[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
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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.
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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.
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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''.
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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.