I

103D CONGRESS

1ST SESSION H. R. 2659

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

relating to the transplantation of organs and of bone marrow.

IN THE HOUSE OF REPRESENTATIVES

JULY 15, 1993

Mr. WAXMAN (for himself, Mr. HALL of Texas, Mr. ROWLAND, Mr. TOWNS,

Mr. UPTON, Mr. KLUG, and Mr. FRANKS of Connecticut) introduced the

following bill; which was referred to the Committee on Energy and Commerce

A BILL

To amend the Public Health Service Act to revise and extend

programs relating to the transplantation of organs and

of bone marrow.

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 and Bone Mar5 row Transplantation Amendments of 1993’’.

6 SEC. 2. ORGAN PROCUREMENT ORGANIZATIONS.

7 (a) IN GENERAL.—Section 371(a) of the Public

8 Health Service Act (42 U.S.C. 273(a)) is amended—

9 (1) by striking paragraphs (2) and (3); and
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1 (2) by inserting after paragraph (1) the follow2 ing paragraph:

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

4 into contracts with, qualified organ procurement organiza5 tions described in subsection (b) and other public or non6 profit private entities for the purpose of—

7 ‘‘(i) planning and conducting programs to pro8 vide information and education to the public on the

9 need for organ donations; and

10 ‘‘(ii) training individuals in requesting such do11 nations.

12 ‘‘(B) In making awards of grants and contracts

13 under subparagraph (A), the Secretary shall give priority

14 to carrying out the purpose described in such subpara15 graph with respect to minority populations.’’.

16 (b) REQUIREMENTS REGARDING QUALIFIED ORGAN

17 PROCUREMENT ORGANIZATIONS.—Section 371(b) of the

18 Public Health Service Act (42 U.S.C. 273(b)) is amend19 ed—

20 (1) in paragraph (1)—

21 (A) in the matter preceding subparagraph

22 (A), by striking ‘‘organization for which grants

23 may be made under subsection (a) is’’ and in24 serting ‘‘organization described in this sub25 section is’’;
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1 (B) in subparagraph (E), by moving the

2 subparagraph 2 ems to the left; and

3 (C) in subparagraph (G)—

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

5 by striking ‘‘has a board of directors or an

6 advisory board which’’ and inserting the

7 following: ‘‘has a board of directors (or an

8 advisory board, in the case of a hospital9 based organization) which’’; and

10 (ii) in clause (i)(II), by striking

11 ‘‘members’’ and all that follows and insert12 ing the following: ‘‘both individuals who

13 have received a transplant of an organ,

14 and individuals who are part of the family

15 of an individual who has donated an organ,

16 which individuals shall constitute not less

than 1 17 ⁄3 of the membership of the board

18 and which members shall, to the extent

19 practicable, be residents of the service area

20 involved,’’; and

21 (2) in paragraph (3)—

22 (A) in subparagraph (A), by striking ‘‘have

23 effective agreements’’ and all that follows and

24 inserting the following: ‘‘with respect to each

25 hospital or other entity in its service area that
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1 has facilities for organ donations, have an effec2 tive agreement with the entity under which the

3 entity identifies potential organ donors and no4 tifies the organ procurement organization,’’;

5 (B) in subparagraph (E), by inserting be6 fore the comma at the end the following: ‘‘,

7 which system shall allocate each type of organ

8 on the basis of a single list, maintained exclu9 sively by the organ procurement organization,

10 of individuals who have been medically referred

11 to a transplant center in the service area of the

12 organization in order to receive a transplant of

13 the type of organ with respect to which the list

14 is maintained, and who are citizens or perma15 nent resident aliens of the United States’’; and

16 (C) in subparagraph (H), by striking ‘‘par17 ticipate’’ and all that follows and inserting the

18 following: ‘‘be a member of, and abide by the

19 rules and requirements of, the Organ Procure20 ment and Transplantation Network established

21 under section 372,’’.

22 SEC. 3. ORGAN PROCUREMENT AND TRANSPLANTATION

23 NETWORK.

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

25 U.S.C. 274(b)) is amended—
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1 (1) in paragraph (1)—

2 (A) in subparagraph (A), by striking

3 ‘‘and’’ after the comma at the end; and

4 (B) by striking subparagraph (B) and in5 serting the following subparagraphs:

6 ‘‘(B) have a board of directors composed of not

7 more than 21 members, whose membership in8 cludes—

9 ‘‘(i) representatives of organ procurement

10 organizations, transplant centers, and voluntary

11 health associations; and

12 ‘‘(ii) both individuals who have received a

13 transplant of an organ, and individuals who are

14 part of the family of an individual who has do15 nated an organ, which individuals shall constitute not less than 1 16 ⁄3 of the membership of

17 the board; and

18 ‘‘(C) establish, through such board of directors,

19 an executive committee and other committees, the

20 chairs of which shall be selected to ensure continuity

21 of leadership for the board.’’; and

22 (2) in paragraph (2)—

23 (A) by striking ‘‘shall—’’ in the matter

24 preceding subparagraph (A) and all that follows
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1 through the end of clause (i) of such subpara2 graph and inserting the following: ‘‘shall—

3 ‘‘(A) establish (in one location or through re4 gional centers)—

5 ‘‘(i) with respect to each type of organ—

6 ‘‘(I) a national list of individuals who

7 have been medically referred to receive a

8 transplant of the type of organ with re9 spect to which the list is maintained and

10 who are citizens or permanent resident

11 aliens of the United States (which list shall

12 include the names of all individuals in13 cluded on lists in effect under section

14 371(b)(3)(E)), and

15 ‘‘(II) a national list of individuals who

16 have been so referred and who are in the

17 United States but are not such citizens or

18 such aliens, and’’; and

19 (B)(i) in subparagraph (J), by striking

20 ‘‘and’’ after the comma at the end;

21 (ii) in subparagraph (K), by striking the

22 period at the end and inserting a comma;

23 (iii) in subparagraph (L), by striking the

24 period at the end and inserting a comma; and
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1 (iv) by adding at the end the following sub2 paragraphs:

3 ‘‘(M) establish the condition that, with respect

4 to the type of organ involved, the list under

5 subclause (II) of subparagraph (A)(i) may be consid6 ered in allocating an organ only if no individual on

7 the list under subclause (I) of such subparagraph is

8 a medically appropriate recipient for the organ,

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),

13 ‘‘(O) make available to the Secretary such in14 formation, books, and records regarding the Net15 work as the Secretary may require, and

16 ‘‘(P) meet such criteria regarding compliance

17 with this part as the Secretary may establish.’’.

18 SEC. 4. NATIONAL BONE MARROW DONOR REGISTRY.

19 (a) IN GENERAL.—

20 (1) TRANSFER OF PROGRAM.—Section 379(a)

21 of the Public Health Service Act (42 U.S.C.

22 274k(a)) is amended in the first sentence by insert23 ing after ‘‘Secretary’’ the following: ‘‘, acting

24 through the Administrator of the Health Resources

25 and Services Administration,’’.
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1 (2) TRANSITIONAL AND SAVINGS PROVISIONS.—

2 (A) With respect to amounts made avail3 able under appropriations Acts for the purpose

4 of carrying out the program transferred pursu5 ant to paragraph (1) from the National Insti6 tutes of Health, the transfer of the program

7 may not be construed as affecting the availabil8 ity of such amounts for such purpose.

9 (B) The Secretary shall ensure that, for

10 fiscal 1994, the number of employees of the De11 partment of Health and Human Services who

12 are engaged in carrying out the program trans13 ferred by paragraph (1) is not less than the

14 number of employees who were so engaged on

15 June 28, 1993.

16 (b) PATIENT ADVOCACY; RECRUITMENT OF DO17 NORS.—Section 379 of the Public Health Service Act (42

18 U.S.C. 274k) is amended—

19 (1) in subsection (b)—

20 (A) in paragraph (2), by striking ‘‘estab21 lish’’ and all that follows and inserting the fol22 lowing: ‘‘establish a program for patient advo23 cacy in accordance with subsection (j);’’; and

24 (B) in paragraph (5), by striking ‘‘recruit’’

25 and all that follows and inserting the following:
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1 ‘‘establish a program for the recruitment of

2 bone marrow donors in accordance with sub3 section (k);’’;

4 (2) by striking subsection (j); and

5 (3) by inserting after subsection (i) the follow6 ing subsections:

7 ‘‘(j) PATIENT ADVOCACY.—For purposes of sub8 section (b)(2), a program for patient advocacy is estab9 lished in accordance with this subsection if—

10 ‘‘(1) the program is headed by a director;

11 ‘‘(2) with respect to the procurement of bone

12 marrow, the program provides that the Director is

13 to serve as an advocate on behalf of—

14 ‘‘(A) individuals who are registered with

15 the Registry to become a recipient of a trans16 plant from a biologically unrelated donor;

17 ‘‘(B) the families of such individuals; and

18 ‘‘(C) the physicians involved;

19 ‘‘(3) the program provides case management

20 services for such individuals, families, and physi21 cians; and

22 ‘‘(4) meets such other criteria as the Secretary

23 may establish.

24 ‘‘(k) RECRUITMENT OF DONORS.—For purposes of

25 subsection (b)(5), a program for the recruitment of bone
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1 marrow donors is established in accordance with this sub2 section if—

3 ‘‘(1) in the case of an individual who is enrolled

4 with the Registry, the program provides for annual

5 (or more frequent) informational mailings to each

6 such individual, which mailings concern the status of

7 the activities of the Registry;

8 ‘‘(2) the program provides for the training of

9 counselors to meet individually with individuals who

10 are so enrolled and who, pursuant to the Registry,

11 have been requested to undergo supplemental testing

12 pursuant to a search for bone marrow for a particu13 lar patient;

14 ‘‘(3) in the case of an individual described in

15 paragraph (2), provide to the individual a general

16 description of the medical condition of the patient

17 involved and an assessment of the possibility that

18 the individual is a medically appropriate donor for

19 the patient;

20 ‘‘(4) with respect to each meeting that, pursu21 ant to the Registry, is held with an individual de22 scribed in paragraph (2), the program provides for

23 the provision to the individual at each such meeting

24 of information regarding the possibility that, if it is

25 determined that it is medically inappropriate for the
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1 individual to be a donor for the patient involved, a

2 sibling of the individual may nevertheless be a medi3 cally appropriate donor for the patient; and

4 ‘‘(5) meets such other criteria as the Secretary

5 may establish.’’.

6 SEC. 5. STUDY BY GENERAL ACCOUNTING OFFICE.

7 (a) IN GENERAL.—Section 379A(a) of the Public

8 Health Service Act (42 U.S.C. 274l(a)) is amended by

9 striking ‘‘conduct’’ in the matter preceding paragraph (1)

10 and all that follows and inserting the following: ‘‘conduct

11 a study for the purpose of—

12 ‘‘(1) assessing the extent to which the program

13 carried out under section 379 maintains the con14 fidentiality of the identity of individuals who are en15 rolled with the Registry;

16 ‘‘(2) assessing the extent to which such individ17 uals cooperate with the Registry when the Registry

18 requests the individuals to undergo supplemental

19 testing regarding the donation of bone marrow;

20 ‘‘(3) assessing, in the case of such individuals

21 who have been determined to be medically appro22 priate donors of bone marrow for the patients in23 volved, the extent to which such individuals are will24 ing to make a donation of bone marrow;
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1 ‘‘(4) assessing the extent to which activities car2 ried out pursuant to section 379(k) provide informa3 tion to the individuals involved that is sufficient for

4 the individuals to make informed decisions regarding

5 the donation of bone marrow;

6 ‘‘(5) assessing the extent to which the case

7 management services provided under section

8 379(j)(3) are effective in assisting patients in receiv9 ing the transplants involved; and

10 ‘‘(6) developing recommendations on improving

11 the program of the Registry, including proposals to

12 increase the number of transplants with successful

13 outcomes while maintaining the confidentiality of the

14 identity of the individuals authorizing the donations

15 of bone marrow.’’.

16 (b) DATE CERTAIN FOR SUBMISSION OF REPORT.—

17 Section 379A(b) of the Public Health Service Act (42

18 U.S.C. 274l(b)) is amended by striking ‘‘1 year’’ and all

19 that follows through ‘‘this part’’ and inserting the follow20 ing: ‘‘2 years after the date of the enactment of the Organ

21 and Bone Marrow Transplantation Amendments of

22 1993’’.
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1 SEC. 6. TRANSFER OF PROGRAMS; MISCELLANEOUS CON2 FORMING AMENDMENTS.

3 (a) IN GENERAL.—The Public Health Service Act

4 (42 U.S.C. 201 et seq.), as amended by the preceding pro5 visions of this Act, is amended—

6 (1) by striking title XVIII;

7 (2)(A) by transferring sections 371 through

8 377 from the current placement of such sections;

9 (B) by redesignating such sections as sections

10 1801 through 1807, respectively;

11 (C) by inserting such sections, in the appro12 priate sequence, after title XVII; and

13 (D) by inserting before section 1801 (as so re14 designated) the following:

15 ‘‘TITLE XVIII—TRANSPLANTATION OF ORGANS

16 AND OF BONE MARROW

17 ‘‘PART A—ORGAN TRANSPLANTATION’’;

18 (3)(A) by striking section 378;

19 (B) by transferring sections 379 and 379A

20 from the current placement of such sections;

21 (C) by redesignating such sections as sections

22 1811 and 1813, respectively;

23 (D) by inserting such sections, in the appro24 priate sequence, at the end of title XVIII (as so des25 ignated); and
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1 (E) by inserting before section 1811 (as so re2 designated) the following:

3 ‘‘PART B—NATIONAL BONE MARROW DONOR

4 REGISTRY’’; and

5 (4) in title III (as amended by section

6 2008(i)(2)(B) of Public Law 103–43)—

7 (A) by striking the part designations and

8 headings for each of parts H and I; and

9 (B) by redesignating parts J through M as

10 parts H through K, respectively.

11 (b) CROSS-REFERENCES; OTHER CONFORMING

12 AMENDMENTS.—Title XVIII of the Public Health Service

13 Act, as added by subsection (a) of this section, is amend14 ed—

15 (1) in section 1801(b)(3)—

16 (A) in subparagraph (C), by striking ‘‘sec17 tion 372(b)(2)(E)’’ and inserting ‘‘section

18 1802(b)(2)(E)’’; and

19 (B) in subparagraph (H), by striking ‘‘sec20 tion 372’’ and inserting ‘‘section 1802’’;

21 (2) in section 1802(b)(2)(A)(i)(I), by striking

22 ‘‘section 371(b)(3)(E)’’ and inserting ‘‘section

23 1801(b)(3)(E)’’;

24 (3) in section 1803, by striking ‘‘section 376’’

25 and inserting ‘‘section 1806’’;
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1 (4) in section 1804—

2 (A) in subsection (a), by striking ‘‘section

3 372 or 373’’ and inserting ‘‘section 1802 or

4 1803’’;

5 (B) in subsection (b)—

6 (i) in paragraph (1), by striking ‘‘sec7 tion 371(a)(1)’’ and inserting ‘‘section

8 1801(a)(1)’’;

9 (ii) by striking paragraph (2);

10 (iii) by redesignating paragraph (3) as

11 paragraph (2); and

12 (iv) in paragraph (2) (as so redesig13 nated), by striking ‘‘section 371(a)(3)’’

14 and inserting ‘‘section 1801(a)(2)’’;

15 (C) in subsection (c), by striking ‘‘section

16 371 or 373’’ each place such term appears and

17 inserting ‘‘section 1801 or 1803’’; and

18 (D) in subsection (d)—

19 (i) in paragraph (2), by striking ‘‘sec20 tion 373’’ and inserting ‘‘section 1803’’;

21 and

22 (ii) by adding at the end the following

23 paragraph:

24 ‘‘(3) The term ‘citizens or permanent resident

25 aliens of the United States’ means individuals who
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1 are citizens or nationals of the United States, or

2 who are aliens lawfully admitted for permanent resi3 dence in the United States (or otherwise perma4 nently residing in the United States under color of

5 law).’’;

6 (5) in section 1805(3), by striking ‘‘section

7 372’’ and inserting ‘‘section 1802’’;

8 (6) in section 1811, by striking ‘‘SEC.’’ and all

9 that follows through ‘‘The Secretary’’ in the first

10 sentence in subsection (a) and inserting the follow11 ing:

12 ‘‘NATIONAL REGISTRY

13 ‘‘SEC. 1811. (a) ESTABLISHMENT.—The Secretary’’;

14 and

15 (7) in section 1813—

16 (A) by striking ‘‘SEC.’’ and all that follows

17 through ‘‘The Comptroller General’’ in sub18 section (a) and inserting the following:

19 ‘‘STUDY BY GENERAL ACCOUNTING OFFICE

20 ‘‘SEC. 1813. (a) IN GENERAL.—The Comptroller

21 General’’; and

22 (B) in subsection (a)—

23 (i) in paragraph (1), by striking ‘‘sec24 tion 379’’ and inserting ‘‘section 1811’’;
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1 (ii) in paragraph (4), by striking ‘‘sec2 tion 379(k)’’ and inserting ‘‘section

3 1811(k)’’; and

4 (iii) in paragraph (5), by striking

5 ‘‘section 379(j)(3)’’ and inserting ‘‘section

6 1811(j)(3)’’.

7 SEC. 7. INFORMATION, EDUCATION, AND TRAINING RE8 GARDING TRANSPLANTATION OF BONE MAR9 ROW.

10 Part B of title XVIII of the Public Health Service

11 Act, as added by section 6(a) of this Act, is amended by

12 inserting after section 1811 the following section:

13 ‘‘INFORMATION, EDUCATION, AND TRAINING

14 ‘‘SEC. 1812. (a) IN GENERAL.—The Secretary may

15 make grants to, and enter into contracts with, public or

16 nonprofit private entities for the purpose of—

17 ‘‘(1) planning and conducting programs to pro18 vide information and education to the public on the

19 need for donations of bone marrow; and

20 ‘‘(2) training individuals in requesting such do21 nations.

22 ‘‘(b) PRIORITIES IN MAKING GRANTS.—In making

23 awards of grants and contracts under subsection (a), the

24 Secretary shall give priority to carrying out the purpose

25 described in such subsection with respect to minority pop26 ulations.’’.
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1 SEC. 8. AUTHORIZATION OF APPROPRIATIONS FOR NEW

2 TITLE XVIII.

3 Title XVIII of the Public Health Service Act, as

4 added by section 6(a) of this Act, is amended by adding

5 at the end the following part:

6 ‘‘PART C—GENERAL PROVISIONS

7 ‘‘AUTHORIZATION OF APPROPRIATIONS

8 ‘‘SEC. 1821. For the purpose of carrying out this title

9 (other than section 1801(a)(1)), there are authorized to

10 be appropriated $20,000,000 for fiscal year 1994, and

11 such sums as may be necessary for each of the fiscal years

12 1995 and 1996.’’.

13 SEC. 9. STUDY REGARDING SYSTEM FOR ALLOCATION OF

14 ORGANS.

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

16 Human Services (in this section referred to as the ‘‘Sec17 retary’’) shall conduct a study for the purpose of determin18 ing the feasibility, fairness, and enforceability of allocating

19 organs in the United States based solely upon the clinical

20 need of the patient involved and the viability of the organ

21 involved, with no consideration given to the geographic

22 area in which the transplant is to be performed or the

23 geographic area in which the donation of the organ is

24 made.

25 (b) REPORT.—Not later than 1 year after the date

26 of the enactment of this Act, the Secretary shall submit
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1 to the Committee on Energy and Commerce of the House

2 of Representatives, and to the Committee on Labor and

3 Human Resources of the Senate, a report describing the

4 findings made in the study required in subsection (a).

5 SEC. 10. ISSUANCE OF REGULATIONS.

6 (a) ORGAN PROCUREMENT AND TRANSPLANTATION

7 NETWORK.—

8 (1) IN GENERAL.—

9 (A) Not later than the expiration of the

10 90-day period beginning on the date of the en11 actment of this Act, the Secretary of Health

12 and Human Services (in this section referred to

13 as the ‘‘Secretary’’) shall issue a proposed rule

14 to establish regulations for criteria under part

15 A of title XVIII of the Public Health Service

16 Act (as added by section 6(a) of this Act).

17 (B) Not later than the expiration of the 1-

18 year period beginning on the date of the enact19 ment of this Act, the Secretary shall issue a

20 final rule to establish the regulations described

21 in subparagraph (A).

22 (2) CONSIDERATION OF CERTAIN BYLAWS AND

23 POLICIES.—In developing regulations under para24 graph (1), the Secretary shall consider the bylaws

25 and policies of the United Network for Organ Shar-
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1 ing (established by contract under section 1802 of

2 the Public Health Service Act, as redesignated by

3 section 6(a) of this Act), as contained in the docu4 ment entitled ‘‘Bylaws and Policies of the United

5 Network for Organ Sharing’’.

6 (3) FAILURE TO ISSUE REGULATIONS BY DATE

7 CERTAIN.—If the Secretary fails to issue a final rule

8 under subparagraph (B) of paragraph (1) before the

9 expiration of the period specified in such subpara10 graph—

11 (A) the proposed rule issued under sub12 paragraph (A) of such paragraph is upon such

13 expiration deemed to be the final rule under

14 subparagraph (B) of such paragraph (and shall

15 remain in effect until the Secretary issues a

16 final rule under such subparagraph); or

17 (B) if no such proposed rule is issued be18 fore such expiration, the bylaws and policies

19 specified in paragraph (2) and in effect upon

20 such expiration are deemed to be the final rule

21 under paragraph (1)(B) (and shall remain in

22 effect until the Secretary issues a final rule

23 under such paragraph).

24 (b) NATIONAL BONE MARROW DONOR REGISTRY.—

25 (1) IN GENERAL.—
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1 (A) Not later than the expiration of the

2 90-day period beginning on the date of the en3 actment of this Act, the Secretary shall issue a

4 proposed rule to establish regulations for stand5 ards, criteria, and procedures under part B of

6 title XVIII of the Public Health Service Act (as

7 added by section 6(a) of this Act).

8 (B) Not later than the expiration of the 1-

9 year period beginning the date of the enactment

10 of this Act, the Secretary shall issue a final rule

11 to establish the regulations described in sub12 paragraph (A).

13 (2) CONSIDERATION OF CERTAIN BYLAWS AND

14 POLICIES.—In developing regulations under para15 graph (1), the Secretary shall consider the bylaws

16 and policies of the entity that operates the National

17 Bone Marrow Donor Registry pursuant to a contract

18 under section 1811 of the Public Health Service Act

19 (as redesignated by section 6(a) of this Act).

20 (3) FAILURE TO ISSUE REGULATIONS BY DATE

21 CERTAIN.—If the Secretary fails to issue a final rule

22 under subparagraph (B) of paragraph (1) before the

23 expiration of the period specified in such subpara24 graph—
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1 (A) the proposed rule issued under sub2 paragraph (A) of such paragraph is upon such

3 expiration deemed to be the final rule under

4 subparagraph (B) of such paragraph (and shall

5 remain in effect until the Secretary issues a

6 final rule under such subparagraph); or

7 (B) if no such proposed rule is issued be8 fore such expiration, the bylaws and policies

9 specified in paragraph (2) and in effect upon

10 such expiration are deemed to be the final rule

11 under paragraph (1)(B) (and shall remain in

12 effect until the Secretary issues a final rule

13 under such paragraph).

14 SEC. 11. EFFECTIVE DATES.

15 (a) IN GENERAL.—The amendments described in this

16 Act are made upon the date of the enactment of this Act.

17 Except as provided in subsection (b), such amendments

18 take effect October 1, 1993, or upon the date of the enact19 ment of this Act, whichever occurs later.

20 (b) QUALIFIED ORGAN PROCUREMENT ORGANIZA21 TIONS.—The amendments made by section 2 take effect

22 January 1, 1994. Before such date, section 371 of the

23 Public Health Service Act, as in effect on the day before

24 the date of the enactment of this Act, continues to be in

25 effect.
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