Patient-Centered Outcomes Research Institute Reauthorization Act

II 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 Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Patient-Centered Out- 4 comes Research Institute Reauthorization Act’’. 5 SEC. 2. REAUTHORIZATION OF PATIENT-CENTERED OUT- 6 COMES RESEARCH INSTITUTE. 7 (a) EXTENSION OF FUNDING.— 8 VerDate Sep 11 2014 23:42 Nov 25, 2019 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S2897.IS S2897 pamtmann on DSKBC07HB2PROD with BILLS 2 •S 2897 IS (1) MANDATORY APPROPRIATIONS.—Section 1 9511 of the Internal Revenue Code of 1986 is 2 amended— 3 (A) in subsection (b)(1)(E), by striking 4 ‘‘2014’’ and all that follows through ‘‘2019’’ 5 and inserting ‘‘2014 through 2029’’; 6 (B) in subsection (d)(2)(A), by striking 7 ‘‘2019’’ and inserting ‘‘2029’’; and 8 (C) in subsection (f), by striking ‘‘2019’’ 9 and inserting ‘‘2029’’. 10 (2) EXTENSION OF MEDICARE TRANSFERS.— 11 Section 1183(a)(2) of the Social Security Act (42 12 U.S.C. 1320e–2(a)(2)) is amended by striking 13 ‘‘2014’’ and all that follows through ‘‘2019’’ and in- 14 serting ‘‘2014 through 2029’’. 15 (3) EXTENSION OF CERTAIN HEALTH INSUR- 16 ANCE FEES.— 17 (A) HEALTH INSURANCE POLICIES.—Sec- 18 tion 4375(e) of the Internal Revenue Code of 19 1986 is amended by striking ‘‘2019’’ and in- 20 serting ‘‘2029’’. 21 (B) SELF-INSURED HEALTH PLANS.—Sec- 22 tion 4376(e) of the Internal Revenue Code of 23 1986 is amended by striking ‘‘2019’’ and in- 24 serting ‘‘2029’’. 25 VerDate Sep 11 2014 23:42 Nov 25, 2019 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S2897.IS S2897 pamtmann on DSKBC07HB2PROD with BILLS 3 •S 2897 IS (b) BOARD COMPOSITION.—Subsection (f) of section 1 1181 of the Social Security Act (42 U.S.C. 1320e) is 2 amended— 3 (1) in paragraph (1)— 4 (A) in subparagraph (C)— 5 (i) in the matter preceding clause 6 (i)— 7 (I) by striking ‘‘Seventeen’’ and 8 inserting ‘‘Twenty-three’’; and 9 (II) by striking ‘‘, not later than 10 6 months after the date of enactment 11 of this section,’’; and 12 (ii) in clause (iii), by striking ‘‘3’’ and 13 inserting ‘‘7’’; and 14 (2) in paragraph (3)— 15 (A) in the first sentence— 16 (i) by striking the ‘‘the members’’ and 17 inserting ‘‘members’’; and 18 (ii) by inserting the following before 19 the period at the end: ‘‘to the extent nec- 20 essary to preserve the evenly staggered 21 terms of the Board.’’; and 22 (B) by inserting the following after the 23 first sentence: ‘‘Any member appointed to fill a 24 vacancy occurring before the expiration of the 25 VerDate Sep 11 2014 23:42 Nov 25, 2019 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S2897.IS S2897 pamtmann on DSKBC07HB2PROD with BILLS 4 •S 2897 IS term for which the member’s predecessor was 1 appointed shall be appointed for the remainder 2 of that term and thereafter may be eligible for 3 reappointment to a full term. A member may 4 serve after the expiration of that member’s 5 term until a successor has been appointed.’’. 6 (c) CONSIDERATION OF FULL RANGE OF OUTCOMES 7 DATA.—Subsection (d)(2) of such section 1181 is amend- 8 ed by adding at the end the following subparagraph: 9 ‘‘(F) CONSIDERATION OF FULL RANGE OF 10 OUTCOMES DATA.—Research shall be designed, 11 as appropriate, to take into account and cap- 12 ture the full range of clinical and patient-cen- 13 tered outcomes relevant to, and that meet the 14 needs of, patients, clinicians, purchasers, and 15 policy makers in making informed health deci- 16 sions. In addition to the relative health out- 17 comes and clinical effectiveness, clinical and pa- 18 tient-centered outcomes shall include the poten- 19 tial burdens and economic impacts of the utili- 20 zation of medical treatments, items, and serv- 21 ices on different stakeholders and decision mak- 22 ers respectively. These potential burdens and 23 economic impacts include medical out-of-pocket 24 costs, including health plan benefit and for- 25 VerDate Sep 11 2014 23:42 Nov 25, 2019 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S2897.IS S2897 pamtmann on DSKBC07HB2PROD with BILLS 5 •S 2897 IS mulary design, non-medical costs to the patient 1 and family, including caregiving, effects on fu- 2 ture costs of care, workplace productivity and 3 absenteeism, and healthcare utilization.’’. 4 (d) ESTABLISHMENT OF EXPERT ADVISORY 5 PANEL.—Subsection (d)(4)(A) of such section 1181 is 6 amended by adding at the end the following new clause: 7 ‘‘(iv) EXPERT ADVISORY PANEL FOR 8 HIGH-IMPACT RESEARCH.—The Institute 9 shall appoint an expert advisory panel for 10 purposes of assisting and advising the In- 11 stitute on ways to take into account and 12 target diseases, conditions, and care inter- 13 ventions that have a high-impact on na- 14 tional health expenditures and advance the 15 incorporation of practical evidence into 16 health care delivery in the national prior- 17 ities for research and the research project 18 agenda under paragraph (1). Such panel 19 shall include members representing private 20 and public payers in addition to the com- 21 position requirements described in sub- 22 paragraph (B).’’. 23 (e) ENSURING COVERAGE FOR CLINICAL TRIALS 24 UNDER EXISTING STANDARD OF CARE.— 25 VerDate Sep 11 2014 23:42 Nov 25, 2019 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S2897.IS S2897 pamtmann on DSKBC07HB2PROD with BILLS 6 •S 2897 IS (1) REVISION TO DEFINITION OF APPROVED 1 CLINICAL TRIAL IN INDIVIDUAL AND GROUP MAR- 2 KET.— 3 (A) IN GENERAL.—Subsection (d)(1) of 4 the first section 2709 of the Public Health 5 Service Act (42 U.S.C. 300gg–8) is amended by 6 adding at the end the following new subpara- 7 graph: 8 ‘‘(D) The study or investigation is ap- 9 proved or funded (which may include funding 10 through in-kind contributions) by the Patient- 11 Centered Outcomes Research Institute estab- 12 lished under section 1181 of the Social Security 13 Act.’’. 14 (B) APPLICABILITY DATE.—The amend- 15 ment made by this paragraph shall apply with 16 respect to plan years beginning on or after Jan- 17 uary 1, 2020. 18 (2) MEDICARE COVERAGE OF ROUTINE COSTS 19 ASSOCIATED WITH CERTAIN CLINICAL TRIALS.— 20 (A) IN GENERAL.—Section 1862(m)(2) of 21 the Social Security Act (42 U.S.C. 22 1395y(m)(2)) is amended, in the matter pre- 23 ceding subparagraph (A), by inserting ‘‘(includ- 24 ing a trial funded by the Patient-Centered Out- 25 VerDate Sep 11 2014 23:42 Nov 25, 2019 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S2897.IS S2897 pamtmann on DSKBC07HB2PROD with BILLS 7 •S 2897 IS comes Research Institute established under sec- 1 tion 1181)’’ after ‘‘means a trial’’. 2 (B) EFFECTIVE DATE.—The amendment 3 made by this subparagraph shall apply with re- 4 spect to items and services furnished on or 5 after the date of the enactment of this Act. 6 (f) ADDITIONS TO ANNUAL REPORTS BY THE INSTI- 7 TUTE.—Subsection (d)(10)(A) of such section 1181 is 8 amended— 9 (1) by inserting ‘‘, including narrative state- 10 ments of funding announcements of the Institute,’’ 11 after ‘‘paragraph (1)(A)’’; and 12 (2) by inserting the following before the semi- 13 colon: ‘‘as well as any barriers that researchers 14 funded by the Institute have encountered in con- 15 ducting studies or clinical trials, including challenges 16 covering the cost of any medical treatments, serv- 17 ices, and items described in subsection (a)(2)(B) for 18 purposes of the research study’’. 19 (g) GAO OVERSIGHT.—Subsection (g)(2)(A) of such 20 section 1181 is amended by adding at the end the fol- 21 lowing new clause: 22 ‘‘(vi) Not less frequently than every 5 23 years, any barriers that researchers funded 24 by the Institute have encountered in con- 25 VerDate Sep 11 2014 23:42 Nov 25, 2019 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S2897.IS S2897 pamtmann on DSKBC07HB2PROD with BILLS 8 •S 2897 IS ducting studies or clinical trials, including 1 challenges covering the cost of any medical 2 treatments, services, and items described 3 in subsection (a)(2)(B) for purposes of the 4 research study.’’. 5 (h) AGENCY FOR HEALTHCARE RESEARCH AND 6 QUALITY ACTIVITIES.— 7 (1) IMPLEMENTATION OF RESEARCH FIND- 8 INGS.—Section 937(b) of the Public Health Service 9 Act (42 U.S.C. 299b–37(b)) is amended to read as 10 follows: 11 ‘‘(b) IMPLEMENTATION.—The Agency for Healthcare 12 Research and Quality, in consultation with relevant med- 13 ical and clinical associations, shall carry out activities to 14 promote the timely implementation of research findings 15 disseminated under subsection (a) into clinical practices, 16 including by assisting users of health information tech- 17 nology focused on clinical decision support in such imple- 18 mentation, in order to improve quality of care, health out- 19 comes, and population health and to promote the ease of 20 use of such implementation.’’. 21 (2) PAPERWORK REDUCTION ACT.—Section 937 22 of the Public Health Service Act (42 U.S.C. 299b– 23 37) is amended by adding at the end the following: 24 VerDate Sep 11 2014 23:42 Nov 25, 2019 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S2897.IS S2897 pamtmann on DSKBC07HB2PROD with BILLS 9 •S 2897 IS ‘‘(h) ADMINISTRATION.—Chapter 35 of title 44, 1 United States Code, shall not apply to any activity carried 2 out under this section.’’. 3 (3) OFFICE OF COMMUNICATION AND KNOWL- 4 EDGE TRANSFER.— 5 (A) IN GENERAL.—Section 937 of the 6 Public Health Service Act (42 U.S.C. 299b– 7 37), as amended by paragraph (1), is further 8 amended— 9 (i) in subsection (a)(1), by striking 10 ‘‘The Office of Communication and Knowl- 11 edge Transfer’’ and all that follows 12 through ‘‘Healthcare Research and Qual- 13 ity)’’ and inserting ‘‘The Agency for 14 Healthcare Research and Quality’’; and 15 (ii) by striking ‘‘Office’’ each place it 16 appears and inserting ‘‘Agency for 17 Healthcare Research and Quality’’. 18 (B) PATIENT-CENTERED OUTCOMES RE- 19 SEARCH TRUST FUND.—Section 20 9511(d)(2)(C)(i) of the Internal Revenue Code 21 of 1986 is amended by striking ‘‘the Office of 22 Communication and Knowledge Transfer’’ and 23 all that follows through ‘‘Healthcare Research 24 VerDate Sep 11 2014 23:42 Nov 25, 2019 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S2897.IS S2897 pamtmann on DSKBC07HB2PROD with BILLS 10 •S 2897 IS and Quality)’’ and inserting ‘‘the Agency for 1 Healthcare Research and Quality’’. 2 (i) PROMOTION OF TIMELY IMPLEMENTATION OF 3 RESEARCH FINDINGS.—Subsection (c) of such section 4 1181 is amended by inserting ‘‘and promotion of the time- 5 ly implementation’’ after ‘‘dissemination’’. 6 (j) IDENTIFICATION OF RESEARCH PRIORITIES.— 7 Subsection (d)(1)(A) of such section 1181 is amended by 8 adding at the end the following new sentence: ‘‘Such prior- 9 ities should reflect a balance between long-term priorities 10 and short-term priorities, and be responsive to changing 11 medical evidence and health care treatments.’’. 12 (k) EFFECTIVE DATE.—Except as otherwise pro- 13 vided in this section, the provisions of, and the amend- 14 ments made by, this section shall take effect on the date 15 of the enactment of this Act. 16 Æ VerDate Sep 11 2014 23:42 Nov 25, 2019 Jkt 099200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6301 E:\BILLS\S2897.IS S2897 pamtmann on DSKBC07HB2PROD with BILLS