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'Comparative Effectiveness' Research Sparks Concerns over Access to Health Care

By Mary Agnes Carey and Alex Wayne, CQ Staff


February 19, 2009 -- It seems like medical common sense: In order to reduce health care costs and increase the quality of care, many lawmakers and health care experts say more research should be done to study which medicines, devices, and procedures work best at treating different diseases.

But a modest proposal to accelerate such "comparative effectiveness" research—signed into law this week by President Obama as part of the $787 billion spending bill intended to stimulate the economy—concerns some Republicans and health industry groups. They fear that Medicare, other government health programs and private insurers may use the results of the studies to deny coverage for treatments deemed less clinically effective—or even more worrying, simply less cost-effective — thereby interfering in doctor-patient relationships.

Lobbyists for drug and medical device makers, as well as some Democrats and patient groups, pressed Democratic leaders, with some success, to alter the wording of the legislation in ways they prefer, and to include language in the conference report accompanying the bill saying Congress doesn't intend for Medicare or other "public or private payers" to use the research to make coverage decisions.

But the vociferous opposition to the provision took Democrats somewhat by surprise and portends difficult fights ahead when President Obama seeks to make broader changes to the health care system, including an expansion of the comparison studies. Compared to the overall size of the stimulus, the $1.1 billion dedicated to comparative effectiveness research—while far more than the $50 million the government spent in fiscal 2009 on such research—is a pittance. Advocates for the research say the concerns are overstated, and opponents are simply trying to protect the interests of health care industry groups worried that their products could be deemed less effective.

"Opponents of health reform are now using scare tactics in a misguided attempt to stop progress in its tracks, blocking attempts to fix the broken health care system that is hurting American families and our economy," AARP chief executive Bill Novelli said Feb. 10.

Insurers also are strong supporters of comparative effectiveness research.

"As a nation, if we can better align treatment with medical best practices, that will improve the quality of care patients get and bring down costs across the board," said Robert Zirkelbach, a spokesman for America's Health Insurance Plans, the trade association for the insurance industry.

The insurance industry's support for the research is not reassuring to people suspicious of the new policy. Rep. Charles Boustany, R-La., a physician, knows firsthand about insurance companies refusing to pay for treatments he thought his patients needed.

"We've had care denied that was absolutely necessary, not only based on my clinical judgment but on the clinical judgment of others," Boustany said in an interview. He worries Medicare might adopt similar practices, using comparative effectiveness research to support its decisions.

When the House Ways and Means Committee debated the stimulus measure in January, Boustany offered an amendment that would have prevented Medicare from basing coverage decisions on cost alone. It was defeated.

Boustany said he would have voted against the stimulus bill even if the comparative effectiveness provision had been written to his liking. He said he hadn't read the version of the provision that became law.

"While I see some value in doing research to see what's the best clinical approach, taking into consideration cost and quality, I'm just deeply concerned about cost alone being a factor in making clinical decisions," he said.

Suspicion of the policy runs even deeper among some conservatives, who see a slow conspiracy unfolding to eventually ration health care. The Washington Times published an inflammatory editorial Feb. 11 comparing some of the stimulus bill's health policy provisions, including the comparative effectiveness language, with the euthanasia programs of Nazi Germany—accompanied by a picture of Adolf Hitler.

Scott Gottlieb, a resident fellow at the American Enterprise Institute who has advised some Republican lawmakers, including Boustany, warns that the comparative effectiveness program could eventually evolve into a policy more far-reaching and controlling than the stimulus describes.

"In terms of the potential for this to morph into my undesirable scenario of having a big government agency making clinical judgements and imposing across clinical practice, I think this is a big victory toward that end," he said this week at an AEI roundtable with reporters.

Some Democrats say they do hope Medicare and other programs will someday use the research to guide decisions about what treatments they will cover.

"If this research gives us useable information that a drug is killing someone, or one drug is preferable to another because the other one has bad side effects, to then say that Medicare couldn't use that information to drive coverage is asinine," said a Democratic aide involved in developing the policy. "It's life-threatening and a ridiculous restriction on federal funds and lives."

But other Democrats, as well as members of the Congressional Black Caucus, have expressed concerns that comparative effectiveness research could hurt patients' access to medical treatments they need. In a Feb. 9 letter to House Democratic leaders, 17 of the chamber's Democrats, including Reps. Jim Moran of Virginia and Allyson Y. Schwartz of Pennsylvania, said while comparative effectiveness research had the potential to make health care more efficient and less expensive, they urged that the stimulus package protect "against the use of this research to deny access to care solely based on cost."

On April 23, 2008, Congressional Black Caucus members wrote the bipartisan leadership of the House Ways and Means Committee asking that any comparative effectiveness research recognize and account for the variation in medical treatment outcomes and "bolster and expand information and knowledge about quality without restricting access to care."

Zirkelbach deflects speculation that insurers expect to use the research to deny payment for less effective treatments.

"You don't have a lot of people out there who want treatments that aren't proven to be as effective as other treatments," he said. "This information will be very valuable at informing the coverage decisions that health plans make. But in no way is it going to dictate the coverage decisions."

Novelli, of AARP, says drug and medical device makers don't want the research performed because "they fear it will cut the profits they make on ineffective drugs and equipment."

"But they won't tell you that this research could save your life by giving your doctors better information so they can prescribe the best treatments available to you."

But AARP has its own concerns about the way the research might be used. Sarah Thomas, director of health for the organization's Public Policy Institute, said there needs to be significant public discussion before Medicare or other public programs start using comparative effectiveness studies to guide coverage.

"I think we would feel very strongly that we really don't want to get in the way of good decisions that physicians make for their patients," she said.

Similarly, health industry lobbyists say their concerns about the policy are more nuanced. David Nexon, senior executive vice president at the Advanced Medical Technology Association, or AdvaMed, which represents device makers, says his organization generally supports comparative effectiveness research—even though, he said, the members of his association recognize that the research will result in winners and losers among them.

Like Boustany, Nexon said his concern is how the research is used.

"I think it would be a mistake for Medicare to make blanket non-coverage decisions based on what treatment works best on average," Nexon said, because different patients respond differently to treatments. "That's typically what these comparative effectiveness research studies find."

"On balance," he said, "while [the research] may be bad for a particular product, or a particular brand a company's making, I think it'll be good for the industry."

Billy Tauzin, a former House Republican who now heads the Pharmaceutical Research and Manufacturers of America, said the public will not support the use of comparative effectiveness research to deny treatment that patients need. "For the government to start deciding that doctors can't provide a medicine that you need ... is not what was intended in these studies. It never was, it never should be," Tauzin said.

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