Title: Patient-Centered Outcomes Research Institute Reauthorization Act
Policy area: Health

Summary:
Patient-Centered Outcomes Research Institute Reauthorization Act
This bill reauthorizes, and extends funding for, the Patient-Centered Outcomes Research Institute (PCORI) through FY2029. The bill also makes other changes related to the institute, such as (1) requiring health insurance plans to cover routine costs for items and services furnished in connection with certain PCORI-funded clinical trials, and (2) directing the Government Accountability Office to review barriers experienced by PCORI researchers when conducting studies or clinical trials.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 2897 Introduced in Senate (IS)]

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116th CONGRESS
  1st Session
                                S. 2897

    To amend title XI of the Social Security Act to reauthorize the 
 Patient-Centered Outcomes Research Institute, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           November 19, 2019

Mr. Warner (for himself, Mr. Cassidy, Mr. Van Hollen, and Mrs. Capito) 
introduced the following bill; which was read twice and referred to the 
                          Committee on Finance

_______________________________________________________________________

                                 A BILL


 
    To amend title XI of the Social Security Act to reauthorize the 
 Patient-Centered Outcomes Research Institute, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Patient-Centered Outcomes Research 
Institute Reauthorization Act''.

SEC. 2. REAUTHORIZATION OF PATIENT-CENTERED OUTCOMES RESEARCH 
              INSTITUTE.

    (a) Extension of Funding.--
            (1) Mandatory appropriations.--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 2029'';
                    (B) in subsection (d)(2)(A), by striking ``2019'' 
                and inserting ``2029''; and
                    (C) in subsection (f), by striking ``2019'' and 
                inserting ``2029''.
            (2) Extension of medicare transfers.--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 2029''.
            (3) Extension of certain health insurance fees.--
                    (A) Health insurance policies.--Section 4375(e) of 
                the Internal Revenue Code of 1986 is amended by 
                striking ``2019'' and inserting ``2029''.
                    (B) Self-insured health plans.--Section 4376(e) of 
                the Internal Revenue Code of 1986 is amended by 
                striking ``2019'' and inserting ``2029''.
    (b) Board Composition.--Subsection (f) of section 1181 of the 
Social Security Act (42 U.S.C. 1320e) is amended--
            (1) in paragraph (1)--
                    (A) in subparagraph (C)--
                            (i) in the matter preceding clause (i)--
                                    (I) by striking ``Seventeen'' and 
                                inserting ``Twenty-three''; and
                                    (II) by striking ``, not later than 
                                6 months after the date of enactment of 
                                this section,''; and
                            (ii) in clause (iii), by striking ``3'' and 
                        inserting ``7''; and
            (2) in paragraph (3)--
                    (A) in the first sentence--
                            (i) by striking the ``the members'' and 
                        inserting ``members''; and
                            (ii) by inserting the following before the 
                        period at the end: ``to the extent necessary to 
                        preserve the evenly staggered terms of the 
                        Board.''; and
                    (B) by inserting the following after the first 
                sentence: ``Any member appointed to fill a vacancy 
                occurring before the expiration of the term for which 
                the member's predecessor was appointed shall be 
                appointed for the remainder of that term and thereafter 
                may be eligible for reappointment to a full term. A 
                member may serve after the expiration of that member's 
                term until a successor has been appointed.''.
    (c) Consideration of Full Range of Outcomes Data.--Subsection 
(d)(2) of such section 1181 is amended by adding at the end the 
following subparagraph:
                    ``(F) Consideration of full range of outcomes 
                data.--Research shall be designed, as appropriate, to 
                take into account and capture the full range of 
                clinical and patient-centered outcomes relevant to, and 
                that meet the needs of, patients, clinicians, 
                purchasers, and policy makers in making informed health 
                decisions. In addition to the relative health outcomes 
                and clinical effectiveness, clinical and patient-
                centered outcomes shall include the potential burdens 
                and economic impacts of the utilization of medical 
                treatments, items, and services on different 
                stakeholders and decision makers respectively. These 
                potential burdens and economic impacts include medical 
                out-of-pocket costs, including health plan benefit and 
                formulary design, non-medical costs to the patient and 
                family, including caregiving, effects on future costs 
                of care, workplace productivity and absenteeism, and 
                healthcare utilization.''.
    (d) Establishment of Expert Advisory Panel.--Subsection (d)(4)(A) 
of such section 1181 is amended by adding at the end the following new 
clause:
                            ``(iv) Expert advisory panel for high-
                        impact research.--The Institute shall appoint 
                        an expert advisory panel for purposes of 
                        assisting and advising the Institute on ways to 
                        take into account and target diseases, 
                        conditions, and care interventions that have a 
                        high-impact on national health expenditures and 
                        advance the incorporation of practical evidence 
                        into health care delivery in the national 
                        priorities for research and the research 
                        project agenda under paragraph (1). Such panel 
                        shall include members representing private and 
                        public payers in addition to the composition 
                        requirements described in subparagraph (B).''.
    (e) Ensuring Coverage for Clinical Trials Under Existing Standard 
of Care.--
            (1) Revision to definition of approved clinical trial in 
        individual and group market.--
                    (A) In general.--Subsection (d)(1) of the first 
                section 2709 of the Public Health Service Act (42 
                U.S.C. 300gg-8) is amended by adding at the end the 
                following new subparagraph:
                    ``(D) The study or investigation is approved or 
                funded (which may include funding through in-kind 
                contributions) by the Patient-Centered Outcomes 
                Research Institute established under section 1181 of 
                the Social Security Act.''.
                    (B) Applicability date.--The amendment made by this 
                paragraph shall apply with respect to plan years 
                beginning on or after January 1, 2020.
            (2) Medicare coverage of routine costs associated with 
        certain clinical trials.--
                    (A) In general.--Section 1862(m)(2) of the Social 
                Security Act (42 U.S.C. 1395y(m)(2)) is amended, in the 
                matter preceding subparagraph (A), by inserting 
                ``(including a trial funded by the Patient-Centered 
                Outcomes Research Institute established under section 
                1181)'' after ``means a trial''.
                    (B) Effective date.--The amendment made by this 
                subparagraph shall apply with respect to items and 
                services furnished on or after the date of the 
                enactment of this Act.
    (f) Additions to Annual Reports by the Institute.--Subsection 
(d)(10)(A) of such section 1181 is amended--
            (1) by inserting ``, including narrative statements of 
        funding announcements of the Institute,'' after ``paragraph 
        (1)(A)''; and
            (2) by inserting the following before the semicolon: ``as 
        well as any barriers that researchers funded by the Institute 
        have encountered in conducting studies or clinical trials, 
        including challenges covering the cost of any medical 
        treatments, services, and items described in subsection 
        (a)(2)(B) for purposes of the research study''.
    (g) GAO Oversight.--Subsection (g)(2)(A) of such section 1181 is 
amended by adding at the end the following new clause:
                            ``(vi) Not less frequently than every 5 
                        years, any barriers that researchers funded by 
                        the Institute have encountered in conducting 
                        studies or clinical trials, including 
                        challenges covering the cost of any medical 
                        treatments, services, and items described in 
                        subsection (a)(2)(B) for purposes of the 
                        research study.''.
    (h) Agency for Healthcare Research and Quality Activities.--
            (1) Implementation of research findings.--Section 937(b) of 
        the Public Health Service Act (42 U.S.C. 299b-37(b)) is amended 
        to read as follows:
    ``(b) Implementation.--The Agency for Healthcare Research and 
Quality, in consultation with relevant medical and clinical 
associations, shall carry out activities to promote the timely 
implementation of research findings disseminated under subsection (a) 
into clinical practices, including by assisting users of health 
information technology focused on clinical decision support in such 
implementation, in order to improve quality of care, health outcomes, 
and population health and to promote the ease of use of such 
implementation.''.
            (2) Paperwork reduction act.--Section 937 of the Public 
        Health Service Act (42 U.S.C. 299b-37) is amended by adding at 
        the end the following:
    ``(h) Administration.--Chapter 35 of title 44, United States Code, 
shall not apply to any activity carried out under this section.''.
            (3) Office of communication and knowledge transfer.--
                    (A) In general.--Section 937 of the Public Health 
                Service Act (42 U.S.C. 299b-37), as amended by 
                paragraph (1), is further amended--
                            (i) in subsection (a)(1), by striking ``The 
                        Office of Communication and Knowledge 
                        Transfer'' and all that follows through 
                        ``Healthcare Research and Quality)'' and 
                        inserting ``The Agency for Healthcare Research 
                        and Quality''; and
                            (ii) by striking ``Office'' each place it 
                        appears and inserting ``Agency for Healthcare 
                        Research and Quality''.
                    (B) Patient-centered outcomes research trust 
                fund.--Section 9511(d)(2)(C)(i) of the Internal Revenue 
                Code of 1986 is amended by striking ``the Office of 
                Communication and Knowledge Transfer'' and all that 
                follows through ``Healthcare Research and Quality)'' 
                and inserting ``the Agency for Healthcare Research and 
                Quality''.
    (i) Promotion of Timely Implementation of Research Findings.--
Subsection (c) of such section 1181 is amended by inserting ``and 
promotion of the timely implementation'' after ``dissemination''.
    (j) Identification of Research Priorities.--Subsection (d)(1)(A) of 
such section 1181 is amended by adding at the end the following new 
sentence: ``Such priorities should reflect a balance between long-term 
priorities and short-term priorities, and be responsive to changing 
medical evidence and health care treatments.''.
    (k) Effective Date.--Except as otherwise provided in this section, 
the provisions of, and the amendments made by, this section shall take 
effect on the date of the enactment of this Act.
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