Obstructive and Central Sleep Apnea Treatment (for Indiana Only)
Clinical coverage rules and coding guidance for non‑surgical and surgical treatments of obstructive and central sleep apnea for UnitedHealthcare members in Indiana.
Policy Summary
PayerUnitedHealthcare
PolicyObstructive and Central Sleep Apnea Treatment (for Indiana Only)
Key ActionSubmit prior authorization with documented attended polysomnography, evidence of PAP failure or intolerance, and DISE findings when requesting implantable hypoglossal nerve stimulation.
Revised medical necessity clinical coverage criteria for surgical treatment of obstructive sleep apnea and implantable hypoglossal nerve stimulation.
Added reference to InterQual CP: Procedures for Orthognathic Surgery (adult and pediatric).
Removed references to InterQual CP criteria for Maxillomandibular Advancement and certain osteotomy procedures.
Added explicit medical necessity criteria for implantable hypoglossal nerve stimulation for members 18-21 years and for adolescents (10-18) with Down syndrome.
Revised language pertaining to medical necessity clinical coverage criteria and removed instruction referencing an external InterQual Medicare procedure WPS if medical necessity cannot be determined.
Added coverage criteria for implantable hypoglossal nerve stimulation in members 18 to 21 years old with moderate to severe OSA, including BMI ≤ 40 kg/m2, AHI ≥15 and ≤100 by attended polysomnography, central+mixed apneas <25% of total AHI, absence of complete concentric palatal collapse on DISE, and PAP therapy failure/refusal.
Added coverage criteria for implantable hypoglossal nerve stimulation in adolescents (10-18 years) with Down syndrome and severe OSA, including AHI ≥10, BMI <95th percentile, central+mixed apneas <25% of total AHI, PAP failure/intolerance, no tracheostomy during sleep, absence of concentric palatal collapse on DISE, and documented contra-indication/failure of adenotonsillectomy where applicable.
Added statements clarifying that benefit coverage is determined by federal, state, or contractual requirements and that medical records documentation may be required to support medical necessity but does not guarantee coverage.
Added definitions for Apnea, Epworth Sleepiness Scale (ESS), and Hypopnea; removed definition of 'Sleep Medicine Training' and updated the BMI definition.
Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.
Indiana-onlypolicy applicability
≥15; ≥10; >30AHI thresholds noted
75% (5yr)Inspire long-term success
18-21 yrsnew age group covered
10-18 yrsDown syndrome pediatric criteria
Coverage Criteria and Medical Necessity Rules
Removable Oral Appliances (OSA)
Covered when ALL of the following are met:
Removable Oral Appliances (OSA): Removable oral appliances are proven and medically necessary for treating obstructive sleep apnea (OSA) under certain circumstances; refer to InterQual CP: Durable Medical Equipment, Noninvasive Airway Assistive Devices for the detailed clinical coverage criteria.
See InterQual criteria for specifics.
Unproven Non‑Surgical Treatments
The following non‑surgical treatments are considered unproven and not medically necessary due to insufficient evidence of efficacy:
List is not necessarily exhaustive; use is not supported by sufficient evidence.
UPPP — Adults
Covered when ALL of the following are met:
UPPP coverage criteria in adults: Uvulopalatopharyngoplasty (UPPP) is proven and medically necessary in an adult patient when all the following are met: moderate to severe OSA (AHI ≥ 15 or RDI ≥ 15) by attended polysomnography; excessive daytime sleepiness documented with an Epworth Sleepiness Scale (ESS) > 10 or another validated tool; and PAP therapy resulted in no therapeutic efficacy or there is patient refusal or intolerance.AHI ≥15 or RDI ≥15; ESS >10
Additional anatomic/procedure‑specific criteria apply for MMA (craniofacial disproportion) or MO (retrolingual obstruction).
Hypoglossal Nerve Stimulation (HNS) — Adults 18–21 and ≥22
Implantable hypoglossal nerve stimulation (HNS) is covered when ALL of the following are met:
HNS coverage criteria (ages 18–21 and ≥22): Implantable HNS with an FDA‑approved device is proven and medically necessary for members aged 18–21 (and for members ≥22 per referenced InterQual criteria) when all of the following are met: BMI ≤ 40 kg/m2; AHI ≥ 15 and ≤ 100 as determined by attended polysomnography; total AHI with central + mixed apneas < 25% of total AHI; absence of complete concentric collapse of the soft palate confirmed by drug‑induced sleep endoscopy (DISE); PAP therapy resulted in no therapeutic efficacy or there is documented patient refusal or intolerance; and device use is consistent with FDA labeling/guidelines.AHI ≥15 and ≤100; central+mixed <25%; BMI ≤40 kg/m2
Hypoglossal Nerve Stimulation — Adolescents (10–18) with Down syndrome
Covered when ALL of the following are met for adolescents with Down syndrome (age 10–18):
Pediatric Down syndrome HNS criteria (10–18 yrs): Implantable HNS with an FDA‑approved device is proven and medically necessary for adolescents aged 10–18 with Down syndrome when all the following are met: diagnosis of severe OSA by an attended polysomnogram within 24 months with AHI ≥ 10 and RDI ≤ 50 events/hour; BMI < 95th percentile for age; total AHI with central + mixed apneas < 25%; contraindication for or not effectively treated with prior adenotonsillectomy when applicable; confirmed failure or intolerance of PAP therapy despite attempts to improve compliance; absence of tracheostomy use during sleep; absence of complete obstruction or concentric collapse of the soft palate on DISE; individual/caregiver refusal of MMA permitted for nonconcentric palatal collapse; and device use consistent with FDA guidelines.AHI ≥10; RDI ≤50; central+mixed <25%; BMI <95th percentile
Aligns with FDA‑expanded pediatric Inspire indication and policy additions.
Unproven Surgical Procedures for OSA
The following surgical procedures are considered unproven and not medically necessary due to insufficient evidence of efficacy:
Not medically necessary — surgical procedures: Laser‑assisted uvulopalatoplasty (LAUP); lingual suspension/tongue fixation; isolated hyoid myotomy; stand‑alone uvulectomy; palatal implants; radiofrequency ablation of soft palate and/or tongue base (when proposed as sole therapy with insufficient evidence); transoral robotic surgery (TORS); and distraction osteogenesis for maxillary expansion (DOME).
List is not all‑inclusive; see evidence summaries for procedure‑specific concerns.
Coverage considerations and evidence-based stance
Coverage considerations and evidence‑based stance informing medical necessity determinations:
Standard diagnostic requirement: Diagnosis and evaluation require polysomnography (PSG) or limited channel testing to establish OSA/CSA.
PSG referenced as diagnostic standard.
First‑line treatments: Lifestyle modification, positional therapy, and PAP (CPAP/APAP/BiPAP) are first‑line therapies; oral appliance therapy is appropriate for select patients intolerant of CPAP per guideline recommendations.
Limited‑evidence devices: Positional devices, nasal dilators, intranasal EPAP, prefabricated oral appliances, and non‑surgical electrical muscular stimulation have limited or low‑quality evidence and may be considered only with documentation of prior therapy intolerance or contraindication.
Hayes and ECRI assessments report low‑quality/inconclusive evidence.
Coverage decision framework
Framework for sequencing and guideline‑aligned placement of therapies:
First‑line therapy per guidelines: CPAP/APAP is recommended as initial therapy for moderate to severe OSA.
AASM and related societies recommend PAP as first‑line.
Oral appliance therapy role: Custom, titratable oral appliances may be used for mild‑to‑moderate OSA or for patients intolerant of CPAP; requires prescription by a sleep physician and fitting/oversight by a qualified dentist with follow‑up testing to confirm efficacy.
AADSM/AASM guidance recommends qualified dentist oversight and follow‑up testing.
HNS placement: Consider HNS as a second‑line or salvage therapy for symptomatic patients who cannot be sufficiently treated with CPAP or other guideline‑recommended therapies; ensure adherence to device labeling and selection criteria.
ERS and AAO‑HNS statements caution against first‑line use; evidence is low quality but suggests benefit in selected patients.
HNS — evidence and contextual criteria
Evidence‑based observations and contextual criteria for HNS:
HNS evidence summary: HNS has demonstrated improvements in AHI, ODI, ESS, and quality‑of‑life measures in clinical trials, case series, meta‑analyses, and the STAR trial; benefits are most consistently reported in patients who failed or were intolerant of CPAP. Limitations include small samples, nonrandomized designs, industry funding in some studies, and limited long‑term comparative data.
STAR trial showed median AHI reduction of 68% at 12 months; systematic reviews/meta‑analyses report sustained benefit in selected cohorts.
TPNS/remedē — evidence and contextual criteria
Evidence‑based observations for transvenous phrenic nerve stimulation (TPNS/remedē):
TPNS/remedē evidence summary: Randomized and observational studies of the remedē system show reductions in AHI/CAI and some quality‑of‑life improvements with follow‑up up to five years; however, overall evidence quality is rated very low to low and additional comparative and long‑term outcome data are needed.AHI ≥20 used in pivotal trial
Pivotal randomized trial reported 51% of treatment versus 11% of control achieved ≥50% AHI reduction at 6 months.
LAUP — evidence and contextual criteria
Evidence‑based observations for LAUP:
LAUP evidence summary: Systematic reviews and meta‑analyses indicate LAUP has low success and cure rates, a substantial proportion of patients experience worsening of AHI, and a high complication rate; evidence is insufficient to support LAUP as an effective treatment for OSA and caution or avoidance is recommended.
Camacho et al. reported ~23% success and 44% worsened AHI; Wischhusen reported high complication rates (~256 complications/1,000 procedures).
Evidence-based coverage statements by procedure
Procedure‑specific evidence summaries and coverage conclusions (evidence generally limited or inconclusive):
LAUP: High complication rates and modest-to-low efficacy; may worsen OSA in a substantial proportion of patients; generally not supported as routine therapy.
Systematic reviews/meta‑analyses report low success and high complication rates.
Lingual suspension / Tongue fixation: Evidence consists mainly of case series with heterogeneous results and variable complication rates; device/tissue‑anchor failures have been reported and long‑term comparative data are lacking.
Complication rates in meta‑analyses vary widely (overall ~12.79% reported).
Hyoid myotomy/suspension: Small series suggest possible AHI reductions when combined with UPPP; evidence is limited and long‑term efficacy is uncertain.
Evidence limited to small nonrandomized studies and case series.
DOME (Distraction Osteogenesis for Maxillary Expansion)
Evidence summary and coverage stance for Distraction Osteogenesis for Maxillary Expansion (DOME):
DOME evidence: DOME has insufficient quality evidence to conclude effectiveness for adult OSA; published literature lacks randomized controlled trials and long‑term outcomes.
Available data are retrospective case series with small sample sizes and no comparison groups.
Transoral Robotic Surgery (TORS)
Evidence summary and limitations for Transoral Robotic Surgery (TORS):
TORS outcomes and limitations: Systematic reviews and meta‑analyses report reductions in AHI and ESS and pooled surgical success in many series, but evidence is limited by retrospective designs, heterogeneity in techniques and patient selection, lack of randomized controlled trials, and variable complication rates; comparative superiority is not established.
Pooled success estimates vary (approximately 48–69%); complication rates reported around 22% in some reviews.
Guideline context informing placement of surgeries and device therapies:
Guideline‑based placement of therapies: Guidelines generally recommend CPAP as first‑line treatment for moderate to severe OSA; oral appliances are appropriate for select patients (mild‑to‑moderate OSA or CPAP intolerance); surgical and implanted device therapies are generally considered for patients who fail or cannot tolerate PAP therapy and should be selected based on patient anatomy, comorbidities, and guideline recommendations.
Specific recommendations vary by society (AASM, AAO‑HNS, ERS, VA/DoD, NICE).
Implantable/device therapies
Device‑specific coverage considerations and alignment with FDA labeling:
FDA‑labeled indications and coverage alignment: Coverage considerations for implantable devices should align with FDA‑labeled indications (for example, Inspire UAS labeled AHI/BMI/age limits and absence of complete concentric collapse on DISE; remedē labeled for moderate‑to‑severe CSA), and documentation of meeting device labeling should be provided for prior authorization review.
FDA approval is informational and does not in itself guarantee coverage; prior authorization documentation recommended.
HNS (ages 18–21) — initial coverage criteria: Member age between 18 and 21 years; attended polysomnography demonstrating AHI ≥ 15 and ≤ 100 and total AHI with central + mixed apneas < 25%; BMI ≤ 40 kg/m2; absence of a complete blockage or complete concentric collapse of the soft palate confirmed by DISE; PAP therapy resulted in no therapeutic efficacy or patient refusal or intolerance; device used in accordance with FDA guidelines.AHI ≥15 and ≤100; central+mixed <25%; BMI ≤40 kg/m2
Documentation (attended PSG, DISE, prior PAP trial) required for prior authorization.
Implantable hypoglossal nerve stimulation (adolescents with Down syndrome)
Covered when ALL of the following are met:
HNS (adolescents 10–18 yrs with Down syndrome) — initial coverage criteria: Member age between 10 and 18 years with Down syndrome; attended polysomnography within 24 months demonstrating AHI ≥ 10 and RDI ≤ 50 events/hour; BMI < 95th percentile for age; total AHI with central + mixed apneas < 25%; contraindication for or not effectively treated with prior adenotonsillectomy when applicable; confirmed failure or intolerance of PAP therapy despite attempts to improve compliance; absence of tracheostomy use during sleep; absence of a complete blockage or concentric collapse of the soft palate on DISE; individual and caregiver refusal of MMA allowed for nonconcentric palatal collapse; device used in accordance with FDA guidelines.AHI ≥10; RDI ≤50; central+mixed <25%; BMI <95th percentile
Aligns with FDA expanded pediatric indication and policy history additions; documentation required.
Uvulopalatopharyngoplasty (UPPP)
Covered when ALL of the following are met:
UPPP (adults) — coverage criteria: Moderate to severe OSA (AHI ≥ 15 or RDI ≥ 15) by attended polysomnography; excessive daytime sleepiness documented with ESS > 10 or another validated tool; and PAP therapy resulted in no therapeutic efficacy or patient refusal or intolerance.AHI ≥15 or RDI ≥15; ESS >10
Additional anatomic criteria apply for MMA (craniofacial disproportion) and MO (retrolingual obstruction) when relevant.
Orthognathic surgical selection criteria (MMA/MO)
Covered when ALL of the following are met (procedure‑specific selection criteria):
Maxillomandibular advancement (MMA): Evidence of craniofacial disproportion or deformity with documented maxillomandibular deficiency appropriate for MMA candidacy.clinical/anatomic evidence
Selection should follow guideline and specialty consultation.
Mandibular osteotomy (MO): Retrolingual or lower pharyngeal functional obstruction demonstrated and appropriate for MO candidacy.anatomic/functional localization
Selection should be based on objective evaluation and multidisciplinary assessment.
Initial coverage — 18 to 21 years
Covered when ALL of the following are met for members aged 18 to 21 years:
18-21 yrs HNS criteria
Age: Member age between 18 and 21 years
Diagnostic thresholds: AHI ≥15 and ≤100 as determined by attended polysomnography; total AHI with central + mixed apneas <25%AHI ≥15 and ≤100; central+mixed <25%
Attended PSG required
Anthropometric: BMI ≤40 kg/m2≤40 kg/m2
Initial coverage — Adolescents 10 to 18 years with Down syndrome
Covered when ALL of the following are met for adolescents aged 10 to 18 years with Down syndrome:
10-18 yrs Down syndrome HNS criteria
Age and diagnosis: Member age between 10 and 18 years with Down syndrome
Severity: Diagnosis of severe OSA by attended polysomnogram within 24 months with AHI ≥10 and RDI ≤50 events/hourAHI ≥10; RDI ≤50
Attended PSG required
Anthropometric: BMI <95th percentile for age<95th percentile
The policy explicitly lists Removable Oral Appliances for treating Central Sleep Apnea as not medically necessary. This reflects the absence of evidence that oral appliances, which are designed to address anatomic upper‑airway obstruction, are effective for CSA—a disorder of ventilatory drive rather than primarily anatomic collapse.
The policy states there is no relevant evidence supporting removable oral appliance use for Central Sleep Apnea and identifies prefabricated oral appliances for OSA as having limited evidence and not recommended by evidence‑based guidelines. Ready‑made or prefabricated devices have shown poorer tolerance and limited efficacy compared with custom, titratable appliances in the available trials.
Several intraoral and non‑surgical devices are described as lacking quality evidence and therefore considered unproven and not medically necessary. Examples include mandibular vertical repositioning devices (e.g., Slow Wave), morning repositioning devices, epigenetic appliances, and Advanced Lightwire Functional (ALF) appliances. The policy notes no high‑quality comparative studies support their safety or effectiveness for OSA.
The policy documents that laser‑assisted uvulopalatoplasty (LAUP) is associated with a high rate of complications and evidence of potential worsening of OSA in a substantial minority of patients; systematic reviews report many complications and low success/cure rates. Given these safety and efficacy concerns, LAUP should be avoided or performed only with caution in select patients using tissue‑sparing techniques.
Evidence assessments cited in the policy find insufficient evidence to support uvulectomy as a stand‑alone procedure for treatment of OSA. The literature does not demonstrate that isolated uvulectomy reliably improves AHI or other clinically meaningful outcomes.
The policy references guideline statements (AASM, NICE) noting that procedures such as LAUP and soft‑palate implants lack adequate evidence of efficacy. AASM does not routinely recommend LAUP for OSA, and NICE has concluded evidence for soft‑palate implants is inadequate to support routine use; both organizations recommend limiting these interventions to research or special arrangements.
The policy specifies that the presence of a tracheostomy used during sleep is an exclusion for implantable hypoglossal nerve stimulation in adolescents with Down syndrome, i.e., members with nocturnal tracheostomy use do not meet the HNS eligibility criteria outlined for that population.
Coverage is not provided when device use would be inconsistent with FDA‑labeled guidelines or when diagnostic evaluation by drug‑induced sleep endoscopy (DISE) demonstrates complete concentric palatal collapse. The policy requires adherence to FDA indications and absence of complete concentric collapse on DISE as part of HNS eligibility.
The policy groups multiple devices and procedures with limited or conflicting evidence as unproven and not medically necessary. This includes items from the non‑surgical and surgical lists (e.g., positional devices, nasal dilators, prefabricated appliances, LAUP, palatal implants, TORS, DOME). The unifying rationale is insufficient high‑quality evidence demonstrating clinically meaningful benefit.
Nasal dilators and intranasal expiratory positive airway pressure (EPAP) devices are reported to have inconsistent or negative effects on AHI and short‑term outcomes. Systematic reviews and randomized trials generally do not show consistent improvement in AHI compared with placebo or CPAP, and therefore these devices lack robust evidence of lasting clinical benefit.
The policy identifies several intraoral or orthodontic approaches that are not evidence‑based and therefore unsupported for OSA treatment. These include mandibular vertical repositioning devices, epigenetic appliances, ALF appliances, and other non‑evidence‑based orthodontic devices; the document notes a lack of quality studies demonstrating safety or efficacy.
For transvenous phrenic nerve stimulation (the remedē/TPNS system) the policy summarizes that available evidence is of very low to low quality, with small studies and limited follow‑up. Because clinical benefit and long‑term safety remain uncertain, indiscriminate use for central sleep apnea is not supported by the current evidence base.
Reiterating the LAUP evidence, the policy highlights an elevated complication burden and reports that a notable proportion of patients experience worsening of OSA after LAUP. For these reasons, LAUP is associated with high complication rates and potential morbidity, supporting the recommendation to avoid the procedure or use extreme caution when considered.
Procedures for which guideline bodies have concluded evidence is inadequate (for example, LAUP and soft‑palate implants per AASM and NICE) are identified as candidates to be considered not medically necessary in the absence of stronger evidence. The policy aligns its coverage stance with these guideline positions.
The policy replaces broader prior language about HNS being appropriate "in certain circumstances" with explicit, prescriptive medical necessity criteria for hypoglossal nerve stimulation. These revised criteria define numeric thresholds (e.g., AHI ranges, BMI limits), DISE findings, central apnea limits, and prior therapy failure requirements that must be met for coverage consideration.
The policy makes an administrative clarification that medical records documentation may be required to assess whether clinical criteria are met but that submission of documentation does not guarantee coverage. Benefit determinations remain subject to federal, state, and contractual requirements.
Billing Codes and Key Numeric Thresholds
Applicable CPT/HCPCS codes (part 1)CPT
0964T
Impression and custom preparation of jaw expansion oral prosthesis for obstructive sleep apnea, including initial adjustment; single arch, without mandibular advancement mechanism
Applicable CPT and related procedure codes (part 2)CPT
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
Neurostimulator and related CPT codesCPT
64570
Removal of cranial nerve (e.g., vagus nerve) neurostimulator electrode array and pulse generator
64582
Open implantation of hypoglossal nerve neurostimulator array, pulse generator, and distal respiratory sensor electrode or electrode array
64583
Revision or replacement of hypoglossal nerve neurostimulator array and distal respiratory sensor electrode or electrode array, including connection to existing pulse generator
64584
Removal of hypoglossal nerve neurostimulator array, pulse generator, and distal respiratory sensor electrode or electrode array
93150
Therapy activation of implanted phrenic nerve stimulator system, including all interrogation and programming
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 / 510(k) / PMA / de novo identifiers citedmixed
Pediatric Down syndrome HNS thresholdAHI ≥ 10 (adolescents 10–18 with Down syndrome, per FDA-expanded pediatric Inspire indication)
Upper severity categorySevere OSA defined as AHI > 30 events/hour
Mild OSA categoryMild OSA defined as AHI ≥ 5 and < 15 events/hour
BMI threshold for HNS
Prior Authorization, Documentation, and Submission Requirements
Prior Authorization
Prior Authorization Required
Prior Authorization Required. Prior authorization is required for implantable hypoglossal nerve stimulation (HNS), related implantable neurostimulator devices, and many surgical procedures for OSA. Providers in Indiana should consult the UnitedHealthcare Community Plan of Indiana prior authorization and notification list for state‑specific code management; certain codes (marked in Applicable Codes) are not managed for medical necessity review in Indiana. Failure to obtain prior authorization when required may result in claim denial.
Refer to the most up to date Indiana prior authorization list: Prior Authorization and Notification: UnitedHealthcare Community Plan of Indiana
Prior Authorization
Prior Authorization Expectations for HNS and Surgery
HNS and related surgical procedures typically require prior authorization. Documentation must show the member meets FDA‑labeled criteria (age, AHI, BMI, central apnea proportion, DISE findings) and that PAP therapy produced no therapeutic benefit or was refused/intolerant. For adolescents and adults, ensure device indication and labeled criteria (AHI/RDI ranges, BMI limits, absence of complete concentric collapse) align with the FDA clearance or expanded indications.
Document member age and BMI
Clinical Background and Definitions
Obstructive sleep apnea (OSA) is a disorder of recurrent upper‑airway collapse during sleep causing apneas and hypopneas that produce symptoms such as excessive daytime sleepiness and can lead to cardiometabolic and neurocognitive consequences. Central sleep apnea (CSA) results from impaired ventilatory drive and is commonly seen in patients with heart failure; CSA and OSA differ in mechanism, which informs why anatomic therapies (e.g., oral appliances) lack evidence in CSA and why device selection and patient evaluation (including polysomnography and DISE when required) are essential for appropriate treatment selection.
Apnea
Apnea definitionCessation of airflow (≥90% decrease) lasting at least 10 seconds; classified as obstructive, central, or mixed based on respiratory effort
Obstructive apnea characteristicObstructive apnea associated with continued or increased inspiratory effort during absent airflow
Central apnea characteristicCentral apnea associated with absent inspiratory effort during the event
Apnea Hypopnea Index (AHI)
Policy Summary
PayerUnitedHealthcare
PolicyObstructive and Central Sleep Apnea Treatment (for Indiana Only)
Key ActionSubmit prior authorization with documented attended polysomnography, evidence of PAP failure or intolerance, and DISE findings when requesting implantable hypoglossal nerve stimulation.
HNS as second‑line: HNS may be considered for selected patients with moderate‑to‑severe OSA who have failed or are intolerant of PAP; patient selection and adherence to device labeling and required anatomic evaluation (e.g., DISE) are essential.
STAR trial and systematic reviews show benefit in selected patients but evidence limitations exist.
CSA therapies: Removable oral appliances lack evidence for treating CSA; implantable phrenic nerve stimulation (remedē) has limited/very‑low quality evidence and is considered investigational/unproven pending additional data.
Evidence for remedē includes RCT and long‑term follow‑up but overall quality is limited.
Surgical interventions: Multi‑level airway surgery (e.g., UPPP, MMA) may be appropriate for selected patients after failure or intolerance of conservative therapies; selection should be based on anatomic localization and guideline recommendations.
UPPP has specific AHI/ESS/prior PAP requirements for coverage.
Experimental/insufficient evidence therapies: Non‑surgical electrical muscular training devices, mandibular vertical repositioning devices, morning repositioning devices, epigenetic/ALF appliances and similar interventions lack quality evidence and are not routinely supported.
These therapies are considered unproven and not medically necessary absent stronger evidence.
Uvulectomy: Insufficient evidence to support uvulectomy as a stand‑alone treatment for OSA.
Hayes found inadequate literature to evaluate efficacy when done alone.
Palatal implants: Small RCTs and case series report modest improvements in AHI and ESS but overall evidence is insufficient to support routine use for OSA.
Randomized and controlled trials limited by small sample sizes and short follow‑up.
Radiofrequency ablation: Short‑term improvements reported in some trials particularly when multilevel treatment is used; overall evidence quality low and long‑term outcomes unclear.
ECRI and recent studies call for larger randomized trials.
TORS: Systematic reviews report reductions in AHI/ESS and pooled surgical success rates (48–69%) but studies are largely retrospective and heterogeneous; comparative superiority over other procedures not demonstrated.
Complication rates vary; long‑term randomized data lacking.
DOME: Insufficient quality evidence to conclude effectiveness for adult OSA; published literature lacks randomized controlled trials and long‑term outcomes.
Available studies are retrospective case series with small samples.
Anatomy: Absence of a complete blockage or complete concentric collapse of the soft palate confirmed by DISE
DISE required
Prior therapy: PAP therapy resulted in no therapeutic efficacy or patient refusal or intolerance
Documentation of prior PAP attempts and intolerance/failure required
Central apneas: Total AHI with central + mixed apneas <25%<25%
Surgical history: Contraindicated for or not effectively treated with prior adenotonsillectomy when applicable
Document prior adenotonsillectomy status
Prior therapy: Confirmed failure or intolerance of PAP therapy despite attempts to improve compliance
Document PAP attempts and compliance strategies
Anatomy: Absence of tracheostomy use during sleep and absence of complete blockage or concentric collapse of the soft palate on DISE; individual/caregiver refusal of MMA allowed for nonconcentric palatal collapse
DISE required to exclude concentric palatal collapse
Regulatory: Device used in accordance with FDA guidelines
Aligns with FDA expanded pediatric indication
Adult (18–21 and ≥22) HNS BMI limit
BMI ≤ 40 kg/m2 required for implantable hypoglossal nerve stimulation candidacy (ages 18–21; referenced for older adults as well)
Pediatric Down syndrome BMI criterionBMI < 95th percentile for age required for adolescents (10–18 years) with Down syndrome
BMI definition sourceBMI calculated as weight (kg) / height (m)^2 per policy definitions
AHI threshold used in remedē pivotal trial
remedē pivotal trial inclusion AHIAHI ≥ 20 events/hour (eligibility threshold used in the remedē pivotal randomized trial)
remedē studied populationAdults with moderate-to-severe central sleep apnea were enrolled in trials using the AHI ≥20 criterion
Evidence quality noteHayes and meta-analyses note overall evidence for PNS/remedē is low to very low despite statistically significant AHI reductions
Inspire UAS labeled AHI
Current Inspire UAS labeled baseline AHI rangeFDA labeling expanded to include baseline AHI lower limit ≤15 and an upper baseline AHI up to 100 events/hour (expanded indication)
Prior Inspire labelingOriginal PMA indicated AHI ≥20 and ≤65 prior to 2023–2024 expansions
DISE requirementDevice intended for patients without complete concentric collapse of the soft palate as confirmed by DISE
Inspire UAS BMI limit
Inspire UAS BMI limit (expanded)FDA expanded the upper BMI limit from 32 to 40 kg/m2 for Inspire UAS labeling
Policy alignmentPolicy references BMI ≤40 kg/m2 for HNS candidacy in the 18–21 age group consistent with the expanded device BMI limit
Original BMI limitPrior device labeling included an upper BMI limit of 32 kg/m2 before expansion
eXciteOSA indication
eXciteOSA labeled indicationAHI < 15 in adults 18 years or older (de novo classification for intraoral electrical stimulation device)
Intended use and ageRemovable intraoral neuromuscular stimulation device intended for adults (≥18 years) with snoring or mild OSA (AHI <15)
Evidence quality cautionPolicy notes evidence for non-surgical electrical stimulation devices is limited and of low/very-low quality
remedē System indication
remedē labeled indicationRemedē System indicated for treatment of moderate-to-severe central sleep apnea in adults (FDA PMA P160039)
Trial evidence notePivotal and subsequent trials used AHI entry criteria (e.g., ≥20) and demonstrated reductions in AHI/CAI with limited-quality evidence
Evidence limitationsHayes and ECRI assessments conclude overall evidence is insufficient/very low quality and additional research is needed
AHI / RDI thresholds
Adult procedural AHI thresholdAHI ≥ 15 (or RDI ≥ 15) used for adult surgical procedures and some HNS indications
Pediatric Down syndrome AHI thresholdAHI ≥ 10 (adolescents 10–18 with Down syndrome; FDA pediatric Inspire indication AHI ≥10 and ≤50)
Inspire expanded upper AHI limitInspire UAS labeling expanded upper baseline AHI to 100 events/hour for selected adult patients
remedē trial thresholdremedē pivotal trial used AHI ≥ 20 events/hour for enrollment
BMI
HNS adult BMI limitBMI ≤ 40 kg/m2 cited for HNS eligibility (ages 18–21 and referenced for adults in policy)
Pediatric Down syndrome BMIBMI < 95th percentile for age required for adolescents (10–18 years) with Down syndrome
Device BMI expansion noteInspire UAS FDA labeling expanded upper BMI limit from 32 to 40 kg/m2, aligning device and policy thresholds
Central + mixed apnea proportion
Central + mixed apnea proportion limitTotal AHI central + mixed apneas must be < 25% of total AHI for HNS eligibility
Measurement methodCentral and mixed apnea proportion evaluated by attended polysomnography used for candidacy assessment
ApplicabilityApplied in HNS eligibility for adults 18–21 and adolescents with Down syndrome (10–18) as documented in policy criteria
Apnea-Hypopnea Index (AHI)
AHI definition and adult age criteriaAHI is number of apneas plus hypopneas per hour measured by attended polysomnography; adults 18–21 HNS criteria specify AHI ≥15 and ≤100 events/hour
Pediatric measurement windowAdolescents with Down syndrome must have an attended polysomnogram within 24 months documenting AHI ≥10 and RDI ≤50
Central + mixed apneas numeric limit<25% of total AHI (central plus mixed apneas) required for HNS candidacy
Applied populationsSpecified for adults 18–21 and adolescents 10–18 with Down syndrome within the policy criteria
Assessment modalityProportion determined from attended polysomnography report
Body Mass Index (BMI)
BMI numeric thresholds by age/indicationAdults 18–21 HNS: BMI ≤ 40 kg/m2; Adolescents (10–18) with Down syndrome: BMI <95th percentile for age
BMI calculationBMI defined as weight in kilograms divided by height in meters squared per policy definitions
Policy-device alignmentPolicy BMI thresholds align with FDA-expanded Inspire UAS BMI upper limit of 40 kg/m2
Provide attended polysomnography results showing AHI/RDI within device/FDA criteria
Document percent central + mixed apneas (total <25% when required)
Provide DISE demonstrating absence of complete concentric collapse of the soft palate when applicable
Document prior PAP attempts and outcome (failure, intolerance, or refusal)
Documentation Required
Required Diagnostic Testing and Prior Therapy Documentation
Submit baseline diagnostic testing and prior therapy documentation with all prior authorization requests. An attended polysomnography (PSG) is generally required to confirm OSA severity and to quantify AHI/RDI and central apnea proportion. If using a home sleep test, include rationale and results per payer guidance. Clinical documentation must also show stability of findings and relevant pre‑treatment measures.
Include the attended PSG report (date, AHI/RDI, central/mixed apnea percentage)
If DISE was performed, include report and findings
If a home sleep study is used, provide justification and full results
Prior Authorization
Prior Authorization Submission Requirements
Prior authorization submission must include a clear indication for the requested therapy, objective test results, and prior conservative therapy attempts. Provide a concise chronology of prior treatments and objective outcome measures to support medical necessity.
Indication and diagnosis with dates
Attended PSG (baseline) and any post‑therapy PSG results
Documentation of prior PAP therapy: dates, mode (CPAP/APAP/BiPAP), adherence efforts, and documented failure or intolerance
Documentation of trials with oral appliance therapy when applicable, and dentist/sleep physician collaboration
Operative reports, DISE, and other procedural findings if already performed
Documentation Required
Medical Record Documentation Used for Reviews
The patient's medical record must contain documentation that fully supports the medical necessity for requested services. Lack of adequate medical record documentation (history, exam, diagnostic tests, prior therapy details) is a common trigger for denial.
Legible relevant medical history and physical exam notes
Full diagnostic test reports (attended PSG, home sleep test, DISE)
Detailed prior therapy records showing attempts, duration, adherence efforts, and reasons for failure or intolerance
Denial Risk
Insufficient Evidence — Devices at Risk for Denial
Certain therapies lack sufficient evidence and submissions for these may be denied or require additional documentation. Specifically, removable oral appliances for central sleep apnea (CSA) have no relevant evidence to support use; non‑surgical electrical muscular training devices (e.g., eXciteOSA) and some positional devices have limited or low‑quality evidence and may be subject to additional review or denial.
Removable oral appliances for CSA: no supporting evidence — submissions at high risk for denial
eXciteOSA and similar intraoral electrical stimulation devices: very low-quality evidence; provide comparative data if available
Positional therapy devices (NightBalance, etc.): evidence is low/inconclusive — include adherence and comparative data when possible
Step Therapy
Therapy Sequencing and Step Therapy Preference
Therapy Sequencing and Step Therapy Preference. Conservative therapies should be attempted and documented prior to invasive procedures or novel device implantation. CPAP (or other PAP modalities) remains first‑line for moderate to severe OSA; oral appliance therapy is preferred for patients intolerant of CPAP or who prefer an alternative. HNS is generally considered after documented CPAP failure or intolerance.
Document PAP therapy trial: mode, duration, adherence interventions, and reasons for discontinuation
If OAT is used, include referral from a medical provider and oversight by a qualified dentist per AASM/AADSM guidance
Documentation Required
Required Clinical Documentation and Objective Outcomes
Required Clinical Documentation and Objective Outcome Measures. Prior authorization and post‑procedure reviews commonly require objective pre‑ and post‑treatment sleep study results, validated symptom scores (e.g., Epworth Sleepiness Scale), and detailed records of prior therapies. Missing these items is a frequent cause for denial.
Pre‑procedure attended PSG and post‑procedure PSG when applicable
Pre‑ and post‑treatment ESS or other validated questionnaires
Documentation of BMI, attended PSG dates and results, and DISE findings if required
For oral appliance requests: medical diagnosis, referral from a medical provider, dental evaluation, and device type (custom, titratable preferred)
AHI definitionApnea-Hypopnea Index (AHI) = (number of apneas + number of hypopneas) per hour of sleep, unit: events/hour (AASM Scoring Manual, 2023)
Use in policyAHI is the primary metric used to define OSA severity and eligibility thresholds in coverage criteria
Measurement standardAttended polysomnography is the standard modality referenced for AHI-based eligibility in policy
OSA severity
Mild OSAAHI or RDI ≥5 and <15 events/hour
Moderate OSAAHI or RDI ≥15 and ≤30 events/hour
Severe OSAAHI or RDI >30 events/hour
Home Sleep Apnea Testing (HSAT)
HSAT definitionHome Sleep Apnea Testing (HSAT) is unattended diagnostic testing without sleep staging; adequate HSAT requires minimum 4 hours and sensors for nasal pressure, chest and abdominal respiratory effort, and oximetry
LimitationsHSAT does not determine sleep stages and is less comprehensive than attended polysomnography
Use caseHSAT may be used for diagnosis in appropriate patients per AASM guidance as noted in policy definitions
Obstructive Sleep Apnea (OSA)
OSA definitionObstructive Sleep Apnea is a sleep-related breathing disorder with decreased or halted airflow due to upper airway obstruction despite ongoing effort to breathe, causing apneas and hypopneas and associated symptoms/physiologic effects
PathophysiologyOccurs when pharyngeal muscles fail to maintain airway patency during sleep
Central Sleep Apnea (CSA)
CSA definitionCentral Sleep Apnea is a temporary interruption of neural output from the respiratory control center leading to loss of respiratory stimulation and airflow cessation
Clinical contextCSA has multiple forms, often associated with heart failure and opioid-related hypoventilation; prevalence in heart failure estimated at 30–50%
Treatment evidenceAvailable treatments for CSA are limited; implantable neurostimulation devices (e.g., remedē) have been studied but evidence is insufficient
Hypoglossal Nerve Stimulation (HNS)
HNS therapy definitionHypoglossal Nerve Stimulation (HNS) is an implantable device that stimulates the hypoglossal nerve to maintain airway patency during sleep as a second-line therapy for moderate-to-severe OSA in CPAP-intolerant patients
Clinical evidence noteEvidence includes STAR trial, systematic reviews, and meta-analyses showing AHI and symptom improvements but overall evidence quality is limited
Selection criteria reliancePatient selection (AHI, BMI, DISE findings, central apnea proportion) is emphasized in policy criteria for HNS eligibility
Intraoral electrical stimulation definitionNoninvasive intraoral device delivering daytime neuromuscular electrical stimulation to tongue muscles (e.g., eXciteOSA) intended to reduce snoring and mild OSA
Device componentsConsists of mouthpiece, rechargeable control unit, and mobile app; typical regimen 20 minutes/day for 6 weeks then maintenance
Regulatory statuseXciteOSA classified as de novo (DEN200018) by FDA for adults with AHI <15
AHI
AHI in trial contextsAHI (events/hour) is the primary efficacy metric in trials (e.g., STAR trial defines moderate-to-severe as AHI ≥15)
Trial outcome measuresTrials commonly report changes in AHI, ODI, ESS, and lowest oxyhemoglobin saturation (LSAT)
Polysomnography requirementAttended polysomnography is the referenced standard for baseline and post-procedure AHI assessments in device trials
TPNS
TPNS (remedē) definitionTransvenous phrenic nerve stimulation (TPNS) is an implantable phrenic nerve stimulation therapy delivered by the remedē System for treatment of central sleep apnea
Intended populationApproved for adults with moderate-to-severe CSA (FDA P160039)
Evidence summaryRandomized trials showed reductions in AHI/CAI but overall evidence judged low/very-low quality and additional long-term data are needed
Success (surgical)
Surgical success common definitionSurgical success often defined as ≥50% reduction in AHI and/or postoperative AHI <20 events/hour in many studies
Variability noteDefinitions of success vary by study and comparison groups; long-term durability and complication rates differ across procedures
Use in evidence synthesisMeta-analyses and systematic reviews commonly report success rates using this composite criterion
Transoral Robotic Surgery (TORS)
TORS definitionTransoral Robotic Surgery (TORS) is a minimally invasive robotic-assisted surgical approach to resect tissue from the tongue base and hypopharynx for management of OSA
Evidence characteristicsEvidence consists mainly of retrospective series and systematic reviews; randomized data and long-term outcomes are limited
Reported outcomesSystematic reviews report reductions in AHI and ESS with pooled surgical success around 48–69% depending on series
Distraction Osteogenesis for Maxillary Expansion (DOME)
DOME definitionDistraction Osteogenesis for Maxillary Expansion (DOME) is a surgical procedure to widen the maxilla using distractor devices, evaluated for adult OSA treatment
Evidence gapPublished literature lacks randomized controlled trials and long-term outcomes; current evidence insufficient to establish effectiveness
Study limitationsExisting studies are retrospective case series with small samples and no comparison groups
Drug-induced sleep endoscopy (DISE)
DISE definition and roleDrug-induced sleep endoscopy (DISE) is an endoscopic evaluation under sedation to assess patterns of upper airway collapse and is required to confirm absence of complete concentric palatal collapse for HNS eligibility
Use in eligibilityDISE findings (absence of complete concentric collapse at soft palate) are explicit criteria for HNS candidacy in both adults and pediatric Down syndrome indications
TimingDISE is part of anatomic assessment prior to implantable HNS per policy and FDA labeling
AHI (attended PSG)
AHI (attended PSG) restatementAHI measured by attended polysomnography is used to determine eligibility thresholds (e.g., adults 18–21: AHI ≥15–≤100; adolescents with Down syndrome: AHI ≥10)
Documentation windowAdolescent Down syndrome criteria require an attended PSG within 24 months documenting the AHI/RDI values
Apnea added definitionApnea defined in policy as cessation of airflow (≥90% decrease) lasting ≥10 seconds; classified as obstructive, central, or mixed
Hypopnea added definitionHypopnea defined as ≥10 seconds with ≥30% airflow reduction and ≥3% oxygen desaturation or associated arousal (AASM Scoring Manual, 2023)
ESS addedEpworth Sleepiness Scale (ESS) referenced as validated tool; ESS >10 used in UPPP candidacy documentation
Body Mass Index (BMI) — updated definition
BMI definition updatedBMI is weight (kg) divided by height (m)^2; policy uses BMI thresholds for device/surgical eligibility (e.g., ≤40 kg/m2 for HNS in 18–21 age group)
Pediatric percentile useFor adolescents with Down syndrome, BMI must be <95th percentile for age rather than an absolute kg/m2 cutoff
Documentation requirementMedical records must document BMI as part of eligibility assessment for procedures and devices