[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[S. 1597 Introduced in Senate (IS)]

103d CONGRESS
  1st Session
                                S. 1597

  To amend the Public Health Service Act to revise and extend certain 
organ procurement and transplantation programs, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

             October 27 (legislative day, October 13), 1993

  Mr. Kennedy 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 certain 
organ procurement and transplantation programs, 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 Transplant Program 
Reauthorization Act of 1993''.

SEC. 2. 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 make grants for the consolidation and 
expansion of qualified organ procurement organizations described in 
subsection (b).
    ``(2) The Secretary may make grants to, and 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--
            ``(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; or
            ``(C) the provision of technical assistance to organ 
        procurement organizations and other entities in the health care 
        system.
    ``(3)(A) In making awards of grants, cooperative agreements and 
contracts under subparagraphs (A) and (B) of paragraph (2), the 
Secretary shall give priority to carrying out the purpose described in 
such paragraph with respect to minority or other populations for which 
there is a greater degree of organ shortages relative to the general 
population.
    ``(B) In making awards of grants, cooperative agreements and 
contracts under paragraph (2)(C), the Secretary shall give priority to 
carrying out the purpose described in such paragraph with respect to 
organ procurement organizations and hospitals with lower rates of 
procurement relative to other such organizations or 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), by 
                striking ``for which grants may be made under 
                subsection (a)'' and inserting ``described in this 
                section'';
                    (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''; and
                                    (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 an organ'';
            (2) by striking paragraph (2);
            (3) by redesignating paragraph (3) as paragraph (2);
            (4) in paragraph (2) (as so redesignated)--
                    (A) by striking subparagraph (A) and inserting the 
                following new subparagraph:
            ``(A) with respect to each hospital or other entity in its 
        service area that has facilities for organ donations, and 
        except as provided in paragraph (3)--
                    ``(i) have in effect an agreement with the entity 
                under which the entity, for the purposes of allocation, 
                identifies potential organ donors and notifies the 
                organ procurement organization, and
                    ``(ii) if such hospital or entity is dissatisfied 
                with the service obtained from its designated organ 
                procurement organization such hospital or entity may 
                seek mediation under a process established by the 
                Secretary within 60 days after the date of enactment of 
                this subparagraph,'';
                    (B) by redesignating subparagraphs (B) through (K) 
                as subparagraphs (C) through (L), respectively;
                    (C) by inserting after subparagraph (A) the 
                following new subparagraph:
            ``(B) conduct and participate in systematic efforts, 
        including public education, to increase the number of potential 
        donors,'';
                    (D) by inserting before the comma in subparagraph 
                (F) (as so redesignated) the following: ``, which 
                system shall, at a minimum, allocate each type of organ 
                either on the basis of a single service area list, or 
                an approved alternate local unit list (as defined in 
                paragraph (4)), 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'';
                    (E) by striking subparagraph (I) (as so 
                redesignated) and inserting the following new 
                subparagraph:
            ``(I) be a member of and abide by the rules and 
        requirements of the Organ Procurement and Transplantation 
        Network established under section 372,'';
                    (F) by striking subparagraph (K) (as so 
                redesignated) and inserting the following new 
                subparagraph:
            ``(K) evaluate annually, and report to the Organ 
        Procurement and Transplantation Network established under 
        section 372, on the effectiveness of the organization in 
        acquiring potentially available organs, particularly among 
        minority populations, and the variation of procurement across 
        hospitals within the organ procurement organization region, and 
        identify a plan to increase procurement, particularly among 
        minority populations and other populations for which there is a 
        greater degree of organ shortages relative to the general 
        population, and at hospitals with low rates of procurement,''; 
        and
                    (G) by adding at the end thereof the following 
                flush sentence:
``Subparagraph (A) shall not be construed as precluding an organ 
procurement organization from requesting that the Secretary permit 
changes in their service area boundaries.''; and
            (5) by adding at the end thereof the following new 
        paragraphs:
    ``(3)(A) The Secretary may waive the requirement that an organ 
procurement organization have an agreement of the type described in 
paragraph (2)(A) in effect if--
            ``(i)(I) the hospital or other entity within the service 
        area of the organ procurement organization is or seeks to be a 
        party to such an agreement with another organ procurement 
        organization; and
            ``(II) the hospital and organ procurement organization can 
        demonstrate to the satisfaction of the Secretary that their 
        affiliation is based on an agreement or understanding between 
        the organ procurement organization for the service area in 
        which the hospital is located, and the organ procurement 
        organization with which the hospital desires to affiliate, and 
        such hospital;
            ``(ii) the hospital or other entity within the service area 
        of the organ procurement organization is or seeks to be a party 
        to such an agreement with another organ procurement 
        organization and can document to the satisfaction of the 
        Secretary, with input from the organ procurement organization 
        for the area in which the hospital is located, that--
                    ``(I) such hospital or entity has received 
                inadequate service from the organ procurement 
                organization for the service area in which the hospital 
                is located; and
                    ``(II) another organ procurement organization is 
                willing and able to provide such hospital or entity 
                adequate service; or
            ``(iii) in such other circumstances as described in 
        regulations promulgated by the Secretary.
    ``(B) The relationship of a hospital or other entity within the 
service area of the organ procurement organization with other organ 
procurement organizations outside the service area that was in effect 
as of June 29, 1993, may continue in effect, pending a determination by 
the Secretary under the waiver process described in subparagraph (A). 
Not later than 3 months after the date of enactment of this paragraph, 
the hospital or other entity shall notify the Secretary in writing of 
its intent to proceed with such an existing relationship.
    ``(C)(i) The Office of Technology Assessment shall conduct a study 
for the purpose of defining--
            ``(I) the appropriate standards by which to judge the 
        quality of performance of organ procurement organizations;
            ``(II) the proper criteria for a determination of 
        inadequate service from an organ procurement organization; and
            ``(III) the process for allowing a hospital to work with an 
        organ procurement organization outside its service area.
    ``(ii) Not later than 1 year after the date of enactment of this 
paragraph, the Office of Technology Assessment shall complete the study 
required under clause (i) and prepare and submit to the Committee on 
Labor and Human Resources of the Senate, the Committee on Energy and 
Commerce of the House of Representatives, and the Secretary, a report 
describing the findings made as a result of the study.
    ``(4)(A) As used in paragraph (2)(F), the term `alternative local 
unit' means--
            ``(i) a unit composed of two or more contiguous 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 or minority population 
        concerns but that is not composed of any subunit of a 
        metropolitan statistical area.
    ``(B) The Organ Procurement and Transplantation Network shall make 
recommendations to the Secretary concerning the approval or denial of 
alternative local unit. 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 principle or designation recommended by the Network. If the 
Secretary does not provide otherwise prior to the expiration of the 90-
day period beginning on the date on which the application is submitted, 
the recommendations of the Network under subparagraph (B) with respect 
to the application of the alternative local unit shall go into 
effect.''.

SEC. 3. ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK.

    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), and individuals who are 
                        part of the family of individuals who have 
                        donated an organ, the number of whom shall make 
                        up not less than 33 percent of the total number 
                        of board members''; and
                    (B) in clause (ii), by inserting ``including a 
                patient affairs committee'' after ``committees,'';
            (2) in paragraph (2)--
                    (A) by striking clause (A)(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)(F), 
                and'';
                    (B) in subparagraph (B), by inserting ``, including 
                requirements under section 371(b),'' after ``membership 
                criteria'';
                    (C) in subparagraph (D), to read as follows:
            ``(D) develop and report to the Secretary, not later than 
        September 30, 1994, and implement not later than September 30, 
        1995, a system of allocating organs in order to ensure that 
        patients in one region have an equivalent probability of 
        receiving an organ as do patients with similar characteristics 
        in another region,'';
                    (D) by redesignating subparagraphs (E) through (L), 
                as subparagraphs (F) through (M), respectively;
                    (E) by inserting after subparagraph (D), the 
                following new subparagraph:
            ``(E) assist organ procurement organizations in the 
        equitable distribution of organs among transplant patients,'';
                    (F) in subparagraph (K) (as so redesignated), by 
                striking ``and'' at the end thereof;
                    (G) in subparagraph (L) (as so redesignated), by 
                striking the period and inserting ``, including making 
                recommendations to organ procurements organizations and 
                the Secretary based on the annual reports required 
                under section 371(b)(2)(K),'';
                    (H) in subparagraph (M) (as so redesignated), by 
                striking the period and inserting a comma; and
                    (I) by adding at the end thereof the following new 
                subparagraphs:
            ``(N) submit to the Secretary for review and approval any 
        change in the amount of fees imposed by the Network for the 
        registration of individuals on the lists maintained under 
        subparagraph (A)(i), such change to be considered as approved 
        if the Secretary does not provide otherwise prior to the 
        expiration of the 90-day period beginning on the date on which 
        the 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, on an annual basis, a report 
        on the clinical and scientific status of the organ 
        transplantations, and
            ``(Q) meet such other criteria regarding compliance with 
        this part as the Secretary may establish.''; and
            (3) by adding at the end thereof the following new 
        paragraph:
    ``(3) In carrying out paragraph (2)(D), the Organ Procurement and 
Transplantation Network shall consult with experts in the area of organ 
allocation and organ donations and consider their recommendations 
regarding the establishment of regions in the country for the purpose 
of allocating organs.''.

SEC. 4. STUDY BY GENERAL ACCOUNTING OFFICE.

    Section 377 of the Public Health Service Act (42 U.S.C. 274f) is 
amended to read as follows:

``SEC. 377. STUDY BY GENERAL ACCOUNTING OFFICE.

    ``(a) In General.--The Comptroller General of the United States 
shall conduct a study for the purpose of determining and making 
recommendations concerning--
            ``(1) the composition of the boards of directors of organ 
        procurement organizations and of the Organ Procurement and 
        Transplantation Network on the date of enactment of this 
        section, and the effect of the Organ Transplant Program 
        Reauthorization Act of 1993 on the composition and functioning 
        of such boards;
            ``(2)(A) the number and percentage of cadaveric organ 
        transplants for foreign nationals categorized by organ 
        procurement organization and by transplant center;
            ``(B) the number and percent of the organizations referred 
        to in subparagraph (A) above the organ procurement transplant 
        network guideline of 10 percent; and
            ``(C) any information on the current rate of organ donation 
        by individuals other than United States citizens or legal 
        residents;
            ``(3) the equitable allocation of organs nationwide, 
        including an analysis of the relative probability of receiving 
        an organ for patients with similar characteristics for each 
        category of transplanted organ by organ procurement 
        organization and the effect of the Organ Transplant Program 
        Reauthorization Act of 1993 on improving the equitable 
        allocation of organs nationwide.
    ``(b) Report.--Not later than 2 years after the date of enactment 
of the Organ Transplant Program Reauthorization Act of 1993, the 
Comptroller General of the United States shall complete the study 
required under subsection (a) and prepare and submit to the Committee 
on Energy and Commerce of the House of Representatives, and to the 
Committee on Labor and Human Resources of the Senate, a report 
describing the findings made as a result of the study.''.

SEC. 5. GENERAL PROVISIONS.

    (a) Limitation.--Section 374(b) of the Public Health Service Act 
(42 U.S.C. 274b(b)) is amended--
            (1) by striking paragraph (2);
            (2) by redesignating paragraph (3) as paragraph (2); and
            (3) in paragraph (2) (as so redesignated), by striking 
        ``371(a)(3)'' and inserting ``371(a)(2)''.
    (b) Repeal.--Section 376 of the Public Health Service Act (42 
U.S.C. 274d) is repealed.
    (c) Transfer.--Section 378 of the Public Health Service Act (42 
U.S.C. 274g) is amended--
            (1) by transferring such section to part H of title III; 
        and
            (2) by inserting such section after section 377.
    (d) Authorization of Appropriations.--Section 378 of the Public 
Health Service Act (42 U.S.C. 274g) is amended by striking ``1991'' and 
all that follows through the period and inserting ``1994, and such sums 
as may be necessary for each of the fiscal years 1995 and 1996.''.

SEC. 6. EFFECTIVE DATES.

    (a) In General.--Except as provided in subsection (b), the 
amendments made by this Act shall become effective on the date of 
enactment of this Act.
    (b) Exception.--The amendments made by sections 2(b)(4)(A) and 
2(b)(4)(D) shall become effective 6 months after the date of enactment 
of this Act. Prior to such date, sections 371(b)(3)(A) and 371(b)(3)(E) 
of the Public Health Service Act, as in effect on the day before the 
date of the enactment of this Act, shall remain in effect.

                                 <all>

S 1597 IS----2