News and Insights
The FDA’s Dense Breast Tissue Notification: A Step Forward, But Insurance Coverage Still Lags
September 10, 2024
Requirement for notification of breast density goes into effect September 10, 2024
Every year, after I had my mammogram, I used to get that letter from the state of Oregon: “Your mammogram shows that your breast tissue is dense. Dense breast tissue is common and is not abnormal. However, dense breast tissue can make it harder to evaluate the results of your mammogram and may also be associated with an increased risk of breast cancer. This information is given to you to raise your awareness and to promote discussion with your health care provider. Together, you can decide if you may benefit from further screening.”
A great start? Absolutely. I’ve always believed that knowledge is power. However, my doctor informed me that I would be paying out of pocket if I wanted further screening because I wasn’t considered high risk. So I didn’t. But in late 2018, after many normal mammograms, I was diagnosed with stage 3B breast cancer. Two years later, I developed a tumor in my brain, a metastasis from the original breast cancer. So now I am stage 4.
Everyone knows that early detection is key to survival—that’s why we get our mammograms, right? But for many of us, it’s not nearly enough. A significant portion of the population—nearly 50% of women over the age of 40—have dense or extremely dense breast tissue, making early detection through regular mammograms less effective. The FDA’s move to mandate that healthcare providers inform women if they have dense breast tissue, which goes into effect today, is a positive step, but it falls short: insurers in many states are still not required to cover the cost of further screenings, leaving many women at risk for undetected cancer.
The Problem with Dense Breast Tissue and Mammograms
For women with dense breast tissue, mammograms can be alarmingly inaccurate. Dense breast tissue and tumors both appear white on a mammogram, making it difficult, if not impossible, to differentiate between the two. Dr. Paula Gordon, a radiologist and professor at the University of British Columbia, aptly describes this problem as “trying to spot a snowman in a snowstorm.” Mammogram accuracy rates plummet to roughly 50% for women with the densest breasts, but further screening can be prohibitively expensive without insurance coverage. As of now, only 38 states require insurers to cover advanced screenings, and even then, the laws are not always comprehensive.
Most insurers will only cover advanced screenings if a woman is considered high-risk. However, this high-risk categorization is often limited to women with a family history of breast cancer: she has a mother, sister or daughter who has had breast cancer, or is a woman who carries a BRCA gene mutation. But as the story of countless women reveals, family history and genetics are just a couple of pieces of the puzzle.
Plus, dense breast tissue is a significant risk factor in and of itself. Research shows that women with the densest breasts are four to six times more likely to develop breast cancer than women with less dense breast tissue. Despite this, insurance companies usually deny coverage for ultrasounds or MRIs unless there is a medically necessary reason to approve the procedure—something that dense breast tissue alone doesn’t qualify for.
A breast MRI costs thousands of dollars and would be required annually for proper monitoring. The result? Women are left in a difficult situation where they are aware of their increased risk but are financially unable to take appropriate action. This creates a health equity issue, where women with the financial means to pay for additional screening have a better chance of early detection, while those who cannot afford it are left at a higher risk for later-stage diagnoses.
This creates a vicious cycle: dense breast tissue makes mammograms less effective, insurers deny coverage for advanced screenings, and cancers go undetected. The cost—financial and in every other way—of treating late-stage cancer far outweighs the cost of advanced screenings. Yet, without insurance mandates at the federal level, this common-sense approach will remain out of reach for most women.
Equitable Screening Access
As awareness around dense breast tissue increases, it is crucial to continue pushing for broader insurance coverage of advanced screenings. Women need more than just notifications—they need accessible, affordable healthcare options that allow them to take action. If I had taken advantage of further screening, my cancer would’ve been discovered much sooner and possibly wouldn’t have resulted in a brain tumor. Having brain surgery is a life altering event, one that I possibly could have avoided.
The FDA’s notification rule is a step in the right direction, but it must be followed by policies that ensure equitable access to life-saving screenings. Just as mammograms have become a standard of care, advanced screenings for women with dense breast tissue must be viewed as medically necessary and covered accordingly.
The longer we delay, the more women we put at risk. No woman should be left having to roll the dice.
POSTED BY: Lisa Heathman
