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Treatment of Obstructive Sleep Apnea (OSA) and Primary Snoring in Adults
MA05.047i

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 positive airway pressure CPAP, auto-adjusting CPAP, or bi-level device.
      • The treating professional provider determines that the use of such a positive airway pressure 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 obstructive sleep apnea (OSA) when diagnosed by a certified sleep study, when all of the following criteria are met:
  • The individual has an in-person clinical evaluation by their treating professional provider prior to a sleep disorder test that is positive for OSA as evidenced by any 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 positive airway pressure CPAP, auto-adjusting CPAP, or bi-level device.
      • The treating professional provider determines that the use of such a positive airway pressure 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 obstructive sleep apnea (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.

HYPOGLOSSAL NERVE STIMULATION 

MEDICALLY NECESSARY
Hypoglossal nerve stimulation is considered medically necessary and therefore, covered for adults with moderate to severe OSA when ALL of the following criteria are met:
  • Age ≥ 22 years
  • Body mass index < 35 kg/m2
  • A polysomnography (PSG) is performed within 24 months of first consultation for HGNS implant
  • AHI ≥15 events per hour with predominantly obstructive events (defined as central and mixed apneas less than 25% of the total AHI)
  • CPAP failure (defined as AHI greater than 15 despite CPAP usage) or CPAP intolerance (defined as less than 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
  • Absence of complete concentric collapse at the soft palate
  • No other anatomical findings that would compromise performance of device (e.g., tonsil size 3 or 4 per standardized tonsillar hypertrophy grading scale)
  • The device is FDA approved and insertion is performed by a qualified professional provider who is a board certified or a board eligible otolaryngologist

NOT MEDICALLY NECESSARY
Hypoglossal nerve stimulation for all other indications is considered not medically necessary and, therefore, not covered.

In addition, hypoglossal nerve stimulation is considered not medically necessary and, therefore, not covered in individuals with ANY of the following contraindications:
  • Individuals with central and mixed apneas that make up more than one-quarter of the total AHI
  • An implantable device that could experience unintended interaction with the HGNS implant system
  • Body mass index ≥ 35​​
  • Neuromuscular disease.
  • Hypoglossal-nerve palsy
  • Severe restrictive or obstructive pulmonary disease
  • Moderate-to-severe pulmonary arterial hypertension
  • Severe valvular heart disease
  • New York Heart Association class III or IV heart failure
  • Recent myocardial infarction or severe cardiac arrhythmias (within the past 6 months)
  • Persistent uncontrolled hypertension despite medication use
  • An active, serious mental illness that reduces the ability to carry out Activities of Daily Living (ADLs) and would interfere with the individual's ability to operate the HNS and report problems to the attending provider
  • Coexisting nonrespiratory sleep disorders that would confound functional sleep assessment
  • Individuals who are or who plan to become pregnant
  • Require Magnetic Resonance Imaging (MRI) with model 3024
  • Require MRI with model 3028 (can undergo MRI on the head and extremities if certain conditions and precautions are met. Please refer to the Manufacturer Guidelines for this model and future models for more information
  • Individuals who are unable or do not have the necessary assistance to operate the sleep remote
  • Individuals with any condition or procedure that has compromised neurological control of the upper airway

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, obstructive sleep apnea (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 OSA are considered experimental/investigational by the Company and not covered.

NASAL EXPIRATORY POSITIVE AIRWAY PRESSURE (EPAP)

EXPERIMENTAL/INVESTIGATIONAL
Although the US Food and Drug Administration (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 expiratory positive airway pressure is considered experimental/investigational by the Company and not covered.

ORAL PRESSURE THERAPY

EXPERIMENTAL/INVESTIGATIONAL
Although the US Food and Drug Administration (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, oral pressure therapy is considered experimental/investigational by the Company and not covered.

DAYTIME ELECTRICAL STIMULATION OF THE TONGUE 

EXPERIMENTAL/INVESTIGATIONAL
​Although the US Food and Drug Administration (FDA) has approved a device for daytime electrical stimulation of the tongue (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, daytime electrical stimulation of the tongue is considered experimental/investigational by the Company and not covered.
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 CPAP, 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., uvulopalatopharyngoplasty [UPPP], uvulopharyngoplasty, uvulopalatal flap, expansion sphincter pharyngoplasty, lateral pharyngoplasty, palatal advancement pharyngoplasty, relocation pharyngoplasty) and/or Maxillomandibular 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 apnea hypopnea index (AHI) or respiratory disturbance index (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 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 or combination retropalatal/retrolingual 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 conjunction 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/retrolingual obstruction, surgery to correct these abnormalities is considered medically necessary and, therefore, covered. Examples of these procedures are tonsillectomy, adenoidectomy, midline glossectomy, septoplasty, lingualplasty, genioplasty, 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 Coblation Services

Radiofrequency ablation (e.g., Somnoplasty 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 coblation method (e.g., ENT Coblator 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 sclerosing agents, and the implantation of palatal implants, such as the Pillar Procedure, are 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., Airvance® [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., Airvance® [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 DME supplier/provider. All documentation is to be prepared contemporaneous with delivery and be available to the Company upon request.

CONSUMABLE SUPPLIES
The durable medical equipment (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 seven 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 five 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 durable medical equipment (DME) supplier may be required to reimburse the Company for overpayments.

BILLING REQUIREMENTS

Procedure code 61885 does not appropriately represent procedures related to hypoglossal nerve stimulation and should not be used to report this procedure.

HCPCS codes C1816, C1820, C1822, C1897, L8682, L8683, L8685, and/or L8686 do not appropriately represent hypoglossal nerve stimulation devices and should not be used to report this procedure.

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

This policy is consistent with Medicare's coverage determination. The Company's payment methodology may differ from Medicare.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, treatment of obstructive sleep apnea (OSA) is covered under the medical benefits of the Company’s Medicare Advantage 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 excluded for the Company’s Medicare Advantage products. Therefore, they are not eligible for reimbursement consideration.

When the treatment of obstructive sleep apnea (OSA) or primary snoring for adults is performed on an individual who has any of the absolute contraindications listed in the 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 dyssomnias 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), electrooculogram (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 7 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 actigraphy (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, protriptyline), indicated for a small number of individuals who satisfy specific criteria
  • A variety of surgical procedures

CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP), AUTO-ADJUSTING CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP), AND BI-LEVEL (INTERMITTENT) POSITIVE AIRWAY PRESSURE

The recommended initial treatment for individuals diagnosed with mild OSA with certain co-morbidities, 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 one which 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 one 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.
In October 2020, the FDA gave 510(k) approval to the Slow Wave DS8, an intra-oral device intended to reduce or alleviate snoring and mild to moderate Obstructive Sleep Apnea 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. ​​

The US Food and Drug Administration (FDA) has approved several custom oral devices to be used in the treatment of OSA. Some examples include Klearway™, Modified Herbst™, 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.

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 ZZOMA Positional Sleeper received premarket clearance through FDA’s 510(k) program for the treatment of mild to moderate, predominantly positional obstructive sleep apnea (OSA) and to reduce or alleviate snoring. Peer reviewed literature is limited to one small (n=38) randomized controlled crossover trial comparing the ZZOMA Positional Device to CPAP for treating OSA. Subjects were initially randomized 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 Zzoma 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 NightBalance Lunoa System received premarket clearance through FDA’s 510(k) program for the treatment of adults with positional OSA with a non-supine apnea-hypopnea index less than 20.  The evidence on NightBalance Sleep Position Training device Includes 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 patients 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 patients used the sleep position trainer for more than 4 h per night, but another observational study found that only a quarter of patients 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 percent to 2.6 percent (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 post treatment 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 U.S. Food and Drug Administration gave 510(k) approval to the Provent sleep apnea therapy, a nasal expiratory positive airway pressure (EPAP) device for the treatment of OSA. The Provent 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 randomized controlled trial. 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.

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 U.S. Food and Drug Administration gave 510(k) approval to the Winx Sleep Therapy System, which uses OPT for the treatment of OSA. This device is proposed to increase the size of the retropalatal 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.

DAYTIME ELECTRICAL STIMULATION OF THE TONGUE

In February 2021, the FDA granted De Novo authorization for the eXciteOSA, a tongue muscle stimulation device intended to reduce snoring and mild OSA for individuals 18 years or older.  The evidence on eXciteOSA includes 2 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 patients 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 patients 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. 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 for the treatment of obstructive sleep apnea (OSA) includes case series and a multicenter prospective, single group, cohort design study (STAR) that were surgically implanted with an upper airway stimulation device with obstructive sleep apnea who had difficulty either accepting or adhering to CPAP therapy and were followed for 5 years. Prospective cohort study is gold standard for epidemiologic studies. The study strengths included measuring primary and secondary outcomes and at 12-month visits, a second randomized study within the study where participants were randomly assigned into two groups with one group having the device turned off for 7 days and the other continued with the device turned on. Polysomnography was performed after the randomization period to measure the effects of therapy withdrawal as compared to continued use of the therapy.

Hypoglossal nerve stimulation has shown improved outcomes in this single arm study when used in a select group of patients. For the patients that met the inclusion criteria for AHI, BMI and favorable pattern for palatal collapse about two-thirds met the study definition of success. Results observed at the 12 month follow-up were maintained at 3 years. Patient based outcomes at 48 months, concluded these patients maintained a sustained benefit on patient reported outcomes (Epworth Sleepiness Score, Functional Outcomes of Sleep Questionnaire and snoring). Conclusions from the 5 year outcomes were that UAS is a nonanatomic surgical treatment with long-term benefit for individuals with moderate to severe OSA who have failed nasal continuous positive airway pressure. Safety and effectiveness were evaluated using multiple outcome measures.

For Individuals with obstructive sleep apnea who are treated with hypoglossal nerve stimulation, the evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

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 uvulopalatopharyngoplasty (UPPP)/laser-assisted uvulopalatoplasty (LAUP), glossectomy, lingualplasty, 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 maxillomandibular 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 retropalatal/retrolingual obstruction, surgery is performed to correct these anomalies. Examples of these surgical procedures are tonsillectomy, adenoidectomy, septoplasty, and genioplasty.

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

Palatopharyngoplasty (e.g., uvulopalatopharyngoplasty [UPPP], uvulopharyngoplasty, uvulopalatal flap, expansion sphincter pharyngoplasty, lateral pharyngoplasty, palatal advancement pharyngoplasty, relocation pharyngoplasty) 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 glossectomy procedure reduces the size of the back of the tongue by excising a v-shaped portion of the center part of the tongue. A lingualplasty 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.

Septoplasty involves major repair of the nasal septum.

Genioplasty 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 Somnoplasty System (Olympus, formally Gyrus ACMI and Somnus 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 Coblator Surgery System (ArthroCare 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 AlRvance™System (Medtronic, Inc.; Jacksonville, FL) and Encore™ System (Siesta Medical; Los Gatos, CA) enable minimally invasive surgical treatment of tongue- and hyoid-based obstructive sleep apnea. 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 (The 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 three-to-four 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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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: https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/intraoral-devices-snoring-andor-obstructive-sleep-apnea-class-ii-special-controls-guidance-document​. Accessed May 12, 2022.

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/k133680.pdf. Accessed May 12, 2022.

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 May 12, 2022.​

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 May 12, 2022.

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 May 12, 2022.

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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 May 12, 2022.

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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, 95971, 95976, 95977

THE FOLLOWING PROCEDURE CODE IS USED TO REPRESENT GENIOGLOSSUS ADVANCEMENT WITHOUT A HYOID SUSPENSION:
41599 

EXPERIMENTAL/INVESTIGATIONAL

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
HCPCS Level II Code Number(s)

MEDICALLY NECESSARY

​C1767 Generator, neurostimulator (implantable), nonrechargeable

C1778 Lead, neurostimulator (implantable)

C1787 Patient programmer, neurostimulator

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

K1027 Oral device/appliance used to reduce upper airway collapsibility, without fixed mechanical hinge, custom fabricated, includes fitting and adjustment​ ​​

L8679 Implantable neurostimulator, pulse generator, any type

L8680 Implantable neurostimulator electrode, each

L8681 Patient programmer (external) for use with implantable programmable neurostimulator pulse generator, replacement only


NOT MEDICALLY NECESSARY

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


​EXPERIMENTAL/INVESTIGATIONAL

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 NASAL EXPIRATORY POSITIVE AIRWAY PRESSURE (EPAP) - PROVENT NASAL DEVICE

E1399 Durable medical equipment, miscellaneous

​

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

K1001 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®)

​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

​
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

7/18/2022
6/29/2022
MA05.047
Medical Policy Bulletin
Medicare Advantage
No
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