New FDA Alternative Requirements Affect Mammography Final Assessment Categories - 10-31-2003
The Food and Drug Administration's Final Rules for Quality Mammography Standards that went into effect in 1999 allow individuals to apply for alternatives to existing regulations. If approved, any facility may choose to use the alternative at its own discretion. If a facility chooses not to use the alternative, the facility must follow the existing regulations.
Under the FDA's Final Rules, the interpreting physician must provide an overall assessment of findings for each examination that fall into one of the following categories: "negative," "benign," "probably benign," "suspicious" and "highly suggestive of malignancy." In cases where no final assessment category can be assigned due to incomplete workup, the interpreting physician can assign "incomplete: need additional imaging information" and provide reasons why no assessment can be made. The FDA recently approved three alternatives to these requirements regarding final assessment categories. Full descriptions are available in Alternative Requirements 9, 12 and 13 on the FDA's "Approved Alternative Requirements" page on their Web site. The new alternative requirements are summarized below.
Alternative Requirement 9 – Interpreting physicians may issue a separate final assessment for each breast. If they choose this option, they must issue a single report and a single lay summary covering the assessment of both breasts. In addition, the interpretation may only count as one examination towards meeting the MQSA experience requirements and may only be billed as a single examination.
Alternative Requirement 12 – In response to feedback from breast imagers, the newest revision of the ACR BI-RADS® Atlas will include a Category 6 and an expanded assessment for Category 0. Category 6, "known biopsy proven malignancy," is a new final assessment category and is the primary component of this alternative requirement. In addition, in cases where no final assessment category can be assigned due to incomplete workup, the interpreting physician may use the expanded assessment, "incomplete: need additional imaging information and/or prior mammograms for comparison." The ACR submitted this alternative request to the FDA so that physicians could legally follow these new BI-RADS® recommendations.
Alternative Requirement 13 – The FDA approved the use of a new final assessment category, "post procedure mammograms for marker placement," only for post procedure mammograms to confirm the deployment and position of a breast tissue marker. The lay summary, which must be provided to the patient, must be specific to the procedure. If the facility makes this post procedure examination part of the interventional study instead of a separately charged examination, then it does not fall under MQSA, and the approved alternative requirement does not apply