Implementing the National Dense Breast Reporting Standard, Expanding Supplemental Screening Using Current Guidelines,...

Area of Science:

• Radiology
• Public Health Policy

Background:

• Over 90% of American women are covered by state-level dense breast notification laws.
• The Food and Drug Administration (FDA) issued a final rule on March 10, 2023, establishing a national standard for dense breast reporting.

Purpose of the Study:

• To inform women about their breast density and its implications for mammogram accuracy and cancer risk.
• To outline strategies for implementing national dense breast reporting standards and supplemental screening.

Main Methods:

• Analysis of existing state-level dense breast notification laws and insurance coverage.
• Review of the FDA's final rule under the Mammography Quality Standards Act (MQSA).

Main Results:

• Effective September 10, 2024, patient letters must state if breasts are "dense" or "not dense," explaining risks and the need for potential supplemental imaging.
• Provider reports must include Breast Imaging Reporting and Data System (BI-RADS) density categories.
• Current landscape includes 21 states and DC with supplemental imaging insurance laws, plus Oklahoma's diagnostic imaging coverage mandate.

Conclusions:

• National implementation of dense breast reporting aims to standardize patient communication and risk assessment.
• Supplemental screening decisions should integrate breast density with other patient risk factors for personalized care.
• Proposed federal legislation, the Find It Early Act, seeks to ensure no-cost screening and diagnostic imaging for at-risk women.