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Comparative Effectiveness Research: the Horizon

October 12, 2010
by Mark Hagland
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Interview: Tom Hubbard, Senior Program Director, The New England Healthcare Institute (NEHI)

Last month, the Cambridge, Mass.-based New England Healthcare Institute (NEHI) released an issue brief, “From Evidence to Practice: Making CER Findings Work for Providers and Patients,” which detailed the hurdles and policy choices facing leaders in comparative effectiveness research, in their efforts to widely disseminate comparative effectiveness research (CER) findings. Given the provisions in the federal healthcare reform legislation, called the Patient Protection and Affordable Care Act (PPACA), passed by Congress and signed by President Obama in March, that will establish the creation of a federal Patient-Centered Outcomes Research Institute to identify research priorities and conduct research comparing the clinical effectiveness of medical treatments, NEHI’s issue brief certainly provides a timely look at the challenges ahead in this dynamic area.

HCI Editor-in-Chief Mark Hagland spoke recently with Tom Hubbard, senior program director at NEHI, on the healthcare reform context of comparative effectiveness research, as well as on the major industry-wide challenges to CER results dissemination related to the state of healthcare IT evolution.

Healthcare Informatics: Can you explain the mechanism for comparative effectiveness research that was established on the federal level via the federal healthcare reform legislation passed into law in March?

Tom Hubbard: Stepping back a few steps, comparative research is certainly nothing new; doctors have been comparing research results for as long as there have been doctors. But there’s no question that the field of comparative effectiveness research has been growing in the last few years. And in the couple of years leading up to the passage of the healthcare reform legislation, despite the fight that broke out, a number of folks on Capitol Hill realized that it would be a good thing to expend funding on CER. The most contentious issue that came up was doing comparisons based on cost-effectiveness. You can do research on clinical effectiveness purely from the patient outcomes standpoint; or you can mix clinical effectiveness and cost-effectiveness. And cost-effectiveness clearly was the most contentious thing. And I think members of Congress had decided to downplay the cost-effectiveness issue even before the healthcare reform debate broke out over this. And clearly, the cost-effectiveness issue became the most contentious, with images of shoving Granny off the ventilator and such.

But many European countries have been applying that mixed model to healthcare decision-making for a long time. And this debate got off to an early start, because the federal stimulus goal provided the incoming Obama administration with the opportunity to fund CER. So $1.1 billion was appropriated both to commission new research, but also to provide money for CER infrastructure, meaning the research networks and tool-building to support CER, and quite a bit of that involved information technology. The research infrastructure includes building the health IT networks to do the data mining to start doing more rapid and real-time research on what’s effective. And that’s the kind of thing that some major hospitals are doing already, diving into their patient data and determining what works best for their patients.

So the stimulus bill turbocharged CER in the same way that it turbocharged IT automation, and that began in January or February of last year. In so doing, it sparked this sort of firestorm that led to Sarah Palin talking about death panels and all that, and that led into the debate over the healthcare reform bill itself. What came out of the healthcare reform bill was pretty much exactly what the leadership in Congress had sketched out before the healthcare reform debate. That is to say that they went with the strategy for CER that had been sketched out by the Senate, specifically Sen. Max Baucus [D-MT], the chairman of the finance committee, and that is, moving CER into this independent, albeit federally funded organization, PCORI—the Patient-Centered Outcomes Research Institute. And that is an organization that is roughly similar in organization and mission to the Institute of Medicine (IOM). It will be governed by a board of governors that will be appointed by the Comptroller General, the head of the U.S. Government Accountability Office (GAO), which is itself an independent agency. So the task of actually appointing the board of governors was handed off to a non-political appointee.