[105th Congress Public Law 196]
[From the U.S. Government Printing Office]
<DOC>
[DOCID: f:publ196.105]
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Public Law 105-196
105th Congress
An Act
To amend the Public Health Service Act to revise and extend the bone
marrow donor program, and for other purposes. <<NOTE: July 16,
1998 - [H.R. 2202]>>
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress <<NOTE: National Bone Marrow
Registry Reauthorization Act of 1998.>> assembled,
SECTION 1. SHORT <<NOTE: 42 USC 201 note.>> 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 recipients suitably matched to
biologically unrelated donors 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 2
years, and each such member may serve as many as 3 consecutive
2-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 member 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 one-third 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 recipient or family members of a patient who has
requested 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 representatives from the Naval Medical
Research and Development Command and from the Division of Organ
[[Page 112 STAT. 632]]
Transplantation of the Health Resources and Services
Administration.''.
(b) Program for Unrelated Marrow Transplants.--
(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 inserting 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 representation of racial and ethnic minority
groups (including 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 donors 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 Registry has provided a notice
that the potential donor may be suitably matched to a particular
patient (which services shall be provided through a mechanism
other than the system of patient advocacy under subsection (d)),
and conduct surveys of donors and potential donors to determine
the extent of satisfaction with such services and to identify
ways in which the services can be improved;
``(7) with respect to searches for unrelated donors of bone
marrow that are conducted through the system under paragraph
(1), collect and analyze and publish data on the number and
percentage of patients 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 comparisons of transplant centers regarding
search and other costs that prior to transplantation are charged
to patients by transplant centers; and''.
(2) Report <<NOTE: 42 USC 274k note.>> of inspector general;
plan regarding
relationship between registry and donor centers.--The Secretary
of Health and Human Services shall ensure that, not later than 1
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 effectuate efficiencies in the relationship between such
Registry and donor centers. The plan shall incorporate, 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 Inspection.
(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 redesignating 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 Registry shall carry out
a program for the recruitment of bone marrow donors.
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Such program shall identify populations that are
underrepresented among potential 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 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 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 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 paragraph
(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.-- <<NOTE: Establishment.>>
``(1) In general.--The Registry shall establish 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 director.
``(B) The Office shall operate a system for patient
advocacy, which shall be separate from mechanisms for
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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 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
individual) 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
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 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).
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``(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
provision of appropriate information (at the start of the search
process and throughout the process) to patients and their
families 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 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. <<NOTE: 42 USC 274l.>>
``(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
transplant of bone marrow from a biologically unrelated donor.
``(b) Information.--The scientific registry under subsection (a)
shall include information with respect to patients 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 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
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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 <<NOTE: 42 USC 274g.>> 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. <<NOTE: 42 USC 274m.>>
``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. <<NOTE: 42 USC 274k note.>>
(a) In General.--During the period indicated pursuant 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 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 circumstances.
(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 <<NOTE: Deadline.>> 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. <<NOTE: Deadline. 42 USC 274k note.>> 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
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compliance with all requirements (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. <<NOTE: 42 USC 274k note.>> EFFECTIVE DATE.
This Act takes effect October 1, 1998, or upon the date of the
enactment of this Act, whichever occurs later.
Approved July 16, 1998.
LEGISLATIVE HISTORY--H.R. 2202:
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HOUSE REPORTS: No. 105-538 (Comm. on Commerce).
CONGRESSIONAL RECORD, Vol. 144 (1998):
May 19, considered and passed House.
June 24, considered and passed Senate.
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