[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2202 Enrolled Bill (ENR)]
H.R.2202
One Hundred Fifth Congress
of the
United States of America
AT THE SECOND SESSION
Begun and held at the City of Washington on Tuesday,
the twenty-seventh day of January, one thousand nine hundred and ninety-
eight
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 Representatives of the
United States of America in Congress assembled,

3b488f8e3c2a08e11c135e2ddfb98faf53b54ec14bce35020429396fbbf49dde

This Act may be cited as the ``National Bone Marrow Registry
Reauthorization Act of 1998''.

35e82c1cd0608007e808a6056c88ab9d2f06c317d6b9ba642a59b652fcbd76bf

(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 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 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. 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.--
``(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 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).
``(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)''.

b1d1e05bda549078e45aca5207845cd2e26eb898c5eb4fd294d746b37a7cecaf

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
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 under subsection
(a). Each such report shall in addition include the data required in
section 379(l) (relating to pretransplant costs).''.

1329c53bc17972c9022e838e853696e071d948a672d3fd738ec6cbfc9db38b01

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.''.

888301711519faa35bd7e78a2fb50fac4b7031f54e99fc777a4fa26f0dccdee0

(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 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.

9401eec06ad85115f27c3675db177d1a1ceafe33be47afdb3015a5cabb183496

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 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.

ba2cb929735520a5113dd809e313b1de0c003c0db4633d1fddcdbfbb628c4430

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.

067df6efd306820ec47076072985867eb19088cb1312426f001ffa5f28050fb9

National Bone Marrow Registry Reauthorization Act of 1998 — HR. 2202

Other Sections

Want the full experience?