#density: Are density and imaging assessments required on post-procedure mammograms?
QUESTION:
For the following procedures, please clarify if the density statement and imaging assessment are required on the report to comply with the new regulations.
- Stereo biopsy
- Needle localization by mammography
- Savi Scout (Marker placement)
- *Post mammogram from a needle localization
- *Post mammogram from a marker placement
*= imaging assessment - Post procedure marker placement?
ANSWER:
Interventional procedures are excluded from the Mammography Quality Standards Act (MQSA). According to 21 CFR 900.2(aa), mammography does not include radiography of the breast performed during invasive interventions for localization or biopsy procedures. However, under the current (and amended) MQSA regulations, if the post-procedure mammogram is logged, reported, and charged as an independent examination, separate from the interventional procedure that precedes it, then the mammogram is subject to all MQSA quality standard requirements, including the requirement to be interpreted by a MQSA qualified interpreting physician and providing a report to the referring healthcare provider, which after September 10, 2024, must include a breast density assessment statement, and a summary of the report in lay language to the patient, which after September 10, 2024, must include a density notification statement.
The assessment category, “Post-Procedure Mammogram for Marker Placement,” is reserved for a post-procedure mammogram to confirm the deployment and position of a breast tissue marker. The lay summary must be specific to the examination and report; for example, if the assessment statement in a report indicates that an examination was a post-procedure mammogram for marker placement, then the lay summary of that report should likewise mention the procedure or the marker placement, but it would not be appropriate to state that the mammogram results were abnormal, worrisome, suspicious for cancer, etc.
Note that if the post-procedure mammogram is included with the interventional procedure and not logged/reported/charged as a separate exam, it does not fall under the MQSA.
All information in this answer and all others are sourced from the MQSA Hotline at +1 (800) 838-7715. For other questions, contact Mammologix or the MQSA Program directly!