Reimbursement of unproven medical tools drives use

NEW YORK (Reuters Health) - Lack of solid evidence doesn't seem to hamper doctors' use of new technology, as long as they can get reimbursed for it, researchers said on Monday.

They found that after the U.S. Congress had mandated Medicare coverage of a digital tool to help detect breast cancer, health providers were quick to pick it up even though it hadn't showed clear-cut benefits for the women.

The technology, known as computer-aided detection, costs more than $100,000 to install, according to the researchers, whose findings are published in the Archives of Internal Medicine.

"It illustrates a bigger problem that exists in our society, where the rails are really greased to get new technologies into practice before we are sure that they are safe," Dr. Joshua J. Fenton, who led the study, told Reuters Health.

"There is no evidence that the use of computer-aided detection reduces breast cancer mortality," he added.

Based on Medicare data, Fenton, of the University of California, Davis, and his colleagues found that in 2001, doctors used computer-aided detection in less than 5 percent of screening mammograms. Two years later, that number had swollen more than five times.

The method was approved by the U.S. Food and Drug Administration in 1998. Small studies have indicated that it might be slightly better at identifying cancers than traditional mammograms, but at the same time it flags a lot of women who don't have the disease.

Pooling the data from these smaller studies suggests that if 100,000 women were screened, using computer-aided detection would identify an extra 50 breast cancer cases and yield more than 1,000 false positives. About 80 of those false positives would go on to have unnecessary biopsies, and an unknown number would experience anxiety or depression.

"There is a whole literature about how women feel when they are told they have an abnormal test," said Dr. Karla Kerlikowske of the University of California, San Francisco, who was not part of the new study.

Based on the data so far, Kerlikowske said, there is no evidence that the digital technique is more effective than cheaper mammograms.

She said the findings were evidence of "technology creep" in medicine, adding that the same thing had happened with Pap smear tests. In 1996, the FDA approved a more expensive test that was believed to be more sensitive and largely replaced the old technique. Last year, however, a large clinical study showed that the new test wasn't any better than the old at detecting abnormal cells in the cervix.

"We are kind of enamored with all this new technology," Kerlikowske told Reuters Health. "Look at all the iPhones!"

But in the case of computer-aided detection, said Fenton, our passion for all things technological was aided by manufacturers, such as California-based R2 Technology Inc., which lobbied hard to ensure Medicare coverage.

After the legislation was passed, reimbursement for screening mammography rose from $86 to $106. While the new study doesn't prove that Medicare coverage was the only thing stoking the popularity of the method, Fenton believes it played a big role.

"This coverage was an important goal for the industry," he said. "Reimbursement was a major plan of their marketing."

At present, Congress doesn't have an advisory body to help it make scientific decisions and recommendations, although Fenton said the Obama administration has talked about establishing one.

Until then, he said, "women need to understand that more isn't necessarily better."

SOURCE: Archives of Internal Medicine, June 14, 2010.