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
II

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.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,
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1 SECTION 1. SHORT TITLE.

2 This Act may be cited as the ‘‘Organ Procurement

3 and Transplantation Network Amendments Act of 2000’’.

4 SEC. 2. ORGAN PROCUREMENT AND TRANSPLANTATION

5 NETWORK.

6 (a) IN GENERAL.—Section 372 of the Public Health

7 Service Act (42 U.S.C. 274) is amended to read as follows:

8 ‘‘SEC. 372. ORGAN PROCUREMENT AND TRANSPLANTATION

9 NETWORK.

10 ‘‘(a) ESTABLISHMENT OF NETWORK.—

11 ‘‘(1) IN GENERAL.—An Organ Procurement

12 and Transplantation Network (in this section re13 ferred to as the ‘Network’ or the ‘OPTN’) is estab14 lished as a private network and shall operate under

15 this section.

16 ‘‘(2) REQUIREMENTS.—The Network shall—

17 ‘‘(A) in accordance with criteria developed

18 under subsection (c)(1)(B), include as members

19 of the Network qualified organ procurement or20 ganizations (as described in section 371(b)),

21 transplant centers, and other entities that have

22 a demonstrated interest in the fields of organ

23 donation or transplantation (such members

24 shall be referred to in this section as ‘Network

25 participants’); and
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1 ‘‘(B) have a policy board (referred to in

2 this section as the ‘OPTN Board’) that meets

3 the requirements of subsection (b).

4 ‘‘(b) OPTN POLICY BOARD.—

5 ‘‘(1) COMPOSITION.—The OPTN Board shall

6 be composed of not more than 36 voting members

7 to be elected under paragraph (2) and 5 nonvoting,

8 ex officio members appointed under paragraph (3).

9 ‘‘(2) ELECTED MEMBERS.—

10 ‘‘(A) IN GENERAL.—The voting members

11 of the OPTN Board shall be elected by the

12 members of the Network described in sub13 section (a)(2)(A), from among the nominees

14 submitted under subparagraph (B), through a

15 fair and open process.

16 ‘‘(B) NOMINATING COMMITTEE.—The

17 nominating committee established under para18 graph (5) shall, prior to each election of OPTN

19 Board members under this paragraph, develop

20 a list of nominees for such election. Such list

21 shall reflect the diversity of Network members

22 described in subsection (a)(2)(A), including fac23 tors such as program type and size and geo24 graphic location. Recommendations may be sub25 mitted to the nominating committee by the Sec-
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1 retary, the members of the Network described

2 in subsection (a)(2)(A), or the general public.

3 ‘‘(C) QUALIFICATIONS.—The OPTN Board

4 shall be composed of—

5 ‘‘(i) transplant surgeons and trans6 plant physicians;

7 ‘‘(ii) representatives of qualified organ

8 procurement organizations, transplant cen9 ters, voluntary health associations, or the

10 general public, including patients awaiting

11 a transplant or transplant recipients or in12 dividuals who have donated an organ, or

13 the family members of such patients, re14 cipients or donors; and

15 ‘‘(iii) individuals distinguished in the

16 fields of ethics, basic, clinical and health

17 services research, biostatistics, health care

18 policy, or health care economics or financ19 ing.

20 ‘‘(D) REPRESENTATION REQUIREMENT.—

21 The OPTN Board shall be structured to ensure

22 that—

23 ‘‘(i) at least 50 but not more than 55

24 percent of the members elected under this
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1 paragraph are transplant surgeons and

2 transplant physicians; and

3 ‘‘(ii) at least 20 but not more than 25

4 percent of the members elected under this

5 paragraph are transplant candidates,

6 transplant recipients, organ donors and

7 family members of such individuals.

8 Nothing in this subparagraph shall be con9 strued to preclude an individual voting member

10 of the OPTN Board from being a representa11 tive described in each of clauses (i) and (iii) or

12 (ii) and (iii) of subparagraph (C) so long as the

13 limitation described in clause (i) of this sub14 paragraph is complied with.

15 ‘‘(3) APPOINTED MEMBERS.—

16 ‘‘(A) IN GENERAL.—The Secretary shall

17 appoint as ex officio, nonvoting members of the

18 OPTN Board, 1 representative from each of the

19 following:

20 ‘‘(i) The Health Resources and Serv21 ices Administration.

22 ‘‘(ii) The National Institutes of

23 Health.

24 ‘‘(iii) The Health Care Financing Ad25 ministration.
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1 ‘‘(iv) The Agency for Healthcare Re2 search and Quality.

3 ‘‘(B) NETWORK ADMINISTRATOR.—The

4 Network Administrator shall appoint an ex offi5 cio nonvoting member of the OPTN Board.

6 ‘‘(4) TERMS OF ELECTED MEMBERS.—

7 ‘‘(A) IN GENERAL.—Except as provided

8 for in this paragraph, members of the OPTN

9 Board elected under paragraph (2) shall serve

10 for a term of 3 years and may be re-elected.

11 ‘‘(B) NEW MEMBERS.—To ensure the staggered rotation of 1 12 ⁄3 of the elected members of

13 the OPTN Board each year, the initial mem14 bers of the OPTN Board elected under para15 graph (2) shall serve for terms of 1, 2, or 3

16 years respectively as designated by the nomi17 nating committee.

18 ‘‘(C) TRANSITION.—Consistent with sub19 section (c)(3), the voting members of the

20 OPTN Board who are serving on the date of

21 enactment of the Organ Procurement and

22 Transplantation Network Amendments Act of

23 2000 may continue to serve until the expiration

24 of their terms. Upon such termination, the

25 nominating committee, in submitting nomina-
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1 tions to fill such vacancies, shall ensure the

staggered rotation of 1 2 ⁄3 of the members elected

3 under paragraph (2) every 3 years.

4 ‘‘(D) CONTRACT STATUS.—A change in the

5 status of a contract under subsection (f), or a

6 change in the contractor, shall not affect the

7 terms of the members of the OPTN Board.

8 ‘‘(5) CHAIRPERSON AND COMMITTEES.—The

9 OPTN Board shall have a chairperson, an executive

10 committee, a nominating committee, a membership

11 committee, and such other committees as the OPTN

12 Board determines to be appropriate.

13 ‘‘(c) GENERAL FUNCTIONS OF THE OPTN BOARD.—

14 ‘‘(1) ESTABLISHMENT OF NETWORK POLICIES

15 AND CRITERIA.—The OPTN Board shall—

16 ‘‘(A) after consultation with Network par17 ticipants and the Network Administrator, estab18 lish and carry out the policies and functions de19 scribed in this section for the Network;

20 ‘‘(B) establish membership criteria for par21 ticipating in the Network;

22 ‘‘(C) establish medical criteria for allo23 cating organs and for listing and de-listing pa24 tients on the national lists maintained under

25 paragraph (2); and
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1 ‘‘(D) establish performance criteria for

2 transplant programs.

3 ‘‘(2) NATIONAL SYSTEM.—The OPTN Board

4 shall maintain a national system to match organs

5 and individuals who need organ transplants. The na6 tional system shall—

7 ‘‘(A) have 1 or more lists of individuals

8 who are in need of organ transplants; and

9 ‘‘(B) be operated in accordance with Net10 work policies and criteria established under

11 paragraph (1).

12 ‘‘(3) NO FIDUCIARY RESPONSIBILITY.—The

13 OPTN Board shall have no voting member who has

14 any fiduciary responsibility to the entity that holds

15 the contract provided for under this section.

16 ‘‘(4) OPTN BOARD REQUIREMENTS.—The

17 OPTN Board shall cooperate with the Network Ad18 ministrator to ensure compliance with the require19 ments of this section including the contract entered

20 into under subsection (f).

21 ‘‘(d) ORGAN TRANSPLANT POLICY.—The OPTN

22 Board shall establish organ transplant policies, including

23 organ allocation policies for potential organ recipients and

24 policies that affect patient outcomes. Such policies shall—

25 ‘‘(1) be based on sound medical principles;
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1 ‘‘(2) be based on valid scientific data;

2 ‘‘(3) be equitable;

3 ‘‘(4) seek to achieve the best use of donated or4 gans;

5 ‘‘(5) be designed to avoid wasting organs, to

6 avoid futile transplants and reduce the risk of re7 transplantation, to promote patient access to trans8 plantation, and to promote the efficient management

9 of organ placement;

10 ‘‘(6) be specific for each organ type or combina11 tion of organ types;

12 ‘‘(7) be based on standardized medical criteria

13 for listing and de-listing candidates from organ

14 transplant waiting lists;

15 ‘‘(8) determine priority rankings (within cat16 egories as appropriate) for candidates who are medi17 cally suitable for transplantation, such rankings

18 shall be based on standardized medical criteria and

19 ordered according to medical urgency and medical

20 appropriateness;

21 ‘‘(9) seek distribution of organs as appropriate

22 based on paragraphs (1) through (8);

23 ‘‘(10) develop and apply appropriate perform24 ance indicators, including patient-focused indicators,

25 to assess transplant program performance and re-
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1 duce inter-transplant program variance to improve

2 program performance; and

3 ‘‘(11) seek to reduce disparities in transplan4 tation resulting from socioeconomic status, race, eth5 nicity, or being medically underserved.

6 ‘‘(e) ENFORCEMENT OF ORGAN TRANSPLANT POL7 ICY.—

8 ‘‘(1) IN GENERAL.—

9 ‘‘(A) PROPOSED POLICY.—This paragraph

10 shall apply to any proposed transplant policy

11 that is developed by the OPTN Board that the

12 Board or the Secretary determines should be

13 enforced under this section or under section

14 1138 of the Social Security Act.

15 ‘‘(B) SUBMISSION OF POLICY.—Not later

16 than 60 days prior to the implementation of a

17 proposed policy described in subparagraph (A),

18 the OPTN Board shall submit such proposed

19 policy to the Secretary.

20 ‘‘(C) PUBLICATION.—Upon receipt of a

21 proposed policy under subparagraph (B), the

22 Secretary shall publish the policy in the Federal

23 Register for a 60-day public comment period.

24 ‘‘(D) ACTION BY SECRETARY.—Not later

25 than 90 days after receipt of a proposed policy
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1 under subparagraph (B), the Secretary shall

2 consider public comments received under sub3 paragraph (C) and shall—

4 ‘‘(i) notify the OPTN Board that the

5 policy is consistent with this section and

6 therefore enforceable; or

7 ‘‘(ii) notify the OPTN Board that the

8 policy is inconsistent with this section and

9 direct the Board to reconsider and revise

10 the policy consistent with the recommenda11 tions of the Secretary.

12 ‘‘(E) RECONSIDERATION.—

13 ‘‘(i) IN GENERAL.—Not later than 30

14 days after receiving a notice from the Sec15 retary under subparagraph (D)(ii), the

16 OPTN Board shall reaffirm the proposed

17 policy or revise and submit such revised

18 policy to the Secretary.

19 ‘‘(ii) ACTION BY SECRETARY.—Not

20 later than 30 days after receiving a revised

21 policy under clause (i), the Secretary

22 shall—

23 ‘‘(I) notify the OPTN Board that

24 the revised policy is consistent with
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1 this section and therefore enforceable;

2 or

3 ‘‘(II) notify the OPTN Board

4 that the revised policy is inconsistent

5 with this section and submit the re6 vised policy, with the comments and

7 proposed revisions of the Secretary, to

8 the Scientific Advisory Committee on

9 Organ Transplantation (referred to in

10 this subsection as the ‘Committee’) es11 tablished under paragraph (2).

12 ‘‘(iii) ACTION BY COMMITTEE.—Not

13 later than 30 days after the submission of

14 a revised policy to the Committee under

15 clause (ii), the Committee may, by a ma16 jority vote, disapprove the comments or re17 vision of the Secretary. If the Committee

18 disapproves such comments or revisions,

19 the revised policy shall not take effect until

20 a majority of the Committee approves the

21 policy or the revisions to such policy.

22 ‘‘(2) SCIENTIFIC ADVISORY COMMITTEE ON

23 ORGAN TRANSPLANTATION.—

24 ‘‘(A) ESTABLISHMENT.—The Secretary

25 shall establish an advisory committee to be
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1 known as the Scientific Advisory Committee on

2 Organ Transplantation. Consistent with the re3 quirements of sections 5 and 10 of the Federal

4 Advisory Committee Act—

5 ‘‘(i) the deliberations of the Com6 mittee shall not be inappropriately influ7 enced by the Secretary or by any special

8 interest and shall only be the result of the

9 independent judgment of the Committee;

10 and

11 ‘‘(ii) the meetings of the Committee

12 shall be open to the public, advance notice

13 of meetings shall be published in the Fed14 eral Register, and records or minutes of

15 meetings shall be made available to the

16 public.

17 ‘‘(B) DUTIES.—The Committee shall make

18 recommendations with respect to policy matters

19 related to reviews conducted under paragraph

20 (1)(E)(ii)(II).

21 ‘‘(C) MEMBERSHIP.—The Committee shall

22 be composed of 15 members, of which—

23 ‘‘(i) five members shall be appointed

24 by the Secretary from nominations sub-
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1 mitted by the OPTN Board under sub2 paragraph (D);

3 ‘‘(ii) five members shall be appointed

4 by the Secretary from nominations sub5 mitted by the Institute of Medicine under

6 subparagraph (D); and

7 ‘‘(iii) five members shall be appointed

8 by the Secretary.

9 ‘‘(D) NOMINATIONS.—The OPTN Board

10 and the Institute of Medicine shall each nomi11 nate, in an independent manner, 5 qualified in12 dividuals to serve on the Committee.

13 ‘‘(E) QUALIFICATIONS.—In appointing in14 dividuals to serve on the Committee under sub15 paragraph (C), the Secretary shall ensure

16 that—

17 ‘‘(i) nine members are transplant phy18 sicians or transplant surgeons of whom—

19 ‘‘(I) 3 shall be selected from the

20 nominations submitted by the OPTN

21 Board; and

22 ‘‘(II) 3 shall be selected from the

23 nominations submitted by the Insti24 tute of Medicine; and
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1 ‘‘(ii) the remaining members are indi2 viduals who are—

3 ‘‘(I) distinguished in the fields of

4 ethics, basic, clinical or health services

5 research, biostatistics, or health care

6 policy, economics or financing; or

7 ‘‘(II) transplant candidates,

8 transplant recipients, organ donors or

9 family members of such individuals.

10 ‘‘(F) EXPERTS.—The Committee shall

11 seek advice from appropriate experts, as need12 ed, to evaluate the proposed policy and revisions

13 under review.

14 ‘‘(G) CHAIRPERSON.—The members of the

15 Committee shall elect a member to serve as the

16 chairperson of the Committee.

17 ‘‘(H) TERMS.—Members of the Committee

18 shall serve for a term of 5 years. Vacancies

19 shall be filled in the same manner as the origi20 nal appointment was made.

21 ‘‘(f) NETWORK ADMINISTRATION AND OPERATION.—

22 The Secretary shall contract with a nonprofit private enti23 ty (referred to in this section as the ‘Network Adminis24 trator’) for the administration and operation of the Net25 work. The Network Administrator shall administer and
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1 operate the OPTN Board in accordance with subsection

2 (b). The Network Administrator shall, pursuant to the

3 policies and criteria established by the OPTN Board—

4 ‘‘(1) maintain and operate a national system as

5 established by the OPTN Board to match organs

6 and individuals who need organ transplants;

7 ‘‘(2) operate in accordance with medical criteria

8 established by the OPTN Board, and administer the

9 national system established under subsection (c)(2);

10 ‘‘(3) maintain 1 or more lists of individuals who

11 need organ transplants as provided for under sub12 section (c)(2)(A);

13 ‘‘(4) maintain a 24-hour communication service

14 to facilitate matching organs with individuals in15 cluded on the list or lists;

16 ‘‘(5) assist organ procurement organizations in

17 obtaining and distributing organs in accordance with

18 the policies established by the OPTN Board;

19 ‘‘(6) adopt and use standards of quality for the

20 acquisition and transportation of donated organs, in21 cluding standards regarding the transmission of in22 fectious diseases;

23 ‘‘(7) prepare and distribute, on a regionalized

24 basis (and, to the extent practicable, among regions

25 or on a national basis), samples of blood sera from
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1 individuals who are included on the list in order to

2 facilitate matching the compatibility of such individ3 uals with organ donors;

4 ‘‘(8) coordinate, as appropriate, the transpor5 tation of organs from organ procurement organiza6 tions to transplant centers;

7 ‘‘(9) provide information to physicians, health

8 care professionals, and the general public regarding

9 organ donation;

10 ‘‘(10) carry out studies and demonstration

11 projects for the purpose of improving procedures for

12 organ procurement and allocation; and

13 ‘‘(11) work actively with organ procurement or14 ganizations, transplant centers, health care pro15 viders, and the public to increase the supply of do16 nated organs.

17 ‘‘(g) DATA COLLECTION, ANALYSIS AND DISTRIBU18 TION.—

19 ‘‘(1) IN GENERAL.—The Network Adminis20 trator shall analyze, maintain, verify, make available

21 and publish timely data to the extent necessary to—

22 ‘‘(A) enable the OPTN Board to fulfill its

23 responsibilities under this section;
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1 ‘‘(B) assess the compliance of members of

2 the Network with performance and other cri3 teria developed pursuant to subsection (c)(1);

4 ‘‘(C) evaluate the quality of care provided

5 to transplant candidates and patients generally

6 and in an individual program;

7 ‘‘(D) provide data needed by the Scientific

8 Registry maintained pursuant to section 373;

9 ‘‘(E) provide transplant candidates and pa10 tients, physicians and others with information

11 needed to evaluate or select a transplant pro12 gram;

13 ‘‘(F) provide a member of the Network

14 with data about the member, including results

15 of analysis or other processing of data originally

16 supplied by the member;

17 ‘‘(G) enable the OPTN Board, the Net18 work Administrator and the Secretary to fulfill

19 respective enforcement and oversight respon20 sibilities under subsections (j) and (k); and

21 ‘‘(H) comply with the requirements under

22 subsection (l).

23 ‘‘(2) TYPES OF DATA.—Data provided under

24 paragraph (1) shall include—
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1 ‘‘(A) data on transplant candidates, trans2 plant recipients, organ donors, donated organs,

3 and transplant programs; and

4 ‘‘(B) as appropriate, data, graft- and pa5 tient-survival rates (actual and adjusted to re6 flect program-specific population disease sever7 ity), program specific data, and aggregate data.

8 ‘‘(h) CONTRACT.—The contract under subsection (f)

9 shall—

10 ‘‘(1) be awarded through a process of competi11 tive bidding as determined by the Secretary; and

12 ‘‘(2) be awarded for a period of no longer than

13 5 years.

14 ‘‘(i) NETWORK MEMBERSHIP AND PATIENT REG15 ISTRATION FEE.—

16 ‘‘(1) IN GENERAL.—The Network Adminis17 trator may assess a fee, to be collected by the Net18 work Administrator, for membership in the Network

19 (to be known as the ‘Network membership fee’), and

20 for the listing of each potential transplant recipient

21 on the national organ matching system maintained

22 by the Network Administrator (to be known as the

23 ‘patient registration fee’), in an amount determined

24 under paragraph (2).
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1 ‘‘(2) AMOUNT.—The amounts of the fees to be

2 assessed under paragraph (1) shall be calculated so

3 as to be—

4 ‘‘(A) reasonable and customary; and

5 ‘‘(B) sufficient to cover the Network’s rea6 sonable costs of operation in accordance with

7 this section.

8 ‘‘(3) ANNUAL RECALCULATION.—

9 ‘‘(A) IN GENERAL.—The fees calculated

10 under paragraph (2) shall be annually recal11 culated, based on—

12 ‘‘(i) changes in the level or cost of

13 contract tasks and other activities related

14 to organ procurement and transplantation;

15 and

16 ‘‘(ii) changes in expected revenues

17 from contract funds, Network membership

18 fees and patient registration fees available

19 to the Network Administrator.

20 ‘‘(B) PROCEDURE.—

21 ‘‘(i) PROPOSAL.—The Network Ad22 ministrator shall submit to the Secretary a

23 written proposal for, and justification of, a

24 recalculated fee under subparagraph (A).
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1 ‘‘(ii) DETERMINATION.—The proposal

2 of the Network Administrator for a recal3 culated fee under clause (i) shall take ef4 fect unless the Secretary, within 60 days of

5 receiving the proposal, provides the Net6 work Administrator with a written deter7 mination, with justification, that the pro8 posed fee level does not meet the require9 ment of subparagraph (A).

10 ‘‘(4) USE OF FEES.—

11 ‘‘(A) IN GENERAL.—All fees collected by

12 the Network Administrator under this sub13 section shall be available to the Network, with14 out fiscal year limitation, for use in carrying

15 out the functions described in subsection (f).

16 ‘‘(B) RESTRICTION.—Fees collected under

17 this subsection may not be used for any activity

18 for which contract funds may not be used under

19 this section.

20 ‘‘(5) RULE OF CONSTRUCTION.—Nothing in

21 this subsection shall be construed as prohibiting the

22 Network Administrator from collecting or accepting

23 other fees, donations or gifts or for using such other

24 fees, donations or gifts to carry out activities other
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1 than those authorized under the contract under this

2 section.

3 ‘‘(j) OVERSIGHT OF NETWORK PARTICIPANTS.—

4 ‘‘(1) MONITORING.—

5 ‘‘(A) IN GENERAL.—The OPTN Board

6 and the Network Administrator shall, on an on7 going and periodic basis, or as requested by the

8 Secretary, monitor the operations of Network

9 participants to determine whether the partici10 pants are maintaining compliance with the cri11 teria and policies established by the OPTN

12 Board.

13 ‘‘(B) PROCEDURES.—

14 ‘‘(i) NOTICE.—In monitoring a Net15 work participant under subparagraph (A),

16 the OPTN Board or the Administrator—

17 ‘‘(I) shall inform the participant

18 and the Secretary upon initiating a

19 compliance review of a Network par20 ticipant; and

21 ‘‘(II) shall inform the participant

22 and the Secretary of any findings in23 dicating noncompliance by the partici24 pant with such criteria and policies.
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1 ‘‘(ii) APPEALS.—The Network Admin2 istrator shall establish procedures for ap3 pealing noncompliance determinations.

4 Such procedures shall ensure due process

5 and shall allow for corrective action.

6 ‘‘(2) PEER REVIEW PROCEEDINGS.—

7 ‘‘(A) IN GENERAL.—The OPTN Board

8 shall establish a peer review system and condi9 tions for the application of peer review require10 ments to ensure that members of the Network

11 comply with policies and criteria established by

12 the OPTN Board under this section. Such peer

13 review system may include prospective reviews

14 and shall be administered by the Network Ad15 ministrator and overseen by the OPTN Board.

16 ‘‘(B) POLICIES, REVIEW AND EVALUA17 TION.—As part of the peer review system estab18 lished under subparagraph (A), the OPTN

19 Board shall establish such policies, and the Net20 work Administrator shall conduct such ongoing

21 and periodic reviews and evaluations of mem22 bers of the Network, as necessary to ensure

23 compliance with the policies and criteria estab24 lished by the OPTN Board under this section.
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1 ‘‘(C) EMERGING ISSUES.—As part of such

2 peer review system established under subpara3 graph (A), the OPTN Board shall establish

4 policies to work with and direct the Network

5 Administrator to respond to emerging issues

6 and problems.

7 ‘‘(k) ENFORCEMENT.—

8 ‘‘(1) RECOMMENDATIONS.—The OPTN Board

9 or the Network Administrator shall provide advice,

10 and make recommendations for appropriate action,

11 to the Secretary concerning the results of any re12 views or evaluations that, in the opinion of the

13 OPTN Board or the Network Administrator,

14 indicate—

15 ‘‘(A) noncompliance by Network partici16 pants with—

17 ‘‘(i) the policies or criteria established

18 by the OPTN Board; or

19 ‘‘(ii) the operating procedures of the

20 Network Administrator; or

21 ‘‘(B) a risk to the health of organ trans22 plant patients or to public safety.

23 ‘‘(2) ENFORCEMENT BY NETWORK.—

24 ‘‘(A) IN GENERAL.—If the OPTN Board

25 determines that one of the members of the net-
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1 work has violated a requirement established by

2 this section or by the Network, the OPTN

3 Board may impose on the member 1 or more of

4 the sanctions described in subparagraph (B), or

5 may recommend that the Secretary take en6 forcement action under paragraph (3).

7 ‘‘(B) TYPES OF SANCTIONS.—The sanc8 tions described in this subparagraph may

9 include—

10 ‘‘(i) the loss of any or all privileges of

11 membership in good standing in the Net12 work;

13 ‘‘(ii) the imposition upon the member

14 of additional or more frequent reviews or

15 evaluations under subsection (j)(1)(A), and

16 assessments of the reasonable costs of such

17 additional or more frequent reviews or

18 evaluations; and

19 ‘‘(iii) such other sanctions as the Sec20 retary may permit the OPTN Board to im21 pose.

22 ‘‘(3) ENFORCEMENT BY THE SECRETARY.—

23 ‘‘(A) IN GENERAL.—If the Secretary, after

24 consultation with the OPTN Board or Network

25 Administrator, determines that a member of the
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1 Network has violated a requirement established

2 by this section or a requirement of a policy that

3 is enforceable under subsection (f), the Sec4 retary may impose on the member 1 or more of

5 the sanctions described in subparagraph (B).

6 ‘‘(B) TYPES OF SANCTIONS.—The sanc7 tions described in this subparagraph shall

8 include—

9 ‘‘(i) requiring the member to follow a

10 directed plan of correction;

11 ‘‘(ii) imposing upon the member a

12 monetary assessment (to be paid to the

13 General Fund of the Treasury) in an

14 amount not to exceed $10,000 for each

15 violation or for each day of violation;

16 ‘‘(iii) requiring the member to pay to

17 the Network Administrator the costs of on18 site monitoring of the member;

19 ‘‘(iv) the loss of any or all privileges

20 of membership in the Network; and

21 ‘‘(v) in cases where the violation cre22 ates a risk to patient health or to public

23 health, such other action as the Secretary

24 determines to be necessary.
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1 ‘‘(C) PROCEDURES.—The Secretary shall

2 develop and implement procedures for the impo3 sition of sanctions under clauses (i) through (v)

4 of subparagraph (B). Such procedures shall

5 include—

6 ‘‘(i) the provision of reasonable notice

7 to the Network member and the OPTN

8 Board that the Secretary is considering

9 imposing a sanction;

10 ‘‘(ii) affording the member a reason11 able opportunity to be heard in response to

12 the notice;

13 ‘‘(iii) the provision of notice to the

14 member that the Secretary has decided to

15 impose a sanction; and

16 ‘‘(iv) the opportunity for the Network

17 member to appeal such sanction.

18 ‘‘(l) ANNUAL REPORT.—

19 ‘‘(1) IN GENERAL.—Not later than September

20 30 of each year, the Network Administrator shall

21 prepare and submit to the Secretary an annual re22 port on the performance and policies of the Network.

23 The report shall include additional items as specified

24 in the contract under this section or requested in a

25 timely manner by the Secretary.
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1 ‘‘(2) REQUIREMENT OF OPTN BOARD AP2 PROVAL.—The OPTN Board shall review and ap3 prove the report required under paragraph (1) prior

4 to the submission of such report to the Secretary.

5 ‘‘(3) SUBMISSION TO CONGRESS.—

6 ‘‘(A) IN GENERAL.—Not later than De7 cember 31 of each year, the Secretary shall

8 transmit the report submitted under paragraph

9 (1) and the comments of the Secretary con10 cerning such report, to the appropriate commit11 tees of Congress.

12 ‘‘(B) CLARIFYING INFORMATION.—The

13 Secretary may, upon the receipt of the report

14 under paragraph (1), but prior to transmission

15 of the report to Congress under subparagraph

16 (A), request that the Network Administrator

17 submit clarifying information or an addenda as

18 needed to fulfill the requirements of this sub19 section.

20 ‘‘(m) AUTHORIZATION OF APPROPRIATIONS.—There

21 is authorized to be appropriated to carry out this section,

22 such sums as may be necessary for each of fiscal years

23 2001 through 2005.’’.
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1 SEC. 3. SCIENTIFIC REGISTRY.

2 Section 373 of the Public Health Service Act (42

3 U.S.C. 274a) is amended to read as follows:

4 ‘‘SEC. 373. SCIENTIFIC REGISTRY.

5 ‘‘The Secretary shall by contract, develop and main6 tain a scientific registry of the recipients of organ trans7 plants. The registry shall include information, with respect

8 to organ transplant patients and transplant procedures,

9 as the Secretary determines to be necessary to an ongoing

10 evaluation of the scientific and clinical status of organ

11 transplantation.’’.

12 SEC. 4. ORGAN DONATION.

13 Part H of title III of the Public Health Service Act

14 (42 U.S.C. 273 et seq.) is amended—

15 (1) by redesignating section 378 (42 U.S.C.

16 274g) as section 379; and

17 (2) by inserting after section 377 (42 U.S.C.

18 274f) the following:

19 ‘‘SEC. 378. ORGAN DONATION AND RESEARCH.

20 ‘‘(a) INTER-AGENCY TASK FORCE ON ORGAN DONA21 TION AND RESEARCH.—

22 ‘‘(1) IN GENERAL.—The Secretary shall estab23 lish an inter-agency task force on organ donation

24 and research (referred to in this section as the ‘task

25 force’) to improve the coordination and evaluation

26 of—
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1 ‘‘(A) federally supported or conducted

2 organ donation efforts and policies; and

3 ‘‘(B) federally supported or conducted

4 basic, clinical and health services research (in5 cluding research on preservation techniques and

6 organ rejection and compatibility).

7 ‘‘(2) COMPOSITION.—The task force shall be

8 composed of—

9 ‘‘(A) the Surgeon General, who shall serve

10 as the chairperson;

11 ‘‘(B) representatives to be appointed by

12 the Secretary from relevant agencies within the

13 Department of Health and Human Services (in14 cluding the Health Resources and Services Ad15 ministration, Health Care Financing Adminis16 tration, National Institutes of Health, and

17 Agency for Healthcare Research and Quality);

18 ‘‘(C) a representative from the Department

19 of Transportation;

20 ‘‘(D) a representative from the Depart21 ment of Defense;

22 ‘‘(E) a representative from the Department

23 of Veterans Affairs;

24 ‘‘(F) a representative from the Office of

25 Personnel Management; and
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•S 2366 RS

1 ‘‘(G) representatives of other Federal

2 agencies or departments as determined to be

3 appropriate by the Secretary.

4 ‘‘(3) ANNUAL REPORT.—In addition to activi5 ties carried out under paragraph (1), the task force

6 shall support the development of the annual report

7 under subsection (d)(2).

8 ‘‘(4) TERMINATION.—The task force may be

9 terminated at the discretion of the Secretary fol10 lowing the completion of at least 2 annual reports

11 under subsection (d). Upon such termination, the

12 Secretary shall provide for the on-going coordination

13 of federally supported or conducted organ donation

14 and research activities.

15 ‘‘(b) EDUCATION.—

16 ‘‘(1) PUBLIC EDUCATION AND AWARENESS.—

17 The Secretary shall, directly or through grants or

18 contracts, carry out a comprehensive and effective

19 national public education program to increase organ

20 donation, including living donation.

21 ‘‘(2) DEVELOPMENT OF CURRICULA AND

22 OTHER EDUCATION ACTIVITIES.—

23 ‘‘(A) IN GENERAL.—The Secretary shall

24 support the development and dissemination of

25 model curricula to train health care profes-
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1 sionals and other appropriate professionals (in2 cluding religious leaders in the community and

3 law enforcement officials) in issues surrounding

4 organ donation, including methods to approach

5 patients and their families, cultural sensitivities,

6 and other relevant issues.

7 ‘‘(B) HEALTH CARE PROFESSIONALS.—

8 For purposes of subparagraph (A), the term

9 ‘health care professionals’ includes—

10 ‘‘(i) medical students, residents and

11 fellows, attending physicians (through con12 tinuing medical education courses and

13 other methods), nurses, social workers, and

14 other allied health professionals; and

15 ‘‘(ii) hospital- or other health care-fa16 cility based chaplains; and

17 ‘‘(iii) emergency medical personnel.

18 ‘‘(c) GRANTS.—The Secretary shall award peer-re19 viewed grants to public and non-profit private entities, in20 cluding States, to carry out studies and demonstration

21 projects to increase organ donation rates, including living

22 donation. The Secretary shall ensure that activities carried

23 out by grantees under this subsection are evaluated for

24 effectiveness and that such findings are disseminated.

25 ‘‘(d) REPORTS.—
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1 ‘‘(1) IOM REPORT ON BEST PRACTICES.—

2 ‘‘(A) IN GENERAL.—The Secretary shall

3 enter into a contract with the Institute of Medi4 cine to conduct an evaluation of the organ do5 nation practices of organ procurement organiza6 tions, States, other countries, and other appro7 priate organizations that have achieved a higher

8 than average organ donation rate.

9 ‘‘(B) BARRIERS.—In conducting the eval10 uation under subparagraph (A), the Institute of

11 Medicine shall examine existing barriers to

12 organ donation.

13 ‘‘(C) REPORT.—Not later than 18 months

14 after the date of enactment of this section, the

15 Institute of Medicine shall submit to the Sec16 retary a report concerning the evaluation con17 ducted under this paragraph. Such report shall

18 include recommendations for administrative ac19 tions and, if necessary, legislation in order to

20 replicate the best practices identified in the

21 evaluation and to otherwise increase organ do22 nation and procurement rates.

23 ‘‘(2) ANNUAL REPORT ON DONATION.—

24 ‘‘(A) IN GENERAL.—Not later than 1 year

25 after the date on which the report is submitted
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1 under paragraph (1)(C), and annually there2 after, the Secretary shall prepare and submit to

3 Congress a report concerning federally sup4 ported or conducted organ donation and pro5 curement activities, including donation and pro6 curement activities evaluated or conducted

7 under subsection (a) to increase organ dona8 tion.

9 ‘‘(B) REQUIREMENTS.—To the extent

10 practicable, each annual report under subpara11 graph (A) shall—

12 ‘‘(i) evaluate the effectiveness of ac13 tivities, identify best practices, and make

14 recommendations regarding broader adop15 tion of best practices with respect to organ

16 donation and procurement;

17 ‘‘(ii) assess organ donation and pro18 curement activities that are recently com19 pleted, current or planned.

20 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There

21 is authorized to be appropriated to carry out this section,

22 $15,000,000 for fiscal year 2001, and such sums as may

23 be necessary for each of fiscal years 2002 through 2005.’’.
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1 SECTION 1. SHORT TITLE.

2 This Act may be cited as the ‘‘Organ Procurement and

3 Transplantation Network Amendments Act of 2000’’.

4 SEC. 2. ORGAN PROCUREMENT AND TRANSPLANTATION

5 NETWORK.

6 (a) IN GENERAL.—Section 372 of the Public Health

7 Service Act (42 U.S.C. 274) is amended to read as follows:

8 ‘‘SEC. 372. ORGAN PROCUREMENT AND TRANSPLANTATION

9 NETWORK.

10 ‘‘(a) ESTABLISHMENT OF NETWORK.—

11 ‘‘(1) IN GENERAL.—An Organ Procurement and

12 Transplantation Network (in this section referred to

13 as the ‘Network’ or the ‘OPTN’) is established under

14 this section and shall be operated by a private non15 profit entity as provided for in subsection (f).

16 ‘‘(2) REQUIREMENTS.—The Network shall—

17 ‘‘(A) in accordance with criteria developed

18 under subsection (c)(1)(B), include as members

19 of the Network qualified organ procurement or20 ganizations (as described in section 371(b)),

21 transplant centers, and other entities that have a

22 demonstrated interest in the fields of organ dona23 tion or transplantation (such members shall be

24 referred to in this section as ‘Network partici25 pants’); and
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•S 2366 RS

1 ‘‘(B) have a policy board (referred to in this

2 section as the ‘OPTN Board’) that meets the re3 quirements of subsection (b).

4 ‘‘(b) OPTN POLICY BOARD.—

5 ‘‘(1) COMPOSITION.—The OPTN Board shall be

6 composed of not more than 36 voting members to be

7 elected under paragraph (2) and 5 nonvoting, ex offi8 cio members appointed under paragraph (3).

9 ‘‘(2) ELECTED MEMBERS.—

10 ‘‘(A) IN GENERAL.—The voting members of

11 the OPTN Board shall be elected by the members

12 of the Network described in subsection (a)(2)(A),

13 from among the nominees submitted under sub14 paragraph (B), through a fair and open process.

15 ‘‘(B) NOMINATING COMMITTEE.—The nomi16 nating committee established under paragraph

17 (5) shall, prior to each election of OPTN Board

18 members under this paragraph, develop a list of

19 nominees for such election. Such list shall reflect

20 the diversity of Network members described in

21 subsection (a)(2)(A), including factors such as

22 program type and size and geographic location.

23 Recommendations may be submitted to the nomi24 nating committee by the Secretary, the members
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1 of the Network described in subsection (a)(2)(A),

2 or the general public.

3 ‘‘(C) QUALIFICATIONS.—The OPTN Board

4 shall be composed of—

5 ‘‘(i) transplant surgeons and trans6 plant physicians;

7 ‘‘(ii) representatives of qualified organ

8 procurement organizations, transplant cen9 ters, voluntary health associations, or the

10 general public, including patients awaiting

11 a transplant or transplant recipients or in12 dividuals who have donated an organ, or

13 the family members of such patients, recipi14 ents or donors; and

15 ‘‘(iii) individuals distinguished in the

16 fields of ethics, basic, clinical and health

17 services research, biostatistics, health care

18 policy, or health care economics or financ19 ing.

20 ‘‘(D) REPRESENTATION REQUIREMENT.—

21 The OPTN Board shall be structured to ensure

22 that—

23 ‘‘(i) approximately 50 percent of the

24 members elected under this paragraph are
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•S 2366 RS

1 transplant surgeons and transplant physi2 cians; and

3 ‘‘(ii) approximately 25 percent of the

4 members elected under this paragraph are

5 transplant candidates, transplant recipi6 ents, organ donors and family members of

7 such individuals.

8 Nothing in this subparagraph shall be construed

9 to preclude an individual voting member of the

10 OPTN Board from being a representative de11 scribed in each of clauses (i) and (iii) or (ii) and

12 (iii) of subparagraph (C) so long as the limita13 tion described in clause (i) of this subparagraph

14 is complied with.

15 ‘‘(3) APPOINTED MEMBERS.—

16 ‘‘(A) IN GENERAL.—The Secretary shall ap17 point as ex officio, nonvoting members of the

18 OPTN Board, 1 representative from each of the

19 following:

20 ‘‘(i) The Health Resources and Services

21 Administration.

22 ‘‘(ii) The National Institutes of Health.

23 ‘‘(iii) The Health Care Financing Ad24 ministration.
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•S 2366 RS

1 ‘‘(iv) The Agency for Healthcare Re2 search and Quality.

3 ‘‘(B) NETWORK ADMINISTRATOR.—The Net4 work Administrator shall appoint an ex officio

5 nonvoting member of the OPTN Board.

6 ‘‘(4) TERMS OF ELECTED MEMBERS.—

7 ‘‘(A) IN GENERAL.—Except as provided for

8 in this paragraph, members of the OPTN Board

9 elected under paragraph (2) shall serve for a

10 term of 3 years and may be re-elected.

11 ‘‘(B) NEW MEMBERS.—To ensure the staggered rotation of 1 12 ⁄3 of the elected members of the

13 OPTN Board each year, the initial members of

14 the OPTN Board elected under paragraph (2)

15 shall serve for terms of 1, 2, or 3 years respec16 tively as designated by the nominating com17 mittee.

18 ‘‘(C) TRANSITION.—Consistent with sub19 section (c)(3), the voting members of the OPTN

20 Board who are serving on the date of enactment

21 of the Organ Procurement and Transplantation

22 Network Amendments Act of 2000 may continue

23 to serve until the expiration of their terms. Upon

24 such termination, the nominating committee, in

25 submitting nominations to fill such vacancies,
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shall ensure the staggered rotation of 1 1 ⁄3 of the

2 members elected under paragraph (2) every 3

3 years.

4 ‘‘(D) CONTRACT STATUS.—A change in the

5 status of a contract under subsection (f), or a

6 change in the contractor, shall not affect the

7 terms of the members of the OPTN Board.

8 ‘‘(5) CHAIRPERSON AND COMMITTEES.—The

9 OPTN Board shall have a chairperson, an executive

10 committee, a nominating committee, a membership

11 committee, and such other committees as the OPTN

12 Board determines to be appropriate.

13 ‘‘(c) GENERAL FUNCTIONS OF THE OPTN BOARD.—

14 ‘‘(1) ESTABLISHMENT OF NETWORK POLICIES

15 AND CRITERIA.—The OPTN Board shall—

16 ‘‘(A) after consultation with Network par17 ticipants and the Network Administrator, estab18 lish and carry out the policies and functions de19 scribed in this section for the Network;

20 ‘‘(B) establish membership criteria for par21 ticipating in the Network;

22 ‘‘(C) establish medical criteria for allocating

23 organs and for listing and de-listing patients on

24 the national lists maintained under paragraph

25 (2); and
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1 ‘‘(D) establish performance criteria for

2 transplant programs.

3 ‘‘(2) NATIONAL SYSTEM.—The OPTN Board

4 shall maintain a national system to match organs

5 and individuals who need organ transplants. The na6 tional system shall—

7 ‘‘(A) have 1 or more lists, derived from a

8 national list, of individuals who are in need of

9 organ transplants; and

10 ‘‘(B) be operated in accordance with Net11 work policies and criteria established under

12 paragraph (1).

13 ‘‘(3) NO FIDUCIARY RESPONSIBILITY.—The

14 OPTN Board shall have no voting member who has

15 any fiduciary responsibility to the entity that holds

16 the contract provided for under this section.

17 ‘‘(4) OPTN BOARD REQUIREMENTS.—The OPTN

18 Board shall cooperate with the Network Adminis19 trator to ensure compliance with the requirements of

20 this section including the contract entered into under

21 subsection (f).

22 ‘‘(d) ORGAN TRANSPLANT POLICY.—The OPTN Board

23 shall establish organ transplant policies, including organ

24 allocation policies for potential organ recipients and poli25 cies that affect patient outcomes. Such policies shall—
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1 ‘‘(1) be based on sound medical principles;

2 ‘‘(2) be based on valid scientific data;

3 ‘‘(3) be equitable;

4 ‘‘(4) seek to achieve the best use of donated or5 gans;

6 ‘‘(5) be designed to avoid wasting organs, to

7 avoid futile transplants and reduce the risk of re8 transplantation, to promote patient access to trans9 plantation, and to promote the efficient management

10 of organ placement;

11 ‘‘(6) be specific for each organ type or combina12 tion of organ types;

13 ‘‘(7) be based on standardized medical criteria

14 for listing and de-listing candidates from organ

15 transplant waiting lists;

16 ‘‘(8) determine priority rankings (within cat17 egories as appropriate) for candidates who are medi18 cally suitable for transplantation, such rankings shall

19 be based on standardized medical criteria and ordered

20 according to medical urgency and medical appro21 priateness;

22 ‘‘(9) seek to reduce disparities in transplantation

23 resulting from socioeconomic status, race, ethnicity,

24 geographic area or region of residence or transplan25 tation, or being medically underserved;
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1 ‘‘(10) develop and apply appropriate perform2 ance indicators, including patient-focused indicators,

3 to assess transplant program performance and reduce

4 inter-transplant program variance to improve pro5 gram performance; and

6 ‘‘(11) seek distribution of organs as appropriate

7 based on paragraphs (1) through (10).

8 ‘‘(e) ENFORCEMENT OF ORGAN TRANSPLANT POL9 ICY.—

10 ‘‘(1) IN GENERAL.—

11 ‘‘(A) PROPOSED POLICY.—This paragraph

12 shall apply to any proposed transplant policy

13 that is developed by the OPTN Board that the

14 Board or the Secretary determines should be en15 forced under this section or under section 1138

16 of the Social Security Act.

17 ‘‘(B) SUBMISSION OF POLICY.—

18 ‘‘(i) IN GENERAL.—Not later than 60

19 days prior to the implementation of a pro20 posed policy described in subparagraph (A),

21 the OPTN Board shall submit such pro22 posed policy to the Secretary.

23 ‘‘(ii) REQUIRED SUBMISSION.—

24 ‘‘(I) REQUEST BY SECRETARY.—If

25 determined appropriate by the Sec-
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•S 2366 RS

1 retary, the Secretary may request that

2 the OPTN Board submit revisions to

3 existing transplant policies, or submit

4 new transplant policies, to the Sec5 retary under this subparagraph. Not

6 later than 90 days after any such re7 quest, the OPTN Board shall submit

8 such revisions or new policy to the Sec9 retary.

10 ‘‘(II) FAILURE TO COMPLY.—If

11 the OPTN Board fails to comply with

12 the request of the Secretary under sub13 clause (I), the Secretary may submit

14 comments concerning such request to

15 the OPTN Board for review. Not later

16 than 60 days after the submission of

17 such comments, the OPTN Board shall,

18 after considering such comments,

19 transmit the policy to the Secretary for

20 review under subparagraph (C).

21 ‘‘(III) APPLICATION OF PROVI22 SIONS.—The provisions of subpara23 graphs (C), (D), and (E) shall apply

24 to any revisions or new policies sub25 mitted under this clause to the same
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1 extent that such subparagraphs apply

2 to policies proposed under subpara3 graph (A).

4 ‘‘(C) PUBLICATION.—Upon receipt of a pro5 posed policy under subparagraph (B), the Sec6 retary shall publish the policy in the Federal

7 Register for a 60-day public comment period.

8 ‘‘(D) ACTION BY SECRETARY.—Not later

9 than 90 days after receipt of a proposed policy

10 under subparagraph (B), the Secretary shall con11 sider public comments received under subpara12 graph (C) and shall—

13 ‘‘(i) notify the OPTN Board that the

14 policy is consistent with this section and

15 therefore enforceable; or

16 ‘‘(ii) notify the OPTN Board that the

17 policy is inconsistent with this section and

18 direct the Board to reconsider and revise the

19 policy consistent with the recommendations

20 of the Secretary.

21 ‘‘(E) RECONSIDERATION.—

22 ‘‘(i) IN GENERAL.—Not later than 30

23 days after receiving a notice from the Sec24 retary under subparagraph (D)(ii), the

25 OPTN Board shall reaffirm the proposed
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1 policy and submit such policy to the Sec2 retary or shall revise such policy and sub3 mit such revised policy to the Secretary.

4 ‘‘(ii) ACTION BY SECRETARY.—Not

5 later than 30 days after receiving a revised

6 or reaffirmed policy under clause (i), the

7 Secretary shall—

8 ‘‘(I) notify the OPTN Board that

9 the revised or reaffirmed policy is con10 sistent with this section and therefore

11 enforceable; or

12 ‘‘(II) notify the OPTN Board that

13 the revised or reaffirmed policy is in14 consistent with this section and submit

15 the revised or reaffirmed policy, with

16 the comments and proposed revisions of

17 the Secretary, to the Scientific Advi18 sory Committee on Organ Transplan19 tation (referred to in this subsection as

20 the ‘Committee’) established under

21 paragraph (2).

22 ‘‘(iii) ACTION BY COMMITTEE.—Not

23 later than 30 days after the submission of

24 a revised or reaffirmed policy to the Com25 mittee under clause (ii), the Committee
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1 may, by a majority vote, disapprove the

2 comments or revisions of the Secretary. If

3 the policy is not disapproved by a majority

4 vote, the OPTN Board shall revise the pol5 icy accordingly and such policy shall be en6 forceable. If the Committee disapproves such

7 comments or revisions, the revised or re8 affirmed policy shall not take effect until a

9 majority of the Committee approves the pol10 icy or the revisions to such policy. Upon the

11 approval of a majority of the Committee of

12 the policy or revisions to such policy, the

13 OPTN Board shall revise the policy accord14 ingly and such policy shall become enforce15 able.

16 ‘‘(2) SCIENTIFIC ADVISORY COMMITTEE ON

17 ORGAN TRANSPLANTATION.—

18 ‘‘(A) ESTABLISHMENT.—The Secretary shall

19 establish an advisory committee to be known as

20 the Scientific Advisory Committee on Organ

21 Transplantation. Consistent with the require22 ments of sections 5 and 10 of the Federal Advi23 sory Committee Act—

24 ‘‘(i) the deliberations of the Committee

25 shall not be inappropriately influenced by
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1 the Secretary or by any special interest and

2 shall only be the result of the independent

3 judgment of the Committee; and

4 ‘‘(ii) the meetings of the Committee

5 shall be open to the public, advance notice

6 of meetings shall be published in the Federal

7 Register, and records or minutes of meetings

8 shall be made available to the public.

9 ‘‘(B) DUTIES.—The Committee shall make

10 recommendations with respect to policy matters

11 related to reviews conducted under paragraph

12 (1)(E)(ii)(II).

13 ‘‘(C) MEMBERSHIP.—The Committee shall

14 be composed of 21 members, of which—

15 ‘‘(i) seven members shall be appointed

16 by the Secretary from nominations sub17 mitted by the OPTN Board under subpara18 graph (D);

19 ‘‘(ii) seven members shall be appointed

20 by the Secretary from nominations sub21 mitted by the Institute of Medicine under

22 subparagraph (D); and

23 ‘‘(iii) seven members shall be ap24 pointed by the Secretary.
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1 ‘‘(D) NOMINATIONS.—The OPTN Board

2 and the Institute of Medicine shall each nomi3 nate, in an independent manner, 12 qualified

4 individuals to serve on the Committee.

5 ‘‘(E) QUALIFICATIONS.—In appointing in6 dividuals to serve on the Committee under sub7 paragraph (C), the Secretary shall ensure that—

8 ‘‘(i) twelve members are transplant

9 physicians or transplant surgeons of

10 whom—

11 ‘‘(I) four shall be selected from the

12 nominations submitted by the OPTN

13 Board; and

14 ‘‘(II) four shall be selected from

15 the nominations submitted by the In16 stitute of Medicine; and

17 ‘‘(ii) the remaining members are indi18 viduals who are—

19 ‘‘(I) distinguished in the fields of

20 ethics, basic, clinical or health services

21 research, biostatistics, or health care

22 policy, economics or financing; or

23 ‘‘(II) transplant candidates,

24 transplant recipients, organ donors or

25 family members of such individuals.
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1 ‘‘(F) EXPERTS.—The Committee shall seek

2 advice from appropriate experts, as needed, to

3 evaluate the proposed policy and revisions under

4 review.

5 ‘‘(G) CHAIRPERSON.—The members of the

6 Committee shall elect a member to serve as the

7 chairperson of the Committee.

8 ‘‘(H) TERMS.—Members of the Committee

9 shall serve for a term of 5 years. Vacancies shall

10 be filled in the same manner as the original ap11 pointment was made.

12 ‘‘(3) STUDY BY GENERAL ACCOUNTING OFFICE.—

13 ‘‘(A) IN GENERAL.—The Comptroller Gen14 eral shall conduct a study of the review process

15 for enforceable transplant policies under this

16 subsection. Such study shall examine the role of

17 the Advisory Committee established under para18 graph (2) in resolving transplant policy matters

19 under this subsection.

20 ‘‘(B) COMPLETION AND REPORT.—Not later

21 than September 30, 2004, the Comptroller Gen22 eral shall complete the study under subpara23 graph (A) and shall prepare and submit to the

24 appropriate committees of Congress a report that

25 contains—
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1 ‘‘(i) the findings of the Comptroller

2 General with respect to the study; and

3 ‘‘(ii) the recommendations of the

4 Comptroller General concerning—

5 ‘‘(I) the continued use of the Advi6 sory Committee to resolve transplant

7 policy matters under this subsection;

8 ‘‘(II) improvements in the com9 position and method of selection of the

10 members of the Advisory Committee;

11 and

12 ‘‘(III) any other improvements in

13 the review process.

14 ‘‘(f) NETWORK ADMINISTRATION AND OPERATION.—

15 The Secretary shall contract with a nonprofit private entity

16 (referred to in this section as the ‘Network Administrator’)

17 for the administration and operation of the Network. The

18 Network Administrator shall administer and operate the

19 OPTN Board in accordance with subsection (b). The Net20 work Administrator shall, pursuant to the policies and cri21 teria established by the OPTN Board—

22 ‘‘(1) maintain and operate a national system as

23 established by the OPTN Board to match organs and

24 individuals who need organ transplants;
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1 ‘‘(2) operate in accordance with medical criteria

2 established by the OPTN Board, and administer the

3 national system established under subsection (c)(2);

4 ‘‘(3) maintain 1 or more lists, derived from a

5 national list, of individuals who need organ trans6 plants as provided for under subsection (c)(2)(A);

7 ‘‘(4) maintain a 24-hour communication service

8 to facilitate matching organs with individuals in9 cluded on the list or lists;

10 ‘‘(5) assist organ procurement organizations in

11 obtaining and distributing organs in accordance with

12 the policies established by the OPTN Board;

13 ‘‘(6) adopt and use standards of quality for the

14 acquisition and transportation of donated organs, in15 cluding standards regarding the transmission of in16 fectious diseases;

17 ‘‘(7) prepare and distribute, on a regionalized

18 basis (and, to the extent practicable, among regions or

19 on a national basis), samples of blood sera from indi20 viduals who are included on the list in order to facili21 tate matching the compatibility of such individuals

22 with organ donors;

23 ‘‘(8) coordinate, as appropriate, the transpor24 tation of organs from organ procurement organiza25 tions to transplant centers;
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1 ‘‘(9) provide information to physicians, health

2 care professionals, and the general public regarding

3 organ donation;

4 ‘‘(10) carry out studies and demonstration

5 projects for the purpose of improving procedures for

6 organ procurement and allocation; and

7 ‘‘(11) work actively with organ procurement or8 ganizations, transplant centers, health care providers,

9 and the public to increase the supply of donated or10 gans.

11 ‘‘(g) DATA COLLECTION, ANALYSIS AND DISTRIBU12 TION.—

13 ‘‘(1) IN GENERAL.—The Network Administrator

14 shall analyze, maintain, verify, make available and

15 publish timely data to the extent necessary to—

16 ‘‘(A) enable the OPTN Board to fulfill its

17 responsibilities under this section;

18 ‘‘(B) assess the compliance of members of

19 the Network with performance and other criteria

20 developed pursuant to subsection (c)(1);

21 ‘‘(C) evaluate the quality of care provided to

22 transplant candidates and patients generally

23 and in an individual program;

24 ‘‘(D) provide data needed by the Scientific

25 Registry maintained pursuant to section 373;
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1 ‘‘(E) provide transplant candidates and pa2 tients, physicians and others with information

3 needed to evaluate or select a transplant pro4 gram;

5 ‘‘(F) provide a member of the Network with

6 data about the member, including results of

7 analysis or other processing of data originally

8 supplied by the member;

9 ‘‘(G) enable the OPTN Board, the Network

10 Administrator and the Secretary to fulfill their

11 responsibilities under this section; and

12 ‘‘(H) comply with the requirements under

13 subsection (l).

14 ‘‘(2) TYPES OF DATA.—Data provided under

15 paragraph (1) shall include—

16 ‘‘(A) data on transplant candidates, trans17 plant recipients, organ donors, donated organs,

18 and transplant programs; and

19 ‘‘(B) as appropriate, data, graft- and pa20 tient-survival rates (actual and adjusted to re21 flect program-specific population disease sever22 ity), program specific data, and aggregate data.

23 ‘‘(h) CONTRACT.—The contract under subsection (f)

24 shall—
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1 ‘‘(1) be awarded through a process of competitive

2 bidding as determined by the Secretary; and

3 ‘‘(2) be awarded for a period of no longer than

4 5 years.

5 ‘‘(i) NETWORK MEMBERSHIP AND PATIENT REGISTRA6 TION FEE.—

7 ‘‘(1) IN GENERAL.—The Network Administrator

8 may assess a fee, to be collected by the Network Ad9 ministrator, for membership in the Network (to be

10 known as the ‘Network membership fee’), and for the

11 listing of each potential transplant recipient on the

12 national organ matching system maintained by the

13 Network Administrator (to be known as the ‘patient

14 registration fee’), in an amount determined under

15 paragraph (2).

16 ‘‘(2) AMOUNT.—The amounts of the fees to be as17 sessed under paragraph (1) shall be calculated so as

18 to be—

19 ‘‘(A) reasonable and customary; and

20 ‘‘(B) sufficient to cover the Network’s rea21 sonable costs of operation in accordance with

22 this section.

23 ‘‘(3) ANNUAL RECALCULATION.—
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1 ‘‘(A) IN GENERAL.—The fees calculated

2 under paragraph (2) shall be annually recal3 culated, based on—

4 ‘‘(i) changes in the level or cost of con5 tract tasks and other activities related to

6 organ procurement and transplantation;

7 and

8 ‘‘(ii) changes in expected revenues from

9 contract funds, Network membership fees

10 and patient registration fees available to the

11 Network Administrator.

12 ‘‘(B) PROCEDURE.—

13 ‘‘(i) PROPOSAL.—The Network Admin14 istrator shall submit to the Secretary a

15 written proposal for, and justification of, a

16 recalculated fee under subparagraph (A).

17 ‘‘(ii) DETERMINATION.—The proposal

18 of the Network Administrator for a recal19 culated fee under clause (i) shall take effect

20 unless the Secretary, within 60 days of re21 ceiving the proposal, provides the Network

22 Administrator with a written determina23 tion, with justification, that the proposed

24 fee level does not meet the requirement of

25 subparagraph (A).
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1 ‘‘(4) USE OF FEES.—

2 ‘‘(A) IN GENERAL.—All fees collected by the

3 Network Administrator under this subsection

4 shall be available to the Network, without fiscal

5 year limitation, for use in carrying out the func6 tions described in subsection (f).

7 ‘‘(B) RESTRICTION.—Fees collected under

8 this subsection may not be used for any activity

9 for which contract funds may not be used under

10 this section.

11 ‘‘(5) RULE OF CONSTRUCTION.—Nothing in this

12 subsection shall be construed as prohibiting the Net13 work Administrator from collecting or accepting other

14 fees, donations or gifts or for using such other fees, do15 nations or gifts to carry out activities other than

16 those authorized under the contract under this section.

17 ‘‘(j) OVERSIGHT OF NETWORK PARTICIPANTS.—

18 ‘‘(1) MONITORING.—

19 ‘‘(A) IN GENERAL.—The OPTN Board and

20 the Network Administrator shall, on an ongoing

21 and periodic basis, or as requested by the Sec22 retary, monitor the operations of Network par23 ticipants to determine whether the participants

24 are maintaining compliance with the criteria

25 and policies established by the OPTN Board.
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1 ‘‘(B) PROCEDURES.—

2 ‘‘(i) NOTICE.—In monitoring a Net3 work participant under subparagraph (A),

4 the OPTN Board or the Administrator—

5 ‘‘(I) shall inform the participant

6 and the Secretary upon initiating a

7 compliance review of a Network partic8 ipant; and

9 ‘‘(II) shall inform the participant

10 and the Secretary of any findings indi11 cating noncompliance by the partici12 pant with such criteria and policies.

13 ‘‘(ii) APPEALS.—The Network Admin14 istrator shall establish procedures for ap15 pealing noncompliance determinations.

16 Such procedures shall ensure due process

17 and shall allow for corrective action.

18 ‘‘(2) PEER REVIEW PROCEEDINGS.—

19 ‘‘(A) IN GENERAL.—The OPTN Board shall

20 establish a peer review system and conditions for

21 the application of peer review requirements to

22 ensure that members of the Network comply with

23 policies and criteria established by the OPTN

24 Board under this section. Such peer review sys25 tem may include prospective reviews and shall be
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1 administered by the Network Administrator and

2 overseen by the OPTN Board.

3 ‘‘(B) POLICIES, REVIEW AND EVALUA4 TION.—As part of the peer review system estab5 lished under subparagraph (A), the OPTN Board

6 shall establish such policies, and the Network Ad7 ministrator shall conduct such ongoing and peri8 odic reviews and evaluations of members of the

9 Network, as necessary to ensure compliance with

10 the policies and criteria established by the OPTN

11 Board under this section.

12 ‘‘(C) EMERGING ISSUES.—As part of such

13 peer review system established under subpara14 graph (A), the OPTN Board shall establish poli15 cies to work with and direct the Network Admin16 istrator to respond to emerging issues and prob17 lems.

18 ‘‘(k) ENFORCEMENT.—

19 ‘‘(1) RECOMMENDATIONS.—The OPTN Board or

20 the Network Administrator shall provide advice, and

21 make recommendations for appropriate action, to the

22 Secretary concerning the results of any reviews or

23 evaluations that, in the opinion of the OPTN Board

24 or the Network Administrator, indicate—
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1 ‘‘(A) noncompliance by Network partici2 pants with—

3 ‘‘(i) the policies or criteria established

4 by the OPTN Board; or

5 ‘‘(ii) the operating procedures of the

6 Network Administrator; or

7 ‘‘(B) a risk to the health of organ trans8 plant patients or to public safety.

9 ‘‘(2) ENFORCEMENT BY NETWORK.—

10 ‘‘(A) IN GENERAL.—If the OPTN Board de11 termines that one of the members of the network

12 has violated a requirement established by this

13 section or by the Network, the OPTN Board may

14 impose on the member 1 or more of the sanctions

15 described in subparagraph (B), or may rec16 ommend that the Secretary take enforcement ac17 tion under paragraph (3).

18 ‘‘(B) TYPES OF SANCTIONS.—The sanctions

19 described in this subparagraph may include—

20 ‘‘(i) the loss of any or all privileges of

21 membership in good standing in the Net22 work;

23 ‘‘(ii) the imposition upon the member

24 of additional or more frequent reviews or

25 evaluations under subsection (j)(1)(A), and
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1 assessments of the reasonable costs of such

2 additional or more frequent reviews or eval3 uations; and

4 ‘‘(iii) such other sanctions as the Sec5 retary may permit the OPTN Board to im6 pose.

7 ‘‘(3) ENFORCEMENT BY THE SECRETARY.—

8 ‘‘(A) IN GENERAL.—If the Secretary, after

9 consultation with the OPTN Board or Network

10 Administrator, determines that a member of the

11 Network has violated a requirement established

12 by this section or a requirement of a policy that

13 is enforceable under subsection (f), the Secretary

14 may impose on the member 1 or more of the

15 sanctions described in subparagraph (B).

16 ‘‘(B) TYPES OF SANCTIONS.—The sanctions

17 described in this subparagraph shall include—

18 ‘‘(i) requiring the member to follow a

19 directed plan of correction;

20 ‘‘(ii) imposing upon the member a

21 monetary assessment (to be paid to the Gen22 eral Fund of the Treasury) in an amount

23 not to exceed $10,000 for each violation or

24 for each day of violation;
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1 ‘‘(iii) requiring the member to pay to

2 the Network Administrator the costs of on3 site monitoring of the member;

4 ‘‘(iv) the loss of any or all privileges of

5 membership in the Network; and

6 ‘‘(v) in cases where the violation cre7 ates a risk to patient health or to public

8 health, such other action as the Secretary

9 determines to be necessary.

10 ‘‘(C) PROCEDURES.—The Secretary shall

11 develop and implement procedures for the impo12 sition of sanctions under clauses (i) through (v)

13 of subparagraph (B). Such procedures shall

14 include—

15 ‘‘(i) the provision of reasonable notice

16 to the Network member and the OPTN

17 Board that the Secretary is considering im18 posing a sanction;

19 ‘‘(ii) affording the member a reason20 able opportunity to be heard in response to

21 the notice;

22 ‘‘(iii) the provision of notice to the

23 member that the Secretary has decided to

24 impose a sanction; and
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1 ‘‘(iv) the opportunity for the Network

2 member to appeal such sanction.

3 ‘‘(l) ANNUAL REPORT.—

4 ‘‘(1) IN GENERAL.—Not later than September 30

5 of each year, the Network Administrator shall prepare

6 and submit to the Secretary an annual report on the

7 performance and policies of the Network. The report

8 shall include additional items as specified in the con9 tract under this section or requested in a timely man10 ner by the Secretary.

11 ‘‘(2) REQUIREMENT OF OPTN BOARD AP12 PROVAL.—The OPTN Board shall review and approve

13 the report required under paragraph (1) prior to the

14 submission of such report to the Secretary.

15 ‘‘(3) SUBMISSION TO CONGRESS.—

16 ‘‘(A) IN GENERAL.—Not later than Decem17 ber 31 of each year, the Secretary shall transmit

18 the report submitted under paragraph (1) and

19 the comments of the Secretary concerning such

20 report, to the appropriate committees of Con21 gress.

22 ‘‘(B) CLARIFYING INFORMATION.—The Sec23 retary may, upon the receipt of the report under

24 paragraph (1), but prior to transmission of the

25 report to Congress under subparagraph (A), re-
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1 quest that the Network Administrator submit

2 clarifying information or an addenda as needed

3 to fulfill the requirements of this subsection.

4 ‘‘(m) AUTHORIZATION OF APPROPRIATIONS.—There is

5 authorized to be appropriated to carry out this section, such

6 sums as may be necessary for each of fiscal years 2001

7 through 2005.’’.

8 SEC. 3. SCIENTIFIC REGISTRY.

9 Section 373 of the Public Health Service Act (42

10 U.S.C. 274a) is amended to read as follows:

11 ‘‘SEC. 373. SCIENTIFIC REGISTRY.

12 ‘‘The Secretary shall by contract, develop and main13 tain a scientific registry of the recipients of organ trans14 plants. The registry shall include information, with respect

15 to organ transplant patients and transplant procedures, as

16 the Secretary determines to be necessary to an ongoing eval17 uation of the scientific and clinical status of organ trans18 plantation.’’.

19 SEC. 4. ORGAN DONATION.

20 Part H of title III of the Public Health Service Act

21 (42 U.S.C. 273 et seq.) is amended—

22 (1) by redesignating section 378 (42 U.S.C.

23 274g) as section 379; and

24 (2) by inserting after section 377 (42 U.S.C.

25 274f) the following:
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1 ‘‘SEC. 378. ORGAN DONATION AND RESEARCH.

2 ‘‘(a) INTER-AGENCY TASK FORCE ON ORGAN DONA3 TION AND RESEARCH.—

4 ‘‘(1) IN GENERAL.—The Secretary shall establish

5 an inter-agency task force on organ donation and re6 search (referred to in this section as the ‘task force’)

7 to improve the coordination and evaluation of—

8 ‘‘(A) federally supported or conducted organ

9 donation efforts and policies; and

10 ‘‘(B) federally supported or conducted basic,

11 clinical and health services research (including

12 research on preservation techniques and organ

13 rejection and compatibility).

14 ‘‘(2) COMPOSITION.—The task force shall be com15 posed of—

16 ‘‘(A) the Surgeon General, who shall serve

17 as the chairperson;

18 ‘‘(B) representatives to be appointed by the

19 Secretary from relevant agencies within the De20 partment of Health and Human Services (in21 cluding the Health Resources and Services Ad22 ministration, Health Care Financing Adminis23 tration, National Institutes of Health, and Agen24 cy for Healthcare Research and Quality);

25 ‘‘(C) a representative from the Department

26 of Transportation;
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1 ‘‘(D) a representative from the Department

2 of Defense;

3 ‘‘(E) a representative from the Department

4 of Veterans Affairs;

5 ‘‘(F) a representative from the Office of Per6 sonnel Management; and

7 ‘‘(G) representatives of other Federal agen8 cies or departments as determined to be appro9 priate by the Secretary.

10 ‘‘(3) ANNUAL REPORT.—In addition to activities

11 carried out under paragraph (1), the task force shall

12 support the development of the annual report under

13 subsection (d)(2).

14 ‘‘(4) TERMINATION.—The task force may be ter15 minated at the discretion of the Secretary following

16 the completion of at least 2 annual reports under sub17 section (d). Upon such termination, the Secretary

18 shall provide for the on-going coordination of feder19 ally supported or conducted organ donation and re20 search activities.

21 ‘‘(b) EDUCATION.—

22 ‘‘(1) PUBLIC EDUCATION AND AWARENESS.—The

23 Secretary shall, directly or through grants or con24 tracts, carry out a comprehensive and effective na-
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1 tional public education program to increase organ do2 nation, including living donation.

3 ‘‘(2) DEVELOPMENT OF CURRICULA AND OTHER

4 EDUCATION ACTIVITIES.—

5 ‘‘(A) IN GENERAL.—The Secretary shall

6 support the development and dissemination of

7 model curricula to train health care professionals

8 and other appropriate professionals (including

9 religious leaders in the community and law en10 forcement officials) in issues surrounding organ

11 donation, including methods to approach pa12 tients and their families, cultural sensitivities,

13 and other relevant issues.

14 ‘‘(B) HEALTH CARE PROFESSIONALS.—For

15 purposes of subparagraph (A), the term ‘health

16 care professionals’ includes—

17 ‘‘(i) medical students, residents and

18 fellows, attending physicians (through con19 tinuing medical education courses and other

20 methods), nurses, social workers, and other

21 allied health professionals; and

22 ‘‘(ii) hospital- or other health care-fa23 cility based chaplains; and

24 ‘‘(iii) emergency medical personnel.
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1 ‘‘(c) GRANTS.—The Secretary shall award peer-re2 viewed grants to public and non-profit private entities, in3 cluding States, to carry out studies and demonstration

4 projects to increase organ donation rates, including living

5 donation. The Secretary shall ensure that activities carried

6 out by grantees under this subsection are evaluated for effec7 tiveness and that such findings are disseminated.

8 ‘‘(d) REPORTS.—

9 ‘‘(1) IOM REPORT ON BEST PRACTICES.—

10 ‘‘(A) IN GENERAL.—The Secretary shall

11 enter into a contract with the Institute of Medi12 cine to conduct an evaluation of the organ dona13 tion practices of organ procurement organiza14 tions, States, other countries, and other appro15 priate organizations that have achieved a higher

16 than average organ donation rate.

17 ‘‘(B) BARRIERS.—In conducting the evalua18 tion under subparagraph (A), the Institute of

19 Medicine shall examine existing barriers to

20 organ donation.

21 ‘‘(C) REPORT.—Not later than 18 months

22 after the date of enactment of this section, the In23 stitute of Medicine shall submit to the Secretary

24 a report concerning the evaluation conducted

25 under this paragraph. Such report shall include
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1 recommendations for administrative actions and,

2 if necessary, legislation in order to replicate the

3 best practices identified in the evaluation and to

4 otherwise increase organ donation and procure5 ment rates.

6 ‘‘(2) ANNUAL REPORT ON DONATION.—

7 ‘‘(A) IN GENERAL.—Not later than 1 year

8 after the date on which the report is submitted

9 under paragraph (1)(C), and annually there10 after, the Secretary shall prepare and submit to

11 Congress a report concerning federally supported

12 or conducted organ donation and procurement

13 activities, including donation and procurement

14 activities evaluated or conducted under sub15 section (a) to increase organ donation.

16 ‘‘(B) REQUIREMENTS.—To the extent prac17 ticable, each annual report under subparagraph

18 (A) shall—

19 ‘‘(i) evaluate the effectiveness of activi20 ties, identify best practices, and make rec21 ommendations regarding broader adoption

22 of best practices with respect to organ dona23 tion and procurement;
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1 ‘‘(ii) assess organ donation and pro2 curement activities that are recently com3 pleted, current or planned.

4 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There is

5 authorized to be appropriated to carry out this section,

6 $15,000,000 for fiscal year 2001, and such sums as may

7 be necessary for each of fiscal years 2002 through 2005.’’.

8 SEC. 5. ORGAN PROCUREMENT ORGANIZATION CERTIFI9 CATION.

10 (a) FINDINGS.—Congress makes the following findings:

11 (1) Organ procurement organizations play an

12 important role in the effort to increase organ dona13 tion in the United States.

14 (2) The current process for the certification and

15 recertification of organ procurement organizations

16 conducted by the Department of Health and Human

17 Services has created a level of uncertainty that is

18 interfering with the effectiveness of organ procurement

19 organizations in raising the level of organ donation.

20 (3) The General Accounting Office, the Institute

21 of Medicine, and the Harvard School of Public Health

22 have identified substantial limitations in the organ

23 procurement organization certification and recertifi24 cation process and have recommended changes in that

25 process.
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1 (4) The limitations in the recertification process

2 include:

3 (A) An exclusive reliance on population4 based measures of performance that do not ac5 count for the potential in the population for

6 organ donation and do not permit consideration

7 of other outcome and process standards that

8 would more accurately reflect the relative capa9 bility and performance of each organ procure10 ment organization.

11 (B) A lack of due process to appeal to the

12 Secretary of Health and Human Services for re13 certification on either substantive or procedural

14 grounds.

15 (5) The Secretary of Health and Human Serv16 ices has the authority under section 1138(b)(1)(A)(i)

17 of the Social Security Act (42 U.S.C. 1320b–

18 8(b)(1)(A)(i)) to extend the period for recertification

19 of an organ procurement organization from 2 to 4

20 years on the basis of its past practices in order to

21 avoid the inappropriate disruption of the nation’s

22 organ system.

23 (6) The Secretary of Health and Human Serv24 ices can use the extended period described in para-
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1 graph (5) for recertification of all organ procurement

2 organizations to—

3 (A) develop improved performance measures

4 that would reflect organ donor potential and in5 terim outcomes, and to test these measures to en6 sure that they accurately measure performance

7 differences among the organ procurement organi8 zations; and

9 (B) improve the overall certification process

10 by incorporating process as well as outcome per11 formance measures, and developing equitable

12 processes for appeals.

13 (b) CERTIFICATION AND RECERTIFICATION OF ORGAN

14 PROCUREMENT ORGANIZATIONS.—Section 371(b)(1) of the

15 Public Health Service Act (42 U.S.C. 273(b)(1)) is

16 amended—

17 (1) by redesignating subparagraphs (D) through

18 (G) as subparagraphs (E) through (H), respectively;

19 (2) by realigning the margin of subparagraph

20 (F) (as so redesignated) so as to align with subpara21 graph (E) (as so redesignated); and

22 (3) by inserting after subparagraph (C) the fol23 lowing:

24 ‘‘(D) notwithstanding any other provision of

25 law, has met the other requirements of this section
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1 and has been certified or recertified by the Secretary

2 within the previous 4-year period as meeting the per3 formance standards to be a qualified organ procure4 ment organization through a process that either—

5 ‘‘(i) granted certification or recertification

6 within such 4-year period with such certification

7 or recertification in effect as of January 1, 2000,

8 and remaining in effect through the earlier of—

9 ‘‘(I) January 1, 2002; or

10 ‘‘(II) the completion of recertification

11 under the requirements of clause (ii); or

12 ‘‘(ii) is defined through regulations that are

13 promulgated by the Secretary by not later than

14 January 1, 2002, that—

15 ‘‘(I) require recertifications of qualified

16 organ procurement organizations not more

17 frequently than once every 4 years;

18 ‘‘(II) rely on outcome and process per19 formance measures that are based on empir20 ical evidence, obtained through reasonable

21 efforts, of organ donor potential and other

22 related factors in each service area of quali23 fied organ procurement organizations;

24 ‘‘(III) use multiple outcome measures

25 as part of the certification process; and
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1 ‘‘(IV) provide for a qualified organ

2 procurement organization to appeal a decer3 tification to the Secretary on substantive

4 and procedural grounds;’’.

5 SEC. 6. TECHNICAL AMENDMENT.

6 Subparagraph (E) of section 371(b)(3) of the Public

7 Health Service Act (42 U.S.C. 273(b)(3)(E)) is amended

8 to read as follows:

9 ‘‘(E) assist the Organ Procurement and Trans10 plantation Network in the allocation of donated or11 gans in accordance with the policies and criteria es12 tablished pursuant to section 372,’’.

13 SEC. 7. STUDY REGARDING IMMUNOSUPPRESSIVE DRUGS.

14 (a) IN GENERAL.—The Secretary of Health and

15 Human Services (referred to in this section as the ‘‘Sec16 retary’’) shall provide for a study to determine the costs

17 of immunosuppressive drugs that are provided to children

18 pursuant to organ transplants and to determine the extent

19 to which health plans, health insurance, and Government

20 programs cover such costs. The Secretary may carry out

21 the study directly or through a grant to the Institute of

22 Medicine (or other public or nonprofit private entity).

23 (b) RECOMMENDATIONS REGARDING CERTAIN

24 ISSUES.—The Secretary shall ensure that, in addition to

25 making determinations under subsection (a), the study
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1 under such subsection makes recommendations regarding

2 the following issues:

3 (1) The costs of immunosuppressive drugs that

4 are provided to children pursuant to organ trans5 plants and to determine the extent to which health

6 plans, health insurance, and Government programs

7 cover such costs.

8 (2) Other issues that are particular to the special

9 health and transplantation needs of children.

10 (c) REPORT.—The Secretary shall ensure that, not

11 later than 6 months after the date of enactment of this Act,

12 the study under subsection (a) is completed and a report

13 describing the findings of the study is submitted to Con14 gress.