[105th Congress Public Law 196]
[From the U.S. Government Printing Office]


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[DOCID: f:publ196.105]


[[Page 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 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.

[[Page 112 STAT. 633]]

        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

[[Page 112 STAT. 634]]

                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).

[[Page 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 
        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

[[Page 112 STAT. 636]]

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

[[Page 112 STAT. 637]]

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:
---------------------------------------------------------------------------

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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