Medical Device Daily Washington Writer

WASHINGTON — More than 20 health policy and economic experts got their "wonk on" Tuesday morning at the Brookings Institution in Washington during a fast-paced discussion about comparative effectiveness research (CER), which has vaulted to the frontlines of the healthcare reform debate.

Mark McClellan, director of the Engelberg Center for Health Care Reform at Brookings, said CER may not only be a key part of bending the healthcare cost curve, but could be the game-changer in health reform.

The American Recovery and Reinvestment Act (ARRA) authorized $1.1 billion for CER: $300 million for the Agency for Healthcare Research and Quality, $400 million for the National Institutes of Health and another $400 million set aside to be spent at the discretion of the Health and Human Services secretary.

The Institute of Medicine was given $1.5 million of the HHS funds to develop recommendations, due June 30, outlining the priorities for a national CER effort, McClellan noted.

But, he said, fulfilling the promise of CER for better quality, outcomes and value in health care will require answering some important questions, such as what research issues should be prioritized, what methods are appropriate for CER, where the data will come from and how the findings will be used to maximize the impact on clinical and health policy decisions.

Brookings commissioned three papers in an effort to tackle those issues.

Because it often take years for the research to yield results, like in the case of randomized clinical trials, a successful prioritization strategy must not only produce results that can be generated and used quickly, but also be guided by long-term considerations, said David Meltzer, director of the University of Chicago's Center for Health and the Social Sciences, who co-authored one of the three Brookings papers.

Simply comparing treatments A and B might not be appropriate if there is a treatment C that might offer some advantages over either of these, Meltzer noted.

Groups charged with making decisions about prioritization should be broadly representative of the people who will be applying the results of CER and should also have relevant methodological and clinical expertise, said Alan Garber, director of the Center for Health Policy at Stanford University School of Medicine (Stanford, California), who co-authored the paper with Meltzer.

However, he added, selecting the right group will not, by itself, guarantee that the prioritization effort will be successful. Any such group will need appropriate information with which to make decisions, and will need to follow procedures that enable them to select a portfolio with the greatest potential for impact, Garber said.

Sen. Max Baucus (D-Montana), chairman of the Senate Finance Committee, argued that CER could have a "great transformative effect" on the U.S. healthcare system, and noted that when Americans go shopping for consumer goods they are readily able to find and evaluate information on the quality and effectiveness of those products.

"But not so for healthcare," Baucus charged, noting that $1 of every $6 spent this year in the U.S. will be related to healthcare.

"Why shouldn't Americans have information on what works and what doesn't when it comes to their health?" he demanded.

CER, which Baucus called basically a form of "shopping," has become such a controversial issue in Congress that lawmakers on both sides of the aisle have suggested its branding be changed to better reflect its purpose, such as patient-centered outcomes research.

In fact, Baucus and Sen. Kent Conrad (D-North Dakota) later on Tuesday reintroduced their CER legislation, tagged the Patient-Centered Outcomes Research Act of 2009.

"Whatever you call it, one thing is certain: we need to address the very real concern that this research might be used to ration healthcare," Baucus said, arguing that this is not the intent of Democrats' plans for CER.

The Baucus-Conrad bill seeks to establish a private, nonprofit corporation to generate scientific evidence and new information on how diseases, disorders and other health conditions can be treated to achieve the best clinical outcome for patients.

During Tuesday's debate, Baucus said he would seek to have his bill included as part of the comprehensive health reform legislation, which the president has sought to have on his desk before the August congressional break.

Sen. Edward Kennedy (D-Massachusetts), chairman of the Senate Health, Education, Labor and Pensions Committee, and other members of the committee Tuesday afternoon introduced their health reform bill, which contained CER provisions, including a measure to create an agency within HHS, known as the Center for Health Outcomes Research and Evaluation, to collect, conduct, support and synthesize research for comparing health outcomes, effectiveness and appropriateness of healthcare services.

CER, Baucus said, is "fundamental for transforming our health system from one that is volume-driven to one that is evidence-based."

Patients must be actively involved in setting the research priorities and in designing research studies, Baucus said, adding that the research findings also must be relevant to patients.

In addition, he said, patient representatives should be trained on technical matters so they can interact with researchers and other stakeholders in developing the priorities and designing the studies.

He added that practicing physicians, and not just research doctors, also need to be at the table in those processes.

Too much of the healthcare delivered in the U.S. is not backed by any evidence that it works better than an alternative, said Peter Orszag, director of the White House Office of Management and Budget.

He noted that a recent report in the Journal of the American Medical Association reported that only about half of the clinical practice guidelines set by the American College of Cardiology (Washington) and American Heart Association (Dallas) are backed by hard evidence.

Similarly, he said, the IOM has suggested that a very large share, perhaps as large as half, of the healthcare delivered in the U.S. is not backed by specific evidence that what doctors are recommending or what is being done works better than an alternative.

That needs to change," Orszag declared.