DESCRIPTION
Digital breast tomosynthesis uses existing 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 involves some additional imaging time and radiation exposure.
On February 11, 2011, the U.S. Food and Drug Administration (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 Mammography Quality Standards Act (MQSA) 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.
POLICY
Digital breast tomosynthesis in the screening or diagnosis of breast cancer is considered investigational.
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member’s health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
There is a lack of evidence to evaluate the clinical importance of digital breast tomosynthesis. There are no controlled studies to show efficacy or to provide comparisons to standard mammography in predicting clinical events or to alter the treatment of individuals.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (3:2011). Digital Breast Tomosynthesis (6.01.53). Retrieved July 14, 2011 from BlueWeb. (5 articles and/or guidelines reviewed)
National Comprehensive Cancer Network. (2011, January). NCCN clinical practice guidelines in oncology™. Breast cancer screening and diagnosis (V.1.2011). Retrieved July 14, 2011 from http://www.nccn.org/professionals/physician_gls/pdf/breast-screening.pdf.
Poplack, S. P., Tosteson, T. D., Kogel, C. A., & Nagy, H. M. (2007). Digital breast tomosynthesis: Initial experience in 98 women with abnormal digital screening mammography. American Journal of Roentgenology, 189, pp. 616-623. Level 4 evidence)
U. S. Food and Drug Administration. (2011, February). 510(k) Premarket Notification Database. P080003. Retrieved July 14, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf8/p080003a.pdf.
Winifred S. Hayes, Inc. Medical Technology Directory. (2011, March). Full-Field Digital Mammography for Breast Cancer Screening. Retrieved July 14, 2011 from www.Hayesinc.com/subscribers. (49 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 12/10/2011
MOST RECENT REVIEW DATE: 12/10/2011
ID_BA
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