Licensing and Regulatory Affairs
Public Act 517 of 2014 was signed into law on January 10, 2015 and will be effective on June 1, 2015. The Act requires mammography facilities to provide certain information to a patient whose mammogram demonstrates heterogeneously dense or extremely dense breast tissue. The information must be in the written lay summary to the patient and include the following information:
"Your mammogram shows that your breast tissue is dense. Dense breast tissue is very common and is not abnormal. However, dense breast tissue can make it harder to find cancer through a mammogram. Also, dense breast tissue may increase your risk for breast cancer. This information about the result of your mammogram is given to you to raise your awareness. Use this information to discuss with your health care provider whether other supplemental tests in addition to your mammogram may be appropriate for you, based on your individual risk. A report of your results was sent to your ordering physician. If you are self-referred, a report of your results was sent to you in addition to this summary."
Beginning with mammography inspections performed on or after June 1, 2015, section inspectors will ask to see evidence of compliance with this requirement.
Public Act 517 of 2014 requires that mammography providers give the above notification to patients that have been determined by the interpreting physician as having dense breasts. The paragraph above will need to be included in the lay summary of the mammography results. This summary is currently required to be sent to the patient by Rule 657 of the Ionizing Radiation Rules which adopts the Mammography Quality Standards Act (MQSA) (42 USC 263b) regulation for medical records and mammography reports. The information about dense breast tissue must be quoted verbatim.
Any time a lay summary is provided to a patient with dense breasts, it will need to include the dense breast notification required by Act 517. If you have questions regarding the lay summary we suggest you refer to the FDA's MQSA Policy Guidance Help System and look for Medical Records and Reports - Communication of Results to Patients. The Radiation Safety Section's enforcement of the lay summary requirement will adhere to guidance issued by the FDA.
The requirements of Act 517 do not apply to radiography of the breast performed during invasive interventions for localization or biopsy procedures.
Updated March 24, 2015