SEC. 1401. COMPARATIVE EFFECTIVENESS RESEARCH.

[a] In General- title XI of the Social Security Act is amended by adding at the end the following new part:

'Part D--Comparative Effectiveness Research

'COMPARATIVE EFFECTIVENESS RESEARCH

'Sec. 1181. [a] Center for Comparative Effectiveness Research Established-

'[1] IN GENERAL- The Secretary shall establish within the Agency for Healthcare Research and Quality a Center for Comparative Effectiveness Research [in this section referred to as the 'Center'] to conduct, support, and synthesize research [including research conducted or supported under section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003] with respect to the outcomes, effectiveness, and appropriateness of health care services and procedures in order to identify the manner in which diseases, disorders, and other health conditions can most effectively and appropriately be prevented, diagnosed, treated, and managed clinically.

'[2] DUTIES- The Center shall--

'[A] conduct, support, and synthesize research relevant to the comparative effectiveness of the full spectrum of health care items, services and systems, including pharmaceuticals, medical devices, medical and surgical procedures, and other medical interventions;

'[B] conduct and support systematic reviews of clinical research, including original research conducted subsequent to the date of the enactment of this section;

'[C] continuously develop rigorous scientific methodologies for conducting comparative effectiveness studies, and use such methodologies appropriately;

'[D] submit to the Comparative Effectiveness Research Commission, the Secretary, and Congress appropriate relevant reports described in subsection [d][2]; and

'[E] encourage, as appropriate, the development and use of clinical registries and the development of clinical effectiveness research data networks from electronic health records, post marketing drug and medical device surveillance efforts, and other forms of electronic health data.

'[3] POWERS-

'[A] OBTAINING OFFICIAL DATA- The Center may secure directly from any department or agency of the United States information necessary to enable it to carry out this section. Upon request of the Center, the head of that department or agency shall furnish that information to the Center on an agreed upon schedule.

'[B] DATA COLLECTION- In order to carry out its functions, the Center shall--

'[i] utilize existing information, both published and unpublished, where possible, collected and assessed either by its own staff or under other arrangements made in accordance with this section,

'[ii] carry out, or award grants or contracts for, original research and experimentation, where existing information is inadequate, and

'[iii] adopt procedures allowing any interested party to submit information for the use by the Center and Commission under subsection [b] in making reports and recommendations.

'[C] ACCESS OF GAO TO INFORMATION- The Comptroller General shall have unrestricted access to all deliberations, records, and nonproprietary data of the Center and Commission under subsection [b], immediately upon request.

'[D] PERIODIC AUDIT- The Center and Commission under subsection [b] shall be subject to periodic audit by the Comptroller General.

'[b] Oversight by Comparative Effectiveness Research Commission-

'[1] IN GENERAL- The Secretary shall establish an independent Comparative Effectiveness Research Commission [in this section referred to as the 'Commission'] to oversee and evaluate the activities carried out by the Center under subsection [a], subject to the authority of the Secretary, to ensure such activities result in highly credible research and information resulting from such research.

'[2] DUTIES- The Commission shall--

'[A] determine national priorities for research described in subsection [a] and in making such determinations consult with a broad array of public and private stakeholders, including patients and health care providers and payers;

'[B] monitor the appropriateness of use of the CERTF described in subsection [g] with respect to the timely production of comparative effectiveness research determined to be a national priority under subparagraph [A];

'[C] identify highly credible research methods and standards of evidence for such research to be considered by the Center;

'[D] review the methodologies developed by the center under subsection [a][2][C];

'[E] not later than one year after the date of the enactment of this section, enter into an arrangement under which the Institute of Medicine of the National Academy of Sciences shall conduct an evaluation and report on standards of evidence for such research;

'[F] support forums to increase stakeholder awareness and permit stakeholder feedback on the efforts of the Center to advance methods and standards that promote highly credible research;

'[G] make recommendations for policies that would allow for public access of data produced under this section, in accordance with appropriate privacy and proprietary practices, while ensuring that the information produced through such data is timely and credible;

'[H] appoint a clinical perspective advisory panel for each research priority determined under subparagraph [A], which shall consult with patients and advise the Center on research questions, methods, and evidence gaps in terms of clinical outcomes for the specific research inquiry to be examined with respect to such priority to ensure that the information produced from such research is clinically relevant to decisions made by clinicians and patients at the point of care;

'[I] make recommendations for the priority for periodic reviews of previous comparative effectiveness research and studies conducted by the Center under subsection [a];

'[J] routinely review processes of the Center with respect to such research to confirm that the information produced by such research is objective, credible, consistent with standards of evidence established under this section, and developed through a transparent process that includes consultations with appropriate stakeholders; and

'[K] make recommendations to the center for the broad dissemination of the findings of research conducted and supported under this section that enables clinicians, patients, consumers, and payers to make more informed health care decisions that improve quality and value.

'[3] COMPOSITION OF COMMISSION-

'[A] IN GENERAL- The members of the Commission shall consist of--

'[i] the Director of the Agency for Healthcare Research and Quality;

'[ii] the Chief Medical Officer of the Centers for Medicare & Medicaid Services; and

'[iii] 15 additional members who shall represent broad constituencies of stakeholders including clinicians, patients, researchers, third-party payers, consumers of Federal and State beneficiary programs.

Of such members, at least 9 shall be practicing physicians, health care practitioners, consumers, or patients.

'[B] QUALIFICATIONS-

'[i] DIVERSE REPRESENTATION OF PERSPECTIVES- The members of the Commission shall represent a broad range of perspectives and shall collectively have experience in the following areas:

'[I] Epidemiology.

'[II] Health services research.

'[III] Bioethics.

'[IV] Decision sciences.

'[V] Health disparities.

'[VI] Economics.

'[ii] DIVERSE REPRESENTATION OF HEALTH CARE COMMUNITY- At least one member shall represent each of the following health care communities:

'[I] Patients.

'[II] Health care consumers.

'[III] Practicing Physicians, including surgeons.

'[IV] Other health care practitioners engaged in clinical care.

'[V] Employers.

'[VI] Public payers.

'[VII] Insurance plans.

'[VIII] Clinical researchers who conduct research on behalf of pharmaceutical or device manufacturers.

'[C] LIMITATION- No more than 3 of the Members of the Commission may be representatives of pharmaceutical or device manufacturers and such representatives shall be clinical researchers described under subparagraph [B][ii][VIII].

'[4] APPOINTMENT-

'[A] IN GENERAL- The Secretary shall appoint the members of the Commission.

'[B] CONSULTATION- In considering candidates for appointment to the Commission, the Secretary may consult with the Government Accountability Office and the Institute of Medicine of the National Academy of Sciences.

'[5] CHAIRMAN; VICE CHAIRMAN- The Secretary shall designate a member of the Commission, at the time of appointment of the member, as Chairman and a member as Vice Chairman for that term of appointment, except that in the case of vacancy of the Chairmanship or Vice Chairmanship, the Secretary may designate another member for the remainder of that member's term. The Chairman shall serve as an ex officio member of the National Advisory Council of the Agency for Health Care Research and Quality under section 931[c][3][B] of the Public Health Service Act.

'[6] TERMS-

'[A] IN GENERAL- Except as provided in subparagraph [B], each member of the Commission shall be appointed for a term of 4 years.

'[B] TERMS OF INITIAL APPOINTEES- Of the members first appointed--

'[i] 8 shall be appointed for a term of 4 years; and

'[ii] 7 shall be appointed for a term of 3 years.

'[7] COORDINATION- To enhance effectiveness and coordination, the Secretary is encouraged, to the greatest extent possible, to seek coordination between the Commission and the National Advisory Council of the Agency for Healthcare Research and Quality.

'[8] CONFLICTS OF INTEREST-

'[A] IN GENERAL- In appointing the members of the Commission or a clinical perspective advisory panel described in paragraph [2][H], the Secretary or the Commission, respectively, shall take into consideration any financial interest [as defined in subparagraph [D]], consistent with this paragraph, and develop a plan for managing any identified conflicts.

'[B] EVALUATION AND CRITERIA- When considering an appointment to the Commission or a clinical perspective advisory panel described paragraph [2][H] the Secretary or the Commission shall review the expertise of the individual and the financial disclosure report filed by the individual pursuant to the Ethics in Government Act of 1978 for each individual under consideration for the appointment, so as to reduce the likelihood that an appointed individual will later require a written determination as referred to in section 208[b][1] of title 18, United States Code, a written certification as referred to in section 208[b][3] of title 18, United States Code, or a waiver as referred to in subparagraph [D][iii] for service on the Commission at a meeting of the Commission.

'[C] DISCLOSURES; PROHIBITIONS ON PARTICIPATION; WAIVERS-

'[i] DISCLOSURE OF FINANCIAL INTEREST- Prior to a meeting of the Commission or a clinical perspective advisory panel described in paragraph [2][H] regarding a 'particular matter' [as that term is used in section 208 of title 18, United States Code], each member of the Commission or the clinical perspective advisory panel who is a full-time Government employee or special Government employee shall disclose to the Secretary financial interests in accordance with subsection [b] of such section 208.

'[ii] PROHIBITIONS ON PARTICIPATION- Except as provided under clause [iii], a member of the Commission or a clinical perspective advisory panel described in paragraph [2][H] may not participate with respect to a particular matter considered in meeting of the Commission or the clinical perspective advisory panel if such member [or an immediate family member of such member] has a financial interest that could be affected by the advice given to the Secretary with respect to such matter, excluding interests exempted in regulations issued by the Director of the Office of Government Ethics as too remote or inconsequential to affect the integrity of the services of the Government officers or employees to which such regulations apply.

'[iii] WAIVER- If the Secretary determines it necessary to afford the Commission or a clinical perspective advisory panel described in paragraph 2[H] essential expertise, the Secretary may grant a waiver of the prohibition in clause [ii] to permit a member described in such subparagraph to--

'[I] participate as a non-voting member with respect to a particular matter considered in a Commission or a clinical perspective advisory panel meeting; or

'[II] participate as a voting member with respect to a particular matter considered in a Commission or a clinical perspective advisory panel meeting.

'[iv] LIMITATION ON WAIVERS AND OTHER EXCEPTIONS-

'[I] DETERMINATION OF ALLOWABLE EXCEPTIONS FOR THE COMMISSION- The number of waivers granted to members of the Commission cannot exceed one-half of the total number of members for the Commission.

'[II] PROHIBITION ON VOTING STATUS ON CLINICAL PERSPECTIVE ADVISORY PANELS- No voting member of any clinical perspective advisory panel shall be in receipt of a waiver. No more than two nonvoting members of any clinical perspective advisory panel shall receive a waiver.

'[D] FINANCIAL INTEREST DEFINED- For purposes of this paragraph, the term 'financial interest' means a financial interest under section 208[a] of title 18, United States Code.

'[9] COMPENSATION- While serving on the business of the Commission [including travel time], a member of the Commission 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; and while so serving away from home and the member's regular place of business, a member may be allowed travel expenses, as authorized by the Director of the Commission.

'[10] AVAILABILITY OF REPORTS- The Commission shall transmit to the Secretary a copy of each report submitted under this subsection and shall make such reports available to the public.

'[11] DIRECTOR AND STAFF; EXPERTS AND CONSULTANTS- Subject to such review as the Secretary deems necessary to assure the efficient administration of the Commission, the Commission may--

'[A] appoint an Executive Director [subject to the approval of the Secretary] and such other personnel as Federal employees under section 2105 of title 5, United States Code, as may be necessary to carry out its duties [without regard to the provisions of title 5, United States Code, governing appointments in the competitive service];

'[B] seek such assistance and support as may be required in the performance of its duties from appropriate Federal departments and agencies;

'[C] enter into contracts or make other arrangements, as may be necessary for the conduct of the work of the Commission [without regard to section 3709 of the Revised Statutes [41 U.S.C. 5]];

'[D] make advance, progress, and other payments which relate to the work of the Commission;

'[E] provide transportation and subsistence for persons serving without compensation; and

'[F] prescribe such rules and regulations as it deems necessary with respect to the internal organization and operation of the Commission.

'[c] Research Requirements- Any research conducted, supported, or synthesized under this section shall meet the following requirements:

'[1] ENSURING TRANSPARENCY, CREDIBILITY, AND ACCESS-

'[A] The establishment of the agenda and conduct of the research shall be insulated from inappropriate political or stakeholder influence.

'[B] Methods of conducting such research shall be scientifically based.

'[C] All aspects of the prioritization of research, conduct of the research, and development of conclusions based on the research shall be transparent to all stakeholders.

'[D] The process and methods for conducting such research shall be publicly documented and available to all stakeholders.

'[E] Throughout the process of such research, the Center shall provide opportunities for all stakeholders involved to review and provide public comment on the methods and findings of such research.

'[2] USE OF CLINICAL PERSPECTIVE ADVISORY PANELS- The research shall meet a national research priority determined under subsection [b][2][A] and shall consider advice given to the Center by the clinical perspective advisory panel for the national research priority.

'[3] STAKEHOLDER INPUT-

'[A] IN GENERAL- The Commission shall consult with patients, health care providers, health care consumer representatives, and other appropriate stakeholders with an interest in the research through a transparent process recommended by the Commission.

'[B] SPECIFIC AREAS OF CONSULTATION- Consultation shall include where deemed appropriate by the Commission--

'[i] recommending research priorities and questions;

'[ii] recommending research methodologies; and

'[iii] advising on and assisting with efforts to disseminate research findings.

'[C] OMBUDSMAN- The Secretary shall designate a patient ombudsman. The ombudsman shall--

'[i] serve as an available point of contact for any patients with an interest in proposed comparative effectiveness studies by the Center; and

'[ii] ensure that any comments from patients regarding proposed comparative effectiveness studies are reviewed by the Commission.

'[4] TAKING INTO ACCOUNT POTENTIAL DIFFERENCES- Research shall--

'[A] be designed, as appropriate, to take into account the potential for differences in the effectiveness of health care items and services used with various subpopulations such as racial and ethnic minorities, women, different age groups [including children, adolescents, adults, and seniors], and individuals with different comorbidities; and

'[B] seek, as feasible and appropriate, to include members of such subpopulations as subjects in the research.

'[d] Public Access to Comparative Effectiveness Information-

'[1] IN GENERAL- Not later than 90 days after receipt by the Center or Commission, as applicable, of a relevant report described in paragraph [2] made by the Center, Commission, or clinical perspective advisory panel under this section, appropriate information contained in such report shall be posted on the official public Internet site of the Center and of the Commission, as applicable.

'[2] RELEVANT REPORTS DESCRIBED- For purposes of this section, a relevant report is each of the following submitted by the Center or a grantee or contractor of the Center:

'[A] Any interim or progress reports as deemed appropriate by the Secretary.

'[B] Stakeholder comments.

'[C] A final report.

'[e] Dissemination and Incorporation of Comparative Effectiveness Information-

'[1] DISSEMINATION- The Center shall provide for the dissemination of appropriate findings produced by research supported, conducted, or synthesized under this section to health care providers, patients, vendors of health information technology focused on clinical decision support, appropriate professional associations, and Federal and private health plans, and other relevant stakeholders. In disseminating such findings the Center shall--

'[A] convey findings of research so that they are comprehensible and useful to patients and providers in making health care decisions;

'[B] discuss findings and other considerations specific to certain sub-populations, risk factors, and comorbidities as appropriate;

'[C] include considerations such as limitations of research and what further research may be needed, as appropriate;

'[D] not include any data that 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; and

'[E] assist the users of health information technology focused on clinical decision support to promote the timely incorporation of such findings into clinical practices and promote the ease of use of such incorporation.

'[2] DISSEMINATION PROTOCOLS AND STRATEGIES- The Center shall develop protocols and strategies for the appropriate dissemination of research findings in order to ensure effective communication of 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 items and services. In developing and adopting such protocols and strategies, the Center shall consult with stakeholders concerning the types of dissemination that will be most useful to the end users of information and may provide for the utilization of multiple formats for conveying findings to different audiences, including dissemination to individuals with limited English proficiency.

'[f] Reports to Congress-

'[1] ANNUAL REPORTS- Beginning not later than one year after the date of the enactment of this section, the Director of the Agency of Healthcare Research and Quality and the Commission shall submit to Congress an annual report on the activities of the Center and the Commission, as well as the research, conducted under this section. Each such report shall include a discussion of the Center's compliance with subsection [c][B][4], including any reasons for lack of complicance with such subsection.

'[2] RECOMMENDATION FOR FAIR SHARE PER CAPITA AMOUNT FOR ALL-PAYER FINANCING- Beginning not later than December 31, 2011, the Secretary shall submit to Congress an annual recommendation for a fair share per capita amount described in subsection [c][1] of section 9511 of the Internal Revenue Code of 1986 for purposes of funding the CERTF under such section.

'[3] ANALYSIS AND REVIEW- Not later than December 31, 2013, the Secretary, in consultation with the Commission, shall submit to Congress a report on all activities conducted or supported under this section as of such date. Such report shall include an evaluation of the overall costs of such activities and an analysis of the backlog of any research proposals approved by the Commission but not funded.

'[g] Funding of Comparative Effectiveness Research- For fiscal year 2010 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 the need for further appropriations and without fiscal year limitation, to the Secretary to carry out this section.

'[h] Construction- Nothing in this section shall be construed to permit the Commission or the Center to mandate coverage, reimbursement, or other policies for any public or private payer.'.

[b] Comparative Effectiveness Research Trust Fund; Financing for the Trust Fund- For provision establishing a Comparative Effectiveness Research Trust Fund and financing such Trust Fund, see section 1802.