[House Report 116-696]
[From the U.S. Government Publishing Office]


116th Congress   }                                  {    Rept. 116-696
                        HOUSE OF REPRESENTATIVES
 2d Session      }                                  {           Part 1

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



 
PROTECTING ACCESS TO INFORMATION FOR EFFECTIVE AND NECESSARY TREATMENT 
                            AND SERVICES ACT

                                _______
                                

 December 24, 2020.--Committed to the Committee of the Whole House on 
            the State of the Union and ordered to be printed

                                _______
                                

Mr. Neal, from the Committee on Ways and Means, submitted the following

                              R E P O R T

                             together with

                            DISSENTING VIEWS

                        [To accompany H.R. 3439]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Ways and Means, to whom was referred the 
bill (H.R. 3439) to amend the Internal Revenue Code of 1986 and 
title XI of the Social Security Act to extend appropriations 
and transfers to the Patient-Centered Outcomes Research Trust 
Fund and to extend certain health insurance fees for such 
transfers, and for other purposes, having considered the same, 
reports favorably thereon with an amendment and recommends that 
the bill as amended do pass.

                                CONTENTS

                                                                   Page
  I. SUMMARY AND BACKGROUND...........................................2
          A. Purpose and Summary.................................     2
          B. Background and Need for Legislation.................     3
          C. Legislative History.................................     3
 II. EXPLANATION OF THE BILL..........................................4
          A. The Protecting Access to Information for Effective 
              and Necessary Treatment (PATIENT) Act of 2019......     4
III. VOTES OF THE COMMITTEE...........................................6
 IV. BUDGET EFFECTS OF THE BILL.......................................8
          A. Committee Estimate of Budgetary Effects.............     8
          B. Statement Regarding New Budget Authority and Tax 
              Expenditures Budget Authority......................     8
          C. Cost Estimate Prepared by the Congressional Budget 
              Office.............................................     8
  V. OTHER MATTERS TO BE DISCUSSED UNDER THE RULES OF THE HOUSE......11
          A. Committee Oversight Findings and Recommendations....    11
          B. Statement of General Performance Goals and 
              Objectives.........................................    11
          C. Information Relating to Unfunded Mandates...........    11
          D. Congressional Earmarks, Limited Tax Benefits, and 
              Limited Tariff Benefits............................    11
          E. Tax Complexity Analysis.............................    12
          F. Duplication of Federal Programs.....................    12
          G. Hearings............................................    12
 VI. CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED...........12
VII. DISSENTING VIEWS................................................30

    The amendment is as follows:
  Strike all after the enacting clause and insert the 
following:

SECTION 1. SHORT TITLE.

  This Act may be cited as the ``Protecting Access To Information for 
Effective & Necessary Treatment and Services Act'' or the ``PATIENTS 
Act''.

SEC. 2. EXTENDING APPROPRIATIONS AND TRANSFERS TO THE PATIENT-CENTERED 
                    OUTCOMES RESEARCH TRUST FUND; EXTENSION OF CERTAIN 
                    HEALTH INSURANCE FEES.

  (a) In General.--
          (1) Internal revenue code.--Section 9511 of the Internal 
        Revenue Code of 1986 is amended--
                  (A) in subsection (b)(1)(E), by striking ``2014'' and 
                all that follows through ``2019'' and inserting ``2014 
                through 2026'';
                  (B) in subsection (d)(2)(A), by striking ``2019'' and 
                inserting ``2026''; and
                  (C) in subsection (f), by striking ``2019'' and 
                inserting ``2026''.
          (2) Title xi of the social security act.--Section 1183(a)(2) 
        of the Social Security Act (42 U.S.C. 1320e-2(a)(2)) is amended 
        by striking ``2014'' and all that follows through ``2019'' and 
        inserting ``2014 through 2026''.
  (b) Extension of Certain Health Insurance Fees.--
          (1) Health insurance policies.--Section 4375(e) of the 
        Internal Revenue Code of 1986 is amended by striking ``2019'' 
        and inserting ``2026''.
          (2) Self-insured health plans.--Section 4376(e) of the 
        Internal Revenue Code of 1986 is amended by striking ``2019'' 
        and inserting ``2026''.
  (c) PCORI Research Priorities.--Section 1181(d)(1)(A) of the Social 
Security Act (42 U.S.C. 1320e(d)(1)(A)) is amended by adding at the end 
the following new sentence: ``Such national priorities shall include 
research with respect to substance use (including opioid use 
disorders), mental health, and maternal morbidity and mortality.''.

                       I. SUMMARY AND BACKGROUND


                         A. Purpose and Summary

    The bill, H.R. 3439, the ``Protecting Access to Information 
for Effective and Necessary Treatment (PATIENT) Act of 2019,'' 
as amended and ordered reported by the Committee on Ways and 
Means on June 26, 2019, amends IRC Section 9511(b) (26 U.S.C. 
Sec. 9511(b)) to appropriate $150 million and an amount equal 
to the net revenues received from the fees on health insurance 
policies and self-insured plans for each of FY2014 through 
FY2026 to the Patient-Centered Outcomes Research Trust Fund 
(PCORTF).
    In addition, H.R. 3439 amends the Internal Revenue Code of 
1986 and title XI of the Social Security Act to extend 
appropriations and transfers to the Patient-Centered Outcomes 
Research Trust Fund (PCORTF) and to extend certain health 
insurance fees for such transfers, and for other purposes.
    H.R. 3439, the ``Protecting Access to Information for 
Effective and Necessary Treatment (PATIENT) Act of 2019,'' was 
introduced by Representative Donald Beyer (D-VA) on June 24, 
2019.

                 B. Background and Need for Legislation

    The Patient Protection and Affordable Care Act (ACA) 
established the Patient-Centered Outcomes Research Institute 
(PCORI) as a nonpartisan, independent research institute to 
conduct comparative clinical effectiveness research to improve 
patient outcomes.\1\ PCORI has funded hundreds of research 
studies focused on improving health outcomes for patients 
through a range of research questions, including in the areas 
of: disparities, chronic diseases, rare diseases, veterans' 
health, pain management, and opioid use.
---------------------------------------------------------------------------
    \1\About Us & Our Funding, PCORI (June 2012, updated 2020), https:/
/www.pcori.org/about-us/financials-and-reports/our-funding.cite.
---------------------------------------------------------------------------
    Three principles guide the work undertaken at PCORI: (1) to 
increase the quantity, quality, and timeliness of usable, 
trustworthy comparative research information; (2) to accelerate 
the implementation and use of research evidence; and (3) to 
exert influence on research funded by others to make it more 
patient-centered and useful. To ensure research results that 
are responsive to concerns across the industry, PCORI develops 
research questions by engaging individuals and organizations 
who represent a broad range of stakeholders, including 
patients, caregivers, clinicians, delivery systems, payers and 
purchasers, researchers, and policymakers, and industry.
    PCORI is guided by a Board of Governors, with members of 
the Board, including the Chair and Vice Chair, appointed by the 
Comptroller General of the United States. The Board also 
includes the Directors of the National Institutes of Health and 
of the Agency for Healthcare Research and Quality, or their 
designees, and 19 other members representing a range of 
stakeholder audiences.
    From FY 2010 through FY 2018, PCORI funded $1.9 billion in 
comparative clinical effectiveness research.\2\ Currently, 
funding for PCORI comes from the Patient-Centered Outcomes 
Research Trust Fund (PCOR Trust Fund), which runs out at the 
end of FY 2019.
---------------------------------------------------------------------------
    \2\2018 Annual Report PCORI at 3 (2018), https://www.pcori.org/
sites/default/files/PCORI-Annual-Report-2018.pdf.
---------------------------------------------------------------------------

                         C. Legislative History


Background

    H.R. 3439 was introduced by Representative Donald Beyer (D-
VA) on June 24, 2019, and was referred to the Committee on Ways 
and Means and additionally the Committee on Energy and 
Commerce.

Committee hearings

    On June 4, 2019, the Committee on Ways and Means held a 
Member Day hearing to discuss the range of issues, concerns, 
and proposals among on-committee and off-committee members. 
Members heard from several colleagues on- and off-Committee on 
a number of topics with great relevance to conversations about 
research within America's health care system.
    Representative Ben McAdams (D-UT) who spoke in favor of 
increased transparency across the health care industry, and 
purposeful efforts to empower patients and payers to examine 
the practices of drug manufacturers and pharmaceutical benefit 
managers. Rep. McAdams also noted how the ability to research 
pricing and coverage would eliminate Americans being vulnerable 
to unknown costs for a visit to an emergency room or for in-
network services received during a hospitalization.
    Representative Elissa Slotkin (D-MI) testified to support 
increased transparency and efficiency across the health care 
industry as two essential components of any successful strategy 
to improve access to care and reduce costs.
    Representative David Schweikert (R-AZ), Committee Member, 
testified about a number of issues that are critical in efforts 
to improve rural health access and outcomes. Rep. Schweikert 
noted the need for Congress to prepare for future policymaking 
in an era where artificial intelligence can conduct a routine 
medical office visit and life-saving cures are available but 
likely cost prohibitive for the average American. He also asked 
Members to consider the impact of promoting research, as 
Congress did through the 21st Century CURES Act, on the 
nation's health care costs in the years ahead.
    Representative Tom Reed (R-NY) championed an all-hands 
approach to combating the scourge of diabetes across the United 
States. Rep. Reed's testimony also highlighted his prior 
collaboration with the Committee on Energy and Commerce Chair, 
Representative Diana DeGette (D-CO), to incorporate funding for 
Type 1 diabetes research.
    Representative Rodney Davis (R-IL) also testified during 
the Member Day hearing on June 4, 2019. In his testimony, Rep. 
Davis explained efforts to champion legislation that would 
provide additional resources to dedicate to research on 
pediatric cancer and other childhood diseases. The proposal 
would designate unused amounts from the Presidential Election 
Campaign Fund for pediatric cancer research.
    On May 16, 2019, the Committee on Ways and Means held a 
hearing, ``Overcoming Racial Disparities and Social 
Determinants in the Maternal Mortality Crisis,'' focusing on 
maternal health.
    On January 17, 2018, the Committee on Ways and Means held a 
hearing, ``The Opioid Crisis: The Current Landscape and CMS 
Actions to Prevent Opioid Misuse'' to discuss federal actions 
around substance abuse disorders and the opioid crisis.

Committee action

    The Committee on Ways and Means marked up H.R. 3439, the 
``Protecting Access to Information for Effective and Necessary 
Treatment (PATIENT) Act of 2019,'' on June 26, 2019, and 
ordered the bill, as amended, favorably reported with a quorum 
being present by recorded vote of 26 to 15.

                      II. EXPLANATION OF THE BILL


  A. The Protecting Access to Information for Effective and Necessary 
                    Treatment (PATIENT) Act of 2019


                             CURRENT LAW\3\
---------------------------------------------------------------------------

    \3\All discussions of Current Law in this report refer to current 
law as of the date of the markup (i.e., June 20, 2019) and do not 
reflect subsequent law changes.
---------------------------------------------------------------------------
    Section 1181 of the Social Security Act (SSA) establishes 
the Patient-Centered Outcomes Research Institute (PCORI) which 
is responsible for coordinating and supporting comparative 
clinical effectiveness research. PCORI has entered into 
contracts with federal agencies as well as with academic and 
private sector research entities for both the management of 
funding and conduct of research. Section 937 of the Public 
Health Service Act (PHSA) requires the Agency for Healthcare 
Research and Quality (AHRQ) to broadly disseminate research 
findings that are published by PCORI and other government-
funded comparative effectiveness research entities.
    Internal Revenue Code of 1986 (IRC) Section 9511 
establishes the ``Patient-Centered Outcomes Research Trust 
Fund'' (PCORTF) to support the activities of PCORI and to fund 
activities under PHSA Section 937. It provides annual funding 
to the PCORTF over the period FY2010-FY2019 from the following 
three sources: (1) annual appropriations; (2) fees on health 
insurance and self-insured plans (IRC Secs. 4375-4377); and (3) 
transfers from the Medicare Hospital Insurance (HI) and 
Supplementary Medical Insurance (SMI) Trust Funds. SSA Section 
1183 provides for the transfer of the required funds from the 
Medicare HI and SMI Trust Funds; transfers to PCORTF from the 
Medicare Trust Funds are calculated based on the number of 
individuals entitled to benefits under Medicare Part A or 
enrolled in Medicare Part B.
    For each of FY2011 through FY2019, IRC Section 9511 
requires 80% of the PCORTF funds to be made available to PCORI, 
and the remaining 20% of funds to be transferred to the 
Secretary of Health and Human Services (HHS Secretary) for 
carrying out PHSA Section 937. Of the total amount transferred 
to HHS, 80% is to be distributed to AHRQ, with the remainder 
going to the HHS Office of the Secretary.

                           REASONS FOR CHANGE

    Effective upon enactment, the PCORI Trust Fund will be 
extended through FY 2026. The Fund will be sustained by 
extending certain health insurance fees enacted in the 
Affordable Care Act through FY 2026. PCORI's national research 
priorities will be extended to include substance use (including 
opioid use disorders), mental health, and maternal morbidity 
and mortality. The Committee believes PCORI continues the 
mission of the ACA by assisting patients in making informed 
health care decisions that improve health care delivery and 
patient outcomes. PCORI does this by producing evidence-based 
information from credible research, incorporating both patients 
and provider perspectives. Extending PCORI funding though FY 
2026 will continue the effective creation of research to 
improve health care outcomes used by patients and other health 
care decision makers.

                       EXPLANATION OF PROVISIONS

Section 1: Short title

    This Act may be cited as the ``Protecting Access To 
Information for Effective and Necessary Treatment Act'' or the 
``PATIENT Act.''

Section 2: Extending Appropriations and transfers to the Patient-
        Centered Outcomes Research Trust Fund; Extension of certain 
        health insurance fees

    Effective upon enactment, the PATIENT Act extends funding 
for the Patient Centered Outcomes Research Institute (PCORI) by 
extending the PCORI Trust Fund through Fiscal Year (FY) 2026. 
The Fund will be sustained by extending certain health 
insurance fees enacted in the ACA, and PCORI's national 
research priorities will be extended to include substance use 
(including opioid use disorders), mental health, and maternal 
morbidity and mortality.

                             EFFECTIVE DATE

    Section 2: Effective beginning on or after enactment.

                      III. VOTES OF THE COMMITTEE

    In compliance with clause 3(b) of rule XIII of the Rules of 
the House of Representatives, the following statement is made 
concerning the vote of the Committee on Ways and Means in its 
consideration of H.R. 3439, the ``Protecting Access to 
Information for Effective and Necessary Treatment (PATIENT) Act 
of 2019,'' on June 26, 2019.

                          Votes on Amendments

    An amendment, which would make PCORI fully discretionary 
offered by Dr. Wenstrup was defeated by a roll call vote of 16 
yeas to 24 nays. The vote was as follows:

----------------------------------------------------------------------------------------------------------------
          Representative             Yea      Nay     Present      Representative      Yea      Nay     Present
----------------------------------------------------------------------------------------------------------------
Mr. Neal.........................  .......       X   .........  Mr. Brady..........       X   .......  .........
Mr. Lewis........................  .......       X   .........  Mr. Nunes..........       X   .......  .........
Mr. Doggett......................  .......       X   .........  Mr. Buchanan.......       X   .......  .........
Mr. Thompson.....................  .......       X   .........  Mr. Smith..........       X   .......  .........
Mr. Larson.......................  .......       X   .........  Mr. Marchant.......       X   .......  .........
Mr. Blumenauer...................  .......       X   .........  Mr. Reed...........       X   .......  .........
Mr. Kind.........................  .......       X   .........  Mr. Kelly..........       X   .......  .........
Mr. Pascrell.....................  .......       X   .........  Mr. Holding........       X   .......  .........
Mr. Davis........................  .......       X   .........  Mr. Smith..........       X   .......  .........
Ms. Sanchez......................  .......       X   .........  Mr. Rice...........       X   .......  .........
Mr. Higgins......................  .......       X   .........  Mr. Schweikert.....       X   .......  .........
Ms. Sewell.......................  .......       X   .........  Ms. Walorski.......  .......  .......  .........
Ms. DelBene......................  .......       X   .........  Mr. LaHood (IL)....       X   .......  .........
Ms. Chu (CA).....................  .......  .......  .........  Mr. Wenstrup.......       X   .......  .........
Ms. Moore........................  .......       X   .........  Mr. Arrington......       X   .......  .........
Mr. Kildee.......................  .......       X   .........  Mr. Ferguson.......       X   .......  .........
Mr. Boyle........................  .......       X   .........  Mr. Estes..........       X   .......  .........
Mr. Beyer........................  .......       X   .........
Mr. Evans........................  .......       X   .........
Mr. Schneider....................  .......       X   .........
Mr. Suozzi.......................  .......       X   .........
Mr. Panetta......................  .......       X   .........
Ms. Murphy.......................  .......       X   .........
Mr. Gomez........................  .......       X   .........
Mr. Horsford.....................  .......       X   .........
----------------------------------------------------------------------------------------------------------------

    An amendment, which would eliminate fees assessed on health 
insurance issuers, including the fees collected to fund PCORI 
and the health insurer fee was offered by Mr. Holding was 
defeated by a roll call vote of 16 yeas to 24 nays. The vote 
was as follows:

----------------------------------------------------------------------------------------------------------------
          Representative             Yea      Nay     Present      Representative      Yea      Nay     Present
----------------------------------------------------------------------------------------------------------------
Mr. Neal.........................  .......       X   .........  Mr. Brady..........       X   .......  .........
Mr. Lewis........................  .......       X   .........  Mr. Nunes..........       X   .......  .........
Mr. Doggett......................  .......       X   .........  Mr. Buchanan.......       X   .......  .........
Mr. Thompson.....................  .......       X   .........  Mr. Smith..........       X   .......  .........
Mr. Larson.......................  .......       X   .........  Mr. Marchant.......       X   .......  .........
Mr. Blumenauer...................  .......       X   .........  Mr. Reed...........       X   .......  .........
Mr. Kind.........................  .......       X   .........  Mr. Kelly..........       X   .......  .........
Mr. Pascrell.....................  .......       X   .........  Mr. Holding........       X   .......  .........
Mr. Davis........................  .......       X   .........  Mr. Smith..........       X   .......  .........
Ms. Sanchez......................  .......       X   .........  Mr. Rice...........       X   .......  .........
Mr. Higgins......................  .......       X   .........  Mr. Schweikert.....       X   .......  .........
Ms. Sewell.......................  .......       X   .........  Ms. Walorski.......  .......  .......  .........
Ms. DelBene......................  .......       X   .........  Mr. LaHood (IL)....       X   .......  .........
Ms. Chu (CA).....................  .......       X   .........  Mr. Wenstrup.......       X   .......  .........
Ms. Moore........................  .......       X   .........  Mr. Arrington......       X   .......  .........
Mr. Kildee.......................  .......       X   .........  Mr. Ferguson.......       X   .......  .........
Mr. Boyle........................  .......       X   .........  Mr. Estes..........       X   .......  .........
Mr. Beyer........................  .......       X   .........
Mr. Evans........................  .......       X   .........
Mr. Schneider....................  .......       X   .........
Mr. Suozzi.......................  .......       X   .........
Mr. Panetta......................  .......       X   .........
Ms. Murphy.......................  .......       X   .........
Mr. Gomez........................  .......       X   .........
Mr. Horsford.....................  .......  .......  .........
----------------------------------------------------------------------------------------------------------------

    The Chairman's amendment in the nature of a substitute was 
agreed to by voice vote (with a quorum being present).
    H.R. 3439 was ordered favorably reported to the House of 
Representatives as amended by an amendment in the nature of a 
substitute offered by Chairman Neal by a roll call vote of 26 
yeas to 15 nays. The vote was as follows:

----------------------------------------------------------------------------------------------------------------
          Representative             Yea      Nay     Present      Representative      Yea      Nay     Present
----------------------------------------------------------------------------------------------------------------
Mr. Neal.........................       X   .......  .........  Mr. Brady..........  .......       X   .........
Mr. Lewis........................       X   .......  .........  Mr. Nunes..........  .......       X   .........
Mr. Doggett......................       X   .......  .........  Mr. Buchanan.......  .......       X   .........
Mr. Thompson.....................       X   .......  .........  Mr. Smith (NE).....  .......       X   .........
Mr. Larson.......................       X   .......  .........  Mr. Marchant.......  .......       X   .........
Mr. Blumenauer...................       X   .......  .........  Mr. Reed...........       X   .......  .........
Mr. Kind.........................       X   .......  .........  Mr. Kelly..........  .......       X   .........
Mr. Pascrell.....................       X   .......  .........  Mr. Holding........  .......       X   .........
Mr. Davis........................       X   .......  .........  Mr. Smith (MO).....  .......       X   .........
Ms. Sanchez......................       X   .......  .........  Mr. Rice...........  .......       X   .........
Mr. Higgins......................       X   .......  .........  Mr. Schweikert.....  .......       X   .........
Ms. Sewell.......................       X   .......  .........  Ms. Walorski.......  .......  .......  .........
Ms. DelBene......................       X   .......  .........  Mr. LaHood.........  .......       X   .........
Ms. Chu (CA).....................       X   .......  .........  Mr. Wenstrup.......  .......       X   .........
Ms. Moore........................       X   .......  .........  Mr. Arrington......  .......       X   .........
Mr. Kildee.......................       X   .......  .........  Mr. Ferguson.......  .......       X   .........
Mr. Boyle........................       X   .......  .........  Mr. Estes..........  .......       X   .........
Mr. Beyer........................       X   .......  .........
Mr. Evans........................       X   .......  .........
Mr. Schneider....................       X   .......  .........
Mr. Suozzi.......................       X   .......  .........
Mr. Panetta......................       X   .......  .........
Ms. Murphy.......................       X   .......  .........
Mr. Gomez........................       X   .......  .........
Mr. Horsford.....................       X   .......  .........
----------------------------------------------------------------------------------------------------------------

                     IV. BUDGET EFFECTS OF THE BILL


               A. Committee Estimate of Budgetary Effects

    In compliance with clause 3(d) of rule XIII of the Rules of 
the House of Representatives, the following statement is made 
concerning the effects on the budget of the bill, H.R. 3439, as 
reported. The Committee agrees with the estimate prepared by 
the Congressional Budget Office (CBO), which is included below.

B. Statement Regarding New Budget Authority and Tax Expenditures Budget 
                               Authority

    In compliance with clause 3(c)(2) of rule XIII of the Rules 
of the House of Representatives, the Committee states that the 
bill involves no new or increased budget authority. The 
Committee states further that the bill involves no new or 
increased tax expenditures.

      C. Cost Estimate Prepared by the Congressional Budget Office

    In compliance with clause 3(c)(3) of rule XIII of the Rules 
of the House of Representatives, requiring a cost estimate 
prepared by the CBO, the following statement by CBO is 
provided.

                                     U.S. Congress,
                                Congressonal Budget Office,
                                Washington, DC, September 12, 2019.
Hon. Richard Neal,
Chairman, Committee on Ways and Means,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for H.R. 3439, the PATIENTS 
Act.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Sarah 
Sajewski.
            Sincerely,
                                         Phillip L. Swagel,
                                                          Director.
    Enclosure.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    

    The bill would
           Extend funding for the Patient-Centered 
        Outcomes Research Trust Fund through 2026
           Impose a private-sector mandate by 
        authorizing fees on health insurance policies
    Estimated budgetary effects would primarily stem from
           Increased direct spending for the Patient-
        Centered Outcomes Research Trust Fund
    Bill summary: H.R. 3439 would reauthorize transfers to the 
Patient Center Outcomes Research (PCOR) Trust Fund and 
collection of certain excise taxes charged to health insurance 
plans.
    Estimated Federal cost: The estimated budgetary effect of 
H.R. 3439 is shown in Table 1. The costs of the legislation 
fall within budget functions 550 (health) and 570 (Medicare).

                                                   TABLE 1.--ESTIMATED BUDGETARY EFFECTS OF H.R. 3439
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                     By fiscal year, millions of dollars--
                                                      --------------------------------------------------------------------------------------------------
                                                        2019   2020   2021   2022   2023   2024   2025   2026   2027   2028   2029  2019-2024  2019-2029
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                     Increases or Decreases (-) in Direct Spendinga
 
Estimated Budget Authority...........................      0    670    700    740    770    800    840    890      0      0      0     3,680      5,410
Estimated Outlays....................................      0    670    700    740    770    800    840    890      0      0      0     3,680     5,410
--------------------------------------------------------------------------------------------------------------------------------------------------------
aH.R. 3439 also would extend authority to collect certain revenues that are already assumed to be collected in CBO's baseline.

    Basis of estimate: CBO's estimate of the budgetary impact 
of H.R. 3439 is based on the amounts historically received by 
the PCOR Trust Fund and disbursed to the Patient-Centered 
Outcomes Research Institute (PCORI, a private entity) and the 
Secretary of Health and Human Services (HHS). For this 
estimate, CBO assumes H.R. 3439 will be enacted near the end of 
fiscal year 2019.

Background

    Under current law, the PCOR Trust Fund is authorized to 
spend amounts transferred to the account each year; however, 
that transfer authority will, along with the authority to 
collect one of the sources of funding, expire on September 30, 
2019. H.R. 3439 would extend through 2026 the authority to 
transfer funds from the Medicare trust funds and other 
specified mandatory appropriations. The bill also would extend 
authority to collect excise taxes on certain health insurance 
policies and to transfer those collections to the fund. The 
trust fund disburses those funds to PCORI and to the Secretary 
of HHS; those entities disseminate the funds to support related 
healthcare research including comparative clinical 
effectiveness research.

Direct Spending

    CBO estimates that enacting H.R. 3439 would increase 
amounts transferred to the PCOR trust fund and subsequently 
spent by PCORI and HHS by $5.4 billion dollars over the 2019-
2029 period.
    Transfers from the Federal Hospital Insurance Trust Fund 
and the Federal Supplementary Medicare Insurance Trust Fund are 
calculated by taking a per-enrollee amount (set at $2.00 in FY 
2014), indexing it by the percentage increase in the projected-
per-capita amount of the National Health Expenditures ($2.57 in 
FY 2020), and then multiplying it by the average number of 
individuals entitled to benefits under Medicare Part A or 
enrolled under Medicare Part B during a given fiscal year 
(about 62 million in FY 2020).
    CBO estimates that the amount transferred to the fund and 
subsequently spent would total $160 million in fiscal year 2020 
and $1.4 billion over the 2020-2029 period. That spending would 
be partially offset by an increase totaling about $0.2 billion 
in Part B premiums paid by Medicare enrollees. Part B premiums 
are set to maintain a contingency reserve of the trust funds, 
so changes in Part B spending trigger a partially offsetting 
adjustment in premiums.
    The fund also would receive transfers of other mandatory 
appropriations totaling $150 million annually. CBO estimates 
the amount disbursed from those appropriated funds would total 
about $1.1 billion over the 2020-2029 period.
    Finally, the fund would spend revenues from an excise tax 
imposed on health insurance policies. (See discussion below on 
collections of those revenues) CBO estimates that spending 
would total $3.2 billion over the 2020-2029 period.

Revenues

    H.R. 3439 would extend, through 2026, the authority to 
collect certain excise taxes on health insurance policies that 
are currently scheduled to expire in 2019. CBO projects that 
those collections would total $4 billion over the 2020-2029 
period. Only a portion of those amounts ($3.2 billion) would be 
available for spending, however, because the Secretary of the 
Treasury is required to transfer to the PCOR trust fund only 
those amounts estimated to exceed reductions in income taxes 
that would result from the excise tax's collection. (When 
certain types of taxes and fees are imposed on goods and 
services, taxable income for workers and business owners 
decline.\1\)
---------------------------------------------------------------------------
    \1\For further information on how indirect taxes and fees may 
reduce collections for other taxes, See Congressional Budget Office, 
The Role of the 25 Percent Revenue Offset in Estimating the Budgetary 
Effects of Legislation (January 2009), www.cbo.gov/publication/20110.
---------------------------------------------------------------------------
    Furthermore, because the excise taxes collected under H.R. 
3439 would be dedicated to a trust fund, they are already 
included in CBO's baseline and are thus not credited to this 
bill. (The Balanced Budget and Emergency Deficit Control Act of 
1985 requires CBO to assume in its baseline projections that 
excise taxes dedicated to trust funds, if expiring, are 
extended.)
    Pay-As-You-Go considerations: The Statutory Pay-As-You-Go 
Act of 2010 establishes budget-reporting and enforcement 
procedures for legislation affecting direct spending or 
revenues. The net changes in outlays subject to those pay-as-
you-go procedures are shown in Table 1.
    Increase in long-term deficits: CBO estimates that enacting 
H.R. 3439 would not increase on-budget deficits in any of the 
four consecutive 10-year periods beginning in 2030.
    Mandates: JCT has determined that the tax provisions of 
H.R. 3439 would impose a private-sector mandate by extending 
fees on health insurance policies to fund transfers to the PCOR 
trust fund. The revenue from those fees are part of the CBO 
baseline because current law requires CBO to assume that excise 
taxes dedicated to a trust fund, if expiring, are extended. For 
private entities, however, paying the fees would extend an 
expiring duty, which is a mandate as defined in the Unfunded 
Mandates Reform Act (UMRA). Based on information from JCT, CBO 
estimates that the cost of the mandate would average $530 
million annually and would exceed the private sector threshold 
established in UMRA ($164 million in 2019, adjusted annually 
for inflation) in each of the first five years that the mandate 
is in effect.
    CBO has determined that the non-tax provisions of H.R. 3439 
would not impose a private-sector mandate as defined in UMRA. 
Neither the tax nor the non-tax provisions of the bill would 
impose intergovernmental mandates as defined in UMRA.
    Estimate prepared by: Federal Costs: Sarah Sajewski; 
Revenues: Bayard Meiser, and the staff of the Joint Committee 
on Taxation; Mandates: Andrew Laughlin, and the staff of the 
Joint Committee on Taxation.
    Estimate reviewed by: Tom Bradley, Chief, Health Systems 
and Medicare Cost Estimates Unit; Susan Willie, Chief, Mandates 
Unit; Leo Lex, Deputy Assistant Director for Budget Analysis; 
Theresa Gullo, Assistant Director for Budget Analysis; John 
McClelland, Assistant Director for Budget Analysis.

     V. OTHER MATTERS TO BE DISCUSSED UNDER THE RULES OF THE HOUSE


          A. Committee Oversight Findings and Recommendations

    With respect to clause 3(c)(1) of rule XIII and clause 
2(b)(1) of rule X of the Rules of the House of Representatives, 
the Committee made findings and recommendations that are 
reflected in this report.

        B. Statement of General Performance Goals and Objectives

    With respect to clause 3(c)(4) of rule XIII of the Rules of 
the House of Representatives, the Committee advises that the 
bill contains no measure that authorizes funding, so no 
statement of general performance goals and objectives for which 
any measure authorizes funding is required.

              C. Information Relating to Unfunded Mandates

    This information is provided in accordance with section 423 
of the Unfunded Mandates Reform Act of 1995 (Pub. L. No. 104-
4).
    The Committee has determined that the bill does contain 
Federal mandates on the private sector through the collection 
of excise taxes on health insurance plans. The Committee has 
determined that the bill does not impose a Federal 
intergovernmental mandate on State, local, or tribal 
governments.

  D. Congressional Earmarks, Limited Tax Benefits, and Limited Tariff 
                                Benefits

    With respect to clause 9 of rule XXI of the Rules of the 
House of Representatives, the Committee has carefully reviewed 
the provisions of the bill, and states that the provisions of 
the bill do not contain any congressional earmarks, limited tax 
benefits, or limited tariff benefits within the meaning of the 
rule.

                       E. Tax Complexity Analysis

    Section 4022(b) of Public Law 105-206, the Internal Revenue 
Service Restructuring and Reform Act of 1998 (the ``RRA''), 
requires the staff of the Joint Committee on Taxation (in 
consultation with the Internal Revenue Service and the Treasury 
Department) to provide a tax complexity analysis. The 
complexity analysis is required for all legislation reported by 
the Senate Committee on Finance, the House Committee on Ways 
and Means, or any committee of conference if the legislation 
includes a provision that directly or indirectly amends the 
Internal Revenue Code of 1986 and has widespread applicability 
to individuals or small businesses.
    Pursuant to clause 3(h)(1) of rule XIII of the Rules of the 
House of Representatives, the staff of the Joint Committee on 
Taxation has determined that a complexity analysis is not 
required under section 4022(b) of the RRA because the bill 
contains no provision that amends the Internal Revenue Code of 
1986 and has ``widespread applicability'' to individuals or 
small businesses within the meaning of the rule.

                   F. Duplication of Federal Programs

    In compliance with clause 3(c)(5) of rule XIII of the Rules 
of the House of Representatives, the Committee states that no 
provision of the bill establishes or reauthorizes: (1) a 
program of the Federal Government known to be duplicative of 
another Federal program; (2) a program included in any report 
to Congress pursuant to section 21 of Public Law 111-139; or 
(3) a program related to a program identified in the most 
recent Catalog of Federal Domestic Assistance, published 
pursuant section 6104 of title 31, United States Code.

                              G. Hearings

    In compliance with Sec. 103(i) of H. Res. 6 (116th 
Congress) (1) the following hearing was used to develop or 
consider H.R. 3439:
    On June 4, 2019, the Committee on Ways and Means held a 
full committee Member Day hearing to discuss the range of 
issues, concerns, and proposals among on-committee and off-
committee members. Members heard from several colleagues on- 
and off-Committee about the importance of research in 
establishing policies that assist patients in making informed 
health care decisions that improves health care delivery and 
patient outcomes.
    On May 16, 2019, the Committee on Ways and Means held a 
hearing, ``Overcoming Racial Disparities and Social 
Determinants in the Maternal Mortality Crisis,'' focusing on 
maternal morbidity and mortality, as well as social 
determinants of health.

       VI. CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED

    In compliance with clause 3(e)(1)(B) of rule XIII of the 
Rules of the House of Representatives, changes in existing law 
proposed 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, existing law in 
which no change is proposed is shown in roman):

         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):

                     INTERNAL REVENUE CODE OF 1986




           *       *       *       *       *       *       *
Subtitle D--Miscellaneous Excise Taxes

           *       *       *       *       *       *       *


CHAPTER 34--TAXES ON CERTAIN INSURANCE POLICIES

           *       *       *       *       *       *       *


Subchapter B--INSURED AND SELF-INSURED HEALTH PLANS

           *       *       *       *       *       *       *


SEC. 4375. HEALTH INSURANCE.

  (a) Imposition of fee.--There is hereby imposed on each 
specified health insurance policy for each policy year ending 
after September 30, 2012, a fee equal to the product of $2 ($1 
in the case of policy years ending during fiscal year 2013) 
multiplied by the average number of lives covered under the 
policy.
  (b) Liability for fee.--The fee imposed by subsection (a) 
shall be paid by the issuer of the policy.
  (c) Specified health insurance policy.--For purposes of this 
section:
          (1) In general.--Except as otherwise provided in this 
        section, the term ``specified health insurance policy'' 
        means any accident or health insurance policy 
        (including a policy under a group health plan) issued 
        with respect to individuals residing in the United 
        States.
          (2) Exemption for certain policies.--The term 
        ``specified health insurance policy'' does not include 
        any insurance if substantially all of its coverage is 
        of excepted benefits described in section 9832(c).
          (3) Treatment of prepaid health coverage 
        arrangements.--
                  (A) In general.--In the case of any 
                arrangement described in subparagraph (B), such 
                arrangement shall be treated as a specified 
                health insurance policy, and the person 
                referred to in such subparagraph shall be 
                treated as the issuer.
                  (B) Description of arrangements.--An 
                arrangement is described in this subparagraph 
                if under such arrangement fixed payments or 
                premiums are received as consideration for any 
                person's agreement to provide or arrange for 
                the provision of accident or health coverage to 
                residents of the United States, regardless of 
                how such coverage is provided or arranged to be 
                provided.
  (d) Adjustments for increases in health care spending.--In 
the case of any policy year ending in any fiscal year beginning 
after September 30, 2014, the dollar amount in effect under 
subsection (a) for such policy year shall be equal to the sum 
of such dollar amount for policy years ending in the previous 
fiscal year (determined after the application of this 
subsection), plus an amount equal to the product of--
          (1) such dollar amount for policy years ending in the 
        previous fiscal year, multiplied by
          (2) the percentage increase in the projected per 
        capita amount of National Health Expenditures, as most 
        recently published by the Secretary before the 
        beginning of the fiscal year.
  (e) Termination.--This section shall not apply to policy 
years ending after September 30, [2019] 2026.

SEC. 4376. SELF-INSURED HEALTH PLANS.

  (a) Imposition of fee.--In the case of any applicable self-
insured health plan for each plan year ending after September 
30, 2012, there is hereby imposed a fee equal to $2 ($1 in the 
case of plan years ending during fiscal year 2013) multiplied 
by the average number of lives covered under the plan.
  (b) Liability for fee.--
          (1) In general.--The fee imposed by subsection (a) 
        shall be paid by the plan sponsor.
          (2) Plan sponsor.--For purposes of paragraph (1) the 
        term ``plan sponsor'' means--
                  (A) the employer in the case of a plan 
                established or maintained by a single employer,
                  (B) the employee organization in the case of 
                a plan established or maintained by an employee 
                organization,
                  (C) in the case of--
                          (i) a plan established or maintained 
                        by 2 or more employers or jointly by 1 
                        or more employers and 1 or more 
                        employee organizations,
                          (ii) a multiple employer welfare 
                        arrangement, or
                          (iii) a voluntary employees' 
                        beneficiary association described in 
                        section 501(c)(9), the association, 
                        committee, joint board of trustees, or 
                        other similar group of representatives 
                        of the parties who establish or 
                        maintain the plan, or
                  (D) the cooperative or association described 
                in subsection (c)(2)(F) in the case of a plan 
                established or maintained by such a cooperative 
                or association.
  (c) Applicable self-insured health plan.--For purposes of 
this section, the term ``applicable self-insured health plan'' 
means any plan for providing accident or health coverage if--
          (1) any portion of such coverage is provided other 
        than through an insurance policy, and
          (2) such plan is established or maintained--
                  (A) by 1 or more employers for the benefit of 
                their employees or former employees,
                  (B) by 1 or more employee organizations for 
                the benefit of their members or former members,
                  (C) jointly by 1 or more employers and 1 or 
                more employee organizations for the benefit of 
                employees or former employees,
                  (D) by a voluntary employees' beneficiary 
                association described in section 501(c)(9),
                  (E) by any organization described in section 
                501(c)(6), or
                  (F) in the case of a plan not described in 
                the preceding subparagraphs, by a multiple 
                employer welfare arrangement (as defined in 
                section 3(40) of Employee Retirement Income 
                Security Act of 1974), a rural electric 
                cooperative (as defined in section 3(40)(B)(iv) 
                of such Act), or a rural telephone cooperative 
                association (as defined in section 3(40)(B)(v) 
                of such Act).
  (d) Adjustments for increases in health care spending.--In 
the case of any plan year ending in any fiscal year beginning 
after September 30, 2014, the dollar amount in effect under 
subsection (a) for such plan year shall be equal to the sum of 
such dollar amount for plan years ending in the previous fiscal 
year (determined after the application of this subsection), 
plus an amount equal to the product of--
          (1) such dollar amount for plan years ending in the 
        previous fiscal year, multiplied by
          (2) the percentage increase in the projected per 
        capita amount of National Health Expenditures, as most 
        recently published by the Secretary before the 
        beginning of the fiscal year.
  (e) Termination.--This section shall not apply to plan years 
ending after September 30, [2019] 2026.

           *       *       *       *       *       *       *


Subtitle I--Trust Fund Code

           *       *       *       *       *       *       *


CHAPTER 98--TRUST FUND CODE

           *       *       *       *       *       *       *


Subchapter A--ESTABLISHMENT OF TRUST FUNDS

           *       *       *       *       *       *       *


SEC. 9511. PATIENT-CENTERED OUTCOMES RESEARCH TRUST FUND.

  (a) Creation of Trust Fund.--There is established in the 
Treasury of the United States a trust fund to be known as the 
``Patient-Centered Outcomes Research Trust Fund'' (hereafter in 
this section referred to as the ``PCORTF''), consisting of such 
amounts as may be appropriated or credited to such Trust Fund 
as provided in this section and section 9602(b).
  (b) Transfers to Fund.--
          (1) Appropriation.--There are hereby appropriated to 
        the Trust Fund the following:
                  (A) For fiscal year 2010, $10,000,000.
                  (B) For fiscal year 2011, $50,000,000.
                  (C) For fiscal year 2012, $150,000,000.
                  (D) For fiscal year 2013--
                          (i) an amount equivalent to the net 
                        revenues received in the Treasury from 
                        the fees imposed under subchapter B of 
                        chapter 34 (relating to fees on health 
                        insurance and self-insured plans) for 
                        such fiscal year; and
                          (ii) $150,000,000.
                  (E) For each of fiscal years [2014, 2015, 
                2016, 2017, 2018, and 2019] 2014 through 2026--
                          (i) an amount equivalent to the net 
                        revenues received in the Treasury from 
                        the fees imposed under subchapter B of 
                        chapter 34 (relating to fees on health 
                        insurance and self-insured plans) for 
                        such fiscal year; and
                          (ii) $150,000,000.
                The amounts appropriated under subparagraphs 
                (A), (B), (C), (D)(ii), and (E)(ii) shall be 
                transferred from the general fund of the 
                Treasury, from funds not otherwise 
                appropriated.
          (2) Trust Fund transfers.--In addition to the amounts 
        appropriated under paragraph (1), there shall be 
        credited to the PCORTF the amounts transferred under 
        section 1183 of the Social Security Act.
          (3) Limitation on transfers to PCORTF.--No amount may 
        be appropriated or transferred to the PCORTF on and 
        after the date of any expenditure from the PCORTF which 
        is not an expenditure permitted under this section. The 
        determination of whether an expenditure is so permitted 
        shall be made without regard to--
                  (A) any provision of law which is not 
                contained or referenced in this chapter or in a 
                revenue Act, and
                  (B) whether such provision of law is a 
                subsequently enacted provision or directly or 
                indirectly seeks to waive the application of 
                this paragraph.
  (c) Trustee.--The Secretary of the Treasury shall be a 
trustee of the PCORTF.
  (d) Expenditures from Fund.--
          (1) Amounts available to the Patient-Centered 
        Outcomes Research Institute.--Subject to paragraph (2), 
        amounts in the PCORTF are available, without further 
        appropriation, to the Patient-Centered Outcomes 
        Research Institute established under section 1181(b) of 
        the Social Security Act for carrying out part D of 
        title XI of the Social Security Act (as in effect on 
        the date of enactment of such Act).
          (2) Transfer of funds.--
                  (A) In general.--The trustee of the PCORTF 
                shall provide for the transfer from the PCORTF 
                of 20 percent of the amounts appropriated or 
                credited to the PCORTF for each of fiscal years 
                2011 through [2019] 2026 to the Secretary of 
                Health and Human Services to carry out section 
                937 of the Public Health Service Act.
                  (B) Availability.--Amounts transferred under 
                subparagraph (A) shall remain available until 
                expended.
                  (C) Requirements.--Of the amounts transferred 
                under subparagraph (A) with respect to a fiscal 
                year, the Secretary of Health and Human 
                Services shall distribute--
                          (i) 80 percent to the Office of 
                        Communication and Knowledge Transfer of 
                        the Agency for Healthcare Research and 
                        Quality (or any other relevant office 
                        designated by Agency for Healthcare 
                        Research and Quality) to carry out the 
                        activities described in section 937 of 
                        the Public Health Service Act; and
                          (ii) 20 percent to the Secretary to 
                        carry out the activities described in 
                        such section 937.
  (e) Net revenues.--For purposes of this section, the term 
``net revenues'' means the amount estimated by the Secretary of 
the Treasury based on the excess of--
          (1) the fees received in the Treasury under 
        subchapter B of chapter 34, over
          (2) the decrease in the tax imposed by chapter 1 
        resulting from the fees imposed by such subchapter.
  (f) Termination.--No amounts shall be available for 
expenditure from the PCORTF after September 30, [2019] 2026, 
and any amounts in such Trust Fund after such date shall be 
transferred to the general fund of the Treasury.

           *       *       *       *       *       *       *

                              ----------                              


                          SOCIAL SECURITY ACT


     TITLE XI--GENERAL PROVISIONS, PEER REVIEW, AND ADMINISTRATIVE 
SIMPLIFICATION

           *       *       *       *       *       *       *



          Part D--Comparative Clinical Effectiveness Research


              comparative clinical effectiveness research

  Sec. 1181. (a) Definitions.--In this section:
          (1) Board.--The term ``Board'' means the Board of 
        Governors established under subsection (f).
          (2) Comparative clinical effectiveness research; 
        research.--
                  (A) In general.--The terms ``comparative 
                clinical effectiveness research'' and 
                ``research'' mean research evaluating and 
                comparing health outcomes and the clinical 
                effectiveness, risks, and benefits of 2 or more 
                medical treatments, services, and items 
                described in subparagraph (B).
                  (B) Medical treatments, services, and items 
                described.--The medical treatments, services, 
                and items described in this subparagraph are 
                health care interventions, protocols for 
                treatment, care management, and delivery, 
                procedures, medical devices, diagnostic tools, 
                pharmaceuticals (including drugs and 
                biologicals), integrative health practices, and 
                any other strategies or items being used in the 
                treatment, management, and diagnosis of, or 
                prevention of illness or injury in, 
                individuals.
          (3) Conflict of interest.--The term ``conflict of 
        interest'' means an association, including a financial 
        or personal association, that have the potential to 
        bias or have the appearance of biasing an individual's 
        decisions in matters related to the Institute or the 
        conduct of activities under this section.
          (4) Real conflict of interest.--The term ``real 
        conflict of interest'' means any instance where a 
        member of the Board, the methodology committee 
        established under subsection (d)(6), or an advisory 
        panel appointed under subsection (d)(4), or a close 
        relative of such member, has received or could receive 
        either of the following:
                  (A) A direct financial benefit of any amount 
                deriving from the result or findings of a study 
                conducted under this section.
                  (B) A financial benefit from individuals or 
                companies that own or manufacture medical 
                treatments, services, or items to be studied 
                under this section that in the aggregate 
                exceeds $10,000 per year. For purposes of the 
                preceding sentence, a financial benefit 
                includes honoraria, fees, stock, or other 
                financial benefit and the current value of the 
                member or close relative's already existing 
                stock holdings, in addition to any direct 
                financial benefit deriving from the results or 
                findings of a study conducted under this 
                section.
  (b) Patient-Centered Outcomes Research Institute.--
          (1) Establishment.--There is authorized to be 
        established a nonprofit corporation, to be known as the 
        ``Patient-Centered Outcomes Research Institute'' 
        (referred to in this section as the ``Institute'') 
        which is neither an agency nor establishment of the 
        United States Government.
          (2) Application of provisions.--The Institute shall 
        be subject to the provisions of this section, and, to 
        the extent consistent with this section, to the 
        District of Columbia Nonprofit Corporation Act.
          (3) Funding of comparative clinical effectiveness 
        research.--For fiscal year 2010 and each subsequent 
        fiscal year, amounts in the Patient-Centered Outcomes 
        Research Trust Fund (referred to in this section as the 
        ``PCORTF'') under section 9511 of the Internal Revenue 
        Code of 1986 shall be available, without further 
        appropriation, to the Institute to carry out this 
        section.
  (c) Purpose.--The purpose of the Institute is to assist 
patients, clinicians, purchasers, and policy-makers in making 
informed health decisions by advancing the quality and 
relevance of evidence concerning the manner in which diseases, 
disorders, and other health conditions can effectively and 
appropriately be prevented, diagnosed, treated, monitored, and 
managed through research and evidence synthesis that considers 
variations in patient subpopulations, and the dissemination of 
research findings with respect to the relative health outcomes, 
clinical effectiveness, and appropriateness of the medical 
treatments, services, and items described in subsection 
(a)(2)(B).
  (d) Duties.--
          (1) Identifying research priorities and establishing 
        research project agenda.--
                  (A) Identifying research priorities.--The 
                Institute shall identify national priorities 
                for research, taking into account factors of 
                disease incidence, prevalence, and burden in 
                the United States (with emphasis on chronic 
                conditions), gaps in evidence in terms of 
                clinical outcomes, practice variations and 
                health disparities in terms of delivery and 
                outcomes of care, the potential for new 
                evidence to improve patient health, well-being, 
                and the quality of care, the effect on national 
                expenditures associated with a health care 
                treatment, strategy, or health conditions, as 
                well as patient needs, outcomes, and 
                preferences, the relevance to patients and 
                clinicians in making informed health decisions, 
                and priorities in the National Strategy for 
                quality care established under section 399H of 
                the Public Health Service Act that are 
                consistent with this section. Such national 
                priorities shall include research with respect 
                to substance use (including opioid use 
                disorders), mental health, and maternal 
                morbidity and mortality.
                  (B) Establishing research project agenda.--
                The Institute shall establish and update a 
                research project agenda for research to address 
                the priorities identified under subparagraph 
                (A), taking into consideration the types of 
                research that might address each priority and 
                the relative value (determined based on the 
                cost of conducting research compared to the 
                potential usefulness of the information 
                produced by research) associated with the 
                different types of research, and such other 
                factors as the Institute determines 
                appropriate.
          (2) Carrying out research project agenda.--
                  (A) Research.--The Institute shall carry out 
                the research project agenda established under 
                paragraph (1)(B) in accordance with the 
                methodological standards adopted under 
                paragraph (9) using methods, including the 
                following:
                          (i) Systematic reviews and 
                        assessments of existing and future 
                        research and evidence including 
                        original research conducted subsequent 
                        to the date of the enactment of this 
                        section.
                          (ii) Primary research, such as 
                        randomized clinical trials, molecularly 
                        informed trials, and observational 
                        studies.
                          (iii) Any other methodologies 
                        recommended by the methodology 
                        committee established under paragraph 
                        (6) that are adopted by the Board under 
                        paragraph (9).
                  (B) Contracts for the management of funding 
                and conduct of research.--
                          (i) Contracts.--
                                  (I) In general.--In 
                                accordance with the research 
                                project agenda established 
                                under paragraph (1)(B), the 
                                Institute shall enter into 
                                contracts for the management of 
                                funding and conduct of research 
                                in accordance with the 
                                following:
                                          (aa) Appropriate 
                                        agencies and 
                                        instrumentalities of 
                                        the Federal Government.
                                          (bb) Appropriate 
                                        academic research, 
                                        private sector 
                                        research, or study-
                                        conducting entities.
                                  (II) Preference.--In entering 
                                into contracts under subclause 
                                (I), the Institute shall give 
                                preference to the Agency for 
                                Healthcare Research and Quality 
                                and the National Institutes of 
                                Health, but only if the 
                                research to be conducted or 
                                managed under such contract is 
                                authorized by the governing 
                                statutes of such Agency or 
                                Institutes.
                          (ii) Conditions for contracts.--A 
                        contract entered into under this 
                        subparagraph shall require that the 
                        agency, instrumentality, or other 
                        entity--
                                  (I) abide by the transparency 
                                and conflicts of interest 
                                requirements under subsection 
                                (h) that apply to the Institute 
                                with respect to the research 
                                managed or conducted under such 
                                contract;
                                  (II) comply with the 
                                methodological standards 
                                adopted under paragraph (9) 
                                with respect to such research;
                                  (III) consult with the expert 
                                advisory panels for clinical 
                                trials and rare disease 
                                appointed under clauses (ii) 
                                and (iii), respectively, of 
                                paragraph (4)(A);
                                  (IV) subject to clause (iv), 
                                permit a researcher who 
                                conducts original research, as 
                                described in subparagraph 
                                (A)(ii), under the contract for 
                                the agency, instrumentality, or 
                                other entity to have such 
                                research published in a peer-
                                reviewed journal or other 
                                publication, as long as the 
                                researcher enters into a data 
                                use agreement with the 
                                Institute for use of the data 
                                from the original research, as 
                                appropriate;
                                  (V) have appropriate 
                                processes in place to manage 
                                data privacy and meet ethical 
                                standards for the research;
                                  (VI) comply with the 
                                requirements of the Institute 
                                for making the information 
                                available to the public under 
                                paragraph (8); and
                                  (VII) comply with other terms 
                                and conditions determined 
                                necessary by the Institute to 
                                carry out the research agenda 
                                adopted under paragraph (2).
                          (iii) Coverage of copayments or 
                        coinsurance.--A contract entered into 
                        under this subparagraph may allow for 
                        the coverage of copayments or 
                        coinsurance, or allow for other 
                        appropriate measures, to the extent 
                        that such coverage or other measures 
                        are necessary to preserve the validity 
                        of a research project, such as in the 
                        case where the research project must be 
                        blinded.
                          (iv) Subsequent use of the data.--The 
                        Institute shall not allow the 
                        subsequent use of data from original 
                        research in work-for-hire contracts 
                        with individuals, entities, or 
                        instrumentalities that have a financial 
                        interest in the results, unless 
                        approved under a data use agreement 
                        with the Institute.
                  (C) Review and update of evidence.--The 
                Institute shall review and update evidence on a 
                periodic basis as appropriate.
                  (D) Taking into account potential 
                differences.--Research shall be designed, as 
                appropriate, to take into account the potential 
                for differences in the effectiveness of health 
                care treatments, services, and items as used 
                with various subpopulations, such as racial and 
                ethnic minorities, women, age, and groups of 
                individuals with different comorbidities, 
                genetic and molecular sub-types, or quality of 
                life preferences and include members of such 
                subpopulations as subjects in the research as 
                feasible and appropriate.
                  (E) Differences in treatment modalities.--
                Research shall be designed, as appropriate, to 
                take into account different characteristics of 
                treatment modalities that may affect research 
                outcomes, such as the phase of the treatment 
                modality in the innovation cycle and the impact 
                of the skill of the operator of the treatment 
                modality.
          (3) Data collection.--
                  (A) In general.--The Secretary shall, with 
                appropriate safeguards for privacy, make 
                available to the Institute such data collected 
                by the Centers for Medicare & Medicaid Services 
                under the programs under titles XVIII, XIX, and 
                XXI, as well as provide access to the data 
                networks developed under section 937(f) of the 
                Public Health Service Act, as the Institute and 
                its contractors may require to carry out this 
                section. The Institute may also request and 
                obtain data from Federal, State, or private 
                entities, including data from clinical 
                databases and registries.
                  (B) Use of data.--The Institute shall only 
                use data provided to the Institute under 
                subparagraph (A) in accordance with laws and 
                regulations governing the release and use of 
                such data, including applicable confidentiality 
                and privacy standards.
          (4) Appointing expert advisory panels.--
                  (A) Appointment.--
                          (i) In general.--The Institute may 
                        appoint permanent or ad hoc expert 
                        advisory panels as determined 
                        appropriate to assist in identifying 
                        research priorities and establishing 
                        the research project agenda under 
                        paragraph (1) and for other purposes.
                          (ii) Expert advisory panels for 
                        clinical trials.--The Institute shall 
                        appoint expert advisory panels in 
                        carrying out randomized clinical trials 
                        under the research project agenda under 
                        paragraph (2)(A)(ii). Such expert 
                        advisory panels shall advise the 
                        Institute and the agency, 
                        instrumentality, or entity conducting 
                        the research on the research question 
                        involved and the research design or 
                        protocol, including important patient 
                        subgroups and other parameters of the 
                        research. Such panels shall be 
                        available as a resource for technical 
                        questions that may arise during the 
                        conduct of such research.
                          (iii) Expert advisory panel for rare 
                        disease.--In the case of a research 
                        study for rare disease, the Institute 
                        shall appoint an expert advisory panel 
                        for purposes of assisting in the design 
                        of the research study and determining 
                        the relative value and feasibility of 
                        conducting the research study.
                  (B) Composition.--An expert advisory panel 
                appointed under subparagraph (A) shall include 
                representatives of practicing and research 
                clinicians, patients, and experts in scientific 
                and health services research, health services 
                delivery, and evidence-based medicine who have 
                experience in the relevant topic, and as 
                appropriate, experts in integrative health and 
                primary prevention strategies. The Institute 
                may include a technical expert of each 
                manufacturer or each medical technology that is 
                included under the relevant topic, project, or 
                category for which the panel is established.
          (5) Supporting patient and consumer 
        representatives.--The Institute shall provide support 
        and resources to help patient and consumer 
        representatives effectively participate on the Board 
        and expert advisory panels appointed by the Institute 
        under paragraph (4).
          (6) Establishing methodology committee.--
                  (A) In general.--The Institute shall 
                establish a standing methodology committee to 
                carry out the functions described in 
                subparagraph (C).
                  (B) Appointment and composition.--The 
                methodology committee established under 
                subparagraph (A) shall be composed of not more 
                than 15 members appointed by the Comptroller 
                General of the United States. Members appointed 
                to the methodology committee shall be experts 
                in their scientific field, such as health 
                services research, clinical research, 
                comparative clinical effectiveness research, 
                biostatistics, genomics, and research 
                methodologies. Stakeholders with such expertise 
                may be appointed to the methodology committee. 
                In addition to the members appointed under the 
                first sentence, the Directors of the National 
                Institutes of Health and the Agency for 
                Healthcare Research and Quality (or their 
                designees) shall each be included as members of 
                the methodology committee.
                  (C) Functions.--Subject to subparagraph (D), 
                the methodology committee shall work to develop 
                and improve the science and methods of 
                comparative clinical effectiveness research by, 
                not later than 18 months after the 
                establishment of the Institute, directly or 
                through subcontract, developing and 
                periodically updating the following:
                          (i) Methodological standards for 
                        research. Such methodological standards 
                        shall provide specific criteria for 
                        internal validity, generalizability, 
                        feasibility, and timeliness of research 
                        and for health outcomes measures, risk 
                        adjustment, and other relevant aspects 
                        of research and assessment with respect 
                        to the design of research. Any 
                        methodological standards developed and 
                        updated under this subclause shall be 
                        scientifically based and include 
                        methods by which new information, data, 
                        or advances in technology are 
                        considered and incorporated into 
                        ongoing research projects by the 
                        Institute, as appropriate. The process 
                        for developing and updating such 
                        standards shall include input from 
                        relevant experts, stakeholders, and 
                        decisionmakers, and shall provide 
                        opportunities for public comment. Such 
                        standards shall also include methods by 
                        which patient subpopulations can be 
                        accounted for and evaluated in 
                        different types of research. As 
                        appropriate, such standards shall build 
                        on existing work on methodological 
                        standards for defined categories of 
                        health interventions and for each of 
                        the major categories of comparative 
                        clinical effectiveness research methods 
                        (determined as of the date of enactment 
                        of the Patient Protection and 
                        Affordable Care Act).
                          (ii) A translation table that is 
                        designed to provide guidance and act as 
                        a reference for the Board to determine 
                        research methods that are most likely 
                        to address each specific research 
                        question.
                  (D) Consultation and conduct of 
                examinations.--The methodology committee may 
                consult and contract with the Institute of 
                Medicine of the National Academies and 
                academic, nonprofit, or other private and 
                governmental entities with relevant expertise 
                to carry out activities described in 
                subparagraph (C) and may consult with relevant 
                stakeholders to carry out such activities.
                  (E) Reports.--The methodology committee shall 
                submit reports to the Board on the committee's 
                performance of the functions described in 
                subparagraph (C). Reports shall contain 
                recommendations for the Institute to adopt 
                methodological standards developed and updated 
                by the methodology committee as well as other 
                actions deemed necessary to comply with such 
                methodological standards.
          (7) Providing for a peer-review process for primary 
        research.--
                  (A) In general.--The Institute shall ensure 
                that there is a process for peer review of 
                primary research described in subparagraph 
                (A)(ii) of paragraph (2) that is conducted 
                under such paragraph. Under such process--
                          (i) evidence from such primary 
                        research shall be reviewed to assess 
                        scientific integrity and adherence to 
                        methodological standards adopted under 
                        paragraph (9); and
                          (ii) a list of the names of 
                        individuals contributing to any peer-
                        review process during the preceding 
                        year or years shall be made public and 
                        included in annual reports in 
                        accordance with paragraph (10)(D).
                  (B) Composition.--Such peer-review process 
                shall be designed in a manner so as to avoid 
                bias and conflicts of interest on the part of 
                the reviewers and shall be composed of experts 
                in the scientific field relevant to the 
                research under review.
                  (C) Use of existing processes.--
                          (i) Processes of another entity.--In 
                        the case where the Institute enters 
                        into a contract or other agreement with 
                        another entity for the conduct or 
                        management of research under this 
                        section, the Institute may utilize the 
                        peer-review process of such entity if 
                        such process meets the requirements 
                        under subparagraphs (A) and (B).
                          (ii) Processes of appropriate medical 
                        journals.--The Institute may utilize 
                        the peer-review process of appropriate 
                        medical journals if such process meets 
                        the requirements under subparagraphs 
                        (A) and (B).
          (8) Release of research findings.--
                  (A) In general.--The Institute shall, not 
                later than 90 days after the conduct or receipt 
                of research findings under this part, make such 
                research findings available to clinicians, 
                patients, and the general public. The Institute 
                shall ensure that the research findings--
                          (i) convey the findings of research 
                        in a manner that is comprehensible and 
                        useful to patients and providers in 
                        making health care decisions;
                          (ii) fully convey findings and 
                        discuss considerations specific to 
                        certain subpopulations, risk factors, 
                        and comorbidities, as appropriate;
                          (iii) include limitations of the 
                        research and what further research may 
                        be needed as appropriate;
                          (iv) do not include practice 
                        guidelines, coverage recommendations, 
                        payment, or policy recommendations; and
                          (v) not include any data which would 
                        violate the privacy of research 
                        participants or any confidentiality 
                        agreements made with respect to the use 
                        of data under this section.
                  (B) Definition of research findings.--In this 
                paragraph, the term ``research findings'' means 
                the results of a study or assessment.
          (9) Adoption.--Subject to subsection (h)(1), the 
        Institute shall adopt the national priorities 
        identified under paragraph (1)(A), the research project 
        agenda established under paragraph (1)(B), the 
        methodological standards developed and updated by the 
        methodology committee under paragraph (6)(C)(i), and 
        any peer-review process provided under paragraph (7) by 
        majority vote. In the case where the Institute does not 
        adopt such processes in accordance with the preceding 
        sentence, the processes shall be referred to the 
        appropriate staff or entity within the Institute (or, 
        in the case of the methodological standards, the 
        methodology committee) for further review.
          (10) Annual reports.--The Institute shall submit an 
        annual report to Congress and the President, and shall 
        make the annual report available to the public. Such 
        report shall contain--
                  (A) a description of the activities conducted 
                under this section, research priorities 
                identified under paragraph (1)(A) and 
                methodological standards developed and updated 
                by the methodology committee under paragraph 
                (6)(C)(i) that are adopted under paragraph (9) 
                during the preceding year;
                  (B) the research project agenda and budget of 
                the Institute for the following year;
                  (C) any administrative activities conducted 
                by the Institute during the preceding year;
                  (D) the names of individuals contributing to 
                any peer-review process under paragraph (7), 
                without identifying them with a particular 
                research project; and
                  (E) any other relevant information (including 
                information on the membership of the Board, 
                expert advisory panels, methodology committee, 
                and the executive staff of the Institute, any 
                conflicts of interest with respect to these 
                individuals, and any bylaws adopted by the 
                Board during the preceding year).
  (e) Administration.--
          (1) In general.--Subject to paragraph (2), the Board 
        shall carry out the duties of the Institute.
          (2) Nondelegable duties.--The activities described in 
        subsections (d)(1) and (d)(9) are nondelegable.
  (f) Board of Governors.--
          (1) In general.--The Institute shall have a Board of 
        Governors, which shall consist of the following 
        members:
                  (A) The Director of Agency for Healthcare 
                Research and Quality (or the Director's 
                designee).
                  (B) The Director of the National Institutes 
                of Health (or the Director's designee).
                  (C) Seventeen members appointed, not later 
                than 6 months after the date of enactment of 
                this section, by the Comptroller General of the 
                United States as follows:
                          (i) 3 members representing patients 
                        and health care consumers.
                          (ii) 7 members representing 
                        physicians and providers, including 4 
                        members representing physicians (at 
                        least 1 of whom is a surgeon), 1 nurse, 
                        1 State-licensed integrative health 
                        care practitioner, and 1 representative 
                        of a hospital.
                          (iii) 3 members representing private 
                        payers, of whom at least 1 member shall 
                        represent health insurance issuers and 
                        at least 1 member shall represent 
                        employers who self-insure employee 
                        benefits.
                          (iv) 3 members representing 
                        pharmaceutical, device, and diagnostic 
                        manufacturers or developers.
                          (v) 1 member representing quality 
                        improvement or independent health 
                        service researchers.
                          (vi) 2 members representing the 
                        Federal Government or the States, 
                        including at least 1 member 
                        representing a Federal health program 
                        or agency.
          (2) Qualifications.--The Board shall represent a 
        broad range of perspectives and collectively have 
        scientific expertise in clinical health sciences 
        research, including epidemiology, decisions sciences, 
        health economics, and statistics. In appointing the 
        Board, the Comptroller General of the United States 
        shall consider and disclose any conflicts of interest 
        in accordance with subsection (h)(4)(B). Members of the 
        Board shall be recused from relevant Institute 
        activities in the case where the member (or an 
        immediate family member of such member) has a real 
        conflict of interest directly related to the research 
        project or the matter that could affect or be affected 
        by such participation.
          (3) Terms; vacancies.--A member of the Board shall be 
        appointed for a term of 6 years, except with respect to 
        the members first appointed, whose terms of appointment 
        shall be staggered evenly over 2-year increments. No 
        individual shall be appointed to the Board for more 
        than 2 terms. Vacancies shall be filled in the same 
        manner as the original appointment was made.
          (4) Chairperson and vice-chairperson.--The 
        Comptroller General of the United States shall 
        designate a Chairperson and Vice Chairperson of the 
        Board from among the members of the Board. Such members 
        shall serve as Chairperson or Vice Chairperson for a 
        period of 3 years.
          (5) Compensation.--Each member of the Board who is 
        not an officer or employee of the Federal Government 
        shall be entitled to compensation (equivalent to the 
        rate provided for level IV of the Executive Schedule 
        under section 5315 of title 5, United States Code) and 
        expenses incurred while performing the duties of the 
        Board. An officer or employee of the Federal government 
        who is a member of the Board shall be exempt from 
        compensation.
          (6) Director and staff; experts and consultants.--The 
        Board may employ and fix the compensation of an 
        Executive Director and such other personnel as may be 
        necessary to carry out the duties of the Institute and 
        may seek such assistance and support of, or contract 
        with, experts and consultants that may be necessary for 
        the performance of the duties of the Institute.
          (7) Meetings and hearings.--The Board shall meet and 
        hold hearings at the call of the Chairperson or a 
        majority of its members. Meetings not solely concerning 
        matters of personnel shall be advertised at least 7 
        days in advance and open to the public. A majority of 
        the Board members shall constitute a quorum, but a 
        lesser number of members may meet and hold hearings.
  (g) Financial and Governmental Oversight.--
          (1) Contract for audit.--The Institute shall provide 
        for the conduct of financial audits of the Institute on 
        an annual basis by a private entity with expertise in 
        conducting financial audits.
          (2) Review and annual reports.--
                  (A) Review.--The Comptroller General of the 
                United States shall review the following:
                          (i) Not less frequently than on an 
                        annual basis, the financial audits 
                        conducted under paragraph (1).
                          (ii) Not less frequently than every 5 
                        years, the processes established by the 
                        Institute, including the research 
                        priorities and the conduct of research 
                        projects, in order to determine whether 
                        information produced by such research 
                        projects is objective and credible, is 
                        produced in a manner consistent with 
                        the requirements under this section, 
                        and is developed through a transparent 
                        process.
                          (iii) Not less frequently than every 
                        5 years, the dissemination and training 
                        activities and data networks 
                        established under section 937 of the 
                        Public Health Service Act, including 
                        the methods and products used to 
                        disseminate research, the types of 
                        training conducted and supported, and 
                        the types and functions of the data 
                        networks established, in order to 
                        determine whether the activities and 
                        data are produced in a manner 
                        consistent with the requirements under 
                        such section.
                          (iv) Not less frequently than every 5 
                        years, the overall effectiveness of 
                        activities conducted under this section 
                        and the dissemination, training, and 
                        capacity building activities conducted 
                        under section 937 of the Public Health 
                        Service Act. Such review shall include 
                        an analysis of the extent to which 
                        research findings are used by health 
                        care decision-makers, the effect of the 
                        dissemination of such findings on 
                        reducing practice variation and 
                        disparities in health care, and the 
                        effect of the research conducted and 
                        disseminated on innovation and the 
                        health care economy of the United 
                        States.
                          (v) Not later than 8 years after the 
                        date of enactment of this section, the 
                        adequacy and use of the funding for the 
                        Institute and the activities conducted 
                        under section 937 of the Public Health 
                        Service Act, including a determination 
                        as to whether, based on the utilization 
                        of research findings by public and 
                        private payers, funding sources for the 
                        Patient-Centered Outcomes Research 
                        Trust Fund under section 9511 of the 
                        Internal Revenue Code of 1986 are 
                        appropriate and whether such sources of 
                        funding should be continued or 
                        adjusted.
                  (B) Annual reports.--Not later than April 1 
                of each year, the Comptroller General of the 
                United States shall submit to Congress a report 
                containing the results of the review conducted 
                under subparagraph (A) with respect to the 
                preceding year (or years, if applicable), 
                together with recommendations for such 
                legislation and administrative action as the 
                Comptroller General determines appropriate.
  (h) Ensuring Transparency, Credibility, and Access.--The 
Institute shall establish procedures to ensure that the 
following requirements for ensuring transparency, credibility, 
and access are met:
          (1) Public comment periods.--The Institute shall 
        provide for a public comment period of not less than 45 
        days and not more than 60 days prior to the adoption 
        under subsection (d)(9) of the national priorities 
        identified under subsection (d)(1)(A), the research 
        project agenda established under subsection (d)(1)(B), 
        the methodological standards developed and updated by 
        the methodology committee under subsection 
        (d)(6)(C)(i), and the peer-review process provided 
        under paragraph (7), and after the release of draft 
        findings with respect to systematic reviews of existing 
        research and evidence.
          (2) Additional forums.--The Institute shall support 
        forums to increase public awareness and obtain and 
        incorporate public input and feedback through media 
        (such as an Internet website) on research priorities, 
        research findings, and other duties, activities, or 
        processes the Institute determines appropriate.
          (3) Public availability.--The Institute shall make 
        available to the public and disclose through the 
        official public Internet website of the Institute the 
        following:
                  (A) Information contained in research 
                findings as specified in subsection (d)(9).
                  (B) The process and methods for the conduct 
                of research, including the identity of the 
                entity and the investigators conducing such 
                research and any conflicts of interests of such 
                parties, any direct or indirect links the 
                entity has to industry, and research protocols, 
                including measures taken, methods of research 
                and analysis, research results, and such other 
                information the Institute determines 
                appropriate) concurrent with the release of 
                research findings.
                  (C) Notice of public comment periods under 
                paragraph (1), including deadlines for public 
                comments.
                  (D) Subsequent comments received during each 
                of the public comment periods.
                  (E) In accordance with applicable laws and 
                processes and as the Institute determines 
                appropriate, proceedings of the Institute.
          (4) Disclosure of conflicts of interest.--
                  (A) In general.--A conflict of interest shall 
                be disclosed in the following manner:
                          (i) By the Institute in appointing 
                        members to an expert advisory panel 
                        under subsection (d)(4), in selecting 
                        individuals to contribute to any peer-
                        review process under subsection (d)(7), 
                        and for employment as executive staff 
                        of the Institute.
                          (ii) By the Comptroller General in 
                        appointing members of the methodology 
                        committee under subsection (d)(6);
                          (iii) By the Institute in the annual 
                        report under subsection (d)(10), except 
                        that, in the case of individuals 
                        contributing to any such peer review 
                        process, such description shall be in a 
                        manner such that those individuals 
                        cannot be identified with a particular 
                        research project.
                  (B) Manner of disclosure.--Conflicts of 
                interest shall be disclosed as described in 
                subparagraph (A) as soon as practicable on the 
                Internet web site of the Institute and of the 
                Government Accountability Office. The 
                information disclosed under the preceding 
                sentence shall include the type, nature, and 
                magnitude of the interests of the individual 
                involved, except to the extent that the 
                individual recuses himself or herself from 
                participating in the consideration of or any 
                other activity with respect to the study as to 
                which the potential conflict exists.
  (i) Rules.--The Institute, its Board or staff, shall be 
prohibited from accepting gifts, bequeaths, or donations of 
services or property. In addition, the Institute shall be 
prohibited from establishing a corporation or generating 
revenues from activities other than as provided under this 
section.
  (j) Rules of Construction.--
          (1) Coverage.--Nothing in this section shall be 
        construed--
                  (A) to permit the Institute to mandate 
                coverage, reimbursement, or other policies for 
                any public or private payer; or
                  (B) as preventing the Secretary from covering 
                the routine costs of clinical care received by 
                an individual entitled to, or enrolled for, 
                benefits under title XVIII, XIX, or XXI in the 
                case where such individual is participating in 
                a clinical trial and such costs would otherwise 
                be covered under such title with respect to the 
                beneficiary.

           *       *       *       *       *       *       *


 trust fund transfers to patient-centered outcomes research trust fund

  Sec. 1183. (a) In General.--The Secretary shall provide for 
the transfer, from the Federal Hospital Insurance Trust Fund 
under section 1817 and the Federal Supplementary Medical 
Insurance Trust Fund under section 1841, in proportion (as 
estimated by the Secretary) to the total expenditures during 
such fiscal year that are made under title XVIII from the 
respective trust fund, to the Patient-Centered Outcomes 
Research Trust Fund (referred to in this section as the 
``PCORTF'') under section 9511 of the Internal Revenue Code of 
1986, of the following:
          (1) For fiscal year 2013, an amount equal to $1 
        multiplied by the average number of individuals 
        entitled to benefits under part A, or enrolled under 
        part B, of title XVIII during such fiscal year.
          (2) For each of fiscal years [2014, 2015, 2016, 2017, 
        2018, and 2019] 2014 through 2026, an amount equal to 
        $2 multiplied by the average number of individuals 
        entitled to benefits under part A, or enrolled under 
        part B, of title XVIII during such fiscal year.
  (b) Adjustments for Increases in Health Care Spending.--In 
the case of any fiscal year beginning after September 30, 2014, 
the dollar amount in effect under subsection (a)(2) for such 
fiscal year shall be equal to the sum of such dollar amount for 
the previous fiscal year (determined after the application of 
this subsection), plus an amount equal to the product of--
          (1) such dollar amount for the previous fiscal year, 
        multiplied by
          (2) the percentage increase in the projected per 
        capita amount of National Health Expenditures, as most 
        recently published by the Secretary before the 
        beginning of the fiscal year.

           *       *       *       *       *       *       *


                         VII. DISSENTING VIEWS

    H.R. 3439, introduced by Representative Beyer (D-VA), 
amends the Internal Revenue Code of 1986 and Title XI of the 
Social Security Act to extend appropriations and transfers to 
the Patient-Centered Outcomes Research Trust Fund and to extend 
certain health insurance fees for such transfers through fiscal 
year 2026.
    Comparative effectiveness research--research that helps to 
inform patients and providers of the risks and benefits of 
different treatment options--has value. But like the National 
Institutes of Health and the Agency for Healthcare Research and 
Quality, the Patient-Centered Outcomes Research Institute 
(PCORI) should be funded primarily by discretionary funding 
that is subject to annual appropriations. H.R. 3439 adds over 
$2.8 billion in new taxes on private health insurance. 
Americans who choose consumer-based savings vehicles, like a 
flexible savings account, pay PCORI's tax on insurance twice. 
It also raids $1.3 billion from the Medicare Part A and Part B 
trust funds. The Medicare Part A trust fund is projected to be 
exhausted by 2026.
    Total spending from PCORI's trust fund has totaled $4 
billion since its inception. Some of the spending has not been 
focused on comparative effectiveness research. In FY 2018, for 
every study on comparative effectiveness research, it approved 
nearly two ``engagement awards.'' It gave half a million 
dollars back to the insurance industry's lobbying group to 
``build and maintain support from health plan leaders'' and to 
``identify important gaps in availability of health insurance 
administrative data.'' It also spent over $19.5 million on 
``engagement award conferences.'' It even gave $25,000 to the 
pharmaceutical trade association's foundation to throw a 
conference.
    Again, PCORI is undoubtedly engaging in some valuable work. 
But this program can continue to do so with discretionary 
funding. Congressional oversight is critical to oversee the 
millions of taxpayer dollars being spent on this program each 
year. Discretionary funding will ensure that Congressional 
oversight occurs on an annual basis.
    Republicans offered two amendments to H.R. 3439. The first, 
offered by Representative Brad Wenstrup (R-OH), reauthorized 
PCORI for five years and made it fully discretionary. The 
second, offered by Representative George Holding (R-NC), 
eliminated fees assessed on health insurance issuers. Such 
``fees''--or taxes--includes the fees collected to fund PCORI 
and the health insurer tax, which is a more than $160 billion 
tax hike over the next decade that will increase the average 
individual market premium by more than $200.
    Both commonsense amendments were rejected by Democrats and 
not adopted. The first amendment, offered by Representative 
Brad Wenstrup (R-OH), failed by a roll call vote of 16 yeas to 
24 nays. The second amendment, offered by Representative 
Holding (R-NC), failed by a roll call vote of 16 yeas to 24 
nays.

                                   Kevin Brady,
                                           Ranking Member, Committee on 
                                               Ways and Means.

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