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PPACA research initiative draws fire for slow start

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One of the lesser-known offspring of the Patient Protection and Affordable Care Act has come under fire for its “sluggish” performance in measuring the effectiveness of health care treatments.

The Patient-Centered Outcomes Research Institute was created by the health care reform law to gauge the effectiveness and appropriateness of health care treatments. It’s doing so through what’s called comparative effectiveness research, which helps researchers determine whether, for example, spinal fusion surgery works better than the alternatives in relieving back pain, or whether proton beam therapy is worth the extra cost to treat prostate cancer.

These are questions that private industry and federal agencies have largely steered clear of. Even the federal Food and Drug Administration, although it judges whether treatments are safe and effective, has avoided comparing whether treatment A is more effective than treatment B.

Peter OszagPCORI was designed to begin to study the question.

But critics have now surfaced, questioning its pace and focus.

Perhaps most notably, Peter Orszag, a vice chairman at Citigroup Inc. and the former director of the Office of Management and Budget in the Obama administration, wrote a Jan. 28 Op/Ed for Bloomberg News Service that said PCORI should be doing more.

“It is simply not possible to make health care more efficient without knowing how treatments stack up against one another,” Orszag wrote. “Apparently, though, [PCORI] is falling down on the job.”

Orszag based his critique at least in part on a report by the Center for American Progress that found PCORI has dedicated less than 40 percent of its research funding to comparative studies.

The CAP report further faults the organization for not giving priority to areas suggested by the Institutes of Medicine. Out of the 284 studies the institute has funded to date, only 34 (or 12 percent) address these priority topics, CAP said.

See also: 8 reasons for employers to keep their PPACA guard up

Its study also suggests that PCORI has spent too much time on general topics such as “improving health care systems,” and “addressing disparities,” and not enough on more specific, treatment-focused studies.

It calls on PCORI to use its position as an independent group to confront powerful industry stakeholders that may profit from expensive new treatments that may be no better than less-expensive options.

“To be truly transformative, the institute must finance a bold research agenda and not play it safe,” the CAP report said.

Orszag and CAP also question the emphasis PCORI has given to identifying and developing communication strategies for spreading CER findings.

Many experts in CER say such dissemination efforts are crucial.

“Adoption of the evidence is a really big problem right now,” said Joshua Di Frances, project manager for the Patient-Centered Comparative Effectiveness Research Center at Brigham and Women’s Hospital in Boston. “If there’s information out there but the adoption of it is very slow, then it is much less likely to improve health outcomes.”

Differing definitions

Joe SelbyFor its part, PCORI has released a statement disputing CAP’s assessment of its funding priorities. Instead of devoting 40 percent of its funding to CER studies, as CAP claims, PCORI’s executive director, Dr. Joe Selby, said his group has actually devoted 62 percent of its research funds to CER since its founding in 2010.

Selby attributed the discrepancy in part to his group’s position that infrastructure startup, education and dissemination efforts are crucial to effective CER, even if they are not dollars dedicated strictly to head-to-head comparison trials.

PCORI is funded by a fee imposed on plan sponsors and issuers of individual and group insurance policies. The law calls for funding to continue through 2019.

Looking ahead, there are signs that PCORI’s plans for 2014 could ease some of the criticism.

The CAP report notes that recently announced initiatives could result in PCORI increasing CER trial studies to cover approximately 70 percent of its research funding in coming months.

Just this week, PCORI announced eight new research initiatives that would provide up to $206 million in funding for CER studies this year. The studies fall under the umbrella of a new program called the Pragmatic Clinical Studies Initiative, which will fund research trials to compare two or more interventions in real-world settings.

“We’re dramatically increasing the amount of funding we’re investing in patient-centered CER and expect to commit roughly $1 billion over the next two years to support this work,” Selby said in a statement.

“Having put in place the foundations necessary to promote patient and stakeholder engagement and to conduct and disseminate high-quality CER, we’re prepared to make substantial investments in a range of projects, including the kinds of bigger, longer comparative studies that can address complex questions and provide more definitive answers.”

Di Frances said PCORI has been in the process of ramping up its CER for some time.

Like much having to do with the PPACA, the slow start of PCORI may simply reflect the challenges in addressing longstanding problems with the nation’s health care system.

“There are many areas of need,” Di Frances noted. “The research that’s being conducted in this area is going to have tremendous value, but it might take a while, especially for some of the large-scale trials.”

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