New mammogram guidelines from FDA shift what patients should know

Women getting their routine mammograms may find new information on their results about breast density.

A ruling from the Food and Drug Administration that requires mammogram facilities to inform patients about breast density – a measurement of tissue in a woman’s breasts – went into effect Tuesday.

It’s a great first step for patients to understand their risk of breast cancer and if they might need additional testing, health experts say, as it's harder for mammograms to detect cancers in dense breasts. The national requirement also helps standardize mammogram reports across the country, eliminating a patchwork of different mandates from each state.

But experts also say it doesn’t go far enough as it doesn't guarantee insurance companies will cover additional testing with an ultrasound or MRI for women with dense breasts, even if health care providers recommend one.

Without insurance coverage, patients may delay the extra testing necessary to find – or rule out – breast cancer. And in a type of cancer where early detection is the key to survivorship, health experts say this delay can make a dramatic difference in treatment, cost, quality of life and even survival.

What is breast density?

Breast density measures the amount of fatty tissue compared to other tissue that makes up muscles and milk ducts, called fibroglandular tissue.

Women with dense breasts have more fibroglandular tissue whereas women who don’t have dense breasts have more fat tissue. Half of women have evenly dense or extremely dense breasts, according to Memorial Sloan Kettering Cancer Center.

Patients can't tell their breast density by the size or shape of their breasts, said Dr. Carolyn Malone, a radiologist at Hackensack University Medical Center in New Jersey. Breast density does not change with diet, exercise or other lifestyle factors.

“We all know that women have different breast sizes – this is the same principle,” she said. “Breast density is who you are.”

However, breasts can lose density as a woman ages, typically around menopause.

Do dense breasts increase cancer risk?

Women with dense breasts have a higher chance of getting breast cancer, according to the Centers for Disease Control and Prevention.

Cancer forms in fibroglandular tissue – not fat cells, said Dr. Anita Mehta, assistant professor of radiology at the GW Cancer Center. Women with dense breasts may have a higher chance of getting cancer because there’s more opportunity for cancer to form in a breast with more fibroglandular tissue.

Mammograms, a type of X-ray, have a harder time detecting cancer in dense breasts.

In a mammogram, fatty tissue shows up as black on the image, while fibroglandular tissue lights up as white. Cancer also shows up as white on the X-ray, so it can be difficult to detect cancer if it’s surrounded by a lot of fibroglandular tissue, several experts said.

“It’s like looking for a snowball in a field of snow,” said Teri Thomas, chief executive of Volpara Health, a software company that helps families understand cancer risk and early detection. “It’s very easy for cancer to be hidden in dense breasts.”

After a mammogram, healthcare providers may recommend women with dense breasts get a breast ultrasound or magnetic resonance imaging (MRI), which are more sensitive for detecting breast cancer. Neither is recommended for routine screening, because they are costly and more likely to show suspicious areas that could be misinterpreted as breast cancer.

What to expect at your next mammogram

Women won’t see any changes to their routine mammograms. The new FDA rule will be seen in their results.

In addition to finding out whether cancer was detected or not, women will also be able to see an overall assessment of their breast density that ranges from “breasts are almost entirely fatty” to “breasts are extremely dense.”

There will also be a summary explaining how dense tissue makes it harder to find breast cancer on a mammogram and raises the risk of developing cancer, encouraging patients to talk to their healthcare provider about breast density.

Before the FDA ruling, 39 states and Washington D.C. had state mandates that required mammogram facilities to notify patients about their breast density or inform them about breast density, in general, Mehta said. Now, the information will be uniform across the country.

However, insurance coverage for recommended additional testing won't be.

Does insurance cover breast ultrasounds, MRIs?

Routine and recommended mammograms have been covered by private insurance since the 2010 passage of the Affordable Care Act, also known as Obamacare. But coverage for supplemental testing due to breast density and other risk factors varies by state and insurance.

Some insurances require prior authorization from health care providers, Thomas said, others may require a patient to meet their deductible before covering the tests.

The lack of universal coverage for breast ultrasounds and MRIs forces many patients with dense breasts to delay recommended testing while they figure out how to afford it, health experts say. The cost of an ultrasound could be a few hundred dollars while a bill for an MRI could easily reach about $1,000.

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As patients delay testing, Thomas says cancer undetected by the mammogram can spread, increasing the need for more aggressive treatment and worsening their chances for survival.

Early-stage breast cancer has a 99% 5-year survival rate, according to the National Breast Cancer Foundation. That drops down to 86% by stage 3, which is considered advanced-stage cancer.

Policymakers are aiming to fix the unpredictable coverage. A bill introduced to Congress in May 2023, called the Find It Early Act, would guarantee full insurance coverage for women with dense breast tissue to get supplemental screening.

The bill was endorsed by medical organizations like the American Cancer Society and the American College of Surgeons. Thomas, whose company Volpara Health also endorsed the bill, says additional testing for women with dense breasts is medically necessary and the U.S. needs to catch up to other high-income countries that cover it.

“As a nation, we can do so much better,” she said. “It’s heartbreaking for me as an American for us to be so shortsighted in terms of these issues.”

Adrianna Rodriguez can be reached at [email protected]

This article originally appeared on USA TODAY: New FDA mammogram guidelines shifts what patients should know