Medical Policy Digital Breast Tomosynthesis
Table of Contents Policy: Commercial Coding Information Information Pertaining to All Policies Policy: Medicare Description References Authorization Information Policy History
Policy Number: 327 BCBSA Reference Number: 6.01.53
Related Policies Scintimammography/Breast-Specific Gamma Imaging/Molecular Breast Imaging, #494 Magnetic Resonance Imaging (MRI) of the Breast, #230 Positron Emission Mammography (PEM), #176
Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity Medicare HMO BlueSM and Medicare PPO BlueSM Members
Digital breast tomosynthesis is INVESTIGATIONAL in the screening or diagnosis of breast cancer.
Prior Authorization Information Commercial Members: Managed Care (HMO and POS) This is NOT a covered service. Commercial Members: PPO, and Indemnity This is NOT a covered service. Medicare Members: HMO BlueSM This is NOT a covered service. Medicare Members: PPO BlueSM This is NOT a covered service.
CPT Codes / HCPCS Codes / ICD-9 Codes The following codes are included below for informational purposes. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member.
1 Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable.
CPT Codes There is no specific CPT code for this service.
Description Digital breast tomosynthesis (DBT) 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.
Current radiographic approaches to mammography produce two-dimensional (2D) images which 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 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.
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 and mediolateral oblique 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.
Examples of digital breast tomosynthesis systems include the Selenia Dimensions 2D Full Field Digital Mammography (FFDM), the Digital Breast Tomosynthesis (DBT) system, and The Selenia Dimensions 3D DBT from Hologic, Inc. All digital breast tomosynthesis systems are considered investigational regardless of the commercial name, the manufacturer, or FDA approval status.
Summary There are no studies currently published that 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 and full-field digital mammography where large clinical studies have demonstrated effectiveness in clinical care.
In addition, there still seem to be open questions about the number of DBT views that are needed. A related question is how the impact of using additional views from standard mammography would compare with the impact from digital breast tomosynthesis. Questions also still remain about the impact of calcifications on interpretation. Finally, more information is needed about the learning curve regarding interpretation of these studies. In summary, the use of digital breast tomosynthesis in generating images for screening or diagnosis of breast cancer is considered investigational. Studies of outcomes (including accuracy and recall rate) with use in clinical practice are needed. In addition, there are unanswered questions about the number of images needed as well as concerns about radiation dose and time for interpretation. For these reasons, DBT is considered investigational.
Policy History Date Action 9/2014 New references added from BCBSA National medical policy. 9/2013 New references from BCBSA National medical policy.
2 11/2011- Medical policy ICD 10 remediation: Formatting, editing and coding updates. 4/2012 No changes to policy statements. 12/2011 New policy effective 12/2011 describing ongoing non-coverage.
Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines
References 1. Tagliafico A, Astengo D, Cavagnetto F et al. One-to-one comparison between digital spot compression view and digital breast tomosynthesis. European radiology 2012; 22(3):539-44. 2. National Cancer Institute (NCI). Factsheet: Mammograms. 2012. Available online at: http://www.cancer.gov/cancertopics/factsheet/detection/mammograms. Last accessed June 2014. 3. Rosenberg RD, Yankaskas BC, Abraham LA et al. Performance benchmarks for screening mammography. Radiology 2006; 241(1):55-66. 4. Brandt KR, Craig DA, Hoskins TL et al. Can digital breast tomosynthesis replace conventional diagnostic mammography views for screening recalls without calcifications? A comparison study in a simulated clinical setting. AJR. American journal of roentgenology 2013; 200(2):291-8. 5. Shen Y, Yang Y, Inoue LY et al. Role of detection method in predicting breast cancer survival: analysis of randomized screening trials. J Natl Cancer Inst 2005; 97(16):1195-203. 6. Smith A. Fundamentals of breast tomosynthesis [WP-00007]. Bedford, MA: Hologic, Inc.; 2008:8. 7. Alakhras M, Bourne R, Rickard M et al. Digital tomosynthesis: A new future for breast imaging? Clinical radiology 2013. 8. Gur D, Abrams GS, Chough DM et al. Digital breast tomosynthesis: observer performance study. AJR. American journal of roentgenology 2009; 193(2):586-91. 9. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Use of digital breast tomosynthesis with mammography for breast cancer screening or diagnosis. TEC Assessments 2014; Volume 28, Tab 6. 10. U.S. Food and Drug Administration (FDA). Summary of Safety and Effectiveness Data (SSED). 2011. Available online at: http://www.accessdata.fda.gov/cdrh_docs/pdf8/P080003b.pdf. Last accessed June 2014. 11. Hologic I. Press release: Hologic Receives FDA Approval for a New Low-dose 3D Mammography (Breast Tomosynthesis) Solution for Breast Cancer Screening. . Bedford, MA2013. 12. Skaane P, Bandos AI, Gullien R et al. Comparison of Digital Mammography Alone and Digital Mammography Plus Tomosynthesis in a Population-based Screening Program. Radiology 2013. 13. Skaane P, Bandos AI, Gullien R et al. Prospective trial comparing full-field digital mammography (FFDM) versus combined FFDM and tomosynthesis in a population-based screening programme using independent double reading with arbitration. European radiology 2013; 23(8):2061-71. 14. Skaane P. Response. Radiology 2013; 267(3):969. 15. Ciatto S, Houssami N, Bernardi D 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. 16. Rafferty EA, Park JM, Philpotts LE et al. Assessing radiologist performance using combined digital mammography and breast tomosynthesis compared with digital mammography alone: results of a multicenter, multireader trial. Radiology 2013; 266(1):104-13. 17. Good WF, Abrams GS, Catullo VJ et al. Digital breast tomosynthesis: a pilot observer study. AJR. American journal of roentgenology 2008; 190(4):865-9. 18. 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. American journal of roentgenology 2011; 196(3):737-41.
3 19. Friedewald SM, Rafferty EA, Rose SL et al. Breast cancer screening using tomosynthesis in combination with digital mammography. JAMA 2014; 311(24):2499-507. 20. Rose SL, Tidwell AL, Bujnoch LJ et al. Implementation of Breast Tomosynthesis in a Routine Screening Practice: An Observational Study. AJR. American journal of roentgenology 2013; 200(6):1401-08. 21. Destounis S, Arieno A, Morgan R. Initial experience with combination digital breast tomosynthesis plus full field digital mammography or full field digital mammography alone in the screening environment. Journal of clinical imaging science 2014; 4:9. 22. Greenberg JS, Javitt MC, Katzen J et al. Clinical Performance Metrics of 3D Digital Breast Tomosynthesis Compared With 2D Digital Mammography for Breast Cancer Screening in Community Practice. AJR. American journal of roentgenology 2014:1-7. 23. Haas BM, Kalra V, Geisel J et al. Comparison of tomosynthesis plus digital mammography and digital mammography alone for breast cancer screening. Radiology 2013; 269(3):694-700. 24. Skaane P, Bandos AI, Eben EB et al. Two-view digital breast tomosynthesis screening with synthetically reconstructed projection images: comparison with digital breast tomosynthesis with full- field digital mammographic images. Radiology 2014; 271(3):655-63. 25. Zuley ML, Guo B, Catullo VJ et al. Comparison of Two-dimensional Synthesized Mammograms versus Original Digital Mammograms Alone and in Combination with Tomosynthesis Images. Radiology 2014; 271(3):664-71. 26. Bernardi D, Caumo F, Macaskill P et al. Effect of integrating 3D-mammography (digital breast tomosynthesis) with 2D-mammography on radiologists' true-positive and false-positive detection in a population breast screening trial. European journal of cancer (Oxford, England : 1990) 2014; 50(7):1232-8. 27. Caumo F, Bernardi D, Ciatto S et al. Incremental effect from integrating 3D-mammography (tomosynthesis) with 2D-mammography: Increased breast cancer detection evident for screening centres in a population-based trial. Breast (Edinburgh, Scotland) 2014; 23(1):76-80. 28. Houssami N, Macaskill P, Bernardi D et al. Breast screening using 2D-mammography or integrating digital breast tomosynthesis (3D-mammography) for single-reading or double-reading - Evidence to guide future screening strategies. European journal of cancer (Oxford, England : 1990) 2014; 50(10):1799-807. 29. Lei J, Yang P, Zhang L et al. Diagnostic accuracy of digital breast tomosynthesis versus digital mammography for benign and malignant lesions in breasts: a meta-analysis. European radiology 2014; 24(3):595-602. 30. Lei J, Yang P, Zhang L et al. Reply to Letter to the Editor re: Diagnostic accuracy of digital breast tomosynthesis versus digital mammography for benign and malignant lesions in breasts: a meta- analysis. European radiology 2014; 24(4):928-9. 31. Bernardi D, Ciatto S, Pellegrini M et al. Prospective study of breast tomosynthesis as a triage to assessment in screening. Breast cancer research and treatment 2012; 133(1):267-71. 32. Michell MJ, Iqbal A, Wasan RK et al. A comparison of the accuracy of film-screen mammography, full-field digital mammography, and digital breast tomosynthesis. Clinical radiology 2012. 33. Zuley ML, Bandos AI, Ganott MA et al. Digital breast tomosynthesis versus supplemental diagnostic mammographic views for evaluation of noncalcified breast lesions. Radiology 2013; 266(1):89-95. 34. Skaane P, Gullien R, Bjorndal H et al. Digital breast tomosynthesis (DBT): initial experience in a clinical setting. Acta radiologica (Stockholm, Sweden : 1987) 2012; 53(5):524-9. 35. 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. American journal of roentgenology 2014; 202(2):273-81. 36. Thibault F, Dromain C, Breucq C et al. Digital breast tomosynthesis versus mammography and breast ultrasound: a multireader performance study. European radiology 2013; 23(9):2441-9. 37. Gennaro G, Hendrick RE, Toledano A et al. Combination of one-view digital breast tomosynthesis with one-view digital mammography versus standard two-view digital mammography: per lesion analysis. European radiology 2013; 23(8):2087-94. 38. American College of Radiology. ACR Appropriateness Criteria®: breast cancer screening; date of origin, 2012. Available online at: http://www.acr.org/Quality-Safety/Appropriateness-Criteria. Last accessed June 2014.
4 39. American College of Radiology. ACR Appropriateness Criteria®: breast microcalcifications – initial diagnostic workup; last review date, 2009. Available online at: http://www.acr.org/Quality- Safety/Appropriateness-Criteria. Last accessed June 2014. 40. American College of Radiology (ACR). ACR, SBI Statement on Skaane et al. -- Tomosynthesis Breast Cancer Screening Study. News Releases 2013. Available online at: http://www.acr.org/About-Us/Media-Center/Press-Releases/2013-Press-Releases/20130110ACR- SBI-Statement-on-Skaane-et-al. Last accessed June 2014. 41. American College of Obstetricians and Gynecologists (ACOG). Breast cancer screening. Washington (DC): American College of Obstetricians and Gynecologists (ACOG); 2011 Aug. 11 p. (ACOG practice bulletin; no. 122). 42. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: breast cancer screening and diagnosis, version 1.2014 (discussion update in progress). Available online at: http://www.nccn.org/professionals/physician_gls/pdf/breast-screening.pdf. Last accessed June 2014. 43. U.S. Preventive Services Task Force. Screening for breast cancer: recommendation statement, updated December 2009. Available online at: http://www.uspreventiveservicestaskforce.org/uspstf09/breastcancer/brcanrs.htm. Last accessed June 2014. 44. U.S. Preventive Services Task Force. Screening for breast cancer (2002). Available online at: http://www.uspreventiveservicestaskforce.org/uspstf/uspsbrca2002.htm. Last accessed June 2014. 45. U.S. Preventive Services Task Force. Screening for Breast Cancer. Available online at: http://www.uspreventiveservicestaskforce.org/breastcancer.htm. Last accessed June 2014.
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