ModifiedUnitedHealthcarePolicy CSNCT0525.10

Obstructive and Central Sleep Apnea Treatment (for North Carolina Only)

Medical policy governing non-surgical and surgical treatments for obstructive and central sleep apnea for members in North Carolina, including coverage stance for oral appliances, positional devices, hypoglossal nerve stimulation, and specified surgical procedures.

Policy Summary

PayerUnitedHealthcare

PolicyObstructive and Central Sleep Apnea Treatment (for North Carolina Only)

Policy CodePolicy CSNCT0525.10

Change TypeRevisions to HNS candidacy and DISE/PSG requirements

Effective Date

Next Review Date

Key ActionWhen requesting hypoglossal nerve stimulation prior authorization, document attended polysomnography results and drug‑induced sleep endoscopy confirming absence of complete concentric palatal collapse.

SourceLink

POLICY UPDATE CHANGES

Coverage criteria for implantable hypoglossal nerve stimulation were revised for adults to require evaluation by attended polysomnography and confirmation of absence of complete concentric collapse at the soft palate by drug‑induced sleep endoscopy.

For adolescents aged 10–18 with Down syndrome, the drug‑induced endoscopy language was standardized to confirm absence of complete blockage or concentric collapse at the soft palate level.

Non‑surgical treatment language: replaced 'sleep medicine physician' with 'physician trained in sleep medicine'.

The list of unproven and not medically necessary devices was updated by replacing 'Advanced Lightweight Functional (ALF) appliances' with 'Advanced Lightwire Functional (ALF) appliances'.

Related policy link title for Orthognathic (Jaw) Surgery (for North Carolina Only) was updated.

Definitions for Physician or Practitioner, Respiratory Disturbance Index (RDI), Respiratory Effort‑Related Arousal (RERA), and Respiratory Event Index (REI) were removed.

NC-onlystate applicability

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unproven/not medically necessary items

AHI thresholdsAHI thresholds specified

AAO-HNSoral appliance first-line (mild-mod)

policy historyrecent revisions listed

Coverage Criteria and Evidence Summaries

Surgical Treatment — Adult OSA

Proven and medically necessary in adults when ALL of the following are met:

Adult surgical OSA criteria: Diagnosis of moderate to severe OSA by attended polysomnography or RDI (AHI or RDI ≥ 15); Excessive daytime sleepiness documented (ESS > 10 or another validated tool); Prior trial of PAP therapy with documentation of no therapeutic efficacy, patient intolerance, or patient refusal; For mandibular osteotomy (MO): evidence of retrolingual or lower pharyngeal obstruction; For maxillomandibular advancement (MMA): craniofacial disproportion or deformity with documented maxillomandibular deficiencyAHI/RDI ≥ 15; ESS > 10

Applies to UPPP, mandibular osteotomy, and maxillomandibular advancement

Implantable Hypoglossal Nerve Stimulation — Adult

Proven and medically necessary in adults with moderate to severe OSA when ALL of the following are met:

Adult hypoglossal nerve stimulation criteria: AHI ≥ 15 and < 100 by attended polysomnography; BMI ≤ 40 kg/m2; Total AHI with central + mixed apneas < 25% as evaluated by attended polysomnography; Prior trial of PAP therapy with documentation of no therapeutic efficacy, patient intolerance, or patient refusal; Absence of a complete blockage or complete concentric collapse of the soft palate confirmed by drug‑induced sleep endoscopy; Device used in accordance with FDA labeling/guidelinesAHI ≥15 and <100; BMI ≤40; central/mixed apneas <25%

Device example: Inspire UAS

Implantable Hypoglossal Nerve Stimulation — Adolescents with Down syndrome

Proven and medically necessary in adolescents aged 10–18 years with Down syndrome when ALL of the following are met:

Adolescent hypoglossal stimulation criteria: Age 10–18 years with Down syndrome and BMI at or below the 95th percentile for age; Diagnosis of severe OSA by polysomnography within 24 months with AHI ≥ 10 and RDI < 50; Total AHI with central + mixed apneas < 25% as evaluated by attended polysomnography; Confirmed failure or intolerance of PAP despite attempts to improve compliance; Contraindication for or failure of adenotonsillectomy when applicable; No tracheostomy use during sleep; Individual and caregiver refusal of MMA for non‑concentric palatal collapse when relevant; Absence of a complete blockage or concentric collapse of the soft palate level confirmed by drug‑induced sleep endoscopy; Device used in accordance with FDA labeling/guidelinesAHI ≥10; RDI <50; central/mixed apneas <25%

Applies to adolescents 10–18 years with Down syndrome

Non-Surgical — Oral Appliance Therapy

Removable oral appliances are proven and medically necessary for treating OSA when documented by a sleep study and appropriate clinical evaluation:

Oral appliance requirements: Diagnosis of OSA by a treating physician (MD or DO) or Advanced Practice Provider; Face‑to‑face evaluation with a physician trained in sleep medicine (or APP under direct physician supervision) prior to initiation of oral appliance therapy; Documentation of prior PAP therapy failure, intolerance, or patient refusal when applicable; Device provision and follow‑up by a qualified dentist using a custom, titratable appliance preferred over prefabricated devices; Follow‑up sleep testing to confirm effectiveness per guideline recommendationsSleep study documentation (PSG or adequate HSAT)

Custom titratable appliances preferred; dental CDT codes may be excluded under medical plan

Unproven / Not Medically Necessary — Various devices

The following devices and techniques are considered unproven or have inconclusive evidence for long-term efficacy:

Unproven/Not medically necessary devices: Devices for treating positional OSA (positional trainers), nasal dilator devices, removable oral appliances for central sleep apnea, intranasal expiratory resistance valves (e.g., Bongo Rx / Provent), prefabricated oral appliances, mandibular vertical repositioning devices, non‑surgical electrical muscular training (e.g., eXciteOSA), morning repositioning devices, Advanced Lightwire Functional (ALF) appliances, and epigenetic appliancesEvidence insufficient or conflicting

Listed items lack high‑quality long‑term RCT evidence and are considered unproven or not medically necessary

Central Sleep Apnea — Neurostimulation

Implantable neurostimulation devices for Central Sleep Apnea (CSA):

CSA neurostimulation stance: Implantable neurostimulation devices for treatment of central sleep apnea are considered unproven and not medically necessary due to insufficient evidence of safety and/or efficacy despite available TPNS trial data; clinical use is not supported as standard therapyInsufficient evidence

Remede (TPNS) pivotal and PAS trials exist but evidence insufficient for broad coverage of CSA neurostimulation

Evidence-based coverage considerations for non-surgical OSA devices

Summary of coverage‑relevant evidence and inferred criteria:

Positional trainers (SPT): Evidence from randomized trials supports short‑term reductions in AHI/ODI for selected mild‑to‑moderate POSA patients (AHI 5–30 with 10–90% supine time) but attrition and limited long‑term data constrain conclusions; consider only for well‑selected positional OSA patientsAHI 5–30; supine time 10–90%

Document baseline AHI and prior therapies

Intranasal EPAP devices: Randomized trials show short‑term AHI reductions versus sham in some patients, but EPAP is inferior to CPAP for moderate‑severe OSA and long‑term effectiveness data are limited; may be considered for patients refusing or intolerant of CPAP in selected mild‑to‑moderate cases with documentation

Document prior CPAP attempts and short‑term efficacy

Prefabricated oral appliances and nasal dilators: Prefabricated (non‑custom) oral devices and nasal dilators lack robust evidence of efficacy compared with custom devices or CPAP and are not recommended

Supported treatment options and contextual criteria

Interventions are generally supported under these conditions per specialty guidance:

Oral appliance therapy for OSA: Consider oral appliance therapy as first‑line for mild‑to‑moderate OSA or as an alternative when CPAP is intolerable or refused; when prescribed, a qualified dentist should provide a custom, titratable appliance with coordinated follow‑up with the sleep physician and repeat sleep testing to confirm efficacyMild‑to‑moderate OSA or CPAP intolerance

AAO‑HNS, AASM, AADSM, and AAOMS guidance cited

Surgical interventions: Surgery (e.g., UPPP, tonsillectomy, MMA, multilevel surgery) may be considered for patients with anatomic obstruction or after documented CPAP failure or intolerance; evidence quality varies and long‑term comparative RCT data are limitedAnatomic obstruction or CPAP failure/refusal

Require documented evaluation by otolaryngology or sleep medicine

Hypoglossal nerve stimulation:

Coverage-aligned trial inclusion conditions

Covered when ALL of the following are met in the clinical evidence/study inclusion context (as reported in trials):

Study‑like inclusion criteria: Patient meets trial entry‑type criteria: moderate‑to‑severe OSA per trial thresholds (e.g., AHI ≥20 for remede TPNS pivotal trial or AHI ≥15 for HNS trials); prior guideline‑recommended therapy attempted and documented (e.g., CPAP) with failure or intolerance when required by the trial; medical stability per trial protocol; baseline attended polysomnography availableAHI thresholds per specific trial (e.g., ≥20 for remede); HNS trials used AHI ≥15

Used to align coverage expectations with published trial populations

Effectiveness markers associated with ongoing benefit

Covered when ANY of the following post‑implant observations are met (trial‑derived effectiveness markers):

Objective improvement: Sustained and clinically meaningful reduction in AHI and oxygen desaturation index (for example, STAR median AHI decreased from 29.3 to 9.0 events/hr at 12 months, ~68% reduction)Substantial reduction in AHI/ODI compared with baseline at 12 months

Observed in STAR and follow‑up studies

Subjective improvement: Clinically meaningful improvement in patient‑reported outcomes (e.g., ESS, FOSQ, quality‑of‑life measures) compared with baselineDocumented ESS and QoL improvement post‑implant

Reported across HNS and TPNS follow‑up studies

Laser-Assisted Uvulopalatoplasty (LAUP) — caution/limited

Coverage decisions should reflect the strength and limitations of available evidence; procedures summarized below have variable evidence and may be considered investigational or limited coverage where evidence is insufficient or shows potential harm.

LAUP: Evidence shows modest mean AHI reduction but a substantial proportion of patients may experience worsening of AHI; LAUP is associated with notable complication rates and low cure rates. Given unfavorable results in systematic reviews and meta‑analyses, LAUP should be performed with caution or considered not medically necessary outside clinical trials

Camacho et al. found 44% of patients worsened and recommended caution or avoidance

Lingual suspension / tongue fixation — investigational/limited

Procedures for tongue base stabilization and suspension have mixed evidence; consider coverage only with specific documentation and when less invasive options have failed.

Lingual suspension / tongue fixation: Evidence is primarily case series and small studies with heterogeneous success rates (reported 25–75% depending on technique) and nontrivial complication/tissue anchor failure rates; consider investigational or limited coverage and require documentation of CPAP failure/intolerance and objective PSG evidence of tongue‑base obstruction when requested

Adjustable device failures and heterogeneous outcomes reported; prior authorization recommended

Hyoid myotomy/suspension — limited/ investigational

Hyoid myotomy/suspension procedures have preliminary evidence but are limited by small nonrandomized studies.

Hyoid myotomy/suspension: Small case series and nonrandomized studies report improvements in AHI in select patients, often when combined with other procedures; evidence is insufficient for broad coverage and may be considered investigational or conditional, requiring documentation of CPAP failure/intolerance and objective outcome measurement

Limited sample sizes and lack of long‑term outcomes

Palatal implants — limited/selective

Palatal implants (e.g., Pillar) have randomized trial data but overall limited effectiveness and short follow‑up.

Palatal implants: Randomized and controlled trials show small‑to‑moderate improvements in AHI and ESS compared with baseline but limited superiority over placebo and short follow‑up; coverage may be limited to selected patients with mild‑to‑moderate retropalatal obstruction after documented failure or intolerance of standard therapy, otherwise considered investigational

Trials limited by small size and short duration

Radiofrequency ablation — investigational/conditional

Radiofrequency ablation (soft palate and/or tongue) has low‑quality heterogeneous evidence with short‑term benefits reported.

Radiofrequency ablation (RFA/TCRFTA/MRFTA): Studies report short‑term reductions in AHI and symptom scores for some patients, but evidence quality is low, heterogeneous, and lacks long‑term outcomes; consider investigational or conditional coverage with requirement for prior therapy documentation and objective outcomes if allowed locally

ECRI and systematic reviews rate evidence as low quality and inconclusive

Transoral Robotic Surgery (TORS) — conditional/limited

Transoral Robotic Surgery (TORS) shows substantial pooled reductions in AHI and ESS but evidence is mostly retrospective and heterogeneous.

TORS for tongue base reduction: Meta‑analyses report significant pre‑to‑post improvements in AHI and ESS with pooled surgical success estimates (~48%–69%), but studies are largely retrospective, heterogeneous in technique and patient selection, and report variable complication rates; coverage may be conditional or limited to specialized centers with prior authorization and documented failure of conservative therapies

Selection bias and lack of RCT data limit definitive coverage conclusions

TORS — evidence considerations

TORS (transoral robotic surgery) evidence and implications

TORS evidence summary: Systematic reviews and meta‑analyses report significant improvements in AHI, ESS, and oxygen saturation after TORS, but the evidence is limited by retrospective designs, heterogeneity in patient selection and surgical technique, lack of randomized trials, and variable complication rates; these limitations should inform cautious coverage decisions and center‑specific considerations

Reported surgical success rates vary and complication rates may be substantial in some series

DOME — evidence considerations

Distraction Osteogenesis for Maxillary Expansion (DOME)

DOME evidence summary: Available evidence consists of small retrospective case series reporting improvements in AHI, ESS, NOSE scores, and nasal airflow metrics but randomized controlled trials and long‑term outcomes are lacking; evidence is insufficient to support routine coverage in adults

Further high‑quality comparative studies needed

Implantable hypoglossal nerve stimulation — adults

Revised coverage criteria (selected excerpts present in this part of the document):

Adult implantable hypoglossal nerve stimulation: Coverage requires attended polysomnography including assessment of total AHI and confirmation that total AHI <25% for central + mixed apneas, and confirmation of absence of a complete blockage or complete concentric collapse of the soft palate by drug‑induced sleep endoscopy prior to device implantationTotal AHI central+mixed apneas <25%

Operational wording updated to require attended PSG and DISE confirmation

Implantable hypoglossal nerve stimulation — adolescents with Down syndrome

Adolescents (10–18 years) with Down syndrome — device eligibility excerpt:

Adolescent hypoglossal nerve stimulation: Coverage requires absence of a complete blockage or concentric collapse of the soft palate level confirmed by drug‑induced sleep endoscopy prior to implantation

Language standardized to 'drug‑induced' endoscopy in the revised criteria

A non‑exhaustive list of surgical procedures and devices is considered unproven or not medically necessary for treatment of obstructive sleep apnea due to insufficient evidence of long‑term safety or efficacy. Examples include isolated hyoid myotomy, Distraction Osteogenesis for Maxillary Expansion (DOME), Laser‑Assisted Uvulopalatoplasty (LAUP), palatal implants, lingual suspension (tongue stabilization/tongue fixation), radiofrequency ablation of the soft palate and/or tongue base, Transoral Robotic Surgery (TORS), and stand‑alone uvulectomy; implantable neurostimulation for central sleep apnea (CSA) is also listed as unproven and not medically necessary.

Prefabricated (non‑custom) oral devices, mandibular vertical repositioning devices, intranasal expiratory resistance valves, non‑surgical electrical muscular training, morning repositioning devices, Advanced Lightwire Functional (ALF) and other epigenetic or orthodontic‑style appliances are similarly identified as unsupported by quality evidence and may be excluded from coverage outside of research contexts.

There is no quality evidence to support the use of removable oral appliances for treatment of central sleep apnea (CSA); CSA is a disorder of ventilatory drive and the policy notes that removable oral appliances—designed to address anatomic obstruction—have not been shown to be effective for CSA. Consequently, removable oral appliances for CSA are considered unsupported and may be denied as medically unnecessary.

The policy also specifically names several device classes for which evidence is lacking, including mandibular vertical repositioning devices (e.g., Slow Wave), morning repositioning devices, epigenetic appliances, and similar intraoral approaches, reinforcing that these technologies are not supported for CSA or general OSA treatment without higher‑quality data.

Prefabricated, ready‑made oral appliances are not addressed as appropriate treatment in AAOMS guidance and randomized evidence favors custom, titratable mandibular advancement devices over prefabricated options; therefore, prefabricated devices lack sufficient evidence to be considered equivalent to custom appliances and are not recommended as standard therapy.

The policy also emphasizes that simple or minimally invasive surgical procedures performed in isolation (for example, some office‑based palate procedures) may improve AHI or symptom scores in selected series but are often not curative and have limited, low‑quality comparative data—supporting cautious use and the expectation that such procedures will be scrutinized for adequate documentation of indications and prior conservative therapy.

The evidence for Laser‑Assisted Uvulopalatoplasty (LAUP) shows an unfavorable balance of modest average AHI reductions, low cure rates, and a substantial proportion of patients with post‑procedure worsening of AHI; systematic reviews report a high complication burden and the authors conclude LAUP should be performed only with caution or avoided.

Given these findings, LAUP is considered to have limited clinical value for OSA and may be excluded from coverage except within rigorously documented clinical trials or when alternative standard therapies are contraindicated and compelling justification is provided.

Procedures that suspend or fix the tongue (lingual suspension/tongue fixation) have limited and heterogeneous evidence: available studies are small, largely nonrandomized or case series, and there are no high‑quality long‑term outcome studies demonstrating durability or clear benefit. As a result, lingual suspension and related tongue‑base anchoring techniques are considered investigational or limited and lack support for broad coverage in routine practice.

Isolated uvulectomy and LAUP performed as standalone interventions are not supported by sufficient evidence to conclude effectiveness for OSA. The policy states that uvulectomy alone lacks adequate published peer‑reviewed data to establish benefit, and LAUP carries documented risks including potential worsening of OSA, so both procedures are generally not considered medically necessary outside of research settings.

Adaptive servo‑ventilation (ASV) is specifically contraindicated for the treatment of central sleep apnea related to chronic heart failure in adults with reduced ejection fraction: AASM guidance recommends against use of ASV targeted to normalize AHI in patients with heart failure and left ventricular ejection fraction <45% with predominant moderate to severe CSA. This safety‑focused restriction reflects trial evidence and guideline recommendations and should guide coverage decisions involving ASV in the CHF population.

NICE guidance cautions that evidence for hypoglossal nerve stimulation is limited in quantity and quality and therefore recommends use only with special arrangements for clinical governance and research; NICE additionally advises that soft‑palate implants should not be used for OSA because efficacy evidence is inadequate. These recommendations support conservative adoption of hypoglossal stimulation and careful consideration of palatal interventions.

Recent policy revisions updated the list of items considered unproven or not medically necessary, clarifying device names (for example, replacing the earlier phrasing with Advanced Lightwire Functional (ALF) appliances) and reiterating that a range of intraoral devices, positional trainers, nasal dilators, intranasal EPAP valves, prefabricated appliances, and several surgical procedures remain unsupported by high‑quality long‑term evidence. These updated exclusions should be applied when evaluating coverage requests.

Devices marketed for positional OSA (positional trainers) and nasal dilators are discussed separately: positional trainers have some trial evidence of short‑term benefit in selected mild‑to‑moderate POSA populations but are limited by attrition and less efficacy than CPAP, while nasal dilators (internal and external) largely do not demonstrate significant AHI improvement in systematic reviews and meta‑analyses.

Intranasal EPAP devices (e.g., Bongo Rx/Provent) show short‑term AHI reductions versus sham in randomized trials for some patients, but are consistently inferior to CPAP for moderate‑to‑severe OSA and suffer from limited long‑term, independent data—supporting consideration as an alternative only in carefully selected patients who refuse or cannot tolerate CPAP and with documentation of prior therapy.

Systematic reviews and small studies of nasal dilators (internal devices such as NoZovent and external strips such as Breathe Right) generally report no significant change in AHI in most studies; a meta‑analysis found twelve of fourteen studies showed no benefit and the pooled analysis did not demonstrate improved AHI. While some internal dilators may modestly improve subjective nasal breathing, the current evidence does not support clinical efficacy of nasal dilators as treatment for OSA.

Lifestyle modification interventions (dietary control, weight loss, exercise and related behavioral measures) may improve some patient‑reported outcomes or physiologic metrics but, based on network meta‑analysis and guideline summaries, behavioral/lifestyle modification alone lacks sufficient efficacy to be considered an effective alternative to standard OSA therapies such as CPAP or appropriately indicated device/surgical interventions and therefore should not be used as sole therapy when definitive treatment is indicated.

Meta‑analyses and systematic reviews report unfavorable results for LAUP: pooled analyses show low success and cure rates, a notable proportion of patients with postoperative worsening of AHI, and a high rate of complications (for example, an average of ~256 complications per 1,000 procedures in one review). Because of these outcomes and study limitations, LAUP is discouraged outside of highly selected circumstances or research.

The document reiterates that both LAUP and isolated uvulectomy carry insufficient evidence of efficacy and documented potential harms—including postoperative worsening of OSA—and therefore are considered insufficiently supported for routine coverage. These procedures may only be considered within clinical research or with robust supporting documentation.

Distraction Osteogenesis for Maxillary Expansion (DOME) lacks randomized controlled trials and high‑quality long‑term outcome data; existing publications are small retrospective series reporting short‑term improvements but are limited by lack of comparison groups, single‑center designs, and incomplete follow‑up. Consequently, DOME is considered to have insufficient evidence to support routine coverage for adult OSA.

The policy's revised list of unproven and not medically necessary devices explicitly names several intraoral and adjunctive appliances that lack quality evidence; among those specifically called out in the update are Advanced Lightwire Functional (ALF) appliances. Other listed items continue to include prefabricated oral appliances, mandibular vertical repositioning devices, intranasal EPAP valves, and various orthodontic or epigenetic appliances—each identified as unsupported by current evidence.

CPT/HCPCS/Device Codes and Clinical Thresholds

Relevant HCPCS and other device/surgical codesHCPCS

A4557	Lead wires (e.g Apnea monitor), per pair
E0485	Oral device/appliance used to reduce upper airway collapsibility, prefabricated, includes fitting and adjustment
E0486	Oral device/appliance used to reduce upper airway collapsibility; custom fabricated, includes fitting and adjustment
E0470	Respiratory assist device, bi-level pressure capability, without backup rate feature
E0471	Respiratory assist device, bi-level pressure capability, with backup rate feature
E0619	Apnea monitor; with recording feature
E1399	Durable medical equipment; miscellaneous
L8679	Implantable neurostimulator, pulse generator, any type
L8680	Implantable neurostimulator electrode, each
L8686	Implantable neurostimulator pulse generator, single array, nonrechargeable, includes extension

1–10 of 12

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Prior-authorization example codes (not a coverage list)HCPCS

E0486	Oral device/appliance used to reduce upper airway collapsibility; custom fabricated, includes fitting and adjustment
E0485	Oral device/appliance used to reduce upper airway collapsibility, prefabricated, includes fitting and adjustment
E0470	Respiratory assist device, bi-level pressure capability, without backup rate feature
E0471	Respiratory assist device, bi-level pressure capability, with backup rate feature
E0619	Apnea monitor; with recording feature
E1399	Durable medical equipment; miscellaneous
L8679	Implantable neurostimulator, pulse generator, any type
L8680	Implantable neurostimulator electrode, each
L8686	Implantable neurostimulator pulse generator, single array, nonrechargeable, includes extension
S2080	Laser-assisted uvulopalatoplasty (LAUP)

1–10 of 11

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Surgical and implantation CPT codesCPT

21142	Reconstruction midface, LeFort I; 2 pieces, segment movement in any direction, without bone graft
21199	Osteotomy, mandible, segmental; with genioglossus advancement
21206	Osteotomy, maxilla, segmental
21685	Hyoid myotomy and suspension
41512	Tongue base suspension, permanent suture technique
41530	Submucosal ablation of the tongue base, radiofrequency, 1 or more sites, per session
41599	Unlisted procedure, tongue, floor of mouth
42145	Palatopharyngoplasty (e.g:, uvulopalatopharyngoplasty)
42299	Unlisted procedure, palate, uvula
64553	Percutaneous implantation of neurostimulator electrode array; cranial nerve

1–10 of 16

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Dental CDT codes (generally excluded under medical plan)mixedNot Covered

D9947	Preventive clinical oral evaluation — dental (example CDT excluded)
D9948	Preventive services — dental (example CDT excluded)
D9949	Preventive services — dental (example CDT excluded)

Medical plan exclusion notemixedNot Covered

D9947

Dental services (CDT codes) are generally excluded from coverage under the medical plan; refer to federal, state, or contractual requirements prior to determining coverage

No explicit codes listed in this sectionmixed

No codes listed

No explicit codes in this sectionmixed

No codes listed

FDA device identifiers mentionedmixed

P130008	Inspire Upper Airway Stimulation system PMA (device identifier referenced)
K180608	Lunoa System 510(k) Premarket Notification
K180619	Bongo intranasal appliance 510(k)

Inspire device PMA notemixed

P130008

Inspire Upper Airway Stimulation system PMA (device identifier referenced)

Additional FDA 510(k)/De Novo identifiersmixed

QNO	eXciteOSA product code (de novo classification)
K191320	Slow Wave DS8 510(k)
K030108	ArthroCare ENT Coblator Surgery System 510(k)
K982717	Somnoplasty System 510(k)
K981677	AlRvlance (Repose) Tongue Suspension system 510(k)
K040417	Pillare System palatal implants 510(k)

eXciteOSA de novo notemixed

QNO	eXciteOSA device de novo product code (DEN200018)

ArthroCare and Somnoplasty notemixed

K030108	ArthroCare ENT Coblator Surgery System 510(k)
K982717	Somnoplasty System 510(k)

Pillar and tongue suspension device notesmixed

K981677	AlRvlance (Repose) Tongue Suspension system 510(k)
K040417	Pillare System palatal implants 510(k)

Referenced but not listedmixed

No codes listed

AHI / RDI for surgical and device candidacy

Adult surgical/device candidacyAHI or RDI ≥ 15 events/hour; severe defined as AHI/RDI > 30 events/hour.

HNS (adult) baseline AHIAHI ≥ 15 and < 100 as determined by attended polysomnography.

Remede/TPNS trial entryRemede randomized trial enrolled adults with AHI ≥ 20 events/hour.

Adolescent (Down syndrome) AHI/RDIAdolescents: diagnosis of severe OSA by PSG with AHI ≥ 10 and RDI < 50 events/hour.

Severe OSA thresholdSevere OSA: AHI/RDI > 30 events/hour.

Prior Authorization, Documentation, and Clinical Workflow

Prior Authorization

Prior Authorization Required

Prior authorization may be required for listed devices and procedures. Submit a request with supporting clinical documentation that directly addresses the policy criteria for the specific device or surgical procedure being requested.

Include device model and FDA indication when applicable (e.g., Inspire UAS, remede TPNS).
If device is state-covered (e.g., codes marked with an asterisk for NC Medicaid), verify contractual rules prior to authorization.

Prior Authorization

PA Expectations for Non‑Surgical Devices

For non‑surgical devices (positional trainers, intranasal EPAP, sleep position trainers, etc.), prior authorization may be required. Provide objective sleep testing results, prior treatment history, and rationale for device selection versus CPAP.

Document AHI severity and positional dependency for positional devices.
For intranasal EPAP (e.g., Provent), include baseline and device-on/device-off PSG or HSAT results and adherence information.

Clinical Background and Evidence Context

Obstructive sleep apnea (OSA) is characterized by recurrent partial or complete upper airway collapse during sleep resulting in reduced or absent airflow, intermittent hypoxemia, sleep fragmentation, and symptoms such as excessive daytime sleepiness; untreated OSA is associated with adverse cardiovascular, metabolic, and neurocognitive outcomes and contributes substantially to morbidity in affected populations.

Management includes diagnostic confirmation (typically attended polysomnography or qualified home sleep testing where appropriate) and a range of therapeutic options—behavioral measures, positive airway pressure (PAP) therapies as first‑line for moderate‑to‑severe disease, custom oral appliance therapy for selected mild‑to‑moderate cases or CPAP‑intolerant patients, and surgical or implantable interventions for anatomically appropriate candidates—each evaluated against the strength of available evidence and guideline recommendations.

Evidence-based coverage considerations for non-surgical OSA devices

Summary of evidence strength and specialty guidance relevant to coverage decisions:

Evidence‑based coverage considerations: Coverage decisions should reflect guideline recommendations (AAO‑HNS, AASM, AADSM, AAOMS) and the variable quality of evidence for surgical and device therapies; treatments supported by randomized trials and robust comparative data are preferred, while interventions with low‑quality, small, or nonrandomized evidence may be investigational or limited

See detailed device‑ and procedure‑specific sections for evidence summaries and coverage implications

Key Definitions and Abbreviations

Apnea definition

Apnea definitionApnea: cessation of airflow ≥ 90% from baseline lasting ≥ 10 seconds.

Apnea classificationApneas are classified as obstructive, central, or mixed based on respiratory effort pattern.

Source standardDefinition aligns with AASM Scoring Manual guidance cited in policy definitions.

AHI

AHI definitionApnea–Hypopnea Index (AHI): number of apneas plus hypopneas per hour of sleep (events/hour).

Severity thresholdsModerate-to-severe OSA commonly defined as AHI ≥ 15 events/hour; severe defined as AHI/RDI > 30 events/hour.

Policy Change Log

2025-10-01related_policy_update

Updated related policy link for Orthognathic (Jaw) Surgery (for North Carolina Only).

2025-04-01coverage_criteria_revision

Revised non-surgical wording to replace 'sleep medicine physician' with 'physician trained in sleep medicine' and updated the list entry name to 'Advanced Lightwire Functional (ALF) appliances'.

2025-04-01device_criteria_revision

Policy Summary

PayerUnitedHealthcare

PolicyObstructive and Central Sleep Apnea Treatment (for North Carolina Only)

Policy CodePolicy CSNCT0525.10

Change TypeRevisions to HNS candidacy and DISE/PSG requirements

Effective Date

Next Review Date

SourceLink

On This Page

Custom, titratable oral appliances are preferred

Non‑surgical electrical muscular stimulation: Evidence is low‑quality and inconclusive (single‑arm studies); routine coverage not supported pending RCTs demonstrating comparative and long‑term benefit

Examples include eXciteOSA

HNS may be an option for selected moderate‑to‑severe OSA patients who have failed or are intolerant of CPAP, with careful patient selection and documentation of pre‑implant testing including attended PSG and DISE to exclude concentric palatal collapse

Moderate‑to‑severe OSA with CPAP failure/intolerance

Consider device labeling and BMI/AHI limits

Epworth Sleepiness Scale (ESS)

ESS threshold for excessive daytime sleepinessEpworth Sleepiness Scale (ESS) > 10 documents excessive daytime sleepiness for surgical candidacy.

ESS instrumentESS is an 8-item questionnaire assessing likelihood of dozing in common situations.

Use in selectionESS >10 is used as part of multi-criteria selection for surgical OSA procedures.

BMI limit for hypoglossal nerve stimulation (adults)

Adult HNS BMI limitBody Mass Index (BMI) ≤ 40 kg/m2 for adult hypoglossal nerve stimulation candidacy.

BMI roleBMI is a required eligibility metric per device labeling and policy criteria.

Policy update noteFDA/labeling expansion reflected in policy revisions allowing upper BMI limit up to 40 for Inspire UAS.

AHI range for mild to moderate POSA

POSA AHI inclusion rangePositional OSA (POSA) trial eligibility commonly used AHI 5–30 events/hour.

Supine time criterion (trial)Trials often required 10–90% supine sleep time for POSA device studies.

PopulationMild-to-moderate POSA defined by lower non‑supine AHI compared with supine AHI and AHI within 5–30 range.

AHI inclusion threshold

Remede randomized trial AHI entryThe remede randomized trial required baseline AHI ≥ 20 events/hour for enrollment.

Population stability requirementParticipants were required to be medically stable and have received appropriate guideline-recommended therapy prior to enrollment.

Primary endpoint contextTrial assessed proportion achieving ≥50% AHI reduction at six months measured by polysomnography.

Inspire UAS baseline AHI and BMI limits (per FDA labeling expansion)

Inspire UAS AHI lower/upper limitsFDA expanded Inspire labeling: AHI lower limit < 15 events/hour and upper baseline AHI up to 100 events/hour.

Inspire UAS BMI expansionFDA expanded upper BMI limit from 32 to 40 kg/m2 for Inspire UAS.

Device indication noteSystem intended for adults who failed or cannot tolerate PAP and who do not have complete concentric collapse at the soft palate.

Pediatric UAS indication (Inspire)

Age and diagnosisPediatric Inspire UAS indication: ages 13–18 years with Down syndrome and severe OSA (AHI ≥ 10 and < 50 events/hour).

Prior therapies and candidacyCandidates must have failed or not tolerate PAP and be contraindicated for or not effectively treated by adenotonsillectomy.

Anatomic collapse exclusionMust not have complete concentric collapse at the soft palate level (confirmed by drug‑induced endoscopy).

Total AHI

Total AHI central + mixed apneas limitTotal AHI requirement revised: central plus mixed apneas must account for < 25% of total AHI as evaluated by attended polysomnography.

Evaluation methodRequirement specifies attended polysomnography (laboratory PSG with technologist present) for assessing central/mixed apnea proportion.

Applies to HNS candidacyThis total AHI central/mixed apneas threshold is used in implantable hypoglossal nerve stimulation eligibility criteria.

Documentation Required

Oral Appliance Prerequisites

Oral appliance therapy requires specific prerequisites to support medical necessity. Authorization requests should document both medical and dental collaboration and appliance details.

Diagnosis and recommendation from a treating physician (MD/DO) or APP trained in sleep medicine after face‑to‑face evaluation.
Referral to or collaboration with a qualified dentist (QD) and documentation that a custom, titratable appliance will be used.
Follow-up plan including dental and sleep‑medicine reassessment and follow-up sleep testing to confirm efficacy.

Prior Authorization

remede (TPNS) PA Expectations

For remede (transvenous phrenic nerve stimulation, TPNS) prior authorization, submit documentation that mirrors enrollment/trial criteria: attended PSG with AHI threshold, prior guideline‑directed therapies tried or contraindicated, and stability of underlying conditions.

Attended polysomnography confirming central sleep apnea and AHI meeting device indication.
Documentation of guideline‑recommended therapy trials and reason for remede (e.g., intolerance or failure).
Device model and FDA approval status, and relevant safety/efficacy data when available.

Prior Authorization

PA: Lingual/Hyoid Suspension and Related Devices

For lingual/tongue suspension, hyoid procedures, and related devices, prior authorization requires objective testing and documentation of prior PAP failure or intolerance.

Attended PSG/HSAT demonstrating OSA with severity metrics (AHI, ODI) within the required timeframe (typically within 6 months).
Evidence of a CPAP trial with documented adherence and reasons for failure/intolerance from the treating physician.
Drug‑induced sleep endoscopy (DISE) findings when required to document site(s) of collapse.

Prior Authorization

PA: Inspire UAS / HNS (Device‑Specific)

For Inspire and other hypoglossal nerve stimulation (HNS) systems, prior authorization must document FDA‑label criteria and revised eligibility elements when applicable.

Attended polysomnography confirming AHI within the device's approved range and total central/mixed apnea percentage within allowed limits.
BMI within the device's labeled limit when applicable (document current BMI).
Absence of complete concentric collapse at the soft palate confirmed by DISE when required by the indication.
Documentation of prior CPAP failure, intolerance, or inability to achieve benefit with positive pressure therapy.

Documentation Required

PA: HNS — Revised Eligibility and Documentation

Hypoglossal nerve stimulation (HNS) requests must reflect updated eligibility criteria and include required diagnostic studies and multidisciplinary evaluations.

Attended polysomnography performed within the timeframe specified by the policy (commonly within 6 months of request).
DISE findings documenting absence of complete concentric collapse when required by the device indication.
Face‑to‑face evaluation notes from a qualified sleep‑medicine or otolaryngology physician and documentation of prior conservative therapy failure (e.g., CPAP).

Step Therapy

Therapy Sequencing — CPAP First

CPAP is considered first‑line therapy for moderate to severe OSA; oral appliances and other alternatives are typically considered only after documented CPAP failure, intolerance, or refusal. Authorization for alternatives must include clear documentation of the CPAP trial.

Document duration, mode (CPAP/APAP/Bi‑level), adherence data, efficacy, and reasons for discontinuation or intolerance.
If CPAP was refused, include documentation of counseling and any attempts to optimize tolerance.

Documentation Required

Required Clinical Evaluation

Face‑to‑face evaluation by an appropriate treating physician (MD/DO) or APP under direct supervision is required for diagnosis and as part of authorization documentation. For procedural/surgical requests, an evaluation by a physician trained in Otolaryngology or Sleep Medicine is recommended.

Include the diagnosing clinician's name, specialty, and certification status (e.g., board certification in sleep medicine).
Document the face‑to‑face visit date and clinical findings that support the requested intervention.

Denial Risk

Documentation and Denial Risk

Failure to provide required documentation (attended PSG/HSAT within policy timeframes, DISE when required, evidence of PAP trial, or absence of a diagnosing physician) may lead to denial or return‑to‑provider for additional information.

Missing attended polysomnography or DISE for implant candidacy increases denial risk.
Incomplete documentation of a PAP trial (no adherence data or no treating clinician attestation) may result in non‑coverage.

The policy history notes an updated, consolidated list of devices considered unproven or not medically necessary and records a non‑substantive name clarification changing prior references to 'Advanced Lightweight Functional' to the correct term Advanced Lightwire Functional (ALF) appliances. This edit clarifies the device nomenclature used in the exclusion list and does not alter the coverage stance that ALF appliances lack quality evidence for OSA treatment.

Use in trials and devices

AHI is the primary metric in multiple device trials and policy eligibility criteria (e.g., HNS, remede, Inspire).

HSAT

HSAT definitionHome Sleep Apnea Testing (HSAT): unattended diagnostic testing for OSA without sleep staging; adequate HSAT = ≥ 4 hours and includes nasal pressure, respiratory inductance plethysmography, and oximetry.

LimitationsHSAT does not determine sleep stages; not all HSATs are performed at home but most are out‑of‑center tests.

Policy usePolicy references PSG (attended) for device candidacy evaluation; HSAT supports OAT and some diagnostic pathways per guidelines.

ESS

ESS definition and scoringEpworth Sleepiness Scale (ESS) is an 8-item questionnaire measuring daytime sleepiness; ESS > 10 indicates excessive daytime sleepiness.

Role in selectionESS >10 is used as documentation of sleepiness for surgical candidacy and outcome assessment.

AdministrationSelf‑reported likelihood of dozing in common daily situations across 8 items.

Positional OSA (POSA)

POSA definitionPositional OSA (POSA): A subtype where AHI is lower in nonsupine positions than supine; trials often include patients with AHI 5–30 and required supine time criteria.

Trial criteria exampleDe Ruiter et al. POSA trial required 10–90% supine sleep time and AHI 5–30 events/hour.

Therapy implicationsPositional therapies may be considered for mild-to-moderate POSA per ERS and device trial evidence but CPAP remains more effective in many cases.

Intranasal EPAP (Provent)

Intranasal EPAP (Provent) descriptionIntranasal EPAP: a nasal expiratory positive airway pressure device that provides expiratory resistance via nasal valves to reduce OSA severity.

Trial evidenceRandomized trials show short-term AHI reductions versus sham in some patients but EPAP is inferior to CPAP for moderate-severe OSA and long-term data are limited.

Use considerationMay be considered for patients refusing or intolerant of CPAP in selected mild‑to‑moderate OSA with documented efficacy.

Oral appliance therapy (OAT)

Oral appliance therapy definitionOral appliance therapy (OAT): custom, titratable mandibular advancement devices fitted by qualified dentists to advance the mandible and reduce airway collapse.

Device typesDevices can be prefabricated (non‑custom) or custom; guidelines recommend custom titratable appliances over non‑custom devices.

Provider collaborationQualified dentist oversight and follow-up with a sleep physician are recommended, with repeat sleep testing to confirm efficacy.

Hypoglossal nerve stimulation (HNS)

HNS descriptionHypoglossal nerve stimulation (HNS)/Upper Airway Stimulation (UAS): an implantable system that stimulates the hypoglossal nerve to maintain upper airway patency during sleep.

Candidate profileConsidered for selected adults with moderate-to-severe OSA who failed or cannot tolerate PAP and do not have complete concentric collapse at the soft palate.

Evidence caveatEvidence quality is limited (nonrandomized studies, small samples); HNS shows AHI and ESS improvements in trials like STAR but long‑term comparative data are limited.

AHI (reiterated)

AHI as primary metricAHI is used as the primary efficacy endpoint in many device and surgical trials (e.g., STAR, remede) and for eligibility criteria.

AHI thresholds repeatedPolicy and trials reference AHI thresholds (e.g., ≥15, ≥20, upper limits for devices) for inclusion and success definitions.

Outcome reportingDevice/surgical studies commonly report AHI reductions, ODI changes, and ESS improvements as core outcomes.

CAI

CAI definitionCentral Apnea Index (CAI): component of AHI counting central apneas; used as an outcome metric in CSA treatments and trial reporting.

Role in eligibility/outcomesProportion of central + mixed apneas (e.g., <25% total AHI) is used to determine candidacy for HNS in adults and adolescents.

CSA device contextRemede (TPNS) trials report CAI and AHI reductions but evidence quality and clinical impact remain uncertain.

LAUP

LAUP definitionLaser-Assisted Uvulopalatoplasty (LAUP): laser ablation of the soft palate/uvula intended to reduce snoring and OSA events.

Evidence noteSystematic review shows modest AHI reduction but potential for worsening OSA in 44% of patients; LAUP should be performed with caution or avoided.

Coverage implicationLAUP may be considered not medically necessary or limited due to risk of harm and low-quality evidence.

Lingual suspension / tongue fixation

Lingual suspension/tongue fixation definitionProcedures that anchor the tongue anteriorly (bone screws, sutures, adjustable devices) to prevent tongue base collapse.

Evidence summaryAvailable data are largely case series and small studies with heterogeneous outcomes and notable device‑related complications (e.g., anchor failures).

Coverage positionConsidered investigational or limited; prior documentation of CPAP failure/intolerance and objective PSG evidence is recommended if considered.

Palatal implants (Pillar, Elevoc)

Palatal implants definitionPalatal implants (e.g., Pillar, Elevoc): small synthetic inserts placed in the soft palate to stiffen it and reduce snoring/OSA events.

Evidence summaryRandomized and controlled trials show small-to-moderate improvements but overall limited effectiveness and short follow-up; superiority over placebo is inconsistent.

Coverage implicationMay be limited to selected patients with mild‑to‑moderate retropalatal obstruction after standard therapy failure; otherwise investigational.

Radiofrequency tissue volume reduction (RFTVR / RFA)

RFTVR / RFA definitionRadiofrequency tissue volume reduction (RFTVR/RFA): low‑intensity radiofrequency energy applied to shrink uvula, soft palate, and/or tongue base.

Evidence summaryStudies report short-term improvements in AHI and symptoms but evidence quality is low and heterogenous; long-term efficacy unclear.

Coverage implicationConsider investigational or conditional with requirement for prior therapy documentation and objective outcome measures if allowed.

Transoral Robotic Surgery (TORS)

TORS definitionTransoral Robotic Surgery (TORS): robotic-assisted resection of tongue base/hypopharyngeal tissue to reduce airway obstruction.

Evidence summaryMeta-analyses report substantial pooled AHI and ESS reductions and ~69% surgical success, but evidence is mostly retrospective and heterogeneous.

Coverage implicationEvidence limitations suggest investigational or conditional coverage in specialized centers with prior authorization and documentation of conservative therapy failure.

Adaptive Servo-Ventilation (ASV)

ASV definitionAdaptive Servo‑Ventilation (ASV): a positive airway pressure modality targeted to normalize AHI in central sleep apnea.

Contraindication noteASV targeted to normalize AHI should not be used for CSAS related to CHF in adults with ejection fraction < 45% and predominant moderate-to-severe CSA (AASM standard against).

Use contextASV may be considered in select CSA populations per guideline option statements when EF >45% or for mild CHF‑related CSAS.

Upper Airway Stimulation (UAS) / HNS

UAS/HNS definitionUpper Airway Stimulation (UAS) / Hypoglossal Nerve Stimulation (HNS): implantable therapy that stimulates the hypoglossal nerve to maintain airway patency during sleep.

Candidate profileTypically for adults with moderate-to-severe OSA who failed or cannot tolerate PAP and without complete concentric collapse at the soft palate; device‑specific AHI/BMI limits apply.

Evidence caveatsEvidence shows AHI and ESS improvements in trials (e.g., STAR) but overall quality is limited; long‑term comparative data are limited.

Attended polysomnography

Attended polysomnography definitionAttended polysomnography (PSG): laboratory sleep study performed with a technologist in attendance to record sleep stages and respiratory events.

Policy requirementPolicy requires use of attended PSG for evaluating candidacy for certain implantable devices (e.g., HNS) and for assessing total AHI and central/mixed apnea proportion.

Contrast with HSATHSAT is unattended and lacks sleep staging; attended PSG is specified for device eligibility assessments.

Drug‑induced sleep endoscopy (DISE)

DISE definitionDrug‑induced sleep endoscopy (DISE): endoscopic evaluation of upper airway collapse performed under pharmacologic sedation to assess site and pattern of obstruction.

Role in HNS candidacyDISE is required to confirm absence of complete blockage or complete concentric collapse at the soft palate level for HNS eligibility.

Policy wordingPolicy revisions standardized language to 'drug‑induced' endoscopy for both adults and adolescents as the confirmatory exam for palatal collapse exclusion.

Revised adult implantable hypoglossal nerve stimulation criteria to require evaluation by attended polysomnography (total AHI <25% for central + mixed apneas) and confirmation of absence of complete blockage or complete concentric collapse of the soft palate by drug-induced sleep endoscopy (DISE).

2025-04-01pediatric_criteria_revisionLatest

Standardized adolescent (ages 10–18) Down syndrome criteria to use the term 'drug‑induced endoscopy' for confirming absence of complete blockage or concentric collapse of the soft palate.