February 21, 2019

ACR Update on Federal Breast Density Notification Requirements

A press release issued by Senator Diane Feinstein (D-CA) on the omnibus government funding bill, recently signed into law by the president, highlights a directive to the US Food and Drug Administration (FDA) to implement breast density reporting requirements. Report language referenced in the funding bill states:

Breast Density.--The Committee recognizes the importance of patients receiving their own personal medical information and directs the Food and Drug Administration to ensure that mammography reports and summaries received by patients and their providers include appropriate information about breast density specified by the Secretary, including, at a minimum, the effect of breast density in masking the presence of breast cancer on a mammogram, the qualitative assessment of the provider who interpreted the mammogram, and a reminder to patients that individuals with dense breast tissue should talk with their providers if they have any questions or concerns about their summary.

The Office of Management and Budget has indicated it is reviewing a proposed rule from the Food and Drug Administration to amend its regulations governing mammography. The amendments would update the regulations issued under the Mammography Quality Standards Act of 1992 (MQSA) and would address, among other updates, breast density reporting by mammography facilities to patients and health care providers.

The FDA is on record saying that it is ”committed to advancing this proposed rule to further empower American patients and providers to make informed health decisions and benefit from innovative mammography services.”

At this time, there are no new federal breast density reporting requirements that facilities must follow.

ACR will remain engaged on this topic as FDA’s rulemaking process moves forward. As soon as any new MQSA reporting requirements are finalized, ACR will analyze and summarize the specific requirements and communicate such changes to our membership.