NEWS! On March 10, 2023 the FDA issued a national requirement for dense breast reporting to patients and their referring providers. All mammography facilities will have to comply by September 10, 2024. Once the rule goes into effect, patients must be sent one of two Federal density notification statements (“not dense” or “dense”), and the mammogram report sent to referring providers must include an assessment of the patient’s breast density. See below for details on both.
Current individual state required “inform” reporting language available here.
Contact the FDA with questions about the new Mammography Quality Standards Act (MQSA) regulations by calling 800-838-7715 or here.
Patient Notifications
If NOT DENSE: “Breast tissue can be either dense or not dense. Dense tissue makes it harder to find breast cancer on a mammogram and also raises the risk of developing breast cancer. Your breast tissue is not dense. Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation.”
If DENSE: “Breast tissue can be either dense or not dense. Dense tissue makes it harder to find breast cancer on a mammogram and also raises the risk of developing breast cancer. Your breast tissue is dense. In some people with dense tissue, other imaging tests in addition to a mammogram may help find cancers. Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation.”
Report to Referring Providers
Written report must include assessment of breast density, classified as one of:
(A) “The breasts are almost entirely fatty.”
(B) “There are scattered areas of fibroglandular density.”
(C) “The breasts are heterogeneously dense, which may obscure small masses.”
(D) “The breasts are extremely dense, which lowers the sensitivity of mammography.”
