Volpara has entered into a Scheme Implementation Agreement with Lunit, Inc.
The Food & Drug Administration has updated the Mammography Quality Standards Act (MQSA) to make patient breast density notification a federal requirement.
Cancer Risk
Breast Density
Dense breast tissue is common but linked to an increased risk for breast cancer. As density increases, mammography accuracy decreases.
What you need to know
Patients
Required "inform" language
Mammography summary lay letter must inform patient if they have dense or non-dense breast tissue.
Providers
Assessment in referring provider reports
Reports for healthcare providers must include an assessment of breast density using the BI-RADS® 5th Edition categories.
Quick Guide
FDA ruling summary, checklist, and Volpara support.
Get ready now
Your checklist for compliance by September 2024
Review MQSA rule update
Contact the MQSA program for assistance
Consider state-level language for insurance coverage
