The FDA is requiring mammography facilities to now begin including information on breast density in mammography reports for patients.

FDA issues breast density reporting mandate, but supplemental screening still out of reach for many

March 14, 2023
by John R. Fischer, Senior Reporter
Over a decade after agreeing that women should be informed about breast density, the FDA has enacted regulatory updates that will require mammography facilities to do just this.

Published on March 9, the amendments to the Mammography Quality Standards Act (MQSA) require these sites to include breast density information in reports following mammograms, including how density affects exam accuracy.

They create a “minimum” reporting standard that calls for specific language to explain the effects of breast density, as well as recommendations for patients to consult with their providers about their own breast density and risks for breast cancer, says the FDA.

Approximately half of women over 40 in the U.S. have dense breast tissue, which can obscure tumors on mammograms and also raises a woman's risk of developing breast cancer.

While the regulation requires information about breast density be included in mammography reports, it does not require facilities to inform women what specific category of breast density tissue they have. To date, only 13 states and Washington, D.C. do include this information in letters sent to women following mammograms.

“Though all states must now use the FDA language at a minimum, we hope those that already provide a woman’s specific density category will continue to include that information — and those that don’t will consider adding it, as it may influence decision-making,” JoAnn Pushkin, executive director of advocacy organization, told HCB News.

Over a decade in the making
About one in eight women will develop breast cancer in their lifetime, according to the Centers for Disease Control and Prevention, meaning that hundreds of thousands of Americans will be affected by the disease each year. The agency says that mammograms continue to be the best solution for screening and detection.

In 1992, Congress passed the Mammography Quality Standards Act (MQSA) to ensure patients had access to quality mammograms and information for detecting breast cancer in its earliest and most treatable stages. The law, which went into effect in 1994, gives the FDA oversight of mammography facilities, including accreditation, certification, annual inspections, and standards enforcement.

In 2011, Pushkin, along with other breast density advocates, testified before federal authorities that women needed to be made aware of the risks posed by breast density. An FDA advisory committee agreed.

In 2019, Congress passed the Breast Density and Mammography Reporting Act, as part of the Fiscal Year 2020 Consolidated Appropriations Act. It called on the FDA to create a nationwide reporting standard that would require all mammography reports to include an assessment of breast density.

In October 2022, the agency finally released a timeline for the release of the updates, saying they would come out in either late 2022 or early 2023.

"When it comes to surviving cancer, early detection is key, as 99% of women who receive an early diagnosis survive it," said Representative Rosa DeLauro (CT-D), who introduced the bill for the law in the House of Representatives, in a statement at the time.

Work still ahead
The amendments bring the MQSA "into the 21st century," according to the FDA, by modernizing regulations with current science and mammography best practices for improving breast cancer detection.

States have until September 10, 2024 to comply with the new updates. Additionally, the amendments allow the FDA to communicate directly, if necessary, with patients and their providers when a facility does not meet quality standards and is not informing patients about its inadequacies.

But they do not require mammography facilities to use more advanced forms of imaging to detect breast cancer. While patients with dense breast tissue may undergo MR or ultrasound, the United States Preventative Task Force has not yet determined if these additional tests are beneficial, according to CBS News.

As a result, many health insurers do not cover these exams, forcing most women to spend thousands out-of-pocket on additional screenings. Those who cannot afford to will often delay or forgo additional tests, putting them at greater risk for later stage diagnoses.

DeLauro and Representative Brian Fitzpatrick (D.-PA) are planning to address this issue by reintroducing the Find It Early Act, which would require all health insurance plans to cover screening, diagnostic mammograms, breast ultrasounds, and MR scans with no cost sharing.

"I will focus my attention in getting our Find It Early Act passed to ensure that once women are notified they have dense breasts they do not face out-of-pocket costs that may lead them to delay and forgo these additional screenings," said DeLauro.

Pushkin also sees this as the next step, saying that it would be an “effective complement” to the required federal “dense” notification. “As more women will now be 'dense'-informed, we would expect an increase in those asking for supplemental screening and hope their providers are knowledgeable about risk assessment and supplemental screening considerations."