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[House Report 107-11]
[From the U.S. Government Publishing Office]

107th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES
 1st Session                                                     107-11

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                 ORGAN DONATION IMPROVEMENT ACT OF 2001

 March 6, 2001.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

 Mr. Tauzin, from the Committee on Energy and Commerce, submitted the 
                               following

                              R E P O R T

                        [To accompany H.R. 624]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 624) to amend the Public Health Service Act to 
promote organ donation, having considered the same, report 
favorably thereon without amendment and recommend that the bill 
do pass.

                                CONTENTS

                                                                   Page
Purpose and Summary..............................................     1
Background and Need for Legislation..............................     2
Hearings.........................................................     3
Committee Consideration..........................................     3
Committee Votes..................................................     3
Committee Oversight Findings.....................................     3
Statement of General Performance Goals and Objectives............     3
New Budget Authority, Entitlement Authority, and Tax Expenditures     3
Committee Cost Estimate..........................................     3
Congressional Budget Office Estimate.............................     3
Federal Mandates Statement.......................................     5
Advisory Committee Statement.....................................     5
Constitutional Authority Statement...............................     5
Applicability to Legislative Branch..............................     5
Section-by-Section Analysis of the Legislation...................     5
Changes in Existing Law Made by the Bill, as Reported............     6

                          Purpose and Summary

    H.R. 624, the Organ Donation Improvement Act of 2001, is 
solely focused on creating new incentives for people to become 
organ donors and provides for studies and demonstration 
projects to encourage organ donation education efforts across 
the country. The bill accomplishes this objective by permitting 
the Secretary of the Department of Health and Human Services to 
make awards of grants or contracts to States, transplant 
centers, qualified organ procurement organizations, or other 
public or private entities for the purpose of providing for the 
payment of travel and subsistence expenses incurred by 
individuals toward making living donations of their organs. In 
addition, the bill orders the Secretary to carry out studies 
and demonstration projects for the purpose of educating the 
public with respect to organ donation. These grants will assist 
the States in carrying out organ donor awareness, public 
education, and outreach activities, and programs designed to 
increase the number of organ donors within a State, including 
living donors.

                  Background and Need for Legislation

    In 1999, 21,715 Americans received the ``gift of life'' 
through transplantation surgery made possible by the generosity 
of organ and tissue donors. Despite the self-sacrifice and 
charity of these donors, this is only a small proportion of the 
more than 70,000 Americans who are now on a waiting list, 
hoping to prolong their lives by finding a matching donor. 
Tragically, the number of patients waiting for organ 
transplants rose more than five times as fast as the number of 
transplant operations in the 1990s, according to an annual 
report by the United Network for Organ Sharing (UNOS). Nearly 
5,000 patients each year (or 13 patients each day), die while 
waiting for a donated heart, liver, kidney, or other organ. It 
is estimated that every 16 minutes, a new name is added to this 
growing waiting list.
    Minorities representing approximately 25 percent of the 
population comprise over 40 percent of the organ transplant 
waiting list, and half of the patients who die while patiently 
waiting for their ``gift of life'' are people of color.
    As the demand for transplantation increases, this shortfall 
in donor organs for those with end-stage organ disease or organ 
failure will become even more pronounced. In order to narrow 
the gap between the supply and the increasing demand for 
donated organs, there must be an effort to encourage willing 
donors and create an environment conducive to organ donation.
    In the last two Congresses, the Committee has held three 
hearings on solid organ transplantation. Among the issues 
raised in these hearings included the need for increasing organ 
donation through initiatives like those included in H.R. 624. 
The Committee found that there are willing donors who would 
like to save the life of another American, but often find 
themselves in financial circumstances that would make donation 
of a life-saving organ even more of a hardship. Travel 
expenses, lengthy hospital stays, and time away from one's job 
can all create financial and emotional strains on donor 
families. These hardships discourage organ donation.
    The Committee also found that our Nation's organ donation 
education efforts need to be strengthened in order to increase 
the number of donors, and encourage family members to discuss 
organ and tissue donation at appropriate times. In addition, 
States need additional funds in order to bolster their organ 
donor awareness, public education, and outreach activities.
    Obstacles to organ donation create disincentives for 
willing donors and ultimately increase waiting times and 
waiting lists for patients with end-stage organ disease and 
organ failure.
    The organ donation provisions contained in H.R. 624 are the 
same provisions that were the subject of markup in Subcommittee 
(September 30, 1999), markup in Full Committee (October 13, 
1999), and House passage (April 4, 2000 by a vote of 275-147) 
of H.R. 2418, the Organ Procurement and Transplantation Network 
Amendments of 2000. The votes against H.R. 2418 were focused on 
the provisions relating to Secretarial authority over the 
allocation process, which have not been included in H.R. 624.

                                Hearings

    The Committee on Energy and Commerce has not held hearings 
on this bill.

                        Committee Consideration

    On February 28, 2001, the Subcommittee on Health was 
discharged from the further consideration of H.R. 624. On 
February 28, 2001, the Full Committee met in open markup 
session and approved H.R. 624, without amendment, by a voice 
vote.

                            Committee Votes

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list the record votes 
on the motion to report legislation and amendments thereto. 
There were no record votes taken in connection with ordering 
H.R. 624 reported.

                      Committee Oversight Findings

    Pursuant to clause 3(c)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee has held no oversight 
hearing.

         Statement of General Performance Goals and Objectives

    This legislation will improve the rate of organ donations 
by providing new incentives for donations and requiring studies 
of organ donations.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    In compliance with clause 3(c)(2) of rule XIII of the Rules 
of the House of Representatives, the Committee finds that H.R. 
624, the Organ Donation Improvement Act of 2001, would result 
in no new or increased budget authority, entitlement authority, 
or tax expenditures or revenues.

                        Committee Cost Estimate

    The Committee adopts as its own the cost estimate prepared 
by the Director of the Congressional Budget Office pursuant to 
section 402 of the Congressional Budget Act of 1974.

                  Congressional Budget Office Estimate

    Pursuant to clause 3(c)(3) of rule XIII of the Rules of the 
House of Representatives, the following is the cost estimate 
provided by the Congressional Budget Office pursuant to section 
402 of the Congressional Budget Act of 1974:

                                     U.S. Congress,
                               Congressional Budget Office,
                                     Washington, DC, March 6, 2001.
Hon. W.J. ``Billy'' Tauzin,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for H.R. 624, the Organ 
Donation Improvement Act of 2001.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Mara Krause.
            Sincerely,
                                          Barry B. Anderson
                                    (For Dan L. Crippen, Director).
    Enclosure.

H.R. 624--Organ Donation Improvement Act of 2001

    H.R. 624 would amend the Public Health Service Act to 
promote organ donation. The bill, as modified, would authorize 
appropriation of $5 million a year in 2002 through 2006 for 
travel and subsistence expenses for qualifying individuals 
making living donation of their organs. H.R. 624, as modified, 
would also authorize appropriation of $15 million in fiscal 
year 2002 for a program to educate the public and for studies 
and demonstrations designed to increase the rate of organ 
donation. It would authorize such sums as may be necessary for 
these activities from 2003 through 2006.
    Assuming appropriations of the necessary amounts, CBO 
estimates that implementing H.R. 624 would cost $6 million in 
2002 and a total of $78 million from 2002 through 2006, without 
adjusting for inflation, and $80 million if inflation 
adjustments are included. The legislation would not affect 
direct spending or receipts; therefore, pay-as-you-go 
procedures would not apply.
    The estimated budgetary impact of H.R. 624 is shown in the 
following table. The table shows two alternative spending 
paths: one assuming no increases to account for anticipated 
inflation, and one with annual inflation adjustments. For 
purposes of this estimate, CBO assumes that outlays will follow 
historical spending rates for similar activities. The costs of 
this legislation fall within budget function 550 (health).
    H.R. 624 contains no private-sector or intergovernmental 
mandates as defined in the Unfunded Mandates Reform Act. The 
bill would provide grants to states and other public and 
private entities for assistance to individuals who donate 
living organs and for educational and outreach activities.

----------------------------------------------------------------------------------------------------------------
                                                                  By fiscal year, in millions of dollars--
                                                           -----------------------------------------------------
                                                              2001     2002     2003     2004     2005     2006
----------------------------------------------------------------------------------------------------------------
                                  CHANGES IN SPENDING SUBJECT TO APPROPRIATION

                                        Without Adjustments for Inflation
Estimated Authorization Level.............................        0       20       20       20       20       20
Estimate Outlays..........................................        0        6       15       18       20       20

                                         With Adjustments for Inflation
Estimated Authorization Level.............................        0       20       20       21       21       21
Estimate Outlays..........................................        0        6       15       19       20       21
----------------------------------------------------------------------------------------------------------------

    The CBO staff contact is Mara Krause. This estimate was 
approved by Peter H. Fontaine, Deputy Assistant Director for 
Budget Analysis.

                       Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

                      Advisory Committee Statement

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act were created by this 
legislation.

                   Constitutional Authority Statement

    Pursuant to clause 3(d)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee finds that the 
Constitutional authority for this legislation is provided in 
Article I, section 8, clause 3, which grants Congress the power 
to regulate commerce with foreign nations, among the several 
States, and with the Indian tribes.

                  Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

             Section-by-Section Analysis of the Legislation

Section 1. Short title

    This section provides the short title of the bill, the 
``Organ Donation Improvement Act of 2001.''

Section 2. Sense of Congress

    Section 2 sets out the sense of Congress with respect to 
organ donation and recognizes the importance of family 
discussions on organ donation. This section also acknowledges 
the generous contributions made by living organ donors, and the 
remarkable advances in medical technology which have made organ 
transplantation possible.

Section 3. Payment of travel and subsistence expenses incurred toward 
        living organ donation

    Section 3 amends Section 377 of the Public Health Service 
Act to permit the Secretary of the Department of Health and 
Human Services to make awards of grants or contracts to States, 
transplant centers, qualified organ procurement organizations, 
or other public or private entities for the purpose of 
providing for the payment of travel and subsistence expenses 
incurred by individuals toward making living donations of their 
organs. Payments under this section may be made for expenses of 
a donating individual only if: (1) the State in which the 
donating individual resides is a different State than the State 
in which the intended recipient of the organ resides and (2) 
the annual income of the intended recipient of the organ does 
not exceed $35,000.
    While Section 4 of H.R. 624 authorizes a grant program to 
the separate States to increase organ donation, which could 
establish their own travel and subsistence programs, the 
Section 3 program is for those donations affecting interstate 
commerce (hence the requirement that the recipient must reside 
in a State other than the residence of the living donor). The 
amount of qualifying expenses for which payments under such 
subsection are made may not exceed the amount of such expenses 
for which payment would have been made if such area had been 
the covered vicinity for the intended recipient, taking into 
account the costs of travel and regional differences in the 
costs of living. Capping qualifying expenses to that which 
might be incurred at a local transplant center was a solution 
proposed to control costs of the program. While recipients can 
receive a transplant from any place they desire, reimbursed 
expenses would be limited to the equivalent of having gone to 
the transplant center closest to the residence of the 
recipient.
    Likewise, the annual income of the intended recipient of 
the organ was capped at $35,000 for the Section 3 program, 
because it was established to assist those recipients of 
relatively modest means who may not be in a position to make a 
prospective donor whole financially for lost wages and costs 
associated with travel.

Section 4. Public awareness; studies and demonstrations

    Section 4 amends Part H of title III of the Public Health 
Service Act to permit the Secretary to make grants to the 
States to carry out studies and demonstration projects for the 
purpose of educating the public with respect to organ donation. 
These grants will assist the States in carrying out organ donor 
awareness, public education, and outreach activities, and 
programs designed to increase the number of organ donors within 
a State, including living donors. Each state would be required 
to establish yearly benchmarks for improving organ donation 
rates in the State; develop, enhance, or expand the State's 
donor registry; and, report to the Secretary on an annual basis 
an assessment of the State's use of these grant funds.

Section 5. Effective date

    The amendments made by this act take effect on the date of 
enactment.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italic, existing law in which no change is 
proposed is shown in roman):

                       PUBLIC HEALTH SERVICE ACT

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      TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE

           *       *       *       *       *       *       *

                       Part H--Organ Transplants

           *       *       *       *       *       *       *

[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--
          [(1) the extent to which the procurement and 
        allocation of organs have been equitable, efficient, 
        and effective;
          [(2) the problems encountered in the procurement and 
        allocation; and
          [(3) the effect of State required-request laws.
  [(b) Report.--Not later than January 7, 1992, the Comptroller 
General of the United States shall complete the study required 
in subsection (a) 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.]

payment of travel and subsistence expenses incurred toward living organ 
                                donation

  Sec. 377. (a) In General.--The Secretary may make awards of 
grants or contracts to States, transplant centers, qualified 
organ procurement organizations under section 371, or other 
public or private entities for the purpose of--
          (1) providing for the payment of travel and 
        subsistence expenses incurred by individuals toward 
        making living donations of their organs (in this 
        section referred as ``donating individuals''); and
          (2) in addition, providing for the payment of such 
        incidental nonmedical expenses that are so incurred as 
        the Secretary determines by regulation to be 
        appropriate.
  (b) Eligibility.--
          (1) In general.--Payments under subsection (a) may be 
        made for the qualifying expenses of a donating 
        individual only if--
                  (A) the State in which the donating 
                individual resides is a different State than 
                the State in which the intended recipient of 
                the organ resides; and
                  (B) the annual income of the intended 
                recipient of the organ does not exceed $35,000 
                (as adjusted for fiscal year 2001 and 
                subsequent fiscal years to offset the effects 
                of inflation occurring after the beginning of 
                fiscal year 2000).
          (2) Certain circumstances.--Subject to paragraph (1), 
        the Secretary may in carrying out subsection (a) 
        provide as follows:
                  (A) The Secretary may consider the term 
                ``donating individuals'' as including 
                individuals who in good faith incur qualifying 
                expenses toward the intended donation of an 
                organ but with respect to whom, for such 
                reasons as the Secretary determines to be 
                appropriate, no donation of the organ occurs.
                  (B) The Secretary may consider the term 
                ``qualifying expenses'' as including the 
                expenses of having one or more family members 
                of donating individuals accompany the donating 
                individuals for purposes of subsection (a) 
                (subject to making payment for only such types 
                of expenses as are paid for donating 
                individuals).
  (c) Limitation on Amount of Payment.--
          (1) In general.--With respect to the geographic area 
        to which a donating individual travels for purposes of 
        subsection (a), if such area is other than the covered 
        vicinity for the intended recipient of the organ, the 
        amount of qualifying expenses for which payments under 
        such subsection are made may not exceed the amount of 
        such expenses for which payment would have been made if 
        such area had been the covered vicinity for the 
        intended recipient, taking into account the costs of 
        travel and regional differences in the costs of living.
          (2) Covered vicinity.--For purposes of this section, 
        the term ``covered vicinity'', with respect to an 
        intended recipient of an organ from a donating 
        individual, means the vicinity of the nearest 
        transplant center to the residence of the intended 
        recipient that regularly performs transplants of that 
        type of organ.
  (d) Relationship to Payments Under Other Programs.--An award 
may be made under subsection (a) only if the applicant involved 
agrees that the award will not be expended to pay the 
qualifying expenses of a donating individual to the extent that 
payment has been made, or can reasonably be expected to be 
made, with respect to such expenses--
          (1) under any State compensation program, under an 
        insurance policy, or under any Federal or State health 
        benefits program; or
          (2) by an entity that provides health services on a 
        prepaid basis.
  (e) Definitions.--For purposes of this section:
          (1) The term ``covered vicinity'' has the meaning 
        given such term in subsection (c)(2).
          (2) The term ``donating individuals'' has the meaning 
        indicated for such term in subsection (a)(1), subject 
        to subsection (b)(2)(A).
          (3) The term ``qualifying expenses'' means the 
        expenses authorized for purposes of subsection (a), 
        subject to subsection (b)(2)(B).
  (f) Authorization of Appropriations.--For the purpose of 
carrying out this section, there is authorized to be 
appropriated $5,000,000 for each of the fiscal years 2000 
through 2005.

              public awareness; studies and demonstrations

  Sec. 377A. (a) Public Awareness.--The Secretary shall 
(directly or through grants or contracts) carry out a program 
to educate the public with respect to organ donation, including 
the need to provide for an adequate rate of such donations.
  (b) Studies and Demonstrations.--The Secretary may make 
grants to public and nonprofit private entities for the purpose 
of carrying out studies and demonstration projects with respect 
to providing for an adequate rate of organ donation.
  (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.
  (d) Annual Report to Congress.--The Secretary shall annually 
submit to the Congress a report on the activities carried out 
under this section, including provisions describing the extent 
to which the activities have affected the rate of organ 
donation.
  (e) Authorization of Appropriations.--
          (1) In general.--For the purpose of carrying out this 
        section, there are authorized to be appropriated 
        $15,000,000 for fiscal year 2000, and such sums as may 
        be necessary for each of the fiscal years 2001 through 
        2005. Such authorization of appropriations is in 
        addition to any other authorizations of appropriations 
        that is available for such purpose.
          (2) Studies and demonstrations.--Of the amounts 
        appropriated under paragraph (1) for a fiscal year, the 
        Secretary may not obligate more than $2,000,000 for 
        carrying out subsection (b).

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