National Bone Marrow Registry Reauthorization Act of 1998
PL 105-196 (H.R.2202), enacted 07/16/1998

PUBLIC LAW 105-196—JULY 16, 1998 
112 STAT. 631 
Public Law 105-196 
105th Congress 
An Act 
To amend the Public Health Service Act to revise and extend the bone marrow 
July 16, 1998 
donor program, and for other purposes. 
|jj jj 22021 
Be it enacted by the Senate and House of Representatives of 
the United States of America in Congress assembled, 
National Bone 
Marrow Registry 
SECTION 1. SHORT TITLE. 
Reauthorization 
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Act of 1998. 
This Act may be cited as the National Bone Marrow Registry 
42 USC 201 note. 
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 unre-
lated 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 direc-
tors 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 oif 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 approxi-
mately one-third of the members of the board expire. 
"(4) The membership of the board shall include representa-
tives 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 
112 STAT. 632 
PUBLIC LAW 105-196—JULY 16, 1998 
Transplantation of the Health Resources and Services Adminis-
tration.". 
(b) PROGRAM FOR UNRELATED MARROW TRANSPLANTS.— 
(1) IN GENERAL.—Section 379(b) of the Public Health Serv-
ice Act (42 U.S.C. 274k(b)) is amended by redesignating para-
graph (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 para-
graph (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". 
42 u s e 274k 
(2) 
REPORT OF INSPECTOR GENERAL; PLAN REGARDING 
note. 
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 incor-
porate, to the extent practicable, the findings and recommenda-
tions 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. 
PUBLIC LAW 105-196—JULY 16, 1998 
112 STAT. 633 
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.— 
Establishment. 
"(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 
112 STAT. 634 
PUBLIC LAW 105-196—JULY 16, 1998 
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). 
PUBLIC LAW 105-196-^ULY 16, 1998 
112 STAT. 635 
"(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: 
"(1) 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. 
42 USC 274/. 
"(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 
112 STAT. 636 
PUBLIC LAW 105-196^JULY 16, 1998 
42 use 274g. 
42 use 274m. 
42 use 274k 
note. 
Deadline. 
Deadline. 
42 use 274k 
note. 
under subsection (a). Each such report shall in addition include 
the data required in section 379(1) (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 
PUBLIC LAW 105-196-^ULY 16, 1998 
112 STAT. 637 
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. 
42 USC 274k 
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: 
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.