II 116th CONGRESS 1st Session S. 2897 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.

1. Short title This Act may be cited as the Patient-Centered Outcomes Research Institute Reauthorization Act . 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.