Medical Policy: 06.01.29
Original Effective Date: May 2012
Reviewed: February 2016
Revised: February 2016
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Digital breast tomosynthesis (frequently called 3D mammography) uses existing digital mammography equipment to obtain additional radiographic data that are used to reconstruct cross-sectional "slices" of breast tissue. Tomosynthesis hopes to improve the accuracy of digital mammography by reducing problems caused by overlapping tissue. Tomosynthesis involves some additional imaging time and radiation exposure.
Digital breast tomosynthesis (DBT) is being developed as an approach to generate more images that hopes to improve the sensitivity and specificity of mammography. Current radiographic approaches to mammography produce two-dimensional (2D) images. 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.
While there is strong evidence that tomosynthesis will have an important role in breast imaging, further studies are needed to assess tomosynthesis’ relationship to long-term clinical outcomes, including reduced mortality. It will also be important to learn which subgroups of women might benefit most from these exams (by age, breast density, frequency of examination, etc.).
United States Preventative Services Task Force (USPSTF) concluded that the current evidence is insufficient to assess the additional benefits and harms of using either digital mammography or MRI instead of film mammography as a screening modality for breast cancer.
National Comprehensive Cancer Network
According to the National Comprehensive Cancer Network, “Early studies show promise for tomosynthesis mammography. Two large trials showing a combined use of digital mammography and tomosynthesis resulted in improved cancer detection and decreased call back rates; of note, this is double the dose of radiation and is a factor in recommending this modality. Definitive studies are still pending.”
American College of Obstetricians and Gynecologists (ACOG) does not provide recommendations on digital mammography.
The published studies have not made it clear if digital breast tomosynthesis should be used for diagnostic, screening, or surveillance purposes. There are concerns over the amount of radiation exposure with digital breast tomosynthesis, thought to be increased radiation than that of full field digital mammography. There are unanswered questions about the number of images needed as well as concerns over the time for interpretation. Further study will be necessary to confirm whether digital mammography with tomosynthesis is a cost-effective approach capable of replacing digital mammography alone as the first-line screening modality of choice for breast cancer screening.
Blue Cross and Blue Shield TEC Assessment
A Blue Cross Blue Shield TEC Assessment, “Use of digital breast tomosynthesis with mammography for breast cancer screening or diagnosis” concluded that recent studies have provided some evidence that adding breast tomosynthesis to mammography may increase the accuracy (and possibly the sensitivity) of screening while reducing the number of women who are recalled unnecessarily. However studies with longer follow-up of women with negative screening results are needed.
Digital breast tomosynthesis is considered investigational in the screening or diagnosis of breast cancer.
Digital tomosynthesis is approved by the U.S. Food and Drug Administration, but is not yet considered the standard of care for breast cancer screening. The impact on mortality and the increased dose of radiation when 3D is added to standard 2D mammography remain unclear.
At present, published studies do not provide adequate information about outcomes (sensitivity, specificity, accuracy, recall rate) when DBT is used in clinical practice. This contrasts to other breast imaging technologies such as computer-aided detection (CAD) and full-field digital mammography (FFDM) where large clinical studies have demonstrated effectiveness in clinical care. Comparative data demonstrating that digital breast tomosynthesis is equal to or better than other breast imaging technologies: with regards to accuracy, sensitivity, and overall improved outcomes, is lacking. Clinical evidence has not yet demonstrated that digital breast tomosynthesis used as an adjunct to standard mammography reduces the mortality rate from breast cancer.
Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
- 77061 Digital breast tomosynthesis; unilateral
- 77062 Digital breast tomosynthesis; bilateral
- 77063 Screening digital breast tomosynthesis, bilateral (in addition to primary screening mammography procedure)
- G0279 Diagnostic digital breast tomosynthesis, unilateral or bilateral
- Tagliafico A, Tagliafico G, Astengo D et al. Mammographic density estimation: one-to-one comparison of digital mammography and digital breast tomosynthesis using fully automated software. Eur Radiol. 2012 Feb 24. [Epub ahead of print].
- Wallis MG, Moa E, Zanca F et al. Two-view and single-view tomosynthesis versus full-field digital mammography: high-resolution X-ray imaging observer study. Radiology. 2012 Mar; 262(3):788-96. Epub 2012 Jan 24.
- Bernardi D, Ciatto S, Pellegrini M et al. Prospective study of breast tomosynthesis as a triage to assessment in screening. Breast Cancer Res Treat. 2012 May; 133(1):267-71. Epub 2012 Jan 22.
- Noroozian M, Hadjiiski L, Rahnama-Moghadam S et al. Digital breast tomosynthesis is comparable to mammographic spot views for mass characterization. Radiology 2012 Jan; 262(1):61-8. Epub 2011 Oct 13.
- Tagliafico A, Astengo D, Cavagnetto F et al. One-to-ne comparison between digital spot compression view and digital breast tomosynthesis. Eur Radiol. 2012 Mar;22(3):539-44. Epub 2011 Oct 11.
- Gur D, Bandos AI, Rockette HE et al. Localized detection and classification of abnormalities on FFDM and tomosynthesis examinations rated under an FROC paradigm. AJR Am J Roentgenol. 2011 Mar; 196(3): 737-41.
- Spangler ML. Zuley ML, Sumkin JH et al. Detection and classification of calcifications on digital breast tomosynthesis and 2D digital mammography: a comparison. AJR Am J Roentgenol. 2011 Feb; 196(2):320-4.
- Williams MB, Judy PG, Gunn S et al. Dual-modality breast tomosynthesis. Radiology. 2012 Apr; 255(1): 191-8.
- Kopans D, Gavenonis S, Halpern E et al. Calcifications in the breast and digital breast tomosynthesis. Breast J. 2011 Nov-Dec; 17(6): 638-44. doi: 10.1111/j.1524-4741.2011.01152.x. Epub 2011 Sep 12.
- Hakim CM, Chough DM, Ganott MA et al. Digital breast tomosynthesis in the diagnostic environment: a subjective side-by-side review. AJR Am J Roentgenol. 2010 Aug; 195(2):W172-6.
- ECRI Institute. Digital tomosynthesis for screening and diagnosing breast cancer. Plymoth Meeting (PA): ECRI Institute; 2012 April 16. 9 p. [ECRI hotline response]. Available: http://www.ecri.org
- Health technology forecast [database online]. Plymouth Meeting (PA): ECRI Institute; 2011 May 2. Digital breast tomosynthesis for screening and diagnosis of breast cancer. Available: http://www.ecri.org
- Skanne P,, Bandos A et al. Comparison of Digital Mammography Alone and Digital Mammography Plus Tomosynthesis in a Population-Based Screening Program. Radiology. 2013 April;267 (1) 47-56.
- Tomosynthesis in the Oslo Breast Cancer Screening Program (DBT). Available clinicaltrials.gov.
- American College of Obstetricians and Gynecologists (ACOG). Breast cancer screening. Washington, DC: American College of Obstetricians and Gynecologists (ACOG); Aug 2011.
- American College of Obstetricians and Gynecologists, Technology Assessment #9: Digital breast tomosynthesis. Obstet Gynecol 2013 Jun;121(6):1415-7.
- Haas BM, et al. Comparison of tomosynthesis plus digital mammography and digital mammography alone for breast cancer screening. Radiol 2013 Jul 30 [Epub ahead of print].
- Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Use of digital breast tomosynthesis with mammography for breast cancer screening or diagnosis. TEC Assessment Program. 2015; 30(TBA).
- Ciatto S, et al. Integration of 3D digital mammography with tomosynthesis for population breast-cancer screening (STORM): a prospective comparison study. Lancet Oncol 2013;14(7):583-9
- U.S. Preventive Services Task Force (USPSTF). Screening for breast cancer: U.S. Preventive Services Task Force recommendation statement. December 2009 addendum. Ann Intern Med 2009 Nov 17;151(10):716-726.
- National Cancer Institute (NCI). Factsheet: Mammograms. 2014. Available online at: http://www.cancer.gov/cancertopics/factsheet/detection/mammograms.
- Friedewald SM, Rafferty EA, Rose SL et al. Breast cancer screening using tomosynthesis in combination with digital mammography. JAMA. 2014; 311(24):2499-507.
- American College of Obstetricians and Gynecologists (ACOG). Management of Women with Dense Breasts Diagnosed by Mammography. Washington, DC: American College of Obstetricians and Gynecologists (ACOG); April 2014.
- Garcia-Leon FJ, Llanos-Mendez A, Isabel-Gomez R. Digital tomosynthesis in breast cancer: A systematic review. Radiologia. 2014 Oct 9 doi: 10.1016/j.rx.2014.06.006.
- Canada Agency for Drugs and Technologies in Health. Rapid Response Report: Digital tomosynthesis for the screening and diagnosis of breast cancer: diagnostic accuracy and guidelines. Dec 2014.
- Rafferty EA, Park JM, Philpotts LE et al. Diagnostic accuracy and recall rates for digital mammography and digital mammography combined with one-view and two-view tomosynthesis: results of an enriched reader study. AJR Am J Roentgenol 2014; 202(2):273-81.
- Lehman CD, Wellman RD, Buist DS, Kerlikowske K, Tosteson AN, Breast Cancer Surveillance Consortium, et al. Diagnostic Accuracy of Digital Screening Mammography With and Without Computer-Aided Detection. JAMA Intern Med. 2015 Sep 28:1-10. [Epub ahead of print]
- Myers ER, Moorman P, Gierisch JM, Havrilesky LJ, Grimm LJ, Ghate S, et al. Benefits and Harms of Breast Cancer Screening: A Systematic Review. JAMA. 2015;314(15):1615-1634.
- National Cancer Institute. Breast Cancer Screening–for health professionals (PDQ®). Updated October 9, 2015. Accessed October 13 2015. Available at URL address: http://www.cancer.gov
- Lang K, Andersson I, et al. Performance of one-view breast tomosynthesis as a stand-alone breast cancer screening modality: results from the Malmo Breast Tomosynthesis Screening Trial, a population-based study. Eur Radiol. 2016; 26(1): 184–190.
- Published online 2015 May 1. doi: 10.1007/s00330-015-3803-3
- National Comprehensive Cancer Network® Clinical Practice Guidelines in Oncology™, Breast Cancer. v.3.2015. Accessed October 2015. Available at URL address: http://www.nccn.org.
- Oeffinger KC, Fontham EH, Etzioni R, Herzig A, Michaelson JS, PhD; Shih YT, et al. Breast Cancer Screening for Women at Average Risk: 2015 Guideline Update From the American Cancer Society. JAMA. 2015;314(15):1599-1614.
Date Reason Action
May 2012 Literature review New policy
May 2013 Annual review Policy renewed
April 2014 Annual review Policy renewed
March 2015 Annual review Policy revised
February 2016 Annual review Policy revised
Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
practice and are neither employees nor agents of Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.