TH ST CONGRESS SESSION S. 1213

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II111TH CONGRESS1ST SESSIONS. 1213To amend title XI of the Social Security Act to provide for the conductof comparative effectiveness research and to amend the Internal RevenueCode of 1986 to establish a Patient-Centered Outcomes Research TrustFund, and for other purposes.IN THE SENATE OF THE UNITED STATESJUNE 9, 2009Mr. BAUCUS (for himself and Mr. CONRAD) introduced the following bill;which was read twice and referred to the Committee on FinanceA BILLTo amend title XI of the Social Security Act to providefor the conduct of comparative effectiveness research andto amend the Internal Revenue Code of 1986 to establisha Patient-Centered Outcomes Research Trust Fund, andfor other purposes.1Be it enacted by the Senate and House of Representa-2 tives of the United States of America in Congress assembled,3SECTION 1. SHORT TITLE.4This Act may be cited as the ‘‘Patient-Centered Out-jbell on PROD1PC69 with BILLS5 comes Research Act of 2009’’.VerDate Nov 24 200803:06 Jun 10, 2009Jkt 079200PO 00000Frm 00001Fmt 6652Sfmt 6201E:\BILLS\S1213.ISS1213

21SEC. 2. COMPARATIVE EFFECTIVENESS RESEARCH.2(a) IN GENERAL.—Title XI of the Social Security Act3 (42 U.S.C. 1301 et seq.) is amended by adding at the end4 the following new part:5‘‘PART D—COMPARATIVE EFFECTIVENESS RESEARCH67‘‘COMPARATIVE‘‘SEC. 1181. (a) DEFINITIONS.—In this section:8‘‘(1) BOARD.—The term ‘Board’ means the9Board of Governors established under subsection (f).1011‘‘(2) COMPARATIVECLINICAL EFFECTIVENESSRESEARCH.—12‘‘(A) INGENERAL.—Theterm ‘compara-13tive clinical effectiveness research’ means re-14search evaluating and comparing the clinical ef-15fectiveness, risks, and benefits of 2 or more16medical treatments, services, and items de-17scribed in subparagraph (B).18jbell on PROD1PC69 with BILLSEFFECTIVENESS RESEARCH‘‘(B) MEDICALTREATMENTS, SERVICES,19AND ITEMS DESCRIBED.—The20ments, services, and items described in this sub-21paragraph are health care interventions, proto-22cols for treatment, care management, and deliv-23ery, procedures, medical devices, diagnostic24tools, pharmaceuticals (including drugs and25biologicals), and any other strategies or items26being used in the treatment, management, andmedical treat- S 1213 ISVerDate Nov 24 200803:06 Jun 10, 2009Jkt 079200PO 00000Frm 00002Fmt 6652Sfmt 6201E:\BILLS\S1213.ISS1213

31diagnosis of, or prevention of illness or injury2in, patients.3‘‘(3)4SEARCH.—The5search’ means research evaluating and comparing6the implications and outcomes of 2 or more health7care strategies to address a particular medical condi-8tion for specific patient populations.9EFFECTIVENESSterm ‘comparative effectiveness re-‘‘(4) CONFLICTSOFINTEREST.—Theterm‘conflicts of interest’ means associations, including11financial and personal, that may be reasonably as-12sumed to have the potential to bias an individual’s13decisions in matters related to the Institute or the14conduct of activities under this section.15‘‘(5) INSTITUTE.—The term ‘Institute’ means16the ‘Patient-Centered Outcomes Research Institute’17established under subsection (b)(1).18‘‘(b) PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE.—20‘‘(1) ESTABLISHMENT.—There is authorized to21be established a nonprofit corporation, to be known22as the ‘Patient-Centered Outcomes Research Insti-23tute’ which is neither an agency nor establishment24of the United States Government. S 1213 ISVerDate Nov 24 2008RE-1019jbell on PROD1PC69 with BILLSCOMPARATIVE03:06 Jun 10, 2009Jkt 079200PO 00000Frm 00003Fmt 6652Sfmt 6201E:\BILLS\S1213.ISS1213

41‘‘(2) APPLICATIONOF PROVISIONS.—TheInsti-2tute shall be subject to the provisions of this section,3and, to the extent consistent with this section, to the4District of Columbia Nonprofit Corporation Act.5‘‘(3) FUNDINGOF COMPARATIVE EFFECTIVE-6NESS RESEARCH.—For7subsequent fiscal year, amounts in the Patient-Cen-8tered Outcomes Research Trust Fund (referred to in9this section as the ‘PCORTF’) under section 951110of the Internal Revenue Code of 1986 shall be avail-11able, without further appropriation, to the Institute12to carry out this section.13‘‘(c) PURPOSE.—The purpose of the Institute is tofiscal year 2010 and each14 assist patients, clinicians, purchasers, and policy makers15 in making informed health decisions by advancing the16 quality and relevance of evidence concerning the manner17 in which diseases, disorders, and other health conditions18 can effectively and appropriately be prevented, diagnosed,19 treated, monitored, and managed through research and20 evidence synthesis that considers variations in patient sub21 populations, and the dissemination of research findings22 with respect to the relative clinical outcomes, clinical effec23 tiveness, and appropriateness of the medical treatments,jbell on PROD1PC69 with BILLS24 services, and items described in subsection (a)(2)(B).25‘‘(d) DUTIES.— S 1213 ISVerDate Nov 24 200803:06 Jun 10, 2009Jkt 079200PO 00000Frm 00004Fmt 6652Sfmt 6201E:\BILLS\S1213.ISS1213

512‘‘(1) IDENTIFYINGESTABLISHING RESEARCH PROJECT e5priorities for comparative clinical effectiveness6research, taking into account factors, includ-7ing—Institute shall identify national‘‘(i) disease incidence, prevalence, and9burden in the United States;10‘‘(ii) evidence gaps in terms of clinical11outcomes;12‘‘(iii) practice variations, including13variations in delivery and outcomes by ge-14ography, treatment site, provider type, and15patient subgroup;16‘‘(iv) the potential for new evidence17concerning certain categories of health care18services or treatments to improve patient19health and well-being, and the quality of20care;21‘‘(v) the effect or potential for an ef-22fect on health expenditures associated with23a health condition or the use of a par-24ticular medical treatment, service, or item; S 1213 ISVerDate Nov 24 2008PRIOR-48jbell on PROD1PC69 with BILLSRESEARCH PRIORITIES AND03:06 Jun 10, 2009Jkt 079200PO 00000Frm 00005Fmt 6652Sfmt 6201E:\BILLS\S1213.ISS1213

61‘‘(vi) the effect or potential for an ef-2fect on patient needs, outcomes, and pref-3erences, including quality of life; and4‘‘(vii) the relevance to assisting pa-5tients and clinicians in making informed6health decisions.7‘‘(B) ESTABLISHING8AGENDA.—9‘‘(i) INGENERAL.—TheInstitute shall10establish and update a research project11agenda for comparative clinical effective-12ness research to address the priorities13identified under subparagraph (A), taking14into consideration the types of such re-15search that might address each priority16and the relative value (determined based17on the cost of conducting such research18compared to the potential usefulness of the19information produced by such research) as-20sociated with the different types of re-21search, and such other factors as the Insti-22tute determines appropriate.23jbell on PROD1PC69 with BILLSRESEARCH PROJECT‘‘(ii) CONSIDERATIONOF NEED TO24CONDUCT A SYSTEMATIC REVIEW.—In25tablishingandupdatingthe S 1213 ISVerDate Nov 24 200803:06 Jun 10, 2009Jkt 079200PO 00000Frm 00006Fmt 6652Sfmt 6201E:\BILLS\S1213.ISS1213es-research

71project agenda under clause (i), the Insti-2tute shall consider the need to conduct a3systematic review of existing research be-4fore providing for the conduct of new re-5search under paragraph (2)(A).67‘‘(2) CARRYINGDA.—8‘‘(A) COMPARATIVE9NESS RESEARCH.—InCLINICAL EFFECTIVE-carrying out the research10project agenda established under paragraph11(1)(B), the Institute shall provide for the con-12duct of appropriate research and the synthesis13of evidence, in accordance with the methodo-14logical standards adopted under paragraph15(10), using methods, including the following:16‘‘(i) Systematic reviews and assess-17jbell on PROD1PC69 with BILLSOUT RESEARCH PROJECT AGEN-ments of existing research and evidence.18‘‘(ii) Primary research, such as ran-19domized clinical trials, molecularly in-20formed trials, and observational studies.21‘‘(iii) Any other methodologies rec-22ommended by the methodology committee23established under paragraph (7) that are24adopted by the Board under paragraph25(10). S 1213 ISVerDate Nov 24 200803:06 Jun 10, 2009Jkt 079200PO 00000Frm 00007Fmt 6652Sfmt 6201E:\BILLS\S1213.ISS1213

81‘‘(B) CONTRACTS2AND CONDUCT OF RESEARCH.—3jbell on PROD1PC69 with BILLSFOR THE MANAGEMENT‘‘(i) INGENERAL.—TheInstitute may4enter into contracts for the management5and conduct of research in accordance with6the research project agenda established7under paragraph (1)(B) with the following:8‘‘(I) Agencies and instrumental-9ities of the Federal Government that10have experience in conducting com-11parative clinical effectiveness research,12such as the Agency for Healthcare13Research and Quality, to the extent14that such contracts are authorized15under the governing statutes of such16agencies and instrumentalities.17‘‘(II) Appropriate private sector18research or study-conducting entities19that have demonstrated the experience20and capacity to achieve the goals of21comparative effectiveness research.22‘‘(ii) CONDITIONSFOR CONTRACTS.—23A contract entered into under this sub-24paragraph shall require that the agency,25instrumentality, or other entity— S 1213 ISVerDate Nov 24 200803:06 Jun 10, 2009Jkt 079200PO 00000Frm 00008Fmt 6652Sfmt 6201E:\BILLS\S1213.ISS1213

jbell on PROD1PC69 with BILLS91‘‘(I) abide by the transparency2and conflicts of interest requirements3that apply to the Institute with re-4spect to the research managed or con-5ducted under such contract;6‘‘(II) comply with the methodo-7logical standards adopted under para-8graph (10) with respect to such re-9search;10‘‘(III) take into consideration11public comments on the study design12that are transmitted by the Institute13to the agency, instrumentality, or14other15(i)(1)(B) during the finalization of the16study design and transmit responses17to such comments to the Institute,18which will publish such comments, re-19sponses, and finalized study design in20accordance21(i)(3)(A)(iii) prior to the conduct of22such research; andentityundersubsectionwithsubsection23‘‘(IV) in the case where the agen-24cy, instrumentality, or other entity is25managing or conducting a compara- S 1213 ISVerDate Nov 24 200803:06 Jun 10, 2009Jkt 079200PO 00000Frm 00009Fmt 6652Sfmt 6201E:\BILLS\S1213.ISS1213

101tive effectiveness research study for a2rare disease, consult with the expert3advisory panel for rare disease ap-4pointed under paragraph (5)(A)(iii)5with respect to such research study.6‘‘(iii) COVERAGE7COINSURANCE.—A8under this subparagraph may allow for the9coverage of copayments or co-insurance, or10allow for other appropriate measures, to11the extent that such coverage or other12measures are necessary to preserve the va-13lidity of a research project, such as in the14case where the research project must be15blinded.16‘‘(C) REVIEWcontract entered intoANDUPDATEEVI-DENCE.—The18evidence on a periodic basis, in order to take19into account new research, evolving evidence,20advances in medical technology, and changes in21the standard of care as they become available,22as appropriate.Institute shall review and update‘‘(D) TAKING24INTO ACCOUNT POTENTIALDIFFERENCES.—Researchshall— S 1213 ISVerDate Nov 24 2008OF1723jbell on PROD1PC69 with BILLSOF COPAYMENTS OR03:06 Jun 10, 2009Jkt 079200PO 00000Frm 00010Fmt 6652Sfmt 6201E:\BILLS\S1213.ISS1213

111‘‘(i) be designed, as appropriate, to2take into account the potential for dif-3ferences in the effectiveness of health care4treatments, services, and items as used5with various subpopulations, such as racial6and ethnic minorities, women, age, and7groups8comorbidities, genetic and molecular sub-9types, or quality of life preferences; andindividualswith‘‘(ii) include members of such sub-11populations as subjects in the research as12feasible and appropriate.13‘‘(E) DIFFERENCESIN TREATMENT MO-14DALITIES.—Research15propriate, to take into account different charac-16teristics of treatment modalities that may affect17research outcomes, such as the phase of the18treatment modality in the innovation cycle and19the impact of the skill of the operator of the20treatment modality.21‘‘(3) STUDYshall be designed, as ap-AND REPORT ON FEASIBILITY OFCONDUCTING RESEARCH IN-HOUSE.—23‘‘(A) STUDY.—The Institute shall conduct24a study on the feasibility of conducting research25in-house. S 1213 ISVerDate Nov 24 2008different1022jbell on PROD1PC69 with BILLSof03:06 Jun 10, 2009Jkt 079200PO 00000Frm 00011Fmt 6652Sfmt 6201E:\BILLS\S1213.ISS1213

121‘‘(B) REPORT.—Not later than 5 years2after the date of enactment of this section, the3Institute shall submit a report to Congress con-4taining the results of the study conducted under5subparagraph (A).6‘‘(4) DATA7‘‘(A) INGENERAL.—TheSecretary shall,8with appropriate safeguards for privacy, make9available to the Institute such data collected by10the Centers for Medicare & Medicaid Services11under the programs under titles XVIII, XIX,12and XXI as the Institute may require to carry13out this section. The Institute may also request14and, if such request is granted, obtain data15from Federal, State, or private entities, includ-16ing data from clinical databases and registries.17‘‘(B) USEOF DATA.—TheInstitute shall18only use data provided to the Institute under19subparagraph (A) in accordance with laws and20regulations governing the release and use of21such data, including applicable confidentiality22and privacy standards.23‘‘(5) APPOINTING24jbell on PROD1PC69 with BILLSCOLLECTION.—EXPERT ADVISORY PANELS.—‘‘(A) APPOINTMENT.— S 1213 ISVerDate Nov 24 200803:06 Jun 10, 2009Jkt 079200PO 00000Frm 00012Fmt 6652Sfmt 6201E:\BILLS\S1213.ISS1213

131‘‘(i)GENERAL.—Theshall, as appropriate, appoint expert advi-3sory panels to assist in identifying research4priorities and establishing the research5project agenda under paragraph (1). Pan-6els shall advise the Institute in matters7such as identifying gaps in and updating8medical evidence in order to ensure that9the information produced from such re-10search is clinically relevant to decisions11made by clinicians and patients at the12point of care.‘‘(ii) EXPERTADVISORY PANELS FOR14PRIMARY RESEARCH.—The15appoint expert advisory panels in carrying16out the research project agenda under17paragraph (2)(A)(ii). Such expert advisory18panels shall, upon request, advise the Insti-19tute and the agency, instrumentality, or20entity conducting the research on the re-21search question involved and the research22design or protocol, including the appro-23priate comparator technologies, important24patient subgroups, and other parameters of25the research, as necessary. Upon the re-Institute shall S 1213 ISVerDate Nov 24 2008Institute213jbell on PROD1PC69 with BILLSIN03:06 Jun 10, 2009Jkt 079200PO 00000Frm 00013Fmt 6652Sfmt 6201E:\BILLS\S1213.ISS1213

141quest of such agency, instrumentality, or2entity, such panels shall be available as a3resource for technical questions that may4arise during the conduct of such research.5‘‘(iii) EXPERTADVISORY PANEL FOR6RARE DISEASE.—Inthe case of a compara-7tive effectiveness research study for rare8disease, the Institute shall appoint an ex-9pert advisory panel for purposes of assist-10ing in the design of such research study11and determining the relative value and fea-12sibility of conducting such research study.13‘‘(B) COMPOSITION.—jbell on PROD1PC69 with BILLS14‘‘(i) INGENERAL.—Anexpert advi-15sory panel appointed under subparagraph16(A) shall include individuals who have ex-17perience in the relevant topic, project, or18category for which the panel is established,19including—20‘‘(I) practicing and research clini-21cians (including relevant specialists22and subspecialists), patients, and rep-23resentatives of patients; and24‘‘(II) experts in scientific and25health services research, health serv- S 1213 ISVerDate Nov 24 200803:06 Jun 10, 2009Jkt 079200PO 00000Frm 00014Fmt 6652Sfmt 6201E:\BILLS\S1213.ISS1213

151ices delivery, and evidence-based medi-2cine.3‘‘(ii) INCLUSIONREPRESENTA-4TIVES OF MANUFACTURERS OF MEDICAL5TECHNOLOGY.—An6appointed under subparagraph (A) may in-7clude a representative of each manufac-8turer of each medical technology that is in-9cluded under the relevant topic, project, or10category for which the panel is established.11jbell on PROD1PC69 with BILLSOF‘‘(6) SUPPORTINGexpert advisory upport and resources to help patient and consumer14representatives on the Board and expert advisory15panels appointed by the Institute under paragraph16(5) to effectively participate in technical discussions17regarding complex research topics. Such support18shall include initial and continuing education to fa-19cilitate effective engagement in activities undertaken20by the Institute and may include regular and ongo-21ing opportunities for patient and consumer rep-22resentatives to interact with each other and to ex-23change information and support regarding their in-24volvement in the Institute’s activities. The Institute25shall provide per diem and other appropriate com-Institute shall provide S 1213 ISVerDate Nov 24 200803:06 Jun 10, 2009Jkt 079200PO 00000Frm 00015Fmt 6652Sfmt 6201E:\BILLS\S1213.ISS1213

161pensation to patient and consumer representatives2for their time spent participating in the activities of3the Institute under this paragraph.45‘‘(7)METHODOLOGY‘‘(A) INGENERAL.—TheInstitute shall es-7tablish a standing methodology committee to8carry out the functions described in subpara-9graph (C).10‘‘(B) APPOINTMENTAND COMPOSITION.—11The methodology committee established under12subparagraph (A) shall be composed of not13more than 17 members appointed by the Comp-14troller General of the United States. Members15appointed to the methodology committee shall16be experts in their scientific field, such as17health services research, clinical research, com-18parative effectiveness research, biostatistics,19genomics, and research methodologies. Stake-20holders with such expertise may be appointed to21the methodology committee.22‘‘(C) FUNCTIONS.—Subject to subpara-23graph (D), the methodology committee shall24work to develop and improve the science and25methods of comparative effectiveness research S 1213 ISVerDate Nov 24 2008COM-MITTEE.—6jbell on PROD1PC69 with BILLSESTABLISHING03:06 Jun 10, 2009Jkt 079200PO 00000Frm 00016Fmt 6652Sfmt 6201E:\BILLS\S1213.ISS1213

jbell on PROD1PC69 with BILLS171by undertaking, directly or through subcontract,2the following activities:3‘‘(i) Not later than 2 years after the4date on which the members of the method-5ology committee are appointed under sub-6paragraph (B), developing and periodically7updating the following:8‘‘(I)Establishand9methodological standards for com-10parative clinical effectiveness research11on major categories of interventions to12prevent, diagnose, or treat a clinical13condition or improve the delivery of14care. Such methodological standards15shall provide specific criteria for inter-16nal validity, generalizability, feasi-17bility, and timeliness of such research18and for clinical outcomes measures,19risk adjustment, and other relevant20aspects of research and assessment21with respect to the design of such re-22search. Any methodological standards23developed and updated under this sub-24clause shall be scientifically based and25include methods by which new infor- S 1213 ISVerDate Nov 24 2008maintain03:06 Jun 10, 2009Jkt 079200PO 00000Frm 00017Fmt 6652Sfmt 6201E:\BILLS\S1213.ISS1213

jbell on PROD1PC69 with BILLS181mation, data, or advances in tech-2nology are considered and incor-3porated into ongoing research projects4by the Institute, as appropriate. The5process for developing and updating6such standards shall include input7from relevant experts, stakeholders,8and decision makers, and shall pro-9vide opportunities for public comment.10Such standards shall also include11methods by which patient subpopula-12tions can be accounted for and evalu-13ated in different types of research. As14appropriate,15build on existing work on methodo-16logical standards for defined cat-17egories of health interventions and for18each of the major categories of com-19parative effectiveness research meth-20ods (determined as of the date of en-21actment of the Patient-Centered Out-22comes Research Act of 2009).suchstandards23‘‘(II) A translation table that is24designed to provide guidance and act25as a reference for the Board to deter- S 1213 ISVerDate Nov 24 2008shall03:06 Jun 10, 2009Jkt 079200PO 00000Frm 00018Fmt 6652Sfmt 6201E:\BILLS\S1213.ISS1213

191mine research methods that are most2likely to address each specific com-3parative clinical effectiveness research4question.5‘‘(ii) Not later than 3 years after such6date, examining the following:7‘‘(I) Methods by which various8aspects of the health care delivery sys-9tem (such as benefit design and per-10formance, and health services organi-11zation, management, information com-12munication, and delivery) could be as-13sessed and compared for their relative14effectiveness, benefits, risks, advan-15tages, and disadvantages in a scientif-16ically valid and standardized way.17‘‘(II) Methods by which efficiency18and value (including the full range of19harms and benefits, such as quality of20life) could be assessed in a scientif-21ically valid and standardized way.22‘‘(D) CONSULTATION23EXAMINATIONS.—24jbell on PROD1PC69 with BILLSAND CONDUCT OF‘‘(i) IN25GENERAL.—Subject(iii), in undertaking the activities described S 1213 ISVerDate Nov 24 200803:06 Jun 10, 2009to clauseJkt 079200PO 00000Frm 00019Fmt 6652Sfmt 6201E:\BILLS\S1213.ISS1213

201in subparagraph (C), the methodology2committee shall—3‘‘(I) consult or contract with 1 or4more of the entities described in5clause (ii); and6‘‘(II) consult with stakeholders7and other entities knowledgeable in8relevant fields, as appropriate.9‘‘(ii) ENTITIESlowing entities are described in this clause:11‘‘(I) The Institute of Medicine ofthe National Academies.13‘‘(II) The Agency for Healthcare14Research and Quality.15‘‘(III) The National Institutes of16Health.17‘‘(IV) Academic, non-profit, or18other private entities with relevant ex-19pertise.20‘‘(iii) CONDUCTOF EXAMINATIONS.—21The methodology committee shall contract22with the Institute of Medicine of the Na-23tional Academies for the conduct of the ex-24aminations described in subclauses (I) and25(II) of subparagraph (C)(ii). S 1213 ISVerDate Nov 24 2008fol-1012jbell on PROD1PC69 with BILLSDESCRIBED.—The03:06 Jun 10, 2009Jkt 079200PO 00000Frm 00020Fmt 6652Sfmt 6201E:\BILLS\S1213.ISS1213

211‘‘(E) REPORTS.—The methodology com-2mittee shall submit reports to the Board on the3committee’s performance of the functions de-4scribed in subparagraph (C). Reports submitted5under the preceding sentence with respect to6the functions described in clause (i) of such7subparagraph shall contain recommendations—8‘‘(i) for the Institute to adopt meth-9odological standards developed and up-10dated by the methodology committee under11such subparagraph; and12‘‘(ii) for such other action as the13methodology committee determines is nec-14essary to comply with such methodological15standards.jbell on PROD1PC69 with BILLS16‘‘(8) PROVIDINGFOR A PEER-REVIEW PROCESS17FOR PRIMARY RESEARCH.—18‘‘(A) INGENERAL.—TheInstitute shall en-19sure that there is a process for peer review of20the21(2)(A)(ii). Under such process—researchconductedunder22‘‘(i) evidence from research conducted23under such paragraph shall be reviewed to24assess scientific integrity and adherence to S 1213 ISVerDate Nov 24 2008paragraph03:06 Jun 10, 2009Jkt 079200PO 00000Frm 00021Fmt 6652Sfmt 6201E:\BILLS\S1213.ISS1213

221methodological standards adopted under2paragraph (10); and3‘‘(ii) a list of the names of individuals4contributing to any peer-review process5during the preceding year or years shall be6made public and included in annual reports7in accordance with paragraph (12)(D).8‘‘(B)peer-review9process shall be designed in a manner so as to10avoid bias and conflicts of interest on the part11of the reviewers and shall be composed of ex-12perts in the scientific field relevant to the re-13search under review.14‘‘(C) USE15jbell on PROD1PC69 with BILLSCOMPOSITION.—SuchOF EXISTING PROCESSES.—‘‘(i) PROCESSESOF ANOTHER ENTI-16TY.—In17into a contract or other agreement with18another entity for the conduct or manage-19ment of research under this section, the20Institute may utilize the peer-review proc-21ess of such entity if such process meets the22requirements under subparagraphs (A) and23(B).the case where the Institute enters24‘‘(ii) PROCESSESOFAPPROPRIATE25MEDICAL JOURNALS.—TheInstitute mayFrm 00022S1213 S 1213 ISVerDate Nov 24 200803:06 Jun 10, 2009Jkt 079200PO 00000Fmt 6652Sfmt 6201E:\BILLS\S1213.IS

231utilize the peer-review process of appro-2priate medical journals if such process3meets the requirements under subpara-4graphs (A) and (B).56‘‘(9) DISSEMINATIONRESEARCH‘‘(A) INGENERAL.—TheInstitute shall8disseminate research findings to clinicians, pa-9tients, and the general public in accordance10with the dissemination protocols and strategies11adopted under paragraph (10). Research find-12ings disseminated—13‘‘(i) shall convey findings of research14so that they are comprehensible and useful15to patients and providers in making health16care decisions;17‘‘(ii) shall discuss findings and other18considerations specific to certain sub-19populations,20comorbidities, as appropriate;riskfactors,and21‘‘(iii) shall include considerations such22as limitations of research and what further23research may be needed, as appropriate; S 1213 ISVerDate Nov 24 2008FIND-INGS.—7jbell on PROD1PC69 with BILLSOF03:06 Jun 10, 2009Jkt 079200PO 00000Frm 00023Fmt 6652Sfmt 6201E:\BILLS\S1213.ISS1213

241‘‘(iv) shall not include practice guide-2lines, coverage recommendations, or policy3recommendations; and4‘‘(v) shall not include any data the5dissemination of which would violate the6privacy of research participants or violate7any confidentiality agreements made with8respect to the use of data under this sec-9tion.jbell on PROD1PC69 with BILLS10‘‘(B) DISSEMINATIONPROTOCOLS11STRATEGIES.—The12tocols and strategies for the appropriate dis-13semination of research findings in order to en-14sure effective communication of such findings15and the use and incorporation of such findings16into relevant activities for the purpose of in-17forming higher quality and more effective and18timely decisions regarding medical treatments,19services, and items. In developing and adopting20such protocols and strategies, the Institute shall21consult with stakeholders, including practicing22clinicians and patients, concerning the types of23dissemination that will be most useful to the24end users of the information and may provideInstitute shall develop pro- S 1213 ISVerDate Nov 24 2008AND03:06 Jun 10, 2009Jkt 079200PO 00000Frm 00024Fmt 6652Sfmt 6201E:\BILLS\S1213.ISS1213

251for the utilization of multiple formats for con-2veying findings to different audiences.jbell on PROD1PC69 with BILLS3‘‘(C) DEFINITIONOFRESEARCH4INGS.—In5findings’ means the results of a study or assess-6ment.7‘‘(10)this paragraph, the term A)(i), the Institute shall adopt the national9priorities identified under paragraph (1)(A), the re-10search project agenda established under paragraph11(1)(B), the methodological standards developed and12updated by the methodology committee under para-13graph (7)(C)(i), any peer-review process provided14under paragraph (8), and dissemination protocols15and strategies developed under paragraph (9)(B) by16majority vote. In the case where the Institute does17not adopt such national priorities, research project18agenda, methodological standards, peer-review proc-19ess, or dissemination protocols and strategies in ac-20cordance with the preceding sentence, the national21priorities, research project agenda, methodological22standards, peer-review process, or dissemination pro-23tocols and strategies shall be referred to the appro-24priate staff or entity within the Institute (or, in the S 1213 ISVerDate Nov 24 2008FIND-03:06 Jun 10, 2009Jkt 079200PO 00000Frm 00025Fmt 6652Sfmt 6201E:\BILLS\S1213.ISS1213

261case of the methodological standards, the method-2ology committee) for further review.3‘‘(11) COORDINATION4SOURCES5SEARCH.—jbell on PROD1PC69 with BILLS6ANDBUILDINGOF RESEARCH AND RECAPACITY‘‘(A) COORDINATIONRE-OF RESEARCH AND7RESOURCES.—The8search conducted, commissioned, or otherwise9funded under this section with comparative clin-10ical effectiveness and other relevant research11and related efforts conducted by public and pri-12vate agencies and organizations in order to en-13sure the most efficient use of the Institute’s re-14sources and that research is not duplicated un-15necessarily.Institute shall coordinate re-16‘‘(B)17SEARCH.—The18comparative clinical effectiveness research and19methodologies, including research training and20development of data resources (such as clinical21registries), through appropriate activities, in-22cluding using up to 20 percent of the amounts23appropriated or credited to the PCORTF under24section 9511(b) of the Internal Revenue Code25of 1986 with respect to a fiscal year to fund ex-BUILDINGCAPACITY03:06 Jun 10, 2009Jkt 079200PO 00000Frm 00026FORRE-Institute may build capacity for S 1213 ISVerDate Nov 24 2008FORFmt 6652Sfmt 6201E:\BILLS\S1213.ISS1213

271tramural efforts of organizations such as the2Cochrane Collaboration (or a successor organi-3zation) and other organizations that develop4and maintain a data network to collect, link,5and analyze data on outcomes and effectiveness6from multiple sources, including electronic7health records.jbell on PROD1PC69 with BILLS8‘‘(C) INCLUSIONIN ANNUAL REPORTS.—9The Institute shall report on any coordination10and capacity building conducted under this11paragraph in annual reports in accordance with12paragraph (12)(E).13‘‘(12) A

2 S 1213 IS 1 SEC. 2. COMPARATIVE EFFECTIVENESS RESEARCH. 2 (a) IN GENERAL.—Title XI of the Social Security Act 3 (42 U.S.C. 1301 et seq.) is amended by adding at the end 4 the following new part: 5 ‘‘PART D—COMPARATIVE EFFECTIVENESS RESEARCH 6 ‘‘COMPARATIVE EFFECTIVENESS RESEARCH

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One individual midterm case report due session 9. Class. Reflection Journal: Do each session on previous session’s case/s and discussion. Put it all together, broken by session, and post as ONE word document before last class session. No need for journal write up on content of midterm case session and the last session. One take-home final due

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