Rule Rule 333-106-0735
Mammography Requirements: Breast Density Notification


As used in this rule:


“Breast Density” refers to the relative amount of different tissues present in the breast. A dense breast has less fat than glandular and connective tissue. Mammogram films of breasts with higher density are harder to read and interpret than those of less dense breasts. (Source: National Cancer Institute).


“Facility” has the meaning given that term in 42 U.S.C. 263b and includes but is not limited to a hospital, outpatient department, clinic, radiology practice, or mobile unit, an office of a physician, or other facility that conducts breast cancer screening or diagnosis through mammography activities. “Facility” does not include a facility of the Department of Veterans Affairs.


“Mammography activities” means the operation of equipment to produce a mammogram, the processing of the film, the initial interpretation of the mammogram and the viewing conditions for that interpretation.


In all cases where a mammogram shows a patient has extreme or heterogeneous breast density, the facility shall incorporate the following notification within the lay summary mammography report provided to the patient:
Your mammogram shows that your breast tissue is dense. Dense breast tissue is common and is not abnormal. However, dense breast tissue can make it harder to evaluate the results of your mammogram and may also be associated with an increased risk of breast cancer. This information about the results of your mammogram is given to you to raise your awareness and to promote discussion with your health care provider. Together, you can decide if you may benefit from further screening. A report of your results was sent to your health care provider.


The Dense Breast Tissue Notification statement and guidelines shall be included in the facility’s policy on how they communicate mammography results to the patient and their health care providers.
Last accessed
Jul. 9, 2020