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Scintimammography refers to the use of radiotracers with nuclear medicine imaging as a diagnostic tool for abnormalities of the breast. Breast-specific gamma imaging (BSGI), or molecular breast imaging (MBI), refers to specific types of imaging machines that are used in conjunction with scintimammography to improve diagnostic performance.
Scintimammography is a diagnostic modality using radiopharmaceuticals to detect tumors of the breast. After intravenous injection of a radiopharmaceutical, the breast is evaluated using planar imaging. Scintimammography is performed with the patient lying prone and the camera positioned laterally, which increases the distance between the breast and the camera. Scintimammography using conventional imaging modalities has relatively poor sensitivity in detecting smaller lesions (eg, <15 mm), because of the relatively poor resolution of conventional gamma cameras in imaging the breast.
BSGI and MBI were developed to address this issue. 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 images can be compared with mammographic images. BSGI and MBI differ primarily in the number and type of detectors used (eg, multicrystal arrays of cesium iodide or sodium iodide, or nonscintillating, semiconductor materials, such as cadmium zinc telluride). In some configurations, a detector is placed on each side of the breast and used to lightly compress it. The maximum distance between the detector and the breast is therefore from the surface to the midpoint of the breast. Much research on BSGI and MBI has been conducted at the Mayo Clinic. The radiotracer typically used is technetium Tc-99m sestamibi. MBI imaging takes approximately 40 minutes.
BSGI and MBI have been suggested for a variety of applications. In a 2010 practice guideline for breast scintigraphy with breast specific gamma cameras, the Society of Nuclear Medicine provided a list of common uses, as follows:
The guideline acknowledged other efforts, such as the American College of Radiology’s Appropriateness Criteria and the American College of Surgeons’ Consensus Conference III.
The primary radiopharmaceutical used with BSGI or MBI is technetium Tc-99m sestamibi (marketed by Draxis Specialty Pharmaceuticals, Cardinal Health 414, Mallinckrodt, and Pharmalucence). The product label states that technetium Tc-99m sestamibi is “indicated for planar imaging as a second-line diagnostic drug after mammography to assist in the evaluation of breast lesions in patients with an abnormal mammogram or a palpable breast mass. Technetium Tc-99m sestamibi is not indicated for breast cancer screening, to confirm the presence or absence of malignancy, and it is not an alternative to biopsy.”
Technetium TC-99m tetrofosmin (Myoview™), a gamma-emitter used in some BSGI studies, is U.S. Food and Drug Administration (FDA)-approved only for cardiac imaging.
The radiation dose associated with BSGI is substantial for diagnostic breast imaging modalities. According to Appropriateness Criteria from the ACR, the radiation dose from BSGI is 10 to 30 mSv, which is 15 to 30 times higher than the dose from a digital mammogram. According to ACR Appropriateness Criteria, at these levels BSGI is not indicated for breast cancer screening.
According to another study, the radiation dose to the breast from the 20 mCi (740 MBq) dose of technetium Tc-99m sestamibi used for BSGI at 1 center is 0.13 rad or 1.3 mGy, less than the 0.75 rad the authors reported for mammography, except that the dose is given to the entire body. The authors asserted that this dose poses an “extremely low risk of harmful effects to the patient” but that it should be reduced by a factor of 5 to 10 if BSGI were to be used as a regular screening technique. The authors also estimated that the cost of BSGI is 3 to 4 times that of mammography.
Another article published online in August 2010 calculated mean glandular doses, and from those, lifetime attributable risks (LAR) of cancer, due to film mammography, digital mammography, BSGI, and positron emission mammography (PEM). The author, who is a consultant to GE Healthcare and a member of the medical advisory boards of Koning (manufacturer of dedicated breast computed tomography [CT]) and Bracco (MR contrast agents), used group risk estimates from the Biological Effects of Ionizing Radiation (BEIR) VII report to assess the risk of radiation-induced cancer and mortality from breast imaging studies. For a patient with average-sized breasts (compressed thickness during mammography of 5.3 cm per breast), estimated LARs of cancer at age 40 were:
Corresponding lifetime attributable risks of cancer mortality at age 40 were:
A major difference in the impact of radiation between mammography, on the one hand, and BSGI or PEM, on the other, is that for mammography, the substantial radiation dose is limited to the breast. With BSGI and PEM, all organs are irradiated, increasing the risks associated with BSGI and PEM. Researchers at the Mayo Clinic have investigated lower dose versions of MBI, and 2 small studies (NCT01653964, NCT01285440; total N=232) are ongoing. (A larger study of reduced-dose MBI in 2000 women with dense breast tissue on mammography and increased cancer risk has been suspended [NCT01723124]). Mayo Clinic researchers assert that this new approach will “make MBI comparable with screening mammography in terms of radiation exposure.” It is unclear whether this statement refers to breast exposure or whole body exposure.
Notes: The term “molecular breast imaging” is used in different ways, sometimes for any type of breast imaging involving molecular imaging, including PEM, and sometimes limited to imaging with a type of breast-specific gamma camera, as used in this policy.
Use of single positron emission computed tomography (SPECT) and positron emission tomography (PET) of the breast are not covered in this policy.
Several scintillation (gamma) cameras have general 510(k) marketing clearance from FDA, which states that they are cleared for “measuring and imaging the distribution of radionuclides in the human body by means of photon detection.” Two examples of gamma cameras used in BSGI or MBI (FDA Product Code IYX) are Dilon 6800® (Dilon Technologies, Newport News, VA) and LumaGEM™ (Gamma Medica, Salem, NH).
Related policies -
POLICYScintimammography, breast-specific gamma imaging, and molecular breast imaging are considered investigational in all applications, including but not limited to their use as an adjunct to mammography or in staging the axillary lymph nodes.
Preoperative or intraoperative sentinel lymph node detection using handheld or mounted mobile gamma cameras is 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 is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
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.
08/14/2013: Policy reviewed; no changes.
07/31/2014: Policy title changed from "Scintimammography/Breast-Specific Gamma Imaging/Molecular Breast Imaging" to "Scintimammography and Gamma Imaging of the Breast and Axilla." Policy description revised. First policy statement revised to change "its" to "their." Deleted the following policy statement: 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. Added the following policy statement: Preoperative or intraoperative sentinel lymph node detection using handheld or mounted mobile gamma cameras is considered investigational.
09/01/2015: Code Reference section updated for ICD-10.
09/25/2015: Policy description updated. Policy statement unchanged. Investigative definition updated in the Policy Guidelines section.
SOURCE(S)Blue Cross Blue Shield Association policy #6.01.18
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.