[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2202 Introduced in House (IH)]







105th CONGRESS
  1st Session
                                H. R. 2202

 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. Hinchey, 
Ms. Kilpatrick, Mr. Boyd, Ms. Slaughter, Mr. Bonilla, Mr. Abercrombie, 
Mrs. Thurman, and Mr. Porter) introduced the following bill; which was 
                 referred to the Committee on Commerce

_______________________________________________________________________

                                 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 Marrow Donor Program 
Reauthorization Act of 1997''.

SEC. 2. REVISION AND EXTENSION OF NATIONAL BONE MARROW DONOR PROGRAM.

    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) by amending part I to read as follows:

    ``PART I--NATIONAL BONE MARROW AND BLOOD STEM CELL DONOR PROGRAM

``SEC. 379. ESTABLISHMENT OF NATIONAL PROGRAM.

    ``(a) In General.--The Secretary shall by contract establish a 
program whose purpose is to carry out in accordance with this part a 
system to assist patients who are in need of a transplant of blood stem 
cells in searching for individuals who are biologically unrelated to 
the patients and willing to be donors of such cells.
    ``(b) Administration of Program.--
            ``(1) In general.--The program under subsection (a) 
        (referred to in this part as the `Program') shall be under the 
        general supervision of the Secretary, and under the direction 
        of a board of directors meeting the requirements of section 
        379C(a).
            ``(2) Consultations.--In developing policies affecting the 
        Program, the Secretary shall consult with the board of 
        directors of the Program and with the bone marrow donor program 
        of the Department of the Navy.
    ``(c) Blood Stem Cells; Relation to Bone Marrow.--For purposes of 
subsection (a), the term `blood stem cells' (referred to in this part 
as `stem cells') means hematopoietic cells found in bone marrow, 
umbilical-cord blood, peripheral blood, and such other sources as may 
be identified.

``SEC. 379A. FUNCTIONS OF NATIONAL PROGRAM.

    ``(a) In General.--In providing for the system under section 
379(a), the Program shall carry out the following:
            ``(1) Establish the system through coordinating with 
        entities that operate programs relevant to the purpose 
        described in such section, including the operation of donor and 
        recipient registries, donor centers, collection centers, and 
        transplant centers.
            ``(2) Maintain registries in accordance with subsection 
        (b).
            ``(3) Recruit potential donors of stem cells, and carry out 
        educational activities, in accordance with subsection (c).
            ``(4) Carry out activities for patient advocacy and case 
        management in accordance with subsection (d).
            ``(5) Collect, analyze, and publish data concerning the 
        donation and transplantation of stem cells.
            ``(6) With respect to searches for a biologically unrelated 
        donor of stem cells that are conducted through the system, 
        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 comparative search 
        costs of transplant centers incurred by patients prior to 
        transplantation.
            ``(7) Support studies and demonstration projects for the 
        purpose of increasing the number of individuals, especially 
        individuals who are members of racial or ethnic minority 
        groups, who are willing to be donors of stem cells.
    ``(b) Registries.--
            ``(1) Donor registry.--
                    ``(A) In general.--The Program shall under 
                subsection (a)(2) maintain one or more registries 
                containing information relating to individuals who are 
                willing to be donors of stem cells to biologically 
                unrelated recipients.
                    ``(B) Bone marrow; cord blood.--Information 
                regarding bone marrow, and information regarding 
                umbilical-cord blood, shall be included for purposes of 
                subparagraph (A).
                    ``(C) Monitoring of scientific data.--In carrying 
                out subparagraph (A), the Program shall monitor the 
                available scientific data on the use as a source of 
                stem cells of bone marrow, umbilical-cord blood, 
                peripheral blood, and such other sources as may be 
                identified, and shall consider such data in carrying 
                out subparagraph (A).
                    ``(D) Priority for underrepresented populations.--
                The Program shall identify populations that are 
                underepresented with respect to the information 
                maintained under subparagraph (A). In the case of 
                populations that are identified under the preceding 
                sentence:
                            ``(i) The Program 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.
                            ``(ii) The Program shall consider racial 
                        and ethnic minority groups to be populations 
                        that have been identified for purposes of this 
                        subparagraph, and shall carry out clause (i) 
                        with respect to such populations.
                    ``(E) Annual updating.--The Program shall annually 
                update information under subparagraph (A) to account 
                for changes in the status of individuals as potential 
                donors of stem cells.
            ``(2) Recipient registry.--
                    ``(A) In general.--The Program shall under 
                subsection (a)(2) maintain one or more registries 
                containing--
                            ``(i) information relating to individuals 
                        who have been a recipient of a stem-cell 
                        transplant from a biologically unrelated donor; 
                        and
                            ``(ii) to the extent practicable, 
                        information relating to individuals who have 
                        been a recipient of such a transplant from an 
                        autologous donation or from a biologically 
                        related donor.
                    ``(B) Patient outcomes; annual report.--Information 
                under subparagraph (A) shall include information 
                regarding medical outcomes for patients who have been a 
                recipient of a stem-cell transplant. Such information 
                shall be categorized according to the diseases that 
                necessitated the transplants and according to the 
                transplant centers involved. The Program shall annually 
                submit to the Secretary a report on such medical 
                outcomes.
            ``(3) Additional information.--In addition to the 
        information required in paragraphs (1) and (2) to be included 
        in the registries under such paragraphs, the Program may 
        include in the registries such information as may be 
        appropriate with respect to the purpose described in section 
        379(a) (including information necessary to conduct an ongoing 
        evaluation of the scientific and clinical status of individuals 
        who have been a recipient of a stem-cell transplant from a 
        biologically unrelated donor of such cells).
    ``(c) Educational Activities.--
            ``(1) Recruitment of donors.--
                    ``(A) In general.--The Program shall under 
                subsection (a)(3) carry out activities, including 
                providing information, for purposes of recruiting 
                individuals to serve as donors of stem cells. Such 
                activities shall include testing potential donors, and 
                providing information to update potential donors.
                    ``(B) Priority for underrepresented populations.--
                In carrying out subparagraph (A), the Program shall 
                give priority to recruiting individuals to serve as 
                donors of stem cells for populations that are 
                identified under subsection (b)(1)(D).
            ``(2) Transplantation as treatment option.--The Program 
        shall under subsection (a)(3) provide information to 
        physicians, other health care professionals, and the public 
        regarding the availability as a potential treatment option of 
        receiving a stem-cell transplant from a biologically unrelated 
        donor.
            ``(3) Contracts for educational activities.--The Program 
        may enter into contracts with public and nonprofit private 
        entities for the purpose of assisting the Program in carrying 
        out paragraphs (1) and (2).
    ``(d) Office of Patient Advocacy and Case Management.--
            ``(1) In general.--The Program shall under subsection 
        (a)(4) establish within the Program an office to be known as 
        the Office of Patient Advocacy and Case Management (referred to 
        in this subsection as the `Office'), which shall be headed by a 
        director appointed by the Program.
            ``(2) Functions.--With respect to utilizing the system 
        under section 379(a) to conduct on behalf of patients searches 
        for a biologically unrelated donor of stem cells, the Office 
        shall carry out the following:
                    ``(A) Through coordinating with donor registries, 
                transplant centers, and other entities, carry out under 
                the Program a system for patient advocacy and case 
                management (separate from mechanisms for donor 
                advocacy).
                    ``(B) In the case of patients who (directly or 
                through family members, physicians, or other 
                individuals) request the assistance of the Program, 
                directly provide individualized services with respect 
                to efficiently utilizing the system under section 
                379(a) to conduct an ongoing search (including 
individualized services regarding each stage of the search process).
                    ``(C) In carrying out subparagraph (B) with respect 
                to a patient--
                            ``(i) serve as an advocate on behalf of the 
                        patient; and
                            ``(ii) provide individualized case 
                        management services on behalf of the patient.
                    ``(D) In carrying out subparagraph (B), monitor the 
                system under section 379(a) to determine--
                            ``(i) whether the search needs of patients 
                        are being met (including the periodic provision 
                        to the patient of information regarding donors 
                        who are suitability matched to the patient, and 
                        of other information regarding the progress 
                        being made in the search; informing the patient 
                        if the search has been interrupted or 
                        discontinued; and identifying and resolving 
                        problems in the search, to the extent 
                        practicable); and
                            ``(ii) whether donor registries, transplant 
                        centers, and other entities are complying with 
                        standards issued under section 379B(a)(4) for 
                        the system for patient advocacy and case 
                        management under this subsection.
                    ``(E) Provide for patients the following data:
                            ``(i) The resources available through the 
                        Program.
                            ``(ii) The comparative search costs of 
                        transplant centers incurred by patients prior 
                        to transplantation.
                            ``(iii) A list of donor registries, 
                        transplant centers, and other entities that 
                        meet the applicable standards, criteria, and 
                        procedures under section 379B.
                            ``(iv) The posttransplant outcomes for 
                        individual transplant centers.
                            ``(v) Such other information as the Program 
                        determines to be appropriate.
                    ``(F) Conduct surveys of patients and their 
                families and physicians to determine the extent of 
                satisfaction with the system for patient advocacy and 
                case management under this subsection, and to identify 
                ways in which the system can be improved.
            ``(3) Additional functions.--In addition to the functions 
        established in paragraph (2) for the Office, the Office may, on 
        behalf of patients who have completed the search described in 
        such paragraph, provide information and education on the 
        process of receiving a stem-cell transplant, including the 
        posttransplant process.

``SEC. 379B. CRITERIA, STANDARDS, AND PROCEDURES.

    ``(a) In General.--For the Program and for entities participating 
in the system established under section 379(a) (including individual 
donor centers, donor and recipient registries, collection centers, and 
transplant centers), the Secretary shall with respect to such system 
establish and enforce the following:
            ``(1) Quality standards and standards for tissue typing, 
        obtaining the informed consent of donors, and providing patient 
        advocacy.
            ``(2) Donor selection criteria, based on established 
        medical criteria, to protect both the donor and the recipient 
        and to prevent the transmission of potentially harmful 
        infectious diseases such as the viruses that cause hepatitis 
        and such as the human immunodeficiency virus (commonly known as 
        HIV).
            ``(3) Procedures to ensure the proper collection and 
        transportation of stem cells.
            ``(4) Standards for the system for patient advocacy and 
        case management carried out under section 379A(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.
            ``(5) Standards that accomplish the following:
                    ``(A) Require the establishment of a system of 
                strict confidentiality of records relating to the 
                identity, address, HLA type, and managing donor center 
                for donors and potential donors, including such records 
                that are electronically maintained.
                    ``(B) Prescribe the purposes for which the records 
                described in subparagraph (A) may be disclosed, and the 
                circumstances and extent of the disclosure.
            ``(6) In the case of donor registries and donor centers 
        participating in the system under section 379(a), procedures to 
        ensure the establishment of a method for integrating with the 
        Program the donor files, searches, and general procedures of 
        such registries and centers.
    ``(b) Penalties for Violation of Confidentiality Provisions.--Any 
person who discloses the content of any record referred to in 
subparagraph (A) of subsection (a)(5) without the prior written consent 
of the donor or potential donor with respect to whom the record is 
maintained, or in violation of the standards described in subparagraph 
(B) of such subsection, shall be fined in accordance with title 18, 
United States Code, or imprisoned for not more than 2 years, or both.

``SEC. 379C. GENERAL PROVISIONS.

    ``(a) Board of Directors.--The Program shall under section 
379(b)(1) appoint a board of directors and shall provide for such board 
in accordance with the following:
            ``(1) The membership of the board shall include 
        representatives of donor centers, transplant centers, and blood 
        banks; recipients of a stem-cell transplant; family members of 
        such a recipient or family members of a patient who has 
        requested the assistance of the Program in searching for a 
        biologically unrelated donor of such cells; persons with 
        expertise in the social sciences; and members of the general 
        public.
            ``(2) The Program shall select a member of the board to 
        serve as the Chair of the board.
            ``(3) The term for a member of the board shall be two 
        years, and a member shall not serve for more than three 
        consecutive 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.
            ``(4) Appointments to the board shall be made such that 
        each year the terms of approximately \1/3\ of the members of 
        the board expire.
            ``(5) A member of the board may continue to serve after the 
        expiration of the term of the member until a successor is 
        appointed.
    ``(b) Procedures Regarding Public Comment on Program.--The 
Secretary shall establish and provide information to the public on 
procedures, which may include establishment of a policy advisory 
committee, under which the Secretary shall receive and consider 
comments from interested persons relating to the manner in which the 
Program is carrying out the functions of the Program under section 379A 
and complying with the criteria, standards, and procedures under 
section 379B.
    ``(c) Provisions Regarding Contract for Program.--
            ``(1) Records.--
                    ``(A) Recordkeeping.--Each recipient of a contract 
                or subcontract under section 379(a) shall keep such 
                records as the Secretary shall prescribe, including 
                records that fully disclose the amount and disposition 
                by the recipient of the proceeds of the contract; the 
total cost of the undertaking in connection with which the contract was 
made; and the amount of the portion of the cost of the undertaking 
supplied by other sources; and such other records as will facilitate an 
effective audit.
                    ``(B) Examination of records.--The Secretary and 
                the Comptroller General of the United States shall have 
                access to any books, documents, papers, and records of 
                the recipient of a contract or subcontract entered into 
                under section 379(a) that are pertinent to the 
                contract, for the purpose of conducting audits and 
                examinations.
            ``(2) Awarding of contract.--
                    ``(A) Eligibility.--Entities eligible to receive a 
                contract under section 379(a) include nonprofit private 
                entities.
                    ``(B) Application for contract.--To be eligible to 
                enter into a contract under section 379(a), an entity 
                shall submit to the Secretary and obtain approval of an 
                application submitted at such time and in such manner, 
                and containing such information, as the Secretary shall 
                by regulation prescribe.

``SEC. 379D. AUTHORIZATION OF APPROPRIATIONS.

    For the purpose of carrying out this part, there are authorized to 
be appropriated $18,000,000 for fiscal year 1998, and such sums as may 
be necessary for each of the fiscal years 1999 through 2002.''.

SEC. 3. MISCELLANEOUS PROVISIONS REGARDING NATIONAL BONE MARROW AND 
              BLOOD STEM CELL DONOR PROGRAM.

    (a) Compliance With New Requirements for Office of Patient Advocacy 
and Case Management.--With respect to requirements for the Office of 
Patient Advocacy and Case Management under part I of title III of the 
Public Health Service Act, the Secretary of Health and Human Services 
shall ensure that, not later than 180 days after the date of the 
enactment of this Act, such Office is in compliance with all 
requirements (established pursuant to the amendment made by section 
2(2)) that are additional to the requirements that under such part were 
in effect for the Office on the day before the date of the enactment of 
this Act.
    (b) Plan Regarding Relationship Between National Program 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 Program develops, evaluates, and implements a plan to effectuate 
efficiencies in the relationship between the Program 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. For 
purposes of this subsection, the terms ``Program'' and ``donor center' 
have the meanings applicable to such terms under part I of title III of 
the Public Health Service Act.
    (c) Rule of Construction Regarding National Heart, Lung, and Blood 
Institute.--The provisions of part I of title III of the Public Health 
Service Act may not be construed as having any legal effect on any 
program of research carried out by the National Heart, Lung and Blood 
Institute with respect to blood stem cells (including such cells found 
in umbilical-cord blood).

SEC. 4. EFFECTIVE DATE.

    This Act takes effect October 1, 1997, or upon the date of the 
enactment of this Act, whichever occurs later.
                                 <all>