Scintimammography and Gamma Imaging of the Breast and Axilla

POLICY NUMBER

A.6.01.18

DESCRIPTION

Scintimammography, breast-specific gamma imaging (BSGI), and molecular breast imaging (MBI) use 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. Breast-specific gamma imaging uses a 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 a 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

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 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.

Scintimammography

Scintimammography is a diagnostic modality using radiopharmaceuticals to detect breast tumors. 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. Special camera positioning to include the axilla may be included when the area of interest is an evaluation for axillary metastases. 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.

Breast-Specific Gamma Imaging

Breast-specific gamma imaging (BSGI) and molecular breast imaging (MBI) were developed to address the poor resolution of conventional gamma cameras. 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. Detector heads are immediately next to the breast, increasing resolution, and images can be compared with mammographic images. Breast-specific gamma imaging 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 compress it lightly. 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 99m (Tc-99m) sestamibi, and MBI 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 a 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 with axillary lymph node dissection for managing patients who have breast cancer. The National Surgical Adjuvant Breast and Bowel Project trial B-32 examined whether sentinel lymph node dissection 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 5,611 women and observed statistically similar results for overall survival, disease-free survival, and regional control based on 8-year Kaplan-Meier estimates. An additional 3-year follow-up of morbidity after surgical node dissection revealed lower morbidity in the sentinel lymph node dissection group, including lower rates of arm swelling, numbness, tingling, and fewer early shoulder abduction deficits. A recent systematic review and meta-analysis reported no significant difference in overall survival (hazard ratio, 0.94; 95% confidence interval, 0.79 to 1.19), no significant difference in disease-free survival (hazard ratio, 0.83; 95% confidence interval, 0.60 to 1.14), and similar rates of locoregional recurrence. However, axillary node dissection was associated with significantly greater surgical morbidity (eg, wound infection, arm swelling, motor neuropathy, numbness) than sentinel node biopsy.

Radiopharmaceuticals

Scintimammography, Breast-Specific Gamma Imaging, and Molecular Breast Imaging

The primary radiopharmaceutical used with BSGI or MBI is Tc-99m sestamibi. The product label states that 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 approved by the Food and Drug Administration (FDA) only for cardiac imaging.

Lymphoscintigraphy and/or Hand-Held Gamma Detection

The primary radiopharmaceuticals used for lymphoscintigraphy include Tc 99m pertechnetate-labeled colloids and Tc 99m tilmanocept (Lymphoseek®). Whereas, Tc 99m sulfur colloid may frequently be used for intraoperative injection and detection of sentinel lymph nodes using hand-held gamma detection probe.

Radiation Exposure

Scintimammography, Breast-Specific Gamma Imaging, and Molecular Breast Imaging

The radiation dose associated with BSGI is substantial for diagnostic breast imaging modalities. According to Appropriateness Criteria from the American College of Radiology, 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 the American College of Radiology, at these levels, BSGI is not indicated for breast cancer screening.

According to a study, the effective dose from a lower “off-label” administered dose of 240 to 300 MBq (6.5-8 mCi) of Tc 99m sestamibi that is made feasible with newer dual-head MBI systems, is 2.0 to 2.5 mSv. For comparison, the effective dose (ie, 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 mSv and 10 mSv, and asserted that the effective dose from MBI “is considered safe for use in routine screening.”

Another article published online in 2010 calculated mean glandular doses and lifetime attributable risks 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) and Bracco (magnetic resonance contrast agents), used group risk estimates from the Biological Effects of Ionizing Radiation 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 lifetime attributable risks 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 to 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 to 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 BRCA variants) 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 PEM, and sometimes it is used synonymously with the term "breast-specific gamma camera," as used in this policy.

Use of single-photon emission computed tomography and positron emission tomography (PET) of the breast are not addressed in this policy.

Several scintillation (gamma) cameras have been cleared for marketing by the FDA through the 510(k) process for “measuring and imaging the distribution of radionuclides in the human body by means of photon detection.” Examples of gamma cameras used in BSGI are the Dilon 6800® (Dilon Technologies) and single-head configurations of Discovery NM750b (GE Healthcare). Dual-head cameras used in MBI include LumaGEM™ (Gamma Medical) (FDA product code IYX) and Discovery NM750b (GE Healthcare).

Tc-99m sestamibi (Sun Pharmaceutical Industries, Lantheus Medical Imaging, Cardinal Health 414, AnazaoHealth, Curium US, Jubilant Draximage) has been approved by the 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 2013, Tc 99m tilmanocept (Lymphoseek; Cardinal Health) was approved by the FDA for use in breast cancer and melanoma as a radioactive diagnostic imaging agent to help localize lymph nodes.

Technetium-99m-sulfur colloid was approved by the FDA through the new drug application (NDA; GE Healthcare, NDA 017456; Mallinckrodt, NDA 017724) process although these products appear to be no longer marketed. In addition, in 2011, Technetium Tc 99m Sulfur Colloid Kit (Sun Pharmaceutical Industries) was approved by the FDA through the NDA process (NDA 017858) for use as an injection to localize lymph nodes in breast cancer patients.

In 2018, the 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.

Related policies -

• Magnetic Resonance Imaging (MRI) of the Breast

• Oncologic Applications of PET Scanning

POLICY

Use of radiopharmaceutical administration and gamma detection (lymphoscintigraphy) for localization of sentinel lymph nodes in individuals with breast cancer may be considered medically necessary.

Scintimammography, 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. 

POLICY EXCEPTIONS

Federal 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.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

The most commonly used radiopharmaceutical in breast-specific gamma imaging or molecular breast imaging is technetium 99m (Tc 99m) sestamibi.

The 2013 Breast Imaging Reporting and Data System (BI-RADS) breast assessment and breast tissue categories are summarized in the table below.

2013 BI-RADS Breast Assessment and Breast Tissue Categories

The most commonly used radiopharmaceuticals for sentinel lymph node detection using either lymphoscintigraphy or hand-held gamma detection include Tc 99m-labeled colloids (eg, sulfur colloid).

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good 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. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

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.

POLICY HISTORY

8/1998: 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 orintraoperative 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.

05/31/2016: Policy number added.

05/31/2018: Medical policy links updated in policy description.

02/01/2019: Policy description updated regarding mammography, lymphoscintigraphy and hand-held gamma detection, and radiopharmaceuticals. Added statement that the use of gamma detection following radiopharmaceutical administration for localization of sentinel lymph nodes in patients with breast cancer may be considered medically necessary. Removed the following statement: Preoperative or intraoperative sentinel lymph node detection using handheld or mounted mobile gamma cameras is considered investigational. Policy Guidelines updated regarding breast assessment and breast tissue categories. Code Reference section updated to change codes from investigational to covered. Added HCPCS codes A9520 and A9541. Added ICD-10 diagnosis codes C50.011 - C50.929, C79.81, and D05.00 - D05.92.

10/21/2019: Policy reviewed; no changes.

12/20/2019: Code Reference section updated to revise code descriptions for CPT codes 78800, 78801, and 78803 effective 01/01/2020.

10/13/2020: Policy description updated regarding radiosensitivity in women with BRCAvariants. Medically necessary statement updated to add "breast specific." Policy Guidelines updated regarding the most commonly used radiopharmaceuticals.

12/30/2021: Policy reviewed. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

11/21/2022: Policy reviewed. Policy statement updated to change "patients" to "individuals."

12/21/2022: Code Reference section updated to revise the description for CPT code 78803, effective 01/01/2023.

10/11/2023: Policy reviewed; no changes.

12/11/2024: Policy reviewed. Policy statement revised to state that the use of radiopharmaceutical administration and gamma detection (lymphoscintigraphy) for localization of sentinel lymph nodes in individuals with breast cancer may be considered medically necessary. It previously stated: 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.

10/01/2025: Code Reference section updated to add new ICD-10 diagnosis codes C50.A0, C50.A1, and C50.A2.

SOURCE(S)

Blue Cross Blue Shield Association policy # 6.01.18

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Medically Necessary Codes

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