David D. Dershaw, MD

In response to a congressional request to report on the current status of breast imaging under the Mammography Quality Standards Act (MQSA), the Institute of Medicine (IOM) issued a report on this topic this past spring. Within it, the IOM comments on the current status of the mammography workforce, quality of mammography interpretation, regulation of mammography services by the Food and Drug Administration (FDA), and the possibility of including nonmammography services under FDA regulation.

In assessing this document, it should be noted that mammography services are perhaps the most regulated medical service provided in the United States. Equipment, personnel (radiologist, technologist, and physicist), reporting, and patient follow-up are all FDA controlled. This regulatory program has undoubtedly improved the quality of mammography in the United States, but it has also increased the cost, time, and effort of mammography services. Because of this, there is little doubt that MQSA has made breast imaging a less desirable career choice and has contributed to the decrease in facilities offering mammography.

Much of what the IOM includes in its report accurately depicts this current status of breast imaging. Additionally, inherent in the recognition by the IOM that mammographic screening saves lives is the conclusion that the threat to the availability of mammography services can result in increasing breast cancer mortality.

There is little doubt that any increase in regulation, as IOM recommends, is unwanted by the breast imaging community. Specifically, the suggestion that the medical audit of outcome data be more stringent than that which is currently performed is unwelcomed. This will result in considerable time, effort, and expense without any proven benefit in quality of image interpretation. The complexity of the medical audit is suggested by the fact that although only two of the 10 (1/5) recommendations of the IOM involve the audit, four of the 12.5 (1/3) pages of the summary detailing the recommendations are needed to describe audit issues.

Another recommendation is that nonradiologist nonphysicians should be trained to participate in mammography interpretation. I think that little needs to be said about how those of us who have spent our careers learning to interpret mammograms feel about this recommendation.

Additionally, IOM suggests that nonmammographic breast imaging, sonography, magnetic resonance imaging, and imaging-guided breast biopsy procedures should be considered for inclusion under FDA regulation. It may be unexpected, but this most sweeping recommendation is perhaps the most attractive of those made by IOM. Implementation of this would eliminate turf battles that have continued to occur in some venues over some of these procedures by guaranteeing that those who are best trained are those who perform them. The advantage to women of improved services that resulted from MQSA would be extended to the rest of breast imaging.

If any of the recommendations for greater breast imaging regulation are implemented, it is essential that funding be included to pay for compliance. As mammography is widely recognized as being undercompensated, additional cost involved in delivering the services of breast imagers would accelerate the diminishing availability of these services. As has been recommended by the Society of Breast Imaging, the subspecialty organization of breast imagers, funding to fully cover the cost of complying with any additional regulations should be assured before further regulations are instituted.

IOM also recommends further study of parameters that might be useful in improving mammography quality, consideration of centers of excellence for mammography, and recommendations to diminish the impact of malpractice litigation on mammography providers. Additionally, IOM has recommended review of all current regulations under MQSA to identify those that are unnecessary and can be eliminated. All of these recommendations are welcomed.

Overall, this report is well written and well thought out. Recognition of the contribution of mammography to the health of women in the United States and the need for efforts to assure that breast imaging services will continue to be available to women throughout the population is an important part of this report. Recognition that regulation under MQSA may be excessive is welcomed. However, those reading this report are cautioned that increased regulation may diminish availability of mammography. Those who hold the future of mammography in their hands should also realize that regulation is expensive and should be compensated. It should not be considered a tax on those delivering these services.

David D. Dershaw, MD, FACR, is director, breast imaging section, department of radiology, Memorial Sloan-Kettering Cancer Center, and professor of radiology, Weill College of Medicine, Cornell University New York City.