ModifiedArizona Complete HealthPolicy CP.MP.180

Implantable Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea

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Medical necessity criteria and coding guidance for implantable hypoglossal (upper airway) nerve stimulation systems (InspireAE and GenioAE) for select patients with moderate to severe obstructive sleep apnea who have failed or are intolerant of PAP; also states DISE is medically necessary when used to evaluate appropriateness.

Policy Summary

PayerArizona Complete Health

PolicyImplantable Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea

Policy CodePolicy CP.MP.180

Change TypeMaterial updates to device criteria, AHI/BMI thresholds, DISE requirement, and coding (Inspire V, Genio)

Effective Date

Next Review Date

Key ActionObtain prior authorization and document PSG within 24 months, device-specific eligibility (AHI/BMI/age), PAP failure/intolerance, and DISE when used to evaluate device appropriateness.

SourceLink

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ModifiedArizona Complete HealthPolicy CP.MP.180

Implantable Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea

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Policy Summary

PayerArizona Complete Health

PolicyImplantable Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea

Policy CodePolicy CP.MP.180

Change TypeMaterial updates to device criteria, AHI/BMI thresholds, DISE requirement, and coding (Inspire V, Genio)

Effective Date

Next Review Date

Key ActionObtain prior authorization and document PSG within 24 months, device-specific eligibility (AHI/BMI/age), PAP failure/intolerance, and DISE when used to evaluate device appropriateness.

SourceLink

POLICY UPDATE CHANGES

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

Updated Inspire criteria: BMI changed to 3C= 40 kg/m2 and AHI threshold clarified to 3E15 and 3C= 100; added rhabdomyolysis as contraindication.

Added specific coverage criteria for the GenioAE System (age 3E=22, BMI 3C=32, AHI 3E=153C=65, cricomental space positive, non-supine AHI >10 or intolerance to positional therapy).

Added CPT and HCPCS codes for hypoglossal nerve stimulation procedures and devices, including new codes for Inspire V.

Updated age/BMI and device-specific criteria to align with FDA updates (Inspire), including changing age/BMI thresholds and adding new age-range30based criteria and contraindications.

Added criteria II. that drug-induced sleep endoscopy (DISE) is medically necessary to evaluate appropriateness of hypoglossal nerve stimulation.

Added new CPT codes 64568 and 64569 for Inspire V and added criteria for the Genio System.

Changed apnea-hypopnea index (AHI) thresholds in criteria (e.g., I.C.3.a to 3E15 and 3C=100; others adjusted to >10 and <50).

Updated verbiage in Criteria I. from 'all of the following criteria' to 'either of the following criteria.'

≤40 / ≤32BMI eligibility thresholds

≥15–≤100AHI (Inspire)

≥15–≤65AHI (Genio)

PSG ≤24mPSG timing

Medically necessaryDISE

64568,64569New codes

Coverage Criteria for Hypoglossal Nerve Stimulation

Initial Therapy — Device-specific criteria

Covered when ALL of the following device-specific conditions are met:

Inspire® Upper Airway Stimulation System

BMI ≤ 40 kg/m2
See policy criteria I.A.1
PSG: Polysomnography (PSG) performed within 24 months of first consultation for the hypoglossal nerve stimulator implant
See policy criteria I.A.2
Age/AHI/PAP conditions
- Adults ≥22: Age ≥ 22 years; diagnosis of moderate to severe OSA with AHI ≥ 15 and ≤ 100; and failure or intolerance of positive airway pressure (PAP) treatments, demonstrated by one of: (a) inability to eliminate OSA (AHI > 15 despite PAP usage), (b) inability to use PAP (usage < five nights per week or ≤ 4 hours/night), or (c) unwillingness to use PAP (returned PAP after attempt)
  See policy criteria I.A.3.a and I.A.3.a.i–iii
- Age 18–21 years; AHI ≥ 15 and ≤ 100; adenotonsillectomy contraindicated or ineffective; failed or intolerant of PAP despite attempts to improve usage; considered other standard of care therapies
  See policy criteria I.A.3.b
- Down syndrome 13–18: Members with Down syndrome age 13–18 years; AHI > 10 and < 50; adenotonsillectomy contraindicated or ineffective; failed or intolerant of PAP despite attempts to improve usage; considered other standard of care therapies
  See policy criteria I.A.3.c
Contraindications: None of the following contraindications are present: combined central and mixed apneas > 25% of total AHI; any anatomical finding that would compromise UAS performance (e.g., complete concentric collapse of the soft palate); any condition/procedure that has compromised neurological control of the upper airway; inability to operate device remote; pregnancy or planning pregnancy; presence of an implantable device with potential interaction; requirement for MRI beyond MR-conditional labeling; rhabdomyolysis
See policy criteria I.A.4.a–h

Genio® System

Age ≥ 22 years
See policy criteria I.B.1
BMI ≤ 32 kg/m2
See policy criteria I.B.2
PSG: Polysomnography (PSG) performed within 24 months of first consultation for the hypoglossal nerve stimulator implant
See policy criteria I.B.3
AHI: Diagnosis of moderate to severe OSA with AHI ≥ 15 and ≤ 65
See policy criteria I.B.4
Cricomental space positive (≥ 0 cm)
See policy criteria I.B.5

DISE appropriateness

Drug-induced sleep endoscopy

DISE is medically necessary when completed to evaluate the appropriateness of a hypoglossal nerve stimulation device

Initial Device Eligibility

Covered when EITHER of the following device-specific criteria sets are met (Inspire Upper Airway Stimulation system criteria OR Genio System criteria), plus absence of listed contraindications and required preoperative evaluations.

Either device-specific criteria: Patient meets either the Inspire device criteria (updated BMI ≤ 40 kg/m2, AHI and age-range provisions, PSG timing, and absence of listed contraindications) OR the Genio system criteria (age ≥22, BMI ≤32 kg/m2, AHI ≥15–≤65, cricomental space positive, positional requirements, PSG timing, and absence of listed contraindications).

Policy verbiage updated to allow either device criteria to satisfy coverage; see device-specific sections for full conditions.

Preoperative Evaluation

Preoperative evaluations required

Preoperative assessments: Required documentation includes a diagnostic polysomnography (PSG) performed within 24 months of first consultation (where specified in device criteria) and documentation of DISE when it is performed to evaluate appropriateness for hypoglossal nerve stimulation.PSG within 24 months (where specified)

See policy criteria I.A.2, I.B.3 and statement II regarding DISE

This policy applies to implantable hypoglossal (upper airway) nerve stimulation systems (e.g., Inspire® and Genio®) as a covered treatment option for select members with moderate to severe obstructive sleep apnea who meet device‑specific criteria. Coverage is limited to members who meet the stated device eligibility requirements (AHI and BMI thresholds, age-related provisions where specified), have documentation of a diagnostic polysomnography within the required timeframe, and have failed, are intolerant of, or have refused standard first‑line therapies such as positive airway pressure (PAP). The policy excludes members with conditions that would compromise device performance or safety, including but not limited to the listed contraindications (for example, central/mixed apneas >25% of total AHI, complete concentric collapse of the soft palate, inability to operate the device remote, pregnancy/planned pregnancy, implantable device interactions, MRI needs outside MR‑Conditional labeling, and rhabdomyolysis).

Contraindications have been updated and explicitly include rhabdomyolysis as a condition that precludes coverage. Other enumerated exclusions and contraindications in the policy include central and mixed apneas constituting >25% of total AHI, anatomical findings that would compromise upper airway stimulation (for example, complete concentric collapse of the soft palate), any condition or procedure that has compromised neurological control of the upper airway, inability to operate the device remote, pregnancy or planned pregnancy, active implantable device interactions, and the need for MRI examinations beyond what is permitted by the device’s MR‑Conditional labeling. These contraindications must be absent for approval.

External guidance from the National Institute for Health and Care Excellence (NICE) highlights that current evidence on hypoglossal nerve stimulation for moderate to severe OSA is limited in quantity and quality and recommends that use should occur only with special arrangements for clinical governance, consent, audit, or research. The policy also notes governance considerations internally: when drug‑induced sleep endoscopy (DISE) is performed to evaluate appropriateness for a hypoglossal nerve stimulation device, DISE is considered medically necessary for that purpose and documentation of the DISE should be made available as part of the preoperative evaluation.

Requests that do not meet the policy’s device‑specific clinical criteria or that meet any listed contraindications will be denied as not medically necessary. Common denial triggers include failure to document required polysomnography within the specified timeframe, AHI or BMI values outside the device‑specific thresholds, absence of documented failure/intolerance/refusal of PAP (or other required conservative therapies), missing DISE documentation when DISE was performed to establish device appropriateness, or presence of any listed contraindication such as rhabdomyolysis or MRI needs beyond MR‑conditional labeling.

Billing and Coding

Covered CPT CodesCPTCovered

42975	Drug-induced sleep endoscopy, with dynamic evaluation of velum, pharynx, tongue base, and larynx for evaluation of sleep-disordered breathing, flexible, diagnostic.
64582	Open implantation of hypoglossal nerve neurostimulator array, pulse generator, and distal respiratory sensor electrode or electrode array.
64583	Revision or replacement of hypoglossal nerve neurostimulator array and distal respiratory sensor electrode or electrode array, including connection to existing pulse generator.
64584	Removal of hypoglossal nerve neurostimulator array, pulse generator, and distal respiratory sensor electrode or electrode array.
64568	Open implantation of cranial nerve (eg, vagus nerve) neurostimulator electrode array and pulse generator.
64569	Revision or replacement of cranial nerve (eg, vagus nerve) neurostimulator electrode array, including connection to existing pulse generator.

HCPCS / Device CodesHCPCSCovered

C1767	Generator, neurostimulator (implantable), nonrechargeable.
C1778	Lead, neurostimulator (implantable).
C1787	Patient programmer, neurostimulator.
L8679	Implantable neurostimulator, pulse generator, any type.
L8680	Implantable neurostimulator electrode, each.
L8681	Patient programmer (external) for use with implantable programmable neurostimulator pulse generator, replacement only.
L8686	Implantable neurostimulator pulse generator, single array, nonrechargeable, includes extension.

Updated CPT codes for Inspire VCPTCovered

64568	New code added for Inspire V (as listed in coding table)
64569	New code added for Inspire V (as listed in coding table)

AHI eligibility ranges (device-specific)

Inspire® AHI rangeAHI ≥ 15 and ≤ 100

Genio® AHI range (general)AHI ≥ 15 and ≤ 65

Genio® AHI — Down syndrome subgroup (age 13–18)AHI > 10 and < 50

BMI eligibility (device-specific)

Inspire® BMI thresholdBMI ≤ 40 kg/m2

Genio® BMI thresholdBMI ≤ 32 kg/m2

Down syndrome subgroup note

Provider Requirements and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for implantation, revision/replacement, removal, device interrogation/diagnostic procedures, and DISE when performed to evaluate candidacy. Submit a prior authorization request before scheduling procedures to avoid claim denials.

Affected CPT/HCPCS codes: 64582, 64583, 64584, 64568, 64569; 42975 (DISE). HCPCS/Codes for implantable generators, leads, and programmers: C1767, C1778, C1787, L8679, L8680, L8681, L8686.

Prior Authorization

Device‑Specific Prior Authorization

Device-specific prior authorization must demonstrate the requested device meets the device-specific clinical criteria in the policy (e.g., Inspire® versus Genio® criteria: age, BMI thresholds, AHI ranges, PSG timing, anatomic/exclusion findings, and documented failure/intolerance of standard therapies). Provide device model/manufacturer and documentation that each device-specific criterion is met.

Specify device (Inspire® or Genio®) on the PA request.
Document device-specific eligibility: Inspire® — BMI ≤ 40 kg/m2, PSG within 24 months, AHI thresholds, PAP failure/intolerance; Genio® — BMI ≤ 32 kg/m2, PSG within 24 months, AHI ≤ 65, cricomental space positive, non‑supine AHI >10 or intolerance/refusal of positional therapy.

Background and Evidence

Obstructive sleep apnea (OSA) results from repetitive collapse of the upper airway during sleep producing apneas and hypopneas that can lead to daytime sleepiness and adverse health outcomes. Continuous positive airway pressure (PAP) is the first‑line therapy, but some patients are unable to tolerate or adhere to PAP. Hypoglossal nerve stimulation (upper airway stimulation) works by stimulating the genioglossus and related tongue‑protruding musculature to maintain airway patency during sleep; this provides a surgical, implantable option for carefully selected patients with moderate to severe OSA who have not benefited from, cannot tolerate, or refuse PAP. The policy’s device‑specific criteria (including updated AHI/BMI and age provisions and the addition of Genio® system criteria) align coverage to evidence and device approvals while requiring preoperative evaluation and absence of contraindications to optimize safety and efficacy.

For context, NICE concludes that evidence for hypoglossal nerve stimulation is limited and recommends restricted use with robust governance and data collection. The policy incorporates this perspective by requiring device‑specific eligibility, preoperative evaluations (including DISE when used to determine appropriateness), and documentation standards to support informed consent, safety monitoring, and audit.

Definitions

Cricomental space definition

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.

Genio requirementGenio criteria require cricomental space positive (≥ 0 cm)

Assessment contextMeasured with head in neutral position as part of preoperative evaluation for Genio® System candidacy

Apnea-Hypopnea Index (AHI) definition

AHI definitionApnea-hypopnea index (AHI) is the number of apneas and hypopneas per hour used to classify severity of obstructive sleep apnea for device eligibility.

Documentation requirementAHI must be documented from diagnostic polysomnography performed within the policy-specified timeframe (e.g., within 24 months)

Policy Summary

PayerArizona Complete Health

PolicyImplantable Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea

Policy CodePolicy CP.MP.180

Change TypeMaterial updates to device criteria, AHI/BMI thresholds, DISE requirement, and coding (Inspire V, Genio)

Effective Date

Next Review Date

Key ActionObtain prior authorization and document PSG within 24 months, device-specific eligibility (AHI/BMI/age), PAP failure/intolerance, and DISE when used to evaluate device appropriateness.

SourceLink

On This Page

Positional/non-supine requirement: Non-supine AHI > 10 on screening PSG, or participant has not tolerated, failed, or refused positional therapy

See policy criteria I.B.6

Failure of standard treatments: Failure, refusal, or intolerance of standard treatments including lifestyle modifications, PAP, oral appliances, or pharmacotherapy (e.g., tirzepatide)

See policy criteria I.B.7

Contraindications: None of the following contraindications are present: combined central and mixed apneas > 25% of total AHI; functional or structural problems preventing implantation/activation/continued use; active implantable medical device interaction; planning pregnancy/current pregnancy/breastfeeding; other conditions that would interfere with Genio use

See policy criteria I.B.8 and I.B.2

Genio subgroup uses age-based criteria (see AHI and age 13–18 provisions)

Apnea-Hypopnea Index (AHI) — updated threshold notes

Updated Inspire AHI wordingI.C.3.a updated from >15 and <100 to ≥15 and ≤100 — applies to adult/age-based Inspire criteria

Multiple AHI editsPolicy includes additional AHI threshold adjustments across criteria (examples include >10 and <50 for certain pediatric/Down syndrome subgroup)

AHI documented on PSGDiagnosis of moderate to severe OSA requires objective AHI values from diagnostic polysomnography performed within specified timeframe

Body Mass Index (BMI) — updated threshold note

Updated Inspire BMI wordingInspire criteria updated to specify BMI ≤ 40 kg/m2 (replaced prior phrasing)

Genio BMI for adultsGenio criteria specify BMI ≤ 32 kg/m2

BMI requirement tied to device-specific criteriaBMI thresholds are part of the device eligibility sets and must be documented in the record

Step Therapy

Step Therapy / Sequencing

Requests that do not follow clinical criteria sequencing or applicable step therapy/standard‑of‑care expectations may be denied. Ensure conservative and standard treatments were attempted (or documented contraindicated/refused) before PA submission.

Document trials of standard therapies: PAP (CPAP/BiPAP) with usage data or documented intolerance; oral appliances/external therapies; lifestyle modifications and positional therapy where applicable.
If PAP was refused, document return of equipment or clear evidence of refusal; if PAP failed, provide PSG or usage data supporting failure (AHI remaining >15 despite PAP usage or inadequate usage defined in policy).

Denial Risk

Denial Triggers to Avoid

Denials may be issued when device‑specific or administrative requirements are not met. Common denial triggers include missing or untimely PSG, inadequate documentation of PAP failure/intolerance/refusal or other conservative therapy attempts, failure to meet device‑specific inclusion/exclusion criteria, or presence of contraindications.

Missing PSG within 24 months of first consultation.
No objective AHI values documented or AHI outside the device‑specific required range.
Insufficient documentation of PAP trial, usage data, or clear intolerance/refusal.
Failure to meet device‑specific anatomical or safety exclusions (e.g., >25% central/mixed apneas, complete concentric palatal collapse, conflicting implantable devices, MRI requirements, pregnancy/breastfeeding, rhabdomyolysis).
Missing preoperative items required by the plan (device model, operative plan, DISE report when used to assess candidacy).

Threshold useAHI thresholds are applied differently by device (see device-specific AHI ranges) and were updated in recent revisions

Drug-induced sleep endoscopy (DISE) definition

DISE definitionDrug-induced sleep endoscopy (DISE) is an endoscopic evaluation under sedation used preoperatively to assess the pattern of upper airway collapse and appropriateness for hypoglossal nerve stimulation.

Medical necessity in policyPolicy states DISE is medically necessary when completed to evaluate appropriateness of a hypoglossal nerve stimulation device.

DocumentationWhen performed, DISE documentation should be available as part of the preoperative evaluation for device candidacy