Economic Impact Analysis of Regulations under the Mammography Quality StandardsAct of 1992

摘要

The Food and Drug Administration (FDA) is charged with ensuring thataccessibility to quality mammography services is maintained for all facilities performing mammographies in accordance with the Mammography Quality Standards Act 1992 (MQSA). Under this statute, FDA is required to certify and annual inspect over 10,000 mammography facilities. Prior to the passage of the MQSA, FDA's oversight responsibility was limited to approving new mammographic processors, X-rays, and tubing. However, MQSA requires that facilities within its jurisdiction meet standards developed by the agency to ensure a reasonable level of quality in order to achieve certification by the agency. FDA is concerned that recent trends by third-party payers to attract payments for mammography sevices have severely limited the ability of facilities to absorb any cost increases caused by the quality standards. These cost increases, as well as excess capacity, may cause low-volume facilities to leave the industry.