Obstructive and Central Sleep Apnea Treatment (for Nebraska Only)
Defines medical necessity, coverage stance, and coding for non-surgical and surgical treatments of obstructive and central sleep apnea for UnitedHealthcare members in Nebraska.
Policy Summary
PayerUnitedHealthcare
PolicyObstructive and Central Sleep Apnea Treatment (for Nebraska Only)
Key ActionWhen requesting coverage for surgical or implantable therapies, include attended polysomnography showing required AHI/RDI thresholds and documentation of prior PAP failure or intolerance.
Added notation that polysomnography should be repeated if there has been clinically significant weight loss or gain, changes in cardiovascular disease, or persistent or recurrent symptoms since the last study.
Replaced generic criterion wording with explicit requirement that moderate to severe OSA be determined by Attended Polysomnography with AHI 5 15 or RDI 5 15.
Replaced adolescent hypoglossal nerve stimulation criterion to specify diagnosis of severe OSA determined by Attended Polysomnography with AHI 5 10 and RDI 4 50 events per hour.
Added CPT/HCPCS codes 0964T, 0965T, 0966T, and E0490 to Applicable Codes.
Added instruction to refer to the Medical Policy titled Sleep Studies (for Nebraska Only) for Non-Surgical Treatment coverage rationale.
Updated FDA and References sections to reflect the most current information.
Nebraskaapplies to
≥15adult AHI/RDI threshold
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≤40
adult HNS BMI limit
AHI ≥10adolescent HNS threshold
4codes added
Coverage Criteria and Evidence-based Determinations
Removable Oral Appliances (OAT)
Non‑surgical removable oral appliance therapy is covered when ALL of the following are met:
Oral Appliance Therapy (OAT) initial criteria: 1) Patient has OSA documented by a sleep study (Polysomnography or Home Sleep Apnea Testing). 2) Face-to-face evaluation with a physician (MD/DO) trained in sleep medicine prior to starting OAT. 3) Treating physician (MD/DO) diagnoses OSA and recommends OAT. 4) If used as an alternative after PAP, documentation of PAP failure, intolerance, or patient refusal must be supplied.
Qualified dentist involvement and follow-up sleep testing per guideline recommendations (see AASM/AADSM).
Adult surgical treatment (UPPP, MO, MMA)
Surgical procedures are covered when ALL of the following are met:
UPPP, MO, MMA surgical criteria (adults): 1) Moderate to severe OSA confirmed by attended polysomnography with AHI ≥ 15 or RDI ≥ 15. 2) Excessive daytime sleepiness documented (Epworth Sleepiness Scale > 10 or another validated tool). 3) PAP therapy resulted in no therapeutic efficacy or there is documented patient refusal or intolerance. 4) Procedure-specific surgical indication: for MMA — craniofacial disproportion or maxillomandibular deficiency; for MO — retrolingual or lower pharyngeal obstruction.AHI or RDI ≥ 15; ESS >10
Repeat attended polysomnography if clinically indicated (significant weight change, cardiovascular disease changes, or recurrent/persistent symptoms).
Hypoglossal nerve stimulation — adult
Implantable hypoglossal nerve stimulation is covered when ALL adult criteria are met:
Hypoglossal nerve stimulation (adults): 1) Body mass index ≤ 40 kg/m2. 2) AHI ≥ 15 and ≤ 100 as determined by attended polysomnography. 3) Total central + mixed apneas < 25% of total AHI on attended PSG. 4) Absence of complete concentric collapse of the soft palate confirmed by drug-induced sleep endoscopy. 5) PAP therapy resulted in no therapeutic efficacy or there is documented patient refusal or intolerance. 6) Device use consistent with FDA labeling and device-specific indications.AHI 15–100; central+mixed <25%; BMI ≤40
Device must be FDA-approved and patient selection may include DISE per device guidance.
Hypoglossal nerve stimulation — adolescents with Down syndrome
Hypoglossal nerve stimulation is covered in adolescents (10–18 years) with Down syndrome when ALL criteria are met:
Hypoglossal stimulation (adolescents with Down syndrome): 1) Severe OSA by attended polysomnography with AHI ≥ 10 and RDI ≤ 50 events per hour. 2) BMI < 95th percentile for age. 3) Total central + mixed apneas < 25% of total AHI. 4) Contraindication to or ineffective prior adenotonsillectomy. 5) Confirmed failure or intolerance of PAP despite attempts to improve compliance. 6) No tracheostomy use during sleep. 7) Absence of complete concentric palatal collapse on DISE. 8) Individual and caregiver refusal of MMA for non-concentric palatal collapse when applicable. 9) Use consistent with FDA expanded pediatric Down syndrome indication and device labeling.AHI ≥10; RDI ≤50; BMI <95th percentile
Applies to adolescents aged ~10–18 years with Down syndrome per FDA indication; DISE often used for selection.
Unproven surgical procedures
Procedures considered unproven and not medically necessary:
Other surgical procedures not medically necessary: Laser-assisted uvulopalatoplasty (LAUP); lingual suspension/tongue fixation; isolated hyoid myotomy; stand‑alone uvulectomy; palatal implants; radiofrequency ablation of soft palate and/or tongue base; transoral robotic surgery (TORS); distraction osteogenesis for maxillary expansion (DOME).
Not an all-inclusive list; these procedures lack sufficient high-quality evidence and/or have notable complication rates.
Unproven non-surgical procedures
Other non‑surgical interventions considered unproven and not medically necessary:
Unproven non-surgical treatments: Devices for positional OSA; nasal dilator devices for OSA; intranasal expiratory resistance valves (e.g., Bongo/Provent); removable oral appliances for central sleep apnea; prefabricated oral appliances/devices; non‑surgical electrical muscular training (intraoral stimulators); mandibular vertical repositioning devices; morning repositioning devices; epigenetic appliances; Advanced Lightwire Functional (ALF) appliances.
Insufficient or low‑quality evidence to support safety and efficacy for treating OSA/CSA.
Overall coverage determination
Summary coverage stance based on available evidence
General evidence-based stance: Most positional devices, nasal dilators, intranasal EPAP devices, prefabricated oral appliances, electrical muscular stimulation devices, and various niche intraoral/orthodontic appliances have limited, low‑quality, or conflicting evidence for long‑term safety and efficacy. CPAP demonstrates greater reductions in AHI compared with positional therapy and EPAP in comparative trials. Some devices show short‑term improvement or adherence in subsets of patients, but durability and comparative effectiveness versus CPAP are not established.
Evidence summarized from systematic reviews, RCTs, and technology assessments.
Intranasal expiratory resistance valves
EPAP devices (e.g., Provent)
EPAP evidence summary: Randomized trials show EPAP can reduce AHI versus sham in short‑term studies and improve subjective sleepiness for some participants; adherence among responders may be high. However, EPAP is inferior to CPAP in efficacy and long‑term comparative data are limited, so routine primary‑therapy coverage for moderate‑severe OSA is not supported without supporting documentation (e.g., CPAP refusal/intolerance).
Short‑term RCTs and extension studies show benefits in responders but limited long‑term evidence.
Positional therapy
Positional therapy devices
Positional device evidence summary: Trials and systematic reviews report reductions in AHI and sometimes better short‑term adherence versus CPAP in positional OSA, but CPAP produces greater AHI improvement. Studies are often short‑term with small samples and higher dropout rates; long‑term efficacy and comparative effectiveness remain uncertain.
Selection for positional therapy should be limited to documented positional OSA and consider prior CPAP trial.
Nasal dilators and intranasal valves
Nasal dilators and intranasal devices
Nasal dilators/EPAP summary: Systematic reviews and small studies generally show nasal dilators do not produce meaningful changes in AHI; intranasal EPAP devices have mixed short‑term results versus sham and are inferior to CPAP. Evidence quality is low and does not support routine use for moderate‑to‑severe OSA as primary therapy.
Use may be considered only for selected patients with documented CPAP intolerance and appropriate counseling about limited evidence.
Oral appliances
Oral appliances and related intraoral devices
Oral appliance evidence summary: Custom, titratable mandibular advancement devices have evidence of benefit for mild to moderate OSA and are guideline‑recommended; prefabricated devices have limited evidence and are inferior. Oral appliances are not supported for treatment of central sleep apnea. Novel vertical or epigenetic appliances lack quality evidence.
Qualified dentist fitting and follow‑up sleep testing recommended per AASM/AADSM guidance.
Electrical muscular stimulation
Non‑surgical electrical muscular training
Electrical stimulation devices summary: Intraoral neuromuscular electrical stimulation devices (e.g., eXciteOSA) have very low‑quality evidence from single‑arm or pre‑post studies suggesting possible improvement in snoring and mild OSA, but randomized comparative data and long‑term outcomes are lacking; overall evidence is inconclusive.
Guidelines provide limited endorsement; further RCTs required.
Unproven/unsupported devices
Other niche devices
Miscellaneous appliance summary: Mandibular vertical repositioning devices, morning repositioning devices, epigenetic appliances, and Advanced Lightwire Functional (ALF) appliances have no quality evidence supporting efficacy for OSA and are considered unsupported or investigational.
Submission for these devices may be denied without strong supporting evidence.
Non‑PAP therapy positioning and evidence
Summary of when non‑PAP therapies are recommended or supported by evidence/guidelines
Oral appliance therapy (OAT): Custom, titratable oral appliances are recommended as first‑line for snoring and as an alternative for mild‑to‑moderate OSA or for patients intolerant of CPAP; qualified dentists should provide fitting and monitoring and sleep physicians should perform follow‑up testing.
AAO‑HNS, AASM, AADSM guidance referenced.
Surgical therapies: Surgery (tonsillectomy, UPPP, MMA and other pharyngeal surgeries) may benefit selected patients with major anatomical obstruction or CPAP intolerance; MMA shows consistent AHI improvements across systematic reviews while outcomes for simpler pharyngeal surgeries are more variable.
Surgical selection should follow guideline recommendations and documented objective testing.
Hypoglossal nerve stimulation (HNS): HNS may reduce AHI and improve daytime sleepiness for selected patients after CPAP failure/intolerance; evidence is largely nonrandomized and from device‑specific studies, so selection should follow FDA labeling and documented prior therapy attempts.
See STAR trial and technology assessments for outcomes and limitations.
Hypoglossal Nerve Stimulation (HNS) — general evidence context
HNS — general evidence context
HNS candidate criteria (evidence context): Studies of HNS enrolled patients with prior CPAP intolerance or failure and baseline AHI consistent with moderate‑to‑severe OSA; patient selection frequently excluded those with complete concentric palatal collapse via DISE. Evidence shows substantial mean AHI reductions in select cohorts (eg, STAR trial) but overall quality is low with limited randomized long‑term comparative data.
Consider HNS only after documented CPAP failure/intolerance and when device labeling criteria are met.
Transvenous Phrenic Nerve Stimulation (TPNS/remedē) — general evidence context
TPNS/remedē — general evidence context
TPNS candidate criteria (evidence context): Trials enrolled adults with moderate‑to‑severe central sleep apnea (eg, AHI ≥ 20 in pivotal trial), medically stable for ≥30 days and having received guideline‑recommended therapy; TPNS reduced AHI/CAI in randomized and observational studies but evidence is limited by small sample sizes and follow‑up.AHI ≥20 (per pivotal trial inclusion)
Device‑specific labeling and cardiac stability criteria should be confirmed.
Surgical evidence summary: Systematic reviews and meta‑analyses report that MMA yields substantial and consistent reductions in AHI; pharyngeal surgeries have more variable outcomes and higher reported adverse events; LAUP and some minimally invasive procedures lack sufficient high‑quality evidence and have notable complication rates.
Patient selection and comparative effectiveness research are needed.
HNS in Down syndrome adolescents
HNS in Down syndrome adolescents — evidence and context
DS adolescent HNS findings: Small series and prospective cohorts in adolescents with Down syndrome and persistent OSA after adenotonsillectomy and CPAP trial report marked AHI reductions (ranges reported ~48–93%), improved quality of life and ESS, with selection typically excluding circumferential palatal collapse via DISE. Evidence is limited by small sample sizes and lack of randomized controls.
Apply pediatric FDA indication criteria and ensure prior therapies were attempted/documented.
Procedures with insufficient or limited evidence
Procedures with insufficient or limited evidence — coverage stance
LAUP: Insufficient quality evidence to conclude LAUP is effective for OSA; systematic reviews report modest success in small series but high complication rates; routine coverage not supported without strong evidence.
LAUP complication rate reported ~256 per 1000 procedures.
Lingual suspension/tongue fixation: Evidence is limited and heterogeneous; some devices report device failures and anchor fractures; not routinely supported as standard therapy.
Reported anchor fractures in series (~31%).
Hyoid myotomy/suspension: Limited evidence with small sample sizes and lack of controls; may be considered selectively but not routinely covered without stronger evidence.
Further research required.
Coverage considerations and guideline-concordant prerequisites
Guideline‑informed coverage considerations
Conservative therapy first: Prior to considering surgical interventions, patients should have failed or been intolerant to CPAP or been assessed for oral appliance therapy when indicated; document trials and attempts to improve PAP compliance.
Supported by AASM, AAO‑HNS, VA/DoD guidance.
Procedure-specific evidence quality: Procedures with low or insufficient evidence (eg, RFA, TORS, DOME, palatal implants) should be used selectively, within research, or require additional justification for coverage.
Guideline and technology assessment cautions apply.
Device indications: Implantable devices (eg, Inspire UAS, remedē) should meet FDA‑labeled indications including AHI and cardiac function criteria where applicable; documentation of device model and indication required for authorization.AHI and cardiac criteria per device labeling
Refer to FDA PMA details.
Device-specific FDA-indication coverage
Coverage aligned to FDA‑labeled indications for implantable devices:
Inspire UAS adult indication: Adults meeting Inspire UAS labeling: baseline AHI and BMI within FDA‑approved ranges (recent expansions: lower AHI limit ≤15, upper baseline AHI up to 100, BMI up to 40), failed or cannot tolerate PAP, and absence of complete concentric collapse at the soft palate level.AHI and BMI per FDA labeling
Document device model and FDA indication in prior authorization.
Inspire UAS pediatric Down syndrome indication: Pediatric patients (per FDA) ages 13–18 with Down syndrome and severe OSA (AHI ≥10 and ≤50), who have not benefited from or are contraindicated for adenotonsillectomy and who have failed or cannot tolerate PAP, without complete concentric palatal collapse on DISE.AHI 10–50
Apply FDA pediatric indication and device labeling.
remedē System indication:
Surgical Treatment Criteria (revised)
Coverage for select surgical procedures and implantable devices is contingent on attended polysomnography meeting specified AHI/RDI thresholds and other clinical criteria.
Adult surgical criteria (attended PSG requirement): Moderate to severe OSA must be determined by attended polysomnography with AHI ≥ 15 or RDI ≥ 15 for consideration of surgical interventions (eg, UPPP, MO, MMA).AHI ≥ 15 or RDI ≥ 15
Repeat attended polysomnography if clinically indicated (weight change, cardiovascular disease changes, or recurrent symptoms).
Coverage for implantable hypoglossal nerve stimulation in adolescents with Down syndrome requires attended polysomnography thresholds and other specified criteria.
Adolescent hypoglossal stimulation: Diagnosis of severe OSA by attended polysomnography with AHI ≥ 10 and RDI ≤ 50 events per hour is required for consideration of implantable HNS in adolescents (approximately age 10–18 years) with Down syndrome, along with the other pediatric device selection criteria (BMI <95th percentile, DISE selection, prior adenotonsillectomy and PAP trial documented, etc.).AHI ≥ 10; RDI ≤ 50
Apply FDA pediatric Down syndrome indication and document attended PSG results in authorization.
The policy explicitly lists devices and procedures considered unproven and not medically necessary. Examples called out include devices for treating positional OSA, nasal dilator devices, intranasal expiratory resistance valves, removable oral appliances for central sleep apnea, prefabricated oral appliances, non‑surgical electrical muscular training, mandibular vertical repositioning devices, morning repositioning devices, epigenetic appliances, ALF appliances, and a range of surgical procedures such as LAUP, lingual suspension, isolated hyoid myotomy, stand‑alone uvulectomy, palatal implants, radiofrequency ablation, TORS, and DOME. These items are identified on the basis of insufficient or low‑quality evidence of safety and efficacy and therefore are explicitly considered unproven in this policy.
The document states there is no relevant evidence supporting the use of removable oral appliances for central sleep apnea (CSA). Because CSA is driven by impaired ventilatory control rather than anatomic upper‑airway collapse, removable oral appliances designed to treat mechanical obstruction are not supported and are identified as unproven/not medically necessary for CSA.
The policy identifies epigenetic appliances and Advanced Lightwire Functional (ALF) appliances as intraoral therapies for which no quality evidence supports efficacy for OSA. These modalities are described among other prefabricated or nonstandard intraoral devices that lack adequate clinical data and therefore are considered unsupported.
Laser‑assisted uvulopalatoplasty (LAUP) is reported to have insufficient quality evidence of effectiveness for OSA and a substantial reported complication profile. Systematic reviews and complication series cite high complication rates (for example, an average of 256 complications per 1,000 procedures in pooled analyses), and the policy concludes further high‑quality study is required and that LAUP should be performed cautiously or avoided in many patients.
Several procedures are highlighted for either high complication rates, device failures, or inconclusive benefit. The policy references LAUP complications, limited and inconsistent benefit from palatal implants, and low‑quality or biased evidence for radiofrequency ablation (RFA). These procedures are identified as having inconclusive benefit or elevated risk, and their routine use for OSA is not supported without stronger evidence.
Interventions supported only by low‑quality or very limited evidence—such as Distraction Osteogenesis for Maxillary Expansion (DOME), many RFA applications, and palatal implants—are described as having insufficient data. The policy indicates therapies with low or very low quality evidence may be considered not medically necessary or investigational in most cases, and additional high‑quality randomized and long‑term studies are needed to establish their role.
The policy notes FDA communications related to certain dental or jaw remodeling devices and indicates that use of these jaw remodeling devices in adults may trigger additional review or exclusion based on safety concerns. Providers should be aware of the referenced FDA safety communication when considering jaw‑remodeling dental devices.
Certain items and procedures are referenced elsewhere in the full policy as potentially not medically necessary under specified conditions; the full policy should be consulted for the detailed list of specific NMN conditions and procedural circumstances (for example, repeat polysomnography requirements and formal exclusions).
The policy provides examples of unproven or nonstandard devices and appliances including positional devices, nasal dilators, intranasal EPAP valves, prefabricated oral appliances, removable oral appliances for CSA, mandibular vertical repositioning devices, morning repositioning devices, epigenetic appliances, and ALF devices. Surgical examples include LAUP, lingual suspension, palatal implants, RFA, TORS, and DOME. These examples are included to clarify commonly encountered nonstandard therapies considered unsupported by current evidence.
The policy enumerates nasal dilators, intranasal valves, and various prefabricated or over‑the‑counter oral appliances among devices lacking convincing evidence for OSA treatment. Specific device classes listed include internal and external nasal dilators, intranasal expiratory resistance valves, and prefabricated oral appliance devices; the cited systematic reviews generally show no meaningful change in AHI with these devices.
Repeated for emphasis in the document, ALF devices and other epigenetic intraoral appliances are described as having no quality evidence supporting efficacy for OSA and are grouped with other unsupported orthodontic‑type therapies.
For implantable neurostimulation to treat central sleep apnea (CSA), the policy summarizes that current evidence is insufficient. Assessments (Hayes 2024) and meta‑analyses show reductions in AHI/CAI in some studies but overall the body of evidence is small, of low quality, and lacks long‑term outcome data; definitive conclusions about efficacy and safety across populations cannot yet be made.
The policy states that stand‑alone procedures such as LAUP, uvulectomy, palatal implants, many lingual suspension techniques, and numerous RFA applications lack sufficient high‑quality evidence to be considered standard therapy for OSA. Given variable outcomes, study bias, and reports of complications or device failure, these procedures are generally considered investigational or not medically necessary in routine practice.
LAUP is specifically noted as not routinely recommended by guideline statements and the policy, and because of mixed efficacy and potential for worsening or complications, the procedure may be considered not medically necessary in many cases absent convincing supportive evidence.
As with other NMN statements in the document, specific not‑medically‑necessary (NMN) conditions and the complete list of NMN items are detailed in the full policy. Providers should refer to that full policy language for exact exclusion criteria and applicable procedural circumstances.
Applicable Codes, Thresholds, and Definition Badges
Applicable Codes (procedures, devices)mixed
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])...
33277
Insertion of phrenic nerve stimulator transvenous sensing lead (List separately).
33278
Removal of phrenic nerve stimulator, including vessel catheterization...
1–10 of 43
1/5
FDA device clearances/approvals citedmixed
K180608
510(k) Premarket Notification for Lunoa System (NightBalance BV) - positional OSA
K180619
510(k) for Bongo intranasal appliance (InnoMed) - mild to moderate OSA
K982717
510(k) for Somnoplasty System (Olympus) - RFA for URAS/OSAS
K030108
510(k) for ArthroCare ENT Coblator Surgery System
DEN200018
De novo for eXciteOSA removable tongue muscle stimulation device
K191320
Slow Wave DS8 510(k) - snoring/mild-moderate OSA
P160039
PMA for remedè System - implantable phrenic nerve stimulator for CSA
K981677
510(k) for AIRvance Tongue Suspension system
K040417
510(k) for Pillar Palatal Implant System
P130008
PMA for Inspire Upper Airway Stimulation system (Inspire Medical Systems)
Applicable CPT/HCPCS Codes (added)mixed
0964T
listed in Applicable Codes (newly added)
0965T
listed in Applicable Codes (newly added)
0966T
listed in Applicable Codes (newly added)
E0490
listed in Applicable Codes (newly added)
AHI / RDI thresholds
Adult surgical AHI/RDI thresholdAHI ≥ 15 or RDI ≥ 15 by attended polysomnography for moderate-to-severe OSA
Adolescent (Down syndrome) AHI thresholdAHI ≥ 10 by attended polysomnography
Adolescent (Down syndrome) RDI limitRDI ≤ 50 events per hour by attended polysomnography
BMI threshold for hypoglossal stimulation (adults)
Adult BMI limit for HNSBMI ≤ 40 kg/m2
BMI use noteBMI used as a screening criterion for candidacy; documented on attended polysomnography/clinical assessment
Prior Authorization, Documentation, and Operational Requirements
Prior Authorization
Prior Authorization, Documentation, and Operational Requirements
Prior authorization is typically required or recommended for many nonstandard devices and implantable systems used to treat sleep-disordered breathing. Requests should confirm device eligibility and include objective documentation of prior PAP attempts or documented CPAP intolerance/failure and relevant diagnostic testing (attended polysomnography or HSAT) as described below.
Prior authorization recommended for nonstandard devices (e.g., prefabricated oral appliances, positional therapy devices, intranasal EPAP, expiratory resistance valves) and for many implantable neurostimulation devices and surgical procedures.
Confirm device eligibility: include record of prior CPAP trial(s), attempts to improve CPAP adherence (mask/interface changes, pressure adjustments, desensitization), or clear documentation of CPAP intolerance or therapeutic failure.
CPAP failure/intolerance must be demonstrated with objective data when applicable: include baseline and on-therapy AHI/ODI from attended PSG or validated HSAT, adherence data (hours/night, duration), and clinician notes explaining intolerance or lack of therapeutic efficacy.
Face-to-face evaluation: lack of documentation of an in-person evaluation by a sleep‑trained physician (MD or DO) and a treating physician diagnosis of OSA may jeopardize approval. Include the face-to-face visit note in the submission.
Required clinical documentation for Oral Appliance Therapy (OAT): treating physician diagnosis and recommendation, documentation of a face-to-face evaluation, description of OSA severity from PSG/HSAT, and justification for OAT (e.g., CPAP intolerance or refusal).
Clinical Background and Evidence Summary
Background: Obstructive sleep apnea (OSA) is characterized by recurrent upper‑airway obstruction during sleep producing apneas and hypopneas with resultant daytime sleepiness and cardiometabolic consequences. Central sleep apnea (CSA) involves diminished or absent respiratory effort from neurologic or ventilatory control causes and is often associated with heart failure. Treatments discussed in the policy include lifestyle measures, positive airway pressure (PAP), oral appliances, implantable neurostimulation devices, positional therapy, and surgery; evidence and indications vary substantially by modality.
Key Definitions and Indexes
Apnea — Definition and classification
Definition of apneaCessation of airflow (≥90% decrease) lasting at least 10 seconds; classified as obstructive, central, or mixed based on respiratory effort
Obstructive apneaAssociated with continued or increased inspiratory effort during the period of absent airflow
Central apneaAssociated with absent inspiratory effort throughout the period of absent airflow
AHI (Apnea Hypopnea Index) — Severity categories and definition
AHI definitionAHI = number of apneas plus hypopneas during the sleep period divided by total sleep time (events/hour)
Severity categoriesMild: AHI ≥5 to <15; Moderate: AHI ≥15 to ≤30; Severe: AHI >30 events/hour
Policy Updates and Material Changes
2025-11-01criteria_revisionLatest
Revised coverage criteria to require attended polysomnography thresholds for adult surgical procedures (AHI ≥ 15 or RDI ≥ 15) and for adolescent hypoglossal nerve stimulation (AHI ≥ 10 and RDI ≤ 50); added instruction to refer to the Nebraska-only Sleep Studies policy; added note to repeat polysomnography with significant clinical changes; added definition of RDI; added CPT/HCPCS codes 0964T, 0965T, 0966T, and E0490.
Policy Summary
PayerUnitedHealthcare
PolicyObstructive and Central Sleep Apnea Treatment (for Nebraska Only)
Key ActionWhen requesting coverage for surgical or implantable therapies, include attended polysomnography showing required AHI/RDI thresholds and documentation of prior PAP failure or intolerance.
Adults with moderate to severe central sleep apnea meeting the remedē System PMA criteria for TPNS, including device‑specified AHI/CAI thresholds and medical stability requirements.
Per device labeling
Document prior guideline‑recommended therapy and cardiac status as required.
Source guidanceApplies to implantable hypoglossal nerve stimulation with an FDA‑approved device in adults
Inspire UAS AHI and BMI limits
Original Inspire UAS PMA AHI limitsAHI ≥ 20 and ≤ 65 (PMA) before 2023 expansion
2023–2024 Inspire expansion — AHI limitsLower limit expanded to ≤ 15 and upper baseline AHI expanded up to 100 (per FDA P130008s090, June 8, 2023)
2023 expansion — BMI limitUpper BMI limit expanded from 32 to 40 for adult candidates
AHI — Inspire UAS AHI lower/upper limits and pediatric notes
Inspire UAS adult AHI lower/upper limitsFDA indication expanded: lower AHI limit ≤ 15 (prior ≥20); upper baseline AHI up to 100 (expanded from 65)
Pediatric/Adolescent (Down syndrome) AHI rangePediatric indication: severe OSA defined as AHI ≥ 10 and RDI ≤ 50 for adolescents in Down syndrome cohorts
Attended PSG requirementAHI must be determined by attended polysomnography for device candidacy per policy revisions
Adult Inspire UAS BMI upper limit expansionFDA expanded the adult BMI upper limit from 32 to 40 kg/m2 (June 8, 2023 update)
BMI documentationBMI should be documented in preoperative evaluation to confirm device labeling criteria
ApplicabilityApplies to adults being considered for Inspire UAS per FDA labeling and policy
Apnea-Hypopnea Index (AHI)
Policy numeric badge — moderate-to-severe OSAModerate OSA: AHI or RDI ≥ 15 to ≤ 30; Severe: AHI > 30 events/hour
AHI definitionAHI = number of apneas plus hypopneas per hour of sleep (events/hour) as defined by AASM Scoring Manual
Use in coverage criteriaAHI thresholds determine eligibility for surgical and device-based treatments per policy
Respiratory Disturbance Index (RDI)
RDI numeric badgeRDI ≥ 15 events/hour used equivalently to AHI ≥ 15 for defining moderate-to-severe OSA in adults
RDI definitionRDI = apneas + hypopneas + respiratory effort–related arousals per hour (events/hour) per AASM Scoring Manual
Adolescent RDI criterionRDI ≤ 50 events/hour specified for adolescent Down syndrome hypoglossal stimulation candidacy
Required clinical documentation more generally: baseline attended polysomnography results (AHI/RDI, ODI, percent central apneas), follow-up PSG/HSAT demonstrating treatment effect when applicable, Epworth Sleepiness Scale or other validated symptom measures, and any drug-induced sleep endoscopy (DISE) findings if used for device/surgical planning.
DOME and other procedures with limited evidence: for DOME include documentation of prior CPAP intolerance/failure, pre- and post-procedure attended PSG results, and supporting imaging or CBCT planning as applicable.
Documentation should reference FDA-approved indications and specific device model when applicable (e.g., Inspire UAS model and labeling), and attest that proposed use aligns with current FDA guidance or expanded indications.
Polysomnography requirement: attended PSG is required for many surgical and implantable device approvals (and should be repeated when clinically indicated — significant weight change, new cardiovascular disease, or recurrent/persistent symptoms). Failure to obtain or include an attended PSG when indicated may affect coverage decisions.
Evidence limitations and denial risk: devices and procedures with low-quality, small-sample, short-term, or conflicting evidence (e.g., prefabricated appliances, positional devices with inconclusive literature, epigenetic/ALF appliances, many palatal implants, LAUP, some lingual suspension methods) carry higher risk for denial or requests for additional justification.
Potential safety concerns from FDA communications (e.g., safety communications about certain jaw remodeling/dental devices) should be disclosed in requests and may prompt additional review or denial.
Step therapy and sequencing: CPAP/APAP is the preferred first-line therapy for most patients. Many non‑PAP alternatives and surgical options are considered only after documented CPAP failure, intolerance, or patient refusal despite attempts to improve adherence.
Hypoglossal nerve stimulation (HNS/Inspire) and other implantable neurostimulation devices: generally considered after documented CPAP failure or intolerance. For Inspire UAS specifically, include documentation of failed/intolerant PAP therapy, attempts to improve PAP compliance, baseline attended PSG meeting AHI and central apnea limits, DISE demonstrating absence of complete concentric collapse at the soft palate (when required), BMI and other FDA-specified eligibility criteria.
Non-surgical treatment steps must be documented prior to surgical consideration: trials of CPAP and/or appropriately fitted custom, titratable oral appliance therapy (when OAT is proposed), adherence and efficacy data, and discussion of alternatives.
SourceAASM Scoring Manual (policy definitions) and policy definitions section
HSAT — Definition and adequacy criteria
HSAT definitionUnattended diagnostic testing for OSA without sleep staging; adequate HSAT is ≥4 hours and includes nasal pressure, chest and abdominal respiratory inductance plethysmography, and oximetry
LimitationsHSAT does not determine sleep stages and may be less comprehensive than attended polysomnography for some indications
Policy useAttended polysomnography is required for specified device/surgical eligibility thresholds per policy
Hypopnea — Definition per policy
Hypopnea definitionAn event ≥10 seconds with ≥30% reduction in airflow and ≥3% oxygen desaturation or associated arousal
SourceAASM Scoring Manual (policy definitions) as cited in policy
Role in AHIHypopneas are counted with apneas to calculate the AHI (events/hour)
Positional OSA (POSA) — Definition and common study criteria
POSA definitionPositional OSA: lower AHI in non‑supine than supine position (studies often enroll AHI 5–30 and require 10–90% supine sleep time)
Common study criteriaMany trials define POSA by baseline AHI range (eg, 5–30) and percentage of sleep in supine position (eg, 10–90%)
ImplicationPositional therapy evidence is limited by short-term follow-up and variable selection criteria
EPAP device — Definition (e.g., Provent)
EPAP device definitionA nasal expiratory resistance valve (eg, Provent) that creates positive expiratory pressure during sleep to reduce upper airway collapse
Evidence summaryRandomized trials show short‑term AHI reductions versus sham in some studies but EPAP is inferior to CPAP and long-term comparative data are limited
Clinical considerationUse may be considered for select patients but is not a substitute for CPAP in moderate-to-severe OSA
Intraoral neuromuscular electrical stimulation — Device definition and intent
Intraoral neuromuscular electrical stimulation definitionA mouthpiece device that delivers electrical stimulation to tongue muscles to strengthen them and potentially reduce snoring or mild OSA (eg, eXciteOSA)
Intended effectIntended to increase tongue muscle tone and reduce upper airway collapsibility; typically used in awake sessions per manufacturer guidance
Evidence noteCurrent evidence is low or very low quality with limited comparative data and long-term outcomes
Custom, titratable oral appliance — Definition and preference over non-custom devices
Custom, titratable oral appliance definitionA custom‑fabricated mandibular advancement device that allows progressive titration by a qualified dentist and is preferred over prefabricated appliances
Recommended usePreferred for adults with mild-to-moderate OSA or as an alternative when CPAP is intolerable; requires dental and sleep physician follow‑up
Not indicated for CSAOral appliances are not supported for treatment of central sleep apnea per policy
Hypoglossal nerve stimulation (HNS) — Definition and clinical role
HNS definitionImplantable hypoglossal nerve stimulation (HNS) is an upper airway stimulation therapy (eg, Inspire UAS) that electrically stimulates the hypoglossal nerve to reduce airway collapse in selected OSA patients
Clinical roleUsed in adults (and select adolescents with Down syndrome per FDA indication) who have failed or cannot tolerate PAP therapy and meet device criteria
Evidence contextEvidence includes STAR trial and observational studies showing AHI reductions but long‑term randomized data are limited
AHI — Apnea-hypopnea index definition (duplicate reference)
AHI — core definitionAHI equals apneas plus hypopneas per hour of sleep and is used to define OSA severity and measure treatment effect
Calculation unitEvents per hour (AASM Scoring Manual) applied in attended polysomnography
Policy applicationAHI thresholds are required by the policy for surgical and device eligibility determinations
TPNS / remedē System — Definition and intended use
TPNS / remedē System definitionTransvenous phrenic nerve stimulation (TPNS) delivered by the remedē System — an implantable device intended to treat moderate to severe central sleep apnea in adults
Indication notePMA approved for moderate-to-severe CSA (P160039) — trials enrolled adults with AHI thresholds (eg, AHI ≥20) and required medical stability
Evidence noteRCTs and observational studies show reductions in AHI/CAI but overall evidence limited by sample size and follow‑up
Palatal implants — Definition (Pillar, Elevo)
Palatal implants definitionSmall woven polyester inserts (eg, Pillar, Elevo) placed in the soft palate to induce fibrosis and stiffening aimed at reducing snoring and potentially mild-to-moderate OSA
MechanismIntended to stiffen the soft palate via inflammatory/fibrotic response around inserts
Evidence noteInsufficient evidence to conclude effectiveness for OSA; larger randomized trials needed
Radiofrequency tissue volume reduction (RFTVR) — Definition and common trade names
RFTVR definitionRadiofrequency tissue volume reduction uses low‑intensity radiofrequency energy (trade names Somnoplasty, Coblation) to shrink uvula, soft palate, and/or tongue tissue to reduce upper airway obstruction
Typical useMay be performed alone or with other therapies for snoring or mild-to-moderate OSA
Evidence noteEvidence supports short‑term improvements in some studies but long‑term randomized data are limited
Radiofrequency Ablation (RFA) — Definition and evidence note
Evidence cautionEvidence for OSA is low quality with small, biased studies and limited long‑term outcomes
Clinical implicationMay provide short‑term benefits in select patients but not routinely recommended without stronger evidence
Transoral Robotic Surgery (TORS) — Definition and evidence context
TORS definitionTransoral Robotic Surgery (TORS) is robotic‑assisted resection of tongue base/hypopharyngeal tissue for OSA management
Evidence contextSystematic reviews show improvements in AHI and ESS but studies are largely retrospective and heterogeneous; selection criteria vary
RecommendationFurther controlled, long‑term studies needed to optimize patient selection and validate outcomes
Upper Airway Stimulation (UAS) / HNS — Definition and device class
UAS / HNS definitionUpper Airway Stimulation (UAS) or Hypoglossal Nerve Stimulation (HNS) is an implantable neurostimulation system (eg, Inspire) that electrically stimulates upper airway muscles to reduce airway collapse
Device classImplantable neurostimulator with sensing and stimulation electrodes, pulse generator, and programming/interrogation functions
Clinical roleUsed for selected adult patients who fail or cannot tolerate PAP and meet device labeling (AHI, BMI, DISE findings) criteria
Inspire UAS — Device-specific definition
Inspire UAS definitionInspire Upper Airway Stimulation (UAS) system is an implantable HNS device indicated for select patients with OSA who have failed or cannot tolerate PAP
Key componentsIncludes implanted stimulation leads, sensing lead(s), and an implantable pulse generator (IPG); requires device activation and follow‑up programming
Regulatory notePMA issued (P130008) with subsequent indication expansions in 2023 and device updates in 2024
remedē System — TPNS device definition
remedē System definitionThe remedē System is an implantable transvenous phrenic nerve stimulation system intended to treat moderate-to-severe central sleep apnea in adults
Intended usePMA‑approved device used in medically stable adults meeting trial inclusion criteria; therapy targets reduction in CAI/AHI
Evidence noteRCTs and observational studies show AHI/CAI reductions but long‑term outcomes and broader impact on morbidity/mortality remain uncertain
Respiratory Disturbance Index (RDI) — Definition added to policy
RDI definitionRDI = number of apneas + hypopneas + respiratory effort‑related arousals per hour of sleep (events/hour) as defined by AASM Scoring Manual
Policy usageRDI thresholds (eg, ≥15) are used interchangeably with AHI thresholds for defining moderate‑to‑severe OSA in adult surgical criteria
Adolescent criterionRDI ≤ 50 events/hour specified for adolescent Down syndrome HNS candidacy