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    v1.0.30
    OpenPayerPolicy UpdatesRadiology/Diagnostic ImagingAmeriHealth Caritas tactile breast imaging Coverag…
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    CurrentAmeriHealth CaritasPolicy CCP.1353

    Tactile breast imaging

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    Defines AmeriHealth Caritas coverage stance for tactile (mechanical/palpation) breast imaging devices (e.g., SureTouch, iBreastExam) and describes alternative covered breast imaging services; intended for providers submitting claims or seeking authorization.

    Policy Summary
    PayerAmeriHealth Caritas
    PolicyTactile breast imaging
    Policy CodePolicy CCP.1353
    Change TypeNo material change
    Effective DateFeb 1, 2018
    Last ReviewJan 1, 2026
    Next Review DateMay 1, 2027
    Key ActionDo not authorize tactile breast imaging devices (e.g., SureTouch, iBreastExam); use mammography, ultrasound, or MRI for screening and diagnostic evaluation.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    Not coveredCoverage stance
    Mammography/Ultrasound/MRIAlternatives
    510(k) notedRegulatory notes
    InsufficientEvidence

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    Coverage Determinations

    Not Medically Necessary / Investigational

    Tactile breast imaging is considered not medically necessary when used for screening or diagnostic evaluation because evidence is insufficient.

    Not medically necessary: Tactile breast imaging with SureTouch Mobile Pressure Mapping System or iBreastExam (and all other tactile breast imaging devices/uses) is investigational/not clinically proven and therefore not medically necessary.

    Supported by limited, heterogeneous diagnostic accuracy and feasibility studies with methodological limitations (selection and verification bias, limited blinding, variable reference standards) and no demonstrated improvement in patient-important outcomes; contemporary guidelines do not incorporate tactile breast imaging into screening or diagnostic algorithms.

    All other uses of tactile breast imaging are considered not medically necessary.

    Specific tactile breast imaging systems identified in this policy — including the SureTouch™ Mobile Pressure Mapping System and the iBreastExam™ — are designated as investigational/not clinically proven and therefore not medically necessary for screening or diagnostic use.

    Covered Indications

    Screening or diagnostic breast evaluation

    Coverage status for breast imaging indications.

    Screening or diagnostic breast evaluation: Mammography, ultrasonography, and magnetic resonance imaging are the recommended and covered breast imaging modalities for screening and diagnostic evaluation; tactile breast imaging (e.g., SureTouch, iBreastExam) is not covered for screening or diagnostic indications.

    Providers should use standard imaging modalities per guideline-based pathways; tactile breast imaging is considered investigational and not medically necessary.

    Not Covered Services

    Tactile breast imaging (for example, the SureTouch and iBreastExam devices) is not covered for any screening or diagnostic indication; these devices are investigational and use for screening or diagnosis is not medically necessary.

    Provider Billing & Authorization Guidance

    Prior Authorization

    Prior authorization — no pathway; investigational

    No prior authorization pathway is available for tactile breast imaging devices; services identified by CPT code 0422T are considered investigational and not medically necessary.

    • Providers should not expect an authorization pathway for tactile breast imaging services.
    Step Therapy

    Preferred alternatives — use standard breast imaging

    Use established, covered breast imaging modalities for screening and diagnostic evaluation: mammography, ultrasonography, or magnetic resonance imaging.

    • Mammography
    • Ultrasonography
    • Magnetic resonance imaging (MRI)
    Documentation Required

    Coding and documentation note — report 0422T; document clinical rationale

    When submitting claims related to tactile breast imaging, report the applicable code (commonly 0422T) and include appropriate supporting documentation, while noting the service is considered investigational and not medically necessary.

    • Commonly submitted code: 0422T — Tactile breast imaging by computer-aided tactile sensors, unilateral or bilateral
    • Include clinical documentation, but expect investigational status to affect coverage determination
    Denial Risk

    Denial risk — investigational service will be denied

    Claims for tactile breast imaging (for example, SureTouch or iBreastExam) will be denied as investigational and not medically necessary.

    • SureTouch Mobile Pressure Mapping System and iBreastExam are identified as investigational/not clinically proven.
    • All other uses of tactile breast imaging are not medically necessary and subject to denial.

    Coding

    Related / commonly submitted codeCPT
    0422TTactile breast imaging by computer-aided tactile sensors, unilateral or bilateral

    Background

    Tactile breast imaging (also referred to as mechanical or palpation imaging) uses a handheld mechanical sensor applied to the breast to record digital pressure or stress data that map palpable lesions and estimate size, shape, hardness, and location. Devices function as computerized palpation systems that document pressure maps during a brief scan of the breast.

    Definitions

    Tactile breast imaging — definition and operational details
    Other namesMechanical imaging; palpation imaging; computerized palpation; stress imaging
    Device formHandheld mechanical sensor applied to the breast to record and store digital pressure/stress data
    Purpose / outputProduces a surface/pressure map to document presence, size, shape, hardness, and location of palpable breast lesions
    Typical lesion scan durationApproximately 1–2 minutes per lesion
    Regulatory classificationFDA classification: breast lesion documentation system (21 CFR 884.2990); product code NKA
    Examples of devices with FDA 510(k) clearanceSureTouch Mobile Pressure Mapping System (BreastView Visual Mapping System, 510(k) K181672) and iBreastExam Gen II (510(k) K190575)

    Revision History

    2018-02-01effective_date

    Policy effective date established.

    2026-01-01last_reviewLatest

    Policy last reviewed; coverage stance remains investigational / not medically necessary for tactile breast imaging devices (e.g., SureTouch, iBreastExam).

    Policy Summary
    PayerAmeriHealth Caritas
    PolicyTactile breast imaging
    Policy CodePolicy CCP.1353
    Change TypeNo material change
    Effective DateFeb 1, 2018
    Last ReviewJan 1, 2026
    Next Review DateMay 1, 2027
    Key ActionDo not authorize tactile breast imaging devices (e.g., SureTouch, iBreastExam); use mammography, ultrasound, or MRI for screening and diagnostic evaluation.
    SourceLink
    On This Page
    Coverage DeterminationsCovered IndicationsNot Covered ServicesProvider Billing & Authorization GuidanceCodingBackgroundDefinitionsRevision History