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New Breast Density Reporting Final Rule Set to Be Released

by | Nov 15, 2022 | News

FDA confirms the new rule, which will update the Mammography Quality Standards Act, will publish before the end of 2022, or early 2023.

The FDA recently confirmed that a new rule updating the Mammography Quality Standards Act of 1992 (MQSA) will publish before the end of 2022 or early 2023, according to the office of House Representative Rosa DeLauro, who introduced legislation, passed in 2019, requiring the FDA to develop the rule. The rule would require providers to inform patients about their breast density status, what it means for that patient’s risk of developing cancer, and inform the patient of what extra screening options they can access.

Current federal regulations require mammography facilities to:

•           Provide a written report on each mammogram to the patient’s healthcare provider

•           Provide a summary of that report in plain language to the patient

•           Breast density notification is not required to be a part of either report

However, once the new rule comes into effect, mammography facilities will need to include that information in both the summary given to the patient and the more detailed report provided to the patient’s physician. The aim is to give patients the ability to make more informed decisions about their health, which could include going for additional breast cancer screening.

The federal rule will also add standardization and consistency in how breast density is communicated to patients as current requirements for breast density reporting mandated by existing state legislation vary greatly, meaning providers in some states may only need to give general information, while others are required to provide a more detailed report to patients.

As with many other types of cancer, early detection of breast cancer increases a woman’s chance of survival, which is why letting a woman know if she has dense breasts, and what extra screening options are available, are important. According to the National Cancer Institute (NCI), almost half of women over the age of 40 have dense breasts and cancer is more difficult to detect via mammogram in dense breasts. Having dense breasts also increases the risk of developing cancer, so additional screening may lead to earlier detection in such patients. However, the NCI adds that the benefits of such extra screening remain unclear.

Given that roughly 287,850 new cases of invasive breast cancer are estimated to be diagnosed in US women this year, according to the American Cancer Society, and the disease is the second leading cause of death for women, the new rule has the potential to save lives.

Look for a more detailed report on the new rule and how it is likely to affect healthcare providers in this article from the December 2022 issue of Diagnostic Testing & Emerging Technologies, posted in advance of PDF publication.

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