    ``(iii) The Health Care Financing 
                        Administration.</DELETED>
                        <DELETED>    ``(iv) The Agency for Healthcare 
                        Research and Quality.</DELETED>
                <DELETED>    ``(B) Network administrator.--The Network 
                Administrator shall appoint an ex officio nonvoting 
                member of the OPTN Board.</DELETED>
        <DELETED>    ``(4) Terms of elected members.--</DELETED>
                <DELETED>    ``(A) In general.--Except as provided for 
                in this paragraph, members of the OPTN Board elected 
                under paragraph (2) shall serve for a term of 3 years 
                and may be re-elected.</DELETED>
                <DELETED>    ``(B) New members.--To ensure the 
                staggered rotation of </DELETED>\<DELETED>1/
                3</DELETED>\ <DELETED>of the elected members of the 
                OPTN Board each year, the initial members of the OPTN 
                Board elected under paragraph (2) shall serve for terms 
                of 1, 2, or 3 years respectively as designated by the 
                nominating committee.</DELETED>
                <DELETED>    ``(C) Transition.--Consistent with 
                subsection (c)(3), the voting members of the OPTN Board 
                who are serving on the date of enactment of the Organ 
                Procurement and Transplantation Network Amendments Act 
                of 2000 may continue to serve until the expiration of 
                their terms. Upon such termination, the nominating 
                committee, in submitting nominations to fill such 
                vacancies, shall ensure the staggered rotation of 
                </DELETED>\<DELETED>1/3</DELETED>\ <DELETED>of the 
                members elected under paragraph (2) every 3 
                years.</DELETED>
                <DELETED>    ``(D) Contract status.--A change in the 
                status of a contract under subsection (f), or a change 
                in the contractor, shall not affect the terms of the 
                members of the OPTN Board.</DELETED>
        <DELETED>    ``(5) Chairperson and committees.--The OPTN Board 
        shall have a chairperson, an executive committee, a nominating 
        committee, a membership committee, and such other committees as 
        the OPTN Board determines to be appropriate.</DELETED>
<DELETED>    ``(c) General Functions of the OPTN Board.--</DELETED>
        <DELETED>    ``(1) Establishment of network policies and 
        criteria.--The OPTN Board shall--</DELETED>
                <DELETED>    ``(A) after consultation with Network 
                participants and the Network Administrator, establish 
                and carry out the policies and functions described in 
                this section for the Network;</DELETED>
                <DELETED>    ``(B) establish membership criteria for 
                participating in the Network;</DELETED>
                <DELETED>    ``(C) establish medical criteria for 
                allocating organs and for listing and de-listing 
                patients on the national lists maintained under 
                paragraph (2); and</DELETED>
                <DELETED>    ``(D) establish performance criteria for 
                transplant programs.</DELETED>
        <DELETED>    ``(2) National system.--The OPTN Board shall 
        maintain a national system to match organs and individuals who 
        need organ transplants. The national system shall--</DELETED>
                <DELETED>    ``(A) have 1 or more lists of individuals 
                who are in need of organ transplants; and</DELETED>
                <DELETED>    ``(B) be operated in accordance with 
                Network policies and criteria established under 
                paragraph (1).</DELETED>
        <DELETED>    ``(3) No fiduciary responsibility.--The OPTN Board 
        shall have no voting member who has any fiduciary 
        responsibility to the entity that holds the contract provided 
        for under this section.</DELETED>
        <DELETED>    ``(4) OPTN board requirements.--The OPTN Board 
        shall cooperate with the Network Administrator to ensure 
        compliance with the requirements of this section including the 
        contract entered into under subsection (f).</DELETED>
<DELETED>    ``(d) Organ Transplant Policy.--The OPTN Board shall 
establish organ transplant policies, including organ allocation 
policies for potential organ recipients and policies that affect 
patient outcomes. Such policies shall--</DELETED>
        <DELETED>    ``(1) be based on sound medical 
        principles;</DELETED>
        <DELETED>    ``(2) be based on valid scientific data;</DELETED>
        <DELETED>    ``(3) be equitable;</DELETED>
        <DELETED>    ``(4) seek to achieve the best use of donated 
        organs;</DELETED>
        <DELETED>    ``(5) be designed to avoid wasting organs, to 
        avoid futile transplants and reduce the risk of 
        retransplantation, to promote patient access to 
        transplantation, and to promote the efficient management of 
        organ placement;</DELETED>
        <DELETED>    ``(6) be specific for each organ type or 
        combination of organ types;</DELETED>
        <DELETED>    ``(7) be based on standardized medical criteria 
        for listing and de-listing candidates from organ transplant 
        waiting lists;</DELETED>
        <DELETED>    ``(8) determine priority rankings (within 
        categories as appropriate) for candidates who are medically 
        suitable for transplantation, such rankings shall be based on 
        standardized medical criteria and ordered according to medical 
        urgency and medical appropriateness;</DELETED>
        <DELETED>    ``(9) seek distribution of organs as appropriate 
        based on paragraphs (1) through (8);</DELETED>
        <DELETED>    ``(10) develop and apply appropriate performance 
        indicators, including patient-focused indicators, to assess 
        transplant program performance and reduce inter-transplant 
        program variance to improve program performance; and</DELETED>
        <DELETED>    ``(11) seek to reduce disparities in 
        transplantation resulting from socioeconomic status, race, 
        ethnicity, or being medically underserved.</DELETED>
<DELETED>    ``(e) Enforcement of Organ Transplant Policy.--</DELETED>
        <DELETED>    ``(1) In general.--</DELETED>
                <DELETED>    ``(A) Proposed policy.--This paragraph 
                shall apply to any proposed transplant policy that is 
                developed by the OPTN Board that the Board or the 
                Secretary determines should be enforced under this 
                section or under section 1138 of the Social Security 
                Act.</DELETED>
                <DELETED>    ``(B) Submission of policy.--Not later 
                than 60 days prior to the implementation of a proposed 
                policy described in subparagraph (A), the OPTN Board 
                shall submit such proposed policy to the 
                Secretary.</DELETED>
                <DELETED>    ``(C) Publication.--Upon receipt of a 
                proposed policy under subparagraph (B), the Secretary 
                shall publish the policy in the Federal Register for a 
                60-day public comment period.</DELETED>
                <DELETED>    ``(D) Action by secretary.--Not later than 
                90 days after receipt of a proposed policy under 
                subparagraph (B), the Secretary shall consider public 
                comments received under subparagraph (C) and shall--
                </DELETED>
                        <DELETED>    ``(i) notify the OPTN Board that 
                        the policy is consistent with this section and 
                        therefore enforceable; or</DELETED>
                        <DELETED>    ``(ii) notify the OPTN Board that 
                        the policy is inconsistent with this section 
                        and direct the Board to reconsider and revise 
                        the policy consistent with the recommendations 
                        of the Secretary.</DELETED>
                <DELETED>    ``(E) Reconsideration.--</DELETED>
                        <DELETED>    ``(i) In general.--Not later than 
                        30 days after receiving a notice from the 
                        Secretary under subparagraph (D)(ii), the OPTN 
                        Board shall reaffirm the proposed policy or 
                        revise and submit such revised policy to the 
                        Secretary.</DELETED>
                        <DELETED>    ``(ii) Action by secretary.--Not 
                        later than 30 days after receiving a revised 
                        policy under clause (i), the Secretary shall--
                        </DELETED>
                                <DELETED>    ``(I) notify the OPTN 
                                Board that the revised policy is 
                                consistent with this section and 
                                therefore enforceable; or</DELETED>
                                <DELETED>    ``(II) notify the OPTN 
                                Board that the revised policy is 
                                inconsistent with this section and 
                                submit the revised policy, with the 
                                comments and proposed revisions of the 
                                Secretary, to the Scientific Advisory 
                                Committee on Organ Transplantation 
                                (referred to in this subsection as the 
                                `Committee') established under 
                                paragraph (2).</DELETED>
                        <DELETED>    ``(iii) Action by committee.--Not 
                        later than 30 days after the submission of a 
                        revised policy to the Committee under clause 
                        (ii), the Committee may, by a majority vote, 
                        disapprove the comments or revision of the 
                        Secretary. If the Committee disapproves such 
                        comments or revisions, the revised policy shall 
                        not take effect until a majority of the 
                        Committee approves the policy or the revisions 
                        to such policy.</DELETED>
        <DELETED>    ``(2) Scientific advisory committee on organ 
        transplantation.--</DELETED>
                <DELETED>    ``(A) Establishment.--The Secretary shall 
                establish an advisory committee to be known as the 
                Scientific Advisory Committee on Organ Transplantation. 
                Consistent with the requirements of sections 5 and 10 
                of the Federal Advisory Committee Act--</DELETED>
                        <DELETED>    ``(i) the deliberations of the 
                        Committee shall not be inappropriately 
                        influenced by the Secretary or by any special 
                        interest and shall only be the result of the 
                        independent judgment of the Committee; 
                        and</DELETED>
                        <DELETED>    ``(ii) the meetings of the 
                        Committee shall be open to the public, advance 
                        notice of meetings shall be published in the 
                        Federal Register, and records or minutes of 
                        meetings shall be made available to the 
                        public.</DELETED>
                <DELETED>    ``(B) Duties.--The Committee shall make 
                recommendations with respect to policy matters related 
                to reviews conducted under paragraph 
                (1)(E)(ii)(II).</DELETED>
                <DELETED>    ``(C) Membership.--The Committee shall be 
                composed of 15 members, of which--</DELETED>
                        <DELETED>    ``(i) five members shall be 
                        appointed by the Secretary from nominations 
                        submitted by the OPTN Board under subparagraph 
                        (D);</DELETED>
                        <DELETED>    ``(ii) five members shall be 
                        appointed by the Secretary from nominations 
                        submitted by the Institute of Medicine under 
                        subparagraph (D); and</DELETED>
                        <DELETED>    ``(iii) five members shall be 
                        appointed by the Secretary.</DELETED>
                <DELETED>    ``(D) Nominations.--The OPTN Board and the 
                Institute of Medicine shall each nominate, in an 
                independent manner, 5 qualified individuals to serve on 
                the Committee.</DELETED>
                <DELETED>    ``(E) Qualifications.--In appointing 
                individuals to serve on the Committee under 
                subparagraph (C), the Secretary shall ensure that--
                </DELETED>
                        <DELETED>    ``(i) nine members are transplant 
                        physicians or transplant surgeons of whom--
                        </DELETED>
                                <DELETED>    ``(I) 3 shall be selected 
                                from the nominations submitted by the 
                                OPTN Board; and</DELETED>
                                <DELETED>    ``(II) 3 shall be selected 
                                from the nominations submitted by the 
                                Institute of Medicine; and</DELETED>
                        <DELETED>    ``(ii) the remaining members are 
                        individuals who are--</DELETED>
                                <DELETED>    ``(I) distinguished in the 
                                fields of ethics, basic, clinical or 
                                health services research, 
                                biostatistics, or health care policy, 
                                economics or financing; or</DELETED>
                                <DELETED>    ``(II) transplant 
                                candidates, transplant recipients, 
                                organ donors or family members of such 
                                individuals.</DELETED>
                <DELETED>    ``(F) Experts.--The Committee shall seek 
                advice from appropriate experts, as needed, to evaluate 
                the proposed policy and revisions under 
                review.</DELETED>
                <DELETED>    ``(G) Chairperson.--The members of the 
                Committee shall elect a member to serve as the 
                chairperson of the Committee.</DELETED>
                <DELETED>    ``(H) Terms.--Members of the Committee 
                shall serve for a term of 5 years. Vacancies shall be 
                filled in the same manner as the original appointment 
                was made.</DELETED>
<DELETED>    ``(f) Network Administration and Operation.--The Secretary 
shall contract with a nonprofit private entity (referred to in this 
section as the `Network Administrator') for the administration and 
operation of the Network. The Network Administrator shall administer 
and operate the OPTN Board in accordance with subsection (b). The 
Network Administrator shall, pursuant to the policies and criteria 
established by the OPTN Board--</DELETED>
        <DELETED>    ``(1) maintain and operate a national system as 
        established by the OPTN Board to match organs and individuals 
        who need organ transplants;</DELETED>
        <DELETED>    ``(2) operate in accordance with medical criteria 
        established by the OPTN Board, and administer the national 
        system established under subsection (c)(2);</DELETED>
        <DELETED>    ``(3) maintain 1 or more lists of individuals who 
        need organ transplants as provided for under subsection 
        (c)(2)(A);</DELETED>
        <DELETED>    ``(4) maintain a 24-hour communication service to 
        facilitate matching organs with individuals included on the 
        list or lists;</DELETED>
        <DELETED>    ``(5) assist organ procurement organizations in 
        obtaining and distributing organs in accordance with the 
        policies established by the OPTN Board;</DELETED>
        <DELETED>    ``(6) adopt and use standards of quality for the 
        acquisition and transportation of donated organs, including 
        standards regarding the transmission of infectious 
        diseases;</DELETED>
        <DELETED>    ``(7) 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 in order to facilitate matching the 
        compatibility of such individuals with organ donors;</DELETED>
        <DELETED>    ``(8) coordinate, as appropriate, the 
        transportation of organs from organ procurement organizations 
        to transplant centers;</DELETED>
        <DELETED>    ``(9) provide information to physicians, health 
        care professionals, and the general public regarding organ 
        donation;</DELETED>
        <DELETED>    ``(10) carry out studies and demonstration 
        projects for the purpose of improving procedures for organ 
        procurement and allocation; and</DELETED>
        <DELETED>    ``(11) work actively with organ procurement 
        organizations, transplant centers, health care providers, and 
        the public to increase the supply of donated organs.</DELETED>
<DELETED>    ``(g) Data Collection, Analysis and Distribution.--
</DELETED>
        <DELETED>    ``(1) In general.--The Network Administrator shall 
        analyze, maintain, verify, make available and publish timely 
        data to the extent necessary to--</DELETED>
                <DELETED>    ``(A) enable the OPTN Board to fulfill its 
                responsibilities under this section;</DELETED>
                <DELETED>    ``(B) assess the compliance of members of 
                the Network with performance and other criteria 
                developed pursuant to subsection (c)(1);</DELETED>
                <DELETED>    ``(C) evaluate the quality of care 
                provided to transplant candidates and patients 
                generally and in an individual program;</DELETED>
                <DELETED>    ``(D) provide data needed by the 
                Scientific Registry maintained pursuant to section 
                373;</DELETED>
                <DELETED>    ``(E) provide transplant candidates and 
                patients, physicians and others with information needed 
                to evaluate or select a transplant program;</DELETED>
                <DELETED>    ``(F) provide a member of the Network with 
                data about the member, including results of analysis or 
                other processing of data originally supplied by the 
                member;</DELETED>
                <DELETED>    ``(G) enable the OPTN Board, the Network 
                Administrator and the Secretary to fulfill respective 
                enforcement and oversight responsibilities under 
                subsections (j) and (k); and</DELETED>
                <DELETED>    ``(H) comply with the requirements under 
                subsection (l).</DELETED>
        <DELETED>    ``(2) Types of data.--Data provided under 
        paragraph (1) shall include--</DELETED>
                <DELETED>    ``(A) data on transplant candidates, 
                transplant recipients, organ donors, donated organs, 
                and transplant programs; and</DELETED>
                <DELETED>    ``(B) as appropriate, data, graft- and 
                patient-survival rates (actual and adjusted to reflect 
                program-specific population disease severity), program 
                specific data, and aggregate data.</DELETED>
<DELETED>    ``(h) Contract.--The contract under subsection (f) shall--
</DELETED>
        <DELETED>    ``(1) be awarded through a process of competitive 
        bidding as determined by the Secretary; and</DELETED>
        <DELETED>    ``(2) be awarded for a period of no longer than 5 
        years.</DELETED>
<DELETED>    ``(i) Network Membership and Patient Registration Fee.--
</DELETED>
        <DELETED>    ``(1) In general.--The Network Administrator may 
        assess a fee, to be collected by the Network Administrator, for 
        membership in the Network (to be known as the `Network 
        membership fee'), and for the listing of each potential 
        transplant recipient on the national organ matching system 
        maintained by the Network Administrator (to be known as the 
        `patient registration fee'), in an amount determined under 
        paragraph (2).</DELETED>
        <DELETED>    ``(2) Amount.--The amounts of the fees to be 
        assessed under paragraph (1) shall be calculated so as to be--
        </DELETED>
                <DELETED>    ``(A) reasonable and customary; 
                and</DELETED>
                <DELETED>    ``(B) sufficient to cover the Network's 
                reasonable costs of operation in accordance with this 
                section.</DELETED>
        <DELETED>    ``(3) Annual recalculation.--</DELETED>
                <DELETED>    ``(A) In general.--The fees calculated 
                under paragraph (2) shall be annually recalculated, 
                based on--</DELETED>
                        <DELETED>    ``(i) changes in the level or cost 
                        of contract tasks and other activities related 
                        to organ procurement and transplantation; 
                        and</DELETED>
                        <DELETED>    ``(ii) changes in expected 
                        revenues from contract funds, Network 
                        membership fees and patient registration fees 
                        available to the Network 
                        Administrator.</DELETED>
                <DELETED>    ``(B) Procedure.--</DELETED>
                        <DELETED>    ``(i) Proposal.--The Network 
                        Administrator shall submit to the Secretary a 
                        written proposal for, and justification of, a 
                        recalculated fee under subparagraph 
                        (A).</DELETED>
                        <DELETED>    ``(ii) Determination.--The 
                        proposal of the Network Administrator for a 
                        recalculated fee under clause (i) shall take 
                        effect unless the Secretary, within 60 days of 
                        receiving the proposal, provides the Network 
                        Administrator with a written determination, 
                        with justification, that the proposed fee level 
                        does not meet the requirement of subparagraph 
                        (A).</DELETED>
        <DELETED>    ``(4) Use of fees.--</DELETED>
                <DELETED>    ``(A) In general.--All fees collected by 
                the Network Administrator under this subsection shall 
                be available to the Network, without fiscal year 
                limitation, for use in carrying out the functions 
                described in subsection (f).</DELETED>
                <DELETED>    ``(B) Restriction.--Fees collected under 
                this subsection may not be used for any activity for 
                which contract funds may not be used under this 
                section.</DELETED>
        <DELETED>    ``(5) Rule of construction.--Nothing in this 
        subsection shall be construed as prohibiting the Network 
        Administrator from collecting or accepting other fees, 
        donations or gifts or for using such other fees, donations or 
        gifts to carry out activities other than those authorized under 
        the contract under this section.</DELETED>
<DELETED>    ``(j) Oversight of Network Participants.--</DELETED>
        <DELETED>    ``(1) Monitoring.--</DELETED>
                <DELETED>    ``(A) In general.--The OPTN Board and the 
                Network Administrator shall, on an ongoing and periodic 
                basis, or as requested by the Secretary, monitor the 
                operations of Network participants to determine whether 
                the participants are maintaining compliance with the 
                criteria and policies established by the OPTN 
                Board.</DELETED>
                <DELETED>    ``(B) Procedures.--</DELETED>
                        <DELETED>    ``(i) Notice.--In monitoring a 
                        Network participant under subparagraph (A), the 
                        OPTN Board or the Administrator--</DELETED>
                                <DELETED>    ``(I) shall inform the 
                                participant and the Secretary upon 
                                initiating a compliance review of a 
                                Network participant; and</DELETED>
                                <DELETED>    ``(II) shall inform the 
                                participant and the Secretary of any 
                                findings indicating noncompliance by 
                                the participant with such criteria and 
                                policies.</DELETED>
                        <DELETED>    ``(ii) Appeals.--The Network 
                        Administrator shall establish procedures for 
                        appealing noncompliance determinations. Such 
                        procedures shall ensure due process and shall 
                        allow for corrective action.</DELETED>
        <DELETED>    ``(2) Peer review proceedings.--</DELETED>
                <DELETED>    ``(A) In general.--The OPTN Board shall 
                establish a peer review system and conditions for the 
                application of peer review requirements to ensure that 
                members of the Network comply with policies and 
                criteria established by the OPTN Board under this 
                section. Such peer review system may include 
                prospective reviews and shall be administered by the 
                Network Administrator and overseen by the OPTN 
                Board.</DELETED>
                <DELETED>    ``(B) Policies, review and evaluation.--As 
                part of the peer review system established under 
                subparagraph (A), the OPTN Board shall establish such 
                policies, and the Network Administrator shall conduct 
                such ongoing and periodic reviews and evaluations of 
                members of the Network, as necessary to ensure 
                compliance with the policies and criteria established 
                by the OPTN Board under this section.</DELETED>
                <DELETED>    ``(C) Emerging issues.--As part of such 
                peer review system established under subparagraph (A), 
                the OPTN Board shall establish policies to work with 
                and direct the Network Administrator to respond to 
                emerging issues and problems.</DELETED>
<DELETED>    ``(k) Enforcement.--</DELETED>
        <DELETED>    ``(1) Recommendations.--The OPTN Board or the 
        Network Administrator shall provide advice, and make 
        recommendations for appropriate action, to the Secretary 
        concerning the results of any reviews or evaluations that, in 
        the opinion of the OPTN Board or the Network Administrator, 
        indicate--</DELETED>
                <DELETED>    ``(A) noncompliance by Network 
                participants with--</DELETED>
                        <DELETED>    ``(i) the policies or criteria 
                        established by the OPTN Board; or</DELETED>
                        <DELETED>    ``(ii) the operating procedures of 
                        the Network Administrator; or</DELETED>
                <DELETED>    ``(B) a risk to the health of organ 
                transplant patients or to public safety.</DELETED>
        <DELETED>    ``(2) Enforcement by network.--</DELETED>
                <DELETED>    ``(A) In general.--If the OPTN Board 
                determines that one of the members of the network has 
                violated a requirement established by this section or 
                by the Network, the OPTN Board may impose on the member 
                1 or more of the sanctions described in subparagraph 
                (B), or may recommend that the Secretary take 
                enforcement action under paragraph (3).</DELETED>
                <DELETED>    ``(B) Types of sanctions.--The sanctions 
                described in this subparagraph may include--</DELETED>
                        <DELETED>    ``(i) the loss of any or all 
                        privileges of membership in good standing in 
                        the Network;</DELETED>
                        <DELETED>    ``(ii) the imposition upon the 
                        member of additional or more frequent reviews 
                        or evaluations under subsection (j)(1)(A), and 
                        assessments of the reasonable costs of such 
                        additional or more frequent reviews or 
                        evaluations; and</DELETED>
                        <DELETED>    ``(iii) such other sanctions as 
                        the Secretary may permit the OPTN Board to 
                        impose.</DELETED>
        <DELETED>    ``(3) Enforcement by the secretary.--</DELETED>
                <DELETED>    ``(A) In general.--If the Secretary, after 
                consultation with the OPTN Board or Network 
                Administrator, determines that a member of the Network 
                has violated a requirement established by this section 
                or a requirement of a policy that is enforceable under 
                subsection (f), the Secretary may impose on the member 
                1 or more of the sanctions described in subparagraph 
                (B).</DELETED>
                <DELETED>    ``(B) Types of sanctions.--The sanctions 
                described in this subparagraph shall include--
                </DELETED>
                        <DELETED>    ``(i) requiring the member to 
                        follow a directed plan of correction;</DELETED>
                        <DELETED>    ``(ii) imposing upon the member a 
                        monetary assessment (to be paid to the General 
                        Fund of the Treasury) in an amount not to 
                        exceed $10,000 for each violation or for each 
                        day of violation;</DELETED>
                        <DELETED>    ``(iii) requiring the member to 
                        pay to the Network Administrator the costs of 
                        onsite monitoring of the member;</DELETED>
                        <DELETED>    ``(iv) the loss of any or all 
                        privileges of membership in the Network; 
                        and</DELETED>
                        <DELETED>    ``(v) in cases where the violation 
                        creates a risk to patient health or to public 
                        health, such other action as the Secretary 
                        determines to be necessary.</DELETED>
                <DELETED>    ``(C) Procedures.--The Secretary shall 
                develop and implement procedures for the imposition of 
                sanctions under clauses (i) through (v) of subparagraph 
                (B). Such procedures shall include--</DELETED>
                        <DELETED>    ``(i) the provision of reasonable 
                        notice to the Network member and the OPTN Board 
                        that the Secretary is considering imposing a 
                        sanction;</DELETED>
                        <DELETED>    ``(ii) affording the member a 
                        reasonable opportunity to be heard in response 
                        to the notice;</DELETED>
                        <DELETED>    ``(iii) the provision of notice to 
                        the member that the Secretary has decided to 
                        impose a sanction; and</DELETED>
                        <DELETED>    ``(iv) the opportunity for the 
                        Network member to appeal such 
                        sanction.</DELETED>
<DELETED>    ``(l) Annual Report.--</DELETED>
        <DELETED>    ``(1) In general.--Not later than September 30 of 
        each year, the Network Administrator shall prepare and submit 
        to the Secretary an annual report on the performance and 
        policies of the Network. The report shall include additional 
        items as specified in the contract under this section or 
        requested in a timely manner by the Secretary.</DELETED>
        <DELETED>    ``(2) Requirement of optn board approval.--The 
        OPTN Board shall review and approve the report required under 
        paragraph (1) prior to the submission of such report to the 
        Secretary.</DELETED>
        <DELETED>    ``(3) Submission to congress.--</DELETED>
                <DELETED>    ``(A) In general.--Not later than December 
                31 of each year, the Secretary shall transmit the 
                report submitted under paragraph (1) and the comments 
                of the Secretary concerning such report, to the 
                appropriate committees of Congress.</DELETED>
                <DELETED>    ``(B) Clarifying information.--The 
                Secretary may, upon the receipt of the report under 
                paragraph (1), but prior to transmission of the report 
                to Congress under subparagraph (A), request that the 
                Network Administrator submit clarifying information or 
                an addenda as needed to fulfill the requirements of 
                this subsection.</DELETED>
<DELETED>    ``(m) Authorization of Appropriations.--There is 
authorized to be appropriated to carry out this section, such sums as 
may be necessary for each of fiscal years 2001 through 
2005.''.</DELETED>

<DELETED>SEC. 3. SCIENTIFIC REGISTRY.</DELETED>

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

<DELETED>``SEC. 373. SCIENTIFIC REGISTRY.</DELETED>

<DELETED>    ``The Secretary shall by contract, develop and maintain a 
scientific registry of the recipients of organ transplants. The 
registry shall include information, with respect to organ transplant 
patients and transplant procedures, as the Secretary determines to be 
necessary to an ongoing evaluation of the scientific and clinical 
status of organ transplantation.''.</DELETED>

<DELETED>SEC. 4. ORGAN DONATION.</DELETED>

<DELETED>    Part H of title III of the Public Health Service Act (42 
U.S.C. 273 et seq.) is amended--</DELETED>
        <DELETED>    (1) by redesignating section 378 (42 U.S.C. 274g) 
        as section 379; and</DELETED>
        <DELETED>    (2) by inserting after section 377 (42 U.S.C. 
        274f) the following:</DELETED>

<DELETED>``SEC. 378. ORGAN DONATION AND RESEARCH.</DELETED>

<DELETED>    ``(a) Inter-Agency Task Force on Organ Donation and 
Research.--</DELETED>
        <DELETED>    ``(1) In general.--The Secretary shall establish 
        an inter-agency task force on organ donation and research 
        (referred to in this section as the `task force') to improve 
        the coordination and evaluation of--</DELETED>
                <DELETED>    ``(A) federally supported or conducted 
                organ donation efforts and policies; and</DELETED>
                <DELETED>    ``(B) federally supported or conducted 
                basic, clinical and health services research (including 
                research on preservation techniques and organ rejection 
                and compatibility).</DELETED>
        <DELETED>    ``(2) Composition.--The task force shall be 
        composed of--</DELETED>
                <DELETED>    ``(A) the Surgeon General, who shall serve 
                as the chairperson;</DELETED>
                <DELETED>    ``(B) representatives to be appointed by 
                the Secretary from relevant agencies within the 
                Department of Health and Human Services (including the 
                Health Resources and Services Administration, Health 
                Care Financing Administration, National Institutes of 
                Health, and Agency for Healthcare Research and 
                Quality);</DELETED>
                <DELETED>    ``(C) a representative from the Department 
                of Transportation;</DELETED>
                <DELETED>    ``(D) a representative from the Department 
                of Defense;</DELETED>
                <DELETED>    ``(E) a representative from the Department 
                of Veterans Affairs;</DELETED>
                <DELETED>    ``(F) a representative from the Office of 
                Personnel Management; and</DELETED>
                <DELETED>    ``(G) representatives of other Federal 
                agencies or departments as determined to be appropriate 
                by the Secretary.</DELETED>
        <DELETED>    ``(3) Annual report.--In addition to activities 
        carried out under paragraph (1), the task force shall support 
        the development of the annual report under subsection 
        (d)(2).</DELETED>
        <DELETED>    ``(4) Termination.--The task force may be 
        terminated at the discretion of the Secretary following the 
        completion of at least 2 annual reports under subsection (d). 
        Upon such termination, the Secretary shall provide for the on-
        going coordination of federally supported or conducted organ 
        donation and research activities.</DELETED>
<DELETED>    ``(b) Education.--</DELETED>
        <DELETED>    ``(1) Public education and awareness.--The 
        Secretary shall, directly or through grants or contracts, carry 
        out a comprehensive and effective national public education 
        program to increase organ donation, including living 
        donation.</DELETED>
        <DELETED>    ``(2) Development of curricula and other education 
        activities.--</DELETED>
                <DELETED>    ``(A) In general.--The Secretary shall 
                support the development and dissemination of model 
                curricula to train health care professionals and other 
                appropriate professionals (including religious leaders 
                in the community and law enforcement officials) in 
                issues surrounding organ donation, including methods to 
                approach patients and their families, cultural 
                sensitivities, and other relevant issues.</DELETED>
                <DELETED>    ``(B) Health care professionals.--For 
                purposes of subparagraph (A), the term `health care 
                professionals' includes--</DELETED>
                        <DELETED>    ``(i) medical students, residents 
                        and fellows, attending physicians (through 
                        continuing medical education courses and other 
                        methods), nurses, social workers, and other 
                        allied health professionals; and</DELETED>
                        <DELETED>    ``(ii) hospital- or other health 
                        care-facility based chaplains; and</DELETED>
                        <DELETED>    ``(iii) emergency medical 
                        personnel.</DELETED>
<DELETED>    ``(c) Grants.--The Secretary shall award peer-reviewed 
grants to public and non-profit private entities, including States, to 
carry out studies and demonstration projects to increase organ donation 
rates, including living donation. The Secretary shall ensure that 
activities carried out by grantees under this subsection are evaluated 
for effectiveness and that such findings are disseminated.</DELETED>
<DELETED>    ``(d) Reports.--</DELETED>
        <DELETED>    ``(1) IOM report on best practices.--</DELETED>
                <DELETED>    ``(A) In general.--The Secretary shall 
                enter into a contract with the Institute of Medicine to 
                conduct an evaluation of the organ donation practices 
                of organ procurement organizations, States, other 
                countries, and other appropriate organizations that 
                have achieved a higher than average organ donation 
                rate.</DELETED>
                <DELETED>    ``(B) Barriers.--In conducting the 
                evaluation under subparagraph (A), the Institute of 
                Medicine shall examine existing barriers to organ 
                donation.</DELETED>
                <DELETED>    ``(C) Report.--Not later than 18 months 
                after the date of enactment of this section, the 
                Institute of Medicine shall submit to the Secretary a 
                report concerning the evaluation conducted under this 
                paragraph. Such report shall include recommendations 
                for administrative actions and, if necessary, 
                legislation in order to replicate the best practices 
                identified in the evaluation and to otherwise increase 
                organ donation and procurement rates.</DELETED>
        <DELETED>    ``(2) Annual report on donation.--</DELETED>
                <DELETED>    ``(A) In general.--Not later than 1 year 
                after the date on which the report is submitted under 
                paragraph (1)(C), and annually thereafter, the 
                Secretary shall prepare and submit to Congress a report 
                concerning federally supported or conducted organ 
                donation and procurement activities, including donation 
                and procurement activities evaluated or conducted under 
                subsection (a) to increase organ donation.</DELETED>
                <DELETED>    ``(B) Requirements.--To the extent 
                practicable, each annual report under subparagraph (A) 
                shall--</DELETED>
                        <DELETED>    ``(i) evaluate the effectiveness 
                        of activities, identify best practices, and 
                        make recommendations regarding broader adoption 
                        of best practices with respect to organ 
                        donation and procurement;</DELETED>
                        <DELETED>    ``(ii) assess organ donation and 
                        procurement activities that are recently 
                        completed, current or planned.</DELETED>
<DELETED>    ``(e) Authorization of Appropriations.--There is 
authorized to be appropriated to carry out this section, $15,000,000 
for fiscal year 2001, and such sums as may be necessary for each of 
fiscal years 2002 through 2005.''.</DELETED>

SECTION 1. SHORT TITLE.

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

SEC. 2. 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:

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

    ``(a) Establishment of Network.--
            ``(1) In general.--An Organ Procurement and Transplantation 
        Network (in this section referred to as the `Network' or the 
        `OPTN') is established under this section and shall be operated 
        by a private nonprofit entity as provided for in subsection 
        (f).
            ``(2) Requirements.--The Network shall--
                    ``(A) in accordance with criteria developed under 
                subsection (c)(1)(B), include as members of the Network 
                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 shall be referred to in this section as 
                `Network participants'); and
                    ``(B) have a policy board (referred to in this 
                section as the `OPTN Board') that meets the 
                requirements of subsection (b).
    ``(b) OPTN Policy Board.--
            ``(1) Composition.--The OPTN Board shall be composed of not 
        more than 36 voting members to be elected under paragraph (2) 
        and 5 nonvoting, ex officio members appointed under paragraph 
        (3).
            ``(2) Elected members.--
                    ``(A) In general.--The voting members of the OPTN 
                Board shall be elected by the members of the Network 
                described in subsection (a)(2)(A), from among the 
                nominees submitted under subparagraph (B), through a 
                fair and open process.
                    ``(B) Nominating committee.--The nominating 
                committee established under paragraph (5) shall, prior 
                to each election of OPTN Board members under this 
                paragraph, develop a list of nominees for such 
                election. Such list shall reflect the diversity of 
                Network members described in subsection (a)(2)(A), 
                including factors such as program type and size and 
                geographic location. Recommendations may be submitted 
                to the nominating committee by the Secretary, the 
                members of the Network described in subsection 
                (a)(2)(A), or the general public.
                    ``(C) Qualifications.--The OPTN Board shall be 
                composed of--
                            ``(i) transplant surgeons and transplant 
                        physicians;
                            ``(ii) representatives of qualified organ 
                        procurement organizations, transplant centers, 
                        voluntary health associations, or the general 
                        public, including patients awaiting a 
                        transplant or transplant recipients or 
                        individuals who have donated an organ, or the 
                        family members of such patients, recipients or 
                        donors; and
                            ``(iii) individuals distinguished in the 
                        fields of ethics, basic, clinical and health 
                        services research, biostatistics, health care 
                        policy, or health care economics or financing.
                    ``(D) Representation requirement.--The OPTN Board 
                shall be structured to ensure that--
                            ``(i) approximately 50 percent of the 
                        members elected under this paragraph are 
                        transplant surgeons and transplant physicians; 
                        and
                            ``(ii) approximately 25 percent of the 
                        members elected under this paragraph are 
                        transplant candidates, transplant recipients, 
                        organ donors and family members of such 
                        individuals.
                Nothing in this subparagraph shall be construed to 
                preclude an individual voting member of the OPTN Board 
                from being a representative described in each of 
                clauses (i) and (iii) or (ii) and (iii) of subparagraph 
                (C) so long as the limitation described in clause (i) 
                of this subparagraph is complied with.
            ``(3) Appointed members.--
                    ``(A) In general.--The Secretary shall appoint as 
                ex officio, nonvoting members of the OPTN Board, 1 
                representative from each of the following:
                            ``(i) The Health Resources and Services 
                        Administration.
                            ``(ii) The National Institutes of Health.
                            ``(iii) The Health Care Financing 
                        Administration.
                            ``(iv) The Agency for Healthcare Research 
                        and Quality.
                    ``(B) Network administrator.--The Network 
                Administrator shall appoint an ex officio nonvoting 
                member of the OPTN Board.
            ``(4) Terms of elected members.--
                    ``(A) In general.--Except as provided for in this 
                paragraph, members of the OPTN Board elected under 
                paragraph (2) shall serve for a term of 3 years and may 
                be re-elected.
                    ``(B) New members.--To ensure the staggered 
                rotation of \1/3\ of the elected members of the OPTN 
                Board each year, the initial members of the OPTN Board 
                elected under paragraph (2) shall serve for terms of 1, 
                2, or 3 years respectively as designated by the 
                nominating committee.
                    ``(C) Transition.--Consistent with subsection 
                (c)(3), the voting members of the OPTN Board who are 
                serving on the date of enactment of the Organ 
                Procurement and Transplantation Network Amendments Act 
                of 2000 may continue to serve until the expiration of 
                their terms. Upon such termination, the nominating 
                committee, in submitting nominations to fill such 
                vacancies, shall ensure the staggered rotation of \1/3\ 
                of the members elected under paragraph (2) every 3 
                years.
                    ``(D) Contract status.--A change in the status of a 
                contract under subsection (f), or a change in the 
                contractor, shall not affect the terms of the members 
                of the OPTN Board.
            ``(5) Chairperson and committees.--The OPTN Board shall 
        have a chairperson, an executive committee, a nominating 
        committee, a membership committee, and such other committees as 
        the OPTN Board determines to be appropriate.
    ``(c) General Functions of the OPTN Board.--
            ``(1) Establishment of network policies and criteria.--The 
        OPTN Board shall--
                    ``(A) after consultation with Network participants 
                and the Network Administrator, establish and carry out 
                the policies and functions described in this section 
                for the Network;
                    ``(B) establish membership criteria for 
                participating in the Network;
                    ``(C) establish medical criteria for allocating 
                organs and for listing and de-listing patients on the 
                national lists maintained under paragraph (2); and
                    ``(D) establish performance criteria for transplant 
                programs.
            ``(2) National system.--The OPTN Board shall maintain a 
        national system to match organs and individuals who need organ 
        transplants. The national system shall--
                    ``(A) have 1 or more lists, derived from a national 
                list, of individuals who are in need of organ 
                transplants; and
                    ``(B) be operated in accordance with Network 
                policies and criteria established under paragraph (1).
            ``(3) No fiduciary responsibility.--The OPTN Board shall 
        have no voting member who has any fiduciary responsibility to 
        the entity that holds the contract provided for under this 
        section.
            ``(4) OPTN board requirements.--The OPTN Board shall 
        cooperate with the Network Administrator to ensure compliance 
        with the requirements of this section including the contract 
        entered into under subsection (f).
    ``(d) Organ Transplant Policy.--The OPTN Board shall establish 
organ transplant policies, including organ allocation policies for 
potential organ recipients and policies that affect patient outcomes. 
Such policies shall--
            ``(1) be based on sound medical principles;
            ``(2) be based on valid scientific data;
            ``(3) be equitable;
            ``(4) seek to achieve the best use of donated organs;
            ``(5) be designed to avoid wasting organs, to avoid futile 
        transplants and reduce the risk of retransplantation, to 
        promote patient access to transplantation, and to promote the 
        efficient management of organ placement;
            ``(6) be specific for each organ type or combination of 
        organ types;
            ``(7) be based on standardized medical criteria for listing 
        and de-listing candidates from organ transplant waiting lists;
            ``(8) determine priority rankings (within categories as 
        appropriate) for candidates who are medically suitable for 
        transplantation, such rankings shall be based on standardized 
        medical criteria and ordered according to medical urgency and 
        medical appropriateness;
            ``(9) seek to reduce disparities in transplantation 
        resulting from socioeconomic status, race, ethnicity, 
        geographic area or region of residence or transplantation, or 
        being medically underserved;
            ``(10) develop and apply appropriate performance 
        indicators, including patient-focused indicators, to assess 
        transplant program performance and reduce inter-transplant 
        program variance to improve program performance; and
            ``(11) seek distribution of organs as appropriate based on 
        paragraphs (1) through (10).
    ``(e) Enforcement of Organ Transplant Policy.--
            ``(1) In general.--
                    ``(A) Proposed policy.--This paragraph shall apply 
                to any proposed transplant policy that is developed by 
                the OPTN Board that the Board or the Secretary 
                determines should be enforced under this section or 
                under section 1138 of the Social Security Act.
                    ``(B) Submission of policy.--
                            ``(i) In general.--Not later than 60 days 
                        prior to the implementation of a proposed 
                        policy described in subparagraph (A), the OPTN 
                        Board shall submit such proposed policy to the 
                        Secretary.
                            ``(ii) Required submission.--
                                    ``(I) Request by secretary.--If 
                                determined appropriate by the 
                                Secretary, the Secretary may request 
                                that the OPTN Board submit revisions to 
                                existing transplant policies, or 
submit new transplant policies, to the Secretary under this 
subparagraph. Not later than 90 days after any such request, the OPTN 
Board shall submit such revisions or new policy to the Secretary.
                                    ``(II) Failure to comply.--If the 
                                OPTN Board fails to comply with the 
                                request of the Secretary under 
                                subclause (I), the Secretary may submit 
                                comments concerning such request to the 
                                OPTN Board for review. Not later than 
                                60 days after the submission of such 
                                comments, the OPTN Board shall, after 
                                considering such comments, transmit the 
                                policy to the Secretary for review 
                                under subparagraph (C).
                                    ``(III) Application of 
                                provisions.--The provisions of 
                                subparagraphs (C), (D), and (E) shall 
                                apply to any revisions or new policies 
                                submitted under this clause to the same 
                                extent that such subparagraphs apply to 
                                policies proposed under subparagraph 
                                (A).
                    ``(C) Publication.--Upon receipt of a proposed 
                policy under subparagraph (B), the Secretary shall 
                publish the policy in the Federal Register for a 60-day 
                public comment period.
                    ``(D) Action by secretary.--Not later than 90 days 
                after receipt of a proposed policy under subparagraph 
                (B), the Secretary shall consider public comments 
                received under subparagraph (C) and shall--
                            ``(i) notify the OPTN Board that the policy 
                        is consistent with this section and therefore 
                        enforceable; or
                            ``(ii) notify the OPTN Board that the 
                        policy is inconsistent with this section and 
                        direct the Board to reconsider and revise the 
                        policy consistent with the recommendations of 
                        the Secretary.
                    ``(E) Reconsideration.--
                            ``(i) In general.--Not later than 30 days 
                        after receiving a notice from the Secretary 
                        under subparagraph (D)(ii), the OPTN Board 
                        shall reaffirm the proposed policy and submit 
                        such policy to the Secretary or shall revise 
                        such policy and submit such revised policy to 
                        the Secretary.
                            ``(ii) Action by secretary.--Not later than 
                        30 days after receiving a revised or reaffirmed 
                        policy under clause (i), the Secretary shall--
                                    ``(I) notify the OPTN Board that 
                                the revised or reaffirmed policy is 
                                consistent with this section and 
                                therefore enforceable; or
                                    ``(II) notify the OPTN Board that 
                                the revised or reaffirmed policy is 
                                inconsistent with this section and 
                                submit the revised or reaffirmed 
                                policy, with the comments and proposed 
                                revisions of the Secretary, to the 
                                Scientific Advisory Committee on Organ 
                                Transplantation (referred to in this 
                                subsection as the `Committee') 
                                established under paragraph (2).
                            ``(iii) Action by committee.--Not later 
                        than 30 days after the submission of a revised 
                        or reaffirmed policy to the Committee under 
                        clause (ii), the Committee may, by a majority 
                        vote, disapprove the comments or revisions of 
                        the Secretary. If the policy is not disapproved 
                        by a majority vote, the OPTN Board shall revise 
                        the policy accordingly and such policy shall be 
                        enforceable. If the Committee disapproves such 
                        comments or revisions, the revised or 
                        reaffirmed policy shall not take effect until a 
                        majority of the Committee approves the policy 
                        or the revisions to such policy. Upon the 
                        approval of a majority of the Committee of the 
                        policy or revisions to such policy, the OPTN 
                        Board shall revise the policy accordingly and 
                        such policy shall become enforceable.
            ``(2) Scientific advisory committee on organ 
        transplantation.--
                    ``(A) Establishment.--The Secretary shall establish 
                an advisory committee to be known as the Scientific 
                Advisory Committee on Organ Transplantation. Consistent 
                with the requirements of sections 5 and 10 of the 
                Federal Advisory Committee Act--
                            ``(i) the deliberations of the Committee 
                        shall not be inappropriately influenced by the 
                        Secretary or by any special interest and shall 
                        only be the result of the independent judgment 
                        of the Committee; and
                            ``(ii) the meetings of the Committee shall 
                        be open to the public, advance notice of 
                        meetings shall be published in the Federal 
                        Register, and records or minutes of meetings 
                        shall be made available to the public.
                    ``(B) Duties.--The Committee shall make 
                recommendations with respect to policy matters related 
                to reviews conducted under paragraph (1)(E)(ii)(II).
                    ``(C) Membership.--The Committee shall be composed 
                of 21 members, of which--
                            ``(i) seven members shall be appointed by 
                        the Secretary from nominations submitted by the 
                        OPTN Board under subparagraph (D);
                            ``(ii) seven members shall be appointed by 
                        the Secretary from nominations submitted by the 
                        Institute of Medicine under subparagraph (D); 
                        and
                            ``(iii) seven members shall be appointed by 
                        the Secretary.
                    ``(D) Nominations.--The OPTN Board and the 
                Institute of Medicine shall each nominate, in an 
                independent manner, 12 qualified individuals to serve 
                on the Committee.
                    ``(E) Qualifications.--In appointing individuals to 
                serve on the Committee under subparagraph (C), the 
                Secretary shall ensure that--
                            ``(i) twelve members are transplant 
                        physicians or transplant surgeons of whom--
                                    ``(I) four shall be selected from 
                                the nominations submitted by the OPTN 
                                Board; and
                                    ``(II) four shall be selected from 
                                the nominations submitted by the 
                                Institute of Medicine; and
                            ``(ii) the remaining members are 
                        individuals who are--
                                    ``(I) distinguished in the fields 
                                of ethics, basic, clinical or health 
                                services research, biostatistics, or 
                                health care policy, economics or 
                                financing; or
                                    ``(II) transplant candidates, 
                                transplant recipients, organ donors or 
                                family members of such individuals.
                    ``(F) Experts.--The Committee shall seek advice 
                from appropriate experts, as needed, to evaluate the 
                proposed policy and revisions under review.
                    ``(G) Chairperson.--The members of the Committee 
                shall elect a member to serve as the chairperson of the 
                Committee.
                    ``(H) Terms.--Members of the Committee shall serve 
                for a term of 5 years. Vacancies shall be filled in the 
                same manner as the original appointment was made.
            ``(3) Study by general accounting office.--
                    ``(A) In general.--The Comptroller General shall 
                conduct a study of the review process for enforceable 
                transplant policies under this subsection. Such study 
                shall examine the role of the Advisory Committee 
                established under paragraph (2) in resolving transplant 
                policy matters under this subsection.
                    ``(B) Completion and report.--Not later than 
                September 30, 2004, the Comptroller General shall 
                complete the study under subparagraph (A) and shall 
                prepare and submit to the appropriate committees of 
                Congress a report that contains--
                            ``(i) the findings of the Comptroller 
                        General with respect to the study; and
                            ``(ii) the recommendations of the 
                        Comptroller General concerning--
                                    ``(I) the continued use of the 
                                Advisory Committee to resolve 
                                transplant policy matters under this 
                                subsection;
                                    ``(II) improvements in the 
                                composition and method of selection of 
                                the members of the Advisory Committee; 
                                and
                                    ``(III) any other improvements in 
                                the review process.
    ``(f) Network Administration and Operation.--The Secretary shall 
contract with a nonprofit private entity (referred to in this section 
as the `Network Administrator') for the administration and operation of 
the Network. The Network Administrator shall administer and operate the 
OPTN Board in accordance with subsection (b). The Network Administrator 
shall, pursuant to the policies and criteria established by the OPTN 
Board--
            ``(1) maintain and operate a national system as established 
        by the OPTN Board to match organs and individuals who need 
        organ transplants;
            ``(2) operate in accordance with medical criteria 
        established by the OPTN Board, and administer the national 
        system established under subsection (c)(2);
            ``(3) maintain 1 or more lists, derived from a national 
        list, of individuals who need organ transplants as provided for 
        under subsection (c)(2)(A);
            ``(4) maintain a 24-hour communication service to 
        facilitate matching organs with individuals included on the 
        list or lists;
            ``(5) assist organ procurement organizations in obtaining 
        and distributing organs in accordance with the policies 
        established by the OPTN Board;
            ``(6) adopt and use standards of quality for the 
        acquisition and transportation of donated organs, including 
        standards regarding the transmission of infectious diseases;
            ``(7) 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 in order to facilitate matching the compatibility 
        of such individuals with organ donors;
            ``(8) coordinate, as appropriate, the transportation of 
        organs from organ procurement organizations to transplant 
        centers;
            ``(9) provide information to physicians, health care 
        professionals, and the general public regarding organ donation;
            ``(10) carry out studies and demonstration projects for the 
        purpose of improving procedures for organ procurement and 
        allocation; and
            ``(11) work actively with organ procurement organizations, 
        transplant centers, health care providers, and the public to 
        increase the supply of donated organs.
    ``(g) Data Collection, Analysis and Distribution.--
            ``(1) In general.--The Network Administrator shall analyze, 
        maintain, verify, make available and publish timely data to the 
        extent necessary to--
                    ``(A) enable the OPTN Board to fulfill its 
                responsibilities under this section;
                    ``(B) assess the compliance of members of the 
                Network with performance and other criteria developed 
                pursuant to subsection (c)(1);
                    ``(C) evaluate the quality of care provided to 
                transplant candidates and patients generally and in an 
                individual program;
                    ``(D) provide data needed by the Scientific 
                Registry maintained pursuant to section 373;
                    ``(E) provide transplant candidates and patients, 
                physicians and others with information needed to 
evaluate or select a transplant program;
                    ``(F) provide a member of the Network with data 
                about the member, including results of analysis or 
                other processing of data originally supplied by the 
                member;
                    ``(G) enable the OPTN Board, the Network 
                Administrator and the Secretary to fulfill their 
                responsibilities under this section; and
                    ``(H) comply with the requirements under subsection 
                (l).
            ``(2) Types of data.--Data provided under paragraph (1) 
        shall include--
                    ``(A) data on transplant candidates, transplant 
                recipients, organ donors, donated organs, and 
                transplant programs; and
                    ``(B) as appropriate, data, graft- and patient-
                survival rates (actual and adjusted to reflect program-
                specific population disease severity), program specific 
                data, and aggregate data.
    ``(h) Contract.--The contract under subsection (f) shall--
            ``(1) be awarded through a process of competitive bidding 
        as determined by the Secretary; and
            ``(2) be awarded for a period of no longer than 5 years.
    ``(i) Network Membership and Patient Registration Fee.--
            ``(1) In general.--The Network Administrator may assess a 
        fee, to be collected by the Network Administrator, for 
        membership in the Network (to be known as the `Network 
        membership fee'), and for the listing of each potential 
        transplant recipient on the national organ matching system 
        maintained by the Network Administrator (to be known as the 
        `patient registration fee'), in an amount determined under 
        paragraph (2).
            ``(2) Amount.--The amounts of the fees to be assessed under 
        paragraph (1) shall be calculated so as to be--
                    ``(A) reasonable and customary; and
                    ``(B) sufficient to cover the Network's reasonable 
                costs of operation in accordance with this section.
            ``(3) Annual recalculation.--
                    ``(A) In general.--The fees calculated under 
                paragraph (2) shall be annually recalculated, based 
                on--
                            ``(i) changes in the level or cost of 
                        contract tasks and other activities related to 
                        organ procurement and transplantation; and
                            ``(ii) changes in expected revenues from 
                        contract funds, Network membership fees and 
                        patient registration fees available to the 
                        Network Administrator.
                    ``(B) Procedure.--
                            ``(i) Proposal.--The Network Administrator 
                        shall submit to the Secretary a written 
                        proposal for, and justification of, a 
                        recalculated fee under subparagraph (A).
                            ``(ii) Determination.--The proposal of the 
                        Network Administrator for a recalculated fee 
                        under clause (i) shall take effect unless the 
                        Secretary, within 60 days of receiving the 
                        proposal, provides the Network Administrator 
                        with a written determination, with 
                        justification, that the proposed fee level does 
                        not meet the requirement of subparagraph (A).
            ``(4) Use of fees.--
                    ``(A) In general.--All fees collected by the 
                Network Administrator under this subsection shall be 
                available to the Network, without fiscal year 
                limitation, for use in carrying out the functions 
                described in subsection (f).
                    ``(B) Restriction.--Fees collected under this 
                subsection may not be used for any activity for which 
                contract funds may not be used under this section.
            ``(5) Rule of construction.--Nothing in this subsection 
        shall be construed as prohibiting the Network Administrator 
        from collecting or accepting other fees, donations or gifts or 
        for using such other fees, donations or gifts to carry out 
        activities other than those authorized under the contract under 
        this section.
    ``(j) Oversight of Network Participants.--
            ``(1) Monitoring.--
                    ``(A) In general.--The OPTN Board and the Network 
                Administrator shall, on an ongoing and periodic basis, 
                or as requested by the Secretary, monitor the 
                operations of Network participants to determine whether 
                the participants are maintaining compliance with the 
                criteria and policies established by the OPTN Board.
                    ``(B) Procedures.--
                            ``(i) Notice.--In monitoring a Network 
                        participant under subparagraph (A), the OPTN 
                        Board or the Administrator--
                                    ``(I) shall inform the participant 
                                and the Secretary upon initiating a 
                                compliance review of a Network 
                                participant; and
                                    ``(II) shall inform the participant 
                                and the Secretary of any findings 
                                indicating noncompliance by the 
                                participant with such criteria and 
                                policies.
                            ``(ii) Appeals.--The Network Administrator 
                        shall establish procedures for appealing 
                        noncompliance determinations. Such procedures 
                        shall ensure due process and shall allow for 
                        corrective action.
            ``(2) Peer review proceedings.--
                    ``(A) In general.--The OPTN Board shall establish a 
                peer review system and conditions for the application 
                of peer review requirements to ensure that members of 
                the Network comply with policies and criteria 
                established by the OPTN Board under this section. Such 
                peer review system may include prospective reviews and 
                shall be administered by the Network Administrator and 
overseen by the OPTN Board.
                    ``(B) Policies, review and evaluation.--As part of 
                the peer review system established under subparagraph 
                (A), the OPTN Board shall establish such policies, and 
                the Network Administrator shall conduct such ongoing 
                and periodic reviews and evaluations of members of the 
                Network, as necessary to ensure compliance with the 
                policies and criteria established by the OPTN Board 
                under this section.
                    ``(C) Emerging issues.--As part of such peer review 
                system established under subparagraph (A), the OPTN 
                Board shall establish policies to work with and direct 
                the Network Administrator to respond to emerging issues 
                and problems.
    ``(k) Enforcement.--
            ``(1) Recommendations.--The OPTN Board or the Network 
        Administrator shall provide advice, and make recommendations 
        for appropriate action, to the Secretary concerning the results 
        of any reviews or evaluations that, in the opinion of the OPTN 
        Board or the Network Administrator, indicate--
                    ``(A) noncompliance by Network participants with--
                            ``(i) the policies or criteria established 
                        by the OPTN Board; or
                            ``(ii) the operating procedures of the 
                        Network Administrator; or
                    ``(B) a risk to the health of organ transplant 
                patients or to public safety.
            ``(2) Enforcement by network.--
                    ``(A) In general.--If the OPTN Board determines 
                that one of the members of the network has violated a 
                requirement established by this section or by the 
                Network, the OPTN Board may impose on the member 1 or 
                more of the sanctions described in subparagraph (B), or 
                may recommend that the Secretary take enforcement 
                action under paragraph (3).
                    ``(B) Types of sanctions.--The sanctions described 
                in this subparagraph may include--
                            ``(i) the loss of any or all privileges of 
                        membership in good standing in the Network;
                            ``(ii) the imposition upon the member of 
                        additional or more frequent reviews or 
                        evaluations under subsection (j)(1)(A), and 
                        assessments of the reasonable costs of such 
                        additional or more frequent reviews or 
                        evaluations; and
                            ``(iii) such other sanctions as the 
                        Secretary may permit the OPTN Board to impose.
            ``(3) Enforcement by the secretary.--
                    ``(A) In general.--If the Secretary, after 
                consultation with the OPTN Board or Network 
                Administrator, determines that a member of the Network 
                has violated a requirement established by this section 
                or a requirement of a policy that is enforceable under 
                subsection (f), the Secretary may impose on the member 
                1 or more of the sanctions described in subparagraph 
                (B).
                    ``(B) Types of sanctions.--The sanctions described 
                in this subparagraph shall include--
                            ``(i) requiring the member to follow a 
                        directed plan of correction;
                            ``(ii) imposing upon the member a monetary 
                        assessment (to be paid to the General Fund of 
                        the Treasury) in an amount not to exceed 
                        $10,000 for each violation or for each day of 
                        violation;
                            ``(iii) requiring the member to pay to the 
                        Network Administrator the costs of onsite 
                        monitoring of the member;
                            ``(iv) the loss of any or all privileges of 
                        membership in the Network; and
                            ``(v) in cases where the violation creates 
                        a risk to patient health or to public health, 
                        such other action as the Secretary determines 
                        to be necessary.
                    ``(C) Procedures.--The Secretary shall develop and 
                implement procedures for the imposition of sanctions 
                under clauses (i) through (v) of subparagraph (B). Such 
                procedures shall include--
                            ``(i) the provision of reasonable notice to 
                        the Network member and the OPTN Board that the 
                        Secretary is considering imposing a sanction;
                            ``(ii) affording the member a reasonable 
                        opportunity to be heard in response to the 
                        notice;
                            ``(iii) the provision of notice to the 
                        member that the Secretary has decided to impose 
                        a sanction; and
                            ``(iv) the opportunity for the Network 
                        member to appeal such sanction.
    ``(l) Annual Report.--
            ``(1) In general.--Not later than September 30 of each 
        year, the Network Administrator shall prepare and submit to the 
        Secretary an annual report on the performance and policies of 
        the Network. The report shall include additional items as 
        specified in the contract under this section or requested in a 
        timely manner by the Secretary.
            ``(2) Requirement of optn board approval.--The OPTN Board 
        shall review and approve the report required under paragraph 
        (1) prior to the submission of such report to the Secretary.
            ``(3) Submission to congress.--
                    ``(A) In general.--Not later than December 31 of 
                each year, the Secretary shall transmit the report 
                submitted under paragraph (1) and the comments of the 
                Secretary concerning such report, to the appropriate 
                committees of Congress.
                    ``(B) Clarifying information.--The Secretary may, 
                upon the receipt of the report under paragraph (1), but 
                prior to transmission of the report to Congress under 
                subparagraph (A), request that the Network 
                Administrator submit clarifying information or an 
                addenda as needed to fulfill the requirements of this 
                subsection.
    ``(m) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, such sums as may be necessary 
for each of fiscal years 2001 through 2005.''.

SEC. 3. SCIENTIFIC REGISTRY.

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

``SEC. 373. SCIENTIFIC REGISTRY.

    ``The Secretary shall by contract, develop and maintain a 
scientific registry of the recipients of organ transplants. The 
registry shall include information, with respect to organ transplant 
patients and transplant procedures, as the Secretary determines to be 
necessary to an ongoing evaluation of the scientific and clinical 
status of organ transplantation.''.

SEC. 4. ORGAN DONATION.

    Part H of title III of the Public Health Service Act (42 U.S.C. 273 
et seq.) is amended--
            (1) by redesignating section 378 (42 U.S.C. 274g) as 
        section 379; and
            (2) by inserting after section 377 (42 U.S.C. 274f) the 
        following:

``SEC. 378. ORGAN DONATION AND RESEARCH.

    ``(a) Inter-Agency Task Force on Organ Donation and Research.--
            ``(1) In general.--The Secretary shall establish an inter-
        agency task force on organ donation and research (referred to 
        in this section as the `task force') to improve the 
        coordination and evaluation of--
                    ``(A) federally supported or conducted organ 
                donation efforts and policies; and
                    ``(B) federally supported or conducted basic, 
                clinical and health services research (including 
                research on preservation techniques and organ rejection 
                and compatibility).
            ``(2) Composition.--The task force shall be composed of--
                    ``(A) the Surgeon General, who shall serve as the 
                chairperson;
                    ``(B) representatives to be appointed by the 
                Secretary from relevant agencies within the Department 
                of Health and Human Services (including the Health 
                Resources and Services Administration, Health Care 
                Financing Administration, National Institutes of 
                Health, and Agency for Healthcare Research and 
                Quality);
                    ``(C) a representative from the Department of 
                Transportation;
                    ``(D) a representative from the Department of 
                Defense;
                    ``(E) a representative from the Department of 
                Veterans Affairs;
                    ``(F) a representative from the Office of Personnel 
                Management; and
                    ``(G) representatives of other Federal agencies or 
                departments as determined to be appropriate by the 
                Secretary.
            ``(3) Annual report.--In addition to activities carried out 
        under paragraph (1), the task force shall support the 
        development of the annual report under subsection (d)(2).
            ``(4) Termination.--The task force may be terminated at the 
        discretion of the Secretary following the completion of at 
        least 2 annual reports under subsection (d). Upon such 
        termination, the Secretary shall provide for the on-going 
        coordination of federally supported or conducted organ donation 
        and research activities.
    ``(b) Education.--
            ``(1) Public education and awareness.--The Secretary shall, 
        directly or through grants or contracts, carry out a 
        comprehensive and effective national public education program 
        to increase organ donation, including living donation.
            ``(2) Development of curricula and other education 
        activities.--
                    ``(A) In general.--The Secretary shall support the 
                development and dissemination of model curricula to 
                train health care professionals and other appropriate 
                professionals (including religious leaders in the 
                community and law enforcement officials) in issues 
                surrounding organ donation, including methods to 
                approach patients and their families, cultural 
                sensitivities, and other relevant issues.
                    ``(B) Health care professionals.--For purposes of 
                subparagraph (A), the term `health care professionals' 
                includes--
                            ``(i) medical students, residents and 
                        fellows, attending physicians (through 
                        continuing medical education courses and other 
                        methods), nurses, social workers, and other 
                        allied health professionals; and
                            ``(ii) hospital- or other health care-
                        facility based chaplains; and
                            ``(iii) emergency medical personnel.
    ``(c) Grants.--The Secretary shall award peer-reviewed grants to 
public and non-profit private entities, including States, to carry out 
studies and demonstration projects to increase organ donation rates, 
including living donation. The Secretary shall ensure that activities 
carried out by grantees under this subsection are evaluated for 
effectiveness and that such findings are disseminated.
    ``(d) Reports.--
            ``(1) IOM report on best practices.--
                    ``(A) In general.--The Secretary shall enter into a 
                contract with the Institute of Medicine to conduct an 
                evaluation of the organ donation practices of organ 
                procurement organizations, States, other countries, and 
                other appropriate organizations that have achieved a 
                higher than average organ donation rate.
                    ``(B) Barriers.--In conducting the evaluation under 
                subparagraph (A), the Institute of Medicine shall 
                examine existing barriers to organ donation.
                    ``(C) Report.--Not later than 18 months after the 
                date of enactment of this section, the Institute of 
                Medicine shall submit to the Secretary a report 
                concerning the evaluation conducted under this 
                paragraph. Such report shall include recommendations 
                for administrative actions and, if necessary, 
                legislation in order to replicate the best practices 
                identified in the evaluation and to otherwise increase 
                organ donation and procurement rates.
            ``(2) Annual report on donation.--
                    ``(A) In general.--Not later than 1 year after the 
                date on which the report is submitted under paragraph 
                (1)(C), and annually thereafter, the Secretary shall 
                prepare and submit to Congress a report concerning 
                federally supported or conducted organ donation and 
                procurement activities, including donation and 
                procurement activities evaluated or conducted under 
                subsection (a) to increase organ donation.
                    ``(B) Requirements.--To the extent practicable, 
                each annual report under subparagraph (A) shall--
                            ``(i) evaluate the effectiveness of 
                        activities, identify best practices, and make 
                        recommendations regarding broader adoption of 
                        best practices with respect to organ donation 
                        and procurement;
                            ``(ii) assess organ donation and 
                        procurement activities that are recently 
                        completed, current or planned.
    ``(e) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, $15,000,000 for fiscal year 
2001, and such sums as may be necessary for each of fiscal years 2002 
through 2005.''.

SEC. 5. ORGAN PROCUREMENT ORGANIZATION CERTIFICATION.

    (a) Findings.--Congress makes the following findings:
            (1) Organ procurement organizations play an important role 
        in the effort to increase organ donation in the United States.
            (2) The current process for the certification and 
        recertification of organ procurement organizations conducted by 
        the Department of Health and Human Services has created a level 
        of uncertainty that is interfering with the effectiveness of 
        organ procurement organizations in raising the level of organ 
        donation.
            (3) The General Accounting Office, the Institute of 
        Medicine, and the Harvard School of Public Health have 
        identified substantial limitations in the organ procurement 
        organization certification and recertification process and have 
        recommended changes in that process.
            (4) The limitations in the recertification process include:
                    (A) An exclusive reliance on population-based 
                measures of performance that do not account for the 
                potential in the population for organ donation and do 
                not permit consideration of other outcome and process 
                standards that would more accurately reflect the 
                relative capability and performance of each organ 
                procurement organization.
                    (B) A lack of due process to appeal to the 
                Secretary of Health and Human Services for 
                recertification on either substantive or procedural 
                grounds.
            (5) The Secretary of Health and Human Services has the 
        authority under section 1138(b)(1)(A)(i) of the Social Security 
        Act (42 U.S.C. 1320b-8(b)(1)(A)(i)) to extend the period for 
        recertification of an organ procurement organization from 2 to 
        4 years on the basis of its past practices in order to avoid 
        the inappropriate disruption of the nation's organ system.
            (6) The Secretary of Health and Human Services can use the 
        extended period described in paragraph (5) for recertification 
        of all organ procurement organizations to--
                    (A) develop improved performance measures that 
                would reflect organ donor potential and interim 
                outcomes, and to test these measures to ensure that 
                they accurately measure performance differences among 
                the organ procurement organizations; and
                    (B) improve the overall certification process by 
                incorporating process as well as outcome performance 
                measures, and developing equitable processes for 
                appeals.
    (b) Certification and Recertification of Organ Procurement 
Organizations.--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 realigning the margin of subparagraph (F) (as so 
        redesignated) so as to align with subparagraph (E) (as so 
        redesignated); and
            (3) by inserting after subparagraph (C) the following:
            ``(D) notwithstanding any other provision of law, has met 
        the other requirements of this section and has been certified 
or recertified by the Secretary within the previous 4-year period as 
meeting the performance standards to be a qualified organ procurement 
organization through a process that either--
                    ``(i) granted certification or recertification 
                within such 4-year period with such certification or 
                recertification in effect as of January 1, 2000, and 
                remaining in effect through the earlier of--
                            ``(I) January 1, 2002; or
                            ``(II) the completion of recertification 
                        under the requirements of clause (ii); or
                    ``(ii) is defined through regulations that are 
                promulgated by the Secretary by not later than January 
                1, 2002, that--
                            ``(I) require recertifications of qualified 
                        organ procurement organizations not more 
                        frequently than once every 4 years;
                            ``(II) rely on outcome and process 
                        performance measures that are based on 
                        empirical evidence, obtained through reasonable 
                        efforts, of organ donor potential and other 
                        related factors in each service area of 
                        qualified organ procurement organizations;
                            ``(III) use multiple outcome measures as 
                        part of the certification process; and
                            ``(IV) provide for a qualified organ 
                        procurement organization to appeal a 
                        decertification to the Secretary on substantive 
                        and procedural grounds;''.

SEC. 6. TECHNICAL AMENDMENT.

    Subparagraph (E) of section 371(b)(3) of the Public Health Service 
Act (42 U.S.C. 273(b)(3)(E)) is amended to read as follows:
            ``(E) assist the Organ Procurement and Transplantation 
        Network in the allocation of donated organs in accordance with 
        the policies and criteria established pursuant to section 
        372,''.

SEC. 7. STUDY REGARDING IMMUNOSUPPRESSIVE DRUGS.

    (a) In General.--The Secretary of Health and Human Services 
(referred to in this section as the ``Secretary'') shall provide for a 
study to determine the costs of immunosuppressive drugs that are 
provided to children pursuant to organ transplants and to determine the 
extent to which health plans, health insurance, and Government programs 
cover such costs. The Secretary may carry out the study directly or 
through a grant to the Institute of Medicine (or other public or 
nonprofit private entity).
    (b) Recommendations Regarding Certain Issues.--The Secretary shall 
ensure that, in addition to making determinations under subsection (a), 
the study under such subsection makes recommendations regarding the 
following issues:
            (1) The costs of immunosuppressive drugs that are provided 
        to children pursuant to organ transplants and to determine the 
        extent to which health plans, health insurance, and Government 
        programs cover such costs.
            (2) Other issues that are particular to the special health 
        and transplantation needs of children.
    (c) Report.--The Secretary shall ensure that, not later than 6 
months after the date of enactment of this Act, the study under 
subsection (a) is completed and a report describing the findings of the 
study is submitted to Congress.
```