CurrentUnitedHealthcarePolicy CS116OH.F

Obstructive Sleep Apnea Treatment Oh Cs

State-specific UnitedHealthcare medical policy for diagnosis and treatment coverage of obstructive and central sleep apnea in Ohio, including non-surgical and surgical therapies, devices, definitions, evidence summaries, and applicable procedure and HCPCS codes. This is Part 1 of 5 and includes coverage rationale, lists of proven vs unproven treatments, definitions, and applicable codes presented in this part.

Policy Summary

PayerUnitedHealthcare

PolicyObstructive Sleep Apnea Treatment Oh Cs

Policy CodePolicy CS116OH.F

Change TypeAdded/Revised coverage for HNS; code updates

Effective DateNov 1, 2025

Next Review Date

Key ActionFor medical necessity clinical coverage criteria for removable oral appliances, surgical procedures, and hypoglossal nerve stimulation, the provider must reference and meet InterQual CP criteria as listed in the policy.

SourceLink

POLICY UPDATE CHANGES

Added language to indicate implantable hypoglossal nerve stimulation is medically necessary in certain circumstances for members 22 years of age and older.

Replaced prior language to indicate implantable HNS is medically necessary for members 18 to 21 years of age with moderate to severe OSA when listed criteria are met.

Added notation that polysomnography should be repeated if clinically significant weight change, changes in cardiovascular disease, or persistent/recurrent symptoms.

Replaced criterion wording regarding absence of complete concentric collapse at the soft palate with clarified phrasing.

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

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

Updated FDA and References sections to reflect the most current information.

Coverage Summary

This Ohio-only medical policy (Policy CS116OH.F) addresses diagnosis and treatment coverage for obstructive (OSA) and central sleep apnea (CSA), referencing InterQual clinical criteria for procedure- and device-specific medical necessity and the Ohio Administrative Code (OAC 5160-101 and related DMEPOS rules) for evaluation of unproven services or those with coverage/quantity limits. The policy states covered (proven) versus not-covered (unproven) positions for a range of non-surgical and surgical therapies (see InterQual references for full criteria), and specifies an effective date of November 1, 2025.

ref”: “b0_0

Quick-reference thresholds and eligibility

Inspire / HNS adult expanded AHI/BMI rangesInspire UAS adult indication expanded (June 8, 2023): lower AHI limit ≤ 15, upper baseline AHI up to 100, BMI upper limit increased from 32 to 40

HNS (adolescents 18–21) clinical thresholdsBMI ≤ 40 kg/m2; AHI ≥ 15 and ≤ 100 by attended polysomnography; total central+mixed apneas < 25% of total AHI; absence of complete concentric palatal collapse on DISE; prior PAP failure/refusal/intolerance

HNS (adolescents 10–18 with Down syndrome) thresholdsAHI ≥ 10 and RDI ≤ 50 events/hr (attended PSG); BMI < 95th percentile for age; total central+mixed apneas < 25%; DISE excludes concentric palatal collapse; prior adenotonsillectomy failure or contraindication; PAP failure/intolerance

Polysomnography recency requirementPSG should be repeated if clinically significant weight change, changes in cardiovascular disease, or persistent/recurrent symptoms; many HNS/DS studies required PSG within prior 6 months

Remedē/TPNS trial AHI eligibilityPivotal remedē trial enrolled adults with AHI ≥ 20 events/hour by PSG (and medically stable ≥30 days) for CSA indications

Device-specific intended AHI ranges (examples)eXciteOSA intended for AHI < 15 (mild OSA); Lunoa (NightBalance) for non-supine AHI < 20 (positional OSA)

Medical Necessity Criteria and Coverage Logic

Application

This policy applies only to Ohio and uses Ohio Administrative Code 5160-101 for evaluation of services stated as unproven or subject to coverage/quantity limits.

Applies only to services provided to members in the state of Ohio.
Services described as unproven or those with coverage or quantity limits will be evaluated for medical necessity using Ohio Administrative Code 5160-101.
Refer to related Ohio Administrative Code rules for DMEPOS general provisions and repairs: Rule 5160-10-01 and Rule 5160-10-02.

Non‑Surgical Treatment - Removable Oral Appliances (OAT / Mandibular Repositioning Devices)

Removable oral appliances (custom, adjustable mandibular repositioning devices) are proven and medically necessary for OSA when ALL of the following criteria are met. Refer to InterQual CP: Durable Medical Equipment, Noninvasive Airway Assistive Devices for detailed clinical decision support.

Coding (CPT / HCPCS / DME)

CPT / Procedure Codes (reference only)CPT

0964T	Impression and custom preparation of jaw expansion oral prosthesis for obstructive sleep apnea, single arch, without mandibular advancement mechanism, including initial adjustment
0965T	Impression and custom preparation of jaw expansion oral prosthesis for obstructive sleep apnea, dual arch, with additional mandibular advancement, non-fixed hinge mechanism, including initial adjustment
0966T	Impression and custom preparation of jaw expansion oral prosthesis for obstructive sleep apnea, dual arch, with additional mandibular advancement, fixed hinge mechanism, including initial adjustment
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, system including pulse generator and lead(s)

1–10 of 29

1/3

HCPCS / DME / Device Codes (reference only)HCPCS

A7049	Expiratory positive airway pressure intranasal resistance valve
E0485	Oral device/appliance used to reduce upper airway collapsibility, adjustable or nonadjustable, prefabricated, includes fitting and adjustment
E0486	Oral device/appliance used to reduce upper airway collapsibility, adjustable or nonadjustable, custom fabricated, includes fitting and adjustment
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
E0493	Oral device/appliance for neuromuscular electrical stimulation of the tongue muscle, used in conjunction with the power source and control electronics unit, controlled by phone application, 90-day supply
E0530	Electronic positional obstructive sleep apnea treatment, with sensor, includes all components and accessories, any type
E1399	Durable medical equipment, miscellaneous
K1027	Oral device/appliance used to reduce upper airway collapsibility, without fixed mechanical hinge, custom fabricated, includes fitting and adjustment
L8679	Implantable neurostimulator, pulse generator, any type

1–10 of 14

1/2

Added Codes (summary of changes)mixed

0964T	CPT/temporary code added (policy references addition)
0965T	CPT/temporary code added (policy references addition)
0966T	CPT/temporary code added (policy references addition)
E0490	HCPCS code added (policy references addition)

Dental CDT codes (e.g., D9947, D9948, D9949) are generally excluded from medical plan coverage; HCPCS code E0486 applies to custom fabricated oral appliances for OSA and includes fitting and adjustment. Verify applicable federal, state, and contractual requirements prior to making coverage determinations.

Provider Actions and Authorization Requirements

Prior Authorization

Implantable hypoglossal nerve stimulation preconditions

Implantable hypoglossal nerve stimulation (HNS) devices and related implantable therapies are evidence-dependent and typically require prior authorization. Documentation submitted for review should demonstrate that pre-implantation clinical and diagnostic preconditions are met. Prior authorization is likely required; reviewers should confirm age, BMI, AHI/RDI, DISE findings, and prior PAP therapy failure/refusal/intolerance as part of the request.

CPT/HCPCS to note: 64582, 64583, 64584
Documentation must demonstrate: age, BMI, AHI/RDI, DISE findings, and PAP failure/refusal/intolerance
Prior authorization likely required

Documentation Required

InterQual criteria reference for specific devices/procedures

For device- and procedure-specific medical necessity criteria (removable oral appliances, surgical procedures, and hypoglossal nerve stimulation), providers must reference the InterQual Clinical Practice (CP) criteria. Use InterQual CP as the primary clinical criteria source when preparing authorization requests for OAT, HNS, and related surgical procedures.

Background, Evidence Summary, and Definitions

Background: the policy covers both Obstructive Sleep Apnea (OSA) and Central Sleep Apnea (CSA), uses InterQual criteria for clinical necessity and Ohio DMEPOS rules for durable equipment, and incorporates society guidelines (AASM, AADSM, AAO-HNS). It reviews non-surgical devices (positional devices, nasal dilators, EPAP, oral appliances, electrical stimulation) and a range of surgical options (e.g., UPPP, MMA, multi-level surgery) as well as implantable neurostimulation therapies (hypoglossal nerve stimulation/HNS and phrenic nerve stimulation/remedē).

Hypoglossal Nerve Stimulation (HNS / UAS) — Evidence & Trial-Level Inclusion

Evidence summary and trial-level inclusion elements for hypoglossal nerve stimulation (HNS/UAS), with implications from major trials and observational studies.

STAR Trial Outcomes: STAR trial (Inspire UAS) showed median AHI decreased ~68% at 12 months (from 29.3 to 9.0 events/hour) with serious procedure-related adverse events <2%; follow-ups at 18 and 36 months indicate durability of effect.

STAR was a multicenter prospective case series with randomized withdrawal phase; lacked a concurrent control group for full duration.

Comparative/Observational Evidence: Systematic reviews and comparative observational studies suggest HNS may improve AHI, ODI, ESS and quality of life in CPAP-intolerant patients, but overall evidence quality rated very low to low; device differences and reoperation needs noted.

Revision History

11/01/2025material_addedLatest

Added language that implantable hypoglossal nerve stimulation (HNS) is medically necessary in certain circumstances for members 22 years of age and older; refers to InterQual CP: Procedures Hypoglossal Nerve Stimulation (HNS) for clinical criteria. (material change)

11/01/2025material_revisedLatest

Revised coverage criteria to state implantable HNS with an FDA‑approved device is medically necessary for members 18 to 21 years of age with moderate to severe OSA when listed criteria are met (material change)

Policy Summary

PayerUnitedHealthcare

PolicyObstructive Sleep Apnea Treatment Oh Cs

Policy CodePolicy CS116OH.F

Change TypeAdded/Revised coverage for HNS; code updates

Effective DateNov 1, 2025

Next Review Date

SourceLink

On This Page

ALL of the following

Diagnosis of Obstructive Sleep Apnea (OSA) documented by a sleep study (polysomnography or adequate HSAT).
Evaluation and documentation by a qualified provider (e.g., dentist with sleep credential or sleep medicine specialist) that oral appliance therapy (OAT) is an appropriate alternative to positive airway pressure (PAP) or for patients with mild to moderate OSA who prefer OAT; or for patients with severe OSA who are intolerant of or refuse PAP and for whom surgery is not indicated or acceptable.
Use of a custom-fabricated, adjustable mandibular repositioning device (not prefabricated/ready-made).
HCPCS E0486 applies to custom fabricated adjustable devices; prefabricated devices are considered not medically necessary.
Documentation of baseline and follow-up objective sleep testing or symptom assessment to demonstrate therapeutic effect or need for continued treatment.
Refer to InterQual for specific criteria on candidacy and continuation

Other Non‑Surgical Procedures — Not Medically Necessary

The following non‑surgical procedures and devices are considered unproven and not medically necessary due to insufficient evidence of efficacy.

ANY of the following

Devices for treating positional OSA (positional devices).
Nasal dilator devices for treating OSA.
Intranasal expiratory resistance valve devices (e.g., Bongo Rx, EPAP).
Prefabricated (ready‑made) oral appliances or devices.
Non‑surgical electrical muscular stimulation devices for OSA (e.g., eXciteOSA, Apone‑Stim 400) — considered unproven for OSA treatment.
Mandibular vertical repositioning devices (e.g., Slow Wave).
Morning repositioning devices.
Epigenetic appliances (e.g., Homeoblock, DNA appliances).
Advanced Lightwire Functional (ALF) appliances and other intraoral/orthodontic therapies not demonstrated to be effective for OSA.
Removable oral appliances for treating Central Sleep Apnea (CSA).

Surgical Treatment — Proven and Medically Necessary for OSA

The following surgical procedures are proven and medically necessary for treating OSA when documented by attended polysomnography. For specific clinical criteria refer to InterQual CP: Procedures. Individual procedure coverage is subject to documented clinical indications consistent with InterQual guidance.

ANY of the following

Maxillomandibular advancement (MMA) / orthognathic surgery (proven and medically necessary when InterQual criteria met).
Consider referral to InterQual CP: Procedures - surgical criteria for MMA.
Osteotomy, anterior segment, mandible (when part of corrective maxillofacial surgery for OSA per InterQual).
Uvulopalatopharyngoplasty (UPPP) when InterQual surgical criteria are met for palatal-level obstruction.
Multi‑level airway surgery (including combinations of palatal, tonsillar, tongue base, and maxillomandibular procedures) when supported by InterQual criteria and clinical evaluation.
Tonsillectomy and/or adenoidectomy (TE) when clinically indicated and supported by InterQual criteria (commonly pediatric indications).
Other palatal surgeries demonstrated effective per InterQual (e.g., selective palate procedures) when criteria met.

Implantable Hypoglossal Nerve Stimulation (HNS) — Adults and Pediatric/Adolescent Criteria

Implantable Hypoglossal Nerve Stimulation (HNS / Upper Airway Stimulation) is medically necessary in specific circumstances. Refer to InterQual CP: Procedures Hypoglossal Nerve Stimulation (HNS) for detailed clinical criteria. Below are summarized candidate selection criteria used by this policy.

ANY of the following

Adults (age ≥ 22)
- Age 22 years or older.
- Documented moderate to severe OSA by attended polysomnography.
- Total AHI and central apnea percentage within ranges specified by InterQual and device labeling (evaluate central + mixed apneas).
- Absence of complete concentric collapse of the soft palate on drug‑induced sleep endoscopy (DISE).
- Failure, intolerance, or refusal of PAP therapy despite optimization.
- Patient meets device‑specific FDA labeling and other InterQual criteria.
Young adults (age 18–21)
- Age 18 to 21 years.
- Body mass index (BMI) ≤ 40 kg/m2.<= 40 kg/m2
- AHI ≥ 15 and ≤ 100 on attended polysomnography.AHI 15–100
- Total AHI < 25% for central + mixed apneas.
- Absence of a complete blockage or complete concentric collapse of the soft palate confirmed by DISE.
- PAP therapy resulted in no therapeutic efficacy or there is documented refusal or intolerance to PAP.
Adolescents (age 10–18) with Down syndrome
- Age 10 to 18 years with a diagnosis of Down syndrome.
- Severe OSA demonstrated by attended polysomnography with AHI ≥ 10 and RDI ≤ 50 events/hour.AHI ≥ 10
- BMI < 95th percentile for age.
- Total AHI < 25% for central + mixed apneas.
- Contraindication to or failure of adenotonsillectomy to adequately treat OSA.
- Documented failure or intolerance of PAP therapy despite attempts to improve compliance.

Implantable Neurostimulation Devices for Central Sleep Apnea (CSA)

Implantable neurostimulation devices for treatment of Central Sleep Apnea (CSA) are considered unproven and not medically necessary due to insufficient evidence of safety and/or efficacy. This includes devices approved for central apnea where clinical benefit has not been established for the targeted indication in the available literature or for applications outside labeled indications.

ANY of the following

Transvenous phrenic nerve stimulation / remedē system (TPNS) for central sleep apnea when proposed for indications not supported by evidence — considered unproven/not medically necessary per this policy.
Other implantable peripheral neurostimulation systems proposed for CSA without adequate evidence of efficacy and safety — not medically necessary.

Other Surgical Procedures — Not Medically Necessary

The following surgical procedures and techniques are considered unproven and not medically necessary for treatment of OSA due to insufficient evidence of efficacy or safety.

ANY of the following

Laser-assisted uvulopalatoplasty (LAUP).
Lingual suspension / tongue fixation procedures (including tongue stabilization, TOTS, Repose, modified tongue‑base suspension).
Lingual tonsillectomy or isolated lingual procedures without demonstrated clinical benefit per InterQual.
Isolated hyoid myotomy or hyoid myotomy with hyomandibular suspension (examples: Encore/AirLift/Encore Suspension System) when not supported by adequate evidence.
Stand‑alone uvulectomy.
Palatal implants (e.g., Pillar, Elevo) — considered not medically necessary for OSA.
Radiofrequency ablation (RFA) of the soft palate and/or tongue base for OSA.
Transoral robotic surgery (TORS) for OSA (when evidence insufficient).
Distraction osteogenesis for maxillary expansion (DOME) for OSA when not supported by sufficient efficacy data.

Documentation Required

Pre-implant assessments for HNS in adolescents

For adolescents being considered for HNS, pre-implant assessments must include an attended polysomnography, drug-induced sleep endoscopy (DISE) confirming absence of complete concentric palatal collapse, and clear documentation of CPAP intolerance, failure, or refusal despite optimization attempts.

Billing Rule

HCPCS E0486 coding note

HCPCS coding note: custom oral appliances and certain dental procedures may be excluded from DME/medical coverage. When billing, confirm HCPCS and dental code applicability and exclude dental-only services per policy.

HCPCS: E0486 (custom fabricated oral appliance note)
Dental codes excluded from DME coverage: D9947, D9948, D9949

Denial Risk

Insufficient evidence procedures and prior authorization implications

Several procedures and implantable approaches lack sufficient evidence of safety or long-term benefit and are considered unproven. Prior authorization reviewers should flag these as noncovered or investigational except in research protocols; consider that inclusion in trial-level coverage may require specific eligibility criteria and the absence of long-term outcome data.

Procedures with insufficient evidence: LAUP, palatal implants, lingual suspension/tongue stabilization variants, isolated hyoid myotomy, stand-alone uvulectomy, radiofrequency ablation of palate/tongue base, transoral robotic surgery (TORS), distraction osteogenesis for maxillary expansion (DOME)
Reviewers should consider trial-level inclusion criteria and note lack of long-term outcomes when determining coverage

Documentation Required

Repeat polysomnography and DISE operational notes

Operational documentation requirements: polysomnography must generally be current (performed within the prior 6 months) unless clinically justified. Repeat attended polysomnography is required when there has been clinically significant weight change, changes in cardiovascular disease status, or persistent/recurrent symptoms since the last study. Drug-induced sleep endoscopy (DISE) is required to document absence of complete concentric palatal collapse for HNS candidate selection.

Polysomnography recency: within 6 months unless clinical circumstances warrant older testing
Conditions prompting repeat PSG: clinically significant weight loss/gain, changes in cardiovascular disease, persistent or recurrent symptoms
DISE requirement: must document soft palate collapse pattern (no complete concentric collapse) for HNS eligibility

Down Syndrome Adolescents Evidence: Small prospective trials and case series of Down syndrome adolescents show substantial AHI reductions (median reductions reported up to 85%) and QOL improvements; evidence limited by small samples and lack of long-term controlled data.

Phase one and small cohort studies required DISE, preimplant PSG within 6 months, and demonstrated CPAP intolerance or tracheostomy dependence in some series.

Evidence synthesis: transvenous phrenic nerve stimulation (remedē) pivotal trial met its primary endpoint with significantly more treatment patients achieving a ≥ 50% AHI reduction at 6 months (51% vs 11%) and acceptable 12‑month safety (most patients free of serious related events). The STAR trial of upper airway stimulation reported a median AHI reduction of about 68% at 12 months. RCT evidence supports multi-level surgery with clinically meaningful AHI reductions (MacKay multicenter RCT). Randomized data (Johal RCT) show custom mandibular repositioning devices are superior to ready-made devices for mild–moderate OSA. Health technology assessments (Hayes, ECRI) conclude evidence for many emerging devices is low-to-very-low quality and that further RCTs and long-term comparative data are needed.

Study / Assessment	Key Finding
STAR trial (Strollo et al., 2014; follow-ups)
Median AHI decreased ≈68% at 12 months (29.3 → 9.0 events/hr); effects maintained at 18–36 months; procedure‑related serious adverse events <2%; study lacked concurrent control group.
Remedē pivotal trial (Costanzo et al., 2016) / remedē follow-up
At 6 months, 51% of treatment patients achieved ≥50% reduction in AHI vs 11% control (difference 41%, 95% CI 25–54, p<0.0001); 138/151 patients had no serious related adverse events at 12 months; improvements in AHI and CAI reported but long‑term comparative data limited.
Johal RCT (2017)
Randomized trial comparing ready‑made vs custom mandibular repositioning devices: custom MRD superior in AHI reduction; ready‑made devices poorly tolerated; limited by small sample and withdrawals.
Hayes / ECRI assessments (positional devices, eXciteOSA, HNS, remedē)
Hayes and ECRI HTAs found overall evidence quality low to very low for several devices: positional device evidence low/inconclusive, eXciteOSA evidence very low and inconclusive, HNS evidence very low but suggests potential benefit in CPAP‑intolerant patients; remedē evidence very low to low with some positive AHI reductions but insufficient for broad conclusions.
MacKay multicenter RCT (2020)
Multicenter RCT of multi‑level surgery vs medical management in moderate–severe OSA: intervention group AHI reduced from ~47.9 to 20.8 at 6 months vs medical 45.3 → 34.5; significant reductions in AHI and ESS but limited by short follow‑up and generalizability.
HNS studies in Down syndrome adolescents (Yu 2022; Calloway 2020; systematic reviews Liu 2022, Rodriguez Lara 2024)
Small prospective trials and case series report substantial AHI reductions (median reductions reported 51–85% across studies) and improved quality‑of‑life measures (e.g., OSA‑18); limited by small samples, lack of controls, and limited long‑term data; some adverse events required revision in a few cases.

Definitions (consolidated):

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

Hypopnea: event ≥10 seconds with ≥30% airflow reduction and ≥3% oxygen desaturation or an associated arousal.

AHI (Apnea‑Hypopnea Index): apneas plus hypopneas per hour of sleep (events/hour); severity: mild ≥5–<15, moderate ≥15–≤30, severe >30.

RDI (Respiratory Disturbance Index): apneas + hypopneas + respiratory effort–related arousals per hour (note: RDI was added to the definitions).

HSAT (Home Sleep Apnea Testing): unattended testing with ≥4 hours and minimum sensors (nasal pressure, chest/abdomen RIP, oximetry).

Polysomnogram (Attended): laboratory-based multi-channel sleep study recording EEG, eye movements, body movements, respiration and heart rate.

DISE (Drug‑Induced Sleep Endoscopy): endoscopic evaluation under sedation to assess pattern of collapse (used to confirm absence of complete concentric palatal collapse for HNS eligibility).

HNS / UAS: hypoglossal nerve stimulation / upper airway stimulation devices (e.g., Inspire) for OSA.

TPNS / PNS / remedē: transvenous phrenic nerve stimulation (remedē) for treatment of central sleep apnea.

ESS: Epworth Sleepiness Scale (patient-reported daytime sleepiness).

BMI: body mass index (kg/m2) with thresholds referenced for device/surgical eligibility (policy lists specific BMI limits where applicable).