When Heather Reimer turned 40, she did what many women her age do: She had her first mammogram. But eight months later, after undergoing an automated whole breast ultrasound, a more sensitive screening method often used to screen women with dense breast tissue, Reimer was diagnosed with triple negative metastatic carcinoma.
Reimer's diagnosis surprised her, in part because she was unaware that having dense breast tissue gives her a higher risk of getting breast cancer and radiologists would have a harder time detecting a tumor on a traditional mammogram. She had the ultrasound to gain extra points through an employer's wellness program.
“I was shocked,” Reimer said of her diagnosis, which led her to form a patient advocacy group called Each One Tell One to raise awareness about breast density. “The standard of breast care is mammography.”
But that decades-old gold standard of breast cancer screening is changing. Decisions about breast cancer screening are becoming more tailored to particular patients as clinicians better understand risk factors, such as breast density and family history, patients become more informed about personal risk, and imaging manufacturers have filled in screening gaps with new technologies. The arsenal of screening modalities still centers around mammography but also includes MRI, handheld and automated ultrasound and digital breast tomosynthesis, a more advanced form of mammography that takes three-dimensional images of the breast.
Breast cancer screening is now “absolutely more personalized,” said Dr. Rachel Brem, director of George Washington University's Breast Imaging and Interventional Center.
Personalizing the way that a woman is screened for breast cancer can help radiologists catch smaller and more treatable cancers earlier. But payers have been slow to change the way they cover screening and supplemental screening methods, which can cost anywhere from $150 for an ultrasound to $1,000 for a MRI. Patients usually have to pay for this out-of-pocket. In addition, some of the supplemental methods raise questions beyond cost, such as higher exposure to radiation, invasiveness (MRI requires an injection) and higher rates of false-positives compared to mammography.
“I don't see the mammogram going away,” said Dr. Stamatia Destounis, an owner of the Elizabeth Wende Breast Care practice in upstate New York. “But no single test is going to give us all the answers.”
Tomosynthesis is one of the newest of the adjunct screening modalities. Radiologists say tomosynthesis catches more cancers and reduces callbacks that are common in mammography. Hologic, a Bedford, Mass.-based manufacturer, introduced tomosynthesis to the U.S. market in 2011. Its first domestic competitor arrived earlier this year when GE Healthcare, based in Wauwatosa,Wis., received approval from the Food and Drug Administration. Siemens Healthcare North America's tomosynthesis technology is waiting for regulatory approval.
A study released this month at the Radiological Society of North America's annual meeting in Chicago found that using a combination of digital mammography and tomosynthesis caught 80% of cancers in women with dense breasts, compared with the 59% of cancers diagnosed in those women who only underwent mammography. The study compared cancer detection rates for about 25,000 women ages 50 to 69 years old. About 40% of the women in the U.S. older than 40 years old have dense breasts.
“Our results show that implementation of tomosynthesis might indicate a new era in breast cancer screening,” Dr. Per Skaane, the study's co-author and a radiologist at Oslo (Norway) University Hospital said in a news release. The study's authors reported receiving financial support from Hologic.
About 11% of the screening systems currently installed in the 8,700 hospitals and breast centers certified by the Food and Drug Administration to perform mammograms are 3-D mammography systems – the vast majority are Hologic machines – and radiologists are increasingly using tomosynthesis to gather both 2-D and 3-D images. (Women usually first undergo a 2-D mammogram, which can be used to assess their tissue density. Most insurers, including the CMS, require a 2-D mammogram in addition to the 3-D exam.)
Growing use of 3-D mammography systems is leading to higher average prices of digital mammography systems. The ECRI Institute said the average prices paid by healthcare providers went up 13% over the last year because more hospitals are buying 3-D systems. The average price of tomosynthesis systems is $417,000.
The American College of Radiology last month issued a position statement calling for insurers to cover 3-D mammography. “To be clear: tomosynthesis is no longer investigational,” the ACR said in the Nov. 24 statement. “Tomosynthesis has been shown to improve key screening parameters compared to digital mammography.”
Medicare will cover tomosynthesis for the first time in 2015. The CMS is also raising reimbursement for ultrasound screening next year. As a result, out-of-pocket costs to cover supplemental screening methods may go down for patients, but some experts and advocates are concerned primary care physicians aren't recommending these types of screening because they're not informed about breast density.
Reimer and other patient advocates like Nancy Cappello, who formed the “Are you Dense?” campaign, have pushed for better recognition of the role density plays in screening. At least 19 states have passed laws requiring providers to notify patients if they have dense breast tissue. Four state laws require insurance coverage.
“Does this increase costs overall for women? Yes,” said Dr. Debra Monticciolo, section chief of breast imaging at Baylor Scott & White Health. “But in the long run if we can find cancers when they are smaller and lower stage, it can be a win.”
Still, some researchers caution against widespread use of supplemental screening. A study published in December in the Annals of Internal Medicine found that using ultrasonography screening for women with dense breast tissue increases costs and led to false positives with few benefits. The authors called for more research into supplemental screening methods.
“Although our results demonstrate that, even under optimistic assumptions, supplementary handheld ultrasonography screening in women with dense breasts but otherwise average risk is not cost-effective, it remains possible that a better-performing technology with targeted application to women with dense breasts or to women at higher than average risk may be useful,” they concluded.
Follow Jaimy Lee on Twitter: @MHjlee
