Major policy changes for mammography standards, provider requirements

Today, the Food and Drug Administration announced new steps that mammography facilities must take to be in compliance, including a requirement to report breast density data to patients and referring doctors. This means patients who undergo breast screening procedures will now be given access to more specific information that will help them make better informed decisions regarding their breast healthcare.

“For the first time in more than 20 years of regulating mammography facilities, the agency is proposing amendments to key regulations that would help improve the quality of mammography services for millions of Americans,” said the FDA in a press statement this morning. “Today’s actions would expand the information mammography facilities must provide to patients and healthcare professionals, allowing for more informed medical decision-making. It would also modernize mammography quality standards and better position the FDA to enforce regulations that apply to the safety and quality of mammography services.”

FDA Commissioner Scott Gottlieb, M.D. admitted in today’s release that the agency has overlooked advances in mammography that can improve the way patients receive care and treatment, including 3-D digital screening tools and the standardization of breast density reporting. Facilities will now have to provide this information in the mammography lay summary letters they give to patients and their referring doctors.

Dense breasts have a higher proportion of fibroglandular tissue compared to fatty tissue, which can make tumor detection more difficult and interpretation of mammography results inaccurate. This is critical because dense breasts are more susceptible to developing cancer and nearly half of all women age 40 and older who get mammograms are found to have dense breasts. The FDA says specific language that explains how breast density can influence the accuracy of mammography is also needed to encourage dialogue between patients who have dense breast and their healthcare providers.

 The new steps would amend regulations issued under the Mammography Quality Standards Act of 1992 (MQSA), which authorizes FDA oversight over mammography facilities, including their accreditation, certification, annual inspections and enforcement of standards to help ensure mammography facilities provide quality care.

The proposed amendments also seek codify three additional categories for the assessments of mammograms, including adding an important category titled “known biopsy proven malignancy,” which would help identify for healthcare professionals those cases where cancer being mammographically evaluated for therapy are already known and identified.

 The proposed amendments would also modernize mammography quality standards and better position FDA to enforce the MQSA regulations which include: 

•  Expressly stating that the FDA can directly notify patients and their healthcare professionals, should facilities be unwilling or unable to do so, that mammography at a facility did not meet quality standards and that reevaluation or repeat of the mammogram at another certified facility may be needed;
• Requiring that only digital accessory components specifically FDA approved or cleared for mammography be used, or that facilities use components that otherwise meet the requirements under the rule; and
• Strengthening record-keeping requirements to minimize information loss and improve access to and transfer of patient mammography records.

“While the majority of certified mammography facilities are dedicated to providing high levels of patient care, today’s proposed regulations would enhance the FDA’s ability to communicate directly, if needed, with patients and their health care professionals in cases where facilities did not meet our quality standards and are not adequately communicating with patients about their facilities’ deficiencies,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health in the news release. 

The proposed rule is online for public comment for 90 days.