Congress weighs increased data collection for breast imaging

May 31, 2005

The Institute of Medicine has recommended sweeping changes to quality standards now being applied to breast imaging facilities. If Congress, which requested the study, enacts these changes, facilities will face a substantially greater burden in collecting patient data, potentially increasing the need for information technology.

The Institute of Medicine has recommended sweeping changes to quality standards now being applied to breast imaging facilities. If Congress, which requested the study, enacts these changes, facilities will face a substantially greater burden in collecting patient data, potentially increasing the need for information technology.

Several companies provide miniPACS and IT reporting software optimized for use in x-ray mammography, and the number of such products has increased with the rising popularity of digital mammography. Expanded data management needs imposed by Congress as part of its pending 2007 review of the Mammography Quality Standards Act could provide a further boost.

The scope of such IT products may have to cover more than mammography. The IOM report suggests that breast MR and ultrasound be regulated as well.

The expansion is needed, according to IOM committee member Dr. Howard Forman, because breast imaging has gone beyond the standard two-view mammogram that was common when the MQSA was introduced in the early 1990s. Stereotactic biopsy, breast MRI, and ultrasound are now routinely used, but the quality and accuracy of the techniques vary widely.

"We're not just talking about mammography anymore," said Forman, an associate professor of diagnostic radiology at Yale University. "We're talking about breast imaging, and that should be included in the overall regulation."

Such a requirement will place increased financial and labor burdens on breast imaging centers, many of which are already struggling to make a profit. To soften the blow, the IOM asks that Congress defray these costs by increasing reimbursement for imaging studies.

The IOM committee included radiologists, pathologists, and cancer researchers. It was tasked with evaluating ways to improve mammography interpretation through voluntary and regulatory means. Congress requested the report in preparation for the 2007 MQSA reauthorization.

"When Congress spends the money to prepare a report of this nature, it's a tip that they see it as being a critical guide," Forman said.

The IOM report suggests that breast imaging centers be required to track cancer detection rates, ratios of biopsy to cancer diagnosis, and percentages of patients with abnormal mammograms, as well as collect data on physician performance and patient outcomes.

In addition, the IOM recommends that Congress ask breast imaging facilities to voluntarily collect other data. These would include tumor staging information from pathology reports and a range of patient demographics. A data center would store the data and provide feedback to individual physicians.