H. Rept. 113-181 - 113th Congress (2013-2014)

Report text available as:

Formatting necessary for an accurate reading of this legislative text may be shown by tags (e.g., <DELETED> or <BOLD>) or may be missing from this TXT display. For complete and accurate display of this text, see the PDF.


House Report 113-181 - HIV ORGAN POLICY EQUITY ACT

[House Report 113-181]
[From the U.S. Government Publishing Office]


113th Congress                                            Rept. 113-181
                        HOUSE OF REPRESENTATIVES
 1st Session                                                     Part 1

======================================================================



 
                      HIV ORGAN POLICY EQUITY ACT

                                _______
                                

 July 30, 2013.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

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

                              R E P O R T

                        [To accompany H.R. 698]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 698) to amend the Public Health Service Act to 
establish safeguards and standards of quality for research and 
transplantation of organs infected with human immunodeficiency 
virus (HIV), having considered the same, report favorably 
thereon without amendment and recommend that the bill do pass.

                                CONTENTS

                                                                   Page
Purpose and Summary..............................................     2
Background and Need for Legislation..............................     2
Hearings.........................................................     2
Committee Consideration..........................................     2
Committee Votes..................................................     2
Committee Oversight Findings.....................................     3
Statement of General Performance Goals and Objectives............     3
New Budget Authority, Entitlement Authority, and Tax Expenditures     3
Earmark, Limited Tax Benefits, and Limited Tariff Benefits.......     3
Committee Cost Estimate..........................................     3
Congressional Budget Office Estimate.............................     3
Federal Mandates Statement.......................................     4
Duplication of Federal Programs..................................     4
Disclosure of Directed Rule Makings..............................     5
Advisory Committee 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............     5
Exchange of Letters With Additional Committees of Referral.......     9

                          Purpose and Summary

    H.R. 698, the HIV Organ Policy Equity Act, was introduced 
on February 14, 2013, by Rep. Lois Capps (D-CA) and 
subsequently referred to the Committee on Energy and Commerce.
    The legislation would amend the Public Health Service Act 
to lift the ban on the transplantation of organs infected with 
the human immunodeficiency virus (HIV). The legislation also 
would require the establishment of standards for the research 
and transplantation of organs infected with HIV.

                  Background and Need for Legislation

    Congress passed the National Organ Transplant Act (NOTA) in 
1984 to guide organ donation and transplantation. In 1988, NOTA 
was amended to include a ban on the transplantation of organs 
infected with HIV.
    Today, medical advances in HIV treatment have improved and 
extended the lives of HIV patients, but also have increased the 
need for organ donations. Research is needed to fully evaluate 
the safety and efficacy of organ transplantation between 
individuals with HIV.
    H.R. 698, the ``HIV Organ Policy Equity Act,'' would lift 
the ban on acquiring HIV infected organs and conduct research 
to set standards for their use in transplantation provided that 
such standards ensure that HIV-infected organs are transplanted 
only into individuals who are already infected with the HIV 
virus. The legislation also would direct the Secretary of the 
Department of Health and Human Services (HHS) to develop and 
implement standards for research on the transplantation of HIV-
infected organs. The Secretary would annually review the 
results of this research and, if warranted, direct the Organ 
Procurement and Transplantation Network (OPTN) to revise its 
quality standards related to the transplantation of HIV-
infected organs. In addition, the legislation would amend the 
Federal criminal code to specify that an HIV-infected organ 
donation does not violate the prohibition in Federal law if the 
donation is made consistent with this legislation.

                                Hearings

    The Committee on Energy and Commerce has not held hearings 
on the legislation.

                        Committee Consideration

    On July 17, 2013, the full Committee met in open markup 
session and approved H.R. 689 by unanimous consent.

                            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. A 
motion by Mr. Upton to order H.R. 698, reported to the House, 
without amendment, was agreed to be a unanimous consent. There 
were no record votes taken in connection with ordering H.R. 698 
reported.

                      Committee Oversight Findings

    Pursuant to clause 3(c)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee has not held oversight 
or legislative hearings on this legislation.

         Statement of General Performance Goals and Objectives

    The goal of the legislation is to study and set standards 
of quality for research and transplantation of organs infected 
with HIV.

        New Budget Authority, Entitlement, 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. 
698, the ``HIV Organ Policy Equity Act,'' would result in no 
new or increased budget authority, entitlement authority, or 
tax expenditures or revenues.

       Earmark, Limited Tax Benefits, and Limited Tariff Benefits

    In compliance with clause 9(e), 9(f), and 9(g) of rule XXI 
of the House of Representatives, the Committee finds that H.R. 
698, the ``HIV Organ Policy Equity Act,'' contains no earmarks, 
limited tax benefits, or limited tariff benefits.

                        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, July 19, 2013.
Hon. Fred Upton,
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. 698, the HIV Organ 
Policy Equity Act.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Lisa Ramirez-
Branum.
            Sincerely,
                                              Douglas W. Elmendorf.
            Enclosure.

H.R. 698--HIV Organ Policy Equity Act

    H.R. 698 would amend provisions of the Public Health 
Service Act that authorize the Secretary of the Department of 
Health and Human Services (HHS) to establish guidelines and 
quality standards for conducting research relating to donated 
organs and for acquiring and procuring such organs.
    The bill would remove a provision in current law that 
prohibits the acquisition and procurement of donated organs 
that are infected with the virus that causes acquired immune 
deficiency syndrome. H.R. 698 also would require the Secretary 
of HHS to develop guidelines for conducting research relating 
to organ transplants from donors who are infected with the 
human immunodeficiency virus (HIV). The Secretary would be 
required to annually review the results of the research to 
determine whether the results warrant revising the quality 
standards for acquiring and procuring donated organs. Finally, 
the bill would authorize the Secretary to establish standards 
for acquiring and procuring donated organs that are infected 
with HIV, provided that any such standards ensure that an organ 
infected with HIV may be transplanted only into individuals who 
are infected with HIV before receiving such organ.
    To implement H.R. 698, CBO estimates that HHS would incur 
administrative costs of less than $500,000 annually and about 
$1 million over the 2014-2018 period. Any such costs would be 
subject to the availability of appropriated funds. Pay-as-you-
go procedures do not apply to this legislation because it would 
not affect direct spending or revenues.
    The bill contains no intergovernmental or private-sector 
mandates as defined in the Unfunded Mandates Reform Act.
    On May 22, 2013, CBO transmitted a cost estimate for S. 
330, the HIV Organ Policy Equity Act, as reported by the Senate 
Committee on Health, Education, Labor, and Pensions on March 
20, 2013. The two pieces of legislation are similar.
    H.R. 698 would require the Secretary to issue guidelines, 
and review research more quickly than as required under S. 330. 
However, CBO estimates that administrative costs would be 
roughly the same--about $1 million over five years--for 
implementation of either H.R. 698 or S. 330.
    The staff contact for this bill is Lisa Ramirez-Branum. The 
estimate was approved by Peter H. Fontaine, 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.

                    Duplication of Federal Programs

    No provision of H.R. 698, the ``HIV Organ Policy Equity 
Act,'' establishes or reauthorizes a program of the Federal 
Government known to be duplicative of another Federal program, 
a program that was included in any report from the Government 
Accountability Office to Congress pursuant to section 21 of 
Public Law 111-139, or a program related to a program 
identified in the most recent Catalog of Federal Domestic 
Assistance.

                  Disclosure of Directed Rule Makings

    The Committee estimates that enacting H.R. 698, the ``HIV 
Organ Policy Equity Act,'' would not direct specific rule 
making within the meaning of 5 U.S.C. 551.

                      Advisory Committee Statement

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

                  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 Act may be cited as the ``HIV Organ Policy Equity 
Act.''

Section 2. Amendments to the Public Health Service Act

    Section 2 would strike language in the Public Health 
Service Act that prohibits the acquisition of HIV-infected 
organs. It also would clarify that the Organ Procurement and 
Transplantation Network (OPTN) may adopt and implement 
standards with respect to HIV-infected organs, provided such 
standards ensure that HIV-infected organs are transplanted only 
into individuals who are already infected with the HIV virus.
    In addition, this section would direct the HHS Secretary, 
not later than one year after enactment, to develop and publish 
guidelines for research on the transplantation of HIV-infected 
organs. The OPTN would revise its standards of quality for HIV-
infected organs, and the Secretary would revise relevant 
regulations based on these guidelines. Not later than two years 
after the date of enactment, and annually thereafter, the 
Secretary would review the results of the research to determine 
if the OPTN quality standards on the transplantation of HIV-
infected organs should be further revised. If such a finding is 
made, the Secretary is required to direct the OPTN to make such 
revisions.

Section 3. Conforming Amendment to Title XVII of the United States Code

    This section would amend the Federal criminal code to 
specify that an HIV-infected organ donation does not violate 
the prohibition in Federal law if the donation is made 
consistent with this legislation.

         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

           *       *       *       *       *       *       *



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

           *       *       *       *       *       *       *



                       Part H--Organ Transplants


                    organ procurement organizations

  Sec. 371. (a) * * *
  (b)(1) * * *

           *       *       *       *       *       *       *

  (3) An organ procurement organization shall--
          (A) * * *

           *       *       *       *       *       *       *

          (C) arrange for the acquisition and preservation of 
        donated organs and provide quality standards for the 
        acquisition of organs which are consistent with the 
        standards adopted by the Organ Procurement and 
        Transplantation Network under section 372(b)(2)(E), 
        [including arranging for testing with respect to 
        preventing the acquisition of organs that are infected 
        with the etiologic agent for acquired immune deficiency 
        syndrome] including arranging for testing with respect 
        to identifying organs that are infected with human 
        immunodeficiency virus (HIV),

           *       *       *       *       *       *       *


             organ procurement and transplantation network

  Sec. 372. (a) * * *
  (b)(1) * * *
  (2) The Organ Procurement and Transplantation Network shall--
          (A) * * *

           *       *       *       *       *       *       *

          (E) adopt and use standards of quality for the 
        acquisition and transportation of donated organs[, 
        including standards for preventing the acquisition of 
        organs that are infected with the etiologic agent for 
        acquired immune deficiency syndrome],

           *       *       *       *       *       *       *

          (3) Clarification.--In adopting and using standards 
        of quality under paragraph (2)(E), the Organ 
        Procurement and Transplantation Network may adopt and 
        use such standards with respect to organs infected with 
        human immunodeficiency virus (HIV), provided that any 
        such standards ensure that organs infected with human 
        immunodeficiency virus may be transplanted only into 
        individuals who are infected with such virus before 
        receiving such organ.

           *       *       *       *       *       *       *


SEC. 377E. GUIDELINES, STANDARDS, AND REGULATIONS WITH RESPECT TO 
                    ORGANS INFECTED WITH HIV.

  (a) In General.--Not later than 1 year after the date of the 
enactment of the HIV Organ Policy Equity Act, the Secretary 
shall develop and publish guidelines for the conduct of 
research relating to transplantation of organs from donors 
infected with human immunodeficiency virus (in this section 
referred to as ``HIV'').
  (b) Corresponding Changes to Standards and Regulations 
Applicable to Research.--Not later than 1 year after the date 
of the enactment of the HIV Organ Policy Equity Act, to the 
extent determined by the Secretary to be necessary to allow the 
conduct of research in accordance with the guidelines developed 
under subsection (a)--
          (1) the Organ Procurement and Transplantation Network 
        shall revise the standards of quality adopted under 
        section 372(b)(2)(E); and
          (2) the Secretary shall revise section 121.6 of title 
        42, Code of Federal Regulations (or any successor 
        regulations).
  (c) Revision of Standards and Regulations Generally.--Not 
later than 2 years after the date of the enactment of the HIV 
Organ Policy Equity Act, and annually thereafter, the 
Secretary, shall--
          (1) review the results of scientific research in 
        conjunction with the Organ Procurement and 
        Transplantation Network to determine whether the 
        results warrant revision of the standards of quality 
        adopted under section 372(b)(2)(E) with respect to 
        donated organs infected with HIV and with respect to 
        the safety of cross-strain transplantation;
          (2) if the Secretary determines under paragraph (1) 
        that such results warrant revision of the standards of 
        quality adopted under section 372(b)(2)(E) with respect 
        to donated organs infected with HIV and with respect to 
        cross-strain transplantation, direct the Organ 
        Procurement and Transplantation Network to revise such 
        standards, consistent with section 372 and in a way 
        that ensures the changes will not reduce the safety of 
        organ transplantation; and
          (3) in conjunction with any revision of such 
        standards under paragraph (2), shall revise section 
        121.6 of title 42, Code of Federal Regulations (or any 
        successor regulations) for consistency with such 
        standards.

           *       *       *       *       *       *       *

                              ----------                              


                      TITLE 18, UNITED STATES CODE



           *       *       *       *       *       *       *
PART I--CRIMES

           *       *       *       *       *       *       *


CHAPTER 51--HOMICIDE

           *       *       *       *       *       *       *


Sec. 1122. Protection against the human immunodeficiency virus

  (a) * * *

           *       *       *       *       *       *       *

  (d) Exception.--An organ donation does not violate this 
section if the donation is in accordance with all applicable 
guidelines and regulations of the Secretary made under section 
377E of the Public Health Service Act.

           *       *       *       *       *       *       *