Breast density notification requirements officially go into effect

Eighteen months after the U.S. Food and Drug Administration finalized its regulations pertaining to breast density notification standards, the final rule is going into effect. 

Starting Tuesday, Sept. 10, imaging facilities will be required to notify all women about their breast density status after completing a mammogram.  

Finalized in March of 2023, the updates to the Mammography Quality Standards Act (MQSA) of 1992 require radiologists to provide the explanation in lay language that is easily understood by patients. The new amendments also call for radiologists to classify patients’ breast density using one of the four BI-RADS categories on imaging reports. 

Those who are informed that they have dense tissue will be given additional information about what it means for their breast cancer risks. The FDA has laid out specific language for providers to use for these patients. It includes a brief statement about supplemental imaging and how women with increased breast density may benefit from additional studies that more ably identify early cancers in dense tissue. 

In the past, density notifications varied widely from state to state, with some not even requiring providers to make women aware of their dense tissue at all. Now, facilities that do not comply with the reporting standard could be subject to hefty fines. 

When the final requirements were finalized, women’s health advocates  applauded the changes. Now, many of those same supporters are taking to X, formerly known as Twitter, to express their gratitude for the new law finally going into effect. 

“FINALLY. This has been a nearly 15-year fight by patient advocates,” JoAnn Pushkin, executive director of DenseBreast-info.org, posted. 

Others took to social media to share their own difficulties stemming from breast density, with one woman stating that her own cancer was missed on mammography exams three different times before it was identified. 

With the new reporting standard taking effect, many patient advocates are now turning their attention to coverage, or lack thereof, for supplemental imaging. Similar to prior breast density notification requirements, insurance coverage of supplemental imaging—breast MRI in particular—is inconsistent throughout the country. Currently, it is not mandatory that insurers pay for supplemental exams for women with dense breast tissue, but that could change now that it has been acknowledged as a risk factor for cancer. 

Learn more about the density notification requirements and how they will affect practices below: