(The Center Square) – A new rule from the U.S. Food & Drug Administration requires notification to women found to have dense breast tissue after a mammogram.
“This was approved in 2019 and now, in 2024, it’s taking effect five years later,” said Dr. Michael Ulissey in an interview with The Center Square.
Ulissey is a Federal Way-based diagnostic radiologist who helped get the new notification law passed in Congress and is pushing for a nationwide law to require health insurance providers to cover the cost of additional screening for women with dense breast tissue.
“Normal tissue on a mammogram is white and breast cancer on a mammogram is white, and we have to tell the difference,” said Ulissey. “It can be like looking for a snowball in a field of snow. It blends in and can be hard to see.”
The breast is made up of glands and fibrous connective tissue, in addition to fat. The more glands and fibrous tissue, the denser the breast, making it more difficult to see a cancer with a mammogram.
A woman with dense breast tissue – nearly half of all women – also has a higher risk of getting a breast cancer diagnosis.
“We have determined over the decades and research that doing some type of supplemental screening for women with dense breast tissue is beneficial in catching a cancer that the mammogram may have missed,” Ulissey said.
The push to get Congress involved started in 2009 with a woman in Connecticut who got regular mammograms but then found a large lump and was told she had dense breast tissue and that’s why the mammogram hadn’t picked it up.
“She went on a mission to get the law in Connecticut changed so that on the mammogram report it must list and describe if the woman has dense breast tissue,” Ulissey said. “It has to describe that and if you’re in the two dense categories, you have to be notified that supplemental screening is necessary, usually with ultrasound or MRI.”
Ulissey explained he was, at that time, on the board for the Texas Radiological Society when a patient named Henda came in with a breast lump.
“She came in every year religiously, and she felt a lump between mammograms, and it was breast cancer,” he said. “She also had dense breast tissue.”
That patient went on a similar mission in Texas and, along with Ulissey’s help, got a law passed there to require patient notification following a mammogram.
After that, Ulissey and others went to Congress to help get the law passed federally.
The law isn’t without consequences.
“We got the law that the woman has to be notified, but then when you tell her that she may need secondary screening, there’s a cost to that,” the doctor said.
“Insurance covers the mammogram, but they generally don’t cover secondary screening,” Ulissey said. “The supplemental screening may cost $300 or $500. If she needs an MRI it could be $1,500, and if she has to pay that out of pocket; that’s a lot of money, so she might not get it done.”
He went on to say, “We created a law in Texas that it has to be paid for. Alaska then passed it and Washington state passed it, and Oregon as well.”
A communications spokesperson with the Washington state Office of the Insurance Commissioner told The Center Square via email Washington already had a law about notification of breast tissue density, and passed a law last session – Senate Bill 5396 – requiring that additional testing be covered.
“The bill had overwhelming support in both chambers, so it’s good to see our Legislature being ahead of the curve on women’s health issues,” the OIC spokesperson’s email read.
Ulissey said he’s on a mission to get secondary screening covered nationwide.
“I spent Monday testifying before a Congressional subcommittee panel on this,” he said. “Hopefully, it will pass. We got the other one done and it took a while, but hopefully we can get this one done, too.”
The Center Square reached out to experts at the University of Washington for comment and received a response via email citing a recently published study from cancer surveillance researchers into the long-term benefits and harms of mammography screening with and without supplemental breast MRI scans.
One of the coauthors was Dr. Kathryn Lowry, a radiologist and associate professor at the UW School of Medicine, who said, “Clinicians struggle to achieve a balance between reducing breast cancer deaths and causing harms to patients: false positives, callbacks, biopsies and costs that ultimately are found to be unnecessary.”
Ulissey pushed back: “I think it’s a whole lot better than a false negative, and you’ve got a cancer cooking and a year later that woman is now going to die of breast cancer.”
“We don’t do women any good by picking up a cancer they can already feel,” he concluded. “If we can pick it up when it’s this little 1-cm cancer, we can make that a speed bump in the woman’s life, instead of a major disaster.”
