II

103D CONGRESS

1ST 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

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’’.

6 SEC. 2. ORGAN PROCUREMENT ORGANIZATIONS.

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

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

9 amended to read as follows:
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1 ‘‘(a)(1) The Secretary may make grants for the con2 solidation and expansion of qualified organ procurement

3 organizations described in subsection (b).

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

5 into cooperative agreements and contracts with, qualified

6 organ procurement organizations described in subsection

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

8 purpose of increasing organ donation through—

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

10 to provide information and education to the public

11 on the need for organ donations;

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

13 such donations; or

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

15 organ procurement organizations and other entities

16 in the health care system.

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

18 agreements and contracts under subparagraphs (A) and

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

20 carrying out the purpose described in such paragraph with

21 respect to minority or other populations for which there

22 is a greater degree of organ shortages relative to the gen23 eral population.

24 ‘‘(B) In making awards of grants, cooperative agree25 ments and contracts under paragraph (2)(C), the Sec-
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1 retary shall give priority to carrying out the purpose de2 scribed in such paragraph with respect to organ procure3 ment organizations and hospitals with lower rates of pro4 curement relative to other such organizations or hos5 pitals.’’.

6 (b) QUALIFIED ORGAN PROCUREMENT ORGANIZA7 TIONS.—Section 371(b) of such Act (42 U.S.C. 273(b))

8 is amended—

9 (1) in paragraph (1)—

10 (A) in the matter preceding subparagraph

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

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

13 in this section’’;

14 (B) by realigning the margin of subpara15 graph (E) so as to align with the margin of

16 subparagraph (D); and

17 (C) in subparagraph (G)—

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

19 by striking ‘‘directors or an advisory

20 board’’ and inserting ‘‘directors (or an ad21 visory board, in the case of a hospital22 based organ procurement organization es23 tablished prior to September 1, 1993)’’;

24 and

25 (ii) in clause (i)—
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1 (I) by striking ‘‘composed of’’ in

2 the matter preceding subclause (I)

3 and inserting ‘‘composed of a reason4 able balance of’’; and

5 (II) by inserting before the

6 comma in subclause (II) the following:

7 ‘‘, including individuals who have re8 ceived a transplant of an organ (or

9 transplant candidates), and individ10 uals who are part of the family of an

11 individual who has donated an

12 organ’’;

13 (2) by striking paragraph (2);

14 (3) by redesignating paragraph (3) as para15 graph (2);

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

17 (A) by striking subparagraph (A) and in18 serting the following new subparagraph:

19 ‘‘(A) with respect to each hospital or other en20 tity in its service area that has facilities for organ

21 donations, and except as provided in paragraph

22 (3)—

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

24 entity under which the entity, for the purposes

25 of allocation, identifies potential organ donors
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1 and notifies the organ procurement organiza2 tion, and

3 ‘‘(ii) if such hospital or entity is dissatis4 fied with the service obtained from its des5 ignated organ procurement organization such

6 hospital or entity may seek mediation under a

7 process established by the Secretary within 60

8 days after the date of enactment of this sub9 paragraph,’’;

10 (B) by redesignating subparagraphs (B)

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

12 respectively;

13 (C) by inserting after subparagraph (A)

14 the following new subparagraph:

15 ‘‘(B) conduct and participate in systematic ef16 forts, including public education, to increase the

17 number of potential donors,’’;

18 (D) by inserting before the comma in sub19 paragraph (F) (as so redesignated) the follow20 ing: ‘‘, which system shall, at a minimum, allo21 cate each type of organ either on the basis of

22 a single service area list, or an approved alter23 nate local unit list (as defined in paragraph

24 (4)), of individuals who have been medically re25 ferred to a transplant center in the service area
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1 of the organization in order to receive a trans2 plant of the type of organ with respect to which

3 the list is maintained’’;

4 (E) by striking subparagraph (I) (as so re5 designated) and inserting the following new

6 subparagraph:

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

8 requirements of the Organ Procurement and Trans9 plantation Network established under section 372,’’;

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

11 redesignated) and inserting the following new

12 subparagraph:

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

14 Organ Procurement and Transplantation Network

15 established under section 372, on the effectiveness of

16 the organization in acquiring potentially available or17 gans, particularly among minority populations, and

18 the variation of procurement across hospitals within

19 the organ procurement organization region, and

20 identify a plan to increase procurement, particularly

21 among minority populations and other populations

22 for which there is a greater degree of organ short23 ages relative to the general population, and at hos24 pitals with low rates of procurement,’’; and
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1 (G) by adding at the end thereof the fol2 lowing flush sentence:

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

4 an organ procurement organization from requesting that

5 the Secretary permit changes in their service area bound6 aries.’’; and

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

8 new paragraphs:

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

10 that an organ procurement organization have an agree11 ment of the type described in paragraph (2)(A) in effect

12 if—

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

14 service area of the organ procurement organization

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

16 another organ procurement organization; and

17 ‘‘(II) the hospital and organ procurement orga18 nization can demonstrate to the satisfaction of the

19 Secretary that their affiliation is based on an agree20 ment or understanding between the organ procure21 ment organization for the service area in which the

22 hospital is located, and the organ procurement orga23 nization with which the hospital desires to affiliate,

24 and such hospital;
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1 ‘‘(ii) the hospital or other entity within the

2 service area of the organ procurement organization

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

4 another organ procurement organization and can

5 document to the satisfaction of the Secretary, with

6 input from the organ procurement organization for

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

8 ‘‘(I) such hospital or entity has received in9 adequate service from the organ procurement

10 organization for the service area in which the

11 hospital is located; and

12 ‘‘(II) another organ procurement organiza13 tion is willing and able to provide such hospital

14 or entity adequate service; or

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

16 in regulations promulgated by the Secretary.

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

18 within the service area of the organ procurement organiza19 tion with other organ procurement organizations outside

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

21 may continue in effect, pending a determination by the

22 Secretary under the waiver process described in subpara23 graph (A). Not later than 3 months after the date of en24 actment of this paragraph, the hospital or other entity
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1 shall notify the Secretary in writing of its intent to proceed

2 with such an existing relationship.

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

4 conduct a study for the purpose of defining—

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

6 judge the quality of performance of organ procure7 ment organizations;

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

9 inadequate service from an organ procurement orga10 nization; and

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

12 work with an organ procurement organization out13 side its service area.

14 ‘‘(ii) Not later than 1 year after the date of enact15 ment of this paragraph, the Office of Technology Assess16 ment shall complete the study required under clause (i)

17 and prepare and submit to the Committee on Labor and

18 Human Resources of the Senate, the Committee on En19 ergy and Commerce of the House of Representatives, and

20 the Secretary, a report describing the findings made as

21 a result of the study.

22 ‘‘(4)(A) As used in paragraph (2)(F), the term ‘alter23 native local unit’ means—

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

25 organ procurement organizations; or
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1 ‘‘(ii) a subdivision of an organ procurement or2 ganization that operates as a distinct procurement

3 and distribution unit as a result of special geo4 graphic or minority population concerns but that is

5 not composed of any subunit of a metropolitan sta6 tistical area.

7 ‘‘(B) The Organ Procurement and Transplantation

8 Network shall make recommendations to the Secretary

9 concerning the approval or denial of alternative local unit.

10 The Network shall assess whether the alternative local

11 units will better promote organ donation and the equitable

12 allocation of organs.

13 ‘‘(C) The Secretary shall approve or deny any alter14 native local unit principle or designation recommended by

15 the Network. If the Secretary does not provide otherwise

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

17 the date on which the application is submitted, the rec18 ommendations of the Network under subparagraph (B)

19 with respect to the application of the alternative local unit

20 shall go into effect.’’.

21 SEC. 3. ORGAN PROCUREMENT AND TRANSPLANTATION

22 NETWORK.

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

24 U.S.C. 274(b)) is amended—

25 (1) in paragraph (1)(B)—
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1 (A) in clause (i)—

2 (i) by striking ‘‘(including organiza3 tions that have received grants under sec4 tion 371)’’; and

5 (ii) by striking ‘‘and’’ at the end

6 thereof and inserting ‘‘including both indi7 viduals who have received a transplant of

8 an organ (or transplant candidates), and

9 individuals who are part of the family of

10 individuals who have donated an organ, the

11 number of whom shall make up not less

12 than 33 percent of the total number of

13 board members’’; and

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

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

16 (2) in paragraph (2)—

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

18 the following new clause:

19 ‘‘(i) with respect to each type of trans20 plant, a national list of individuals who have

21 been medically referred to receive a transplant

22 of the type of organs with respect to which the

23 list is maintained (which list shall include the

24 names of all individuals included on lists in ef25 fect under section 371(b)(2)(F), and’’;
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1 (B) in subparagraph (B), by inserting ‘‘,

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

3 after ‘‘membership criteria’’;

4 (C) in subparagraph (D), to read as fol5 lows:

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

7 later than September 30, 1994, and implement not

8 later than September 30, 1995, a system of allocat9 ing organs in order to ensure that patients in one

10 region have an equivalent probability of receiving an

11 organ as do patients with similar characteristics in

12 another region,’’;

13 (D) by redesignating subparagraphs (E)

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

15 (M), respectively;

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

17 the following new subparagraph:

18 ‘‘(E) assist organ procurement organizations in

19 the equitable distribution of organs among trans20 plant patients,’’;

21 (F) in subparagraph (K) (as so redesig22 nated), by striking ‘‘and’’ at the end thereof;

23 (G) in subparagraph (L) (as so redesig24 nated), by striking the period and inserting ‘‘,

25 including making recommendations to organ
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1 procurements organizations and the Secretary

2 based on the annual reports required under sec3 tion 371(b)(2)(K),’’;

4 (H) in subparagraph (M) (as so redesig5 nated), by striking the period and inserting a

6 comma; and

7 (I) by adding at the end thereof the follow8 ing new subparagraphs:

9 ‘‘(N) submit to the Secretary for review and ap10 proval any change in the amount of fees imposed by

11 the Network for the registration of individuals on

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

13 change to be considered as approved if the Secretary

14 does not provide otherwise prior to the expiration of

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

16 the change is submitted to the Secretary,

17 ‘‘(O) make available to the Secretary such in18 formation, books, and records regarding the Net19 work as the Secretary may require,

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

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

22 the organ transplantations, and

23 ‘‘(Q) meet such other criteria regarding compli24 ance with this part as the Secretary may establish.’’;

25 and
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1 (3) by adding at the end thereof the following

2 new paragraph:

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

4 Procurement and Transplantation Network shall consult

5 with experts in the area of organ allocation and organ do6 nations and consider their recommendations regarding the

7 establishment of regions in the country for the purpose

8 of allocating organs.’’.

9 SEC. 4. STUDY BY GENERAL ACCOUNTING OFFICE.

10 Section 377 of the Public Health Service Act (42

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

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

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

14 United States shall conduct a study for the purpose of

15 determining and making recommendations concerning—

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

17 of organ procurement organizations and of the

18 Organ Procurement and Transplantation Network

19 on the date of enactment of this section, and the ef20 fect of the Organ Transplant Program Reauthoriza21 tion Act of 1993 on the composition and functioning

22 of such boards;

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

24 organ transplants for foreign nationals categorized
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1 by organ procurement organization and by trans2 plant center;

3 ‘‘(B) the number and percent of the organiza4 tions referred to in subparagraph (A) above the

5 organ procurement transplant network guideline of

6 10 percent; and

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

8 organ donation by individuals other than United

9 States citizens or legal residents;

10 ‘‘(3) the equitable allocation of organs nation11 wide, including an analysis of the relative probability

12 of receiving an organ for patients with similar char13 acteristics for each category of transplanted organ

14 by organ procurement organization and the effect of

15 the Organ Transplant Program Reauthorization Act

16 of 1993 on improving the equitable allocation of or17 gans nationwide.

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

19 of enactment of the Organ Transplant Program Reauthor20 ization Act of 1993, the Comptroller General of the United

21 States shall complete the study required under subsection

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

23 and Commerce of the House of Representatives, and to

24 the Committee on Labor and Human Resources of the
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1 Senate, a report describing the findings made as a result

2 of the study.’’.

3 SEC. 5. GENERAL PROVISIONS.

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

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

6 (1) by striking paragraph (2);

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

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

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

11 (b) REPEAL.—Section 376 of the Public Health Serv12 ice Act (42 U.S.C. 274d) is repealed.

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

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

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

16 title III; and

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

18 (d) AUTHORIZATION OF APPROPRIATIONS.—Section

19 378 of the Public Health Service Act (42 U.S.C. 274g)

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

21 through the period and inserting ‘‘1994, and such sums

22 as may be necessary for each of the fiscal years 1995 and

23 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 effec4 tive on the date of enactment of this Act.

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

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

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

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

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

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

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