Report urges sweeping changes to quality standards

May 24, 2005

Breast imaging facilities may come under increased regulatory scrutiny, as new recommendations prepared for Congress call for additional data tracking and mandatory accreditation for breast ultrasound and MRI. The report also includes suggestions to offset financial burdens incurred by centers adopting these new measures.

Breast imaging facilities may come under increased regulatory scrutiny, as new recommendations prepared for Congress call for additional data tracking and mandatory accreditation for breast ultrasound and MRI. The report also includes suggestions to offset financial burdens incurred by centers adopting these new measures.

A key recommendation in the Improving Breast Imaging Quality Standards report prepared by the Institute of Medicine would expand current Mammography Quality Standards Act medical auditing regulations requiring breast centers to collect data on physician performance and patient outcomes. Facilities would need to track their cancer detection rate, ratio of biopsy to cancer diagnosis, and percentages of patients with abnormal mammograms.

Providing ways for radiologists to obtain feedback on their breast cancer detection performance through data tracking is critical in terms of increasing mammography quality, said Dr. Etta Pisano, director of breast imaging at the University of North Carolina, Chapel Hill, and a member of the IOM report committee.

The report also suggests data collection and tracking of all women who receive a recommendation for additional imaging. Currently, facilities track only women referred for biopsy whose screening mammograms are assessed as BI-RADS 4 or 5.

Such a requirement will undoubtedly increase financial and resource costs for breast centers, many of which are already struggling to make ends meet. To soften the blow, the IOM asks that Congress defray these costs by increasing reimbursement.

"Under current MQSA regulations, we do not capture any reliable information about physician interpretation," said Dr. Howard Forman, an associate professor of diagnostic radiology at Yale University, and a member of the IOM report committee. "With these recommendations, we may still not be able to capture all of the data that we'd like, but we can begin moving in a direction that identifies the best interpreting physicians and practices, and where the best imaging occurs."

The report 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 MQSA reauthorization in 2007, and it will likely carry weight, Forman said.

"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," he said.

In addition to upgrading mandatory data tracking regulations, the IOM recommends that Congress institute an advanced voluntary audit. Through this program, sites would collect tumor staging information from pathology reports and collect a range of patient demographic data. A data center would store the data and provide feedback to individual physicians.

To encourage participation, the IOM suggests establishing a no-fault medical liability system to handle misdiagnoses. Participating physicians would first need to demonstrate a track record of high quality performance.

Facilities whose data show high levels of accuracy would be designated "Breast Imaging Centers of Excellence" and could be rewarded for their high-quality services through additional reimbursement, according to the report.

"We need evidence if we are to identify the metrics that improve imaging interpretation," Forman said. "What better evidence than to create centers of excellence, where we might pilot programs to see what types of activities improve imaging interpretation?"

Even published data on the impact of initiatives such as double-reading, computer-aided detection, and high-volume reading of mammograms are highly variable, he said. While many radiologists assume these initiatives are better, Forman found insufficient evidence to support such a claim.

"What we have done is make suggestions about how to get the evidence that will allow us to make these decisions in the future," he said.

Regarding the current workforce shortage, the IOM recommends loan repayment and visa waiver programs to help recruit residents to breast imaging. Increased reimbursement would also have a positive impact on the breast imaging workforce. The committee advises the FDA to use its annual inspections as an opportunity to collect data on mammography services by region to evaluate access to services.

Of practical import are recommendations geared to streamline the FDA inspection process under MQSA, including reducing redundant tests and paperwork contained in the current rule, Pisano said.

As for expanding MQSA to other modalities such as MRI and ultrasound, it's about time, Forman said. Breast imaging has gone beyond the standard two-view mammogram that was common when 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," he said. "We're talking about breast imaging, and that should be included in the overall regulation."

While few radiologists may welcome the thought of increased regulation, Pisano pointed out an upside.

"Radiologists in general tend to perform imaging tests at the highest quality possible," she said. "Other specialists, in other disciplines, may be performing low-quality breast ultrasound and MRI. The positive side of agreeing to more regulation is that the best quality imaging is provided to patients."

For more information from the Diagnostic Imaging archives:

Breast centers tune up for peak performance

3T breast MR heightens speed and spatial detail

Closing doors in mammography threaten continued access to care

Breast center model puts emphasis on patients