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DESCRIPTIONScintimammography is a diagnostic modality using radiopharmaceuticals to provide tumor-specific imaging of the breast. Recently, this modality has begun to be referred to as breast-specific gamma imaging (BSGI) or molecular breast imaging (MBI) when gamma cameras specifically devoted to breast imaging are used. After injection of the radiopharmaceutical, the breast is evaluated with planar or single positron emission computed tomography (SPECT) radionuclide imaging. Use of positive emission tomography (PET) of the breast is not covered in this policy. Scintimammography has been proposed primarily as an adjunct to mammography and physical examination in patients who have palpable masses or suspicious mammograms as a technique to improve patient selection for biopsy. If sufficiently predictive of benign lesion, scintimammography might be used to recommend against performing a biopsy, thus reducing the number of negative biopsies. Alternatively, if predictive of a malignant lesion in someone whose mammogram is interpreted as benign, then the sensitivity of screening would be improved. If scintimammography accurately assesses axillary lymph node status, patients might either undergo needed axillary dissection or avoid it when unnecessary.
Various different radiopharmaceuticals may be used, including but not limited to technetium-99m sestamibi (Miraluma®), thallium-201, indium-111 satumomab pendetide (Oncoscint CR/OV®), indium-111 pentetreotide (OctreoScan®), technetium-99m tetrofosmin, and technetium-99m arcitumomab (CEA-Scan®). At the present time, only technetium-99m sestamibi has specific U. S. Food and Drug Administration (FDA) approval for use in breast imaging. The labeling states that technetium-99m sestamibi is a second-line diagnostic test after mammography to assist in the evaluation of breast lesions in patients with an abnormal mammogram or breast mass. It is not indicated for breast cancer screening or to confirm the presence or absence of malignancy, and it is not an alternative to biopsy prompted by an abnormal mammogram or breast mass.
Several scintillation or gamma cameras have general 510(k) marketing clearance from the FDA, which states that they are cleared for "use in imaging the distribution of radionuclides in the human body using planar imaging techniques." Two examples of gamma cameras used in scintimammography/breast- specific gamma imaging are Dilon 6800 (Dilon Technologies) and LumaGEM™ (Gamma Medica Instruments).
POLICYScintimammography, breast-specific gamma imaging, and molecular breast imaging are considered investigational in all applications, including but not limited to its use as an adjunct to mammography or in staging the axillary lymph nodes.
Radiopharmaceuticals used in the above mentioned procedures include, but are not limited to technetium-99m sestabmibi (Miraluma®), thallium-201, indium-111 satumomab pendetide (Oncoscint CR/OV®), indium-11 pentetreotide (OctreoScan®), and technetium-99m arcitumomab (CEA-Scan®) are considered investigational.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY8/1998: Approved by Medical Policy Advisory Committee (MPAC)
1/29/2001: HCPCS A4642 added
2/11/2002: Investigational definition added
5/2/2002: Type of Service and Place of Service deleted
9/10/2004: Code Reference section updated, HCPCS A4642 note "(Included in code S8080, do not report separately)" added, HCPCS A9500, A9505, Q3088, S8080 added with note "Included in code S8080, do not report separately"
8/24/2005: Code Reference section updated, HCPCS A4641 added
3/14/2006: Coding updated. HCPCS revisions added to policy
3/21/2006: Policy reviewed, no changes
1/3/2007: Code reference section updated per the 2007 CPT/HCPCS revisions
7/18/2007: Policy reviewed, no changes
12/19/2007: Coding updated per 2008 CPT/HCPCS revisions
7/22/2008: Policy reviewed, no changes
8/26/2009: Description updated. Policy statement updated. HCPCS codes A9549 and A9565 were deleted from the coding reference section due to deleted code status. These codes were deleted as of 2006 and 2007.
05/28/2010: Policy reviewed. No changes to policy description; policy statement unchanged. FEP verbiage added to the Policy Exceptions section. Added CPT codes 78800, 78801, and 78802 and ICD-9 procedure code 92.19 to the Non-Covered codes table.
12/30/2010: Added "molecular breast imaging" to the policy title and statement.
07/12/2012: Policy reviewed; no changes.
SOURCE(S)Blue Cross Blue Shield Association policy #6.01.18
CODE REFERENCEThis is not an all-inclusive list of non-covered procedure codes.
All codes billed for this procedure are considered investigational and not eligible for coverage.