Digital breast tomosynthesis, also referred to as three-dimensional (3D) mammography, creates a three-dimensional picture of the breast from many angles using low-dose x-rays. The breast is positioned in a similar fashion to a conventional mammogram, with slightly less compression, while a scanner rotates around the breast in an arc formation. Several images are taken over approximately seven seconds. Once the images are taken, computer programs produce clear and highly-focused 3D representations of the breast that the radiologist can then view as thin layers of breast tissue, similar to CT scan images. This technology allows for greater accuracy and easier identification of abnormalities.
Digital breast tomosynthesis is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Digital breast tomosynthesis is considered medically appropriate if ANY ONE of the following are met:
Individual at average risk of breast cancer with ALL of the following:
Age 40 and over
Individual at increased risk of breast cancer if ANY ONE of the following are met:
Age 25 or older with prior thoracic radiation therapy between the ages of 10 and 30
Women age 30 or older with lifetime risk of breast cancer ≥ 20% based on personal history of lobular carcinoma in situ (LCIS), atypical ductal hyperplasia (ADH), or atypical lobular hyperplasia (ALH)
Women age 30 or older with lifetime risk of breast cancer ≥ 20% according to risk assessment tools that are based mainly on family history, e.g. Claus, BRCAPRO, BOADICEA, Tyrer-Cuzick
Women age 35 or older with five-year Gail Model risk of invasive breast cancer ≥ 1.7%
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
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.
American College of Obstetricians and Gynecologists. (2011, reaffirmed 2014). Practice Bulletin #122. Breast cancer screening. Retrieved September 21, 2016 from https://www.acog.org.
American College of Obstetricians and Gynecologists. (2015, March). Committee Opinion #625. Mamagement of women with dense breasts diagnosed by mammography. Retrieved September 19, 2017 from https://www.acog.org.
American College of Radiology. (2014). ACR statement on breast tomosynthesis. Retrieved August 24, 2016 from www.acr.org.
Bernardi, D., Macaskill, P., Pellegrini, M., Valentini, M., Fantὀ, C., Ostillio, L., et al. (2016). Breast cancer screening with tomosynthesis (3D mammography) with acquired or synthetic 2D mammography compared with 2D mammography alone (STORM-2): a population-based prospective study. Lancet Oncology, 17 (8), 1105-1113. Abstract retrieved August 25, 2016 from PubMed database.
BlueCross BlueShield Association. Evidence Positioning System. (10:2016). Digital Breast Tomosynthesis (6.01.53). Retrieved October 5, 2018 from https://www.evidencepositioningsystem.com/(65 articles and/or guidelines reviewed)
Hodgson, R., Heywang-Kobrunner, Harvey, S., Edwards, E., Shaikh, J., Arber, M., et al. (2016) Systematic review of 3D mammography for breast cancer screening. The Breast, (27), 52-61. (Level 2 evidence)
McDonald, E., Oustimov, A., Weinstein, S., Synnestvedt, M., Schnall, M., & Conant, E. (2016). Effectiveness of digital breast tomosynthesis compared with digital mammography: outcomes analysis from 3 years of breast cancer screening. The Journal of the American Medical Association Oncology, 2 (6), 737-743. Abstract retrieved August 26, 2016 from PubMed database.
Melnikow, J., Fenton, J.J., Miglioretti, D., Whitlock, E.P., Weyrich, M.S. (2016). Screening for breast cancer with digital breast tomosynthesis. Evidence Synthesis No. 125. AHRQ Publication No. 14-05201-EF-2. Rockville, MD: Agency for Healthcare Research and Quality; 2016. Retrieved August 24, 2016 from http://www.ncbi.nlm.nih.gov.
National Comprehensive Cancer Network. (2017, June). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™). Breast Cancer Screening and Diagnosis (V.1.2017). Retrieved September 19, 2017 from http://www.nccn.org.
U. S. Food and Drug Administration. (2011, February). 510(k) Premarket Notification Database. P080003. Retrieved July 14, 2011 from http://www.accessdata.fda.gov.
U.S. Preventive Services Task Force. (2016). Breast cancer: screening. Retrieved March 1, 2016 from http://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/breast-cancer-screening.
MOST RECENT REVIEW DATE: 11/8/2018
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.