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Use of unproven mammography tool soars with Medicare coverage
Date:6/14/2010

ious study of more than 200,000 women who had mammograms, published in the New England Journal of Medicine in 2007, Fenton and colleagues found that CAD produced excessive false-positive results. His research demonstrated that when it was used, 32 percent more women were recalled for additional tests and 20 percent more women had a breast biopsy, yet use of the software had no clear impact on the early detection of breast cancer.

"This argues that we need a way of evaluating technologies before we put them into practice," Fenton said. "The government has a huge stake in this. And once the train leaves the station, it's difficult to call it back."

In the current review, Fenton suggests that intense lobbying by manufacturers of the technology, combined with the politically volatile issue of breast cancer screening, resulted in fast-track approval by the government of Medicare coverage of the device. He also argues that industry representatives were better able to market the device, which require a large capital investment of over $100,000, after providers were assured their costs would be reimbursed by the government insurance program.

In an accompanying commentary in the same issue of the Archives, Karla Kerlikowske, professor of medicine, epidemiology and biostatistics at UC San Francisco, says health-care providers and others cannot presume that newer technologies are better than existing ones.

"Health-care providers should not adopt new technologies without first demanding scientific evidence beyond that required for FDA approval," she writes, adding that such evidence should include not just clinical benefits, but also important associated harms and whether benefits outweigh those harms.


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Contact: Dorsey Griffith
dorsey.griffith@ucdmc.ucdavis.edu
916-734-9118
University of California - Davis - Health System
Source:Eurekalert

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