II

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.

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

3 SECTION 1. SHORT TITLE.

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

5 and Transplantation Network Amendments Act of 2000’’.

6 SEC. 2. ORGAN PROCUREMENT AND TRANSPLANTATION

7 NETWORK.

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

9 Service Act (42 U.S.C. 274) is amended to read as follows:
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1 ‘‘SEC. 372. ORGAN PROCUREMENT AND TRANSPLANTATION

2 NETWORK.

3 ‘‘(a) ESTABLISHMENT OF NETWORK.—

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

5 and Transplantation Network (in this section re6 ferred to as the ‘Network’ or the ‘OPTN’) is estab7 lished as a private network and shall operate under

8 this section.

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

10 ‘‘(A) in accordance with criteria developed

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

12 of the Network qualified organ procurement or13 ganizations (as described in section 371(b)),

14 transplant centers, and other entities that have

15 a demonstrated interest in the fields of organ

16 donation or transplantation (such members

17 shall be referred to in this section as ‘Network

18 participants’); and

19 ‘‘(B) have a policy board (referred to in

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

21 the requirements of subsection (b).

22 ‘‘(b) OPTN POLICY BOARD.—

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

24 be composed of not more than 36 voting members

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

26 ex officio members appointed under paragraph (3).
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1 ‘‘(2) ELECTED MEMBERS.—

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

3 of the OPTN Board shall be elected by the

4 members of the Network described in sub5 section (a)(2)(A), from among the nominees

6 submitted under subparagraph (B), through a

7 fair and open process.

8 ‘‘(B) NOMINATING COMMITTEE.—The

9 nominating committee established under para10 graph (5) shall, prior to each election of OPTN

11 Board members under this paragraph, develop

12 a list of nominees for such election. Such list

13 shall reflect the diversity of Network members

14 described in subsection (a)(2)(A), including fac15 tors such as program type and size and geo16 graphic location. Recommendations may be sub17 mitted to the nominating committee by the Sec18 retary, the members of the Network described

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

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

21 shall be composed of—

22 ‘‘(i) transplant surgeons and trans23 plant physicians;

24 ‘‘(ii) representatives of qualified organ

25 procurement organizations, transplant cen-
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1 ters, voluntary health associations, or the

2 general public, including patients awaiting

3 a transplant or transplant recipients or in4 dividuals who have donated an organ, or

5 the family members of such patients, re6 cipients or donors; and

7 ‘‘(iii) individuals distinguished in the

8 fields of ethics, basic, clinical and health

9 services research, biostatistics, health care

10 policy, or health care economics or financ11 ing.

12 ‘‘(D) REPRESENTATION REQUIREMENT.—

13 The OPTN Board shall be structured to ensure

14 that—

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

16 percent of the members elected under this

17 paragraph are transplant surgeons and

18 transplant physicians; and

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

20 percent of the members elected under this

21 paragraph are transplant candidates,

22 transplant recipients, organ donors and

23 family members of such individuals.

24 Nothing in this subparagraph shall be con25 strued to preclude an individual voting member
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1 of the OPTN Board from being a representa2 tive described in each of clauses (i) and (iii) or

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

4 limitation described in clause (i) of this sub5 paragraph is complied with.

6 ‘‘(3) APPOINTED MEMBERS.—

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

8 appoint as ex officio, nonvoting members of the

9 OPTN Board, 1 representative from each of the

10 following:

11 ‘‘(i) The Health Resources and Serv12 ices Administration.

13 ‘‘(ii) The National Institutes of

14 Health.

15 ‘‘(iii) The Health Care Financing Ad16 ministration.

17 ‘‘(iv) The Agency for Healthcare Re18 search and Quality.

19 ‘‘(B) NETWORK ADMINISTRATOR.—The

20 Network Administrator shall appoint an ex offi21 cio nonvoting member of the OPTN Board.

22 ‘‘(4) TERMS OF ELECTED MEMBERS.—

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

24 for in this paragraph, members of the OPTN
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1 Board elected under paragraph (2) shall serve

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

3 ‘‘(B) NEW MEMBERS.—To ensure the staggered rotation of 1 4 ⁄3 of the elected members of

5 the OPTN Board each year, the initial mem6 bers of the OPTN Board elected under para7 graph (2) shall serve for terms of 1, 2, or 3

8 years respectively as designated by the nomi9 nating committee.

10 ‘‘(C) TRANSITION.—Consistent with sub11 section (c)(3), the voting members of the

12 OPTN Board who are serving on the date of

13 enactment of the Organ Procurement and

14 Transplantation Network Amendments Act of

15 2000 may continue to serve until the expiration

16 of their terms. Upon such termination, the

17 nominating committee, in submitting nomina18 tions to fill such vacancies, shall ensure the

staggered rotation of 1 19 ⁄3 of the members elected

20 under paragraph (2) every 3 years.

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

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

23 change in the contractor, shall not affect the

24 terms of the members of the OPTN Board.
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1 ‘‘(5) CHAIRPERSON AND COMMITTEES.—The

2 OPTN Board shall have a chairperson, an executive

3 committee, a nominating committee, a membership

4 committee, and such other committees as the OPTN

5 Board determines to be appropriate.

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

7 ‘‘(1) ESTABLISHMENT OF NETWORK POLICIES

8 AND CRITERIA.—The OPTN Board shall—

9 ‘‘(A) after consultation with Network par10 ticipants and the Network Administrator, estab11 lish and carry out the policies and functions de12 scribed in this section for the Network;

13 ‘‘(B) establish membership criteria for par14 ticipating in the Network;

15 ‘‘(C) establish medical criteria for allo16 cating organs and for listing and de-listing pa17 tients on the national lists maintained under

18 paragraph (2); and

19 ‘‘(D) establish performance criteria for

20 transplant programs.

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

22 shall maintain a national system to match organs

23 and individuals who need organ transplants. The na24 tional system shall—
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1 ‘‘(A) have 1 or more lists of individuals

2 who are in need of organ transplants; and

3 ‘‘(B) be operated in accordance with Net4 work policies and criteria established under

5 paragraph (1).

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

7 OPTN Board shall have no voting member who has

8 any fiduciary responsibility to the entity that holds

9 the contract provided for under this section.

10 ‘‘(4) OPTN BOARD REQUIREMENTS.—The

11 OPTN Board shall cooperate with the Network Ad12 ministrator to ensure compliance with the require13 ments of this section including the contract entered

14 into under subsection (f).

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

16 Board shall establish organ transplant policies, including

17 organ allocation policies for potential organ recipients and

18 policies that affect patient outcomes. Such policies shall—

19 ‘‘(1) be based on sound medical principles;

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

21 ‘‘(3) be equitable;

22 ‘‘(4) seek to achieve the best use of donated or23 gans;

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

25 avoid futile transplants and reduce the risk of re-
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1 transplantation, to promote patient access to trans2 plantation, and to promote the efficient management

3 of organ placement;

4 ‘‘(6) be specific for each organ type or combina5 tion of organ types;

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

7 for listing and de-listing candidates from organ

8 transplant waiting lists;

9 ‘‘(8) determine priority rankings (within cat10 egories as appropriate) for candidates who are medi11 cally suitable for transplantation, such rankings

12 shall be based on standardized medical criteria and

13 ordered according to medical urgency and medical

14 appropriateness;

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

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

17 ‘‘(10) develop and apply appropriate perform18 ance indicators, including patient-focused indicators,

19 to assess transplant program performance and re20 duce inter-transplant program variance to improve

21 program performance; and

22 ‘‘(11) seek to reduce disparities in transplan23 tation resulting from socioeconomic status, race, eth24 nicity, or being medically underserved.
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1 ‘‘(e) ENFORCEMENT OF ORGAN TRANSPLANT POL2 ICY.—

3 ‘‘(1) IN GENERAL.—

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

5 shall apply to any proposed transplant policy

6 that is developed by the OPTN Board that the

7 Board or the Secretary determines should be

8 enforced under this section or under section

9 1138 of the Social Security Act.

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

11 than 60 days prior to the implementation of a

12 proposed policy described in subparagraph (A),

13 the OPTN Board shall submit such proposed

14 policy to the Secretary.

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

16 proposed policy under subparagraph (B), the

17 Secretary shall publish the policy in the Federal

18 Register for a 60-day public comment period.

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

20 than 90 days after receipt of a proposed policy

21 under subparagraph (B), the Secretary shall

22 consider public comments received under sub23 paragraph (C) and shall—
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1 ‘‘(i) notify the OPTN Board that the

2 policy is consistent with this section and

3 therefore enforceable; or

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

5 policy is inconsistent with this section and

6 direct the Board to reconsider and revise

7 the policy consistent with the recommenda8 tions of the Secretary.

9 ‘‘(E) RECONSIDERATION.—

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

11 days after receiving a notice from the Sec12 retary under subparagraph (D)(ii), the

13 OPTN Board shall reaffirm the proposed

14 policy or revise and submit such revised

15 policy to the Secretary.

16 ‘‘(ii) ACTION BY SECRETARY.—Not

17 later than 30 days after receiving a revised

18 policy under clause (i), the Secretary

19 shall—

20 ‘‘(I) notify the OPTN Board that

21 the revised policy is consistent with

22 this section and therefore enforceable;

23 or

24 ‘‘(II) notify the OPTN Board

25 that the revised policy is inconsistent
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1 with this section and submit the re2 vised policy, with the comments and

3 proposed revisions of the Secretary, to

4 the Scientific Advisory Committee on

5 Organ Transplantation (referred to in

6 this subsection as the ‘Committee’) es7 tablished under paragraph (2).

8 ‘‘(iii) ACTION BY COMMITTEE.—Not

9 later than 30 days after the submission of

10 a revised policy to the Committee under

11 clause (ii), the Committee may, by a ma12 jority vote, disapprove the comments or re13 vision of the Secretary. If the Committee

14 disapproves such comments or revisions,

15 the revised policy shall not take effect until

16 a majority of the Committee approves the

17 policy or the revisions to such policy.

18 ‘‘(2) SCIENTIFIC ADVISORY COMMITTEE ON

19 ORGAN TRANSPLANTATION.—

20 ‘‘(A) ESTABLISHMENT.—The Secretary

21 shall establish an advisory committee to be

22 known as the Scientific Advisory Committee on

23 Organ Transplantation. Consistent with the re24 quirements of sections 5 and 10 of the Federal

25 Advisory Committee Act—
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1 ‘‘(i) the deliberations of the Com2 mittee shall not be inappropriately influ3 enced by the Secretary or by any special

4 interest and shall only be the result of the

5 independent judgment of the Committee;

6 and

7 ‘‘(ii) the meetings of the Committee

8 shall be open to the public, advance notice

9 of meetings shall be published in the Fed10 eral Register, and records or minutes of

11 meetings shall be made available to the

12 public.

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

14 recommendations with respect to policy matters

15 related to reviews conducted under paragraph

16 (1)(E)(ii)(II).

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

18 be composed of 15 members, of which—

19 ‘‘(i) five members shall be appointed

20 by the Secretary from nominations sub21 mitted by the OPTN Board under sub22 paragraph (D);

23 ‘‘(ii) five members shall be appointed

24 by the Secretary from nominations sub-
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1 mitted by the Institute of Medicine under

2 subparagraph (D); and

3 ‘‘(iii) five members shall be appointed

4 by the Secretary.

5 ‘‘(D) NOMINATIONS.—The OPTN Board

6 and the Institute of Medicine shall each nomi7 nate, in an independent manner, 5 qualified in8 dividuals to serve on the Committee.

9 ‘‘(E) QUALIFICATIONS.—In appointing in10 dividuals to serve on the Committee under sub11 paragraph (C), the Secretary shall ensure

12 that—

13 ‘‘(i) nine members are transplant phy14 sicians or transplant surgeons of whom—

15 ‘‘(I) 3 shall be selected from the

16 nominations submitted by the OPTN

17 Board; and

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

19 nominations submitted by the Insti20 tute of Medicine; and

21 ‘‘(ii) the remaining members are indi22 viduals who are—

23 ‘‘(I) distinguished in the fields of

24 ethics, basic, clinical or health services
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1 research, biostatistics, or health care

2 policy, economics or financing; or

3 ‘‘(II) transplant candidates,

4 transplant recipients, organ donors or

5 family members of such individuals.

6 ‘‘(F) EXPERTS.—The Committee shall

7 seek advice from appropriate experts, as need8 ed, to evaluate the proposed policy and revisions

9 under review.

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

11 Committee shall elect a member to serve as the

12 chairperson of the Committee.

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

14 shall serve for a term of 5 years. Vacancies

15 shall be filled in the same manner as the origi16 nal appointment was made.

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

18 The Secretary shall contract with a nonprofit private enti19 ty (referred to in this section as the ‘Network Adminis20 trator’) for the administration and operation of the Net21 work. The Network Administrator shall administer and

22 operate the OPTN Board in accordance with subsection

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

24 policies and criteria established by the OPTN Board—
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1 ‘‘(1) maintain and operate a national system as

2 established by the OPTN Board to match organs

3 and individuals who need organ transplants;

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

5 established by the OPTN Board, and administer the

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

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

8 need organ transplants as provided for under sub9 section (c)(2)(A);

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

11 to facilitate matching organs with individuals in12 cluded on the list or lists;

13 ‘‘(5) assist organ procurement organizations in

14 obtaining and distributing organs in accordance with

15 the policies established by the OPTN Board;

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

17 acquisition and transportation of donated organs, in18 cluding standards regarding the transmission of in19 fectious diseases;

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

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

22 or on a national basis), samples of blood sera from

23 individuals who are included on the list in order to

24 facilitate matching the compatibility of such individ25 uals with organ donors;
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1 ‘‘(8) coordinate, as appropriate, the transpor2 tation of organs from organ procurement organiza3 tions to transplant centers;

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

5 care professionals, and the general public regarding

6 organ donation;

7 ‘‘(10) carry out studies and demonstration

8 projects for the purpose of improving procedures for

9 organ procurement and allocation; and

10 ‘‘(11) work actively with organ procurement or11 ganizations, transplant centers, health care pro12 viders, and the public to increase the supply of do13 nated organs.

14 ‘‘(g) DATA COLLECTION, ANALYSIS AND DISTRIBU15 TION.—

16 ‘‘(1) IN GENERAL.—The Network Adminis17 trator shall analyze, maintain, verify, make available

18 and publish timely data to the extent necessary to—

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

20 responsibilities under this section;

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

22 the Network with performance and other cri23 teria developed pursuant to subsection (c)(1);
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1 ‘‘(C) evaluate the quality of care provided

2 to transplant candidates and patients generally

3 and in an individual program;

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

5 Registry maintained pursuant to section 373;

6 ‘‘(E) provide transplant candidates and pa7 tients, physicians and others with information

8 needed to evaluate or select a transplant pro9 gram;

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

11 with data about the member, including results

12 of analysis or other processing of data originally

13 supplied by the member;

14 ‘‘(G) enable the OPTN Board, the Net15 work Administrator and the Secretary to fulfill

16 respective enforcement and oversight respon17 sibilities under subsections (j) and (k); and

18 ‘‘(H) comply with the requirements under

19 subsection (l).

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

21 paragraph (1) shall include—

22 ‘‘(A) data on transplant candidates, trans23 plant recipients, organ donors, donated organs,

24 and transplant programs; and
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1 ‘‘(B) as appropriate, data, graft- and pa2 tient-survival rates (actual and adjusted to re3 flect program-specific population disease sever4 ity), program specific data, and aggregate data.

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

6 shall—

7 ‘‘(1) be awarded through a process of competi8 tive bidding as determined by the Secretary; and

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

10 5 years.

11 ‘‘(i) NETWORK MEMBERSHIP AND PATIENT REG12 ISTRATION FEE.—

13 ‘‘(1) IN GENERAL.—The Network Adminis14 trator may assess a fee, to be collected by the Net15 work Administrator, for membership in the Network

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

17 for the listing of each potential transplant recipient

18 on the national organ matching system maintained

19 by the Network Administrator (to be known as the

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

21 under paragraph (2).

22 ‘‘(2) AMOUNT.—The amounts of the fees to be

23 assessed under paragraph (1) shall be calculated so

24 as to be—

25 ‘‘(A) reasonable and customary; and
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1 ‘‘(B) sufficient to cover the Network’s rea2 sonable costs of operation in accordance with

3 this section.

4 ‘‘(3) ANNUAL RECALCULATION.—

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

6 under paragraph (2) shall be annually recal7 culated, based on—

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

9 contract tasks and other activities related

10 to organ procurement and transplantation;

11 and

12 ‘‘(ii) changes in expected revenues

13 from contract funds, Network membership

14 fees and patient registration fees available

15 to the Network Administrator.

16 ‘‘(B) PROCEDURE.—

17 ‘‘(i) PROPOSAL.—The Network Ad18 ministrator shall submit to the Secretary a

19 written proposal for, and justification of, a

20 recalculated fee under subparagraph (A).

21 ‘‘(ii) DETERMINATION.—The proposal

22 of the Network Administrator for a recal23 culated fee under clause (i) shall take ef24 fect unless the Secretary, within 60 days of

25 receiving the proposal, provides the Net-
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1 work Administrator with a written deter2 mination, with justification, that the pro3 posed fee level does not meet the require4 ment of subparagraph (A).

5 ‘‘(4) USE OF FEES.—

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

7 the Network Administrator under this sub8 section shall be available to the Network, with9 out fiscal year limitation, for use in carrying

10 out the functions described in subsection (f).

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

12 this subsection may not be used for any activity

13 for which contract funds may not be used under

14 this section.

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

16 this subsection shall be construed as prohibiting the

17 Network Administrator from collecting or accepting

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

19 fees, donations or gifts to carry out activities other

20 than those authorized under the contract under this

21 section.

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

23 ‘‘(1) MONITORING.—

24 ‘‘(A) IN GENERAL.—The OPTN Board

25 and the Network Administrator shall, on an on-
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1 going and periodic basis, or as requested by the

2 Secretary, monitor the operations of Network

3 participants to determine whether the partici4 pants are maintaining compliance with the cri5 teria and policies established by the OPTN

6 Board.

7 ‘‘(B) PROCEDURES.—

8 ‘‘(i) NOTICE.—In monitoring a Net9 work participant under subparagraph (A),

10 the OPTN Board or the Administrator—

11 ‘‘(I) shall inform the participant

12 and the Secretary upon initiating a

13 compliance review of a Network par14 ticipant; and

15 ‘‘(II) shall inform the participant

16 and the Secretary of any findings in17 dicating noncompliance by the partici18 pant with such criteria and policies.

19 ‘‘(ii) APPEALS.—The Network Admin20 istrator shall establish procedures for ap21 pealing noncompliance determinations.

22 Such procedures shall ensure due process

23 and shall allow for corrective action.

24 ‘‘(2) PEER REVIEW PROCEEDINGS.—
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1 ‘‘(A) IN GENERAL.—The OPTN Board

2 shall establish a peer review system and condi3 tions for the application of peer review require4 ments to ensure that members of the Network

5 comply with policies and criteria established by

6 the OPTN Board under this section. Such peer

7 review system may include prospective reviews

8 and shall be administered by the Network Ad9 ministrator and overseen by the OPTN Board.

10 ‘‘(B) POLICIES, REVIEW AND EVALUA11 TION.—As part of the peer review system estab12 lished under subparagraph (A), the OPTN

13 Board shall establish such policies, and the Net14 work Administrator shall conduct such ongoing

15 and periodic reviews and evaluations of mem16 bers of the Network, as necessary to ensure

17 compliance with the policies and criteria estab18 lished by the OPTN Board under this section.

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

20 peer review system established under subpara21 graph (A), the OPTN Board shall establish

22 policies to work with and direct the Network

23 Administrator to respond to emerging issues

24 and problems.

25 ‘‘(k) ENFORCEMENT.—
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1 ‘‘(1) RECOMMENDATIONS.—The OPTN Board

2 or the Network Administrator shall provide advice,

3 and make recommendations for appropriate action,

4 to the Secretary concerning the results of any re5 views or evaluations that, in the opinion of the

6 OPTN Board or the Network Administrator,

7 indicate—

8 ‘‘(A) noncompliance by Network partici9 pants with—

10 ‘‘(i) the policies or criteria established

11 by the OPTN Board; or

12 ‘‘(ii) the operating procedures of the

13 Network Administrator; or

14 ‘‘(B) a risk to the health of organ trans15 plant patients or to public safety.

16 ‘‘(2) ENFORCEMENT BY NETWORK.—

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

18 determines that one of the members of the net19 work has violated a requirement established by

20 this section or by the Network, the OPTN

21 Board may impose on the member 1 or more of

22 the sanctions described in subparagraph (B), or

23 may recommend that the Secretary take en24 forcement action under paragraph (3).
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1 ‘‘(B) TYPES OF SANCTIONS.—The sanc2 tions described in this subparagraph may

3 include—

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

5 membership in good standing in the Net6 work;

7 ‘‘(ii) the imposition upon the member

8 of additional or more frequent reviews or

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

10 assessments of the reasonable costs of such

11 additional or more frequent reviews or

12 evaluations; and

13 ‘‘(iii) such other sanctions as the Sec14 retary may permit the OPTN Board to im15 pose.

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

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

18 consultation with the OPTN Board or Network

19 Administrator, determines that a member of the

20 Network has violated a requirement established

21 by this section or a requirement of a policy that

22 is enforceable under subsection (f), the Sec23 retary may impose on the member 1 or more of

24 the sanctions described in subparagraph (B).
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1 ‘‘(B) TYPES OF SANCTIONS.—The sanc2 tions described in this subparagraph shall

3 include—

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

5 directed plan of correction;

6 ‘‘(ii) imposing upon the member a

7 monetary assessment (to be paid to the

8 General Fund of the Treasury) in an

9 amount not to exceed $10,000 for each

10 violation or for each day of violation;

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

12 the Network Administrator the costs of on13 site monitoring of the member;

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

15 of membership in the Network; and

16 ‘‘(v) in cases where the violation cre17 ates a risk to patient health or to public

18 health, such other action as the Secretary

19 determines to be necessary.

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

21 develop and implement procedures for the impo22 sition of sanctions under clauses (i) through (v)

23 of subparagraph (B). Such procedures shall

24 include—
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1 ‘‘(i) the provision of reasonable notice

2 to the Network member and the OPTN

3 Board that the Secretary is considering

4 imposing a sanction;

5 ‘‘(ii) affording the member a reason6 able opportunity to be heard in response to

7 the notice;

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

9 member that the Secretary has decided to

10 impose a sanction; and

11 ‘‘(iv) the opportunity for the Network

12 member to appeal such sanction.

13 ‘‘(l) ANNUAL REPORT.—

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

15 30 of each year, the Network Administrator shall

16 prepare and submit to the Secretary an annual re17 port on the performance and policies of the Network.

18 The report shall include additional items as specified

19 in the contract under this section or requested in a

20 timely manner by the Secretary.

21 ‘‘(2) REQUIREMENT OF OPTN BOARD AP22 PROVAL.—The OPTN Board shall review and ap23 prove the report required under paragraph (1) prior

24 to the submission of such report to the Secretary.

25 ‘‘(3) SUBMISSION TO CONGRESS.—
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1 ‘‘(A) IN GENERAL.—Not later than De2 cember 31 of each year, the Secretary shall

3 transmit the report submitted under paragraph

4 (1) and the comments of the Secretary con5 cerning such report, to the appropriate commit6 tees of Congress.

7 ‘‘(B) CLARIFYING INFORMATION.—The

8 Secretary may, upon the receipt of the report

9 under paragraph (1), but prior to transmission

10 of the report to Congress under subparagraph

11 (A), request that the Network Administrator

12 submit clarifying information or an addenda as

13 needed to fulfill the requirements of this sub14 section.

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

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

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

18 2001 through 2005.’’.

19 SEC. 3. SCIENTIFIC REGISTRY

20 Section 373 of the Public Health Service Act (42

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

22 ‘‘SEC. 373. SCIENTIFIC REGISTRY.

23 ‘‘The Secretary shall by contract, develop and main24 tain a scientific registry of the recipients of organ trans25 plants. The registry shall include information, with respect
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1 to organ transplant patients and transplant procedures,

2 as the Secretary determines to be necessary to an ongoing

3 evaluation of the scientific and clinical status of organ

4 transplantation.’’.

5 SEC. 4. ORGAN DONATION.

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

7 (42 U.S.C. 273 et seq.) is amended—

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

9 274g) as section 379; and

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

11 274f) the following:

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

13 ‘‘(a) INTER-AGENCY TASK FORCE ON ORGAN DONA14 TION AND RESEARCH.—

15 ‘‘(1) IN GENERAL.—The Secretary shall estab16 lish an inter-agency task force on organ donation

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

18 force’) to improve the coordination and evaluation

19 of—

20 ‘‘(A) federally supported or conducted

21 organ donation efforts and policies; and

22 ‘‘(B) federally supported or conducted

23 basic, clinical and health services research (in24 cluding research on preservation techniques and

25 organ rejection and compatibility).
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1 ‘‘(2) COMPOSITION.—The task force shall be

2 composed of—

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

4 as the chairperson;

5 ‘‘(B) representatives to be appointed by

6 the Secretary from relevant agencies within the

7 Department of Health and Human Services (in8 cluding the Health Resources and Services Ad9 ministration, Health Care Financing Adminis10 tration, National Institutes of Health, and

11 Agency for Healthcare Research and Quality);

12 ‘‘(C) a representative from the Department

13 of Transportation;

14 ‘‘(D) a representative from the Depart15 ment of Defense;

16 ‘‘(E) a representative from the Department

17 of Veterans Affairs;

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

19 Personnel Management; and

20 ‘‘(G) representatives of other Federal

21 agencies or departments as determined to be

22 appropriate by the Secretary.

23 ‘‘(3) ANNUAL REPORT.—In addition to activi24 ties carried out under paragraph (1), the task force
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1 shall support the development of the annual report

2 under subsection (d)(2).

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

4 terminated at the discretion of the Secretary fol5 lowing the completion of at least 2 annual reports

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

7 Secretary shall provide for the on-going coordination

8 of federally supported or conducted organ donation

9 and research activities.

10 ‘‘(b) EDUCATION.—

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

12 The Secretary shall, directly or through grants or

13 contracts, carry out a comprehensive and effective

14 national public education program to increase organ

15 donation, including living donation.

16 ‘‘(2) DEVELOPMENT OF CURRICULA AND

17 OTHER EDUCATION ACTIVITIES.—

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

19 support the development and dissemination of

20 model curricula to train health care profes21 sionals and other appropriate professionals (in22 cluding religious leaders in the community and

23 law enforcement officials) in issues surrounding

24 organ donation, including methods to approach
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1 patients and their families, cultural sensitivities,

2 and other relevant issues.

3 ‘‘(B) HEALTH CARE PROFESSIONALS.—

4 For purposes of subparagraph (A), the term

5 ‘health care professionals’ includes—

6 ‘‘(i) medical students, residents and

7 fellows, attending physicians (through con8 tinuing medical education courses and

9 other methods), nurses, social workers, and

10 other allied health professionals; and

11 ‘‘(ii) hospital- or other health care-fa12 cility based chaplains; and

13 ‘‘(iii) emergency medical personnel.

14 ‘‘(c) GRANTS.—The Secretary shall award peer-re15 viewed grants to public and non-profit private entities, in16 cluding States, to carry out studies and demonstration

17 projects to increase organ donation rates, including living

18 donation. The Secretary shall ensure that activities carried

19 out by grantees under this subsection are evaluated for

20 effectiveness and that such findings are disseminated.

21 ‘‘(d) REPORTS.—

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

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

24 enter into a contract with the Institute of Medi25 cine to conduct an evaluation of the organ do-
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1 nation practices of organ procurement organiza2 tions, States, other countries, and other appro3 priate organizations that have achieved a higher

4 than average organ donation rate.

5 ‘‘(B) BARRIERS.—In conducting the eval6 uation under subparagraph (A), the Institute of

7 Medicine shall examine existing barriers to

8 organ donation.

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

10 after the date of enactment of this section, the

11 Institute of Medicine shall submit to the Sec12 retary a report concerning the evaluation con13 ducted under this paragraph. Such report shall

14 include recommendations for administrative ac15 tions and, if necessary, legislation in order to

16 replicate the best practices identified in the

17 evaluation and to otherwise increase organ do18 nation and procurement rates.

19 ‘‘(2) ANNUAL REPORT ON DONATION.—

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

21 after the date on which the report is submitted

22 under paragraph (1)(C), and annually there23 after, the Secretary shall prepare and submit to

24 Congress a report concerning federally sup25 ported or conducted organ donation and pro-
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1 curement activities, including donation and pro2 curement activities evaluated or conducted

3 under subsection (a) to increase organ dona4 tion.

5 ‘‘(B) REQUIREMENTS.—To the extent

6 practicable, each annual report under subpara7 graph (A) shall—

8 ‘‘(i) evaluate the effectiveness of ac9 tivities, identify best practices, and make

10 recommendations regarding broader adop11 tion of best practices with respect to organ

12 donation and procurement;

13 ‘‘(ii) assess organ donation and pro14 curement activities that are recently com15 pleted, current or planned.

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

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

18 $15,000,000 for fiscal year 2001, and such sums as may

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

Æ