105TH CONGRESS
2D SESSION
H. R. 2202
AN ACT
To amend the Public Health Service Act to revise
and extend the bone marrow donor program, and
for other purposes.
105TH CONGRESS
2D SESSION
H. R. 2202
AN ACT
To amend the Public Health Service Act to revise and extend
the bone marrow donor program, and for other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘National Bone Marrow
Registry Reauthorization Act of 1998’’.
SEC. 2. REAUTHORIZATION.
(a) ESTABLISHMENT OF REGISTRY.—Section 379(a)
of the Public Health Service Act (42 U.S.C. 274k(a)) is
amended—
(1) by striking ‘‘(referred to in this part as the
‘Registry’) that meets’’ and inserting ‘‘(referred to
in this part as the ‘Registry’) that has the purpose
of increasing the number of transplants for recipi-
ents suitably matched to biologically unrelated do-
nors of bone marrow, and that meets’’;
(2) by striking ‘‘under the direction of a board
of directors that shall include representatives of’’
and all that follows and inserting the following:
‘‘under the direction of a board of directors meeting
the following requirements:
‘‘(1) Each member of the board shall serve for
a term of two years, and each such member may
serve as many as three consecutive two-year terms,
except that such limitations shall not apply to the
Chair of the board (or the Chair-elect) or to the
member of the board who most recently served as
the Chair.
‘‘(2) A member of the board may continue to
serve after the expiration of the term of such mem-
ber until a successor is appointed.
‘‘(3) In order to ensure the continuity of the
board, the board shall be appointed so that each
year the terms of approximately 1⁄3 of the members
of the board expire.
‘‘(4) The membership of the board shall include
representatives of marrow donor centers and marrow
transplant centers; recipients of a bone marrow
transplant; persons who require or have required
such a transplant; family members of such a recipi-
ent or family members of a patient who has re-
quested the assistance of the Registry in searching
for an unrelated donor of bone marrow; persons with
expertise in the social sciences; and members of the
general public; and in addition nonvoting representa-
tives from the Naval Medical Research and Develop-
ment Command and from the Division of Organ
Transplantation of the Health Resources and Serv-
ices Administration.’’.
(b) PROGRAM FOR UNRELATED MARROW TRANS-
PLANTS.—
(1) IN GENERAL.—Section 379(b) of the Public
Health Service Act (42 U.S.C. 274k(b)) is amended
by redesignating paragraph (7) as paragraph (8),
and by striking paragraphs (2) through (6) and in-
serting the following:
‘‘(2) carry out a program for the recruitment of
bone marrow donors in accordance with subsection
(c), including with respect to increasing the rep-
resentation of racial and ethnic minority groups (in-
cluding persons of mixed ancestry) in the enrollment
of the Registry;
‘‘(3) carry out informational and educational
activities in accordance with subsection (c);
‘‘(4) annually update information to account for
changes in the status of individuals as potential do-
nors of bone marrow;
‘‘(5) provide for a system of patient advocacy
through the office established under subsection (d);
‘‘(6) provide case management services for any
potential donor of bone marrow to whom the Reg-
istry has provided a notice that the potential donor
may be suitably matched to a particular patient
(which services shall be provided through a mecha-
nism other than the system of patient advocacy
under subsection (d)), and conduct surveys of donors
and potential donors to determine the extent of sat-
isfaction with such services and to identify ways in
which the services can be improved;
‘‘(7) with respect to searches for unrelated do-
nors of bone marrow that are conducted through the
system under paragraph (1), collect and analyze and
publish data on the number and percentage of pa-
tients at each of the various stages of the search
process, including data regarding the furthest stage
reached; the number and percentage of patients who
are unable to complete the search process, and the
reasons underlying such circumstances; and com-
parisons of transplant centers regarding search and
other costs that prior to transplantation are charged
to patients by transplant centers; and’’.
(2) REPORT
OF
INSPECTOR
GENERAL; PLAN
REGARDING
RELATIONSHIP
BETWEEN
REGISTRY
AND
DONOR
CENTERS.—The Secretary of Health
and Human Services shall ensure that, not later
than one year after the date of the enactment of this
Act, the National Bone Marrow Donor Registry
(under section 379 of the Public Health Service Act)
develops, evaluates, and implements a plan to effec-
tuate efficiencies in the relationship between such
Registry and donor centers. The plan shall incor-
porate, to the extent practicable, the findings and
recommendations made in the inspection conducted
by the Office of the Inspector General (Department
of Health and Human Services) as of January 1997
and known as the Bone Marrow Program Inspec-
tion.
(c) PROGRAM FOR INFORMATION AND EDUCATION.—
Section 379 of the Public Health Service Act (42 U.S.C.
274k) is amended by striking subsection (j), by redesig-
nating subsections (c) through (i) as subsections (e)
through (k), respectively, and by inserting after subsection
(b) the following subsection:
‘‘(c) RECRUITMENT; PRIORITIES; INFORMATION AND
EDUCATION.—
‘‘(1) RECRUITMENT; PRIORITIES.—The Reg-
istry shall carry out a program for the recruitment
of bone marrow donors. Such program shall identify
populations that are underrepresented among poten-
tial donors enrolled with the Registry. In the case of
populations that are identified under the preceding
sentence:
‘‘(A) The Registry shall give priority to
carrying out activities under this part to in-
crease representation for such populations in
order to enable a member of such a population,
to the extent practicable, to have a probability
of finding a suitable unrelated donor that is
comparable to the probability that an individual
who is not a member of an underrepresented
population would have.
‘‘(B) The Registry shall consider racial
and ethnic minority groups (including persons
of mixed ancestry) to be populations that have
been identified for purposes of this paragraph,
and shall carry out subparagraph (A) with re-
spect to such populations.
‘‘(2) INFORMATION AND EDUCATION REGARD-
ING RECRUITMENT; TESTING AND ENROLLMENT.—
‘‘(A) IN GENERAL.—In carrying out the
program under paragraph (1), the Registry
shall carry out informational and educational
activities for purposes of recruiting individuals
to serve as donors of bone marrow, and shall
test and enroll with the Registry potential do-
nors. Such information and educational activi-
ties shall include the following:
‘‘(i) Making information available to
the general public, including information
describing the needs of patients with re-
spect to donors of bone marrow.
‘‘(ii) Educating and providing infor-
mation to individuals who are willing to
serve as potential donors, including provid-
ing updates.
‘‘(iii) Training individuals in request-
ing individuals to serve as potential donors.
‘‘(B) PRIORITIES.—In carrying out infor-
mational and educational activities under sub-
paragraph (A), the Registry shall give priority
to recruiting individuals to serve as donors of
bone marrow for populations that are identified
under paragraph (1).
‘‘(3) TRANSPLANTATION
AS
TREATMENT
OP-
TION.—In addition to activities regarding recruit-
ment, the program under paragraph (1) shall pro-
vide information to physicians, other health care
professionals, and the public regarding the availabil-
ity, as a potential treatment option, of receiving a
transplant of bone marrow from an unrelated
donor.’’.
(d) PATIENT ADVOCACY AND CASE MANAGEMENT.—
Section 379 of the Public Health Service Act (42 U.S.C.
274k), as amended by subsection (c) of this section, is
amended by inserting after subsection (c) the following
subsection:
‘‘(d) PATIENT ADVOCACY; CASE MANAGEMENT.—
‘‘(1) IN GENERAL.—The Registry shall estab-
lish and maintain an office of patient advocacy (in
this subsection referred to as the ‘Office’).
‘‘(2) GENERAL FUNCTIONS.—The Office shall
meet the following requirements:
‘‘(A) The Office shall be headed by a direc-
tor.
‘‘(B) The Office shall operate a system for
patient advocacy, which shall be separate from
mechanisms for donor advocacy, and which
shall serve patients for whom the Registry is
conducting, or has been requested to conduct, a
search for an unrelated donor of bone marrow.
‘‘(C) In the case of such a patient, the Of-
fice shall serve as an advocate for the patient
by directly providing to the patient (or family
members, physicians, or other individuals acting
on behalf of the patient) individualized services
with respect to efficiently utilizing the system
under subsection (b)(1) to conduct an ongoing
search for a donor.
‘‘(D) In carrying out subparagraph (C),
the Office shall monitor the system under sub-
section (b)(1) to determine whether the search
needs of the patient involved are being met, in-
cluding with respect to the following:
‘‘(i) Periodically providing to the pa-
tient (or an individual acting on behalf of
the patient) information regarding donors
who are suitability matched to the patient,
and 
other 
information 
regarding 
the
progress being made in the search.
‘‘(ii) Informing the patient (or such
other individual) if the search has been in-
terrupted or discontinued.
‘‘(iii) Identifying and resolving prob-
lems in the search, to the extent prac-
ticable.
‘‘(E) In carrying out subparagraph (C),
the Office shall monitor the system under sub-
section (b)(1) to determine whether the Reg-
istry, donor centers, transplant centers, and
other entities participating in the Registry pro-
gram are complying with standards issued
under subsection (e)(4) for the system for pa-
tient advocacy under this subsection.
‘‘(F) The Office shall ensure that the fol-
lowing data are made available to patients:
‘‘(i) The resources available through
the Registry.
‘‘(ii) A comparison of transplant cen-
ters regarding search and other costs that
prior to transplantation are charged to pa-
tients by transplant centers.
‘‘(iii) A list of donor registries, trans-
plant centers, and other entities that meet
the applicable standards, criteria, and pro-
cedures under subsection (e).
‘‘(iv) The posttransplant outcomes for
individual transplant centers.
‘‘(v) Such other information as the
Registry determines to be appropriate.
‘‘(G) The Office shall conduct surveys of
patients (or family members, physicians, or
other individuals acting on behalf of patients)
to determine the extent of satisfaction with the
system for patient advocacy under this sub-
section, and to identify ways in which the sys-
tem can be improved.
‘‘(3) CASE MANAGEMENT.—
‘‘(A) IN GENERAL.—In serving as an advo-
cate for a patient under paragraph (2), the Of-
fice shall provide individualized case manage-
ment services directly to the patient (or family
members, physicians, or other individuals acting
on behalf of the patient), including—
‘‘(i) individualized case assessment;
and
‘‘(ii) the functions described in para-
graph (2)(D) (relating to progress in the
search process).
‘‘(B) POSTSEARCH FUNCTIONS.—In addi-
tion to the case management services described
in paragraph (1) for patients, the Office may,
on behalf of patients who have completed the
search for an unrelated donor, provide informa-
tion and education on the process of receiving
a transplant of bone marrow, including the
posttransplant process.’’.
(e) CRITERIA, STANDARDS, AND PROCEDURES.—Sec-
tion 379(e) of the Public Health Service Act (42 U.S.C.
274k), as redesignated by subsection (c) of this section,
is amended by striking paragraph (4) and inserting the
following:
‘‘(4) standards for the system for patient advo-
cacy operated under subsection (d), including stand-
ards requiring the provision of appropriate informa-
tion (at the start of the search process and through-
out the process) to patients and their families and
physicians;’’.
(f) REPORT.—Section 379 of the Public Health Serv-
ice Act, as amended by subsection (c) of this section, is
amended by adding at the end the following subsection:
‘‘(l) ANNUAL REPORT REGARDING PRETRANSPLANT
COSTS.—The Registry shall annually submit to the Sec-
retary the data collected under subsection (b)(7) on com-
parisons of transplant centers regarding search and other
costs that prior to transplantation are charged to patients
by transplant centers. The data shall be submitted to the
Secretary through inclusion in the annual report required
in section 379A(c).’’.
(g) CONFORMING AMENDMENTS.—Section 379 of the
Public Health Service Act, as amended by subsection (c)
of this section, is amended—
(1) in subsection (f), by striking ‘‘subsection
(c)’’ and inserting ‘‘subsection (e)’’; and
(2) in subsection (k), by striking ‘‘subsection
(c)(5)(A)’’ and inserting ‘‘subsection (e)(5)(A)’’ and
by striking ‘‘subsection (c)(5)(B)’’ and inserting
‘‘subsection (e)(5)(B)’’.
SEC. 3. RECIPIENT REGISTRY.
Part I of title III of the Public Health Service Act
(42 U.S.C. 274k et seq.) is amended by striking section
379A and inserting the following:
‘‘SEC. 379A. BONE MARROW SCIENTIFIC REGISTRY.
‘‘(a) ESTABLISHMENT OF RECIPIENT REGISTRY.—
The Secretary, acting through the Registry under section
379 (in this section referred to as the ‘Registry’), shall
establish and maintain a scientific registry of information
relating to patients who have been recipients of a trans-
plant of bone marrow from a biologically unrelated donor.
‘‘(b) INFORMATION.—The scientific registry under
subsection (a) shall include information with respect to pa-
tients described in subsection (a), transplant procedures,
and such other information as the Secretary determines
to be appropriate to conduct an ongoing evaluation of the
scientific and clinical status of transplantation involving
recipients of bone marrow from biologically unrelated do-
nors.
‘‘(c) ANNUAL REPORT ON PATIENT OUTCOMES.—
The Registry shall annually submit to the Secretary a re-
port concerning patient outcomes with respect to each
transplant center. Each such report shall use data col-
lected and maintained by the scientific registry under sub-
section (a). Each such report shall in addition include the
data required in section 379(l) (relating to pretransplant
costs).’’.
SEC. 4. AUTHORIZATION OF APPROPRIATIONS.
Title III of the Public Health Service Act (42 U.S.C.
241 et seq.) is amended—
(1) by transferring section 378 from the cur-
rent placement of the section and inserting the sec-
tion after section 377; and
(2) in part I, by inserting after section 379A
the following section:
‘‘SEC. 379B. AUTHORIZATION OF APPROPRIATIONS.
‘‘For the purpose of carrying out this part, there are
authorized to be appropriated $18,000,000 for fiscal year
1999, and such sums as may be necessary for each of the
fiscal years 2000 through 2003.’’.
SEC. 5. STUDY BY GENERAL ACCOUNTING OFFICE.
(a) IN GENERAL.—During the period indicated pur-
suant to subsection (b), the Comptroller General of the
United States shall conduct a study of the National Bone
Marrow Donor Registry under section 379 of the Public
Health Service Act for purposes of making determinations
of the following:
(1) The extent to which, relative to the effective
date of this Act, such Registry has increased the
representation of racial and ethnic minority groups
(including persons of mixed ancestry) among poten-
tial donors of bone marrow who are enrolled with
the Registry, and whether the extent of increase re-
sults in a level of representation that meets the
standard established in subsection (c)(1)(A) of such
section 379 (as added by section 2(c) of this Act).
(2) The extent to which patients in need of a
transplant of bone marrow from a biologically unre-
lated donor, and the physicians of such patients,
have been utilizing the Registry in the search for
such a donor.
(3) The number of such patients for whom the
Registry began a preliminary search but for whom
the full search process was not completed, and the
reasons underlying such circumstances.
(4) The extent to which the plan required in
section 2(b)(2) of this Act (relating to the relation-
ship between the Registry and donor centers) has
been implemented.
(5) The extent to which the Registry, donor
centers, donor registries, collection centers, trans-
plant centers, and other appropriate entities have
been complying with the standards, criteria, and
procedures under subsection (e) of such section 379
(as redesignated by section 2(c) of this Act).
(b) REPORT.—A report describing the findings of the
study under subsection (a) shall be submitted to the Con-
gress not later than October 1, 2001. The report may not
be submitted before January 1, 2001.
SEC. 6. COMPLIANCE WITH NEW REQUIREMENTS FOR OF-
FICE OF PATIENT ADVOCACY.
With respect to requirements for the office of patient
advocacy under section 379(d) of the Public Health Serv-
ice Act, the Secretary of Health and Human Services shall
ensure that, not later than 180 days after the effective
date of this Act, such office is in compliance with all re-
quirements (established pursuant to the amendment made
by section 2(d)) that are additional to the requirements
that under section 379 of such Act were in effect with
respect to patient advocacy on the day before the date of
the enactment of this Act.
SEC. 7. EFFECTIVE DATE.
This Act takes effect October 1, 1998, or upon the
date of the enactment of this Act, whichever occurs later.
Passed the House of Representatives May 19, 1998.
Attest:
Clerk.