Obstructive and Central Sleep Apnea Treatment (for New Mexico Only)
Clinical coverage and medical necessity criteria for non‑surgical and surgical treatments of obstructive and central sleep apnea for UnitedHealthcare members in New Mexico.
Policy Summary
PayerUnitedHealthcare
PolicyObstructive and Central Sleep Apnea Treatment (for New Mexico Only)
Policy CodePolicy CS116NM.D
Change TypeCriteria revisions and code additions
Effective DateNov 1, 2025
Next Review DateN/A
Key ActionObtain and document attended polysomnography demonstrating required AHI/RDI thresholds and submit prior authorization with supporting PSG and prior PAP therapy documentation.
Added notation that polysomnography should be repeated if there has been clinically significant weight loss or gain, changes in cardiovascular disease, or persistent or recurrent symptoms since the last study.
Replaced criterion requiring 'diagnosis of moderate to severe OSA (AHI or RDI ≥ 15)' with 'moderate to severe OSA (AHI ≥ 15 or RDI ≥ 15) as determined by Polysomnography (Attended)'.
Replaced criterion for adolescents with Down syndrome for hypoglossal nerve stimulation to specify diagnosis of severe OSA as determined by Polysomnography (Attended) and an AHI ≥ 10 and RDI ≤ 50 events per hour.
Added CPT/HCPCS codes 0964T, 0965T, 0966T, and E0490 to applicable codes.
Added definition of 'Respiratory Disturbance Index (RDI)'.
New Mexicoapplies only to
AHI ≥15adult moderate OSA threshold
AHI ≥10adolescent HNS AHI threshold
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1FDA-cleared HNS device referenced
4new codes added
Coverage Criteria and Evidence-based Coverage Decisions
UPPP, MO, MMA — adult
Covered when ALL of the following are met
Adult surgical criteria: Moderate to severe OSA as determined by attended polysomnography (AHI ≥ 15 or RDI ≥ 15); excessive daytime sleepiness documented (Epworth Sleepiness Scale > 10 or another validated tool); and a trial of PAP therapy that resulted in no therapeutic efficacy, patient refusal, or intolerance.AHI ≥ 15 or RDI ≥ 15; ESS > 10
Additional procedure‑specific anatomic criteria apply for MMA and MO (see policy).
Hypoglossal nerve stimulation — adult
Covered when ALL of the following are met
Hypoglossal nerve stimulation (adult): Body mass index ≤ 40 kg/m2; AHI ≥ 15 and ≤ 100 as determined by attended polysomnography; total central + mixed apneas < 25% of the AHI; absence of complete concentric collapse of the soft palate on drug‑induced sleep endoscopy (DISE); and PAP therapy resulted in no therapeutic efficacy, patient refusal, or intolerance.BMI ≤ 40; AHI 15–100; central+mixed <25%
Device must be FDA‑approved (e.g., Inspire) and used in accordance with FDA guidelines.
Hypoglossal nerve stimulation — adolescent Down syndrome
Covered when ALL of the following are met
Hypoglossal nerve stimulation (adolescents with Down syndrome): Age 10–18 years with Down syndrome; attended polysomnography demonstrating severe OSA with AHI ≥ 10 and RDI ≤ 50 events/hour; BMI < 95th percentile for age; total central + mixed apneas < 25% of the AHI; contraindication to or not effectively treated with prior adenotonsillectomy; confirmed failure or intolerance of PAP despite attempts to improve compliance; absence of tracheostomy use during sleep; absence of complete concentric collapse of the soft palate on DISE; and individual and caregiver refusal of MMA for non‑concentric palatal collapse.AHI ≥ 10; RDI ≤ 50; central+mixed <25%
Device must be FDA‑approved for this pediatric Down syndrome indication and criteria reference the FDA pediatric expansion.
Removable Oral Appliances
Covered when ALL of the following are met
Oral Appliance Therapy (OAT): Diagnosis of OSA documented by a sleep study (polysomnography or HSAT); a face‑to‑face evaluation by a qualified sleep‑trained physician (MD/DO) or an APP supervised by such a physician prior to initiating OAT; a treating physician or supervised APP has diagnosed OSA and recommended OAT; and when OAT is used as an alternative to PAP, documentation that PAP therapy resulted in no therapeutic efficacy, intolerance, or refusal.OSA documented by sleep study; face‑to‑face evaluation prior to OAT
A qualified dentist must fit a custom, titratable appliance and a plan for periodic dental and sleep physician follow‑up including objective follow‑up sleep testing should be documented per guideline recommendations.
Unproven non-surgical
Not medically necessary
Unproven non‑surgical therapies: Devices for treating positional OSA; nasal dilator devices; intranasal expiratory resistance valve (e.g., Bongo Rx); removable oral appliances for treating central sleep apnea; prefabricated oral appliances/devices; non‑surgical electrical muscular training (eg, eXciteOSA with inconclusive evidence); mandibular vertical repositioning devices (eg, Slow Wave); morning repositioning devices; epigenetic appliances; and Advanced Lightwire Functional (ALF) appliances.Insufficient evidence of efficacy
These items are considered unproven and not medically necessary based on available evidence summaries.
Implantable neurostimulation — CSA
Not medically necessary
Implantable neurostimulation for CSA: Implantable neurostimulation devices (eg, transvenous or other implantable phrenic nerve or neurostimulation systems) for treatment of Central Sleep Apnea are unproven and not medically necessary due to insufficient evidence of safety and/or efficacy.Insufficient evidence
Although some trials show short‑term AHI improvements, limitations in study design, lack of long‑term data, and potential biases support a noncoverage stance.
Evidence-based coverage considerations for device categories
Evidence‑summary based coverage considerations
Implantable hypoglossal nerve stimulation: FDA‑cleared option for select adults with moderate‑to‑severe OSA who are unable or unwilling to use PAP; requires documentation of prior PAP intolerance or failure and diagnostic confirmation by attended polysomnography.Moderate‑to‑severe OSA (per device/guideline thresholds)
Device example: Inspire; patient selection and exclusions (eg, complete concentric palatal collapse) per device labeling and DISE findings.
Positional therapy devices: Short‑term studies and systematic reviews report some AHI improvement and possibly better short‑term adherence than CPAP, but overall evidence is low‑to‑moderate quality with unclear long‑term efficacy; consider for positional OSA when CPAP is unacceptable and patient meets positional criteria.POSA criteria per ERS (supine AHI ≥2× non‑supine and non‑supine AHI <15)
Includes vibratory devices and NightBalance/Lunoa evidence summaries.
Covered when aligned with guideline‑recommended indications and processes
OAT general coverage conditions: A qualified medical diagnosis of OSA is documented; patient is an appropriate candidate for OAT (for example, mild‑to‑moderate OSA or intolerance/failure of CPAP); referral to and fitting by a qualified dentist using a custom, titratable appliance; and documentation of a plan for periodic dental and sleep physician follow‑up including objective follow‑up sleep testing to confirm efficacy.
Based on AASM, AAO‑HNS, AADSM, and AAOMS guidance; custom titratable appliances preferred over prefabricated devices.
Surgical treatment - coverage conditions
Surgical interventions may be covered when ALL of the following apply
Surgery coverage conditions: Documentation of OSA with appropriate diagnostic testing (eg, attended polysomnography) and trial/failed or intolerance of medically appropriate non‑surgical therapies where applicable; anatomic upper‑airway obstruction amenable to the planned surgery identified by appropriate specialists; expected clinical benefit justifies surgical risk based on available evidence; and a documented surgical plan with pre‑ and post‑operative evaluation is provided.
Evidence quality varies by procedure; MMA has consistent effectiveness data while pharyngeal procedures have more heterogeneous outcomes.
Study-based enrollment criteria (informational)
Patients included in the cited studies generally met the following:
Common trial enrollment criteria: Adults (age ≥ 18) or study‑specified pediatric/adolescent cohorts; attended polysomnography demonstrating moderate‑to‑severe disease per trial definitions; prior trial and failure/intolerance of CPAP for hypoglossal nerve stimulation studies; and DISE used in some pediatric/Down syndrome HNS studies to exclude circumferential palatal collapse.See supporting study protocols for numeric AHI/RDI ranges
Informational summary of typical study selection criteria, not policy rules.
Coverage-relevant evidence summaries
Coverage stance depends on strength of evidence and demonstrated clinical benefit; many procedures are considered experimental/inconclusive due to low‑quality evidence.
Implantable neurostimulation for CSA: Early RCTs show AHI reductions with transvenous phrenic nerve stimulation but limitations include lack of long‑term follow‑up, small sample sizes, and potential bias; evidence insufficient for routine coverage.Evidence insufficient for routine coverage
See remedē trial summaries and evidence assessments.
LAUP: Systematic reviews and trials provide mixed outcomes with potential for worsening OSA and significant complication rates; evidence insufficient to support routine use.Not routinely covered; experimental/investigational
Meta‑analysis shows some worsening of AHI in subsets; use with caution or not at all.
Lingual suspension/tongue fixation:
General coverage logic for surgical/device interventions
Surgical or device‑based interventions are considered when ALL of the following apply:
initial: Patient has documented OSA with objective baseline testing (eg, attended polysomnography) and clinically significant symptom burden.AHI/RDI classification per clinician
See guideline references for severity distinctions.
prior_therapy: Patient has attempted and is intolerant of or has inadequate response to first‑line noninvasive therapy (eg, CPAP) or appropriate oral appliance therapy, with documentation of trials and attempts to optimize adherence.Documented trial/intolerance
AASM and AAO‑HNS recommend CPAP as initial therapy for moderate‑to‑severe OSA; consider oral appliance for mild‑moderate disease.
procedure_selection: Procedure selection (eg, RFA, TORS, MMA, UPPP, HNS) is based on anatomic site(s) of obstruction identified by multidisciplinary evaluation and expected benefit justifies surgical risk.
RFA_consider: RFA may be considered for patients with mild to moderate OSA who cannot tolerate or refuse CPAP or oral appliances, recognizing evidence quality is low and long‑term safety/efficacy are uncertain.Clinical judgment per guideline option recommendations
Transoral Robotic Surgery (TORS) coverage considerations:
TORS_consider: TORS may be considered as part of multilevel surgical management for select patients with tongue‑base obstruction not amenable to less invasive approaches, with counseling on morbidity and limited high‑quality comparative evidence.Patient selection and counseling on morbidity
Studies show AHI and ESS improvements but evidence is limited by retrospective series and lack of RCTs; reported complication rates can be substantial.
DOME (maxillary expansion)
Distraction osteogenesis for maxillary expansion (DOME):
DOME_not_well_supported: Insufficient quality evidence to conclude effectiveness for adult OSA; considered experimental/investigational pending higher‑quality comparative studies and long‑term outcomes.Lack of RCTs and long‑term outcomes
Existing case series report improvements but are limited by small size and lack of controls.
HNS_guidance: Hypoglossal nerve stimulation is positioned as a second‑line/salvage therapy for select patients with moderate‑to‑severe OSA intolerant of PAP; guideline panels caution against first‑line use and recommend selection based on AHI, BMI, anatomy, and prior PAP failure.Patient selection per guideline/device criteria (eg AHI, BMI, DISE findings)
ERS, AASM, VA/DoD and other guideline statements highlight salvage role and selection limits (eg AHI upper bounds, BMI limits historically).
ASV_CSA_CHF: Adaptive servo‑ventilation (ASV) is not recommended for CSA related to heart failure in adults with LVEF ≤ 45% and moderate/severe CSA; may be considered when LVEF > 45% or in mild CHF‑related CSA per AASM guidance.LVEF cutoff 45%
AASM practice parameter (Aurora 2016).
Device-specific coverage criteria
Coverage expectations align with device‑specific FDA indications and selection criteria:
Inspire UAS adult indication: Patient selection must meet Inspire device criteria: adults within the device AHI limits (expanded lower limit ≤15 and upper limit up to 100 per PMA supplement), have failed or are intolerant of PAP therapy, do not have complete concentric collapse at the soft palate level, and have BMI within device‑specified limits (expanded upper BMI to 40).AHI and BMI limits per PMA supplements
Refer to Inspire PMA and supplements for exact numeric limits and exclusion criteria.
Inspire UAS pediatric Down syndrome indication: Pediatric patients (per FDA expansion) with Down syndrome meeting the pediatric criteria (eg, ages and AHI/RDI thresholds) who are contraindicated for or not effectively treated by adenotonsillectomy and who have failed or cannot tolerate PAP may meet the pediatric indication, provided absence of complete concentric palatal collapse on DISE.AHI 10–50 per pediatric PMA expansion
See FDA pediatric supplemental PMA documentation (March 20, 2023) for full criteria.
Surgical Treatment — Adult
Coverage criteria were revised for selected surgeries and hypoglossal nerve stimulation; polysomnography (attended) is required to establish thresholds.
Adult surgical procedures (e.g., UPPP, MO, MMA): Covered when attended polysomnography demonstrates moderate to severe OSA defined as AHI ≥ 15 or RDI ≥ 15 and other procedure‑specific criteria are met.AHI ≥ 15 or RDI ≥ 15
Polysomnography should be repeated if there has been clinically significant weight change, changes in cardiovascular disease, or persistent/recurrent symptoms since the last study.
Implantable Hypoglossal Nerve Stimulation — Adolescents with Down Syndrome
Coverage criteria for adolescents (ages 10-18) with Down syndrome were revised to specify attended polysomnography thresholds.
Adolescent hypoglossal nerve stimulation (10-18 years): Covered when attended polysomnography demonstrates severe OSA with AHI ≥ 10 and RDI ≤ 50 events per hour and device‑specific FDA criteria are met.AHI ≥ 10 and RDI ≤ 50
Polysomnography must be attended; device must be FDA‑approved for this pediatric indication and DISE should exclude circumferential palatal collapse where required.
The policy lists several specific surgical procedures as unproven and not medically necessary for treatment of OSA because of insufficient evidence of efficacy. Examples include laser-assisted uvulopalatoplasty (LAUP), lingual suspension (tongue suspension/tongue fixation), isolated hyoid myotomy, stand‑alone uvulectomy, palatal implants, radiofrequency ablation of the soft palate and/or tongue base, transoral robotic surgery (TORS), and distraction osteogenesis for maxillary expansion (DOME). Systematic reviews and meta‑analyses report primarily case series, small sample sizes, heterogeneous approaches, and inconsistent outcomes across these procedures, limiting conclusions about safety and long‑term effectiveness.
The policy explicitly states that removable oral appliances are not supported for treatment of Central Sleep Apnea (CSA) because CSA is driven by impaired respiratory drive rather than anatomic obstruction; no relevant evidence was identified to support oral appliances for CSA. Submissions for removable oral appliances proposed to treat CSA are therefore at risk for denial due to insufficient evidence of efficacy.
Several intraoral and craniofacial appliance types are identified as lacking quality evidence and are not supported for OSA treatment. The document notes morning repositioning devices, epigenetic appliances (for example Homeoblock™, DNA®), and Advanced Lightwire Functional (ALF) appliances have no quality published studies demonstrating efficacy. Similarly, mandibular vertical repositioning devices (e.g., Slow Wave) were not supported by quality evidence. These devices are considered unsupported and would be subject to noncoverage determinations.
Drug‑induced sleep endoscopy (DISE) was used as an enrollment or pre‑implantation assessment in several adolescent and Down syndrome hypoglossal nerve stimulation studies. These studies often excluded patients with circumferential (complete concentric) palatal collapse identified on DISE, and DISE findings informed candidate selection for implantation in pediatric/Down syndrome cohorts.
The policy indicates that uvulectomy as a stand‑alone procedure is not supported by sufficient evidence to treat OSA. Evidence reviews (Hayes 2023) conclude there is inadequate peer‑reviewed literature to establish the efficacy of isolated uvulectomy for OSA.
The National Institute for Health and Care Excellence (NICE) guidance is cited to state that evidence for soft‑palate (palatal) implants is inadequate to demonstrate efficacy for OSA. NICE therefore advises that soft‑palate implants should not be used for treatment of OSA outside special arrangements for research and clinical governance.
The Inspire Upper Airway Stimulation (UAS) system carries device‑specific exclusions in its indication. Per the FDA device labeling and policy discussion, patients with complete concentric collapse at the soft palate level are excluded from Inspire implantation; absence of this collapse (often assessed by DISE) is required for appropriate device candidacy.
This policy is intended to assist interpretation of UnitedHealthcare standard benefit plans in New Mexico; however, federal, state, or contractual requirements may differ and govern in the event of conflict. Providers should verify that applicable plan or regulatory requirements do not override the policy statements before relying on them for coverage decisions.
In summary, the policy groups investigational or experimental device and procedure categories that lack sufficient quality evidence and are generally considered not medically necessary. These include: removable oral appliances for CSA, numerous positional and novel oral devices (mandibular vertical repositioning, morning repositioning, epigenetic, ALF), many minimally invasive palatal and soft‑tissue interventions (palatal implants, certain RFA protocols, LAUP), TORS and some tongue‑base procedures, DOME (maxillary expansion), and implantable neurostimulation for CSA. The common rationale is insufficient high‑quality randomized or long‑term comparative data demonstrating clinically meaningful benefit and acceptable safety.
Nasal dilators and intranasal expiratory resistance valves (EPAP) are described as having limited or low‑quality evidence. Systematic reviews show most studies found no significant change in AHI with external or internal nasal dilators, and randomized trials of EPAP (eg, Provent) demonstrated recurrence of OSA after CPAP withdrawal and inferiority to CPAP in moderate‑to‑severe OSA. The policy concludes evidence is insufficient to broadly support these devices as alternatives to CPAP for moderate‑to‑severe OSA.
The document reiterates that morning repositioning devices, epigenetic appliances, and ALF appliances have no quality evidence supporting their use for OSA. Because no published clinical studies demonstrate benefit, these devices are considered unsupported and would be subject to noncoverage determinations if submitted as OSA therapies.
Evidence regarding Laser‑Assisted Uvulopalatoplasty (LAUP) is heterogeneous and insufficient to support routine use. Systematic reviews and meta‑analyses report mixed outcomes, small and mainly nonrandomized studies, and a notable portion of patients with worsening AHI after LAUP. Given inconsistent efficacy data and limited long‑term follow‑up, LAUP results are considered inconclusive and not reliably effective.
LAUP may worsen obstructive sleep apnea in some patients and has been associated with a relatively high complication rate in pooled analyses. The policy cites meta‑analytic findings showing a proportion of patients experienced AHI worsening after LAUP and emphasizes that, because of these safety and outcome concerns, LAUP is not considered medically necessary as routine therapy for OSA.
The policy states that procedures supported only by low‑quality, biased, or inconclusive evidence are considered investigational. Examples discussed include certain palatal implant studies and radiofrequency ablation reports, which are primarily small, nonrandomized series or studies judged to have high risk of bias; until robust controlled data exist, these procedures are considered investigational or not medically necessary.
Distraction osteogenesis for maxillary expansion (DOME) is described as having insufficient quality evidence to support its use in adults with OSA. The literature is limited to case series and retrospective cohorts without randomized comparisons or long‑term outcomes; therefore DOME is considered investigational or not medically necessary pending higher‑quality studies.
The policy notes that some minimally invasive procedures and device uses fall outside their cleared or approved indications and may lack supporting evidence. Examples include certain palatal implants, RFA protocols, and tongue suspension devices; when use is outside of FDA‑cleared indications or lacks corroborating high‑quality evidence, the therapy may be considered unsupported and not medically necessary.
No additional not medically necessary statements are present in the provided policy fragment.
Applicable Codes, Thresholds, and Coding Guidance
Jaw expansion prosthesis 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.
Covered and referenced device and surgical codesmixed
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.
41512
Tongue base suspension, permanent suture technique.
41530
Submucosal ablation of the tongue base, radiofrequency, 1 or more sites, per session.
Implantable neurostimulator codesmixed
L8679
Implantable neurostimulator, pulse generator, any type.
L8680
Implantable neurostimulator electrode, each.
Described devices (FDA-cleared)mixed
P130008S089
PMA supplement for Inspire Upper Airway Stimulation expanded indications (pediatric Down syndrome, ages 13-18, AHI ≥10 and ≤50).
Placeholder — no explicit CPT/HCPCS/ICD codes providedmixed
No codes listed
Procedures and devices discussed (codes not listed)mixed
K180608
FDA 510(k) or device identifier referenced in supporting information (include for cross-reference).
FDA-cleared/authorized devices referencedmixed
DEN200018
eXciteOSA device — de novo for removable tongue muscle stimulation (AHI <15).
K191320
Slow Wave DS8 — 510(k) for reduction/alleviation of snoring.
P160039
remedē System PMA for implantable phrenic nerve stimulator for CSA.
K981677
AIRvance Tongue Suspension system 510(k).
K040417
Pillar Palatal Implant System 510(k).
K030108
ArthroCare ENT Coblator Surgery System 510(k).
K982717
Somnoplasty System 510(k).
Referenced FDA device identifiers and PMA/510(k)/de novo numbersmixed
K180619
Additional FDA 510(k) identifier referenced in documentation (include for cross-reference).
P130008S098
PMA supplement for Inspire V Model 3150 Implantable Pulse Generator (approved Aug 1, 2024).
Applicable CPT/HCPCS Codes (added)mixed
E0486
Oral device/appliance used to reduce upper airway collapsibility, 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.
Prior Authorization, Documentation, and Operational Requirements
Prior Authorization
Prior Authorization for Surgical/Device Interventions
Prior authorization is required for surgical and device-based interventions listed below. Requests should include documentation that conservative therapy (including a trial of positive airway pressure [PAP] when clinically appropriate) was attempted and either produced no therapeutic benefit, was not tolerated, or was refused. Prior authorization decisions for implantable devices are aligned with eligibility criteria used in key clinical studies and FDA-labeled indications.
Prior authorization required for implantable hypoglossal nerve stimulation devices (e.g., Inspire) and implantable neurostimulation devices (e.g., remedé) prior to implantation.
Include documentation of prior PAP trial (type, duration, adherence data) or documentation of intolerance/refusal.
Provide attended polysomnography results demonstrating AHI and/or RDI meeting device-specific thresholds and repeat polysomnography if clinically indicated (e.g., significant weight change, new cardiovascular disease, persistent/recurrent symptoms).
Document drug-induced sleep endoscopy (DISE) when required by device labeling (e.g., to confirm absence of complete concentric collapse for Inspire).
Prior Authorization
Prior authorization reflects study eligibility
Clinical Background and Context
Obstructive Sleep Apnea (OSA) is characterized by recurrent upper airway obstruction during sleep producing apneas and hypopneas with associated symptoms such as excessive daytime sleepiness, impaired quality of life, and cardiometabolic consequences. Diagnostic severity is commonly expressed using the Apnea‑Hypopnea Index (AHI), and management options include positive airway pressure (first‑line), oral appliance therapy for appropriate candidates, and surgical or device‑based approaches for selected patients.
Definitions and Measurement Thresholds
Apnea / Hypopnea / AHI — definitions and calculation
Apnea definitionApnea: cessation of airflow lasting at least 10 seconds (≥90% decrease in sensor excursions compared to baseline)
Hypopnea definitionHypopnea: ≥30% reduction in airflow for at least 10 seconds associated with ≥3% oxygen desaturation or an arousal
AHI calculationAHI = (Apneas + Hypopneas) × 60 / total sleep time (events per hour); used as primary efficacy endpoint in device and surgical studies
OSA severity categories — AASM
Mild OSAAHI or RDI ≥ 5 and < 15 events/hour
Moderate OSAAHI or RDI ≥ 15 and ≤ 30 events/hour
Policy Change Log
2025-11-01material_revisionLatest
Revised surgical coverage criteria: replaced wording to require attended polysomnography determination of moderate to severe OSA (AHI ≥15 or RDI ≥15) and added guidance to repeat polysomnography after significant weight or cardiovascular changes or recurrent symptoms.
2025-11-01material_revision
Revised adolescent Down syndrome hypoglossal nerve stimulation criteria to require attended polysomnography with AHI ≥10 and RDI ≤50 events/hour.
2025-11-01
Policy Summary
PayerUnitedHealthcare
PolicyObstructive and Central Sleep Apnea Treatment (for New Mexico Only)
Policy CodePolicy CS116NM.D
Change TypeCriteria revisions and code additions
Effective DateNov 1, 2025
Next Review DateN/A
Key ActionObtain and document attended polysomnography demonstrating required AHI/RDI thresholds and submit prior authorization with supporting PSG and prior PAP therapy documentation.
Nasal dilators generally do not change AHI; EPAP devices (eg, Provent) can reduce AHI in some short‑term trials but are inferior to CPAP and limited by short follow‑up and selection bias; evidence insufficient to broadly support as alternatives to CPAP for moderate‑severe OSA.
Varies by study; many short‑term trials
Consider limited use only in select, well‑documented cases.
Oral appliances and intraoral devices: Custom mandibular repositioning devices have evidence supporting use in mild‑to‑moderate OSA; prefabricated devices are less effective; intraoral electrical stimulation devices (eg, eXciteOSA) have very low‑quality evidence with inconclusive support for mild OSA and snoring.Mild‑to‑moderate OSA for custom MRD
Follow guideline recommendations regarding custom, titratable appliances and follow‑up testing.
Unsupported/experimental devices: Mandibular vertical repositioning devices, morning repositioning devices, and epigenetic appliances have no quality evidence to support efficacy and are considered unsupported.None
Such devices are likely investigational/not medically necessary.
Case series report variable success and device‑related complications (including anchor failures); evidence limited and further study required.
May be considered investigational or limited coverage
Device failure rates in case series limit generalizability.
Hyoid myotomy/suspension: Small nonrandomized studies report AHI improvement but evidence is limited; not adequate to support broad coverage without further research.Insufficient evidence for broad coverage
Consider within context of multilevel surgical planning.
Palatal implants: Randomized trials and case series report modest and mixed results; overall evidence limited by small samples and short follow‑up and does not support broad efficacy claims.Limited/conditional or investigational
NICE guidance advises against routine use for OSA due to inadequate efficacy evidence.
Radiofrequency ablation (RFA): Some short‑term improvements reported for mild‑to‑moderate OSA but evidence quality is low with high bias and lack of long‑term outcomes; results remain inconclusive.Investigational or limited coverage
ECRI and systematic reviews characterize evidence as low quality.
Anatomic/diagnostic correlation
Many guidelines recommend multilevel surgery when multiple obstruction sites exist.
remedē System indication: The remedē System is indicated for treatment of moderate to severe central sleep apnea in adults per its PMA approval; coverage should follow the PMA indication and supporting evidence.Moderate‑to‑severe CSA per PMA
PMA P160039.
Other FDA cleared/de novo devices: Devices cleared via 510(k) or de novo (eg, Somnoplasty, Coblator, AIRvance, Pillar implants, eXciteOSA, Slow Wave DS8) have specific labeled indications (snoring, mild‑to‑moderate OSA, tissue ablation); coverage should align with FDA indications and the supporting evidence base.Varies by device
Refer to individual device FDA documentation for approved indications.
Prior authorization requirements reflect the eligibility criteria used in pivotal clinical trials and in FDA approvals. Requests for implantable devices should demonstrate that the member meets device-specific enrollment/labeling criteria (including AHI/RDI thresholds, BMI limits, and anatomic findings when required).
Align submitted clinical data with trial eligibility (e.g., STAR trial, remedē trials) — include baseline AHI, percent central/mixed apneas, BMI, and relevant exclusionary findings.
For treatments evaluated in randomized trials, supply the same key diagnostic and pre-implant testing used in those studies (e.g., attended PSG within 6 months, DISE findings).
Documentation Required
Documentation of initial evaluation required
Documentation of an initial face-to-face evaluation by a qualified physician (MD or DO) trained in sleep medicine, or an Advanced Practice Provider under direct physician supervision, is required before initiating oral appliance therapy (OAT) or advancing to device/surgical interventions.
Evaluation must document diagnosis of OSA and a treating physician or supervised APP recommendation for OAT or next-line therapy.
For OAT coverage, include provider name, specialty, date of face-to-face visit, and clinical rationale.
Denial Risk
Denial risk for unsupported device categories
For removable oral appliances and other non-surgical devices, denials may be issued for device categories lacking quality evidence or for indications unsupported by the literature.
High denial risk: removable oral appliances for central sleep apnea (CSA), mandibular vertical repositioning devices, morning repositioning devices, epigenetic appliances, and Advanced Lightwire Functional (ALF) appliances.
Requests for these unsupported categories should include high-quality evidence demonstrating efficacy for the requested indication; absence of such evidence may result in denial.
Denial Risk
Devices lacking evidence
Several device categories lack sufficient high-quality evidence to support coverage. When such devices are requested, prior authorization reviewers will evaluate the quality, size, and duration of supporting studies and may deny when evidence is inadequate.
Devices lacking evidence include mandibular vertical repositioning devices, morning repositioning devices, epigenetic appliances, and ALF devices.
Limited or low-quality studies, absence of randomized controlled trials, small sample sizes, short follow-up, or manufacturer-sponsored bias increase the likelihood of noncoverage.
Denial Risk
Evidence limitations may trigger denial
Evidence limitations (small samples, retrospective designs, lack of control groups, short follow-up) may trigger denial or requests for additional information. Provide robust, peer-reviewed clinical data when requesting coverage for less-established procedures or devices.
Submit full study details for supporting literature (design, sample size, follow-up duration, outcomes, and conflicts of interest).
If available, include comparative data versus standard therapies (CPAP) or guideline-supported alternatives.
Prior authorization will generally require documentation that conservative therapies were attempted prior to surgical or implantable device interventions. CPAP is expected as the first-line therapy for moderate to severe OSA unless contraindicated or not tolerated.
Conservative therapy requirement: documented trial of PAP (CPAP/APAP/BiPAP) with dates, adherence data, therapeutic efficacy assessment, and efforts to optimize tolerance.
If PAP was not used, include clinical justification (e.g., intolerance despite optimization, refusal) and documentation of attempts to improve adherence.
Oral appliance therapy (OAT) may be acceptable for mild–moderate OSA or for patients intolerant of PAP; document supervising providers and treatment response.
Documentation Required
Clinical documentation for OAT
Clinical documentation required for Oral Appliance Therapy (OAT) must follow guideline-based pathways and include diagnosis, supervision, and evidence of prior PAP trial or reason for PAP intolerance/refusal when applicable.
Face-to-face evaluation by a qualified sleep physician (or supervised APP) prior to OAT.
Treating physician or APP must document diagnosis of OSA and recommend OAT as part of a care plan.
If OAT is being used because PAP failed or was not tolerated, include physician documentation of no therapeutic efficacy, intolerance, or refusal.
Provide follow-up testing results (e.g., PSG or HSAT) demonstrating OAT effectiveness when available, per AASM and AADSM guidance.
Documentation Required
Pre-implantation testing documented in studies
Pre-implantation testing documented in pivotal studies is expected with prior authorization requests for implantable stimulators and other device implants. Submit the same baseline evaluations used in clinical trials and device labeling.
Attended polysomnography within six months prior to implantation (or sooner if clinical changes) documenting baseline AHI/RDI and apnea phenotype (obstructive vs central/mixed).
Drug-induced sleep endoscopy (DISE) results when required to assess palate collapse (e.g., confirm absence of complete concentric collapse for Inspire eligibility).
For CSA implantable systems (e.g., remedé), document prior guideline-directed therapy, stability criteria, and baseline AHI thresholds consistent with study inclusion.
Prior Authorization
Inspire and device-specific indication constraints
Device-specific FDA indication constraints must be documented in prior authorization requests. Failure to demonstrate that the patient meets FDA-labeled criteria may result in denial.
Inspire UAS: document baseline AHI within device limits (currently lower bound ≥ 15 for adults and device-specific upper bounds per labeling), BMI within FDA-specified limits (≤ 40 kg/m2 per recent labeling), absence of complete concentric collapse on DISE, and prior PAP failure/intolerance.
remedē System (phrenic nerve stimulation): document indication for moderate–severe CSA per labeling and prior guideline-recommended therapies as required by study eligibility.
For newly approved device models, include model number and relevant FDA approval language to show conformance with labeling.
Severe OSA
AHI or RDI > 30 events/hour (AASM definition)
Epworth Sleepiness Scale (ESS) — threshold for excessive daytime sleepiness
ESS instrumentEpworth Sleepiness Scale (ESS) is an 8‑item questionnaire assessing daytime sleepiness
Excessive sleepiness thresholdESS score > 10 is used as a criterion for excessive daytime sleepiness in policy criteria
Use in coverage criteriaESS >10 is cited as required documentation of excessive daytime sleepiness for certain surgical indications (eg, UPPP)
HNS device descriptionHypoglossal nerve stimulation (HNS) is an implanted system (eg, Inspire) with a chest pulse generator and hypoglossal nerve lead that senses respiration and stimulates the nerve to move the tongue forward to open the airway
Clinical positioningInspire is indicated for adults intolerant of PAP and has device‑specific AHI/BMI selection criteria
Pediatric expansion noteFDA expanded Inspire pediatric indication for select adolescents with Down syndrome under specified PSG thresholds
Trial evidenceRandomized trials (eg Berry et al., 2011) show EPAP can reduce AHI in some patients but evidence limited by short follow-up and selection bias
Not first-line for moderate-severe OSAEPAP is generally inferior to CPAP and not broadly supported as alternative for moderate-severe OSA
eXciteOSA descriptionIntraoral electrical stimulation device delivering neuromuscular stimulation to the tongue (daily awake sessions) intended for snoring and mild OSA
FDA classificationeXciteOSA was cleared via de novo (DEN200018) for snoring and mild OSA with AHI < 15
Evidence qualitySystematic reviews and assessments report very low to low-quality evidence with limited comparative data
Qualified dentist (QD) — role definition for OAT
Qualified dentist roleA qualified dentist (QD) evaluates, fits, and follows patients using oral appliance therapy in collaboration with the diagnosing medical provider
Guideline supportAADSM and AASM recommend referral to a dental professional for custom, titratable appliances and follow-up testing
Documentation implicationPolicy requires documentation of medical diagnosis and collaboration with a QD when OAT is used as alternative to failed/intolerant PAP
Custom titratable oral appliance — definition
DefinitionCustom titratable oral appliance: dentist‑fitted mandibular advancement device that can be adjusted to optimize efficacy and limit dental side effects
Preferred over prefabricated devicesGuidelines suggest custom, titratable appliances over non‑custom devices due to greater efficacy and safety monitoring
Follow-up requirementSleep physician follow-up and objective testing are recommended to confirm efficacy after fitting
AHI — reiterated definition in definitions section
AHI definition (reiterated)AHI = number of apnea + hypopnea events per hour of sleep; primary efficacy endpoint in device and surgical studies
Use in policyAHI thresholds are required to document moderate-to-severe disease for coverage considerations
Measurement standardPolicy specifies attended polysomnography as determination method for AHI in many device/surgical criteria
PNS / TPNS — phrenic nerve stimulation definition
PNS/TPNS definitionPhrenic nerve stimulation (transvenous phrenic nerve stimulation, PNS/TPNS) is an implantable therapy (eg, remedē System) intended to treat central sleep apnea
Indication contextremedē System is PMA‑approved for moderate-to-severe CSA in adults
Evidence statusPolicy states evidence for PNS in CSA is insufficient for broad conclusions and additional research is needed
Palatal implants — definition
Palatal implants descriptionSmall woven polyester inserts placed in the soft palate intended to stiffen the palate and reduce airway collapse and snoring
Common trade namesExamples include Pillar® and Elevo® palatal implants
Evidence notePolicy finds insufficient evidence to conclude palatal implants are effective for OSA
RFTVR definitionRadiofrequency tissue volume reduction (RFTVR) uses low‑intensity radiofrequency energy to shrink the uvula, soft palate, and/or tongue to reduce airway obstruction
Trade namesExamples include Somnoplasty™ and Coblation®
Evidence notePolicy states evidence may support short‑term results but long‑term safety/efficacy remains uncertain
RFTVR — alternative phrasing / additional note
Alternative phrasingRFTVR also described as use of low‑intensity radiofrequency energy for uvula/soft palate/tongue tissue shrinkage; trade names Somnoplasty and Coblation referenced
Clinical contextOften performed alone or as part of multilevel procedures; evidence quality low
ImplicationConsidered investigational/limited when long‑term outcomes are lacking
Transoral Robotic Surgery (TORS) — definition
TORS definitionTransoral Robotic Surgery (TORS): robotic-assisted surgical approach to access and resect tissue from the tongue base and hypopharynx for OSA management
Use caseConsidered for tongue-base obstruction as part of multilevel surgical management
Evidence noteExisting studies are limited and mostly retrospective; long-term RCT data lacking
DOME — definition
DOME definitionDistraction Osteogenesis for Maxillary Expansion (DOME): surgical technique using custom distractors to expand the maxilla as potential OSA treatment
Evidence statusPolicy states insufficient quality evidence to conclude effectiveness for adult OSA
Typical patient contextReported in case series for CPAP-intolerant patients without palatine or lingual tonsillar hypertrophy
Inspire UAS system — definition and pediatric indication note
Inspire UAS system descriptionInspire Upper Airway Stimulation (UAS) system: an implantable hypoglossal nerve stimulation system intended to treat OSA in adults; device senses respiration and stimulates hypoglossal nerve to move the tongue forward
Pediatric expansion noteFDA expanded pediatric indication for select adolescents with Down syndrome (AHI ≥10 and ≤50) with other criteria; policy incorporated attended PSG requirement for this indication
Device selection criteriaInspire use requires meeting device PMA numeric AHI/BMI limits and absence of complete concentric palatal collapse on DISE
remedē System — definition
remedē System definitionThe remedē System is an implantable transvenous phrenic nerve stimulator indicated for treatment of moderate-to-severe central sleep apnea in adults (PMA P160039)
Evidence notePolicy states evidence for implantable neurostimulation in CSA is limited and further research is needed
Trial exampleCostanzo et al. (2016) randomized patients with AHI ≥ 20 to PNS vs control with primary endpoint AHI reduction ≥50% at 6 months
eXciteOSA — definition
eXciteOSA definitioneXciteOSA: a removable intraoral neuromuscular tongue stimulation device cleared by FDA (de novo DEN200018) for snoring and mild OSA (AHI < 15)
Use protocolTypically used as an awake daily 20‑minute protocol for several weeks per device instructions in trials/reports
Evidence noteSystematic reviews identify very low-quality evidence; comparative RCT data versus other OSA treatments are lacking
Respiratory Disturbance Index (RDI) — definition added in revisions
RDI definition (policy addition)Respiratory Disturbance Index (RDI) defined and added to policy definitions; used interchangeably with AHI for severity classification in some criteria
Policy usePolicy requires attended polysomnography to determine RDI where used for eligibility (eg adult surgical criteria and adolescent HNS thresholds)
Pediatric boundFor adolescents with Down syndrome considered for HNS, policy specifies RDI ≤ 50 events/hour as an upper bound
added_codes
Added CPT/HCPCS codes 0964T, 0965T, 0966T, and E0490 to the applicable codes list.
2025-11-01added_definition
Added definition for Respiratory Disturbance Index (RDI).