FDA Mandates Breast Density Information with Mammography Results

On March 9, 2023, the United States Food and Drug Administration (FDA) issued a final rule, amending the Mammography Quality Standards Act (MQSA) of 1992, to require mammogram providers to notify women if they have dense breast tissue and recommend that they consult with a doctor about whether they need additional screening. Mammogram providers will be required to implement the new standards within 18 months.

Dense breasts have been identified as a risk factor for developing breast cancer and can make cancers more difficult to detect on a mammogram. Approximately half of the women over the age of 40 in the United States have dense breast tissue.

New Jersey implemented a similar law in 2014 which, requires mammogram providers to notify patients if they have dense breast tissue. New Jersey also requires insurers to cover breast follow-up evaluations, such as ultrasounds in women with dense breast tissue.

Click Here to read the entire April 2023 Healthcare Law Update now!

For more information, contact:
John D. Fanburg, Chair | 973.403.3107 | jfanburg@bracheichler.com
Carol Grelecki | 973.403.3140 | cgrelecki@bracheichler.com
Harshita Rathore | 973.364.8393 | hrathore@bracheichler.com