[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[S. 2150 Introduced in Senate (IS)]







105th CONGRESS
  2d Session
                                S. 2150

 To amend the Public Health Service Act to revise and extend the bone 
             marrow donor program, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              June 9, 1998

 Mr. Frist (for himself, Mr. Kennedy, Mr. Jeffords, Mr. Wellstone, Ms. 
Mikulski, and Mr. Torricelli) introduced the following bill; which was 
 read twice and referred to the Committee on Labor and Human Resources

_______________________________________________________________________

                                 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 Representatives 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 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 
        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 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 
        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, 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 
enactment of this Act, whichever occurs later.
                                 <all>