Latest Review Date: June 2024

Category: Durable Medical Equipment (DME)   

POLICY:

Continuous positive airway pressure (CPAP) for the treatment of obstructive sleep apnea (OSA) in adults may be considered medically necessary for individuals who meet either of the following criteria on polysomnography:

1. Apnea Hypopnea Index (AHI), Respiratory Disturbance Index (RDI) or Respiratory Event Index (REI) ≥ 15 events per hour; OR
2. AHI, RDI or REI ≥ 5, and < 15 events per hour with documentation demonstrating any of the following symptoms:
   • Excessive daytime sleepiness, as documented by either a cumulative or total score >10 on the Epworth Sleepiness scale or inappropriate daytime napping, (e.g., during driving, conversation or eating) or sleepiness that interferes with daily activities; or
   • Impaired cognition or mood disorders; or
   • Hypertension; or
   • Ischemic heart disease , congestive heart  failure or history of stroke; or
   • Cardiac arrhythmias; or
   • Pulmonary hypertension; or
   • Insomnia.

Note: Polysomnography should be performed per guidelines in Medical Policy #305 Polysomnography for Respiratory Sleep Disorders Testing.

CPAP for CHILDREN

CPAP for the treatment of obstructive sleep apnea (OSA) in children (17 years of age or younger) may be considered medically necessary when the following criteria are met:

• There is a documented diagnosis of obstructive sleep apnea (OSA) and polysomnography demonstrates an apnea-hypopnea index (AHI) or RDI ≥ one (1); AND
  • with excessive daytime sleepiness, behavioral problems or hyperactivity
• OR an AHI or RDI ≥5 

BiPAP

BiPAP for the treatment of Obstructive Sleep Apnea may be considered medically necessary when used by individuals diagnosed with OSA when prior to initiating therapy, a complete (full or split night), approved facility based, attended polysomnography has been performed and the test results have confirmed the diagnosis of OSA and ALL the following criteria are met:

• CPAP would have met the medical criteria for coverage as defined in the previous policy statement and CPAP has been tried and proven ineffective.
• Failed CPAP is defined as any of the following criteria documented in the medical record:
  • Individual intolerance (claustrophobia, discomfort and/or pain due to pressure)
  • Optimal PAP pressure has not been achieved, proven by evidence of respiratory events (apneas, hypopneas, etc) while on high pressures of CPAP (>10 cm H₂O). 

Compliance Documentation

Compliance documentation should be maintained in the suppliers record. This documentation should include that the physician certifies the individual is compliant with the treatment and the sleep disorder has improved based on the treatment OR a recorded compliance document indicating proper usage. (≥ 4 hours per night on 70% of the nights during a 30 consecutive day period during the initial 90 days of usage) (Compliance documentation that extended beyond the 90 days will be reviewed on an individual basis i.e. Accidents, change in physical status, surgery, etc.)

Replacement Devices

Previously covered devices may be considered medically necessary to be replaced when the following criteria are met: (a repeat sleep study is not required)

• The equipment has suffered irreparable damage (cost more to repair than to replace) and has been in the home for 3 years or longer; OR
• The individual's condition has changed and a different piece of equipment is determined to be medically necessary.

Replacement devices will not be covered for replacing functioning equipment with a newer more advanced model. (Compliance documentation is not required for replacement equipment.)

Oral Pressure Therapy (OPT) is considered investigational (e.g. Winx™, Sleep Therapy System by ApniCure).

Oral appliances (tongue retaining devices or mandibular advancing/positioning devices) for the treatment of obstructive sleep apnea may be considered medically necessary when all the following criteria are met:

• Nocturnal polysomnogram has been performed in an approved facility or home sleep study and a diagnosis of OSA has been made; AND
• Devices are used in individuals who prefer oral appliances to CPAP, who do not respond to CPAP, OR have failed CPAP treatment; and ordered by the physician treating the individual for the diagnosed OSA: AND
• The device must be fitted by qualified dental personnel (Over the counter devices or prefabricated, even if fitted by dental personnel are not covered) AND
• There is absence of temporomandibular dysfunction or periodontal disease.

Oral appliances for snoring are considered investigational.

Palate and mandible expansion devices (mRNA) are considered investigational for the treatment of OSA.

EPAP

Nasal Expiratory Airway Pressure (EPAP) (e.g. PROVENT®) is considered investigational.

The use of a sleep positioning trainer with vibration is considered investigational for the treatment of positional OSA.

The use of neuromuscular electrical tongue stimulation is considered investigational for the treatment of OSA.

Surgical management of OSA (i.e., adenotonsillectomy, uvulopalatopharyngoplasty, orthognathic surgery, hypoglossal nerve stimulation) is discussed in medical policy #621- Surgical Treatment of Snoring and Obstructive Sleep Apnea Syndrome.

DESCRIPTION OF PROCEDURE OR SERVICE:

Obstructive sleep apnea (OSA) syndrome is characterized by repetitive episodes of upper airway obstruction due to the collapse of the upper airway during sleep. Conventional medical management of OSA includes weight loss, avoidance of stimulants, body position adjustment, oral appliances, and use of continuous positive airway pressure (CPAP) during sleep. Novel treatments include nasal expiratory positive airway pressure (EPAP) and oral pressure therapy.

Obstructive Sleep Apnea

Obstructive sleep apnea (OSA) syndrome is characterized by repetitive episodes of upper airway obstruction due to the collapse of the upper airway during sleep. This causes a drop in blood oxygenation and brief arousal and can occur as frequently as every minute throughout the night. The main risk factors for OSA include obesity, male sex, older age, large neck size, instability of the respiratory control system, and craniofacial dysmorphisms; additional factors include cardiovascular disease, diabetes, and metabolic syndrome. Since disorders linked to OSA are more common in ethnic minority groups, there are data supporting an increased risk of OSA in African Americans and American Indians.

The most common signs and symptoms in adults are snoring, excessive daytime sleepiness, and hypertension. Excessive daytime sleepiness may be subjective and is assessed by questionnaires such as the Epworth Sleepiness Scale, a short self-administered, questionnaire that asks patients how likely they are to fall asleep in different scenarios such as watching TV, sitting quietly in a car, or sitting and talking to someone. Daytime sleepiness is uncommon in young children with OSA. Symptoms in children may include disturbed sleep and daytime neurobehavioral problems. In otherwise healthy children, OSA is usually associated with adenotonsillar hypertrophy and/or obesity.

The hallmark of OSA is snoring. The snoring abruptly ceases during the apneic episodes and during the brief period of patient arousal and then resumes when the patient again falls asleep. The sleep fragmentation associated with repeated sleep disruption can lead to impairment of daytime activity. Adults with OSA-associated daytime somnolence are thought to be at higher risk for collisions involving motorized vehicles (i.e., cars, trucks, heavy equipment), while OSA in children may result in neurocognitive impairment and behavioral problems.

Cardiovascular and pulmonary systems can also be affected by OSA. For example, apnea leads to periods of hypoxemia, alveolar hypoventilation, hypercapnia, and acidosis. This, in turn, can cause systemic hypertension, cardiac arrhythmias, pulmonary hypertension, and cor pulmonale. Systemic hypertension is common in patients with OSA. Severe OSA is also associated with decreased survival, presumably related to severe hypoxemia, hypertension, or an increase in automobile collisions related to daytime sleepiness. It is estimated that about 7% of adults have moderate or severe OSA, 20% have mild OSA, and the referral population of OSA patients represents a small proportion of patients who have clinically significant and treatable disease.

Diagnosis

Definitions of terms and scoring criteria for OSA are presented in Table 1. Obstructive sleep apnea is widely underdiagnosed with up to 95% of individuals with clinically significant OSA reporting no prior OSA diagnosis. Moreover, under diagnosis is particularly prevalent in Black patients. The criterion standard for a diagnosis of sleep disorders is a polysomnogram performed in a sleep laboratory. A standard polysomnogram includes electroencephalogram (EEG), submental electromyogram, and electrooculogram (to detect rapid eye movement sleep) for sleep staging. Polysomnography (PSG) also typically includes electrocardiography and monitoring of respiratory airflow and effort, snoring, oxygen desaturation, and sleep position. An attended study ensures that the electrodes and sensors are functioning adequately and do not dislodge during the night. In addition, an attendant is able to identify severe OSA in the first part of the night and titrate continuous positive airway pressure (CPAP) in the second part of the night, commonly known as a "split-night" study. If successful, this strategy eliminates the need for additional PSG for CPAP titration. 

A variety of devices have also been developed specifically to evaluate OSA at home. They range from portable full PSG systems to single-channel oximeters. Available devices evaluate different parameters, which may include oximetry, respiratory and cardiac monitoring, and sleep/wake activity, but most portable monitors do not record EEG activity.

Table 1. Definitions of Terms and Scoring Criteria for OSA

Terms	Definition
Respiratory Event
Apnea	The frequency of apneas and hypopneas is measured from channels assessing oxygen desaturation, respiratory airflow, and respiratory effort. In adults, apnea is defined as a drop in airflow by 90% or more of pre-event baseline for at least 10 seconds. Due to faster respiratory rates in children, pediatric scoring criteria define an apnea as 2 or more missed breaths, regardless of its duration in seconds.
Hypopnea	Hypopnea in adults is scored when the peak airflow drops by at least 30% of pre-event baseline for at least 10 seconds in association with either at least 4% arterial oxygen desaturation or an arousal. Hypopneas in children are scored by a 50% or greater drop in nasal pressure and either a 3% or more decrease in oxygen saturation or an associated arousal.
RERA	Respiratory event-related arousal is defined as an event lasting at least 10 seconds associated with flattening of the nasal pressure waveform and/or evidence of increasing respiratory effort, terminating in an arousal but not otherwise meeting criteria for apnea or hypopnea
Respiratory event reporting
AHI	The apnea/hypopnea index is the average number of apneas or hypopneas per hour of sleep
RDI	The respiratory disturbance index is the number of apneas, hypopneas, or respiratory event-related arousals per hour of sleep time. RDI is often used synonymously with the AHI.
REI	The respiratory event index is the number of events per hour of monitoring time. Used as an alternative to AHI or RDI in home sleep studies when actual sleep time from EEG is not available.
OSA	Obstructive sleep apnea is repetitive episodes of upper airway obstruction due to the collapse and obstruction of the upper airway during sleep
Mild OSA	In adults: AHI or RDI of 5 to <15 In children: AHI ≥1.0 to < 5
Moderate OSA	AHI or RDI of 15 to < 30. Children: AHI of ≥ 5 to <10
Severe OSA	Adults: AHI or RDI ≥30 Children: AHI of ≥10
UARS	Upper airway resistance syndrome is characterized by a partial collapse of the airway and results in increased resistance to airflow. The increased respiratory effort is associated with multiple sleep fragmentations, as measured by very short alpha EEG arousals.
Positive airway pressure
APAP	Auto-adjusting positive airway pressure may be used either to provide treatment or to determine the most effective pressure for CPAP
PAP	PAP may be continuous (CPAP) or auto-adjusting (APAP) or bi-level (bi-PAP). CPAP is a more familiar abbreviation for delivery of positive airway pressure.
PAP failure	Usually defined as an AHI >20 events per hour while using CPAP
PAP intolerance	CPAP use for <4 hours per night for ≥5 nights per week, or refusal to use CPAP. CPAP intolerance may be observed in patients with mild, moderate, or severe OSA

AHI: Apnea/hypopnea Index; APAP: auto-adjusting positive airway pressure; CPAP: continuous positive airway pressure; EEG: electroencephalogram; OSA: obstructive sleep apnea; RDI: Respiratory Disturbance Index; REI: Respiratory Event Index; RERA: respiratory event-related arousal: UARS: upper airway resistance syndrome.

Treatment

Medical management of OSA in adults may include weight loss, avoidance of stimulants, body position adjustment, oral appliances, and use of various types of positive airway pressure (PAP) therapy (i.e., fixed CPAP, bilevel PAP, or auto-adjusting positive airway pressure [APAP]) during sleep. This evidence review addresses established and novel devices including the Daytime-Nighttime Appliance (BioModeling Solutions), the mandibular Repositioning Nighttime Appliance (BioModeling Solutions), eXciteOSA (Signifier Medical Technologies), NightBalance Sleep Position Trainer (Phillips), Provent, and Winx. Provent is a single-use nasal expiratory resistance valve device containing valves inserted into the nostrils and secured with adhesive. The Winx system uses oral pressure therapy to treat OSA.

Surgical management of OSA (i.e., adenotonsillectomy, uvulopalatopharyngoplasty, orthognathic surgery) is discussed in medical policy #621 (Surgical Treatment of Snoring and Obstructive Sleep Apnea).

Risk Factors for OSA

Although not an exclusive list, patients with all the following symptoms are considered to be at high risk for obstructive sleep apnea (OSA):

• habitual snoring;
• observed apneas;
• excessive daytime sleepiness;
• a body mass index (BMI) greater than 35kg/m²

If no bed partner is available to report snoring or observed apneas, other signs and symptoms suggestive of OSA (e.g., age of the patient, male gender, thick neck, craniofacial or upper airway soft tissue abnormalities, or unexplained hypertension) may be considered. Objective clinical prediction rules are being developed; however, at the present time, risk assessment is based primarily on clinical judgment.

The STOP-BANG questionnaire is a method developed for non-sleep specialists to assess the signs and symptoms of OSA (Snore, Tired, Observed apnea, blood Pressure, BMI, Age, Neck, Gender) and has been shown to have 97% sensitivity and a negative predictive value of 96% (specificity of 33%) for the identification of patients with severe OSA (Apnea/Hypopnea Index [AHI] score >30). Overnight oximetry has been used by some sleep specialists as a component of the risk assessment but is not adequate for the diagnosis of OSA. Therefore, a follow-up polysomnography (PSG) or home sleep study would still be required to confirm or exclude a diagnosis of OSA.

OSA in Children

The presentation of OSA in children may differ from that of adults. In addition, the first-line treatment in children is usually adenotonsillectomy. Continuous positive airway pressure (CPAP) is an option for children who are not candidates for surgery or who have an inadequate response to surgery.

Significant Weight Change

There is no established threshold for significant change in weight. Studies have reported improvements in OSA with an average weight loss of 20 kg or 20% of body weight.

KEY POINTS:

This evidence review was created with a search of the PubMed database. The most recent literature update was performed through May 6, 2024.

Summary of Evidence:

For individuals who have OSA who receive PAP devices, the evidence includes RCTs and systematic reviews of RCTs , and a cohort study. Relevant outcomes are symptoms, functional outcomes, and QOL. Conventional medical management of OSA includes weight loss, avoidance of stimulants, body position adjustment, oral appliances, and use of continuous PAP (CPAP) during sleep. A diagnostic sleep study may be followed by a trial of APAP to evaluate the efficacy and adjust pressure. Studies have suggested that both CPAP and APAP are associated with improvements in sleep architecture. Additionally, 11-year follow-up of obese patients with severe OSA from the Sleep Heart Health Study found a reduction in all-cause mortality with PAP use which appeared after 6 to 7 years. If the patient is intolerant of CPAP, APAP or bilevel PAP may also be indicated. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have OSA who use oral appliances, the evidence includes RCTs and systematic reviews of RCTs. Relevant outcomes are symptoms, functional outcomes, and QOL. Conventional medical management of OSA includes weight loss, avoidance of stimulants, body position adjustment, oral appliances, and use of CPAP during sleep. Oral appliances are an accepted therapy for mild-to-moderate OSA. A 2015 and 2022 meta-analysis demonstrated the efficacy of oral appliances for measures of OSA, but they were generally less effective than CPAP. Conflicting data exists on if custom-made oral devices demonstrate superior impact on symptoms and QOL outcomes compared to ready-made oral devices, based on available RCTs. Oral appliances may be an appropriate alternative in patients who refuse or cannot tolerate PAP devices. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have OSA who use neuromuscular electrical tongue stimulation, the evidence includes 1 RCT and 5 prospective single-arm studies (3 with overlapping patient populations). Relevant outcomes are symptoms, functional outcomes, and QOL. The RCT found high adherence to the eXciteOSA device treatment protocol, and exploratory analyses showed improvements in respiratory event index [REI], apnea index, and hypopnea index relative to a sham control but no significant changes in Epworth Sleepiness Scale (ESS) scores. The study was limited by sample size and short follow-up period. The single-arm studies suggest that eXciteOSA may reduce snoring intensity and improve sleep quality, but improvements on the Apnea-Hypopnea Index (AHI) were mixed. Studies were limited to evaluations after the 6-week course of therapy or 2 weeks post-intervention. Larger, well-designed, controlled studies are needed to evaluate improvement in patients who meet the criteria for treatable OSA , to assess continued use after the 6-week trial period, and the durability of observed benefits. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have OSA who receive novel OSA treatments (e.g., palate expansion, EPAP, oral pressure therapy, supine vibration), the evidence includes RCTs, prospective single-arm studies, and a meta-analysis of case series. Relevant outcomes are symptoms, functional outcomes, and QOL. The evidence on palate and mandible expansion devices includes a few small series. Further study with well-designed trials is needed to evaluate this treatment. The evidence on nasal EPAP devices in patients with OSA has been reported in prospective case series, an industry-sponsored RCT, smaller RCTs, and a systematic review that did not include the industry-sponsored RCT. The main finding of the industry-sponsored RCT was a decrease in the AHI, with a minor impact on oxygenation, and a decrease in ESS. One small RCT with 22 patients found no benefit of an oral EPAP therapy device when added to an oral appliance. One nonrandomized comparative trial with historical controls and a retrospective chart review evaluated a daytime sleep procedure (PAP-NAP) to reduce resistance to CPAP titration or use. Additional study is needed to evaluate the efficacy of this intervention. Several RCTs, observational studies, and a meta-analysis have been published with a sleep positioning device that vibrates when the individual is in a supine position. Drop-out rates were high and long-term compliance is unknown. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements:

American Academy of Otolaryngology-Head and Neck Surgery

In 2021, the American Academy of Otolaryngology-Head and Neck Surgery updated its position statement on the treatment of OSA. The academy states that adenotonsillectomy is the first line treatment in pediatric OSA. In most adults, CPAP is the first-line treatment. Surgical procedures may be considered when positive airway pressure (PAP) therapy is inadequate.

American Academy of Pediatrics

The American Academy of Pediatrics (AAP; 2012) published guidelines on the diagnosis and management of uncomplicated childhood OSA associated with adenotonsillar hypertrophy and/or obesity in an otherwise healthy child treated in the primary care setting, which updated the AAP's 2002 guidelines. Adenotonsillectomy was recommended as the first-line treatment for patients with adenotonsillar hypertrophy, and patients should be reassessed clinically postoperatively to determine whether additional treatment is required. High-risk patients should be reevaluated with an objective test or referred to a sleep specialist. CPAP was recommended if adenotonsillectomy was not performed or if OSA persisted postoperatively. Weight loss was recommended in addition to other therapy in patients who are overweight or obese, and intranasal corticosteroids are an option for children with mild OSA in whom adenotonsillectomy is contraindicated or for mild postoperative OSA.

American Academy of Sleep Medicine

The American Academy of Sleep Medicine (AASM) also issued guidelines in 2009 on the evaluation, management, and long-term care of adults with OSA.  The levels of recommendation are "standard" (generally accepted patient-care strategy, with a high degree of certainty; level 1 to 2 evidence), "guideline" (moderate degree of clinical certainty; level 2 to 3 evidence), or "option" (uncertain clinical use; insufficient or inconclusive evidence).

Treatment with positive airway pressure (PAP)

• CPAP is indicated for patients with moderate to severe OSA (Standard) and mild OSA (Option).
• Bilevel PAP can be considered in CPAP-intolerant patients (Consensus).
• Autotitrating positive airway pressure (APAP) can be considered in CPAP-intolerant patients (Consensus).

Treatment with oral appliances (OA) is indicated for "patients with mild to moderate OSA, who prefer OAs to CPAP, or who do not respond to CPAP, or are not appropriate candidates for CPAP, or who fail CPAP … (Guideline)."

• Mandibular repositioning appliance covers the upper and lower teeth.
• Tongue-retaining device holds the tongue in a forward position.

The AASM (2019) also published a clinical practice guideline on the treatment of OSA with PAP that was based on a systematic review of the evidence. "A STRONG (i.e., "We recommend…") recommendation is one that clinicians should follow under most circumstances. A CONDITIONAL recommendation (i.e., "We suggest…") reflects a lower degree of certainty regarding the outcome and appropriateness of the patient-care strategy for all patients."

The AASM provided strong recommendations for the following use of PAP therapy in adults:

• Use of PAP to treat OSA in adults with excessive sleepiness.
• That PAP therapy be initiated at home using APAP or in-laboratory PAP titration in adults with no significant morbidities.
• Use of CPAP or APAP for ongoing treatment of OSA.
• That clinicians provide educational interventions with the initiation of PAP.
• The AASM provided conditional recommendations (suggest) for the following use of PAP therapy in adults:
• Use of PAP to treat OSA in adults with impaired sleep-related quality of life (QOL).
• Use of PAP to treat OSA in adults with comorbid hypertension.
• Use CPAP or APAP over Bilevel PAP in the routine treatment of OSA.
• That behavioral and/or troubleshooting interventions be given during the initial period of PAP therapy.
• That clinicians use telemonitoring during the initial period of PAP therapy.

The AASM and the American Academy of Dental Sleep Medicine (2015) published guidelines on the treatment of OSA and snoring with OA therapy.20, The 2 societies provided a recommendation of "standard" that sleep physicians consider prescription of OA, rather than no treatment, for adults with OSA who are intolerant of CPAP therapy or prefer alternative therapy. The quality of evidence was rated as moderate. "Guideline" recommendations were provided for the use of custom, titratable appliance over noncustom oral devices, that qualified dentists provide oversight, that sleep physicians conduct follow-up sleep testing to improve or confirm treatment efficacy, and that patients return for periodic office visits with a qualified dentist and a sleep physician.

American Society of Metabolic and Bariatric Surgery

The American Society of Metabolic and Bariatric Surgery (ASMBS) Clinical Issues Committee published guidelines on the perioperative management of obstructive sleep apnea in 2012. The guidelines were reviewed in October 2015 and no changes were recommended. The guidelines note that while some reports in the literature recommend routine screening for OSA prior to bariatric surgery, other reports suggest clinical screening only does not result in any increase in postoperative pulmonary complications after laparoscopic Roux-en-Y gastric bypass, and that most current surgical practices refer patients with clinical symptoms of OSA for polysomnography, but do not make this a routine preoperative test prior to bariatric surgery. ASMBS provided, based on the evidence in the literature to date, the following guidelines regarding OSA in the bariatric surgery patient and its perioperative management:

• OSA is highly prevalent in the bariatric patient population. The high prevalence demonstrated in some studies suggests that consideration be given to testing all patients, and especially those with any preoperative symptoms suggesting obstructive sleep apnea.
• Patients with moderate to severe OSA should bring their CPAP machines, or at least their masks, with them at the time of surgery and use them following bariatric surgery at the discretion of the surgeon.
• Routine pulse oximetry or capnography for postoperative monitoring of patients with OSA after bariatric surgery should be utilized, but the majority of these patients do not routinely require an ICU setting.
• No clear guidelines exist upon which to base recommendations for retesting for OSA following bariatric surgery. Strong consideration should be given to retesting patients who present years after bariatric surgery with regain of weight, a history of previous OSA, and who are being reevaluated for appropriate medical and potential reoperative surgical therapy.

American Heart Association

In 2021, the American Heart Association (AHA) published a scientific statement on OSA and cardiovascular disease.

The treatment options for OSA and eligibility for their use are described in the statement and briefly summarized below:

• CPAP: "The Centers for Medicare & Medicaid Services cover CPAP on the basis of an AHI [apnea/hypopnea index] or REI [respiratory event index] ≥15 events per hour or AHI (or REI) ≥5 with documented symptoms of excessive daytime sleepiness, impaired cognition, mood disorders or insomnia, or documented comorbidities (i.e., hypertension, ischemic heart disease, or history of stroke)."
• APAP: "Same as CPAP."
• Bilevel PAP: "Patients intolerant of CPAP pressure or who require additional ventilatory support."
• Positional therapy: "Indicated for positional sleep apnea defined by breathing events only (isolated) or predominantly in the supine posture often considered as supine AHI at least double the lateral AHI."
• Oral appliances: "Alternative to CPAP for mild to moderate OSA or in patients who do not tolerate CPAP."

The statement also notes the following with regard to treatment:

"All patients with OSA should be considered for treatment, including behavioral modifications and weight loss as indicated. Continuous positive airway pressure should be offered to patients with severe OSA, whereas oral appliances can be considered for those with mild to moderate OSA or for continuous positive airway pressure–intolerant patients. Follow-up sleep testing should be performed to assess the effectiveness of treatment."

National Institute for Health and Care Excellence

NICE provides guidance on medical management in individuals with varying degrees of OSA.

They recommend offering fixed-level CPAP in those with mild OSA when symptoms affect QOL and usual daytime activities if lifestyle changes alone have been unsuccessful or are considered inappropriate. They recommend APAP as an alternative to fixed-level CPAP in those unable to tolerate CPAP. In individuals who cannot tolerate or refuse CPAP, they recommend offering a customized mandibular advancement device. In individuals with moderate to severe OSA, CPAP is recommended as a treatment option, with APAP offered as an alternative in those unable to tolerate CPAP. Similarly, a customized mandibular advancement device may be used if an individual refuses PAP or is unable to tolerate PAP. NICE also states that a positional modifier may be considered for those with mild to moderate positional OSA if other treatments are unsuitable or not tolerated, but this should not be a first-line treatment option.

NICE, published guidance on daytime intraoral neuromuscular electrical tongue stimulation for obstructive sleep apnea in 2023. A rapid review of evidence identified 1single-arm trial and 1 pilot study and also considered 2 submissions from patient organizations about the procedure. NICE recommended that the procedure should only be used in a research setting due to an inadequate quantity and quality of evidence and that further adequately powered RCTs and analysis of observational data should be used to assess efficacy, safety, and adherence.

American Thoracic Society

The American Thoracic Society (2016) published a research statement on the long-term effects and treatment of mild OSA in adults. The Society's systematic review concluded:

• Daytime sleepiness: subjective improvement with CPAP; unclear effect with non-CPAP therapies
• Quality of life: small improvements seen in different domains in different studies
• Neurocognition: treatment effects inconsistent.

U.S. Preventive Services Task Force Recommendations

None.

KEY WORDS:

Continuous positive airway pressure, CPAP, Bi-level positive airway pressure, BiPAP, obstructive sleep apnea syndrome, OSA, OSAS, upper airway resistance syndrome, UARS, auto-titrate CPAP, auto-adjusting CPAP, APAP, oral appliances, OA, mandibular repositioning device, MRA,  BiPAP BiFlex, Repose, C-Flex, A-Flex, Auto-CPAP, nasal expiratory positive airway pressure, Winx™ Sleep Therapy System, Oral Pressure Therapy (OPT), Hypoglossal Nerve Stimulator, DNA Appliance, mRNA Appliance, mandible expanding devices, Provent®,tongue stimulation, supine vibration, eXciteOSA, NightBalance, Sleep Position Trainer, Slow Wave DS8

APPROVED BY GOVERNING BODIES:

A variety of oral appliances have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process for treatment of snoring and mild-to-moderate OSA, including the Narval™ CC, Lamberg Sleep Well Smartrusion, 1st Snoring Appliance, Full Breath Sleep Appliance, PM Positioner, Snorenti, Snorex, Osap, DeSRA, Elastomeric Sleep Appliance, Snoremaster Snore Remedy, Snore-noMore, Napa, Snoar™ Open Airway Appliance, and The Equalizer Airway Device.

Various PAP devices have been cleared by the FDA through the 510(k) process since 1977. Bilevel positive airway pressure devices were first cleared for marketing in 1996.

Table 2. Novel devices for OSA Treatment 

Device	Manufacturer	Description	510 (K) Number	FDA Product Code	Year
Treatment
Provent®	Ventus Medical	Nasal expiratory resistance valve	K102404	OHP	2010
Winx™	Apnicure, Inc.	Nasal expiratory resistance valve	K122130	OZR	2012
mRNA Appliance®	BioModeling Solutions	Expandable oral appliance for the treatment of snoring and mild-to-moderate OSA	K130067	LRK	2014
NightBalance Lunoa System	Philips	The positional sleep trainer is worn with an elasticized chest strap, and is intended to keep patients with positional obstructive sleep apnea from sleeping in the supine position.	K180608	MYB	2018
eXciteOSA®	Signifier Medical Technologies	The device delivers neuromuscular stimulation during the day to strengthen the tongue in order to reduce snoring and mild sleep apnea. It is used for 20 minutes once a day for a period of 6‐weeks, and once a week thereafter.	K223446	QNO	2021
Respire Clear	Respire Medical, LLC	The device is an oral appliance used in the treatment of mild to moderate OSA. It helps move a patient's jaw forward, thus opening their airways, and allowing them to breathe more easily throughout the night.	K214096	LQZ, LRK	2022
CARE (Complete Airway Repositioning and /or Expansion)	Vivos Therapeutics, Inc.	The device is intended to reduce nighttime snoring and to treat mild and moderate obstructive sleep apnea in adults, 18 years of age and older. The device is also intended to treat moderate and severe obstructive sleep apnea in adults, 18 years of age and older along with positive airway pressure devices and/or myofunctional therapy, as needed.	K230947	LRK; LQZ	2023

FDA: Food and Drug Administration; OSA: obstructive sleep apnea

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP: Special benefit consideration may apply.  Refer to member’s benefit plan. 

CURRENT CODING:

CPT:              

94660

Continuous positive airway pressure ventilation (CPAP), initiation and management

HCPCS:

A4604	Tubing with integrated heating element for use with positive airway pressure device
A7027	Combination oral/nasal mask, used with continuous positive airway pressure device, each
A7028	Oral cushion for combination oral/nasal mask, replacement only, each
A7029	Nasal pillow for combination oral/nasal mask, replacement only, pair
A7030	Full face mask used with positive airway pressure device, each
A7031	Face mask interface, replacement for full face mask, each
A7032	Cushion for use on nasal mask interface, replacement only, each
A7033	Pillow for use on nasal cannula type interface, replacement only, pair
A7034	Nasal interface (mask or cannula type) used with positive airway pressure device, with or without head strap
A7035	Headgear used with positive airway pressure device
A7036	Chin strap used with positive airway pressure device
A7037	Tubing used with positive airway pressure device
A7038	Filter, disposable, used with positive airway pressure device
A7039	Filter, nondisposable, used with positive airway pressure device
A7044	Oral interface used with positive airway pressure device, each
A7045	Exhalation port with or without swivel used with accessories for positive airway devices, replacement only
A7046	Water chamber for humidifier, used with positive airway pressure device, replacement, each
A7047	Oral interface used with respiratory suction pump, each
A7049	Expiratory positive airway pressure intranasal resistance valve
E0470	Respiratory assist device, bi-level pressure capability, without backup rate feature, used with non-invasive interface, e.g., nasal or facial mask (intermittent assist device with continuous positive airway pressure device)
E0471	Respiratory assist device, bi-level pressure capability, with back-up rate feature, used with noninvasive interface, e.g., nasal or facial mask (intermittent assist device with continuous positive airway pressure device)
E0472	Respiratory assist device, bi-level pressure capability, with backup rate feature, used with invasive interface, e.g., tracheostomy tube (intermittent assist device with continuous positive airway pressure device)
E0485	Oral device/appliance used to reduce upper airway collapsibility,
E0486	Oral device/appliance used to reduce upper airway collapsibility, adjustable or on-adjustable, prefabricated, includes fitting and adjustment. custom fabricated, includes fitting and adjustment
E0490	Power source and control electronics unit for oral device/appliance for neuromuscular electrical stimulation of the tongue muscle, controlled by hardware remote
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 (Effective 1/1/24)
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 (Effective 1/1/24)
E0530	Electronic positional obstructive sleep apnea treatment, with sensor, includes all components and accessories, any type(Effective 1/1/24)
E0561	Humidifier, non-heated, used with positive airway pressure device
E0562	Humidifier, heated, used with positive airway pressure device
E0601	Continuous airway pressure (CPAP) device-(This code should also be used to bill the APAP devices.)
E1399	Durable medical equipment, miscellaneous
K1027	Oral device/appliance used to reduce upper airway collapsibility, without fixed mechanical hinge, custom fabricated, includes fitting and adjustment

PREVIOUS CODING

K1001	Electronic positional obstructive sleep apnea treatment, with sensor, includes all components and accessories, any type(deleted 12/31/23)
K1028	Power source and control electronics unit for oral device/appliance for neuromuscular electrical stimulation of the tongue muscle controlled by phone application (deleted 12/31/23)
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 (deleted 12/31/23)

REFERENCES:

1. Abreu AR, Stefanovski D, Patil SP, et al. Neuromuscular electrical stimulation for obstructive sleep apnoea: comparing adherence to active and sham therapy. ERJ Open Res. Nov 2023; 9(6).
2. American Society of Anesthesiologists Task Force on Perioperative Management of patients with obstructive sleep a. Practice guidelines for the perioperative management of patients with obstructive sleep apnea: an updated report by the American Society of Anesthesiologists Task Force on Perioperative Management of patients with obstructive sleep apnea. Anesthesiology. Feb 2014; 120(2):268-286.
3. American Society for Metabolic & Bariatric Surgery. Peri-operative management of obstructive sleep apnea. 2012. asmbs.org/2012/03/peri-operative-management-of-obstructive-sleep-apnea/.
4. Balk EM, Moorthy D, Obadan NO et al. Diagnosis and Treatment of Obstructive Sleep Apnea in Adults. Comparative Effectiveness Review No. 32 (Prepared by Tufts Evidence-based Practice Center under Contract No. 290-2007-100551) AHRQ Publication No. 11-EHC052-EF. Rockville MD: Agency for Healthcare Research and Quality Jul 2011.
5. Baptista PM, Martinez Ruiz de Apodaca P, Carrasco M, et al. Daytime Neuromuscular Electrical Therapy of Tongue Muscles in Improving Snoring in Individuals with Primary Snoring and Mild Obstructive Sleep Apnea. J Clin Med. Apr 27 2021; 10(9).
6. Belkhode V, Godbole S, Nimonkar S, et al. Comparative evaluation of the efficacy of customized maxillary oral appliance with mandibular advancement appliance as a treatment modality for moderate obstructive sleep apnea patients-a randomized controlled trial. Trials. Feb 01 2023; 24(1): 73.
7. Berry RB, Kryger MH, Massie CA. A novel nasal expiratory positive airway pressure (EPAP) device for the treatment of obstructive sleep apnea: a randomized controlled trial. Sleep 2011; 34(4):479-485.
8. Berry RB, Uhles ML, Abaluck BK, et al. NightBalance Sleep Position Treatment Device Versus Auto-Adjusting Positive Airway Pressure for Treatment of Positional Obstructive Sleep Apnea. J Clin Sleep Med. Jul 15 2019; 15(7): 947-956.
9. Beyers J, Dieltjens M, Kastoer C, et al. Evaluation of a Trial Period With a Sleep Position Trainer in Patients With Positional Sleep Apnea. J Clin Sleep Med. Apr 15 2018; 14(4): 575-583.
10. Bosschieter PFN, Uniken Venema JAM, Vonk PE, et al. Equal effect of a noncustom vs a custom mandibular advancement device in treatment of obstructive sleep apnea. J Clin Sleep Med. Sep 01 2022; 18(9): 2155-2165.
11. Buyse B, Ciordas S, Hoet F, et al. Positional obstructive sleep apnoea: challenging findings in consecutive patients treated with a vibrating position trainer. Acta Clin Belg. Dec 2019; 74(6): 405-413.
12. Chowdhuri S, Quan SF, Almeida F, et al. An official American Thoracic Society research statement: impact of mild obstructive sleep apnea in adults. Am J Respir Crit Care Med. May 1 2016; 193(9):e37-54.
13. de Ruiter MHT, Benoist LBL, de Vries N, et al. Durability of treatment effects of the Sleep Position Trainer versus oral appliance therapy in positional OSA: 12-month follow-up of a randomized controlled trial. Sleep Breath. May 2018; 22(2): 441-450.
14. Fox N, Hirsch-Allen AJ, Goodfellow E, et al. The impact of a telemedicine monitoring system on positive airway pressure adherence in patients with obstructive sleep apnea: a randomized controlled trial. Sleep. Apr 01 2012; 35(4): 477-81.
15. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
16. Johal A, Haria P, Manek S, et al. Ready-made versus custom-made mandibular repositioning devices in sleep apnea: a randomized clinical trial. J Clin Sleep Med. Feb 15 2017; 13(2):175-182.
17. Jonas DE, Amick HR, Feltner C, et al. Screening for obstructive sleep apnea in adults: evidence report and systematic review for the US Preventive Services Task Force. JAMA. Jan 24 2017; 317(4):415-433.
18. Kapur VK, Auckley DH, Chowdhuri S, et al. Clinical practice guideline for diagnostic testing for adult obstructive sleep apnea: an American Academy of Sleep Medicine Clinical Practice Guideline. J Clin Sleep Med. Mar 15 2017; 13(3):479-504.
19. Kotecha B, Wong PY, Zhang H, et al. A novel intraoral neuromuscular stimulation device for treating sleep-disordered breathing. Sleep Breath. Dec 2021; 25(4): 2083-2090.
20. Kryger MH, Berry RB, Massie CA. Long-term use of a nasal expiratory positive airway pressure (EPAP) device as a treatment for obstructive sleep apnea (OSA). J Clin Sleep Med 2011; 7(5):449-453B.
21. Kureshi SA, Gallagher PR, McDonough JM, et al. Pilot study of nasal expiratory positive airway pressure devices for the treatment of childhood obstructive sleep apnea syndrome. J Clin Sleep Med. 2014; 10(6):663-669.
22. Lai V, Tong BK, Tran C, et al. Combination therapy with mandibular advancement and expiratory positive airway pressure valves reduces obstructive sleep apnea severity. Sleep. Aug 01 2019; 42(8).
23. Liao J, Shi Y, Gao X, et al. Efficacy of Oral Appliance for Mild, Moderate, and Severe Obstructive Sleep Apnea: A Meta-analysis.Otolaryngol Head Neck Surg. May 2024; 170(5): 1270-1279.
24. Lisan Q, Van Sloten T, Marques Vidal P, et al. Association of Positive Airway Pressure Prescription With Mortality in Patients With Obesity and Severe Obstructive Sleep Apnea: The Sleep Heart Health Study. JAMA Otolaryngol Head Neck Surg. Jun 01 2019; 145(6): 509-515.
25. Marcus CL, Brooks LJ, Draper KA et al. Diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics 2012 130(3):e714-55.  //pediatrics.aappublications.org/content/130/3/576.full.pdf+html?sid=d61600bf-6989-4879- 8d96-43f0421d186a.
26. McEvoy RD, Antic NA, Heeley E, et al. CPAP for prevention of cardiovascular events in obstructive sleep apnea. N Engl J Med. Sep 8 2016; 375(10):919-931.
27. Mutter TC, Chateau D, Moffatt M, et al. A matched cohort study of postoperative outcomes in obstructive sleep apnea: could preoperative diagnosis and treatment prevent complications? Anesthesiology. Oct 2014; 121(4):707-718.
28. National Institute for Health and Care Excellence (NICE). Daytime intraoral neuromuscular electrical tongue stimulation using are movable device for obstructive sleep apnoea [IPG760]. April 19, 2023. https://www.nice.org.uk/guidance/ipg760/resources/daytime-intraoral-neuromuscular-electrical-tongue-stimulation-using-a-removable-device-for-obstructive-sleep-apnoea-pdf-1899876394571461.
29. National Institute for Health and Care Excellence (NICE). Obstructive sleep apnoea/hypopnoea syndrome and obesity hypoventilation syndrome in over 16s: NG202. Published August 20, 2021; https://www.nice.org.uk/guidance/ng202/chapter/1-Obstructive-sleep-apnoea hypopnoea-syndrome#treatments-for-mild-osahs.
30. Nokes B, Baptista PM, de Apodaca PMR, et al. Transoral awake state neuromuscular electrical stimulation therapy for mild obstructive sleep apnea. Sleep Breath. May 2023; 27(2): 527-534.
31. Nokes B, Schmickl CN, Brena R, et al. The impact of daytime transoral neuromuscular stimulation on upper airway physiology - Amechanistic clinical investigation. Physiol Rep. Jun 2022; 10(12): e15360.
32. Patil SP, Ayappa IA, Caples SM, et al. Treatment of Adult Obstructive Sleep Apnea With Positive Airway Pressure: An American Academy of Sleep Medicine Systematic Review, Meta-Analysis, and GRADE Assessment. J Clin Sleep Med. Feb 15 2019; 15(2): 301-334.
33. Patil SP, Ayappa IA, Caples SM, et al. Treatment of Adult Obstructive Sleep Apnea with Positive Airway Pressure: An American Academy of Sleep Medicine Clinical Practice Guideline. J Clin Sleep Med. Feb 15 2019; 15(2): 335-343.
34. Pattipati M, Gudavalli G, Zin M, et al. Continuous Positive Airway Pressure vs Mandibular Advancement Devices in the Treatment of Obstructive Sleep Apnea: An Updated Systematic Review and Meta-Analysis. Cureus. Jan 2022; 14(1): e21759.
35. Srijithesh PR, Aghoram R, Goel A, et al. Positional therapy for obstructive sleep apnoea. Cochrane Database Syst Rev. May 01 2019; 5: CD010990
36. 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. Oct 1 2013; 159(7):471-483.
37. 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. Journal of Clinical Sleep Medicine 2015; 11(7):773-6. www.aasmnet.org/practiceparameters.aspx?cid=102.
38. 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.
39. Schwab R J, Kim C, Siegel L C, et al. Mechanism of action of a novel device using oral pressure therapy (OPT) for the treatment of OSA. Am J Respir Crit Care Med 185; 2012:A6811.
40. 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. Jan 2013; 31(1):10-13.
41. Strohl KP, Brown DB, Collop N, et al. An official American Thoracic Society Clinical Practice Guideline: sleep apnea, sleepiness, and driving risk in noncommercial drivers. An update of a 1994 Statement. Am J Respir Crit Care Med. Jun 1 2013; 187(11):1259-1266.
42. Ulibarri VA, Krakow B, McIver ND. The PAP-NAP one decade later: patient risk factors, indications, and clinically relevant emotional and motivational influences on PAP use. Sleep Breath. Dec 2020; 24(4): 1427-1440.
43. Ulibarri VA, Krakow B, McIver ND. The PAP-NAP one decade later: patient risk factors, indications, and clinically relevant emotional and motivational influences on PAP use. Sleep Breath. Dec 2020; 24(4): 1427-1440.
44. U.S. Preventive Services Task Force, Bibbins-Domingo K, Grossman DC, et al. Screening for obstructive sleep apnea in adults: US Preventive Services Task Force Recommendation Statement. JAMA. Jan 24 2017; 317(4):407-414.
45. Vanderveken OM, Boudewyns A, Kashyap B et al. Cardiovascular Implications in the Treatment of Obstructive Sleep Apnea. J of Cardiovas. Transl. Res. 2011; 4: 53-60.
46. Vicini C, Dallan I, et al. Surgery vs. ventilation in adult severe obstructive sleep apnea syndrome. Am J Otolaryngol, Jan-Feb 2010; 31(1): 14-20.
47. Yu J, Zhou Z, McEvoy RD, et al. Association of Positive Airway Pressure With Cardiovascular Events and Death in Adults With Sleep Apnea: A Systematic Review and Metaanalysis. JAMA. Jul 11 2017; 318(2): 156-166.
48. 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.
49. Wessolleck E, Bernd E, Dockter S, et al. Intraoral electrical muscle stimulation in the treatment of snoring. Somnologie (Berl). 2018;22(Suppl 2): 47-52.

POLICY HISTORY:

Medical Policy Group, August 2002

Medical Policy Administration Committee, September 2002

Available for comment December 18, 2002-February 3, 2003

Medical Policy Group, October 2003 (1)

Medical Policy Group, October 2004

Medical Policy Group, February 2005 (3)

Medical Policy Administration Committee, July 2005

Available for comment August 6-September 19, 2005

Medical Policy Group, October 2005 (1)

Medical Policy Administration Committee, October 2005

Available for comment October 24-December 7, 2005

Medical Policy Group, July 2006 (1)

Medical Policy Administration Committee, August 2006

Available for comment August 4-September 18, 2006

Medical Policy Group, February 2007

Medical Policy Group, July 2007 (1)

Medical Policy Administration Committee, July 2007

Available for comment July 27-August 15, 2007

Medical Policy Group, August 2007 (1)

Medical Policy Administration Committee, August 2007

Available for comment August 16-September 29, 2007

Medical Policy Group, February 2009 (1)

Medical Policy Group, March 2010 (3): Policy update regarding Medical management, and clarification, References added, Key Points

Medical Policy Administration Committee April 2010

Available for comment March 24-May 7, 2010

Medical Policy Group, June 2010 (3)

Medical Policy Administration Committee, July 2010

Medical Policy Group, July 2010 (3)

Medical Policy Administration Committee, August 2010

Available for comment August 6-September 18, 2010

Medical Review Group, March 2011 (3)

Medical Policy Administration Committee, March 2011

Available for comment April 4 – May 18, 2011

Medical Policy Group, July 2011; Update to Benefit Application Section –Monsanto Grp

Medical Policy Group, April 2012 (3): Updated Policy to add oral devices (Provent), Key Points, Approved by Governing Bodies, & References

Medical Policy Administration Committee; May 2012

Available for comment May 10 through June 25, 2012

Medical Policy Group, May 2012 (3): Updated Key Points and References

Medical Policy Group, May 2012 (3): Added information regarding non-coverage of the Winx™ System, Oral Pressure Therapy (by ApniCure)

Available for comment June 14 through July 30, 2012

Medical Policy Panel, May 2013

Medical Policy Group, May 2013 (3):  2013 Updates – no new literature available for review through April 17, 2013; no changes in policy statement

Medical Policy Group, December 2013 (5):  2014 Coding Update – added new code A7047 to current coding effective 01/01/2014.

Medical Policy Group, April 2014 (5):  Updated Maximums for CPAP tubing; Policy section reworked and organized to include Medical and Surgical management of OSA under new effective date. 

Medical Policy Administration Committee May 2014

Available for comment May 6 through June 19, 2014

Medical Policy Panel, May 2014

Medical Policy Group, June 2014(5):  Updated Policy statement adding investigational statement for hypoglossal nerve stimulation; Key word, Key Points, Approved by Governing Bodies, & References updated with literature review through April 25, 2014.

Medical Policy Administration Committee June 2014

Available for comment June 19 through August 2, 2014

Medical Policy Group, July 2014(5): Updated policy statement to included RERA(respiratory event- related arousals) in the definition of RDI; Rearranged and added information under description and added reference July 2014.

Medical Policy Administration Committee, July 2014.

Medical Policy Panel November 2014

Medical Policy Group, November 2014 (5):  Updated key points and references per literature review; no change in policy statement.

Medical Policy Panel, May 2015

Medical Policy Group, May 2015 (6):  Updates to Description, Key Points, Approved by Governing Bodies, Key Words and References; no change to policy statement.

Medical Policy Group, October 2015 (6):  Clarification to Policy section – Related Supply Coverage, A4604 and A7037 covered for a combined max of 1 per 120 days. Added new Key Word (hypoglossal nerve stimulation)

Medical Policy Panel, November 2015

Medical Policy Group, December 2015 (6):  Updates to Description, Key Points and References; no change in policy statement.

Medical Policy Group, March 2016 (6): Updates to Description, Policy Statement, Key Points, Key Words, Approved by Governing Bodies, Coding and References to remove information on surgical treatment of OSA.  Surgical Treatment is now covered in medical policy #621 – Surgical Management of Obstructive Sleep Apnea. Policy statement regarding BiPAP coverage for OSA moved from MP#203 and added to this policy; no changes in policy intent.

Medical Policy Group, November 2016 (6): Added clarification statement to policy statement: “Note: Nocturnal polysomnogram testing to determine coverage should be performed per guidelines in medical policy #305.”, included “or home sleep study” under policy statement for oral appliances.

Medical Policy Panel, November 2016

Medical Policy Group, December 2016 (6): Updates to Background, Key Points, Practice Guidelines, removed K codes from Coding section and References. No change to policy statement.

Medical Policy Panel, June 2017

Medical Policy Group, July 2017 (6): Updates to Policy statement, added “Palate and mandible expansion devices do not meet medical criteria for coverage and are considered investigational for the treatment of OSA.”, Key Points, Coding, Key Words, Preventive Services Task Force and References.

Medical Policy Panel, June 2018

Medical Policy Group, July 2018 (6): Updates to Description, Policy statement (included REI/RDI) with no change to policy intent, Key Points and Practice Guidelines.

Medical Policy Panel, June 2019

Medical Policy Group, July 2019 (6): Updates to Key Points, Practice Guidelines and Coding (A7028-A7039).

Medical Policy Panel, June 2020

Medical Policy Group, June 2020 (6): Updates to Key Points, Practice Guidelines, Coding (A7027), Key Words (Provent)and References. Removed old policy statement. No change to policy intent.

Medical Policy Panel, June 2021

Medical Policy Group, June 2021 (6): Updates to Policy statement to include investigational devices: sleep positioning trainer /daytime electrical stimulation. Devices previously investigational for dates of service prior to June 18, 2021 per MP 495 Investigational Criteria. Updates to Key Points, Practice Guidelines, Governing Bodies, Key Words, Coding (K1001) and References.

Medical Policy Group, September 2021 (6): Coding update 10/1/21: Updates to Key Words, Governing Bodies and Coding (K1027).

Medical Policy Group, March 2022 Quarterly Coding Update. Added HCPCS K1028/K1029 to Current Coding section.

Medical Policy Panel, June 2022

Medical Policy Group, June 2022 (6): Updates to Description, Key Points, Practice Guidelines, Governing Bodies and References.

Medical Policy Group, March 2023 Quarterly Coding Update. Added HCPCS A7049 to Current Coding section. Updates to Benefit Application.

Medical Policy Panel, June 2023

Medical Policy Group, June 2023 (6): Updates to Description, Key Points, Governing Bodies, Practice Guidelines, Benefit Application and References.

Medical Policy Group, July 2023 (6): Updated Current Coding to include: A4604, A7029, A7030, A7031, A7032, A7033, A7044, A7045, A7046.

Medical Policy Group, September 2023 Quarterly HCPCS Coding Update. K1028 description revised, added E0490-E0491 to Current Coding section.

Medical Policy Group, December 2023: 2024 Annual HCPCS Coding Update. Added E0492, E0493, E0530. Deleted K1001, K1028, K1029.

Medical Policy Panel, June 2024

Medical Policy Group, June 2024 (6): Updates to Key Points, Governing Bodies, Practice Guidelines and References.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.