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[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[S. 1213 Introduced in Senate (IS)]

111th CONGRESS
  1st Session
                                S. 1213

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 Patient-Centered Outcomes Research Trust 
                     Fund, and for other purposes.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                              June 9, 2009

Mr. Baucus (for himself and Mr. Conrad) introduced the following bill; 
     which was read twice and referred to the Committee on Finance

_______________________________________________________________________

                                 A BILL

 
To amend title XI of the Social Security Act to provide for the conduct 
of comparative effectiveness research and to amend the Internal Revenue 
 Code of 1986 to establish a Patient-Centered Outcomes 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 ``Patient-Centered Outcomes 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, care 
                management, and delivery, procedures, medical devices, 
                diagnostic tools, pharmaceuticals (including drugs and 
                biologicals), and any other strategies or items being 
                used in the treatment, management, 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 for 
        specific patient populations.
            ``(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 `Patient-
        Centered Outcomes Research Institute' established under 
        subsection (b)(1).
    ``(b) Patient-Centered Outcomes Research Institute.--
            ``(1) Establishment.--There is authorized to be established 
        a nonprofit corporation, to be known as the `Patient-Centered 
        Outcomes 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 2010 and each subsequent fiscal year, amounts in 
        the Patient-Centered Outcomes Research Trust Fund (referred to 
        in this section as the `PCORTF') 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 assist patients, 
clinicians, purchasers, and policy makers in making informed health 
decisions by advancing the quality and relevance of evidence concerning 
the manner in which diseases, disorders, and other health conditions 
can effectively and appropriately be prevented, diagnosed, treated, 
monitored, and managed through research and evidence synthesis that 
considers variations in patient subpopulations, and the dissemination 
of research findings with respect to the relative clinical outcomes, 
clinical 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;
                            ``(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;
                            ``(vi) the effect or potential for an 
                        effect on patient needs, outcomes, and 
                        preferences, including quality of life; and
                            ``(vii) the relevance to assisting patients 
                        and clinicians in making informed health 
                        decisions.
                    ``(B) Establishing research project agenda.--
                            ``(i) In general.--The Institute shall 
                        establish and update a research project agenda 
                        for comparative clinical effectiveness research 
                        to address the priorities identified under 
                        subparagraph (A), taking into consideration the 
                        types of such 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 the 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 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 (10), 
                using methods, including the following:
                            ``(i) Systematic reviews and assessments of 
                        existing research and evidence.
                            ``(ii) Primary research, such as randomized 
                        clinical trials, molecularly informed trials, 
                        and observational studies.
                            ``(iii) Any other methodologies recommended 
                        by the methodology committee established under 
                        paragraph (7) that are adopted by the Board 
                        under paragraph (10).
                    ``(B) Contracts for the management and conduct of 
                research.--
                            ``(i) In general.--The Institute may enter 
                        into contracts for the management and conduct 
                        of research in accordance with the research 
                        project agenda established under paragraph 
                        (1)(B) with the following:
                                    ``(I) 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, to the extent that such 
                                contracts are authorized under the 
                                governing statutes of such agencies and 
                                instrumentalities.
                                    ``(II) Appropriate private sector 
                                research or study-conducting entities 
                                that have demonstrated the experience 
                                and capacity to achieve the goals of 
                                comparative effectiveness research.
                            ``(ii) 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 (10) with respect to such 
                                research;
                                    ``(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)(B) 
                                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 subsection (i)(3)(A)(iii) prior to 
                                the conduct of such research; and
                                    ``(IV) in the case where the 
                                agency, instrumentality, or other 
                                entity is managing or conducting a 
                                comparative effectiveness research 
                                study for a rare disease, consult with 
                                the expert advisory panel for rare 
                                disease appointed under paragraph 
                                (5)(A)(iii) with respect to such 
                                research study.
                            ``(iii) 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, evolving 
                evidence, advances in medical technology, and changes 
                in the standard of care 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, age, and groups of 
                        individuals with different comorbidities, 
                        genetic and molecular sub-types, or quality of 
                        life preferences; and
                            ``(ii) include members of such 
                        subpopulations as subjects in the research as 
                        feasible and appropriate.
                    ``(E) Differences in treatment modalities.--
                Research shall be designed, as appropriate, to take 
                into account different characteristics of treatment 
                modalities that may affect research outcomes, such as 
                the phase of the treatment modality in the innovation 
                cycle and the impact of the skill of the operator of 
                the treatment modality.
            ``(3) Study and report on feasibility of conducting 
        research in-house.--
                    ``(A) Study.--The Institute shall conduct a study 
                on the feasibility of conducting research in-house.
                    ``(B) Report.--Not later than 5 years after the 
                date of enactment of this section, the Institute shall 
                submit a report to Congress containing the results of 
                the study conducted under subparagraph (A).
            ``(4) 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, including 
                data from clinical databases and registries.
                    ``(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.
            ``(5) Appointing expert advisory panels.--
                    ``(A) Appointment.--
                            ``(i) In general.--The Institute shall, as 
                        appropriate, appoint expert advisory panels to 
                        assist in identifying research priorities and 
                        establishing the research project agenda under 
                        paragraph (1). Panels shall advise the 
                        Institute in matters such as identifying gaps 
                        in and updating medical evidence 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.
                            ``(ii) Expert advisory panels for primary 
                        research.--The Institute shall appoint expert 
                        advisory panels in carrying out the research 
                        project agenda under paragraph (2)(A)(ii). Such 
                        expert advisory panels shall, upon request, 
                        advise the Institute and the agency, 
                        instrumentality, or entity conducting the 
                        research on the research question involved and 
                        the research design or protocol, including the 
                        appropriate comparator technologies, important 
                        patient subgroups, and other parameters of the 
                        research, as necessary. Upon the request of 
                        such agency, instrumentality, or entity, such 
                        panels shall be available as a resource for 
                        technical questions that may arise during the 
                        conduct of such research.
                            ``(iii) Expert advisory panel for rare 
                        disease.--In the case of a comparative 
                        effectiveness research study for rare disease, 
                        the Institute shall appoint an expert advisory 
                        panel for purposes of assisting in the design 
                        of such research study and determining the 
                        relative value and feasibility of conducting 
                        such research study.
                    ``(B) Composition.--
                            ``(i) In general.--An expert advisory panel 
                        appointed under subparagraph (A) shall include 
                        individuals who have experience in the relevant 
                        topic, project, or category for which the panel 
                        is established, including--
                                    ``(I) practicing and research 
                                clinicians (including relevant 
                                specialists and subspecialists), 
                                patients, and representatives of 
                                patients; and
                                    ``(II) experts in scientific and 
                                health services research, health 
                                services delivery, and evidence-based 
                                medicine.
                            ``(ii) Inclusion of representatives of 
                        manufacturers of medical technology.--An expert 
                        advisory panel appointed under subparagraph (A) 
                        may include a representative of each 
                        manufacturer of each medical technology that is 
                        included under the relevant topic, project, or 
                        category for which the panel is established.
            ``(6) Supporting patient and consumer representatives.--The 
        Institute shall provide support and resources to help patient 
        and consumer representatives on the Board and expert advisory 
        panels appointed by the Institute under paragraph (5) to 
        effectively participate in technical discussions regarding 
        complex research topics. Such support shall include initial and 
        continuing education to facilitate effective engagement in 
        activities undertaken by the Institute and may include regular 
        and ongoing opportunities for patient and consumer 
        representatives to interact with each other and to exchange 
        information and support regarding their involvement in the 
        Institute's activities. The Institute shall provide per diem 
        and other appropriate compensation to patient and consumer 
        representatives for their time spent participating in the 
        activities of the Institute under this paragraph.
            ``(7) 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.--The methodology 
                committee established under subparagraph (A) shall be 
                composed of not more than 17 members appointed 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, genomics, 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 and methods of comparative effectiveness 
                research by undertaking, directly or through 
                subcontract, the following activities:
                            ``(i) Not later than 2 years after the date 
                        on which the members of the methodology 
                        committee are appointed under subparagraph (B), 
                        developing and periodically updating the 
                        following:
                                    ``(I) Establish and maintain 
                                methodological standards for 
                                comparative clinical effectiveness 
                                research on major categories of 
                                interventions to prevent, diagnose, or 
                                treat a clinical condition or improve 
                                the delivery of care. Such 
                                methodological standards shall provide 
                                specific criteria for internal 
                                validity, generalizability, 
                                feasibility, and timeliness of such 
                                research and for clinical outcomes 
                                measures, risk adjustment, and other 
                                relevant aspects of research and 
                                assessment with respect to the design 
                                of such research. Any methodological 
                                standards developed and updated under 
                                this subclause shall be scientifically 
                                based and include methods by which new 
                                information, data, or advances in 
                                technology are considered and 
                                incorporated into ongoing research 
                                projects by the Institute, as 
                                appropriate. The process for developing 
                                and updating such standards shall 
                                include input from relevant experts, 
                                stakeholders, and decision makers, and 
                                shall provide opportunities for public 
                                comment. Such standards shall also 
                                include methods by which patient 
                                subpopulations can be accounted for and 
                                evaluated in different types of 
                                research. As appropriate, such 
                                standards shall build on existing work 
                                on methodological standards for defined 
                                categories of health interventions and 
                                for each of the major categories of 
                                comparative effectiveness research 
                                methods (determined as of the date of 
                                enactment of the Patient-Centered 
                                Outcomes Research Act of 2009).
                                    ``(II) A translation table that is 
                                designed to provide guidance and act as 
                                a reference for the Board to determine 
                                research methods that are most likely 
                                to address each specific comparative 
                                clinical effectiveness research 
                                question.
                            ``(ii) Not later than 3 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, information 
                                communication, 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 efficiency 
                                and value (including the full range of 
                                harms and benefits, such as quality of 
                                life) 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.
                                    ``(IV) Academic, non-profit, or 
                                other private entities with relevant 
                                expertise.
                            ``(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.
            ``(8) Providing for a peer-review process for primary 
        research.--
                    ``(A) In general.--The Institute shall ensure that 
                there is a process for peer review of the research 
                conducted under paragraph (2)(A)(ii). Under such 
                process--
                            ``(i) evidence from research conducted 
                        under such paragraph shall be reviewed to 
                        assess scientific integrity and adherence to 
                        methodological standards adopted under 
                        paragraph (10); 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 (12)(D).
                    ``(B) Composition.--Such peer-review process shall 
                be 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.--
                            ``(i) Processes of another entity.--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).
                            ``(ii) Processes of appropriate medical 
                        journals.--The Institute may utilize the peer-
                        review process of appropriate medical journals 
                        if such process meets the requirements under 
                        subparagraphs (A) and (B).
            ``(9) 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 (10). 
                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, coverage recommendations, 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 timely decisions 
                regarding medical treatments, services, and items. In 
                developing and adopting such protocols and strategies, 
                the Institute shall consult with stakeholders, 
                including practicing clinicians and patients, 
                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) Definition of research findings.--In this 
                paragraph, the term `research findings' means the 
                results of a study or assessment.
            ``(10) Adoption.--Subject to subsection (i)(1)(A)(i), 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 (7)(C)(i), 
        any peer-review process provided under paragraph (8), and 
        dissemination protocols and strategies developed under 
        paragraph (9)(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.
            ``(11) 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) Building capacity for research.--The 
                Institute may build capacity for comparative clinical 
                effectiveness research and methodologies, including 
                research training and development of data resources 
                (such as clinical registries), through appropriate 
                activities, including using up to 20 percent of the 
                amounts appropriated or credited to the PCORTF under 
                section 9511(b) of the Internal Revenue Code of 1986 
                with respect to a fiscal year to fund extramural 
                efforts of organizations such as the Cochrane 
                Collaboration (or a successor organization) and other 
                organizations that develop and maintain a data network 
                to collect, link, and analyze data on outcomes and 
                effectiveness from multiple sources, including 
                electronic health records.
                    ``(C) 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 (12)(E).
            ``(12) 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 
                PCORTF 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 (9)(B), and methodological standards 
                developed and updated by the methodology committee 
                under paragraph (7)(C)(i) that are adopted under 
                paragraph (10) during the preceding year;
                    ``(D) the names of individuals contributing to any 
                peer-review process provided under paragraph (8) during 
                the preceding year or years, in a manner such that 
                those individuals cannot be identified with a 
                particular research project; and
                    ``(E) a description of efforts by the Institute 
                under paragraph (11) 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.
                    ``(F) any other relevant information (including 
                information on the membership of the Board, expert 
                advisory panels appointed under paragraph (5), the 
                methodology committee established under paragraph (7), 
                and the executive staff of the Institute, any conflicts 
                of interest with respect to the members of such Board, 
                expert 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).
    ``(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)(10) 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 diagnostic 
                        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 
                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 (i)(4)(B).
                            ``(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.--The Comptroller General of the 
                United States shall designate a Chairperson and Vice-
                Chairperson of the Board from among the members of the 
                Board appointed under paragraph (1)(D).
                    ``(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 expert advisory 
                panel appointed under subsection (d)(5), members of the 
                methodology committee established under subsection 
                (d)(7), and individuals selected to contribute to any 
                peer-review process under subsection (d)(8); 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 through public notice at least 7 days 
        prior to the meeting.
            ``(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 PCORTF 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, or whether other sources of funding not 
                described in clauses (i) through (iii) would be 
                appropriate:
                            ``(i) The transfer of funds from the 
                        Federal Hospital Insurance Trust Fund under 
                        section 1817 and the Federal Supplementary 
                        Medical Insurance Trust Fund under section 1841 
                        to the PCORTF under section 1183.
                            ``(ii) The amounts appropriated under 
                        subparagraphs (A), (B), (C), (D)(ii), and 
                        (E)(ii) of subsection (b)(1) of such section 
                        9511.
                            ``(iii) 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) Ensuring Transparency, Credibility, and Access.--The 
Institute shall establish procedures to ensure that the following 
requirements for ensuring transparency, credibility, and access are 
met:
            ``(1) Public comment periods.--
                    ``(A) In general.--The Institute shall provide for 
                a public comment period of not less than 45 and not 
                more than 60 days at the following times:
                            ``(i) 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)(7)(C)(i), the peer-review process generally 
                        provided under subsection (d)(8), and 
                        dissemination protocols and strategies 
                        developed by the Institute under subsection 
                        (d)(9)(B) in accordance with subsection 
                        (d)(10).
                            ``(ii) Prior to the finalization of 
                        individual study designs.
                            ``(iii) After the release of draft findings 
                        with respect to a systematic review and 
                        assessment of existing research and evidence 
                        under subsection (d)(2)(A)(i).
                    ``(B) Transmission of public comments on study 
                design.--The Institute shall transmit public comments 
                submitted during the public comment period described in 
                subparagraph (A)(ii) to the entity conducting research 
                with respect to which the individual study design is 
                being finalized.
            ``(2) Additional forums.--The Institute shall, in addition 
        to the public comment periods described in paragraph (1)(A), 
        support forums to increase public awareness and obtain and 
        incorporate public input and feedback through media (such as an 
        Internet website) on the following:
                    ``(A) The identification of research priorities, 
                including research topics, and the establishment of the 
                research project agenda under subparagraphs (A) and 
                (B), respectively, of subsection (d)(1).
                    ``(B) Research findings.
                    ``(C) Any other duties, activities, or processes 
                the Institute determines appropriate.
            ``(3) 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:
                    ``(A) 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) with respect to each medical 
                        treatment, service, and item described in 
                        subsection (a)(2)(B);
                            ``(v) any key decisions made by the 
                        Institute and any appropriate committees of the 
                        Institute;
                            ``(vi) the identity of investigators 
                        conducting such research and any conflicts of 
                        interest of such investigators; and
                            ``(vii) any progress reports the Institute 
                        determines appropriate.
                    ``(B) Notice of each of the public comment periods 
                under paragraph (1)(A), including deadlines for public 
                comments for such periods.
                    ``(C) Public comments submitted during each of the 
                public comment periods under paragraph (1)(A), 
                including such public comments submitted on draft 
                findings under clause (iii) of such paragraph.
                    ``(D) Bylaws, processes, and proceedings of the 
                Institute, to the extent practicable and as the 
                Institute determines appropriate.
                    ``(E) 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.
            ``(4) Conflicts of interest.--The Institute shall--
                    ``(A) in appointing members to an expert advisory 
                panel under subsection (d)(5) and the methodology 
                committee under subsection (d)(7), and in selecting 
                individuals to contribute to any peer-review process 
                under subsection (d)(8) 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)(12), 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.
    ``(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.

   ``limitations on use of comparative effectiveness research by the 
                               secretary

    ``Sec. 1182. The Secretary may only use evidence and findings from 
comparative effectiveness research conducted under section 1181 to make 
a determination regarding coverage under title XVIII if such use is 
through an iterative and transparent process which meets the following 
requirements:
            ``(1) Stakeholders and other individuals have the 
        opportunity to provide informed and relevant information with 
        respect to the determination.
            ``(2) Stakeholders and other individuals have the 
        opportunity to review draft proposals of the determination and 
        submit public comments with respect to such draft proposals.
            ``(3) In making the determination, the Secretary 
        considers--
                    ``(A) all other relevant evidence, studies, and 
                research in addition to such comparative effectiveness 
                research; and
                    ``(B) evidence and research that demonstrates or 
                suggests a benefit of coverage with respect to a 
                specific subpopulation of individuals, even if the 
                evidence and findings from the comparative 
                effectiveness research demonstrates or suggests that, 
                on average, with respect to the general population the 
                benefits of coverage do not exceed the harm.

``trust fund transfers to patient-centered outcomes research trust fund

    ``Sec. 1183.  (a) In General.--The Secretary shall provide for the 
transfer, from the Federal Hospital Insurance Trust Fund under section 
1817 and the Federal Supplementary Medical Insurance Trust Fund under 
section 1841, in proportion (as estimated by the Secretary) to the 
total expenditures during such fiscal year that are made under title 
XVIII from the respective trust fund, to the Patient-Centered Outcomes 
Research Trust Fund (referred to in this section as the `PCORTF') under 
section 9511 of the Internal Revenue Code of 1986, the following:
            ``(1) For fiscal year 2013, an amount equal to $1 
        multiplied by the average number of individuals entitled to 
        benefits under part A, or enrolled under part B, of title XVIII 
        during such fiscal year.
            ``(2) For each of fiscal years 2014, 2015, 2016, 2017, 
        2018, and 2019, an amount equal to $2 multiplied by the average 
        number of individuals entitled to benefits under part A, or 
        enrolled under part B, of 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, 2014, the dollar 
amount in effect under subsection (a)(2) 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 subsection), plus an amount 
equal to the product of--
            ``(1) such dollar amount for 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 before the beginning of the fiscal year.''.
    (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 Patient-Centered Outcomes Research 
Institute established under section 1181'' before the period at the 
end.
    (c) Patient-Centered Outcomes 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. PATIENT-CENTERED OUTCOMES 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 `Patient-Centered 
Outcomes Research Trust Fund' (hereafter in this section referred to as 
the `PCORTF'), 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) Appropriation.--There are hereby appropriated to the 
        Trust Fund the following:
                    ``(A) For fiscal year 2010, $10,000,000.
                    ``(B) For fiscal year 2011, $50,000,000.
                    ``(C) For fiscal year 2012, $150,000,000.
                    ``(D) For fiscal year 2013--
                            ``(i) 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; and
                            ``(ii) $150,000,000.
                    ``(E) For each of fiscal years 2014, 2015, 2016, 
                2017, 2018, and 2019--
                            ``(i) 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; and
                            ``(ii) $150,000,000.
        The amounts appropriated under subparagraphs (A), (B), (C), 
        (D)(ii), and (E)(ii) shall be transferred from the general fund 
        of the Treasury, from funds not otherwise appropriated.
            ``(2) Trust fund transfers.--In addition to the amounts 
        appropriated under paragraph (1), there shall be credited to 
        the PCORTF the amounts transferred under section 1183 of the 
        Social Security Act.
            ``(3) American recovery and reinvestment funds.--In 
        addition to the amounts appropriated under paragraph (1) and 
        the amounts credited under paragraph (2), of amounts 
        appropriated for comparative effectiveness research to be 
        allocated at the discretion of the Secretary of Health and 
        Human Services under the heading Agency for Healthcare Research 
        and Quality under the heading Department of Health and Human 
        Services under title VIII of Division A of the American 
        Recovery and Reinvestment Act of 2009 (Public Law 111-5), 
        $10,000,000 shall be transferred to the Trust Fund.
            ``(4) Limitation on transfers to pcortf.--No amount may be 
        appropriated or transferred to the PCORTF on and after the date 
        of any expenditure from the PCORTF 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 PCORTF.
    ``(d) Expenditures From Fund.--Amounts in the PCORTF are available, 
without further appropriation, to the Patient-Centered Outcomes 
Research Institute established by section 2(a) of the Patient-Centered 
Outcomes 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 
Patient-Centered Outcomes 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 PCORTF after September 30, 2019, 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. Patient-Centered Outcomes 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, 
2012, a fee equal to the product of $2 ($1 in the case of policy years 
ending during fiscal year 2013) 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, 2014, 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, 2019.

``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, 2012, 
there is hereby imposed a fee equal to $2 ($1 in the case of plan years 
ending during fiscal year 2013) 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, 2014, 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, 2019.

``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''.

SEC. 3. COORDINATION WITH FEDERAL COORDINATING COUNCIL FOR COMPARATIVE 
              EFFECTIVENESS RESEARCH.

    Section 804 of Division A of the American Recovery and Reinvestment 
Act of 2009 (42 U.S.C. 299b-8) is amended--
            (1) in subsection (c)--
                    (A) in paragraph (1), by striking ``and'' at the 
                end;
                    (B) in paragraph (2), by striking the period at the 
                end and inserting ``; and''; and
                    (C) by adding at the end the following new 
                paragraph:
            ``(3) provide support to the Patient-Centered Outcomes 
        Research Institute established under section 1181(b)(1) of the 
        Social Security Act (referred to in this section as the 
        `Institute').'';
            (2) in subsection (d)(2)--
                    (A) by redesignating subparagraph (B) as 
                subparagraph (C); and
                    (B) by inserting after subparagraph (A) the 
                following new subparagraph:
                    ``(B) Inclusion of chairperson of the board of 
                governors of the patient-centered outcomes research 
                institute.--In the case where the Chairperson of the 
                Board of Governors of the Patient-Centered Outcomes 
                Research Institute established under section 1181(f) of 
                the Social Security Act is a senior Federal officer or 
                employee with responsibility for a health-related 
                program, the members of the council shall include such 
                Chairperson.''.
            (3) in subsection (e)(2), by striking ``regarding its 
        activities'' and all that follows through the period at the end 
        and inserting ``containing--
                    ``(A) an inventory of its activities with respect 
                to comparative effectiveness research conducted by 
                relevant Federal departments and agencies; and
                    ``(B) recommendations concerning better 
                coordination of comparative effectiveness research by 
                such departments and agencies.'';
            (4) by redesignating subsection (g) as subsection (h); and
            (5) by inserting after subsection (f) the following new 
        subsection:
    ``(g) Coordination With the Patient-Centered Outcomes Research 
Institute.--The Council shall coordinate with the Institute in carrying 
out its duties under this section.''.

SEC. 4. GAO REPORT ON NATIONAL COVERAGE DETERMINATIONS PROCESS.

    Not later than 18 months after the date of enactment of this Act, 
the Comptroller General of the United States shall submit a report to 
Congress on the process for making national coverage determinations (as 
defined in section 1869(f)(1)(B) of the Social Security Act (42 U.S.C. 
1395ff(f)(1)(B))) under the Medicare program under title XVIII of the 
Social Security Act. Such report shall include a determination whether, 
in initiating and conducting such process, the Secretary of Health and 
Human Services has complied with applicable law and regulations, 
including requirements for consultation with appropriate outside 
experts, providing appropriate notice and comment opportunities to the 
public, and making information and data (other than proprietary data) 
considered in making such determinations available to the public and to 
nonvoting members of any advisory committees established to advise the 
Secretary with respect to such determinations.
                                 <all>
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