DraftUnitedHealthcarePolicy CS116KS.02

Obstructive and Central Sleep Apnea Treatment (for Kansas Only)

Clinical coverage and medical necessity guidance for non-surgical and surgical treatments for obstructive and central sleep apnea for UnitedHealthcare members in Kansas.

Policy Summary

PayerUnitedHealthcare

PolicyObstructive and Central Sleep Apnea Treatment (for Kansas Only)

Policy CodePolicy CS116KS.02

Change TypeCriteria and coding updates

Effective DateNov 1, 2025

Next Review Date

Key ActionObtain prior authorization using InterQual® HNS criteria and document attended polysomnography and drug-induced sleep endoscopy when applicable.

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; for medical necessity clinical coverage criteria, refer to InterQual® CP: Procedures Hypoglossal Nerve Stimulation (HNS).

Replaced prior adult criterion wording to specify evaluation of central + mixed apneas by attended polysomnography and to require drug-induced sleep endoscopy to confirm absence of complete concentric collapse of the soft palate.

Replaced adolescent Down syndrome criteria to require attended polysomnography for diagnosis of severe OSA and clarified terminology to require drug-induced sleep endoscopy.

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

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.

Kansas-onlyjurisdiction

Yes

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HNS criteria present

1FDA‑cleared HNS device cited

very lowevidence quality (eXciteOSA)

Coverage and Medical Necessity Criteria

(untitled)

Covered when ALL of the following are met:

ALL of the following

Obstructive Sleep Apnea (OSA) diagnosis documented by a qualified medical provider with objective testing (Polysomnography or Home Sleep Apnea Testing) as referenced in policy and InterQual® criteria.
Non‑surgical first‑line therapy has been attempted and documented unless clinically contraindicated. Examples include: positive airway pressure (PAP) therapy (CPAP, APAP, BiPAP) or removable custom, titratable oral appliance therapy (OAT) when appropriate, with documentation of therapeutic trials and adherence efforts.
For removable oral appliances: device is custom fabricated and titratable and prescribed and monitored by a qualified dentist in collaboration with the treating sleep physician; follow‑up sleep testing or objective assessment of efficacy is performed as recommended by guidelines (e.g., AASM, AADSM).
Prefabricated (ready‑made) appliances are not supported due to insufficient evidence.
Devices or procedures for positional OSA, nasal dilators, intranasal EPAP devices, prefabricated oral appliances, non‑surgical electrical muscular training devices (including eXciteOSA), mandibular vertical repositioning devices, morning repositioning devices, epigenetic appliances, and ALF appliances are considered unproven and not medically necessary for routine treatment of OSA due to insufficient or low‑quality evidence.

Clinical coverage considerations and device-specific constraints

Clinical coverage considerations and device‑specific constraints:

ALL of the following

Positional therapy devices (e.g., sleep position trainers, vibratory devices): evidence is mixed with short‑term adherence sometimes better than CPAP but overall AHI reduction is generally inferior to CPAP; long‑term comparative effectiveness and durability remain uncertain.
EPAP / Intranasal expiratory resistance valve devices (e.g., Provent): some randomized trial evidence shows short‑term reductions in AHI and improved symptoms for selected patients, but limitations include short follow‑up, loss to follow‑up, and lack of direct comparison with established therapies; routine use should be considered only when guideline‑directed treatments are not tolerated or are inappropriate and with documented follow‑up.
Nasal dilators: current evidence does not demonstrate clinically meaningful improvements in OSA outcomes (AHI) in most studies; nasal dilators may improve nasal airflow but are not supported as effective OSA therapy.
Repeat polysomnography (attended) should be performed when clinically indicated (e.g., significant weight change, changes in cardiovascular status, persistent or recurrent symptoms since last study) prior to advanced interventions or implantable therapies.

Procedure and Device Codes

Procedures and surgical CPT codesCPT

0964T	Impression and custom preparation of jaw expansion oral prosthesis for obstructive sleep apnea, including initial adjustment; single arch, without mandibular advancement mechanism.
0965T	Impression and custom preparation of jaw expansion oral prosthesis for obstructive sleep apnea, including initial adjustment; dual arch, with additional mandibular advancement, non-fixed hinge mechanism.
0966T	Impression and custom preparation of jaw expansion oral prosthesis for obstructive sleep apnea, including initial adjustment; dual arch, with additional mandibular advancement, fixed hinge mechanism.
21142	Reconstruction midface, LeFort I; 2 pieces, segment movement in any direction, without bone graft.
21199	Osteotomy, mandible, segmental; with genioglossus advancement.
21206	Osteotomy, maxilla, segmental (e.g., Wassmund or Schuchard).
21685	Hyoid myotomy and suspension.
33276	Insertion of phrenic nerve stimulator system (pulse generator and stimulating lead[s]), including vessel catheterization, all imaging guidance, and pulse generator initial analysis with diagnostic mode activation, when performed.
33277	Insertion of phrenic nerve stimulator transvenous sensing lead (List separately in addition to code for primary procedure).
33278	Removal of phrenic nerve stimulator, including vessel catheterization, all imaging guidance, and interrogation and programming, when performed; system, including pulse generator and lead(s).

1–10 of 29

1/3

HCPCS/HCPCS-like codes and descriptorsHCPCS

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

FDA device approvals and clearances citedmixed

K180608	510(k) Premarket Notification — Lunoa System (NightBalance BV) (positional OSA)
K180619	510(k) approval — Bongo intranasal appliance (InnoMed Healthscience, Inc.)
K982717	510(k) — Somnoplasty System (Olympus) RFA for upper airway
K030108	510(k) — ArthroCare ENT Coblator Surgery System
QNO	De novo product code for eXciteOSA (tongue muscle stimulation) DEN200018
K191320	510(k) — Slow Wave DS8 snoring device
P160039	PMA — remedē System (implantable phrenic nerve stimulator) for moderate to severe central sleep apnea
P130008	PMA — Inspire Upper Airway Stimulation (UAS) system; supplemented with S089, S090, S098 expansions
K981677	510(k) — AIRvance Tongue Suspension system
K040417	510(k) — Pillar Palatal Implant System

Applicable CPT/HCPCS Codes Addedmixed

0964T	Added CPT/HCPCS code 0964T (as listed in policy changes)
0965T	Added CPT/HCPCS code 0965T (as listed in policy changes)
0966T	Added CPT/HCPCS code 0966T (as listed in policy changes)
E0490	Added HCPCS code E0490 (as listed in policy changes)

AHI/Age/BMI thresholds for hypoglossal nerve stimulation

Adult (18–21) HNS eligibilityBMI ≤ 40 kg/m2; AHI ≥ 15 and ≤ 100 on attended polysomnography; total central + mixed apneas <25% of AHI; absence of complete blockage or complete concentric soft‑palate collapse on drug‑induced sleep endoscopy; prior PAP failure/refusal/intolerance; used per FDA guidance.

Adults ≥22 yearsMedically necessary in certain circumstances per InterQual® CP: Procedures Hypoglossal Nerve Stimulation — refer to InterQual for full criteria.

Adolescents 10–18 years with Down syndromeAttended polysomnography documenting severe OSA with AHI ≥ 10 and RDI ≤ 50; BMI <95th percentile for age; total central + mixed apneas <25% of AHI; prior adenotonsillectomy ineffective or contraindicated; confirmed PAP failure/intolerance despite optimization; absence of tracheostomy during sleep; absence of complete concentric palatal collapse on DISE; used per FDA guidance.

AHI inclusion threshold (remedē RCT)

Prior Authorization, Documentation, and Clinical Workflow

Prior Authorization

Prior Authorization Required

Prior authorization is required for implantable hypoglossal nerve stimulation (HNS) and other implantable neurostimulation devices when coverage is being requested. UnitedHealthcare relies on InterQual® CP: Procedures Hypoglossal Nerve Stimulation (HNS) for primary medical necessity criteria; prior authorization should confirm that the member meets InterQual® pathway requirements and device-labeled indications (AHI, BMI limits, CPAP failure/intolerance, absence of complete concentric palatal collapse when applicable). Obtain prior authorization before scheduling implantation.

Prior authorization required and review uses InterQual® HNS criteria
Confirm device-labeled eligibility (AHI, BMI, DISE findings, prior PAP failure/intolerance)
Documented prior CPAP attempt or intolerance required

Denial Risk

Implantable Neurostimulation Prior Authorization & Evidence Considerations

Implantable neurostimulation for Central Sleep Apnea (e.g., transvenous phrenic nerve stimulation/remedē) is considered unproven for some indications and may be not medically necessary when evidence is insufficient. Requests for CSA neurostimulation require rigorous documentation of qualifying diagnostic testing (including AHI/CAI thresholds) and prior guideline-directed therapy; absence of high-quality evidence or device failures may lead to denial.

Background and Evidence Summary

Obstructive sleep apnea (OSA) is characterized by recurrent upper airway obstruction during sleep leading to apneas and hypopneas with symptoms such as excessive daytime sleepiness, loud snoring, witnessed apneas, and physiologic consequences including fluctuating oxygenation, increased heart rate, hypertension, and impaired glucose tolerance. Central sleep apnea (CSA) is due to diminished or absent respiratory drive and is common in heart failure; treatments for CSA have limited accepted effectiveness and implantable neurostimulation approaches remain investigational.

The overall evidence base for many devices and surgical procedures is limited by small sample sizes, predominance of single‑arm or pre‑post studies, and few randomized controlled trials. Systematic reviews and technology assessments repeatedly note low or very‑low quality evidence, heterogeneity in techniques and outcomes, short follow‑up, and inconsistent reporting; these limitations underlie the policy’s stance that many interventions remain unproven or require higher‑quality comparative research before routine coverage can be recommended.

Definitions and Key Terms

Apnea — definition and classification

Apnea definitionCessation of airflow (≥90% decrease in apnea sensor excursions from baseline) lasting at least 10 seconds.

Obstructive apneaApnea with continued or increased inspiratory effort throughout the period of absent airflow.

Central apneaApnea with absent inspiratory effort throughout the period of absent airflow.

Mixed apneaApnea with absent inspiratory effort in the initial portion followed by resumption of inspiratory effort in the second portion.

Apnea Hypopnea Index (AHI)

AHI metricAHI = number of apneas plus hypopneas per hour of sleep (events/hour) as defined by AASM scoring criteria.

Policy Updates

2025-11-01criteria_revisionLatest

Revised implantable hypoglossal nerve stimulation (HNS) adult criteria to specify attended polysomnography for evaluation of central + mixed apneas and to require drug‑induced sleep endoscopy to confirm absence of complete concentric collapse of the soft palate; added guidance to repeat polysomnography after significant weight or clinical changes.

2025-11-01scope_update

Added language directing clinicians to refer to InterQual® CP: Procedures Hypoglossal Nerve Stimulation (HNS) for medical necessity clinical coverage criteria and noted HNS may be medically necessary for members 22 years and older per InterQual® pathways.

Policy Summary

PayerUnitedHealthcare

PolicyObstructive and Central Sleep Apnea Treatment (for Kansas Only)

Policy CodePolicy CS116KS.02

Change TypeCriteria and coding updates

Effective DateNov 1, 2025

Next Review Date

Key ActionObtain prior authorization using InterQual® HNS criteria and document attended polysomnography and drug-induced sleep endoscopy when applicable.

SourceLink

On This Page

Removable oral appliances are not indicated for central sleep apnea (CSA); removable oral appliances and other removable devices lack evidence for CSA indications and are not supported for CSA treatment.

When using device‑specific or novel technologies, document prior therapies tried, objective measures of failure or intolerance (e.g., PAP adherence data, polysomnography results), device type, patient selection rationale, and planned follow‑up testing to assess efficacy.

remedē pivotal RCT inclusion AHIAHI ≥ 20 events per hour on polysomnography (baseline requirement for randomized trial).

AHI inclusion threshold (CSA systematic review criteria)

Systematic review / HF trial AHI criterionAHI ≥ 10 events per hour (criterion used in HF/CSA systematic review trials).

AHI for Inspire UAS

Inspire UAS FDA‑labeled AHI (original)Intended for patients with baseline AHI ≥ 20 and ≤ 65 per original PMA (P130008).

Inspire UAS FDA expansion AHI rangesFDA expanded indication to include lower AHI limit ≤ 15 and upper baseline AHI up to 100 for certain adult indications; pediatric (13–18 years with Down syndrome) AHI ≥ 10 and ≤ 50 per PMA supplement.

BMI limit for Inspire UAS (expanded)

Original Inspire BMI limitUpper BMI limit was 32 kg/m2 in the original FDA labeling.

Expanded Inspire BMI limitFDA expanded the upper BMI limit to 40 kg/m2 for certain adult indications (P130008s090).

Ejection fraction limit for ASV

ASV contraindication ejection fractionAdaptive servo‑ventilation (ASV) targeted to normalize AHI should not be used for CSAS related to CHF in adults with ejection fraction ≤ 45% and predominant moderate or severe CSA (AASM recommendation).

Implantable neurostimulation for CSA considered unproven/not medically necessary in many circumstances
Clinical trial evidence requirements (e.g., remedē pivotal AHI thresholds) must be met
Document prior guideline-recommended therapies for CSA and heart failure

Denial Risk

Unproven Treatments — Not Medically Necessary

Treatments or devices lacking sufficient evidence are considered not medically necessary. Examples include prefabricated oral appliances/devices, removable oral appliances for treating Central Sleep Apnea (CSA), nasal dilator devices, positional support devices not supported by quality evidence, non-surgical electrical muscular training devices with inadequate comparative data, epigenetic/ALF appliances, and other listed novel devices or procedures.

Unproven/not medically necessary: prefabricated oral appliances, oral appliances for CSA, nasal dilators, positional devices, noninvasive electrical stimulation devices, epigenetic/ALF appliances
Requests for these items may be denied for lack of efficacy evidence

Documentation Required

CPAP First-Line; Conservative Therapy Documentation Required Before HNS

Prior to considering implantable HNS, conservative therapies must be attempted and documented. CPAP is the first-line therapy for moderate-to-severe OSA and should be trialed; HNS is typically considered second-line when CPAP has failed, is not tolerated, or is refused. Documentation should include details of PAP modality (CPAP/APAP/BiPAP), duration, adherence attempts, and reasons for failure/intolerance.

CPAP (or other PAP) must be attempted and documented prior to HNS
Document PAP modality, duration, adherence efforts, and objective reasons for failure/intolerance
Conservative therapy documentation required for adolescents with Down syndrome as well

Documentation Required

Pre-implant Diagnostic Testing and Documentation

Pre-implant diagnostic testing expectations and required documentation: an attended polysomnography (PSG) documenting AHI that meets device or trial-specific thresholds is required (repeat PSG if clinically significant weight change, cardiovascular changes, or persistent/recurrent symptoms). For HNS, document baseline AHI/ODI, proportion of central + mixed apneas (total < 25% when required), and drug-induced sleep endoscopy (DISE) findings to exclude complete concentric palatal collapse when indicated.

Attended PSG required with documented baseline AHI/ODI and central+mixed apnea proportion
Repeat PSG when clinically indicated (weight change, CV disease changes, persistent symptoms)
DISE required to exclude complete concentric palatal collapse when device labeling or criteria require it

Documentation Required

Required Clinical Documentation and Baseline/Outcome Measures for HNS

Required clinical documentation for HNS prior authorization should include: attended polysomnography reports with baseline AHI/ODI and central apnea proportion, documentation of prior PAP trial(s) with reasons for failure/intolerance, DISE report (when used), baseline and planned follow-up objective outcome measures (post-implant PSG results), and confirmation that device-labeled criteria (AHI range, BMI limit, absence of complete concentric palatal collapse) are met.

Attended PSG report with baseline AHI, ODI, and central+mixed apnea %
Documentation of prior PAP trial(s) including attempts to improve compliance
DISE report confirming absence of complete concentric collapse when required
Plan for and documentation of post-implant objective outcomes (repeat PSG)
Confirmation that patient meets FDA/device labeling (AHI, BMI, age limits)

Denial Risk

AHI Thresholds, Device-Labeled Indications, and Risk of Denial

Device-specific eligibility and AHI threshold documentation: confirm the patient meets the FDA-approved device labeling and pivotal trial thresholds (for example, Inspire UAS labeling and the remedē trial AHI requirements). Failure to document qualifying AHI (or to meet device AHI/BMI/DISE criteria) or evidence of device failures/limited evidence for a specific system may result in denial of coverage.

Confirm device-labeled AHI and BMI ranges and other labeled criteria prior to authorization
Ensure PSG documents qualifying AHI (and CAI/central apnea proportions when required)
Evidence of device-specific failures or insufficient evidence can preclude coverage

Prior Authorization

Prior Authorization Recommended for Novel Surgical or Implantable Procedures

For novel surgical procedures (e.g., DOME, hyoid/tongue suspension, Airlift/Airlift-related techniques), prior authorization is recommended and should include objective sleep study confirmation of OSA, documentation of prior conservative therapy attempts or intolerance (including PAP), and pre- and post-operative PSG outcomes. Procedures with limited or insufficient evidence require supporting clinical documentation and may be denied if evidence is inadequate or device failure rates are concerning.

Prior authorization recommended for DOME and novel surgical procedures
Provide pre- and post-procedure PSG results and documentation of prior conservative therapy attempts
Document device/procedure safety data; high device failure rates may preclude coverage

Severity thresholdsMild: AHI ≥5 to <15; Moderate: AHI ≥15 to ≤30; Severe: AHI >30 events/hour.

Use in trialsAHI is the primary metric for classifying OSA severity and is used as an outcome in pivotal HNS and CSA trials.

Home Sleep Apnea Testing (HSAT)

HSAT definitionHome Sleep Apnea Testing (HSAT) = unattended diagnostic testing to assess OSA without sleep staging; adequate HSAT is ≥4 hours and must include nasal pressure, chest and abdominal respiratory belts, and oximetry.

LimitationsHSAT does not determine sleep stages and may be insufficient when central or mixed apneas must be quantified; attended polysomnography is preferred when device candidacy requires central apnea proportion assessment.

Obstructive Sleep Apnea (OSA)

OSA clinical summaryObstructive Sleep Apnea (OSA) = repetitive episodes of decreased or ceased airflow during sleep due to upper airway obstruction, causing apneas and hypopneas with symptoms such as daytime sleepiness and snoring.

DiagnosisDiagnosis is established by polysomnography or HSAT with documented AHI/RDI meeting OSA thresholds.

Typical consequencesUntreated OSA associated with fluctuating oxygen levels, hypertension, and impaired glucose tolerance.

Central Sleep Apnea (CSA)

CSA clinical summaryCentral Sleep Apnea (CSA) = sleep‑disordered breathing marked by decreased or absent respiratory effort from the central respiratory control center, often associated with heart failure or opioid‑related hypoventilation.

Clinical contextCSA is common in heart failure (estimated 30–50% prevalence) and treatments have limited accepted effectiveness; device therapies for CSA remain investigational for many indications.

Apnea‑Hypopnea Index (AHI) — trial use

AHI use in STAR trialAHI (events/hour) used to define moderate‑to‑severe OSA and primary outcome in STAR HNS studies; values ≥15 considered moderate‑to‑severe in trial context.

AHI outcome exampleSTAR reported median AHI reduction from 29.3 to 9.0 events/hour at 12 months (68% reduction).

Oxygen Desaturation Index (ODI)

ODI definitionOxygen Desaturation Index (ODI) = number of times per hour that oxygen saturation drops by ≥4 percentage points; used as a primary outcome in HNS and TPNS studies.

Study useODI reported alongside AHI in STAR and remedē studies to demonstrate improvement in oxygenation events per hour.

Responder (HNS studies)

Responder definition (HNS)Responder commonly defined as ≥50% postoperative decrease in AHI from baseline (used in HNS studies such as Yu 2022 and others).

ApplicationResponder threshold used to report proportion achieving clinically meaningful AHI reduction in single‑arm and cohort HNS studies.

Primary effectiveness endpoint (remedē pivotal trial)

remedē primary effectiveness endpointProportion of patients achieving ≥50% reduction in AHI from baseline to 6 months on full‑night polysomnography assessed by masked investigators (primary endpoint in the remedē pivotal RCT).

Palatal implants

Palatal implants descriptionPalatal implants = small woven polyester inserts placed in the soft palate to stiffen it and reduce airway collapse; examples include Pillar® and Elevo®.

Evidence noteAvailable evidence is limited and does not conclusively support effectiveness for OSA; further RCTs needed.

Radiofrequency tissue volume reduction (RFTVR)

RFTVR definitionRadiofrequency tissue volume reduction (RFTVR) = use of low‑intensity radiofrequency energy to shrink uvula, soft palate, and/or tongue tissue (trade names Somnoplasty™, Coblation®).

Clinical noteMay provide short‑term AHI improvements in some studies but larger randomized trials and long‑term data are lacking.

Adaptive servo-ventilation (ASV) — definition and contraindications

UAS / HNS definitionUpper Airway Stimulation (UAS) / Hypoglossal Nerve Stimulation (HNS) = an implantable stimulation system (e.g., Inspire) indicated for selected adults with OSA who fail or cannot tolerate PAP and who meet device‑specific AHI, BMI, and anatomic criteria.

ContextDevice implantation requires specialized evaluation including attended polysomnography and DISE to exclude complete concentric palatal collapse per policy and FDA labeling.

Upper Airway Stimulation (UAS) / HNS

UAS / HNS clinical contextImplantable HNS is a surgically implanted device that stimulates upper airway muscles during sleep to reduce OSA events; considered for patients intolerant of CPAP with documented baseline AHI/ODI and appropriate anatomic findings.

Device examplesInspire® UAS system is the FDA‑approved example cited in trials and policy.

Attended polysomnography

Attended polysomnography definitionAttended polysomnography (PSG) = laboratory‑based sleep study with technologist present that records multiple physiologic channels to evaluate AHI, central/mixed apnea proportions, and other metrics relevant for device candidacy.

RoleRequired to evaluate central/mixed apnea percentage for HNS eligibility and to confirm severity when device‑specific criteria call for attended PSG.

Drug-induced sleep endoscopy (DISE)

DISE definitionDrug‑induced sleep endoscopy (DISE) = endoscopic assessment under medication‑induced sleep to evaluate airway collapse patterns; used to confirm absence of complete concentric palatal collapse for HNS candidates.

Requirement for HNSPolicy requires DISE confirmation of absence of complete concentric collapse of the soft palate for HNS eligibility in adults and adolescents per FDA and policy language.

2025-11-01adolescent_criteria_update

Clarified adolescent Down syndrome HNS criteria to require attended polysomnography for diagnosis of severe OSA and to specify drug‑induced sleep endoscopy terminology for collapse assessment.

2025-11-01coding_update

Added CPT/HCPCS codes 0964T, 0965T, 0966T, and E0490 to the policy's applicable codes list.