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







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, and Mr. Sessions) 
introduced the following bill; which was read twice and referred to the 
          Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
To amend the Public Health Service Act to revise and extend 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,

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 as a private network and shall operate 
        under this section.
            ``(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) at least 50 but not more than 55 
                        percent of the members elected under this 
                        paragraph are transplant surgeons and 
                        transplant physicians; and
                            ``(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.
                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 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 distribution of organs as appropriate based on 
        paragraphs (1) through (8);
            ``(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 to reduce disparities in transplantation 
        resulting from socioeconomic status, race, ethnicity, or being 
        medically underserved.
    ``(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.--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.
                    ``(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 or revise 
                        and submit such revised policy to the 
                        Secretary.
                            ``(ii) Action by secretary.--Not later than 
                        30 days after receiving a revised policy under 
                        clause (i), the Secretary shall--
                                    ``(I) notify the OPTN Board that 
                                the revised policy is consistent with 
                                this section and therefore enforceable; 
                                or
                                    ``(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).
                            ``(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.
            ``(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 15 members, of which--
                            ``(i) five members shall be appointed by 
                        the Secretary from nominations submitted by the 
                        OPTN Board under subparagraph (D);
                            ``(ii) five members shall be appointed by 
                        the Secretary from nominations submitted by the 
                        Institute of Medicine under subparagraph (D); 
                        and
                            ``(iii) five members shall be appointed by 
                        the Secretary.
                    ``(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.
                    ``(E) Qualifications.--In appointing individuals to 
                serve on the Committee under subparagraph (C), the 
                Secretary shall ensure that--
                            ``(i) nine members are transplant 
                        physicians or transplant surgeons of whom--
                                    ``(I) 3 shall be selected from the 
                                nominations submitted by the OPTN 
                                Board; and
                                    ``(II) 3 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.
    ``(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 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 respective 
                enforcement and oversight responsibilities under 
                subsections (j) and (k); 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.''.
                                 <all>