Breast Transillumination, Electrical Impedance Scanning (EIS), and Elastography
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Clinical policy governing coverage stance for breast transillumination (optical imaging), electrical impedance scanning (EIS), and elastography techniques for breast cancer detection and characterization; applies to Aetna members and providers submitting claims to Aetna.
No material clinical or coverage changes in this revision.
Coverage Determinations
Experimental and Investigational (Not Established)
The following procedures are considered experimental and investigational because effectiveness has not been established:
Listed items are considered experimental/investigational per policy.
Evidence summaries and caveats
Summary of evidence and key caveats from cited studies:
Heterogeneity in methods, cutoffs, and study design limit generalizability; see technical limitations and need for validation.
Evidence limitations and guideline context
Evidence limitations and guideline context relevant to coverage decisions:
See meta-analyses and study limitations noted in the literature.
May prompt additional review or exclusion from standard management pathways.
Quantification and depth limitations described in experimental studies.
The policy lists several modalities as experimental and investigational because effectiveness has not been established, including breast elastography (any method) (ultrasound or magnetic resonance), combined shear‑wave elastography with ultrasonography, electrical impedance scanning (EIS) for distinguishing benign from malignant lesions, and other emerging techniques such as non‑elastographic quantitative ultrasound tissue characterization, optical coherence micro‑elastography, opto‑acoustic imaging, and transillumination.
Systematic reviews have not identified effectiveness data supporting use of digital infrared thermal imaging (DITI), EIS, or elastography for population breast cancer screening. A comprehensive review found substantial heterogeneity across studies, no effectiveness trials, and concluded there is insufficient evidence to recommend these technologies for screening.
Available evidence indicates power Doppler ultrasound alone is unsuitable to discriminate local breast cancer recurrence from post‑treatment fibrosis; authors cautioned that relying on Doppler (or elastography/Doppler) alone to avoid biopsy could lead to poorer clinical outcomes compared with biopsying all suspicious masses.
A contemporary UpToDate review of diagnostic evaluation of suspected breast cancer does not reference non‑elastographic quantitative ultrasound (QUS) tissue characterization as a management option, indicating it is not incorporated into that major clinical resource.
Similarly, the National Comprehensive Cancer Network (NCCN) Breast Cancer guideline (Version 2.2022) does not describe non‑elastographic QUS tissue characterization as a diagnostic or screening strategy, reflecting absence from major practice guidelines.
Because these techniques lack established effectiveness and guideline endorsement, the policy considers them experimental/investigational. This classification underlies the exclusion from established coverage and informs that claims for these services may be subject to noncoverage or denial.
The evidence base contains no effectiveness studies and shows wide variability in diagnostic accuracy measures across trials; therefore there is insufficient evidence to support EIS, DITI, or elastography as stand‑alone screening tools for breast cancer.
Authors have warned that using shear‑wave elastography (SWE) or Doppler findings alone to defer biopsy of suspicious lesions may worsen clinical outcomes compared with the current standard practice of performing biopsies on all suspicious masses.
Many studies cited are limited by small sample sizes, retrospective designs, and single‑instrument or single‑center cohorts. These methodological limitations and heterogeneity in techniques and cut‑off values reduce confidence in generalizability and warrant larger, prospective multicenter validation before routine adoption.
Given the lack of guideline inclusion and the limited, heterogeneous evidence base, non‑elastographic quantitative ultrasound (QUS) is not supported as a primary diagnostic or screening modality for breast cancer at this time.
Indications and Adjunctive Uses
Detection or characterization of breast lesions/breast cancer using listed investigational modalities
Use of the listed investigational modalities for detection or characterization of breast lesions/breast cancer is considered investigational:
Background and policy scope describe investigational status.
Adjunctive use of elastography for characterization of focal breast lesions in symptomatic patients or for further evaluation of indeterminate imaging findings
Adjunctive elastography use has been studied but remains investigational per policy:
Examples include improved specificity and combined-modality AUC gains reported in multiple studies and meta-analyses.
Adjunctive use of SWE/STE/MRE for characterization of breast masses
Shear-wave and related elastography techniques have shown promising diagnostic performance in studies:
Meta-analyses report high pooled AUCs and pooled sensitivities/specificities; cut-off values vary across studies.
Intraoperative margin and lymph node assessment (research/early feasibility)
Investigational intraoperative applications are early-feasibility and research-stage:
Feasibility studies imaged fresh specimens and recommended further work before clinical adoption.
Adjunct to B-mode ultrasound for characterization of suspicious breast lesions
Adjunct to B-mode ultrasound — potential benefits reported but not established as standard of care:
Reported biopsy reduction and BI-RADS downgrades in pooled analyses; technique-dependent cutoffs.
Predicting response to neoadjuvant chemotherapy (investigational)
Investigational role in predicting treatment response:
Studies reported multi-center data and model performance metrics; further external validation recommended.
Adjunctive or investigational imaging to assist lesion characterization or research applications
Adjunctive or investigational imaging applications under investigation:
Technical and study limitations such as penetration depth, quantification accuracy, and lack of guideline endorsement are noted.
Billing Codes and Technical Parameters
| 0351T | Optical coherence tomography of breast or axillary lymph node, excised tissue, each specimen |
| 0352T | Optical coherence tomography of breast or axillary lymph node, excised tissue, each specimen |
| 0353T | Optical coherence tomography of breast, surgical cavity |
| 0354T | Optical coherence tomography of breast, surgical cavity |
| 0689T | Quantitative ultrasound tissue characterization (non-elastographic), including interpretation and report, obtained without diagnostic ultrasound examination of the same anatomy (eg, organ, gland, tissue, target structure) |
| 0690T | Quantitative ultrasound tissue characterization (non-elastographic), including interpretation and report, obtained with diagnostic ultrasound examination of the same anatomy (eg, organ, gland, tissue, target structure) (List separately in addition to code for primary procedure) |
| 76391 | Magnetic resonance (eg, vibration) elastography |
| 76981 | Ultrasound, elastography; parenchyma (eg, organ) |
| 76982 | Ultrasound, elastography |
| 76983 | Ultrasound, elastography |
| C50.011 | Malignant neoplasm of breast (example start of malignant codes list) |
| C50.929 | Malignant neoplasm of breast |
| C79.81 | Secondary malignant neoplasm of the breast |
| D05.00 | Carcinoma in situ of breast |
| D05.92 | Carcinoma in situ of breast (end range listed) |
| D24.1 | Benign neoplasm of breast |
| D24.9 | Benign neoplasm of breast |
| N60.01 | Disorder of breast (example start of range) |
| N65.1 | Disorders of breast (range end) |
| Z12.39 | Encounter for other screening for malignant neoplasm of breast |
| No codes listed |
| K083095 | FDA 510(k) Regen SonixTouch Ultrasound Scanner (example device referenced) |
Provider Requirements and Operational Notes
Codes affected — prior authorization note
Codes listed in the policy are associated with the experimental/investigational determinations above; prior authorization requirements for these codes (if any) follow standard payer rules. Providers should submit appropriate documentation when requesting coverage and be aware services such as elastography, quantitative ultrasound tissue characterization, opto-acoustic imaging, and related CPT/HCPCS codes may be denied as experimental/investigational.
- Affected CPT/HCPCS (examples listed in policy): 0351T–0354T, 0689T–0690T, 76391, 76981–76983, 19301–19302, 77065–77067
- Affected HCPCS: C9788
- ICD-10 examples listed in policy: C50.xx, C79.81, D05.xx, D24.xx, N60.01–N65.1, Z12.39
Provide prior standard imaging and indication
When these imaging techniques are used clinically, include the clinical indication and prior standard imaging results (mammography, diagnostic ultrasound, MRI) in the request and report. Documenting prior imaging and the reason additional testing is being pursued facilitates interpretation and any utilization review.
- Provide prior standard imaging: screening or diagnostic mammography, diagnostic ultrasound, and MRI findings when available
- State specific clinical indication and prior imaging dates/results in the request/report
Screening use unsupported
Current evidence is insufficient to support routine use of DITI, EIS, non-elastographic QUS, opto-acoustic imaging, transillumination, or elastography for breast cancer screening. These modalities are not recommended as replacements for established screening (mammography) and may be considered investigational.
- Screening use unsupported: DITI, EIS, non-elastographic QUS, elastography, opto-acoustic imaging, transillumination
Use of elastography methods to determine biopsy — caution
Evidence suggests caution when relying on elastography-derived parameters to decide against biopsy for suspicious masses. Use of elastography alone to defer biopsy may lead to poorer outcomes compared with performing biopsies on all suspicious lesions.
- Elastography should not be used in isolation to rule out biopsy for suspicious masses
- Ensure histologic confirmation when clinical concern persists
Not applicable content in this window
Some content in this provider-actions window is informational or not applicable to operational rules; no additional operational steps are specified for those items.
- Not applicable content in this window: placeholder or administrative notes without operational effect
Guideline absence may prompt review
Absence from major guidelines (e.g., UpToDate, NCCN) for many of these technologies may prompt individual case review when requested; lack of guideline support is a consideration for denial or for requiring additional documentation.
- Guideline absence may prompt case-by-case review
- Requests may require supplemental clinical justification and prior imaging/pathology
Clinical Policy Bulletins are developed to assist in administering plan benefits
Clinical Policy Bulletins are developed to assist in administering plan benefits and do not guarantee coverage. Providers remain responsible for clinical decisions and should follow the plan's documentation and authorization processes.
- CPBs are administrative guidance — not coverage guarantees
- Follow payer-specific prior authorization and documentation procedures
Quantitative SWE reporting — document parameters
When shear-wave elastography (SWE) quantitative measures are reported, document technical parameters to aid interpretation — including ROI selection and reported stiffness metrics such as mean elasticity (Emean) and maximum elasticity (Emax).
- Report ROI size/location and device/technique
- Include quantitative SWE parameters: Emean, Emax (and specify units)
Studies cited require histological confirmation
Many diagnostic accuracy studies cited in the evidence base required histological confirmation as the reference standard. When applicable, include pathology results or plan for histologic confirmation in the care pathway.
- Studies cited use histopathology as reference standard — document biopsy/surgical pathology when available
- Retrospective study designs and selection criteria may limit generalizability
Adjunctive use after standard imaging
These modalities are primarily discussed as adjuncts to standard imaging in the literature; consider them only after conventional imaging pathways (mammography, diagnostic ultrasound, MRI) have been applied and documented.
- Adjunctive use after standard imaging: elastography and other emerging modalities may be considered only with prior conventional imaging documented
- Do not substitute these technologies for standard diagnostic or screening modalities
Prior Authorization Notes
Elastography / QUS — prior auth not specified
Elastography/QUS prior authorization status is listed as 'not specified' in the imaging prior authorization notes; check the full policy or payer prior authorization rules for any submission requirements.
- Imaging prior auth notes: Elastography / QUS — not specified.
Opto‑acoustic/EIS/QUS — use as primary diagnostic/screening modality may require review
The policy describes opto‑acoustic/photoacoustic imaging, EIS, and non‑elastographic QUS tissue characterization as emerging modalities and indicates they are not supported as primary diagnostic or screening modalities; case‑by‑case review or prior authorization may be required if billed as such.
- Policy note: use as primary diagnostic/screening modality may prompt review.
Contrast and Imaging Agent Notes
Opto‑acoustic imaging — no exogenous contrast or ionizing radiation
Opto‑acoustic imaging generates maps of blood oxygen saturation and total hemoglobin using endogenous optical contrast, without injection of exogenous contrast agents or use of ionizing radiation.
- Policy: images of blood oxygen saturation and total hemoglobin are generated using endogenous contrast without external contrast or ionizing radiation.
Contrast rules — opto‑acoustic uses endogenous hemoglobin contrast
Opto‑acoustic (photoacoustic) imaging uses endogenous hemoglobin contrast and does not require exogenous contrast agents for generation of functional blood oxygenation or hemoglobin maps.
- The policy describes opto‑acoustic imaging as producing diagnostic images via endogenous optical contrast.
Definitions and Technical Terms
Mammography remains the generally accepted standard for breast cancer screening and diagnosis. Novel imaging techniques such as optical/transillumination, EIS, elastography (ultrasound and MR), opto‑acoustic/photoacoustic imaging, and quantitative ultrasound approaches have been investigated to address limitations like dense breast tissue and lesion characterization, but most are investigational and lack established clinical utility.
Explicit Not-Covered Statements
Not covered: Breast elastography (ultrasound or MRI) for detection or characterization of breast cancer; combined shear‑wave elastography with ultrasonography; and other listed investigational modalities including opto‑acoustic imaging, optical coherence micro‑elastography, non‑elastographic QUS, EIS, and transillumination are considered investigational and excluded from established coverage.
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