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Editor: Katharine Van Tassel
Akron Univ. School of Law

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Monday, February 16, 2009

Comparing Medical Treatments

The New York Times highlights a provision of the stimulus bill that will provide funding for comparing the effectiveness of different medical treatments for the same health problem. 

Under the legislation, researchers will receive $1.1 billion to compare drugs, medical devices, surgery and other ways of treating specific conditions. The bill creates a council of up to 15 federal employees to coordinate the research and to advise President Obama and Congress on how to spend the money.

The program responds to a growing concern that doctors have little or no solid evidence of the value of many treatments. Supporters of the research hope it will eventually save money by discouraging the use of costly, ineffective treatments.

The soaring cost of health care is widely seen as a problem for the economy. Spending on health care totaled $2.2 trillion, or 16 percent of the nation’s gross domestic product, in 2007, and the Congressional Budget Office estimates that, without any changes in federal law, it will rise to 25 percent of the G.D.P. in 2025. . . .

As Congress translated the idea into legislation, it became a lightning rod for pharmaceutical and medical-device lobbyists, who fear the findings will be used by insurers or the government to deny coverage for more expensive treatments and, thus, to ration care. In addition, Republican lawmakers and conservative commentators complained that the legislation would allow the federal government to intrude in a person’s health care by enforcing clinical guidelines and treatment protocols.

The money will be immediately available to the Health and Human Services Department but can be spent over several years. Some money will be used for systematic reviews of published scientific studies, and some will be used for clinical trials making head-to-head comparisons of different treatments.

For many years, the government has regulated drugs and devices and supported biomedical research, but the goal was usually to establish if a particular treatment was safe and effective, not if it was better than the alternatives.  Consumer groups, labor unions, large employers and pharmacy benefit managers supported the new initiative, saying it would fill gaps in the evidence available to doctors and patients.

“The new research will eventually save money and lives,” said Representative Pete Stark, Democrat of California. The United States spends more than $2 trillion a year on health care, but “we have little information about which treatments work best for which patients,” said Mr. Stark, who is the chairman of the Ways and Means Subcommittee on Health.  In the absence of information on what works, Mr. Stark said, patients are put at risk, and billions of dollars are spent each year on ineffective or unnecessary treatments. . . .

Lawmakers and lobbyists agree that researchers should compare the clinical merits of different treatments. Whether they should also consider cost is hotly debated. Representative Charles Boustany Jr., a Louisiana Republican who is a heart surgeon, said he worried that “federal bureaucrats will misuse this research to ration care, to deny life-saving treatments to seniors and disabled people.” . . .

Congress did not say exactly how the findings should be used. Private insurers can use the data in deciding whether to cover new drugs and medical procedures, but it is unclear how Medicare will use the information. Under existing law, Medicare generally covers any treatment that is “reasonable and necessary for the diagnosis or treatment of illness or injury,” and the agency does not have clear legal authority to take costs into account when deciding whether to cover a particular treatment. . . .

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