Komen Advocated for Policy to Standardize Notifications in Mammography Reports, Giving People More Data to Understand Breast Cancer Risk

Susan G. Komen®, the world’s leading breast cancer organization, today commends the implementation of a U.S. Food and Drug Administration (FDA) rule that mammography reports include information about a woman’s breast density. The new, federal requirement standardizes the notification language people receive, ensuring all individuals across the country have consistent information about the makeup of their breast tissue.

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New U.S. Food and Drug Administration rule gives patients and health care providers additional information about a person's breast density, an important factor in determining breast cancer risk. (Graphic: Business Wire)

“Knowledge is power, and all women can now have informed conversations with their medical providers about the screening plan that’s right for them based on factors influencing their personal breast cancer risk, including breast density,” said Molly Guthrie, Vice President of Policy & Advocacy at Susan G. Komen. “This may mean additional tests are recommended to accurately screen for breast cancer.”

Breast density is a measurement on a mammogram of the fibrous and glandular tissue which includes the lobules and ducts that make and carry milk, compared to fatty tissue in the breast. Dense breasts are common, affecting about 40-50% of U.S. women ages 40-74. However, breast density is only one factor that can affect a woman’s breast cancer risk. Age, gender, genetics, family health history and lifestyle factors play important roles in a person’s overall risk. Women with very dense breasts are 4-5 times more likely to develop breast cancer, and dense breast tissue can obscure tumors in mammograms. Komen encourages women to talk with their health care providers about their breast density and whether additional breast imaging may be right for them.

By September 10, 2024, mammography reports are required to include a breast density assessment. The reports will include an overall finding – breasts are dense, or breasts are not dense – and additional detail about the level of density:

• Breasts are almost entirely fatty (not dense)
• Breasts have scattered areas of fibroglandular density (not dense)
• Breasts are heterogeneously dense, which may obscure small masses (dense)
• Breasts are extremely dense, which lowers sensitivity of mammography (dense)

Widespread access to annual screening mammography beginning at age 40, without patient cost sharing, is available to millions because of the Affordable Care Act (ACA). However, if breast imaging is needed beyond a screening mammogram, patients are often faced with hundreds-to-thousands of dollars in out-of-pocket costs, creating a significant financial barrier to needed care.

"We want everyone to know that dense breast tissue alone doesn't necessitate additional imaging—it's just one factor in breast cancer risk," Guthrie added. "For those who do need imaging beyond a mammogram, out-of-pocket costs are often a barrier. That's why we’ve been advocating for state and federal legislation to eliminate these expenses. We have the technology to detect breast cancer earlier and save lives, financial barriers shouldn't stand in the way. It's crucial for people to understand and have affordable access to the breast imaging they need based on their individual risk."

Susan G. Komen’s Center for Public Policy has been working with state and federal lawmakers to pass legislation that removes the out-of-pocket expense for imaging beyond a screening mammogram. To date, 26 states have eliminated out-of-pocket costs to patients with state-regulated health insurance plans for diagnostic and/or supplemental imaging. At the federal level, the Access to Breast Cancer Diagnosis Act has been introduced in the U.S. House and Senate but passage is unlikely this Congress. Komen urges legislative action to remove financial and administrative barriers to needed breast imaging, ensuring all people can follow recommended screening guidelines based on their individual risk.

Komen’s Center for Public Policy recently hosted a webinar to explain the new FDA rule and what it means for patients. Access the recording here to learn more.

About Susan G. Komen^®

Susan G. Komen^® is the world’s leading nonprofit breast cancer organization, working to save lives and end breast cancer forever. Komen has an unmatched, comprehensive 360-degree approach to fighting this disease across all fronts and supporting millions of people in the U.S. and in countries worldwide. We advocate for patients, drive research breakthroughs, improve access to high-quality care, offer direct patient support and empower people with trustworthy information. Founded by Nancy G. Brinker, who promised her sister, Susan G. Komen, that she would end the disease that claimed Suzy’s life, Komen remains committed to supporting those affected by breast cancer today, while tirelessly searching for tomorrow’s cures. Visit komen.org or call 1-877 GO KOMEN. Connect with us on social at www.komen.org/contact-us/follow-us/.

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