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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

Fecha de vigencia original: 09/15/11

Revisado: 12/03/15

Editado: 12/15/15

Tema: Tomosíntesis digital de mama

ESTA GUÍA DE COBERTURA MÉDICA NO ES UNA AUTORIZACIÓN, CERTIFICACIÓN, EXPLICACIÓN DE LOS BENEFICIOS NI UNA GARANTÍA DE PAGO, NI SUSTITUYE NI CONSTITUYE AVISOS MÉDICOS. TODAS LAS DECISIONES MÉDICAS SON RESPONSABILIDAD EXCLUSIVA DEL PACIENTE Y EL MÉDICO. LOS BENEFICIOS SE DETERMINAN EN EL CONTRATO GRUPAL, EL FOLLETO DE BENEFICIOS PARA LOS MIEMBROS O EL CERTIFICADO INDIVIDUAL DEL SUSCRIPTOR EN VIGENCIA AL MOMENTO EN QUE SE PRESTARON LOS SERVICIOS. ESTA GUÍA DE COBERTURA MÉDICA SE APLICA A TODAS LAS LÍNEAS COMERCIALES A MENOS QUE SE INDIQUE LO CONTRARIO EN LA SECCIÓN EXCEPCIONES DEL PROGRAMA.

           
Declaración de Posición Facturación/ Codificación Reembolso Excepciones del programa Definiciones Guías relacionadas
           
Otros Referencias Actualizaciones      
           

DESCRIPCIÓN:

La tomosíntesis digital de mama (DBT) usa los equipos de mamografía digital modificados para obtener datos radiológicos adicionales. Los datos son utilizados para recosntruir los “cortes” transversales del tejido mamario.

El sistema Selenia Dimensions 3D (Hologic, Inc.) recibió la aprobación previa a la comercialización de la Administración de Alimentos y Medicinas de los EE. UU. (FDA) en febrero de 2011. Este dispositivo está indicado para generar imágenes mamográficas digitales que se pueden usar para analizar y diagnosticar el cáncer de mama. El sistema Selenia Dimensions (2D y 3D) está destinado para usarse en las mismas aplicaciones clínicas que los sistemas de mamografía en 2D para analizar los mamogramas de detección. El sistema Selenia Dimensions se puede usar para adquirir mamogramas digitales en 2D y mamogramas en 3D (FDA).

DECLARACIÓN DE POSICIÓN:

La tomosíntesis digital de mama (DBT) se considera como experimental o en fase de investigación para todas las indicaciones. La evidencia sobre la DBT está limitada en cuanto a resultados de salud a largo plazo y su utilidad clínica en el examen y diagnóstico de cáncer de mama. Además, no existen criterios de selección publicados o guías de práctica clínica para la tomosíntesis de mama digital.

INFORMACIÓN PARA FACTURACIÓN/CODIFICACIÓN:

Los siguientes códigos se pueden usar para describir la tomosíntesis digital de mama.

Codificación CPT:

77061

Unilateral non-screening tomosynthesis (Investigational)

77062

Bilateral non-screening tomosynthesis (Investigational)

77063

Screening tomosynthesis (add-on code) (Investigational)

Codificación HCPCS:

G0279

Diagnostic digital breast tomosynthesis, unilateral or bilateral (Investigational)

Los códigos CPT 76376 y 76377, y los códigos HCPCS G0202, G0204 y G0206 no describen específicamente la tomosíntesis digital de mama. Los códigos CPT 76376 y 76377, y los códigos HCPCS G0202, G0204 y G0206 se consideran como experimentales o en fase de investigación cuando se usan para describir la tomosíntesis digital de mama.

Códigos de diagnóstico ICD-9 que respaldan la necesidad médica:

Todos los diagnósticos para la tomosíntesis digital de mama (DBT) se consideran como experimentales o en fase de investigación.

INFORMACIÓN DE REEMBOLSOS:

Consulte la sección titulada DECLARACIÓN DE POSICIÓN.

EXCEPCIONES DEL PROGRAMA:

Programa para empleados federales (FEP, Federal Employee Program): seguir las pautas del FEP.

Organización de cuentas estatales (SAO, State Account Organization): seguir las pautas de la SAO.

Productos Medicare Advantage:

La siguiente Determinación de cobertura local (LCD, Local Coverage Determination) se revisó en la fecha de edición más reciente de la guía: Detección y mamografía de diagnóstico, (L29328) ubicada en fcso.com. Se encontró “No National Coverage Determination (NCD)” para la última fecha de revisión de las pautas.

DEFINICIONES:

No se aplica ninguna definición específica de la guía.

GUÍAS RELACIONADAS:

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

OTROS:

Otros nombres que se usan para informar la tomosíntesis digital de mama:

REFERENCIAS:

  1. 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.
  2. American College of Obstetricians and Gynecologists (ACOG). Breast cancer screening, 2011.
  3. American College of Obstetricians and Gynecologists (ACOG) Technology Assessment Digital Breast Tomosynthesis Number 9, 2013.
  4. American Society of Breast Disease Statement on Digital Breast Tomosynthesis, 2013.
  5. 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.
  6. Blue Cross Blue Shield Association Medical Policy Reference Manual Digital Breast Tomosynthesis 6.01.53, 06/15.
  7. 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.
  8. 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.
  9. Chen SC, Carton AK, Albert M et al. Initial clinical experience with contrast-enhanced digital breast tomosynthesis. Academic Radiology 2007; 14(2): 229-38.
  10. 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.
  11. Conant EF. Clinical implementation of digital breast tomosynthesis. Radiologic Clinics of North America 2014; 52(3): 499-518.
  12. 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).
  13. Digital breast tomosynthesis. Technology Assessment in Obstetrics and Gynecology No. 9. American College of Obstetricians and Gynecologists. Obstetrics & Gynecology 2013; 121: 1415-1417.
  14. D’Orsi CJ, Newell MS. On the frontline of screening for breast cancer. Seminars in Oncology 2011; 38(2): 119-127.
  15. 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.
  16. Friedewald SM, Rafferty EA, Rose SL et al. Breast cancer screening using tomosynthesis in combination with digital mammography. JAMA 2014; 11(24): 2499-2507.
  17. 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.
  18. 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.
  19. Gur D, Abrams GS, Chough DM et al. Digital breast tomosynthesis: observer performance study. American Journal of Roentgenology 2009; 193 (2):586-591.
  20. 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.
  21. 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.
  22. 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.
  23. 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.
  24. 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.
  25. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology™ Breast Cancer Screening and Diagnosis Version 1.2015.
  26. 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.
  27. 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.
  28. 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
  29. 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.
  30. 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.
  31. 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.
  32. 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.
  33. Rosenberg RD, Yankaskas BC, Abraham LA et al. Performance benchmarks for screening mammography. Radiology 2006; 241(1): 55-66.
  34. Schell MJ, Yankaskas BC, Ballard-Barbash R et al. Evidence-based target recall rates for screening mammography. Radiology 2007; 243(3): 681-689.
  35. Screening for Breast Cancer. U.S. Preventive Services Task Force, 12/09 (current as of July 2010).
  36. 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.
  37. 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.
  38. 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.
  39. 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.
  40. 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.
  41. Teertstra HJ, Loo CE, van den Bosch MA et al. Breast tomosynthesis in clinical practice: initial results. European Radiology 2010; 20(1):16-24.
  42. U.S. Preventive Services Task Force (USPSTF). Screening for Breast Cancer, 12/09.
  43. 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.
  44. 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.
  45. 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.

APROBACIÓN DEL COMITÉ:

Esta Guía de cobertura médica (MCG, Medical Coverage Guideline) fue aprobada por el Comité de Cobertura y Normas Médicas de BCBSF el 12/03/15.

INFORMACIÓN DE LAS ACTUALIZACIONES DE LA GUÍA:

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.

05/01/15

Updated Medicare Advantage program exception

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.

Date Printed: August 23, 2017: 05:53 AM