Patient-Centered Outcomes Research Institute
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|Legal status||501(c)(1) organization|
|Joe V. Selby, MD, MPH|
The Patient-Centered Outcomes Research Institute (PCORI) is a United States-based non-governmental institute created as part of a modification to the Social Security Act by clauses in the Patient Protection and Affordable Care Act. It is a government-sponsored organization charged with investigating the relative effectiveness of various medical treatments. Medicare may consider the Institute's research in the determining what sorts of therapies it will cover.
PCORI is charged with examining the "relative health outcomes, clinical effectiveness, and appropriateness" of different medical treatments by evaluating existing studies and conducting its own. Its nineteen-member board includes patients, physicians, nurses, hospitals, drug makers, device manufacturers, insurers, payers, government officials and health experts. It will not have the power to mandate or even endorse coverage rules or reimbursement for any particular treatment. Medicare may take the Institute’s research into account when deciding what procedures it will cover, so long as the new research is not the sole justification and the agency allows for public input.
The law governing PCORI prohibits it from developing or employing "a dollars-per-quality adjusted life year (or similar measure that discounts the value of a life because of an individual's disability) as a threshold to establish what type of health care is cost effective or recommended". This makes it different from the United Kingdom's National Institute for Health and Care Excellence, which determines cost-effectiveness directly based on quality-adjusted life year valuations.
According to Cecilia Rivera Casale, Senior Advisor for Minority Health at the Agency for Healthcare Research and Quality, PCORI "will have the opportunity to work with researchers to develop methodologies for addressing the specific needs of priority populations that traditionally have not been the focus of randomized controlled trials. This work is part of a more general effort to develop more pragmatic, less time-consuming research methods appropriate for these populations."
PCORI is funded through the Patient-Centered Outcomes Research Trust Fund (PCORTF), which was authorized by the United States Congress as part of the Patient Protection and Affordable Care Act of 2010.
PCORI receives income from the general fund of the Treasury and a small fee assessed on Medicare, private health insurance and self-insured plans. The act mandates a $2 fee, adjusted for inflation, for each person covered on a group plan.
Funding from PCORI enabled the creation of PCORNet, a network of healthcare institutions that allows analysis of routine healthcare data. Each participating site in PCORNet transforms its data into a format specified by the PCORNet Common Data Model in order to conduct comparative effectiveness research.
In April 2017, the PCORI awarded a $13-million-dollar, 5-year grant to the Treatment Research Institute to study addiction treatment. David Gastfriend will act as principal investigator. The study will compare evidence-based practices (such as cognitive-behavioral relapse prevention, peer support, contingency management, and FDA-approved medications) with standard care practices typically offered to patients with opioid use disorders (OUD). With 800 OUD patients, it will be one of the largest ever randomized controlled clinical trials of addiction treatment.
Congress established PCORI as a private nonprofit organization, not as a federal agency, and Congress funded it with a new tax called the "Patient-Centered Outcomes Research Institute Fee", which is projected to collect an estimated $3.5–$4.5 billion through 2019. The organization does not need to receive annual appropriations from Congress, and it will not be subject to the usual financial controls imposed on federal agencies. Critics[who?] charge that PCORI receives only a cursory annual review by the United States Comptroller General, who also appoints PCORI's board.
PCORI duplicates other federal agencies work. Federal agencies already engage and support similar comparative effectiveness research to that of PCORI. Although comparative effectiveness research activities were boosted by the American Recovery and Reinvestment Act of 2009, which gave a special appropriation of $1.1 billion to the Agency for Healthcare Research and Quality, the National Institutes of Health, and the Secretary of Health and Human Services, the sequestration reduced funding to the National Institutes of Health, which ultimately reduced federal funding of comparative effectiveness research. Congress requires PCORI to distribute a certain amount of its funds back to the United States Department of Health and Human Services.
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