Medical Policy: 06.01.22
Original Effective Date: August 2006
Reviewed: July 2021
Revised: July 2021
This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
Scintimammography, also know as nuclear medicine breast imaging, refers to the use of radiotracers with nuclear medicine imaging as a diagnostic tool for abnormalities of the breast. Breast specific gamma imaging (BSGI) also known as molecular breast imaging (MBI) refers to specific types of imaging machines that are used in conjunction with scintimammography to improve diagnostic performance.
Note: The term molecular breast imaging (MBI) may be used in different ways, sometimes for any type of breast imaging involving molecular imaging, including positron emission mammography (PEM), and sometimes is limited to imaging with a type of breast specific gamma camera.
These modalities have been proposed primarily as adjuncts to mammography and physical examination in patients who have palpable masses or suspicious mammograms as a technique to improve patient selection for biopsy. It has been suggested scintimammography has the potential to reduce unnecessary invasive biopsies by differentiating benign from malignant lesions. Breast specific gamma imaging (BSGI) or molecular breast imaging (MBI) have been suggested for evaluating suspected recurrence in patients who are at high risk, for patients in whom breast MRI is indicated but who are not candidates due to contraindications, and among patients in whom breast imaging is technically difficult, such as those with radio dense breast tissue.
Scintimammography is performed while the patient is 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 (< 15 mm), because of this relatively poor resolution BSGI/MBI were developed to address this issue.
Breast-specific gamma imaging (BSGI) and is also sometimes referred to as “molecular breast imaging (MBI)” is a scintimammography examination that uses a special breast optimized gamma camera. This is performed while the patient is seated in a position similar to that of 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/MBI uses high-resolution gamma cameras. These cameras, specially designed to image the breast, offer improved signal-to-noise ratio and improved spatial resolution to produce high-contrast images of small lesions. The dedicated breast cameras facilitate imaging from several angles to more closely resemble the cranial-caudal and medial-lateral-oblique mammographic views.
The primary radiopharmaceutical used is technetium-sestamibi (MIBI). MIBI accumulates in tissues with increased mitochondrial activity, such as rapidly growing tumors. After intravenous injection, MIBI rapidly (within two minutes) accumulates within breast tumors and slowly, over the courses of hours is “washed out” out of the cells by P-glycoprotein receptor, allowing imaging to be performed immediately after injection, but also allowing ample time for clinicians to perform all desired views and data collection.
Positron emission mammography (PEM) is an imaging modality that has higher resolution than PET-CT and can be performed on patients unable to have an MRI scan. PEM uses a pair of dedicated gamma radiation detectors placed above and below the breast and mild breast compression to detect coincident gamma rays after administration of fluorine-18 fluorodeoxyglucose (18F-FDG), the positron-emitting radionuclide used in whole-body PET studies for the detection of metastatic disease. Whereas PEM has high imaging sensitivity for breast lesions, its clinical utility requires further investigation. PEM cannot provide the anatomical detail that is provided by MRI. The radiation dose associated with PEM is larger than with mammography and is an important consideration when using this modality. Studies are ongoing to determine the effects on sensitivity and specificity of PET when the radiation dose is reduced and to find alternate radiopharmaceutical tracers.
Screening, diagnosis, and management for individuals with breast cancer.
Scintimammography including Breast Specific Gamma Imaging (BSGI), Molecular Breast Imaging (MBI) and Positron Emission Mammography (PEM).
The following tests are currently being used to make decisions for individuals with undetermined or suspicious breast lesions to assist in provider decision making:
Decisions to initiate treatment which:
A test must detect the presence or absence of a condition, the risk of developing a condition in the future, or treatment response (beneficial or adverse).
A test is clinically useful if the use of the results informs management decisions that improve the net health outcome of care. The net health outcome can be improved if patients receive correct therapy, or more effective therapy, or avoid unnecessary therapy, or avoid unnecessary testing.
There is limited evidence on the use of scintimammography including breast specific gamma imaging (BSGI)/molecular breast imaging (MBI), and positron emission mammography (PEM) for screening individuals who have an elevated risk of breast cancer or in individuals with factors that limit the sensitivity of mammography. It has not been demonstrated that BSGI, BMI, and/or PEM provides better diagnostic accuracy compared with the current standard of care imaging which includes MRI of the breast. The evidence indicates there is a relatively high radiation dose currently associated with BSGI/MBI compared to mammography and MRI of the breast. The evidence is insufficient to determine the effects of this technology on net health outcomes.
The American College of Radiology recommends against the use of BSGI/MBI for screening. The consideration of the potential use of BSGI/MBI for screening individuals with dense breasts or at high risk of breast cancer should await the development of a lower dose regimen, and if warranted, larger higher quality studies with study populations representative of patients encountered in clinical practice. A large quality head-to-head comparison of BSGI/MBI and MRI would be needed, especially for individuals at high risk of breast cancer, because MRI, alternated with mammography, is currently the recommended screening technique.
There is emerging evidence that breast scintigraphy enhanced mammography may improve detection of early breast cancers among women with mammographically dense breasts, current evidence does not support their routine use as alternative screening procedures.
2018 ACR: Breast Cancer Screening in Women at Higher-Than-Average Risk: In 2018, the ACR issued an updated appropriateness criteria for individuals in higher than average risk using Molecular Breast Imaging (MBI). This criteria states the following, "…is not recommended for screening surveillance in any higher-risk population."
In 2017, the American College of Radiology (ACR), revised their breast cancer screening guidelines to the following:
Variant 1: Breast cancer screening. Average-risk women: women with MBI and FDG-PET Breast Dedicated Supplementing mammography with molecular breast imaging (MBI) in women with dense breasts increases the cancer detection rate [44,45]. However, there have been no large population studies of MBI for screening, and the whole-body radiation dose with this technique is concerning. Positron emission tomography with fluorine18-2-fluoro-2-deoxy-D-glucose (FDG-PET) breast is similarly limited by radiation dose and lack of evidence in large screening populations.
Variant 2: Breast cancer screening. Intermediate-risk women: women with personal history of breast cancer, lobular neoplasia, atypical ductal hyperplasia, or 15% to 20% lifetime risk of breast cancer. MBI and FDG-PET Breast Dedicated Supplementing mammography with MBI in women with dense breasts increases the cancer detection rate. However, there have been no large population studies of MBI for screening and whole-body radiation dose with this technique is concerning. FDG-PET breast is similarly limited by radiation dose and lack of evidence in large screening populations.
Variant 3: Breast cancer screening. High-risk women: women with a BRCA gene mutation and their untested first-degree relatives, women with a history of chest irradiation between 10 to 30 years of age, women with 20% or greater lifetime risk of breast cancer. MBI and FDG-PET Breast Dedicated Supplementing mammography with MBI in women with dense breasts increases the cancer detection rate. However, there have been no large population studies of MBI for screening and the whole-body radiation dose with this technique is concerning. FDG-PET breast is similarly limited by radiation dose and lack of evidence in large screening populations.
Summary of Recommendations
The American College of Radiology (ACR) criteria for breast cancer screening does not indicate the use of scintimammography, BSGI, MBI, and/or PEM in breast cancer screening.
Mammography is the recommended method for breast cancer screening of women in the general population. However, mammography alone does not perform as well as mammography plus supplemental screening in high-risk women. Therefore, supplemental screening with MRI or ultrasound is recommended in selected high-risk populations. Screening breast MRI is recommended in women at high risk for breast cancer based on family history or genetic predisposition. Ultrasound is an option for those high-risk women who cannot undergo MRI. Recent literature also supports the use of breast MRI in some women of intermediate risk, and ultrasound may be an option for intermediate-risk women with dense breasts. There is insufficient evidence to support the use of other imaging modalities, such as thermography, breast-specific gamma imaging, positron emission mammography, and optical imaging, for breast cancer screening.
In 2009, the American College of Radiology issued a guideline for initial diagnostic workup for breast microcalcifications:
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 marketed no longer. 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.
Scintimammography including Breast Specific Gamma Imaging (BSGI), Molecular Breast Imaging (MBI), and Positron Emission Mammography (PEM) is considered investigational for all indications, because the evidence is insufficient to determine the effects of this technology on net health outcomes.
To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc. They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.
*CPT® is a registered trademark of the American Medical Association.