Blue Cross Blue Shield MA BSGI/MBI Coverage Update

Coverage Criteria

Investigational imaging (Scintimammography/BSGI/MBI)

Investigational imaging: Scintimammography, BSGI, and MBI are investigational in all applications, including as adjuncts to mammography or for staging axillary lymph nodes.

Investigational = not covered due to insufficient evidence

Lymphoscintigraphy and SLN localization

SLN localization: Use of radiopharmaceutical administration and gamma detection (lymphoscintigraphy and/or intraoperative hand-held gamma detection) for localization of sentinel lymph nodes in individuals with breast cancer may be considered medically necessary.

Supported by randomized trials and systematic reviews showing high SLN identification rates and similar long-term outcomes to axillary dissection with less morbidity

Adjunctive use in dense or high-risk breasts

Adjunctive screening/diagnostic use of BSGI/MBI in women with dense breasts or high risk:

Summary: Evidence from diagnostic accuracy studies indicates that adding BSGI or MBI to mammography increases sensitivity but decreases specificity; small numbers of additional cancers may be detected in some high-risk or dense-breasted populations, but the potential harms from additional radiation exposure and insufficient evidence of improved net health outcomes make the application investigational/unsupported as routine adjunctive screening.

Based on prospective and retrospective diagnostic accuracy studies; weigh incremental detection against radiation risks

Indeterminate or suspicious lesions

BSGI/MBI for characterization of indeterminate or suspicious lesions:

Summary: Compared with biopsy, BSGI/MBI negative predictive values ranged from 83% to 94%; because biopsy is the criterion standard and missing cancer has serious consequences, BSGI/MBI does not achieve the extremely high NPV needed to change management and should not replace tissue diagnosis.NPV 83%-94%

Do not substitute for biopsy; evidence insufficient to improve net health outcome

Post-neoadjuvant residual tumor detection

Use of BSGI/scintimammography to detect residual tumor post-neoadjuvant therapy:

Summary: A meta-analysis reported pooled sensitivity of 86% and pooled specificity of 69% for BSGI detecting residual tumor after neoadjuvant therapy compared with histopathology; no studies show superiority to other imaging approaches or clinical utility to change outcomes, so evidence is insufficient to demonstrate net health benefit.sensitivity 86%, specificity 69%

Comparative effectiveness vs other imaging not established

Surgical planning for breast-conserving therapy

Use of BSGI/scintimammography for surgical planning:

Summary: Retrospective data suggest MRI identifies more patients unsuitable for breast-conserving therapy than BSGI; prospective comparative studies are lacking and evidence is insufficient to demonstrate that BSGI improves net health outcomes for preoperative surgical planning.

Do not replace MRI per current evidence

Axillary metastases detection

Scintimammography/BSGI for axillary metastases detection:

Summary: Meta-analyses and diagnostic accuracy studies indicate that sensitivity and specificity of BSGI/scintimammography for detecting axillary metastases are insufficient to replace surgical nodal dissection; evidence is insufficient to improve net health outcome.

Imaging cannot replace nodal staging surgery

Sentinel lymph node localization

Lymphoscintigraphy and intraoperative gamma detection for sentinel lymph node localization:

Summary: Preoperative lymphoscintigraphy and intraoperative hand-held gamma detection to localize sentinel lymph nodes for biopsy have high identification success rates; radiopharmaceutical detection generally outperforms blue-dye methods and is similar to indocyanine green fluorescence. SLN biopsy provides similar long-term oncologic outcomes as full axillary dissection with reduced morbidity, supporting the medical necessity of SLN localization using radiopharmaceuticals and gamma detection.

Supported by randomized trials, nonrandomized studies, and systematic reviews

The Tc-99m sestamibi product label specifies that it is indicated for planar imaging as a second-line diagnostic agent to assist in evaluation of breast lesions after an abnormal mammogram or palpable mass, and that 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.

BSGI, MBI, and scintimammography do not have sufficient diagnostic performance to replace tissue diagnosis or surgical nodal staging. Compared with biopsy, reported negative predictive values for BSGI/MBI ranged from 83%–94%, which is inadequate to eliminate the need for biopsy in suspicious lesions. Likewise, meta-analytic data show sensitivity and specificity for detection of axillary metastases are not high enough for these imaging modalities to replace surgical nodal dissection.

Scintimammography, breast-specific gamma imaging (BSGI), and molecular breast imaging (MBI) are considered investigational in all applications, including use as adjuncts to mammography or for staging of axillary lymph nodes; when billed for these indications they may be denied as investigational.

The policy does not support use of BSGI/MBI/scintimammography as replacements for standard imaging pathways or invasive diagnostic procedures. Specifically, Tc-99m sestamibi is not an alternative to biopsy per its product labeling, and evidence does not support substituting BSGI/MBI/scintimammography for tissue diagnosis of suspicious lesions or for surgical nodal dissection for axillary staging.

Covered Indications

Adjunctive diagnostic imaging for women with dense breasts or higher risk when mammography is inconclusive

Adjunctive diagnostic indication: Consider BSGI/MBI as adjunctive diagnostic imaging in select cases (eg, women with dense breasts or higher risk) when mammography is inconclusive, recognizing increased sensitivity but lower specificity and uncertain impact on net health outcomes.

See detailed diagnostic accuracy evidence; weigh radiation exposure

Sentinel lymph node localization for breast cancer staging

SLN mapping indication: Preoperative lymphoscintigraphy and/or intraoperative hand-held gamma probe detection to identify sentinel lymph nodes for biopsy in patients with breast cancer is considered medically necessary as an alternative to full axillary dissection.

Supported by RCTs and systematic reviews demonstrating similar oncologic outcomes and lower morbidity

Summary of diagnostic adjunct uses and limitations including sentinel lymph node localization (supported)

Coding

CPT CodesCPT

78800	Radiopharmaceutical localization of tumor, inflammatory process or distribution of radiopharmaceutical agent(s) (includes vascular flow and blood pool imaging, when performed); planar, single area (eg, head, neck, chest, pelvis), single day imaging.
78801	Radiopharmaceutical localization of tumor, inflammatory process or distribution of radiopharmaceutical agent(s) (includes vascular flow and blood pool imaging, when performed); planar, 2 or more areas (eg, abdomen and pelvis, head and chest), 1 or more days imaging or single area imaging over 2 or more days

HCPCS Codes (A9500 informational; S8080 investigational)HCPCS

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

Provider Actions and Billing Requirements

Prior Authorization

Prior Authorization Required

Precertification/preauthorization is required if the procedure described in this policy is performed inpatient.

Precertification/preauthorization IS REQUIRED for all products if procedure is performed inpatient.

Prior Authorization

Outpatient Prior Authorization

For outpatient services described in this policy, prior authorization is not required for Commercial Managed Care (HMO and POS), Commercial PPO and Indemnity, Medicare HMO Blue, and Medicare PPO Blue.

Commercial Managed Care (HMO and POS), Outpatient = Prior authorization is not required.
Commercial PPO and Indemnity, Outpatient = Prior authorization is not required.
Medicare HMO Blue, Outpatient = Prior authorization is not required.
Medicare PPO Blue, Outpatient = Prior authorization is not required.

Definitions

inv-26: Scintimammography — definition and key technique points

DefinitionPlanar gamma-camera imaging of the breast after IV radiopharmaceutical injection performed with the patient prone and the camera positioned laterally to evaluate the breast (scintimammography).

Typical radiotracerTechnetium-99m (eg, Tc-99m sestamibi) is typically used for scintimammography imaging.

Patient positioning & techniquePatient lies prone with camera positioned laterally; special camera positioning may be used to include the axilla when evaluating for axillary metastases.

Resolution/limitationsConventional scintimammography has relatively poor resolution and limited sensitivity for smaller lesions (eg, <15 mm).

inv-27: BSGI / MBI — definition and device/technique notes

Definition

Background

Mammography remains the primary screening modality for breast cancer but has reduced sensitivity in women with dense breasts and certain high-risk groups. Adjunctive nuclear breast imaging techniques such as scintimammography, BSGI, and MBI use radiopharmaceuticals and gamma cameras to detect lesions and have shown higher sensitivity when added to mammography in some studies. However, increased sensitivity has been accompanied by lower specificity and additional radiation exposure, and current evidence is insufficient to show a net health outcome benefit for routine adjunctive use.

Frequency Limits

inv-34: Frequency limits — unspecified (inventory placeholder)

Frequency limitsNo specific frequency limits are specified in the policy (unspecified).

Policy history notePolicy updated annually with literature reviews; frequency limits were not defined in the reviewed excerpts.

Preauthorization implicationPolicy notes precertification is required if procedures are performed inpatient, but no frequency constraints for outpatient imaging are provided in the excerpt.

Prior Authorization

Inpatient precertification for listed modalities

Precertification is required for any modality listed in this policy when performed inpatient; outpatient prior authorization is not required for the specified commercial and Medicare products.

Inpatient procedures require precertification/preauthorization for all products.
Outpatient prior authorization is not required for Commercial Managed Care (HMO and POS), Commercial PPO and Indemnity, Medicare HMO Blue SM, or Medicare PPO Blue SM.

Note

Unspecified prior authorization note

No additional prior authorization guidance is specified in the inventory excerpt.

Inventory placeholder — refer to full policy for product-specific outpatient prior authorization rules if applicable.

Contrast / Radiopharmaceutical Rules

Billing Rule

Primary radiotracer — Tc-99m sestamibi

The primary radiotracer typically used for BSGI/MBI in the literature is technetium-99m (Tc-99m) sestamibi; other agents are referenced for lymphoscintigraphy and related procedures.

Tc-99m sestamibi is the typical radiotracer for BSGI/MBI.
MBI acquisition protocols may take approximately 40 minutes.

Billing Rule

Radiotracer references and rules

Nuclear medicine radiotracers referenced include Tc-99m sestamibi and agents used for lymphoscintigraphy (eg, Tc-99m–labeled colloids or tilmanocept); the policy references radiopharmaceutical use but does not impose explicit agent-specific rules in the excerpt.

Radiopharmaceuticals commonly used for lymphoscintigraphy include Tc-99m–labeled colloids and Tc-99m tilmanocept.

Not Covered / Investigational Uses

Not covered: BSGI, MBI, and scintimammography for breast cancer screening or to replace biopsy. The Tc-99m sestamibi label explicitly states it is not indicated for breast cancer screening and is not an alternative to biopsy, and diagnostic studies do not demonstrate sufficient negative predictive value or accuracy to substitute for tissue diagnosis or standard imaging pathways; therefore these uses are considered investigational and are not covered.

OpenPayer

Scintimammography, Breast-Specific Gamma Imaging (BSGI), Molecular Breast Imaging (MBI), and Lymphoscintigraphy

Coverage Criteria

Covered Indications

Coding

Provider Actions and Billing Requirements

Definitions

Background

Frequency Limits

Prior Authorization

Contrast / Radiopharmaceutical Rules

Not Covered / Investigational Uses