Breast Density Notification Laws Have Passed, But Now What?

Your patient has received a letter in the mail informing them about their dense breast tissue. While it’s great to be informed, it’s important to know what to do next, especially when it comes to their increased risk of breast cancer. So, what’s their next move?

What is Breast Density?

Breast density reflects the amount of fibrous and glandular tissue in a woman’s breasts compared with the amount of fatty tissue in the breasts, as seen on a mammogram. Your breast density can only be determined by getting a mammogram.

According to an article in Cancer Epidemiology, Biomarkers & Prevention, Fifty percent of women have dense breast tissue, which can increase your risk for breast cancer considerably. In fact, it is considered a higher risk than having a first degree relative with breast cancer.

Women with dense breast tissue are facing a double jeopardy – a higher risk of breast cancer and the fact that a mammogram can miss the cancer diagnosis 40-50% of the time. Therefore, additional imaging modalities are needed to screen these women for breast cancer. The two most common additional screening modalities are ultrasound and Magnetic Resonance Imaging (MRI).

What have we done?

On March 28, 2019, the Food and Drug Administration announced changes to the Mammography Quality Standards Act to include reporting of dense breast tissue to patients. This was an initiative proposed by Nancy and Joe Capello who formed the nonprofit “Are you Dense?” and led the grassroots movements of the density notification laws.

Nancy Cappello, PhD, launched the move for legislative action after being diagnosed with advanced-stage breast cancer in 2004 despite decades of normal mammography results.

The Food and Drug Administration released information to the public on initiatives to implement these standards nationwide on Thursday March 9, 2023. Thus, requiring mammogram providers to notify women if they have dense breast tissue and recommend that they consult with a doctor about whether they need additional screening. In fact, mammogram providers will now be required to implement the new standards within the next 18 months. Learn more about the changes made to the Mammography Quality Standards Act.

What still needs to be done?

While density notification laws are helpful there is still a significant disadvantage that women with dense breast are facing. Mandating knowledge for the patient is absolutely empowering and can help women ask the right questions to their physicians, but that still doesn’t ensure proper follow up.

We are still missing a big step!

A 2019 study by the Journal of Women’s Health found that Breast Density Notification Laws have not translated into greater knowledge of breast density for the public and have not increased recommendations for supplemental screening among primary care providers.

If we are notifying patients of their higher risk of breast cancer due to their breast density, then why are they still not being recommended to undergo more vigorous screening as indicated?

This is due to the breast density dilemma.

What are the three roadblocks leading to the breast density dilemma?

  1. There are no specific guidelines to help assist physicians with the decisions of what supplemental imaging is needed and when for women with dense breast.

    The guidelines for screening women with dense breasts have not been fully revised by the United States Preventative Task Force Services (USPTFS), National Comprehensive Cancer Network (NCCN),  or American Cancer Society (ACS) since 2016. As a result, there are currently no specific recommendations regarding which supplemental imaging techniques should be used.

    In 2019, the NCCN noted that ultrasound imaging, when used in together with mammography, may increase the detection of cancer with the disclaimer that there are higher false positive rates (incorrectly identifying a noncancerous lesion as potentially cancerous) with ultrasounds.

    Recent data shows that using automated whole breast ultrasound alongside 3D mammography has significantly increased cancer detection rates in women with dense breasts. An automated whole breast ultrasound is an ultrasound of the entire breast completed by a machine rather than an ultrasound technologist alone.

    This technique has been found to detect 20% more cancers in women with dense breast and with increase accuracy that previous handheld alone ultrasound technology.

    Additionally, abbreviated, or fast MRI has shown to increase breast cancer detection rates by 16 out of every 1000 women with dense breasts. This technique is typically recommended for women at high risk of developing breast cancer.

  2. There is not one standard risk assessment tool to determine a patient’s risk for breast cancer.

    The are several risk assessment tools available to calculate a patient’s risk for breast cancer development, however they are all slightly different. While some models include a wide range of risk factors, such as family history, nulliparity (not bearing children), and additional estrogen use, others only consider a few.

    Surprisingly, breast density, one of the most common risk factors for breast cancer, is not included in every model. The GAIL and Claus models are frequently used by physicians, but they overlook breast density in their calculations. The Tyrer-Cruzick model considers a more extensive family history and breast density for a more comprehensive risk assessment.

  3. There is no mandated health insurance coverage for supplemental imaging for breast cancer screening.

    Currently, medical insurance coverage for supplemental imaging for dense breast is not mandatory, and many insurance companies do not cover the cost of these imaging tests. One of the main reasons for this is the lack of specific guidelines by a national cancer network recommending when these tests should be conducted in women with dense breasts. As a result, the cost of supplemental imaging techniques, such as automated whole breast ultrasound or MRI, can range from $200 to $1200.

Operation Breast Density was formed to help become the next steps for women after they receive their breast density notification letter.

Operation Breast Density is a Michigan-based nonprofit organization who strives to educate, create access, and provide financial assistance to women enduring this breast density health care disparity. The mission of the organization is to empower women with knowledge of breast density, educate clinicians on the supplemental imaging these women need, and to optimize and individualize breast cancer screening for all women.

When a patient receives their density notification letter, it is recommended they visit our website and calculate their lifetime risk of breast cancer via the Tyrer-Cruzick model. Patients are then urged to print their risk score results and bring them to their physician. Their physician can then review their risk assessment results with them and their most recent mammogram imaging to assist with making decisions on what supplemental imaging is indicated for them.

We have also provided researched evidence-based algorithms that guide clinicians on how to appropriately risk assess a patient and screen them for breast cancer according to their risk assessment score and density.

In addition, we provide guidance to physicians and patients on how to navigate medical insurance coverage of their supplemental imaging.

Finally, if a patient is unable to get medical insurance coverage for their supplemental imaging, Operation Breast Density will provide financial assistance to ensure that patient obtains proper breast cancer screening. Learn more about breast density.

By Shoshana Hallowell, MD, FACS


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