IB
Union Calendar No. 305
105TH CONGRESS
2D SESSION
H. R. 2202
[Report No. 105–538]
To amend the Public Health Service Act to revise and extend the bone
marrow donor program, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
JULY 17, 1997
Mr. YOUNG of Florida (for himself, Mr. BLILEY, Mr. SAXTON, Mr. STOKES,
Mr. HOYER, Mr. HALL of Ohio, Mr. MCDADE, Mr. SHAW, Mr. WATTS
of Oklahoma, Mr. WAXMAN, Mr. HEFLEY, Mr. MOAKLEY, Mr. DELLUMS,
Mr. HILLEARY, Mr. BORSKI, Ms. GRANGER, Mr. HORN, Mr. COBURN,
Mr. HASTINGS of Florida, Mr. THOMPSON, Mr. PICKETT, Mr. MASCARA,
Mr. PETERSON of Minnesota, Mr. THORNBERRY, Mr. GORDON, Mr.
BLUNT, Mr. MCNULTY, Mr. PASTOR, Mr. MORAN of Virginia, Ms. ROS-
LEHTINEN, Mrs. MINK of Hawaii, Ms. EDDIE BERNICE JOHNSON of
Texas, Ms. DUNN, Mr. FALEOMAVAEGA, Mr. CONDIT, Mr. DUNCAN, Mr.
GREENWOOD, Mr. GUTIERREZ, Mr. SHIMKUS, Mr. CLAY, Mr. BOB
SCHAFFER of Colorado, Mr. BOEHLERT, Mr. DEFAZIO, Mr. QUINN, Ms.
NORTON, Mr. CALVERT, Mr. WISE, Ms. PELOSI, Mr. FRELINGHUYSEN,
Mr. FROST, Mrs. LOWEY, Mr. BARTON of Texas, Ms. DELAURO, Mr.
LATHAM, Mr. FOLEY, Mr. SPENCE, Mr. CANADY of Florida, Mr. HIN-
CHEY, Ms. KILPATRICK, Mr. BOYD, Ms. SLAUGHTER, Mr. BONILLA, Mr.
ABERCROMBIE, Mrs. THURMAN, and Mr. PORTER) introduced the follow-
ing bill; which was referred to the Committee on Commerce
MAY 18, 1998
Additional sponsors: Mr. MCCOLLUM, Mr. STARK, Mr. COOK, Mr. SESSIONS,
Mr. SHAYS, Mr. BENTSEN, Mr. HOBSON, Mrs. KELLY, Mr. GONZALEZ,
Mr. DAVIS of Florida, Mr. WALSH, Ms. STABENOW, Mr. MCDERMOTT,
Ms. PRYCE of Ohio, Mr. MARKEY, Mr. DAVIS of Illinois, Mr. CARDIN,
Mr. SKEEN, Mr. CLYBURN, Mr. BILIRAKIS, Ms. MCKINNEY, Mr. GEKAS,
Mr. FATTAH, Mr. GOSS, Mr. KLUG, Mr. YOUNG of Alaska, Mrs.
FOWLER, Mr. BURTON of Indiana, Mr. RANGEL, Mr. KING of New York,
Mr. VISCLOSKY, Mr. OWENS, Mr. MCKEON, Mr. EVANS, Mr. TAYLOR of
Mississippi, Ms. DEGETTE, Ms. RIVERS, Mrs. MORELLA, Ms. LOFGREN,
Mr. WEXLER, Mr. MILLER of Florida, Mr. CRANE, Mr. HYDE, Mr.
BLAGOJEVICH, Mr. NETHERCUTT, Ms. ROYBAL-ALLARD, Mr. KENNEDY
of Rhode Island, Mrs. MCCARTHY of New York, Mr. SCOTT, Mr. BROWN
of California, Mr. PRICE of North Carolina, Mr. MENENDEZ, Mr. FAZIO
of California, Mr. COYNE, Mr. TURNER, Mr. WYNN, Mr. PAYNE, Mr.
HALL of Texas, Mr. CLEMENT, Ms. ESHOO, Mrs. JOHNSON of Connecti-
cut, Mr. ROTHMAN, Mr. MICA, Mr. CALLAHAN, Mr. FORD, Mr. MURTHA,
Mr. STEARNS, Mr. SANDLIN, Mr. CUMMINGS, Mr. KENNEDY of Massa-
chusetts, Mr. LEWIS of California, Mr. SCARBOROUGH, Mr. PACKARD,
Mrs. MEEK of Florida, Mr. TRAFICANT, Ms. KAPTUR, Mr. EHLERS, Mr.
KLECZKA, Ms. FURSE, Mrs. MALONEY of New York, Mr. BONO, Mr.
DICKS, Mr. FOGLIETTA, Mr. RUSH, Mr. LAHOOD, Mr. LEACH, Mr. REG-
ULA, Mr. WOLF, Mr. GIBBONS, Mr. WICKER, Mr. HOUGHTON, Mr.
BALDACCI, Mr. PARKER, Mr. BASS, Mr. DEUTSCH, Mr. SABO, Mr. WATT
of North Carolina, Mr. LOBIONDO, Mr. CONYERS, Mr. BARCIA of Michi-
gan, Mr. EWING, Mr. BARRETT of Wisconsin, Mr. EDWARDS, Mr. LEWIS
of Georgia, Ms. BROWN of Florida, Mr. MATSUI, Mr. GOODLATTE, Mr.
HILLIARD, Mr. BILBRAY, Mr. CHRISTENSEN, Mr. SCHIFF, Mr.
PORTMAN, Mr. GUTKNECHT, Mr. WAMP, Mrs. NORTHUP, Mr. BAESLER,
Mr. MANZULLO, Mr. JENKINS, Ms. MILLENDER-MCDONALD, Mr.
VENTO, Mr. JOHNSON of Wisconsin, Mr. ENSIGN, Mr. DAVIS of Virginia,
Mr. CHABOT, Ms. WOOLSEY, Mr. FILNER, Mr. MOLLOHAN, Mr.
DELAHUNT, Mr. WELDON of Florida, Mrs. MYRICK, Mr. ENGEL, Mr.
BLUMENAUER, Mr. DIXON, Ms. JACKSON-LEE, Mr. BURR of North Caro-
lina, Mr. SMITH of Oregon, Mr. SAWYER, Mr. BISHOP, Mr. BONIOR, Mrs.
CLAYTON, Mr. HINOJOSA, Mr. KUCINICH, Mr. LIPINSKI, Ms. MCCARTHY
of Missouri, Mr. MILLER of California, Mr. NEAL of Massachusetts, Mrs.
CAPPS, Mr. BERMAN, Ms. CARSON, Mr. BROWN of Ohio, Mr. LANTOS,
Ms. LEE, Mr. MCGOVERN, and Mr. JEFFERSON
MAY 18, 1998
Reported with an amendment, committed to the Committee of the Whole
House on the State of the Union and ordered to be printed
[Strike out all after the enacting clause and insert the part printed in italic]
[For text of introduced bill, see copy of bill as introduced on July 17, 1997]
A BILL
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 in-
creasing the number of transplants for recipients suit-
ably 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 fol-
lowing 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 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 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 trans-
plant; 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 unre-
lated 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 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 represen-
tation of racial and ethnic minority groups (includ-
ing 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 Registry
has provided a notice that the potential donor may be
suitably matched to a particular patient (which serv-
ices shall be provided through a mechanism other
than the system of patient advocacy under subsection
(d)), and conduct surveys of donors and potential do-
nors 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, in-
cluding data regarding the furthest stage reached; the
number and percentage of patients who are unable to
complete the search process, and the reasons underly-
ing such circumstances; and comparisons of trans-
plant centers regarding search and other costs that
prior to transplantation are charged to patients by
transplant centers; and’’.
(2) REPORT OF INSPECTOR GENERAL; PLAN RE-
GARDING
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, evalu-
ates, and implements a plan to effectuate efficiencies
in the relationship between such Registry and donor
centers. The plan shall incorporate, to the extent prac-
ticable, 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 redesignat-
ing 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 popu-
lations that are underrepresented among potential do-
nors enrolled with the Registry. In the case of popu-
lations that are identified under the preceding sen-
tence:
‘‘(A) The Registry shall give priority to car-
rying out activities under this part to increase
representation for such populations in order to
enable a member of such a population, to the ex-
tent 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 activi-
ties 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 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 provide
information to physicians, other health care profes-
sionals, and the public regarding the availability, as
a potential treatment option, of receiving a trans-
plant 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 sub-
section:
‘‘(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 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 conduct-
ing, 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 di-
rectly providing to the patient (or family mem-
bers, 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 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 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 com-
plying with standards issued under subsection
(e)(4) for the system for patient advocacy under
this subsection.
‘‘(F) The Office shall ensure that the follow-
ing 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 pa-
tients (or family members, physicians, or other
individuals acting on behalf of patients) to deter-
mine the extent of satisfaction with the system
for patient advocacy under this subsection, and
to identify ways in which the system can be im-
proved.
‘‘(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 information and
education on the process of receiving a trans-
plant 
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 fol-
lowing:
‘‘(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 throughout
the process) to patients and their families and physi-
cians;’’.
(f) REPORT.—Section 379 of the Public Health Service
Act, as amended by subsection (c) of this section, is amend-
ed 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 ‘‘sub-
section (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 transplant of bone
marrow from a biologically unrelated donor.
‘‘(b) INFORMATION.—The scientific registry under sub-
section (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 sci-
entific and clinical status of transplantation involving re-
cipients 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 main-
tained 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).’’.
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 pursu-
ant 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 rep-
resentation of racial and ethnic minority groups (in-
cluding persons of mixed ancestry) among potential
donors of bone marrow who are enrolled with the Reg-
istry, and whether the extent of increase results in a
level of representation that meets the standard estab-
lished 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 rea-
sons underlying such circumstances.
(4) The extent to which the plan required in sec-
tion 2(b)(2) of this Act (relating to the relationship
between the Registry and donor centers) has been im-
plemented.
(5) The extent to which the Registry, donor cen-
ters, donor registries, collection centers, transplant
centers, and other appropriate entities have been com-
plying with the standards, criteria, and procedures
under subsection (e) of such section 379 (as redesig-
nated 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 Service
Act, the Secretary of Health and Human Services shall en-
sure that, not later than 180 days after the effective date
of this Act, such office is in compliance with all require-
ments (established pursuant to the amendment made by sec-
tion 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 enact-
ment 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.
Union Calendar No. 305
105TH CONGRESS
2D SESSION
H. R. 2202
[Report No. 105–538]
A BILL
To amend the Public Health Service Act to revise
and extend the bone marrow donor program, and
for other purposes.
MAY 18, 1998
Reported with an amendment, committed to the Commit-
tee of the Whole House on the State of the Union and
ordered to be printed