Breast density reporting requirements change, clinical guidance remains unchanged

Key takeaways :

• Updates in breast density reporting include a lay language summary for patients that may cause issues for providers.
• The clinical guidance on breast density remains unchanged.

BALTIMORE — A late-breaking session at the ACOG Annual Clinical & Scientific Meeting highlighted FDA updates in breast density reporting that include a lay summarization for patients while ACOG clinical guidance on breast density remains unchanged.

In March 2023, the FDA updated mammography regulations issued under the Mammography Quality Standards Act of 1992 with an effective date of September 2023 so radiology centers can make updates to their reporting, strategy and software.

This update requires breast density reporting to be included in mammography reports to clinicians, but will now require a lay language summary for patients with an FDA-developed paragraph on the importance of breast density. The FDA provides two lay summaries: one for dense breasts and one for non-dense breasts.

For patients with non-dense breasts, the summary relays that their breast tissue is not dense and advises them to discuss density risks with a health care provider. For patients with dense breasts, the summary recommends other imaging tests in addition to mammography for identifying possible cancers and directs patients to discuss breast density with a health care provider.

“The reporting structure is changing, the patients are going to get the report, but the clinical guidance remains unchanged,” Christopher M, Zahn, MD, chief of clinical practice and health equity and quality at ACOG, said during the presentation. “Unfortunately, we recognize that this is a problem for both patients and clinicians because they're going to come to us. So, we will have to provide some reassurance and hope that we will continue to have research to get us to a point where we know if additional imaging is necessary and if it will improve outcomes.”

According to Zahn, the new summaries will put more pressure on clinicians. Patients will be reading these reports and visiting health care providers with the expectation of more tests despite no evidence suggesting that additional evaluation is required, Zahn said.

In addition, the United States Preventive Services Task Force update lowered the age for screening mammography initiation from age 50 years to age 40 years for women aged 40 to 74 years.

ACOG recommends compliance with the new FDA rule. The organization’s clinical guidance on breast density remains unchanged with no recommendations for the use of alternative or adjunctive tests for asymptomatic, otherwise low-risk individuals with dense breasts. Additional research is required to identify appropriate methods to enhance detection and minimize false positive screening results, Zahn said.