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DESCRIPTIONDigital breast tomosynthesis (DBT) is being developed as an approach to generate images that may improve the sensitivity and specificity of mammography. Current radiographic approaches to mammography produce two-dimensional (2D) images. These 2D systems can have limitations due to overlapping tissue in the breast that may hide lesions (cancers) or cause benign masses to appear suspicious. DBT may be utilized along with full-field digital mammography (FFDM) in screening for breast cancer and may also be used as a technique for the diagnosis of breast cancer in helping to clarify equivocal mammographic findings.
In evaluating DBT, studies must consider test accuracy (sensitivity and specificity) as well as recall rates. In addition, the incremental value of DBT might be compared to using additional views from traditional mammography. Radiation exposure is also a very important consideration. Finally, issues such as the duration of the examination (breast compression) are also important.
To acquire the three-dimensional (3D) DBT images, the x-ray tube head is moved in a 15 degree arc over the stationary breast acquiring 11 to 21 (typically 15) x-ray projection images. The projection images are reconstructed to produce cross-sectional “slices” through the breast. The nominal thickness of the slices can vary from 0.5 to 10 mm, with 1 mm being the “normal” thickness.
The same detector and x-ray tube are used to acquire both the 2D and 3D images. Images can be acquired in any orientation of the gantry, including the standard cranio-caudal (CC) and mediolateral oblique (MLO) mammography views, which may be useful in comparing new images with older mammography results. The 2D and 3D images can be acquired during a single breast compression, or they can be acquired separately.
On February 11, 2011, the FDA approved Hologic, Inc. to market its Selenia Dimensions 2D Full Field Digital Mammography (FFDM) and Digital Breast Tomosynthesis (DBT) system. This DBT is the first mammography system that provides 3D images of the breast for breast cancer screening and diagnosis. The FDA approved the 2D modality of this system two years ago. Since then, a number of facilities in the U.S. have been using the Selenia Dimensions 2D (with the DBT locked). Facilities that have an accredited (or have applied to be accredited) Selenia Dimensions 2D unit can activate the DBT modality of the unit after applying to and obtaining FDA approval to extend its certificate to include the DBT modality.
Because DBT is a new mammographic modality, facilities wanting to use DBT on patients must meet all MQSA (Mammography Quality Standards Act) applicable requirements: (1) personnel must obtain at least 8 hours of DBT training; (2) the unit must undergo a mammography equipment evaluation prior to use; and (3) the facility must follow the manufacturer's recommended quality control procedures.
Currently, the Accreditation Bodies (ABs) do not have the capability to review DBT images, and thus, cannot accredit the DBT modality portion of the unit. Therefore, a facility wanting to use the DBT modality of its accredited (or have applied to be accredited) Selenia Dimensions 2D unit will need to apply to FDA to extend its certification to include the DBT modality.
The Selenia Dimensions 3D DBT is a hardware and software upgrade to the Selenia Dimensions 2D FFDM system, which is FDA approved for conventional mammography imaging (P010025/S013, approved December 22, 2008).
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 service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
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.
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.