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Digital breast tomosynthesis (DBT) uses modified digital mammography equipment to obtain additional radiographic data that are used to reconstruct cross-sectional “slices” of breast tissue. Tomosynthesis may improve the accuracy of digital mammography by reducing problems caused by overlapping tissue. Tomosynthesis typically involves additional imaging time and radiation exposure, although recent improvements may change this.
Conventional mammography produces two-dimensional (2D) images of the breast. Overlapping tissue on a 2D image can mask suspicious lesions or make benign tissue appear suspicious, particularly in women with dense breast tissue. As a result, women may be recalled for additional mammographic spot views. Inaccurate results may lead to unnecessary biopsies and emotional stress, or to a potential delay in diagnosis. Spot views often are used to evaluate microcalcifications, opacities, or architectural distortions; to distinguish masses from overlapping tissue; and to view possible findings close to the chest wall or in the retro-areolar area behind the nipple. The National Cancer Institute reports that approximately 20% of cancers are missed at mammography screening. Average recall rates are approximately 10%, with an average cancer detection rate of 4.7 per 1000 screening mammography examinations. The Mammography Quality Standards Act audit guidelines anticipate 2 to 10 cancers detected per 1000 screening mammograms. Interval cancers, which are detected between screenings, tend to have poorer prognoses.
Digital breast tomosynthesis was developed to improve the accuracy of mammography by capturing a group of tomograms of the breast, further clarifying areas of overlapping tissue. Developers proposed that its use would result in increased sensitivity and specificity, as well as fewer recalls due to inconclusive results. Digital breast tomosynthesis produces multiple low-dose images per view along an arc over the breast. During breast tomosynthesis, the compressed breast remains stationary while the x-ray tube moves approximately 1° for each image in a 15° to 50° arc, acquiring 11 to 49 images. These images are projected as cross-sectional “slices” of the breast, with each slice typically 1-mm thick. Adding breast tomosynthesis takes about 10 seconds per view. In one study in a research setting, mean time for interpretation of results was 1.22 (1.15) minutes for digital mammography and 2.39 (1.65) minutes for combined digital mammography and breast tomosynthesis.
With conventional 2D mammography, breast compression helps decrease tissue overlap and improve visibility. By reducing problems with overlapping tissue, compression with breast tomosynthesis may be reduced by up to 50%. This change could result in improved patient satisfaction.
A machine equipped with breast tomosynthesis can perform 2D digital mammography, DBT, or a combination of both 2D mammography and DBT during a single compression. Radiation exposure from tomosynthesis is roughly equivalent to mammography. Therefore, adding tomosynthesis to mammography doubles the radiation dose, although it still is below the maximum allowable dose established in the U.S. Mammography Quality Standards Act.
Studies typically compare 1-view (ie, mediolateral oblique [MLO] view), or more commonly, 2-view (MLO plus craniocaudal view) breast tomosynthesis alone or combined with standard 2D mammography, with standard 2D mammography alone. A 2014 TEC Assessment (updated in 2015) focused on 2-view tomosynthesis. The FDA Radiological Devices Panel, which reviewed this new modality in 2011, recommended that 2- view breast tomosynthesis is preferable to 1-view tomosynthesis (both used in combination with full-field digital mammography).
In May 2013, the U.S. Food and Drug Administration (FDA) approved new tomosynthesis software that permits creation of 2D images (called C-view) from images obtained during tomosynthesis. As a result, 2D mammography may become unnecessary, thereby lowering radiation dose. In other words, it is possible that only the tomosynthesis procedure will be needed, with the ability to create both conventional 2D and DBT images. It is too early to gauge how traditional mammography plus tomosynthesis compares with C-view plus tomosynthesis.
The Selenia® Dimensions® 3D System manufactured by Hologic (Bedford, MA), received FDA approval on February 11, 2011, through the premarket application (PMA) approval process (PMA P080003). This system is a software and hardware upgrade of the Selenia® Dimensions 2D full-field digital mammography system, which FDA approved in 2008. The SenoClaire™ breast tomosynthesis system, from GE Healthcare (Waukesha, WI), received FDA approval on August 26, 2014, through the PMA process. SenoClaire is an imaging option for the Senographe™ Essential Full-Field Digital Mammography system. A screening examination using this system may consist of either a 2-view mammogram or a 1-view craniocaudal mammogram with a 1-view mediolateral oblique tomosynthesis image. On April 21, 2015, FDA approved the Mammomat™ Inspiration® mammography platform with tomosynthesis option by Siemens Medical Solutions (Malvern, PA). FDA product code: OTE.
Facilities using a digital breast tomosynthesis system must apply to FDA for a certificate extension covering use of the breast tomosynthesis portion of the unit. The Mammography Quality Standards Act requires interpreting physicians, radiologic technologists, and medical physicists to complete 8 hours of digital breast tomosynthesis training, and mandates a detailed mammography equipment evaluation before use.
In May 2013, FDA also approved Hologic's C-View™ 2D imaging software. This software is used to create 2D images from the tomosynthesis results, intended to eliminate the need for a separate mammogram.
POLICYDigital breast tomosynthesis is considered investigational in the screening or diagnosis of breast cancer.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
POLICY GUIDELINESInvestigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY07/21/2011: Approved by Medical Policy Advisory Committee.
09/25/2012: Policy reviewed; no changes.
11/06/2013: Policy reviewed; no changes.
09/23/2014: Policy reviewed; description revised. Policy statement unchanged.
02/23/2015: Added HCPCS code G0279 to the Code Reference section.
04/27/2015: Added CPT codes 77061, 77062, and 77063 to the Code Reference section.
07/13/2015: Code Reference section updated for ICD-10.
10/22/2015: Policy description updated regarding tomosynthesis systems. Policy statement unchanged. Investigative definition updated in policy guidelines section.
01/20/2016: Policy description updated. Policy statement unchanged.
05/31/2016: Policy number added.
SOURCE(S)Blue Cross Blue Shield Association policy # 6.01.53
This may not be a comprehensive list of procedure codes applicable to this policy.
Unlisted diagnostic radiographic procedure
Digital breast tomosynthesis; unilateral
Digital breast tomosynthesis; bilateral
Screening digital breast tomosynthesis, bilateral (List separately in addition to code for primary procedure)
Diagnostic digital breast tomosynthesis, unilateral or bilateral (List separately in addition to G0204 or G0206)