Digital Breast Tomosynthesis is a Hot Topic

You have probably heard something about Digital Breast Tomosynthesis (DBT), a technology that offers an innovative way of performing breast cancer screenings. The X-ray source is rotated over a limited arc angle while the breast is compressed, acquiring a series of low-dose exposures that create a series of digital images. These projection-view (PC) images are then reconstructed into thin slices and pulled together to create a 3D image that may reduce the camouflaging effects of overlaying fibroglandular tissues. The disadvantages and advantages of this new technology vary with each system, and there still isn’t a universally accepted version of the optimal application. With all the evolving opinions about it, we at EviCore healthcare are here to provide you with the latest on DBT.

Legislation Around the Country

So far, the FDA has approved three DBT devices (Hologic’s Selenia Dimensions 3D System, GE Healthcare’s SenoClaire, and Siemen’s Mammomat inspiration with tomosynthesis option). In May of 2013, the FDA approved Hologics C-View 2D imaging software for mammography. Images generated using 3D tomosynthesis data result in less radiation exposure. In November 2014, CMS assigned billing codes and reimbursement values to screening DBT. ACR also released a position statement declaring tomosynthesis is no longer investigational. Most recently, in January of this year, AMA approved three new CPT codes specific to DBT (77061, 77062, and 77063). Modeling studies have suggested possible net cost savings with DBT by avoiding the use of follow-up services such as MRI, biopsies, etc.

In May of 2013, the FDA approved Hologics C-View 2D imaging software for mammography. It was then found that images generated using 3D tomosynthesis data resulted in less radiation exposure. In November 2014, CMS assigned billing codes and reimbursement values to screening DBT. So far, the FDA has approved three DBT devices: Hologic’s Selenia Dimensions 3D System, GE Healthcare’s SenoClaire, and Siemen’s Mammomat inspiration with tomosynthesis option. ACR has released a position statement declaring that tomosynthesis is no longer investigational. Most recently, in January of this year, AMA approved three new CPT codes specific to DBT (77061, 77062, and 77063). Modeling studies have suggested the potential for net cost savings with DBT per the projected reduction in the use of follow-up services such as MRI, biopsies, etc.

Fast Changing Technology and Imaging Industry Environment

Because results are somewhat promising, DBT has been increasingly a hot topic in academia, research circles, and the press. Recent studies have reported improvements in sensitivity, reductions in recall rates, and improved cancer detection rates with DBT. In addition to weighing the scientific evidence (what is the demonstrated long-term impact on clinical outcomes?), we should ask ourselves relevant economic questions, such as: what groups would benefit the most from efforts to define the most appropriate role for DBT (screening vs. diagnostic)? There seems little doubt, however, that formulation of clear clinical guidelines would assist practices in deciding whether to utilize DBT, and for which patients.

EviCore finds this new technology very promising. We have a team of experienced clinical doctors and nurses who will continue to monitor peer review literature and the stance of stakeholder organizations on DBT. At this time, because of the variable evidence associated with this technology, EviCore is not able to recommend removing the experimental and investigational status for digital breast tomosynthesis (DBT)—despite promising midterm findings. We will continue to update our payers on any new evidence and findings that appear in the coming months.

At EviCore we provide thought leadership and assistance to payers on benefit solutions that we manage. It’s one of the ways we strive to improve the healthcare system and people’s lives by helping those we serve navigate the healthcare system, find the right care path, and enable the best outcomes.