ACCOUNT ; Recommending to Center national priorities for research described in subsection taking into
Index of Sec 1401. ...ACCOUNT potential for differences in effectiveness of health care items, services and systems used with various subpopulations ; Designing to take into
Index of Sec 1401. ...APPOINTMENT to Commission or clinical perspective advisory panel described subsection ; Considering
Index of Sec 1401. ...BENEFICIARY programs ; 16 additional members representing broad constituencies of stakeholders including clinicians, patients, researchers, third-party payers and consumers of Federal and State
Index of Sec 1401. ...CERTIFICATION as referred in section 208(b)(3) of title 18, United States Code or waiver as referred in subparagraph for service on Commission at meeting of Commission ; Written
Index of Sec 1401. ...CLINICAL procedures for specific clinical circumstances ; Term standards and protocols of clinical excellence meaning clinical or practice guidelines consisting of set of directions or principles based on evidence and designed to assist health care practitioner with decisions about appropriate diagnostic, therapeutic or other
Index of Sec 1401. ...CLINICAL care ; Other health care practitioners engaged in
Index of Sec 1401. ...CLINICAL decision support, relevant expert organizations and Federal and private health plans and other relevant stakeholders ; Center providing for dissemination of appropriate findings produced by research supported, conducted or synthesized under section to health care providers, patients, vendors of health information technology focused on
Index of Sec 1401. ...CLINICAL decision support to promote timely incorporation of findings into clinical practices and promoting ease of use of incorpoations ; Assisting users of health information technology focused on
Index of Sec 1401. ...CLINICAL effectiveness research data networks from electronic health records, post marketing drug and medical device surveillance efforts and other forms of electronic health data ; Encouraging development and use of clinical registries and development of
Index of Sec 1401. ...CLINICAL excellence developed by relevant expert organizations ; Take into consideations standards and protocols of
Index of Sec 1401. ...CLINICAL excellence meaning clinical or practice guidelines consisting of set of directions or principles based on evidence and designed to assist health care practitioner with decisions about appropriate diagnostic, therapeutic or other clinical procedures for specific clinical circumstances ; Term standards and protocols of
Index of Sec 1401. ...CLINICAL outcomes for specific research inquiry to be examined with respect to priority to ensure that information produced from research being clinically relevant to decisions making by clinicians and patients at point of care ; Evidence gaps in terms of
Index of Sec 1401. ...CLINICAL perspective advisory panels for research priorities under section consulting with patients and other stakeholders and advising Center on research questions ; Appointing
Index of Sec 1401. ...CLINICAL perspective advisory panel described in subsection ; Appointing members of Commission or
Index of Sec 1401. ...CLINICAL perspective advisory panel described subsection ; Considering appointment to Commission or
Index of Sec 1401. ...CLINICAL perspective advisory panel described in subsection regarding particular matter ; Prior to meeting of Commission or
Index of Sec 1401. ...CLINICAL perspective advisory panel described in subsection not participating with respect to particular matter considered in meeting of Commission or clinical perspective advisory panel if member having financial interest to be affected by advice given to Secretary with respect to matter ; Member of Commission or
Index of Sec 1401. ...CLINICAL perspective advisory panel described in subsection essential expertise ; Determining necessary to afford Commission or
Index of Sec 1401. ...CLINICAL perspective advisory panel ; Participating as non-voting member with respect to particular matter considered in meeting of Commission or
Index of Sec 1401. ...CLINICAL perspective advisory panel receiving waiver ; No more than two nonvoting members of
Index of Sec 1401. ...CLINICAL perspective advisory panel for particular national research priority ; Research considering advice given to Center by
Index of Sec 1401. ...CLINICAL practices and promoting ease of use of incorpoations ; Assisting users of health information technology focused on clinical decision support to promote timely incorporation of findings into
Index of Sec 1401. ...CLINICAL practice guidelines including voluntary health organization ; Development of national
Index of Sec 1401. ...CLINICAL procedures for specific clinical circumstances ; Term standards and protocols of clinical excellence meaning clinical or practice guidelines consisting of set of directions or principles based on evidence and designed to assist health care practitioner with decisions about appropriate diagnostic, therapeutic or other
Index of Sec 1401. ...CLINICAL effectiveness research data networks from electronic health records, post marketing drug and medical device surveillance efforts and other forms of electronic health data ; Encouraging development and use of clinical registries and development of
Index of Sec 1401. ...CLINICAL research including original research conducted subsequent to date of enactment of section ; Conduct and support systematic reviews of
Index of Sec 1401. ...CLINICAL specialty or other professional organization representing physicians based on field of medicine ;
Index of Sec 1401. ...CLINICAL studies ; Term relevant expert organization meaning organization with expertise in rigorous application of evidence-based scientific methods for design of
Index of Sec 1401. ...CLINICAL trial and costs otherwise to be covered under title with respect to beneficiary ; Benefits under title XVIII, XIX or XXI in case where individual participating in
Index of Sec 1401. ...COMPARATIVE effectiveness of full spectrum of health care items, services and systems including pharmaceuticals ; Conducting, supporting and synthesizing research relevant to
Index of Sec 1401. ...COMPARATIVE effectiveness research ; Center awarding grants or contracts to private entities and governmental agencies with experience in conducting
Index of Sec 1401. ...COMPARATIVE effectiveness research recommended to be national priority under subparagraph ; Monitoring appropriateness of use of CERTF described in subsection with respect to timely production of
Index of Sec 1401. ...COMPARATIVE effectiveness research and studies conducted by Center under subsection ; Make recommendations to Center for priority for periodic reviews of previous
Index of Sec 1401. ...COMPARATIVE effectiveness studies and using methodologies appropriately ; Continuously developing rigorous scientific methodologies for conducting
Index of Sec 1401. ...COMPARATIVE effectiveness studies reviewed by Center ; Ensuring that comments from patients regarding proposed
Index of Sec 1401. ...COMPENSATION ; Providing transportation and subsistence for persons serving without
Index of Sec 1401. ...COMPLIANCE with subsection ; Report including discussion of Center's
Index of Sec 1401. ...CONFIDENTIALITY agreements making with respect to use of data under section ; Dissemination of which violating privacy of research participants or violating
Index of Sec 1401. ...HEALTH care decisions improving quality and value ; Findings of research conducted and supported under section enabling clinicians, patients, consumers and payers to make more informed
Index of Sec 1401. ...BENEFICIARY programs ; 16 additional members representing broad constituencies of stakeholders including clinicians, patients, researchers, third-party payers and consumers of Federal and State
Index of Sec 1401. ...CONTRACTS or making other arrangements ; Entering into
Index of Sec 1401. ...COMPARATIVE effectiveness research ; Center awarding grants or contracts to private entities and governmental agencies with experience in conducting
Index of Sec 1401. ...CLINICAL procedures for specific clinical circumstances ; Term standards and protocols of clinical excellence meaning clinical or practice guidelines consisting of set of directions or principles based on evidence and designed to assist health care practitioner with decisions about appropriate diagnostic, therapeutic or other
Index of Sec 1401. ...APPOINTMENT ; Comptroller General or Secretary reviewing expertise of individual and financial disclosure report filed by individual pursuant to Ethics in Government Act of 1978 for individual under consideations for
Index of Sec 1401. ...CLINICAL decision support, relevant expert organizations and Federal and private health plans and other relevant stakeholders ; Center providing for dissemination of appropriate findings produced by research supported, conducted or synthesized under section to health care providers, patients, vendors of health information technology focused on
Index of Sec 1401. ...CONFIDENTIALITY agreements making with respect to use of data under section ; Dissemination of which violating privacy of research participants or violating
Index of Sec 1401. ...DISSEMINATION to individuals with limited English proficiency ; Center consulting with stakeholders concerning types of dissemination to be useful to end users of information and providing for utilization of multiple formats for conveying findings to different audiences including
Index of Sec 1401. ...DISSEMINATION of research from Commission or Center and findings making by Commission or Center to be consistent with processes established under subsection ;
Index of Sec 1401. ...DISSEMINATION of research findings in order to ensure effective communication of findings and use and incorporation of findings into relevant activities for purpose of informing higher quality and more effective and efficient decisions regarding medical items and services ; Center developing protocols and strategies for appropriate
Index of Sec 1401. ...CONVEYING findings to different audiences including dissemination to individuals with limited English proficiency ; Center consulting with stakeholders concerning types of dissemination to be useful to end users of information and providing for utilization of multiple formats for
Index of Sec 1401. ...DRUG and medical device surveillance efforts and other forms of electronic health data ; Encouraging development and use of clinical registries and development of clinical effectiveness research data networks from electronic health records, post marketing
Index of Sec 1401. ...EXECUTIVE department for purpose prior to transmittal to Congress and President ; Reports under subparagraph not to be submitted to Office of Management and Budget or other Federal agency or
Index of Sec 1401. ...FINANCIAL interest to be affected by advice given to Secretary with respect to matter ; Member of Commission or clinical perspective advisory panel described in subsection not participating with respect to particular matter considered in meeting of Commission or clinical perspective advisory panel if member having
Index of Sec 1401. ...FINANCIAL interest meaning financial interest under section 208(a) of title 18, United States coding ; Term
Index of Sec 1401. ...FINANCIAL interests in accordance with requiring waiver under section 208(b) of title 18, United States Code or other interests as deemed relevant by Secretary ;
Index of Sec 1401. ...HEALTH ; Potential for new evidence concerning certain categories, health care services or treatments to improve patient
Index of Sec 1401. ...CLINICAL decision support, relevant expert organizations and Federal and private health plans and other relevant stakeholders ; Center providing for dissemination of appropriate findings produced by research supported, conducted or synthesized under section to health care providers, patients, vendors of health information technology focused on
Index of Sec 1401. ...CLINICAL procedures for specific clinical circumstances ; Term standards and protocols of clinical excellence meaning clinical or practice guidelines consisting of set of directions or principles based on evidence and designed to assist health care practitioner with decisions about appropriate diagnostic, therapeutic or other
Index of Sec 1401. ...CLINICAL care ; Other health care practitioners engaged in
Index of Sec 1401. ...HEALTH care decisions improving quality and value ; Findings of research conducted and supported under section enabling clinicians, patients, consumers and payers to make more informed
Index of Sec 1401. ...HEALTH care items, services and systems used with various subpopulations ; Designing to take into account potential for differences in effectiveness of
Index of Sec 1401. ...HEALTH care items, services and systems including pharmaceuticals ; Conducting, supporting and synthesizing research relevant to comparative effectiveness of full spectrum of
Index of Sec 1401. ...HEALTH care services or treatments to improve patient health ; Potential for new evidence concerning certain categories,
Index of Sec 1401. ...HEALTH data ; Encouraging development and use of clinical registries and development of clinical effectiveness research data networks from electronic health records, post marketing drug and medical device surveillance efforts and other forms of electronic
Index of Sec 1401. ...HEALTH organization ; Development of national clinical practice guidelines including voluntary
Index of Sec 1401. ...HEALTH plans and other relevant stakeholders ; Center providing for dissemination of appropriate findings produced by research supported, conducted or synthesized under section to health care providers, patients, vendors of health information technology focused on clinical decision support, relevant expert organizations and Federal and private
Index of Sec 1401. ...DRUG and medical device surveillance efforts and other forms of electronic health data ; Encouraging development and use of clinical registries and development of clinical effectiveness research data networks from electronic health records, post marketing
Index of Sec 1401. ...INAPPROATIONS political or stakeholder influence ; Establishment of agenda and conduct of research to be insulated from
Index of Sec 1401. ...INCORPOATIONS ; Assisting users of health information technology focused on clinical decision support to promote timely incorporation of findings into clinical practices and promoting ease of use of
Index of Sec 1401. ...CLINICAL practices and promoting ease of use of incorpoations ; Assisting users of health information technology focused on clinical decision support to promote timely incorporation of findings into
Index of Sec 1401. ...INCORPORATION of findings into relevant activities for purpose of informing higher quality and more effective and efficient decisions regarding medical items and services ; Center developing protocols and strategies for appropriate dissemination of research findings in order to ensure effective communication of findings and use and
Index of Sec 1401. ...INFORMATION produced from research being clinically relevant to decisions making by clinicians and patients at point of care ; Evidence gaps in terms of clinical outcomes for specific research inquiry to be examined with respect to priority to ensure that
Index of Sec 1401. ...INFORMATION to Center on agreed upon schedule ; Head of department or agency furnishing that
Index of Sec 1401. ...INFORMATION for use by Center in making reports and recommendations ; Interesting party to submit
Index of Sec 1401. ...INFORMATION produced through data being timely and credible ; Make recommendations to Center for policies allowing for public access of data produced under section when ensuring that
Index of Sec 1401. ...INFORMATION produced by research being objective ; Annually reviewing processes of Center and make reports to Congress and President regarding research conducted, supported or synthesized by Center to confirm that
Index of Sec 1401. ...INFORMATION to Commission on agreed upon schedule ; Head of department or agency furnishing
Index of Sec 1401. ...INFORMATION contained in report to be posted on official public Internet site of Center and Commission as applicable ; Appropriate
Index of Sec 1401. ...INFORMATION resulting from research ; Establishing independent Comparative Effectiveness Research Commission to advise Center and evaluating activities carried out by Center under subsection to ensure activities resulting in highly credible research and
Index of Sec 1401. ...INFORMATION necessary to enable to carry out that section ; Center securing directly from department or agency of United States
Index of Sec 1401. ...INFORMATION necessary to enable Commission to carry out that section ; Commission securing directly from department or agency of United States
Index of Sec 1401. ...CONVEYING findings to different audiences including dissemination to individuals with limited English proficiency ; Center consulting with stakeholders concerning types of dissemination to be useful to end users of information and providing for utilization of multiple formats for
Index of Sec 1401. ...CLINICAL decision support to promote timely incorporation of findings into clinical practices and promoting ease of use of incorpoations ; Assisting users of health information technology focused on
Index of Sec 1401. ...CLINICAL decision support, relevant expert organizations and Federal and private health plans and other relevant stakeholders ; Center providing for dissemination of appropriate findings produced by research supported, conducted or synthesized under section to health care providers, patients, vendors of health information technology focused on
Index of Sec 1401. ...INTERNAL organization and operation of Commission ; Prescribing rules and regulations as deeming necessary with respect to
Index of Sec 1401. ...MEDICAL items and services ; Center developing protocols and strategies for appropriate dissemination of research findings in order to ensure effective communication of findings and use and incorporation of findings into relevant activities for purpose of informing higher quality and more effective and efficient decisions regarding
Index of Sec 1401. ...MEDICINE ; Clinical specialty or other professional organization representing physicians based on field of
Index of Sec 1401. ...MEDICINE ; Nothing in section to be construed to authorize Federal officer or employee to exercise supervision or control over practice of
Index of Sec 1401. ...CLINICAL perspective advisory panel receiving waiver ; No more than two nonvoting members of
Index of Sec 1401. ...PAYMENTS relating to work of Commission ; Make advance, progress and other
Index of Sec 1401. ...COMPARATIVE effectiveness research and studies conducted by Center under subsection ; Make recommendations to Center for priority for periodic reviews of previous
Index of Sec 1401. ...CONFIDENTIALITY agreements making with respect to use of data under section ; Dissemination of which violating privacy of research participants or violating
Index of Sec 1401. ...COMPARATIVE effectiveness research recommended to be national priority under subparagraph ; Monitoring appropriateness of use of CERTF described in subsection with respect to timely production of
Index of Sec 1401. ...MEDICINE ; Clinical specialty or other professional organization representing physicians based on field of
Index of Sec 1401. ...PROFICIENCY ; Center consulting with stakeholders concerning types of dissemination to be useful to end users of information and providing for utilization of multiple formats for conveying findings to different audiences including dissemination to individuals with limited English
Index of Sec 1401. ...INFORMATION produced through data being timely and credible ; Make recommendations to Center for policies allowing for public access of data produced under section when ensuring that
Index of Sec 1401. ...PUBLIC comment on methods and findings of research ; Center providing opportunities for stakeholders involved to review and provide
Index of Sec 1401. ...PUBLIC Internet site of Center and Commission as applicable ; Appropriate information contained in report to be posted on official
Index of Sec 1401. ...PUBLIC internet website of Commission after date of transmittal ; Reports to be published on
Index of Sec 1401. ...APPOINTMENT ; Comptroller General or Secretary reviewing expertise of individual and financial disclosure report filed by individual pursuant to Ethics in Government Act of 1978 for individual under consideations for
Index of Sec 1401. ...CLINICAL excellence meaning clinical or practice guidelines consisting of set of directions or principles based on evidence and designed to assist health care practitioner with decisions about appropriate diagnostic, therapeutic or other clinical procedures for specific clinical circumstances ; Term standards and protocols of
Index of Sec 1401. ...INFORMATION produced from research being clinically relevant to decisions making by clinicians and patients at point of care ; Evidence gaps in terms of clinical outcomes for specific research inquiry to be examined with respect to priority to ensure that
Index of Sec 1401. ...HEALTH data ; Encouraging development and use of clinical registries and development of clinical effectiveness research data networks from electronic health records, post marketing drug and medical device surveillance efforts and other forms of electronic
Index of Sec 1401. ...TITLE with respect to beneficiary ; Benefits under title XVIII, XIX or XXI in case where individual participating in clinical trial and costs otherwise to be covered under
Index of Sec 1401. ...TITLE 18, United States coding ; Term financial interest meaning financial interest under section 208(a) of
Index of Sec 1401. ...TITLE 18, United States Code or other interests as deemed relevant by Secretary ; Financial interests in accordance with requiring waiver under section 208(b) of
Index of Sec 1401. ...TITLE 18 ; Later requiring written determination as referred in section 208(b)(1) of
Index of Sec 1401. ...TITLE 18, United States Code or waiver as referred in subparagraph for service on Commission at meeting of Commission ; Written certification as referred in section 208(b)(3) of
Index of Sec 1401. ...TITLE XI of Social Security Act amended by adding at end following new part ;
Index of Sec 1401. ...CLINICAL trial and costs otherwise to be covered under title with respect to beneficiary ; Benefits under title XVIII, XIX or XXI in case where individual participating in
Index of Sec 1401. ...TRANSMITTAL to Congress and President ; Reports under subparagraph not to be submitted to Office of Management and Budget or other Federal agency or executive department for purpose prior to
Index of Sec 1401. ...TRANSMITTAL ; Reports to be published on public internet website of Commission after date of
Index of Sec 1401. ...TRANSPARENT process including consultations with appropriate stakeholders ; Consistent with standards of evidence developed under section and developed through
Index of Sec 1401. ...COMPENSATION ; Providing transportation and subsistence for persons serving without
Index of Sec 1401. ...CLINICAL perspective advisory panel ; Participating as non-voting member with respect to particular matter considered in meeting of Commission or
Index of Sec 1401. ...1st Session |
To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes.
Mr. Dingell (for himself, Mr. Rangel, Mr. Waxman, Mr. George Miller of California, Mr. Stark, Mr. Pallone, and Mr. Andrews) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, Education and Labor, Oversight and Government Reform, and the Budget, 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
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
(a) In general.—Title XI of the Social Security Act is amended by adding at the end the following new part:
“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);
“(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 highly credible research;
“(F) 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; and
“(G) appoint clinical perspective advisory panels for research priorities under this section, which shall consult with patients and other stakeholders 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.
“(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 such 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 in making reports and recommendations.
In carrying out clause (ii), the Center may award grants or contracts (or provide for intergovernmental transfers, as applicable) to private entities and governmental agencies with experience in conducting comparative effectiveness research, such as the National Institutes of Health and other relevant Federal health agencies.
“(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) Comparative Effectiveness Research Trust Fund; financing for the trust fund.—For the provision establishing a Comparative Effectiveness Research Trust Fund and financing such Trust Fund, see section 1802.