[Congressional Record Volume 142, Number 122 (Monday, September 9, 1996)]
[Senate]
[Pages S10080-S10087]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




  ORGAN AND BONE MARROW TRANSPLANT PROGRAM REAUTHORIZATION ACT OF 1995

  Mr. LOTT. Mr. President, I ask unanimous consent the Senate proceed 
to the immediate consideration of Calendar No. 377, S. 1324.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The clerk will report.
  The legislative clerk read as follows:

       A bill (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.

  The Senate proceeded to consider the bill, which had been reported 
from the Committee on Labor and Human Resources, with an amendment to 
strike all after the enacting clause and inserting in lieu thereof the 
following:

     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 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 ``donations,'' 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 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

[[Page S10081]]

       (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 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 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'. 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 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

[[Page S10082]]

     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 report required under section 377, the 
     Network contractor, in consultation with the Network and the 
     Secretary, shall present to the Secretary and the appropriate 
     committees of Congress, a plan to 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 all populations 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.--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 Secretary shall, not later than 30 days after 
     the expiration of such period, prepare and submit to the 
     appropriate committees of Congress a report describing the 
     reasons why the Secretary is not in compliance with paragraph 
     (1) and the plans that will be implemented to provide for the 
     issuance of the final rule under such paragraph.

     SEC. 104. TERMS AND CONDITIONS OF 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 striking ``in the health care system''; and
       (B) 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 
     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. 
     274f) 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, 375 and 377, $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
       (3) 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).''.

[[Page S10083]]

       (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 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 by striking subsection (j), 
     and inserting 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 availability of unrelated 
     donor marrow transplants and 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 groups 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 
     population groups with such shortages.''.
       (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 amended by adding at the end 
     thereof 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 as 
     appropriate 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 expediting 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.''.


                           Amendment No. 5205

  (Purpose: To restore and modify certain qualified organ procurement 
               organization board of director provisions)

  Mr. LOTT. Mr. President, I understand Senator Kassebaum has an 
amendment at the desk. I ask for its immediate consideration.
  The PRESIDING OFFICER. The clerk will report.

[[Page S10084]]

  The legislative clerk read as follows:

       The Senator from Mississippi [Mr. Lott], for Mrs. 
     Kassebaum, proposes an amendment numbered 5205.

  The amendment is as follows:

       Beginning on page 41, strike line 23, and all that follows 
     through line 4 on page 42, and insert the following:
       ``(i) in clause (i)--''.
       On page 43, between lines 6 and 7, insert the following:
       ``(ii) in clause (ii), by inserting `, administrative 
     functions of the organ procurement organization, ' after 
     `organs'; and
       ``(iii) in clause (iii), to read as follows:
       `(iii) in the case of a hospital-based organ procurement 
     organization, has no authority over any non-transplant-
     related activity of the organization.';''.

  Mr. LOTT. Mr. President, I ask unanimous that the amendment be 
considered read and agreed to, the bill be deemed read a third time, 
passed, the motion to reconsider be laid upon the table, and that any 
statements relating to the bill be printed at the appropriate place in 
the Record.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The amendment (No. 5205) was agreed to.
  The bill (S. 1324) was deemed read for a third time and passed, as 
follows:

                                S. 1324

       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 1996''.
                TITLE I--SOLID-ORGAN TRANSPLANT PROGRAM

     SEC. 101. SHORT TITLE.

       This title may be cited as the ``Solid-Organ Transplant 
     Program Reauthorization Act of 1996''.

     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 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 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,'';

       (ii) in clause (ii), by inserting ``, administrative 
     functions of the organ procurement organization,'' after 
     ``organs''; and
       (iii) in clause (iii), to read as follows:
       ``(iii) in the case of a hospital-based organ procurement 
     organization, has no authority over any non-transplant-
     related activity of the organization.'';
       (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 ``donations,'' 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 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 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;

[[Page S10085]]

       ``(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 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'. 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 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

[[Page S10086]]

     year after the completion of the Institute of Medicine report 
     required under section 377, the Network contractor, in 
     consultation with the Network and the Secretary, shall 
     present to the Secretary and the appropriate committees of 
     Congress, a plan to 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 all 
     populations 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.--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 Secretary shall, not later than 30 days after 
     the expiration of such period, prepare and submit to the 
     appropriate committees of Congress a report describing the 
     reasons why the Secretary is not in compliance with paragraph 
     (1) and the plans that will be implemented to provide for the 
     issuance of the final rule under such paragraph.

     SEC. 104. TERMS AND CONDITIONS OF 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 striking ``in the health care system''; and
       (B) 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 
     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. 
     274f) 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, 375 and 377, $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 1996''.

     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
       (3) 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 potential marrow donors for 
     which there is a greater degree of marrow donor shortage than 
     that of the general population; and

[[Page S10087]]

       ``(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 by striking subsection (j), 
     and inserting 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 availability of unrelated 
     donor marrow transplants and 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 groups 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 
     population groups with such shortages.''.
       (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 amended by adding at the end 
     thereof 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 as 
     appropriate 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 expediting 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.''.

                          ____________________