Medicare coverage of an unproven mammography device has increased usage of the device, according to a study conducted by researchers at the UC Davis Cancer Center.

For the study, lead author Joshua Fenton, assistant professor in the UC Davis Department of Family and Community Medicine, and colleagues from the University of Washington and University of Minnesota, examined the use of computer-aided detection (CAD), a tool designed to help radiologists interpret mammograms, since Congress mandated that Medicare pay for it 10 years ago.

Results from the study revealed that the prevalence of CAD jumped from 5% in 2001 when Medicare began covering it, to 27% in 2003. The increase in computer-aided detection use occurred even though “systemic reviews point to uncertainty regarding whether CAD has a clinically important impact on key breast cancer outcomes,” Fenton wrote.

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“This illustrates how industry and government interact to determine the course of health-care practice, and it’s not really guided by science,” Fenton said. “This is a case in which expensive technology gets widely adopted in clinical practice before it is proven effective.”

Based on the study’s findings, Fenton suggest 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.

“Health-care providers should not adopt new technologies without first demanding scientific evidence beyond that required for FDA approval,” wrote Karla Kerlikowsky, professor of medicine, epidemiology, and biostatistics at UC San Francisco, adding that such evidence should include not just clinical benefits but also important associated harms and whether benefits outweigh those harms.

The study’s findings were published in the Archives of Internal Medicine (2010 Jun 14;170(11):987-9).