Regulatory Focus™ > News Articles > Patient-Centered Outcomes Research Institute Poised to Alter Medical Landscape

Patient-Centered Outcomes Research Institute Poised to Alter Medical Landscape

Posted 29 December 2011 | By

2012 may well go down as the year comparative effectiveness research (CER) finally goes mainstream in the United States. Included in the sprawling healthcare overhaul bill-The Patient Protection and Affordable Care Act of 2010 (PPACA)-was a little-noticed but potentially influential quasi-governmental agency known as the Patient-Centered Outcomes Research Institute, or PCORI.

Starting in 2012, a new fee of $1-per-insured-individual will be charged to health insurance plans to help fund research to compare the effectiveness of drugs, medical devices, tests and treatments. The implications-rationing, coverage determinations, and FDA marketing withdrawals- already have some experts nervous.

Dr. Joe Selby, the institute's new director, says that what doctors and policy-making bodies do with the information is out of his hands. PCORI's role, says Selby, "is to make the evidence available."

Insurers, for their part, plan to aggressively use the data to drive best practices and reduce ineffective treatments. While this isn't new-insurers have been conducting CER for decades-it does carry with it the credibility of a government agency.

PCORI does have some limitations that have been set upon it as a result of the 2010 political battles over the PPACA.  For one, the government cannot direct PCORI's research agenda-the result of fears over government-sponsored "death panels". DHHS, too, is limited in how it can use the research in making coverage decisions as a result of those same fears.

PCORI seems to be taking its job seriously.  Its board of governors reads like a who's who of the health policy world, and has already received "an extremely high volume" of applications for its Pilot Projects Grants program.  PCORI's ability to translate their research in to success may well make it a game-changer in 2012.

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