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Date Printed: December 17, 2017: 04:19 PM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative 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.

04-78000-20

Original Effective Date: 09/15/11

Reviewed: 10/31/17

Revised: 11/15/17

Subject: Digital Breast Tomosynthesis

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates    
           

DESCRIPTION:

Digital breast tomosynthesis (DBT) uses modified digital mammography equipment to obtain additional radiographic data. The data is used to reconstruct cross-sectional “slices” of breast tissue.

The Food and Drug Administration (FDA) has approved several digital breast tomosynthesis (DBT) systems and software (e.g., Selenia Dimensions 3D System (Hologic, Inc.), MAMMOMAT Inspiration with Tomosynthesis Option (Siemens), SenoClaire DBT System (GE Healthcare), Senographe Pristina 3D (GE Healthcare), ASPIRE Cristalle Digital Breast Tomosynthesis Option (Fujifilm Medical Systems), PowerLook® Tomo Detection Software (iCAD, Inc.)).

POSITION STATEMENT:

Digital breast tomosynthesis (DBT) is considered experimental or investigational for all indications.

The evidence on DBT is limited with regards to long-term health outcomes and its clinical utility in the screening and diagnosis of breast cancer. Also, there are no published selection criteria or clinical practice guidelines for digital breast tomosynthesis.

BILLING/CODING INFORMATION:

CPT Coding:

77061

Digital breast tomosynthesis; unilateral (Investigational)

77062

Digital breast tomosynthesis; bilateral (Investigational)

77063

Screening digital breast tomosynthesis, bilateral (Investigational)

HCPCS Coding:

G0279

Diagnostic digital breast tomosynthesis, unilateral or bilateral (Investigational)

CPT code 76376, 76377 and HCPCS codes G0202, G0204 and G0206 do not specifically describe digital breast tomosynthesis. CPT code 76376, 76377 and HCPCS codes G0202, G0204 and G0206 are considered experimental or investigational when used to describe breast tomosynthesis.

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

The following Local Coverage Determination (LCD) was reviewed on the last guideline reviewed date: Screening and Diagnostic Mammography, (L36342) located at fcso.com. No National Coverage Determination (NCD) was found at the time of the last guideline reviewed date.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

Breast Scintigraphy (Scintimammography)/ Breast-Specific Gamma Imaging/Molecular Breast Imaging, 04-78000-14
Magnetic Resonance Imaging of the Breast, 04-70540-09

OTHER:

Other names used to report digital breast tomosynthesis:

Breast tomosynthesis (BT)
Three-dimensional (3D) breast imaging
Three-dimensional (3D) digital tomosynthesis
Three-dimensional (3D) mammography

REFERENCES:

  1. American Academy of Family Physicians (AAFP). Clinical Preventive Service Recommendation. Breast Cancer, 2016.
  2. American College of Obstetricians and Gynecologists (ACOG). Breast cancer screening, 2011.
  3. American College of Obstetricians and Gynecologists (ACOG) Committee Opinion: Management of women with dense breasts diagnosed by mammography Number 625, March 2015.
  4. American College of Radiology ACR Appropriateness Criteria®: Breast cancer screening, 2017
  5. American College of Radiology ACR Appropriateness Criteria®: Breast pain, 2016.
  6. American Society of Breast Disease Statement on Digital Breast Tomosynthesis, 2013.
  7. Andersson I, Ikeda DM, Zackrisson S et al. Breast tomosynthesis and digital mammography: a comparison of breast cancer visibility and BIRADS classification in a population of cancers with subtle mammographic findings. European Radiology 2008; 18(12): 2817-2825.
  8. 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.
  9. Blue Cross Blue Shield Association Medical Policy Reference Manual Digital Breast Tomosynthesis 6.01.53, 09/17.
  10. Blue Cross Blue Shield Association Technology Evaluation Center (TEC). Use of digital breast tomosynthesis with mammography for breast cancer screening. TEC Assessments 2015; Volume 29, Tab 29.
  11. Blue Cross 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.
  12. Carton AK, Gavenonis SC, Currivan JA et al. Dual-energy contrast-enhanced digital breast tomosynthesis-a feasibility study. British Journal of Radiology 2010; 83: 344-350.
  13. Chen SC, Carton AK, Albert M et al. Initial clinical experience with contrast-enhanced digital breast tomosynthesis. Academic Radiology 2007; 14(2): 229-38.
  14. 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 Oncology 2013; 14(7): 583-589.
  15. Conant EF. Clinical implementation of digital breast tomosynthesis. Radiologic Clinics of North America 2014; 52(3): 499-518.
  16. 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).
  17. Digital breast tomosynthesis. Technology Assessment in Obstetrics and Gynecology No. 9. American College of Obstetricians and Gynecologists. Obstetrics & Gynecology 2013; 121: 1415-1417.
  18. D’Orsi CJ, Newell MS. On the frontline of screening for breast cancer. Seminars in Oncology 2011; 38(2): 119-127.
  19. Fornvik D, Zackrisson S, Ljungberg O et al. Breast tomosynthesis: accuracy of tumor measurement compared with digital mammography and ultrasonography. Acta Radiologica 2010; 51(3): 240-247.
  20. Friedewald SM, Rafferty EA, Rose SL et al. Breast cancer screening using tomosynthesis in combination with digital mammography. JAMA 2014; 11(24): 2499-2507.
  21. Gennaro G, Toledano A, di Maggio C et al. Digital breast tomosynthesis versus digital mammography: a clinical performance study. European Radiology 2010; 20(7): 1545-1553.
  22. Gilbert FJ, Tucker L, Gillan MG et al. The TOMMY trial: a comparison of TOMosynthesis with digital MammographY in the UK NHS Breast Screening Programme--a multicentre retrospective reading study comparing the diagnostic performance of digital breast tomosynthesis and digital mammography with digital mammography alone. Health Technology Assessment 2015 Janl 19(4): i-xxv, 1-136.
  23. Gur D, Abrams GS, Chough DM et al. Digital breast tomosynthesis: observer performance study. American Journal of Roentgenology 2009; 193 (2):586-591.
  24. Hakim CM, Chough DM, Ganott MA et al. Digital breast tomosynthesis in the diagnostic environment: A subjective side-by-side review. American Journal of Roentgenology 2010; 195: W172-W176.
  25. 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 2014; 50(10): 1799-1807.
  26. Institute for Clinical and Economic Review (ICER): The Comparative Clinical Effectiveness and Value of Supplemental Screening Tests Following Negative Mammography in Women with Dense Breast Tissue, January 2014.
  27. Kontos D, Bakic PR, Carlton AK et al. Parenchymal texture analysis in digital breast tomosynthesis for breast cancer risk estimation: a preliminary study. Acad Radiology 2009; 16(3): 28.-298.
  28. Lång K, Andersson I, Rosso A. Performance of one-view breast tomosynthesis as a stand-alone breast cancer screening modality: results from the Malmö Breast Tomosynthesis Screening Trial, a population-based study. European Radiology Jan 2016; 26(1):184-190.
  29. Lang K, Anderson I, Rosso A et al. Performance of one-view breast tomosynthesis as a stand-alone breast cancer screening modality: results from the Malmö Breast Tomosynthesis Screening Trial, a population-based study. European Radiology 2015; May 1.
  30. Lång K, Nergarden M, Andersson I. False positives in breast cancer screening with one-view breast tomosynthesis: An analysis of findings leading to recall, work-up and biopsy rates in the Malmö Breast Tomosynthesis Screening Trial. European Radiology Nov 2016; 26(11):3899-3907.
  31. Lauby-Secretan B, Scoccianti C, Loomis D et al. Breast-cancer screening--viewpoint of the IARC Working Group. New England Journal Medicine 2015 372(24): 2353-2358.
  32. Lourenco AP, Barry-Brooks M, Baird GL et al. Changes in recall type and patient treatment following implementation of screening digital breast tomosynthesis. Radiology 2015; 274(2): 337-342.
  33. National Cancer Institute: Breast Cancer Screening (PDQ®)- Health Professional Version, 06/19/17.
  34. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology™ Breast Cancer Screening and Diagnosis Version 1. 2017- June 2, 2017.
  35. Nelson H D, Fu R, Cantor A et al. Effectiveness of breast cancer screening: Systematic review and meta-analysis to update the 2009 U.S. Preventive Services Task Force recommendation. Annals of Internal Medicine 2016; 164(4): 1-12.
  36. Noroozian M, Hadjiiski L, Rahnama-Moghadam S et al. Digital breast tomosynthesis is comparable to mammographic spot views for mass characterization. Radiology 2012; 262(1): 61-68.
  37. Partyka L, Lourenco AP, Mainiero MB. Detection of mammographically occult architectural distortion on digital breast tomosynthesis screening: initial clinical experience. American Journal of Roentgenology 2014; 203(1): 216-222.
  38. Pisano ED, Gatsonis C, Hendrick E et al. Diagnostic performance of digital versus film mammography for breast-cancer screening. New England Journal of Medicine 2005; 353(17): 1773-1783.
  39. Poplack SP, Tosteson TD, Kogel CA et al. Digital breast tomosynthesis: initial experience in 98 women with abnormal digital screening mammography. American Journal of Roentgenology 2007; 189: 616-623.
  40. Powell JL, Hawley JR, Lipari AM et al. Impact of the addition of digital breast tomosynthesis (DBT) to standard 2D digital screening mammography on the rates of patient recall, cancer detection, and recommendations for short-term follow-up. Academic Radiology March 2017; 24(3):302-307.
  41. 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): 104-112.
  42. 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. American Journal of Roentgenology 2014; 201(2): 273-281.
  43. Rose SL, Tidwell AL, Bujnoch LJ et al. Implementation of breast tomosynthesis in a routine screening practice: an observational study. American Journal of Radiology 2013; 200: 1401-1408.
  44. Rosenberg RD, Yankaskas BC, Abraham LA et al. Performance benchmarks for screening mammography. Radiology 2006; 241(1): 55-66.
  45. Schell MJ, Yankaskas BC, Ballard-Barbash R et al. Evidence-based target recall rates for screening mammography. Radiology 2007; 243(3): 681-689.
  46. Siu AL. Screening for breast cancer: U.S. Preventive Services Task Force Recommendation Statement. Annals of Internal Medicine 2016; 164(4): 279-296.
  47. 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 June 2014; 271(3): 655-663.
  48. 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; 267(1): 47-56.
  49. Skanne 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): 2061-2071.
  50. Seo M, Chang JM, Kim SA et al. Addition of digital breast tomosynthesis to full-field digital mammography in the diagnostic setting: additional value and cancer detectability. Journal of Breast Cancer Dec 2016; 1 9(4):438-446.
  51. Spangler ML, Zuley ML, Sumkin JH et al. Detection and classification of calcifications on digital breast tomosynthesis and 2D digital mammography: a comparison. American Journal of Roentgenology 2001; 196(2): 320-324.
  52. Svahn TM, Chakraborty DP, Ikeda D et al. Breast tomosynthesis and digital mammography: a comparison of diagnostic accuracy. British Institute of Radiology 2012; 1-9.
  53. Svahn T, Andersson I, Chakraborty D et al. The diagnostic accuracy of dual-view digital mammography, single-view breast tomosynthesis and a dual-view combination of breast tomosynthesis and digital mammography in a free-response observer performance study. Radiation Protection Dosimetry 2010; 139 (1-3): 113-117.
  54. Teertstra HJ, Loo CE, van den Bosch MA et al. Breast tomosynthesis in clinical practice: initial results. European Radiology 2010; 20(1):16-24.
  55. Tagliafico AS, Calabrese M, Mariscotti G et al. Adjunct screening with tomosynthesis or ultrasound in women with mammography-negative dense breasts: interim report of a prospective comparative trial. Journal of Clinical Oncology June 2016; 34(16): 1882-1888.
  56. U.S. Preventive Services Task Force (USPSTF). Screening for Breast Cancer, 01/16.
  57. 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; 262(3):788-796.
  58. 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.
  59. Zuley ML, Bandos AI, Abrams GS et al. Time to diagnosis and performance levels during repeat interpretations of digital breast tomosynthesis: preliminary observations. Academic Radiology 2010; 17(4): 450-455.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the Florida Blue Medical Policy & Coverage Committee on 10/31/17.

GUIDELINE UPDATE INFORMATION:

09/15/11

New Medical Coverage Guideline.

10/15/11

Updated billing/coding information section; CPT code 76376 and HCPCS codes G0202, G0204 and G0206 are considered experimental or investigational when used to describe breast tomosynthesis.

12/15/11

Guideline reviewed; maintain position statement.

04/01/12

Code update, added 76377.

11/15/12

Annual review; maintain position statement. Updated references.

12/15/13

Annual review; maintain position statement. Add Medicare Advantage products program exception Updated references.

01/01/15

Annual review; maintain position statement. Added code (77061, 77062, 77063, and G0279). Updated references.

04/23/15

Code update; deleted parenthetical statement for code G0204 and G0206.

12/15/15

Review; maintain position statement. Revised description. Added FDA information for MAMMOMAT Inspiration with Tomosynthesis Option to description. Revised position statement. Updated program exception and references.

12/15/16

Annual review; no change to position statement. Updated references.

11/15/17

Annual review; no change to position statement. Updated references.

Date Printed: December 17, 2017: 04:19 PM