mp-452 - Medical Policies - Alabama
Scintimammography and Gamma Imaging of the Breast and Axilla
Policy Number: MP-452
Latest Review Date: September 2020
Policy Grade: B
Scintimammography, breast-specific gamma imaging, and molecular breast imaging is considered not medically necessary and investigational in all applications, including but not limited to their use as an adjunct to mammography or in staging the axillary lymph nodes.
The use of breast-specific gamma detection following radiopharmaceutical administration for localization of sentinel lymph nodes in individuals with breast cancer may be considered medically necessary.
DESCRIPTION OF PROCEDURE OR SERVICE:
Scintimammography, breast-specific gamma imaging (BSGI), and molecular breast imaging (MBI) all refer to the use of radiotracers with nuclear medicine imaging as a diagnostic tool for abnormalities of the breast. These tests are distinguished by the use of differing gamma camera technology which may improve diagnostic performance for detecting small lesions. BSGI uses single-head breast-specific gamma camera and a compression device; whereas, MBI uses dual-head breast-specific gamma cameras that also produce breast compression. Preoperative lymphoscintigraphy and/or intraoperative hand-held gamma detection of sentinel lymph nodes is a method of identifying sentinel lymph nodes for biopsy after radiotracer injection. Surgical removal of one or more sentinel lymph nodes is an alternative to full axillary lymph node dissection for staging evaluation and management of breast cancer.
Mammography is the main screening modality for breast cancer, despite its limitations in terms of less than ideal sensitivity and specificity. Limitations of mammography are a particular issue for women at high risk of breast cancer, for whom cancer risk exceeds the inconvenience of more frequent screening starting at a younger age with more frequent false-positive results. Furthermore, the sensitivity of mammography is lower in women with radiographically dense breasts, which is more common among younger women. The clinical utility of adjunctive screening tests is primarily in the evaluation of women with inconclusive results on mammography. A biopsy is generally performed on a breast lesion if imaging cannot rule out malignancy with certainty. Therefore, adjunctive tests will be most useful in women with inconclusive mammograms if they have a high negative predictive value (NPV), and can preclude the need for biopsy. Additional imaging for asymptomatic women who have dense breasts and negative mammograms has been suggested, but the best approach is subject to debate (see the 2013 TEC Special Report).
Scintimammography is a diagnostic modality using radiopharmaceuticals to detect tumors of the breast. After intravenous injection of a radiopharmaceutical, the breast is evaluated with 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. Special camera positioning to include the axilla may be included when the area of interest is evaluation for axillary metastases. Scintimammography using conventional imaging modalities has relatively poor sensitivity in detecting smaller lesions (e.g., smaller than 15mm) because of the relatively poor resolution of conventional gamma cameras in imaging the breast.
Breast-Specific Gamma Imaging
Breast-specific gamma imaging (BSGI) and molecular breast imaging (MBI) were developed to address this issue. Breast-specific gamma cameras acquire images while the patient is seated in a position similar to mammography and the breast is lightly compressed. Detector heads are immediately next to the breast, increasing resolution, and the images can be compared with the mammographic images. Breast-specific gamma imaging and molecular breast imaging differ primarily in the type and number of detectors used (e.g., multi-crystal arrays of cesium iodide or sodium iodide, or non-scintillating, 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. The radiotracer typically used is technetium Tc-99m sestamibi. MBI imaging takes approximately 40 minutes.
Lymphoscintigraphy and Hand-Held Gamma Detection
Preoperative lymphoscintigraphy and/or intraoperative hand-held gamma detection of sentinel lymph nodes is a method of identifying sentinel lymph nodes for biopsy after radiotracer injection. Surgical removal of one or more sentinel lymph nodes is an alternative to full axillary lymph node dissection for staging evaluation and management of breast cancer. Several trials have compared outcomes following sentinel lymph node biopsy versus axillary lymph node dissection for managing patients with breast cancer. The National Surgical Adjuvant Breast and Bowel Project (NSABP) trial B-32 examined whether sentinel lymph node dissection (SLND) provides similar survival and regional control as full axillary lymph node dissection in the surgical staging and management of patients with clinically invasive breast cancer. This multicenter randomized controlled trial included 5611 women and observed statistically similar results for overall survival, disease-free survival, and regional control based on 8-year Kaplan-Meier estimates. Additional 3-year follow-up of morbidity after surgical node dissection revealed lower morbidity in the SLND group, including lower rates of arm swelling, numbness, tingling, and fewer early shoulder abduction deficits. A recent systematic review and meta-analysis by Ram et al (2014) reported no significant difference in overall survival (hazard ratio [HR], 0.94; 95% confidence interval [CI], 0.79 to1.19), no significant difference in disease-free survival (HR=0.83; 95% CI, 0.60 to 1.14), and similar rates of locoregional recurrence. However, axillary node dissection was associated with significantly greater surgical morbidity (e.g., wound infection, arm swelling, motor neuropathy, numbness) than sentinel node biopsy.
Scintimammography, BSGI, and MBI
The primary radiopharmaceutical used with BSGI or MBI is technetium 99m (Tc 99m) sestamibi. The product label states that technetium-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.
Preoperative or Intraoperative Lymphoscintigraphy and/or Hand-Held Gamma Detection of Sentinel Lymph Nodes
The primary radiopharmaceuticals used for lymphoscintigraphy include Tc-99m-pertechnetate-labeled colloids and Tc-99m-tilmanocept (Lymphoseek). Whereas, Tc-99m sulfur colloid may be frequently used for intraoperative injection and detection of sentinel lymph nodes using hand-held gamma detection probe.
Scintimammography, BSGI, and MBI
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, at these levels BSGI is not indicated for breast cancer screening.
According to a 2015 study by Hruska and O’Connor (who report receiving royalties from licensed technologies by an agreement with Mayo Clinic and Gamma Medica), the effective dose from a lower “off-label” administered dose of 240-300 MBq (6.5-8 mCi) of Tc 99m sestamibi that is made feasible with newer dual-head MBI systems, is 2.0-2.5 mSv. For comparison, the effective dose (i.e., mean glandular dose) of digital mammography is estimated to be about 0.5 mSv. However, it is important to note that the dose for MBI is given to the entire body. The authors compared this dose with the estimated annual background radiation, which varies worldwide between 2.5 – 10 mSv and asserted that the effective dose from MBI “is considered safe for use in routine screening.”
A 2010 article 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 of this study, 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:
- 5 per 100,000 for digital mammography (breast cancer only),
- 7 per 100,000 for screen film mammography (breast cancer only),
- 55-82 per 100,000 for BSGI (depending on the dose of technetium Tc-99m sestamibi), and
- 75 for 100,000 for PEM.
Corresponding lifetime attributable risks of cancer mortality at age 40 were:
- 1.3 per 100,000 for digital mammography (breast cancer only),
- 1.7 per 100,000 for screen film mammography (breast cancer only),
- 26-39 per 100,000 for BSGI, and
- 31 for 100,000 for PEM.
A major difference in the impact of radiation between mammography and BSGI or PEM 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 radiation exposure.
Although the use of BSGI (or MBI) has been proposed for women at high-risk of breast cancer, there is controversy and speculation over whether some women (eg, those with BRCAvariants) have a heightened radiosensitivity. If women with BRCA variants are more radiosensitive than the general population, studies may underestimate the risks of breast imaging with ionizing radiation (ie, mammography, BSGI, MBI, positron emission mammography, single-photon emission computed tomography/computed tomography, breast-specific computed tomography, tomosynthesis) in these women. In contrast, ultrasonography and MRI do not use radiation. More research is needed to resolve this issue. Also, the risk associated with radiation exposure will be greater for women at high-risk of breast cancer, whether or not they are more radiosensitive because they start screening at a younger age when the risks associated with radiation exposure are greater. In addition, a large, high-quality, head-to-head comparison of BSGI (or MBI) and MRI would be needed, especially for women at high-risk of breast cancer, because MRI, alternated with mammography, is currently the recommended screening technique.
Notes: The term “molecular breast imaging” is used in different ways, sometimes for any type of breast imaging involving molecular imaging, including positron emission mammography (PEM) and sometimes it is used synonymously with the term breast-specific gamma camera, as used in this review.
Use of single photon emission computed tomography (SPECT) and positron emission tomography (PET) of the breast are not covered in this review.
The most recent literature review was updated through July 13, 2020.
Summary of Evidence
Scintimammography, Breast-Specific Gamma Imaging, and Molecular Breast Imaging for Diagnosis
For individuals who have dense breasts or high risk for breast cancer who receive scintimammography, BSGI or MBI as an adjunct to mammography, the evidence includes diagnostic accuracy studies. Relevant outcomes are overall survival, disease-specific survival, test validity, and treatment-related morbidity. Three prospective studies have assessed the incremental difference in diagnostic accuracy when BSGI (or MBI) is added to mammography in women at increased risk. Sensitivity was higher with combined BSGI (or MBI) and mammography, but specificity was lower. A retrospective study found improved diagnostic accuracy and specificity with BSGI compared to ultrasonography when added to mammmography. Studies of women at increased risk of breast cancer and negative mammograms found that a small number of additional cancers were detected. Studies tended to include women at different risk levels (e.g., women with dense breasts and those with BRCA1). Moreover, any potential benefits need to be weighed against potential risks of additional radiation exposure. The evidence is insufficient to determine the effects of the technology on health outcomes.
For individuals who have indeterminate or suspicious breast lesions who receive scintimammography and BSGI, the evidence includes diagnostic accuracy studies. Relevant outcomes are overall survival, disease-specific survival, test validity, and treatment-related morbidity. In the available studies, compared with biopsy, the negative predictive value (NPV) of BSGI or MBI varied from 83% to 94%. Given the relative ease and diagnostic accuracy of the criterion standard of biopsy, coupled with the adverse consequences of missing a breast cancer, the NPV of BSGI or MBI would have to be extremely high to alter treatment decisions. The evidence to date does not demonstrate this level of NPV. Moreover, the value of BSGI in evaluating indeterminate or suspicious lesions must be compared with other modalities that would be used, such as spot views for diagnostic mammography. The evidence is insufficient to determine the effects of the technology on health outcomes.
For individuals who have breast cancer undergoing surgical planning for breast-conserving therapy who receive scintimammography and BSGI for disease detection, the evidence includes a retrospective observational study. Relevant outcomes are OS, disease-specific survival, test validity, and treatment-related morbidity. In the retrospective study, results suggested that MRI identified more patients than BSGI who were not appropriate candidates for breast-conserving therapy. Prospective comparative studies are needed. The evidence is insufficient to determine the effects of the technology on health outcomes.
Scintimammography and BSGI for Treatment
For individuals who have breast cancer undergoing detection of axillary metastases who receive scintimammography and BSGI, the evidence includes diagnostic accuracy studies and systematic reviews of diagnostic accuracy studies. Relevant outcomes are overall survival, disease-specific survival, test accuracy and validity, and treatment-related morbidity. A meta-analysis of the available diagnostic accuracy studies found that the sensitivity and specificity of BGSI is not high enough for this technology to replace the current standard practice, surgical nodal dissection. The evidence is insufficient to determine the effects of the technology on health outcomes.
Radiopharmaceutical and Gamma Detection for Treatment
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 includes three studies and a meta-analysis. Relevant outcomes are overall survival, disease-specific survival, test validity, and treatment-related morbidity. Evidence indicates that using radiopharmaceutical and gamma detection for localization of sentinel lymph nodes yield high success rates in identifying sentinel lymph nodes; additionally, the diagnostic performance generally offers better detection rates using radiopharmaceutical than with blue dye methods and similiar detection rates with indocyanine green fluorescence. The evidence indicates 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.
Practice Guidelines, and Position Statements
Society of Nuclear Medicine
The Society of Nuclear Medicine released a 2010 procedure guideline on breast scintigraphy using breast-specific gamma cameras. The guideline was based on consensus, not on a systematic review of the literature or assessment of study quality, and most of it discusses procedures and specifications of the examination, documentation and recording, quality control, and radiation safety. The guidelines also listed common clinical indications for breast-specific gamma imaging but did not discuss the level of evidence for each indication.
American College of Obstetricians and Gynecologists
The American College of Obstetricians and Gynecologists (2017) updated its 2011 practice bulletin on breast cancer screening in average-risk women. There was no discussion or recommendation for scintimammography or any other gamma imaging techniques for routine screening.
American College of Radiology
Appropriateness Criteria from the American College of Radiology rated breast-specific gamma imaging a 1 or 2 (indicating "usually not appropriate" for breast cancer screening), in patients with high or intermediate breast cancer risk (last reviewed in 2017), palpable breast masses (last reviewed in 2017), and workup of breast pain (last reviewed in 2018). New guidelines on screening for breast cancer in above average-risk patients (last reviewed in 2018) do not mention breast-specific gamma imaging comment on do not recommend the use of MBI for breast cancer screening in any higher-risk population. The guidelines state, “further advances in detector technology to allow lower dosing, more widespread penetration of MBI-guided biopsy capabilities, and additional large prospective trials (to include incidence screening results) will be needed before MBI can be embraced as a screening tool, even in women at elevated risk.”
American Society of Clinical Oncology
In 2016, the American Society of Clinical Oncology reaffirmed its 2014 recommendations on the use of sentinel node biopsy (SNB) for patients with early-stage breast cancer. The recommendations were based on randomized controlled trials, systematic reviews, meta-analyses, and clinical practice guidelines from 2012 through July 2016. The recommendations included:
“Women without sentinel lymph node (SLN) metastases should not receive axillary lymph node dissection (ALND). Women with one to two metastatic SLNs who are planning to undergo breast-conserving surgery with whole-breast radiotherapy should not undergo ALND (in most cases). Women with SLN metastases who will undergo mastectomy should be offered ALND. These three recommendations are based on randomized controlled trials. Women with operable breast cancer and multicentric tumors, with ductal carcinoma in situ, who will undergo mastectomy, who previously underwent breast and/or axillary surgery, or who received preoperative/neoadjuvant systemic therapy may be offered SNB. Women who have large or locally advanced invasive breast cancer (tumor size T3/T4), inflammatory breast cancer, or ductal carcinoma in situ (when breast-conserving surgery is planned) or are pregnant should not undergo SNB.”
National Comprehensive Cancer Network
The National Comprehensive Cancer Network guideline for Breast Cancer (v.4.2020) for invasive breast cancer with clinical stage I, IIA, IIB, and IIIA T3, N1, M0 (BINV-D) includes sentinel node mapping and excision for clinically node negative patients at time of diagnosis or following negative FNA or core biopsy of clinically positive nodes at time of diagnosis. If the sentinel nodes are found to be negative on pathological examination, then no further axillary surgery is suggested (category 1 recommendation).
Network guidelines on breast cancer screening and diagnosis (v.1.2019) state: “Current evidence does not support the routine use of molecular imaging (e.g. breast-specific gamma imaging, sestamibi scan, or positron emission mammography) as screening procedures, but there is emerging evidence that these tests may improve detection of early breast cancers among women with mammographically dense breasts. However, the whole-body effective radiation dose with these tests is substantially higher than that of mammography.”
U.S. Preventive Services Task Force Recommendations
Scintimammography, breast-specific gamma imaging, BSGI, molecular breast imaging, MBI, Miraluma®, Dilon 6800®, LumaGEM™, RadioGenix™ System
APPROVED BY GOVERNING BODIES:
Several scintillation or gamma cameras have general 510(k) marketing clearance from the FDA, which states that they are cleared for “measuring and imaging the distribution of radionuclides in the human body by means of photon detection.” Examples of gamma cameras used in breast-specific gamma imaging are Dilon 6800® (Dilon Technologies, Newport News, VA) and single-head configurations of Discovery NM750b (GE Healthcare, Milwaukee, WI). Dual-head cameras used in molecular breast imaging include LumaGEM™ (Gamma Medical, Salem, NH) (FDA product code IYX) and Discovery NM750b (GE Healthcare, Milwaukee, WI).
Technetium 99m (Tc-99m) sestamibi (marketed by Sun Pharmaceuticals Industries, Lantheus Medical Imaging, Cardinal Health 414, AnazaoHealth, Curium US, Jubilant Draximage) has been approved by FDA with the following labeling: “Breast Imaging: 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.”
In March 2013, Tc-99m-tilmanocept (Lymphoseek; Cardinal Health) was first approved by the FDA for use in breast cancer and melanoma as a radioactive diagnostic imaging agent that may help to localize lymph nodes.
Technetium-99m-sulfur colloid was approved by FDA through the new drug application (GE Healthcare, NDA 017456; Mallinckrodt, NDA 017724) process although these products appear to be marketed no longer. In addition, in 2011, Technetium Tc 99m Sulfur Colloid Kit (Sun Phamaceutical Industries) was approved by FDA through the NDA process (NDA 017858) for use as an injection to localize lymph nodes in breast cancer patients.
In 2018, FDA granted approval to Northstar Medical Radioisotopes for its RadioGenix™ System, which produces molybdenum 99, the material used to generate Tc 99m. Previously, molybdenum 99 was only produced from enriched uranium in facilities outside of the United States.
Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.
ITS: Home Policy provisions apply
FEP: Special benefit consideration may apply. Refer to member’s benefit plan. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.
Lymphatics and lymph node imaging
Radiopharmaceutical localization of tumor or distribution of radiopharmaceutical agent(s); planar, single area, single day imaging
Radiopharmaceutical localization of tumor or distribution of radiopharmaceutical agent(s); planar, 2 or more areas, 1 or more days imaging or single area imaging over 2 or more days
Radiopharmaceutical localization of tumor or distribution of radiopharmaceutical agent(s); tomographic (SPECT), single area, single day imaging
Scintimammography (radioimmunoscintigraphy of the breast), unilateral, including supply of radiopharmaceutical
- American College of Obstetricians and Gynecologists (ACOG). Breast cancer screening, ACOG Practice Bulletin no. 122. Washington, DC: American College of Obstetricians and Gynecologists; Aug 2011: guidelines.gov/content.aspx?id=34275&search=scintimammography.
- American College of Obstetricians and Gynecologists Committee on Practice Bulletins-Gynecology. Breast Cancer Risk Assessment Screening in Average-Risk Women Practice Bulletin 179. 2017; www.acog.org Accessed August 23, 2017.
- American College of Radiology (ACR). Appropriateness criteria®: breast cancer screening, date of origin 2012. Available online at: www.acr.org/Quality-Safety/Appropriateness- Criteria/Diagnostic.
- American College of Radiology (ACR). Appropriateness criteria®: breast microcalcifications - initial diagnostic workup, last review date 2009. Available online at: www.acr.org/Quality- Safety/Appropriateness-Criteria/Diagnostic.
- American College of Radiology (ACR). Appropriateness criteria®: breast pain, date of origin 2014. acsearch.acr.org/docs/3091546/Narrative/.
- American College of Radiology (ACR). Appropriateness criteria®: palpable breast masses, last review date 2012. Available online at: www.acr.org/Quality-Safety/Appropriateness- Criteria/Diagnostic/Breast-Imaging.
- Berrington de Gonzalez A, Berg CD, Visvanathan K et al. Estimated risk of radiation-induced breast cancer from mammographic screening for young BRCA mutation carriers. J Natl Cancer Inst 2009; 101(3):205-209.
- 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. TEC Assessments 2013; Volume 28, Tab 15.
- Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). TEC Special Report: screening asymptomatic women with dense breasts and normal mammograms for breast cancer. TEC Assessments 2013; Volume 28, Tab 2.
- 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; 14(8):945-950.
- 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; 247(3):651-657.
- Brem RF, Ioffe M, Rapelyea JA et al. Invasive lobular carcinoma: Detection with mammography, sonography, MRI, and breast-specific gamma imaging. AJR Am J Roentgenol 2009; 192(2):379-383.
- Brem RF, Petrovitch I, Rapelyea JA et al. Breast-specific gamma imaging with 99m Tc-sestamibi and magnetic resonance imaging in the diagnosis of breast cancer—a comparative study. Breast J 2007; 13(5):465-469.
- 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.
- Brem RF, Ruda RC, Yang JL, et al. Breast-Specific gamma-Imaging for the Detection of Mammographically Occult Breast Cancer in Women at Increased Risk. J Nucl Med. May 2016; 57(5):678-684.
- 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. Acad Radiol 2010; 17(6):735-743.
- Bricou A, Duval MA, Charon Y et al. Mobile gamma cameras in breast cancer care - A review. Eur J Surg Oncol 2013.
- Bruening W, Launders J, Pinkney N et al. Effectiveness of Noninvasive Diagnostic Tests for Breast Abnormalities. Comparative Effectiveness Review No. 2. (Prepared by ECRI Evidence-based Practice Center under contract No. 290-02-0019.) Rockville, MD: Agency for Healthcare Research and Quality. February 2006. Available at: www.effectivehealthcare.arhq.gov/reports/final.cfm.
- Cho MJ, Yang JH, Yu YB, et al. Validity of breast-specific gamma imaging for Breast Imaging Reporting and Data System 4 lesions on mammography and/or ultrasound. Ann Surg Treat Res. Apr 2016; 90(4):194-200.
- Committee on Practice Bulletins-Gynecology. Practice Bulletin Number 179: Breast cancer risk assessment and screening in average-risk women. Obstet Gynecol. Jul 2017;130(1):e1-e16.
- Edwards C, Williams S, McSwain AP et al. Breast-specific gamma imaging influences surgical management in patients with breast cancer. Breast J 2013; 19(5):512-519.
- Ernestos B, Nikolaos P, Koulis G et al. Increased chromosomal radiosensitivity in women carrying BRCA1/BRCA2 mutations assessed with the G2 assay. Int J Radiat Oncol Biol Phys 2010; 78(4):1199-1205.
- FDA. Gamma Medica™ Instruments 510(k) summary - January 18, 2000. Available online at: www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K993813.
- GE Healthcare. Myoview™kit for the preparation of technetium Tc99m tetrofosmin for injection, May 2011. Available online at: www.gehealthcare.com/en/Products/Categories/Nuclear_Imaging_Agents/Myoview.
- Goldsmith SJ, Parsons W, Guiberteau MJ et al. SNM practice guideline for breast scintigraphy with breast-specific gamma-cameras 1.0. J Nucl Med Technol 2010; 38(4):219-224.
- 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. Nucl Med Commun. Jul 2016; 37(7):675-688.
- Health risks from exposure to low levels of ionizing radiation: BEIR VII, Phase 2. Washington, DC: National Research Council of the National Academies Press; 2006.
- Hendrick RE. Radiation doses and cancer risks from breast imaging studies. Radiology 2010; 257(1):246-253.
- Hruska CB, Boughey JC, Phillips SW et al. Scientific Impact Recognition Award: Molecular breast imaging: a review of the Mayo Clinic experience. Am J Surg 2008; 196(4):470-476.
- 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.
- Hruska CB, O'Connor MK. Nuclear imaging of the breast: translating achievements in instrumentation into clinical use. Med Phys 2013; 40(5):050901.
- Hruska CB, Phillips SW, Whaley DH et al. Molecular breast imaging: use of a dual-head dedicated gamma camera to detect small breast tumors. AJR Am J Roentgenol 2008; 191(6):1805-1815.
- Hruska CB, Rhodes DJ, Collins DA et al. Evaluation of molecular breast imaging in women undergoing myocardial perfusion imaging with Tc-99m sestamibi. J Womens Health 2012; 21(7):730-738.
- Hussain R, Buscombe JR. A meta-analysis of scintimammography: an evidence-based approach to its clinical utility. Nucl Med Commun 2006; 27(7):589-594.
- Johnson CB, Boneti C, Korourian S, et al. Intraoperative injection of subareolar or dermal radioisotope results in predictable identification of sentinel lymph nodes in breast cancer. Ann Surg. Oct 2011;254(4):612-618.
- Jones EA, Phan TD, Johnson NM et al. A protocol for imaging axillary lymph nodes in patients undergoing breast-specific γ-imaging. J Nucl Med Technol 2010; 38(1):28-31.
- Keto JL, Kirstein L, Sanchez DP et al. MRI versus breast-specific gamma imaging (BSGI) in newly diagnosed ductal cell carcinoma-in-situ: a prospective head-to-head trial. Ann Surg Oncol 2012; 19(1):249-252.
- 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? Am J Surg 2009; 198(4):470-474.
- Kim BS, Moon BI, Cha ES. A comparative study of breast-specific gamma imaging with the conventional imaging modality in breast cancer patients with dense breasts. Ann Nucl Med 2012; 26(10):823-829.
- Kim BS. Usefulness of breast-specific gamma imaging as an adjunct modality in breast cancer patients with dense breast: a comparative study with MRI. Ann Nucl Med 2012; 26(2):131-137.
- Kim JS, Lee SM, Cha ES. The diagnostic sensitivity of dynamic contrast-enhanced magnetic resonance imaging and breast-specific gamma imaging in women with calcified and non-calcified DCIS. Acta Radiol 2013.
- Lantheus Medical Imaging. Cardiolite® kit for the preparation of technetium Tc99m sestamibi for injection, July 2010. Available online at: www.cardiolite.com/healthcare-professionals/prescribing-info.asp.
- Lee HS, Ko BS, Ahn SH et al. Diagnostic performance of breast-specific gamma imaging in the assessment of residual tumor after neoadjuvant chemotherapy in breast cancer patients. Breast Cancer Res Treat. May 2014;145(1):91-100.
- Lyman GH, Somerfield MR, Giuliano AE. Sentinel Lymph Node Biopsy for Patients with Early-Stage Breast Cancer: 2016 American Society of Clinical Oncology Clinical Practice Guideline Update Summary. J Oncol Pract. Mar 2017; 13(3):196-198.
- Martin RC, 2nd, Edwards MJ, Wong SL, et al. Practical guidelines for optimal gamma probe detection of sentinel lymph nodes in breast cancer: results of a multi-institutional study. For the University of Louisville Breast Cancer Study Group. Surgery. Aug 2000;128(2):139-144.
- Mathew MA, Saha AK, Saleem T, et al. Pre-operative lymphoscintigraphy before sentinel lymph node biopsy for breast cancer. Breast. Feb 2010;19(1):28-32.
- Medical Policy Reference Manual. Scintimammography/Breast-Specific Gamma Imaging/Molecular Breast Imaging. 6.01.18 Oct. 2010.
- Meissnitzer T, Seymer A, Keinrath P, et al. The added value of semiquantitative Breast-Specific Gamma Imaging in the work-up of suspicious breast lesions compared to mammography, ultrasound and 3T MR Imaging. Br J Radiol. Apr 17 2015:20150147.
- Monticciolo DL, Newell MS, Moy L, et al. Breast cancer screening in women at higher-than-average risk: Recommendations from the ACR. J Am Coll Radiol. Mar 2018;15(3 Pt A):408-414.
- Moy L, Heller SL, Bailey L, et al. ACR Appropriateness Criteria(R) Palpable Breast Masses. J Am Coll Radiol. May 2017; 14(5s):S203-s224.
- National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Breast Cancer. Version 2.2019. https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed July 9, 2019.
- National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Breast Cancer Screening and Diagnosis. Version 1.2019. May17, 2019; https://www.nccn.org/professionals/physician_gls/pdf/breast-screening.pdf.
- National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Breast Cancer. Version 1.2018. https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed July 26, 2018.
- National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Breast Cancer Screening and Diagnosis. Version 2.2018. 2018; https://www.nccn.org/professionals/physician_gls/pdf/breast-screening.pdf. Accessed July 26, 2018.
- National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Breast Cancer. Version 2.2017. www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed August 23, 2017.
- National Research Council of the National Academies. Health risks from exposure to low levels of ionizing radiation: BEIR VII, Phase 2—Committee to Assess Health Risks for Exposure to Low Levels of Ionizing Radiation. Washington, DC: National Academies Press, 2006.
- O’Connor M, Rhodes D, Hruska C. Molecular breast imaging. Expert Rev Anticancer Ther 2009; 9(8):1073-1080.
- Park JS, Lee AY, Jung KP et al. Diagnostic Performance of Breast-Specific Gamma Imaging (BSGI) for Breast Cancer: Usefulness of Dual-Phase Imaging with 99mTc-sestamibi. Nucl Med Mol Imaging 2013; 47(1):18-26.
- Park KS, Chung HW, Yoo YB et al. Complementary role of semiquantitative analysis of breast-specific gamma imaging in the diagnosis of breast cancer. AJR Am J Roentgenol 2014; 202(3):690-695.
- Pesek S, Ashikaga T, Krag LE, et al. The false-negative rate of sentinel node biopsy in patients with breast cancer: a meta-analysis. World J Surg. Sep 2012;36(9):2239-2251.
- Rechtman LR, Lenihan MJ, Lieberman JH et al. Breast-specific gamma imaging for the detection of breast cancer in dense versus nondense breasts. AJR Am J Roentgenol 2014; 202(2):293-298.
- Rhodes DJ, Hruska CB, Conners AL, et al. Journal club: molecular breast imaging at reduced radiation dose for supplemental screening in mammographically dense breasts. AJR Am J Roentgenol. Feb 2015; 204(2):241-251.
- 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.
- Rhodes DJ, O’Connor MK, Phillips SW et al. Molecular breast imaging: a new technique using technetium Tc 99m scintimammography to detect small tumors of the breast. Mayo Clin Proc 2005; 80(1):24-30.
- Schillaci O, Scopinaro F, Spanu A et al. Detection of axillary lymph node metastases in breast cancer with Tc-99m tetrofosmin scintigraphy. Int J Oncol 2002; 20(3):483-487.
- Schillaci O, Spanu A, Danieli R et al. Molecular breast imaging with gamma emitters. Q J Nucl Med Mol Imaging 2013; 57(4):340-351.
- Shermis RB, Wilson KD, Doyle MT, et al. Supplemental Breast Cancer Screening With Molecular Breast Imaging for Women With Dense Breast Tissue. AJR Am J Roentgenol. Aug 2016; 207(2):450-457.
- Silverstein MJ, Recht A, Lagios MD et al. Image-detected breast cancer: state-of-the-art diagnosis and treatment. J Am Coll Surg 2009; 209(4):504-520.
- Society for Nuclear Medicine. The SNM procedure guideline for breast scintigraphy with breast-specific gamma cameras 1.0. June 4, 2010. Available online at interactive.snm.org/docs/BreastScintigraphyGuideline_V1.0.pdf. Accessed October 2010.
- Spanu A, Chessa F, Battista Meloni G et al. Scintimammography with high resolution dedicated breast camera and mammography in multifocal, multicentric and bilateral breast cancer detection: A comparative study. Q J Nucl Med Mol Imaging 2009; 53(2):133-143.
- Spanu A, Chessa F, Battista Meloni G et al. The role of planar scintimammography with high-resolution dedicated breast camera in the diagnosis of primary breast cancer. Clin Nucl Med 2008; 33(11):739-742.
- 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. Q J Nucl Med Mol Imaging 2009; 53(3)271-280.
- Spanu A, Dettori G, Nuvoli S et al. (99)mTc-tetrofosmin SPET in the detection of both primary breast cancer and axillary lymph node metastasis. Eur J Nucl Med 2001; 28(12):1781-1794.
- Spanu A, Farris A, Chessa F et al. Planar scintimammography and SPECT in neoadjuvant chemo or hormonotherapy response evaluation in locally advanced primary breast cancer. Int J Oncol 2008; 32(6):1275-1283.
- Spanu A, Sanna D, Chessa F et al. The clinical impact of breast scintigraphy acquired with a breast specific gamma-camera (BSGC) in the diagnosis of breast cancer: incremental value versus mammography. Int J Oncol 2012; 41(2):483-489.
- Sun X, Liu JJ, Wang YS, et al. Roles of preoperative lymphoscintigraphy for sentinel lymph node biopsy in breast cancer patients. Jpn J Clin Oncol. Aug 2010;40(8):722-725.
- Sun Y, Wei W, Yang HW et al. Clinical usefulness of breast-specific gamma imaging as an adjunct modality to mammography for diagnosis of breast cancer: a systemic review and meta-analysis. Eur J Nucl Med Mol Imaging 2013; 40(3):450-463.
- Taillefer R. The role of 99mTc-sestamibi and other conventional radiopharmaceuticals in breast cancer diagnosis. Semin Nucl Med. 1999; 29(1):16-40.
- Tan H, Jiang L, Gu Y et al. Visual and semi-quantitative analyses of dual-phase breast-specific gamma imaging with Tc-99m-sestamibi in detecting primary breast cancer. Ann Nucl Med 2014; 28(1):17-24.
- Unkart J, Wallace A. Use of lymphoscintigraphy with Tc-99m tilmanocept does not affect the number of nodes removed during sentinel node biopsy in breast cancer [abstract]. J Nucl Med. 2016;57(Suppl 2):615.
- van der Vorst JR, Schaafsma BE, Verbeek FP, et al. Randomized comparison of near-infrared fluorescence imaging using indocyanine green and 99(m) technetium with or without patent blue for the sentinel lymph node procedure in breast cancer patients. Ann Surg Oncol. Dec 2012;19(13):4104-4111.
- 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 technique. AJR Am J Roentgenol 2012; 198(1):W69-75.
- Werner J, Rapelyea JA, Yost KG et al. Quantification of radio-tracer update in axillary lymph nodes using breast specific gamma imaging (BSGI): benign radio-tracer extravasation versus uptake secondary to breast cancer. Breast J 2009; 15(6):579-582.
- Whiting P, Rutjes AW, Reitsma JB et al. The development of QUADAS: a tool for the quality assessment of studies of diagnostic accuracy included in systematic reviews. BMC Med Res Methodol 2003; 3:25.
- Whiting PF, Rutjes AW, Westwood ME et al. QUADAS-2: a revised tool for the quality assessment of diagnostic accuracy studies. Ann Intern Med 2011; 155(8):529-536.
- Xu HB, Li L, Xu Q. Tc-99m sestamibi scintimammography for the diagnosis of breast cancer: meta-analysis and meta-regression. Nucl Med Commun 2011; 32(11):980-988.
- 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. Am J Surg 2009; 197(2):159-163.
Medical Policy Group, January 1998 (3)
Medical Policy Group, March 2006 (3)
Medical Policy Group, January 2008 (2)
Medical Policy Panel, October 2010
Medical Policy Group, October 2010 (3)
Medical Policy Administration Committee, October 2010
Available for comment October 21 through December 6, 2010
Medical Policy Group June 2012 (3): 2012 Updates – Description, Key Points and References
Medical Policy Panel, May 2013
Medical Policy Group, May 2013 (3): 2013 Updates to Description, Key Points and References; no change in policy statement
Medical Policy Group, June 2013 (3): 2013 additional update to Description, Key Points and References per TEC update; no change in policy statement.
Medical Policy Panel, May 2014
Medical Policy Group, June 2014 (3): 2014 Updates to Title, Description, Policy Statement, Key Points & References; added to policy statement “Preoperative or intraoperative sentinel lymph node detection using handheld or mounted mobile gamma cameras does not meet Blue Cross and Blue Shield of Alabama’s medical criteria for coverage and is considered investigational.”
Medical Policy Administration Committee, July 2014
Available for comment June 23 through August 6, 2014
Medical Policy Panel, May 2015
Medical Policy Group, June 2015 (3): 2015 Updates to Key Points and References; no change to policy statement.
Medical Policy Panel, September 2016
Medical Policy Group, October 2016 (3): 2016 Updates to Description, Key Points, Approved by Governing Bodies, Coding & References; policy statement updated to reflect that the use of gamma detection following radiopharmaceutical administration for localization of sentinel lymph nodes in patient with breast cancer meets Blue Cross and Blue Shield of Alabama’s medical criteria for coverage.
Available for comment October 26 through December 10, 2016
Medical Policy Panel, September 2017
Medical Policy Group, October 2017 (3): 2017 Updates to Key Points, Description, Approved by Governing Bodies & References; removed policy statement for dates of service prior to August 7, 2014. No change in policy statement.
Medical Policy Panel, September 2018
Medical Policy Group, October 2018 (7): Updates to Description, Key Points, Approved by Governing Bodies & References. Added Key Words: “RadioGenix™ System”. No change in policy statement.
Medical Policy Panel, September 2019
Medical Policy Group, October 2019 (7): Updated Key Points and References. Removed previous Policy Statement for dates of service prior to 2016. No change in intent.
Medical Policy Group, November 2019 (2): 2020 Annual Coding Update. Revised CPT codes 78800 and 78801 to include planar; 78803 revised to include single area, single day imaging.
Medical Policy Panel, September 2020
Medical Policy Group, September 2020 (2): Updates to Key Points; No change to Policy Statement.
This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.
The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.
As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.
The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:
- The technology must have final approval from the appropriate government regulatory bodies;
- The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
- The technology must improve the net health outcome;
- The technology must be as beneficial as any established alternatives;
- The improvement must be attainable outside the investigational setting.
Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:
- In accordance with generally accepted standards of medical practice; and
- Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
- Not primarily for the convenience of the patient, physician or other health care provider; and
- Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.