II

106TH CONGRESS

2D SESSION S. 2398

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

relating to organ procurement and transplantation.

IN THE SENATE OF THE UNITED STATES

APRIL 11, 2000

Mr. FITZGERALD (for himself, Mr. SCHUMER, Mr. DURBIN, Mr. SANTORUM,

Mr. SPECTER, Ms. MIKULSKI, Mr. SARBANES, and Mr. KERREY) 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

the programs relating to organ procurement and transplantation.

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 Transplantation

5 Fairness Act of 2000’’.

6 SEC. 2. FINDINGS.

7 (a) IN GENERAL.—Congress makes the following

8 findings:
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1 (1) It is in the public interest to maintain and

2 continually improve a national network to ensure the

3 fair and effective distribution of organs among pa4 tients on the national waiting list irrespective of

5 their place of residence or the location of the trans6 plant program with which they are listed, and to en7 sure quality and facilitate collaboration among net8 work members and individual medical practitioners

9 participating in the network activities.

10 (2) The Organ Procurement and Transplan11 tation Network (referred to in this section as the

12 ‘‘Network’’) was created in 1984 by the National

13 Organ Transplant Act (Public Law 98–507) in order

14 to facilitate an equitable allocation of organs among

15 all patients on a national basis.

16 (3) The Federal Government should continue to

17 provide Federal oversight of the Network and is re18 sponsible for protecting the public’s health care in19 terest and ensuring that the policies of the Network

20 meet the goals established by this Act.

21 (4) The responsibility for developing, estab22 lishing, and maintaining medical criteria and stand23 ards for organ procurement and transplantation

24 should be a function of the Network, and the Sec25 retary of Health and Human Services should provide
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1 oversight to ensure compliance with this Act and

2 other applicable laws.

3 (5) The network should be operated by a pri4 vate organization under contract with the Depart5 ment of Health and Human Services.

6 (6) The Federal Government is responsible for

7 ensuring that the efforts of the Network serve pa8 tients and donor families in the procurement and

9 distribution of organs.

10 (7) The Federal Government should take imme11 diate action to improve organ donation rates and in12 crease the number of organs available for transplan13 tation.

14 (8) There is a significant disparity between the

15 number of organ donors and the number of individ16 uals waiting for organ transplants, and it is in the

17 public’s best interest to have a system of organ allo18 cation that ensures that transplant candidates with

19 similar severity of illness have similar likelihood of

20 transplantation irrespective of their place of resi21 dence or the location of the transplant program with

22 which they are listed.

23 (b) SENSE OF CONGRESS REGARDING ORGAN DONA24 TION.—It is the sense of Congress that—
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1 (1) the factors that impact organ donation

2 rates are complex and require a multifaceted ap3 proach to increase organ donation rates;

4 (2) the Federal Government should lead the na5 tional effort to increase organ donation and develop

6 programs with the transplant community to research

7 and implement a best practices approach to increas8 ing organ donation; and

9 (3) a generous contribution has been made by

10 each individual who has donated an organ to save a

11 life.

12 SEC. 3. ORGAN PROCUREMENT ORGANIZATIONS.

13 Section 371 of the Public Health Service Act (42

14 U.S.C. 273) is amended to read as follows:

15 ‘‘SEC. 371. ORGAN PROCUREMENT ORGANIZATIONS.

16 ‘‘(a) AUTHORITY OF THE SECRETARY.—The Sec17 retary may make grants to, and enter into contracts with,

18 qualified organ procurement organizations described in

19 subsection (b), and other nonprofit private entities, for the

20 purpose of carrying out special projects designed to in21 crease the number of organ donors.

22 ‘‘(b) QUALIFIED ORGANIZATIONS.—

23 ‘‘(1) REQUIREMENTS.—A qualified organ pro24 curement organization for which grants may be

25 made under subsection (a) is an organization that,
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1 as determined by the Secretary, will carry out the

2 functions described in paragraph (2), and that—

3 ‘‘(A) is a nonprofit entity;

4 ‘‘(B) has accounting and other fiscal proce5 dures (as specified by the Secretary) necessary

6 to ensure the fiscal stability of the organization;

7 ‘‘(C) has an agreement with the Secretary

8 to be reimbursed under title XVIII of the Social

9 Security Act for the procurement of kidneys;

10 ‘‘(D) notwithstanding any other provision

11 of law, has met the other requirements of this

12 subsection and has been certified or recertified

13 by the Secretary as meeting the performance

14 standards to be a qualified organ procurement

15 organization through a process that—

16 ‘‘(i) granted certification or recertifi17 cation within the previous 4 years with

18 such certification in effect as of October 1,

19 2000, and remaining in effect through the

20 earlier of—

21 ‘‘(I) January 1, 2002; or

22 ‘‘(II) the completion of recertifi23 cation under the requirements of

24 clause (ii); or
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1 ‘‘(ii) is set forth in regulations pre2 scribed by the Secretary not later than

3 January 1, 2002, that—

4 ‘‘(I) require recertifications of

5 qualified organ procurement organiza6 tions not more frequently than once

7 every 4 years;

8 ‘‘(II) rely on outcome and proc9 ess performance measures that are

10 based on available, practical empirical

11 evidence of organ donor potential or

12 other related factors in each service

13 area of qualified organ procurement

14 organizations;

15 ‘‘(III) use multiple outcome

16 measures as part of the certification

17 process;

18 ‘‘(IV) provide for the filing and

19 approval of a corrective action plan by

20 a qualified organ procurement organi21 zation if the Secretary notifies the

22 organ procurement organization that

23 it has failed to meet the performance

24 measures after the first 2 years of the

25 4 year certification period, which cor-
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1 rective action plan shall apply for the

2 3 years following approval of such

3 plan;

4 ‘‘(V) provide for a qualified

5 organ procurement organization to

6 appeal a decertification to the Sec7 retary on substantive and procedural

8 grounds;

9 ‘‘(E) has procedures to obtain payment for

10 nonrenal organs provided to transplant centers;

11 ‘‘(F) has a defined service area that is of

12 sufficient size to assure maximum effectiveness

13 in the procurement of organs;

14 ‘‘(G) has a director and other such staff,

15 including the organ donation coordinators and

16 organ procurement specialists necessary to ef17 fectively obtain organs from donors in its serv18 ice area; and

19 ‘‘(H) has a board of directors or an advi20 sory board that—

21 ‘‘(i) is composed of—

22 ‘‘(I) members who represent hos23 pital administrators, intensive care or

24 emergency room personnel, tissue
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1 banks, and voluntary health organiza2 tions in its service area;

3 ‘‘(II) members who represent the

4 public residing in such area;

5 ‘‘(III) a physician with knowl6 edge, experience, or skill in the field

7 of histocompatibility or an individual

8 with a doctorate degree in biological

9 science with knowledge, experience, or

10 skill in the field of histocompatibility;

11 ‘‘(IV) a physician with knowledge

12 or skill in the field of neurology; and

13 ‘‘(V) from each transplant center

14 in its service area, a member who is

15 a surgeon who has practicing privi16 leges in such center and who performs

17 organ transplant surgery;

18 ‘‘(ii) has the authority to recommend

19 policies for the procurement of organs and

20 the other functions described in paragraph

21 (2); and

22 ‘‘(iii) has no authority over any other

23 activity of the organization.

24 ‘‘(2) FUNCTIONS.—An organ procurement orga25 nization shall—
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1 ‘‘(A) have effective agreements, to identify

2 potential organ donors, with all of the hospitals

3 and other health care entities in its service area

4 that have facilities for organ donation;

5 ‘‘(B) conduct and participate in systematic

6 efforts, including professional education, to ac7 quire all usable organs from potential donors;

8 ‘‘(C) arrange for the acquisition and pres9 ervation of donated organs and provide quality

10 standards for the acquisition of organs which

11 are consistent with the standards adopted by

12 the Organ Procurement and Transplantation

13 Network under section 372(b)(2)(F), including

14 arranging for testing with respect to preventing

15 the acquisition of organs that are infected with

16 the etiologic agent for acquired immune defi17 ciency syndrome;

18 ‘‘(D) arrange for the appropriate tissue

19 typing of donated organs;

20 ‘‘(E) assist the Organ Procurement and

21 Transplantation Network in the equitable dis22 tribution of organs among patients on a na23 tional basis;

24 ‘‘(F) provide or arrange for the transpor25 tation of donated organs to transplant centers;
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1 ‘‘(G) have arrangements to coordinate its

2 activities with transplant centers in its service

3 area;

4 ‘‘(H) participate in the Organ Procure5 ment and Transplantation Network established

6 under section 372;

7 ‘‘(I) have arrangements to cooperate with

8 tissue banks for the retrieval, processing, pres9 ervation, storage, and distribution of tissues as

10 may be appropriate to assure that all usable tis11 sues are obtained from potential donors;

12 ‘‘(J) evaluate annually the effectiveness of

13 the organization in acquiring potentially avail14 able organs; and

15 ‘‘(K) assist hospitals in establishing and

16 implementing protocols for assuring that all

17 deaths and imminent deaths are reported to the

18 appropriate organ procurement organization.’’.

19 SEC. 4. ORGAN PROCUREMENT AND TRANSPLANTATION

20 NETWORK.

21 Section 372 of the Public Health Service Act (42

22 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) IN GENERAL.—The Secretary shall by regula4 tion provide for the establishment and operation of an

5 Organ Procurement and Transplantation Network that

6 meets the requirements of subsection (b).

7 ‘‘(b) REQUIREMENTS.—

8 ‘‘(1) IN GENERAL.—The Organ Procurement

9 and Transplantation Network shall carry out the

10 functions described in paragraph (2) and shall—

11 ‘‘(A) be operated by a private entity under

12 contract with the Department of Health and

13 Human Services; and

14 ‘‘(B) have a board of directors—

15 ‘‘(i) not more than 50 percent of

16 which members are transplant surgeons or

17 transplant physicians;

18 ‘‘(ii) at least 25 percent of which

19 members are transplant candidates, trans20 plant recipients, organ donors, and family

21 members; and

22 ‘‘(iii) that includes representatives of

23 organ procurement organizations, vol24 untary health associations, and the general

25 public; and
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1 ‘‘(iv) that shall establish an executive

2 committee and other committees, whose

3 chairpersons shall be selected to ensure

4 continuity of the board.

5 ‘‘(2) FUNCTIONS.—The Organ Procurement

6 and Transplantation Network shall—

7 ‘‘(A) establish and maintain one or more

8 lists derived from a national list of individuals

9 who need organ transplants;

10 ‘‘(B) establish a national system, through

11 the use of computers and in accordance with es12 tablished medical criteria, to match organs and

13 individuals included on such lists;

14 ‘‘(C) establish membership criteria for hos15 pitals, for performing organ transplants, and

16 for individual members;

17 ‘‘(D) maintain a 24-hour telephone service

18 to facilitate matching organs with individuals

19 included in such lists;

20 ‘‘(E) allocate organs so that transplant

21 candidates with similar severity of illness have

22 similar likelihood of receiving a transplant irre23 spective of their place of residence or the loca24 tion of the transplant program with which they

25 are listed;
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1 ‘‘(F) adopt and use standards of quality

2 for the acquisition and transportation of do3 nated organs, including standards for pre4 venting the acquisition of organs that are in5 fected with the etiologic agent for acquired im6 mune deficiency syndrome;

7 ‘‘(G) prepare and distribute, on a national

8 basis, samples of blood sera from individuals

9 who are included on such lists in order to facili10 tate matching the compatibility of such individ11 uals with organ donors;

12 ‘‘(H) coordinate, as appropriate, the trans13 portation of organs from organ procurement or14 ganizations to transplant centers;

15 ‘‘(I) provide information to physicians and

16 other health professionals and the general pub17 lic regarding organ donation;

18 ‘‘(J) collect, analyze, and publish data con19 cerning organ donation and transplants;

20 ‘‘(K) provide data to the Secretary in order

21 to permit the Secretary to carry out the Sec22 retary’s responsibilities under this part, and to

23 the Scientific Registry maintained pursuant to

24 section 373;
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1 ‘‘(L) respond in a timely fashion and to

2 the extent permitted, to requests for data from

3 researchers and investigators;

4 ‘‘(M) carry out studies and demonstration

5 projects for the purpose of improving proce6 dures for organ procurement and allocation;

7 ‘‘(N) work actively to increase the supply

8 of donated organs;

9 ‘‘(O) submit to the Secretary an annual re10 port containing information on the comparative

11 costs and patient outcomes at each transplant

12 center affiliated with the Organ Procurement

13 and Transplantation Network; and

14 ‘‘(P) submit to the Secretary an annual re15 port containing such financial information, as

16 determined by the Secretary, to be necessary to

17 evaluate the cost of operating the Organ Pro18 curement and Transplantation Network.

19 ‘‘(3) AVAILABILITY OF PATIENT LISTING FEES

20 AND PARTICIPATION FEES.—

21 ‘‘(A) IN GENERAL.—Any fees described in

22 subparagraph (B) that are collected by the

23 Organ Procurement and Transplantation

24 Network—
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1 ‘‘(i) shall be available to the Organ

2 Procurement and Transplantation Net3 work, without fiscal year limitation, for use

4 in carrying out the functions of the Organ

5 Procurement Transplantation Network

6 under this section; and

7 ‘‘(ii) shall not be used for any activity

8 (including lobbying or other political activ9 ity) that is not authorized under this sec10 tion.

11 ‘‘(B) COVERED FEES.—Subparagraph (A)

12 applies with respect to the following:

13 ‘‘(i) Listing fees.

14 ‘‘(ii) Fees imposed as a condition of

15 being a participant in the Organ Procure16 ment and Transplantation Network.

17 ‘‘(C) CONSTRUCTION.—No provision of

18 this paragraph may be construed to prohibit the

19 Organ Procurement and Transplantation Net20 work from—

21 ‘‘(i) collecting fees other than the fees

22 described in subparagraph (B); or

23 ‘‘(ii) using fees covered by clause (i)

24 for an activity covered by subparagraph

25 (A)(ii) or other activity.
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1 ‘‘(c) ORGAN ALLOCATION.—

2 ‘‘(1) DEVELOPMENT OF POLICIES.—The Organ

3 Procurement and Transplantation Network shall de4 velop organ-specific policies (including combinations

5 of organs, such as for kidney-pancreas transplants),

6 subject to the review of and approval by the Sec7 retary, for the equitable allocation of cadaveric or8 gans to individuals on the national waiting list.

9 ‘‘(2) LISTING CRITERIA.—Standardized min10 imum listing criteria for including individuals on the

11 national list shall be established and, to the extent

12 possible, shall—

13 ‘‘(A) contain explicit thresholds for the

14 listing of a patient;

15 ‘‘(B) avoid futile transplants or the wast16 ing of organs;

17 ‘‘(C) be expressed through objective and

18 measurable medical criteria; and

19 ‘‘(D) be reviewed periodically and revised

20 as appropriate.

21 ‘‘(3) REQUIREMENTS RELATING TO TRANS22 PLANT CANDIDATES.—Where appropriate for the

23 specific organ, transplant candidates shall—

24 ‘‘(A) be grouped by status categories from

25 most to least medically urgent with—
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1 ‘‘(i) sufficient categories to avoid

2 grouping together individuals with substan3 tially different medical urgency;

4 ‘‘(ii) explicit thresholds for differen5 tiating among patients; and

6 ‘‘(iii) explicit standards for the move7 ment of individuals among the status cat8 egories;

9 ‘‘(B) be expressed through objective and

10 measurable medical criteria; and

11 ‘‘(C) be reviewed periodically and revised

12 as appropriate.

13 ‘‘(4) REQUIREMENTS FOR ALLOCATION POLI14 CIES AND PROCEDURES.—Organ allocation policies

15 and procedures shall be established in accordance

16 with sound medical judgment and shall—

17 ‘‘(A) be designed and implemented to allo18 cate organs among transplant candidates—

19 ‘‘(i) in order of decreasing medical ur20 gency status;

21 ‘‘(ii) over the largest geographic area

22 practicable in a manner consistent with

23 organ viability so that neither place of resi24 dence nor place of listing shall be a major

25 determinant; and
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1 ‘‘(iii) so as to maintain organ viability

2 and avoid organ wastage; and

3 ‘‘(B) be reviewed periodically and revised

4 as appropriate.

5 ‘‘(5) POLICIES WHERE MEDICAL URGENCY IS

6 NOT AN APPROPRIATE MEASUREMENT.—Where med7 ical urgency is not an appropriate measurement for

8 organ allocation, policies and procedures shall be es9 tablished in accordance with sound medical judg10 ment.

11 ‘‘(d) AUTHORITY OF THE SECRETARY.—The policies

12 and rules established by the Organ Procurement and

13 Transplantation Network that are to be enforceable shall

14 be subject to review and approval by the Secretary. The

15 Secretary shall—

16 ‘‘(1) in consultation with the Organ Procure17 ment and Transplantation Network, develop mecha18 nisms to promote and review compliance with the re19 quirements of this section;

20 ‘‘(2) establish and approve all fees, dues, or

21 similar costs charged to support the operation of the

22 Organ Procurement and Transplantation Network;

23 ‘‘(3) establish procedures for receiving from in24 terested persons critical comments relating to the

25 manner in which the Organ Procurement and Trans-
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1 plantation Network is carrying out the duties of the

2 Network under subsection (b); and

3 ‘‘(4) take such action, as determined by the

4 Secretary, to enforce the requirements of this section

5 as well as the requirements under title XVIII of the

6 Social Security Act.

7 ‘‘(5) if the Organ Procurement and Transplan8 tation Network fails to submit a policy on a matter

9 which the Secretary determines should be enforced

10 under this section or section 1138 of the Social Se11 curity Act, or the Organ Procurement and Trans12 plantation Network submits a policy that the Sec13 retary determines is inconsistent with the goals of

14 this Act, submit to the board of directors or advisory

15 board of the Organ Procurement and Transplan16 tation Network the Secretary’s version of such pol17 icy.

18 ‘‘(e) NATIONAL TRANSPLANT ADVISORY BOARD.—

19 ‘‘(1) ESTABLISHMENT.—The Secretary shall, by

20 regulation, provide for the establishment of a Na21 tional Organ Transplant Advisory Board (referred to

22 in this subsection as the ‘Board’).

23 ‘‘(2) MEMBERSHIP.—The Board shall carry out

24 the functions described in paragraph (3) and shall

25 be comprised of individuals that—
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1 ‘‘(A) include a broad spectrum of rep2 resentatives of the medical and scientific com3 munity, including transplant surgeons, trans4 plant physicians, epidemiologists, and health

5 service researchers, as well as representatives

6 from organ procurement organizations and the

7 community of transplant patients, family mem8 bers and donor families;

9 ‘‘(B) are selected by the Secretary;

10 ‘‘(C) serve terms of not less than 3 years.

11 ‘‘(3) FUNCTIONS.—The Board shall assist the

12 Secretary in ensuring that the Organ Procurement

13 and Transplantation Network is grounded on the

14 best available medical science and is effective and

15 equitable as possible and shall—

16 ‘‘(A) at the request of the Secretary, re17 view the policies and rules of the Organ Pro18 curement and Transplantation Network;

19 ‘‘(B) advise and propose to the Secretary

20 policies, rules, and regulations affecting organ

21 procurement and transplantation;

22 ‘‘(C) at the request of the Secretary, re23 view and consider policies and regulations af24 fecting organ transplantation developed by the

25 Secretary;
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1 ‘‘(D) advise the Secretary with respect to

2 comments received by the Secretary under sub3 section (d)(3);

4 ‘‘(E) meet at the request of the Secretary,

5 but not less than 2 times each year; and

6 ‘‘(F) elect a Chairperson and Vice-chair7 person as well as any other officers as deter8 mined appropriate by the Board.

9 ‘‘(4) AUTHORIZATION OF APPROPRIATIONS.—

10 For the purpose of carrying out this subsection,

11 there are authorized to be appropriated $1,000,000

12 for each of the fiscal years 2000 through 2005.’’.

13 SEC. 5. SCIENTIFIC REGISTRY.

14 Section 373 of the Public Health Service Act (42

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

16 ‘‘SEC. 373. SCIENTIFIC REGISTRY.

17 ‘‘The Secretary shall, by grant or contract, develop

18 and maintain a scientific registry of the recipients of organ

19 transplants. The registry shall include such information

20 concerning patients and transplant procedures as the Sec21 retary determines to be necessary to an ongoing evaluation

22 to the scientific and clinical status of organ transplan23 tation. The registry shall also include such information

24 concerning both donors and patients in transplants involv25 ing living donors. The Secretary shall prepare for inclusion
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1 in the report under section 376 an analysis of information

2 derived from the registry.’’.

3 SEC. 6. ADMINISTRATION.

4 Section 375 of the Public Health Service Act (42

5 U.S.C. 274c) is amended to read as follows:

6 ‘‘SEC. 375. ADMINISTRATION.

7 ‘‘The Secretary shall designate and maintain an iden8 tifiable administrative unit in the Public Health Service

9 to—

10 ‘‘(1) administer this part and coordinate with

11 organ procurement activities under title XVIII of the

12 Social Security Act;

13 ‘‘(2) administer and coordinate programs, as

14 determined by the Secretary, to increase organ dona15 tion rates;

16 ‘‘(3) provide technical assistance to organ pro17 curement organizations, the Organ Procurement and

18 Transplantation Network established under section

19 372, and other entities in the health care system in20 volved in organ donations, procurements, and trans21 plants; and

22 ‘‘(4) provide information—

23 ‘‘(A) to patients, their families, and their

24 physicians about transplantation; and
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1 ‘‘(B) to patients and their families about

2 resources available nationally and in each State,

3 and the comparative costs and patient outcomes

4 at each transplant center affiliated with the

5 Organ Procurement and Transplantation Net6 work, in order to assist the patients and fami7 lies with the costs associated with transplan8 tation.’’.

9 SEC. 7. ADDITIONAL AMENDMENTS.

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

11 (42 U.S.C. 273 et seq.) is amended—

12 (1) in section 374 (42 U.S.C. 274b)—

13 (A) in subsection (b)(1), by striking ‘‘and

14 may not exceed $100,000’’ and inserting ‘‘and

15 other organizations for the purpose of increas16 ing the supply of transplantable organs’’; and

17 (B) in subsection (b)(2), by striking the

18 second sentence;

19 (2) in section 376 (42 U.S.C. 274d), by striking

20 ‘‘Committee on Energy and Commerce’’ and insert21 ing ‘‘Committee on Commerce’’; and

22 (3) by striking section 377 (42 U.S.C. 274f).
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1 SEC. 8. PAYMENT OF TRAVEL AND SUBSISTENCE EXPENSES

2 INCURRED TOWARD LIVING ORGAN DONA3 TION.

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

5 (42 U.S.C. 273 et seq.) is amended by inserting after sec6 tion 376 the following section:

7 ‘‘SEC. 376A. TRAVEL AND SUBSISTENCE PAYMENTS FOR

8 LIVING ORGAN DONATION.

9 ‘‘(a) IN GENERAL.—The Secretary may make awards

10 of grants or contracts to States, transplant centers, quali11 fied organ procurement organizations under section 371,

12 or other public or private entities for the purpose of—

13 ‘‘(1) providing for the payment of travel and

14 subsistence expenses incurred by individuals toward

15 making living donations of their organs (referred to

16 in this section as ‘donating individuals’); and

17 ‘‘(2) in addition, providing for the payment of

18 such incidental nonmedical expenses that are so in19 curred as the Secretary determines by regulation to

20 be appropriate.

21 ‘‘(b) ELIGIBILITY.—

22 ‘‘(1) IN GENERAL.—Payments under subsection

23 (a) may be made for the qualifying expenses of a do24 nating individual only if—

25 ‘‘(A) the State in which the donating indi26 vidual resides is a different State than the
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1 State in which the intended recipient of the

2 organ resides; and

3 ‘‘(B) the annual income of the intended re4 cipient of the organ does not exceed $35,000

5 (as adjusted for fiscal year 2002 and subse6 quent fiscal years to offset the effects of infla7 tion occurring after the beginning fiscal year

8 2001).

9 ‘‘(2) CERTAIN CIRCUMSTANCES.—Subject to

10 paragraph (1), the Secretary may in carrying out

11 subsection (a) provide as follows:

12 ‘‘(A) The Secretary may consider the term

13 ‘donating individuals’ as including individuals

14 who in good faith incur qualifying expenses to15 ward the intended donation of an organ but

16 with respect to whom, for such reason as the

17 Secretary determines to be appropriate, no do18 nation of the organ occurs.

19 (B) The Secretary may consider the term

20 ‘qualifying expenses’ as including the expenses

21 of having one or more family members of do22 nating individuals accompany the donating indi23 viduals for purposes of subsection (a) (subject

24 to making payment for only such types of ex25 penses as are paid for donating individuals).
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1 ‘‘(c) LIMITATION ON AMOUNT OF PAYMENT.—

2 ‘‘(1) IN GENERAL.—With respect to the geo3 graphic area to which a donating individual travels

4 for purposes of section (a), if such area is other than

5 the covered vicinity for the intended recipient of the

6 organ, the amount of qualifying expenses for which

7 payments under such subsection are made may not

8 exceed the amount of such expenses for which pay9 ment would have been made if such area had been

10 the covered vicinity for the intended recipient, taking

11 into account the costs of travel and regional dif12 ferences in the cost of living.

13 ‘‘(2) COVERED VICINITY.—For purposes of this

14 section, the term ‘covered vicinity’ with respect to an

15 intended recipient of an organ from a donating indi16 vidual, means the vicinity of the nearest transplant

17 center to the residence of the intended recipient that

18 regularly performs transplants of that type of organ.

19 ‘‘(d) RELATIONSHIP TO PAYMENTS UNDER OTHER

20 PROGRAMS.—An award may be made under subsection (a)

21 only if the applicant agrees that the award will not be ex22 pended to pay the qualifying expenses of a donating indi23 vidual to the extent that payment has been made, or can

24 reasonably be expected to be made, with respect to such

25 expenses—
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1 ‘‘(1) under any State compensation program,

2 under an insurance policy, or under any Federal or

3 State health benefits program; or

4 ‘‘(2) by an entity that provides health services

5 on a prepaid basis.

6 ‘‘(e) DEFINITIONS.—In this section:

7 ‘‘(1) COVERED VICINITY.—The term ‘covered

8 vicinity’ has the meaning given such term in sub9 section (c)(2).

10 ‘‘(2) DONATING INDIVIDUAL.—The term ‘do11 nating individual’ has the meaning indicated for

12 such term in subsection (a)(1), subject to subsection

13 (b)(2)(A).

14 ‘‘(3) QUALIFYING EXPENSES.—The term ‘quali15 fying expenses’ means the expenses authorized for

16 purposes of subsection (a), subject to subsection

17 (b)(2)(B).

18 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—For the

19 purpose of carrying out this section, there is authorized

20 to be appropriated $5,000,000 for each of fiscal years

21 2000 through 2005.’’.
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1 SEC. 9. PROGRAMS AND DEMONSTRATION PROJECTS TO

2 INCREASE ORGAN DONATION.

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

4 (42 U.S.C. 273 et seq.) is amended by inserting after sec5 tion 377 the following:

6 ‘‘SEC. 377A. INITIATIVES TO INCREASE ORGAN DONATION.

7 ‘‘(a) PUBLIC AWARENESS.—The Secretary shall (di8 rectly or through grants or contracts) carry out a program

9 to educate the public with respect to organ donation.

10 ‘‘(b) STUDIES AND DEMONSTRATIONS.—The Sec11 retary may make grants to public and nonprofit entities

12 for the purpose of carrying out studies and demonstration

13 projects with respect to increasing rates of organ donation.

14 The Secretary shall—

15 ‘‘(1) give priority to those studies and dem16 onstration projects that are founded upon a best

17 practices approach to increasing organ donation con18 sent rates;

19 ‘‘(2) give priority to those geographic areas

20 with lower organ donation consent rates, especially

21 among minorities;

22 ‘‘(3) provide assistance to qualified organ pro23 curement organizations described under section 371

24 to implement programs and projects, that as deter25 mined by Secretary through studies and demonstra-
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1 tion projects, have proven to be effective in increas2 ing organ donation rates; and

3 ‘‘(4) provide assistance to the study and consid4 eration of presumed consent as an opportunity to in5 crease organ donation rates.

6 ‘‘(c) GRANTS TO STATES.—The Secretary may make

7 grants to states for the purpose of carrying out public edu8 cation and outreach programs designed to increase the

9 number of organ donors within the State. To be eligible,

10 each State shall—

11 ‘‘(1) submit an application to the Secretary, in

12 such form as prescribed by the Secretary; and

13 ‘‘(2) establish yearly benchmarks for improve14 ment in organ donation rates in the State.

15 ‘‘(d) CONGRESSIONAL MEDAL.—

16 ‘‘(1) DESIGN.—The Secretary shall design a

17 bronze medal with suitable emblems, devices, and in18 scriptions, to be determined by the Secretary, to

19 commemorate organ donors and their families.

20 ‘‘(2) ELIGIBILITY.—Any organ donor, or the

21 family of any organ donor, shall be eligible for a

22 medal under this subsection.

23 ‘‘(3) REQUIREMENTS.—The Secretary shall di24 rect the Organ Procurement and Transplantation

25 Network, established under section 372, to—
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1 ‘‘(A) establish an application procedure re2 quiring the relevant organ procurement organi3 zations, described in section 371, through which

4 an individual or their family made an organ do5 nation, to submit documentation supporting the

6 eligibility of that individual or their family to

7 receive a medal; and

8 ‘‘(B) determine through the documentation

9 provided, and, if necessary, independent inves10 tigation, whether the individual or family is eli11 gible to receive a medal.

12 ‘‘(4) DELIVERY.—The Secretary shall make

13 suitable arrangements as necessary with the Sec14 retary of the Treasury to strike and deliver the med15 als described in paragraph (3).

16 ‘‘(5) PRESENTATION.—The Secretary shall pro17 vide for the presentation to the relevant organ pro18 curement organizations all medals struck pursuant

19 to this section to individuals or families that, in ac20 cordance with paragraph (3), the Organ Procure21 ment and Transplantation Network has determined

22 eligible to receive medals.

23 ‘‘(6) LIMITATION.—

24 ‘‘(A) IN GENERAL.—Except as provided in

25 subparagraph (B), only 1 medal may be pre-
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1 sented to a family under paragraph (5). Such

2 medal shall be presented to the donating family

3 member, or in the case of a deceased donor, the

4 family member who signed the consent form au5 thorizing, or who otherwise authorized, the do6 nation of the organ involved.

7 ‘‘(B) ADDITIONAL MEDALS.—In the case

8 of a family in which more than 1 member is an

9 organ donor, an additional medal may be pre10 sented to each such organ donor or their family.

11 ‘‘(7) DUPLICATES.—The Secretary or the

12 Organ Procurement and Transplantation Network

13 may provide duplicates of a medal—

14 ‘‘(A) to any recipient of a medal under

15 paragraph (4) under such regulation as the

16 Secretary may issue; and

17 ‘‘(B) the cost of which shall be sufficient

18 to cover the costs of such duplicates.

19 ‘‘(8) NATIONAL MEDALS.—The medals struck

20 pursuant to this subsection are national medals for

21 purposes of section 5111 of title 31, United States

22 Code.

23 ‘‘(9) APPLICABILITY OF PROVISIONS.—No pro24 vision of law governing procurement or public con25 tracts shall be applicable to the procurement of
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1 goods or services necessary for carrying out the pro2 visions of this subsection.

3 ‘‘(10) FUNDING.—

4 ‘‘(A) AGREEMENTS.—The Secretary of the

5 Treasury may enter into an agreement with the

6 Organ Procurement and Transplantation Net7 work to collect funds to offset expenditures re8 lating to the issuance of medals authorized

9 under this subsection.

10 ‘‘(B) PAYMENT AND LIMITATION.—

11 ‘‘(i) PAYMENT.—Except as provided

12 in clause (ii), all funds received by the

13 Organ Procurement and Transplantation

14 Network under this paragraph shall be

15 promptly paid to the Secretary of the

16 Treasury.

17 ‘‘(ii) LIMITATION.—Not more than 5

18 percent of any funds received under this

19 paragraph may be used to pay administra20 tive costs incurred by the Organ Procure21 ment and Transplantation Network as a

22 result of an agreement established under

23 this subsection.

24 ‘‘(C) DEPOSITS AND EXPENDITURES.—

25 Notwithstanding any other provision of law—
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1 ‘‘(i) all amounts received by the Sec2 retary of the Treasury under paragraph

3 (10)(A)(i) shall be deposited in the Numis4 matic Public Enterprise Fund, as de5 scribed in section 5134 of title 31, United

6 States Code; and

7 ‘‘(ii) the Secretary of the Treasury

8 shall charge such fund with all expendi9 tures relating to the issuance of medals au10 thorized under this subsection.

11 ‘‘(D) START-UP COSTS.—A one-time

12 amount of not to exceed $55,000 shall be pro13 vided by the Secretary to the Organ Procure14 ment and Transplantation Network to cover ini15 tial start-up costs to be paid back in full within

16 3 years of the date of enactment of this section

17 from funds received under this subsection.

18 ‘‘(11) DEFINITION.—For the purposes of this

19 section, the term ‘organ’ means the human kidney,

20 liver, heart, lung, pancreas, and any other human

21 organ (other than corneas and eyes) specified by

22 regulation by the Secretary.

23 ‘‘(12) EFFECTIVE DATE.—This subsection shall

24 be effective for the 5-year period beginning on the

25 date of the enactment of this section.
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1 ‘‘(e) ANNUAL REPORT TO CONGRESS.—The Sec2 retary shall submit to the Congress an annual report on

3 the activities carried out under this section, including pro4 visions describing the extent to which the activities have

5 affected the rate of organ donation.

6 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—

7 ‘‘(1) IN GENERAL.—For the purpose of car8 rying out this section, there are authorized to be ap9 propriated $10,000,000 for fiscal year 2000, and

10 such sums as may be necessary for each of the fiscal

11 years 2001 through 2005. Such authorization of ap12 propriations is in addition to any other authoriza13 tions of appropriations that are available for such

14 purpose.

15 ‘‘(2) PUBLIC AWARENESS.—Of the amounts ap16 propriated under paragraph (1) for a fiscal year, the

17 Secretary may not obligate more than $2,000,000

18 for carrying out subsection (a).’’.

19 SEC. 10. AUTHORIZATION OF APPROPRIATIONS.

20 Section 378 of the Public Health Service Act (42

21 U.S.C. 274g) is amended to read as follows:
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•S 2398 IS

1 ‘‘SEC. 378. AUTHORIZATION OF APPROPRIATIONS FOR

2 ORGAN PROCUREMENT AND TRANSPLAN3 TATION NETWORK.

4 ‘‘For the purpose of providing for the Organ Procure5 ment and Transplantation Network under section 372,

6 and for the Scientific Registry under section 373, there

7 are authorized to be appropriated $4,000,000 for fiscal

8 year 2000, and such sums as may be necessary for each

9 of fiscal years 2001 through 2005.’’.

10 SEC. 11. PREEMPTION.

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

12 (42 U.S.C. 273 et seq.) is amended by inserting after sec13 tion 378 the following:

14 ‘‘SEC. 378A. PREEMPTION.

15 ‘‘No State or political subdivision of a State shall es16 tablish or continue in effect any law, rule, regulation, or

17 other requirement that would restrict in any way the abil18 ity of any transplant hospital, organ procurement organi19 zation, or other entity to comply with the organ allocation

20 policies of the Network under this part.’’.

21 SEC. 12. EFFECTIVE DATE.

22 The amendments made by this Act shall take effect

23 on October 1, 2000, or upon the date of enactment of this

24 Act, whichever occurs later.

Æ