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    v1.0.28
    OpenPayerPolicy UpdatesSleep MedicineAmbetter Nevada hypoglossal nerve stimulation Cove…
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    ModifiedAmbetter NevadaPolicy CP.MP.180

    Implantable Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea

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    Defines medical necessity criteria, patient selection, contraindications, and coding for implantable hypoglossal (upper airway) nerve stimulation systems (Inspire® and Genio®) for treatment of moderate to severe OSA for Ambetter Nevada members.

    Policy Summary
    PayerAmbetter Nevada
    PolicyImplantable Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea
    Policy CodePolicy CP.MP.180
    Change TypeCriteria updates, device-specific additions, coding changes
    Effective Date
    Next Review Date
    Key ActionObtain prior authorization with documentation including recent PSG (within 24 months), BMI, age, DISE when performed, and evidence of PAP failure/intolerance per device-specific criteria.
    SourceLink

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    POLICY UPDATE CHANGES

    Added criteria II stating that drug-induced sleep endoscopy (DISE) is medically necessary when completed to evaluate the appropriateness of a hypoglossal nerve stimulation device.

    Updated Inspire criteria: clarified BMI threshold (≤ 40 kg/m2), specified PSG within 24 months of first consultation, and adjusted AHI wording to ≥15 and ≤100 for certain age groups.

    Added coverage criteria specific to the Genio® System including age ≥ 22, BMI ≤ 32 kg/m2, AHI ≥ 15 and ≤ 65, cricomental space positive requirement, and non-supine AHI > 10 or intolerance/refusal of positional therapy.

    Added new CPT codes (64568, 64569) for Inspire V and updated coding table entries for hypoglossal nerve stimulation procedures and related HCPCS.

    Added contraindication for members with rhabdomyolysis and other updated contraindications I.D.a–I.D.g and I.D.8.

    Revised policy language to allow either of the major device-specific criteria groups to satisfy coverage (changed from 'all' to 'either').

    ≤40Inspire BMI eligibility
    ≥15–≤100Inspire AHI range
    ≥15–≤65Genio AHI range
    24 moPSG timing
    RequiredDISE status
    2New CPT codes

    Medical Necessity and Device Eligibility

    Initial Therapy / Device-specific eligibility

    Covered when either of the following device-specific criteria sets are met

    Criteria I.A (Inspire Upper Airway Stimulation system): Device-specific eligibility for Inspire including BMI ≤ 40 kg/m2, PSG within 24 months, age- and diagnosis-specific AHI thresholds (e.g., AHI ≥ 15 and ≤ 100 for most age groups; AHI > 10 and < 50 for certain Down syndrome patients), documentation of PAP failure/refusal/intolerance, absence of contraindications, and DISE findings when required.See Inspire criteria

    Policy language revised to allow either device-specific pathway; see Inspire criteria block for nested detail.

    Anatomical features that would prevent effective upper airway stimulation are explicit contraindications and should be documented during preoperative evaluation. The policy lists as exclusions any finding that would compromise device performance — for example, the presence of complete concentric collapse of the soft palate identified on airway assessment or DISE. These anatomic patterns predict poor response to hypoglossal nerve stimulation and are considered disqualifying for implantation.

    Providers should ensure that objective airway assessments (including DISE when performed) specifically comment on soft-palate collapse patterns and other structural abnormalities that could impede stimulation efficacy; requests lacking documentation that these anatomic issues were assessed may be denied.

    The policy expands and clarifies contraindications that preclude coverage. Contraindications include: central and mixed apneas > 25% of total AHI; any anatomical finding that would compromise performance of upper airway stimulation (e.g., complete concentric collapse of the soft palate); conditions or prior procedures that have compromised neurological control of the upper airway; inability to operate the device remote; pregnancy or planned pregnancy; presence of an implantable device that may interact with the stimulator; need for MRI beyond the device's MR Conditional labeling; and rhabdomyolysis, which was added explicitly as a contraindication.

    When evaluating candidacy, clinicians must document absence of these contraindications in the medical record. Requests that indicate one or more of these contraindications are present should be considered not medically necessary per the policy.

    The National Institute for Health and Care Excellence (NICE) concluded that current evidence on safety and efficacy of hypoglossal nerve stimulation for moderate to severe OSA is limited in quantity and quality. NICE therefore recommends that the procedure be used only with special arrangements for clinical governance, consent, and audit or research. This policy references that advisory conclusion as an evidence-consideration note when counseling members and documenting benefit decisions.

    For members who do not meet the device-specific eligibility criteria (for example, AHI, BMI, age ranges, PSG timing, or DISE findings) or who have listed contraindications, the policy treats the procedure as not medically necessary. Providers should first ensure documentation of prior standard-of-care therapy attempts (e.g., PAP therapy usage/failure, oral appliance attempts, positional therapy) and objective testing including a PSG performed within 24 months and any completed DISE.

    If a member remains ineligible or has a contraindication, alternatives include continued optimization of conservative management (weight loss, positional therapy, oral appliances, or PAP retrial/optimization) or referral for other surgical options when clinically appropriate. Prior authorization requests that do not demonstrate meeting device-specific criteria or absence of contraindications are subject to denial.

    Procedure and Supply Codes

    Referenced CPT CodesCPT
    42975Drug-induced sleep endoscopy, with dynamic evaluation of velum, pharynx, tongue base, and larynx for evaluation of sleep-disordered breathing, flexible, diagnostic.
    64582Open implantation of hypoglossal nerve neurostimulator array, pulse generator, and distal respiratory sensor electrode or electrode array.
    64583Revision or replacement of hypoglossal nerve neurostimulator array and distal respiratory sensor electrode or electrode array, including connection to existing pulse generator.
    64584Removal of hypoglossal nerve neurostimulator array, pulse generator, and distal respiratory sensor electrode or electrode array.
    64568Open implantation of cranial nerve (eg, vagus nerve) neurostimulator electrode array and pulse generator.
    64569Revision or replacement of cranial nerve (eg, vagus nerve) neurostimulator electrode array, including connection to existing pulse generator.
    Referenced HCPCS / Supply CodesHCPCS
    C1767Generator, neurostimulator (implantable), nonrechargeable.
    C1778Lead, neurostimulator (implantable).
    C1787Patient programmer, neurostimulator.
    L8679Implantable neurostimulator, pulse generator, any type.
    L8680Implantable neurostimulator electrode, each.
    L8681Patient programmer (external) for use with implantable programmable neurostimulator pulse generator, replacement only.
    L8686Implantable neurostimulator pulse generator, single array, nonrechargeable, includes extension.
    New CPT Codes for Inspire VCPT
    64568Added new code for Inspire V (procedure code as listed in policy)
    64569Added new code for Inspire V (procedure code as listed in policy)
    Body mass index (BMI) — device thresholds
    Inspire BMI thresholdBMI ≤ 40 kg/m2
    Genio BMI thresholdBMI ≤ 32 kg/m2
    Context for Inspire changeInspire criteria B updated from 'Age > 22 years' to 'BMI ≤ 40 kg/m2' to align with FDA updates
    Apnea-hypopnea index (AHI) — device-specific ranges
    Inspire AHI eligibility (age ≥22 and 18–21)AHI ≥ 15 and ≤ 100
    Inspire Down syndrome (age 13–18)AHI > 10 and < 50

    Prior Authorization, Documentation, and Denial Triggers

    Prior Authorization

    Prior Authorization Required

    Prior authorization is required before implantation or revision/removal of hypoglossal nerve neurostimulation systems and related procedures. Affected procedure and supply codes include implantation, revision/replacement, removal, and DISE evaluation. Submit clinical documentation supporting device-specific criteria and treatment history at the time of authorization request.

    • Prior authorization required for implantation, revision/replacement, and removal procedures (e.g., CPT 64582, 64583, 64584; CPT 64568, 64569 as applicable).
    • Prior authorization required for drug-induced sleep endoscopy (DISE) when completed to evaluate device appropriateness (CPT 42975).
    • Include HCPCS/NDC/implantable device codes for pulse generators, leads, and patient programmers as applicable.
    Documentation Required

    Device‑Specific Documentation Required

    Providers must document objective evidence that device-specific eligibility criteria are met. For Inspire®, Genio®, or other specified systems, include PSG results, AHI values within the device-specific ranges, BMI and age documentation, and DISE findings when DISE has been performed.

    Clinical Context and Evidence Notes

    Obstructive sleep apnea (OSA) is characterized by repetitive upper airway collapse during sleep producing apneas and hypopneas with downstream clinical consequences. Continuous positive airway pressure (PAP) remains first-line therapy but many patients have intolerance or inadequate adherence. Hypoglossal nerve stimulation (upper airway stimulation, UAS) offers a surgical alternative for select patients who are intolerant of PAP and meet device-specific anatomic and physiologic criteria.

    Two FDA-cleared systems are addressed in this policy: the Inspire® system (an implanted pulse generator and sensing/stimulation leads) and the Genio® System (an implantable stimulator with an external controller/patch). Device-specific selection criteria (including AHI, BMI, age, and airway anatomy/DISE findings) are required because efficacy and safety data supporting UAS come from trials and labeling that define these eligibility parameters.

    Consistent with the NICE assessment, the policy notes limitations in the quantity and quality of evidence for hypoglossal nerve stimulation and highlights the importance of governance, informed consent, and audit or research arrangements when implementing the procedure in clinical practice.

    Terms and Device-Specific Definitions

    Cricomental space — definition / measurement
    DefinitionCricomental space is the distance between the neck and the bisection of a line from the chin to the cricoid membrane when the head is in a neutral position
    Measurement noteMeasured with head in neutral position; Genio criteria require cricomental space positive (≥ 0 cm)
    RelevanceUsed as a device-specific anatomical requirement for the Genio System
    Hypoglossal nerve stimulation / UAS — system components
    Inspire system componentsInspire consists of an implantable pulse generator (IPG), stimulation lead, sensing lead, and external physician and patient programmers
    Genio system componentsGenio consists of an implantable stimulator plus an external wearable controller/patch that stimulates hypoglossal nerve branches (as described in background and Genio criteria)
    Policy Summary
    PayerAmbetter Nevada
    PolicyImplantable Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea
    Policy CodePolicy CP.MP.180
    Change TypeCriteria updates, device-specific additions, coding changes
    Effective Date
    Next Review Date
    Key ActionObtain prior authorization with documentation including recent PSG (within 24 months), BMI, age, DISE when performed, and evidence of PAP failure/intolerance per device-specific criteria.
    SourceLink
    On This Page
    Medical Necessity and Device EligibilityProcedure and Supply CodesPrior Authorization, Documentation, and Denial TriggersClinical Context and Evidence NotesTerms and Device-Specific Definitions
    Genio AHI eligibility
    AHI ≥ 15 and ≤ 65
    Polysomnography timing
    Required timing for diagnostic PSGPolysomnography performed within 24 months of first consultation for the hypoglossal nerve stimulator implant
    Applies to Inspire and GenioPSG timing is specified in both Inspire (I.A.2) and Genio (I.B.3) criteria
    Titration note addedPolicy adds note regarding titration PSG following implantation
    Apnea-Hypopnea Index (AHI) — numeric clarifications
    AHI numeric clarificationsPolicy clarifies AHI range language — e.g., I.C.3.a changed from '>15 and <100' to '≥15 and ≤100'
    Alternate AHI expressionsElsewhere AHI thresholds retained or adjusted (for Down syndrome: changed to 'AHI > 10 and < 50')
    Device-specific referencesAHI thresholds are referenced in device-specific criteria sections for Inspire and Genio
    Body Mass Index (BMI) — updated eligibility
    Updated Inspire eligibility limitInspire BMI eligibility limit updated to ≤ 40 kg/m2 (replaced prior <35 references in criteria C)
    Policy-wide BMI adjustmentEarlier references to BMI <35 were adjusted in device age-stratified criteria to align with FDA-labeled ranges
    Impact on device selectionBMI threshold change affects which members meet Inspire device-specific eligibility
    • Polysomnography (PSG) performed within 24 months of first consultation; include full PSG report and AHI/oxygen desaturation data.
    • Document BMI at time of evaluation and patient age to confirm device-specific thresholds (e.g., Inspire® BMI ≤ 40 kg/m2; Genio® BMI ≤ 32 kg/m2; age requirements per device).
    • If DISE has been completed, include DISE report detailing upper airway collapse patterns and any findings relevant to device candidacy.
    Denial Risk

    Denial Triggers — Not Meeting Device Criteria

    Denials are likely when documentation does not establish that the member meets device criteria or when key objective data are missing or outside allowable ranges.

    • AHI outside device-specific ranges (e.g., <15 or > device upper limit for adult pathways) or not clearly documented on the PSG.
    • PSG older than 24 months from first consultation or absent full PSG report.
    • Missing or incomplete BMI or age documentation to confirm eligibility thresholds.
    • Absence of DISE report when DISE was performed but findings not provided; or DISE findings that demonstrate contraindicating anatomy (e.g., complete concentric collapse of the soft palate as applicable).
    • Insufficient evidence of failure/intolerance/refusal of standard treatments (see separate failure/intolerance requirements).
    Denial Risk

    Denial Triggers — Eligibility and Contraindications

    Requests may be denied if contraindications or exclusionary conditions are present or if the member cannot safely use the device.

    • Combined central and mixed apneas > 25% of total AHI.
    • Anatomical findings that would compromise stimulation effectiveness (e.g., complete concentric collapse of the soft palate where applicable).
    • Active implantable devices or other implants that may interact with the neurostimulator.
    • Patient is pregnant, planning pregnancy, breastfeeding, or requires MRI beyond MR‑conditional labeling.
    • Any medical condition or procedure that compromises neurological control of the upper airway or would prevent implantation, activation, or ongoing use (including documented rhabdomyolysis).
    • Member lacks necessary cognitive/physical assistance to operate device remote or follow-up care requirements.
    Documentation Required

    Failure or Intolerance of Standard Treatments Required

    Authorization requires documented failure, intolerance, refusal, or inability to use standard treatments before considering implantable hypoglossal stimulation, except where device-specific alternate age pathways apply.

    • Document trials and outcomes for positive airway pressure (PAP) therapy (CPAP/BiPAP): inability to eliminate OSA (AHI >15 despite PAP), inadequate usage (less than required nights/hours defined by policy), or documented intolerance/refusal.
    • Document trial and failure/intolerance/refusal of other standard therapies as applicable: oral appliances (mandibular advancement devices), positional therapy (or non‑supine AHI >10 where positional therapy not tolerated/failed/refused), lifestyle modifications, and pharmacotherapy (if relevant).
    • For pediatric or alternate device pathways (e.g., ages 13–21 or Down syndrome subgroup), document adenotonsillectomy contraindication/ineffectiveness and attempts to optimize PAP when required.
    FunctionSystems stimulate hypoglossal nerve branches to maintain airway patency during inspiration; physician configures settings and patient uses remote to control therapy
    DISE — drug-induced sleep endoscopy
    DISE definitionDrug-induced sleep endoscopy (DISE) is a preoperative endoscopic evaluation performed under sedation to assess patterns of airway collapse
    Role in evaluationDISE is medically necessary when completed to evaluate appropriateness for a hypoglossal nerve stimulation device (policy criteria II)
    Coding referenceCPT 42975 is the referenced procedure code for DISE in the policy coding table
    AHI — apnea-hypopnea index definition and role
    AHI definitionApnea-hypopnea index (AHI) is the polysomnography-derived measure used in the policy to determine severity and device eligibility
    Use in criteriaSpecific numeric AHI thresholds are applied by device and age group (e.g., Inspire ≥15–≤100; Genio ≥15–≤65; Down syndrome >10–<50)
    Documentation requirementPSG results reporting AHI within the specified device ranges must be included in prior authorization documentation