Section 6301 of the bill establishes an independent, not-for-profit corporation, the Patient-Centered Outcomes Research Institute (PCORI)
"to assist patients, clinicians, purchasers, and policy-makers in making informed health decisions by advancing the quality and relevance of evidence concerning the manner in which diseases, disorders, and other health conditions can effectively and appropriately be prevented, diagnosed, treated, monitored, and managed through research and evidence synthesis that considers variations in patient subpopulations, and the dissemination of research findings with respect to the relative health outcomes, clinical effectiveness, and appropriateness of the medical treatments, services, ... "
PCORI would be funded by a Patient-Centered Outcomes Research Trust Fund, financed by transfers beginning in 2013 from two other federal medical trust funds. The use of a trust fund for financing helps protect the institute from day-to-day political considerations in funding decisions.
The bill calls for PCORI to establish research priorities and a project agenda based on the prevalence and burden of diseases in the U.S. particularly chronic conditions, as well as a host of patient care and cost-control variables. The proposed research priorities will be open to a public-comment period as well.
The bill also identifies PCORI's research methods: primary research and systematic reviews of existing studies. To conduct its research, the institute will contract with federal agencies -- the National Institutes of Health (NIH) and Agency for Healthcare Research and Quality (AHRQ) to start -- and non-government researchers.
Research conducted for the institute will be peer reviewed, and the bill allows PCORI to use the processes of the NIH and AHRQ or academic journals. Within 90 days, research findings will be made available to the medical community and general public. AHRQ is also authorized to take proactive steps to disseminate the findings to physicians, health care providers, patients, insurance providers, and even health care technology vendors. The bill calls as well for AHRQ to award grants for training in the research methods used by the institute.
The new law imposes some restrictions on the use of comparative effectiveness research. Perhaps in response to the phony "death-panel" claims -- that comparative-effectiveness research would be used for making end-of-life decisions on individual patients -- made by the bill's opponents, the bill prohibits the use of comparative effectiveness research findings "in a manner that treats extending the life of an elderly, disabled, or terminally ill individual as of lower value than extending the life of an individual who is younger, nondisabled, or not terminally ill."