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Jan. 24 --The Patient-Centered Outcomes Research Institute (PCORI) is falling short of its mission and should increase its investment in comparative effectiveness research (CER), according to a report released Jan. 24 by the Center for American Progress (CAP).
PCORI is an independent, nonprofit organization created under the Affordable Care Act to conduct research for patients and caregivers on the best health-care outcomes.
CAP said less than 40 percent of PCORI's funding went to CER in the first four years of its existence. The rest of PCORI's funding went toward communicating and disseminating research, improving health-care systems, addressing disparities and accelerating patient-centered outcomes research and methodological research, CAP said.
The report also said PCORI hasn't initiated a single CER study of medical devices and has launched only a few CER studies of drugs.
Topher Spiro, vice president for health policy at CAP, said in a briefing on the report that CAP is urging PCORI “to rapidly scale up its investment in CER to at least 80 percent of its funding by fiscal year 2016.”
“While critics claim the health law did nothing to control costs, the Patient-Centered Outcomes Research Institute has the potential to bend the cost curve over the long term,” Spiro said. “The institute must carry out a bold research agenda so that it lives up to that potential.”
The comparative effectiveness research funded by PCORI is a critical component of the ACA's mission to reduce health-care costs while improving quality of care, CAP said in a press release on the report. Unlike research on clinical efficacy that evaluates whether a single medical intervention works, CER evaluates two or more medical interventions and provides both patients and doctors with the information they need to understand the value of available treatment options.
In addition to increasing funding for CER, CAP also recommended that the institute:
• maximize the number of projects and funding per project under its recent plan for a new CER funding initiative (in the first quarter of 2014, PCORI plans to launch a new funding initiative to expand its support of patient-centered CER);
• prioritize CER that addresses the Institute of Medicine's top 25 priority topics;
• prioritize funding for analyses in the short term that synthesize existing CER studies (for example, a clear synthesis of the studies comparing Avastin and Lucentis, drugs that are used to treat eye diseases, might lead private payers and physicians to favor the more cost-effective drug); and
• make available on its website a comprehensive list of all research grants.
With PCORI's budget more than doubling in 2014, the time to push for improvements is now, CAP said. These changes are critical to fulfilling PCORI's mission and improving the health-care system.
Joe Selby, executive director of PCORI, said in the briefing that the pragmatic studies initiative, which will launch Feb. 8, is an attempt to address these concerns.
According to PCORI's website, the initiative will fund investigator-initiated large pragmatic clinical trials, large simple trials or large-scale observational studies that meet all the following criteria:
• involve broadly representative patient populations;
• have strong endorsement and study participation by relevant patient organizations, professional organizations and/or payer or purchaser organizations;
• aim to address prevention, diagnosis, treatment or management of a disease or symptom, improve the performance of health-care systems and eliminate health or health-care disparities;
• take place within typical clinical care and community settings; and
• have a sample large enough to allow precise estimates of effect sizes and support evaluation of potential differences in treatment effectiveness in patient subgroups.
Funded studies will compare two or more alternatives that are known to be efficacious for a particular clinical condition, PCORI said. These may include specific drugs, devices and procedures.
Selby said that under this initiative, PCORI will fund six to nine studies costing up to $15 million twice a year. According to PCORI's website, the current list of priority topics for these studies includes:
• the Institute of Medicine's 100 initial priority topics for comparative effectiveness research;
• the Agency for Healthcare Research and Quality's future research needs project initiative; and
• topics specifically identified by PCORI's multi-stakeholder advisory panels.
Selby said the initiative “will increase rapidly the number of questions being addressed” by PCORI.
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