ModifiedUnitedHealthcarePolicy CS116.AL

Obstructive and Central Sleep Apnea Treatment

Clinical coverage and medical necessity policy for non-surgical and surgical treatments of obstructive and central sleep apnea for UnitedHealthcare members, including device, appliance, and neurostimulation interventions; excludes certain state-specific versions.

Policy Summary

PayerUnitedHealthcare

PolicyObstructive and Central Sleep Apnea Treatment

Policy CodePolicy CS116.AL

Change TypeCriteria revisions and code additions

Effective DateNov 1, 2025

Next Review DateN/A

Key ActionWhen requesting authorization for surgical or implantable therapies, include attended polysomnography documentation demonstrating the specified AHI/RDI thresholds and evidence of prior PAP failure or intolerance when required.

SourceLink

POLICY UPDATE CHANGES

Revised coverage criteria for Uvulopalatopharyngoplasty (UPPP), Mandibular Osteotomy (MO), and Maxillomandibular Osteotomy and Advancement (MMA) in an adult patient to specify diagnosis by attended polysomnography with AHI ≥ 15 or RDI ≥ 15.

Revised criterion for implantable hypoglossal nerve stimulation in adolescents with Down syndrome to require diagnosis by attended polysomnography with AHI ≥ 10 and RDI ≤ 50 events per hour.

Added definition of 'Respiratory Disturbance Index (RDI)'.

Added CPT/HCPCS codes 0964T, 0965T, 0966T, and E0490 to applicable codes.

Noted that polysomnography should be repeated after clinically significant weight change, cardiovascular disease changes, or persistent/recurrent symptoms since prior study.

Removed content/language pertaining to the state of Louisiana.

4new CPT/HCPCS codes added

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

major coverage revisions

1Inspire pediatric expansion noted

90%MMA AHI improvement

68%STAR median AHI reduction

Coverage Criteria and Evidence-based Determinations

Removable Oral Appliances (OAT) — Non-surgical

Covered when ALL of the following are met

Oral Appliance Coverage Criteria: 1) Patient has OSA documented by a sleep study (polysomnography or home sleep apnea test) as determined by a qualified medical provider; 2) Face-to-face evaluation by a qualified physician (MD or DO) trained in Sleep Medicine or an Advanced Practice Provider working under direct physician supervision has occurred prior to initiating Oral Appliance Therapy (OAT); 3) A treating physician (MD or DO) or Advanced Practice Provider has diagnosed OSA and recommended OAT; 4) If PAP was tried, documentation demonstrates no therapeutic efficacy, intolerance, or patient refusal when OAT is being used as an alternative.

Refer to the Medical Policy titled Sleep Studies for diagnostic testing details.

Other Non-Surgical Procedures — Not Medically Necessary

The following are unproven and not medically necessary

Unproven non-surgical interventions: Devices for treating positional OSA; nasal dilator devices for OSA; intranasal expiratory resistance valves (e.g., Bongo Rx/EPAP); removable oral appliances for central sleep apnea (CSA); prefabricated oral appliances/devices; non-surgical electrical muscular training (e.g., eXciteOSA) and other intraoral awake neuromuscular stimulators; mandibular vertical repositioning devices (e.g., Slow Wave); morning repositioning devices; epigenetic appliances; Advanced Lightwire Functional (ALF) appliances.

Insufficient or low-quality evidence of efficacy; see cited evidence summaries.

Surgical Treatments — UPPP, MO, MMA and Implantable Hypoglossal Nerve Stimulation

Covered when ALL of the following are met

UPPP, MO, MMA general criteria: Moderate to severe OSA as determined by attended polysomnography (AHI ≥ 15 or RDI ≥ 15); excessive daytime sleepiness documented (e.g., Epworth Sleepiness Scale > 10 or other validated tool); PAP therapy resulted in no therapeutic efficacy or there is documented patient refusal or intolerance.AHI/RDI ≥15

Polysomnography should be repeated after clinically significant weight change, changes in cardiovascular disease, or persistent/recurrent symptoms.

MMA additional criteria: Craniofacial disproportion or deformity with evidence of maxillomandibular deficiency present to support maxillomandibular advancement (MMA).

Anatomic indication required for MMA.

MO additional criteria: Retrolingual or lower pharyngeal functional obstruction identified to support mandibular osteotomy (MO).

Anatomic/functional evaluation recommended.

Implantable neurostimulation for Central Sleep Apnea

CSA neurostimulation stance: Implantable neurostimulation devices for the treatment of Central Sleep Apnea (CSA) are considered unproven and not medically necessary due to insufficient evidence of safety and/or efficacy.

See remedē evidence summaries for trial data and limitations.

Evidence‑based coverage implications (summary)

Coverage considerations based on evidence summarized in this section

Hypoglossal nerve stimulation: FDA‑cleared hypoglossal nerve stimulation (Inspire) is a treatment option for moderate to severe OSA in patients unable or unwilling to use PAP; authorization should document inability/unwillingness to use PAP and assessment of device candidacy per FDA labeling.

Supported by STAR trial and FDA PMA data.

Oral appliance therapy (OAT) for OSA: Custom, titratable oral appliances (mandibular advancement devices) are supported for OSA when prescribed and followed under collaborative medical and dental care; follow-up sleep testing to confirm efficacy is recommended and prefabricated devices lack guideline endorsement.

AASM and AADSM recommend custom devices and coordinated follow-up.

Positional therapy devices may reduce AHI in patients with position-dependent OSA and can have favorable short-term adherence but are generally inferior to CPAP for AHI reduction; consider for selected patients with documented positional dependence.

Evidence is low to moderate and long-term benefit is unclear.

Coverage considerations and clinical criteria

Policy‑relevant coverage considerations reflected in guidelines and evidence:

Oral appliance therapy considerations: Custom, titratable oral appliances are preferred over non-custom devices; qualified dental oversight and collaborative management with a medical provider are recommended, and follow-up sleep testing is advised to confirm efficacy and monitor dental side effects.

AASM, AADSM, and AAO-HNS guidance support these practices.

When oral appliances are appropriate: Oral appliance therapy may be considered for adult patients who are intolerant of CPAP or prefer an alternative, and as first-line therapy for primary snoring.

AASM and AAO-HNS guidance support this use.

CPAP and weight management: CPAP is recommended as initial therapy for many patients with OSA; overweight/obese patients should be counseled and encouraged to pursue weight loss as part of management.

ACP and AASM guidelines recommend CPAP first-line and weight management interventions.

Typical study-based inclusion

Interventions documented in the evidence were applied under the following typical inclusion elements:

Common inclusion elements for surgical and implantable device studies: Adult patients (often ≥18 years); diagnosis confirmed by attended polysomnography with AHI ≥15 for moderate-to-severe OSA where specified by trials; documented failure or intolerance of CPAP for device therapies such as HNS; anatomic/functional evaluation (e.g., DISE, tonsillar hypertrophy, velopharyngeal obstruction) when specified for surgical selection.AHI >= 15 where specified

Derived from trial inclusion criteria for surgical and device studies.

Implantable transvenous phrenic nerve stimulation (remedē) — evidence summary

Evidence from randomized trial(s) and long-term follow-up demonstrate effectiveness in reducing CSA severity but have limitations.

remedē trial findings: The remedē transvenous phrenic nerve stimulation pivotal randomized trial (n=151, baseline AHI ≥20) showed 51% of treated patients achieved ≥50% AHI reduction at 6 months versus 11% of controls; a 5-year post-approval study reported sustained improvements in AHI, CAI and ESS with few serious adverse events but limitations include lack of long-term controlled data and incomplete follow-up of original cohort.

Evidence judged low to very-low quality in technology assessments; additional comparative and longitudinal studies needed.

LAUP — evidence summary

Multiple studies and systematic reviews report mixed efficacy and substantial complication rates.

LAUP outcomes: Some single-center series report AHI improvements after multi-session LAUP, but systematic reviews report high complication rates (e.g., ~256 complications per 1,000 procedures) and modest success (≈23%), with a notable proportion of patients experiencing worsening AHI; LAUP should be used with caution or avoided given unfavorable aggregate results.

Evidence quality is low and complications are common per systematic reviews.

Lingual suspension / tongue fixation — evidence summary

Suture- or device-based tongue suspension techniques show variable success with generally low-quality evidence.

lingual suspension outcomes: Systematic reviews and case series report heterogeneous complication rates (pooled overall ~12.8%) and variable success rates for tongue suspension and related techniques; device failures (e.g., tissue anchor fractures) and inconsistent long-term outcomes limit widespread adoption.

Evidence largely consists of observational studies and case series with high heterogeneity.

Hyoid myotomy / hyomandibular suspension — evidence summary

Adjustable hyoid suspension procedures show some improvements in AHI in small series but evidence is limited.

hyoid suspension outcomes: Small nonrandomized studies and case series report mean AHI reductions and symptomatic improvement with hyoid myotomy/hyomandibular suspension, often when combined with other procedures; studies are limited by small samples, lack of controls, and short follow-up, and complications including bleeding, seroma, and infection have been reported.

Further high-quality studies are needed.

Palatal implants — evidence summary

Multiple randomized and nonrandomized studies provide mixed results for palatal implants in mild-to-moderate OSA.

palatal implant outcomes: Randomized controlled trials and meta-analyses show small-to-moderate reductions in AHI and ESS versus baseline but inconsistent superiority over placebo/sham; objective cure rates in case series vary (e.g., ~34%); overall evidence is insufficient to establish durable effectiveness for OSA.

NICE guidance and systematic reviews recommend caution given limited and mixed data.

Surgical/device therapy after failure or intolerance of noninvasive therapy

Covered when ALL of the following are met:

Primary conditions: Patient has OSA and has failed or is intolerant of CPAP or other noninvasive therapy (e.g., oral appliance), or is deemed an appropriate surgical candidate by a specialist; surgery is selected based on patient-specific anatomy and prior therapy attempts.clinical judgment

Guideline-based expectation (AASM, VA/DoD) supports surgery for patients not managed with CPAP or oral appliances; document prior noninvasive therapy attempts and anatomic rationale.

Procedures considered investigational/limited evidence

These interventions have limited, low-quality, or insufficient evidence and require careful justification:

Limited evidence interventions: Palatal implants, radiofrequency ablation (soft palate and/or tongue), distraction osteogenesis for maxillary expansion (DOME), transoral robotic surgery (TORS) and selected other procedures show small, short-term improvements in some studies but lack robust randomized controlled trials and long-term outcomes; use requires careful justification and documentation of rationale and alternatives.evidence quality

NICE recommends against routine use of soft-palate implants for OSA; ECRI and other assessments note inconclusive evidence for several procedures.

Hypoglossal/Upper Airway Stimulation (Inspire) — selection criteria

Covered when ALL of the following are met (per FDA indications and guideline suggestions):

Inspire patient selection: Baseline AHI within device-labeled range (original PMA AHI ≥20 and ≤65; labeling expansions include lower limit ≤15 and upper limit up to 100); BMI within device limits (expanded upper limit to 40); documented failure, intolerance, or refusal of PAP despite attempts to improve compliance; absence of complete concentric collapse at the soft palate on DISE; for pediatric Down syndrome indication, age 13-18 years with AHI ≥10 and ≤50 and other pediatric-specific criteria met.see device labeling

Device selection and documentation should align with FDA PMA and updated supplements.

Non-implantable devices and positional therapy — coverage considerations

Covered when ALL of the following are met:

Oral appliances and positional devices: For mild-to-moderate OSA (device-specific AHI ranges), consider custom mandibular advancement devices fabricated by a qualified dental provider as alternatives to PAP; positional therapy devices (e.g., Lunoa/NightBalance) may be considered for positional OSA when non-supine AHI is below device-specific limits (e.g., non-supine AHI <20 for Lunoa); intranasal or other FDA-cleared devices may be considered when used within their cleared AHI ranges and indications.device-specific AHI limits per FDA clearances

Follow device labeling and guideline recommendations (VA/DoD, AASM).

Phrenic nerve stimulation (remedē) — selection criteria

Covered when ALL of the following are met:

remedē patient selection: Patient has moderate to severe central sleep apnea as defined clinically and by attended polysomnography aligning with the remedē PMA labeling and trial criteria (e.g., study inclusion AHI thresholds); documentation supports indication, prior guideline-recommended therapies, and medical stability.AHI thresholds as per remedē PMA and trials (e.g., ≥20 in pivotal trial)

Evidence shows reductions in AHI and CAI but limitations in long-term comparative effectiveness remain; coverage may require additional justification.

Surgical interventions (e.g., maxillomandibular advancement, UPPP, radiofrequency, palatal implants) — coverage considerations

Covered when ALL of the following are met:

Surgical therapy selection: Surgical options (e.g., MMA, UPPP, radiofrequency ablation, palatal implants) may be considered for patients who cannot tolerate or are not appropriate candidates for recommended noninvasive therapies; selection should be individualized based on patient anatomy, prior therapy attempts, and guideline/society recommendations.varies by procedure

Guidelines (AASM, VA/DoD) provide conditional or weak recommendations for selected procedures; document rationale and prior noninvasive therapy attempts.

Surgical Treatment (Adult UPPP, MO, MMA)

Covered when ALL of the following are met

Adult surgical criteria: Diagnosis of moderate to severe OSA as determined by attended polysomnography with AHI ≥ 15 or RDI ≥ 15.AHI ≥ 15 OR RDI ≥ 15

Revised to require attended polysomnography; document repeat PSG when clinically indicated per policy history.

Implantable Hypoglossal Nerve Stimulation (Adolescents with Down Syndrome)

Covered when ALL of the following are met

Adolescent hypoglossal stimulation: Diagnosis of severe OSA as determined by attended polysomnography with AHI ≥ 10 and RDI ≤ 50 events per hour in adolescents (age 10-18) with Down syndrome; BMI <95th percentile for age; total central + mixed apneas <25% of total AHI; failure/intolerance of prior adenotonsillectomy when applicable and confirmed failure/intolerance of PAP despite compliance-improvement attempts; absence of tracheostomy during sleep; absence of complete concentric palatal collapse on DISE; used in accordance with FDA guidance for this pediatric indication.AHI ≥ 10 AND RDI ≤ 50

Criterion updated to specify attended polysomnography per policy revision.

This policy lists a number of non‑surgical devices and certain surgical procedures as unproven or unsupported based on the available evidence. Examples of non‑surgical items identified as unproven include positional OSA devices, nasal dilator devices, intranasal expiratory resistance valves (e.g., Bongo Rx), removable oral appliances for central sleep apnea (CSA), and prefabricated oral appliances or devices. In addition, several surgical procedures are noted as having insufficient evidence of efficacy and are not considered established treatments for OSA, including laser‑assisted uvulopalatoplasty (LAUP), lingual suspension/tongue fixation, isolated hyoid myotomy, stand‑alone uvulectomy, palatal implants, radiofrequency ablation of the soft palate and/or tongue, transoral robotic surgery (TORS), and distraction osteogenesis for maxillary expansion (DOME).

The policy explicitly states there is no relevant evidence to support the use of removable oral appliances for the treatment of central sleep apnea (CSA). Because CSA is a disorder of ventilatory control rather than primary anatomic airway collapse, removable oral appliances—designed to address structural obstruction—lack supportive data and authorization requests for this indication are at risk for denial.

Several intraoral and orthodontic‑style therapies are identified as lacking quality evidence. These include mandibular vertical repositioning devices (e.g., Slow Wave), morning repositioning devices, epigenetic appliances, and Advanced Lightwire Functional (ALF) appliances. The document reports no quality evidence supporting these approaches for OSA and therefore they are considered unproven.

In adolescent hypoglossal nerve stimulation studies for patients with Down syndrome, drug‑induced sleep endoscopy (DISE) was used for selection and those with circumferential palatal collapse on DISE were excluded from enrollment. This exclusion reflects the importance of anatomic pattern of collapse in determining candidacy for upper airway stimulation in adolescents.

Procedures for which the available evidence is judged insufficient—effectively excluding them as established, standalone treatments—include laser‑assisted uvulopalatoplasty (LAUP), palatal implants, and uvulectomy performed alone. Systematic reviews and evidence assessments cited in the policy conclude that larger, higher‑quality randomized trials and longer‑term outcomes are needed before these procedures can be considered effective for OSA.

The National Institute for Health and Care Excellence (NICE) guidance is cited, stating that current evidence for soft‑palate (palatal) implants is inadequate to demonstrate efficacy for OSA and therefore soft‑palate implants should not be used for treatment of OSA according to NICE.

The policy notes that use of devices or procedures outside the populations, severity ranges, or other conditions specified in FDA labeling (for example, device‑specific AHI or BMI limits and contraindications such as complete concentric collapse at the soft palate) may not meet coverage expectations and could be excluded from coverage when used outside labeled indications.

As part of a template update the policy removed language that was specific to the state of Louisiana. This state‑specific wording is no longer included in the policy text or coverage criteria.

The policy identifies a range of devices and procedures that are considered limited or not medically necessary due to insufficient evidence. Examples include implantable neurostimulation devices for CSA, removable oral appliances for CSA, many positional and nasal devices, and prefabricated oral appliances. Multiple surgical and non‑surgical interventions lacking robust evidence are listed as investigational or limited in support.

Evidence for prefabricated oral appliances is limited and there is a paucity of data demonstrating their safety or efficacy for OSA; study data favor custom, titratable devices over ready‑made appliances. Similarly, mandibular vertical repositioning devices lack quality evidence supporting their use for OSA.

The policy reiterates the lack of evidence for mandibular vertical repositioning devices, morning repositioning devices, epigenetic appliances, and ALF appliances. No published, high‑quality studies were identified to support their efficacy for OSA, and their effect on health outcomes remains unknown.

For the remedē transvenous phrenic nerve stimulation system used to treat central sleep apnea, available randomized trials and follow‑up studies show reductions in AHI/CAI and some symptom measures, but technology assessments (Hayes, ECRI) conclude the overall evidence quality is limited for some populations; additional RCTs and long‑term comparative outcomes are needed to establish broader effectiveness and safety.

Uvulectomy alone, laser‑assisted uvulopalatoplasty (LAUP), and palatal implants are judged to lack sufficient high‑quality evidence to support their use as effective standalone treatments for OSA. The policy cites evidence reviews that found modest or inconsistent efficacy and notable complication rates, leading to their exclusion as established therapies.

Procedures supported primarily by small, uncontrolled series or studies at high risk of bias—such as many radiofrequency ablation (RFA) reports, some TORS applications, and other single‑center case series—may be considered investigational or not medically necessary in the absence of higher‑quality comparative and long‑term data.

The policy states that devices lacking evidence of benefit for the specified OSA severity or without documented FDA clearance/indication for the intended use may be considered not medically necessary. FDA clearance alone does not guarantee coverage; clinical evidence for the indicated population and severity is required to support medical necessity determinations.

This excerpt does not reproduce the formal, explicit 'not medically necessary' (NMN) statements in full; readers should refer to the complete policy document for the full list of NMN conditions and formal coverage determinations.

Applicable Codes and Test/Severity Thresholds

Applicable CPT/HCPCS/Other Codesmixed

0964T	Impression and custom preparation of jaw expansion oral prosthesis for obstructive sleep apnea, including initial adjustment; single arch, without mandibular advancement mechanism.
0965T	Impression and custom preparation of jaw expansion oral prosthesis for obstructive sleep apnea, including initial adjustment; dual arch, with additional mandibular advancement, non-fixed hinge mechanism.
0966T	Impression and custom preparation of jaw expansion oral prosthesis for obstructive sleep apnea, including initial adjustment; dual arch, with additional mandibular advancement, fixed hinge mechanism.
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 (e.g., Wassmund or Schuchard).
21685	Hyoid myotomy and suspension.
33276	Insertion of phrenic nerve stimulator system (pulse generator and stimulating lead[s]), including vessel catheterization, all imaging guidance, and pulse generator initial analysis with diagnostic mode activation, when performed.
33277	Insertion of phrenic nerve stimulator transvenous sensing lead (List separately in addition to code for primary procedure).
33278	Removal of phrenic nerve stimulator, including vessel catheterization, all imaging guidance, and interrogation and programming, when performed; system, including pulse generator and lead(s).

1–10 of 43

1/5

Codes referenced in textmixed

Not specified

The provided document segment does not list explicit CPT/HCPCS/ICD-10 codes for surgeries or implants; only study and device names are reported.

Codingmixed

not specified

The document section provided does not list specific CPT/HCPCS/ICD codes for the procedures discussed.

FDA 510(k) device identifiers mentionedmixed

K180608	Lunoa System 510(k) Premarket Notification (positional OSA device).
K180619	Bongo intranasal appliance 510(k) approval.

FDA product codes / PMA / 510(k) / de novo identifiersmixed

P130008	Inspire Upper Airway Stimulation PMA identifier (PMA and supplements referenced).
K180608	Lunoa System 510(k) Premarket Notification.
K180619	Bongo intranasal appliance 510(k).
DEN200018	eXciteOSA de novo classification (QNO).
K191320	Slow Wave DS8 510(k).

Applicable Codes - Addedmixed

0964T	CPT/HCPCS code added (description provided in Applicable Codes section).
0965T	CPT/HCPCS code added (description provided in Applicable Codes section).
0966T	CPT/HCPCS code added (description provided in Applicable Codes section).
E0490	HCPCS code added (description provided in Applicable Codes section).

AHI / RDI severity thresholds — Mild/Moderate/Severe definitions and surgical/device thresholds

Mild OSAAHI or RDI ≥5 and <15 events/hour

Moderate OSAAHI or RDI ≥15 and ≤30 events/hour

Severe OSAAHI or RDI >30 events/hour

Surgical/device adult thresholdFor UPPP/MO/MMA: diagnosis of moderate to severe OSA as determined by attended polysomnography with AHI ≥15 or RDI ≥15

Implantable hypoglossal (adult) AHI rangeAHI ≥15 and ≤100 on attended polysomnography (plus BMI ≤40 and central+mixed apneas <25%)

Prior Authorization, Documentation, and Clinical Workflow

Billing Rule

Coding-based authorization note

Prior authorization, documentation, and coding-based checks may be required per plan rules. Include all relevant procedure, device, and implantable codes (e.g., CPT/HCPCS/ICD-10/L868x/L8679/L8680) with authorization requests. Listing of a code in policy does not guarantee coverage; confirm benefit, plan-specific PA rules, and any applicable exclusions prior to submission.

Include HCPCS/CPT codes listed in policy (e.g., E0485, E0486, E0490, E0530, L8679, L8680, L8686) on PA requests when applicable
Dental codes (D9947-D9949) are generally excluded from medical coverage — verify contractual rules before submission
PA may request operative reports, device model/serial numbers, and manufacturer documentation for implantable neurostimulators

Prior Authorization

Background, Definitions, and Device Overviews

Obstructive Sleep Apnea (OSA) is characterized by repetitive upper airway obstruction during sleep causing apneas and hypopneas with resultant daytime sleepiness and potential cardiovascular and metabolic consequences. Central Sleep Apnea (CSA) involves reduced or absent respiratory effort and is often associated with heart failure; treatment options for CSA are limited and current evidence for implantable neurostimulation in CSA is considered insufficient for broad conclusions about safety and efficacy.

Apnea / Hypopnea / AHI — definitions and diagnostic thresholds

Apnea definitionApnea: cessation of airflow (≥90% decrease) lasting ≥10 seconds; classified as obstructive, central, or mixed based on respiratory effort

Hypopnea definitionHypopnea: ≥10 seconds with ≥30% reduction in airflow and ≥3% oxygen desaturation or associated arousal

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

OSA severity — Mild/Moderate/Severe definitions (AHI/RDI ranges)

Policy Revision History

2026-04-01template_updateLatest

Template update removed content/language pertaining to the state of Louisiana.

2025-11-01coverage_revision

Revised surgical coverage criteria to require diagnosis of moderate to severe OSA by attended polysomnography (AHI ≥15 or RDI ≥15) and clarified when polysomnography should be repeated after significant clinical changes; updated adolescent hypoglossal stimulation criterion to require attended polysomnography (AHI ≥10 and RDI ≤50) and added device/code updates.

2025-11-01coding_update

Policy Summary

PayerUnitedHealthcare

PolicyObstructive and Central Sleep Apnea Treatment

Policy CodePolicy CS116.AL

Change TypeCriteria revisions and code additions

Effective DateNov 1, 2025

Next Review DateN/A

SourceLink

On This Page

Implantable hypoglossal nerve stimulation (adults): Body mass index ≤ 40 kg/m2; baseline AHI ≥ 15 and ≤ 100 on attended polysomnography; total central + mixed apneas comprise < 25% of total AHI; absence of complete concentric collapse of the soft palate confirmed by drug-induced sleep endoscopy (DISE); documented failure, intolerance, or refusal of PAP therapy; device used per FDA labeling and guidance.AHI ≥15 and ≤100; BMI ≤40; central+mixed <25%

Device must be FDA-approved and patient selection aligned with labeling (see Inspire PMA).

Implantable hypoglossal nerve stimulation (adolescents with Down syndrome): Age 10-18 years with Down syndrome; diagnosis of severe OSA as determined by attended polysomnography with AHI ≥ 10 and RDI ≤ 50 events/hour; BMI less than the 95th percentile for age; total central + mixed apneas < 25% of total AHI; contraindication to or ineffective prior adenotonsillectomy; confirmed failure or intolerance of PAP despite attempts to improve compliance; absence of tracheostomy use during sleep; absence of complete concentric palatal collapse on DISE; used in accordance with FDA guidance for this pediatric expansion.AHI ≥10 AND RDI ≤50

Criteria revised to require attended polysomnography for confirmation.

Nasal dilators and intranasal EPAP: Evidence for nasal dilators and EPAP devices is mixed or limited; they may provide short-term reductions in AHI for some patients but are inferior to CPAP for moderate-to-severe OSA and should be limited to selected patients with counseling about evidence limitations.

Provent (EPAP) trial showed short-term AHI reductions but study limitations exist.

Non-surgical electrical muscular stimulation: Intraoral electrical stimulation devices (e.g., eXciteOSA) have low-quality evidence suggesting possible benefit for snoring and mild OSA but lack robust comparative RCTs and long-term outcomes; consider investigational or limited coverage pending stronger evidence.

Available evidence is low quality with small single-arm studies.

Removable oral appliances for CSA: There is no relevant evidence supporting removable oral appliances for treatment of central sleep apnea (CSA).

Requests for oral appliances to treat CSA are at risk for denial.

Surgical referral indications: Referral for surgical consultation is appropriate for patients with major upper-airway anatomical obstruction or for those intolerant/unaccepting of PAP, with procedure selection individualized based on anatomy and guideline recommendations.

AASM task force supports surgery for patients with major anatomic obstruction despite overall low-quality evidence.

MMA effectiveness: Maxillomandibular advancement (MMA) has demonstrated substantial AHI/RDI improvements in selected patients and is considered an effective surgical option when anatomically indicated.

Multiple systematic reviews/meta-analyses report large effect sizes though limitations exist.

AHI severity thresholds used in studies — examples of thresholds used for trial inclusion

Trial AHI >15 inclusionSome surgical trials enrolled patients with baseline AHI >15 events/hour (e.g., UPPP RCTs)

HNS (STAR) typical entrySTAR trial participants had median baseline AHI ~29 events/hour (moderate-to-severe) and were CPAP-intolerant

remedē pivotal trial exampleremedē pivotal trial required AHI ≥20 events/hour for enrollment

AHI inclusion threshold (remedē pivotal trial)

remedē pivotal trial inclusionRequired baseline AHI ≥20 events/hour as measured by polysomnography for enrollment

Trial population size151 eligible patients randomized in the multicenter pivotal trial

Primary endpointProportion achieving ≥50% AHI reduction at 6 months (51% treatment vs 11% control)

AHI inclusion for systematic review (Voigt et al.)

Systematic review inclusion (Voigt et al.)Included randomized studies with AHI ≥10 events/hour as an inclusion criterion for CSA trials in HF populations

ScopeVoigt et al. reviewed therapies for CSA in heart failure with reduced ejection fraction comparing ASV, CPAP, and few TPNS trials

Comparator prevalenceMost trials examined ASV (8 studies) and CPAP (9 studies); TPNS had limited RCT data

AHI thresholds referenced in guideline context — examples from guidelines

Inspire UAS original PMA AHI limitsOriginal PMA: AHI ≥20 and ≤65 events/hour (Inspire UAS)

Inspire UAS expanded labelingExpanded indication: lower AHI limit ≤15 and upper limit up to 100 events/hour; BMI upper limit expanded to 40

Guideline-referenced exampleERS guidance referenced AHI <50/hr as an example range for HNS consideration in guideline context

AHI and BMI device thresholds — device-specific AHI/BMI examples

Inspire device AHI/BMI criteriaInspire originally approved for AHI ≥20–≤65; labeling expanded to include AHI ≥15 and up to 100 and BMI upper limit expanded from 32 to 40

eXciteOSA indicationeXciteOSA cleared for snoring/mild OSA; eXciteOSA cited for use in mild OSA (AHI <15) in the policy summary

Lunoa positional deviceLunoa System 510(k) clearance prescribed for positional OSA with non‑supine AHI <20

AHI and Respiratory Disturbance Index (RDI) — policy thresholds and adolescent criteria

Adult surgical/device threshold (policy decision)Policy requires attended polysomnography showing AHI ≥15 or RDI ≥15 for adult surgical procedures (e.g., UPPP, MO, MMA)

Adolescent HNS criterionFor adolescents with Down syndrome: diagnosis by attended polysomnography with AHI ≥10 and RDI ≤50 events/hour

Hypoglossal adult device central apnea limitTotal AHI must have <25% central + mixed apneas for implantable hypoglossal nerve stimulation eligibility

Provider prerequisites for oral appliance or surgical authorization

For oral appliance or surgical authorization, document a face-to-face evaluation and medical diagnosis from a qualified medical provider before referral to dental or surgical care. Provide evidence of prior PAP therapy failure, intolerance, or refusal when required by coverage criteria.

Face-to-face evaluation by a physician (MD/DO) trained in sleep medicine or an APP under direct supervision required prior to OAT (chunk 3,41)
Treating physician or APP must document diagnosis of OSA and recommend OAT or surgery (chunk 3,43)
For surgical PA (e.g., UPPP, MMA, MO), include attended polysomnography confirming AHI/RDI thresholds and documentation of PAP failure/intolerance (chunk 5)

Prior Authorization

Device therapy prior authorization considerations

Device therapies (hypoglossal nerve stimulation, transvenous phrenic nerve stimulation, implantable neurostimulators) frequently require prior authorization with device-specific clinical documentation and evidence of prior guideline-recommended therapy.

For HNS (Inspire): include attended polysomnography AHI/ODI, BMI, DISE findings confirming absence of complete concentric collapse when applicable, and documentation of PAP failure/intolerance (chunks 20,5,62)
For remedē/TPNS: provide attended PSG baseline AHI/CAI, documentation patient had guideline-recommended therapies, medical stability, and trial eligibility (AHI thresholds per studies/trials) (chunks 69,72,74)
Include device model, FDA indication alignment, and any available trial data (e.g., STAR, remedē pivotal trials) with PA

Prior Authorization

Prior authorization for transvenous phrenic nerve stimulation

Prior authorization for transvenous phrenic nerve stimulation (TPNS/remedē) should document study eligibility per trial design and FDA/clinical guidance, including minimum AHI thresholds and receipt of guideline‑recommended therapy.

Trials and pivotal studies required AHI ≥ 20 for enrollment — include attended PSG demonstrating AHI threshold when requesting PA (chunk 74)
Document prior use of guideline-recommended therapies and medical stability for at least 30 days as required by the pivotal trial (chunk 74)
Provide evidence of expected benefit and address scarcity of long-term comparative data in justification (chunks 69,72)

Prior Authorization

Prior authorization to confirm prior therapy and selection

Prior authorization reviews must confirm prior therapy trials and the clinical rationale for selecting the requested surgical or device intervention.

Document attempts with PAP (CPAP/APAP/BiPAP) including duration, adherence efforts, and reasons for failure/intolerance/refusal (chunk 5,59)
If oral appliance therapy was tried, include device type (custom vs. prefabricated), titration details, and follow-up sleep testing results (chunks 3,34,42)
For HNS or device implantation, include multidisciplinary rationale and evidence that less invasive options were ineffective or not tolerated (chunks 20,43,42)

Prior Authorization

Implantable neurostimulation prior auth

Implantable neurostimulation devices generally require PA that aligns patient eligibility with FDA-labeled indications and available clinical evidence; where FDA labeling exists, ensure documentation maps to those criteria.

For Inspire HNS, document AHI range, BMI limit, and absence of complete concentric collapse per FDA labeling and DISE when required (chunk 112)
For pediatric Down syndrome indications, include age, prior adenotonsillectomy status, and failure/intolerance to PAP per expanded FDA indication (chunk 113)
Attach FDA PMA or summary evidence statements when available to support PA

Denial Risk

Lack of long-term follow-up, small sample sizes, or limited controls may trigger denials or requests for justification

Lack of long-term follow-up, small sample sizes, or limited controlled data in the evidence base may trigger PA denial or requests for additional justification; include longest available follow-up data and risk/benefit discussion.

Highlight follow-up duration from pivotal trials (e.g., STAR long-term data) and acknowledge limitations when present (chunks 62,59)
Provide rationale and clinical context if requesting coverage despite limited long-term evidence (e.g., patient-specific factors, lack of alternative options) (chunks 60,69)
Be prepared for requests for outcome monitoring or registry participation as a condition of approval

Denial Risk

Potential denials for out-of-label device use

Requests for device use outside FDA-labeled indications or outside labeled AHI/BMI/age ranges are at risk for denial. Explicitly document why out-of-label use is reasonable and include supporting evidence or peer-reviewed literature.

When requesting coverage beyond FDA limits (e.g., higher BMI, AHI outside labeled range, different age groups), include strong clinical justification and literature support
Indicate whether use is investigational or experimental in absence of supporting evidence; such requests may be denied (chunks 69,78)

Documentation Required

Polysomnography documentation necessary

Attended polysomnography documentation is necessary for many surgical and device authorizations. Ensure PSG reports include specific metrics and meet the policy's updated thresholds.

Include date of attended PSG, AHI, ODI, CAI/central apnea percentage, and sleep staging where relevant (chunks 5,62,69)
Repeat PSG when clinically indicated (significant weight change, cardiovascular status change, or persistent/recurrent symptoms since prior study) as noted in policy history (chunk 131)
Failure to document attended polysomnography meeting thresholds may result in denial (chunk 131)

Documentation Required

Collaborative care and PAP intolerance

Document collaborative care between medical providers and dentists for oral appliance therapy, and clearly state PAP intolerance or failure when OAT is requested.

Include referral note from diagnosing medical provider to qualified dentist and plan for shared follow-up (chunk 19,43)
For OAT, document PAP trial details and objective follow-up sleep testing to confirm efficacy (chunk 42)
Specify whether oral appliance is custom, titratable, and fabricated by qualified dental personnel; prefabricated devices lack evidence and may be denied (chunks 34,3)

Documentation Required

Diagnosis, referral, and follow‑up documentation

Diagnosis, referral, and follow-up documentation must show a medical diagnosis by a qualified medical provider prior to dentist referral and include planned medical follow-up.

Medical provider (MD/DO or APP under supervising physician) must diagnose OSA and document treatment recommendations before dental evaluation (chunks 3,43)
Attach medical records showing ongoing medical follow-up plans and any recommended repeat PSGs or titration studies (chunks 19,42)
Include documentation of multidisciplinary care plans when surgery or implantable devices are considered (chunks 20,5)

Documentation Required

Document FDA-indication alignment

Align PA documentation with FDA indications when applicable. If the device is FDA-approved for specific AHI, BMI, age, or collapse-pattern criteria, include evidence that the patient meets those exact criteria.

For Inspire HNS, include attended PSG showing AHI within the FDA range, BMI documentation, and DISE results regarding palatal collapse where required (chunk 112)
For pediatric Down syndrome indications, include age, prior therapies, and failure of adenotonsillectomy or PAP as specified in FDA expansion (chunk 113)

Step Therapy

PAP as first-line requirement

Positive airway pressure (PAP) is expected as first-line therapy for most patients with moderate to severe OSA. PA requests for downstream therapies should document that PAP was ineffective, not tolerated, or refused after an adequate trial.

Document PAP modality used (CPAP/APAP/BiPAP), duration, adherence efforts, and objective response data when available (chunk 18,5)
If PAP was not used, include clinical reasons for refusal or contraindication documented by the treating physician (chunks 5,43)

Step Therapy

Recommended treatment sequencing

Recommended treatment sequencing follows guidelines: attempt conservative and less invasive options (PAP, oral appliances, positional therapy) before surgical or implantable therapies unless contraindicated.

Offer CPAP/APAP as first-line for moderate-severe OSA; consider custom oral appliance for CPAP-intolerant patients (chunks 42,46)
Positional therapy or oral appliances may be reasonable for selected mild-to-moderate OSA prior to surgery (chunks 108,63)
Document why less invasive options were inadequate or not appropriate when requesting surgery or implantable devices

Prior Authorization

Studies required prior guideline recommended therapy and medical stability

PA reviewers expect that studies supporting device or surgical use required prior guideline-recommended therapy and demonstration of medical stability; include explicit statements and evidence of these prerequisites.

For TPNS/remedē requests, document medical stability for at least 30 days and prior guideline-recommended therapy as in the pivotal trial (chunk 74)
For HNS, include documentation of PAP trial and adherence, along with DISE results when required to demonstrate anatomy consistent with device labeling (chunks 62,20)
Provide perioperative medical optimization records and cardiopulmonary assessments if requested

Step Therapy

Consider less invasive options first

Consider less invasive options first: oral appliances (custom, titratable) and positional therapy should be offered when clinically appropriate before advancing to surgical or implantable solutions.

Custom, titratable oral appliances are preferred over non-custom or prefabricated devices; prefabricated devices lack evidence and may be denied (chunks 42,34)
Use positional therapy for positional-dependent OSA as an alternative in selected patients (chunk 46)
Document trials of these less invasive modalities and objective outcomes where available

OSA severity — MildAHI or RDI ≥5 and <15 events/hour

OSA severity — ModerateAHI or RDI ≥15 and ≤30 events/hour

OSA severity — SevereAHI or RDI >30 events/hour

HSAT adequacy — Home Sleep Apnea Test minimum duration and sensor requirements

Minimum HSAT durationAdequate HSAT requires a minimum of four hours of recording time

Minimum HSAT sensorsHSAT must include nasal pressure, chest and abdominal respiratory inductance plethysmography, and oximetry

HSAT limitationHSAT does not determine sleep staging; not all HSATs are performed at home despite the name

Oral Appliance Therapy (OAT) — definition and mechanism

OAT definitionNon-surgical intraoral devices worn during sleep to maintain airway patency by mandibular advancement, tongue retention, or combined mechanisms

MechanismWorks by advancing the mandible or preventing tongue collapse to reduce airway obstruction and snoring

Clinical practice noteAASM recommends collaborative management between dentists and physicians with follow-up sleep testing to confirm efficacy

Hypoglossal nerve stimulation — device description (Inspire example)

Hypoglossal nerve stimulation descriptionImplanted device that senses respiration and stimulates the hypoglossal nerve to advance the tongue and open the airway (example: Inspire UAS)

Implant componentsLead to hypoglossal nerve at tongue base and chest pulse generator with a pressure sensor to detect respiration

Indication contextFDA-cleared for patients with moderate to severe OSA who cannot tolerate PAP and meet device-specific AHI/BMI and DISE criteria

EPAP — nasal expiratory positive airway pressure devices definition

Clinical evidenceTrials (e.g., Provent) show short-term reductions in AHI for some patients but mixed results and are generally inferior to CPAP for moderate-severe OSA

Typical useOften offered as a simple, reusable option for selected patients intolerant of CPAP

Noninvasive electrical muscle stimulation — device definition and examples

Noninvasive electrical muscle stimulation definitionIntraoral devices that deliver electrical stimulation to tongue muscles while awake to reduce snoring and potentially mild OSA (examples: eXciteOSA, Apone-Stim)

Usage regimen exampleeXciteOSA recommended use: 20 minutes daily while awake for 6 weeks then maintenance once weekly

Evidence qualitySystematic reviews and assessments identify very low to low-quality evidence with limited comparative or long-term data

Intraoral awake neuromuscular electric stimulation — definition and examples

Intraoral awake neuromuscular stimulation definitionNon‑invasive intraoral device delivering electrical stimulation to tongue muscles while awake aiming to reduce snoring and improve mild OSA

Devices includedApone-Stim and eXciteOSA were evaluated in systematic reviews identifying modest snoring improvement and limited AHI data

Evidence limitationsStudies are small, often single-arm, with high risk of bias and lack long-term comparative outcomes

Maxillomandibular advancement (MMA) — surgical definition and outcomes summary

MMA definitionMaxillomandibular advancement (MMA) is a major surgical procedure advancing the maxilla and mandible to enlarge the airway

Outcomes summaryMeta-analysis (Zaghi et al.) found ~90% of patients experienced improvements in AHI/RDI after MMA

Evidence limitationsStudies are subject to selection bias and limited long-term follow-up and comparisons

AHI — Apnea-Hypopnea Index definition and use

AHI definition (restated)AHI = number of apneas plus hypopneas per hour of sleep; primary efficacy metric in device and surgical studies

Use in policy thresholdsAHI thresholds (e.g., ≥15 for moderate disease) are used to define eligibility for procedures and device trials

Calculation sourceAASM Scoring Manual (2023) definitions cited in policy

PNS / TPNS — phrenic nerve stimulation definition

PNS / TPNS definitionPhrenic nerve stimulation (transvenous) is an implantable therapy (remedē System) that stimulates the phrenic nerve to treat central sleep apnea

Indicationremedē indicated for moderate to severe central sleep apnea in adults per FDA approval

Evidence summaryRCT (Costanzo 2016) and PAS 5‑year follow-up show reductions in AHI/CAI but overall evidence assessed as low/insufficient in some reviews

Transvenous phrenic nerve stimulation (TPNS) — remedē system description

remedē system descriptionAn implantable transvenous phrenic nerve stimulator that delivers stimulation to the phrenic nerve to reduce central sleep apnea events

Pivotal trial enrollmentCostanzo et al. randomized 151 patients with AHI ≥20 to stimulation versus control

Long-term dataPost-approval study reported sustained improvements at 5 years in AHI, CAI, and ESS in a subset of patients

LAUP — Laser-assisted uvulopalatoplasty definition

LAUP definitionLaser-assisted uvulopalatoplasty (LAUP) is a minimally invasive outpatient laser procedure applied to the soft palate (Er:YAG and Nd:YAG) to reduce snoring and OSA

Safety concernsSystematic reviews report high complication rates (e.g., ~256 complications per 1,000 procedures) and mixed efficacy

RecommendationPolicy concludes insufficient evidence to support LAUP as effective for OSA treatment

Palatal implants (Pillar, Elevo) — definition and limited evidence

Palatal implants definitionSmall woven polyester inserts placed in the soft palate to stiffen tissue and reduce airway collapse (e.g., Pillar, Elevo)

Evidence noteMeta-analyses and trials show modest AHI/ESS reductions but overall evidence is limited and inconsistent for durable OSA treatment

Regulatory contextPillar Palatal Implant System received FDA 510(k) clearance (K040417); NICE advises against soft-palate implants for OSA due to inadequate evidence

Radiofrequency tissue volume reduction (RFTVR/RFA) — definition

RFTVR/RFA definitionRadiofrequency tissue volume reduction uses low-intensity radiofrequency energy to shrink uvula, soft palate, and/or tongue tissues (trade names Somnoplasty™, Coblation®)

Clinical resultsSome studies show short-term AHI improvements in mild-to-moderate OSA but evidence lacks randomized long-term trials

Policy stanceAdditional larger randomized trials are needed to establish long-term safety and efficacy

Transoral Robotic Surgery (TORS) — definition and target anatomy

TORS definitionTransoral Robotic Surgery (TORS) is a robotic surgical approach for base-of-tongue and hypopharyngeal tissue resection to treat OSA by reducing obstructive tissue

Outcome summarySystematic reviews report AHI reductions and surgical success rates but note low-quality evidence and heterogeneity across studies

Evidence limitationsComparative RCTs and long-term outcomes are lacking

Distraction osteogenesis for maxillary expansion (DOME) — definition and proposed benefit

DOME definitionDistraction osteogenesis for maxillary expansion (DOME) surgically expands the maxilla to widen the palate and nasal floor and potentially improve airflow

Clinical evidenceCase series report improvements in AHI and symptoms but high-quality randomized trials and long-term data are lacking

Use contextConsidered investigational/limited evidence pending stronger comparative data

Upper Airway Stimulation (UAS) / Inspire — device overview and FDA context

UAS / Inspire overviewInspire Upper Airway Stimulation is an implantable hypoglossal nerve stimulation system that senses respiration and stimulates the hypoglossal nerve to reduce OSA events

FDA PMA contextInspire received PMA (P130008) with labeled AHI/BMI selection limits and has had expanded indications including pediatric Down syndrome and adult AHI/BMI range changes

Efficacy evidenceSTAR trial and subsequent studies reported marked reductions in AHI and improvements in ESS and quality-of-life measures

remedē System — device overview

remedē system overviewremedē is an implantable transvenous phrenic nerve stimulation system indicated for treatment of moderate to severe central sleep apnea in adults

Regulatory statusremedē received FDA approval (P160039) for moderate to severe CSA in adults

Evidence summaryPivotal RCT (Costanzo 2016) and PAS follow-up show reductions in AHI and CAI with some sustained benefit but overall evidence considered limited by some assessments

eXciteOSA / positional and intranasal devices — device examples and indications

eXciteOSA / positional/intranasal exampleseXciteOSA is a noninvasive intraoral electrical stimulation device for mild OSA/snoring; Lunoa and Bongo are device examples with device‑specific AHI indications (Lunoa non‑supine AHI <20; Bongo for mild‑moderate OSA)

Evidence qualityeXciteOSA evidence is low quality with small single-arm studies; positional and intranasal devices have variable, device-specific clearances and mixed evidence

Regulatory notesLunoa (K180608) and Bongo (K180619) obtained FDA 510(k) clearances with specified device indications

Respiratory Disturbance Index (RDI) — definition added to policy

RDI definition (policy addition)Respiratory Disturbance Index (RDI) = apneas + hypopneas + respiratory effort‑related arousals per hour; added definition in policy

Use alongside AHIPolicy uses RDI interchangeably with AHI for severity categories and surgical eligibility (e.g., RDI ≥15 for adult surgery)

Adolescent threshold exampleAdolescent hypoglossal stimulation criteria reference RDI ≤50 events/hour with AHI ≥10

Added CPT/HCPCS codes 0964T, 0965T, 0966T, and E0490 to the list of applicable codes.