FDA proposes changes to mammography regulations

March 27, 2019
by Thomas Dworetzky, Contributing Reporter
New proposed mammogram policy changes focusing on the treatment of women with dense breast tissue and facility compliance with standards were announced today by the U.S. Food and Drug Administration.

The changes are the first to “modernize” breast screening in over two decades.

“As part of our overall commitment to protecting the health of women, we’re proposing new policies to modernize our oversight of mammography services, by capitalizing on a number of important advances in mammography, like the increased use of 3-D digital screening tools and the need for more uniform breast density reporting,” said FDA Commissioner Dr. Scott Gottlieb in a statement.

The proposal would amend the Mammography Quality Standards Act of 1992 (MQSA), which authorizes agency oversight over mammography facilities, and would “better position FDA to enforce the MQSA regulations and take action when violations are found,” according to the agency.

The proposed changes would add information about breast density to the letter given patients and reports sent to referring medical professionals. Specifically, three additional categories would be added to assessment codification – including one called “known biopsy proven malignancy,” as well as including detail about the facility as an aid to follow-up conversations.

Dense breasts, which are a cancer risk factor, can also make mammograms tougher to read.

The proposed changes include, the FDA noted:

-Expressly stating that the FDA can directly notify patients and their health care 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;

-Strengthening record-keeping requirements to minimize information loss and improve access to and transfer of patient mammography records.

“Once finalized, these proposed amendments will enhance our oversight of mammography facilities, including in the key area of enforcement and patient communication,” said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, explaining that, “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.”

The proposed rule can be found at www.regulations.gov for public comment.

When asked about the possibility of provider pushback, Shuren told reporters, according to CNBC, that, “we’ll have to see what kind of feedback we receive,” adding that, “we’re certainly imposing additional and stronger requirements on these facilities,” but he stressed that the agency thinks “this is important to protect the public health and best serve patients.”

In February, Federal legislation was signed into law that had a regulation requiring mammographers to add the dense breast tissue information to both the lay letter and report to referring physicians.

“The legal mandate is meant to educate women regarding dense breasts and explain that mammography is less sensitive in the denser breast categories. The denser the breast tissue, the more difficult it is to identify a small mass that may be cancerous, as it may hide in the dense background,” Dr. Stamatia Destounis, a clinical professor and managing partner at the Elizabeth Wende Breast Care center, told HCB News at the time. “It is also meant to inform the health care providers that will get questions regarding this topic from their patients.”

But she advised at that time that the new law is not all that is needed.

“We need to encourage open communication among health care providers, radiologists and women getting a mammogram on the benefits and limitations of mammography in denser breast tissue categories,” she told HCB News. “We need education regarding other screening tests that may be appropriate for these patients; identification of the higher-risk patient for breast cancer, and commitment to educating women and their physicians on the benefits of screening; and communication with insurers to make certain these additional screening tests are reimbursed so the patient does not have the financial burden of the screening studies.”

The National Cancer Institute (NCI) estimates that 12.4 percent of women will develop the disease during their lives. In 2018, according to NCI, over 260,000 women were diagnosed with breast cancer and more than 40,920 women died from it.