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National Breast Density Inform Legislation Enacted

National breast density inform legislation was enacted as part of the funding bill signed into law on February 15. The federal legislation will require mammography facilities to include up-to-date information about breast density in mammography reports provided to patients and their physicians. This follows 36 state laws that require communication about breast density to women after their mammogram, according to DenseBreast-Info.org.

As announced by Senator Dianne Feinstein (California) on February 16, “As part of the funding bill Congress passed yesterday, the FDA must now ensure mammography reports include appropriate breast density information. Dense tissue can hide cancer on mammograms, so this information is vital to catching breast cancer early.” 

“While the state density inform laws encompass about 89% of American women, the laws vary in depth and breadth of notification. More importantly, not all current density inform laws actually require that women be provided information about their own breast density,” says JoAnn Pushkin, executive director of DenseBreast-info.org. “Implementation of this national law will help to address this disparity, as all imaging facilities that perform mammography screening will be required to provide at least the level of information required by the FDA’s new reporting requirement.” 

The law directs the FDA, through the regulatory process, to develop reporting language and ensure that mammography reports and summaries received by patients and their providers include appropriate information about breast density. The information must include, at a minimum, the following:

• the effect of breast density in masking the presence of breast cancer on a mammogram;
• the qualitative assessment of [breast density by] the provider who interprets the mammogram; and
• a reminder to patients that individuals with dense breast tissue should talk with their providers if they have any questions or concerns about their summary.

According to Pushkin, who has led efforts at both the federal legislative and regulatory levels for a breast density reporting standard, “After work on the introduction of New York’s ‘inform’ law, I turned my attention to the federal level, as it was clear all women would benefit from having this important piece of information which may lead to earlier stage diagnoses of breast cancer. This law is an important step forward, advanced by the efforts of many advocates, including those of the late Dr. Nancy Cappello of Are You Dense?. We are all grateful for the dedication and resolve of Sen. Dianne Feinstein and Rep. Rosa DeLauro who have championed patient notification in the several past congresses.”