Effective Sept. 10, healthcare facilities providing breast imaging services will be required to notify patients of their breast density in mammography reports.
Nina Vincoff, MD, division chief of breast imaging for New Hyde Park, N.Y.-based Northwell Health, told Becker's what the new regulation means for radiologists.
What is the FDA breast density notification requirement?
Radiologists are required to send two mammography reports, one to physicians and a more simplified "lay" report to patients. A patient's breast density has almost always been included in the report radiologists send to physicians. Whether breast density has been included in the patient report has varied by state.
New York, where Dr. Vincoff practices, since 2013 has required providers to inform patients if they have dense breasts.
"Over time, more and more states have put in this kind of legislation, but what needed to be in the letter varied state by state. The language wasn't always the same and some states didn't have breast density legislation at all," Dr. Vincoff said. "The FDA is stepping in now and saying, 'This needs to happen in every single state and you need to use very specific language.'"
Why should patients know their breast density?
Dense breast mammograms are significantly whiter than non-dense breast mammograms. Cancer, too, typically appears white on a mammogram, meaning a radiologist is often "looking for something white in a field of white," Dr. Vincoff said.
"But having dense breasts doesn't just make your mammogram more difficult to read, it also increases your risk for developing breast cancer," she said.
Having dense breasts means a patient may be a good candidate for additional cancer screening.
"It's really important information for a patient [to have] for both reasons," Dr. Vincoff said. The FDA regulation requires patients in every state to be notified not only of their breast density, but also told what that density means. Patients will learn that their density means their mammogram might be limited and they might have an increased risk for developing breast cancer.
What screenings should physicians offer patients with dense breasts?
Ultrasound and MRI are the two procedures offered for patients with dense breasts, according to Dr. Vincoff, though what is best for each patient varies.
"If you are otherwise low risk and have dense breasts, then ultrasound might be a good test for you," Dr. Vincoff said. "If you are at increased risk and you have dense breasts, MRI might be a better test for you."
One issue with the regulation is it does not standardize what physicians should do after a patient is notified of their breast density, she said.
MRI-aided breast cancer screenings have been shown to contribute to false-positive biopsy recommendations while simultaneously preventing cancer deaths, according to a recent study.
"There aren't clear guidelines around the next steps," Dr. Vincoff said. "What might make you choose ultrasound versus MRI? That information isn't spelled out anywhere for people in this letter and doctors might not be aware of some of those distinctions."
Will insurers cover additional cancer screening for patients with dense breasts?
Some patients who learn they have dense breasts may seek out, and be candidates for, additional breast cancer screenings. While the FDA now requires providers to inform patients of their breast density, it does not impose any requirements on insurance companies to cover additional screenings based on those findings.
"The FDA isn't in that business; that's not what the FDA does," Dr. Vincoff said. "This notification isn't necessarily going to allow the women who might benefit from having supplemental screening have access to it. They're going to be empowered with knowledge, but they still might not have access."
Dr. Vincoff said coverage is the next step for organizations that lobbied for the breast density notification, adding, "there's going to be a lot of action happening in the Capitol next week."
Will anything change with the new FDA breast density notification requirement?
The new FDA regulation does not change much for radiologists or physicians. Instead, it ensures patients in every state will now have information their physicians have had access to for years.
"It's not about how we read the mammogram or even about the report that we're sending to your doctor. [Breast density] has always been in the letters that went to the doctors. Where it wasn't within, was the letters that went to the patients. That's what's changing."