ModifiedUnitedHealthcarePolicy CS116NJ.AJ

Obstructive and Central Sleep Apnea Treatment (for New Jersey Only)

Medical policy governing coverage and medical necessity criteria for non‑surgical and surgical treatments of obstructive and central sleep apnea for members in New Jersey.

Policy Summary

PayerUnitedHealthcare

PolicyObstructive and Central Sleep Apnea Treatment (for New Jersey Only)

Policy CodePolicy CS116NJ.AJ

Change TypeCriteria revisions and code additions

Effective DateNovember 1, 2025

Next Review DateN/A

Key ActionProvide documentation of attended polysomnography showing required AHI/RDI thresholds and prior PAP failure or intolerance when seeking coverage for surgery or implantable device therapy.

SourceLink

POLICY UPDATE CHANGES

Added notation to indicate 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

Revised coverage criteria for UPPP, Mandibular Osteotomy (MO), and Maxillomandibular Osteotomy and Advancement (MMA) in adults to specify AHI ≥ 15 or RDI ≥ 15 on attended polysomnography

Replaced criterion wording for implantable hypoglossal nerve stimulation in adolescents with Down syndrome to specify Polysomnography (Attended) with AHI ≥ 10 and RDI ≤ 50 events per hour

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

Updated FDA and reference material

AHI ≥15 / RDI ≥15adult surgical eligibility threshold added

AHI ≥10 / RDI ≤50adolescent HNS threshold

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.

new CPT/HCPCS codes added

8+device categories reviewed

generally lowevidence quality (many devices)

Coverage and Medical Necessity Criteria

Oral Appliance Therapy (OAT) — Covered with criteria

Removable Oral Appliances (OAT) — Non-Surgical Treatment

OAT coverage criteria: Removable Oral Appliances are proven and medically necessary for treating OSA when diagnosis is documented by an appropriate sleep study (Polysomnography or Home Sleep Apnea Testing). A face-to-face evaluation with a physician (MD/DO) trained in sleep medicine or an Advanced Practice Provider working under direct physician supervision must occur prior to initiating OAT; a treating physician/APP must diagnose OSA and recommend OAT. Documentation must show PAP therapy resulted in no therapeutic efficacy or there is documented intolerance or refusal of PAP when applicable.

Refer to the Sleep Studies policy for testing details and to InterQual criteria for removable Oral Appliances.

Surgical procedures and implantable neurostimulation — Covered with detailed criteria

Surgical Treatment — Covered when ALL criteria are met

UPPP, MO, MMA coverage: Uvulopalatopharyngoplasty (UPPP), mandibular osteotomy (MO), and maxillomandibular osteotomy and advancement (MMA) are proven and medically necessary in adults when all of the following are met: diagnosis of moderate to severe OSA by attended polysomnography with AHI ≥ 15 or RDI ≥ 15; excessive daytime sleepiness documented (ESS > 10 or other validated tool); and PAP therapy resulted in no therapeutic efficacy or there is documented patient refusal or intolerance. Additional anatomic criteria apply for MMA (craniofacial disproportion/maxillomandibular deficiency) and for MO (retrolingual or lower pharyngeal obstruction).AHI >= 15 or RDI >= 15

Polysomnography (Attended) should be repeated if clinically significant weight change, changes in cardiovascular disease, or persistent/recurrent symptoms since the last study.

Implantable hypoglossal nerve stimulation (adults): Implantable hypoglossal nerve stimulation with an FDA‑approved device is proven and medically necessary in adults when all of the following are met: BMI ≤ 40 kg/m2; AHI ≥ 15 and ≤ 100 on attended polysomnography; total AHI < 25% for central plus mixed apneas; absence of complete concentric collapse of the soft palate confirmed by drug‑induced sleep endoscopy (DISE); and PAP therapy resulted in no therapeutic efficacy or there is documented patient refusal or intolerance. Device use must follow FDA labeling and guidance.AHI 15-100; BMI <= 40; central+mixed <25%

Device must be FDA-approved; absence of complete concentric collapse is required per DISE.

Implantable hypoglossal nerve stimulation (adolescents with Down syndrome): Implantable hypoglossal nerve stimulation with an FDA‑approved device is proven and medically necessary in adolescents (aged 10–18 years) with Down syndrome when all of the following are met: severe OSA diagnosed by attended polysomnography with AHI ≥ 10 and RDI ≤ 50; BMI < 95th percentile for age; total AHI < 25% for central plus mixed apneas; contraindication to or ineffective prior adenotonsillectomy; confirmed failure or intolerance of PAP despite attempts to improve compliance; absence of tracheostomy during sleep; absence of complete concentric collapse at the soft palate on DISE; individual and caregiver refusal of MMA for non‑concentric palatal collapse; and use consistent with FDA guidelines.AHI >= 10; RDI <= 50; BMI <95th percentile

Polysomnography must be attended; DISE required to exclude circumferential palatal collapse.

Unproven / Not Medically Necessary Treatments

Unproven / Not Medically Necessary

Non-surgical unproven treatments: Devices and appliances lacking sufficient evidence are considered unproven and not medically necessary for OSA/CSA. These include devices for positional OSA (general), nasal dilator devices, intranasal expiratory resistance valves (e.g., Bongo Rx), removable oral appliances for central sleep apnea, prefabricated oral appliances/devices, non‑surgical electrical muscle stimulation modalities, mandibular vertical repositioning devices, morning repositioning devices, epigenetic appliances, and Advanced Lightwire Functional (ALF) appliances.

Listed due to insufficient evidence of efficacy.

Surgical unproven procedures: The following surgical procedures are unproven and not medically necessary due to insufficient quality evidence: 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 (when unsupported by robust comparative data), transoral robotic surgery (TORS), and distraction osteogenesis for maxillary expansion (DOME).

Evidence limited by small, heterogeneous studies, short follow-up, or safety concerns.

Implantable neurostimulation for CSA:

Coverage stance by device category

Coverage considerations based on evidence summaries for device categories:

Positional therapy (vibratory/position trainers): Evidence is mixed and generally low to moderate quality; some RCTs and systematic reviews show short‑term AHI reduction versus inactive control and better short‑term adherence, but CPAP produces greater reductions in AHI. Long‑term durability and comparative effectiveness remain uncertain.

Examples include NightBalance and chest‑worn sleep position trainers; long‑term studies needed.

Nasal dilators: Available studies are small and heterogeneous; overall evidence does not demonstrate consistent AHI improvement and tends to not support nasal dilators as an effective substitute for CPAP.

Further OSA‑specific outcome studies required.

Intranasal EPAP devices (e.g., Provent): Randomized trials show EPAP can reduce AHI versus sham in some patients with mild‑to‑moderate OSA and responders may have good adherence; however, EPAP is inferior to CPAP for moderate‑severe OSA and evidence is limited by short follow‑up and selection of responders.

May be considered in select patients who refuse or cannot tolerate CPAP, recognizing inferiority to CPAP.

Evidence-based recommendations

Professional society recommendations and evidence summaries relevant to coverage decisions:

Oral appliance therapy recommendations: Guidelines recommend that when oral appliance therapy is prescribed for adult OSA, a qualified dentist use a custom, titratable appliance with oversight and follow‑up by a sleep physician; follow‑up sleep testing is recommended to confirm efficacy.

AASM/AADSM/AAOMS guidance: strength of evidence low to moderate.

Indications for oral appliances: Oral appliance therapy is suggested as first‑line for primary snoring and as an alternative for mild‑to‑moderate OSA or for patients intolerant of or refusing CPAP.

AADSM and AAOMS position statements support use in appropriate patients.

CPAP as first-line: CPAP is recommended as initial therapy for adults with OSA; non‑CPAP therapies (oral appliances, positional devices) are alternatives when CPAP is not tolerated or refused.

AASM and ERS guidance support CPAP as first‑line especially for moderate‑to‑severe OSA.

Study-defined eligibility and response criteria

Study-defined eligibility and response criteria described in the evidence:

UPPP trial inclusion (Browaldh 2013): Adults >18 years; AHI ≥ 15; ESS ≥ 8; daytime sleepiness ≥3 times/week; BMI < 36 kg/m2; Friedman stage I or II; prior failure of CPAP and mandibular repositioning device not used in prior 3 months. Primary outcome: change in AHI at 6 months.AHI >= 15; BMI < 36; ESS >= 8

Randomized controlled trial with 6‑month PSG follow‑up.

HNS (STAR trial) eligibility: Adults with moderate‑to‑severe OSA intolerant of or unwilling to use CPAP underwent implantation and were assessed by polysomnography; primary outcomes included AHI and ODI with responder analyses and randomized therapy‑withdrawal phases.AHI >= 15 (moderate-to-severe)

Median AHI reduction reported at 12 months; safety events <2%.

Remedē (TPNS) randomized trial eligibility:

Coverage considerations / evidence-derived criteria

Coverage considerations based on available evidence:

General requirement: Interventions should be considered when adequate diagnostic testing (attended PSG or validated home sleep testing) documents OSA/CSA severity and when there is documented intolerance or failure of CPAP when applicable; clinical documentation should include pre‑ and post‑treatment PSG metrics and prior therapy attempts.

Derived from multiple studies noting requirement for PSG and prior therapy documentation.

Procedures with insufficient evidence: LAUP, palatal implants, lingual suspension/tongue fixation, isolated hyoid myotomy, uvulectomy, radiofrequency ablation, TORS, and DOME have limited or low‑quality evidence; coverage may be restricted to investigational pathways unless robust supporting data and appropriate patient selection are documented.

Evidence limited by small sample sizes, high bias, heterogeneity, and limited long‑term outcomes.

Device‑specific safety concerns: Reported device complications (e.g., anchor fractures with lingual suspension, implant extrusions, infection, bleeding, and other procedure‑specific adverse events) should be disclosed and weighed in coverage decisions; documented complication rates and device failures must be considered.

Conditional consideration after PAP/oral appliance failure

Guideline-based considerations and summarized evidence support conditional use in select patients when noninvasive therapies fail:

General conditional considerations: Surgical or device interventions (RFA, TORS, MMA, UPPP, HNS, palatal implants) may be considered for patients who are intolerant of or have failed PAP or oral appliance therapy and when patient anatomy supports the chosen procedure. Evidence quality is generally low and long‑term outcomes are limited; careful patient selection, documentation of prior therapy failure/intolerance, and objective pre/post testing are required.

Recommendations summarized from AASM and AAO‑HNS guidance.

Procedure-specific summaries

Procedure-specific evidence summaries and guideline positions:

Radiofrequency ablation (RFA): RFA may provide short‑term improvements for selected patients with mild‑to‑moderate OSA who cannot tolerate or refuse CPAP or oral appliances, but evidence is low quality, studies are small and heterogeneous, and long‑term efficacy and safety remain uncertain.

ECRI and systematic reviews judge evidence low and inconclusive.

Transoral Robotic Surgery (TORS): TORS demonstrates short‑term improvements in AHI and symptoms in case series and meta‑analyses (surgical success rates reported in the range of ~48–69%), but evidence is mostly retrospective and often combined with multilevel procedures; complication rates can be substantial and comparative long‑term data are lacking.

Further prospective comparative studies needed.

Distraction osteogenesis (DOME): Available evidence for DOME is insufficient to conclude effectiveness for adult OSA; studies are primarily retrospective case series without control groups and lack long‑term outcomes.

Considered investigational in the absence of stronger evidence.

Device-specific coverage considerations

Coverage/consideration should align with FDA-labeled indications and patient selection as documented below.

Inspire UAS adult indication: Patient selection must meet FDA‑labeled criteria: baseline AHI and BMI within device‑specific limits (FDA labeling expanded to include lower AHI limits ≤15 and upper baseline AHI up to 100, and BMI upper limit expanded to 40), prior failure or intolerance to PAP, and absence of complete concentric collapse at the soft palate level per DISE.AHI and BMI limits per device labeling

FDA PMA and subsequent supplements define specific labeling and selection criteria.

Inspire UAS pediatric indication (Down syndrome): Pediatric selection per FDA: ages 13–18 with Down syndrome and severe OSA (AHI ≥ 10 and ≤ 50) who do not have complete concentric collapse at the soft palate level, contraindicated for or not effectively treated by adenotonsillectomy, and confirmation of PAP failure/intolerance despite attempts to improve compliance.AHI >=10 and <=50

FDA expanded pediatric indication March 20, 2023.

Revised coverage groups

Revised coverage criteria for select surgical procedures and for implantable hypoglossal nerve stimulation in adolescents with Down syndrome.

Adult surgical eligibility: Covered when ALL of the following are met: diagnosis of moderate to severe OSA as determined by Polysomnography (Attended) with AHI ≥ 15 or RDI ≥ 15; and other procedure‑specific criteria as specified in the policy (e.g., ESS, prior PAP failure/intolerance, anatomic findings).AHI ≥ 15 or RDI ≥ 15

Polysomnography (Attended) repeat requirement added when clinically indicated (weight change, cardiovascular changes, recurrent symptoms).

Adolescent hypoglossal nerve stimulation (Down syndrome aged 10-18): Covered when ALL of the following are met: diagnosis of severe OSA by Polysomnography (Attended) with AHI ≥ 10 and RDI ≤ 50 events per hour; and other device‑specific criteria as applicable per full policy and FDA labeling.AHI ≥ 10 and RDI ≤ 50

Policy text clarified to specify attended polysomnography for adolescent device candidacy.

Dental services provided by dentists (for example, codes D9947, D9948, D9949) are generally considered dental benefits and are excluded from coverage under the medical plan. When evaluating claims or prior authorization requests for oral appliances or related dental procedures, verify federal, state, and contractual requirements as they may mandate different coverage determinations for dental versus medical benefits. Specific HCPCS and CPT entries in this policy (e.g., E0486, E0485, 0964T–0966T) are listed for reference but do not themselves establish medical coverage when a dental service exclusion or program-specific fee schedule restriction applies.

There is no relevant evidence to support the use of removable oral appliances for treating central sleep apnea (CSA); these devices are designed to address mechanical airway obstruction and not the disordered respiratory drive that characterizes CSA. Similarly, the literature does not identify quality evidence supporting mandibular vertical repositioning devices, or a range of other novel oral/dental devices (including prefabricated appliances and certain non‑standard repositioning devices) for CSA or for OSA outside established indications. Implantable neurostimulation for CSA (for example, phrenic nerve stimulation systems) has an evolving evidence base but has been judged insufficient in some assessments to establish safety and clinical effectiveness for routine use in CSA.

No published studies were identified that evaluate morning repositioning devices for sleep‑disordered breathing; as a result, their effect on clinically meaningful outcomes for obstructive or central sleep apnea is unknown and they are considered unsupported by quality evidence.

Epigenetic appliances and Advanced Lightwire Functional (ALF) appliances are intraoral orthodontic‑style devices proposed to change jaw position or growth. The available literature contains no quality evidence demonstrating efficacy of these devices for obstructive sleep apnea; therefore they are considered unproven for OSA.

In pediatric and adolescent studies of hypoglossal nerve stimulation (including cohorts with Down syndrome), pre‑implant evaluation routinely included drug‑induced sleep endoscopy (DISE) to assess patterns of airway collapse. Patients with circumferential (complete concentric) palatal collapse were excluded from implantation in these reported cohorts, consistent with device-label anatomic exclusions.

Laser‑assisted uvulopalatoplasty (LAUP) has been assessed in systematic reviews and primary studies but the overall quality of evidence is insufficient to conclude effectiveness for OSA. LAUP is therefore considered to lack adequate evidence to support routine coverage.

Some procedures (LAUP among them) have been associated with potential harm, including worsening of the apnea‑hypopnea index in a subset of patients. When considering interventions with reported risks of adverse outcomes or potential to worsen OSA, careful patient selection and documentation of expected benefit versus risk are required; absent strong supporting evidence, these procedures should be evaluated cautiously and may be limited or excluded.

Soft‑palate implant systems have not demonstrated sufficient, high‑quality evidence of clinical benefit for OSA, and technology assessments and guidance (including historical NICE advice) recommend against routine use for OSA. Given inadequate evidence of efficacy and potential device‑related complications, palatal implants are not supported as a standard therapy for OSA.

Per device labeling and FDA approvals, patients with complete concentric collapse at the soft palate are anatomic exclusions for implanted upper airway stimulation systems (for example, Inspire UAS). Device candidacy and coverage consideration should follow the manufacturer’s indications and any DISE findings that document concentric palatal collapse.

Certain Category III CPT codes and other entries are not included on the State of New Jersey Medicaid Fee Schedule and therefore may not be covered under that program. Examples noted in this policy include codes such as 0964T, 0965T, and 0966T; verify state Medicaid fee schedules and contract‑specific rules when adjudicating claims or authorizations for these services.

The policy identifies an unproven / not medically necessary list that includes multiple device categories and procedures lacking sufficient evidence; this list specifically calls out several oral device types and procedures and categorically states that implantable neurostimulation for central sleep apnea is considered unproven or not medically necessary based on current evidence limitations. Coverage determinations for these technologies should reflect the limited or insufficient evidence base.

Nasal dilators and intranasal expiratory resistance valve devices (EPAP) have inconsistent and generally low‑quality evidence for improving OSA outcomes. Systematic reviews and pooled analyses typically do not show meaningful reductions in AHI, so these devices are not supported as substitutes for CPAP in moderate‑to‑severe OSA and are considered of limited evidence for routine coverage.

Technologies for which the literature lacks quality evidence (for example, morning repositioning devices, epigenetic appliances, and ALF appliances) are considered experimental or unproven. Absent robust, controlled trial data demonstrating clinically meaningful improvements in OSA outcomes, these interventions are not recommended for routine coverage.

The body of evidence for LAUP contains methodological limitations and mixed outcomes, and current syntheses conclude there is insufficient quality evidence to establish LAUP’s effectiveness for OSA; payers should treat LAUP as unsupported for routine coverage unless new high‑quality evidence becomes available.

Implantable neurostimulation devices intended to treat central sleep apnea (for example, the remedē phrenic nerve stimulation system) have limited and, in some assessments, insufficient evidence to confirm clinical benefit and long‑term safety for CSA. Technology assessments have highlighted small study sizes, short follow‑up, and uncertain impact on relevant clinical outcomes, supporting a stance that such devices remain unproven for routine use in CSA.

Standalone uvulectomy and LAUP lack sufficient evidence to conclude effectiveness for OSA and therefore may be considered not medically necessary in the absence of compelling supporting data. Published reviews and evidence briefs note inadequate controlled data to recommend these as routine, isolated interventions for OSA.

Distraction osteogenesis for maxillary expansion (DOME) has been studied primarily in retrospective case series and lacks randomized controlled data and long‑term outcomes; current evidence is insufficient to support routine use for adult OSA.

The FDA has issued safety communications regarding certain jaw remodeling dental devices for adults, raising safety concerns; such devices should be considered with caution and may be judged unsafe or not medically appropriate pending further evidence and regulatory guidance.

Within the excerpted policy text there are no explicit additional not‑medically‑necessary (NMN) statements beyond the unproven/ investigational listings and procedural exclusions summarized here; however, several procedures and devices are explicitly described as unproven or not medically necessary due to insufficient evidence (see unproven lists and not medically necessary sections).

Coding and Indexable Identifiers

DME / Oral Appliance / Positional Device CodesHCPCS

E0486	Oral device/appliance used to reduce upper airway collapsibility, adjustable or nonadjustable, custom fabricated, includes fitting and adjustment
E0485	Oral device/appliance used to reduce upper airway collapsibility, adjustable or nonadjustable, prefabricated, includes fitting and adjustment
K1027	Oral device/appliance used to reduce upper airway collapsibility, without fixed mechanical hinge, custom fabricated, includes fitting and adjustment
A7049	Expiratory positive airway pressure intranasal resistance valve
E0493	Oral device/appliance for neuromuscular electrical stimulation of the tongue muscle, used in conjunction with power source, 90-day supply
E0530	Electronic positional obstructive sleep apnea treatment, with sensor, includes all components and accessories, any type
E0490	Power source and control electronics unit for oral device/appliance for neuromuscular electrical stimulation of the tongue muscle, controlled by hardware remote
E0492	Power source and control electronics unit for oral device/appliance for neuromuscular electrical stimulation of the tongue muscle, controlled by phone application
E1399	Durable medical equipment, miscellaneous

Implantable Neurostimulation / Surgical CodesCPT

64582	Open implantation of hypoglossal nerve neurostimulator array, pulse generator, and distal respiratory sensor electrode or electrode array
64583	Revision or replacement of hypoglossal nerve neurostimulator array and distal respiratory sensor electrode or electrode array, including connection to existing pulse generator
64584	Removal of hypoglossal nerve neurostimulator array, pulse generator, and distal respiratory sensor electrode or electrode array
93150	Therapy activation of implanted phrenic nerve stimulator system, including all interrogation and programming
93151	Interrogation and programming (minimum one parameter) of implanted phrenic nerve stimulator system
33276	Insertion of phrenic nerve stimulator system [pulse generator and stimulating lead(s)], including vessel catheterization, all imaging guidance, and pulse generator initial analysis

Miscellaneous / Category III / State-excluded Codesmixed

0964T	Impression and custom preparation of jaw expansion oral prosthesis for obstructive sleep apnea, single arch, without mandibular advancement mechanism
0965T	Impression and custom preparation of jaw expansion oral prosthesis, dual arch, with additional mandibular advancement, non-fixed hinge mechanism
0966T	Impression and custom preparation of jaw expansion oral prosthesis, dual arch, with additional mandibular advancement, fixed hinge mechanism
S2080	Laser-assisted uvulopalatoplasty (LAUP)
S2900	Surgical techniques requiring use of robotic surgical system

FDA 510(k)/PMA/De Novo device clearances mentionedmixed

K982717	510(k) Somnoplasty System (Olympus) approval for reduction of airway obstructions
K030108	510(k) ArthroCare ENT Coblator Surgery System approval
DEN200018	De Novo classification for eXciteOSA tongue stimulation device (AHI <15) - Class II
K191320	510(k) Slow Wave DS8 for snoring/mild-moderate OSA
P160039	PMA for remedē System (phrenic nerve stimulator) for central sleep apnea
K981677	510(k) AIRvance Tongue Suspension System (formerly Repose)
K040417	510(k) Pillar Palatal Implant System for OSA
K180608	510(k) Lunoa System for positional OSA
K180619	510(k) Bongo intranasal appliance for mild-moderate OSA

FDA Regulatory Identifiersmixed

K982717	510(k) approval for Somnoplasty System (Olympus) - Nov 2, 1998
K030108	510(k) approval for ArthroCare ENT Coblator Surgery System - Feb 3, 2003
DEN200018	de novo classification for eXciteOSA device (Class II, product code QNO) - Feb 5, 2021
K191320	510(k) Premarket Notification for Slow Wave DS8 - Oct 2, 2020
P160039	PMA for remedē System (phrenic nerve stimulator) - Oct 6, 2017
K981677	510(k) approval for AIRvance Tongue Suspension system (Medtronic ENT) - Aug 27, 1999
K040417	510(k) approval for Pillar Palatal Implant System (Medtronic ENT) - Jul 28, 2004
P130008	PMA for Inspire Upper Airway Stimulation system (Inspire Medical Systems) - Apr 30, 2014 and subsequent supplements

Added CPT/HCPCS Codesmixed

0964T	CPT code added (exact descriptor not provided in this excerpt)
0965T	CPT code added (exact descriptor not provided in this excerpt)
0966T	CPT code added (exact descriptor not provided in this excerpt)
E0490	HCPCS code added (exact descriptor not provided in this excerpt)

AHI thresholds for procedures

AHI threshold for adult moderate–severe OSA (surgical eligibility)AHI ≥ 15 (or RDI ≥ 15) on attended polysomnography

AHI range for adult hypoglossal nerve stimulationAHI ≥ 15 and ≤ 100 as determined by Polysomnography (Attended)

AHI threshold referenced for some adolescent indicationsAHI ≥ 10 for adolescents with Down syndrome (see device-specific criteria)

Central + mixed apnea proportion

Maximum central + mixed apnea proportion for HNS candidacyTotal AHI < 25% for central + mixed apneas as evaluated by attended polysomnography

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is expected for many implantable or durable device therapies for sleep-disordered breathing. Requests should document that the proposed device and patient meet device-specific FDA-labeled indications and payer criteria, as well as prior therapy history (see items).

Expect prior authorization for implantable systems (e.g., hypoglossal nerve stimulation/Inspire, remedē transvenous phrenic nerve stimulation) and certain durable devices or procedures (e.g., hyoid suspension/Airlift/Encore, lingual suspension devices, some implantable neurostimulators).
Prior authorization must document FDA-indication concordance (AHI ranges, BMI limits, age limits, absence of complete concentric palatal collapse when required) and adherence to device labeling.
When device implantation is proposed, include pre-procedure testing (attended polysomnography, DISE when required), documentation of prior guideline-recommended therapies tried (CPAP, oral appliance where applicable), and clinician specialty involvement.

Documentation Required

Oral Appliance Therapy — Documentation Expectations

Clinical Background and Scope

Obstructive sleep apnea (OSA) is characterized by recurrent upper‑airway obstruction during sleep causing apneas and hypopneas that fragment sleep and can lead to daytime sleepiness and cardiometabolic consequences. This policy addresses non‑surgical therapies (such as CPAP and custom oral appliances) and surgical or implantable device therapies, and it aligns coverage considerations with the quality of available evidence, FDA indications, and professional guideline recommendations.

Definitions and Key Terms

Apnea

Apnea (event) definitionCessation of airflow (≥ 90% decrease in Apnea sensor excursions compared to baseline) lasting at least 10 seconds; classified as obstructive, central, or mixed by respiratory effort

Obstructive apnea characteristicContinued or increased inspiratory effort throughout the period of absent airflow

Central apnea characteristicAbsent inspiratory effort throughout the period of absent airflow

Mixed apnea characteristicAbsent inspiratory effort initially with resumption of inspiratory effort later in the event

Apnea Hypopnea Index (AHI)

AHI (formal definition)Apnea-Hypopnea Index = (Apneas + Hypopneas) × 60 / total sleep time in minutes; unit = events per hour

Policy Updates and Material Changes

Policy Summary

PayerUnitedHealthcare

PolicyObstructive and Central Sleep Apnea Treatment (for New Jersey Only)

Policy CodePolicy CS116NJ.AJ

Change TypeCriteria revisions and code additions

Effective DateNovember 1, 2025

Next Review DateN/A

Key ActionProvide documentation of attended polysomnography showing required AHI/RDI thresholds and prior PAP failure or intolerance when seeking coverage for surgery or implantable device therapy.

SourceLink

On This Page

Implantable neurostimulation devices for treatment of central sleep apnea (e.g., remedē) are considered unproven and not medically necessary in some assessments due to insufficient evidence of safety and/or long‑term clinical benefit in relevant populations.

Further research and longer‑term data required.

Prefabricated oral appliances: Randomized and guideline evidence favor custom, titratable oral appliances over prefabricated (ready‑made) devices. Evidence is insufficient to support routine use of prefabricated devices for OSA.

Custom MADs are preferred per AASM/AADSM guidance.

Non‑surgical electrical muscle stimulation (intraoral; eXciteOSA): Evidence from small single‑arm and pre‑post studies is very low quality; some signals for snoring and mild OSA improvement exist but comparative and long‑term efficacy versus established therapies is not demonstrated.AHI < 15 per device labeling for eXciteOSA

Insufficient evidence to support routine coverage for OSA; further RCTs required.

Mandibular vertical repositioning, morning repositioning, epigenetic, ALF appliances: No quality evidence identified to support efficacy or safety for treating OSA; considered experimental/unproven.

Claims may be denied due to lack of supporting evidence.

Surgical therapy evidence: Surgery may benefit patients with major anatomic upper airway obstruction or who are intolerant of CPAP; overall quality of evidence for many surgical options is low and outcomes vary by procedure and patient selection.

AASM task force and systematic reviews note low quality evidence and need for improved comparative trials.

Adults medically stable ≥30 days who had received guideline‑recommended therapy, age ≥18, and AHI ≥ 20 by polysomnography were randomized to stimulation versus no stimulation for 6 months; primary endpoint was proportion achieving ≥50% AHI reduction at 6 months.

Treatment group achieved significantly higher responder rate (51% vs 11%).

Pediatric Down syndrome HNS eligibility: Adolescents with Down syndrome included in studies were at least 10 years old (some cohorts <22), had severe OSA after adenotonsillectomy and trial of CPAP, underwent DISE to exclude circumferential palatal collapse, and had pre‑ and post‑implant PSGs at specified intervals; responder often defined as ≥50% postoperative decrease in AHI.age >=10; DISE excludes circumferential palatal collapse

Follow‑up PSGs at 2, 6, and 12 months reported in phase‑one cohorts.

See summarized complication rates and device‑specific reports.

Non‑implantable/neurostimulation devices: Devices such as eXciteOSA, Slow Wave DS8, and intranasal/positional devices have device‑specific intended uses and AHI criteria (e.g., eXciteOSA labeled for AHI < 15); coverage should be consistent with FDA‑cleared/de novo indications and supporting evidence.eXciteOSA: AHI < 15

Refer to FDA regulatory identifiers for device‑specific labeling.

Phrenic nerve stimulation (remedē) is approved by PMA for treatment of moderate‑to‑severe central sleep apnea in adults; consideration should follow labeled indications and trial evidence documenting prior guideline‑recommended therapy and documented eligibility criteria in clinical trials.Moderate-to-severe CSA per labeling

PMA approval Oct 6, 2017; trial eligibility often required AHI ≥ 20.

Adolescent HNS central/mixed apnea requirementTotal AHI < 25% for central + mixed Apneas (pediatric/Down syndrome criteria)

Apnea-Hypopnea Index (AHI)

AHI definition (standard)Apnea-Hypopnea Index (AHI) = (Apneas + Hypopneas) × 60 / total sleep time in minutes; reported as events per hour

Device-specific AHI examples — eXciteOSAeXciteOSA labeled for AHI < 15 (removable tongue muscle stimulator for snoring/mild OSA)

Device-specific AHI examples — Inspire UASInspire UAS adult labeling originally AHI ≥ 20 and ≤ 65; expanded to lower limit ≤ 15 and upper baseline AHI up to 100 per FDA supplements

Adult surgical OSA threshold

Adult surgical OSA eligibility thresholdAHI ≥ 15 or RDI ≥ 15 as determined by Polysomnography (Attended)

Documentation requirement related to PSGPolysomnography (Attended) should be repeated if clinically significant weight change, cardiovascular disease changes, or persistent/recurrent symptoms since the last study

Symptom severity criterionExcessive daytime sleepiness documented (e.g., ESS > 10) is required for some surgical indications

Adolescent hypoglossal stimulation threshold

Adolescent HNS AHI/RDI thresholds (Down syndrome)AHI ≥ 10 and RDI ≤ 50 events per hour as determined by Polysomnography (Attended)

Adolescent HNS age and BMI referencesAdolescents aged 10–18 years with Down syndrome; BMI < 95th percentile for age referenced in device criteria

Additional adolescent HNS criteriaRequires prior adenotonsillectomy failure or contraindication, confirmed PAP failure/intolerance, absence of tracheostomy during sleep, and absence of complete concentric palatal collapse on DISE

Oral appliance therapy (OAT) requires specific documentation and coordination between a sleep-medicine clinician and a qualified dental provider. Prior authorization or clinical review should include evidence of diagnosis, face-to-face evaluation, and documentation of prior PAP trial or intolerance when applicable.

Face-to-face evaluation by a physician (MD/DO) trained in sleep medicine or an Advanced Practice Provider (APP) under direct supervision of such a physician prior to initiating OAT.
Treating physician or APP must diagnose OSA and recommend OAT; referral to a qualified dentist (QD) may follow for device fitting.
Use of custom, titratable oral appliances is preferred over non-custom or prefabricated devices per professional guidance; the qualified dentist should provide ongoing oversight.
Follow-up sleep testing should be performed to confirm treatment efficacy when oral appliances are used.

Documentation Required

remedē Trial Enrollment and Outcome Documentation

For remedē (implantable transvenous phrenic nerve stimulation) trial enrollment and outcomes, prior authorization and clinical records should reflect trial eligibility criteria and documented outcomes as reported in clinical studies.

Enrollment criteria in pivotal trials typically required adults with AHI ≥ 20 events/hour by polysomnography and prior receipt of guideline-recommended therapies.
Prior authorization should include baseline attended PSG AHI, prior therapy history, and documentation of clinical stability and guideline-directed care prior to implantation.
Post-implant follow-up data (AHI reductions, safety/complications, and functional outcomes) should be available to support clinical decision-making.

Prior Authorization

Prior Authorization Likely Required

Prior authorization is likely required for novel or surgical device therapies and for many durable device claims. Providers should anticipate pre-service review to establish medical necessity and device eligibility.

Procedures/devices such as hyomandibular suspension (Airlift/Encore), lingual suspension devices, implantable neurostimulators, and some positional or electrical stimulation devices commonly require prior review.
Include device model, FDA status, intended indication, and supporting clinical evidence with the authorization request.

Prior Authorization

Prior Authorization Should Document CPAP/Oral Appliance Failure

Prior authorization and clinical review should document failure, intolerance, or refusal of positive airway pressure (PAP) therapy or oral appliance therapy when required by device indications or surgical criteria.

Document attempts at PAP therapy (CPAP, APAP, BiPAP) including objective adherence data, tolerance issues, or clinically appropriate reasons for refusal.
When oral appliance therapy is an expected prior step, supply documentation of trial, intolerance, or inadequate therapeutic efficacy as applicable.
For hypoglossal nerve stimulation (Inspire) and similar devices, demonstrate prior PAP failure/intolerance consistent with FDA labeling and guideline-based sequencing.

Billing Rule

Added Applicable CPT/HCPCS Codes

Applicable CPT/HCPCS codes have been added to the policy coding list; include relevant codes with authorization and billing submissions and confirm state fee-schedule applicability.

Added codes include CPT/HCPCS: 0964T, 0965T, 0966T, E0490 along with existing codes E0486, E0485, A7049, E0492, E0493, E0530, E1399, K1027, L8679, L8680, L8686, S2080, S2900.
Note: CPT codes 0964T, 0965T, and 0966T are not on the State of New Jersey Medicaid Fee Schedule and may not be covered by NJ Medicaid; codes marked with an asterisk in the policy may have state-specific exclusions.
HCPCS clarification: E0486 applies to custom-fabricated oral devices and includes fitting and adjustment; dental procedure codes (e.g., D9947–D9949) are generally excluded under the medical plan—check contractual rules.

Documentation Required

Documentation Requirements for Oral Appliance Therapy

Documentation requirements for Oral Appliance Therapy (OAT) are strict; failure to provide required clinical documentation may lead to denial of coverage or request for additional information.

Required: face-to-face evaluation by a sleep-medicine trained physician (MD/DO) or qualifying APP before OAT initiation, documented medical diagnosis of OSA (attended PSG or HSAT), and physician recommendation for OAT.
Required: documentation of prior PAP therapy trial with objective adherence or documented intolerance/refusal when OAT is being used as an alternative to PAP.
Include treatment plan from qualified dentist, device type (custom vs prefabricated), fitting and titration notes, and planned follow-up testing.

Denial Risk

Oral Appliances for CSA — Lack of Evidence

Removable oral appliances are not supported by evidence for treatment of central sleep apnea (CSA). Claims for OAT for CSA should be carefully evaluated and are likely to be denied as not medically necessary.

No relevant evidence supports removable oral appliances for CSA; CSA is a neurologic/central ventilatory control disorder not addressed by oral mandibular repositioning devices.
If OAT is proposed for a patient with CSA, provide strong supporting rationale and alternate evidence; expect denial risk in absence of compelling justification.

Denial Risk

Morning Repositioning Devices — Evidence Gap

Morning repositioning devices have no published studies identified; their effect on health outcomes is unknown and requests for coverage will face evidence gaps.

No published clinical studies were identified for morning repositioning devices; coverage requests will require supporting data demonstrating clinical benefit.
Expect denials or requests for clinical justification where manufacturers' or clinicians' claims are not supported by peer-reviewed evidence.

Denial Risk

Evidence Limitations That May Affect Approval

The body of evidence for many devices and surgical procedures is limited by small sample sizes, short follow-up, lack of randomized controlled trials, and heterogeneity; these limitations may affect approval decisions.

Common evidence limitations include retrospective designs, high risk of bias, short-term follow-up, and inconsistent outcome measures (AHI definitions, hypopnea scoring).
Approval may require supplemental justification such as higher-quality studies, registry data, or objective pre/post-treatment PSG results demonstrating clinically meaningful benefit.

Denial Risk

Evidence Insufficiency and Study Limitations

Insufficient or low-quality evidence for many emerging devices and procedures (e.g., positional trainers, some myofunctional or stimulation devices, novel surgeries) necessitates careful review; absence of robust data may prompt denial.

Expect additional scrutiny for devices with only single-arm studies, manufacturer-sponsored reports without independent replication, or short-term outcome data.
Where evidence is insufficient, prior authorization reviewers may request longitudinal outcomes, comparative effectiveness data versus CPAP, or documented functional improvements (ESS, FOSQ).

Denial Risk

Evidence Limitations May Prompt Denial

Insufficient high-quality evidence, small sample sizes, and lack of long-term outcomes may lead to coverage denial for certain devices or procedures; provide comprehensive clinical rationale when requesting approval.

Denials are more likely when the requested intervention lacks randomized comparisons to standard therapy (CPAP) or does not demonstrate durable clinical benefit.
Provide complete pre- and post-treatment PSG/HST metrics, documented symptom improvement, and clinician rationale to mitigate denial risk.

Denial Risk

Device Indication Noncompliance

Devices must be used in accordance with their FDA indications. Requests that do not meet labeled indications (AHI, BMI, age limits, anatomical exclusions) are at risk for denial as noncompliant with device labeling.

Example: Inspire UAS has specific baseline AHI and BMI parameters and requires absence of complete concentric collapse at the soft palate level on DISE for adult and pediatric Down syndrome indications when applicable.
When the device's FDA labeling requires prior PAP failure/intolerance or other sequenced therapies, those prerequisites must be documented.

Documentation Required

Required Clinical Documentation for Device Eligibility

Required clinical documentation for device eligibility and oral appliance provision should be comprehensive and include both objective testing and narrative clinical justification.

Pre-treatment attended polysomnography (PSG) or an accepted home sleep apnea test (HSAT) with reported AHI, oxygen saturation metrics, and central apnea percentage where relevant.
Documentation of prior conservative therapies (CPAP trial with adherence data, oral appliance trial) and reasons for failure/intolerance or refusal.
DISE findings when required to evaluate for concentric palatal collapse prior to hypoglossal nerve stimulation or other palate-targeted implants.
Face-to-face evaluations, consultation notes from sleep-medicine physicians, operative notes, device model and manufacturer, and planned post-procedure follow-up schedule.

Note

Device Description (Inspire)

Professional societies and FDA summaries describe the Inspire Upper Airway Stimulation device and its intended population. Include device description and relevant FDA approvals in the authorization package when applicable.

Inspire UAS is an implanted system with a chest pulse generator, respiratory sensor, and hypoglossal nerve lead that stimulates the tongue to reduce airway collapse.
FDA approvals/PMA expansions set AHI and BMI ranges and age groups (adult and pediatric Down syndrome expansions); include applicable PMA references in requests.

Documentation Required

Referral and Diagnosis

Referral and diagnosis steps must be clearly documented prior to dental involvement for OAT. The medical diagnosis of OSA is a prerequisite for dental fitting and authorization.

A medical provider must diagnose OSA (attended PSG or HSAT) and document that diagnosis before referral to a qualified dentist for oral appliance therapy.
The treating sleep physician should coordinate care and document treatment sequencing, especially when combining OAT with other therapies.

Documentation Required

Follow-up Testing and Oversight

Follow-up testing and oversight are recommended and often required to confirm the effectiveness of oral appliances and other device therapies; include planned post-treatment testing in authorization requests.

Sleep physicians should conduct follow-up sleep testing to confirm or adjust therapy efficacy for patients treated with oral appliances (AASM guideline).
Qualified dentists and sleep physicians should schedule periodic office visits to monitor dental side effects, occlusal changes, and device performance.
Post-implantation follow-up PSG/HST at intervals specified by clinical evidence or device labeling (for example, 2–12 months in many HNS studies) should be documented when available.

Documentation Required

Pre- and Post-Procedure Testing Documented in Studies

Pre- and post-procedure testing (attended PSG and DISE when indicated) are elements commonly required or expected in clinical studies and by device labeling; include these data when available.

Pre-implant attended PSG establishing baseline AHI, central apnea percentage, and oxygenation metrics is typically required.
DISE is required when device labeling or institutional protocols mandate confirmation of absence of complete concentric palatal collapse prior to hypoglossal nerve stimulation.
Post-procedure PSG/HST results demonstrating objective changes in AHI/ODI and reporting of adverse events should be submitted for continued coverage consideration.

Documentation Required

Expected Clinical Documentation

Expected clinical documentation for device and surgical requests includes objective sleep metrics, prior therapy history, clinical examination findings, and multidisciplinary coordination notes.

Pre- and post-treatment PSG/HST metrics (AHI, ODI, lowest O2 saturation, percent central apneas) with dates and laboratories noted.
Narrative documentation of prior PAP or oral appliance attempts, adherence data, reasons for discontinuation/intolerance, and noninvasive therapy optimization attempts.
DISE findings, imaging, and surgical consult notes when relevant to anatomic selection or exclusion criteria.

Documentation Required