DESCRIPTION
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. This technology allows for greater accuracy and easier identification of abnormalities.
POLICY
Digital breast tomosynthesis (3D mammogram) is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
MEDICAL APPROPRIATENESS
Digital breast tomosynthesis (3D mammogram) is considered medically appropriate if ANY ONE of the following are met:
Individual at average risk of breast cancer with ALL of the following:
Annual screening
Age 40 and over
Individual at increased risk of breast cancer if ANY ONE of the following are met:
Individual with personal history of radiation to chest when ALL of the following are met:
Radiation occurred between ages 10 and 30 years
Annual screening to begin ten years after radiation therapy but not prior to age 30
Women age 30 or older with lifetime risk of breast cancer equal to or greater than 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 equal to or greater than 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 equal to or greater than 1.7%
IMPORTANT REMINDERS
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 or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
SOURCES
Agency for Healthcare Research and Quality. (2016). Evidence Synthesis No. 125. Screening for breast cancer with digital breast tomosynthesis. Retrieved August 24, 2016 from http://www.ncbi.nlm.nih.gov.
American College of Obstetricians and Gynecologists. (2013, June; reaffirmed 2024). Technology Assessment #9.Digital breast tomosynthesis. Retrieved February 26, 2024 from https://www.acog.org.
American College of Obstetricians and Gynecologists. (2015, March; reaffirmed 2020). Committee Opinion #625.Management of women with dense breasts diagnosed by mammography. Retrieved February 28, 2022 from https://www.acog.org.
American College of Radiology. (2017). ACR Appropriateness Criteria®. Breast cancer screening. Retrieved April 9, 2021 from www.acr.org.
American College of Radiology. (2021). ACR Appropriateness Criteria®. Supplemental breast cancer screening based on breast density. Retrieved February 28, 2022 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.
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)
Houssami, N., Zackrisson, S., Blazek, K.., Hunter, K., Bernardi, D., Lang, K., & Hofvind, S. (2021). Meta-analysis of prospective studies evaluating breast cancer detection and interval cancer rates for digital breast tomosynthesis versus mammography population screening. European Journal of Cancer. 148, 14-23. Abstract retrieved March1, 2022.
Ko, MJ., Park, AD., Kim, SH., Ko, ES., Shin, KH., Lim, W., & et al. (2021). Accuracy of digital breast tomosynthesis for detecting breast cancer in the diagnostic setting: A systematic review and meta-analysis. Korean Journal of Radiology, 22 (8), 1240-1252. (Level 1 evidence)
Kulkarni, S., Freitas, V., & Muradali, D. (2022). Digital breast tomosynthesis: potential benefits in routine clinical practice. Canadian Association of Radiologist Journal, 73 (1), 107-120. (Level 4 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.
National Comprehensive Cancer Network. (2023, October). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™). Breast cancer screening and diagnosis (V.3.2023). Retrieved February26, 2024 from the National Comprehensive Cancer Network.
National Comprehensive Cancer Network. (2024, February). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™). Genetic/familial high-risk assessment: breast, ovarian and pancreatic (V.3.2024). Retrieved February 26, 2024 from the National Comprehensive Cancer Network.
Phi, X., Tagliafico, A., Houssami, N., Greuter, M., & de Bock, G. (2018). Digital breast tomosynthesis for breast cancer screening and diagnosis in women with dense breasts – a systematic review and meta-analysis. BMC Cancer, 18, 380. (Level 1 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.
U.S. Preventive Services Task Force. (2016). Screening for breast cancer: U.S. Preventive Services task force recommendation statement. Retrieved September 11, 2019 from https://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/breast-cancer-screening1.
Winifred S. Hayes, Inc. Medical Technology Directory. (2017, October; last update search December 2021). Digital breast tomosynthesis for breast cancer diagnosis and screening. Retrieved February 26, 2024 from www.Hayesinc.com/subscribers. (70 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 12/10/2011
MOST RECENT REVIEW DATE: 4/11/2024
ID_BT
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.
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