#density: Is density required on mammogram reports for patients with implants?

QUESTION:

We have several clients who are asking about the breast density ruling when there are implants with little or no breast tissue seen or available on the mammogram. Is there to be a density on the mammogram reports? If so, please advise on what to tell our clients.

ANSWER:

As of September 10, 2024, if a report does not contain a density assessment statement, or a lay summary letter does not include a density notification statement, they will be in violation of the MQSA regulations.

The amended MQSA regulations do not dictate which density assessment to assign to a particular exam of a particular patient. The requirement is to use one of the required density assessment statements from the list in the regulations in every report to a referring provider, and one of the density notification statements from the regulations in every lay summary to a patient. The required breast density notification language is intended to provide a uniform density notification for all patients nationwide to receive a baseline, consistent set of key density information.

The regulations do not prohibit facilities from providing patients with additional information, including information that may be required by any applicable State breast density reporting requirements. However, any additional information given to patients should be separate and distinct from the required Federal breast density notification statements.

All information in this answer and all others are sourced from the MQSA Hotline at +1 (800) 838-7715. For other questions, contact Mammologix or the MQSA Program directly!