[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2824 Introduced in House (IH)]

111th CONGRESS
  1st Session
                                H. R. 2824

  To enhance the conduct and support of federally funded comparative 
effectiveness research relating to health care, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             June 11, 2009

Mrs. Christensen (for herself, Mr. Herger, and Mr. Boustany) introduced 
 the following bill; which was referred to the Committee on Energy and 
 Commerce, and in addition to the Committees on Ways and Means, Armed 
   Services, and Veterans' Affairs, for a period to be subsequently 
   determined by the Speaker, in each case for consideration of such 
 provisions as fall within the jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL


 
  To enhance the conduct and support of federally funded comparative 
effectiveness research relating to health care, 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 ``Doctor-Patient Relationship and 
Research Protection Act''.

SEC. 2. FEDERAL COORDINATING COUNCIL FOR COMPARATIVE EFFECTIVENESS 
              RESEARCH.

    (a) Authority.--Paragraph (1) of section 804(c) of title VIII of 
division A of the American Recovery and Reinvestment Act of 2009 (42 
U.S.C. 299b-8(c)) is amended to read as follows:
            ``(1) notwithstanding the provisions under the heading 
        `agency for healthcare research and quality' of this title and 
        any other provision of law, have full authority to direct and 
        coordinate all Federal funding of comparative effectiveness 
        health care research, including such research conducted or 
        supported by the Departments of Health and Human Services, 
        Veterans Affairs, and Defense; and''.
    (b) Membership.--Subsection (d) of section 804 of title VIII of 
division A of the American Recovery and Reinvestment Act of 2009 (42 
U.S.C. 299b-8) is amended to read as follows:
    ``(d) Membership.--
            ``(1) In general.--The members of the Council shall include 
        one senior officer or employee from each of the following 
        agencies:
                    ``(A) The Agency for Healthcare Research and 
                Quality.
                    ``(B) The Secretary of Health and Human Services.
                    ``(C) The Director of the National Institutes of 
                Health.
                    ``(D) 20 members, 9 of whom are not full-time 
                government employees, appointed by the Comptroller 
                General of the United States 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 of the Social Security Act.
                                    ``(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 of the Social Security 
                                Act 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 
                                Federal employees health benefits 
                                program under chapter 89 of title 5 of 
                                the United States Code, a health 
                                program of the Department of Veterans 
                                Affairs under chapter 17 of title 38 of 
                                such Code, or a medical care program of 
                                the Indian Health Service or of a 
                                tribal organization).
                            ``(iv) 3 members representing private 
                        payers, of whom at least 1 member shall 
                        represent health insurance issuers and at least 
                        1 member shall represent employers who self-
                        insure employee benefits.
                            ``(v) 3 members representing 
                        pharmaceutical, device, and technology 
                        manufacturers or developers.
                            ``(vi) 1 member representing nonprofit 
                        organizations involved in health services 
                        research.
                            ``(vii) 1 member representing organizations 
                        that focus on quality measurement and 
                        improvement or decision support.
                            ``(viii) 1 member representing independent 
                        health services researchers.
                            ``(ix) 1 member representing research in 
                        differences in treatment outcomes along the 
                        lines of racial and ethnic background, gender, 
                        and geography.
                            ``(x) 1 member representing research in 
                        treating rural populations.
                    ``(E) Qualifications.--At least half of the members 
                of the Council shall be physicians or other experts 
                with clinical expertise.
            ``(2) Chairman; vice chairman.--The Secretary shall serve 
        as Chairman of the Council and shall designate a member to 
        serve as Vice Chairman.''.
    (c) Rules of Construction.--Subsection (g) of section 804 of title 
VIII of division A of the American Recovery and Reinvestment Act of 
2009 (42 U.S.C. 299b-8) is amended to read as follows:
    ``(g) Rules of Construction.--
            ``(1) Coverage.--Nothing in this section shall be 
        construed--
                    ``(A) to permit the Council to mandate or recommend 
                coverage, reimbursement, or other policies for any 
                public or private payer; or
                    ``(B) as preventing the Secretary of Health and 
                Human Services from covering the routine costs of 
                clinical care received by an individual entitled to, or 
                enrolled for, benefits under title XVIII, XIX, or XXI 
                of the Social Security Act 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 finding.--No report submitted under this 
        section or research findings disseminated by the Council shall 
        be construed as mandates, guidelines, or recommendations for 
        payment, coverage, or treatment.''.
    (d) Transparency, Credibility, and Access.--Section 804 of title 
VIII of division A of the American Recovery and Reinvestment Act of 
2009 (42 U.S.C. 299b-8) is amended by adding at the end the following:
    ``(h) Transparency, Credibility, and Access.--The Council shall 
establish procedures to ensure that the following requirements for 
ensuring transparency, credibility, and access are met:
            ``(1) Public comment period.--
                    ``(A) Comment prior to obligation of funds for 
                research.--Before any Federal funds may be obligated to 
                conduct or support comparative effectiveness research, 
                the Council shall provide for a period of not less than 
                30 days for the public to comment on the research 
                proposal.
                    ``(B) Comment after research results published.--
                After the publication of the results of research 
                described in subparagraph (A), the Council shall 
                provide for a period of 60 days for the public to 
                comment on such results.
                    ``(C) Transmission of public comments.--The Council 
                shall ensure the transmission of public comments 
                submitted under subparagraph (A) to the entity 
                conducting the research with respect to which the 
                individual study design is being finalized.
            ``(2) Additional forums.--The Council shall, in addition to 
        the public comment period described in paragraph (1), support 
        forums to increase public awareness and obtain and incorporate 
        public feedback through media (such as an Internet website) on 
        the following:
                    ``(A) The identification of comparative 
                effectiveness research priorities.
                    ``(B) Comparative effectiveness research findings.
                    ``(C) Any other duties, activities, or processes 
                the Council determines appropriate.
            ``(3) Public availability.--The Council shall make 
        available to the public and disclose through the official 
        public Internet website of the Council, and through other 
        forums and media the Council determines appropriate, the 
        following:
                    ``(A) The process and methods for the conduct of 
                comparative effectiveness research pursuant to this 
                section, including--
                            ``(i) the identity of the entity conducting 
                        any such research;
                            ``(ii) any links the entity has to industry 
                        (including such links that are not directly 
                        tied to the particular research);
                            ``(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 Council determines 
                        appropriate);
                            ``(v) the identity of investigators 
                        conducting such research and any conflicts of 
                        interest of such investigators; and
                            ``(vi) any progress reports the Council 
                        determines appropriate.
                    ``(B) Public comments submitted during each public 
                comment period under paragraph (1)(A).
                    ``(C) Bylaws, processes, and proceedings of the 
                Council, to the extent practicable and as the Council 
                determines appropriate.
                    ``(D) Not later than 60 days after receipt by the 
                Council of a relevant report or comparative 
                effectiveness research finding, appropriate information 
                contained in such report or finding.
            ``(4) Conflicts of interest.--
                    ``(A) In general.--The Council shall--
                            ``(i) in appointing members to an advisory 
                        panel, and in selecting individuals to 
                        contribute to any peer-review process and for 
                        employment as executive staff of the Council, 
                        take into consideration any conflicts of 
                        interest of potential appointees, participants, 
                        and staff; and
                            ``(ii) include a description of any such 
                        conflicts of interest and conflicts of interest 
                        of Council members in an annual report to the 
                        Congress, 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.
                    ``(B) Definition.--In this subsection, the term 
                `conflict 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 Council or the conduct of the 
                comparative effectiveness research.''.

SEC. 3. APPLICATION OF FEDERALLY FUNDED CLINICAL COMPARATIVE 
              EFFECTIVENESS RESEARCH.

    (a) Limitation on CMS.--The Administrator of the Centers for 
Medicare & Medicaid Services may not use federally funded clinical 
comparative effectiveness research data to make coverage determinations 
under title XVIII of the Social Security Act for medical treatments, 
services, and items on the basis of cost.
    (b) Requirement for Implementation.--Federally funded clinical 
comparative effectiveness research and related evaluation and 
communication activities shall reflect the principle that clinicians 
and patients should have the best available evidence upon which to make 
choices in health care items and services, in providers, and in health 
care delivery systems, recognizing that patient subpopulations and 
patient and physician preferences may vary.
    (c) Appeals of Certain Medicare Coverage Determinations.--In the 
case of a national or local coverage determination under title XVIII of 
the Social Security Act that has been made utilizing federally funded 
comparative effectiveness research, an individual entitled to benefits 
under such title shall--
            (1) be an eligible requester under section 1869(h)(1)(B) of 
        such Act in relation;
            (2) have expedited access (as specified by the Secretary) 
        to coverage determinations, redeterminations, and appeals 
        relating to such determinations; and
            (3) have full access to all administrative or judicial 
        review under section 1869 of such Act with respect to such 
        determinations.
    (d) Rule of Construction.--Nothing in this Act or the amendments 
made by this Act shall be construed to require coverage of any drug, 
biological product, device, or treatment that has been determined by 
the Food and Drug Administration to be unsafe.
    (e) Disaggregation of Research Results.--No Federal funds may be 
made available to any person for any federally funded clinical 
comparative effectiveness research, unless the person agrees to ensure 
that, whenever possible, the methodology and research protocols will 
include variables that not only measure, but can be disaggregated to 
analyze and identify, any differences along the lines of racial and 
ethnic background, gender, and geography that may exist among and 
within patient subpopulations.
    (f) Definitions.--In this section:
            (1) The term ``federally funded clinical comparative 
        effectiveness research'' means research that--
                    (A) evaluates and compares the clinical 
                effectiveness, risks, and benefits of 2 or more medical 
                treatments, services, and items; and
                    (B) is conducted or supported in accordance with 
                provisions of title VIII of division A of the American 
                Recovery and Reinvestment Act of 2009 or with the use 
                of other Federal funds.
            (2) The term ``medical treatments, services, and items'' 
        means health care interventions, protocols for treatment, 
        procedures, medical devices, diagnostic tools, pharmaceuticals 
        (including drugs and biologicals), and any other processes or 
        items being used in the treatment and diagnosis of, or 
        prevention of illness or injury in, patients.
            (3) The term ``patient subpopulations'' means populations 
        of patients of different racial and ethnic backgrounds, 
        genders, and geographic locations.
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