Medical Policy Scintimammography/-Specific Gamma Imaging/Molecular

Table of Contents  Policy: Commercial  Coding Information  Information Pertaining to All Policies  Policy: Medicare  Description  References  Authorization Information  Policy History

Policy Number: 494 BCBSA Reference Number: 6.01.18

Related Policies  MRI of the Breast, #230  Oncologic Applications of PET Scanning, #229

Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity Medicare HMO BlueSM and Medicare PPO BlueSM Members

Scintimammography, breast-specific gamma imaging (BSGI), and molecular breast imaging (MBI) are INVESTIGATIONAL in all applications, including, but not limited to their use as an adjunct to or in staging the axillary lymph nodes.

Preoperative or intraoperative sentinel lymph node detection using handheld or mounted mobile gamma cameras is INVESTIGATIONAL.

Prior Authorization Information Pre-service approval is required for all inpatient services for all products. See below for situations where prior authorization may be required or may not be required for outpatient services. Yes indicates that prior authorization is required. No indicates that prior authorization is not required. Outpatient Inpatient Commercial Managed Care (HMO This is not a covered service. This is not a covered service. and POS) Commercial PPO and Indemnity This is not a covered service. This is not a covered service. Medicare HMO BlueSM This is not a covered service. This is not a covered service. Medicare PPO BlueSM This is not a covered service. This is not a covered service.

1 CPT Codes / HCPCS Codes / ICD-9 Codes The following codes are included below for informational purposes. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member. A draft of future ICD-10 Coding related to this document, as it might look today, is included below for your reference.

Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable.

CPT Codes CPT codes: Code Description 78800 localization of tumor or distribution of radiopharmaceutical agent(s); limited area 78801 Radiopharmaceutical localization of tumor or distribution of radiopharmaceutical agent(s); multiple areas

HCPCS Codes HCPCS codes: Code Description A9500 Technetium tc-99m sestamibi, diagnostic, per study dose S8080 Scintimammography (radioimmunoscintigraphy of the breast), unilateral, including supply of radiopharmaceutical

ICD-9 Diagnosis Codes ICD-9 Diagnosis codes: Code Description 174.0 Malignant neoplasm of nipple and areola of female breast 174.1 Malignant neoplasm of central portion of female breast 174.2 Malignant neoplasm of upper-inner quadrant of female breast 174.3 Malignant neoplasm of lower-inner quadrant of female breast 174.4 Malignant neoplasm of upper-outer quadrant of female breast 174.5 Malignant neoplasm of lower-outer quadrant of female breast 174.6 Malignant neoplasm of axillary tail of female breast 174.8 Malignant neoplasm of other specified sites of female breast 174.9 Malignant neoplasm of breast (female), unspecified 175.0 Malignant neoplasm of nipple and areola of male breast 175.9 Malignant neoplasm of other and unspecified sites of male breast Secondary and unspecified malignant neoplasm of lymph nodes of axilla and upper 196.3 limb 198.81 Secondary malignant neoplasm of breast 217 Benign neoplasm of breast 233.0 Carcinoma in situ of breast 793.80 Abnormal mammogram, unspecified 793.81 Mammographic microcalcification 793.82 Inconclusive mammogram 793.89 Other (abnormal) findings on radiological examination of breast

ICD-10 Diagnosis Codes ICD-10-CM Diagnosis codes: Code Description

2 C50.011 Malignant neoplasm of nipple and areola, right female breast C50.012 Malignant neoplasm of nipple and areola, left female breast C50.019 Malignant neoplasm of nipple and areola, unspecified female breast C50.021 Malignant neoplasm of nipple and areola, right male breast C50.022 Malignant neoplasm of nipple and areola, left male breast C50.029 Malignant neoplasm of nipple and areola, unspecified male breast C50.111 Malignant neoplasm of central portion of right female breast C50.112 Malignant neoplasm of central portion of left female breast C50.119 Malignant neoplasm of central portion of unspecified female breast C50.121 Malignant neoplasm of central portion of right male breast C50.122 Malignant neoplasm of central portion of left male breast C50.129 Malignant neoplasm of central portion of unspecified male breast C50.211 Malignant neoplasm of upper-inner quadrant of right female breast C50.212 Malignant neoplasm of upper-inner quadrant of left female breast C50.219 Malignant neoplasm of upper-inner quadrant of unspecified female breast C50.221 Malignant neoplasm of upper-inner quadrant of right male breast C50.222 Malignant neoplasm of upper-inner quadrant of left male breast C50.229 Malignant neoplasm of upper-inner quadrant of unspecified male breast C50.311 Malignant neoplasm of lower-inner quadrant of right female breast C50.312 Malignant neoplasm of lower-inner quadrant of left female breast C50.319 Malignant neoplasm of lower-inner quadrant of unspecified female breast C50.321 Malignant neoplasm of lower-inner quadrant of right male breast C50.322 Malignant neoplasm of lower-inner quadrant of left male breast C50.329 Malignant neoplasm of lower-inner quadrant of unspecified male breast C50.411 Malignant neoplasm of upper-outer quadrant of right female breast C50.412 Malignant neoplasm of upper-outer quadrant of left female breast C50.419 Malignant neoplasm of upper-outer quadrant of unspecified female breast C50.421 Malignant neoplasm of upper-outer quadrant of right male breast C50.422 Malignant neoplasm of upper-outer quadrant of left male breast C50.429 Malignant neoplasm of upper-outer quadrant of unspecified male breast C50.511 Malignant neoplasm of lower-outer quadrant of right female breast C50.512 Malignant neoplasm of lower-outer quadrant of left female breast C50.519 Malignant neoplasm of lower-outer quadrant of unspecified female breast C50.521 Malignant neoplasm of lower-outer quadrant of right male breast C50.522 Malignant neoplasm of lower-outer quadrant of left male breast C50.529 Malignant neoplasm of lower-outer quadrant of unspecified male breast C50.611 Malignant neoplasm of axillary tail of right female breast C50.612 Malignant neoplasm of axillary tail of left female breast C50.619 Malignant neoplasm of axillary tail of unspecified female breast C50.621 Malignant neoplasm of axillary tail of right male breast C50.622 Malignant neoplasm of axillary tail of left male breast C50.629 Malignant neoplasm of axillary tail of unspecified male breast C50.811 Malignant neoplasm of overlapping sites of right female breast C50.812 Malignant neoplasm of overlapping sites of left female breast C50.819 Malignant neoplasm of overlapping sites of unspecified female breast C50.821 Malignant neoplasm of overlapping sites of right male breast C50.822 Malignant neoplasm of overlapping sites of left male breast C50.829 Malignant neoplasm of overlapping sites of unspecified male breast C50.911 Malignant neoplasm of unspecified site of right female breast C50.912 Malignant neoplasm of unspecified site of left female breast C50.919 Malignant neoplasm of unspecified site of unspecified female breast

3 C50.921 Malignant neoplasm of unspecified site of right male breast C50.922 Malignant neoplasm of unspecified site of left male breast C50.929 Malignant neoplasm of unspecified site of unspecified male breast C77.3 Secondary and unspecified malignant neoplasm of axilla and upper limb lymph nodes C79.81 Secondary malignant neoplasm of breast D05.00 Lobular carcinoma in situ of unspecified breast D05.01 Lobular carcinoma in situ of right breast D05.02 Lobular carcinoma in situ of left breast D05.10 Intraductal carcinoma in situ of unspecified breast D05.11 Intraductal carcinoma in situ of right breast D05.12 Intraductal carcinoma in situ of left breast D05.80 Other specified type of carcinoma in situ of unspecified breast D05.81 Other specified type of carcinoma in situ of right breast D05.82 Other specified type of carcinoma in situ of left breast D05.90 Unspecified type of carcinoma in situ of unspecified breast D05.91 Unspecified type of carcinoma in situ of right breast D05.92 Unspecified type of carcinoma in situ of left breast D24.1 Benign neoplasm of right breast D24.2 Benign neoplasm of left breast D24.9 Benign neoplasm of unspecified breast R92.0 Mammographic microcalcification found on diagnostic imaging of breast R92.1 Mammographic calcification found on diagnostic imaging of breast R92.2 Inconclusive mammogram R92.8 Other abnormal and inconclusive findings on diagnostic imaging of breast

Description Scintimammography refers to the use of radiotracers with nuclear 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 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.(1)

BSGI and MBI have been suggested for a variety of applications. In a 2010 practice guideline for breast with breast specific gamma cameras,(2) the Society of provided a list of common uses, as follows:

4 1. Among patients with recently detected breast malignancy: for initial staging; detecting multicentric, multifocal, or bilateral disease; and assessing response to neoadjuvant chemotherapy. 2. Among patients at high risk for malignancy: to evaluate suspected recurrence; when mammography is limited; or when previous malignancy was occult on mammogram. 3. Among patients with indeterminate breast abnormalities and remaining diagnostic concerns: to evaluate lesions identified by other breast imaging techniques, palpable or nonpalpable; to aid in biopsy targeting, and other settings (eg, diffuse or multiple clusters of microcalcifications, unexplained architectural distortion) 4. Among patients with technically difficult breast imaging, such as radiodense breast tissue or implants, free silicone, or paraffin injections. 5. Among patients for whom breast magnetic resonance imaging (MRI) is indicated but contraindicated, eg, patients with implanted pacemakers or pumps, or as an alternative for patients who meet MRI screening criteria, such as presence of BRCA1/BRCA2 mutations. 6. Among patients undergoing preoperative chemotherapy: to monitor tumor response to determine the impact of therapy or plan for residual disease.

The guideline acknowledged other efforts, such as the American College of ’s Appropriateness Criteria(3-5) and the American College of Surgeons’ Consensus Conference III.(6)

Summary Evidence to date does not provide sufficient support for any of the uses discussed. The published literature on breast specific gamma imaging (BSGI), molecular breast imaging (MBI), and scintimammography with breast specific is limited by a number of factors. Studies include populations that usually do not represent those encountered in clinical practice and that have mixed indications. There are methodologic limitations of the available studies, which have been judged to have medium to high risk of bias, and they do not provide information about impacts on therapeutic efficacy. Limited evidence on diagnostic accuracy of BSGI indicates that the test has a relatively high sensitivity and specificity for detecting malignancy. However, evidence does not establish that BSGI improves outcomes when used as an adjunct to mammography for . In available studies, Negative predictive value of BSGI has not been high enough to preclude biopsy in patients with inconclusive mammograms. The relatively high radiation dose also should be taken into account. In addition, evidence is insufficient to conclude that BSGI is better than magnetic resonance imaging for this purpose. Larger, higher-quality studies are required to determine whether BSGI has a useful role as an adjunct to mammography. For these reasons, BSGI is considered investigational.

Diagnostic accuracy of scintimammography for detecting axillary metastases is inadequate to preclude nodal dissection. Similarly, mobile gamma cameras for preoperative or intraoperative detection of sentinel lymph nodes have not shown improved diagnostic performance in comparison with standard gamma probes. Evidence comprises small studies with inconsistent results. For these reasons, detection of axillary metastases using scintimammography, BSGI, MBI, or preoperative or intraoperative mobile gamma cameras is considered investigational.

Policy History Date Action 11/2014 BCBSA National medical policy review. New investigational indications described. Coding information clarified. Effective 10/1/2014. 7/2014 Updated Coding section with ICD10 procedure and diagnosis codes, effective 10/2015. 11/2011- Medical policy ICD 10 remediation: Formatting, editing and coding updates. 4/2012 No changes to policy statements. 9/2011 Reviewed - Medical Policy Group - Urology and Obstetrics/Gynecology. No changes to policy statements. 7/2011 Reviewed - Medical Policy Group - Hematology and . No changes to policy statements. 6/2011 BCBSA National medical policy review.

5 Changes to policy statements. 10/2010 Reviewed - Medical Policy Group - Urology and Obstetrics/Gynecology. No changes to policy statements. 9/2010 Reviewed - Medical Policy Group - Hematology and Oncology. No changes to policy statements. 11/2009 BCBSA National medical policy review. No changes to policy statements. 9/2009 Reviewed - Medical Policy Group - Hematology and Oncology. No changes to policy statements. 10/2008 Reviewed - Medical Policy Group - Urology and Obstetrics/Gynecology. No changes to policy statements. 10/2008 Reviewed - Medical Policy Group - Hematology and Oncology. No changes to policy statements. 9/2008 BCBSA National medical policy review. No changes to policy statements. 10/2007 Reviewed - Medical Policy Group - Urology and Obstetrics/Gynecology. No changes to policy statements. 9/2007 Reviewed - Medical Policy Group - Hematology and Oncology. No changes to policy statements. 8/2007 BCBSA National medical policy review. No changes to policy statements.

Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines

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