[House Report 106-557]
[From the U.S. Government Publishing Office]



106th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES
 2d Session                                                     106-557

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PROVIDING FOR THE CONSIDERATION OF H.R. 2418, THE ORGAN PROCUREMENT AND 
               TRANSPLANTATION NETWORK AMENDMENTS OF 1999

                                _______
                                

   April 3, 2000.--Referred to the House Calendar and ordered to be 
                                printed

                                _______
                                

    Mr. Linder, from the Committee on Rules, submitted the following

                              R E P O R T

                       [To accompany H. Res. 454]

    The Committee on Rules, having had under consideration 
House Resolution 454, by a nonrecord vote, report the same to 
the House with the recommendation that the resolution be 
adopted.

                summary of provisions of the resolution

    The resolution provides for the consideration of H.R. 2418, 
the Organ Procurement and Transplantation Network Amendments of 
1999, under a structured rule. The rule provides one hour of 
general debate divided equally between the chairman and ranking 
minority member of the Committee on Commerce.
    The rule makes in order the Committee on Commerce amendment 
in the nature of a substitute now printed in the bill as an 
original bill for the purpose of amendment. The rule also makes 
in order only those amendments printed in this report which may 
be offered only in the order printed in this report, may be 
offered only by a Member designated in this report, shall be 
considered as read, shall be debatable for the time specified 
in this report equally divided and controlled by the proponent 
and an opponent, shall not be subject to amendment, and shall 
not be subject to a demand for a division of the question in 
the House or in the Committee of the Whole.
    The rule waives all points of order against the amendment 
printed in this report. The rule allows the Chairman of the 
Committee of the Whole to postpone votes during consideration 
of the bill, and reduce voting time to five minutes on a 
postponed question if the vote follows a fifteen minute vote. 
Finally, the rule provides one motion to recommit with or 
without instructions.

           Summary of Amendments Made in Order Under the Rule

    DeGette: Provide a technical revision to language in the 
bill to ensure that our nation's organ transplantation system 
recognizes children's unique health care needs and provides for 
a study of immunosuppressive drug coverage for children, in 
follow-up to the congressionally mandated Institute of Medicine 
study on Medicare immunosuppressive drug coverage, and on 
children's unique growth and developmental health and organ 
transplant needs. 10 minutes.
    Luther: Ensures that the policies of the Network could not 
be thwarted or preempted by state or local law. 10 minutes.
    LaHood/Moakley/Rush/Peterson (PA): Provides that the 
policies and rules established by the Network shall be subject 
to review and approval by the Secretary of HHS; requires both 
HHS and its contractor to apply scientific principles to the 
development of organ allocation policies, and; ensures that 
data necessary to evaluate and improve the organ transplant 
system are provided to the public. 60 minutes.
    Barrett (WI)/Kleczka: Provides a financial incentive for 
states to creatively tackle the challenges inherent in organ 
donation awareness and education; authorizes direct grants to 
states and allows partnerships with other public agencies or 
private sector institutions within states to mutually undertake 
organ donation activities. 20 minutes.
    Scarborough/Thurman: Nullifies the final rule issued by the 
Secretary of HHS that gives HHS the sole authority to approve 
or disapprove organ allocation policies that are currently 
established by the private-sector transplant community. 30 
minutes.
    Text of amendments made in order under the rule:

1. An Amendment To Be Offered by Representative DeGette of Colorado, or 
                  a Designee, Debatable for 10 Minutes

  Page 8, strike lines 11 through 14 and insert the following:
          ``(10) The Network shall recognize the differences in 
        health and in organ transplantation issues between 
        children and adults throughout the system and adopt 
        criteria, policies, and procedures that address the 
        unique health care needs of children.
  Page 29, line 18, redesignate section 8 as section 9 and 
insert after line 17 the following:

SEC. 7. STUDY REGARDING IMMUNOSUPPRESSIVE DRUGS.

  (a) In General.--The Secretary of Health and Human Services 
(referred to in this section as the ``Secretary'') shall 
provide for a study to determine the costs of immunosuppressive 
drugs that are provided to children pursuant to organ 
transplants and to determine the extent to which health plans 
and health insurance cover such costs. The Secretary may carry 
out the study directly or through a grant to the Institute of 
Medicine (or other public or nonprofit private entity).
  (b) Recommendations Regarding Certain Issues.--The Secretary 
shall ensure that, in addition to making determinations under 
subsection (a), the study under such subsection makes 
recommendations regarding the following issues:
          (1) The costs of immunosuppressive drugs that are 
        provided to children pursuant to organ transplants and 
        to determine the extent to which health plans, health 
        insurance and government programs cover such costs.
          (2) The extent of denial of organs to be released for 
        transplant by coroners and medical examiners.
          (3) The special growth and developmental issues that 
        children have pre- and post-organ transplantation.
          (4) Other issues that are particular to the special 
        health and transplantation needs of children.
  (c) Report.--The Secretary shall ensure that, not later than 
December 31, 2000, the study under subsection (a) is completed 
and a report describing the findings of the study is submitted 
to the Congress.
                              ----------                              


2. An Amendment To Be Offered by Representative Luther of Minnesota or 
                  a Designee, Debatable for 10 Minutes

    Page 8, after line 14, insert the following subsection (and 
redesignate subsequent subsections accordingly):
    ``(c) Compliance With Organ Allocation Policies.--No State 
or local governing entity shall establish or continue in effect 
any law, rule, regulation, or other requirement that would 
restrict in any way the ability of any transplant hospital, 
organ procurement organization, or other party to comply with 
organ allocation policies of the Network.
                              ----------                              


3. An Amendment To Be Offered by Representative LaHood of Illinois, or 
 Representative Moakley of Massachusetts, or a Designee, Debatable for 
                               60 Minutes

  Page 14, strike line 21 and all that follows through page 17, 
line 17, and insert the following:
  ``(h) Certain Scientific and Administrative Principles.--
          ``(1) Scientific principles.--Policies under 
        subsection (b) for the allocation of organs--
                  ``(A) shall be based on sound medical 
                principles;
                  ``(B) shall be based on valid scientific 
                data;
                  ``(C) shall be equitable and seek to achieve 
                the best use of donated organs;
                  ``(D) shall be designed to avoid wasting 
                organs, to avoid futile transplants, to promote 
                patient access to transplantation, and to 
                promote the efficient management of organ 
                placement;
                  ``(E) shall be specific for each organ type 
                or combination of organ types;
                  ``(F) shall, where appropriate for the 
                specific organ, provide status categories that 
                group transplant candidates from most to least 
                medically urgent;
                  ``(G) shall not use patient waiting time as a 
                criterion unless medically appropriate; and
                  ``(H) shall be designed to share organs over 
                as broad a geographic area as feasible, 
                consistent with subparagraphs (A) through (G).
          ``(2) Patient listing and status.--Policies under 
        subsection (b) for listing patients shall address the 
        suitability of patients for transplants, appropriate 
        priority status of each candidate, and the situations 
        for removing candidates from the waiting list. Such 
        policies shall be uniform for each organ type, 
        objective, and medically appropriate.
          ``(3) Review and approval of policies; consistency 
        with scientific principles.--The policies and rules 
        established by the Network shall be subject to review 
        and approval by the Secretary (after consultation with 
        the advisory committee under paragraph (4)), and no 
        policy or rule established under subsection (b) may be 
        inconsistent with paragraph (1) or (2). The 
        applicability of sanctions under subsection (g) to any 
        Network participant is subject to review and approval 
        by the Secretary.
          ``(4) Independent scientific review.--The Secretary 
        shall establish (consistent with the Federal Advisory 
        Committee Act) an advisory committee to provide 
        recommendations to the Secretary on the policies and 
        rules of the Network, and on such other matters as the 
        Secretary determines to be appropriate.
          ``(5) Patient listing and other fees.--
                  ``(A) Availability; restriction.--Fees 
                collected by the Network--
                          ``(i) are available to the Network, 
                        without fiscal year limitation, for use 
                        in carrying out the functions of the 
                        Network under this section; and
                          ``(ii) may not be used for any 
                        activity for which contract funds 
                        awarded under subsection (a) may not be 
                        used.
                  ``(B) Applicability.--Subparagraph (A) 
                applies only to patient listing fees of the 
                Network and to fees imposed as a condition of 
                being a Network participant, and such fees are 
                subject to the approval of the Secretary. Such 
                subparagraph does not prohibit the Network from 
                collecting other fees and using such fees for 
                purposes other than those specified in such 
                subparagraph.
                  ``(C) Gifts.--This section does not prohibit 
                the Network from accepting gifts of money or 
                services, including for purposes other than 
                those specified in subparagraph (A). The 
                Network may accept gifts of money or services 
                to carry out activities to provide for an 
                increase in the rate of organ donation.
          ``(6) Information.--The Network shall provide to the 
        Secretary such information and data regarding the 
        Network and Network participants as the Secretary 
        determines to be appropriate. The Network shall provide 
        data in a timely manner, with suitable patient 
        confidentiality protections, to independent 
        investigators and scientific reviewers.
          ``(7) Limitation on amount of contract.--The amount 
        provided under a contract under subsection (a) in any 
        fiscal year may not exceed $6,000,000 for the operation 
        of the Network, including the scientific registry under 
        subsection (c). Such limitation does not apply to 
        amounts provided under the contract for increasing 
        organ donation and procurement.
                              ----------                              


 4. An Amendment To Be Offered by Representative Barrett of Wisconsin, 
                or a Designee, Debatable for 20 Minutes

  Page 28, after line 3, insert the following subsection (and 
redesignate subsequent subsections accordingly):
  ``(c) Grants to States.--The Secretary may make grants to 
States for the purpose of assisting States in carrying out 
organ donor awareness, public education and outreach activities 
and programs designed to increase the number of organ donors 
within the State, including living donors. To be eligible, each 
State shall--
          ``(1) submit an application to the Department in the 
        form prescribed;
          ``(2) establish yearly benchmarks for improvement in 
        organ donation rates in the State;
          ``(3) develop, enhance or expand a State donor 
        registry, which shall be available to hospitals, organ 
        procurement organizations, and other States upon a 
        search request; and
          ``(4) report to the Secretary on an annual basis a 
        description and assessment of the State's use of these 
        grant funds, accompanied by an assessment of 
        initiatives for potential replication in other States.
Funds may be used by the State or in partnership with other 
public agencies or private sector institutions for education 
and awareness efforts, information dissemination, activities 
pertaining to the State organ donor registry, and other 
innovative donation specific initiatives, including living 
donation.
  Page 28, line 12, strike ``$10,000,000'' and insert 
``$15,000,000''.
                              ----------                              


5. An Amendment To Be Offered by Representative Scarborough of Florida, 
 or Representative Thurman of Florida, or a Designee, Debatable for 20 
                                Minutes

  Page 29, after line 17, insert the following:

SEC. 8. NULLIFICATION OF FINAL RULE RELATING TO ORGAN PROCUREMENT AND 
                    TRANSPLANTATION NETWORK.

  Notwithstanding any other provision of law, the final rule 
relating to the Organ Procurement and Transplantation Network, 
promulgated by the Secretary of Health and Human Services and 
published in the Federal Register on April 2, 1998 (63 Fed. 
Reg. 16296 et seq. adding part 121 to title 42, Code of Federal 
Regulations) and amended on October 20, 1999 (64 Fed. Reg. 
56649 et seq.), shall have no force or legal effect.
  Page 29, line 18, redesignate section 8 as section 9.

                                  
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