National Bone Marrow Registry Reauthorization Act of 1998

Summary: National Bone Marrow Registry Reauthorization Act of 1998 - Amends the Public Health Service Act to set forth the purpose of the National Bone Marrow Donor Registry and impose requirements regarding its board of directors. 
Sets forth program functions, including regarding collection, analysis, and publication of data on donor searches. 
Mandates implementation of a plan to effectuate efficiencies between the Registry and donor centers. 
Requires the Registry to:  (1) recruit donors; (2) give priority to recruiting populations underrepresented among potential donors; and (3) consider racial and ethnic minority groups underrepresented. 
Requires the Registry to maintain an office of patient advocacy meeting specified requirements, including providing case management. Allows the office to provide information on the process of receiving a bone marrow transplant, including the posttransplant process. 
Mandates maintenance of a scientific registry regarding patients who have received marrow from an unrelated donor. 
Authorizes appropriations to carry out the Registry provisions. 
Mandates a study of the Registry and report to the Congress by the Comptroller General regarding specified aspects of the Registry. 
Directs the Secretary of Health and Human Services, by a specified period after the effective date of this Act, to ensure that the office of patient advocacy (mandated by this Act) is in compliance with certain requirements.

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 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)''.

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 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).''.

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 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.

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 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. 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.