H.R. 3200/Division B/Title IV/Subtitle A

==SUBTITLE A — COMPARATIVE EFFECTIVENESS RESEARCH==

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

``Sec. 1181. Comparative Effectiveness Research .

``(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);