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Treatment of Obstructive Sleep Apnea (OSA) and Primary Snoring
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Policy

ORAL APPLIANCES

MEDICALLY NECESSARY
Custom-Fabricated Oral Appliance

A custom-fabricated oral appliance is considered medically necessary and, therefore, covered when either of the following criteria are met​:
  • ​In adults with primary snoring when diagnosed by a certified sleep study who failed behavioral measures (weight loss in obese individuals, sleep-position changes, refraining from alcohol and sedatives)
  • In adults with obstructive sleep apnea (OSA) when diagnosed by a certified sleep study as evidenced by either of the following:
    • ​An apnea hypopnea index (AHI) or respiratory disturbance index (RDI) that is greater than or equal to 15 events per hour with a minimum of 30 events
    • ​An AHI or RDI greater than or equal to 5, and less than or equal to 14 events per hour, with a minimum of 10 events and any of the following:
      • ​​Excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia
      • Hypertension, ischemic heart disease, or history of stroke
    • ​An AHI greater than 30 or an RDI greater than 30 and either of the following:
      • The individual is not able to tolerate a continuous positive airway pressure (CPAP), auto-adjusting CPAP, or bi-level device.
      • The treating professional provider determines that the use of such a CPAP, auto-adjusting CPAP, or bi-level device is contraindicated.   ​​
Custom-Fabricated Mandibular Advancement Oral Appliance

A custom-fabricated mandibular advancement oral appliance is considered medically necessary and, therefore, covered for adults with OSA when diagnosed by a certified sleep study, when any of the following criteria are met:
  • ​An AHI or RDI that is greater than or equal to 15 events per hour with a minimum of 30 events
    • ​​An AHI or RDI greater than or equal to 5, and less than or equal to 14 events per hour, with a minimum of 10 events and any of the following:
      • ​Excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia
      • Hypertension, ischemic heart disease, or history of stroke
    • ​​An AHI greater than 30 or an RDI greater than 30 and either of the following:
      • ​The individual is not able to tolerate a CPAP, auto-adjusting CPAP, or bi-level device.
      • ​The treating professional provider determines that the use of such a CPAP, auto-adjusting CPAP, or bi-level device is contraindicated.
    NOT MEDICALLY NECESSARY
    Prefabricated Oral Appliance

    A prefabricated oral appliance for the treatment of primary snoring or OSA is considered not medically necessary and, therefore, not covered because the available published peer-reviewed literature does not support its use in the treatment of these conditions.

    POSITIONAL TREATMENT (NON-SUPINE POSTURE)

    EXPERIMENTAL/INVESTIGATIONAL
    Although the US Food and Drug Administration (FDA) has approved devices for treating positional OSA ( e.g., ZZOMA Positional Sleeper, NightBalance​ Sleep Position Trainer​), the Company has determined that the safety and/or effectiveness of these devices compared to similar established technologies cannot be established by review of the available published peer-reviewed literature. Therefore, devices for treating positional OSA are​ considered experimental/investigational by the Company and not covered.

    PALATE AND MANDIBLE EXPANSION DEVICES

    EXPERIMENTAL/INVESTIGATIONAL
    Although the FDA has approved devices for palate and mandible expansion (e.g., mandibular Repositioning-Nighttime Appliance® [mRNA appliance®]), to reduce night time snoring and mild to moderate OSA in adults, the Company has determined that the safety and/or effectiveness of this device compared to similar established technologies cannot be established by review of the available published peer-reviewed literature. Therefore, palate and mandible expansion devices for the treatment of OSA are considered experimental/investigational by the Company and not covered.

    NASAL EXPIRATORY POSITIVE AIRWAY PRESSURE (EPAP)

    EXPERIMENTAL/INVESTIGATIONAL
    Although the FDA has approved a device for nasal expiratory positive airway pressure (EPAP), the Company has determined that the safety and/or effectiveness of this device cannot be established by review of the available published peer-reviewed literature. Therefore, nasal EPAP is considered experimental/investigational by the Company and not covered.

    ORAL PRESSURE THERAPY

    EXPERIMENTAL/INVESTIGATIONAL
    Although the FDA has approved a device for oral pressure therapy (OPT), the Company has determined that the safety and/or effectiveness of this device cannot be established by review of the available published peer-reviewed literature. Therefore, OPT is considered experimental/investigational by the Company and not covered.

    NEUROMUSCULAR ELECTRICAL TONGUE STIMULATION 

    EXPERIMENTAL/INVESTIGATIONAL
    ​Although the FDA has approved a device for neuromuscular electrical tongue stimulation (eXciteOSA®​​), the Company has determined that the safety and/or effectiveness of this device cannot be established by review of the available published peer-reviewed literature. Therefore, neuromuscular ​electrical tongue stimulation is considered experimental/investigational by the Company and not covered.​

    HYPOGLOSSAL NERVE STIMULATION

    MEDICALLY NECESSARY
    Hypoglossal nerve stimulation is considered medically necessary and, therefore, covered for adults with OSA when all of the following criteria are met:
    • Age ≥18 years​​
    • AHI ≥15 and events per hour with predominantly obstructive events (defined as central and mixed apneas <25% of the total AHI)
    • CPAP failure (defined as AHI >15 despite CPAP us​​age) or CPAP intolerance (defined as <4 hours per night, 5 nights per week or the CPAP has been returned) including shared decision making that the individual was intolerant of CPAP despite consultation with a sleep expert
    • Body mass index <35 kg/m2  
    • Absence of complete concentric collapse at the soft palate
    Hypoglossal nerve stimulation is considered medically necessary and, therefore, covered for adolescents or young adults with Down syndrome and OSA when all of the following criteria are met:
    • Age 13 to 18 years ​
    • AHI >10 and <50 with less than 25% central apneas 
    • Are contraindicated for or not effectively treated by adenotonsillectomy
    • Have either tracheotomy or be ineffectively treated with CPAP due to noncompliance, discomfort, undesirable side effects, persistent symptoms despite compliance use, or refusal to use the device
    • Body mass index ≤95th percentile for age 
    • Absence of complete concentric collapse at the soft palate ​
    ​EXPERIMENTAL/INVESTIGATIONAL​
    Hypoglossal nerve stimulation for all other uses is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.​

    SURGICAL TREATMENT AND OTHER PROCEDURES

    MEDICALLY NECESSARY
    Surgical treatment for OSA is considered medically necessary and, therefore, covered for either of the following:
    • Individuals who have OSA when conservative treatments (e.g., weight loss, nasal PAP, auto-adjusting CPAP, or bi-level positive airway pressure if appropriate) have failed, and there is an underlying documented, specific, surgically correctable abnormality that is causing the sleep apnea
    • Individuals who have severe heart failure or severe pulmonary disease and cannot tolerate CPAP, auto-adjusting CPAP, or bi-level positive airway pressure, and for whom other measures have failed
    Palatopharyngoplasty (e.g., Misspelled WordUvulopalatopharyngoplasty [UPPP], Misspelled WordUvulopharyngoplasty, Misspelled WordUvulopalatal Flap, Expansion Sphincter Misspelled WordPharyngoplasty, Lateral Misspelled WordPharyngoplasty, Palatal Advancement Misspelled WordPharyngoplasty, Relocation Misspelled WordPharyngoplasty), and/or Misspelled WordMaxillomandibular Advancement (MMA)

    Palatopharyngoplasty and/or MMA are considered medically necessary and, therefore, covered for individuals with OSA when all of the following criteria are met:
    • The individual has a sleep disorder test that is positive for clinically significant OSA as evidenced by either of the following:
      • An AHI or RDI that is greater than or equal to 15 events per hour
      • ​An AHI or RDI greater than or equal to 5, and less than or equal to 14 events per hour, and any of the following:
        • Excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia
        • Hypertension, ischemic heart disease, or history of stroke
    • The individual has failed to respond to CPAP/bi-level positive airway pressure, defined as the inability to reduce the AHI below 5 or the inability to tolerate CPAP/bi-level positive airway pressure, or other appropriate noninvasive treatment
      • Failure to respond to CPAP/bi-level positive airway pressure, determined at the time of CPAP/bi-level positive airway pressure titration, which is performed immediately following the sleep disorder test that confirms the diagnosis and severity of OSA
    • A specialist's documentation that combination retropalatal/Misspelled Wordretrolingual obstruction is the cause of OSA​
    Note: Under rare circumstances, an MMA procedure may require repositioning of teeth using an interdental fixation device. The insertion and application of the device is eligible for reimbursement when performed in Misspelled Wordconjunction with an MMA.

    Genioglossus Advancement

    Genioglossus advancement with or without hyoid suspension that does not use a suspension system is considered medically necessary and, therefore, covered only when performed in conjunction with other surgical interventions to treat OSA (e.g., inferior sagittal mandibular osteotomy, UPPP). When genioglossus advancement is not performed in conjunction with other medically necessary procedures for the treatment of OSA, it is considered experimental/investigational and, therefore, not covered because its safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.

    Tracheostomy

    Tracheostomy is considered medically necessary and, therefore, covered for the treatment of OSA when, in the judgment of the professional provider, an individual is unresponsive to other means of treatment, or in cases in which other means of treatment would be ineffective or not indicated.

    Other Surgical Procedures

    When OSA is caused by specific anatomic abnormalities of the upper airway such as, but not limited to, enlarged tonsils, enlarged adenoids, an enlarged tongue, small jaw structure, or retropalatal/Misspelled Wordretrolingual obstruction, surgery to correct these abnormalities is considered medically necessary and, therefore, covered. Examples of these procedures are tonsillectomy, adenoidectomy, midline Misspelled Wordglossectomy, Misspelled Wordseptoplasty, Misspelled Wordlingu​alplasty, Misspelled Wordgenioplasty, and inferior sagittal mandibular osteotomy. Medical necessity is based on documentation that the anatomic abnormality is contributing to the OSA.

    NOT MEDICALLY NECESSARY
    Surgical treatment of primary snoring in the absence of OSA is considered not medically necessary and, therefore, not covered because the available published peer-reviewed literature does not support its use in the diagnosis or treatment of illness or injury.

    EXPERIMENTAL/INVESTIGATIONAL
    The following procedures are considered experimental/investigational and, therefore, not covered for OSA because their safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.

    Laser-Assisted Uvulopalatoplasty

    Laser-assisted uvulopalatoplasty (LAUP) is considered experimental/investigational because the safety and/or effectiveness of this procedure cannot be established by review of the available published peer-reviewed literature.

    Radiofrequency Ablation and Misspelled WordCoblation Services

    Radiofrequency ablation (e.g., Misspelled WordSomnoplasty System) to reduce excess tissue in individuals with sleep-disordered breathing associated with OSA is considered experimental/investigational because the safety and/or effectiveness of this procedure cannot be established by review of the available published peer-reviewed literature.

    The Misspelled Wordcoblation method (e.g., ENT Misspelled WordCoblator Surgery System) to reduce excess tissue in individuals to help stop snoring is considered experimental/investigational because the safety and effectiveness of this procedure cannot be established by review of the available published peer-reviewed literature.

    Palatal Stiffening/Implant Procedures

    Palatal stiffening procedures including, but not limited to, the cautery-assisted palatal stiffening operation (CAPSO) procedure, injection of Misspelled Wordsclerosing agents, and the implantation of palatal implants, such as the Pillar procedure, are considered experimental/investigational because the safety and/or effectiveness of these procedures cannot be established by review of the available published peer-reviewed literature.

    Tongue Base Suspension/Hyoid Suspension Systems

    Tongue-base suspension systems (e.g., Misspelled WordAirvance™ [Medtronic]; formally the Repose™ Bone Screw System [Influence] and The Encore™ System [Siesta Medical]) are considered experimental/investigational because the safety and/or effectiveness of this procedure cannot be established by review of the available published peer-reviewed literature.

    Hyoid suspension systems (e.g., Misspelled WordAirvance™ [Medtronic]; and The Encore™ System [Siesta Medical]) are considered experimental/investigational because the safety and/or effectiveness of this procedure cannot be established by review of the available published peer-reviewed literature.

    REQUIRED DOCUMENTATION

    The Company may conduct reviews and audits of services to our members regardless of the participation status of the provider. Medical record documentation must be maintained on file to reflect the medical necessity of the care and services provided. These medical records may include but are not limited to: records from the professional provider’s office, hospital, nursing home, home health agencies, therapies, and test reports. This policy is consistent with Medicare's documentation requirements, including the following required documentation:

    PRESCRIPTION (ORDER) REQUIREMENTS
    Before submitting a claim to the Company, the supplier must have on file a timely, appropriate, and complete order for each item billed that is signed and dated by the professional provider who is treating the member. Requesting a provider to sign a retrospective order at the time of an audit or after an audit for submission as an original order, reorder, or updated order will not satisfy the requirement to maintain a timely professional provider order on file.

    PROOF OF DELIVERY
    Medical record documentation must include a contemporaneously prepared delivery confirmation or member’s receipt of supplies and equipment. The medical record documentation must include a copy of delivery confirmation if delivered by a commercial carrier and a signed copy of delivery confirmation by member/caregiver if delivered by the durable medical equipment (DME) supplier/provider. All documentation is to be prepared contemporaneous with delivery and be available to the Company upon request.

    CONSUMABLE SUPPLIES
    The DME supplier must monitor the quantity of accessories and supplies an individual is actually using. Contacting the individual regarding replenishment of supplies should not be done earlier than approximately 7 days prior to the delivery/shipping date. Dated documentation of this contact with the individual is required in the individual’s medical record. Delivery of the supplies should not be done earlier than approximately 5 days before the individual would exhaust their on-hand supply.

    If required documentation is not available on file to support a claim at the time of an audit or record request, the DME supplier may be required to reimburse the Company for overpayments.

    BILLING REQUIREMENTS

    Inclusion of a code in this policy does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

    Guidelines

    BENEFIT APPLICATION

    Subject to the terms and conditions of the applicable benefit contract, treatment of obstructive sleep apnea (OSA) is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met. However, services that are identified in this policy as experimental/investigational or not medically necessary are not eligible for coverage or reimbursement by the Company.

    Services that are experimental/investigational are a benefit contract exclusion for all products of the Company. Therefore, they are not eligible for reimbursement consideration.

    When the treatment of OSA or primary snoring is performed on an individual who has any of the absolute contraindications listed in this policy, that service is considered not medically necessary and, therefore, not covered.

    US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

    There are numerous devices approved by the FDA for OSA and snoring.

    Description

    Sleep apnea is a respiratory dysfunction that results in a cessation or near cessation of respiration for a minimum of 10 seconds. Sleep apnea syndromes are classified as Misspelled Worddyssomnias and include central, obstructive, or mixed apnea. Central sleep apnea is defined as a neurologic condition causing cessation of all respiratory effort during sleep. Usually, there is no mechanical obstruction associated with central sleep apnea. Obstructive sleep apnea (OSA) occurs when respiratory effort is present with the temporary collapse and obstruction of the upper airway; it is characterized by repetitive pauses in breathing. Mixed sleep apnea is a combination of central sleep apnea and OSA, with the central apneic element usually presenting prior to the obstructive apneic component. Undiagnosed and untreated individuals have repeated apneic episodes during the night, causing pronounced disruption of their sleep cycles and various daytime symptomatology.

    OSA is commonly associated with airway obstruction caused by one or more of the following:
    • Obesity
    • Specific anatomic abnormalities of the upper airway such as, but not limited to, enlarged tonsils, enlarged adenoids, an enlarged tongue, and small jaw structure
    • Retropalatal/retrolingual obstruction, adenotonsillar hypertrophy, mandibular deficiency, or macroglossia
    • Upper airway tumor
    • Excessive pressure across the collapsible segment of the upper airway
    • Insufficient activity of the muscles of the upper airway to maintain patency
    Symptoms of OSA may include, but are not limited to, the following:
    • Snoring
    • Morning headache
    • Excessive daytime sleepiness (not explained by other factors)
    • Choking or gasping during sleep
    • Recurrent awakenings from sleep
    • Fatigue and impaired concentration
    OSA occurs most often in moderately to severely obese individuals and affects more men than women. Complications may include cardiac rhythm disturbances and hypertension. The mortality rate from stroke and myocardial infarction is significantly higher in individuals with OSA than in the general population. For obesity-related sleep apnea, weight loss often reduces obstructive apneic episodes, improves blood gases, and lessens daytime drowsiness.

    The diagnosis of OSA is made by evaluating an individual’s symptoms and measuring physiological parameters during sleep, called sleep testing. Sleep testing is classified as follows:
    • Type I: A sleep study performed in a facility that measures electroencephalogram (EEG), Misspelled Wordelectrooculogram (EOG), electrocardiogram (EKG), electromyogram (EMG), oxygen saturation, respiratory effort, and airflow.
    • Type II: A sleep study performed with portable equipment that measures a minimum of seven channels (including EEG, EOG, EMG, ECG/heart rate, airflow, respiratory effort, and oxygen saturation).
    • Type III: An unattended sleep study performed with portable equipment that measures a minimum of four simultaneous and continuous recording channels (including oxygen saturation, respiratory movement, airflow, and EKG/heart rate).
    • Type IV: An unattended sleep study performed with portable equipment that measures three or more physiological parameters, one of which is airflow.
    • Sleep testing devices that measure three or more channels that include Misspelled Wordactigraphy (measurement of movement), oximetry (oxygen saturation), and peripheral arterial tone (pulsatile volume changes) when used to aid in the diagnosis of OSA.
    The apnea-hypopnea index (AHI) and respiratory disturbance index (RDI) are considered diagnostic for mild OSA if more than five and less than 15 observed apneas or hypopneas occur per hour of sleep. The AHI is equal to the average number of episodes of apnea and hypopnea per hour. The RDI is equal to the average number of respiratory disturbances per hour. Moderate to severe sleep apnea is generally defined as an AHI or RDI greater than or equal to 15 events an hour, or an AHI greater than five and less than or equal to 14 events per hour with additional symptoms (e.g., excessive daytime sleepiness, insomnia, mood disorders, hypertension). Individuals with severe OSA have more than 30 events recorded per hour of sleep.

    PRIMARY SNORING

    Primary snoring (also known as simple snoring, noisy breathing during sleep, snoring without sleep apnea, benign snoring, rhythmical snoring, and continuous snoring) is characterized by loud upper airway breathing sounds in sleep without episodes of apnea. Although snoring is a sign of upper airway obstruction during sleep, testing may determine that there are no indications of reduced airflow or other signs of sleep apnea. When no clinically significant underlying pathology is found, these individuals may be diagnosed with primary snoring.

    TREATMENT OF OSA

    OSA is chronic and relapsing; therefore, multiple therapeutic approaches may be necessary. Treatment options for mild to moderate OSA include:
    • Weight reduction
    • Sleep position training
    • Oral appliances designed to keep the tongue and jaw forward
    • Nasal continuous positive airway pressure (CPAP)
    • Medications (i.e., medroxyprogesterone acetate, Misspelled Wordprotriptyline), indicated for a small number of individuals who satisfy specific criteria
    • A variety of surgical procedures
    CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP), AUTO-ADJUSTING CPAP, AND BI-LEVEL (INTERMITTENT) POSITIVE AIRWAY PRESSURE

    The recommended initial treatment for individuals diagnosed with mild OSA with certain comorbidities, moderate OSA, or severe OSA is a trial of CPAP. CPAP is a noninvasive technique that prevents upper airway occlusion by splinting the pharyngeal airway with low levels of positive pressure delivered through the nares via a nasal mask. The purpose is to prevent the collapse of the oropharyngeal walls and the obstruction of airflow during sleep. Auto-adjusting CPAP automatically adjusts the level of air pressure for each breath taken based on the level of resistance. Bi-level positive airway pressure also delivers continuous pressure and allows the pressure to be adjusted separately during inspiration and expiration. The device cycles between a predetermined inspiratory PAP phase and a preset expiratory PAP phase.

    ORAL APPLIANCES

    Oral appliances are used for:
    • Individuals diagnosed with primary snoring and/or mild OSA who do not respond to or are not appropriate candidates for behavioral measures such as weight loss or sleep position training
    • Individuals with OSA who refuse or do not respond to nasal CPAP or auto-adjusting CPAP
    • Individuals who refuse or are not candidates for surgical interventions
    The effectiveness of the oral appliance is determined by its ability to advance the mandible in a vertical and sagittal plane. Appliances that are custom-made and adjustable have been found to be more effective than fixed, thermoplastic-type appliances. In general, prefabricated devices are not effective. It has been shown that tongue retaining and other inactive devices do not improve AHI, oxygen saturation, Epworth Sleepiness Scale, or blood pressure.

    A custom-fabricated oral appliance is individually and uniquely made for a specific individual. It involves taking an impression of the individual’s teeth and making a positive model of plaster or equivalent material​. Custom fabrication requires more than trimming, bending, or making other modifications to a substantially prefabricated item. A custom-fabricated oral appliance may include a prefabricated component (e.g., the joint mechanism).

    A custom-fabricated mandibular advancement device incorporates all of the below:
    • A fixed mechanical hinge at the sides, front, or palate. A fixed hinge is defined as a mechanical joint containing an inseparable pivot point. Interlocking flanges, tongue and groove mechanisms, hook and loop or hook and eye clasps, elastic straps or bands, etc. (not all-inclusive) do not meet this requirement.
    • Capability to protrude the individual's mandible beyond the front teeth when adjusted to maximum protrusion.
    • Incorporates a mechanism that allows the mandible to be easily advanced by the individual in increments of 1 millimeter or less.
    • Retains the adjustment setting when removed from the mouth.
    • Maintains the adjusted mouth position during sleep.
    • Remains fixed in place during sleep to prevent dislodging the device.
    • Requires no return visits beyond the initial 90-day fitting and adjustment period to perform ongoing modification and adjustments in order to maintain effectiveness.
    The US Food and Drug Administration (FDA) has approved several custom oral devices to be used in the treatment of OSA. Some examples include Misspelled WordKlearway™, Modified Misspelled WordHerbst™, Elastic Mandibular Advancement (EMA™), Thornton Adjustable Positioner (TAP™), Adjustable PM Positioner™, Silencer™, and Oral Pressure Appliance (OPAP™). Individuals requiring these devices must have impressions of their mouths made.

    In October 2020, the FDA gave 510(k) approval to the Slow Wave DS8, an intraoral device intended to reduce or alleviate snoring and mild to moderate OSA while sleeping in adults. This mandibular repositioning device acts to increase the users’ pharyngeal space and improves their ability to exchange air during sleep. The device consists of two separate trays worn on the maxilla and mandible and it does not incorporate a mechanical hinge. The DS8 allows the user to open and close their jaw when asleep and provides full lateral movement of the mandible. This custom-fabricated oral device ​is created from a digital intraoral scan and is 3D digitally printed in a lab. ​​​

    POSITIONAL TREATMENT (NON-SUPINE POSTURE)

    ZZOMA POSITIONAL SLEEPER
    Positional treatment for sleep-related disorders include devices designed to prevent individuals from rolling onto their backs (supine position) during sleep. This prevents the soft tissues of the throat from sagging down into the airway and disrupting air flow, causing snoring, breathing difficulty, and awakenings that disturb normal sleep patterns. In May 2010, the Misspelled WordZzoma Positional Sleeper received premarket clearance through the FDA’s 510(k) program for the treatment of mild to moderate, predominantly positional OSA and to reduce or alleviate snoring. Peer-reviewed literature is limited to one small (n=38) randomized controlled crossover trial comparing the Misspelled WordZzoma Positional Device to CPAP for treating OSA. Subjects were initially randomly assigned to either a full night of CPAP therapy or positional device use then crossed over to the opposite therapy for a second full night of study intervention. Although the Misspelled WordZzoma device reduced AHI in the study sample, statistically significant improvement was noted for CPAP compared to baseline. Evidence at this time is insufficient to permit conclusions regarding the effect of this technology on health outcomes.

    NIGHTBALANCE SLEEP POSITION TRAINER
    In May 2018, the Misspelled WordNightBalance Misspelled WordLunoa System received premarket clearance through the FDA’s 510(k) program for the treatment of adults with positional OSA with a Misspelled Wordnonsupine AHI less than 20. The evidence on the Misspelled WordNightBalance Sleep Position Training device includes randomized controlled trials (RCTs) and single-arm studies. The RCTs suggest that the device may be as effective as oral appliances and more comfortable than positive airway pressure in individuals with positional OSA. However, the studies are limited by a high dropout rate and short follow-up. A 6-month prospective study found that 64% of individuals used the sleep position trainer for more than 4 hours per night, but another observational study found that only a quarter of individuals may be both able to tolerate the device and have a reduction in supine AHI in the short term. Further study is needed to evaluate who may receive benefit and continue utilization after the trial period.

    PALATE AND MANDIBLE EXPANSION DEVICES

    Palate and mandible expansion devices function as an expander for palate/jaw/bone acting to increase pharyngeal space and propose to treat, reduce, and eliminate OSA. In May 2014, the FDA gave 510(k) approval to the Mandibular Repositioning Nighttime Appliance (mRNA), an intraoral device for the treatment of mild to moderate OSA. In a 2017 study, Singh and Cress reported on a series of 19 individuals who had mild to moderate sleep apnea who were treated with a Daytime Nighttime Appliance (DNA) or mRNA. Only individuals who complied with oral appliance wear were included in the study. The mean AHI was reduced from 12.85 to 6.2 events per hour (P<0.001) without the appliance, while the oxygen saturation index improved from 6.3% to 2.6% (P<0.001). Moreover, these devices have been studied in severe OSA. In 2016, Singh et al. reported on a series of 15 consecutive individuals with severe sleep apnea who were treated with a DNA appliance or mRNA appliance. All individuals had failed to comply with CPAP. Pre- and Misspelled Wordposttreatment AHI was assessed in a home sleep study without the oral appliance. AHI decreased from a mean 45.9 events per hour to 16.5 (P<0.01) after a mean 9.7 months of treatment. Limitations of these studies included uncertain blinding of the physician evaluating the sleep study, the small number of individuals studied, the lack of intention-to-treat analysis, and the lack of long-term follow-up. 

    NASAL EXPIRATORY POSITIVE AIRWAY PRESSURE (EPAP)

    In December 2010, the FDA gave 510(k) approval to the Misspelled WordProvent sleep apnea therapy, a nasal expiratory positive airway pressure (EPAP) device for the treatment of OSA. The Misspelled WordProvent device, which is placed just inside the nostrils, is proposed to increase pressure in the airway in an effort to prevent the collapse of the airway during sleep. Use of the EPAP device has been reported in several prospective case series and one industry-sponsored RCT. The main finding of the trial was a decrease in AHI with minor impact on oxygenation and the Epworth Sleepiness Scale (ESS). Evidence at this time is insufficient to permit conclusions regarding the effect of this technology on health outcomes. This device has been discontinued. 

    In January 2020, the FDA gave 510(k) approval to the​ Misspelled WordULTepap™ system for the treatment of mild to moderate OSA in adults greater than 66 pounds. The system is composed of headgear, nasal pillows, and a pair of cartridge valves that produce resistance on Misspelled Wordexhalation resulting in therapeutic back pressure to open the upper airway. Evidence at this time is insufficient to permit conclusions regarding the effect of this technology on health outcomes. ​​
     
    ORAL PRESSURE THERAPY

    Oral pressure therapy (OPT) provides light negative pressure to the oral cavity by using a flexible mouthpiece connected to a bedside console that delivers negative pressure. In October 2012, the FDA gave 510(k) approval to the Misspelled WordWinx Sleep Therapy System, which uses OPT for the treatment of OSA. This device is proposed to increase the size of the Misspelled Wordretropalatal airway by pulling the soft palate forward and stabilizing the base of the tongue. Evidence at this time is insufficient to permit conclusions regarding the effect of this technology on health outcomes.

    NEUROMUSCULAR ELECTRICAL TONGUE STIMULATION 

    In February 2021, the FDA granted de novo authorization for the Misspelled WordeXciteOSA, a tongue muscle stimulation device intended to reduce snoring and mild OSA for individuals 18 years or older. The evidence on Misspelled WordeXciteOSA includes two prospective single-arm studies in individuals with primary snoring or mild OSA; no controlled trials were identified. ​The available evidence suggests that when used for 20 minutes a day over 6 weeks, the treatment may reduce snoring. In the overall population, the effects on AHI were not clinically significant. For the subgroup of individuals with mild OSA, the improvement in AHI in these uncontrolled trials remained modest. With a mean ESS of less than 10, this group of individuals might not be considered symptomatic. Controlled studies are needed to evaluate whether individuals who meet criteria for treatable OSA improve and whether individuals would continue use after the 6-week trial period.​

    HYPOGLOSSAL NERVE STIMULATION

    In April 2014, the Inspire II Upper Airway Stimulation System (UAS) (Inspire Medical Systems) received FDA approval for use in individuals 22 years and older who have been confirmed to fail or cannot tolerate positive airway pressure treatments and who do not have a complete concentric collapse at the soft palate level. In 2020, the indication was expanded to include individuals between 18 and 21 years of age with moderate to severe OSA. ​On March 20, 2023, the FDA expanded the indication to include pediatric individuals between 13 and 18 years of age, with Down syndrome and severe OSA. Implanted components include the implantable pulse generator (IPG), stimulation lead, and sensing lead, and external components include the physician programmer and the patient programmer (sleep remote). The IPG detects the individual's breathing pattern and maintains an open airway with mild stimulation of the hypoglossal nerve, which controls tongue movement, during inhaled breathing. The professional provider adjusts the stimulation settings using the external physician programmer. The patient sleep remote allows the individual to turn therapy on before they go to sleep and to turn therapy off when they wake up. Studies suggest that UAS may improve OSA symptoms in individuals with moderate to severe OSA in whom prior CPAP/BPAP did not work or was not tolerated.

    The evidence on hypoglossal nerve stimulation (HGNS) for the treatment of OSA includes a systematic review consisting of 200 individuals, a European Misspelled Wordpostmarket registry with 60 individuals followed for 1 year, and a prospective cohort of about 100 individuals with published results up to 5 years.

    The Stimulation Therapy for Apnea Reduction (STAR) trial (Misspelled WordStrollo et al., 2014) evaluated the clinical safety and effectiveness of upper airway stimulation at 12 months for the treatment of moderate to severe OSA. Using a multicenter, prospective, single-group, cohort design, an upper airway stimulation device was surgically implanted in individuals with OSA who had difficulty either accepting or adhering to CPAP therapy (n=126). The primary outcome measures were the AHI, with a score of 15 or greater indicating moderate to severe apnea and the oxygen desaturation index (ODI). Secondary outcome measures were the ESS, the Functional Outcomes of Sleep Questionnaire (FOSQ), and the percentage of sleep time with the oxygen saturation less than 90%. The study included 83% men. The mean age was 54.5 years, and the mean body mass index (BMI) was 28.4. The median AHI score at 12 months decreased 68%, from 29.3 events per hour to 9.0 events per hour; the ODI score decreased 70%, from 25.4 events per hour to 7.4 events per hour. Secondary outcome measures showed a reduction in the effects of sleep apnea and improved quality of life. In the randomized phase, the mean AHI score did not differ significantly from the 12-month score in the nonrandomized phase among the 23 participants in the therapy maintenance group (8.9 and 7.2 events per hour, respectively); the AHI score was significantly higher (indicating more severe apnea) among the 23 participants in the therapy withdrawal group (25.8 vs 7.6 events per hour). The ODI results followed a similar pattern. The rate of procedure-related serious adverse events was less than 2%. The authors concluded that upper airway stimulation led to significant improvements in objective and subjective measurements of the severity of obstructive sleep apnea. This study was funded by Inspire Medical Systems.

    Follow-up studies of the same population at 18, 36, and 60 months indicate that the treatment effects, improvements in AHI and ODI scores, are maintained over time. Limitations are the same as the initial study (Misspelled WordStrollo et al., 2015; Woodson et al., 2016; Woodson et al., 2018).

    Gillespie et al. (2017) reported the 4-year outcomes of the STAR trial as described above (Stroll et al., 2014). Ninety-one of the 126 participants completed the 4-year follow-up. This study focused on the self-reported individual secondary outcomes collected every 6 months through a total of 48 months. Secondary outcome measures include subjective sleepiness and sleep-related quality of life with the validated ESS and the FOSQ and snoring level. Daytime sleepiness as measured by ESS was significantly reduced (P=0.01), and sleep-related quality of life as measured by FOSQ significantly improved (P=0.01) when compared with baseline. Soft to no snoring was reported by 85% of bed partners. At 48 months, three participants had undergone elective Misspelled Wordexplantation of the Inspire UAS system, three had died, and 25 participants had been lost to follow-up. Two individuals required reoperation between 36 and 48 months for lead-related failure. The reported main study limitation was the increased number of individuals lost to follow-up at 48 months compared with 36 months.

    A systematic review identified six case series (n=200) assessing HGNS (Misspelled WordCertal et al., 2015). No comparative trials were identified. Two series were identified on the Inspire II System and included the STAR trial (previously described). Three series were identified with the HGNS system and included the 2014 study of 31 individuals previously described. One series of 13 individuals who received the Aura 6000 System was identified. When data were combined for meta-analysis, AHI and ODI scores improved over 50% (e.g., AHI from 44 to 20 events per hour, ODI scores from 21 to 10), and ESS scores improved from 12 to 7. All selected studies described minor complications such as tongue weakness, tongue soreness, pain/swelling at the neck incision, fever, and lack of tongue response to stimulation. Of the 200 individuals, nine (4.5%) had serious device-related adverse events that led to the removal of the stimulator.​

    The available published evidence suggests that Inspire use is relatively safe and the technology results in a meaningful improvement in the net health outcomes in individuals with a BMI of 35 or less. Inspire is currently being studied in an expanded population of individuals with a BMI of 40 or less (Adherence and Outcome of Upper Airway Stimulation [UAS] for OSA International Registry [ADHERE, NCT02907398]). ​

    SURGICAL TREATMENTS

    Surgical treatments for OSA are used to achieve upper airway reconstruction and can be divided into phase I and phase II procedures. Phase I surgeries advance the tongue off the back of the throat by advancing the front of the jaw and consist of one or a combination of procedures, including Misspelled Worduvulopalatopharyngoplasty (UPPP)/laser-assisted uvulopalatoplasty (LAUP), Misspelled Wordglossectomy, Misspelled Wordlingualplasty, genioglossus advancement with or without hyoid suspension, inferior sagittal mandibular osteotomy, and tracheostomy. Phase II surgery achieves advancement of both the maxilla and mandible and is called Misspelled Wordmaxillomandibular osteotomy and advancement (MMA).

    When OSA is caused by specific anatomic abnormalities of the upper airway such as, but not limited to, enlarged tonsils, enlarged adenoids, an enlarged tongue, small jaw structure, or Misspelled Wordretropalatal/retrolingual obstruction, surgery is performed to correct these anomalies. Examples of these surgical procedures are tonsillectomy, adenoidectomy, Misspelled Wordseptoplasty, and Misspelled Wordgenioplasty.

    The following are descriptions of surgical procedures that may be performed for the treatment of OSA:

    Misspelled WordPalatopharyngoplasty (e.g., Misspelled Worduvulopalatopharyngoplasty [UPPP], Misspelled Worduvulopharyngoplasty, Misspelled Worduvulopalatal flap, expansion sphincter Misspelled Wordpharyngoplasty, lateral Misspelled Wordpharyngoplasty, palatal advancement Misspelled Wordpharyngoplasty, relocation Misspelled Wordpharyngoplasty) enlarges and opens the airway by removing or shortening the uvula, removing the tonsils and adenoids if present, and/or removing part of the soft palate or roof of the mouth.

    An inferior sagittal mandibular osteotomy brings the lower bone of the jaw forward, while an MMA procedure separates the maxilla and the mandible; both enlarge the retrolingual​ airway.

    A midline Misspelled Wordglossectomy procedure reduces the size of the back of the tongue by excising a v-shaped portion of the center part of the tongue. A Misspelled Wordlingualplasty is a more aggressive procedure that additionally removes side wedges.

    A genioglossus advancement procedure with or without hyoid suspension pulls the back of the tongue forward, thereby enlarging the airspace behind the tongue. It is performed under general anesthesia through an incision inside the lower lip. A rectangular or circular segment of chin bone (just below the four front teeth) is pulled forward and held in place with a titanium screw or plate. A hyoid advancement is performed by making an incision in the neck just above the Adam's apple. The hyoid bone is moved forward and attached to the Adam's apple or to the jawbone. This additional procedure also enlarges the airspace behind the tongue.

    Tracheostomy is the surgical opening of the trachea to facilitate breathing. This procedure remains the surgical approach with the greatest effectiveness because it bypasses all areas of obstruction in the nasal, palatal, lingual, and pharyngeal areas. However, tracheostomy is associated with significant morbidity.

    Tonsillectomy is the surgical removal of tonsils or a tonsil.

    Adenoidectomy is the surgical removal of adenoids.

    Misspelled WordSeptoplasty involves major repair of the nasal septum.

    Misspelled WordGenioplasty is the surgical advancement or reduction of the chin. This surgery is often performed to correct a maxillofacial abnormality that is causing OSA.

    Radiofrequency ablation reduces excess tissue of the palate, uvula, and tongue base in individuals with sleep-disordered breathing associated with OSA. The Misspelled WordSomnoplasty System (Olympus, formally Gyrus ACMI and Misspelled WordSomnus Medical Technologies; Center Valley, PA) is a device with an FDA 510(k) approval for reducing the incidence of airway obstruction in individuals suffering from upper airway resistance syndrome or OSA. There is insufficient published peer-reviewed literature to establish the efficacy of this procedure at this time.

    The ENT Misspelled WordCoblator Surgery System (Misspelled WordArthroCare Corp.; Austin, TX) is a device that has FDA approval for otorhinolaryngology (ear, nose, and throat [ENT]) procedures such as throat surgery to reduce excess tissue in the uvula/soft palate for the treatment of snoring. It is also approved for traditional uvulopalatoplasty and tonsillectomy. Tissue is vaporized, one cell layer at a time, without using heat energy. There is insufficient published peer-reviewed literature to establish the efficacy of this procedure at this time.

    The Misspelled WordAlRvance™ System (Medtronic, Inc.; Jacksonville, FL) and Encore™ System (Siesta Medical; Los Gatos, CA) enable minimally invasive surgical treatment of tongue- and hyoid-based OSA. There are two surgical procedures that may be performed with these systems to treat OSA: the tongue suspension procedure and the hyoid suspension procedure.

    The tongue suspension procedure with these systems employs a titanium screw that is secured to the anterior mandible and a permanent suture that is looped through the posterior tongue base. When the suture is tightened, the tongue base is stabilized, which prevents collapse and airway obstruction.

    The hyoid suspension procedure with these systems employs two titanium screws with attached sutures that are implanted in the lower mandible. When the sutures are looped around the hyoid bone, the hyoid bone is suspended to help maintain an open airway. There is insufficient published peer-reviewed literature to establish the safety and efficacy of these systems at this time.

    Palatal stiffening procedures include a cautery-assisted palatal stiffening operation (CAPSO), injection of sclerosing agents, and the insertion of palatal implants (Pillar™ Palatal Implant System, also known as the Pillar procedure [Restore Medical Inc.; St Paul, MN acquired by Medtronic, Inc.; Jacksonville, FL in 2008]).

    The CAPSO procedure uses a cautery to induce a midline palatal scar designed to stiffen the soft palate to eliminate excessive snoring. There is insufficient published peer-reviewed literature to establish the safety and efficacy of this procedure at this time.

    The Pillar procedure involves the placement of three tiny woven inserts that stiffen the structure of the soft palate to help reduce the vibration that causes snoring and limit the ability of the soft palate to obstruct the airway. The Pillar™ Palatal Implant System has FDA 510(k) approval. The device is a cylindrical-shaped segment of braided polyester filaments that is permanently implanted submucosally in the soft palate. It is intended to reduce the incidence of airway obstruction in individuals suffering from mild to moderate OSA.

    There is insufficient published peer-reviewed literature to establish the efficacy of palatal stiffening procedures at this time.

    Laser-assisted uvulopalatoplasty (LAUP) utilizes a carbon dioxide (CO2) laser that progressively reshapes the uvula and associated soft-palate tissues in order to enlarge the oropharyngeal airway. Less tissue is removed than with UPPP, as LAUP usually does not remove tonsils or lateral pharyngeal wall tissues. The procedure, using local anesthesia, is typically performed in an outpatient setting three to seven times and at 3- to 4-week intervals. LAUP cannot be considered an equivalent procedure to the standard UPPP, with the laser representing a surgical tool that the provider opts to use. There is insufficient published peer-reviewed literature to establish the efficacy of LAUP at this time.

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    Pang KP, Terris DJ. Modified cautery-assisted palatal stiffening operation: new method for treating snoring and mild obstructive sleep apnea. Otolaryngol Head Neck Surg. 2007;136(5):823-826.

    Paruthi S. Management of obstructive sleep apnea in children. [UpToDate Web site]. 08/21/2025. Available at: https://www.uptodate.com/contents/management-of-obstructive-sleep-apnea-in-children/print?search=Management of obstructive sleep apnea in children&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1 [via subscription only]. Accessed September 29, 2025. 

    Patel RM, Wang HZ, Jamro EL, et al. Response to Hypoglossal Nerve Stimulation Changes With Body Mass Index and Supine Sleep. JAMA Otolaryngol Head Neck Surg. 2024;150(5):421-428. 


    Permut I, az-Abad M, Chatila W, et al. Comparison of positional therapy to CPAP in patients with positional obstructive sleep apnea. J Clin Sleep Med. 2010;6(3):238-243.

    Phillips CL, Grunstein RR, Darendeliler MA, et al. Health Outcomes of CPAP versus Oral Appliance Treatment for Obstructive Sleep Apnea: A Randomised Controlled Trial. Am J Respir Crit Care Med. 2013;187(8):879-887.

    Pliska BT, Almeida F. Effectiveness and outcome of oral appliance therapy. Dent Clin North Am. 2012;56(2):433-444.

    Qaseem A, Holty JE, Owens DK, et al. Management of obstructive sleep apnea in adults: A clinical practice guideline from the American College of Physicians. Ann Intern Med. 2013;159(7):471-483.

    Ramar K, Dort LC, Katz SG, et al. Clinical Practice Guideline for the Treatment of Obstructive Sleep Apnea and Snoring with Oral Appliance Therapy: An Update for 2015. J Clin Sleep Med. 2015;11(7):773-827.

    Riaz M, Certal V, Nigam G, et al. Nasal expiratory positive airway pressure devices (Provent) for OSA: a systematic review and meta-analysis. Sleep Disord. 2015;2015:734798.

    Roland PS, Rosenfeld RM, Brooks LJ, et al. Clinical practice guideline: Polysomnography for sleep disordered breathing prior to tonsillectomy in children. Otolaryngol Head Neck Surg. 2011; 145(1Suppl):S1-15.

    Schwartz AR, Jacobowitz O, Eisele DW, et al. Targeted Hypoglossal Nerve Stimulation for Patients With Obstructive Sleep Apnea: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2023;149(6):512-520.

    Singh GD, Cress SE. Biomimetic oral appliance therapy in adults with mild to moderate obstructive sleep apnea using combined maxillo-mandibular correction. [ClinMed Web site]. 2017. Available at:

    https://clinmedjournals.org/articles/jsdm/journal-of-sleep-disorders-and-management-jsdm-3-014.pdf. Accessed September 29, 2025. 

    Singh GD, Griffin T, Cress SE. Biomimetic oral appliance therapy in adults with severe obstructive sleep apnea. [Omics International Web site]. 01/28/2016. Available at: https://www.omicsonline.org/open-access/biomimetic-oral-appliance-therapy-in-adults-with-severe-obstructivesleep-apnea-2 167-0277-1000227.pdf. Accessed September 29, 2025. 

    Soose RJ, Woodson BT, Gillespie MB, et al. Upper airway stimulation for obstructive sleep apnea: self-reported outcomes at 24 months. J Clin Sleep Med. 2016;12(1):43-48.

    Spencer J, Patel M, Mehta N, et al. Special consideration regarding the assessment and management of patients being treated with mandibular advancement oral appliance therapy for snoring and obstructive sleep apnea. Cranio. 2013;31(1):10-13.

    Steward DL. Effectiveness of multilevel (tongue and palate) radiofrequency tissue ablation for patients with obstructive sleep apnea syndrome. Laryngoscope. 2004;114(12):2073-2084.

    Steward DL, Huntley TC, Woodson BT, Surdulescu V. Palate implants for obstructive sleep apnea: multi-institution, randomized, placebo-controlled study. Otolarygol Head Neck Surg. 2008;139(4):506-510.

    Steward DL, Weaver EM, Woodson BT. A comparison of radiofrequency treatment schemes for obstructive sleep apnea syndrome. Otolaryngol Head Neck Surg. 2004;130(5):579-585.

    Strollo PJ, Jr., Soose RJ, Maurer JT, et al. Upper-airway stimulation for obstructive sleep apnea. N Engl J Med. 2014;370(2):139-149.

    Strollo PJ, Jr., Gillespie MB, Soose RJ, et al. Upper airway stimulation for obstructive sleep apnea: durability of the treatment effect at 18 months. Sleep. 2015;38(10):1593-1598.

    Stuck BA, Sauter A, Hormann K, et al. Radiofrequency surgery of the soft palate in the treatment of snoring. A placebo-controlled trial. Sleep. 2005;28(7):847-850.

    Sundaram S, Lim J, Lasserson TJ. Surgery for obstructive apnea. Cochrane Database Syst Rev. 2005;4.CD001004. Confirmatory update 2008.

    Suurna M. Hypoglossal nerve stimulation for adult patients with obstructive sleep apnea. [UpToDate Web site]. 04/24/2025. Available at: Hypoglossal nerve stimulation for adult patients with obstructive sleep apnea - UpToDate  [via subscription only]. Accessed September 29, 2025. 


    Tihacek-Sojic L, Andjelkovic M, Milac-Lemic A, Milosevic B. The effectiveness of oral appliances in elderly patients with obstructive sleep apnea treated with lorazepam: a pilot study. J Oral Rehabil.  2012;5:1365-2842.

    US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). AIRvance™ Bone Screw System. Premarket approval letter, #K122391. [FDA Web site]. 01/10/2013. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf12/K 122391.pdf. Accessed September 29, 2025. 

    US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Apnea Guard. 510(k) summary. [FDA Web site]. 07/22/2011. Available at:  https://www.accessdata.fda.gov/cdrh_docs/pdf11/k111110.pdf. Accessed September 29, 2025. 

    US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). ArthroCare 8000S Coblator, Coblator Surgery System. Premarket approval letter. [FDA Web site]. 12/06/2005. Available at: http://www.accessdata.fda.gov/cdrh_docs/pd f5/K053297.pdf. Accessed September 29, 2025. 

    US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). BioModeling Solutions, Inc. Warning Letter. [FDA Web site]. 01/12/2018. Available at:
    https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm592704.htm. Accessed September 29, 2025.

    US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Class II Special Controls Guidance Document: Intraoral devices for snoring and/or obstructive sleep apnea; guidance for industry and FDA. [FDA Web site]. 11/12/2002. Available at: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea - Class II Special Controls Guidance Document for Industry and FDA | FDA. Accessed September 29, 2025.

    US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). ENCORE™ System 510(k). 03/26/2014. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf13/k13 3680.pdf. Accessed September 29, 2025.

    US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Inspire Upper Airway Stimulation (UAS). PMA supplement, P130008S090. [FDA Web site]. 06/08/2023. Available at: Correspondence Generator (CorGen) (fda.gov) . Accessed September 29, 2025.

    US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Inspire Upper Airway Stimulation (UAS). PMA supplement, P130008S089. [FDA Web site]. 03/20/2023. Available at: Correspondence Generator (CorGen) (fda.gov) . Accessed September 29, 2025.

    US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Inspire Upper Airway Stimulation (UAS). PMA supplement, P130008S021. [FDA Web site]. 06/23/2017. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130008S021. Accessed September 29, 2025.

    US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Inspire Upper Airway Stimulation (UAS). Premarket approval letter, #P13008. [FDA Web site]. 04/30/2014. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130008a.pdf. Accessed September 29, 2025.

    US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Luco Hybrid OSA Appliance®. 510(k) summary. [FDA Web site]. 12/18/2013. Available at:  https://www.accessdata.fda.gov/cdrh_docs/pdf13/k130797.pdf. Accessed September 29, 2025.

    US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). MRNA Appliance. 510(k) summary. [FDA Web site]. 05/08/2014. Available at:  https://www.accessdata.fda.gov/cdrh_docs/pdf13/K130067.pdf. Accessed September 29, 2025.

    US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Pillar™ Palatal Implant System. Premarket approval letter. [FDA Web site]. 07/28/2004. Available at:  http://www.accessdata.fda.gov/cdrh_docs/pdf4/K040417.pdf. Accessed September 29, 2025.

    US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). PROVENT® Sleep Apnea Therapy 510(k). 12/02/2010. Available at: http://www.accessdata.fda.gov/cdrh_doc s/pdf10/K102404.pdf. Accessed September 29, 2025. .

    US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Repose™ Bone Screw System. Premarket approval letter, #K011723. [FDA Web site]. 12/18/2002. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/K011723.pdf. Accessed September 29, 2025.

    US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Somnoplasty System. Premarket approval letter, #K982717. [FDA Web site]. 11/02/1998. Available at:  http://www.accessdata.fda.gov/cdrh_docs/pdf/K982717.pdf. Accessed September 29, 2025.

    US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). ULTepap 510(k). 02/21/2020. Available at: K191728.pdf (fda.gov). Accessed September 29, 2025.

    US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Winx Sleep Therapy System 510(k). 10/31/2012. Available at:  http://www.accessdata.fda.gov/cdrh_docs/pdf12/K122130.pdf. Accessed September 29, 2025.

    US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). ZZOMA Positional Sleeper 510(k). 05/11/2010. Available at:  http://www.accessdata.fda.gov/cdrh_docs/pdf10/K100160.pdf. Accessed September 29, 2025.

    van den Broek E, Richard W, van Tinteren H, de Vries N. UPPP combined with radiofrequency thermotherapy of the tongue base for the treatment of obstructive sleep apnea syndrome. Eur Arch Otorhinolaryngol. 2008;265(11):1361-1365.

    Vanderveken OM, Devolder A, Marklund M, et al. Comparison of custom-made and a thermoplastic oral appliance for the treatment of mild sleep apnea. Am J Respir Crit Care Med. 2008;178(2):197-202.

    Veasey SC, Guilleminault C, Strohl KP, et al. Standards of practice parameters. Sleep-related breathing disorders. Medical therapy for obstructive sleep apnea: a review by the Medical Therapy for Obstructive Sleep Apnea Task Force of the Standards of Practice Committee of the American Academy of Sleep Medicine (AASM). Sleep. 2006;29(8):1036-1044.

    Vicente E, Marin JM, Carrizo S, Naya MJ. Tongue-base suspension in conjunction with uvulopalatopharyngoplasty for treatment of severe obstructive sleep apnea: Long-term follow-up results.  Laryngoscope. 2006;116(7):1223-1227.

    Vicini C, Dallan I, Campanini A, et al. Surgery vs ventilation in adult severe obstructive sleep apnea syndrome. Am J Otolaryngol. 2010;31(1):14-20.

    Walker RP, Grigg-Damberger M, Gopalsami C, Totten MC. Laser-assisted uvulopalatoplasty for snoring and obstructive sleep apnea: results in 179 patients. Laryngoscope. 1995;105(9 pt 1):938-943.

    Walker RP, Levine HL, Hopp ML, Greene D. Extended follow-up of palatal implants for OSA treatment. Otolaryngol Head Neck Surg. 2007;137(5):822-827.

    Walker RP, Levine HL, Hopp ML, et al. Palatal implants: a new approach for the treatment of obstructive sleep apnea. Otolaryngol Head Neck Surg. 2006;135(4):549-554.

    Wassmuth Z, Mair E, Loube D, Leonard D. Cautery-assisted palatal stiffening operation for the treatment of obstructive sleep apnea syndrome. Otolaryngol Head Neck Surg. 2000;123(1 pt 1):55-60.

    Weaver EM, Kapur VK. Surgical treatment of obstructive sleep apnea in adults. [UpToDate Web site]. 08/02/2024. Available at:
    https://www.uptodate.com/contents/surgical-treatment-of-obstructive-sleep-apnea-in-adults?search=hypoglossal nerve stimulator&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1 [via subscription only]. Accessed September 29, 2025. 

    Woodson BT, Steward DL, Weaver EM, et al. A randomized trial of temperature-controlled radiofrequency, continuous positive airway pressure, and placebo for obstructive sleep apnea syndrome. Otolaryngol Head Neck Surg. 2003;128(6):848-861.

    Woodson BT, Soose RJ, Gillespie MB, et al. Three-year outcomes of cranial nerve stimulation for obstructive sleep apnea: the STAR Trial. Otolaryngol Head Neck Surg. 2016;154(1):181-188.

    Woodson BT, Gillespie MB, Soose RJ, et al. Randomized controlled withdrawal study of upper airway stimulation on OSA: short- and long-term effect. Otolaryngol Head Neck Surg. 2014;151(5):880-887.

    Yaremchuk K. Palatal procedures for obstructive sleep apnea. Otolaryngol Clin North Am. 2016;49(6):1383-1397.​


    Yu M, Ma Y, Han F, et al. Long-term efficacy of mandibular advancement devices in the treatment of adult obstructive sleep apnea: A systematic review and meta-analysis. PLoS One. 2023;18(11):e0292832.

    Coding

    CPT Procedure Code Number(s)
    MEDICALLY NECESSARY

    21110, 21141, 21142, 21143, 21145, 21146, 21147, 21195, 21196, 21198, 21199, 21206, 21497, 21685, 31600, 42145, 64582, 64583, 64584, 95836, 95970, 95976, 95977 

    THE FOLLOWING PROCEDURE CODE IS USED TO REPRESENT GENIOGLOSSUS ADVANCEMENT WITHOUT A HYOID SUSPENSION

    41599 

    EXPERIMENTAL/INVESTIGATIONAL

    THE FOLLOWING PROCEDURE CODES ARE USED TO REPRESENT PALATE AND MANDIBLE EXPANSION DEVICES

    0964T, ​0965T, 0966T​, 41530 

    THE FOLLOWING PROCEDURE CODE IS USED TO REPRESENT TONGUE BASE SUSPENSION USING A TONGUE BASE SUSPENSION SYSTEM (e.g., Airvance™ [Medtronic]; and/or The Encore™ System [Siesta Medical])

    41512 

    THE FOLLOWING PROCEDURE CODE IS USED TO REPRESENT OTHER RADIOFREQUENCY ABLATION PROCEDURES AND COBLATION SERVICES

    42299

    THE FOLLOWING PROCEDURE CODE IS USED TO REPRESENT PALATAL STIFFENING/IMPLANT PROCEDURES (EG, CAUTERY-ASSISTED PALATAL STIFFENING OPERATION (CAPSO), INJECTION OF SCLEROSING AGENTS, PILLAR PALATAL IMPLANT SYSTEM)

    42299

    ICD - 10 Procedure Code Number(s)
    N/A
    ICD - 10 Diagnosis Code Number(s)
    G47.33 Obstructive sleep apnea (adult) (pediatric)

    R06.83 Snoring
    ​
    ​HYPOGLOSSAL NERVE STIMULATION IS MEDICALLY NECESSARY FOR INDIVIDUALS BETWEEN THE AGES OF 13 THROUGH 18 WHEN REPORTED WITH OSA:  

    G47.33 Obstructive sleep apnea (adult) (pediatric)

    AND

    ONE OF THE FOLLOWING:

    Q90.0 Trisomy 21, nonmosaicism (meiotic nondisjunction)

    Q90.1 Trisomy 21, mosaicism (mitotic nondisjunction)

    Q90.2 Trisomy 21, translocation

    Q90.9 Down syndrome, unspecified​
    HCPCS Level II Code Number(s)
    ​MEDICALLY NECESSARY

    C1767Generator, neurostimulator (implantable), nonrechargeable
    C1778Lead, neurostimulator (implantable)
    C1787Patient programmer, neurostimulator
    C8007Open implantation of hypoglossal nerve neurostimulator array and pulse generator, not requiring insertion of a separate distal respiratory sensor electrode or electrode array
    C8008Revision or replacement of hypoglossal nerve neurostimulator array including connection to existing pulse generator
    C8009Removal of hypoglossal nerve neurostimulator array and pulse generator
    C8011Open implantation of hypoglossal nerve(s) neurostimulator electrode array(s) and receiver, including external power source and all system components
    C8012Revision or replacement of hypoglossal nerve(s) neurostimulator electrode array(s) and receiver
    C8013Removal of hypoglossal nerve(s) neurostimulator electrode array(s) and receiver
    E0486Oral device/appliance used to reduce upper airway collapsibility, adjustable or nonadjustable, custom fabricated, includes fitting and adjustment
    K1027Oral device/appliance used to reduce upper airway collapsibility, without fixed mechanical hinge, custom fabricated, includes fitting and adjustment
    K1037Docking station for use with oral device/appliance used to reduce upper airway collapsibility
    L8679Implantable neurostimulator, pulse generator, any type
    L8680Implantable neurostimulator electrode, each
    L8681Patient programmer (external) for use with implantable programmable neurostimulator pulse generator, replacement only
    L8688Implantable neurostimulator pulse generator, dual array, non-rechargeable​ ​


    NOT MEDICALLY NECESSARY

    E0485 Oral device/appliance used to reduce upper airway collapsibility, adjustable or nonadjustable, prefabricated, includes fitting and adjustment

    EXPERIMENTAL/INVESTIGATIONAL

    A7049 Expiratory positive airway pressure intranasal resistance valve​

    E0190 Positioning cushion/pillow/wedge, any shape or size, includes all components and accessories

    S2080 Laser-assisted uvulopalatoplasty (LAUP)

    THE FOLLOWING PROCEDURE CODE IS USED TO REPRESENT PALATE AND MANDIBLE EXPANSION DEVICES

    E0486 Oral device/appliance used to reduce upper airway collapsibility, adjustable or nonadjustable, custom fabricated, includes fitting and adjustment

    ​​THE FOLLOWING PROCEDURE CODE IS USED TO REPRESENT​ NIGHTBALANCE SLEEP POSITIONAL TRAINER DEVICE ​​

    E0530 Electronic positional obstructive sleep apnea treatment, with sensor, includes all components and accessories, any type

    THE FOLLOWING PROCEDURE CODES ARE USED TO REPRESENT DAYTIME ELECTRICAL STIMULATION OF THE TONGUE DEVICE (eXciteOSA®​​)​​

    E0490 Power source and control electronics unit for oral device/appliance for neuromuscular electrical stimulation of the tongue muscle, controlled by hardware remote

    E0491 Oral device/appliance for neuromuscular electrical stimulation of the tongue muscle, used in conjunction with the power source and control electronics unit, controlled by hardware remote, 90-day supply​​​​​

    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​

    ​​THE FOLLOWING PROCEDURE CODES ARE USED TO REPRESENT WINX SLEEP THERAPY SYSTEM

    A7002 Tubing, used with suction pump, each

    A7047 Oral interface used with respiratory suction pump, each

    E0600 Respiratory suction pump, home model, portable or stationary, electric

    THE FOLLOWING PROCEDURE CODE IS USED TO REPRESENT IMPLANTATION OF PALATAL IMPLANTS (PILLAR PROCEDURE)

    C9727 Insertion of implants into the soft palate; minimum of 3 implants​​

    Revenue Code Number(s)
    N/A



    Coding and Billing Requirements

    Policy History

    ​
    Revisions from 11.00.06w
    01/01/2026

    		Inclusion of a policy in a Code Update memo does not imply that a full review of
    the policy was completed at this time.

    ​This policy has been identified for the 4/1/2026 code update, retro-effective to 01/01/2026. 

    The following HCPCS codes have been added to this policy as Medically Necessary:

    • C8007: Open implantation of hypoglossal nerve neurostimulator array and pulse generator, not requiring insertion of a separate distal respiratory sensor electrode or electrode array 
    • C8008: Revision or replacement of hypoglossal nerve neurostimulator array including connection to existing pulse generator 
    • C8009: Removal of hypoglossal nerve neurostimulator array and pulse generator 
    • C8011: Open implantation of hypoglossal nerve(s) neurostimulator electrode array(s) and receiver, including external power source and all system components 
    • C8012: Revision or replacement of hypoglossal nerve(s) neurostimulator electrode array(s) and receiver
    • ​ C8013: Removal of hypoglossal nerve(s) neurostimulator electrode array(s) and receiver​
    ​



    ​Revisions From 11.00.06v:
    ​10/29/2025
    		​This policy has been reviewed and reissued to communicate the Company’s continuing position on the treatment of obstructive sleep apnea (OSA) and primary snoring for adults.​​
    07/01/2025

    		​This policy has been identified for the code update, effective 07/01/2025.

    Inclusion of a policy in a Code Update memo does not imply that a full review of
    the policy was completed at this time.

    The following CPT code has been added to this policy:
    • 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

    Revisions From 11.00.06u:
    02/17/2025​This version of the policy will become effective 02/17/2025.

    The intent of this policy has not changed; however, the body mass index (BMI) policy criterion for hypoglossal nerve stimulation (HGNS) in adults with obstructive sleep apnea (OSA) was revised to 35 kg/m​2,​ and the Company's coverage position has changed from Not Medically Necessary to Experimental/Investigational for all other uses of HGNS.​​

    In addition, Daytime Electrical Stimulation of the Tongue was revised to Neuromuscular Electrical Tongue Stimulation. ​    ​

    ​Revisions From 11.00.06t:
    04/01/2024
    		​This policy has been identified for the HCPCS code update, effective 04/01/2024.

    Inclusion of a policy in a Code Update memo does not imply that a full review of
    the policy was completed at this time.

    The following HCPC code has been added to this policy:

    • ​K1037 Docking station for use with oral device/appliance used to reduce upper airway collapsibility​

    Revisions From 11.00.06s:
    01/02/2024
    		​This policy has been identified for the HCPCS code update, effective 01/02/2024.

    Inclusion of a policy in a Code Update memo does not imply that a full review of
    the policy was completed at this time.

    The following HCPCS codes have been termed and removed from this policy:
    K1001 Electronic positional obstructive sleep apnea treatment, with sensor, includes all components and accessories, any type

    K1028 Power source and control electronics unit for oral device/appliance for neuromuscular electrical stimulation of the tongue muscle, controlled by phone application

    K1029 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​

    The following HCPC codes have been added to this policy as Experimental/Investigational:

    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​

    Revisions From 11.00.06r:
    11/15/2023​This version of the policy will become effective 11/15/2023. 

    The intent of this policy remains unchanged; however, criteria for hypoglossal nerve stimulation was revised in consideration of expanded US Food and Drug Administration (FDA) labeling for the Inspire upper airway stimulation system. 

    In addition, the description section of the policy has been revised to incorporate information on the ULTepap™ system​. 

    The following Healthcare Common Procedure Coding System (HCPCS) code used to represent the Provent nasal EPAP device has been removed from the policy:
    • ​E1399 Durable medical equipment, miscellaneous​

    Revisions From 11.00.06q:
    10/01/2023​This policy has been identified for the HCPCS code update, effective 10/01/2023.

    Inclusion of a policy in a Code Update memo does not imply that a full review of
    the policy was completed at this time.​

    The following HCPCS codes have been added to this policy as Experimental/Investigational:

    E0490 Power source and control electronics unit for oral device/appliance for neuromuscular electrical stimulation of the tongue muscle, controlled by hardware remote

    E0491 Oral device/appliance for neuromuscular electrical stimulation of the tongue muscle, used in conjunction with the power source and control electronics unit, controlled by hardware remote, 90-day supply

    The following HCPCS code narrative has been revised: K1028

    FROM: Power source and control electronics unit for oral device/appliance for neuromuscular electrical stimulation of the tongue muscle for the reduction of snoring and obstructive sleep apnea, controlled by phone application

    TO: Power source and control electronics unit for oral device/appliance for neuromuscular electrical stimulation of the tongue muscle, controlled by phone application​

    Revisions From 11.00.06p:
    04/01/2023This policy has been identified for the HCPCS code update, effective 04/01/2023.

    Inclusion of a policy in a Code Update memo does not imply that a full review of
    the policy was completed at this time.​

    The following HCPCS code has been added to this policy as Experimental/Investigational:

    A7049 Expiratory positive airway pressure intranasal resistance valve

    Revisions From 11.00.06o:
    07/18/2022This version of the policy will become effective 07/18/2022. 

    The following CPT code has been revised in this policy:
    • 64582
    The following CPT codes have been deleted from the policy:
    • ​64568
    • 64569
    • ​64570
    In addition, the following policy criteria for Hypoglossal Nerve Stimulation was revised to include a Not Medically Necessary statement when policy criteria is not met:

    NOT MEDICALLY NECESSARY
    Hypoglossal nerve stimulation not meeting the above criteria is considered not medically necessary and, therefore, not covered.​

    Revisions From 11.00.06n:
    04/01/2022This policy has been identified for the HCPCS code update, effective 04/01/2022.

    The following HCPCS code has     been added to this policy as Experimental and Investigational replacing NOC code E1399:

    K1028: Power Source and control electronics unit for oral device/appliance for neuromuscular electrical stimulation of the tongue muscle for the reduction of snoring and obstructive sleep apnea, controlled by phone application

    K1029: 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

    Revisions From 11.00.06m:
    01/03/2022
    		This version of the policy will become effective 01/03/2022.

    The intent of this policy remains unchanged; however, the policy criteria for Custom-Fabricated Oral Appliance has been revised to incorporate individuals with obstructive sleep apnea (OSA). 

    In addition, the policy criteria for Custom-Fabricated Mandibular Advancement Oral Appliances has been revised to remove the individual face-to-face evaluation. 

    A policy statement was included to communicate that Daytime Electrical Stimulation of the Tongue     is considered experimental/investigational for the treatment of obstructive sleep apnea.

    In addition, the policy statement for Positional Treatment (Non-Supine Posture) was revised to incorporate the Nightbalance system as experimental/investigational for the treatment of positional obstructive sleep apnea. 

    The following HCPCS codes have been added to this policy:

    THE FOLLOWING PROCEDURE CODE IS USED TO REPRESENT THE NIGHTBALANCE SLEEP POSITIONAL TRAINER DEVICE

    K1001 Electronic positional obstructive sleep apnea treatment, with sensor, includes all            components and accessories, any type​


    THE FOLLOWING PROCEDURE CODE IS USED TO REPRESENT DAYTIME ELECTRICAL STIMULATION OF THE TONGUE DEVICE, (eXciteOSA®​​)

    E1399 Durable medical equipment, miscellaneous

    _________________________________

    ​​

    Note: 12/15/2021, this policy in notification was revised to incorporate the following 1/1/2022 code updates:

    The following CPT codes have been added to the policy: 64582, 64583, 64584.

    The following CPT code has been termed from the policy: 0466T, 0467T and 0468T.

    The following CPT narratives have been revised in this policy: 64568​


    Revisions From 11.00.05l:
    10/01/2021This policy has been identified for the HCPCS code update, effective 10/01/2021.

    Inclusion of a policy in a Code Update memo does not imply that a full review of
    the policy was completed at this time.​

    The following HCPCS code has been added to this policy:
    K1027 Oral device/appliance used to reduce upper airway collapsibility, without fixed mechanical hinge, custom fabricated, includes fitting and adjustment​

    Revisions From 11.00.06k:
    03/15/2020This version of the policy will become effective 03/152020.

    The intent of this policy remains unchanged; however, policy criteria for Hypoglossal Nerve Stimulation have been revised in consideration of revisions within the US Food and Drug Administration (FDA) labeling, and additional studies that included a higher BMI.

    The following ICD-10 CM codes have been added to this policy:

    Q90.0 Trisomy 21, nonmosaicism (meiotic nondisjunction)

    Q90.1 Trisomy 21, mosaicism (mitotic nondisjunction)

    Q90.2 Trisomy 21, translocation


    Revisions From 11.00.05j:
    03/04/2019This version of the policy will become effective 03/04/2019. The policy title has been updated.

    The Company's coverage position has changed from Experimental/Investigational to Medically Necessary for hypoglossal nerve stimulation.

    The billing requirements were updated to remove procedures code guidance because more specific codes can be used for hypoglossal nerve stimulation.

    The following HCPCS/ICD-10 codes have been added to the policy: L8688; Q90.9.

    The following CPT code has been removed from the policy: 95971.

    Revisions From 11.00.06i:
    01/01/2019This version of the policy will become effective 01/01/2019.

    The following CPT codes have been deleted from this policy: 95974, 95975

    The following CPT codes have been added to this policy: 95836, 95976, 95977

    The following CPT codes have been revised in this policy: 95970, 95971

    Revisions From 11.00.06h:
    06/18/2018This version of the policy will become effective 06/18/2018.

    The intent of this policy remains unchanged, but the policy has been updated to include palate and mandible expansion devices are considered experimental/investigational for the treatment of obstructive sleep apnea.

    The following HCPCS code has been added to additionally represent palate and mandible expansion devices:

    E0486 Oral device/appliance used to reduce upper airway collapsibility, adjustable or nonadjustable, custom fabricated, includes fitting and adjustment (Experimental/Investigational)

    Effective 10/05/2017 this policy has been updated to the new policy template format.
    1/1/2026
    4/1/2026
    11.00.06
    Medical Policy Bulletin
    Commercial
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