,,ii #aafth ,,congress #ast ,session ,s4 #bhig ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,november #ai1 #bjai,mr4 ,warner 7for himself1 ,mr4 ,cassidy1 ,mr4 ,van ,hollen1 and ,mrs4 ,capito7 introduced the following bill2 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 ,institute1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,patient-,centered ,outcomes ,research ,institute ,reauthorization ,act4 #b4 ,reauthorization of ,patient-,centered ,outcomes ,research ,institute 7a7 ,extension of funding 7#a7 ,mandatory appropriations ,section #ieaa of the ,internal ,revenue ,code of #aihf is amended-- 7,a7 in subsection 7b77#a77;,e71 by striking #bjad and all that follows through #bjai and inserting #bjad through #bjbi2 7,b7 in subsection 7d77#b77;,a71 by striking #bjai and inserting #bjbi2 and 7,c7 in subsection 7f71 by striking #bjai and inserting #bjbi4 7#b7 ,extension of ,medicare transfers ,section #aahc7;a77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;e-#b7;a77#b77 is amended by striking #bjad and all that follows through #bjai and inserting #bjad through #bjbi4 7#c7 ,extension of certain health insurance fees 7,a7 ,health insurance policies ,section #dcge7;e7 of the ,internal ,revenue ,code of #aihf is amended by striking #bjai and inserting #bjbi4 7,b7 ,self-insured health plans ,section #dcgf7;e7 of the ,internal ,revenue ,code of #aihf is amended by striking #bjai and inserting #bjbi4 7b7 ,board composition ,subsection 7f7 of section #aaha of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;e7 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 in subparagraph 7,c7-- 7i7 in the matter preceding clause 7i7-- 7,i7 by striking ,seventeen and inserting ,twenty-three2 and 7,,ii7 by striking 1 not later than #f months after the date of enactment of this section12 and 7ii7 in clause 7iii71 by striking #c and inserting #g2 and 7#b7 in paragraph 7#c7-- 7,a7 in the first sentence-- 7i7 by striking the the members and inserting members2 and 7ii7 by inserting the following before the period at the end3 to the extent necessary to preserve the evenly staggered terms of the ,board42 and 7,b7 by inserting the following after the first sentence3 ,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 term4 ,a member may serve after the expiration of that member's term until a successor has been appointed44 7c7 ,consideration of full range of outcomes data ,subsection 7d77#b7 of such section #aaha is amended by adding at the end the following subparagraph3 7,f7 ,consideration of full range of outcomes data ,research shall be designed1 as appropriate1 to take into account and capture the full range of clinical and patient-centered outcomes relevant to1 and that meet the needs of1 patients1 clinicians1 purchasers1 and policy makers in making informed health decisions4 ,in addition to the relative health outcomes and clinical effectiveness1 clinical and patient-centered outcomes shall include the potential burdens and economic impacts of the utilization of medical treatments1 items1 and services on different stakeholders and decision makers respectively4 ,these potential burdens and economic impacts include medical out-of-pocket costs1 including health plan benefit and formulary design1 non-medical costs to the patient and family1 including caregiving1 effects on future costs of care1 workplace productivity and absenteeism1 and healthcare utilization4 4 7d7 ,establishment of expert advisory panel ,subsection 7d77#d77;,a7 of such section #aaha is amended by adding at the end the following new clause3 7iv7 ,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 diseases1 conditions1 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 7#a74 ,such panel shall include members representing private and public payers in addition to the composition requirements described in subparagraph 7,b74 4 7e7 ,ensuring coverage for clinical trials under existing standard of care 7#a7 ,revision to definition of approved clinical trial in individual and group market 7,a7 ,in general ,subsection 7d77#a7 of the first section #bgji of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#h7 is amended by adding at the end the following new subparagraph3 7,d7 ,the study or investigation is approved or funded 7which may include funding through in-kind contributions7 by the ,patient-,centered ,outcomes ,research ,institute established under section #aaha of the ,social ,security ,act4 4 7,b7 ,applicability date ,the amendment made by this paragraph shall apply with respect to plan years beginning on or after ,january #a1 #bjbj4 7#b7 ,medicare coverage of routine costs associated with certain clinical trials 7,a7 ,in general ,section #ahfb7m77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciey7m77#b77 is amended1 in the matter preceding subparagraph 7,a71 by inserting 7including a trial funded by the ,patient-,centered ,outcomes ,research ,institute established under section #aaha7 after means a trial4 7,b7 ,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 ,act4 7f7 ,additions to annual reports by the ,institute ,subsection 7d77#aj77;,a7 of such section #aaha is amended-- 7#a7 by inserting 1 including narrative statements of funding announcements of the ,institute1 after paragraph 7#a77;,a72 and 7#b7 by inserting the following before the semicolon3 as well as any barriers that researchers funded by the ,institute have encountered in conducting studies or clinical trials1 including challenges covering the cost of any medical treatments1 services1 and items described in subsection 7a77#b77;,b7 for purposes of the research study4 7g7 ,,gao oversight ,subsection 7g77#b77;,a7 of such section #aaha is amended by adding at the end the following new clause3 7vi7 ,not less frequently than every #e years1 any barriers that researchers funded by the ,institute have encountered in conducting studies or clinical trials1 including challenges covering the cost of any medical treatments1 services1 and items described in subsection 7a77#b77;,b7 for purposes of the research study4 4 7h7 ,agency for ,healthcare ,research and ,quality activities 7#a7 ,implementation of research findings ,section #icg7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bii;b-#cg7;b77 is amended to read as follows3 7b7 ,implementation ,the ,agency for ,healthcare ,research and ,quality1 in consultation with relevant medical and clinical associations1 shall carry out activities to promote the timely implementation of research findings disseminated under subsection 7a7 into clinical practices1 including by assisting users of health information technology focused on clinical decision support in such implementation1 in order to improve quality of care1 health outcomes1 and population health and to promote the ease of use of such implementation4 4 7#b7 ,paperwork ,reduction ,act ,section #icg of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bii;b-#cg7 is amended by adding at the end the following3 7h7 ,administration ,chapter #ce of title #dd1 ,united ,states ,code1 shall not apply to any activity carried out under this section4 4 7#c7 ,office of ,communication and ,knowledge ,transfer 7,a7 ,in general ,section #icg of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bii;b-#cg71 as amended by paragraph 7#a71 is further amended-- 7i7 in subsection 7a77#a71 by striking ,the ,office of ,communication and ,knowledge ,transfer and all that follows through ,healthcare ,research and ,quality7 and inserting ,the ,agency for ,healthcare ,research and ,quality2 and 7ii7 by striking ,office each place it appears and inserting ,agency for ,healthcare ,research and ,quality4 7,b7 ,patient-,centered ,outcomes ,research ,trust ,fund ,section #ieaa7;d77#b77;,c77i7 of the ,internal ,revenue ,code of #aihf is amended by striking the ,office of ,communication and ,knowledge ,transfer and all that follows through ,healthcare ,research and ,quality7 and inserting the ,agency for ,healthcare ,research and ,quality4 7i7 ,promotion of timely implementation of research findings ,subsection 7c7 of such section #aaha is amended by inserting and promotion of the timely implementation after dissemination4 7j7 ,identification of research priorities ,subsection 7d77#a77;,a7 of such section #aaha is amended by adding at the end the following new sentence3 ,such priorities should reflect a balance between long-term priorities and short-term priorities1 and be responsive to changing medical evidence and health care treatments44 7k7 ,effective date ,except as otherwise provided in this section1 the provisions of1 and the amendments made by1 this section shall take effect on the date of the enactment of this ,act4