H. R. 2202—3
Such program shall identify populations that are underrep-
resented among potential donors enrolled with the Registry.
In the case of populations that are identified under the preced-
ing sentence:
‘‘(A) The Registry shall give priority to carrying out
activities under this part to increase 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
respect to such populations.
‘‘(2) INFORMATION
AND
EDUCATION
REGARDING
RECRUIT-
MENT; 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 individ-
uals to serve as donors of bone marrow, and shall test
and enroll with the Registry potential donors. Such
information and educational activities shall include the
following:
‘‘(i) Making information available to the general
public, including information describing the needs of
patients with respect to donors of bone marrow.
‘‘(ii) Educating and providing information to
individuals who are willing to serve as potential
donors, including providing updates.
‘‘(iii) Training individuals in requesting individuals
to serve as potential donors.
‘‘(B) PRIORITIES.—In carrying out informational and
educational activities under subparagraph (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 OPTION.—In addition
to activities regarding recruitment, the program under para-
graph (1) shall provide information to physicians, other health
care professionals, and the public regarding the availability,
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 establish and main-
tain 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 director.
‘‘(B) The Office shall operate a system for patient
advocacy, which shall be separate from mechanisms for
H. R. 2202—4
donor advocacy, and which shall serve patients for whom
the Registry is conducting, or has been requested to con-
duct, a search for an unrelated donor of bone marrow.
‘‘(C) In the case of such a patient, the Office 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 subsection (b)(1) to determine
whether the search needs of the patient involved are being
met, including with respect to the following:
‘‘(i) Periodically providing to the patient (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 individ-
ual) if the search has been interrupted or discontinued.
‘‘(iii) Identifying and resolving problems in the
search, to the extent practicable.
‘‘(E) In carrying out subparagraph (C), the Office shall
monitor the system under subsection (b)(1) to determine
whether the Registry, donor centers, transplant centers,
and other entities participating in the Registry program
are complying with standards issued under subsection (e)(4)
for the system for patient advocacy under this subsection.
‘‘(F) The Office shall ensure that the following data
are made available to patients:
‘‘(i) The resources available through the Registry.
‘‘(ii) A comparison of transplant centers regarding
search and other costs that prior to transplantation
are charged to patients by transplant centers.
‘‘(iii) A list of donor registries, transplant centers,
and other entities that meet the applicable standards,
criteria, and procedures under subsection (e).
‘‘(iv) The posttransplant outcomes for individual
transplant centers.
‘‘(v) Such other information as the Registry deter-
mines 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 subsection,
and to identify ways in which the system can be improved.
‘‘(3) CASE MANAGEMENT.—
‘‘(A) IN
GENERAL.—In serving as an advocate for a
patient under paragraph (2), the Office shall provide
individualized case management 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 paragraph (2)(D)
(relating to progress in the search process).
H. R. 2202—5
‘‘(B) POSTSEARCH FUNCTIONS.—In addition 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
information and education on the process of receiving a
transplant of bone marrow, including the posttransplant
process.’’.
(e) CRITERIA, STANDARDS, AND PROCEDURES.—Section 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 advocacy operated
under subsection (d), including standards requiring the provi-
sion of appropriate information (at the start of the search
process and throughout the process) to patients and their fami-
lies and physicians;’’.
(f ) REPORT.—Section 379 of the Public Health Service 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 Secretary the data collected
under subsection (b)(7) on comparisons of transplant centers regard-
ing 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 sci-
entific registry of information relating to patients who have been
recipients of a transplant of bone marrow from a biologically unre-
lated donor.
‘‘(b) INFORMATION.—The scientific registry under subsection (a)
shall include information with respect to patients described in sub-
section (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
donors.
‘‘(c) ANNUAL REPORT
ON PATIENT OUTCOMES.—The Registry
shall annually submit to the Secretary a report concerning patient
outcomes with respect to each transplant center. Each such report
shall use data collected and maintained by the scientific registry
H. R. 2202—6
under subsection (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 current placement
of the section and inserting the section 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 pursuant to sub-
section (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 potential donors of bone marrow who are
enrolled with the Registry, and whether the extent of increase
results 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 unrelated 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 cir-
cumstances.
(4) The extent to which the plan required in section 2(b)(2)
of this Act (relating to the relationship between the Registry
and donor centers) has been implemented.
(5) The extent to which the Registry, donor centers, donor
registries, collection centers, transplant 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 Congress not later
than October 1, 2001. The report may not be submitted before
January 1, 2001.
SEC. 6. COMPLIANCE WITH NEW REQUIREMENTS FOR OFFICE OF
PATIENT ADVOCACY.
With respect to requirements for the office of patient advocacy
under section 379(d) of the Public Health Service 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
H. R. 2202—7
compliance with all requirements (established pursuant to the
amendment made by section 2(d)) that are additional to the require-
ments 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.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.