Blue Cross and Blue Shield of Montana (BCBSMT) has made a decision to price all screening mammogram services at a single reimbursement rate, independent of technique used. Additional views, digital reconstruction or digital tomosynthesis (including CPT and HCPCS codes 77063, G0279) services are not accorded additional reimbursement as they are considered discretionary by the facility and professional providing the services and have not been proven to improve the outcomes beyond conventional mammograms.
The current BCBSMT Medical Policy, based on comprehensive scientific literature review, concludes that digital breast tomosynthesis mammograms have not been proven to be superior to conventional technology for overall outcomes and long-term results. The current Medical Policy (RAD601.055) is available for review at the bcbsmt.com website. BCBSMT Medical Policies undergo regular review and revisions at least annually and when significant medical literature publications become available. All new medical specialty society recommendations and published literature are considered in determining the coverage rationale.
A significant number of service reimbursement appeals have been submitted to BCBSMT and forwarded for peer review, to multiple different Independent Peer Review Organizations. All of those appeal reviews have validated the initial service denial. The IRO reviews were performed by multiple specialists, including radiologists, gynecologists, surgeons and primary care physicians. Summary information from those reviews is presented below.
Tomosynthesis is a modification of digital mammography and uses a moving x-ray source and digital detector. A three-dimensional volume of data is acquired and reconstructed using computer algorithms to generate thin sections of images. As a modification of digital mammography, tomosynthesis has all the advantages of a standard digital mammogram. In addition, thin slice reconstruction improves the delineation of a lesion in the slice by eliminating overlap from surrounding structures. With the commonly used current technology, this process more than doubles the breast radiation dose of digital mammography. Some studies are finding reduced overall recall rates, but with similar or higher biopsy rates. One factor that may reduce immediate recall rates with tomosynthesis is that the technology obtains additional breast images at the time of initial screening.
- In the screening setting, some small, unblinded, short-term, retrospective studies have shown that tomosynthesis can help decrease recall rates.
- In the diagnostic setting, some small, unblinded, short-term, retrospective studies have shown that tomosynthesis improved lesion characterization, thereby decreasing the number of biopsies, leading to fewer false positive biopsies and higher rates of cancer detection.
Multiple sources indicate that the impact of DBT on outcomes (including accuracy and recall rate) needs to be fully investigated prior to routine use in clinical practice. Some of the shortcomings of the published literature include that available studies are all single institutional studies. The studies varied in the number of tomosynthesis views that were used. Additional cases of patients with cancer were added retrospectively to the study population in some studies. In other words, radiologists in the study had prior knowledge of cancer cases before reading DBT. Therefore, these studies were not prospective evaluations of this technology in a clinical setting.
At the present time, routine use of tomosynthesis is not recommended by any national guidelines as part of annual breast cancer screening exam.
The most current position statement from the American College of Radiology states: "A new digital technology, breast tomosynthesis, has shown to be an advance over digital mammography, with higher cancer detection rates and fewer patient recalls for additional testing." The same statement also says it is "important to further elucidate which subgroups of women will benefit most from these exams." This highlights the fact that there is a lack of any randomized trial that helps specify which clinical scenarios such testing will lead to improved outcome over current standard of care. It may be that this test would be best used in conjunction with a diagnostic mammogram and not with a screening mammogram. At the present time, more data is needed to determine what is the best clinical scenario for testing and so it would appear that the current data is still lacking, though the retrospective data is promising.
The American College of Obstetricians and Gynecologists (ACOG) does not recommend routine use of alternative or adjunctive tests to screening mammography. Current published evidence does not demonstrate meaningful outcome benefits (e.g., reduction in breast cancer mortality) with supplemental tests (e.g., ultrasonography and magnetic resonance imaging) to screening mammography or with alternative screening modalities (e.g., breast tomosynthesis or thermography) in women with dense breasts who do not have additional risk factors. Based on ACOG, "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."
The National Comprehensive Cancer Network ("NCCN") practice guideline for breast cancer does not include digital breast tomosynthesis in either screening or diagnostic breast cancer recommendations.
Current USPSTF category A or B recommendations do not include tomosynthesis as a breast cancer screening technique. The draft recommendations for 2015 indicate that current studies do not provide information on diagnostic test characteristics of tomosynthesis for breast cancer screening, as no studies report on a comprehensive reference standard. Ongoing studies registered with clinical trials.gov suggest that results of the application of a comprehensive reference standard to a screening population may become available within a few years. Studies are needed that employ the standard approach to breast imaging interpretation in the United States (single reading), and that report on both interval cancers identified by a comprehensive reference standard and longer term outcomes, including effects of the addition of tomosynthesis to digital mammography on the stage distribution of detected cancers, breast cancer recurrence or 2nd (contralateral) breast cancers and mortality rates. USPSTF summarizes that the evidence is insufficient to assess the harms or benefits of these digital tomosynthesis methods for screening.
In summary, BCBSMT has made a decision to price all screening mammogram services at a single reimbursement rate, independent of technique used. Additional views, digital reconstruction or digital tomosynthesis (including CPT and HCPCS codes 77063, G0279) services are not accorded additional reimbursement, as they are considered discretionary by the facility and professional providing the service. The current Medical Policy (RAD601.055) is available for review at the bcbsmt.com website. BCBSMT Medical Policies undergo regular review and revisions at least annually and when significant medical literature publications become available. All new medical specialty society recommendations and published literature are considered in determining the coverage rationale.
References used for this summary may include information from the following sources:
- Tagliafico A, Astengo D, Cavagnetto F et al. One-to-one comparison between digital spot compression view and digital breast tomosynthesis. Eur Radiol 2012; 22(3):539-44.
- National Cancer Institute (NCI). Factsheet: Mammograms. 2012. Available online at: http://www.cancer.gov/cancertopics/factsheet/detection/mammograms . Last accessed June 2014.
- Rosenberg RD, Yankaskas BC, Abraham LA et al. Performance benchmarks for screening mammography. Radiology 2006; 241(1):55-66.
- 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 Am J Roentgenol 2013; 200(2):291-8.
- 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.
- Smith A. Fundamentals of breast tomosynthesis [WP-00007]. Bedford, MA: Hologic, Inc.; 2008:8.
- Alakhras M, Bourne R, Rickard M et al. Digital tomosynthesis: A new future for breast imaging? Clin Radiol 2013.
- Gur D, Abrams GS, Chough DM et al. Digital breast tomosynthesis: observer performance study. AJR Am J Roentgenol 2009; 193(2):586-91.
- 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.
- 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.
- Hologic Inc. Press release: Hologic Receives FDA Approval for a New Low-dose 3D Mammography (Breast Tomosynthesis) Solution for Breast Cancer Screening. Bedford, MA2013.
- 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.
- 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. Eur Radiol 2013; 23(8):2061-71.
- Skaane P. Response. Radiology 2013; 267(3):969.
- 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.
- 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.
- Good WF, Abrams GS, Catullo VJ et al. Digital breast tomosynthesis: a pilot observer study. AJR Am J Roentgenol 2008; 190(4):865-9.
- 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; 196(3):737-41.
- Friedewald SM, Rafferty EA, Rose SL et al. Breast cancer screening using tomosynthesis in combination with digital mammography. JAMA 2014; 311(24):2499-507.
- Rose SL, Tidwell AL, Bujnoch LJ et al. Implementation of Breast Tomosynthesis in a Routine Screening Practice: An Observational Study. AJR Am J Roentgenol 2013; 200(6):1401-08.
- 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. J Clin Imaging Sci 2014; 4:9.
- 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 Am J Roentgenol 2014:1-7.
- 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.
- 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.
- 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.
- 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. Eur J Cancer 2014; 50(7):1232-8.
- 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.
- 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. Eur J Cancer 2014; 50(10):1799-807.
- 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. Eur Radiol 2014; 24(3):595-602.
- 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 metaanalysis. Eur Radiol 2014; 24(4):928-9.
- 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; 133(1):267-71.
- Michell MJ, Iqbal A, Wasan RK et al. A comparison of the accuracy of film-screen mammography, fullfield digital mammography, and digital breast tomosynthesis. Clin Radiol 2012.
- 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.
- Skaane P, Gullien R, Bjorndal H et al. Digital breast tomosynthesis (DBT): initial experience in a clinical setting. Acta Radiol 2012; 53(5):524-9.
- 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.
- Thibault F, Dromain C, Breucq C et al. Digital breast tomosynthesis versus mammography and breast ultrasound: a multireader performance study. Eur Radiol 2013; 23(9):2441-9.
- 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. Eur Radiol 2013; 23(8):2087-94.
- 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.
- 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.
- 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.
- 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).
- 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.
- 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.
- U.S. Preventive Services Task Force. Screening for breast cancer (2002). Available online at: http://www.uspreventiveservicestaskforce.org/uspstf/uspsbrca2002.htm . Last accessed June 2015.
- U.S. Preventive Services Task Force. Screening for Breast Cancer. Available online at: http://www.uspreventiveservicestaskforce.org/breastcancer.htm . Last accessed June 2015.