the entire set is critical for achieving the objective of further improving the effectiveness of breast cancer detection. In particular, adopting supportive elements in conjunction with additional regulatory requirements will be essential to sustain access to breast imaging services. Increasing regulation without providing financial and other support could not only fail to improve quality but could also result in decreased access. In addition, although this report was intended to inform the next reauthorization of MQSA, which is now projected for 2007, most of these recommendations could and should be implemented immediately. Indeed, adoption of many of the recommendations is long overdue.

A BRIEF HISTORY OF MQSA

The adoption and use of X-ray mammography increased greatly during the 1980s (Bassett et al., 1993; Lerner, 2001; IOM, 2001). As a result, mammography was included in the 1985 Nationwide Evaluation of X-Ray Trends (NEXT) study, organized by FDA and the Conference of Radiation Control Program Directors. That study determined that mammography facilities across the country varied widely with regard to image quality and radiation dose.

To combat the problem of poor mammography quality, the American College of Radiology (ACR) established the Mammography Accreditation Program in 1987, at the behest of the American Cancer Society. Although this was a critical first step toward improving mammography quality, the ACR program was voluntary; by 1992, only 7,246 facilities out of an estimated 11,000 had applied for accreditation, and many of these were motivated by awareness that MQSA was about to become law. Of those that had applied for accreditation, only 4,662 were fully accredited (Barr, 2004). In addition, the lack of onsite inspections potentially allowed substandard facilities to obtain ACR accreditation. Despite these limitations, the voluntary program resulted in some significant improvements, including improvements in quality control practices of medical physicists and radio logic technologists (Hendrick et al., 1998).

During this same time period, states began to pass legislation requiring health insurance coverage of mammography, and many stipulated quality assurance requirements as well. By 1993, 41 states and the District of Columbia had either passed legislation or established regulations addressing the quality of mammography (Smith and D’Orsi, 2004). In 1990, the first federal regulations of mammography quality went into effect via the Breast and Cervical Cancer Mortality Prevention Act, which aimed to increase access to mammograms for low-income women. Participating state facilities had to be ACR accredited, certified by the Health Care Financing Administration (now the Centers for Medicare and Medicaid Services), and use the ACR’s Breast Imaging Reporting and Data System (Barr, 2004). In addition, the Omnibus Budget Reconciliation Act of 1990 extended Medicare coverage to mammography facilities meeting certain standards (Houn et al., 1995). However, oversight was minimal at best. Clinical images were not evaluated for quality, and facilities merely claimed to meet the given standards (Barr, 2004).

In 1991 and 1992, the Senate Committee on Labor and Human Resources1 discussed the quality of mammography programs across the country as part of a larger hearing on breast cancer. It was noted that the “patchwork of Federal, State, and private stan-

1  

The name of this committee was changed to Committee on Health, Education, Labor, and Pensions on January 19, 1999.



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