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    v1.0.31
    OpenPayerPolicy UpdatesCardiologyProvidence Health Plan CCM Coverage | OpenPayer
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    CurrentProvidence Health PlanPolicy 450

    Cardiac Contractility Modulation for Heart Failure

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    This Medicare medical policy governs coverage and documentation requirements for cardiac contractility modulation systems used to manage heart failure for Providence Medicare Advantage members. It applies to systems covered under Medicare criteria, including coverage with evidence development studies or Medicare-approved investigational device exemption pathways; cardiac contractility modulation-defibrillator systems are outside the policy scope.

    Policy Summary
    PayerProvidence Health Plan
    PolicyCardiac Contractility Modulation for Heart Failure
    Policy CodePolicy 450
    Change TypeRevised
    Effective DateNov 1, 2026
    Last ReviewSep 1, 2026
    Next Review DateNov 1, 2026
    Key ActionSubmit clinical documentation for pre-service review, including NCD criteria, optimized GDMT, heart-team oversight, device name, and the required registry or study NCT number.
    SourceLink
    POLICY UPDATE CHANGES

    The policy replaced the prior Medicare decision memo reference with National Coverage Determination 20.39 for cardiac contractility modulation for heart failure.

    Cardiac contractility modulation-defibrillator systems were removed from the scope of this policy.

    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.

    Medicare Only
    Product and benefit application
    NCD 20.39Primary CMS coverage reference
    3 monthsMinimum documented optimized GDMT before CCM
    CED requiredMedicare coverage pathway requirement
    2Examples of in-scope CCM systems identified
    CCM-D excludedDevice category outside policy scope

    Medicare Coverage Criteria

    Medicare coverage pathway

    Covered when furnished under the applicable Medicare coverage pathway and the NCD criteria are met.

    Qualifying Medicare pathway: CCM for heart failure is covered when furnished in the context of a Medicare-approved coverage with evidence development (CED) study, including an approved registry or clinical trial, or through a Medicare-approved Investigational Device Exemption (IDE) pathway.

    Apply current CMS guidance and NCD 20.39 requirements if there is a conflict.

    Documentation supporting medical necessity

    Documentation must establish each listed clinical requirement.

    Clinical and administrative requirements

    • Document the condition being treated.
    • Document that the patient meets the FDA market-authorized indications for use and has no contraindications for the device used.
    • Document that the patient remains symptomatic despite optimized guideline-directed medical therapy (GDMT).At least 3 months of optimized GDMT
    • Confirm that the patient is under the care of a heart team.
    • Provide the name of the CCM device that will be used.
    • Provide the NCT number for the registry or study in which the member or provider is enrolled.

      Enrollment is a requirement under the Medicare criteria.

    This policy addresses cardiac contractility modulation (CCM) systems only. Cardiac contractility modulation-defibrillator (CCM-D) systems, including the OPTIMIZER Integra CCM-D System, are outside the scope of this policy.

    Coding and Billing

    Cardiac contractility modulation proceduresCPT
    0408TInsertion or replacement of permanent cardiac contractility modulation system; pulse generator with transvenous electrodes
    0409TInsertion or replacement of permanent cardiac contractility modulation system, including contractility evaluation when performed, and programming of sensing and therapeutic parameters; pulse generator with transvenous electrodes
    0410TInsertion or replacement of permanent cardiac contractility modulation system, including contractility evaluation when performed, and programming of sensing and therapeutic parameters; atrial electrode only
    0411TInsertion or replacement of permanent cardiac contractility modulation system, including contractility evaluation when performed, and programming of sensing and therapeutic parameters; ventricular electrode only
    0412TRemoval of permanent cardiac contractility modulation system; pulse generator only
    0413TRemoval of permanent cardiac contractility modulation system; transvenous electrode, atrial or ventricular
    0414TRemoval and replacement of permanent cardiac contractility modulation system; pulse generator only
    0415TRepositioning of previously implanted cardiac contractility modulation system; transvenous electrode, atrial or ventricular lead
    0416TRelocation of skin pocket for implanted cardiac contractility modulation pulse generator
    0417TProgramming device evaluation, in person, with iterative adjustment of the implantable device to test function and select optimal permanent programmed values, with analysis, review and report, implantable cardiac contractility modulation system
    1–10 of 12
    1/2
    Cardiac contractility modulation supplyHCPCS
    K1030External recharging system for battery, internal, for use with implanted cardiac contractility modulation generator, replacement only
    Optimized GDMT Before CCM
    TherapyOptimized guideline-directed medical therapy (GDMT)
    Minimum durationAt least 3 months
    Clinical requirementThe patient must remain symptomatic despite optimized GDMT

    Provider Submission Requirements

    Documentation Required

    Pre-Service Review Documentation Required

    Submit all clinical documentation needed to review medical necessity for CCM, including the applicable NCD criteria, the device's FDA market-authorized indication, and confirmation that no contraindications apply. Include documentation that the member remains symptomatic despite at least 3 months of optimized guideline-directed medical therapy (GDMT) and is under the care of a heart team.

    • Condition being treated
    • Applicable NCD criteria
    • FDA market-authorized indication and absence of contraindications
    • At least 3 months of optimized GDMT with persistent symptoms
    • Heart-team involvement
    Prior Authorization

    Prior Authorization Recommended for Unlisted Potentially Covered Services

    For an unlisted code submitted for a potentially covered service addressed in this policy, prior authorization is recommended to help avoid a post-service denial. Unlisted codes remain subject to medical-necessity, coding, and pricing review at the claim level.

    Device Background

    A cardiac contractility modulation system includes an implantable pulse generator, ventricular septal pacing leads, an external charger, and an external programming device. The system delivers programmed electrical stimulation to the ventricular septum during the absolute refractory period; the stimulation is non-excitatory and is intended to increase the strength of cardiac contraction. Clinical goals include alleviating heart failure symptoms and improving quality of life, functional capacity, and exercise tolerance.

    Key Definitions

    Cardiac Contractility Modulation (CCM)
    System typeImplantable cardiac system
    Stimulation siteVentricular septum
    Electrical functionDelivers periodic programmed electrical stimulation during the absolute refractory period to increase the strength of cardiac contraction
    Coverage With Evidence Development (CED)
    Coverage pathwayMedicare coverage with evidence development (CED)
    Eligible servicesServices furnished in approved clinical studies or registries meeting specified evidence-development requirements
    Additional pathway
    Policy Summary
    PayerProvidence Health Plan
    PolicyCardiac Contractility Modulation for Heart Failure
    Policy CodePolicy 450
    Change TypeRevised
    Effective DateNov 1, 2026
    Last ReviewSep 1, 2026
    Next Review DateNov 1, 2026
    Key ActionSubmit clinical documentation for pre-service review, including NCD criteria, optimized GDMT, heart-team oversight, device name, and the required registry or study NCT number.
    SourceLink
    On This Page
    Medicare Coverage CriteriaCoding and BillingProvider Submission RequirementsDevice BackgroundKey Definitions
    • Request prior authorization before service when an unlisted code is used for a potentially covered service
    Documentation Required

    Support Applicable NCD Criteria

    Submit the clinical documentation necessary to demonstrate that all applicable Medicare NCD 20.39 criteria are met, including the required coverage pathway and enrollment information.

    • Document the applicable NCD criteria
    • Document enrollment in the applicable Medicare-approved registry, clinical trial, or other qualifying pathway
    Documentation Required

    Identify the Device and Study

    Identify the specific CCM device that will be used and provide the applicable registry or study NCT number. Enrollment in an applicable registry or study is required under the Medicare criteria.

    • Device name
    • Registry or study NCT number

    Unsupported block type: documentation

    Denial Risk

    Qualifying Medicare Coverage Pathway Required

    Coverage may be denied when CCM is not furnished under an applicable Medicare coverage pathway, such as coverage with evidence development (CED) or an approved investigational device exemption (IDE) pathway.

    • Confirm the service is furnished under an applicable Medicare pathway
    • Medicare-approved registries and clinical trials may qualify under CED
    • An applicable Medicare-approved IDE pathway may also support coverage
    Denial Risk

    NCD Criteria Must Be Established

    Coverage may be denied or delayed when the applicable NCD 20.39 requirements are not demonstrated in the submitted documentation.

    • Submit evidence that all applicable NCD criteria are satisfied
    • Include required registry or study enrollment information
    Denial Risk

    CCM-D Systems Are Out of Scope

    CCM-defibrillator (CCM-D) systems are outside the scope of this policy and are not addressed as covered CCM systems under this policy.

    • The OPTIMIZER Integra CCM-D System, by Optimizer Dynamic, is an example of a CCM-D system outside policy scope
    • This policy addresses CCM systems such as the OPTIMIZER Smart System and the Cardiac Contractility Modulation (CCM) System by Optimizer Dynamic
    Denial Risk

    Unlisted Codes for Non-Covered Services Will Be Denied

    An unlisted code submitted for a non-covered service addressed in this policy will be denied as not covered. Inclusion of a code or a payment amount does not establish Medicare coverage or medical necessity.

    • Unlisted codes are reviewed for medical necessity, correct coding, and pricing at the claim level
    Coverage may also be available through a Medicare-approved Investigational Device Exemption (IDE) pathway
    Guideline-Directed Medical Therapy (GDMT)
    TherapyOptimized guideline-directed medical therapy (GDMT)
    Condition managedHeart failure
    TimingUsed before consideration of cardiac contractility modulation (CCM)