Continuing Controversy Over Comparative Effectiveness Research

Wayne J. Guglielmo

August 12, 2009

August 12, 2009 — For years, comparative effectiveness research (CER) was the unsexy province of a small cadre of scientists and policy wonks, but in recent months CER — an examination of which treatments work best in routine clinical practice — has been at the center of a pivotal and increasingly acrimonious policy debate.

Some date the start of that debate to the introduction last year of the ill-fated Comparative Effectiveness Research Act of 2008, sponsored by Sen. Max Baucus, chairman of the Senate Committee on Finance, and committee member Sen. Kent Conrad (D-ND). The bill never made it out of committee. But things really fired up earlier this year as Congress worked to hammer out the stimulus package.

In its final form that bill directed $1.1 billion to CER. The Agency for Healthcare Research and Quality (AHRQ) — which for years had limped along on an annual budget that peaked at $30 million in 2008 — received 10 times that amount to fund CER studies. The remaining appropriation was divided equally between the National Institutes of Health and the office of the Secretary of the Department of Health and Human Services. To assist these agencies, the legislation also established a Federal Coordinating Council for Comparative Effectiveness Research, a 15-member panel drawn from a cross-section of government administrators.

The American Recovery and Reinvestment Act of 2009, as it was officially known, specifically prohibited CER from being used to develop new national clinical guidelines — or to assist public or private payers in reaching new coverage determinations. But that didn't stop critics from pouncing on the CER provisions as well as on other elements of the stimulus package in the weeks and days leading up to President Obama signing the bill into law on February 17.

Four days before the signing, for example, Tom Price (R-GA), chairman of the Republican Study Committee, a caucus of more than 100 conservative House members, released a statement decrying the proposed legislation's government-run healthcare provisions. Price reserved his harshest criticism for the Federal Coordinating Council, which he said "lays the groundwork for a permanent government rationing board prescribing care in place of doctors and patients."

In the months since Rep. Price raised his alarm — months during which Congress has wrestled with healthcare reform — the debate over CER has grown even more contentious.

Of the 3 major committees working on reform proposals, only the Senate's Health, Energy, Labor, & Pensions (HELP) Committee has managed to move a bill along that contains far-reaching CER provisions, including the creation of a "center" within the Agency for Healthcare Research and Quality. In the other Senate committee working on reform legislation, the Finance Committee, Chairman Baucus, sensing a political hot potato, has elected to pursue CER under a separate legislative bill, which in an acknowledged attempt at rebranding he has dubbed "The Patient-Centered Outcomes Research Act of 2009."

The third committee working on reform — the so called House Tri-Committee — has also sparred over CER. Although the Tri-Committee proposal includes CER provisions similar to those adopted by the Senate HELP Committee, some of these were amended prior to recess to make them more palatable to critics. Among other things, committee members inserted language that prohibits the use of CER to either deny or ration care or to guide Medicare coverage decisions. Committee members will continue marking up the bill when Congress returns in September.

Physicians Stake Out the Middle Ground

If broader healthcare reform is to move ahead, it seems clear, compromise on CER will need to be part of the mix. For now, though, the spectrum of opinion seems fairly well frozen.

At one extreme, critics continue in their suspicion of the government's motives. Although they acknowledge the importance of comparative effectiveness research as a mechanism for providing clinicians with the best and most reliable treatment information, they have little faith that it will not ultimately be used, by public and private payers alike, to contain costs.

"CER is a good thing when there's a firewall in place between what the clinicians use it for and what payers use it for," Dennis Smith, senior fellow in healthcare reform at The Heritage Foundation, told Medscape Medical News. "If lawmakers really wanted to use it to educate clinicians, they would have put it in the hands of a nongovernmental entity — a consortium of universities, for instance." Smith views the real goal of CER as currently formulated as a "power grab" by the government.

At the opposite extreme, some proponents of CER think that lawmakers have gone too far in erecting firewalls between CER and payers. A recent editorial in the New York Times is indicative of their point of view: "Both public and private insurance plans...should be allowed — not prohibited — to base reimbursement policies on comparative effectiveness findings."

A more radical version of this argument was put forth a few weeks ago in the New York Times Magazine by Princeton Bioethicist Peter Singer. Asked Singer in the article: "Is there any limit to how much you would want your insurer to pay for a drug that adds six months to someone's life? If there is any point at which you say, 'No, an extra six months isn't worth that much,' then you think that healthcare should be rationed." Singer favors a CER organization similar to Britain's National Institute for Health and Clinical Excellence, known as NICE.

In between these 2 extremes, physicians have staked out their own territory. Almost universally, they have spoken through their associations and specialty societies to urge lawmakers to continue their investment in CER, subject to the proper safeguards.

In a July 13 letter to the chairmen and ranking members of the House Tri-Committee, for instance, officials from the American Academy of Family Physicians, the American College of Physicians, and the Society of General Internal Medicine threw their collective support behind the committee's "approach" — one that requires CER to be "scientifically valid," the product of "a trusted source," and used solely to advance the best information possible.

And what about the prognostications of a government power grab?

"It comes down to a fundamental question of trust — to whether you believe this is being done for the right reasons," Ted Epperly, MD, president of AAFP and a family physician in Boise, Idaho, explained to Medscape Medical News.

"Speaking not only as an individual family doc for more than 30 years but as the president of my academy, I can say that the majority of my members do see the government as an honest broker in this matter — and don't see the gloomier, darker underbelly that some others see," Dr. Epperly said.

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