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Medical Policy: 06.01.22
Original Effective Date: August 2006
Reviewed: December 2011
Revised: November 2007
Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Description:
Scintimammography is a nuclear imaging procedure performed with a gamma camera after intravenous administration of a radionuclide tracer, Tc99m methoxyisobutylisonitrile. It has been proposed to be used adjunctively with mammography as a method to improve patient selection for breast biopsy in individuals with suspicious or non-diagnostic mammography results or palpable breast lesions. It has been suggested scintimammography has the potential to reduce unnecessary invasive biopsies by differentiating benign from malignant lesions.
Clinical studies have not clearly demonstrated the ability of scintimammography to differentiate between benign and malignant breast lesions, or for detecting and staging axillary lymph node metastases in patients with known breast cancer, improves net health outcomes. As an adjunctive diagnostic test after mammography, the sensitivity and corresponding negative predictive value of scintimammography have not been proven high enough to influence treatment decisions. Scintimammography using large, planar whole-body cameras also presents challenges with detector positioning which significantly compromises spatial resolution.
Breast-specific gamma imaging (BSGI) is performed using recently developed high-resolution gamma cameras. These cameras, specially designed to image the breast, offer improved signal-to-noise ratio and improved spatial resolution to produce high-contrast images of small lesions. The dedicated breast cameras facilitate imaging from several angles to more closely resemble the cranial-caudal and medial-lateral-oblique mammographic views.
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Prior Approval:
Not applicable
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Policy:
Scintimammography is considered investigational for all indications, including but not limited to:
- As an adjunct to mammography for imaging breast tissue
- Detection of axillary metastases in patients with breast cancer
- Staging the axillary lymph nodes in patients with breast cancer
Breast-specific gamma imaging (BSGI) is considered investigational for all indications, including but not limited to:
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As a primary or second screening test for women considered at high-risk for breast cancer either by family history or confirmed BRCA1 or BRCA2 mutation
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As a second screening test for breast cancer after an indeterminate or suspicious mammogram
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To evaluate palpable masses not detected by mammogram or ultrasound
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As an adjunct for the diagnosis of breast cancer to determine the extent of the primary lesion, evaluate the axillary lymph nodes, or detect secondary occult lesions
While recent studies have produced promising observations, patient populations were small and highly select. Larger, multicenter studies are needed to validate the potential of BSGI as an adjunct screening or diagnostic modality and to further identify the subset of patients for whom this technology will improve net health outcomes and contribute to clinical management.
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Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
- S8080 Scintimammography (radioimmunoscintigraphy of the breast), unilateral, including supply of radiopharmaceutical
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Selected References:
- Bongers V et al. The Use of Scintimammography for Detecting the Recurrence of Loco-regional Breast Cancer: Histopathologically Proven Results. Nucl Med Comm 2004 Feb;25(2):145-9.
- Coover LR et al. Scintimammography with dedicated breast camera detects and localizes occult carcinoma. J Nucl Med 2004 Apr;45(4):553-8.
- Papantoniou V et al. 99mTc-(V)DMSA scintimammography in the assessment of breast lesions: comparative study with 99mTc-MIBI. Eur J Nucl Med 2001 Jul;28(7):923-8.
- Chiou JF, Lin MC, Chen DR et al. Usefulness of thallium-201 SPECT scintimammography to differentiate benign from malignant breast masses in mammographically dense breasts. Cancer Invest 2003; 21(6):863-8.
- Blue Cross Blue Shield Association. Technology Evaluation Center. Scintimammography. Technology Evaluation Center Assessments. 1997; Vol.12, Tab 19.
- Fondrinier E et al. Clinical experience with 99mTc MIBI scintimammography in patients with breast microcalcifications. Breast. 2004 Aug; 13(4):316-20.
- Bone B et al. Comparison of 99mTC sestamibi scintimammography and dynamic MR imaging as adjuncts to mammography in the diagnosis of breast cancer. Acta Radiol. 2003 Jan;44(1):28-34.
- Agency for Healthcare Research and Quality. Effectiveness of Noninvasive Diagnostic Tests for Breast Abnormalities. March 2006.
- 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; 237:274-280.
- O'Connor MK, Phillips SW, Hruska CB et al. Molecular Breast Imaging: Advantages and Limitations of a Scintimammographic Technique in Patients with Small Breast Tumors. Breast J. 2007 Jan-Feb; 13(1):3-11.
- 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. Breast J 2007 Sep-Oct; 13(5):465-9.
- Schillaci O, Cossu E, Roman P et al. High-resolution gamma-camera for molecular breast imaging: First clinical results. Phys Med. 2006;21S1:121-124.
- Brem RF, Fishman M, Rapelyea JA. Detection of ductal carcinoma in situ with mammography, breast-specific gamma imaging, and magnetic resonance imaging: a comparative study. Acad Radiol. 2007 Aug; 14(8):945-50.
- Brem RF, Floerke AC, Rapelyea JA et al. Breast-specific gamma imaging as an adjunct imaging modality for the diagnosis of breast cancer. Radiology. 2008 Jun;247(3):651-7.
- 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. Am J Surg. 2008 May;195(5):631-5;discussion 635.
- ECRI Institute. Breast-specific Gamma Imaging for Diagnosis and Screening of Breast Cancer. Plymouth Meeting (PA): ECRI Institute; 2010 January 18. 7p. [ECRI hotline response]. Also available: http://www.ecri.org.
- Hendrick RE. Radiation doses and Cancer risks from breast imaging studies. Radiology. 2010 Aug 24. [Epub ahead of print].
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Policy History:
Date Reason Action
June 2010 Annual review Policy renewed
December 2011 Annual review Policy renewed
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Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
practice and are neither employees nor agents of Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.
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