[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[S. 1324 Introduced in Senate (IS)]

  1st Session
                                S. 1324

 To amend the Public Health Service Act to revise and extend the solid-
  organ procurement and transplantation programs, and the bone marrow 
                 donor program, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

             October 17 (legislative day, October 10), 1995

Mrs. Kassebaum (for herself, Mr. Kennedy, and Mr. Frist) 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 solid-
  organ procurement and transplantation programs, and 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 ``Organ and Bone Marrow Transplant 
Program Reauthorization Act of 1995''.

                TITLE I--SOLID-ORGAN TRANSPLANT PROGRAM

SEC. 101. SHORT TITLE.

    This title may be cited as the ``Solid-Organ Transplant Program 
Reauthorization Act of 1995''.

SEC. 102. ORGAN PROCUREMENT ORGANIZATIONS.

    (a) In General.--Subsection (a) of section 371 of the Public Health 
Service Act (42 U.S.C. 273(a)) is amended to read as follows:
    ``(a)(1) The Secretary may enter into cooperative agreements and 
contracts with qualified organ procurement organizations described in 
subsection (b) and other public or nonprofit private entities for the 
purpose of increasing organ donation through approaches such as--
            ``(A) the planning and conducting of programs to provide 
        information and education to the public on the need for organ 
        donations;
            ``(B) the training of individuals in requesting such 
        donations;
            ``(C) the provision of technical assistance to organ 
        procurement organizations and other entities that can 
        contribute to organ donation;
            ``(D) the performance of research and the performance of 
        demonstration programs by organ procurement organizations and 
        other entities that may increase organ donation;
            ``(E) the voluntary consolidation of organ procurement 
        organizations and tissue banks; or
            ``(F) increasing organ donation and access to 
        transplantation with respect to minority populations for which 
        there is a greater degree of organ shortages relative to the 
        general population.
    ``(2)(A) In entering into cooperative agreements and contracts 
under subparagraphs (A) and (B) of paragraph (1), the Secretary shall 
give priority to increasing donations and improving consent rates for 
the purpose described in such paragraph.
    ``(B) In entering into cooperative agreements and contracts under 
paragraph (1)(C), the Secretary shall give priority to carrying out the 
purpose described in such paragraph with respect to increasing 
donations from both organ procurement organizations and hospitals.''.
    (b) Qualified Organ Procurement Organizations.--Section 371(b) of 
such Act (42 U.S.C. 273(b)) is amended--
            (1) in paragraph (1)--
                    (A) in the matter preceding subparagraph (A)--
                            (i) by striking ``for which grants may be 
                        made under subsection (a)'' and inserting 
                        ``described in this section''; and
                            (ii) by striking ``paragraph (2)'' and 
                        inserting ``Paragraph (3)'';
                    (B) by realigning the margin of subparagraph (E) so 
                as to align with the margin of subparagraph (D); and
                    (C) in subparagraph (G)--
                            (i) in the matter preceding clause (i), by 
                        striking ``directors or an advisory board'' and 
                        inserting ``directors (or an advisory board, in 
                        the case of a hospital-based organ procurement 
                        organization established prior to September 1, 
                        1993)''; and
                            (ii) in clause (i)--
                                    (I) by striking ``composed of'' in 
                                the matter preceding subclause (I) and 
                                inserting ``composed of a reasonable 
                                balance of'';
                                    (II) by inserting before the comma 
                                in subclause (II) the following: ``, 
                                including individuals who have received 
                                a transplant of an organ (or transplant 
                                candidates), and individuals who are 
                                part of the family of an individual who 
                                has donated or received an organ or who 
                                is a transplant candidate'';
                                    (III) by striking subclause (IV) 
                                and inserting the following new 
                                subclause:
                            ``(IV) physicians or other health care 
                        professionals with knowledge and skill in the 
                        field of neurology, emergency medicine, or 
                        trauma surgery''; and
                                    (IV) in subclause (V), by striking 
                                ``a member'' and all that follows 
                                through the comma and insert the 
                                following: ``a member who is a surgeon 
                                or physician who has privileges to 
                                practice in such centers and who is 
                                actively and directly involved in 
                                caring for transplant patients,'';
            (2) by striking paragraph (2);
            (3) by redesignating paragraph (3) as paragraph (2);
            (4) in paragraph (2) (as so redesignated)--
                    (A) in subparagraph (A)--
                            (i) by striking ``a substantial majority'' 
                        and inserting ``all'';
                            (ii) by striking ``donation,'' and 
                        inserting ``donation, unless they have been 
                        previously granted by the Secretary a waiver 
                        from paragraph (1)(A) or have waivers pending 
                        under section 1138 of the Social Security 
                        Act''; and
                            (iii) by adding at the end thereof the 
                        following: ``except that the Secretary may 
                        waive the requirements of this subparagraph 
                        upon the request of the organ procurement 
                        organization if the Secretary determines that 
                        such an agreement would not be helpful in 
                        promoting organ donation,'';
                    (B) by redesignating subparagraphs (B) through (K) 
                as subparagraphs (D) through (M), respectively,
                    (C) by inserting after subparagraph (A) the 
                following new subparagraphs:
            ``(B) conduct and participate in systematic efforts, 
        including public education, to increase the number of potential 
        donors, including minority populations for which there is a 
        greater degree of organ shortage than that of the general 
        population,
            ``(C) be a member of and abide by the rules and 
        requirements of the Organ Procurement and Transplantation 
        Network (referred to in this part as the `Network') established 
        under section 372,'';
                    (D) by inserting before the comma in subparagraph 
                (G) (as so redesignated) the following: ``, which 
                system shall, at a minimum, allocate each type of organ 
                on the basis of--
                    ``(i) a single list encompassing the entire service 
                area;
                    ``(ii) a list that encompasses at least an entire 
                State;
                    ``(iii) a list that encompasses an approved 
                alternative local unit (as defined in paragraph (3)) 
                that is approved by the Network and the Secretary, or
                    ``(iv) a list that encompasses another allocation 
                system which has been approved by the Network and the 
                Secretary,
        of individuals who have been medically referred to a transplant 
        center in the service area of the organization in order to 
        receive a transplant of the type of organ with respect to which 
        the list is maintained and had been placed on an organ specific 
        waiting list;'';
                    (E) by inserting before the comma in subparagraph 
                (I) (as so redesignated) the following: ``and work with 
                local transplant centers to ensure that such centers 
                are actively involved with organ donation efforts''; 
                and
                    (F) by inserting after ``evaluate annually'' in 
                subparagraph (L) (as so redesignated) the following 
                ``and submit data to the Network contractor on'' the 
                effectiveness of the organization,''; and
            (5) by adding at the end thereof the following new 
        paragraph:
    ``(3)(A) As used in paragraph (2)(G), the term `alternative local 
unit' means--
            ``(i) a unit composed of two or more organ procurement 
        organizations; or
            ``(ii) a subdivision of an organ procurement organization 
        that operates as a distinct procurement and distribution unit 
        as a result of special geographic, rural, or minority 
        population concerns but that is not composed of any subunit of 
        a metropolitan statistical area.
    ``(B) The Network shall make recommendations to the Secretary 
concerning the approval or denial of alternative local units. The 
Network shall assess whether the alternative local units will better 
promote organ donation and the equitable allocation of organs.
    ``(C) The Secretary shall approve or deny any alternative local 
unit designation recommended by the Network. The Secretary shall have 
60 days, beginning on the date on which the application is submitted to 
the Secretary, to approve or deny the recommendations of the Network 
under subparagraph (B) with respect to the application of the 
alternative local unit.''.
    (c) Affect of Amendments.--The amendments made by subsection (b) 
shall not be construed to affect the provisions of section 1138(a) of 
the Social Security Act (42 U.S.C. 1320b-8(a)).
    (d) Effective Date.--The amendments made by subsection (b) shall 
apply to organ procurement organizations and the Organ Procurement and 
Transplantation Network beginning January 1, 1996.

SEC. 103. ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK.

    (a) Operation.--Subsection (a) of section 372 of the Public Health 
Service Act (42 U.S.C. 274(a)) is amended to read as follows:
    ``(a)(1) Congress finds that--
            ``(A) it is in the public interest to maintain and improve 
        a durable system for promoting and supporting a central network 
        to assist organ procurement organizations in the nationwide 
        distribution of organs among transplant patients;
            ``(B) it is desirable to continue the partnership between 
        public and private enterprise, by continuing to provide Federal 
        Government oversight and assistance for services performed by 
        the Network; and
            ``(C) the Federal Government should actively oversee 
        Network activities to ensure that the policies and procedures 
        of the Network for serving patient and donor families and 
        procuring and distributing organs are fair, efficient and in 
        compliance with all applicable legal rules and standards; 
        however, the initiative and primary responsibility for 
        establishing medical criteria and standards for organ 
        procurement and transplantation stills resides with the 
        Network.
    ``(2) The Secretary shall provide by contract for the operation of 
the Network which shall meet the requirements of subsection (b).
    ``(3) The Network shall be recognized as a private entity that has 
an expertise in organ procurement and transplantation with the primary 
purposes of encouraging organ donation, maintaining a `wait list', and 
operating and monitoring an equitable and effective system for 
allocating organs to transplant recipients, and shall report to the 
Secretary instances of continuing noncompliance with policies (or when 
promulgated, rules) and requirements of the Network.
    ``(4) The Network may assess a fee (to be known as the `patient 
registration fee'), to be collected by the contractor for listing each 
potential transplant recipient on its national organ matching system, 
in an amount which is reasonable and customary and determined by the 
Network and approved as such by the Secretary. The patient registration 
fee shall be calculated so as to be sufficient to cover the Network's 
reasonable costs of operation in accordance with this section. The 
Secretary shall have 60 days, beginning on the date on which the 
written application justifying the proposed fee as reasonable is 
submitted to the Secretary, to provide the Network with a written 
determination and rationale for such determination that the proposed 
increase is not reasonable and customary and that the Secretary 
disapproves the recommendation of the Network under this paragraph with 
respect to the change in fee for listing each potential transplant 
recipient.
    ``(5) Any increase in the patient registration fee shall be limited 
to an increase that is reasonably required as a result of--
            ``(A) increases in the level or cost of contract tasks and 
        other activities related to organ procurement and 
        transplantation; or
            ``(B) decreases in expected revenue from patient 
        registration fees available to the contractor.
The patient registration fees shall not be increased more than once 
during each year.
    ``(6) All fees collected by the Network contractor under paragraph 
(4) shall be available to the Network without fiscal year limitation. 
The contract with the Network contractor shall provide that 
expenditures of such funds (including patient registration fees 
collected by the contractor and or contract funds) are subject to an 
annual audit under the provisions of the Office of Management and 
Budget Circular No. A-133 entitled `Audits of Institutions of Higher 
Learning and Other Nonprofit Institutions' to be performed by the 
Secretary or an authorized auditor at the discretion of the Secretary. 
A report concerning the audit and recommendations regarding 
expenditures shall be submitted to the Network, the contractor, and the 
Secretary.
    ``(7) The Secretary may institute and collect a data management fee 
from transplant hospitals and organ procurement organizations. Such 
fees shall be directed to and shall be sufficient to cover--
            ``(A) the costs of the operation and administration of the 
        Scientific Registry in accordance with the contract under 
        section 373; and
            ``(B) the costs of contracts and cooperative agreements to 
        support efforts to increase organ donation under section 371.
Such data management fee shall be set annually by the Network in an 
amount determined by the Network, in consultation with the Secretary, 
and approved by the Secretary. Such data management fee shall be 
calculated to be sufficient to cover the reasonable costs of operation 
in accordance with section 373. Such data management fee shall be 
calculated based on the number of transplants performed or facilitated 
by each transplant hospital or center, or organ procurement 
organization. The per transplant data management fee shall be divided 
so that the patient specific transplant center will pay 80 percent and 
the procuring organ procurement organization will pay 20 percent of the 
per transplant data management fee. Such fees shall be available to the 
Secretary and the contractor operating the Scientific Registry without 
fiscal year limitation. The expenditure (including fees or contract 
funds) of such fees by the contractor shall be subject to an annual 
independent audit (performed by the Secretary or an authorized auditor 
at the discretion of the Secretary) and reported along with 
recommendations regarding such expenditures, to the Network, the 
contractor and the Secretary.
    ``(8) The Secretary and the Comptroller General shall have access 
to all data collected by the contractor or contractors in carrying out 
its responsibilities under the contract under this section and section 
373.''.
    (b) Requirements.--Section 372(b) of the Public Health Service Act 
(42 U.S.C. 274(b)) is amended--
            (1) in paragraph (1)(B)--
                    (A) in clause (i)--
                            (i) by striking ``(including organizations 
                        that have received grants under section 371)''; 
                        and
                            (ii) by striking ``; and'' at the end 
                        thereof and inserting ``(including both 
                        individuals who have received a transplant of 
                        an organ (or transplant candidates), 
                        individuals who are part of the family of 
                        individuals who have donated or received an 
                        organ, the number of whom shall make up a 
                        reasonable portion of the total number of board 
                        members), and the Division of Organ 
                        Transplantation of the Bureau of Health 
                        Resources Development (the Health Resources and 
                        Services Administration) shall be represented 
                        at all meetings except for those pertaining to 
                        the Network contractor's internal business;'';
                    (B) in clause (ii)--
                            (i) by inserting ``including a patient 
                        affairs committee and a minority affairs 
                        committee'' after ``committees,''; and
                            (ii) by striking the period; and
                    (C) by adding at the end thereof the following new 
                clauses:
                    ``(iii) that shall include representation by a 
                member of the Division of Organ Transplantation of the 
                Bureau of Health Resources Development (the Health 
                Resources and Services Administration) as a 
                representative at all meetings (except for those 
                portions of committee meetings pertaining to the 
                Network contractor's internal business) of all 
                committees (including the executive committee, finance 
                committee, nominating committee, and membership and 
                professional standards committee) under clause (ii);
                    ``(iv) that may include a member from an organ 
                procurement organization on all committees under clause 
                (ii); and
                    ``(v) that may include physicians or other health 
                care professionals with knowledge and skill in the 
                field of neurology, emergency medicine, and trauma 
                surgery on all committees under clause (ii).''; and
            (2) in paragraph (2)--
                    (A) in subparagraph (A)--
                            (i) in the matter preceding clause (i), by 
                        striking ``or through regional centers'' and 
                        inserting ``and at each Organ Procurement 
                        Organization''; and
                            (ii) by striking clause (i) and inserting 
                        the following new clause:
                    ``(i) with respect to each type of transplant, a 
                national list of individuals who have been medically 
                referred to receive a transplant of the type of organs 
                with respect to which the list is maintained (which 
                list shall include the names of all individuals 
                included on lists in effect under section 
                371(b)(2)(G)), and'';
                    (B) in subparagraph (B), by inserting ``, including 
                requirements under section 371(b),'' after ``membership 
                criteria'';
                    (C) by redesignating subparagraphs (E) through (L), 
                as subparagraphs (F) through (M), respectively;
                    (D) by inserting after subparagraph (D), the 
                following new subparagraph:
            ``(E) assist and monitor organ procurement organizations in 
        the equitable distribution of organs among transplant 
        patients,'';
                    (E) in subparagraph (K) (as so redesignated), by 
                striking ``and'' at the end thereof;
                    (F) in subparagraph (L) (as so redesignated), by 
                striking the period and inserting ``, including making 
                recommendations to organ procurements organizations and 
                the Secretary based on data submitted to the Network 
                under section 371(b)(2)(L),'';
                    (G) in subparagraph (M) (as so redesignated)--
                            (i) by striking ``annual'' and inserting 
                        ``biennial'';
                            (ii) by striking ``the comparative costs 
                        and'';
                            (iii) by striking the period and inserting 
                        the following: ``, including survival 
                        information, waiting list information, and 
                        information pertaining to the qualifications 
                        and experience of transplant surgeons and 
                        physicians affiliated with the specific Network 
                        programs,''; and
                    (H) by adding at the end thereof the following new 
                subparagraphs:
            ``(N) submit to the Secretary for approval a written notice 
        containing a justification, as reasonable and customary, of any 
        proposed increase in the patient registration fees as 
        maintained under subparagraph (A)(i), such change to be 
        considered as so approved if the Secretary does not provide 
        written notification otherwise prior to the expiration of the 
        60-day period beginning on the date on which the notice of 
        proposed change is submitted to the Secretary,
            ``(O) make available to the Secretary such information, 
        books, and records regarding the Network as the Secretary may 
        require,
            ``(P) submit to the Secretary, in a manner prescribed by 
        the Secretary, an annual report concerning the scientific and 
        clinical status of organ donation and transplantation, and
            ``(Q) meet such other criteria regarding compliance with 
        this part as the Secretary may establish.''.
    (c) Procedures.--Section 372(c) of the Public Health Service Act 
(42 U.S.C. 274(c)) is amended--
            (1) in paragraph (1), by striking ``and'' at the end 
        thereof;
            (2) in paragraph (2), by striking the period and inserting 
        a semicolon; and
            (3) by adding at the end thereof the following new 
        paragraphs:
            ``(3) working through and with, the Network contractor to 
        define priorities; and
            ``(4) working through, working with, and directing the 
        Network contractor to respond to new emerging issues and 
        problems.''.
    (d) Expansion of Access.--Section 372 of the Public Health Service 
Act (42 U.S.C. 274) is amended by adding at the end thereof the 
following new subsection:
    ``(d) Expansion of Access to Committees and Board of Directors.--
Not later than 1 year after the completion of the Institute of Medicine 
study, the Network contractor, in consultation with the Network and the 
Secretary, shall implement the study recommendations relating to the 
access of all interested constituencies and organizations to membership 
on the Network Board of Directors and all of its committees. Ensuring 
the reasonable mix of minorities shall be a priority of the plan for 
implementation.''.
    (e) Regulations.--
            (1) In general.--Not later than the expiration of the 1-
        year period beginning on the date of enactment of this Act, the 
        Secretary of Health and Human Services shall issue a final rule 
        to establish the regulations for criteria under part H of title 
        III of the Public Health Service Act (42 U.S.C. 273 et seq.).
            (2) Consideration of certain bylaws and policies.--In 
        developing regulations under paragraph (1), the Secretary shall 
        consider the bylaws and policies of the Network.
            (3) Failure to issue regulations by date certain.--
                    (A) In general.--If the Secretary fails to issue a 
                final rule under paragraph (1) prior to the expiration 
                of the period referred to in such paragraph, the notice 
                of proposed rule making issued by the Secretary on 
                September 8, 1994, (which shall be referred to as the 
                ``proposed final rule'') shall be deemed to be the 
                final rule under paragraph (1), and shall remain in 
                effect until the Secretary issues a final rule under 
                such paragraph.
                    (B) Conflict between rule and policy.--Except as 
                otherwise provided in this paragraph, and effective as 
                described in paragraph (1), if the Secretary determines 
                that there is a conflict between the proposed final 
                rule and Network policy, the Secretary shall ensure 
                that the proposed final rule is enforced until the 
                final rule is issued.
                    (C) New policies.--The Secretary shall require that 
                new policies developed after September 8, 1994, (the 
                date of the publication of the ``Notice of Proposed 
                Rule Making'') shall go through the policy development 
                process as described in section 121.3(a)(6) of such 
                ``Notice of Proposed Rule Making''.

SEC. 104. TERMS AND CONDITIONS OF GRANTS AND CONTRACTS.

    Section 374 of the Public Health Service Act (42 U.S.C. 274b) is 
amended--
            (1) in subsection (b)(2), by striking ``two years'' and 
        inserting ``(three years)'';
            (2) in subsection (c)--
                    (A) by redesignating paragraph (1) and (2) as 
                paragraphs (2) and (3), respectively; and
                    (B) by inserting before paragraph (2) (as so 
                redesignated) the following new paragraph:
    ``(1) The Secretary shall annually withhold not to exceed $250,000 
or 10 percent of the amount of the data management fees collected under 
section 372 (whichever is greater) to be used to fund contracts as 
described in section 371.'';
            (3) by redesignating subsection (d) as subsection (e); and
            (4) by adding at the end thereof the following new 
        subsection:
    ``(d) No contract in excess of $25,000 may be made under this part 
using funds withheld under subsection (c)(1) unless an application for 
such contract has been submitted to the Secretary, recommended by the 
Network and approved by the Secretary. Such an application shall be in 
such form and be submitted in such a manner as the Secretary shall 
prescribe.''.

SEC. 105. ADMINISTRATION.

    Section 375 of the Public Health Service Act (42 U.S.C. 274c) is 
amended--
            (1) in section 375 (42 U.S.C. 274c), by inserting before 
        the dash the following: ``oversee the Network, the Scientific 
        Registry and to'';
            (2) in paragraph (3)--
                    (A) by inserting ``and oversight'' after 
                ``assistance'';
                    (B) by striking ``in the health care system''; and
                    (C) by striking ``and'' at the end thereof;
            (3) in paragraph (4), by striking the period and inserting 
        ``; and''; and
            (4) by adding at the end thereof the following new 
        paragraph:
            ``(5) through contract, prepare a triennial organ 
        procurement organization specific data report (the initial 
        report to be completed not later than 18 months after the date 
        of enactment of this paragraph) that includes--
                    ``(A) data concerning the effectiveness of each 
                organ procurement organization in acquiring potentially 
                available organs, particularly among minority 
                populations;
                    ``(B) data concerning the variation of procurement 
                across hospitals within the organ procurement 
                organization region;
                    ``(C) a plan to increase procurement, particularly 
                among minority populations for which there is a greater 
                degree of organ shortages relative to the general 
                population; and
                    ``(D) a plan to increase procurement at hospitals 
                with low rates of procurement.''.

SEC. 106. STUDY AND REPORT.

    Section 377 of the Public Health Service Act (42 U.S.C. 174f) is 
amended to read as follows:

``SEC. 377. STUDY AND REPORT.

    ``(a) Evaluation by the Institute of Medicine.--
            ``(1) In general.--The Secretary shall enter into a 
        contract with a public or nonprofit private entity to conduct a 
        study and evaluation of--
                    ``(A) the role of and the impact of the Federal 
                Government in the oversight and support of solid-organ 
                transplantation, the Network (which on the date of 
                enactment of this section carries out its functions by 
                government contract) and the solid organ 
                transplantation scientific registry; and
                    ``(B) the access of all interested constituencies 
                and organizations to membership on the Network board of 
                directors and all Network committees;
            ``(2) Institute of medicine.--The Secretary shall request 
        the Institute of Medicine of the National Academy of Sciences 
        to enter into the contract under paragraph (1) to conduct the 
        study and evaluation described in such paragraph. If the 
        Institute declines to conduct the study and evaluation under 
        such paragraph, the Secretary shall carry out such activities 
        through another public or nonprofit private entity.
    (b) Report.--Not later than 2 years after the date of enactment of 
this section, the Institute of Medicine (or other entity as the case 
may be) shall complete the study required under subsection (a)(1) and 
prepare and submit to the Committee on Labor and Human Resources of the 
Senate, a report describing the findings made as a result of the 
study.''.

SEC. 107. GENERAL PROVISIONS.

    (a) Contracts.--Section 374 of the Public Health Service Act (42 
U.S.C. 274b) is amended--
            (1) in the section heading, by striking ``GRANTS AND'';
            (2) in subsection (a), by striking ``grant may be made 
        under this part or contract'' and inserting ``contract may 
        be'';
            (3) in subsection (b)--
                    (A) in paragraph (1)--
                            (i) by striking ``grant'' and inserting 
                        ``contract''; and
                            (ii) by striking ``and may not exceed 
                        $100,000'';
                    (B) by striking paragraph (2);
                    (C) by redesignating paragraph (3) as paragraph 
                (2); and
                    (D) in paragraph (2) (as so redesignated)--
                            (i) by striking ``Grants or contracts'' and 
                        inserting ``Contracts''; and
                            (ii) by striking ``371(a)(3)'' and 
                        inserting ``371(a)(2)'';
            (4) in subsection (c)--
                    (A) by striking ``grant or'' each place that such 
                appears; and
                    (B) in paragraph (1), by striking ``grants and''; 
                and
            (5) in subsection (d)(2), by striking ``and for purposes of 
        section 373, such term includes bone marrow''.
    (b) Repeal.--Sections 376 and 378 of the Public Health Service Act 
(42 U.S.C. 274d and 274g) are repealed.

SEC. 108. AUTHORIZATION OF APPROPRIATION.

    Part H of title III of the Public Health Service Act (42 U.S.C. 273 
et seq.) is amended by adding at the end thereof the following new 
section:

``SEC. 378. AUTHORIZATION OF APPROPRIATIONS.

    ``There are authorized to be appropriated to carry out sections 
371, 372, and 373, $1,950,000 for fiscal year 1997, and $1,100,000 for 
fiscal year 1998, and to carry out section 371, $250,000 for each of 
the fiscal years 1999 through 2001.''.

SEC. 109. EFFECTIVE DATES.

    The amendments made by this title shall become effective on the 
date of enactment of this Act.

                  TITLE II--BONE MARROW DONOR PROGRAM

SEC. 201. SHORT TITLE.

    This title may be cited as the ``Bone Marrow Transplantation 
Program Reauthorization Act of 1995''.

SEC. 202. REAUTHORIZATION.

    (a) Establishment of Donor Registry.--Section 379(a) of the Public 
Health Service Act (42 U.S.C. 274k(a)) is amended--
            (1) by striking ```Registry''' and inserting ```Donor 
        Registry''';
            (2) by inserting after the end parenthesis the following: 
        ``the primary purpose of which shall be increasing unrelated 
        donor marrow transplants,''; and
            (2) by adding at the end thereof the following: ``With 
        respect to the board of directors--
            ``(1) each member of the board shall serve for a term of 2 
        years, and each such member may serve as many as three 
        consecutive 2-year terms;
            ``(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) to ensure the continuity of the board, not more than 
        one-third of the board shall be composed of members newly 
        appointed each year;
            ``(4) all appointed and elected positions within committees 
        established by the board shall be for 2-year periods;
            ``(5) the terms of approximately one-third of the members 
        of each such committee will be subject each year to 
        reappointment or replacement;
            ``(6) no individual shall serve more than three consecutive 
        2-year terms on any such committee; and
            ``(7) the board and committees shall be composed of a 
        reasonable balance of representatives of donor centers, 
        transplant centers, blood banks, marrow transplant recipients, 
        individuals who are family members of an individual who has 
        required, received, or is registered with the Donor Registry to 
        become a recipient of a transplant from a biologically 
        unrelated marrow donor, with nonvoting representatives from the 
        Naval Medical Research and Development Command and the Division 
        of Organ Transplantation of the Bureau of Health Resources 
        Development (of the Health Resources and Services 
        Administration).''.
    (b) Program for Unrelated Marrow Transplants.--Section 379(b) of 
such Act (42 U.S.C. 274k(b)) is amended--
            (1) in paragraph (4) to read as follows:
            ``(4) provide information to physicians, other health care 
        professionals, and the public regarding the availability of 
        unrelated marrow transplantation as a potential treatment 
        option;'';
            (2) in paragraph (5) to read as follows:
            ``(5) establish a program for the recruitment of new bone 
        marrow donors that includes--
                    ``(A) the priority to increase minority potential 
                marrow donors for which there is a greater degree of 
                marrow donor shortage than that of the general 
                population; and
                    ``(B) the compilation and distribution of 
                informational materials to educate and update potential 
                donors;'';
            (3) by redesignating paragraphs (6) and (7) as paragraphs 
        (8) and (9), respectively; and
            (4) by inserting after paragraph (5), the following new 
        paragraphs:
            ``(6) annually update the Donor Registry to account for 
        changes in potential donor status;
            ``(7) not later than 1 year after the date on which the 
        `Bone Marrow Program Inspection' (hereafter referred to in this 
        part as the `Inspection') that is being conducted by the Office 
        of the Inspector General on the date of enactment of this 
        paragraph is completed, in consultation with the Secretary, and 
        based on the findings and recommendations of the Inspection, 
        the marrow donor program shall develop, evaluate, and implement 
        a plan to streamline and make more efficient the relationship 
        between the Donor Registry and donor centers;''.
    (c) Information and Education Program.--Section 379 of such Act (42 
U.S.C. 274k) is amended--
            (1) by redesignating subsection (j) as subsection (k); and
            (2) by inserting after subsection (i), the following new 
        subsection:
    ``(j) Information and Education Program.--
            ``(1) In general.--The Secretary may enter into contracts 
        with, public or nonprofit private entities for the purpose of 
        increasing unrelated allogeneic marrow transplants, by enabling 
        such entities to--
                    ``(A) plan and conduct programs to provide 
                information and education to the professional health 
                care community on the availability of unrelated 
                allogeneic marrow transplants as a potential treatment 
                option;
                    ``(B) plan and conduct programs to provide 
                information and education to the public on the need for 
                donations of bone marrow;
                    ``(C) train individuals in requesting bone marrow 
                donations; and
                    ``(D) recruit, test and enroll marrow donors with 
                the priority being minorities for which there is a 
                greater degree of marrow donor shortage than that of 
                the general population.
            ``(2) Priorities.--In awarding contracts under paragraph 
        (1), the Secretary shall give priority to carrying out the 
        purposes described in such paragraph with respect to minority 
        populations.''.
    (d) Patient Advocacy and Case Management.--
            (1) In general.--Section 379 of such Act (42 U.S.C. 274k), 
        as amended by subsection (c), is further amended--
                    (A) by redesignating subsection (k) as subsection 
                (l); and
                    (B) by inserting after subsection (j), the 
                following new subsection:
    ``(k) Patient Advocacy and Case Management.--
            ``(1) Establishment.--The Donor Registry shall establish 
        and maintain an office of patient advocacy and case management 
        that meets the requirements of this subsection.
            ``(2) Functions.--The office established under paragraph 
        (1) shall--
                    ``(A) be headed by a director who shall serve as an 
                advocate on behalf of--
                            ``(i) individuals who are registered with 
                        the Donor Registry to search for a biologically 
                        unrelated bone marrow donor;
                            ``(ii) the physicians involved; and
                            ``(iii) individuals who are included in the 
                        Donor Registry as potential marrow donors.
                    ``(B) establish and maintain a system for patient 
                advocacy that directly assists patients, their 
                families, and their physicians in a search for an 
                unrelated donor;
                    ``(C) provide individual case management services 
                to directly assist individuals and physicians referred 
                to in subparagraph (A), including--
                            ``(i) individualized case assessment and 
                        tracking of preliminary search through 
                        activation (including when the search process 
                        is interrupted or discontinued);
                            ``(ii) informing individuals and physicians 
                        on regular intervals of progress made in 
                        searching for appropriate donors; and
                            ``(iii) identifying and resolving 
                        individual search problems or concerns;
                    ``(D) collect and analyze data concerning the 
                number and percentage of individuals proceeding from 
                preliminary to formal search, formal search to 
                transplantation, the number and percentage of patients 
                unable to complete the search process, and the 
                comparative costs incurred by patients prior to 
                transplant;
                    ``(E) survey patients to evaluate how well such 
                patients are being served and make recommendations for 
                streamlining the search process; and
                    ``(F) provide individual case management services 
                to individual marrow donors.
            ``(3) Evaluation.--
                    ``(A) In general.--The Secretary shall evaluate the 
                system established under paragraph (1) and make 
                recommendations concerning the success or failure of 
                such system in improving patient satisfaction, and any 
                impact the system has had on assisting individuals in 
                proceeding to transplant.
                    ``(B) Report.--Not later than April 1, 1996, the 
                Secretary shall prepare and make available a report 
concerning the evaluation conducted under subparagraph (A), including 
the recommendations developed under such subparagraph.''.
            (2) Donor registry functions.--Section 379(b)(2) of such 
        Act (42 U.S.C. 274k(b)(2)) is amended by striking ``establish'' 
        and all that follows through ``directly assists'' and inserting 
        ``integrate the activities of the patient advocacy and case 
        management office established under subsection (k) with the 
        remaining Donor Registry functions by making available 
        information on (A) the resources available through the Donor 
        Registry Program, (B) the comparative costs incurred by 
        patients prior to transplant, and (C) the marrow donor 
        registries that meet the standards described in paragraphs (3) 
        and (4) of subsection (c), to assist''.
    (e) Study and Reports.--Section 379A of such Act (42 U.S.C. 274l) 
is amended to read as follows:

``SEC. 379A. STUDIES, EVALUATIONS AND REPORTS.

    ``(a) Evaluation by the Institute of Medicine.--
            ``(1) In general.--The Secretary shall enter into a 
        contract with a public or nonprofit private entity to conduct a 
        study and evaluation of--
                    ``(A) the role of a national bone marrow transplant 
                program supported by the Federal Government in 
                facilitating the maximum number of unrelated marrow 
                donor transplants; and
                    ``(B) other possible clinical or scientific uses of 
                the potential donor pool or accompanying information 
                maintained by the Donor Registry or the unrelated 
                marrow donor scientific registry.
            ``(2) Institute of medicine.--The Secretary shall request 
        the Institute of Medicine of the National Academy of Sciences 
        to enter into the contract under paragraph (1) to conduct the 
        study and evaluation described in such paragraph. If the 
        Institute declines to conduct the study and evaluation under 
        such paragraph, the Secretary shall carry out such activities 
        through another public or nonprofit private entity.
            ``(3) Report.--Not later than 2 years after the date of 
        enactment of this section, the Institute of Medicine (or other 
        entity as the case may be) shall complete the study required 
        under paragraph (1) and prepare and submit to the Committee on 
        Labor and Human Resources of the Senate, a report describing 
        the findings made as a result of the study.
    ``(b) Bone Marrow Consolidation.--
            ``(1) In general.--The Secretary shall conduct--
                    ``(A) an evaluation of the feasibility of 
                integrating or consolidating all federally funded bone 
                marrow transplantation scientific registries, 
                regardless of the type of marrow reconstitution 
                utilized; and
                    ``(B) an evaluation of all federally funded bone 
                marrow transplantation research to be conducted under 
                the direction and administration of the peer review 
                system of the National Institutes of Health.
            ``(2) Report.--Not later than 1 year after the date of 
        enactment of this section, the Secretary shall prepare and 
        submit to the Committee on Labor and Human Resources of the 
        Senate a report concerning the evaluations conducted under 
        paragraph (1).
            ``(3) Definition.--As used in paragraph (1), the term 
        `marrow reconstitution' shall encompass all sources of 
        hematopoietic cells including marrow (autologous, related or 
        unrelated allogeneic, syngeneic), autologous marrow, allogeneic 
        marrow (biologically related or unrelated), umbilical cord 
        blood cells, peripheral blood progenitor cells, or other 
        approaches that may be utilized.''.
    (f) Bone Marrow Transplantation Scientific Registry.--Part I of 
title III of such Act (42 U.S.C. 274k et seq.) is amended by adding at 
the end thereof the following new section:

``SEC. 379B. BONE MARROW SCIENTIFIC REGISTRY.

    ``(a) Establishment.--The Secretary, acting through the Donor 
Registry, shall establish and maintain a bone marrow scientific 
registry of all recipients of biologic unrelated allogeneic marrow 
donors.
    ``(b) Information.--The bone marrow transplantation scientific 
registry established under subsection (a) shall include information 
with respect to patients who have received biologic unrelated 
allogeneic marrow transplant, transplant procedures, pretransplant and 
transplant costs, and other information the Secretary determines to be 
necessary to conduct an ongoing evaluation of the scientific and clinic 
status of unrelated allogeneic marrow transplantation.
    ``(c) Report.--The Donor Registry shall submit to the Secretary on 
an annual basis a report using data collected and maintained by the 
bone marrow transplantation scientific registry established under 
subsection (a) concerning patient outcomes with respect to each 
transplant center and the pretransplant comparative costs involved at 
such transplant centers.''.
    (g) Authorization of Appropriations.--Part I of title III of such 
Act (42 U.S.C. 274k et seq.) as amended by subsection (f), is further 
amended by adding at the end thereof the following new section:

``SEC. 379C. AUTHORIZATION OF APPROPRIATIONS.

    ``There are authorized to be appropriated to carry out section 379, 
$13,500,000 for fiscal year 1997, $12,150,000 for fiscal year 1998, and 
such sums as may be necessary for fiscal year 1999.''.
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