HR 2502 IHCommentsClose CommentsPermalink

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.CommentsClose CommentsPermalink

May 19, 2009CommentsClose CommentsPermalink

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 concernedCommentsClose CommentsPermalink

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.CommentsClose CommentsPermalink

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,CommentsClose CommentsPermalink

SECTION 1. SHORT TITLE.

This Act may be cited as the ‘Comparative Effectiveness Research Act of 2009’.CommentsClose CommentsPermalink

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:CommentsClose CommentsPermalink

‘Part D--Comparative Effectiveness Research

‘COMPARATIVE EFFECTIVENESS RESEARCH

‘Sec. 1181. (a) Definitions- In this section:CommentsClose CommentsPermalink





‘(1) BOARD- The term ‘Board’ means the Board of Governors established under subsection (f).CommentsClose CommentsPermalink





‘(2) COMPARATIVE CLINICAL EFFECTIVENESS RESEARCH-CommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(5) INSTITUTE- The term ‘Institute’ means the ‘Health Care Comparative Effectiveness Research Institute’ established under subsection (b)(1).CommentsClose CommentsPermalink





‘(b) Health Care Comparative Effectiveness Research Institute-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(d) Duties-CommentsClose CommentsPermalink





‘(1) IDENTIFYING RESEARCH PRIORITIES AND ESTABLISHING RESEARCH PROJECT AGENDA-CommentsClose CommentsPermalink





‘(A) IDENTIFYING RESEARCH PRIORITIES- The Institute shall identify national priorities for comparative clinical effectiveness research, taking into account factors, including--CommentsClose CommentsPermalink





‘(i) disease incidence, prevalence, and burden in the United States;CommentsClose CommentsPermalink





‘(ii) evidence gaps in terms of clinical outcomes;CommentsClose CommentsPermalink





‘(iii) practice variations, including variations in delivery and outcomes by geography, treatment site, provider type, and patient subgroup;CommentsClose CommentsPermalink





‘(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; andCommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(B) ESTABLISHING RESEARCH PROJECT AGENDA-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(2) CARRYING OUT RESEARCH PROJECT AGENDA-CommentsClose CommentsPermalink





‘(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:CommentsClose CommentsPermalink





‘(i) Systematic reviews and assessments of existing research and evidence.CommentsClose CommentsPermalink





‘(ii) Clinical research, such as randomized controlled trials and observational studies.CommentsClose CommentsPermalink





‘(iii) Any other methodologies recommended by the methodology committee established under paragraph (6) that are adopted by the Board under paragraph (9).CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(iii) CONDITIONS FOR CONTRACTS- A contract entered into under this subparagraph shall require that the agency, instrumentality, or other entity--CommentsClose CommentsPermalink





‘(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;CommentsClose CommentsPermalink





‘(II) comply with the methodological standards adopted under paragraph (9) with respect to such research; andCommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(D) TAKING INTO ACCOUNT POTENTIAL DIFFERENCES- Research shall--CommentsClose CommentsPermalink





‘(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; andCommentsClose CommentsPermalink





‘(ii) seek to include members of such subpopulations as subjects in the research as feasible and appropriate.CommentsClose CommentsPermalink





‘(3) DATA COLLECTION-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(4) APPOINTING ADVISORY PANELS-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(5) ESTABLISHING METHODOLOGY COMMITTEE-CommentsClose CommentsPermalink





‘(A) IN GENERAL- The Institute shall establish a standing methodology committee to carry out the functions described in subparagraph (C).CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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:CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(ii) Not later than 2 years after such date, examining the following:CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(II) Methods by which cost-effectiveness and value could be assessed in a scientifically valid and standardized way.CommentsClose CommentsPermalink





‘(D) CONSULTATION AND CONDUCT OF EXAMINATIONS-CommentsClose CommentsPermalink





‘(i) IN GENERAL- Subject to clause (iii), in undertaking the activities described in subparagraph (C), the methodology committee shall--CommentsClose CommentsPermalink





‘(I) consult or contract with 1 or more of the entities described in clause (ii); andCommentsClose CommentsPermalink





‘(II) consult with stakeholders and other entities knowledgeable in relevant fields, as appropriate.CommentsClose CommentsPermalink





‘(ii) ENTITIES DESCRIBED- The following entities are described in this clause:CommentsClose CommentsPermalink





‘(I) The Institute of Medicine of the National Academies.CommentsClose CommentsPermalink





‘(II) The Agency for Healthcare Research and Quality.CommentsClose CommentsPermalink





‘(III) The National Institutes of Health.CommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(i) for the Institute to adopt methodological standards developed and updated by the methodology committee under such subparagraph; andCommentsClose CommentsPermalink





‘(ii) for such other action as the methodology committee determines is necessary to comply with such methodological standards.CommentsClose CommentsPermalink





‘(6) PROVIDING FOR A PEER-REVIEW PROCESS-CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(i) evidence from research conducted under this section shall be reviewed to assess scientific integrity and adherence to methodological standards adopted under paragraph (8); andCommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(7) DISSEMINATION OF RESEARCH FINDINGS-CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(i) shall convey findings of research so that they are comprehensible and useful to patients and providers in making health care decisions;CommentsClose CommentsPermalink





‘(ii) shall discuss findings and other considerations specific to certain subpopulations, risk factors, and comorbidities, as appropriate;CommentsClose CommentsPermalink





‘(iii) shall include considerations such as limitations of research and what further research may be needed, as appropriate;CommentsClose CommentsPermalink





‘(iv) shall not include practice guidelines or policy recommendations; andCommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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:CommentsClose CommentsPermalink





‘(i) The process and methods for the conduct of research under this section, including--CommentsClose CommentsPermalink





‘(I) the identity of the entity conducting such research;CommentsClose CommentsPermalink





‘(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);CommentsClose CommentsPermalink





‘(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);CommentsClose CommentsPermalink





‘(IV) research protocols (including measures taken, methods of research, methods of analysis, research results, and such other information as the Institute determines appropriate);CommentsClose CommentsPermalink





‘(V) the identity of investigators conducting such research and any conflicts of interest of such investigators; andCommentsClose CommentsPermalink





‘(VI) any progress reports the Institute determines appropriate.CommentsClose CommentsPermalink





‘(ii) Public comments submitted during each of the public comment periods under subsection (i)(1).CommentsClose CommentsPermalink





‘(iii) Bylaws, processes, and proceedings of the Institute, to the extent practicable and as the Institute determines appropriate.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(v) All reports, findings, results, and studies conducted by or through the Institute.CommentsClose CommentsPermalink





The Institute shall obtain and incorporate public feedback through media (such as an Internet website) on the information disclosed.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(E) DEFINITION OF RESEARCH FINDINGS- In this paragraph, the term ‘research findings’ means the results of a study, appraisal, or assessment.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(9) COORDINATION OF RESEARCH AND RESOURCES AND BUILDING CAPACITY FOR RESEARCH-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(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;CommentsClose CommentsPermalink





‘(B) the research project agenda and budget of the Institute for the following year;CommentsClose CommentsPermalink





‘(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;CommentsClose CommentsPermalink





‘(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;CommentsClose CommentsPermalink





‘(E) a description of efforts by the Institute under paragraph (9) to--CommentsClose CommentsPermalink





‘(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; andCommentsClose CommentsPermalink





‘(ii) build capacity for comparative clinical effectiveness research and other relevant research and related efforts through appropriate activities; andCommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(11) CONFLICTS OF INTEREST- The Institute shall--CommentsClose CommentsPermalink





‘(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; andCommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(e) Administration-CommentsClose CommentsPermalink





‘(1) IN GENERAL- Subject to paragraph (2), the Board shall carry out the duties of the Institute.CommentsClose CommentsPermalink





‘(2) NONDELEGABLE DUTIES- The activities described in subsections (b)(3)(D), (d)(1), and (d)(8) are nondelegable.CommentsClose CommentsPermalink





‘(f) Board of Governors-CommentsClose CommentsPermalink





‘(1) IN GENERAL- The Institute shall have a Board of Governors, which shall consist of the following members:CommentsClose CommentsPermalink





‘(A) The Secretary of Health and Human Services (or the Secretary’s designee).CommentsClose CommentsPermalink





‘(B) The Director of the Agency for Healthcare Research and Quality (or the Director’s designee).CommentsClose CommentsPermalink





‘(C) The Director of the National Institutes of Health (or the Director’s designee).CommentsClose CommentsPermalink





‘(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:CommentsClose CommentsPermalink





‘(i) 3 members representing patients and health care consumers.CommentsClose CommentsPermalink





‘(ii) 3 members representing practicing physicians, including surgeons.CommentsClose CommentsPermalink





‘(iii) 3 members representing agencies that administer public programs, as follows:CommentsClose CommentsPermalink





‘(I) 1 member representing the Centers for Medicare & Medicaid Services who has experience in administering the program under title XVIII.CommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(v) 3 members representing pharmaceutical, device, and technology manufacturers or developers.CommentsClose CommentsPermalink





‘(vi) 1 member representing nonprofit organizations involved in health services research.CommentsClose CommentsPermalink





‘(vii) 1 member representing organizations that focus on quality measurement and improvement or decision support.CommentsClose CommentsPermalink





‘(viii) 1 member representing independent health services researchers.CommentsClose CommentsPermalink





‘(2) QUALIFICATIONS-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(B) CONFLICTS OF INTEREST-CommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(3) TERMS-CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(i) 6 shall be appointed for a term of 6 years;CommentsClose CommentsPermalink





‘(ii) 6 shall be appointed for a term of 4 years; andCommentsClose CommentsPermalink





‘(iii) 6 shall be appointed for a term of 2 years.CommentsClose CommentsPermalink





‘(B) LIMITATION- No individual shall be appointed to the Board under paragraph (1)(D) for more than 2 terms.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(D) VACANCIES-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(4) CHAIRPERSON AND VICE-CHAIRPERSON-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(B) TERM- The members so designated shall serve as Chairperson and Vice-Chairperson of the Board for a period of 3 years.CommentsClose CommentsPermalink





‘(5) COMPENSATION-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(6) DIRECTOR AND STAFF; EXPERTS AND CONSULTANTS- The Board may--CommentsClose CommentsPermalink





‘(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;CommentsClose CommentsPermalink





‘(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;CommentsClose CommentsPermalink





‘(C) enter into contracts or make other arrangements and make such payments as may be necessary for performance of the duties of the Institute;CommentsClose CommentsPermalink





‘(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); andCommentsClose CommentsPermalink





‘(E) prescribe such rules, regulations, and bylaws as the Board determines necessary with respect to the internal organization and operation of the Institute.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(g) Financial Oversight-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(2) REVIEW OF AUDIT AND REPORT TO CONGRESS- The Comptroller General of the United States shall--CommentsClose CommentsPermalink





‘(A) review the results of the audits conducted under paragraph (1); andCommentsClose CommentsPermalink





‘(B) submit a report to Congress containing the results of such audits and review.CommentsClose CommentsPermalink





‘(h) Governmental Oversight-CommentsClose CommentsPermalink





‘(1) REVIEW AND REPORTS-CommentsClose CommentsPermalink





‘(A) IN GENERAL- The Comptroller General of the United States shall review the following:CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(I) is objective and credible;CommentsClose CommentsPermalink





‘(II) is produced in a manner consistent with the requirements under this section; andCommentsClose CommentsPermalink





‘(III) is developed through a transparent process.CommentsClose CommentsPermalink





‘(ii) The overall effect of the Institute and the effectiveness of activities conducted under this section, including an assessment of--CommentsClose CommentsPermalink





‘(I) the utilization of the findings of research conducted under this section by health care decision makers; andCommentsClose CommentsPermalink





‘(II) the effect of the Institute and such activities on innovation and on the health economy of the United States.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(2) FUNDING ASSESSMENT-CommentsClose CommentsPermalink





‘(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:CommentsClose CommentsPermalink





‘(i) The amounts appropriated under subparagraphs (A), (B), (C), (D)(ii), and (E)(ii) of subsection (b)(1) of such section 9511.CommentsClose CommentsPermalink





‘(ii) Private sector contributions under subparagraphs (D)(i) and (E)(i) of such subsection (b)(1).CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(i) Public Comment Periods-CommentsClose CommentsPermalink





‘(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:CommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(B) Prior to the finalization of individual study designs.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(j) Rules-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(2) ESTABLISHMENT AND PROHIBITION ON ACCEPTING OUTSIDE FUNDING OR CONTRIBUTIONS- The Institute may not--CommentsClose CommentsPermalink





‘(A) establish a corporation other than as provided under this section; orCommentsClose CommentsPermalink





‘(B) accept any funds or contributions other than as provided under this part.CommentsClose CommentsPermalink





‘(k) Rules of Construction-CommentsClose CommentsPermalink





‘(1) COVERAGE- Nothing in this section shall be construed--CommentsClose CommentsPermalink





‘(A) to permit the Institute to mandate coverage, reimbursement, or other policies for any public or private payer; orCommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.’.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(c) Comparative Effectiveness Research Trust Fund; Financing for Trust Fund-CommentsClose CommentsPermalink





(1) ESTABLISHMENT OF TRUST FUND-CommentsClose CommentsPermalink





(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:CommentsClose CommentsPermalink

‘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).CommentsClose CommentsPermalink





‘(b) Transfers to Fund-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(2) FROM MEDICARE TRUST FUNDS-CommentsClose CommentsPermalink





‘(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:CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(i) such dollar amount for the previous fiscal year; multiplied byCommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(A) any provision of law which is not contained or referenced in this chapter or in a revenue Act, andCommentsClose CommentsPermalink





‘(B) whether such provision of law is a subsequently enacted provision or directly or indirectly seeks to waive the application of this paragraph.CommentsClose CommentsPermalink





‘(c) Trustee- The Secretary of Health and Human Services shall be a trustee of the CERTF.CommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(1) the fees received in the Treasury under subchapter B of chapter 34, overCommentsClose CommentsPermalink





‘(2) the decrease in the tax imposed by chapter 1 resulting from the fees imposed by such subchapter.CommentsClose CommentsPermalink





‘(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.’.CommentsClose CommentsPermalink





(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:CommentsClose CommentsPermalink





‘Sec. 9511. Comparative Effectiveness Research Trust Fund.’.CommentsClose CommentsPermalink





(2) FINANCING FOR FUND FROM FEES ON INSURED AND SELF-INSURED HEALTH PLANS-CommentsClose CommentsPermalink





(A) GENERAL RULE- Chapter 34 of the Internal Revenue Code of 1986 is amended by adding at the end the following new subchapter:CommentsClose CommentsPermalink

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

‘Sec. 4375. Health insurance.CommentsClose CommentsPermalink





‘Sec. 4376. Self-insured health plans.CommentsClose CommentsPermalink





‘Sec. 4377. Definitions and special rules.CommentsClose CommentsPermalink

‘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.CommentsClose CommentsPermalink





‘(b) Liability for Fee- The fee imposed by subsection (a) shall be paid by the issuer of the policy.CommentsClose CommentsPermalink





‘(c) Specified Health Insurance Policy- For purposes of this section:CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(3) TREATMENT OF PREPAID HEALTH COVERAGE ARRANGEMENTS-CommentsClose CommentsPermalink





‘(A) IN GENERAL- In the case of any arrangement described in subparagraph (B)--CommentsClose CommentsPermalink





‘(i) such arrangement shall be treated as a specified health insurance policy, andCommentsClose CommentsPermalink





‘(ii) the person referred to in such subparagraph shall be treated as the issuer.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(1) such dollar amount for policy years ending in the previous fiscal year, multiplied byCommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(e) Termination- This section shall not apply to policy years ending after September 30, 2020.CommentsClose CommentsPermalink

‘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.CommentsClose CommentsPermalink





‘(b) Liability for Fee-CommentsClose CommentsPermalink





‘(1) IN GENERAL- The fee imposed by subsection (a) shall be paid by the plan sponsor.CommentsClose CommentsPermalink





‘(2) PLAN SPONSOR- For purposes of paragraph (1) the term ‘plan sponsor’ means--CommentsClose CommentsPermalink





‘(A) the employer in the case of a plan established or maintained by a single employer,CommentsClose CommentsPermalink





‘(B) the employee organization in the case of a plan established or maintained by an employee organization,CommentsClose CommentsPermalink





‘(C) in the case of--CommentsClose CommentsPermalink





‘(i) a plan established or maintained by 2 or more employers or jointly by 1 or more employers and 1 or more employee organizations,CommentsClose CommentsPermalink





‘(ii) a multiple employer welfare arrangement, orCommentsClose CommentsPermalink





‘(iii) a voluntary employees’ beneficiary association described in section 501(c)(9),CommentsClose CommentsPermalink





the association, committee, joint board of trustees, or other similar group of representatives of the parties who establish or maintain the plan, orCommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(1) any portion of such coverage is provided other than through an insurance policy, andCommentsClose CommentsPermalink





‘(2) such plan is established or maintained--CommentsClose CommentsPermalink





‘(A) by one or more employers for the benefit of their employees or former employees,CommentsClose CommentsPermalink





‘(B) by one or more employee organizations for the benefit of their members or former members,CommentsClose CommentsPermalink





‘(C) jointly by 1 or more employers and 1 or more employee organizations for the benefit of employees or former employees,CommentsClose CommentsPermalink





‘(D) by a voluntary employees’ beneficiary association described in section 501(c)(9),CommentsClose CommentsPermalink





‘(E) by any organization described in section 501(c)(6), orCommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(1) such dollar amount for plan years ending in the previous fiscal year, multiplied byCommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(e) Termination- This section shall not apply to plan years ending after September 30, 2020.CommentsClose CommentsPermalink

‘SEC. 4377. DEFINITIONS AND SPECIAL RULES.

‘(a) Definitions- For purposes of this subchapter--CommentsClose CommentsPermalink





‘(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)).CommentsClose CommentsPermalink





‘(2) INSURANCE POLICY- The term ‘insurance policy’ means any policy or other instrument whereby a contract of insurance is issued, renewed, or extended.CommentsClose CommentsPermalink





‘(3) UNITED STATES- The term ‘United States’ includes any possession of the United States.CommentsClose CommentsPermalink





‘(b) Treatment of Governmental Entities-CommentsClose CommentsPermalink





‘(1) IN GENERAL- For purposes of this subchapter--CommentsClose CommentsPermalink





‘(A) the term ‘person’ includes any governmental entity, andCommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(3) EXEMPT GOVERNMENTAL PROGRAM DEFINED- For purposes of this subchapter, the term ‘exempt governmental program’ means--CommentsClose CommentsPermalink





‘(A) any insurance program established under title XVIII of the Social Security Act,CommentsClose CommentsPermalink





‘(B) the medical assistance program established by title XIX or XXI of the Social Security Act,CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(i) members of the Armed Forces of the United States, orCommentsClose CommentsPermalink





‘(ii) veterans, andCommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(c) Treatment as Tax- For purposes of subtitle F, the fees imposed by this subchapter shall be treated as if they were taxes.CommentsClose CommentsPermalink





‘(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.’.CommentsClose CommentsPermalink





(B) CLERICAL AMENDMENTS-CommentsClose CommentsPermalink





(i) Chapter 34 of such Code is amended by striking the chapter heading and inserting the following:CommentsClose CommentsPermalink

‘CHAPTER 34--TAXES ON CERTAIN INSURANCE POLICIES

‘SUBCHAPTER A. Policies issued by foreign insurers.CommentsClose CommentsPermalink

‘SUBCHAPTER B. Insured and self-insured health plans.CommentsClose CommentsPermalink

‘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:CommentsClose CommentsPermalink

‘Chapter 34--Taxes on Certain Insurance Policies’.