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

by John R. Fischer, Senior Reporter | March 14, 2023
Women's Health

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."

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