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    v1.0.28
    OpenPayerPolicy UpdatesWound CareAmbetter Nevada ultrasound/NNWT Coverage Update | …
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    CurrentAmbetter NevadaPolicy CP.MP.139

    Low-Frequency Ultrasound and Noncontact Normothermic Wound Therapy

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    Defines the health plan's coverage stance and criteria for use of low-frequency ultrasound wound therapy and noncontact normothermic wound therapy for wound management for members/enrollees.

    Policy Summary
    PayerAmbetter Nevada
    PolicyLow-Frequency Ultrasound and Noncontact Normothermic Wound Therapy
    Policy CodePolicy CP.MP.139
    Change TypeNo material change
    Effective Date
    Next Review Date
    Key ActionFollow plan prior authorization requirements and review applicable Medicare LCD/LCA guidance (including CPT 97610) before submitting authorization requests.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    2therapies addressed

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    97610, E0231, E0232codes referenced
    2 small trialsRCT evidence noted
    NICE MTG5external guidance
    2CMS references

    Coverage Determinations

    Coverage stance — unsupported therapies

    Policy statements

    Main policy stance: I. Current evidence does not support the use of low-frequency ultrasound wound therapy.

    Policy declares lack of supportive evidence; therapy considered not supported.

    Main policy stance: II. Current evidence does not support the use of noncontact normothermic wound therapy (NNWT).

    Policy declares lack of supportive evidence; therapy considered not supported.

    It is the policy of the Health Plan that current evidence does not support the use of low-frequency ultrasound wound therapy. Based on the available literature and the Health Plan’s evidence review, these therapies are not considered supported treatment options for wound management and may be subject to denial when billed as covered services.

    When applying this clinical policy to Medicaid members/enrollees, state Medicaid coverage provisions take precedence if they conflict with the policy. Providers should consult the relevant state Medicaid manual for any differing coverage provisions before rendering services or submitting claims.

    The evidence base for both low-frequency ultrasound and noncontact normothermic wound therapy (NNWT) is inconclusive. A Cochrane review identified two randomized trials of low-frequency ultrasound that were significantly underpowered and found no difference in the proportion of ulcers healed versus no ultrasound. Several small RCTs reported favorable point estimates for ultrasound added to standard care but did not achieve statistical significance, and at least one small trial reported a positive result that requires confirmation. Overall, additional larger randomized trials are necessary to demonstrate a clear benefit before these therapies can be recommended as medically necessary.

    Coding and Billing References

    Covered/Referenced CPT CodesCPT
    97610Low frequency, non-contact, non-thermal ultrasound, including topical application(s) when performed, wound assessment, and instruction(s) for ongoing care; per day
    Referenced HCPCS CodesHCPCS
    E0231Noncontact wound-warming device (temperature control unit, AC adapter and power cord) for use with warming card and wound cover
    E0232Warming card for use with the noncontact wound-warming device and noncontact wound-warming wound cover
    Referenced CPT Codes (CMS referenced)CPT
    97610Low frequency, non-contact, non-thermal ultrasound (as referenced in CMS Local Coverage Article)

    Provider Responsibilities, Authorization & Documentation

    Prior Authorization

    Prior authorization and coding (informational)

    This policy references CPT 97610 and HCPCS E0231/E0232 for informational purposes; providers should follow the health plan's prior authorization requirements when submitting these codes for wound therapies.

    • 97610 — Low frequency, non-contact, non-thermal ultrasound; per day
    • E0231 — Noncontact wound-warming device
    • E0232 — Warming card for use with the device
    Prior Authorization

    Prior authorization and code review required

    Review applicable Medicare Local Coverage Determinations/Articles (including guidance referencing CPT code 97610) and the Health Plan's medical necessity criteria prior to requesting authorization; when state Medicaid provisions conflict with this policy, state Medicaid rules take precedence.

    • Check CMS NCDs/LCDs and Local Coverage Articles before authorization (see CMS Local Coverage Article for CPT 97610).

    Clinical Background

    Effective wound healing depends on several fundamental principles: adequate vascularization to deliver oxygen and nutrients; removal of devitalized tissue through debridement (with surgical debridement preferred for large necrotic areas or infection); control of infection; and maintenance of an appropriate moisture balance in the wound bed. Adjunctive technologies such as low-frequency ultrasound and NNWT aim to assist these goals, but clinical use should align with evidence-based standards and the Health Plan’s coverage determinations.

    Therapy Definitions

    Low-frequency ultrasound debridement — description
    MethodNoncontact debridement performed 5–15 mm from the wound surface using ultrasound to atomize saline into a continuous mist delivered to the treatment site.
    MechanismDevice makes multiple passes with the treatment head; atomized saline mist cleanses and debrides by removing necrotic tissue, fibrosis, exudate, and bacteria with minimal bleeding and pain.
    DeliverySaline is atomized by ultrasound technology to produce a continuous mist applied to the wound bed during a predetermined treatment session.
    Intended effectAccelerate wound healing through removal of necrotic tissue and contaminants while minimizing bleeding and pain.
    Noncontact normothermic wound therapy (NNWT)
    Definition
    Policy Summary
    PayerAmbetter Nevada
    PolicyLow-Frequency Ultrasound and Noncontact Normothermic Wound Therapy
    Policy CodePolicy CP.MP.139
    Change TypeNo material change
    Effective Date
    Next Review Date
    Key ActionFollow plan prior authorization requirements and review applicable Medicare LCD/LCA guidance (including CPT 97610) before submitting authorization requests.
    SourceLink
    On This Page
    Coverage DeterminationsCoding and Billing ReferencesProvider Responsibilities, Authorization & DocumentationClinical BackgroundTherapy Definitions
  1. Follow Health Plan-specific medical necessity and prior authorization processes.
  2. Note

    Preferred initial debridement — surgical debridement favored

    Surgical debridement is the preferred approach for removing large areas of necrotic tissue or when there is any evidence of infection; consider surgical debridement as the initial debridement in these scenarios.

    • Indicated for large necrotic areas and whenever there is evidence of infection (e.g., cellulitis, sepsis).
    • Used to obtain deep tissue for culture/pathology or manage undermined wound edges.
    Billing Rule

    Billing highlight — coding is informational; follow plan rules

    When billing for wound therapies, reference current CPT and HCPCS coding guidance; this clinical policy is a medical necessity guide and inclusion of codes does not guarantee coverage—claims are adjudicated per plan rules and coding manuals.

    • Codes listed are informational only; inclusion/exclusion does not ensure coverage.
    • Providers must use the most up-to-date professional coding guidance prior to claim submission.
    Documentation Required

    Coding and documentation note — use current coding guidance

    Reference current CPT/HCPCS manuals when submitting claims; the policy's code descriptions are informational and coverage determinations depend on claims adjudication and the member's benefit terms.

    • 97610 description provided for informational purposes.
    • HCPCS E0231 and E0232 descriptions provided for informational purposes.
    Documentation Required

    Provider responsibility — document medical necessity and exercise clinical judgment

    Providers must exercise professional medical judgment and maintain documentation that supports medical necessity; coverage decisions remain subject to the member's benefit terms, exclusions, limitations and the Health Plan's administrative policies.

    • Document clinical rationale, wound findings, previous therapies, and rationale for chosen treatment.
    • Retain records demonstrating medical necessity in case of coverage review.
    Denial Risk

    Denial risk — unsupported therapies may be denied

    Use of low-frequency ultrasound wound therapy or noncontact normothermic wound therapy (NNWT) is not supported by current evidence per this policy and therefore may be denied if billed or requested.

    • Policy states current evidence does not support low-frequency ultrasound wound therapy.
    • Policy states current evidence does not support NNWT.
    Denial Risk

    Denial risk — nonconformance with Medicaid/Medicare provisions

    Claims or services that conflict with state Medicaid manuals or that do not follow applicable Medicare NCDs/LCDs and Medicare Coverage Articles may be denied; review and follow those authorities when applicable.

    • For Medicaid members, state Medicaid coverage provisions take precedence over this clinical policy.
    • For Medicare members, review all applicable NCDs, LCDs, and Medicare Coverage Articles prior to applying this policy.
    Therapy that uses radiant heat to maintain 100% relative humidity and normothermia in the wound bed to provide an optimal environment for healing.
    EnvironmentProduces a warmed, fully humidified wound microenvironment (100% relative humidity) to support tissue repair.
    Delivery modeNoncontact application of radiant heat to the wound bed, preserving a moist, normothermic surface.
    Low-frequency, non-contact, non-thermal ultrasound debridement (CMS LCA reference)
    CPT referenceCPT code 97610: Low frequency, non-contact, non-thermal ultrasound (as referenced in the CMS Local Coverage Article).
    Source guidanceReferenced in CMS Local Coverage Article: Low frequency, non-contact, non-thermal ultrasound (A56175), published Nov 1, 2018 (revised Mar 7, 2024).
    ContextCMS Local Coverage Article links this code to low-frequency, non-contact, non-thermal ultrasound debridement practices for informational/review purposes.