The negative impact of MQSA (Mammography Quality Standards Act) on rural mammography programs.

Since Roentgen's discovery in 1895, physicians and scientists have found ways to use x-ray to evaluate and diagnose disease. In 1960, Dr. Richard Egan modified an x-ray machine to image the breast, for example. In 1982, one study found that deaths from breast cancer could be reduced 40 percent by using screening mammography. In 1991, Congress appropriated $90 million for breast cancer research, a figure that rose to $406 million several years later. The Mammography Quality Standards Act (MQSA), passed in 1992, requires all mammography facilities to meet minimum quality standards for equipment, radiologists, physicists and technologists. Regulations require extensive records of medical audit and outcome analysis, personnel qualification and medical reporting. Inspection and certification are now the responsibility of the Food and Drug Administration (FDA). Although they ensure compliance with the law, these inspections cost each facility $1,549 annually and the average cost to reach compliance with MQSA is $18,000. These fees are easily absorbed by high-volume centers but are burdensome for smaller, lower volume centers. Screening exams, to be useful, must be simple, accessible and cost-effective. MQSA's regulations have added significant costs and in most cases, the smaller centers will be forced to raise prices or discontinue offering mammography for a segment of the population with little or no other recourse for screening. The FDA should look for ways to perform more cost-effective inspections that still enforce regulations and monitor quality. Inspections should be unannounced and fines raised for violations. Implementation costs must be more realistic and the amount of paperwork reduced.