29–006 

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 


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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. 


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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 standVerDate Mar 15 2010 20:03 Aug 01, 2013 Jkt 029006 PO 00000 Frm 00003 Fmt 6659 Sfmt 6602 E:\HR\OC\HR181P1.XXX HR181P1

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ards 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. 


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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 HIVinfected 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): 


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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), øincluding 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 organsø, 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. 

* * * * * * * 


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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 

* * * * * * * 


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§ 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. 

* * * * * * * 


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EXCHANGE Of LETTERS WITH ADDITIONAL COMMITTEES OF REfERRAL 

ONE: HUNDRED TH1R1EENTH CONGRESS 

<l:ongre55 of tile 'l1nited ~tate5 

i1.ousr of 'Rrprcscnratiocs COMMITTEE ON THE JUDICIARY 

2138 RAYBUflN Ho~n:;E OFFICE BUILDING 

The Honorable Fred Upton 

Chainnan 

Committee on Energy and Commerce 

2125 Rayburn House Office Building 

Washington, D.C. 20515 

Dear Chairman Upton, 

WASHII'!GTON, DC 20515-6216 

2:/5-3951 

July 22, 2013 

I am writing with respect to H.R. 698, the "HIV Organ Policy Equity Act," which the 

Committee on Energy and Commerce reported favorably on July 17, 2013. As a result of your 

having consulted with us on provisions in H.R. 698 that fall within the Rule X jurisdiction of the 

Committee on the Judiciary, I agree to discharge our Committee from further consideration of 

this bill so that it may proceed expeditiously to the House floor for consideration. 

The judiciary Committee takes this action with our mutual understanding that by 

foregoing consideration of H.R. 698 at this time, we do not waiye any jurisdiction over subject 

matter contained in this or similar legislation, and that our Committee will be appropriately 

consulted and involved as the bill or similar legislation moves forward so that we may address 

any remaining issues in our jurisdiction. Our Committee also reserves the right to seek 

appointment of an appropriate number of conferees to any House-Senate conference involving 

this or similar legislation, and asks that you support any such request. 

I would appreciate a response to this letter confirming this understanding with respect to 

H.R. 698, and would ask that a copy of our exchange of letters on this matter be included in the 

Congressional Rec?rd during Floor consideration ofH.R. 698. 

ilCereIY' 

o Cloodlal1e 

Chainnan 

,&ff 
10 


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Hon. Fred Upton 

July 22. 2013 

Page 2 

cc: The Honorable John Conyers, Jr. 

The lIonorable Henry Waxman 

The Honorable John Boehner, Speaker 

Mr. Thomas J. Wickham, Jr., Parliamentarian 
11 


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FRED UPTON, MICHIGAN 

CHA1RMAN 

ONE HUNDRED THIRTEENTH CONGRESS 

HENRY A. WAXMAN, CALIFORNIA 

RANKING MEMBER 

(:ongrt~~ of tbe ilniteb ~tatt~ 

~ou£lt of !\eprtStntatll.1e£l 

COMMITTEE ON ENERGY AND COMMERCE 

2125 RAYBURN HOUSE OFFICE BUILDING 

WASHINGTON, DC 20515-6115 1202)225-2927 

120:2):225-3641 

July 23, 2013 

The Honorable Bob Goodlatte 

Chairman 

Committee on the Judiciary 

2138 Rayburn House Office Building 

Washington, D.C. 20515 

Dear Chairman Goodlatte, 

Thank you for your letter regarding H.R. 698, the "HIV Organ Policy Equity Act." As 

you noted, there are provisions of the bill that fall within the Rule X jurisdiction of the 

Committee on the Judiciary. 

I appreciate your willingness to forgo action on H.R. 698, and I agree that your decision 

is not a waiver of any of the Committee on the Judiciary's jurisdiction over the subject matter 

contained in this or similar legislation, and that the Committee will be appropriately consulted 

and involved as the bill or similar legislation moves forward to address any remaining issues in 

the Committee's jurisdictiorL In addition, I understand the Committee reserves the right to seek 

the appointment of conferees to any House-Senate conference involving this or similar 

legislation, for which you will have my support. 

I will include a copy of your letter and this response in the Congressional Record during 

consideration ofH.R. 698 on the House floor. 

Sincerely, 

~~ ....... --- o