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[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2502 Introduced in House (IH)]

111th CONGRESS
  1st Session
                                H. R. 2502

To amend title XI of the Social Security Act to provide for the conduct 
of comparative effectiveness research and to amend the Internal Revenue 
 Code of 1986 to establish a Comparative Effectiveness Research Trust 
                     Fund, and for other purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                              May 19, 2009

 Mr. Schrader (for himself, Mr. McMahon, Mr. Connolly of Virginia, Mr. 
    Kind, Mrs. Halvorson, Mr. Crowley, Ms. Schwartz, Mr. Himes, Mr. 
    Altmire, Ms. Bean, Mrs. Tauscher, and Mrs. Davis of California) 
 introduced the following bill; which was referred to the Committee on 
    Ways and Means, and in addition to the Committee on Energy and 
Commerce, for a period to be subsequently determined by the Speaker, in 
   each case for consideration of such provisions as fall within the 
                jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL

 
To amend title XI of the Social Security Act to provide for the conduct 
of comparative effectiveness research and to amend the Internal Revenue 
 Code of 1986 to establish a Comparative Effectiveness Research Trust 
                     Fund, 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 ``Comparative Effectiveness Research 
Act of 2009''.

SEC. 2. COMPARATIVE EFFECTIVENESS RESEARCH.

    (a) In General.--Title XI of the Social Security Act (42 U.S.C. 
1301 et seq.) is amended by adding at the end the following new part:

              ``Part D--Comparative Effectiveness Research

                  ``comparative effectiveness research

    ``Sec. 1181.  (a) Definitions.--In this section:
            ``(1) Board.--The term `Board' means the Board of Governors 
        established under subsection (f).
            ``(2) Comparative clinical effectiveness research.--
                    ``(A) In general.--The term `comparative clinical 
                effectiveness research' means research evaluating and 
                comparing the clinical effectiveness, risks, and 
                benefits of 2 or more medical treatments, services, and 
                items described in subparagraph (B).
                    ``(B) Medical treatments, services, and items 
                described.--The medical treatments, services, and items 
                described in this subparagraph are health care 
                interventions, protocols for treatment, procedures, 
                medical devices, diagnostic tools, pharmaceuticals 
                (including drugs and biologicals), and any other 
                processes or items being used in the treatment and 
                diagnosis of, or prevention of illness or injury in, 
                patients.
            ``(3) Comparative effectiveness research.--The term 
        `comparative effectiveness research' means research evaluating 
        and comparing the implications and outcomes of 2 or more health 
        care strategies to address a particular medical condition.
            ``(4) Conflicts of interest.--The term `conflicts of 
        interest' means associations, including financial and personal, 
        that may be reasonably assumed to have the potential to bias an 
        individual's decisions in matters related to the Institute or 
        the conduct of activities under this section.
            ``(5) Institute.--The term `Institute' means the `Health 
        Care Comparative Effectiveness Research Institute' established 
        under subsection (b)(1).
    ``(b) Health Care Comparative Effectiveness Research Institute.--
            ``(1) Establishment.--There is authorized to be established 
        a nonprofit corporation, to be known as the ``Health Care 
        Comparative Effectiveness Research Institute'' which is neither 
        an agency nor establishment of the United States Government.
            ``(2) Application of provisions.--The Institute shall be 
        subject to the provisions of this section, and, to the extent 
        consistent with this section, to the District of Columbia 
        Nonprofit Corporation Act.
            ``(3) Funding of comparative effectiveness research.--For 
        fiscal year 2009 and each subsequent fiscal year, amounts in 
        the Comparative Effectiveness Research Trust Fund (referred to 
        in this section as the `CERTF') under section 9511 of the 
        Internal Revenue Code of 1986 shall be available, without 
        further appropriation, to the Institute to carry out this 
        section.
    ``(c) Purpose.--The purpose of the Institute is to improve health 
care delivered to individuals in the United States by advancing the 
quality and thoroughness of evidence concerning the manner in which 
diseases, disorders, and other health conditions can effectively and 
appropriately be prevented, diagnosed, treated, and managed clinically 
through research and evidence synthesis, and the dissemination of 
research findings with respect to the relative outcomes, effectiveness, 
and appropriateness of the medical treatments, services, and items 
described in subsection (a)(2)(B).
    ``(d) Duties.--
            ``(1) Identifying research priorities and establishing 
        research project agenda.--
                    ``(A) Identifying research priorities.--The 
                Institute shall identify national priorities for 
                comparative clinical effectiveness research, taking 
                into account factors, including--
                            ``(i) disease incidence, prevalence, and 
                        burden in the United States;
                            ``(ii) evidence gaps in terms of clinical 
                        outcomes;
                            ``(iii) practice variations, including 
                        variations in delivery and outcomes by 
                        geography, treatment site, provider type, and 
                        patient subgroup;
                            ``(iv) the potential for new evidence 
                        concerning certain categories of health care 
                        services or treatments to improve patient 
                        health and well-being, and the quality of care; 
                        and
                            ``(v) the effect or potential for an effect 
                        on health expenditures associated with a health 
                        condition or the use of a particular medical 
                        treatment, service, or item.
                    ``(B) Establishing research project agenda.--
                            ``(i) In general.--The Institute shall 
                        establish and update a research project agenda 
                        to address the priorities identified under 
                        subparagraph (A), taking into consideration the 
                        types of research that might address each 
                        priority and the relative value (determined 
                        based on the cost of conducting such research 
                        compared to the potential usefulness of the 
                        information produced by such research) 
                        associated with such different types of 
                        research, and such other factors as the 
                        Institute determines appropriate.
                            ``(ii) Consideration of need to conduct a 
                        systematic review.--In establishing and 
                        updating the research project agenda under 
                        clause (i), the Institute shall consider the 
                        need to conduct a systematic review of existing 
                        research (including research on comparative 
                        effectiveness conducted with funds provided 
                        under division A of Public Law 111-5) before 
                        providing for the conduct of new research under 
                        paragraph (2)(A).
            ``(2) Carrying out research project agenda.--
                    ``(A) Comparative clinical effectiveness 
                research.--In carrying out the research project agenda 
                established under paragraph (1)(B), the Institute shall 
                provide for the conduct of appropriate research and the 
                synthesis of evidence, in accordance with the 
                methodological standards adopted under paragraph (9), 
                using methods, including the following:
                            ``(i) Systematic reviews and assessments of 
                        existing research and evidence.
                            ``(ii) Clinical research, such as 
                        randomized controlled trials and observational 
                        studies.
                            ``(iii) Any other methodologies recommended 
                        by the methodology committee established under 
                        paragraph (6) that are adopted by the Board 
                        under paragraph (9).
                    ``(B)(i) Contracts with federal agencies and 
                instrumentalities.--The Institute may enter into 
                contracts with agencies and instrumentalities of the 
                Federal Government that have experience in conducting 
                comparative clinical effectiveness research, such as 
                the Agency for Healthcare Research and Quality, for the 
                management and conduct of research in accordance with 
                the research project agenda established under paragraph 
                (1)(B), to the extent that such contracts are 
                authorized under the governing statutes of such 
                agencies and instrumentalities.
                    ``(ii) Contracts with other entities.--The 
                Institute may enter into contracts with appropriate 
                private sector research or study-conducting entities 
                for the conduct of research described in clause (i).
                    ``(iii) Conditions for contracts.--A contract 
                entered into under this subparagraph shall require that 
                the agency, instrumentality, or other entity--
                            ``(I) abide by the transparency and 
                        conflicts of interest requirements that apply 
                        to the Institute with respect to the research 
                        managed or conducted under such contract;
                            ``(II) comply with the methodological 
                        standards adopted under paragraph (9) with 
                        respect to such research; and
                            ``(III) take into consideration public 
                        comments on the study design that are 
                        transmitted by the Institute to the agency, 
                        instrumentality, or other entity under 
                        subsection (i)(1) during the finalization of 
                        the study design and transmit responses to such 
                        comments to the Institute, which will publish 
                        such comments, responses, and finalized study 
                        design in accordance with paragraph (7)(C) 
                        prior to the conduct of such research.
                    ``(iv) Coverage of copayments or coinsurance.--A 
                contract entered into under this subparagraph may allow 
                for the coverage of copayments or co-insurance, or 
                allow for other appropriate measures, to the extent 
                that such coverage or other measures are necessary to 
                preserve the validity of a research project, such as in 
                the case where the research project must be blinded.
                    ``(C) Review and update of evidence.--The Institute 
                shall review and update evidence on a periodic basis, 
                in order to take into account new research and evolving 
                evidence as they become available, as appropriate.
                    ``(D) Taking into account potential differences.--
                Research shall--
                            ``(i) be designed, as appropriate, to take 
                        into account the potential for differences in 
                        the effectiveness of health care treatments, 
                        services, and items as used with various 
                        subpopulations, such as racial and ethnic 
                        minorities, women, different age groups, and 
                        individuals with different comorbidities; and
                            ``(ii) seek to include members of such 
                        subpopulations as subjects in the research as 
                        feasible and appropriate.
            ``(3) Data collection.--
                    ``(A) In general.--The Secretary shall, with 
                appropriate safeguards for privacy, make available to 
                the Institute such data collected by the Centers for 
                Medicare & Medicaid Services under the programs under 
                titles XVIII, XIX, and XXI as the Institute may require 
                to carry out this section. The Institute may also 
                request and, if such request is granted, obtain data 
                from Federal, State, or private entities.
                    ``(B) Use of data.--The Institute shall only use 
                data provided to the Institute under subparagraph (A) 
                in accordance with laws and regulations governing the 
                release and use of such data, including applicable 
                confidentiality and privacy standards.
            ``(4) Appointing advisory panels.--
                    ``(A) In general.--The Institute may appoint 
                permanent or ad hoc advisory panels as determined 
                appropriate by the Institute to assist in the 
                establishment and carrying out of the research project 
                agenda under paragraphs (1) and (2), respectively. 
                Panels may advise or guide the Institute in matters 
                such as identifying gaps in and updating medical 
                evidence and identifying research priorities and 
                potential study designs in order to ensure that the 
                information produced from such research is clinically 
                relevant to decisions made by clinicians and patients 
                at the point of care and may provide advice throughout 
                the conduct of research.
                    ``(B) Composition.--An advisory panel appointed 
                under subparagraph (A) shall include representatives of 
                clinicians and patients and may include experts in 
                scientific and health services research, health 
                services delivery, and the manufacture of health items 
                who have experience in the relevant topic, project, or 
                category for which the panel is established.
            ``(5) Establishing methodology committee.--
                    ``(A) In general.--The Institute shall establish a 
                standing methodology committee to carry out the 
                functions described in subparagraph (C).
                    ``(B) Appointment and composition.--Members shall 
                be appointed to the methodology committee established 
                under subparagraph (A) by the Comptroller General of 
                the United States. Members appointed to the methodology 
                committee shall be experts in their scientific field, 
                such as health services research, clinical research, 
                comparative effectiveness research, biostatistics, and 
                research methodologies. Stakeholders with such 
                expertise may be appointed to the methodology 
                committee.
                    ``(C) Functions.--Subject to subparagraph (D), the 
                methodology committee shall work to develop and improve 
                the science of comparative effectiveness research by 
                undertaking the following activities:
                            ``(i) Not later than 1 year after the date 
                        on which the members of the methodology 
                        committee are appointed under subparagraph (B), 
                        developing and periodically updating 
                        methodological standards regarding outcomes 
                        measures, risk adjustment, statistical 
                        protocols, evaluation of evidence, conduct of 
                        research, and other aspects of research and 
                        assessment to be used when conducting research 
                        on comparative clinical effectiveness (and 
                        procedures for the use of such standards) in 
                        order to help ensure accurate and effective 
                        comparisons. Such standards shall also include 
                        methods by which new information, data, or 
                        advances in technology are considered and 
                        incorporated into ongoing research projects by 
                        the Institute, as appropriate. In developing 
                        and updating methodological standards under 
                        this clause, the methodology committee shall 
                        ensure that such standards are scientifically 
                        based.
                            ``(ii) Not later than 2 years after such 
                        date, examining the following:
                                    ``(I) Methods by which various 
                                aspects of the health care delivery 
                                system (such as benefit design and 
                                performance, and health services 
                                organization, management, and delivery) 
                                could be assessed and compared for 
                                their relative effectiveness, benefits, 
                                risks, advantages, and disadvantages in 
                                a scientifically valid and standardized 
                                way.
                                    ``(II) Methods by which cost-
                                effectiveness and value could be 
                                assessed in a scientifically valid and 
                                standardized way.
                    ``(D) Consultation and conduct of examinations.--
                            ``(i) In general.--Subject to clause (iii), 
                        in undertaking the activities described in 
                        subparagraph (C), the methodology committee 
                        shall--
                                    ``(I) consult or contract with 1 or 
                                more of the entities described in 
                                clause (ii); and
                                    ``(II) consult with stakeholders 
                                and other entities knowledgeable in 
                                relevant fields, as appropriate.
                            ``(ii) Entities described.--The following 
                        entities are described in this clause:
                                    ``(I) The Institute of Medicine of 
                                the National Academies.
                                    ``(II) The Agency for Healthcare 
                                Research and Quality.
                                    ``(III) The National Institutes of 
                                Health.
                            ``(iii) Conduct of examinations.--The 
                        methodology committee shall contract with the 
                        Institute of Medicine of the National Academies 
                        for the conduct of the examinations described 
                        in subclauses (I) and (II) of subparagraph 
                        (C)(ii).
                    ``(E) Reports.--The methodology committee shall 
                submit reports to the Board on the committee's 
                performance of the functions described in subparagraph 
                (C). Reports submitted under the preceding sentence 
                with respect to the functions described in clause (i) 
                of such subparagraph shall contain recommendations--
                            ``(i) for the Institute to adopt 
                        methodological standards developed and updated 
                        by the methodology committee under such 
                        subparagraph; and
                            ``(ii) for such other action as the 
                        methodology committee determines is necessary 
                        to comply with such methodological standards.
            ``(6) Providing for a peer-review process.--
                    ``(A) In general.--The Institute shall ensure that 
                there is a process for peer review of the research 
                conducted under this section. Under such process--
                            ``(i) evidence from research conducted 
                        under this section shall be reviewed to assess 
                        scientific integrity and adherence to 
                        methodological standards adopted under 
                        paragraph (8); and
                            ``(ii) a list of the names of individuals 
                        contributing to any peer-review process during 
                        the preceding year or years shall be made 
                        public and included in annual reports in 
                        accordance with paragraph (10)(D).
                    ``(B) Composition.--Such peer-review process shall 
                have been designed in a manner so as to avoid bias and 
                conflicts of interest on the part of the reviewers and 
                shall be composed of experts in the scientific field 
                relevant to the research under review.
                    ``(C) Use of existing processes.--In the case where 
                the Institute enters into a contract or other agreement 
                with another entity for the conduct or management of 
                research under this section, the Institute may utilize 
                the peer-review process of such entity if such process 
                meets the requirements under subparagraphs (A) and (B).
            ``(7) Dissemination of research findings.--
                    ``(A) In general.--The Institute shall disseminate 
                research findings to clinicians, patients, and the 
                general public in accordance with the dissemination 
                protocols and strategies adopted under paragraph (8). 
                Research findings disseminated--
                            ``(i) shall convey findings of research so 
                        that they are comprehensible and useful to 
                        patients and providers in making health care 
                        decisions;
                            ``(ii) shall discuss findings and other 
                        considerations specific to certain 
                        subpopulations, risk factors, and 
                        comorbidities, as appropriate;
                            ``(iii) shall include considerations such 
                        as limitations of research and what further 
                        research may be needed, as appropriate;
                            ``(iv) shall not include practice 
                        guidelines or policy recommendations; and
                            ``(v) shall not include any data the 
                        dissemination of which would violate the 
                        privacy of research participants or violate any 
                        confidentiality agreements made with respect to 
                        the use of data under this section.
                    ``(B) Dissemination protocols and strategies.--The 
                Institute shall develop protocols and strategies for 
                the appropriate dissemination of research findings in 
                order to ensure effective communication of such 
                findings and the use and incorporation of such findings 
                into relevant activities for the purpose of informing 
                higher quality and more effective and efficient 
                decisions regarding medical treatments, services, and 
                items. In developing and adopting such protocols and 
                strategies, the Institute shall consult with 
                stakeholders concerning the types of dissemination that 
                will be most useful to the end users of the information 
                and may provide for the utilization of multiple formats 
                for conveying findings to different audiences.
                    ``(C) Public availability.--The Institute shall 
                make available to the public and disclose through the 
                official public Internet website of the Institute, and 
                through other forums and media the Institute determines 
                appropriate, the following:
                            ``(i) The process and methods for the 
                        conduct of research under this section, 
                        including--
                                    ``(I) the identity of the entity 
                                conducting such research;
                                    ``(II) any links the entity has to 
                                industry (including such links that are 
                                not directly tied to the particular 
                                research being conducted under this 
                                section);
                                    ``(III) draft study designs 
                                (including research questions and the 
                                finalized study design, together with 
                                public comments on such study design 
                                and responses to such comments);
                                    ``(IV) research protocols 
                                (including measures taken, methods of 
                                research, methods of analysis, research 
                                results, and such other information as 
                                the Institute determines appropriate);
                                    ``(V) the identity of investigators 
                                conducting such research and any 
                                conflicts of interest of such 
                                investigators; and
                                    ``(VI) any progress reports the 
                                Institute determines appropriate.
                            ``(ii) Public comments submitted during 
                        each of the public comment periods under 
                        subsection (i)(1).
                            ``(iii) Bylaws, processes, and proceedings 
                        of the Institute, to the extent practicable and 
                        as the Institute determines appropriate.
                            ``(iv) Not later than 90 days after receipt 
                        by the Institute of a relevant report or 
                        research findings, appropriate information 
                        contained in such report or findings.
                            ``(v) All reports, findings, results, and 
                        studies conducted by or through the Institute.
                The Institute shall obtain and incorporate public 
                feedback through media (such as an Internet website) on 
                the information disclosed.
                    ``(D) Funding.--At least 5 percent of the funds 
                made available each fiscal year under the CERTF shall 
                be expended on activities under this paragraph.
                    ``(E) Definition of research findings.--In this 
                paragraph, the term `research findings' means the 
                results of a study, appraisal, or assessment.
            ``(8) Adoption.--Subject to subsection (i)(1), the 
        Institute shall adopt the national priorities identified under 
        paragraph (1)(A), the research project agenda established under 
        paragraph (1)(B), the methodological standards developed and 
        updated by the methodology committee under paragraph (5)(C)(i), 
        any peer-review process provided under paragraph (6), and 
        dissemination protocols and strategies developed under 
        paragraph (7)(B) by majority vote. In the case where the 
        Institute does not adopt such national priorities, research 
        project agenda, methodological standards, peer-review process, 
        or dissemination protocols and strategies in accordance with 
        the preceding sentence, the national priorities, research 
        project agenda, methodological standards, peer-review process, 
        or dissemination protocols and strategies shall be referred to 
        the appropriate staff or entity within the Institute (or, in 
        the case of the methodological standards, the methodology 
        committee) for further review.
            ``(9) Coordination of research and resources and building 
        capacity for research.--
                    ``(A) Coordination of research and resources.--The 
                Institute shall coordinate research conducted, 
                commissioned, or otherwise funded under this section 
                with comparative clinical effectiveness and other 
                relevant research and related efforts conducted by 
                public and private agencies and organizations in order 
                to ensure the most efficient use of the Institute's 
                resources and that research is not duplicated 
                unnecessarily.
                    ``(B) Inclusion in annual reports.--The Institute 
                shall report on any coordination and capacity building 
                conducted under this paragraph in annual reports in 
                accordance with paragraph (10)(E).
            ``(10) Annual reports.--The Institute shall submit an 
        annual report to Congress and the President, and shall make the 
        annual report available to the public. Such report shall 
        contain--
                    ``(A) a description of the activities conducted 
                under this section during the preceding year, including 
                the use of amounts appropriated or credited to the 
                CERTF under section 9511(b) of the Internal Revenue 
                Code of 1986 to carry out this section, research 
                projects completed and underway, and a summary of the 
                findings of such projects;
                    ``(B) the research project agenda and budget of the 
                Institute for the following year;
                    ``(C) a description of research priorities 
                identified under paragraph (1)(A), dissemination 
                protocols and strategies developed by the Institute 
                under paragraph (7)(B), and methodological standards 
                developed and updated by the methodology committee 
                under paragraph (5)(C)(i) that are adopted under 
                paragraph (8) during the preceding year;
                    ``(D) the names of individuals contributing to any 
                peer-review process provided under paragraph (6) during 
                the preceding year or years, in a manner such that 
                those individuals cannot be identified with a 
                particular research project;
                    ``(E) a description of efforts by the Institute 
                under paragraph (9) to--
                            ``(i) coordinate the research conducted, 
                        commissioned, or otherwise funded under this 
                        section and the resources of the Institute with 
                        research and related efforts conducted by other 
                        private and public entities; and
                            ``(ii) build capacity for comparative 
                        clinical effectiveness research and other 
                        relevant research and related efforts through 
                        appropriate activities; and
                    ``(F) any other relevant information (including 
                information on the membership of the Board, advisory 
                panels appointed under paragraph (4), the methodology 
                committee established under paragraph (6), and the 
                executive staff of the Institute, any conflicts of 
                interest with respect to the members of such Board, 
                advisory panels, and methodology committee, or with 
                respect to any individuals selected for employment as 
                executive staff of the Institute, and any bylaws 
                adopted by the Board during the preceding year).
            ``(11) Conflicts of interest.--The Institute shall--
                    ``(A) in appointing members to an advisory panel 
                under subsection (d)(4) and the methodology committee 
                under subsection (d)(5), and in selecting individuals 
                to contribute to any peer-review process under 
                subsection (d)(6) and for employment as executive staff 
                of the Institute, take into consideration any conflicts 
                of interest of potential appointees, participants, and 
                staff; and
                    ``(B) include a description of any such conflicts 
                of interest and conflicts of interest of Board members 
                in the annual report under subsection (d)(10), except 
                that, in the case of individuals contributing to any 
                such peer review process, such description shall be in 
                a manner such that those individuals cannot be 
                identified with a particular research project.
    ``(e) Administration.--
            ``(1) In general.--Subject to paragraph (2), the Board 
        shall carry out the duties of the Institute.
            ``(2) Nondelegable duties.--The activities described in 
        subsections (b)(3)(D), (d)(1), and (d)(8) are nondelegable.
    ``(f) Board of Governors.--
            ``(1) In general.--The Institute shall have a Board of 
        Governors, which shall consist of the following members:
                    ``(A) The Secretary of Health and Human Services 
                (or the Secretary's designee).
                    ``(B) The Director of the Agency for Healthcare 
                Research and Quality (or the Director's designee).
                    ``(C) The Director of the National Institutes of 
                Health (or the Director's designee).
                    ``(D) 18 members appointed by the Comptroller 
                General of the United States not later than 6 months 
                after the date of enactment of this section, as 
                follows:
                            ``(i) 3 members representing patients and 
                        health care consumers.
                            ``(ii) 3 members representing practicing 
                        physicians, including surgeons.
                            ``(iii) 3 members representing agencies 
                        that administer public programs, as follows:
                                    ``(I) 1 member representing the 
                                Centers for Medicare & Medicaid 
                                Services who has experience in 
                                administering the program under title 
                                XVIII.
                                    ``(II) 1 member representing 
                                agencies that administer State health 
                                programs (who may represent the Centers 
                                for Medicare & Medicaid Services and 
                                have experience in administering the 
                                program under title XIX or the program 
                                under title XXI or be a governor of a 
                                State).
                                    ``(III) 1 member representing 
                                agencies that administer other Federal 
                                health programs (such as a health 
                                program of the Department of Defense 
                                under chapter 55 of title 10, United 
                                States Code, the Federal employees 
                                health benefits program under chapter 
                                89 of title 5 of such Code, a health 
                                program of the Department of Veterans 
                                Affairs under chapter 17 of title 38 of 
                                such Code, or a medical care program of 
                                the Indian Health Service or of a 
                                tribal organization).
                            ``(iv) 3 members representing private 
                        payers, of whom at least 1 member shall 
                        represent health insurance issuers and at least 
                        1 member shall represent employers who self-
                        insure employee benefits.
                            ``(v) 3 members representing 
                        pharmaceutical, device, and technology 
                        manufacturers or developers.
                            ``(vi) 1 member representing nonprofit 
                        organizations involved in health services 
                        research.
                            ``(vii) 1 member representing organizations 
                        that focus on quality measurement and 
                        improvement or decision support.
                            ``(viii) 1 member representing independent 
                        health services researchers.
            ``(2) Qualifications.--
                    ``(A) Diverse representation of perspectives.--The 
                Board shall represent a broad range of perspectives and 
                collectively have scientific expertise in clinical 
                practice and clinical health sciences research, 
                including epidemiology, decisions sciences, health 
                economics, and statistics.
                    ``(B) Conflicts of interest.--
                            ``(i) In general.--In appointing members of 
                        the Board under paragraph (1)(D), the 
                        Comptroller General of the United States shall 
                        take into consideration any conflicts of 
                        interest of potential appointees. Any conflicts 
                        of interest of members appointed to the Board 
                        under paragraph (1) shall be disclosed in 
                        accordance with subsection (d)(7).
                            ``(ii) Recusal.--A member of the Board 
                        shall be recused from participating with 
                        respect to a particular research project or 
                        other matter considered by the Board in 
                        carrying out its research project agenda under 
                        subsection (d)(2) in the case where the member 
                        (or an immediate family member of such member) 
                        has a financial or personal interest directly 
                        related to the research project or the matter 
                        that could affect or be affected by such 
                        participation.
            ``(3) Terms.--
                    ``(A) In general.--A member of the Board appointed 
                under paragraph (1)(D) shall be appointed for a term of 
                6 years, except with respect to the members first 
                appointed under such paragraph--
                            ``(i) 6 shall be appointed for a term of 6 
                        years;
                            ``(ii) 6 shall be appointed for a term of 4 
                        years; and
                            ``(iii) 6 shall be appointed for a term of 
                        2 years.
                    ``(B) Limitation.--No individual shall be appointed 
                to the Board under paragraph (1)(D) for more than 2 
                terms.
                    ``(C) Expiration of term.--Any member of the Board 
                whose term has expired may serve until such member's 
                successor has taken office, or until the end of the 
                calendar year in which such member's term has expired, 
                whichever is earlier.
                    ``(D) Vacancies.--
                            ``(i) In general.--Any member appointed to 
                        fill a vacancy prior to the expiration of the 
                        term for which such member's predecessor was 
                        appointed shall be appointed for the remainder 
                        of such term.
                            ``(ii) Vacancies not to affect power of 
                        board.--A vacancy on the Board shall not affect 
                        its powers, but shall be filled in the same 
                        manner as the original appointment was made.
            ``(4) Chairperson and vice-chairperson.--
                    ``(A) In general.--From among the members of the 
                Board appointed under paragraph (1)(D), the Comptroller 
                General of the United States shall designate a member 
                who is a physician with national research credentials 
                as Chairperson of the Board and another member as Vice-
                Chairperson of the Board.
                    ``(B) Term.--The members so designated shall serve 
                as Chairperson and Vice-Chairperson of the Board for a 
                period of 3 years.
            ``(5) Compensation.--
                    ``(A) In general.--A member of the Board shall be 
                entitled to compensation at the per diem equivalent of 
                the rate provided for level IV of the Executive 
                Schedule under section 5315 of title 5, United States 
                Code.
                    ``(B) Travel expenses.--While away from home or 
                regular place of business in the performance of duties 
                for the Board, each member of the Board may receive 
                reasonable travel, subsistence, and other necessary 
                expenses.
            ``(6) Director and staff; experts and consultants.--The 
        Board may--
                    ``(A) employ and fix the compensation of an 
                executive director and such other personnel as may be 
                necessary to carry out the duties of the Institute;
                    ``(B) seek such assistance and support as may be 
                required in the performance of the duties of the 
                Institute from appropriate departments and agencies of 
                the Federal Government;
                    ``(C) enter into contracts or make other 
                arrangements and make such payments as may be necessary 
                for performance of the duties of the Institute;
                    ``(D) provide travel, subsistence, and per diem 
                compensation for individuals performing the duties of 
                the Institute, including members of any advisory panel 
                appointed under subsection (d)(4), members of the 
                methodology committee established under subsection 
                (d)(5), and individuals selected to contribute to any 
                peer-review process under subsection (d)(6); and
                    ``(E) prescribe such rules, regulations, and bylaws 
                as the Board determines necessary with respect to the 
                internal organization and operation of the Institute.
            ``(7) Meetings and hearings.--The Board shall meet and hold 
        hearings at the call of the Chairperson or a majority of its 
        members. In the case where the Board is meeting on matters not 
        related to personnel, Board meetings shall be open to the 
        public and advertised.
            ``(8) Quorum.--A majority of the members of the Board shall 
        constitute a quorum for purposes of conducting the duties of 
        the Institute, but a lesser number of members may meet and hold 
        hearings.
    ``(g) Financial Oversight.--
            ``(1) Contract for audit.--The Institute shall provide for 
        the conduct of financial audits of the Institute on an annual 
        basis by a private entity with expertise in conducting 
        financial audits.
            ``(2) Review of audit and report to congress.--The 
        Comptroller General of the United States shall--
                    ``(A) review the results of the audits conducted 
                under paragraph (1); and
                    ``(B) submit a report to Congress containing the 
                results of such audits and review.
    ``(h) Governmental Oversight.--
            ``(1) Review and reports.--
                    ``(A) In general.--The Comptroller General of the 
                United States shall review the following:
                            ``(i) Processes established by the 
                        Institute, including those with respect to the 
                        identification of research priorities under 
                        subsection (d)(1)(A) and the conduct of 
                        research projects under this section. Such 
                        review shall determine whether information 
                        produced by such research projects--
                                    ``(I) is objective and credible;
                                    ``(II) is produced in a manner 
                                consistent with the requirements under 
                                this section; and
                                    ``(III) is developed through a 
                                transparent process.
                            ``(ii) The overall effect of the Institute 
                        and the effectiveness of activities conducted 
                        under this section, including an assessment 
                        of--
                                    ``(I) the utilization of the 
                                findings of research conducted under 
                                this section by health care decision 
                                makers; and
                                    ``(II) the effect of the Institute 
                                and such activities on innovation and 
                                on the health economy of the United 
                                States.
                    ``(B) Reports.--Not later than 5 years after the 
                date of enactment of this section, and not less 
                frequently than every 5 years thereafter, the 
                Comptroller General of the United States shall submit a 
                report to Congress containing the results of the review 
                conducted under subparagraph (A), together with 
                recommendations for such legislation and administrative 
                action as the Comptroller General determines 
                appropriate.
            ``(2) Funding assessment.--
                    ``(A) In general.--The Comptroller General of the 
                United States shall assess the adequacy and use of 
                funding for the Institute and activities conducted 
                under this section under the CERTF under section 9511 
                of the Internal Revenue Code of 1986. Such assessment 
                shall include a determination as to whether, based on 
                the utilization of findings by public and private 
                payers, each of the following are appropriate sources 
                of funding for the Institute, including a determination 
                of whether such sources of funding should be continued 
                or adjusted:
                            ``(i) The amounts appropriated under 
                        subparagraphs (A), (B), (C), (D)(ii), and 
                        (E)(ii) of subsection (b)(1) of such section 
                        9511.
                            ``(ii) Private sector contributions under 
                        subparagraphs (D)(i) and (E)(i) of such 
                        subsection (b)(1).
                    ``(B) Report.--Not later than 8 years after the 
                date of enactment of this section, the Comptroller 
                General of the United States shall submit a report to 
                Congress containing the results of the assessment 
                conducted under subparagraph (A), together with 
                recommendations for such legislation and administrative 
                action as the Comptroller General determines 
                appropriate.
    ``(i) Public Comment Periods.--
            ``(1) In general.--The Institute shall provide for a public 
        comment period of not less than 30 and not more than 60 days at 
        the following times:
                    ``(A) Prior to the adoption of the national 
                priorities identified under subsection (d)(1)(A), the 
                research project agenda established under subsection 
                (d)(1)(B), the methodological standards developed and 
                updated by the methodology committee under subsection 
                (d)(5)(C)(i), the peer-review process generally 
                provided under subsection (d)(6), and dissemination 
                protocols and strategies developed by the Institute 
                under subsection (d)(7)(B) in accordance with 
                subsection (d)(8).
                    ``(B) Prior to the finalization of individual study 
                designs.
            ``(2) Transmission of public comments on study design.--The 
        Institute shall transmit public comments submitted during the 
        public comment period described in paragraph (1)(B) to the 
        entity conducting research with respect to which the individual 
        study design is being finalized.
    ``(j) Rules.--
            ``(1) Gifts.--The Institute, or the Board and staff of the 
        Institute acting on behalf of the Institute, may not accept 
        gifts, bequeaths, or donations of services or property.
            ``(2) Establishment and prohibition on accepting outside 
        funding or contributions.--The Institute may not--
                    ``(A) establish a corporation other than as 
                provided under this section; or
                    ``(B) accept any funds or contributions other than 
                as provided under this part.
    ``(k) Rules of Construction.--
            ``(1) Coverage.--Nothing in this section shall be 
        construed--
                    ``(A) to permit the Institute to mandate coverage, 
                reimbursement, or other policies for any public or 
                private payer; or
                    ``(B) as preventing the Secretary from covering the 
                routine costs of clinical care received by an 
                individual entitled to, or enrolled for, benefits under 
                title XVIII, XIX, or XXI in the case where such 
                individual is participating in a clinical trial and 
                such costs would otherwise be covered under such title 
                with respect to the beneficiary.
            ``(2) Reports and findings.--None of the reports submitted 
        under this section or research findings disseminated by the 
        Institute shall be construed as mandates, guidelines, or 
        recommendations for payment, coverage, or treatment.
            ``(3) Physician out.--None of the reports submitted under 
        this section or research findings disseminated by the Institute 
        shall be construed to prevent the physician and patient to 
        ultimately determine what is best for the patient involved 
        given the individual circumstances of different patients.''.
    (b) Coordination With Provider Education and Technical 
Assistance.--Section 1889(a) of the Social Security Act (42 U.S.C. 
1395zz(a)) is amended by inserting ``and to enhance the understanding 
of and utilization by providers of services and suppliers of research 
findings disseminated by the Health Care Comparative Effectiveness 
Research Institute established under section 1181'' before the period 
at the end.
    (c) Comparative Effectiveness Research Trust Fund; Financing for 
Trust Fund.--
            (1) Establishment of trust fund.--
                    (A) In general.--Subchapter A of chapter 98 of the 
                Internal Revenue Code of 1986 (relating to 
                establishment of trust funds) is amended by adding at 
                the end the following new section:

``SEC. 9511. COMPARATIVE EFFECTIVENESS RESEARCH TRUST FUND.

    ``(a) Creation of Trust Fund.--There is established in the Treasury 
of the United States a trust fund to be known as the `Comparative 
Effectiveness Research Trust Fund' (hereafter in this section referred 
to as the `CERTF'), consisting of such amounts as may be appropriated 
or credited to such Trust Fund as provided in this section and section 
9602(b).
    ``(b) Transfers to Fund.--
            ``(1) From arra funding for cer.--There are hereby 
        transferred to the CERTF the amounts appropriated to carry out 
        comparative effectiveness research under division A of Public 
        Law 111-5. whether appropriated for the National Institutes of 
        Health, the Secretary of Health and Human Services, or the 
        Agency for Healthcare Research and Quality, which are not 
        otherwise obligated or expended as of the date of the enactment 
        of this section.
            ``(2) From medicare trust funds.--
                    ``(A) In general.--The Secretary of Health and 
                Human Services shall provide for the transfer, from the 
                Federal Hospital Insurance Trust Fund under section 
                1817 of the Social Security Act and the Federal 
                Supplementary Medical Insurance Trust Fund under 
                section 1841 of such Act, in proportion (as estimated 
                by the Secretary) to the total expenditures during such 
                fiscal year that are made under title XVIII of such 
                title from the respective trust fund, to the CERTF the 
                following:
                            ``(i) For fiscal year 2010, an amount equal 
                        to 50 cents multiplied by the average number of 
                        individuals entitled to benefits under part A, 
                        or enrolled under part B, of title XVIII of 
                        such Act during such fiscal year.
                            ``(ii) For each of fiscal years 2011 
                        through 2020, an amount equal to $1 multiplied 
                        by the average number of individuals entitled 
                        to benefits under part A, or enrolled under 
                        part B, of such title XVIII during such fiscal 
                        year.
                    ``(B) Adjustments for increases in health care 
                spending.--In the case of any fiscal year beginning 
                after September 30, 2011, the dollar amount in effect 
                under subparagraph (A)(ii) for such fiscal year shall 
                be equal to the sum of such dollar amount for the 
                previous fiscal year (determined after the application 
                of this subparagraph), plus an amount equal to the 
                product of--
                            ``(i) such dollar amount for the previous 
                        fiscal year; multiplied by
                            ``(ii) the percentage increase in the 
                        projected per capita amount of National Health 
                        Expenditures from the calendar year in which 
                        the previous fiscal year ends to the calendar 
                        year in which the fiscal year involved ends, as 
                        most recently published by the Secretary before 
                        the beginning of the fiscal year.
            ``(3) Additional transfers for fiscal years 2010 through 
        2020.--There are hereby appropriated to the CERTF for each of 
        fiscal years 2010 through 2020, an amount equivalent to the net 
        revenues received in the Treasury from the fees imposed under 
        subchapter B of chapter 34 (relating to fees on health 
        insurance and self-insured plans) for such fiscal year.
            ``(4) Limitation on transfers to certf.--No amount may be 
        appropriated or transferred to the CERTF on and after the date 
        of any expenditure from the CERTF which is not an expenditure 
        permitted under this section. The determination of whether an 
        expenditure is so permitted shall be made without regard to--
                    ``(A) any provision of law which is not contained 
                or referenced in this chapter or in a revenue Act, and
                    ``(B) whether such provision of law is a 
                subsequently enacted provision or directly or 
                indirectly seeks to waive the application of this 
                paragraph.
    ``(c) Trustee.--The Secretary of Health and Human Services shall be 
a trustee of the CERTF.
    ``(d) Expenditures From Fund.--Amounts in the CERTF are available, 
without further appropriation, to the Health Care Comparative 
Effectiveness Research Institute established by section 2(a) of the 
Comparative Effectiveness Research Act of 2009 for carrying out part D 
of title XI of the Social Security Act (as in effect on the date of 
enactment of the Comparative Effectiveness Research Act of 2009).
    ``(e) Net Revenues.--For purposes of this section, the term `net 
revenues' means the amount estimated by the Secretary of the Treasury 
based on the excess of--
            ``(1) the fees received in the Treasury under subchapter B 
        of chapter 34, over
            ``(2) the decrease in the tax imposed by chapter 1 
        resulting from the fees imposed by such subchapter.
    ``(f) Termination.--No amounts shall be available for expenditure 
from the CERTF after September 30, 2020, and any amounts in such Trust 
Fund after such date shall be transferred to the general fund of the 
Treasury.''.
                    (B) Clerical amendment.--The table of sections for 
                subchapter A of chapter 98 of such Code is amended by 
                adding at the end the following new item:

``Sec. 9511. Comparative Effectiveness Research Trust Fund.''.
            (2) Financing for fund from fees on insured and self-
        insured health plans.--
                    (A) General rule.--Chapter 34 of the Internal 
                Revenue Code of 1986 is amended by adding at the end 
                the following new subchapter:

         ``Subchapter B--Insured and Self-Insured Health Plans

``Sec. 4375. Health insurance.
``Sec. 4376. Self-insured health plans.
``Sec. 4377. Definitions and special rules.

``SEC. 4375. HEALTH INSURANCE.

    ``(a) Imposition of Fee.--There is hereby imposed on each specified 
health insurance policy for each policy year ending after September 30, 
2009, a fee equal to the product of $1 (50 cents in the case of policy 
years ending during fiscal year 2010) multiplied by the average number 
of lives covered under the policy.
    ``(b) Liability for Fee.--The fee imposed by subsection (a) shall 
be paid by the issuer of the policy.
    ``(c) Specified Health Insurance Policy.--For purposes of this 
section:
            ``(1) In general.--Except as otherwise provided in this 
        section, the term `specified health insurance policy' means any 
        accident or health insurance policy (including a policy under a 
        group health plan) issued with respect to individuals residing 
        in the United States.
            ``(2) Exemption for certain policies.--The term `specified 
        health insurance policy' does not include any insurance if 
        substantially all of its coverage is of excepted benefits 
        described in section 9832(c).
            ``(3) Treatment of prepaid health coverage arrangements.--
                    ``(A) In general.--In the case of any arrangement 
                described in subparagraph (B)--
                            ``(i) such arrangement shall be treated as 
                        a specified health insurance policy, and
                            ``(ii) the person referred to in such 
                        subparagraph shall be treated as the issuer.
                    ``(B) Description of arrangements.--An arrangement 
                is described in this subparagraph if under such 
                arrangement fixed payments or premiums are received as 
                consideration for any person's agreement to provide or 
                arrange for the provision of accident or health 
                coverage to residents of the United States, regardless 
                of how such coverage is provided or arranged to be 
                provided.
    ``(d) Adjustments for Increases in Health Care Spending.--In the 
case of any policy year ending in any fiscal year beginning after 
September 30, 2013, the dollar amount in effect under subsection (a) 
for such policy year shall be equal to the sum of such dollar amount 
for policy years ending in the previous fiscal year (determined after 
the application of this subsection), plus an amount equal to the 
product of--
            ``(1) such dollar amount for policy years ending in the 
        previous fiscal year, multiplied by
            ``(2) the percentage increase in the projected per capita 
        amount of National Health Expenditures from the calendar year 
        in which the previous fiscal year ends to the calendar year in 
        which the fiscal year involved ends, as most recently published 
        by the Secretary of Health and Human Services before the 
        beginning of the fiscal year.
    ``(e) Termination.--This section shall not apply to policy years 
ending after September 30, 2020.

``SEC. 4376. SELF-INSURED HEALTH PLANS.

    ``(a) Imposition of Fee.--In the case of any applicable self-
insured health plan for each plan year ending after September 30, 2011, 
there is hereby imposed a fee equal to $1 (50 cents in the case of plan 
years ending during fiscal year 2012) multiplied by the average number 
of lives covered under the plan.
    ``(b) Liability for Fee.--
            ``(1) In general.--The fee imposed by subsection (a) shall 
        be paid by the plan sponsor.
            ``(2) Plan sponsor.--For purposes of paragraph (1) the term 
        `plan sponsor' means--
                    ``(A) the employer in the case of a plan 
                established or maintained by a single employer,
                    ``(B) the employee organization in the case of a 
                plan established or maintained by an employee 
                organization,
                    ``(C) in the case of--
                            ``(i) a plan established or maintained by 2 
                        or more employers or jointly by 1 or more 
                        employers and 1 or more employee organizations,
                            ``(ii) a multiple employer welfare 
                        arrangement, or
                            ``(iii) a voluntary employees' beneficiary 
                        association described in section 501(c)(9),
                the association, committee, joint board of trustees, or 
                other similar group of representatives of the parties 
                who establish or maintain the plan, or
                    ``(D) the cooperative or association described in 
                subsection (c)(2)(F) in the case of a plan established 
                or maintained by such a cooperative or association.
    ``(c) Applicable Self-Insured Health Plan.--For purposes of this 
section, the term `applicable self-insured health plan' means any plan 
for providing accident or health coverage if--
            ``(1) any portion of such coverage is provided other than 
        through an insurance policy, and
            ``(2) such plan is established or maintained--
                    ``(A) by one or more employers for the benefit of 
                their employees or former employees,
                    ``(B) by one or more employee organizations for the 
                benefit of their members or former members,
                    ``(C) jointly by 1 or more employers and 1 or more 
                employee organizations for the benefit of employees or 
                former employees,
                    ``(D) by a voluntary employees' beneficiary 
                association described in section 501(c)(9),
                    ``(E) by any organization described in section 
                501(c)(6), or
                    ``(F) in the case of a plan not described in the 
                preceding subparagraphs, by a multiple employer welfare 
                arrangement (as defined in section 3(40) of Employee 
                Retirement Income Security Act of 1974), a rural 
                electric cooperative (as defined in section 
                3(40)(B)(iv) of such Act), or a rural telephone 
                cooperative association (as defined in section 
                3(40)(B)(v) of such Act).
    ``(d) Adjustments for Increases in Health Care Spending.--In the 
case of any plan year ending in any fiscal year beginning after 
September 30, 2011, the dollar amount in effect under subsection (a) 
for such plan year shall be equal to the sum of such dollar amount for 
plan years ending in the previous fiscal year (determined after the 
application of this subsection), plus an amount equal to the product 
of--
            ``(1) such dollar amount for plan years ending in the 
        previous fiscal year, multiplied by
            ``(2) the percentage increase in the projected per capita 
        amount of National Health Expenditures from the calendar year 
        in which the previous fiscal year ends to the calendar year in 
        which the fiscal year involved ends, as most recently published 
        by the Secretary of Health and Human Services before the 
        beginning of the fiscal year.
    ``(e) Termination.--This section shall not apply to plan years 
ending after September 30, 2020.

``SEC. 4377. DEFINITIONS AND SPECIAL RULES.

    ``(a) Definitions.--For purposes of this subchapter--
            ``(1) Accident and health coverage.--The term `accident and 
        health coverage' means any coverage which, if provided by an 
        insurance policy, would cause such policy to be a specified 
        health insurance policy (as defined in section 4375(c)).
            ``(2) Insurance policy.--The term `insurance policy' means 
        any policy or other instrument whereby a contract of insurance 
        is issued, renewed, or extended.
            ``(3) United states.--The term `United States' includes any 
        possession of the United States.
    ``(b) Treatment of Governmental Entities.--
            ``(1) In general.--For purposes of this subchapter--
                    ``(A) the term `person' includes any governmental 
                entity, and
                    ``(B) notwithstanding any other law or rule of law, 
                governmental entities shall not be exempt from the fees 
                imposed by this subchapter except as provided in 
                paragraph (2).
            ``(2) Treatment of exempt governmental programs.--In the 
        case of an exempt governmental program, no fee shall be imposed 
        under section 4375 or section 4376 on any covered life under 
        such program.
            ``(3) Exempt governmental program defined.--For purposes of 
        this subchapter, the term `exempt governmental program' means--
                    ``(A) any insurance program established under title 
                XVIII of the Social Security Act,
                    ``(B) the medical assistance program established by 
                title XIX or XXI of the Social Security Act,
                    ``(C) any program established by Federal law for 
                providing medical care (other than through insurance 
                policies) to individuals (or the spouses and dependents 
                thereof) by reason of such individuals being--
                            ``(i) members of the Armed Forces of the 
                        United States, or
                            ``(ii) veterans, and
                    ``(D) any program established by Federal law for 
                providing medical care (other than through insurance 
                policies) to members of Indian tribes (as defined in 
                section 4(d) of the Indian Health Care Improvement 
                Act).
    ``(c) Treatment as Tax.--For purposes of subtitle F, the fees 
imposed by this subchapter shall be treated as if they were taxes.
    ``(d) No Cover Over to Possessions.--Notwithstanding any other 
provision of law, no amount collected under this subchapter shall be 
covered over to any possession of the United States.''.
                    (B) Clerical amendments.--
                            (i) Chapter 34 of such Code is amended by 
                        striking the chapter heading and inserting the 
                        following:

           ``CHAPTER 34--TAXES ON CERTAIN INSURANCE POLICIES

                              ``Subchapter A. Policies issued by 
                                        foreign insurers.
                              ``Subchapter B. Insured and self-insured 
                                        health plans.

         ``Subchapter A--Policies Issued By Foreign Insurers''.

                            (ii) The table of chapters for subtitle D 
                        of such Code is amended by striking the item 
                        relating to chapter 34 and inserting the 
                        following new item:

          ``Chapter 34--Taxes on Certain Insurance Policies''.

                                 <all>
```