II

105TH CONGRESS

2D SESSION S. 2150

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

marrow donor program, and for other purposes.

IN THE SENATE OF THE UNITED STATES

JUNE 9, 1998

Mr. FRIST (for himself, Mr. KENNEDY, Mr. JEFFORDS, Mr. WELLSTONE, Ms.

MIKULSKI, and Mr. TORRICELLI) 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

the bone marrow donor program, 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 ‘‘National Bone Marrow

5 Registry Reauthorization Act of 1998’’.

6 SEC. 2. REAUTHORIZATION.

7 (a) ESTABLISHMENT OF REGISTRY.—Section 379(a)

8 of the Public Health Service Act (42 U.S.C. 274k(a)) is

9 amended—
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1 (1) by striking ‘‘(referred to in this part as the

2 ‘Registry’) that meets’’ and inserting ‘‘(referred to

3 in this part as the ‘Registry’) that has the purpose

4 of increasing the number of transplants for recipi5 ents suitably matched to biologically unrelated do6 nors of bone marrow, and that meets’’;

7 (2) by striking ‘‘under the direction of a board

8 of directors that shall include representatives of’’

9 and all that follows and inserting the following:

10 ‘‘under the direction of a board of directors meeting

11 the following requirements:

12 ‘‘(1) Each member of the board shall serve for

13 a term of two years, and each such member may

14 serve as many as three consecutive two-year terms,

15 except that such limitations shall not apply to the

16 Chair of the board (or the Chair-elect) or to the

17 member of the board who most recently served as

18 the Chair.

19 ‘‘(2) A member of the board may continue to

20 serve after the expiration of the term of such mem21 ber until a successor is appointed.

22 ‘‘(3) In order to ensure the continuity of the

23 board, the board shall be appointed so that each

year the terms of approximately 1 24 ⁄3 of the members

25 of the board expire.
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1 ‘‘(4) The membership of the board shall include

2 representatives of marrow donor centers and marrow

3 transplant centers; recipients of a bone marrow

4 transplant; persons who require or have required

5 such a transplant; family members of such a recipi6 ent or family members of a patient who has re7 quested the assistance of the Registry in searching

8 for an unrelated donor of bone marrow; persons with

9 expertise in the social sciences; and members of the

10 general public; and in addition nonvoting representa11 tives from the Naval Medical Research and Develop12 ment Command and from the Division of Organ

13 Transplantation of the Health Resources and Serv14 ices Administration.’’.

15 (b) PROGRAM FOR UNRELATED MARROW TRANS16 PLANTS.—

17 (1) IN GENERAL.—Section 379(b) of the Public

18 Health Service Act (42 U.S.C. 274k(b)) is amended

19 by redesignating paragraph (7) as paragraph (8),

20 and by striking paragraphs (2) through (6) and in21 serting the following:

22 ‘‘(2) carry out a program for the recruitment of

23 bone marrow donors in accordance with subsection

24 (c), including with respect to increasing the rep25 resentation of racial and ethnic minority groups (in-
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1 cluding persons of mixed ancestry) in the enrollment

2 of the Registry;

3 ‘‘(3) carry out informational and educational

4 activities in accordance with subsection (c);

5 ‘‘(4) annually update information to account for

6 changes in the status of individuals as potential do7 nors of bone marrow;

8 ‘‘(5) provide for a system of patient advocacy

9 through the office established under subsection (d);

10 ‘‘(6) provide case management services for any

11 potential donor of bone marrow to whom the Reg12 istry has provided a notice that the potential donor

13 may be suitably matched to a particular patient

14 (which services shall be provided through a mecha15 nism other than the system of patient advocacy

16 under subsection (d)), and conduct surveys of donors

17 and potential donors to determine the extent of sat18 isfaction with such services and to identify ways in

19 which the services can be improved;

20 ‘‘(7) with respect to searches for unrelated do21 nors of bone marrow that are conducted through the

22 system under paragraph (1), collect and analyze and

23 publish data on the number and percentage of pa24 tients at each of the various stages of the search

25 process, including data regarding the furthest stage
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1 reached; the number and percentage of patients who

2 are unable to complete the search process, and the

3 reasons underlying such circumstances; and com4 parisons of transplant centers regarding search and

5 other costs that prior to transplantation are charged

6 to patients by transplant centers; and’’.

7 (2) REPORT OF INSPECTOR GENERAL; PLAN

8 REGARDING RELATIONSHIP BETWEEN REGISTRY

9 AND DONOR CENTERS.—The Secretary of Health

10 and Human Services shall ensure that, not later

11 than one year after the date of the enactment of this

12 Act, the National Bone Marrow Donor Registry

13 (under section 379 of the Public Health Service Act)

14 develops, evaluates, and implements a plan to effec15 tuate efficiencies in the relationship between such

16 Registry and donor centers. The plan shall incor17 porate, to the extent practicable, the findings and

18 recommendations made in the inspection conducted

19 by the Office of the Inspector General (Department

20 of Health and Human Services) as of January 1997

21 and known as the Bone Marrow Program Inspec22 tion.

23 (c) PROGRAM FOR INFORMATION AND EDUCATION.—

24 Section 379 of the Public Health Service Act (42 U.S.C.

25 274k) is amended by striking subsection (j), by redesig-
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1 nating subsections (c) through (i) as subsections (e)

2 through (k), respectively, and by inserting after subsection

3 (b) the following subsection:

4 ‘‘(c) RECRUITMENT; PRIORITIES; INFORMATION AND

5 EDUCATION.—

6 ‘‘(1) RECRUITMENT; PRIORITIES.—The Reg7 istry shall carry out a program for the recruitment

8 of bone marrow donors. Such program shall identify

9 populations that are underrepresented among poten10 tial donors enrolled with the Registry. In the case of

11 populations that are identified under the preceding

12 sentence:

13 ‘‘(A) The Registry shall give priority to

14 carrying out activities under this part to in15 crease representation for such populations in

16 order to enable a member of such a population,

17 to the extent practicable, to have a probability

18 of finding a suitable unrelated donor that is

19 comparable to the probability that an individual

20 who is not a member of an underrepresented

21 population would have.

22 ‘‘(B) The Registry shall consider racial

23 and ethnic minority groups (including persons

24 of mixed ancestry) to be populations that have

25 been identified for purposes of this paragraph,
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1 and shall carry out subparagraph (A) with re2 spect to such populations.

3 ‘‘(2) INFORMATION AND EDUCATION REGARD4 ING RECRUITMENT; TESTING AND ENROLLMENT.—

5 ‘‘(A) IN GENERAL.—In carrying out the

6 program under paragraph (1), the Registry

7 shall carry out informational and educational

8 activities for purposes of recruiting individuals

9 to serve as donors of bone marrow, and shall

10 test and enroll with the Registry potential do11 nors. Such information and educational activi12 ties shall include the following:

13 ‘‘(i) Making information available to

14 the general public, including information

15 describing the needs of patients with re16 spect to donors of bone marrow.

17 ‘‘(ii) Educating and providing infor18 mation to individuals who are willing to

19 serve as potential donors, including provid20 ing updates.

21 ‘‘(iii) Training individuals in request22 ing individuals to serve as potential donors.

23 ‘‘(B) PRIORITIES.—In carrying out infor24 mational and educational activities under sub25 paragraph (A), the Registry shall give priority
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1 to recruiting individuals to serve as donors of

2 bone marrow for populations that are identified

3 under paragraph (1).

4 ‘‘(3) TRANSPLANTATION AS TREATMENT OP5 TION.—In addition to activities regarding recruit6 ment, the program under paragraph (1) shall pro7 vide information to physicians, other health care

8 professionals, and the public regarding the availabil9 ity, as a potential treatment option, of receiving a

10 transplant of bone marrow from an unrelated

11 donor.’’.

12 (d) PATIENT ADVOCACY AND CASE MANAGEMENT.—

13 Section 379 of the Public Health Service Act (42 U.S.C.

14 274k), as amended by subsection (c) of this section, is

15 amended by inserting after subsection (c) the following

16 subsection:

17 ‘‘(d) PATIENT ADVOCACY; CASE MANAGEMENT.—

18 ‘‘(1) IN GENERAL.—The Registry shall estab19 lish and maintain an office of patient advocacy (in

20 this subsection referred to as the ‘Office’).

21 ‘‘(2) GENERAL FUNCTIONS.—The Office shall

22 meet the following requirements:

23 ‘‘(A) The Office shall be headed by a direc24 tor.
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1 ‘‘(B) The Office shall operate a system for

2 patient advocacy, which shall be separate from

3 mechanisms for donor advocacy, and which

4 shall serve patients for whom the Registry is

5 conducting, or has been requested to conduct, a

6 search for an unrelated donor of bone marrow.

7 ‘‘(C) In the case of such a patient, the Of8 fice shall serve as an advocate for the patient

9 by directly providing to the patient (or family

10 members, physicians, or other individuals acting

11 on behalf of the patient) individualized services

12 with respect to efficiently utilizing the system

13 under subsection (b)(1) to conduct an ongoing

14 search for a donor.

15 ‘‘(D) In carrying out subparagraph (C),

16 the Office shall monitor the system under sub17 section (b)(1) to determine whether the search

18 needs of the patient involved are being met, in19 cluding with respect to the following:

20 ‘‘(i) Periodically providing to the pa21 tient (or an individual acting on behalf of

22 the patient) information regarding donors

23 who are suitability matched to the patient,

24 and other information regarding the

25 progress being made in the search.
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1 ‘‘(ii) Informing the patient (or such

2 other individual) if the search has been in3 terrupted or discontinued.

4 ‘‘(iii) Identifying and resolving prob5 lems in the search, to the extent prac6 ticable.

7 ‘‘(E) In carrying out subparagraph (C),

8 the Office shall monitor the system under sub9 section (b)(1) to determine whether the Reg10 istry, donor centers, transplant centers, and

11 other entities participating in the Registry pro12 gram are complying with standards issued

13 under subsection (e)(4) for the system for pa14 tient advocacy under this subsection.

15 ‘‘(F) The Office shall ensure that the fol16 lowing data are made available to patients:

17 ‘‘(i) The resources available through

18 the Registry.

19 ‘‘(ii) A comparison of transplant cen20 ters regarding search and other costs that

21 prior to transplantation are charged to pa22 tients by transplant centers.

23 ‘‘(iii) A list of donor registries, trans24 plant centers, and other entities that meet
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1 the applicable standards, criteria, and pro2 cedures under subsection (e).

3 ‘‘(iv) The posttransplant outcomes for

4 individual transplant centers.

5 ‘‘(v) Such other information as the

6 Registry determines to be appropriate.

7 ‘‘(G) The Office shall conduct surveys of

8 patients (or family members, physicians, or

9 other individuals acting on behalf of patients)

10 to determine the extent of satisfaction with the

11 system for patient advocacy under this sub12 section, and to identify ways in which the sys13 tem can be improved.

14 ‘‘(3) CASE MANAGEMENT.—

15 ‘‘(A) IN GENERAL.—In serving as an advo16 cate for a patient under paragraph (2), the Of17 fice shall provide individualized case manage18 ment services directly to the patient (or family

19 members, physicians, or other individuals acting

20 on behalf of the patient), including—

21 ‘‘(i) individualized case assessment;

22 and

23 ‘‘(ii) the functions described in para24 graph (2)(D) (relating to progress in the

25 search process).
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1 ‘‘(B) POSTSEARCH FUNCTIONS.—In addi2 tion to the case management services described

3 in paragraph (1) for patients, the Office may,

4 on behalf of patients who have completed the

5 search for an unrelated donor, provide informa6 tion and education on the process of receiving

7 a transplant of bone marrow, including the

8 posttransplant process.’’.

9 (e) CRITERIA, STANDARDS, AND PROCEDURES.—Sec10 tion 379(e) of the Public Health Service Act (42 U.S.C.

11 274k), as redesignated by subsection (c) of this section,

12 is amended by striking paragraph (4) and inserting the

13 following:

14 ‘‘(4) standards for the system for patient advo15 cacy operated under subsection (d), including stand16 ards requiring the provision of appropriate informa17 tion (at the start of the search process and through18 out the process) to patients and their families and

19 physicians;’’.

20 (f) REPORT.—Section 379 of the Public Health Serv21 ice Act, as amended by subsection (c) of this section, is

22 amended by adding at the end the following subsection:

23 ‘‘(l) ANNUAL REPORT REGARDING PRETRANSPLANT

24 COSTS.—The Registry shall annually submit to the Sec25 retary the data collected under subsection (b)(7) on com-
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1 parisons of transplant centers regarding search and other

2 costs that prior to transplantation are charged to patients

3 by transplant centers. The data shall be submitted to the

4 Secretary through inclusion in the annual report required

5 in section 379A(c).’’.

6 (g) CONFORMING AMENDMENTS.—Section 379 of the

7 Public Health Service Act, as amended by subsection (c)

8 of this section, is amended—

9 (1) in subsection (f), by striking ‘‘subsection

10 (c)’’ and inserting ‘‘subsection (e)’’; and

11 (2) in subsection (k), by striking ‘‘subsection

12 (c)(5)(A)’’ and inserting ‘‘subsection (e)(5)(A)’’ and

13 by striking ‘‘subsection (c)(5)(B)’’ and inserting

14 ‘‘subsection (e)(5)(B)’’.

15 SEC. 3. RECIPIENT REGISTRY.

16 Part I of title III of the Public Health Service Act

17 (42 U.S.C. 274k et seq.) is amended by striking section

18 379A and inserting the following:

19 ‘‘SEC. 379A. BONE MARROW SCIENTIFIC REGISTRY.

20 ‘‘(a) ESTABLISHMENT OF RECIPIENT REGISTRY.—

21 The Secretary, acting through the Registry under section

22 379 (in this section referred to as the ‘Registry’), shall

23 establish and maintain a scientific registry of information

24 relating to patients who have been recipients of a trans25 plant of bone marrow from a biologically unrelated donor.
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1 ‘‘(b) INFORMATION.—The scientific registry under

2 subsection (a) shall include information with respect to

3 patients described in subsection (a), transplant proce4 dures, and such other information as the Secretary deter5 mines to be appropriate to conduct an ongoing evaluation

6 of the scientific and clinical status of transplantation in7 volving recipients of bone marrow from biologically unre8 lated donors.

9 ‘‘(c) ANNUAL REPORT ON PATIENT OUTCOMES.—

10 The Registry shall annually submit to the Secretary a

11 report concerning patient outcomes with respect to each

12 transplant center. Each such report shall use data col13 lected and maintained by the scientific registry under sub14 section (a). Each such report shall in addition include the

15 data required in section 379(l) (relating to pretransplant

16 costs).’’.

17 SEC. 4. AUTHORIZATION OF APPROPRIATIONS.

18 Title III of the Public Health Service Act (42 U.S.C.

19 241 et seq.) is amended—

20 (1) by transferring section 378 from the cur21 rent placement of the section and inserting the sec22 tion after section 377; and

23 (2) in part I, by inserting after section 379A

24 the following section:
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1 ‘‘SEC. 379B. AUTHORIZATION OF APPROPRIATIONS.

2 ‘‘For the purpose of carrying out this part, there are

3 authorized to be appropriated $18,000,000 for fiscal year

4 1999, and such sums as may be necessary for each of the

5 fiscal years 2000 through 2003.’’.

6 SEC. 5. STUDY BY GENERAL ACCOUNTING OFFICE.

7 (a) IN GENERAL.—During the period indicated pur8 suant to subsection (b), the Comptroller General of the

9 United States shall conduct a study of the National Bone

10 Marrow Donor Registry under section 379 of the Public

11 Health Service Act for purposes of making determinations

12 of the following:

13 (1) The extent to which, relative to the effective

14 date of this Act, such Registry has increased the

15 representation of racial and ethnic minority groups

16 (including persons of mixed ancestry) among poten17 tial donors of bone marrow who are enrolled with

18 the Registry, and whether the extent of increase re19 sults in a level of representation that meets the

20 standard established in subsection (c)(1)(A) of such

21 section 379 (as added by section 2(c) of this Act).

22 (2) The extent to which patients in need of a

23 transplant of bone marrow from a biologically unre24 lated donor, and the physicians of such patients,

25 have been utilizing the Registry in the search for

26 such a donor.
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1 (3) The number of such patients for whom the

2 Registry began a preliminary search but for whom

3 the full search process was not completed, and the

4 reasons underlying such circumstances.

5 (4) The extent to which the plan required in

6 section 2(b)(2) of this Act (relating to the relation7 ship between the Registry and donor centers) has

8 been implemented.

9 (5) The extent to which the Registry, donor

10 centers, donor registries, collection centers, trans11 plant centers, and other appropriate entities have

12 been complying with the standards, criteria, and

13 procedures under subsection (e) of such section 379

14 (as redesignated by section 2(c) of this Act).

15 (b) REPORT.—A report describing the findings of the

16 study under subsection (a) shall be submitted to the Con17 gress not later than October 1, 2001. The report may not

18 be submitted before January 1, 2001.

19 SEC. 6. COMPLIANCE WITH NEW REQUIREMENTS FOR

20 OFFICE OF PATIENT ADVOCACY.

21 With respect to requirements for the office of patient

22 advocacy under section 379(d) of the Public Health Serv23 ice Act, the Secretary of Health and Human Services shall

24 ensure that, not later than 180 days after the effective

25 date of this Act, such office is in compliance with all re-
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1 quirements (established pursuant to the amendment made

2 by section 2(d)) that are additional to the requirements

3 that under section 379 of such Act were in effect with

4 respect to patient advocacy on the day before the date of

5 the enactment of this Act.

6 SEC. 7. EFFECTIVE DATE.

7 This Act takes effect October 1, 1998, or upon the

8 date of enactment of this Act, whichever occurs later.

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