Manufacturers and patient advocates say providers should inform women if they have dense breast tissue and in many cases offer supplemental breast cancer screening methods for these patients, but some radiologists are pressing for more data about the practices.
About 40% of women in the U.S. have dense breast tissue, an issue that increases a patient's risk of getting breast cancer and also makes it harder to diagnose from a mammogram.
During the past three years, California, Connecticut, New York, Texas and Virginia have passed legislation that will require healthcare providers to notify a patient if she has dense breast tissue. There are bills pending in other states, as well as federal legislation that was introduced in the U.S. House of Representatives in 2011.
In Connecticut, which was the first state to pass a patient notification law, payers are required to cover the costs of supplemental screening methods, such as ultrasound, MRI and X-ray.
Ultrasound, in particular, can detect certain tumors that mammograms cannot, but it can also lead to false positives and unnecessary biopsies, which has raised concern with some radiologists about patient anxiety and increased costs to the healthcare system.
“We want the science to lead us,” said Dr. Debra Monticciolo, chairwoman of the American College of Radiology's Commission on Quality and Safety.
However, patients may be less willing to wait for the science. A study released last week at the Radiological Society of North America's annual meeting in Chicago found that 63% of women in their 40s would be willing to pay between $300 and $500 in out-of-pocket costs each year for an automated whole breast ultrasound if they were informed they had dense breast tissue.
The researchers acknowledged the study has some limitations. It surveyed a small sample of patients—about 100 women who had received routine screening at a Stanford Hospital and Clinics outpatient facility—and the study was conducted only in English.
The researchers said during an RSNA news conference that they plan to expand the study to other demographics and regions.
The market potential has already been noticed by manufacturers.
GE Healthcare announced last month that it acquired U-Systems, the Sunnyvale, Calif.-based company that developed the first automated breast ultrasound, which was approved as an adjunct to mammography. The Food and Drug Administration approved the new technology in September. Financial terms of the transaction were not disclosed. The new technology is expected to cost about $225,000, said Paul Mullen, GE Healthcare's chief marketing officer for global ultrasound.
While mammography remains the first and primary method of breast cancer screening, Mullen said he would expect the 3,800 facilities that conduct, on average, more than 30 mammography scans a day to be more likely to buy the new ultrasound technology. Hospitals that are seeking to differentiate their facilities may also be early adopters.
He noted that the device can be used by a technologist, making the procedure less pricey than handheld ultrasound, which has traditionally served as one supplemental screening method and requires a physician to conduct the exam. The process, though, isn't perfect. There are four categories of breast density, which can change over the course of a woman's life. Age, weight and hormone levels are a few factors that affect how dense a woman's breast tissue is.
Monticciolo said supplemental screening methods can lead to more paperwork and more labor-intensive services that are not efficient for hospitals. In addition, the data about supplemental screening is “immature,” she said. “The inherent risk has not been clearly defined.”