CurrentBlue Cross Blue Shield - IowaPolicy N/A

Scintimammography / Breast Specific Gamma Imaging (BSGI) / Molecular Breast Imaging (MBI) / Positron Emission Mammography (PEM) Coverage Policy

This policy governs the use and coverage determination for scintimammography, breast-specific gamma imaging (BSGI)/molecular breast imaging (MBI), and positron emission mammography (PEM) for diagnostic and treatment-related breast imaging indications for Blue Cross Blue Shield - Iowa members.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyScintimammography / BSGI / MBI / PEM coverage criteria (investigational for all indications)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateAug 1, 2006

Next Review DateN/A

Key ActionDo not submit claims for scintimammography/BSGI/MBI/PEM as covered — these modalities are considered investigational for all indications and may be denied.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

investigationalcoverage stance

10–30 mSvtypical BSGI dose

2.0–2.5 mSvreduced-dose MBI

up to 82%sensitivity example

2nd-line

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Tc-99m sestamibi label

Coverage Determination and Evidence Summary

Investigational — all indications

Policy conclusion

Investigational for all indications: Scintimammography, BSGI, MBI, and PEM are considered investigational for all indications because the evidence is insufficient to demonstrate improvement in net health outcomes.

Policy statement

Contextual coverage criteria (descriptive)

Use and study-selection context

Intended use population: Individuals with dense breasts or those at high risk for breast cancer as supplemental screening or for diagnostic evaluation of indeterminate lesions.

From clinical context and populations sections

Prior imaging: Typically used as a supplemental or second-line test after mammography or when mammography is inconclusive; comparators include mammography, ultrasonography, and MRI.

Comparators and sequencing described in interventions and comparators sections

Test type and procedure: Procedures use IV radiotracers (eg, Tc-99m sestamibi or 18F-FDG for PEM) followed by nuclear medicine imaging; BSGI/MBI are performed with the patient seated with light breast compression, whereas planar scintimammography is performed prone with lateral camera positioning.

Technique differences described in interventions section

Evidence-based considerations for use

Evidence synthesis summaries relevant to coverage decisions

Dense or high-risk breasts: Adding BSGI/MBI to mammography increases sensitivity but reduces specificity; a small number of additional cancers may be detected. Any potential benefit must be weighed against higher radiation exposure (reduced-dose Tc-99m sestamibi effective dose reported ~2.4 mSv vs digital mammography ~0.5 mSv).

Evidence summary from prospective studies and dose comparison

Indeterminate or suspicious lesions: BSGI/MBI demonstrate variable diagnostic accuracy versus biopsy with reported NPV ranging ~83%–94%; because biopsy is the diagnostic gold standard, BSGI/MBI NPV would need to be extremely high to safely obviate biopsy. Clinical utility depends on lesion prevalence and comparison with other modalities (spot mammography, ultrasound, MRI).

Evidence summary from diagnostic accuracy studies

Indeterminate or Suspicious Lesions

Indeterminate or Suspicious Breast Lesions — key points

Indeterminate/Suspicious Lesions: Studies of BSGI/MBI for indeterminate or suspicious lesions report negative predictive values between approximately 83% and 94%; given the ease and accuracy of biopsy and the consequences of missed cancer, reported NPVs are not sufficient to replace biopsy when biopsy is indicated.

Clinical utility varies by type and prevalence of mammographic abnormality

Detection of Residual Tumor After Neoadjuvant Therapy

Residual tumor after neoadjuvant therapy — key points

Diagnostic accuracy: Systematic review/meta-analysis reported pooled sensitivity of 86% (95% CI 78%–92%) and pooled specificity of 69% (95% CI 64%–74%) for BSGI detecting residual tumor versus histopathology; per-study sensitivity ranged widely (33%–100%).

Heterogeneity across small studies; largest retrospective study N=122 showed sensitivity 74%, specificity 72%, NPV 33%, PPV 94%

Comparative evidence: No studies directly compared BSGI to MRI or PET-FDG for residual tumor detection, and no studies assessed the effect of BSGI on management decisions or health outcomes.

Lack of comparative and clinical utility evidence limits conclusions

Preoperative Planning for Breast-Conserving Surgery

Preoperative planning for breast-conserving surgery — key points

Clinical validity: No studies were identified evaluating clinical validity of gamma imaging for disease detection during preoperative planning for breast-conserving surgery.

Insufficient evidence to establish test performance for this indication

Clinical utility (direct evidence): A retrospective study (Edwards et al. 2013) suggested limited impact of BSGI on surgical decision making compared with MRI (12% preoperative management change with BSGI vs 29% with MRI) and similar or higher re-excision and subsequent mastectomy rates in some comparisons; overall evidence is retrospective and inadequate to demonstrate clinical utility.

Prospective comparative studies needed

Coverage criteria summary

Coverage considerations based on available evidence

Preoperative planning: Retrospective evidence is insufficient to establish clinical utility of BSGI for guiding surgical decision-making; MRI identified more patients not appropriate for breast-conserving therapy in the cited study.

Prospective comparative studies needed

Axillary metastases detection: Although meta-analyses report pooled sensitivities and specificities for scintimammography/BSGI, current evidence does not support replacing surgical nodal dissection or sentinel lymph node biopsy with these imaging tests; no outcome studies compare management based on imaging to proceeding directly to nodal dissection.

Imaging not accurate enough to replace surgical staging

The primary radiopharmaceutical used with breast-specific gamma imaging (BSGI) and molecular breast imaging (MBI) is Tc-99m sestamibi. Per product labeling, Tc-99m sestamibi is indicated as a second-line diagnostic agent after mammography to assist in evaluation of breast lesions and is not indicated for breast cancer screening, to confirm presence or absence of malignancy, and is not an alternative to biopsy.

Tc-99m tetrofosmin (eg, Myoview) is a gamma-emitter that has been used in some BSGI studies but is approved only for cardiac imaging by the U.S. FDA; therefore Tc-99m tetrofosmin is not an FDA-approved radiotracer for breast imaging indications.

Product labeling for Tc-99m sestamibi explicitly states that the agent is indicated for planar imaging as a second-line diagnostic after mammography to aid evaluation of breast lesions, and that it is not indicated for screening, not intended to confirm presence/absence of malignancy, and not an alternative to biopsy.

FDA-cleared gamma camera systems and vendor-specific device examples are described in the source; however, regardless of camera type, the labeled clinical role of Tc-99m sestamibi remains as a supplemental diagnostic agent rather than a primary screening or confirmatory test.

Studies comparing BSGI/MBI with the criterion standard (biopsy) report negative predictive values (NPV) in the range of approximately 83%–94%. Because tissue diagnosis by biopsy is the definitive standard and the clinical consequences of missing cancer are substantial, BSGI/MBI NPV would need to be extremely high to safely forgo biopsy in patients with indeterminate or suspicious mammographic abnormalities.

Therefore, BSGI/MBI should not be used as a substitute for biopsy when biopsy is indicated; imaging alone does not provide sufficient NPV to reliably rule out malignancy in suspicious lesions.

No studies were identified that evaluated the clinical validity of gamma imaging for disease detection during preoperative planning for breast-conserving surgery. The absence of clinical validity data means the ability of these modalities to detect disease in this surgical-planning context has not been established.

Given this lack of validation, there is insufficient evidence to support routine use of gamma imaging (BSGI/MBI/scintimammography) for informing surgical decisions in preoperative planning for breast-conserving therapy.

Although some studies and meta-analyses have evaluated scintimammography/BSGI for detection of axillary metastases, the evidence indicates that these imaging tests are not accurate enough to replace surgical nodal dissection (or sentinel lymph node biopsy) for axillary staging.

Relying on BSGI/scintimammography in place of recommended surgical staging could miss nodal disease and lead to inappropriate management; imaging results may be considered adjunctive information but do not substitute for standard surgical approaches.

The policy document presents coding guidance in the Codes section (CPT and HCPCS listings) but does not provide explicit, modality‑specific coverage rules tied to those codes in this excerpt. Where codes are listed, providers should follow the Codes section for billing but note that the document does not translate those codes into permissive coverage statements in this partial text.

BSGI/MBI and related scintigraphic modalities have primarily been studied as adjuncts to established diagnostic pathways (eg, after mammography) rather than as replacements for standard diagnostics. Caution is advised when interpreting adjunct imaging findings: these modalities should be used to supplement, not supplant, established diagnostic tests such as diagnostic mammography spot views, ultrasound, MRI where indicated, or biopsy.

Because evidence to date focuses on diagnostic accuracy rather than demonstrated impact on patient management or outcomes, clinicians should avoid substituting BSGI/MBI for established diagnostics when those tests are available and indicated.

Radiotracer labeling and regulatory summaries indicate that BSGI/MBI is not supported for routine breast cancer screening; Tc-99m sestamibi labeling specifically states it is not indicated for screening and is intended as a second-line diagnostic adjunct after mammography.

When considering supplemental screening modalities for individuals (eg, those with dense breasts or high risk), MRI is the guideline-recommended option in many high-risk protocols; BSGI/MBI carries ionizing radiation and remains unsupported as a routine screening replacement per tracer labeling and guideline context.

No randomized controlled trials or other direct evidence were identified that demonstrate improved health outcomes when patient management is guided by BSGI/MBI compared with standard care. The evidence base is therefore primarily diagnostic accuracy studies and indirect (chain-of-evidence) data.

Because direct evidence of clinical utility (eg, changes in management that improve survival or reduce morbidity) is lacking, clinical benefit of routine use of these modalities has not been established.

BSGI/MBI and scintimammography should not be used to replace biopsy or as a standalone test to rule out cancer in lesions that are indeterminate or suspicious on mammography; the diagnostic standard remains histopathologic evaluation.

Imaging results may inform further workup but do not provide sufficient negative predictive certainty to obviate tissue diagnosis in cases where biopsy is clinically indicated.

MBI/BSGI diagnostic performance studies and pooled analyses report variable sensitivity and specificity; while some pooled estimates (eg, for residual tumor detection) show moderate to high sensitivity, the overall evidence is heterogeneous and lacks prospective data demonstrating clinical utility.

Guideline assessments (American College of Radiology Appropriateness Criteria) have rated MBI as usually not appropriate for breast cancer screening in multiple contexts, reflecting concerns about radiation dose, limited prospective outcome data, and remaining technical and clinical limitations.

The excerpt contains some unspecified items and placeholders related to codes and administrative fields in the Codes section; these are not substantive coverage criteria and indicate that additional coding detail exists elsewhere in the full document.

Providers should consult the Codes section and the full policy for complete administrative and billing instructions where needed.

Diagnostic and Treatment-Related Indications (Reviewed — Not Covered)

Diagnostic and treatment-related breast imaging indications (adjunct to mammography, lesion characterization, residual disease detection, surgical planning, axillary metastasis detection)

Proposed/Studied Indications: Adjunct to mammography for individuals with dense breasts or at increased risk; diagnostic evaluation of indeterminate or suspicious breast lesions; detection of residual tumor after neoadjuvant therapy; preoperative planning for breast-conserving therapy; and evaluation for axillary metastases.

Listed studied clinical indications; evidence insufficient for coverage

Supplemental screening or diagnostic evaluation in dense-breasted or high-risk individuals; detection of residual tumor or planning for breast-conserving therapy

Indication - supplemental/diagnostic: Individuals with dense breasts or at high risk for breast cancer as supplemental imaging after mammography or to evaluate indeterminate breast lesions.

From clinical context and interventions sections

Explicit Noncoverage Statements

Policy position: Scintimammography, BSGI, MBI, and PEM are considered investigational for all indications because current evidence is insufficient to demonstrate improvement in net health outcomes.

As investigational services, these modalities are not supported for coverage across the diagnostic and treatment-related breast imaging indications reviewed (adjunct screening, indeterminate lesion evaluation, residual tumor detection, preoperative planning, and axillary metastasis assessment).

Use of Tc-99m sestamibi for breast cancer screening is explicitly contraindicated by the product labeling; the label also states that the tracer is not an alternative to biopsy for confirming presence or absence of malignancy.

Consequently, claims for screening use of Tc-99m sestamibi or for use of BSGI/MBI in lieu of biopsy for suspicious lesions are inconsistent with labeling and the evidence base, and are not supported.

No direct evidence (randomized trials or comparative management studies) was identified that demonstrates BSGI/MBI or scintimammography improve health outcomes when used to guide clinical management, therefore the clinical utility remains unproven.

Because the evidence is limited to diagnostic accuracy studies without demonstrated impact on patient-centered outcomes, coverage for these modalities is not supported based on current evidence.

This section/entry is a fallback for unspecified items in the NOT COVERED section of the excerpt and does not add substantive new exclusion language; consult the full policy for any additional not-covered statements.

Procedure and Supply Codes

See Codes tablemixed

No codes listed

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 (e.g., 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.
78999	Unlisted miscellaneous procedure, diagnostic nuclear medicine.

HCPCS codesHCPCS

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

inv-23: MBI administered activity / effective dose

Administered activity240–300 MBq (6.5–8 mCi)

Effective dose (reported for reduced off-label dose)2.0–2.5 mSv

Typical acquisition timeApproximately 40 minutes for MBI

inv-24: None listed (placeholder)

Thresholds listedNone listed

NotesNo additional administered-activity thresholds provided in codes section

Authorization, Documentation, and Billing Guidance

Documentation Required

Benefit verification and prior imaging/clinical context required

Verify member benefits and prior imaging/clinical information before ordering. Document relevant prior imaging (mammography, ultrasound, MRI) and the clinical context (palpable mass, abnormal mammogram, dense breasts, high-risk status, prior neoadjuvant therapy) in the medical record to support the use of scintimammography/BSGI/MBI/PEM.

Include dates and results of prior mammography, ultrasound, and MRI when available.
State the indication (screening adjunct for dense breasts, evaluation of indeterminate lesion, evaluation after neoadjuvant therapy, or other) in the order and report.

Prior Authorization

Prior authorization — none specified in this section

No formal prior authorization requirement is specified within this section of the policy. When facility or local plan rules require prior authorization, follow the payer-specific process.

Prior Authorization Notes

Note

Prior Authorization

BSGI/scintimammography — no PA thresholds specified here

BSGI/scintimammography is listed without explicit prior-authorization thresholds in this section; verify payer-specific authorization requirements before ordering.

Comparators section notes MRI, PET-FDG, and ultrasound as alternative tests; no authorization thresholds provided.

Prior Authorization

MBI/CEM as supplemental screening — verify prior authorization per payer

MBI and contrast-enhanced mammography (CEM) are described as potential supplemental screening options when MRI cannot be performed; prior authorization for these uses may be required depending on the payer.

NCCN: “Consider CEM or MBI … for those who qualify for but cannot undergo MRI.”
Policy: prior authorization may be required per payer for supplemental modality use.

Radiopharmaceutical and Contrast Considerations

Billing Rule

Tc-99m sestamibi is the primary radiopharmaceutical; tetrofosmin is cardiac-only

The primary radiopharmaceutical used with BSGI/MBI is technetium-99m sestamibi; technetium-99m tetrofosmin is approved only for cardiac imaging.

Policy text: “The primary radiopharmaceutical used with BSGI or MBI is Tc 99m sestamibi.”
Tetrofosmin (Myoview) is approved only for cardiac imaging.

Billing Rule

CEM considerations — contrast reactions and higher radiation

When considering CEM, be aware it carries risk of iodinated contrast reactions and higher breast radiation per exam compared with standard mammography; weigh these risks when used as a supplemental imaging option.

NCCN: “CEM carries a risk of iodinated contrast reactions… CEM also has a higher breast radiation exposure per exam than standard mammography.”

Terms and Techniques

inv-50: Scintimammography / BSGI / MBI / PEM definitions

Scintimammography definitionPlanar nuclear medicine breast imaging after IV radiotracer injection with the patient lying prone and lateral camera positioning

BSGI/MBI definitionBreast-specific gamma imaging (BSGI) / molecular breast imaging (MBI): dedicated breast gamma cameras with detectors adjacent to the lightly compressed breast in a seated position to improve resolution versus conventional gamma cameras

PEM definitionPositron emission mammography (PEM): dedicated paired detectors above and below the breast using 18F-FDG with mild compression for higher-resolution positron-emission imaging

inv-51: BSGI/MBI terminology

Synonymous usage'Breast-specific gamma imaging' and 'molecular breast imaging' are often used interchangeably to describe dedicated gamma-camera breast imaging

Detector differences

Clinical and Technical Background

Scintimammography uses radiopharmaceuticals and gamma cameras to detect breast tumors; BSGI/MBI employ dedicated breast gamma cameras with detectors positioned adjacent to the compressed breast to improve spatial resolution compared with planar scintimammography. Positron emission mammography (PEM) uses 18F‑FDG with paired detectors and mild compression to provide higher-resolution positron emission imaging.

These modalities have been proposed as adjunctive imaging — for example, to evaluate palpable masses, suspicious mammograms, dense breasts, or when MRI is contraindicated — but current evidence is insufficient to demonstrate net benefit in clinical outcomes.

Policy History and References

2006-08-01policy_effective

Policy effective date recorded in document metadata.

2010-01-01revision

Policy history includes revisions beginning in 2010 (legacy policy actions summarized).

2016-05-01evidence_update

Inclusion of multiple studies and systematic reviews (eg, Radiology 2011; AJR 2015; J Nucl Med 2016) informing diagnostic performance of BSGI/MBI for dense breasts and suspicious lesions.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyScintimammography / BSGI / MBI / PEM coverage criteria (investigational for all indications)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateAug 1, 2006

Next Review DateN/A

Key ActionDo not submit claims for scintimammography/BSGI/MBI/PEM as covered — these modalities are considered investigational for all indications and may be denied.

SourceLink

On This Page

Adjunct imaging for dense/high-risk breasts; diagnostic workup of indeterminate or suspicious breast lesions; detection of residual tumor after neoadjuvant therapy (evidence reviewed but clinical utility not definitively established).

Indications explored in evidence: Adjunct imaging for individuals with dense breasts or increased risk to detect additional cancers; evaluation of indeterminate or suspicious lesions to aid diagnosis; detection of residual tumor after neoadjuvant therapy—evidence reviewed but clinical utility not definitively established.

Evidence varies by indication; benefits must be weighed against radiation and comparator tests

Indeterminate or suspicious breast lesions

Indeterminate/Suspicious Lesions: BSGI/MBI diagnostic studies report NPVs approximately 83%–94% versus biopsy; given biopsy is the criterion standard and the consequences of missed cancer, current NPVs are insufficient to replace biopsy when indicated.

Utility depends on mammographic abnormality type and disease prevalence

Detection of residual tumor after neoadjuvant therapy

Residual tumor detection after neoadjuvant therapy: Meta-analysis reported pooled sensitivity ~86% and pooled specificity ~69% for BSGI versus histopathology; per-study sensitivity ranged 33%–100%; no comparative studies versus MRI or PET-FDG and no studies assessing impact on management or outcomes.

Heterogeneous small studies; largest retrospective study N=122

Disease detection during preoperative planning for breast-conserving surgery

Preoperative planning for breast-conserving surgery: No clinical validity studies were identified for gamma imaging in preoperative planning; retrospective data suggest MRI identifies more patients unsuitable for breast-conserving therapy than BSGI.

Insufficient evidence to support routine use for preoperative planning

Preoperative planning for breast-conserving surgery

Preoperative planning (BSGI/MBI): Considered for informing treatment plans in diagnosed breast cancer, but current evidence (retrospective) is insufficient to demonstrate clinical utility; MRI may identify more candidates not appropriate for breast-conserving therapy.

Prospective comparative studies needed

Evaluation to detect axillary metastases in individuals with breast cancer

Detection of axillary metastases: Scintimammography/BSGI have pooled sensitivity and specificity in meta-analyses but are not accurate enough to replace surgical nodal dissection or sentinel lymph node biopsy; no outcome studies compare imaging-directed management to standard surgical staging.

Use only as adjunctive information; do not substitute for surgical staging

Supplemental breast cancer screening when MRI cannot be performed

Supplemental screening when MRI not possible: When MRI cannot be performed, NCCN and other sources note that CEM or MBI may increase cancer detection but also increase recalls and benign biopsies; MBI has higher whole-body radiation than mammography and is generally rated 'usually not appropriate' by ACR for screening indications.

Consider only after shared decision-making and when MRI is contraindicated or unavailable

Supplemental screening or diagnostic evaluation in women with dense breasts or suspicious lesions (supported by referenced literature listed in this section).

References supporting potential indications: Multiple referenced studies and reviews evaluate MBI/BSGI for supplemental screening in dense breasts and for evaluation of suspicious lesions and surgical planning; these evidentiary sources are listed in the references section.

References provided in document

Evidence and guideline assessments indicate that scintimammography/BSGI/MBI are not accurate enough to replace surgical nodal dissection for axillary staging. Meta-analytic pooled estimates exist but no outcome studies compare imaging-guided management versus standard surgical staging.

Guidelines (eg, ACR Appropriateness Criteria) and the evidence base suggest that using these imaging modalities in place of surgical nodal dissection is not appropriate and therefore not covered.

Refer to modality-specific sections for any dose guidance

Policy-level: Prior approval — Not applicable for this policy section.

Verify whether the member's specific benefit plan requires authorization prior to scheduling.

Prior Authorization

Prior authorization recommendation for supplemental screening

For supplemental breast screening (e.g., dense breasts or when MRI is contraindicated), consider guideline recommendations and shared decision-making; the NCCN notes MBI as an option when MRI is not possible and that supplemental modalities may increase cancer detection but also recalls and benign biopsies.

Use MBI/BSGI only after documenting that standard screening (mammography ± tomosynthesis) and MRI (if indicated) are not sufficient or are contraindicated.
Discuss radiation exposure risks of MBI (whole-body effective dose higher than mammography) with the patient.

Billing Rule

Coding and billing

Report services using appropriate CPT, HCPCS, Revenue and ICD diagnosis codes. Use specific CPT/HCPCS codes for nuclear medicine breast imaging and radiopharmaceuticals when available; if no specific CPT exists, report the appropriate unlisted or nuclear medicine procedure code per billing guidelines.

Covered/used codes may include CPT 78800, 78801, and unlisted 78999 as appropriate.
HCPCS A9500 (technetium tc-99m sestamibi, per study dose) and S8080 (scintimammography, unilateral, including supply) are referenced — bill radiopharmaceuticals separately where required.
Include ICD diagnosis codes that document the clinical indication (e.g., abnormal mammogram, palpable mass, prior breast cancer).

Note

Use of Tc-99m sestamibi is indicated in

Tc-99m sestamibi is labeled by the FDA for planar breast imaging as a second-line diagnostic agent after mammography to assist evaluation of breast lesions in patients with an abnormal mammogram or palpable mass; it is not indicated for screening, to confirm presence/absence of malignancy, or as an alternative to biopsy.

Use Tc-99m sestamibi consistent with FDA labeling: adjunctive/second-line evaluation after abnormal mammography or palpable lesion.
Do not use Tc-99m sestamibi for routine breast cancer screening.

Documentation Required

Evidentiary requirements for clinical validity

Clinical validity evidence for scintimammography/BSGI/MBI/PEM is limited. Diagnostic accuracy studies show increased sensitivity when added to mammography in some populations (e.g., dense breasts or select high-risk groups) but often at the expense of lower specificity and increased radiation exposure; overall, evidence is insufficient to demonstrate improved net health outcomes.

Studies included prospective and retrospective diagnostic accuracy designs; many used varying risk populations and some were from the same research groups.
Any potential incremental detection must be weighed against additional radiation and biopsy-related harms.

Denial Risk

Because biopsy is the criterion standard

Biopsy (histopathology) remains the criterion standard for diagnosing breast cancer. Given the relative ease and diagnostic accuracy of biopsy, imaging tests would require extremely high negative predictive value to replace or obviate tissue diagnosis.

In populations with mammographic abnormalities highly suggestive of cancer, NPV of adjunct imaging will be lower and cannot reliably exclude malignancy.
Do not defer recommended biopsy based solely on BSGI/MBI/PEM findings when imaging and clinical suspicion indicate biopsy.

Denial Risk

Risk when replacing surgical node dissection

Scintimammography/BSGI/MBI is not sufficiently accurate to replace surgical nodal dissection for axillary staging. Small-study meta-analyses show imperfect sensitivity and specificity and no evidence that replacing surgical staging with imaging improves outcomes.

Do not use BSGI/MBI results to omit recommended surgical node dissection for axillary staging.
If imaging is used for nodal evaluation, document that it is adjunctive and not a substitute for operative staging.

Documentation Required

Study inclusion and required study/test documentation

Studies considered for policy evaluation required suitable reference standards, clear patient/sample selection criteria, and reporting of clinical characteristics. Ensure that any clinical documentation and submitted studies include these elements when used for coverage or appeals.

Reference standard should be specified (e.g., histopathology for lesion evaluation, surgical pathology for residual disease or nodal status).
Report patient selection and clinical characteristics that match the indication for testing.

Documentation Required

Studies considered required reporting of and study-level documentation expectations

Reports of studies and clinical test results should include diagnostic performance metrics and study-level details: sensitivity, specificity, NPV, PPV, patient risk level, imaging dose, and comparator modality where applicable.

Include imaging parameters (radiotracer and administered activity), effective dose estimates, and comparison to mammography/MRI/ultrasound when relevant.
Document whether studies used reduced-dose protocols and the impact on diagnostic accuracy.

Step Therapy

Step therapy / sequencing and comparators in practice

No formal step therapy or modality sequencing is mandated by this policy; however, clinical practice and comparators indicate mammography (± tomosynthesis), ultrasound, and MRI are the primary comparators and commonly used before considering MBI/BSGI/PEM as adjuncts.

Sequence imaging according to clinical indication: start with mammography (screening/diagnostic), then targeted ultrasound or MRI as indicated; consider MBI/BSGI/PEM when these are inconclusive, contraindicated, or as supplemental screening per guideline recommendations.
Document why conventional imaging (mammography, ultrasound, MRI) was insufficient or contraindicated if ordering MBI/BSGI/PEM.

Prior Authorization

Nuclear medicine prior authorization not specified — verify with payer

Nuclear medicine aspects are not specified in this section for prior authorization; check payer rules for nuclear medicine breast imaging.

Codes and coding guidance provided but no PA expectations specified for nuclear medicine in this section.

Billing Rule

Use HCPCS A9500 to report Tc-99m sestamibi per study dose

Report radiopharmaceuticals using the HCPCS listing for Tc-99m sestamibi (A9500) where applicable; codes section lists A9500 as “Technetium tc-99m sestamibi, diagnostic, per study dose.”

HCPCS A9500 description: Technetium tc-99m sestamibi, diagnostic, per study dose.

BSGI/MBI differ by number and type of detectors (e.g., multicrystal arrays vs semiconductor detectors)

Patient positioningPerformed seated in a mammography-like position with light breast compression

inv-52: Terminology note about 'molecular breast imaging' usage

Variable usage of 'molecular breast imaging'Term may refer broadly to any breast molecular imaging including PEM or narrowly to breast-specific gamma camera imaging; usage varies across sources

Implication for interpretationConfirm modality and radiotracer when reviewing reports because terminology may be inconsistent

Regulatory/clinical notePEM and BSGI/MBI have different radiotracers and dose profiles; distinguish in clinical decision-making

inv-53: BSGI / MBI summary with radiotracer examples

Primary radiotracersTc-99m sestamibi commonly used for BSGI/MBI; 18F-FDG used for PEM

Detector configurationsMBI/BSGI use detector heads adjacent to the breast, sometimes dual-head or paired detectors, improving resolution vs conventional cameras

Typical exam durationMBI exams take approximately 40 minutes

inv-54: Outcomes of interest (survival, test validity, etc.)

Outcomes of interestOverall survival and disease-specific survival

Test performance metricsSensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV)

Clinical outcomesTreatment-related morbidity and impact on management (e.g., biopsy decisions, surgical planning)

inv-55: Planar scintimammography positioning

Positioning for planar scintimammographyPatient lies prone with the camera positioned laterally to image the breast; camera can be positioned to include the axilla when evaluating for axillary metastases

Resolution limitationConventional planar scintimammography has relatively poor resolution for lesions <15 mm

Procedure noteUses IV radiotracer followed by planar imaging acquisition

inv-56: BSGI patient positioning description

Patient positioning for BSGIPatient is seated in a mammography-like position and the breast is lightly compressed with detector heads immediately next to the breast

Detector proximity benefitDetectors adjacent to the breast increase spatial resolution compared with conventional gamma cameras

Procedure flowIV radiotracer injection followed by seated acquisition; technique differs by detector type and number

inv-57: Scintimammography/BSGI/MBI general definition

General definitionNuclear medicine breast imaging modalities that use IV radiotracers and gamma-detection to image breast tissue for detection of primary tumors and, in some studies, axillary metastases

Modalities includedScintimammography (planar), breast-specific gamma imaging (BSGI/MBI), and positron emission mammography (PEM)

Intended useProposed as adjuncts to mammography for palpable masses, suspicious mammograms, dense breasts, or when MRI is contraindicated

inv-58: Comparator: surgical node dissection / SLN biopsy

Comparator standardSurgical node dissection (including sentinel lymph node biopsy) is the standard comparator for axillary staging

Role of imagingScintimammography/BSGI may provide adjunctive information but is not a substitute for surgical staging

ImplicationImaging results alone should not replace recommended surgical management for axillary staging

inv-59: Radiopharmaceutical localization (CPT 78800/78801)

Relevant CPT codes78800, 78801, 78999 for radiopharmaceutical localization and diagnostic nuclear medicine procedures

Billing guidanceUse appropriate CPT codes to report radiopharmaceutical localization procedures as listed in Codes section

Unlisted code78999 may be used for unlisted diagnostic nuclear medicine procedures

inv-60: Scintimammography / BSGI (HCPCS S8080) definition

HCPCS S8080Scintimammography (radioimmunoscintigraphy of the breast), unilateral, including supply of radiopharmaceutical

Procedure typeDescribed as scintimammography of the breast, unilateral, including supply of radiopharmaceutical

Coding noteReport with appropriate CPT/HCPCS codes per Codes section

inv-61: Tc-99m sestamibi (A9500) HCPCS supply code

HCPCS A9500Technetium tc-99m sestamibi, diagnostic, per study dose

Primary radiopharmaceuticalTc-99m sestamibi is the primary radiopharmaceutical used with BSGI/MBI

Labeling cautionProduct labeling states Tc-99m sestamibi is not indicated for breast cancer screening or to confirm presence/absence of malignancy

2016-08-01evidence_update

Additional studies on supplemental screening and diagnostic utility (eg, Brem 2016; Cho 2016) were added to the reference list and evidence synthesis.

2016-12-01meta_analysis_inclusion

Systematic reviews and meta-analyses (eg, Guo et al. 2016) on residual tumor detection after neoadjuvant therapy were incorporated into the policy evidence base.

2020-11-01evidence_update

More recent comparative studies and reviews (eg, Eur Radiol 2020) on adjunct imaging for dense breasts were cited and summarized.

2025-10-28guideline_and_references_updateLatest

Guideline references updated to include NCCN and ACR documents through 2025 and multiple references refreshed in the bibliography.

Policy administrative history, coding lists, and code table entries (CPT and HCPCS) are recorded in the Codes section of the full document. For billing and claim submission, providers should reference the Codes section (including CPT 78800, 78801, 78999 and HCPCS A9500, S8080) and applicable payer billing guidance.

Prior authorization is listed as not applicable in the policy header; however, the investigational status of these services means claims may be denied as not medically necessary per contract language.