Coverage Policy Manual
Policy #: 1997195
Category: Medicine
Initiated: January 1996
Last Review: July 2018
  Sleep Apnea and Other Pulmonary Diseases, Ventilation Support and Respiratory Assist Devices

Description:
THIS POLICY ADDRESSES DEVICES USED IN THE TREATMENT OF OBSTRUCTIVE SLEEP APNEA AND OTHER PULMONARY CONDITIONS, BOTH PRIMARY AND SECONDARY.
 
PLEASE SEE POLICY #2009019 FOR DETAILS REGARDING TESTING FOR SLEEP DISORDERS
 
Obstructive sleep apnea syndrome (OSA) is characterized by repetitive episodes of upper airway obstruction due to the collapse and obstruction of the upper airway during sleep. In patients with OSA, the normal pharyngeal narrowing is accentuated by anatomic factors, such as a short, fat "bull" neck, elongated palate and uvula, or large tonsillar pillars with redundant lateral pharyngeal wall mucosa. Furthermore, OSA may be associated with a wide variety of craniofacial abnormalities, including micrognathia, retrognathia, or maxillary hypoplasia. In addition, OSA is associated with obesity. Obstruction anywhere along the upper airway can result in apnea. Therefore, OSA is associated with a heterogeneous group of anatomic variants producing obstruction.
 
Upper airway resistance syndrome (UARS) is a variant of OSA that is characterized by a partial collapse of the airway, resulting in increased resistance to airflow. The increased respiratory effort is associated with multiple sleep fragmentations, as measured by very short alpha electroencephalographic (EEG) arousals (“Respiratory Event Related Arousals,” or “RERAs”). The resistance to airflow is typically subtle and does not result in scoreable apneic or hypopneic events. RERAs are scored if there is a sequence of breaths lasting at least 10 seconds characterized by increasing respiratory effort or flattening of the nasal pressure waveform leading to an arousal from sleep when the sequence of breaths does not meet criteria for an apnea or hypopnea. Snoring may not be a feature of UARS. However, it does result in increasingly negative intrathoracic pressure during inspiration, which can be measured using an esophageal manometer as an adjunct to a polysomnogram. Therefore, this diagnosis rests on polysomnographic documentation of greater than 10 EEG arousals per hour of sleep correlated with episodes of greater than normal negative intrathoracic pressures.
 
Apnea is defined as the cessation of respiration for at least 10 seconds. The apnea index consists of the total number of apneic events per hour of sleep. Hypopnea is a reduction but not cessation of air exchange. Apneic and hypopneic events are combined into the apneic/hypopneic index (AHI). In turn, the AHI is often referred to as the respiratory disturbance index (RDI). Levels of oxygen saturation are typically reported as the amount of time spent with oxygen saturation below a criterion level (such as 90%), the number of times oxygen drops below a certain level, or the mean and minimum levels of oxygen saturation or the number of times the O2 saturation drops at least 4 percentage points.
 
Central sleep apnea syndromes (CSAS) are characterized by sleep disordered breathing associated with diminished or absent respiratory effort, coupled with excessive daytime sleepiness, frequent nocturnal awakenings, or both. The International Classification of Sleep Disorders (ICSD-2) lists 6 forms of CSAS:
Primary Central Sleep Apnea, Central Sleep Apnea Due to Cheyne Stokes Breathing Pattern, Central Sleep Apnea Due to Medical Condition Not Cheyne Stokes, Central Sleep Apnea Due to High-Altitude Periodic Breathing, Central Sleep Apnea Due to Drug or Substance, and Primary Sleep Apnea of Infancy.
 
Medical management of OSA includes weight loss, oral appliances, and various types of positive pressure therapy (i.e., fixed CPAP, bilevel positive airway pressure [BiPAP], or auto-adjusting CPAP). CPAP involves the administration of air, usually through the nose, by an external device at a fixed pressure to maintain the patency of the upper airway. Bilevel positive airway pressure is similar to CPAP, but these devices are capable of generating 2 adjustable pressure levels. Auto-adjusting CPAP adjusts the level of pressure based on the level of resistance and thus administers a lower mean level of positive pressure during the night. It has been hypothesized that both bilevel positive airway pressure and auto-adjusting CPAP are more comfortable for the patient and thus might improve patient compliance or acceptance.  In 2010, a nasal expiratory resistance valve (PROVENT®, Ventus Medical) received marketing clearance through the U.S. Food and Drug Administration’s (FDA) 510(k) for the treatment of OSA. PROVENT is a single use device containing valves that are inserted into the nostrils and secured with adhesive. The Winx™ system, which uses oral pressure therapy (OPT) for the treatment of OSA, received marketing clearance in 2012. OPT provides light negative pressure to the oral cavity by using a flexible mouthpiece connected to a bedside console that delivers negative pressure. 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.
 
 
Adaptive Servo-Ventilation (ASV) is a form of closed-loop mechanical ventilation, pressure preset, and volume or flow cycled. It can be delivered at default settings or with variable inspiratory and expiratory pressure. The VPAP Adapt (ResMed) device is a non-invasive flow generator that continually measures the patient’s ventilation and adjusts the degree of support to control the ventilation to at least equal the target ventilation. The target is 90% of the patient’s recent average ventilation time. The VPAP Adapt system has alarms to alert the patient to changes that affect the treatment and is used in conjunction with a face mask. This may not be a comprehensive list but other ResMed devices include AutoSet CS, AutoSet CS2, CPAP Adapt and VPAP AdaptSV. Respironics has the BiPAP auto SV or HEART PAP.
 
Oral appliances can be broadly categorized as mandibular advancing/positioning devices or tongue-retaining devices. Oral appliances can either be “off the shelf” or custom made for the patient by a dental laboratory or similar provider. A number of oral appliances have received marketing clearance through the U.S. Food and Drug Administration’s 510(k) pathway (product code LQZ) for the treatment of snoring and mild to moderate sleep apnea, including the Narval CC™, LambergSleepWell-Smarttrusion, 1st Snoring Appliance, Full Breath Sleep Appliance, PM Positioner, Snorenti, Snorex, Osap, Desra, Elastomeric Sleep Appliance, Snoremaster Snore Remedy, Snore-no-More, Napa, Snoar™ Open Airway Appliance, and The Equalizer Airway Device.
 
The Pneumopedics mRNA Appliance (Biomodelling Solutions) is a palate/jaw/bone expanding device for the treatment of snoring and mild to moderate obstructive sleep apnea. The mRNA appliance is a part of the DNA appliance system. DNA  appliances use 3-D Axial springs to expand the bony palate and jaw and are proposed to treat, reduce, and eventually eliminate OSA.
 
In 2010, a nasal expiratory resistance valve (PROVENT, Ventus Medical) received marketing clearance 510(K) for the treatment of OSA. PROVENT is a single use device containing valves that are inserted into the nostrils and secured with adhesive.
 
In 2014, the mRNA Appliance® was cleared for marketing by FDA through the 510(k) process (K130067) for the treatment of snoring and mild to moderate obstructive sleep apnea. FDA product code: LRK.
 
 

Policy/
Coverage:
Effective July 2018
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Continuous Positive Airway Pressure (CPAP) meets primary coverage criteria for effectiveness and is covered in adult or pediatric patients with obstructive sleep apnea meeting the following criteria:
    • The AHI is greater than or equal to 15 events per hour; OR
    • The AHI is from 5-14 events per hour with documented symptoms of excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia; hypertension, ischemic heart disease, or history of stroke.
 
Auto-adjusting positive airway pressure (APAP) meet primary coverage criteria for effectiveness and is covered in adult or pediatric patients with obstructive sleep apnea meeting the following criteria:
 
    • An Apnea/Hypopnea Index (AHI), Respiratory Disturbance Index (RDI) or Respiratory Event
Index (REI) of at least 15 events per hour, or
    • An AHI, RDI, or REI of at least 5 events per hour in a patient with excessive daytime sleepiness
or unexplained hypertension, or
    • If there is a significant change in weight or change in symptoms suggesting that continuous
positive airway pressure (CPAP) should be re-titrated or possibly discontinued.
 
 
Auto-adjusting positive airway pressure (APAP) meets primary coverage criteria for effectiveness and is covered during a 2-week trial to initiate and titrate CPAP in adult patients meeting the criteria above for CPAP coverage. A trial of auto-adjusting CPAP is warranted in those unable to tolerate fixed CPAP with documentation of acceptable pressures and reasons for intolerance of fixed CPAP.
 
Bilevel Positive Airway Pressure (BPAP) meets primary coverage criteria for effectiveness and is covered in the following circumstances:
    • Obstructive sleep apnea
        • Non-response or failed trial in individuals compliant to CPAP therapy.
        • Non-response is defined as an AHI greater than or equal to 15 events per hour; or an AHI from 5-14 events per hour (with documented symptoms of excessive daytime sleepiness, impaired cognition, mood disorders, insomnia, hypertension, ischemic heart disease or history of stroke) with use of CPAP at least 5 hours per night for at least 60 days.
 
    • Restrictive thoracic disorders
        • Documentation of progressive neuromuscular disease or severe thoracic cage abnormality AND  
        • Arterial blood gas PaCO2, done while awake and breathing the patient's usual FIO2 is >= 45 mm Hg; OR  
        • Sleep oximetry demonstrates oxygen saturation <= 88% for at least five continuous minutes during recorded sleep while breathing the patient's usual FIO2; OR
        • For progressive neuromuscular disease the maximal inspiratory pressure is < 60 cm H2O or forced vital capacity is < 50% of predicted AND
        • Chronic obstructive pulmonary disease does not contribute significantly to the patient's pulmonary limitation
 
    • Severe Chronic Obstructive Pulmonary Disease (COPD) FIO2 is >= 52 mm Hg, AND
        • Sleep oximetry demonstrates oxygen saturation <=88% for a least five continuous minutes, done while breathing oxygen at 2 LPM or the patient's usual FIO2, whichever is higher, AND
        • Prior to initiating therapy, obstructive sleep apnea and treatment with CPAP has been considered and ruled out.
 
    • Central Sleep Apnea: A complete facility-based, attended polysomnogram must document the following  
        • The diagnosis of central sleep apnea and the exclusion of obstructive sleep apnea (OSA) as the predominant cause of sleep-associated hypoventilation, AND  
        • CPAP has been ruled out as effective therapy if OSA is a component of sleepassociated hypoventilation, AND  
        • Oxygen saturation <= 88% for at least five continuous minutes, done while breathing the patient's usual FIO2, AND  
        • Significant improvement of sleep-associated hypoventilation with the use of a BiPAP device on the settings that will be prescribed for initial use at home, while breathing the patient's usual FIO2.
 
Intraoral appliances (tongue-retaining devices or mandibular advancing/positioning devices) meets primary coverage criteria of effectiveness and is covered in patients with OSA under the following conditions:
    • OSA, defined by an apnea/hypopnea index (AHI) of at least 15 per hour or an AHI of at least 5 events per hour in a patient with excessive daytime sleepiness or unexplained hypertension, AND  
    • A documented sleep study has been completed (per policy criteria) AND
    • A trial with CPAP has failed or is contraindicated, AND
    • The device is prescribed by a treating physician, AND
    • The device is custom-fitted by qualified dental personnel, AND
    • There is absence of temporomandibular dysfunction or periodontal disease
 
Adaptive Servo-Ventilation (ASV) meets primary coverage criteria and is covered for the treatment of central sleep apnea related to normal ejection fraction congestive heart failure for patients who have failed initial therapy with CPAP.
 
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Adaptive Servo-Ventilation (ASV) device does not meet primary coverage criteria and is not covered for the treatment of central sleep apnea related to low ejection fraction congestive heart failure for patients who have failed initial therapy with CPAP.
 
Nasal expiratory positive airway pressure (EPAP) device does not meet primary coverage criteria of effectiveness in improving health outcomes. For contracts without primary coverage criteria, nasal expiratory positive airway pressure is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Palate and mandible expansion devices for the treatment of OSA do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, palate and mandible expansion devices for the treatment of OSA are investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective Prior to July 2018
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Continuous Positive Airway Pressure (CPAP) meets primary coverage criteria for effectiveness and is covered in adult or pediatric patients with obstructive sleep apnea meeting the following criteria:
    • The AHI is greater than or equal to 15 events per hour; OR
    • The AHI is from 5-14 events per hour with documented symptoms of excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia; hypertension, ischemic heart disease, or history of stroke.
 
Auto-adjusting positive airway pressure (APAP) meet primary coverage criteria for effectiveness and is covered in adult or pediatric patients with obstructive sleep apnea meeting the following criteria:
    • The AHI is greater than or equal to 15 events per hour; OR
    • The AHI is from 5-14 events per hour with documented symptoms of excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia; hypertension, ischemic heart disease, or history of stroke.
 
Auto-adjusting positive airway pressure (APAP) meets primary coverage criteria for effectiveness and is covered during a 2-week trial to initiate and titrate CPAP in adult patients meeting the criteria above for CPAP coverage. A trial of auto-adjusting CPAP is warranted in those unable to tolerate fixed CPAP with documentation of acceptable pressures and reasons for intolerance of fixed CPAP.
 
Bilevel Positive Airway Pressure (BPAP) meets primary coverage criteria for effectiveness and is covered in the following circumstances:
  • Obstructive sleep apnea
      • Non-response or failed trial in individuals compliant to CPAP therapy.
      • Non-response is defined as an AHI greater than or equal to 15 events per hour; or an AHI from 5-14 events per hour (with documented symptoms of excessive daytime sleepiness, impaired cognition, mood disorders, insomnia, hypertension, ischemic heart disease or history of stroke) with use of CPAP at least 5 hours per night for at least 60 days.
 
  • Restrictive thoracic disorders
      • Documentation of progressive neuromuscular disease or severe thoracic cage abnormality AND
      • Arterial blood gas PaCO2, done while awake and breathing the patient's usual FIO2 is >= 45 mm Hg; OR
      • Sleep oximetry demonstrates oxygen saturation <= 88% for at least five continuous minutes during recorded sleep while breathing the patient's usual FIO2; OR
      • For progressive neuromuscular disease the maximal inspiratory pressure is < 60 cm H2O or forced vital capacity is < 50% of predicted AND
      • Chronic obstructive pulmonary disease does not contribute significantly to the patient's pulmonary limitation
 
  • Severe Chronic Obstructive Pulmonary Disease (COPD) FIO2 is >= 52 mm Hg, AND
      • Sleep oximetry demonstrates oxygen saturation <=88% for a least five continuous minutes, done while breathing oxygen at 2 LPM or the patient's usual FIO2, whichever is higher, AND
      • Prior to initiating therapy, obstructive sleep apnea and treatment with CPAP has been considered and ruled out.
 
  • Central Sleep Apnea: A complete facility-based, attended polysomnogram must document the following
      • The diagnosis of central sleep apnea and the exclusion of obstructive sleep apnea (OSA) as the predominant cause of sleep-associated hypoventilation, AND
      • CPAP has been ruled out as effective therapy if OSA is a component of sleepassociated hypoventilation, AND
      • Oxygen saturation <= 88% for at least five continuous minutes, done while breathing the patient's usual FIO2, AND
      • Significant improvement of sleep-associated hypoventilation with the use of a BiPAP device on the settings that will be prescribed for initial use at home, while breathing the patient's usual FIO2.
 
Intraoral appliances (tongue-retaining devices or mandibular advancing/positioning devices) meets primary coverage criteria of effectiveness and is covered in patients with OSA under the following conditions:
  • OSA, defined by an apnea/hypopnea index (AHI) of at least 15 per hour or an AHI of at least 5 events per hour in a patient with excessive daytime sleepiness or unexplained hypertension, AND
  • A documented sleep study has been completed (per policy criteria) AND
  • A trial with CPAP has failed or is contraindicated, AND
  • The device is prescribed by a treating physician, AND
  • The device is custom-fitted by qualified dental personnel, AND
  • There is absence of temporomandibular dysfunction or periodontal disease
 
Adaptive Servo-Ventilation (ASV) meets primary coverage criteria and is covered for the treatment of central sleep apnea related to normal ejection fraction congestive heart failure for patients who have failed initial therapy with CPAP.
 
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Adaptive Servo-Ventilation (ASV) device does not meet primary coverage criteria and is not covered for the treatment of central sleep apnea related to low ejection fraction congestive heart failure for patients who have failed initial therapy with CPAP.
 
Nasal expiratory positive airway pressure (EPAP) device does not meet primary coverage criteria of effectiveness in improving health outcomes. For contracts without primary coverage criteria, nasal expiratory positive airway pressure is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Palate expansion devices do not meet primary coverage criteria of effectiveness in improving health outcomes for the treatment of OSA. For contracts without primary coverage criteria, palate expansion devices are considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage (Added November 2017)
 
 
Effective Prior to January 2017
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
CPAP meets primary coverage criteria for effectiveness and is covered in adult or pediatric patients with obstructive sleep apnea meeting the following criteria:
 
        • The AHI is greater than or equal to 15 events per hour; OR
        • The AHI is from 5-14 events per hour with documented symptoms of excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia; hypertension, ischemic heart disease, or history of stroke.
 
Auto-adjusting CPAP (APAP) meets primary coverage criteria for effectiveness and is covered in adult patients meeting the criteria above for CPAP coverage (Amended November 2015).
 
BPAP meets primary coverage criteria for effectiveness and is covered in the following circumstances:
 
    • Obstructive sleep apnea
        • Non-response or failed trial in individuals compliant to CPAP therapy.
        • Non-response is defined as an AHI greater than or equal to 15 events per hour; or an AHI from 5-14 events per hour (with documented symptoms of excessive daytime sleepiness, impaired cognition, mood disorders, insomnia, hypertension, ischemic heart disease or history of stroke) with use of CPAP at least 5 hours per night for at least 60 days.
 
    • Restrictive thoracic disorders
        • Documentation of progressive neuromuscular disease or severe thoracic cage abnormality AND
        • Arterial blood gas PaCO2, done while awake and breathing the patient's usual FIO2 is >= 45 mm Hg; OR
        • Sleep oximetry demonstrates oxygen saturation <= 88% for at least five continuous minutes during recorded sleep while breathing the patient's usual FIO2; OR
        • For progressive neuromuscular disease the maximal inspiratory pressure is < 60 cm H2O or forced vital capacity is < 50% of predicted AND
        • Chronic obstructive pulmonary disease does not contribute significantly to the patient's pulmonary limitation
 
    • Severe Chronic Obstructive Pulmonary Disease (COPD)
        • When arterial blood gas PaCO2, done while awake and breathing the patient's usual FIO2 is >= 52 mm Hg,   AND
        • Sleep oximetry demonstrates oxygen saturation <=88% for a least five continuous minutes, done while breathing oxygen at 2 LPM or the patient's usual FIO2, whichever is higher, AND
        • Prior to initiating therapy, obstructive sleep apnea and treatment with CPAP has been considered and ruled out.
 
    • Central Sleep Apnea: A complete facility-based, attended polysomnogram must document the following
        • The diagnosis of central sleep apnea and the exclusion of obstructive sleep apnea (OSA) as the predominant cause of sleep-associated hypoventilation, AND
        • CPAP has been ruled out as effective therapy if OSA is a component of sleep-associated hypoventilation, AND
        • Oxygen saturation <= 88% for at least five continuous minutes, done while breathing the patient's usual FIO2, AND
        • Significant improvement of sleep-associated hypoventilation with the use of a BiPAP device on the settings that will be prescribed for initial use at home, while breathing the patient's usual FIO2.
 
Intraoral appliances (tongue-retaining devices or mandibular advancing/positioning devices) meets primary coverage criteria of effectiveness and is covered in patients with OSA under the following conditions:
    • OSA, defined by an apnea/hypopnea index (AHI) of at least 15 per hour or an AHI of at least 5 events per hour in a patient with excessive daytime sleepiness or unexplained hypertension, AND
    • A documented sleep study has been completed (per policy criteria) AND
    • A trial with CPAP has failed or is contraindicated, AND
    • The device is prescribed by a treating physician, AND
    • The device is custom-fitted by qualified dental personnel, AND
    • There is absence of temporomandibular dysfunction or periodontal disease
 
Adaptive Servo-Ventilation (ASV) meets primary coverage criteria and is covered for the treatment of central sleep apnea related to congestive heart failure for patients who have failed initial therapy with CPAP.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Nasal expiratory positive airway pressure (EPAP) device does not meet primary coverage criteria of effectiveness in improving health outcomes.  For contracts without primary coverage criteria, nasal expiratory positive airway pressure is considered investigational.  Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective prior to October 2012
Independently adjusted inspiratory and expiratory positive airway pressure instrumentation for the treatment of sleep disordered breathing meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes when CPAP therapy, used for the following indications, has failed:
    • The AHI is greater than or equal to 15 events per hour; OR
    • The AHI is from 5-14 events per hour with documented symptoms of excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia; hypertension, ischemic heart disease, or history of stroke.
 
The apnea-hypopnea index (AHI) is defined as the average number of episodes of both apneas and hypoapneas per hour, and must be based on a minimum of two hours of recording time without CPAP, reported by polysomnogram.
 
Any other use of independently adjusted inspiratory and expiratory positive airway pressure instrumentation for the treatment of sleep disordered breathing is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For contracts without primary coverage criteria, any other use of independently adjusted inspiratory and expiratory positive airway pressure instrumentation for the treatment of sleep disordered breathing is considered investigational.  Other uses are considered investigational.  Investigational services are an exclusion in the member certificate of coverage.

Rationale:
Definition of Clinically Significant OSA: The original rationale for the diagnosis and treatment of OSA was based on epidemiologic studies that suggested increased mortality in patients with an apneic index greater than 20. However, considering that an apneic/hypopnea index (AHI) of 5 is considered normal, there is obviously a great range of severity of OSA, ranging from those with only snoring as a complication to those with associated severe excessive daytime sleepiness, hypertension, or cardiac arrhythmias. If OSA is considered mild to moderate and snoring is the only manifestation, an intervention would be considered not medically necessary. For example, pronounced snoring may be considered predominantly a social annoyance to the patient's bed partner with no impact on the patient him/herself.
 
In 2011, the Agency for Healthcare Research and Quality (AHRQ) conducted a comparative effectiveness review (CER) on the diagnosis and treatment of OSA in adults (Balk, 2011). The CER found strong evidence that an AHI greater than 30 events/hour is an independent predictor of all-cause mortality, with low or insufficient evidence for an association between AHI and other clinical outcomes. The CER found moderate evidence that type 3 and type 4 monitors may have the ability to accurately predict AHI suggestive of OSA and that type 3 monitors perform better than type 4 monitors at AHI cutoffs of 5, 10, and 15 events per hour. Despite no or weak evidence for an effect of CPAP on clinical outcomes, given the large magnitude of effect on the intermediate outcomes of AHI, Epworth Sleepiness Scale (ESS), and arousal index, the strength of evidence that CPAP is an effective treatment to alleviate sleep apnea signs and symptoms was rated moderate. The strength of the evidence that mandibular advancement devices improve sleep apnea signs and symptoms was rated moderate, and there was moderate evidence that CPAP is superior to mandibular advancement devices in improving sleep study measures.
 
BPAP and APAP
A 1995 study by Reeves-Hoche et al. randomized patients with OSA to receive either CPAP or BiPAP (Reeves-Hoche, 1995). The authors found that patient complaints and effective use were similar in both groups but that the dropout rate was significantly higher in the CPAP group. This study suggests that BPAP should be limited to those patients who have failed a prior trial of CPAP. The 2011 AHRQ CER found moderate evidence that APAP and fixed pressure CPAP result in similar levels of compliance (hours used per night) and treatment effects for patients with OSA (Balk, 2011). Evidence-based guidelines from the AASM concluded that CPAP and APAP devices have similar outcomes in terms of AHI, oxygen saturation, and arousals (Berry, 2002; Littner, 2002; Kushida, 2006; Morgenthaler, 2006). As indicated in the 2011 AHRQ CER, increased compliance with APAP devices has not been well-documented in clinical trials (Hussain, 2004; Marrone, 2004; Stammnitz, 2004). Thus, the issues associated with APAP are similar to BiPAP; i.e., APAP may be considered medically necessary in patients who have failed a prior trial of CPAP. In addition to the studies (described previously) that used unattended APAP devices to titrate CPAP pressure, 2007 AASM practice parameters on autotitration identified 5 randomized trials supporting the use of unattended APAP to determine a fixed CPAP treatment pressure for patients with moderate to severe OSA without significant comorbidities affecting respiration (Morgenthaler, 2008). This new practice parameter was considered an option (uncertain clinical use), with automatic titration or treatment requiring close clinical follow-up (standard). The practice parameters for the use of APAP issued by the AASM point out that results may vary with different APAP devices based on different underlying technologies, and thus caution must be exercised in selecting a particular device for use (Berry, 2002; Littner, 2002; Kushida, 2006; Morgenthaler, 2006).
 
Nasal Expiratory Positive Airway Pressure (EPAP)
One randomized controlled trial and several prospective case series have been published with the PROVENT device.
 
In 2011, Berry et al. reported an industry-sponsored multicenter double-blind randomized sham-controlled trial of nasal EPAP (Berry, 2011). Two-hundred and fifty patients with OSA and an AHI of 10 or more per hour were randomized to nasal EPAP (n=127) or a sham device (n=123) for 3 months. PSG was performed on 2 nights (device-on, device off, in a random order) at week 1 (92% follow-up) and after 3 months of treatment (78% follow-up). EPAP reduced the AHI from a median of 13.8 to 5.0 (-52.7%) at week 1 and from 14.4 to 5.6 (-42.7%) at 3 months. This was a significantly greater reduction in AHI than the sham group (-7.3% at week 1 and -10.1% at 3 months). Over 3 months, the decrease in ESS was statistically greater in the EPAP group (from 9.9 to 7.2) than in the sham group (from 9.6 to 8.3), although the clinical significance of a 1 point difference in the ESS is unclear. Treatment success and oxygenation data were presented only for the 58% of per-protocol patients who had an AHI of 5 or more per hour on the device-off PSG night. The oxygenation results (oxygenation desaturation index and % of total sleep time with SpO2 <90%) showed small but statistically significant decreases at 1 week and 3 months. Treatment success, defined as a 50% or greater reduction in the AHI or an AHI reduced to less than 10 (if device-off AHI was 10 or more), was greater in the EPAP group at 1 week (62% vs. 27.2%) and 3 months (50.7% vs. 22.4%). Device-related adverse events were reported by 45% of patients in the EPAP group and 34% of patients in the sham group, with 7% of patients in the EPAP group discontinuing the study due to adverse events. Overall, the validity of these results is limited by the high dropout rate, and the clinical significance of the results is uncertain.
 
An open-label extension of the 2011 randomized study by Berry et al. evaluated 12-month safety and durability of the treatment response in patients who had an initial favorable response to EPAP (Kryger, 2011). Included were 41 patients (32% of 127) in the EPAP arm of the study who used the device for an average of at least 4 hours per night on at least 5 nights per week during months 1 and 2 and had at least a 50% reduction in AHI, or reduction to less than 10 events per hour, compared to the device-off PSG. Of the 51 patients (40% of 127) eligible, 41 enrolled in the extension study, and 34 (27% of 127) were still using the EPAP device at the end of 12 months. Median AHI was reduced from 15.7 to 4.7 events per hour; the percentage of patients who met criteria for success was not reported. The arousal index was modestly decreased (from 23.9 to 19.0). Over 12 months of treatment, the ESS decreased from 11.1 to 6.0. The median percentage of reported nights used (entire night) was 89.3%. Device-related adverse events were reported by 42% of patients, and the most frequently reported adverse events were difficulty exhaling, nasal discomfort, dry mouth, headache, and insomnia. This open-label extension study is limited by the inclusion of responders only and by the potential for a placebo effect on the ESS. However, the data suggest that some patients may respond to this device, and the patient compliance data might indicate a positive effect on daytime sleepiness that leads to continued use of the device in about 1 in 4 patients. Additional controlled studies are needed to distinguish between these alternatives.
Evidence-based guidelines on BiPAP, APAP, and dental appliances have been published by the AASM (Berry, 2002; Littner, 2002; Kushida, 2006; Morgenthaler, 2006). The Practice Parameters provided a recommendation of “guideline” (moderate clinical certainty) that although not as efficacious as CPAP, oral appliances are indicated for use in patients with mild to moderate OSA who prefer oral appliances to CPAP, or who do not respond to CPAP, are not appropriate candidates for CPAP, or who fail treatment attempts with CPAP or treatment with behavioral measures such as weight loss or sleep-position change. Patients with severe OSA should have an initial trial of nasal CPAP because greater effectiveness has been shown with this intervention than with the use of oral appliances. Oral appliances should be fitted by qualified dental personnel who are trained and experienced in the overall care of oral health, the temporomandibular joint, dental occlusion and associated oral structures. There was moderate clinical certainty that BiPAP was appropriate as an optional therapy in some cases in which high pressure is needed and the patient experiences difficulty exhaling against a fixed pressure or coexisting central hypoventilation present (Kushida, 2006). APAP was not recommended to diagnose OSA, for split-night studies or for patients with heart failure, significant lung disease such as chronic obstructive pulmonary disease, patients expected to have nocturnal arterial oxyhemoglobin desaturation due to conditions other than OSA (e.g., obesity hypoventilation syndrome), patients who do not snore, and patients who have central sleep apnea syndromes (Morgenthaler, 2008). Unattended APAP in patients without significant comorbidities was considered an option (uncertain clinical use). The guidelines indicated that patients being treated on the basis of APAP titration must have close clinical follow-up to determine treatment effectiveness and safety, especially during the first few weeks of PAP use, and a re-evaluation and, if necessary, a standard CPAP titration should be performed if symptoms do not resolve or if the APAP treatment otherwise appears to lack efficacy.
 
In 2008 the United Kingdom’s National Institute for Health and Clinical Excellence (NICE) issued guidance on CPAP treatment of OSA, based on a review of the literature and expert opinion (NICE, 2008). The recommendations included:
  • Moderate to severe OSA/hypopnea syndrome (OSAHS) can be diagnosed from patient history and a sleep study using oximetry or other monitoring devices carried out in the person’s home. In some cases, further studies that monitor additional physiological variables in a sleep laboratory or at home may be required, especially when alternative diagnoses are being considered. The severity of OSAHS is usually assessed on the basis of both severity of symptoms (particularly the degree of sleepiness) and the sleep study, by using either the AHI or the oxygen desaturation index. OSAHS is considered mild when the AHI is 5–14 in a sleep study, moderate when the AHI is 15–30, and severe when the AHI is over 30. In addition to the AHI, the severity of symptoms is also important.
  • CPAP is recommended as a treatment option for adults with moderate or severe symptomatic OSAHS. CPAP is only recommended as a treatment option for adults with mild OSAHS if: they have symptoms that affect their quality of life and ability to go about their daily activities, and lifestyle advice and any other relevant treatment options have been unsuccessful or are considered inappropriate.
  • Treatments aim to reduce daytime sleepiness by reducing the number of episodes of apnea/hypopnea experienced during sleep. The alternatives to CPAP are lifestyle management, dental devices, and surgery. Lifestyle management involves helping people to lose weight, stop smoking and/or decrease alcohol consumption. Dental devices are designed to keep the upper airway open during sleep. The efficacy of dental devices has been established in clinical trials, but these devices are traditionally viewed as a treatment option only for mild and moderate OSAHS. Surgery involves resection of the uvula and redundant retrolingual soft tissue. However, there is a lack of evidence of clinical effectiveness, and surgery is not routinely used in clinical practice.
  • The diagnosis and treatment of OSAHS, and the monitoring of the response, should be carried out by a specialist service with appropriately trained medical and support staff.
  • The Committee discussed the use of CPAP therapy for children and adolescents with OSAHS. The Committee heard that OSAHS is less common among children than in adults and that the clinical issues and etiology in children are different from those encountered in adults. The Committee concluded that the recommendations for CPAP should apply only to adults with OSAHS.
 
2013 Update
This policy is updated with results of a search of the MEDLINE database conducted through September 2013.
 
The Winx™ system, which uses oral pressure therapy (OPT) for the treatment of OSA, received marketing clearance from the FDA in 2012. One single-center feasibility study evaluating the use of OPT for the treatment of obstructive sleep apnea was identified (Moayer, 2013). A search of the clinicaltrials.gov website identified one ongoing observational study evaluating the use of the Winx™ system (NCT01683721). The study is expected to enroll 1000 subjects with an estimated completion date of February 2014.
 
No full-length, peer-reviewed studies on oral pressure therapy have been identified in the published literature. Therefore, it is not possible to evaluate the efficacy of this treatment based on scientific evidence.   The coverage statement has been changed to address the use of oral pressure therapy.
 
 
2014 Update
A literature search conducted through June 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
BiPAP and APAP
A 1995 study by Reeves-Hoche et al randomized adult patients with OSA to receive either CPAP or BiPAP. The authors found that patient complaints and effective use were similar in both groups but that the dropout rate was significantly higher in the CPAP group. This study suggests that BiPAP should be limited to those patients who have failed a prior trial of CPAP. However, two randomized trials comparing CPAP and BiPAP in children found no difference in adherence between the 2 devices (Marcus, 2006; Marcus, 2012) The 2011 AHRQ CER found moderate evidence that APAP and fixed pressure CPAP result in similar levels of compliance (hours used per night) and treatment effects for patients with OSA.
 
2016 Update
A literature search conducted through October 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
The 2016 SAVE RCT found no benefit of randomization to CPAP on the primary composite outcome of death or hospitalization for cardiovascular events in 2717 adults with moderate-to-severe OSA and cardiovascular disease (McEvoy, 2016). With a mean duration of adherence to CPAP therapy of 3.3 hours per night, CPAP significantly reduced daytime sleepiness (adjusted difference in ESS, -2.5; 95% CI, -2.8 to -2.2; p<0.001) and improved health-related quality of life (HR-QOL) and mood.
 
A 2015 systematic review identified 18 studies (total N=920 patients) that had data on pre- and postnasal EPAP (Riaz, 2015). Study designs included 10 conference papers and 8 publications (case series, cohort studies, RCTs). Of the patients included in the meta-analysis (n=345 patients) AHI decreased from 27.32 to 12.78 events per hour (p<0.001). For 359 patients, ESS patient was modestly improved from 9.9 to 7.4 (p<0.001). Data from the Berry RCT (described above) were not included in the meta-analysis as mean data were not reported. Response to nasal EPAP was variable and inconsistent, and there were no clear characteristics (demographic factors, medical history, and/or physical exam finding) that predicted a favorable response.
 
Cowie and colleagues investigated the effects of adaptive servo-ventilation in patients who had heart failure with reduced ejection fraction and predominantly central sleep apnea (Cowie, 2015). They randomly assigned 1325 patients with a left ventricular ejection fraction of 45% or less, an apnea-hypopnea index (AHI) of 15 or more events (occurrences of apnea or hypopnea) per hour, and a predominance of central events to receive guideline-based medical treatment with adaptive servo-ventilation or guideline-based medical treatment alone (control). The primary end point in the time-to-event analysis was the first event of death from any cause, lifesaving cardiovascular intervention (cardiac transplantation, implantation of a ventricular assist device, resuscitation after sudden cardiac arrest, or appropriate lifesaving shock), or unplanned hospitalization for worsening heart failure. In the adaptive servo-ventilation group, the mean AHI at 12 months was 6.6 events per hour. The incidence of the primary end point did not differ significantly between the adaptive servo-ventilation group and the control group (54.1% and 50.8%, respectively; hazard ratio, 1.13; 95% confidence interval [CI], 0.97 to 1.31; P=0.10). All-cause mortality and cardiovascular mortality were significantly higher in the adaptive servo-ventilation group than in the control group (hazard ratio for death from any cause, 1.28; 95% CI, 1.06 to 1.55; P=0.01; and hazard ratio for cardiovascular death, 1.34; 95% CI, 1.09 to 1.65; P=0.006). Adaptive servo-ventilation had no significant effect on the primary end point in patients who had heart failure with reduced ejection fraction and predominantly central sleep apnea, but all-cause and cardiovascular mortality were both increased with this therapy (NCT00733343).
 
2017 Update
A literature search conducted through October 2017 did not reveal any new information that would prompt a change in the coverage statement.  The key identified literature is summarized below.
 
Mandibular Advancement Device
In 2017, Johal and colleagues reported randomized crossover trial of ready-made versus custom-made mandibular repositioning devices (Johal, 2017). Twenty-five patients with mild-to-moderate OSA (mean AHI, 13.3 events/h; range, 10.9-25 events/h) were randomized to a 3-month trial of a ready-made or custom-made device, with a 2-week washout between treatments. An overnight home sleep study was performed at baseline and on the last night of the 3-month trial period. Patients used the custom made device for more nights per week (7 vs 3, p=0.004) and hours per night (5 vs 3, p=0.006) than the ready-made device. Treatment response (AHI <5 events/h) was obtained in 64% of patients during use of the custom-made device phase compared to a 24% response rate with the ready-made device (p<0.001). Treatment failure (<50% reduction in AHI) was more frequent with the ready-made device (36%) than the custom device (4%), while ESS of at least 10 was more frequent during the ready-made phase (66%) compared to the custom made phase (33%). An improvement in quality of life was observed only during the custom-made device phase.
 
ONGOING AND UNPUBLISHED CLINICAL TRIALS
A search of ClinicalTrials.gov in October 2017 identified over 200 studies on diagnosis and medical management of OSA.
 
2018 Update
Annual policy review completed with a literature search using the MEDLINE database through June 2018. The key identified literature is summarized below.
 
Palate and Mandible Expansion
Singh et al reported on a series of 15 consecutive patients with severe sleep apnea who were treated with a DNA Appliance or mRNA Appliance (Singh, 2016). All patients had failed to comply with CPAP. Pre- and posttreatment 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. Singh et al and Cress reported on a series of 19 patients who had mild-to-moderate OSA who were treated with a DNA or mRNA Appliance (Singh, 2016; Singh, 2017). Only patients who complied with oral appliance wear were included in the study. The mean AHI was reduced from 12.85 to 6.2 events per hour (p<0.001) without the appliance while the Oxygen Saturation Index improved from 6.3% to 2.6% (p<0.001). Limitations of these studies included the use of a home sleep study rather than the more accurate laboratory PSG, uncertain blinding of the physician evaluating the sleep study, the small number of patients studied, the lack of intention-to-treat analysis, and the lack of long-term follow-up.
 
Positive Airway Pressure Devices
Yu et al conducted a meta-analysis assessing the association between PAP and cardiovascular events and death  (Yu, 2017).  They included 10 trials with a total of 7266 patients with sleep apnea. There were 356 major adverse cardiovascular events and 613 deaths observed during follow-up (range, 6-57 months). The analysis found no significant association of PAP with a composite outcome of acute coronary syndrome events, stroke, or vascular death (relative risk, 0.77; 95% CI, 0.53 to 1.13). Trials were grouped according to adherence to PAP (<4 vs ≥ 4 h/d), type of sleep apnea (obstructive vs central), and type of PAP (CPAP vs adaptive servo-ventilation). Meta-regression identified no association between PAP with outcomes for different levels of apnea severity, follow-up duration, or adherence to PAP. As reported by McEvoy et al, the largest trial included in the meta-analysis was the Sleep Apnea Cardiovascular Endpoints RCT, which found no benefit of CPAP on the primary composite outcome of death or hospitalization for cardiovascular events in 2717 adults with moderate-to-severe OSA and cardiovascular disease who were followed for a median of 44 months (McEvoy, 2016). With a mean duration of adherence to CPAP therapy of 3.3 hours per night, CPAP significantly reduced daytime sleepiness (adjusted difference in ESS score, -2.5; 95% CI, -2.8 to -2.2; p<0.001) and improved health-related quality of life and mood.

CPT/HCPCS:
94660Continuous positive airway pressure ventilation (CPAP), initiation and management
95801Sleep study, unattended, simultaneous recording; minimum of heart rate, oxygen saturation, and respiratory analysis (eg, by airflow or peripheral arterial tone)
95980Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude and duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient measurements) gastric neurostimulator pulse generator/transmitter; intraoperative, with programming
A4604Tubing with integrated heating element for use with positive airway pressure device
A7027Combination oral/nasal mask, used with continuous positive airway pressure device, each
A7028Oral cushion for combination oral/nasal mask, replacement only, each
A7029Nasal pillows for combination oral/nasal mask, replacement only, pair
A7030Full face mask used with positive airway pressure device, each
A7031Face mask interface, replacement for full face mask, each
A7032Cushion for use on nasal mask interface, replacement only, each
A7034Nasal interface (mask or cannula type) used with positive airway pressure device, with or without head strap
A7035Headgear used with positive airway pressure device
A7036Chinstrap used with positive airway pressure device
A7037Tubing used with positive airway pressure device
A7038Filter, disposable, used with positive airway pressure device
A7039Filter, nondisposable, used with positive airway pressure device
A7046Water chamber for humidifier, used with positive airway pressure device, replacement, each
E0470Respiratory assist device, bi-level pressure capability, without backup rate feature, used with noninvasive interface, e.g., nasal or facial mask (intermittent assist device with continuous positive airway pressure device)
E0471Respiratory 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)
E0472Respiratory 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)
E0485Oral device/appliance used to reduce upper airway collapsibility, adjustable or nonadjustable, prefabricated, includes fitting and adjustment
E0486Oral device/appliance used to reduce upper airway collapsibility, adjustable or nonadjustable, custom fabricated, includes fitting and adjustment
E0561Humidifier, nonheated, used with positive airway pressure device
E0562Humidifier, heated, used with positive airway pressure device
E0601Continuous positive airway pressure (CPAP) device
E1399Durable medical equipment, miscellaneous

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Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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