Print

Date Printed: October 23, 2017: 02:12 AM

Private Property of Blue Cross and Blue Shield of Florida.
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.

04-78000-14

Original Effective Date: 09/15/01

Reviewed: 10/19/16

Revised: 11/15/16

Subject: Scintimammography and Gamma Imaging of the Breast

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:

Scintimammography, breast specific-gamma imaging (BSGI) or molecular breast imaging (MBI), refers to the use of radiotracers with nuclear medicine cameras used to generate diagnostic images of the breast. This is done with the intent of improving the diagnostic performance imaging in the detection of breast malignancies.

Scintimammography is a diagnostic modality which uses radiopharmaceuticals to detect tumors of the breast. After injection of a radiopharmaceutical, the breast is evaluated with planar imaging. Scintimammography using conventional imaging modalities has relatively poor sensitivity in detecting smaller lesions (e.g., smaller than 15 mm), because of the relatively poor resolution of conventional gamma cameras in imaging the breast. Interest in scintimammography has increased in recent years with the development of breast-specific gamma imaging (BSGI) techniques that resemble those utilized in conventional mammography, allowing more detailed visualization of the breasts. Breast-specific gamma cameras acquire images while the patient is seated in a position similar to that in mammography, and the breast is lightly compressed. The detector head(s) is immediately next to the breast, increasing resolution, and the images can be compared with the mammographic images. Breast-specific gamma imaging systems can differ primarily in the type and number of detectors used (multi-crystal arrays of cesium iodide or sodium iodide versus semiconductor materials, such as cadmium zinc telluride, respectively). In some configurations, a detector is placed on each side of the breast, and they lightly compress the breast. The maximum distance between the detector and the breast is therefore from the surface to the midpoint of the breast. The radiotracer usually utilized is technetium Tc99m sestamibi. MBI imaging takes approximately 40 minutes.

Several scintillation cameras (gamma camera) have received general 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) (e.g., Dilon 6800, LumaGEM™, Sentinella 102).

Localization of Sentinel Lymph Nodes Using Radiopharmaceutical and Gamma Detection

Breast cancer staging requires evaluation of draining lymph node groups and primarily axillary lymph nodes.  Sentinel lymph node identification can be performed using a simple procedure to inject into the skin and under the skin a radiotracer that travels within the lymphatic channels of the breast and accumulates in draining lymph nodes.  The first appearing lymph nodes or the lymph nodes with the greatest uptake of radiotracer are identified as sentinel nodes.

For individuals who have breast cancer undergoing sentinel lymph node biopsy for detection of axillary metastases who receive radiopharmaceutical and gamma detection for localization of sentinel lymph nodes, the evidence has indicated that sentinel lymph node biopsy provides similar long-term outcomes as full axillary lymph node dissection for control of breast cancer and offers more favorable early results with reduced arm swelling and better quality of life. The evidence is sufficient to determine qualitatively that the technology results in a meaningful improvement in the net health outcome.

POSITION STATEMENT:

Scintimammography, breast- specific gamma imaging, and molecular breast imaging is considered experimental or investigational in all applications, including but not limited to use as an adjunct to mammography or in staging the axillary lymph nodes. There is insufficient evidence in the peer-reviewed literature to support the use of scintimammography, breast specific gamma imaging, and molecular breast imaging as an adjunct to mammography or in staging the axillary lymph nodes.

Use of gamma detection following radiopharmaceutical administration for localization of sentinel lymph nodes in members with breast cancer meets the definition of medical necessity.

BILLING/CODING INFORMATION:

There is no specific CPT code that describes breast -specific gamma imaging, molecular breast imaging.

CPT code 78800 and 78801 does not specifically describe scintimammography, breast-specific gamma imaging, or molecular breast imaging. CPT code 78800 and 78801 is considered experimental or investigational when used to describe scintimammography, breast -specific gamma imaging, or molecular breast imaging.

HCPCS code (S8080) may be used to describe scintimammography.

There is no specific HCPCS code that describes breast-specific gamma imaging or molecular breast imaging. HCPCS code A9500 does not specifically describe the radiopharmaceutical for scintimammography, breast-specific gamma imaging, or molecular breast imaging. HCPCS code A9500 is considered experimental or investigational when used to describe scintimammography, breast -specific gamma imaging, or molecular breast imaging.

Sentinel lymph node detection: There is no specific CPT or HCPCS code that describes gamma detection for localization of sentinel lymph nodes. HCPCS codes A9541 and A9520 may be used to describe gamma detection for localization of sentinel lymph nodes.

HCPCS Coding:

S8080

Scintimammography (radioimmunoscintigraphy of the breast), unilateral, including supply of radiopharmaceutical (experimental or investigational)

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:

No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline reviewed date.

DEFINITIONS:

Molecular breast imaging (MBI): a variant on scintimammography that uses gamma cameras and a radioactive tracer to obtain images of metabolic patterns.

Scintimammography: a method of imaging metabolic patterns of tissues by tracking the metabolism of a radioactive tracer with gamma cameras.

RELATED GUIDELINES:

None applicable.

OTHER:

Other names used to report scintimammography:

Note: 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.

Breast scintigraphy
Breast specific-gamma imaging (BSGI)
Gammagram
Mammoscintigraphy
Molecular breast imaging (MBI)
Radionclide scanning, breast
Radiopharmaceutical localization of tumor(s), breast
Scintimammography (SMM)
Technetium sestamibi scan
Technetium-99m sestamibi (MIBI)
Tumor localization, breast
Tumor specific imaging, breast
99m Tc-methoxyisobutyl isonitrile (MIBI)

REFERENCES:

  1. American Cancer Society-Mammograms and Other Breast Imaging Procedures, 2014.
  2. American College of Radiology ACR Appropriateness Criteria® Breast Cancer Screening, 2012.
  3. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Breast-specific gamma imaging (BSGI), molecular breast imaging (MBI), or scintimammography with breast-specific gamma camera. Technology Evaluation Center Technology Assessment Program Executive Summary. June 2013; 28(2): 1-29.
  4. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Special report: screening asymptomatic women with dense breasts and normal mammograms for breast cancer. Technology Evaluation Center Technology Evaluation Center Assessment Program. April 2014; 28(15): 1-25.
  5. Blue Cross Blue Shield Association Medical Policy Scintimammography/Breast Specific Gamma Imaging 6.01.18, 09/16.
  6. Brem RF, Floerke AC, Rapelyea JA. Breast-specific gamma imaging as an adjunct imaging modality for the diagnosis of breast cancer. Radiology 2008; 247(3): 651-657.
  7. Brem RF, Loffe M, Rapelyea JA et al. Invasive lobular carcinoma: detection with mammography, sonography, MRI, and breast-specific gamma imaging. American Journal of Roentgenology 2009; 192:379-383.
  8. Brem RF, Petrovitch I, Rapelyea JA et al. Breast-specific gamma imaging with 99mTc-Sestamibi and magnetic resonance imaging in the diagnosis of breast cancer--a comparative study. The Breast Journal 2007; 13 (5): 465-469.
  9. Brem RF, Rapelyea JA, Zisman G et al. Occult breast cancer: scintimammography with high-resolution breast-specific gamma camera in women at high risk for breast Cancer. Radiology 2005; 237(1): 274-280.
  10. Brem RF, Shahan C, Rapleyea JA et al. Detection of occult foci of breast cancer using breast-specific gamma imaging in women with one mammographic or clinically suspicious breast lesion. Academic Radiology 2010; 17: 735-743.
  11. Bruening W, Uhl S, Fontanarosa J et al. Noninvasive Diagnostic Tests for Breast Abnormalities: Update of a 2006 Review. Comparative Effectiveness Review No. 47. (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No. 290- 02-0019.) AHRQ Publication No. 12-EHC014-EF. Rockville, MD: Agency for Healthcare Research and Quality; February 2012.
  12. Coover LR, Caravaglia G, Kuhn P et al. Scintimammography with dedicated breast camera detects and localizes occult carcinoma. Journal of Nuclear Medicine 2004; 45(4): 553-558.
  13. ECRI Target Report-Scintimammography for Diagnosis of Suspicious Breast Lesions, 08/00.
  14. Effectiveness of Noninvasive Tests for Breast Abnormalities: Comparative Effectiveness Review, No 2, Wendy Bruening, Ph.D., Jason Launders, M.Sc. Nathan Pinkney, B.S., R.D.N.S., and others, Rockville, MD: Agency for Healthcare Research and Quality. February 2006.
  15. Gommans GM, vander Zant FM, van Dongen A et al. (99M) Technetium-sestamibi scintimammography in non-palpable breast lesions found on screening X-ray mammography. European Journal of Surgical Oncology 2007; 33(1): 23-27.
  16. Guo C, Zhang C, Liu J, et al. Is Tc-99m sestamibi scintimammography useful in the prediction of neoadjuvant chemotherapy responses in breast cancer? A systematic review and meta-analysis. Nuclear Medicine Communications. 2016;37(7):675-688.
  17. Hendrick RE. Radiation doses and cancer risks from breast imaging studies. Radiology 2010; 257(1): 246-253.
  18. Hruska CB, Boughey JC, Phillips et al. Scientific impact recognition award: Molecular breast imaging: a review of the Mayo Clinic experience. American Journal of Surgery 2008; 196(4): 470-6.
  19. Hruska CB, O’Connor MK. Nuclear imaging of the breast: translating achievements in instrumentation into clinical use. Medical Pysics 2013; 40(5): 050901-050901-23.
  20. Hruska CB, Conners AL, Jones KN et al. Half-time Tc-99m sestamibi imaging with a direct conversion molecular breast imaging system. EJNMMI Res 2014; 4(1):5.
  21. Hruska CB, Phillips SW, Whaley DH et al. Molecular breast imaging: use of a dual-head dedicated gamma camera to detect small breast tumors. American Journal of Roentgenology 2008; 191: 1805-1815.
  22. Jones EA, Phan TD, Blanchard DA et al. Breast-specific y-Imaging: molecular imaging of the breast using 99m Tc-sestamibi and small-field-of-view y-camera. Journal of Nuclear Medicine Technology 2009; 37 (4): 201-205.
  23. Jones EA, Phan TD, Johnson NM et al. A protocol for imaging axillary lymph nodes in patients undergoing breast-specific gamma-imaging. Journal of Nuclear Medicine Technology 2010; 38(1): 28-31.
  24. Lyman GH, Giuliano AE, Somerfield MR, et al. American Society of Clinical Oncology guideline recommendations for sentinel lymph node biopsy in early-stage breast cancer. Journal of Clinical Oncology. 2005; 23(30):7703-7720.
  25. Khalkhali I, Baum JK, Villanueva-Meyer J et al. (99m) Tc Sestamibi Breast Imaging for the Examination of Patients with Dense and Fatty Breasts: Multicenter Study. Radiology 2002; 222(1): 149-155.
  26. Khalkhali I, Villanueva-Meyer J et al. Diagnostic accuracy of Tc Sestamibi Breast Imaging: Multicenter Trial Results. Journal of Nuclear Medicine. 2000 Dec; 41 (12): 1973-1979.
  27. Killelea BK, Gillego A, Kirstein LJ et al. George Peters Award: How does breast-specific gamma imaging affect the management of patients with newly diagnosed breast cancer? American Journal of Surgery 2009; 198: 470-474.
  28. Klaus AJ, Klingensmith WC, Parker SH et al. Comparative value of 99m Tc-Sestamibi scintimammography and sonography in the diagnostic workup of breast masses. American Journal of Roentgenology 2000; 174: 1779-1783.
  29. Liberman M, Sampalis F, Mulder DS et al. Breast cancer diagnosis by scintimammography: a meta-analysis and review of the literature. Breast Cancer Research and Treatment 2003; 80(1): 115-126.
  30. Lumachi F, Ferretti G, Povolato M et al. Axillary lymph node metastases detection with 99m Tc-sestamibi scintimammography in patients with breast cancer undergoing curative surgery. Anticancer Research 2007; 27(4C): 2949-2952.
  31. Medicare National Coverage Determinations Manual Chapter 1, Part 4 (Sections 200-310.0) Coverage Determinations-220.4 Mammograms, 2009.
  32. National Comprehensive Cancer Network┬« Clinical Practice Guidelines in Oncology™ Breast Cancer Screening and Diagnosis Version 1.2015.
  33. Polan RL, Klein BD, Richman RH. Scintimammography in patients with minimal mammographic or clinical findings. Radiographics 2001; 21: 641-655.
  34. Quon, A, Gambhir SS. FDG-PET and beyond: molecular breast cancer imaging. Journal of Clinical Oncology 2005; 23(8): 1664-1673.
  35. Rhodes DJ, Hruska CB, Phillips SW et al. Dedicated dual-head gamma imaging for breast cancer screening in women with mammographically dense breasts. Radiology 2011; 258(1):106-118.
  36. Schillaci O. Is there a clinical role for scintimammography in breast cancer diagnosis? Journal of Nuclear Medicine. 2005 Oct; 46 (10): 1571-1573.
  37. Silverstein MJ, Recht A, Lagios MD et al. Image detected breast cancer: state-of-the-art diagnosis and treatment. Journal of the American College of Surgeons 2009; 209(4): 504-20.
  38. Society of Nuclear Medicine (SNM) Practice Guideline for Breast Scintigraphy with Breast-Specific y-Cameras 1.0*, August 2010.
  39. Spanu A, Chessa F, Sanna D et al. Scintimammography with a high resolution dedicated breast camera in comparison with SPECT/CT in primary breast cancer detection. The Quarterly Journal of Nuclear Medicine and Molecular Imaging 2009; 53:271-280.
  40. Spanu A, Cottu P, Manca A et al. Scintimammography with dedicated breast camera in unifocal and multifocal/multicentric primary breast cancer detection: a comparative study with SPECT. International Journal of Oncology 2007; 31(2): 369-377.
  41. Tadwalker RV, Rapelyea JA, Torrente J et al. Breast-specific gamma imaging as an adjunct modality for the diagnosis of invasive breast cancer with correlation to tumour size and grade. The British Journal of Radiology 2012; 85 (1014): e212-216.
  42. Taillefer R. Clinical Applications of 99m Tc-Sestamibi Scintimammography. Seminars in Nuclear Medicine 2005; 53 (2): 100-115.
  43. U.S. Preventive Services Task Force (USPSTF). Screening for Breast Cancer, 12/09.
  44. Weigert JM, Bertrand ML, Lanzkowsky L et al. Results of a multicenter patient registry to determine the clinical impact of breast-specific gamma imaging, a molecular breast imaging techniques. American Journal of Roentegenology 2012; 198(1): W69-75.
  45. Zhou M, Johnson N, Gruner S et al. Clinical utility of breast-specific gamma imaging for evaluating disease extent in the newly diagnosed breast cancer patient. American Journal of surgery 2009; 197: 159-163.
  46. Zhou M, Johnson N, Blanchard D et al. Real-world application of breast-specific gamma imaging, initial experience at a community breast center and its potential impact on clinical care. American Journal of Surgery 2008; 195: 631-635.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 10/19/16.

GUIDELINE UPDATE INFORMATION:

09/15/01

Original policy – investigational.

09/15/02

Reviewed and revised – continue investigational.

10/15/03

Annual review; remains investigational.

07/15/04

Scheduled review. No change in coverage statement.

08/15/05

Scheduled review. Updated references. Maintain investigational statement.

07/15/06

Scheduled review. No change in coverage statement (investigational). Updated references.

07/15/07

Scheduled review; no change in investigational status; reformatted guideline; updated references.

05/15/08

Scheduled review. No change in position statement. Updated references.

06/15/09

Annual review. Added specific gamma imaging to the guideline title and description section. Added specific gamma imaging to position statement (experimental or investigational).

12/15/10

Annual review: Revised guideline title; added “breast scintigraphy” and “molecular breast imaging”. Revised description. Revised position statement; added molecular breast imaging (experimental or investigational). Updated references.

04/15/11

Reviewed; no change in position statement. Updated references.

08/15/12

Annual review. Updated description. Maintain position statement, added in all applications, including but not limited to its use as an adjunct to mammography or in staging the axillary lymph nodes. Added 78800, 78801 and A9500. Updated references.

12/15/13

Scheduled review. No change in position statement. Added Medicare Advantage products program exception. Updated references.

11/15/14

Annual review. No change in position statement. Updated references.

12/15/15

Review; updated description, added position statement for preoperative or intraoperative sentinel lymph node detection using handheld or mounted mobile gamma cameras. Updated references.

11/15/16

Revision; added statement for gamma detection. Updated description and references.

Date Printed: October 23, 2017: 02:12 AM