June 1, 2015 — ECRI Institute’s health technology assessment service released an emerging technology brief concerning digital breast tomosynthesis (3-D mammography). The information is based on ECRI’s technology forecast report, "Digital Breast Tomosynthesis for Screening and Diagnosis of Breast Cancer."
Digital breast tomosynthesis is a 3-D breast imaging technique based on full-field digital mammography (FFDM) technology. Unlike conventional mammography units, a tomosynthesis system's X-ray tube sweeps in an arc around the breast to acquire between 50 and 100 two-dimensional (2-D) projections from slightly different angles in about 10 to 20 seconds. The resulting 2-D images are digitally manipulated to create tomograms (i.e., slices) in any plane, thus allowing for 3-D reconstruction that reveals depth. The slices can be displayed individually or in a dynamic "movie" mode.
Providing a 3-D reconstruction of the breast eliminates the problem of overlying tissue that might be mistaken for lesions or that might obscure small cancers, according to technology developers.
Developers contend that the 3-D images offered by digital breast tomosynthesis might overcome the shortcomings of digital mammography, which produces 2-D images that can mask some small lesions or mistakenly identify dense breast tissue as tumors, potentially missing some cancers or increasing false positives. Some studies suggest that digital breast tomosynthesis may reduce recall rates and increase the number of breast cancers detected compared with digital mammography alone.
Initial diffusion appears to be slow, but its uptake is increasing, with three manufacturers having systems on the market as of April 2015. In recent years, most providers have invested heavily in upgrading to digital mammography, with digital systems representing more than 95 percent of all U.S. mammography units in service as of early 2015.
The U.S. Centers for Medicare and Medicaid Services (CMS) now covers for digital breast tomosynthesis, but several private third-party payers consider the technology investigational and deny coverage. Others consider the technology integral to digital mammography and thus, not separately reimbursable. Without additional reimbursement to recoup acquisition costs, some providers are unlikely to upgrade to digital breast tomosynthesis until they replace their existing digital mammography units.
Some providers appear to be investing in the technology to gain a marketing advantage in competitive markets for women's health services. Manufacturers are also supporting provider marketing efforts with direct-to-consumer campaigns positioning it as being clinically superior to standard digital mammography.
The ECRI Institute is an independent nonprofit organization that conducts research into the most effective approaches for improving patient care.
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April 18, 2024 
