[House Report 118-140]
[From the U.S. Government Publishing Office]


118th Congress }                                          { Report 
                        HOUSE OF REPRESENTATIVES
 1st Session   }                                          { 118-140

======================================================================
 
  SECURING THE U.S. ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK ACT

                                _______
                                

 July 11, 2023.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

Mrs. Rodgers of Washington, from the Committee on Energy and Commerce, 
                        submitted the following

                              R E P O R T

                        [To accompany H.R. 2544]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 2544) to improve the Organ Procurement and 
Transplantation Network, and for other purposes, having 
considered the same, reports favorably thereon without 
amendment and recommends that the bill do pass.

                                CONTENTS

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

                          Purpose and Summary

    H.R. 2544, the ``Securing the U.S. Organ Procurement and 
Transplantation Network Act.'' introduced by Representatives 
Larry Bucshon (R-IN) and Robin Kelly (D-IL), amends the Public 
Health Service Act to allow for competition within the Organ 
Procurement and Transplantation Network (OPTN) contract 
process. The legislation also makes technical changes and 
requires the Comptroller General to conduct a review of the 
OPTN and submit its findings to the House Energy and Commerce 
Committee and the Senate Health, Education, Labor, and Pensions 
committee.

                  Background and Need for Legislation

    Close to 104,000 people are on the national organ 
transplant wait list.\1\ Around 41,000 patients in need of an 
organ received a transplant from either a living or deceased 
donor in 2022, which is just a fraction of the total organ 
transplant waitlist.\2\ The National Academy of Sciences issued 
a report in 2022 that found that the current U.S. organ 
transplant system is demonstrably inequitable, with wide 
variation in performance across the system.\3\ The report found 
that approximately one in five kidneys from deceased donors are 
not used, and at least 17 people a day die waiting for an organ 
transplant.
---------------------------------------------------------------------------
    \1\Organ Procurement and Transplantation Network Modernization 
Initiative, Health Resources and Service Administration (HRSA).
    \2\Id.
    \3\National Academies of Sciences, Engineering, and Medicine, 
Realizing the Promise of Equity in the Organ Transplantation System, 
(Feb. 2022).
---------------------------------------------------------------------------
    In the U.S., procurement of organs from deceased donors for 
transplantation is done by organ procurement organizations 
(OPOs). OPOs are responsible for working with donor hospitals 
to identify opportunities for organ donation, working with 
donor families to obtain consent for organ donation, when 
necessary, conducting testing to identify potential for disease 
transmission or other safety issues, and safely procuring and 
transporting all transplantable organs based on OPTN 
policies.\4\ There are currently 57 OPOs with each assigned to 
their own donation service area (DSA). The Social Security Act 
requires than an OPO be a member of the OPTN, a membership 
organization that links all professionals in the U.S. organ 
donation and transplantation system. The OPTN is responsible 
for governing how deceased donor organs are allocated to 
individuals on the waiting list.
---------------------------------------------------------------------------
    \4\U.S. Centers for Medicare and Medicaid Services, Organ 
Procurement Organization (OPO) Conditions for Coverage Final Rule: 
Revisions to Outcome Measures for OPOs CMS-3380-F, (Nov. 20, 2020).
---------------------------------------------------------------------------
    A single contractor has operated the OPTN since it was 
created, and there has been little to no competition for the 
contract. This has stifled innovation and hindered efforts to 
increase equity in organ allocation, according to a review by 
the U.S. Digital Service.\5\ Additionally, this contractor has 
been the subject of Congressional investigations and 
allegations from patients, families, transplant centers, and 
others, of consistent mismanagement, lack of technical 
expertise, failure to provide adequate oversight of OPOs, and 
risks to patient safety.\6\ In fact, the Centers for Medicare 
and Medicaid Services (CMS) has estimated that if OPOs 
increased their performance, approximately 5,6000 more organs 
per year could be transplanted.\7\
---------------------------------------------------------------------------
    \5\The Washington Post, Thousands of Lives Depend on a Transplant 
Network in Need of ``Vast Restructuring,'' (July 31, 2022).
    \6\Senate Finance Committee, Memo on ``A System in Need of Repair: 
Addressing Organizational Failures of the U.S.'s Organ Procurement and 
Transplantation Network,'' (Aug. 3, 2022).
    \7\Id.
---------------------------------------------------------------------------
    The management of the organ transplant system in the U.S. 
needs reform. H.R. 2544 is necessary to increase competition 
within the OPTN with the ultimate goal of improving OPO 
performance and patient outcomes.

                            Committee Action

    On April 19, 2023, the Subcommittee on Health held a 
hearing on H.R. 2544. The Subcommittee received testimony from:
           Carole Johnson, Administrator, Health 
        Resources and Services Administration
    On May 17, 2023, the Subcommittee on Health met in open 
markup session and forwarded H.R. 2544, without amendment, to 
the full Committee by a record vote of 28 yeas and 0 nays. On 
May 24, 2023, the full Committee on Energy and Commerce met in 
open markup session and ordered H.R. 2544, without amendment, 
favorably reported to the House by a record vote of 49 yeas and 
0 nays.

                            Committee Votes

    Clause 3(b) of rule XIII requires the Committee to list the 
record votes on the motion to report legislation and amendments 
thereto. The following reflects the record votes taken during 
the Committee consideration:


                 Oversight Findings and Recommendations

    Pursuant to clause 2(b)(1) of rule X and clause 3(c)(1) of 
rule XIII, the Committee held a hearing and made findings that 
are reflected in this report.

             New Budget Authority, Entitlement Authority, 
                          and Tax Expenditures

    Pursuant to clause 3(c)(2) of rule XIII, the Committee 
finds that H.R. 2544 would result in no new or increased budget 
authority, entitlement authority, or tax expenditures or 
revenues.

                  Congressional Budget Office Estimate

    Pursuant to clause 3(c)(3) of rule XIII, at the time this 
report was filed, the cost estimate prepared by the Director of 
the Congressional Budget Office pursuant to section 402 of the 
Congressional Budget Act of 1974 was not available.

                       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.

         Statement of General Performance Goals and Objectives

    Pursuant to clause 3(c)(4) of rule XIII, the general 
performance goal or objective of this legislation is to allow 
for competition within the OPTN contracting process to improve 
the United States' organ transplantation system and improve 
health outcomes for patients.

                    Duplication of Federal Programs

    Pursuant to clause 3(c)(5) of rule XIII, no provision of 
H.R. 2544 is known to be duplicative of another Federal 
program, including any program that was included in a report to 
Congress pursuant to section 21 of Public Law 111-139 or the 
most recent Catalog of Federal Domestic Assistance.

              Related Committee and Subcommittee Hearings

    Pursuant to clause 3(c)(6) of rule XIII, the following 
related hearing was used to develop or consider H.R. 2544: 
``Examining Existing Federal Programs to Build a Stronger 
Health Workforce and Improve Primary Care,'' held on April 19, 
2023. Witness was HRSA Administrator, Carole Johnson.

                        Committee Cost Estimate

    Pursuant to clause 3(d)(1) of rule XIII, 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. At the time this report was 
filed, the estimate was not available.

       Earmark, Limited Tax Benefits, and Limited Tariff Benefits

    Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, the 
Committee finds that H.R. 2544 contains no earmarks, limited 
tax benefits, or limited tariff benefits.

                      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

    Section 1 provides the short title of ``Securing the U.S. 
Organ Procurement and Transplantation Network Act.''

Section 2. Organ procurement and transplantation network

    Section 2 amends section 372 of the Public Health Service 
Act (PHSA) to clarify HRSA's authority to award grants, 
contracts, or cooperative agreements, as the Secretary 
determines appropriate, for the purpose of carrying out the 
functions of the OPTN. The section also requires that the OPTN 
contacting process to be competitive and to be operated through 
awards to public or private entities made by the Secretary that 
are distinct from the awards made to support the organization 
tasked with supporting the board of directors.

Section 3. Technical amendments

    Section 3 makes technical changes to Title III of the PHSA.

Section 4. GAO review

    Section 4 requires the Comptroller General to conduct a 
review of the historical financing of OPTN, including the 
utilization of registration fees among entities that have 
previously been awarded contracts; and to report its finding 
and recommendations to Congress.

         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 italics, and 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)(1) The Secretary may make grants for the 
planning of qualified organ procurement organizations described 
in subsection (b).
  (2) The Secretary may make grants for the establishment, 
initial operation, consolidation, and expansion of qualified 
organ procurement organizations described in subsection (b).
  (b)(1) A qualified organ procurement organization for which 
grants may be made under subsection (a) is an organization 
which, as determined by the Secretary, will carry out the 
functions described in paragraph (2) and--
          (A) is a nonprofit entity,
          (B) has accounting and other fiscal procedures (as 
        specified by the Secretary) necessary to assure the 
        fiscal stability of the organization,
          (C) has an agreement with the Secretary to be 
        reimbursed under title XVIII of the Social Security Act 
        for the procurement of kidneys,
          (D) notwithstanding any other provision of law, has 
        met the other requirements of this section and has been 
        certified or recertified by the Secretary within the 
        previous 4-year period as meeting the performance 
        standards to be a qualified organ procurement 
        organization through a process that either--
                  (i) granted certification or recertification 
                within such 4-year period with such 
                certification or recertification in effect as 
                of January 1, 2000, and remaining in effect 
                through the earlier of--
                          (I) January 1, 2002; or
                          (II) the completion of 
                        recertification under the requirements 
                        of clause (ii); or
                  (ii) is defined through regulations that are 
                promulgated by the Secretary by not later than 
                January 1, 2002, that--
                          (I) require recertifications of 
                        qualified organ procurement 
                        organizations not more frequently than 
                        once every 4 years;
                          (II) rely on outcome and process 
                        performance measures that are based on 
                        empirical evidence, obtained through 
                        reasonable efforts, of organ donor 
                        potential and other related factors in 
                        each service area of qualified organ 
                        procurement organizations;
                          (III) use multiple outcome measures 
                        as part of the certification process; 
                        and
                          (IV) provide for a qualified organ 
                        procurement organization to appeal a 
                        decertification to the Secretary on 
                        substantive and procedural grounds;
          (E) has procedures to obtain payment for non-renal 
        organs provided to transplant centers,
          (F) has a defined service area that is of sufficient 
        size to assure maximum effectiveness in the procurement 
        and equitable distribution of organs, and that either 
        includes an entire metropolitan statistical area (as 
        specified by the Director of the Office of Management 
        and Budget) or does not include any part of the area,
          (G) has a director and such other staff, including 
        the organ donation coordinators and organ procurement 
        specialists necessary to effectively obtain organs from 
        donors in its service area, and
          (H) has a board of directors or an advisory board 
        which--
                  (i) is composed of--
                          (I) members who represent hospital 
                        administrators, intensive care or 
                        emergency room personnel, tissue banks, 
                        and voluntary health associations in 
                        its service area,
                          (II) members who represent the public 
                        residing in such area,
                          (III) a physician with knowledge, 
                        experience, or skill in the field of 
                        [histocompatability] histocompatibility 
                        or an individual with a doctorate 
                        degree in a biological science with 
                        knowledge, experience, or skill in the 
                        field of histocompatibility,
                          (IV) a physician with knowledge or 
                        skill in the field of neurology, and
                          (V) from each transplant center in 
                        its service area which has arrangements 
                        described in paragraph (3)(G) with the 
                        organization, a member who is a surgeon 
                        who has practicing privileges in such 
                        center and who performs organ 
                        transplant surgery,
                  (ii) has the authority to recommend policies 
                for the procurement of organs and the other 
                functions described in paragraph (3), and
                  (iii) has no authority over any other 
                activity of the organization.
  (2)(A) Not later than 90 days after the date of the enactment 
of this paragraph, the Secretary shall publish in the Federal 
Register a notice of proposed rulemaking to establish criteria 
for determining whether an entity meets the requirement 
established in paragraph (1)(E).
  (B) Not later than 1 year after the date of enactment of this 
paragraph, the Secretary shall publish in the Federal Register 
a final rule to establish the criteria described in 
subparagraph (A).
  (3) An organ procurement organization shall--
          (A) have effective agreements, to identify potential 
        organ donors, with a substantial majority of the 
        hospitals and other health care entities in its service 
        area which have facilities for organ donations,
          (B) conduct and participate in systematic efforts, 
        including professional education, to acquire all usable 
        organs from potential donors,
          (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 
        identifying organs that are infected with human 
        immunodeficiency virus (HIV),
          (D) arrange for the appropriate tissue typing of 
        donated organs,
          (E) have a system to allocate donated organs 
        equitably among transplant patients according to 
        established medical criteria,
          (F) provide or arrange for the transportation of 
        donated organs to transplant centers,
          (G) have arrangements to coordinate its activities 
        with transplant centers in its service area,
          (H) participate in the Organ Procurement 
        Transplantation Network established under section 372,
          (I) have arrangements to cooperate with tissue banks 
        for the retrieval, processing, preservation, storage, 
        and distribution of tissues as may be appropriate to 
        assure that all usable tissues are obtained from 
        potential donors,
          (J) evaluate annually the effectiveness of the 
        organization in acquiring potentially available organs, 
        and
          (K) assist hospitals in establishing and implementing 
        protocols for making routine inquiries about organ 
        donations by potential donors.
  (c) Pancreata procured by an organ procurement organization 
and used for islet cell transplantation or research shall be 
counted for purposes of certification or recertification under 
subsection (b).

           *       *       *       *       *       *       *


             organ procurement and transplantation network

  Sec. 372. (a) [The Secretary shall by contract] In General_
The Secretary shall  provide for the [establishment and] 
continued operation of an Organ Procurement and Transplantation 
Network which meets the requirements of subsection (b). [The 
amount provided under such contract in any fiscal year may not 
exceed $7,000,000. Funds for such contracts shall be made 
available from funds available to the Public Health Service 
from appropriations for fiscal years beginning after fiscal 
year 1984.] The Secretary may award grants, contracts, or 
cooperative agreements, as the Secretary determines 
appropriate, for purposes of carrying out this section.
  (b) Composition._[(1) The Organ Procurement and 
Transplantation Network shall carry out the functions described 
in paragraph (2) and shall--]
          [(A) be a private nonprofit entity that has an 
        expertise in organ procurement and transplantation, 
        and]
          (1) In general.--The Organ Procurement and 
        Transplantation Network shall--
                  (A) be operated through awards to public or 
                private entities made by the Secretary that are 
                distinct from the awards made to support the 
                organization tasked with supporting the board 
                of directors described in subparagraph (B); and
          (B) have a board of directors--
                  (i) that includes representatives of organ 
                procurement organizations (including 
                organizations that have received grants under 
                section 371), transplant centers, voluntary 
                health associations, and the general public; 
                and
                  (ii) that shall establish an executive 
                committee and other committees, whose 
                chairpersons shall be selected to ensure 
                continuity of leadership for the board.
  (2) The Organ Procurement and Transplantation Network shall--
          (A) establish in one location or through regional 
        centers--
                  (i) a national list of individuals who need 
                organs, and
                  (ii) a national system, through the use of 
                computers and in accordance with established 
                medical criteria, to match organs and 
                individuals included in the list, especially 
                individuals whose immune system makes it 
                difficult for them to receive organs,
          (B) establish membership criteria and medical 
        criteria for allocating organs and provide to members 
        of the public an opportunity to comment with respect to 
        such criteria,
          (C) maintain a twenty-four-hour telephone service to 
        facilitate matching organs with individuals included in 
        the list,
          (D) assist organ procurement organizations in the 
        nationwide distribution of organs equitably among 
        transplant patients,
          (E) adopt and use standards of quality for the 
        acquisition and transportation of donated organs,
          (F) prepare and distribute, on a regionalized basis 
        (and, to the extent practicable, among regions or on a 
        national basis), samples of blood sera from individuals 
        who are included on the list and whose immune system 
        makes it difficult for them to receive organs, in order 
        to facilitate matching the compatibility of such 
        individuals with organ donors,
          (G) coordinate, as appropriate, the transportation of 
        organs from organ procurement organizations to 
        transplant centers,
          (H) provide information to physicians and other 
        health professionals regarding organ donation,
          (I) collect, analyze, and publish data concerning 
        organ donation and transplants,
          (J) carry out studies and demonstration projects for 
        the purpose of improving procedures for organ 
        procurement and allocation,
          (K) work actively to increase the supply of donated 
        organs,
          (L) submit to the Secretary an annual report 
        containing information on the comparative costs and 
        patient outcomes at each transplant center affiliated 
        with the organ procurement and transplantation network,
          (M) recognize the differences in health and in organ 
        transplantation issues between children and adults 
        throughout the system and adopt criteria, polices, and 
        procedures that address the unique health care needs of 
        children,
          (N) carry out studies and demonstration projects for 
        the purpose of improving procedures for organ donation 
        procurement and allocation, including but not limited 
        to projects to examine and attempt to increase 
        transplantation among populations with special needs, 
        including children and individuals who are members of 
        racial or ethnic minority groups, and among populations 
        with limited access to transportation, and
          (O) provide that for purposes of this paragraph, the 
        term ``children'' refers to individuals who are under 
        the age of 18.
          (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 (in this paragraph 
        referred to as ``HIV''), provided that any such 
        standards ensure that organs infected with HIV may be 
        transplanted only into individuals who--
                  (A) are infected with HIV before receiving 
                such organ; and
                  (B)(i) are participating in clinical research 
                approved by an institutional review board under 
                the criteria, standards, and regulations 
                described in subsections (a) and (b) of section 
                377E; or
                  (ii) if the Secretary has determined under 
                section 377E(c) that participation in such 
                clinical research, as a requirement for such 
                transplants, is no longer warranted, are 
                receiving a transplant under the standards and 
                regulations under section 377E(c).
  (c) The Secretary shall establish procedures for--
          (1) receiving from interested persons critical 
        comments relating to the manner in which the Organ 
        Procurement and Transplantation Network is carrying out 
        the duties of the Network under subsection (b); and
          (2) the consideration by the Secretary of such 
        critical comments.

           *       *       *       *       *       *       *


           general provisions respecting grants and contracts

  Sec. 374. (a) No grant may be made under this part or 
contract entered into under section 372 or 373 unless an 
application therefor has been submitted to, and approved by, 
the Secretary. Such an application shall be in such form and 
shall be submitted in such manner as the Secretary shall by 
regulation prescribe.
  (b)(1) A grant for planning under section 371(a)(1) may be 
made for one year with respect to any organ procurement 
organization and may not exceed $100,000.
  (2) Grants under section 371(a)(2) may be made for two years. 
No such grant may exceed $500,000 for any year and no organ 
procurement organization may receive more than $800,000 for 
initial operation or expansion.
  (3) Grants or contracts under section 371(a)(3) may be made 
for not more than 3 years.
  (c)(1) The Secretary shall determine the amount of a grant or 
contract made under section 371 or 373. Payments under such 
grants and contracts may be made in advance on the basis of 
estimates or by the way of reimbursement, with necessary 
adjustments on account of underpayments or overpayments, and in 
such installments and on such terms and conditions as the 
Secretary finds necessary to carry out the purposes of such 
grants and contracts.
  (2)(A) Each recipient of a grant or contract under [section 
371 or 373] section 371, 372, or 373 shall keep such records as 
the Secretary shall prescribe, including records which fully 
disclose the amount and disposition by such recipient of the 
proceeds of such grant or contract, the total cost of the 
undertaking in connection with which such grant or contract was 
made, and the amount of that portion of the cost of the 
undertaking supplied by other sources, and such other records 
as will facilitate an effective audit.
  (B) The Secretary and the Comptroller General of the United 
States, or any of their duly authorized representatives, shall 
have access for the purpose of audit and examination to any 
books, documents, papers, and records of the recipient of a 
grant or contract under [section 371 or 373] section 371, 372, 
or 373 that are pertinent to such grant or contract.
  (d) For purposes of this part:
          (1) The term ``transplant center'' means a health 
        care facility in which transplants of organs are 
        performed.
          (2) The term ``organ'' means the human kidney, liver, 
        heart, lung, pancreas, and any other human organ (other 
        than corneas and eyes) specified by the Secretary by 
        regulation and for purposes of section 373, such term 
        includes bone marrow.

                             administration

  Sec. 375. The Secretary shall designate and maintain an 
identifiable administrative unit in the Public Health Service 
to--
          (1) administer this part and coordinate with the 
        organ procurement activities under title XVIII of the 
        Social Security Act[,];
          (2) conduct a program of public information to inform 
        the public of the need for organ donations[,];
          (3) provide technical assistance to organ procurement 
        organizations, the Organ Procurement and 
        Transplantation Network established under section 372, 
        and other entities in the health care system involved 
        in organ donations, procurement, and [transplants, and] 
        transplants; and
          (4) provide information--
                  
                  [(i)] (A) to patients, their families, and 
                their physicians about transplantation; and
                  [(ii)] (B) to patients and their families 
                about the resources available nationally and in 
                each State, and the comparative costs and 
                patient outcomes at each transplant center 
                affiliated with the organ procurement and 
                transplantation network, in order to assist the 
                patients and families with the costs associated 
                with transplantation.

                                 report

  Sec. 376. Not later than [February 10 of 1991 and of each 
second year thereafter] 2 years after the date of enactment of 
the Securing the U.S. Organ Procurement and Transplantation 
Network Act and every second year thereafter, the Secretary 
shall publish, and submit to the Committee on Energy and 
Commerce of the House of Representatives and the [Committee on 
Labor and Human Resources of the Senate.] Committee on Health, 
Education, Labor, and Pensions of the Senate, a report on the 
scientific and clinical status of organ transplantation. The 
Secretary shall consult with the Director of the National 
Institutes of Health and the Commissioner of the Food and Drug 
Administration in the preparation of the report.

           *       *       *       *       *       *       *


                                  [all]