ModifiedPremera BluecrossPolicy 7.01.101

Surgical Treatments for Obstructive Sleep Apnea (Apnea Syndrome)

Defines medical necessity, site-of-service, documentation, and coding for surgical and device treatments of obstructive sleep apnea, including hypoglossal nerve stimulation and palatopharyngoplasty; intended for providers requesting review of these procedures.

Policy Summary

PayerPremera Bluecross

PolicySurgical Treatments for Obstructive Sleep Apnea (Apnea Syndrome)

Policy CodePolicy 7.01.101

Change TypeMaterial coverage and criteria updatescoding additions

Effective DateJun 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization with documentation of CPAP trial/failure, AHI, BMI, age, and device-specific findings when requesting surgical or HNS coverage.

SourceLink

POLICY UPDATE CHANGES

Policy statement is added that HNS using other FDA-approved devices (e.g., Genio) is considered investigational for treating clinically significant OSA syndrome.

Submucosal cryolysis is considered investigational.

BMI and age criteria for hypoglossal nerve stimulation (HNS) were changed multiple times; most recently BMI criteria were narrowed from ≤40 to ≤35 kg/m² and adult age changed to ≥18 (with Down syndrome age adjustments).

Multiple new HCPCS codes (C8007-C8009, C8011-C8013) were added to the coding section effective April 1, 2026.

UPPPPrimary elective procedure

AHI ≥15Adult AHI threshold

≤35HNS BMI threshold

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

15–100Inspire AHI range

severalHistorical edits

Coverage Criteria and Determinations

Palatopharyngoplasty (including UPPP) — Initial Therapy

Covered when ALL of the following are met

Palatopharyngoplasty (UPPP) medical necessity: Palatopharyngoplasty (e.g., UPPP and named variants) may be considered medically necessary for the treatment of clinically significant obstructive sleep apnea (OSA) in appropriately selected adults who have failed an adequate trial of continuous positive airway pressure (CPAP) or failed an adequate trial of an oral appliance.Clinically significant OSA as defined in Related Information (e.g., AHI/RDI ≥15 or AHI/RDI ≥5 with symptoms)

Includes multiple named palatopharyngoplasty procedures (e.g., UPPP)

Hyoid suspension, tongue modification, and maxillofacial surgery

Covered when ALL of the following are met

Hyoid/tongue/maxillofacial surgery medical necessity: Hyoid suspension, surgical modification of the tongue, and/or maxillofacial surgery (including mandibular-maxillary advancement) may be considered medically necessary in appropriately selected adults with clinically significant OSA and objective documentation of hypopharyngeal obstruction who have failed an adequate trial of CPAP or failed an adequate trial of an oral appliance.Objective documentation of hypopharyngeal obstruction

Includes maxillofacial procedures such as MMA; documentation requirements apply

Hypoglossal nerve stimulation (HNS) — Inspire device (adults)

Covered when ALL of the following are met

Inspire HNS adult criteria: Hypoglossal nerve stimulation with the FDA‑approved Inspire device may be considered medically necessary in adults who meet all of the following: age ≥18 years; AHI ≥15 and ≤100 with ≤25% central apneas; documented CPAP failure (residual AHI ≥15 while on CPAP) or inability to tolerate CPAP (e.g., CPAP use <4 hours/night for ≥5 nights/week); body mass index (BMI) ≤35 kg/m²; and absence of complete concentric (circumferential) collapse at the soft palate on drug‑induced sleep endoscopy (DISE). The specific device name (Inspire) should be documented in the clinical record.age ≥18; AHI 15–100; central apneas ≤25%; BMI ≤35 kg/m²; absence of complete concentric collapse on DISE

Device‑specific labeling and DISE‑based exclusion apply; prior PAP trial documentation required

Hypoglossal nerve stimulation (HNS) — Inspire device (Down syndrome, pediatric)

Covered when ALL of the following are met

Inspire HNS for Down syndrome (ages 13–18): Hypoglossal nerve stimulation with the FDA‑approved Inspire device may be considered medically necessary for individuals with Down syndrome aged 13–18 who meet all of the following: AHI >10 and <50 with ≤25% central apneas after prior adenotonsillectomy; either have a tracheotomy or are ineffectively treated with CPAP due to noncompliance, intolerance, persistent symptoms despite compliant use, or refusal to use CPAP; BMI ≤95th percentile for age; and absence of complete concentric collapse at the soft palate on DISE.age 13–18; AHI 10–50; central apneas ≤25%; BMI ≤95th percentile for age

Requires prior adenotonsillectomy and DISE assessment; documents CPAP inability/intolerance

Minimally invasive procedures — Investigational / Not covered

Not covered (investigational)

Investigational minimally invasive procedures: The following minimally invasive procedures are considered investigational (not medically necessary) for the sole or adjunctive treatment of OSA/UARS: endoscopically assisted nasomaxillary expansion; laser‑assisted uvulopalatoplasty (LAUP); radiofrequency volumetric tissue reduction of palatal tissues and/or tongue (e.g., Somnoplasty); palatal stiffening procedures (including CAPSO, palatal implants such as Pillar, and injection of sclerosing agents); submucosal cryolysis therapy (e.g., CryOSAA/Cryosa System); tongue base suspension (e.g., Airvance/Repose); and other minimally invasive procedures not otherwise described.listed procedures

Designated investigational due to insufficient evidence of net health benefit

Hypoglossal Nerve Stimulation (HNS) — selection criteria (subset of appropriately selected patients)

HNS may be considered for a subset of appropriately selected patients when ALL of the following are met:

HNS selection criteria (general): Patient selection for hypoglossal nerve stimulation should meet all of the following: appropriate adult age per device labeling (historically ≥22 years, more recent labeling and policy language may use ≥18); diagnosis of moderate to severe OSA (AHI thresholds per device/study selection) with <25% central apneas; documented CPAP failure or inability to tolerate CPAP; BMI within device/study limits (examples cited in studies/policies include ≤32 or ≤35 kg/m², with later supplements increasing allowable BMI in some data to ≤40); and a favorable pattern of palatal collapse (absence of complete concentric collapse on DISE).AHI and BMI per device/study limits; central apneas <25%

Criteria reflect study selection and clinical input; exact numeric thresholds vary with device labeling and policy history

Not sufficiently proven / investigational

Procedures considered insufficiently supported (evidence does not demonstrate net health benefit):

Insufficient evidence procedures: Laser‑assisted uvulopalatoplasty (LAUP); single‑stage or multi‑session radiofrequency volumetric reduction of the palate and/or base of tongue; palatal stiffening procedures; tongue base suspension; endoscopically assisted maxillary expansion; and submucosal cryolysis are considered insufficiently supported by the evidence to demonstrate net health benefit for treatment of OSA.N/A

Systematic reviews, sham‑controlled trials, and small feasibility studies show inconsistent or inadequate outcomes

Hypoglossal nerve stimulation / Selected surgical therapies

Covered when ALL of the following are met (per device labeling, society statements, and CMS context):

Device/surgical candidate criteria (overview)

PAP trial: Documented trial of PAP with failure or intolerance (e.g., residual AHI >15 despite PAP, or inadequate usage defined as <4 hours/night for ≥5 nights/week).residual AHI >15 or inadequate usage
From device supplement text and CMS context
AHI within device/society indicated range.AHI ≥15 (and for Inspire expanded indication AHI ≤100)
CMS cites risk threshold of AHI ≥15; device supplements specify ranges
Age and population: Patient age meets device/society criteria (adult or specified pediatric indications such as Down syndrome cohorts).

Investigational and evolving coverage criteria

Policy contains covered and investigational determinations with evolving criteria:

Investigational procedures and device distinctions: Submucosal cryolysis is considered investigational. Hypoglossal nerve stimulation using other FDA‑approved devices (e.g., Genio) is considered investigational for treating clinically significant OSA syndrome in this policy.N/A

From policy history and recent policy statements

HNS candidacy thresholds (historical/changed): AHI eligibility thresholds and BMI/age limits for HNS have changed over time (examples: AHI eligibility changed from ≥20 to ≥15; BMI criteria changed between ≤32, ≤40, and most recently to ≤35 kg/m²; age criteria adjusted in policy history).Historical AHI and BMI values referenced in policy history

Exact current criteria are device‑dependent and reflected elsewhere in the policy

All interventions intended solely to treat simple snoring in the absence of documented obstructive sleep apnea (OSA) are not medically necessary. The policy explicitly states that snoring alone is not considered a medical condition and lists treatments such as laser-assisted uvulopalatoplasty (LAUP), palatal stiffening procedures, and radiofrequency volumetric tissue reduction of the palate among examples that are not covered when used for snoring without documented OSA.

Conventional surgical procedures for OSA that are addressed outside the minimally invasive procedural section include uvulopalatopharyngoplasty (UPPP) and other palatopharyngoplasty variants, hyoid suspension, surgical modification of the tongue, and maxillofacial procedures such as mandibular-maxillary advancement (MMA). These established approaches are described as established surgical options for individuals who have failed conservative therapy (for example, PAP) and are treated under separate coverage or surgical policy pathways rather than the minimally invasive procedures listed as investigational.

The evidence base and coverage stance for hypoglossal nerve stimulation (HNS) and related procedures vary by jurisdiction and guideline. For example, the National Institute for Health and Care Excellence (NICE, 2017) concluded that evidence on the safety and efficacy of HNS was limited and advised use only in the context of clinical trials. Regulatory clearances and device labeling influence coverage decisions, and some jurisdictions or guideline panels may adopt more restrictive positions pending higher‑quality evidence.

Hypoglossal nerve stimulation delivered with FDA‑approved devices other than the Inspire system (for example, Genio) is explicitly designated investigational in this policy and is excluded from coverage for clinically significant OSA. Policy history records the addition of this investigational determination.

Surgical treatments for OSA that do not meet the policy’s specified medical‑necessity criteria are considered not medically necessary and may be denied. This includes procedures proposed without documented clinically significant OSA, without required prior conservative therapy (e.g., trial and failure or intolerance of CPAP or an oral appliance where specified), or without the objective documentation required for certain surgeries (for example, evidence of hypopharyngeal obstruction for hyoid/tongue/maxillofacial procedures).

The policy identifies multiple procedures as insufficiently supported by the evidence and therefore investigational or not medically necessary for OSA/UARS. Examples named in the policy include laser‑assisted uvulopalatoplasty (LAUP); single‑stage or multistage radiofrequency volumetric tissue reduction of the palate and base of tongue; palatal stiffening procedures (such as CAPSO and palatal implants); tongue base suspension; and endoscopically assisted maxillary expansion. Systematic reviews, randomized trials, and feasibility studies cited in the policy show inconsistent benefits, limited durability data, or small sample sizes that do not demonstrate a clear net health benefit.

Device regulatory status and the strength of published clinical evidence are important factors in determining not‑medically‑necessary or investigational status. Procedures or devices without FDA approval for OSA (for example, submucosal cryolysis systems not approved for OSA) or those with limited/low‑quality outcome data are more likely to be designated investigational or not covered. The policy’s coverage decisions reference device 510(k)/PMA histories and note that regulatory labeling influences clinical selection criteria.

Submucosal cryolysis therapy (e.g., the Cryosa system) is listed in the policy as investigational and, accordingly, not covered for the treatment of OSA. The regulatory status cited in the policy indicates that the Cryosa System is not FDA approved for use in individuals with OSA, and the policy history documents the addition of the investigational statement for cryolysis.

Procedure, Device, and Billing Codes

Procedure CPT codes and descriptionsCPT

0978T	Submucosal cryolysis therapy; soft palate, base of tongue, and lingual tonsil (effective 07/01/25)
0979T	Submucosal cryolysis therapy; soft palate only (effective 07/01/25)
0980T	Submucosal cryolysis therapy; base of tongue and lingual tonsil only (effective 07/01/25)
21199	Osteotomy, mandible, segmental; with genioglossus advancement
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
42145	Palatopharyngoplasty (e.g., uvulopalatopharyngoplasty)
42299	Unlisted procedure, palate, uvula
42950	Pharyngoplasty (plastic or reconstructive operation on pharynx)

1–10 of 16

1/2

HCPCS / C-codes and implant suppliesHCPCS

C1767	Generator, neurostimulator (implantable), nonrechargeable
C1778	Lead, neurostimulator (implantable)
C8007	Open implantation of hypoglossal nerve neurostimulator array and pulse generator, not requiring insertion of a separate distal respiratory sensor electrode or electrode array (eff. 04/01/26)
C8008	Revision or replacement of hypoglossal nerve neurostimulator array including connection to existing pulse generator (eff. 04/01/26)
C8009	Percutaneous placement of permanent common carotid embolic protection device, including all system components and imaging guidance; bilateral (eff. 04/01/26)
C8011	Open implantation of hypoglossal nerve(s) neurostimulator electrode array(s) and receiver, including external power source and all system components (eff. 04/01/26)
C8012	Revision or replacement of hypoglossal nerve(s) neurostimulator electrode array(s) and receiver (eff. 04/01/26)
C8013	Removal of hypoglossal nerve(s) neurostimulator electrode array(s) and receiver (eff. 04/01/26)

No explicit CPT/ICD codes in this sectionmixed

No codes listed

Device PMA and supplementsmixed

P130008	PMA for Inspire UAS (original)
S039	Supplement expanding adolescent indication
S089	Supplement expanding Down syndrome pediatric indication (13-18)
S090	Supplement expanding adult AHI and BMI indications
S098	PMA supplement (Inspire V system) approved Aug 2024

Examples of device 510(k)/product codesmixed

K982717	510(k) for radiofrequency ablation (Somnoplasty), 1998
K040417	510(k) for Pillar Palatal Implant, 2004
K122391	510(k) for AIRvance/Repose tongue base suspension, 1999
K111179	510(k) for tongue base suspension device, 2011
MNQ	FDA product code for hypoglossal nerve stimulation (Inspire)

HCPCS / CPT codes recently added or movedmixed

C8007	HCPCS code added effective April 1, 2026
C8008	HCPCS code added effective April 1, 2026
C8009	HCPCS code added effective April 1, 2026
C8011	HCPCS code added effective April 1, 2026
C8012	HCPCS code added effective April 1, 2026
C8013	HCPCS code added effective April 1, 2026
C1607	HCPCS code added Jan 1, 2026 then removed from this policy and moved to policy 10.01.533
0978T	CPT code added (historical entry)
0979T	CPT code added (historical entry)
0980T	CPT code added (historical entry)

AHI / RDI thresholds — adult and pediatric

AdultsClinically significant OSA: AHI or RDI ≥15 events/hour, or AHI/RDI ≥5 with one or more OSA-related signs or symptoms (e.g., excessive daytime sleepiness, hypertension, cardiovascular disease, or stroke).

PediatricsClinically significant OSA: AHI or RDI ≥5 events/hour, or AHI/RDI ≥1.5 with excessive daytime sleepiness, behavioral problems, or hyperactivity.

AHI definitionAHI = total number of apneas and hypopneas per hour of sleep (used to classify mild/moderate/severe).

Body Mass Index (BMI) — device-specific selection thresholds for HNS

Device-specific adult BMI thresholds (Inspire studies/selection)

Authorization, Documentation, and Clinical Steps

Prior Authorization

Prior Authorization Required

Prior authorization is required for listed elective surgical and device procedures related to OSA, including hypoglossal nerve stimulation (HNS) and specified minimally invasive OSA surgeries. Submit a prior authorization request with complete clinical documentation before scheduling procedures.

Affected services include Uvulopalatopharyngoplasty (UPPP), hypoglossal nerve stimulation (Inspire device), hyoid suspension, surgical modification of the tongue, maxillofacial surgery (including MMA), and other listed procedures.
Site-of-service rules apply; certain elective procedures are only medically necessary in ambulatory surgical centers or hospital outpatient departments when ASC access or clinical risk criteria are met.

Step Therapy

PAP-first Step

Continuous positive airway pressure (CPAP/PAP) is the preferred first-line therapy for most individuals with OSA. Surgery or device implantation should generally be considered only after documentation of an adequate trial of PAP (or oral appliance when applicable) that demonstrates failure or intolerance.

Clinical Definitions and Key Terms

Clinically significant OSA (adults) — AHI/RDI thresholds and symptomatic definitions

Adult clinically significant OSA (primary)AHI or RDI ≥15 events/hour, or AHI/RDI ≥5 with one or more OSA-related signs or symptoms (e.g., excessive daytime sleepiness, hypertension, cardiovascular disease, or stroke).

AHI severity classificationMild: AHI 5–14; Moderate: AHI 15–29; Severe: AHI ≥30 (adult thresholds used for clinical classification).

Treatment contextCMS guidance links treatment consideration to AHI/RDI thresholds, noting elevated cardiovascular risk at AHI/RDI ≥15.

Clinically significant OSA (children) — pediatric AHI/RDI thresholds and symptom criteria

Pediatric clinically significant OSAAHI or RDI ≥5 events/hour, or AHI/RDI ≥1.5 with excessive daytime sleepiness, behavioral problems, or hyperactivity.

Pediatric severity ranges

Clinical and Policy Background

Background: Obstructive sleep apnea (OSA) results from repetitive upper‑airway collapse during sleep, producing intermittent airflow limitation, oxygen desaturation, and sleep fragmentation. Positive airway pressure (PAP), typically continuous positive airway pressure (CPAP), is the preferred first‑line therapy. When PAP is ineffective because of persistent OSA despite use, intolerance, or inadequate adherence, selected surgical procedures or device‑based therapies such as hypoglossal nerve stimulation (HNS) may be considered as second‑line options to reduce airway collapsibility by anterior displacement and stiffening of the tongue and upper airway structures.

Policy Revision History and Changes

2026-06-01minor_updateLatest

Minor update added header clarifying site of service review does not apply to Indian Health Services (IHS) facilities.

2026-04-01coding_update

Added new HCPCS codes C8007–C8009 and C8011–C8013 effective April 1, 2026.

2026-03-01policy_statement_added

Policy Summary

PayerPremera Bluecross

PolicySurgical Treatments for Obstructive Sleep Apnea (Apnea Syndrome)

Policy CodePolicy 7.01.101

Change TypeMaterial coverage and criteria updatescoding additions

Effective DateJun 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization with documentation of CPAP trial/failure, AHI, BMI, age, and device-specific findings when requesting surgical or HNS coverage.

SourceLink

On This Page

e.g., original PMA ≥22 years; supplements expand pediatric/young adult indications and device labeling may use ≥18 years

AAO‑HNS supports HNS as second‑line treatment in selected patients

BMI: Patient BMI is within the safety/effectiveness limits described in device labeling or supplements.Example: BMI limits cited in supplements ranged up to ≤40 kg/m² (historical and supplement‑specific) though policy currently specifies BMI ≤35 kg/m² for adult Inspire criteria

Document BMI in authorization request

BMI ≤32 kg/m² (commonly used in study selection; some studies used ≤35 kg/m²).

Expanded device labeling (safety data note)Supplement S090 noted BMI upper limit with available safety/effectiveness data increased from ≤32 to ≤40 kg/m² (historical labeling).

Apnea–Hypopnea Index (AHI) — moderate-severe OSA and trial requirements

Moderate–severe OSA requirementHNS candidacy based on moderate to severe OSA; device trials/studies required specific AHI ranges (e.g., AHI thresholds used in trials and selection criteria).

Central apnea limitDevice criteria commonly require ≤25% central apneas in the diagnostic study.

Prior CPAP trial requirementDocumented CPAP failure or inability to tolerate CPAP is required (trial and intolerance/failure definitions referenced in device studies and clinical input).

Apnea-Hypopnea Index (AHI) specific citation — AHI ≥15 and Inspire expanded indication AHI 15–100

Common AHI eligibility thresholdAHI ≥15 events/hour cited as a risk threshold and common eligibility criterion for treatment consideration.

Inspire expanded AHI indicationInspire PMA supplement S090 expanded indication to include AHI ≥15 and ≤100 for adults.

CMS contextCMS review noted risk of hypertension with AHI/RDI ≥15, supporting treatment at this threshold.

Body Mass Index (BMI) — note on BMI upper limit changes (≤32 → ≤40 in data / later adjustments)

Historical BMI upper limit change (policy history)Policy wording changed from BMI ≤32 kg/m² to BMI ≤40 kg/m² to align with expanded FDA indication (6/8/2023 supplement S090).

Later policy adjustmentSubsequent policy edits updated BMI criteria to ≤35 kg/m² to align with current evidence and policy updates (noted in history entries through 2024).

Device supplement noteSupplement S090 explicitly stated safety/effectiveness data available up to BMI ≤40 kg/m² (historical device labeling).

Apnea-Hypopnea Index (AHI) — historically referenced thresholds across policy versions

Early AHI categories referencedPolicy history has referenced AHI categories such as 5–14 (mild), 15–30 (moderate), and ≥30 (severe) across versions.

Shift in HNS eligibility AHIHNS eligibility threshold was changed historically from ≥20 to ≥15 to align with FDA indication (noted in 2019 history).

Documentation of evolving thresholdsMultiple history entries document incremental edits to AHI thresholds used in policy statements and device criteria over time.

Body Mass Index (BMI) — historical BMI thresholds for HNS

Documented historical BMI thresholds for HNSPolicy and study selection have referenced BMI limits of ≤32 kg/m², later expanded to ≤40 kg/m² in device supplement S090, and more recently narrowed to ≤35 kg/m² in policy edits.

Study selection vs labelingSome HNS studies used BMI ≤32 or ≤35 kg/m² as selection criteria while device labeling noted data up to BMI ≤40 kg/m².

Policy history recordsHistory entries (2023–2024) explicitly note these BMI threshold changes and alignment with FDA supplements.

Document attempt and outcomes of PAP therapy (objective adherence data, residual AHI if applicable, reasons for intolerance) prior to surgical consideration.

Exceptions include pediatric adenotonsillectomy for enlarged tonsils and select patients (e.g., certain adolescents with Down syndrome) where prior surgery or inability to tolerate PAP is documented.

Prior Authorization

Prior Authorization Expectations for HNS and Minimally Invasive Surgeries

For HNS and minimally invasive OSA surgeries, prior authorization is expected and the request must include documentation demonstrating prior conservative therapy and candidate selection per device labeling or clinical criteria.

For HNS (Inspire): age, AHI, percent central apneas, documented CPAP failure/intolerance (objective use or residual AHI thresholds), BMI, absence of complete concentric collapse on DISE, and device name/model.
For minimally invasive procedures: documentation of clinically significant OSA (AHI/RDI), previous PAP or oral appliance trials and objective failure or intolerance, and specific anatomic findings when required.

Denial Risk

Documentation & Denial Risk

Medical necessity reviews require submission of complete clinical documentation. Procedures that do not meet the policy criteria, including cases without documented OSA or without required prior PAP trials, may be denied as not medically necessary.

Include diagnostic sleep study results (AHI or RDI), symptomatology, BMI, prior PAP therapy details (duration, adherence, residual AHI), prior oral appliance trials, and DISE findings when applicable.
Interventions for snoring without documented OSA and investigational devices/techniques (e.g., Genio HNS per policy, submucosal cryolysis, listed minimally invasive procedures) are considered not medically necessary or investigational and may be denied.

Billing Rule

Billing/Coding and Site-of-Service Notes

Ensure coding and site-of-service rules are applied when requesting authorization and submitting claims. Authorization is required for coded surgical/device services and coding updates or new HCPCS/CPT additions must be reflected in requests.

Follow current CPT/HCPCS codes for HNS and related procedures; check recent policy history for coding updates (e.g., additions effective 2024–2026).
Site-of-service review does not apply to Indian Health Services (IHS) facilities per the policy history update.

Children: mild AHI ≥1 to <5; moderate AHI >5 to 10; severe AHI >10 (per table definitions).

Scoring differencesPediatric apnea scoring differs (≥2 missed breaths) and hypopnea criteria have pediatric-specific thresholds for airflow reduction and desaturation/arousal.

Complete concentric collapse (DISE) — definition and role as exclusion for HNS

DefinitionComplete concentric (circumferential) oropharyngeal collapse on drug-induced sleep endoscopy (DISE).

Role for HNS candidacyPresence of concentric collapse on DISE decreases likelihood of HNS success and is an exclusion criterion per FDA labeling for Inspire UAS.

DISE utilityDISE classifies collapse patterns (flat anterior-posterior versus concentric) and informs device/surgical selection decisions.

CPAP intolerance definition — usage-based definition

Usage-based CPAP intolerance definitionCPAP intolerance: CPAP use for less than 4 hours per night for ≥5 nights per week or refusal to use PAP.

ApplicabilityCPAP intolerance may be observed in patients with mild, moderate, or severe OSA and is used in candidate selection for alternative therapies.

Documentation implicationMedical records should document CPAP usage patterns to demonstrate intolerance when proposing surgical or device therapies.

PAP failure — operational definition often used

Operational PAP failure definitionPAP failure is usually defined as an AHI ≥15–20 events per hour while using PAP (residual AHI >15 often cited in device materials).

Device supplement wordingDevice labeling and supplements reference residual AHI >15 despite PAP as evidence of inadequate control and may be used to document PAP failure for HNS candidacy.

Clinical contextPAP failure supports consideration of surgical or device therapies when intolerance is not the issue.

PAP failure / intolerance — alternative definitions referenced in policy

Alternative PAP failure/intolerance definitionsPolicy references alternative definitions: inability to eliminate OSA (residual AHI >15 despite PAP) or insufficient usage (CPAP use <4 hours/night ≥5 nights/week) as evidence of failure/intolerance.

Documentation noteAuthorization requests should include residual AHI on PAP or objective CPAP usage data to substantiate failure/intolerance.

Policy alignmentDevice labeling, CMS context, and policy history converge on these operational definitions for eligibility determination.

HNS — hypoglossal nerve stimulation definition

DefinitionHypoglossal nerve stimulation (HNS) — neurostimulation of the hypoglossal (cranial nerve XII) that causes anterior movement and stiffening of the tongue to reduce airway collapsibility.

Clinical effectHNS alleviates obstruction at both the soft palate and tongue base by dilating the pharynx via genioglossus activation.

Devices referencedTwo FDA‑approved devices discussed: Inspire UAS (PMA) and Genio (CE-marked; Genio considered investigational in this policy).

Maxillary expansion procedures — DOME and endoscopically assisted nasomaxillary expansion referenced

Procedures namedMaxillary expansion procedures referenced include distraction osteogenesis maxillary expansion (DOME) and endoscopically assisted nasomaxillary expansion (EASE).

Evidence contextThese maxillary expansion techniques are discussed in the references and included among examined surgical approaches for OSA; some remain investigational in policy context.

Use caseMaxillary expansion may be considered in patients with narrow maxilla/nasal floor as part of surgical management strategies; policy lists them among referenced procedures.

Policy statement added that hypoglossal nerve stimulation (HNS) using other FDA‑approved devices (e.g., Genio) is considered investigational for treating clinically significant OSA; HCPCS code C1607 removed from this policy.

2026-01-01coding_update

Coding update added HCPCS code C1607 effective January 1, 2026 (later moved out of this policy).

2025-11-01clinical_update

Policy updated with literature review through November 17, 2025; references added and investigational determination for submucosal cryolysis documented earlier in 2025.

2025-08-01interim_review

Interim review approved July 8, 2025; site-of-service ASC criteria added effective November 7, 2025 and related policy references updated.

2024-10-01policy_renumbering_and_threshold_changes

Policy 7.01.101 was deleted and replaced with 7.01.554 (approved Sept 10, 2024); BMI criteria for HNS narrowed from ≤40 to ≤35 kg/m² and adult age criterion changed from ≥22 to ≥18 (Down syndrome age ranges also revised).

2023-11-01criteria_change

Criteria for HNS in adults changed from BMI ≤32 kg/m² to ≤40 kg/m² to align with expanded FDA indication approved June 8, 2023.

2022-08-01criteria_alignment

Changed CPAP-failure criterion for HNS from residual AHI ≥20 to ≥15 for consistency with FDA indication and other policies.

2019-09-01criteria_alignment

Indication for hypoglossal nerve stimulation changed from AHI ≥20 to AHI ≥15 to align with FDA‑approved indication.

2013-07-24policy_replacement

Policy replaced and updated with literature search through April 17, 2013; added investigational policy statement for implantable hypoglossal nerve stimulators and specified AHI-based diagnostic thresholds for OSA.