As revised by section 10602 of the Senate Manager’s Amendment. Establishes a private, nonprofit entity, the Patient-Centered Outcomes Research Institute (PCORI), overseen by a Comptroller General-appointed Board of Governors on which the Directors of the NIH and AHRQ are to reside. The purpose of PCORI is to assist patients, clinicians, purchasers, and policymakers in making informed health decisions through the advancement of comparative clinical effectiveness research (CER). CER is the term given to denote research evaluating and comparing health outcomes and the clinical effectiveness, risks, and benefits of two or more medical treatments, services, and items.
Sets forth the duties of PCORI, including identification of national research priorities and to establish and carry out a research agenda.
Authorizes PCORI to appoint permanent or ad hoc expert advisory panels as to assist in identifying research priorities and establishing the research project agenda, including an expert panel for clinical trials and another for rare diseases.
Calls upon the Comptroller General to appoint a 15-member methodology committee, and specifies that the Directors of the NIH and AHRQ (or their designees) are to serve on the methodology committee in addition to the 15 appointments. Requires the methodology committee to, not later than 18 months following PCORI’s establishment, develop and improve the science and methods of CER and produce reports to the Board of Governors in accordance with its responsibilities.
Specifies the manner in which PCORI’s research findings are to be made available to clinicians, patients, and the general public, clarifying that such findings do not constitute practice guidelines, coverage recommendations, payment or policy recommendations. Further stipulates a host of limitations relative to PCORI’s research findings, that such findings may only be used to make a determination regarding Medicare coverage if such use is through an iterative and transparent process which includes public comment and considers the effect on subpopulations.
Delineates certain annual reporting requirements to the Congress and the President, as well as specifies other transparency-related provisions relative to public comment opportunities and so forth. Tasks AHRQ, in consultation with NIH, with broadly disseminating PCORI’s research findings.
Establishes a Patient-Centered Outcomes Research Trust Fund (“Trust Fund”) funded via transfers from Medicare in proportion to the total expenditures during certain FYs in addition to fees imposed on insured and self-insured health plans. Also appropriates to the Trust Fund $10 million in FY 2010; $50 million in FY 2011; and $150 million for each of FYs 2012-2019.