Calendar No. 378

103D CONGRESS

2D SESSION S. 1597

[Report No. 103–233]

A BILL

To amend the Public Health Service Act to revise

plantation programs, and for other purposes.and extend certain organ procurement and transMARCH 7 (legislative day, FEBRUARY 22), 1994

Reported with an amendment
II

Calendar No. 378

103D CONGRESS

2D SESSION S. 1597

To amend the Public Health Service Act to revise and extend certain organ

procurement and transplantation programs, and for other purposes.

IN THE SENATE OF THE UNITED STATES

OCTOBER 27 (legislative day, OCTOBER 13), 1993

Mr. KENNEDY introduced the following bill; which was read twice and referred

to the Committee on Labor and Human Resources

MARCH 7 (legislative day, FEBRUARY 22), 1994

Reported by Mr. KENNEDY, 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

certain organ procurement and transplantation programs, and for other purposes.

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 Transplant Pro5 gram Reauthorization Act of 1993’’.
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1 SEC. 2. ORGAN PROCUREMENT ORGANIZATIONS.

2 (a) IN GENERAL.—Subsection (a) of section 371 of

3 the Public Health Service Act (42 U.S.C. 273(a)) is

4 amended to read as follows:

5 ‘‘(a)(1) The Secretary may make grants for the con6 solidation and expansion of qualified organ procurement

7 organizations described in subsection (b).

8 ‘‘(2) The Secretary may make grants to, and enter

9 into cooperative agreements and contracts with, qualified

10 organ procurement organizations described in subsection

11 (b) and other public or nonprofit private entities for the

12 purpose of increasing organ donation through—

13 ‘‘(A) the planning and conducting of programs

14 to provide information and education to the public

15 on the need for organ donations;

16 ‘‘(B) the training of individuals in requesting

17 such donations; or

18 ‘‘(C) the provision of technical assistance to

19 organ procurement organizations and other entities

20 in the health care system.

21 ‘‘(3)(A) In making awards of grants, cooperative

22 agreements and contracts under subparagraphs (A) and

23 (B) of paragraph (2), the Secretary shall give priority to

24 carrying out the purpose described in such paragraph with

25 respect to minority or other populations for which there
3

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1 is a greater degree of organ shortages relative to the gen2 eral population.

3 ‘‘(B) In making awards of grants, cooperative agree4 ments and contracts under paragraph (2)(C), the Sec5 retary shall give priority to carrying out the purpose de6 scribed in such paragraph with respect to organ procure7 ment organizations and hospitals with lower rates of pro8 curement relative to other such organizations or hos9 pitals.’’.

10 (b) QUALIFIED ORGAN PROCUREMENT ORGANIZA11 TIONS.—Section 371(b) of such Act (42 U.S.C. 273(b))

12 is amended—

13 (1) in paragraph (1)—

14 (A) in the matter preceding subparagraph

15 (A), by striking ‘‘for which grants may be made

16 under subsection (a)’’ and inserting ‘‘described

17 in this section’’;

18 (B) by realigning the margin of subpara19 graph (E) so as to align with the margin of

20 subparagraph (D); and

21 (C) in subparagraph (G)—

22 (i) in the matter preceding clause (i),

23 by striking ‘‘directors or an advisory

24 board’’ and inserting ‘‘directors (or an ad25 visory board, in the case of a hospital-
4

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1 based organ procurement organization es2 tablished prior to September 1, 1993)’’;

3 and

4 (ii) in clause (i)—

5 (I) by striking ‘‘composed of’’ in

6 the matter preceding subclause (I)

7 and inserting ‘‘composed of a reason8 able balance of’’; and

9 (II) by inserting before the

10 comma in subclause (II) the following:

11 ‘‘, including individuals who have re12 ceived a transplant of an organ (or

13 transplant candidates), and individ14 uals who are part of the family of an

15 individual who has donated an

16 organ’’;

17 (2) by striking paragraph (2);

18 (3) by redesignating paragraph (3) as para19 graph (2);

20 (4) in paragraph (2) (as so redesignated)—

21 (A) by striking subparagraph (A) and in22 serting the following new subparagraph:

23 ‘‘(A) with respect to each hospital or other en24 tity in its service area that has facilities for organ
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1 donations, and except as provided in paragraph

2 (3)—

3 ‘‘(i) have in effect an agreement with the

4 entity under which the entity, for the purposes

5 of allocation, identifies potential organ donors

6 and notifies the organ procurement organiza7 tion, and

8 ‘‘(ii) if such hospital or entity is dissatis9 fied with the service obtained from its des10 ignated organ procurement organization such

11 hospital or entity may seek mediation under a

12 process established by the Secretary within 60

13 days after the date of enactment of this sub14 paragraph,’’;

15 (B) by redesignating subparagraphs (B)

16 through (K) as subparagraphs (C) through (L),

17 respectively;

18 (C) by inserting after subparagraph (A)

19 the following new subparagraph:

20 ‘‘(B) conduct and participate in systematic ef21 forts, including public education, to increase the

22 number of potential donors,’’;

23 (D) by inserting before the comma in sub24 paragraph (F) (as so redesignated) the follow25 ing: ‘‘, which system shall, at a minimum, allo-
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1 cate each type of organ either on the basis of

2 a single service area list, or an approved alter3 nate local unit list (as defined in paragraph

4 (4)), of individuals who have been medically re5 ferred to a transplant center in the service area

6 of the organization in order to receive a trans7 plant of the type of organ with respect to which

8 the list is maintained’’;

9 (E) by striking subparagraph (I) (as so re10 designated) and inserting the following new

11 subparagraph:

12 ‘‘(I) be a member of and abide by the rules and

13 requirements of the Organ Procurement and Trans14 plantation Network established under section 372,’’;

15 (F) by striking subparagraph (K) (as so

16 redesignated) and inserting the following new

17 subparagraph:

18 ‘‘(K) evaluate annually, and report to the

19 Organ Procurement and Transplantation Network

20 established under section 372, on the effectiveness of

21 the organization in acquiring potentially available or22 gans, particularly among minority populations, and

23 the variation of procurement across hospitals within

24 the organ procurement organization region, and

25 identify a plan to increase procurement, particularly
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1 among minority populations and other populations

2 for which there is a greater degree of organ short3 ages relative to the general population, and at hos4 pitals with low rates of procurement,’’; and

5 (G) by adding at the end thereof the fol6 lowing flush sentence:

7 ‘‘Subparagraph (A) shall not be construed as precluding

8 an organ procurement organization from requesting that

9 the Secretary permit changes in their service area bound10 aries.’’; and

11 (5) by adding at the end thereof the following

12 new paragraphs:

13 ‘‘(3)(A) The Secretary may waive the requirement

14 that an organ procurement organization have an agree15 ment of the type described in paragraph (2)(A) in effect

16 if—

17 ‘‘(i)(I) the hospital or other entity within the

18 service area of the organ procurement organization

19 is or seeks to be a party to such an agreement with

20 another organ procurement organization; and

21 ‘‘(II) the hospital and organ procurement orga22 nization can demonstrate to the satisfaction of the

23 Secretary that their affiliation is based on an agree24 ment or understanding between the organ procure25 ment organization for the service area in which the
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1 hospital is located, and the organ procurement orga2 nization with which the hospital desires to affiliate,

3 and such hospital;

4 ‘‘(ii) the hospital or other entity within the

5 service area of the organ procurement organization

6 is or seeks to be a party to such an agreement with

7 another organ procurement organization and can

8 document to the satisfaction of the Secretary, with

9 input from the organ procurement organization for

10 the area in which the hospital is located, that—

11 ‘‘(I) such hospital or entity has received in12 adequate service from the organ procurement

13 organization for the service area in which the

14 hospital is located; and

15 ‘‘(II) another organ procurement organiza16 tion is willing and able to provide such hospital

17 or entity adequate service; or

18 ‘‘(iii) in such other circumstances as described

19 in regulations promulgated by the Secretary.

20 ‘‘(B) The relationship of a hospital or other entity

21 within the service area of the organ procurement organiza22 tion with other organ procurement organizations outside

23 the service area that was in effect as of June 29, 1993,

24 may continue in effect, pending a determination by the

25 Secretary under the waiver process described in subpara-
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1 graph (A). Not later than 3 months after the date of en2 actment of this paragraph, the hospital or other entity

3 shall notify the Secretary in writing of its intent to proceed

4 with such an existing relationship.

5 ‘‘(C)(i) The Office of Technology Assessment shall

6 conduct a study for the purpose of defining—

7 ‘‘(I) the appropriate standards by which to

8 judge the quality of performance of organ procure9 ment organizations;

10 ‘‘(II) the proper criteria for a determination of

11 inadequate service from an organ procurement orga12 nization; and

13 ‘‘(III) the process for allowing a hospital to

14 work with an organ procurement organization out15 side its service area.

16 ‘‘(ii) Not later than 1 year after the date of enact17 ment of this paragraph, the Office of Technology Assess18 ment shall complete the study required under clause (i)

19 and prepare and submit to the Committee on Labor and

20 Human Resources of the Senate, the Committee on En21 ergy and Commerce of the House of Representatives, and

22 the Secretary, a report describing the findings made as

23 a result of the study.

24 ‘‘(4)(A) As used in paragraph (2)(F), the term ‘alter25 native local unit’ means—
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1 ‘‘(i) a unit composed of two or more contiguous

2 organ procurement organizations; or

3 ‘‘(ii) a subdivision of an organ procurement or4 ganization that operates as a distinct procurement

5 and distribution unit as a result of special geo6 graphic or minority population concerns but that is

7 not composed of any subunit of a metropolitan sta8 tistical area.

9 ‘‘(B) The Organ Procurement and Transplantation

10 Network shall make recommendations to the Secretary

11 concerning the approval or denial of alternative local unit.

12 The Network shall assess whether the alternative local

13 units will better promote organ donation and the equitable

14 allocation of organs.

15 ‘‘(C) The Secretary shall approve or deny any alter16 native local unit principle or designation recommended by

17 the Network. If the Secretary does not provide otherwise

18 prior to the expiration of the 90-day period beginning on

19 the date on which the application is submitted, the rec20 ommendations of the Network under subparagraph (B)

21 with respect to the application of the alternative local unit

22 shall go into effect.’’.
11

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1 SEC. 3. ORGAN PROCUREMENT AND TRANSPLANTATION

2 NETWORK.

3 Section 372(b) of the Public Health Service Act (42

4 U.S.C. 274(b)) is amended—

5 (1) in paragraph (1)(B)—

6 (A) in clause (i)—

7 (i) by striking ‘‘(including organiza8 tions that have received grants under sec9 tion 371)’’; and

10 (ii) by striking ‘‘and’’ at the end

11 thereof and inserting ‘‘including both indi12 viduals who have received a transplant of

13 an organ (or transplant candidates), and

14 individuals who are part of the family of

15 individuals who have donated an organ, the

16 number of whom shall make up not less

17 than 33 percent of the total number of

18 board members’’; and

19 (B) in clause (ii), by inserting ‘‘including a

20 patient affairs committee’’ after ‘‘committees,’’;

21 (2) in paragraph (2)—

22 (A) by striking clause (A)(i) and inserting

23 the following new clause:

24 ‘‘(i) with respect to each type of trans25 plant, a national list of individuals who have

26 been medically referred to receive a transplant
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1 of the type of organs with respect to which the

2 list is maintained (which list shall include the

3 names of all individuals included on lists in ef4 fect under section 371(b)(2)(F), and’’;

5 (B) in subparagraph (B), by inserting ‘‘,

6 including requirements under section 371(b),’’

7 after ‘‘membership criteria’’;

8 (C) in subparagraph (D), to read as fol9 lows:

10 ‘‘(D) develop and report to the Secretary, not

11 later than September 30, 1994, and implement not

12 later than September 30, 1995, a system of allocat13 ing organs in order to ensure that patients in one

14 region have an equivalent probability of receiving an

15 organ as do patients with similar characteristics in

16 another region,’’;

17 (D) by redesignating subparagraphs (E)

18 through (L), as subparagraphs (F) through

19 (M), respectively;

20 (E) by inserting after subparagraph (D),

21 the following new subparagraph:

22 ‘‘(E) assist organ procurement organizations in

23 the equitable distribution of organs among trans24 plant patients,’’;
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1 (F) in subparagraph (K) (as so redesig2 nated), by striking ‘‘and’’ at the end thereof;

3 (G) in subparagraph (L) (as so redesig4 nated), by striking the period and inserting ‘‘,

5 including making recommendations to organ

6 procurements organizations and the Secretary

7 based on the annual reports required under sec8 tion 371(b)(2)(K),’’;

9 (H) in subparagraph (M) (as so redesig10 nated), by striking the period and inserting a

11 comma; and

12 (I) by adding at the end thereof the follow13 ing new subparagraphs:

14 ‘‘(N) submit to the Secretary for review and ap15 proval any change in the amount of fees imposed by

16 the Network for the registration of individuals on

17 the lists maintained under subparagraph (A)(i), such

18 change to be considered as approved if the Secretary

19 does not provide otherwise prior to the expiration of

20 the 90-day period beginning on the date on which

21 the change is submitted to the Secretary,

22 ‘‘(O) make available to the Secretary such in23 formation, books, and records regarding the Net24 work as the Secretary may require,
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1 ‘‘(P) submit to the Secretary, on an annual

2 basis, a report on the clinical and scientific status of

3 the organ transplantations, and

4 ‘‘(Q) meet such other criteria regarding compli5 ance with this part as the Secretary may establish.’’;

6 and

7 (3) by adding at the end thereof the following

8 new paragraph:

9 ‘‘(3) In carrying out paragraph (2)(D), the Organ

10 Procurement and Transplantation Network shall consult

11 with experts in the area of organ allocation and organ do12 nations and consider their recommendations regarding the

13 establishment of regions in the country for the purpose

14 of allocating organs.’’.

15 SEC. 4. STUDY BY GENERAL ACCOUNTING OFFICE.

16 Section 377 of the Public Health Service Act (42

17 U.S.C. 274f) is amended to read as follows:

18 ‘‘SEC. 377. STUDY BY GENERAL ACCOUNTING OFFICE.

19 ‘‘(a) IN GENERAL.—The Comptroller General of the

20 United States shall conduct a study for the purpose of

21 determining and making recommendations concerning—

22 ‘‘(1) the composition of the boards of directors

23 of organ procurement organizations and of the

24 Organ Procurement and Transplantation Network

25 on the date of enactment of this section, and the ef-
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1 fect of the Organ Transplant Program Reauthoriza2 tion Act of 1993 on the composition and functioning

3 of such boards;

4 ‘‘(2)(A) the number and percentage of cadaveric

5 organ transplants for foreign nationals categorized

6 by organ procurement organization and by trans7 plant center;

8 ‘‘(B) the number and percent of the organiza9 tions referred to in subparagraph (A) above the

10 organ procurement transplant network guideline of

11 10 percent; and

12 ‘‘(C) any information on the current rate of

13 organ donation by individuals other than United

14 States citizens or legal residents;

15 ‘‘(3) the equitable allocation of organs nation16 wide, including an analysis of the relative probability

17 of receiving an organ for patients with similar char18 acteristics for each category of transplanted organ

19 by organ procurement organization and the effect of

20 the Organ Transplant Program Reauthorization Act

21 of 1993 on improving the equitable allocation of or22 gans nationwide.

23 ‘‘(b) REPORT.—Not later than 2 years after the date

24 of enactment of the Organ Transplant Program Reauthor25 ization Act of 1993, the Comptroller General of the United
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1 States shall complete the study required under subsection

2 (a) and prepare and submit to the Committee on Energy

3 and Commerce of the House of Representatives, and to

4 the Committee on Labor and Human Resources of the

5 Senate, a report describing the findings made as a result

6 of the study.’’.

7 SEC. 5. GENERAL PROVISIONS.

8 (a) LIMITATION.—Section 374(b) of the Public

9 Health Service Act (42 U.S.C. 274b(b)) is amended—

10 (1) by striking paragraph (2);

11 (2) by redesignating paragraph (3) as para12 graph (2); and

13 (3) in paragraph (2) (as so redesignated), by

14 striking ‘‘371(a)(3)’’ and inserting ‘‘371(a)(2)’’.

15 (b) REPEAL.—Section 376 of the Public Health Serv16 ice Act (42 U.S.C. 274d) is repealed.

17 (c) TRANSFER.—Section 378 of the Public Health

18 Service Act (42 U.S.C. 274g) is amended—

19 (1) by transferring such section to part H of

20 title III; and

21 (2) by inserting such section after section 377.

22 (d) AUTHORIZATION OF APPROPRIATIONS.—Section

23 378 of the Public Health Service Act (42 U.S.C. 274g)

24 is amended by striking ‘‘1991’’ and all that follows

25 through the period and inserting ‘‘1994, and such sums
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1 as may be necessary for each of the fiscal years 1995 and

2 1996.’’.

3 SEC. 6. EFFECTIVE DATES.

4 (a) IN GENERAL.—Except as provided in subsection

5 (b), the amendments made by this Act shall become effec6 tive on the date of enactment of this Act.

7 (b) EXCEPTION.—The amendments made by sections

8 2(b)(4)(A) and 2(b)(4)(D) shall become effective 6 months

9 after the date of enactment of this Act. Prior to such date,

10 sections 371(b)(3)(A) and 371(b)(3)(E) of the Public

11 Health Service Act, as in effect on the day before the date

12 of the enactment of this Act, shall remain in effect.

13 SECTION 1. SHORT TITLE.

14 This Act may be cited as the ‘‘Organ Transplant

15 Program Reauthorization Act of 1993’’.

16 SEC. 2. ORGAN PROCUREMENT ORGANIZATIONS.

17 (a) IN GENERAL.—Subsection (a) of section 371 of the

18 Public Health Service Act (42 U.S.C. 273(a)) is amended

19 to read as follows:

20 ‘‘(a)(1) The Secretary may make grants for the consoli21 dation and expansion of qualified organ procurement orga22 nizations described in subsection (b).

23 ‘‘(2) The Secretary may make grants to, and enter into

24 cooperative agreements and contracts with, qualified organ

25 procurement organizations described in subsection (b) and
18

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1 other public or nonprofit private entities for the purpose

2 of increasing organ donation through—

3 ‘‘(A) the planning and conducting of programs

4 to provide information and education to the public on

5 the need for organ donations;

6 ‘‘(B) the training of individuals in requesting

7 such donations; or

8 ‘‘(C) the provision of technical assistance to

9 organ procurement organizations and other entities

10 in the health care system.

11 ‘‘(3)(A) In making awards of grants, cooperative

12 agreements and contracts under subparagraphs (A) and (B)

13 of paragraph (2), the Secretary shall give priority to carry14 ing out the purpose described in such paragraph with re15 spect to minority or other populations for which there is

16 a greater degree of organ shortages relative to the general

17 population.

18 ‘‘(B) In making awards of grants, cooperative agree19 ments and contracts under paragraph (2)(C), the Secretary

20 shall give priority to carrying out the purpose described in

21 such paragraph with respect to organ procurement organi22 zations and hospitals with lower rates of procurement rel23 ative to other such organizations or hospitals.’’.
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1 (b) QUALIFIED ORGAN PROCUREMENT ORGANIZA2 TIONS.—Section 371(b) of such Act (42 U.S.C. 273(b)) is

3 amended—

4 (1) in paragraph (1)—

5 (A) in the matter preceding subparagraph

6 (A), by striking ‘‘for which grants may be made

7 under subsection (a)’’ and inserting ‘‘described

8 in this section’’;

9 (B) by realigning the margin of subpara10 graph (E) so as to align with the margin of sub11 paragraph (D); and

12 (C) in subparagraph (G)—

13 (i) in the matter preceding clause (i),

14 by striking ‘‘directors or an advisory

15 board’’ and inserting ‘‘directors (or an ad16 visory board, in the case of a hospital-based

17 organ procurement organization established

18 prior to September 1, 1993)’’; and

19 (ii) in clause (i)—

20 (I) by striking ‘‘composed of’’ in

21 the matter preceding subclause (I) and

22 inserting ‘‘composed of a reasonable

23 balance of’’; and

24 (II) by inserting before the comma

25 in subclause (II) the following: ‘‘, in-
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1 cluding individuals who have received

2 a transplant of an organ (or trans3 plant candidates), and individuals who

4 are part of the family of an individual

5 who has donated an organ’’;

6 (2) by striking paragraph (2);

7 (3) by redesignating paragraph (3) as para8 graph (2);

9 (4) in paragraph (2) (as so redesignated)—

10 (A) by redesignating subparagraphs (B)

11 through (K) as subparagraphs (C) through (L),

12 respectively,

13 (B) by inserting after subparagraph (A) the

14 following new subparagraph:

15 ‘‘(B) conduct and participate in systematic ef16 forts, including public education, to increase the num17 ber of potential donors,’’;

18 (C) by inserting before the comma in sub19 paragraph (F) (as so redesignated) the following:

20 ‘‘, which system shall, at a minimum, allocate

21 each type of organ on the basis of—

22 ‘‘(i) a single list encompassing the entire

23 service area;

24 ‘‘(ii) a list that encompasses at least an en25 tire State; or
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1 ‘‘(iii) a list that encompasses an approved

2 alternative local unit (as defined in paragraph

3 (4)),

4 of individuals who have been medically referred to a

5 transplant center in the service area of the organiza6 tion in order to receive a transplant of the type of

7 organ with respect to which the list is maintained;’’;

8 (D) by striking subparagraph (I) (as so re9 designated) and inserting the following new sub10 paragraph:

11 ‘‘(I) be a member of and abide by the rules and

12 requirements of the Organ Procurement and Trans13 plantation Network established under section 372,’’;

14 and

15 (E) by striking subparagraph (K) (as so re16 designated) and inserting the following new sub17 paragraph:

18 ‘‘(K) evaluate annually, and report to the Organ

19 Procurement and Transplantation Network estab20 lished under section 372, on the effectiveness of the or21 ganization in acquiring potentially available organs,

22 particularly among minority populations, and the

23 variation of procurement across hospitals within the

24 organ procurement organization region, and identify

25 a plan to increase procurement, particularly among
22

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1 minority populations and other populations for which

2 there is a greater degree of organ shortages relative to

3 the general population, and at hospitals with low

4 rates of procurement, and’’; and

5 (5) by adding at the end thereof the following

6 new paragraphs:

7 ‘‘(3)(A) The Office of Technology Assessment shall con8 duct a study for the purpose of defining—

9 ‘‘(i) the appropriate standards by which to judge

10 the quality of performance of organ procurement or11 ganizations; and

12 ‘‘(ii) the proper criteria for a determination of

13 inadequate service from an organ procurement orga14 nization.

15 ‘‘(B) Not later than 2 years after the date of enactment

16 of this paragraph, the Office of Technology Assessment shall

17 complete the study required under subparagraph (A) and

18 prepare and submit to the Committee on Labor and Human

19 Resources of the Senate, the Committee on Energy and

20 Commerce of the House of Representatives, and the Sec21 retary, a report describing the findings made as a result

22 of the study.

23 ‘‘(C) For purposes of this paragraph the term ‘organ’

24 means a human kidney, liver, heart, lung, pancreas, and
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1 any other human organ or tissue specified by the Secretary

2 for purposes of this paragraph.

3 ‘‘(4)(A) As used in paragraph (2)(F), the term ‘alter4 native local unit’ means—

5 ‘‘(i) a unit composed of two or more contiguous

6 organ procurement organizations; or

7 ‘‘(ii) a subdivision of an organ procurement or8 ganization that operates as a distinct procurement

9 and distribution unit as a result of special geo10 graphic, rural, or minority population concerns but

11 that is not composed of any subunit of a metropolitan

12 statistical area.

13 ‘‘(B) The Organ Procurement and Transplantation

14 Network shall make recommendations to the Secretary con15 cerning the approval or denial of alternative local units.

16 The Network shall assess whether the alternative local units

17 will better promote organ donation and the equitable alloca18 tion of organs.

19 ‘‘(C) The Secretary shall approve or deny any alter20 native local unit principle or designation recommended by

21 the Network. If the Secretary does not provide otherwise

22 prior to the expiration of the 90-day period beginning on

23 the date on which the application is submitted, the rec24 ommendations of the Network under subparagraph (B) with
24

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1 respect to the application of the alternative local unit shall

2 go into effect.’’.

3 (c) EFFECTIVE DATE.—The amendments made by sub4 section (b)(5) shall apply to organ procurement organiza5 tions beginning January 1, 1995.

6 SEC. 3. ORGAN PROCUREMENT AND TRANSPLANTATION

7 NETWORK.

8 Section 372(b) of the Public Health Service Act (42

9 U.S.C. 274(b)) is amended—

10 (1) in paragraph (1)(B)—

11 (A) in clause (i)—

12 (i) by striking ‘‘(including organiza13 tions that have received grants under sec14 tion 371)’’; and

15 (ii) by striking ‘‘; and’’ at the end

16 thereof and inserting ‘‘(including both indi17 viduals who have received a transplant of

18 an organ (or transplant candidates), and

19 individuals who are part of the family of

20 individuals who have donated an organ, the

21 number of whom shall make up not less

22 than 40 percent of the total number of

23 board members); and’’; and
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1 (B) in clause (ii), by inserting ‘‘including

2 a patient affairs committee’’ after ‘‘committees,’’;

3 and

4 (2) in paragraph (2)—

5 (A) in subparagraph (A), by striking clause

6 (i) and inserting the following new clause:

7 ‘‘(i) with respect to each type of transplant,

8 a national list of individuals who have been

9 medically referred to receive a transplant of the

10 type of organs with respect to which the list is

11 maintained (which list shall include the names

12 of all individuals included on lists in effect

13 under section 371(b)(2)(F), and’’;

14 (B) in subparagraph (B), by inserting ‘‘,

15 including requirements under section 371(b),’’

16 after ‘‘membership criteria’’;

17 (C) by redesignating subparagraphs (E)

18 through (L), as subparagraphs (F) through (M),

19 respectively;

20 (D) by inserting after subparagraph (D),

21 the following new subparagraph:

22 ‘‘(E) assist organ procurement organizations in

23 the equitable distribution of organs among transplant

24 patients,’’;
26

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1 (E) in subparagraph (K) (as so redesig2 nated), by striking ‘‘and’’ at the end thereof;

3 (F) in subparagraph (L) (as so redesig4 nated), by striking the period and inserting ‘‘,

5 including making recommendations to organ

6 procurements organizations and the Secretary

7 based on the annual reports required under sec8 tion 371(b)(2)(K),’’;

9 (G) in subparagraph (M) (as so redesig10 nated), by striking the period and inserting a

11 comma; and

12 (H) by adding at the end thereof the follow13 ing new subparagraphs:

14 ‘‘(N) submit to the Secretary for review and ap15 proval any change in the amount of fees imposed by

16 the Network for the registration of individuals on the

17 lists maintained under subparagraph (A)(i), such

18 change to be considered as approved if the Secretary

19 does not provide otherwise prior to the expiration of

20 the 90-day period beginning on the date on which the

21 change is submitted to the Secretary,

22 ‘‘(O) make available to the Secretary such infor23 mation, books, and records regarding the Network as

24 the Secretary may require,
27

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1 ‘‘(P) submit to the Secretary, on an annual

2 basis, a report on the clinical and scientific status of

3 the organ transplantations, and

4 ‘‘(Q) meet such other criteria regarding compli5 ance with this part as the Secretary may establish.’’.

6 SEC. 4. STUDY BY GENERAL ACCOUNTING OFFICE.

7 Section 377 of the Public Health Service Act (42

8 U.S.C. 274f) is amended to read as follows:

9 ‘‘SEC. 377. STUDY BY GENERAL ACCOUNTING OFFICE.

10 ‘‘(a) STUDY.—

11 ‘‘(1) IN GENERAL.—The Comptroller General of

12 the United States shall conduct a study for the pur13 pose of determining and making recommendations

14 concerning—

15 ‘‘(A) the composition of the boards of direc16 tors of organ procurement organizations and of

17 the Organ Procurement and Transplantation

18 Network on the date of enactment of this section,

19 and the effect of the Organ Transplant Program

20 Reauthorization Act of 1993 on the composition

21 and functioning of such boards;

22 ‘‘(B)(i) the number and percentage of

23 cadaveric organ transplants for foreign nationals

24 and nonresident aliens categorized by organ pro25 curement organization and by transplant center
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1 and information on any reciprocal agreements

2 between organ procurement organizations and

3 foreign countries or territories;

4 ‘‘(ii) the number and percent of the organi5 zations referred to in clause (i) above the organ

6 procurement transplant network guideline of 10

7 percent; and

8 ‘‘(III) any information on the current rate

9 of organ donation by individuals other than

10 United States citizens or legal residents;

11 ‘‘(C) organ donation rates and the impact

12 of various organ allocation systems on organ

13 procurement rates; and

14 ‘‘(D) the equitable allocation of organs na15 tionwide, including an analysis of the relative

16 probability of receiving an organ for patients

17 with similar characteristics for each category of

18 transplanted organ by organ procurement orga19 nization and recommendations for developing a

20 regional allocation system in order to ensure

21 that—

22 ‘‘(i) patients in one region have an

23 equivalent probability of receiving an organ

24 as do patients with similar characteristics

25 in another region; and
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1 ‘‘(ii) patients within a region have an

2 equivalent probability of receiving an organ

3 as do other patients with similar character4 istics in that region.

5 ‘‘(2) EQUITABLE ALLOCATION.—In carrying out

6 paragraph (1) with respect to subparagraph (D), the

7 Comptroller General shall—

8 ‘‘(A) recommend regions for allocating or9 gans to encompass as large a geographic area as

10 is practical, taking into account medical appro11 priateness, and the geographic proximity of pa12 tients with comparable priority for receiving an

13 organ;

14 ‘‘(B) take into account the impact on organ

15 donation and procurement rates; and

16 ‘‘(C) consult with experts in the area of organ al17 location and organ donations and consider their rec18 ommendations regarding the establishment of regions

19 in the country for the purpose of allocating organs.

20 ‘‘(b) REPORT.—Not later than 2 years after the date

21 of enactment of the Organ Transplant Program Reauthor22 ization Act of 1993, the Comptroller General of the United

23 States shall complete the study required under subsection

24 (a) and prepare and submit to the Committee on Energy

25 and Commerce of the House of Representatives, and to the
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1 Committee on Labor and Human Resources of the Senate,

2 a report describing the findings made as a result of the

3 study.’’.

4 SEC. 5. GENERAL PROVISIONS.

5 (a) LIMITATION.—Section 374(b) of the Public Health

6 Service Act (42 U.S.C. 274b(b)) is amended—

7 (1) by striking paragraph (2);

8 (2) by redesignating paragraph (3) as para9 graph (2); and

10 (3) in paragraph (2) (as so redesignated), by

11 striking ‘‘371(a)(3)’’ and inserting ‘‘371(a)(2)’’.

12 (b) REPEAL.—Section 376 of the Public Health Service

13 Act (42 U.S.C. 274d) is repealed.

14 (c) TRANSFER.—Section 378 of the Public Health

15 Service Act (42 U.S.C. 274g) is amended—

16 (1) by transferring such section to part H of title

17 III; and

18 (2) by inserting such section after section 377.

19 (d) AUTHORIZATION OF APPROPRIATIONS.—Section

20 378 of the Public Health Service Act (42 U.S.C. 274g) is

21 amended by striking ‘‘1991’’ and all that follows through

22 the period and inserting ‘‘1994, and such sums as may be

23 necessary for each of the fiscal years 1995 and 1996.’’.
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1 SEC. 6. EFFECTIVE DATES.

2 (a) IN GENERAL.—Except as provided in subsection

3 (b), the amendments made by this Act shall become effective

4 on the date of enactment of this Act.

5 (b) EXCEPTION.—The amendments made by section

6 2(b)(4)(C) shall become effective 9 months after the date of

7 enactment of this Act. Prior to such date, section

8 371(b)(3)(E) of the Public Health Service Act, as in effect

9 on the day before the date of the enactment of this Act, shall

10 remain in effect.