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 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 (ie, cars, trucks, heavy equipment), while OSA in children may result in neurocognitive impairment and behavioral problems.

OSA can also affect the cardiovascular and pulmonary systems.^1, 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.^1,

Diagnosis`

The criterion standard for a diagnosis of sleep disorders is a polysomnogram performed in a sleep laboratory.^2, A standard polysomnogram includes electroencephalogram(EEG), submental electromyogram, and electrooculogram (to detect rapid eye movement sleep) for sleep staging. Polysomnography also typically includes electrocardiography and monitoring of respiratory airflow, 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 polysomnography for CPAP titration.

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 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 increased respiratory effort, terminating in 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 ≥1.5 is abnormal
Moderate OSA	AHI or RDI of 15 to < 30
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	Positive airway pressure (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;EEG: electroencephalogram; OSA: obstructive sleep apnea; PAP: positive airway pressure; RDI: Respiratory Disturbance Index; REI: Respiratory Event Index; RERA: respiratory event-related arousal: UARS: upper airway resistance syndrome.

Due to faster respiratory rates in children, pediatric scoring criteria define an apnea as two or more missed breaths, regardless of its duration in seconds. In pediatric patients, an AHI greater than 1.5 events per hour is considered abnormal, and an AHI of 10 or more may be considered severe.

A variety of devices have been developed specifically to evaluate OSA at home. They range from portable full polysomnography 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.

Treatment

Medical management of OSA in adults may include educational interventions at initiation of PAP therapy, weight loss, avoidance of stimulants, body position adjustment, oral appliances, and use of various types of positive airway pressure therapy (ie, fixed CPAP, bilevel positive airway pressure, or auto-adjusting positive airway pressure) during sleep. This policy, addresses CPAP, oral appliances, and novel devices including the Daytime-Nighttime Appliance (BioModeling Solutions), the mandibular Repositioning Nighttime Appliance (BioModeling Solutions), 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 (ie, adenotonsillectomy, uvulopalatopharyngoplasty, orthognathic surgery) is discussed in Surgical Treatment of Snoring and Obstructive Sleep Apnea Syndrome (Policy #006 in the Surgery Section).

Regulatory Status

A variety of oral appliances have been cleared for marketing by theU.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-no-More, Napa, Snoar™ Open Airway Appliance, and The Equalizer Airway Device. FDA product code: LQZ.

In 2014, the mRNA Appliance® (BioModeling Solutions) was cleared for marketing by the FDA through the 510(k) process (K130067) for the treatment of snoring and mild-to-moderate OSA. FDA product code: LRK.

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. FDA product codes: BZD, MNT.

In 2010, a nasal expiratory resistance valve (Provent®, Ventus Medical) was cleared for marketing by the FDA through the 510(k) process for the treatment of OSA. The Winx™ system received marketing clearance in 2012. FDA product codes: OHP, OZR.

In 2017, SleepImage System (MyCardio) was cleared for marketing by the FDA through the 510(k) process to aid in the evaluation of sleep disorders (K163696). The SleepImage System is considered software as a medical device that provides automated analysis of sleep data from a single photoplethysmogram sensor. FDA product code: MNR

Related Policies

• Home Cardiorespiratory Monitoring (Policy #011 in the DME Section)
• Actigraphy (Policy #048 in the Medicine Section)
• Polysomnography for Non‒Respiratory Sleep Disorders (Policy #087 in the Medicine Section)
• Surgical Treatment of Snoring and Obstructive Sleep Apnea Syndrome (Policy #006 in the Surgery Section)

A. A single unattended (unsupervised) home sleep apnea test with a minimum of 3 recording channels with the following sensors: nasal pressure, chest and abdominal respiratory inductance plethysmography, and oximetry; or alternatively peripheral arterial tone (PAT), oximetry and actigraphy is considered medically necessary in adults who are at high-risk for obstructive sleep apnea (OSA) and have no evidence of a health condition that might alter ventilation or require alternative treatment, i.e., central sleep apnea, heart failure, chronic pulmonary disease, obesity hypoventilation syndrome, neuromuscular disorders with sleep-related symptoms, injurious or potentially injurious parasomnias, or narcolepsy. The Policy Guidelines section defines high pretest probability.

B. A single unattended (unsupervised) home sleep apnea test with a minimum of recording channels as described above, is considered medically necessary as a screening tool in members who are scheduled for bariatric surgery and have no evidence of a health condition that might alter ventilation or require alternative treatment (see Policy Guidelines section).

C. Unattended home sleep apnea tests are considered investigational in children (<18 years of age).

D. Repeated unattended (unsupervised) home sleep apnea test with a minimum of 3 recording channels with the following sensors: nasal pressure, chest and abdominal respiratory inductance plethysmography, and oximetry; or alternatively PAT, oximetry and actigraphy, is considered medically necessary in adults under the following circumstances:
1. To assess efficacy of surgery or oral appliances or devices; OR
2. To reevaluate the diagnosis of OSA and need for continued CPAP, e.g., if there is a significant change in weight or change in symptoms suggesting that CPAP should be retitrated or possibly discontinued.

E. Supervised polysomnography (PSG) performed in a sleep laboratory is considered medically necessary in members with a moderate or high pretest probability of OSA in the following situations:
1. Pediatric members (i.e., <18 years of age); OR
2. When members do not meet criteria for an unattended home sleep apnea test as described above; OR
3. A previous home study failed to establish the diagnosis of OSA in a member with a high pretest probability of OSA; OR
4. A previous home study was technically inadequate; OR
5. Failure of resolution of symptoms or recurrence of symptoms during treatment; OR
6. When testing is done to rule out other sleep disorders such as central sleep apnea, injurious or potentially injurious parasomnias, or narcolepsy (see separate medical policy on 'Polysomnography for Non‒Respiratory Sleep Disorders' - Policy #087 in the Medicine Section); OR
7. Presence of a comorbidity that might alter ventilation or decrease the accuracy of a home sleep apnea test, including, but not limited to heart failure, neuromuscular disease, chronic pulmonary disease, or obesity hypoventilation syndrome.

F. A repeated supervised PSG performed in a sleep laboratory is considered medically necessary in members who meet the criteria above for an in-laboratory PSG under the following circumstances:
1. To initiate and titrate CPAP in adults members who have:
 An AHI or RDI of at least 15 events per hour, OR
 An AHI or RDI of at least 5 events per hour in a member with one or more signs or symptoms associated with OSA (e.g., excessive daytime sleepiness, hypertension [uncontrolled despite optimal medical therapy], cardiovascular heart disease, or stroke).
(NOTE: A split-night study, in which moderate-to-severe OSA is documented during the first portion of the study using PSG, followed by CPAP during the second portion of the study, can eliminate the need for a second study to titrate CPAP. See Policy Guidelines section for criteria to perform a split-night study.)
2. To initiate and titrate CPAP in children:
 In pediatric members, an AHI or RDI of >5; OR
 An AHI or RDI >1.5 in a member with excessive daytime sleepiness, behavioral problems or hyperactivity.
3. To assess efficacy of surgery (including adenotonsillectomy) or oral appliances/devices (for members who have had a prior PSG performed in a sleep laboratory meeting above criteria in policy statement I.E. and for whom a home sleep apnea test would not be considered medically necessary based on criteria in policy statement I.A. and/or I.D. above.)
G. A supervised, full night, polysomnography positive airway pressure (PAP) titration in a sleep laboratory is medically necessary in an adult member after an initial diagnostic sleep study (in-laboratory polysomnography or home sleep study) has confirmed the presence of clinically significant obstructive sleep apnea and has documented significant oxygen desaturation as indicated by either:
 O2 saturation <90% for greater than 30% of recording time during the initial diagnostic sleep study; OR
 O2 saturation <80% for greater than 1% of recording time during the initial diagnostic sleep study.
(NOTE: The above indication was based on input received when the policy was clinically vetted by a sleep specialist.)

H. Supervised or unattended home sleep apnea tests that do not meet the above criteria are considered investigational.

I. The use of an abbreviated daytime sleep study (PAP-NAP) as a supplement to standard sleep studies is considered investigational.

J. Multiple sleep latency testing is considered investigational in the diagnosis of OSA.

A. Auto-adjusting positive airway pressure (APAP) is considered medically necessary for titration of pressure in adults with clinically significant obstructive sleep apnea (OSA) defined as those who have:
• 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 member with one or more signs or symptoms associated with OSA (e.g., excessive daytime sleepiness, hypertension [uncontrolled despite optimal medical therapy], cardiovascular heart disease, or stroke); OR
• If there is a significant change in weight or change in symptoms suggesting that continuous positive airway pressure (CPAP) should be retitrated or possibly discontinued.
  
B. Continuous positive pressure (CPAP) is considered medically necessary in adult or pediatric members with clinically significant OSA.
• Clinically significant OSA in adults is defined as:
  • An AHI, RDI, or REI >15, OR
  • An AHI, RDI, or REI >5 in a member with one or more signs or symptoms associated with OSA (e.g., excessive daytime sleepiness, hypertension [uncontrolled despite optimal medical therapy], cardiovascular heart disease, or stroke).
• Clinically significant OSA in pediatric members is defined as:
  • An AHI or RDI >5, OR
  • An AHI or RDI >1.5 in a member with excessive daytime sleepines, behavioral problems, or hyperactivity.

C. Bilevel positive airway pressure (BiPAP) without back up (E0470) or auto-adjusting PAP is considered medically necessary in members with any of the following:
1. clinically significant OSA AND who have failed a prior trial of CPAP,
2. who do not tolerate fixed CPAP,
3. BiPAP is found to be more effective in the sleep lab (e.g., children).

D. BiPAP with back up (E0471) is also considered medically necessary for any of the following:
1. Members with coexisting OSA and chronic hypercapnic respiratory failure;
2. Members with OSA plus obesity hypoventilation syndrome whose alveolar hypoventilation failed to improve despite CPAP therapy;
3. Members with OSA plus significant central sleep apnea.

E. BiPAP with a backup respiratory rate or Adaptive Servo-Ventilation (ASV) is considered medically necessary for the treatment of central or treatment-emergent sleep apnea when all of the following criteria are met:
• Diagnostic PSG shows 5 or more predominantly obstructive respiratory events (obstructive or mixed apneas, hypopneas, or respiratory effort-related arousals (RERAs) per hour of sleep;
• PSG during use of positive airway pressure without a backup rate shows significant resolution of obstructive events and emergence or persistence of central apneas or central hypopneas with all of the following:
  • central apnea/hypopnea index of greater than or equal to 5 per hour
  • the number of central apneas/hypopneas greater than or equal to 50% of total number of apneas/hypopneas

(NOTE: Adaptive Servo-Ventilation, autoSV/BiPAP and autoSV advanced devices should not be used in patients with symptomatic chronic congestive heart failure [CHF] with reduced ejection fraction [LVEF less than or equal to 45%]. ResMed Ltd. identified a significant increase in the risk of cardiovascular death in patients with symptomatic chronic heart failure [NYHA II - IV] with reduced ejection fraction [LVEF less than or equal to 45%] and moderate to severe predominant central sleep apnea [AHI greater than or equal to 15, CAHI/AHI greater than or equal to 50% and CAI greater than or equal to 10].

Philips Respironics issued the same warning for at-risk patients using BiPAP autoSV/BiPAP autoSV Advanced devices.

In patients with LVEF greater than 45% or mild CHF-related central sleep apnea, ASV may be used as an option for treatment, at the clinical discretion of the prescribing qualified healthcare professional.)

F. Coverage of PAP Therapy Device (E0601, E0470, E0471)
1. When medically necessary, a PAP therapy device may be rented up to an initial 90 day trial period.
2. Continued coverage of a PAP device beyond the first three (3) months of therapy requires that, no sooner than the 31st day but no later than the 91st day after initiating therapy, there must be documentation the member is adhering to PAP therapy.

Objective evidence of adherence to use of the PAP device is defined as:
• Use of PAP >4 hours per night on 70% of nights during a consecutive thirty (30) day period anytime during the first three (3) months of initial usage.

If the above criterion is not met, continued coverage of PAP device and related accessories will be considered not medically necessary.
3. Replacement Criteria:
a. The replacement of a PAP device is considered medically necessary with a prescription from a qualified health professional when it is out of warranty and is malfunctioning due to reasonable wear and tear and cannot be repaired.
b. For PAP replacements, warranty expiration must be verified, if the device is less than five (5) years old as per the reasonable useful lifetime (RUL).
c. Equipment and accessories are limited to the most cost effective equipment and accessories that meets the member's needs.
d. Duplicate equipment is considered a convenience (e.g., travel PAP) and is not considered medically necessary.
e. Replacement of a PAP device for the purposes of upgrading technology is not considered medically necessary.

(NOTE: The "reasonable useful lifetime" of a CPAP machine is 5 years. It may be considered appropriate to replace a medically necessary CPAP machine after 5 years. Useful lifetime is based on the date of delivery of the equipment to the member, not the actual age of the equipment.)

G. Intraoral appliances (tongue-retaining devices or mandibular advancing/positioning devices) is considered medically necessary in adult members with clinically significant OSA under the following conditions:
 OSA, defined by an AHI, RDI, or REI of at least 15 per hour or an AHI, RDI, or REI of at least 5 events per hour in a member with one or more signs or symptoms associated with OSA (e.g., excessive daytime sleepiness, hypertension [uncontrolled despite optimal medical therapy], cardiovascular heart disease, or stroke), AND
 The device is prescribed by a treating physician, AND
 The device is custom-fabricated by qualified dental personnel, or ENT specialist, AND
(NOTE: When an oral appliance is custom-fabricated by an ENT specialist, periodontal disease must be ruled out by a qualified dental personnel.)
 There is absence of temporomandibular dysfunction or periodontal disease.
(NOTE: According to UpToDate, custom-fabricated intraoral appliances are preferred compared to self-administered over-the-counter (ie, boil and bite) varieties because they are more effective, more comfortable, and more likely to be retained by both the upper and lower teeth, insuring that the lower jaw does not fall out of the appliance during sleep. For this reason, over-the-counter intraoral appliances are considered not medically necessary and thus, not eligible for reimbursement.

CPAP has been shown to have greater effectiveness than oral appliances in general. This difference in efficacy is more pronounced for patients with severe OSA, as oral appliances have been shown to be less efficacious in patients with severe OSA than they are in patients with mild-moderate OSA. Therefore, it is particularly important that members with severe OSA should have an initial trial of CPAP and that all reasonable attempts are made to continue treatment with CPAP, prior to the decision to switch to an oral appliance.

Also, please note that the appropriate code to report an oral appliance which is usually fabricated by a dentist for the treatment of OSA is HCPCS E0486. In contrast, CPT 21085 is for a surgical splint that is fabricated by the oral surgeon in the office and is subsequently brought to the operating room for use after an orthognathic procedure.)

H. Biomimetic oral appliance therapy (BOAT) or use of biomimetic oral appliances/palate and mandible expansion devices (e.g., Daytime-Nighttime Appliance® system [DNA appliance®], mandibular Repositioning-Nighttime Appliance® [mRNA appliance®] is considered investigational in the treatment of obstructive sleep apnea,

I. Nasal expiratory positive airway pressure and oral pressure therapy devices are considered investigational.

J. Positional therapy and use of devices for positional therapy are considered investigational in the treatment of obstructive sleep apnea.

(NOTE: According to UpToDate, there is lack of long-term efficacy and adherence data on the use of devices for positional therapy. In addition, an article by Ravesloot MJL, et al, published in the Journal of Clinical Sleep Medicine (2017) on 'Efficacy of the New Generation of Devices for Positional Therapy for Patients With Positional Obstructive Sleep Apnea: A Systematic Review of the Literature and Meta-Analysis', concluded that additional long-term, high-quality studies are needed to confirm the role of positional therapy as a single or as combination treatment modality for patients with obstructive sleep apnea and to assess long-term compliance. Furthermore, the authors of the Cochrane Database of Systematic Reviews: Positional Therapy for OSA (May 2019) indicated that all the studies were of short duration so they are unable to comment on the long-term effects of positional therapy. They stated that long-term studies are important as most of the quality-of-life outcomes will be evident only when therapies are given over a longer period of time. The certainty of evidence was low to moderate.)

Specialist Training

Polysomnographiy or home sleep apnea testing should be performed in appropriately selected patients and the test summary results reviewed by a physician who is trained in sleep medicine.

Medical professionals who interpret a polysomnogram or home sleep apnea test should be trained in sleep medicine and should review the raw data from PSG and home sleep apnea tests to detect artifacts and data loss.

Treatment of patients diagnosed with OSA should be initiated and monitored by a professional trained in sleep medicine. It is important to monitor symptoms and adherence to positive airway pressure (PAP) treatment (eg, review of symptoms and device utilization at 90 days with a minimum of 4 hours per night for at least 5 nights per week).

Risk Factors for Obstructive sleep apnea

Although not an exclusive list, patients with all of 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 35 kg/m².

The STOP-BANG questionnaire, a method developed for nonsleep specialists, assesses the signs and symptoms of OSA (Snore, Tired, Observed apnea, blood Pressure, BMI, Age, Neck, Gender), has been shown to have 97% sensitivity and 96% negative predictive value (specificity, 33%) for the identification of patients with severe OSA (Apnea/Hypopnea Index [AHI] >30 events per hour). Overnight oximetry has been used by some sleep specialists as a component of the risk assessment but is inadequate for the diagnosis of OSA. Therefore, a follow-up polysomnography (PSG) or home sleepapnea test 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. Children frequently exhibit behavioral problems or hyperactivity rather than daytime sleepiness. Obesity is defined as a BMI greater than the 90th percentile for the weight/height ratio. Although the definition of severe OSA in children is not well established, an AHI or RDI greater than 1.5 events per hour is considered abnormal (an AHI or RDI ³10 events per hour may be considered severe). 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.

Bariatric Surgery Patients

Screening for OSA should be performed routinely in patients scheduled for bariatric surgery, due to the high prevalence of OSA in this population. The optimal screening approach is not certain. An in-laboratory PSG or home sleep apnea test is the most accurate screening method. Some experts recommend a symptom-based screening instrument, followed by PSG in patients who exceed a certain threshold, as an alternative to performing PSG in all patients. It should be noted that there is a high prevalence of obesity hypoventilation syndrome in patients who are candidates for bariatric surgery. Therefore, obesity hypoventilation syndrome should be ruled out prior to home sleep apnea testing in this population.

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.

Multiple Sleep Latency Test

The multiple sleep latency test (MSLT) is an objective measure of the tendency to fall asleep in the absence of alerting factors, while the maintenance of wakefulness test is an objective measure of the ability to stay awake under soporific conditions (used to assess occupational safety). The MSLT and maintenance of wakefulness test are not routinely indicated in the evaluation and diagnosis of OSA or in the assessment of change following treatment with CPAP. The MSLT may be indicated in the evaluation of patients with suspected narcolepsy to confirm the diagnosis (often characterized by cataplexy, sleep paralysis, and hypnagogic/hypnopompic hallucinations) or to differentiate between suspected idiopathic hypersomnia and narcolepsy. Narcolepsy and OSA can co-occur. Because it is not possible to differentiate between the excessive sleepiness caused by OSA and by narcolepsy, OSA should be treated before confirming a diagnosis of narcolepsy with the MSLT.

Split-Night Studies

American Academy of Sleep Medicine practice parameters (2005) have indicated that a split-night study (initial diagnostic PSG followed by CPAP titration during PSG on the same night) is an alternative to 1 full night of diagnostic PSG followed by a second night of titration if the following 4 criteria are met:

a. An AHI of at least 40 events per hour is documented during a minimum of 2 hours of diagnostic PSG. Split-night studies may sometimes be considered at an AHI between 20 and 40 events per hour, based on clinical judgment (eg, if there are also repetitive long obstructions and major desaturations). However, at AHI values below 40, determination of CPAP-level requirements, based on split-night studies, may be less accurate than in full-night calibrations.
b. CPAP titration is carried out for more than 3 hours (because respiratory events can worsen as the night progresses).
c. PSG documents that CPAP eliminates or nearly eliminates the respiratory events during rapid eye movement (REM) and non-REM sleep, including REM sleep with the patient in the supine position.
d. A second full night of PSG for CPAP titration is performed if the diagnosis of a sleep-related breathing disorder is confirmed, but criteria b and c are not met.

Full correspondence does not exist between CPT codes and the most current categorization scheme for the different types of studies. The 2005 practice parameters from the American Academy of Sleep Medicine list 4 types of monitoring procedures: type 1, standard attended in-lab comprehensive PSG; type 2, comprehensive portable PSG; type 3, modified portable sleep apnea testing (also referred to as cardiorespiratory sleep studies), consisting of 4 or more channels of monitoring; and type 4, continuous single or dual bioparameters, consisting of 1 or 2 channels, typically oxygen saturation, or airflow. Types 1 and 2 would be considered polysomnographic studies, and types 3 and 4 would be considered polygraphic sleep studies. The terms sleep studies and PSG are often used interchangeably. CPT coding distinguishes between sleep studiesthat do not include electroencephalographic (EEG) monitoring, and PSG, which includes EEG monitoring. PSG is usually conducted in a sleep laboratory and attended by a technologist, but may also be conducted with type 2 portable monitoring. The type of study is further characterized as attended (supervised) or unattended by a technologist. Home or portable monitoring implies unattended sleep studies, typically conducted in the patient's home. There are no specific codes for remotely monitored home sleep studies. They would likely be reported with the CPT code for the sleep study with the GT modifier ("via interactive audio and video telecommunications systems") appended. There is no CPT code for "unattended" PSG.

Cardiorespiratory sleep studies without EEG may be called polygraphic studies and can be attended or unattended by a technologist. CPT codes 95807 and 95806 distinguish polygraphic sleep studies that are attended or unattended, but there are no codes that distinguish between type 3 and type 4 sleep studies. A wide variety of portable monitors and proprietary automated scoring systems are being tested and marketed, but the optimum combination of sensors and scoring algorithms is currently unknown. Current recommendations are that the portable monitoring device have 4 channels (oxygen saturation, respiratory effort, respiratory airflow, heart rate) and permit review of the raw data. Type 4 monitors with fewer than 3 channels are not recommended due to reduced diagnostic accuracy and higher failure rates. As with attended PSG, it is important that the raw data from home sleep studies be reviewed by a professional trained in sleep medicine to detect artifacts and data loss.


Medicare Coverage:
There are multiple NCDs and LCDs applicable to the Diagnosis and Medical Management of Obstructive Sleep Apnea Syndrome. For eligibility and coverage information, please refer to the following:

Diagnosis of Obstructive Sleep Apnea (OSA)

National Coverage Determination (NCD) for Sleep Testing for Obstructive Sleep Apnea (OSA) (240.4.1). Available to be accessed at CMS National Coverage Determinations (NCDs) Alphabetical Index search page: https://www.cms.gov/medicare-coverage-database/indexes/ncd-alphabetical-index.aspx.

Local Coverage Determination (LCD): Outpatient Sleep Studies (L35050). Available to be accessed at Novitas Solutions, Inc., Medical Policy Search page: https://www.novitas-solutions.com/webcenter/portal/MedicareJL/LcdSearch?_afrLoop=90769712476969#!%40%40%3F_afrLoop%3D90769712476969%26centerWidth%3D100%2525%26leftWidth%3D0%2525%26rightWidth%3D0%2525%26showFooter%3Dfalse%26showHeader%3Dfalse%26_adf.ctrl-state%3D63y7eftob_46.

Management of Obstructive Sleep Apnea (OSA)

National Coverage Determination (NCD) for Continuous Positive Airway Pressure (CPAP) Therapy For
Obstructive Sleep Apnea (OSA) (240.4). Available to be accessed at CMS National Coverage Determinations (NCDs) Alphabetical Index search page: https://www.cms.gov/medicare-coverage-database/indexes/ncd-alphabetical-index.aspx.

Suppliers must review the actual LCD, the related Policy Article, and the Standard Documentation Requirements (SDR) article to be sure to have all of the relevant information necessary and applicable to the item(s) provided. A Standard Written Order (SWO) must be communicated to the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving a completed SWO, the claim shall be denied as not reasonable and necessary.

Local Coverage Determination (LCD): Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea (L33718). Available to be accessed at Noridian Healthcare Services, LLC, (DME MAC), Local Coverage Determinations (LCDs) search page: https://www.cms.gov/medicare-coverage-database/indexes/lcd-list.aspx?Cntrctr=389&ContrVer=1&CntrctrSelected=389*1&s=38&DocType=All&bc=AggAAAAAAAAAAA%3d%3d&#ResultsAnchor.

Local Coverage Article: Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea - Policy Article (A52467)

Local Coverage Determination (LCD): Oral Appliances for Obstructive Sleep Apnea (L33611). Available to be accessed at Noridian Healthcare Services, LLC, (DME MAC), Local Coverage Determinations (LCDs) search page: https://www.cms.gov/medicare-coverage-database/indexes/lcd-list.aspx?Cntrctr=389&ContrVer=1&CntrctrSelected=389*1&s=38&DocType=All&bc=AggAAAAAAAAAAA%3d%3d&#ResultsAnchor.

Local Coverage Article: Oral Appliances for Obstructive Sleep Apnea - Policy Article (A52512). Available to be accessed at Noridian Healthcare Services, LLC, (DME MAC), Local Coverage Determinations (LCDs) search page: https://www.cms.gov/medicare-coverage-database/indexes/lcd-list.aspx?Cntrctr=389&ContrVer=1&CntrctrSelected=389*1&s=38&DocType=All&bc=AggAAAAAAAAAAA%3d%3d&#ResultsAnchor.

Local Coverage Determination (LCD): Respiratory Assist Devices (L33800). Available to be accessed at Noridian Healthcare Services, LLC, (DME MAC), Local Coverage Determinations (LCDs) search page: https://www.cms.gov/medicare-coverage-database/indexes/lcd-list.aspx?Cntrctr=389&ContrVer=1&CntrctrSelected=389*1&s=38&DocType=All&bc=AggAAAAAAAAAAA%3d%3d&#ResultsAnchor.

Local Coverage Article: Respiratory Assist Devices - Policy Article (A52517)

There is no National Coverage Determination (NCD) or Local Coverage Determination (LCD) for jurisdiction JL for positional therapy for the treatment of obstructive sleep apnea. Therefore, Medicare Advantage will follow the Horizon BCBSNJ Medical Policy.

Medicaid Coverage:
For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.

FIDE SNP Coverage:
For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.

[RATIONALE: This policy was created in 1996 and has been updated regularly with searches of the PubMed database. The most recent literature update was performed through May 11, 2020.

Evidence reviews assess the clinical evidence to determine whether the use of technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life (QOL), and ability to function-including benefits and harms. Every clinical condition has specific outcomes that are important to patients and managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of technology, two domains are examined: the relevance, and quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Suspected Obstructive Sleep Apnea
Clinical Context and Test Purpose

The purpose of home sleep apnea tests in patients with suspected obstructive sleep apnea (OSA) is to diagnosis the condition and to inform a decision on appropriate treatment.

The question addressed in this policy is: Do home sleep apnea tests improve the net health outcome?

The following PICO was used to select literature to inform this policy.

Patients

The relevant populations of interest is patients with suspected OSA.

Interventions

The tests being considered is home sleep apnea testing. Tests reviewed are multichannel home sleep testing and limited channel sleep testing (auto-adjusting positive airway pressure [APAP],Apnea Risk Evaluation System).

Comparators

The established test for OSA is in-laboratory polysomnography (PSG). Laboratory PSG is a more complex procedure than home testing and more limited in its availability.

Outcomes

The general outcomes of interest are the number of apneas or hypopneas during sleep, measured by the Apnea/Hypopnea Index (AHI), and subjective symptoms of sleepiness, typically measured with the Epworth Sleepiness Scale (ESS) or the Functional Outcomes of Sleep Questionnaire (FOSQ) (see Table 2).

Table 2. Health Outcome Measures Relevant to OSA

Outcome	Measure	Description	Clinically Meaningful Difference (If Known)
Change in AHI	AHI	Mean change in AHI from baseline to posttreatment	Change from severe-to-moderate or mild OSA
AHI success	Percentage of patients achieving success	Studies may use different definitions of success, but the most common for AHI success is the Sher criteria	Sher criteria include a decrease in AHI of ≥50% and an AHI <20 events per hour. Alternative measures of success may be AHI <15, <10, or <5 events per hour
ODI	Oxygen levels in blood during sleep	The number of times per hour of sleep that the blood oxygen level drops by ≥4 percentage points	More than 5 events per hour
ESS	Scale ranges from 0 to 24	The ESS is a short self-administered questionnaire that asks patients how likely they are to fall asleep in 8 different situations (eg, watching TV, sitting quietly in a car, or sitting and talking to someone)	An ESS of ≥10 is considered excessively sleepy
FOSQ	30 questions	Disease-specific quality of life questionnaire that evaluates functional status related to excessive sleepiness	A score of ≥18 is the threshold for normal sleep-related functioning, and a change of ≥2 points is considered a clinically meaningful improvement

AHI: Apnea/Hypopnea Index; ESS: Epworth Sleepiness Score; FOSQ: Functional Outcomes of Sleep Questionnaire; ODI: Oxygen Desaturation Index; OSA: obstructive sleep apnea.

Beneficial outcomes of a true-positive are effective treatment resulting in a decrease in respiratory events during sleep and a reduction in subject sleepiness.

Harmful outcomes of a false-positive test include unnecessary treatment. Harmful outcomes of a false-negative test include not receiving the correct treatment.

Review of Evidence
Multichannel Home Sleep Apnea Testing

Balk et al (2011) conducted a comparative effectiveness review for the Agency for Healthcare Research and Quality (AHRQ) on the diagnosis and treatment of OSA in adults.^3, Reviewers found strong evidence that an AHI greater than 30 events per hour is an independent predictor of all-cause mortality, with low or insufficient evidence for an association between AHI and other clinical outcomes. Reviewers found moderate evidence that type 3 and 4 monitors may have the ability to accurately predict an 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.

Home sleep testing with three recording channels that include respiratory effort, airflow, and oxygen saturation, but not heart rate, are considered by some, including the Centers for Medicare & Medicaid, to be sufficient for home sleep apnea tests. Corral et al (2017) reported a multicenter noninferiority trial of home sleep testing using a 3-channel monitor compared with in-laboratory PSG in 430 patients.^4, Included in the study were patients referred to tertiary hospitals in Spain for suspected OSA, who had snoring or sleep apneas observed by a partner, ESS score of ten or greater, and absence of clinical suspicion of any other sleep pathology. Both groups of patients who were diagnosed with OSA received continuous positive airway pressure (CPAP) titration with a single APAP session at home. The median baseline ESS score was 13 in both groups. CPAP was indicated in 68% of patients in the PSG arm compared with 53% in the home sleep testing group, with the difference attributed to the underestimation of AHI in-home sleep studies. All patients, including those treated with CPAP and those who were not, were assessed at six-month follow-up. ESS score improved by -4.2 (95% confidence interval [CI], -4.8 to -3.6) in the home sleep testing group and by -4.9 (95% CI, -5.4 to -4.3) in the PSG group. With a noninferiority margin of two points on the ESS, home sleep testing was noninferior to in-laboratory PSG.

Subsection Summary: Multichannel Home Sleep Apnea Testing

Based on this evidence and society guidelines, portable monitoring with a minimum of four recording channels (including oxygen saturation, respiratory movements, airflow, an electrocardiogram or heart rate), or with a device that measures peripheral arterial tone, actigraphy, and oxygen saturation, for the diagnosis of OSA in adults who are at high-risk for OSA improves outcomes, when clinical evaluation and follow-up are conducted by a medical professional experienced in the diagnosis and treatment of sleep disorders.

Limited Channel Home Sleep Apnea Testing
Use of Auto-Adjusting Positive Airway Pressure for Diagnosis and Treatment Supervised by a Sleep Specialist

Mulgrew et al (2007) published a randomized validation study of the diagnosis and management of OSA with a single-channel monitor followed by APAP.^5, They developed a diagnostic algorithm that had a 94% positive predictive value for moderate-to-severe OSA assessed by PSG. Patients who passed the screening (n=68) were randomized to attend in-laboratory PSG with CPAP titration or home monitoring with a portable APAP unit. No difference was observed between lab PSG and home-managed patients for any of the outcome measures. Senn et al (2006) assessed whether an empirical approach, using a 2-week trial of APAP, could effectively diagnose OSA.^6, Patients (n=76) were included in the study if they had been referred by primary care physicians for evaluation of suspected OSA, were habitual snorers, complained of daytime sleepiness, and had an ESS score of 8 or greater (mean, 13.6). At the end of the two-week trial, patients were asked to rate the perceived effect of treatment and to indicate whether they had used CPAP for more than two hours per night and were willing to continue treatment. Patients without a clear benefit of CPAP received further evaluation, including clinical assessment and PSG. Compared with PSG, patient responses showed a sensitivity of 80%, a specificity of 97%, a positive predictive value of 97%, and a negative predictive value of 78%.

Berry et al (2008) randomized 106 patients referred for a sleep study for suspected OSA at a local Veterans Administration center to portable monitoring followed by APAP or to PSG for diagnosis and treatment.^7, Patients were screened with a detailed sleep and medical history questionnaire, and patients on α-blockers or not in sinus rhythm were excluded due to the type of portable monitoring device used (Watch-PAT 100). Of the 53 patients randomized to PSG, 6 (11%) did not have PSG-defined OSA; in the portable monitoring arm, 4 (8%) of 53 patients were found not to have OSA. Treatment outcomes were similar in both groups, with a 7-point improvement in ESS score, 3-point improvement in the FOSQ score, and a machine estimate of residual AHI of 3.5 events per hour in the portable monitoring APAP group and 5.3 in the PSG group.

Apnea Risk Evaluation System

Ayappa et al (2008) reported on a validation study of a small apnea monitor that is self-applied to the forehead.^8, The device measures blood oxygen saturation and pulse rate, airflow, snoring levels, head movement, and head position. The study enrolled 80 individuals with a high likelihood of OSA and 22 with a low-risk of OSA; results of simultaneous Apnea Risk Evaluation System recording and PSG were available for 92 individuals. When healthy subjects were excluded from the analysis, sensitivity (91%) and specificity (92%) were relatively high for an AHI of 15 or more events per hour but dropped considerably with an AHI between 5 and 15 (sensitivity, 97%; specificity, 78%). Five percent of the subjects could not tolerate the device and were excluded from the analysis.

SleepImage System

The SleepImage System is cloud-based software a medical device that generates AHI from data recorded with a single photoplethysmogram sensor. The SleepImage algorithms calculate heart rate variability, respiration, and oxygen saturation with cardiopulmonary coupling analysis. Hilmisson et al (2020) compared results calculated by the SleepImage System with manually scored PSG in 805 children ages 5 to 9.9 yrs of age who participated in the Childhood Adenotonsillectomy Trial (CHAT).^9, The CHAT study included 1244 habitually snoring children who were referred for PSG. A total of 805 children had successfully collected data from the sensor. Concordance between the SleepImage-derived AHI and PSG-derived AHI is shown in Table 3. Kappa was 0.81, 0.89, and 0.91 for mild, moderate, and severe sleep apnea, respectively. A proposed benefit is that this would be easier for children compared to a test requiring multiple sensors and improve access. Further study in a wider population is needed to evaluate whether this system might be a suitable method for evaluating sleep parameters in the home.

Table 3 Clinical Validity of the SleepImage System

Study	Initial N	Final N	Excluded Samples	Prevalence of Condition	Clinical Validity: Agreement (95% CI)
					Mild Sleep Apnea AHI > 1.0	Moderate Sleep Apnea AHI > 5.0	High Risk AHI > 10.0
Hilmission et al (2020)9,	1244	805	439	64%	0.914 (0.895 to 0.934)	0.967 (0.954 to 0.979)	0.986 (0.978 to 0.994)

CI: confidence interval.

Subsection Summary: Limited Channel Home Sleep Apnea Testing

The evidence for limited channel home sleep apnea testing (includes type four monitors) in patients who have OSA consists of studies on diagnostic accuracy. A number of questions remain about the ability of these home sleep apnea tests to detect clinically significant OSA without sensors for respiratory effort, airflow, and oxygen saturation (or alternatively peripheral arterial tone, actigraphy, and oxygen saturation).

Diagnosed Obstructive Sleep Apnea
Clinical Context and Therapy Purpose

The purpose of medical management in patients who have OSA is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The question addressed in this policy is: Does management with PAP, oral appliances, or novel OSA treatments improve the net health outcome?

The following PICO was used to select literature to inform this policy.

Patients

The relevant population of interest is patients with OSA.

Interventions

The therapy being considered is the medical management of OSA in adults, which may include the use of various types of PAP therapy (ie, fixed CPAP, bilevel PAP, or APAP) during sleep.

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 PAP is similar to CPAP but these devices are capable of generating two adjustable pressure levels. APAP 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 PAP and APAP are more comfortable for the patient and thus might improve patient compliance or acceptance.

Oral appliances can be broadly categorized as mandibular advancing or positioning devices or tongue-retaining devices. Oral appliances can either be "off the shelf" or customized for the patient by a dental laboratory or similar provider.

The Daytime-Nighttime Appliance (DNA Appliance) and the mandibular Repositioning Nighttime Appliance (mRNA Appliance) are customized palate and mandible expanding devices. In addition to the upper-jaw device that is common to both the DNA Appliance and the rRNA Appliance (worn both during the day and night), the mRNA Appliance moves the mandible forward and is worn during sleep. The DNA Appliance and mRNA Appliance systems use 3-dimensional axial springs, which are proposed to gradually expand the upper and lower jaw and airway to treat and eventually eliminate mild-to-moderate OSA.

Other devices being marketed for the treatment of OSA are 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. Oral pressure therapy 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.

Comparators

The following therapy is currently being used to make decisions about the treatment of OSA. The criterion standard treatment is CPAP or its variants. The major limitation of PAP therapy is poor patient compliance due to the need to wear a face or nasal mask.

Outcomes

The outcomes of interest are a decrease in AHI and oxygen desaturation Index on PSG and improvement in a measure of sleepiness such as the ESS or FOSQ (see Table 2), which are typically conducted within weeks or months.

Review of Evidence
Positive Airway Pressure Devices

The American Academy of Sleep Medicine (AASM) commissioned a task force (Patil et al[2019]) to conduct an updated systematic review and meta-analysis of studies for the AASM (2019) guidelines on PAP for the treatment of OSA.^10,11, Meta-analyses of 184 studies indicated that PAP use leads to clinically significant reductions in disease severity (−23 events/h; 95% CI: −29 to −18 events/h), both subjective and objective sleepiness, daytime and nighttime blood pressure, and motor vehicle accidents, and improved sleep-related QOL. The overall quality of evidence for the outcome of sleepiness was high and the overall quality of evidence for sleep-related QOL and for blood pressure was moderate. The quality of evidence on the effect of PAP on cardiovascular events and mortality was low to moderate, with benefits reported in non-randomized studies but not in RCTs. The task force concluded that the potential benefits of CPAP outweighed the harms in symptomatic patients. PAP initiation in the home had equivalent effects on patient outcomes compared to in-laboratory titration, and there were no clinically significant differences in patient outcomes with the use of auto-adjusting or bilevel PAP compared with standard continuous PAP. PAP adherence was improved with the use of educational, behavioral, troubleshooting, and telemonitoring interventions.

The review by Balk et al (2011) for AHRQ concluded that the strength of evidence for CPAP for OSA was moderate based on the large magnitude of effect on the intermediate outcomes of the AHI, ESS score, and arousal index, even though there was weak evidence demonstrating an effect of CPAP on clinical outcomes.^3, In addition, reviewers 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. There was moderate evidence that CPAP is superior to mandibular advancement devices in improving sleep study measures.

Evidence-based guidelines from the AASM concluded that CPAP and APAP devices have similar outcomes in terms of AHI, oxygen saturation, and arousals.^12,13,14,15, As indicated in the AHRQ report, increased compliance with APAP devices has not been well-documented in clinical trials.^16,17,18, Thus, the issues associated with APAP are similar to those for bilevel PAP.

Yu et al (2017) conducted a meta-analysis assessing the association between PAP and cardiovascular events and death.^19, 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 (2016), 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.^20, 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 QOL and mood. Lisan et al (2019) reported 11-year follow-up of a cohort of 392 patients from the Sleep Heart Health Study who had obesity and severe OSA.^21, For the 81 patients who were prescribed PAP therapy, the propensity-matched hazard ratio for all-cause mortality was 0.58 (95% CI, 0.35 to 0.96) compared to matched patients who did not receive a prescription for PAP. Survival curves indicated that the difference in mortality appeared six to seven years after initiation of PAP. Exploratory analysis indicated that PAP might also be associated with a lower risk of cardiovascular mortality.

An improvement in postoperative outcomes with CPAP was suggested by Mutter et al (2014) in a matched comparison of patients with OSA who had been diagnosed prior to surgery (2640 surgeries), those not diagnosed until up to 5 years after surgery (1571 surgeries), and 16277 surgeries for patients without a diagnosis of OSA over 21 years of available data.^22, In multivariate analysis, the risk of respiratory complications was increased for both diagnosed and undiagnosed OSA patients compared with controls (odds ratio, 2.08; p<0.001). The risk of cardiovascular complications, primarily cardiac arrest and shock, was higher in OSA patients not diagnosed until after surgery (relative risk, 2.20; 95% CI, 1.16 to 4.17; p=0.02), but not in those diagnosed prior to surgery (relative risk, 0.75; 95% CI, 0.43 to 1.28; p=0.29); the difference between groups was statistically significant (p=0.009). There was a significant trend toward a higher risk with increasing OSA severity. Study limitations included the inability to determine whether CPAP was used perioperatively, and, because body mass index could not be determined, potential confounding from the close association between obesity and OSA.

Monitoring of APAP use by daily transmission to a web-based database and review by a research coordinator has been shown to improve compliance to positive airway pressure (PAP) therapy (191 min/d vs 105 min/d).^23, For the telemedicine arm of this randomized trial, as reported by Fox et al (2012), the research coordinator reviewed the transmitted data daily and contacted the patient if any of the following were present: mask leak greater than 40 L/min for more than 30% of the night, less than 4 hours of use for 2 consecutive nights, machine-measured AHI of more than 10 events per hour, and 90th percentile of pressure greater than 16 cm H₂O. Evaluation by their physician sleep specialist after three months of therapy showed a similar modest decrease in AHI for the two groups (1.6 for telemedicine vs 0.7 for controls).

Subsection Summary: Positive Airway Pressure Devices

PAP devices are accepted therapies for OSA. Studies have suggested that both CPAP and APAP are associated with improvements in sleep architecture. Although PAP has been associated with an improvement in intermediate outcomes in multiple studies, it has not been shown to improve hard cardiovascular outcomes. Interpretation of this finding is limited by the duration of follow-up (from 6 to 57 months) and mean CPAP use (<4 hours per night in the largest studies). Eleven-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 six to seven years.

Oral Appliances

A systematic review of the evidence on the treatment of OSA with oral appliance therapy was performed by Ramar et al (2015), as part of an update of practice guidelines by AASM and the American Academy of Dental Sleep Medicine.^24, Meta-analysis showed that oral appliances reduced the AHI, arousal index, and Oxygen Desaturation Index, and increased oxygen saturation. However, oral appliances had no significant effect on sleep architecture or sleep efficiency. The meta-analysis found CPAP to be more effective than oral appliances in reducing the AHI, arousal index, and Oxygen Desaturation Index, and in improving oxygen desaturation, supporting the use of CPAP as first-line therapy for treating OSA.

Johal et al (2017) reported on a randomized crossover trial of ready-made vs custom-made mandibular repositioning devices.^25, Twenty-five patients with mild-to-moderate OSA (mean AHI, 13.3 events per hour; range, 10.9-25 events per hour) were randomized to a 3-month trial of a ready-made or the custom-made device, with a 2-week washout between treatments. An overnight home sleep apnea test was performed at baseline and on the last night of the three-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 per hour) was obtained in 64% of patients during use of the custom-made device phase compared with a 24% response rate using the ready-made device (p<0.001). Treatment failure (<50% reduction in AHI) was more frequent with the ready-made device (36%) than with the custom device (4%), while an ESS score of at least 10 was more frequent during the ready-made phase (66%) than with the custom-made phase (33%). An improvement in the QOL was observed only during the custom-made device phase.

In the AHRQ report (2011) on the diagnosis and treatment of OSA in adults, the strength of the evidence that mandibular advancement devices improve sleep apnea signs and symptoms was rated moderate.^3,

Subsection Summary: Oral Appliances

Custom oral appliances, which may include mandibular repositioning or tongue-retaining devices, are an accepted therapy for mild-to-moderate OSA. A 2015 meta-analysis found efficacy of oral appliances for measures of OSA, but they were less effective than CPAP. The strength of evidence for mandibular repositioning devices was rated as moderate by AHRQ.

Novel Obstructive Sleep Apnea Treatments
Palate and Mandible Expansion

Singh et al (2016) reported on a series of 15 consecutive patients with severe sleep apnea who were treated with a DNA Appliance or mRNA Appliance.^26, All patients had failed to comply with CPAP. Pre- and post-treatment AHI was assessed in a home sleep apnea test 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 (2016) and Cress (2017) reported on a series of 19 patients who had mild-to-moderate OSA who were treated with a DNA or mRNA Appliance.^27, 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) with 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 apnea test 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.

PAP-NAP

Krakow et al (2008) reported on the use of a daytime abbreviated sleep study to acclimate patients with complex insomnia to PAP.^28, Patients had been referred by psychiatrists or primary care physicians for unspecified insomnia conditions, insomnia due to a mental disorder, or hypnotic dependence. Nearly all patients had anxiety, fear, and/or resistance regarding PAP therapy or the diagnosis of OSA. Thirty-nine patients who would not complete a titration protocol (full-night or split-night) were offered a daytime procedure (PAP-NAP) prior to night-time titration. The PAP-NAP protocol had five components: pretest instructions to maximize chances for daytime napping; introduction of PAP therapy addressing barriers to use; type 3 monitoring hookup (ten channels without electroencephalography leads); PAP therapy during one to two hours in bed in which the patient had the opportunity to fall asleep with the mask in place; and post-test follow-up. Thirty-five of 39 nap-tested patients subsequently scheduled and completed an overnight titration or split-night study with full PSG. The effect of the PAP-NAP intervention on compliance was compared with historical controls (n=38) who had insomnia, mental health conditions, and OSA with resistance to CPAP who completed titration. A prescription for PAP therapy was filled by 85% of the PAP-NAP group compared with 35% of controls. Regular use during a 30-day period was recorded by the PAP device in 67% of the intervention group and in 23% of controls. Adherence, defined as at least 5 days a week with an average of at least 4 hours a day, was 56% in the PAP-NAP group and 17% in controls.

Nasal Expiratory Positive Airway Pressure

Evidence on nasal expiratory positive airway pressure (EPAP) includes a moderately sized RCT and a systematic review of the Provent device.

Berry et al (2011) reported on an industry-sponsored multicenter, double-blind, randomized sham-controlled trial of EPAP.^29, Two hundred fifty patients with OSA and an AHI of 10 or more events per hour were randomized to nasal EPAP (n=127) or to a sham device (n=123) for 3 months. PSG was performed on 2 nights (device-on, device-off, in random order) at week 1 (92% follow-up) and after 3 months of treatment (78% follow-up). EPAP reduced median AHI from 13.8 to 5.0 events per hour (-52.7%) at week 1 and from 14.4 to 5.6 events per hour (-42.7%) at 3 months. This reduction in AHI in the treatment group was significantly greater (-7.3% at week 1, -10.1% at 3 months) than in the sham group. Over three months, the decrease in ESS score 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 ESS score 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 events per hour on the device-off PSG night. The oxygenation results (Oxygenation Desaturation Index and percent of total sleep time with oxygen saturation <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 reduction to less than 10 events per hour (if device-off AHI was ³10 events per hour), was greater in the EPAP group at 1 week (62% vs 27.2%) and at 3 months (50.7% vs 22.4%). Device-related adverse events were reported by 45% of patients in the EPAP group and by 34% of patients in the sham group, with 7% of patients in the EPAP group discontinuing due to adverse events. Overall, the validity of these results was limited by the high dropout rate, and uncertainty of the clinical significance of the results.

Kryger et al (2011), in an open-label extension of the randomized study by Berry et al (2011), evaluated 12-month safety and durability of the treatment response in patients who had an initially favorable response to EPAP.^30, Included were 41 (32%) of the 127 patients 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 a 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 with the device-off PSG. Of the 51 (40%) of 127 eligible patients, 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). After 12 months of treatment, the ESS score 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, most frequently difficulty exhaling, nasal discomfort, dry mouth, headache, and insomnia. This open-label extension study was limited by its inclusion only of responders and by the potential for a placebo effect on the ESS score. However, the data suggested that some patients might have responded 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 25% of patients. Additional controlled studies are needed to distinguish between these alternatives.

A systematic review by Riaz et al (2015) identified 18 studies (total n=920 patients) that had data on pre- and postnasal EPAP.^31, Study designs included ten conference papers and eight publications (case series, cohort studies, RCTs). For 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 score modestly improved from 9.9 to 7.4 (p<0.001). Data from the Berry et al (2011) RCT (described above) were not included in this meta-analysis because mean data were not reported. Response to the 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.

Kureshi et al (2014) reported on a small (n=14) double-blind, pilot, crossover RCT of EPAP in children to evaluate efficacy and compliance with this new treatment.^32, PSG with EPAP or a placebo device showed a significant mean improvement in Obstructive Apnea Index with EPAP (0.6 vs 4.2, p=0.01), but responses varied (three did not improve, two worsened). No other measures were statistically significant in this trial. For responders who used the devices at home for 30 days, adherence was 83% of nights. ESS scores improved from 11 to 7 (p=0.031) and Obstructive Sleep Apnea-18 questionnaire scores improved from 50 to 39 (p=0.028). Other outcome measures did not improve significantly.

Oral and OroNasal Pressure Therapy

Lai et al (2019) reported a study with 22 patients with OSA who were incomplete responders to an oral appliance (AHI > 5).^33, They were assessed with the oral appliance plus either an oral or an oronasal EPAP. Both the oral and oral/nasal devices were studied in the same night (split night PSG); the order of the EPAP devices was randomized. Power analysis indicated that 20 participants would be sufficient to detect a an AHI difference of 7 between conditions. Five patients (23%) had at least a 50% reduction in total AHI with the oral EPAP compared to the oral appliance alone, while 10 patients (45%) had a 50% reduction in AHI with the combined oral and nasal EPAP valves. Neither of these was statistically significant. Only 2 patients (9%) achieved an AHI of less than 5 with the oral EPAP device compared to 9 (41%) with the combined oral and nasal valves. However, sleep efficiency was disrupted with the oronasal EPAP valves.

Subsection Summary: Novel Obstructive Sleep Apnea Treatments

The evidence on palate and mandible expansion devices includes a few small cohort studies. 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 several prospective case series, an industry-sponsored RCT, and a systematic review that did not include the RCT. The main finding of the RCT was a decrease in AHI with a minor impact on oxygenation and ESS scores. An oral EPAP device did not have significant benefit when added to an oral appliance.

One comparative trial with historical controls used a PAP-NAP study of patients with complex insomnia who are resistant to CPAP titration or use. This single study of PAP-NAP does not provide sufficient evidence to form conclusions on the efficacy of this approach in improving compliance with CPAP. The patient population was highly selected and the behavioral intervention may be dependent on the specific clinicians providing treatment. In addition, historical controls were used, and they were not well-matched to the study population. For these reasons, the internal validity and generalizability of the results are uncertain.

Summary of Evidence
Diagnosis

For individuals who have suspected OSA who receive home sleep apnea testing with at least three recording channels, the evidence includes RCTs. Relevant outcomes are test accuracy, symptoms, functional outcomes, and resource utilization. RCTs have reported that home sleep apnea testing (with sensors for respiratory effort, airflow, and oxygen saturation, or alternatively with peripheral arterial tone, actigraphy and oxygen saturation) is noninferior to testing in the sleep lab for adults with a high pretest probability of OSA and absence of comorbid conditions as determined by clinical evaluation. A positive portable monitoring study with channels that include arterial oxygen saturation, airflow, and respiratory effort has a high positive predictive value for OSA and can be used as the basis for a CPAP trial to determine the efficacy of treatment. A negative portable monitoring study cannot be used to rule out OSA. Patients who have a negative result from portable monitoring or have a positive study but do not respond to CPAP should undergo further evaluation. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have suspected OSA who receive limited channel home sleep apnea testing, the evidence includes studies on diagnostic accuracy. Relevant outcomes are test accuracy, symptoms, functional outcomes, and resource utilization. The ability to detect clinically significant OSA without sensors for respiratory effort, airflow, and oxygen saturation, or alternatively without peripheral arterial tone, actigraphy and oxygen saturation, lacks support in the literature. The evidence is insufficient to determine the effects of the technology on health outcomes.

Treatment

For individuals who have OSA who receive PAP devices or 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. A diagnostic sleep study may be followed by a trial of APAP to evaluate the efficacy and adjust pressure. APAP or bilevel PAP may also be indicated if the patient is intolerant of CPAP. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have OSA who receive novel OSA treatments (eg, palate expansion, EPAP, oral pressure therapy), the evidence includes RCTs 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, and a systematic review that did not include the RCT. The main finding of the RCT was a decrease in the AHI, with minor impact on oxygenation, and a decrease in ESS score. One comparative trial with historical controls used a PAP-NAP to study patients with complex insomnia resistant to CPAP titration or use. Additional study is needed to evaluate with greater certainty the efficacy of this intervention. One small RCT with 22 patients found no benefit of an oral EPAP therapy device when added to an oral appliance. The evidence is insufficient to determine the effects of the technology on health outcomes.

SUPPLEMENTAL INFORMATION
Clinical Input From Physician Specialty Societies and Academic Medical Centers

While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted.

2014 Input

In response to requests, input was received from 7 physician specialty societies (8 reviewers) and 4 academic medical centers (6 reviewers) while this policy was under review in 2014. Input focused on the routine screening of patients scheduled to undergo bariatric surgery. There was a consensus that routine screening is considered medically necessary in this population due to the high prevalence of obstructive sleep apnea (OSA) in patients with a body mass index greater than 40 kg/m², combined with the increased rate of perioperative complications in patients with OSA. The input was mixed on whether the use of portable home sleep testing was appropriate for patients scheduled for bariatric surgery. Concerns were raised about the high prevalence of obesity hypoventilation syndrome in this population, which is a contraindication to home sleep testing. Other reviewers considered home sleep testing to be appropriate in patients scheduled for bariatric surgery, with the caveat that obesity hypoventilation syndrome should be ruled out prior to home sleep testing.

2010 Input

In response to requests, input was received from 1 physician specialty society and 6 academic medical centers (8 reviewers) while this policy was under review in 2010. Input focused on the sensors required for unattended home sleep studies and on diagnosis and treatment of OSA in children. In general, reviewers supported the requirement that home monitors measure four parameters, including respiratory effort, airflow, and oxygen saturation, and their use is restricted to adults. Some exceptions were noted for specific situations. The 2010 update included recommendations from reviewers on indications specific to pediatric patients.

2009 Input

In response to requests, input was received from 5 physician specialty societies (6 reviewers) and 3 academic medical centers while this policy was under review in 2009. Professional society guidelines and position statements were also reviewed. In general, input supported the use of polysomnography, portable sleep monitoring tests, multiple sleep latency tests, and continuous positive airway pressure for adults as described in the policy. The update included reviewers' recommendations for clarifications and modifications to the policy statements.

Practice Guidelines and Position Statements
American Academy of Sleep Medicine

In 2017, the American Academy of Sleep Medicine (AASM) published clinical practice guidelines on diagnostic testing for adult OSA.^34, AASM provided the following recommendations (Table 4).

Table 4. Recommendations on Diagnostic Testing for Adult OSA

Recommendation Statement	SOR	QOE	Benefits vs Harms
We recommend that clinical tools, questionnaires, and prediction algorithms not be used to diagnose OSA in adults, in the absence of PSG or HSAT	Strong	Moderate	High certainty that harms outweigh benefits
We recommend that PSG, or HSAT with a technically adequate device, be used for the diagnosis of OSA in uncomplicated adult patients presenting with signs and symptoms that indicate an increased risk of moderate to severe OSA.	Strong	Moderate	High certainty that benefits outweigh harms
We recommend that if a single HSAT is negative, inconclusive, or technically inadequate, PSG be performed for the diagnosis of OSA.	Strong	Low	High certainty that benefits outweigh harms
We recommend that PSG, rather than home sleep testing, be used for patients with significant cardiorespiratory disorder, potential respiratory muscle weakness, awake or suspected sleep hypoventilation, chronic opioid medication use, history of stoke or severe insomnia.	Strong	Very low	High certainty that benefits outweigh harms
We suggest that, if clinically appropriate, a split-night diagnostic protocol, rather than a full-night diagnostic protocol for PSG be used for the diagnosis of OSA	Weak	Low	Low certainty that benefits outweigh harms
We suggest that when the initial PSG is negative, and there is still clinical suspicion for OSA, a second PSG be considered for the diagnosis of OSA.	Weak	Very low	Low certainty that benefits outweigh harms

HSAT: home sleep apnea testing; OSA: obstructive sleep apnea; PSG: polysomnography; QOE: quality of evidence; SOR: strength of recommendation.

The AASM considers a technically adequate home sleep apnea test (HSAT) device to incorporate "a minimum of the following sensors: nasal pressure, chest and abdominal respiratory inductance plethysmography, and oximetry; or else PAT [peripheral arterial tone] with oximetry and actigraphy." The guidelines refer to the AASM Manual for the Scoring of Sleep and Associated Events for additional information regarding HSAT sensor requirements.

The AASM also issued guidelines in 2009 on the evaluation, management, and long-term care of adults with OSA.^35, 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).

Diagnosis

The AASM recommended that patients who are obese, retrognathic, hypertensive, or who complain of snoring or daytime sleepiness should be assessed for presence or absence as well as the severity of OSA using the following methods (standard):

• Sleep history assessment includes witnessed apneas, gasping/choking at night, excessive sleepiness, total sleep amount, nocturia, morning headaches, and decreased concentration and memory.
• Physical assessment includes evaluation of respiratory, cardiovascular, and neurologic systems and signs of upper respiratory narrowing.
• Objective testing, under an AASM-accredited program, and attended by trained technical personnel. The diagnosis of OSA is confirmed if the number of obstructive events (apneas, hypopneas plus respiratory event related to arousals) is greater than 15 events/hour or greater than 5 events/hour in a patient reporting any of the following: unintentional sleep episodes during wakefulness; daytime sleepiness, unrefreshing sleep; fatigue; insomnia; waking up breath holding, gasping, or choking; or a bed partner describing loud snoring, breathing interruptions, or both.
  • In laboratory polysomnography (standard) records electroencephalogram, electrooculogram, chin electromyogram, airflow, oxygen saturation, respiratory effort, and heart rate.
  • Home testing with portable monitors should at minimum, record airflow, respiratory effort, and blood oxygenation.

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

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

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.

• Use of PAP to treat OSA in adults with impaired sleep-related quality of life.
• Use of PAP to treat OSA in adults with comorbid hypertension.
• Use CPAP or APAP over BPAP 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 (2011) published evidence-based guidelines on respiratory indications for PSG in children.^36, "Standard" recommendations were made for the following: PSG in children should be performed and interpreted in accordance with the AASM Manual for the Scoring of Sleep and Associated Events; PSG is indicated when the clinical assessment suggested the diagnosis of OSA in children; children with mild OSA preoperatively should have clinical evaluation following adenotonsillectomy to assess for residual symptoms. If there are residual symptoms of OSA, PSG should be performed; PSG was indicated following adenotonsillectomy to assess for residual OSA in children with preoperative evidence for moderate-to-severe OSA, obesity, craniofacial anomalies that obstruct the upper airway, and neurologic disorders; PSG was indicated for positive airway pressure titration in children with OSA.

The AASM (2017) published a position statement on the clinical use of a home sleep apnea test.^37,The AASM indicated that a home sleep apnea test should be ordered by a physician after "a face-to-face examination" to diagnose OSA or evaluate treatment efficacy and should not be used for general screening of asymptomatic populations. The AASM supported the review of raw data and interpretation by aphysician board-certified in sleep medicine, stating that automatically scored data "could lead to sub-optimal care that jeopardizes patient health and safety".

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.^38,39, AAP recommended that all children or adolescents be screened for snoring, and PSG is performed in children or adolescents with snoring and symptoms or signs of OSA as listed in the guideline. If PSG is not available, an alternative diagnostic test or referral to a specialist may be considered (option). The estimated prevalence rates of OSA in children or adolescents ranged from 1.2% to 5.7%. 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 College of Physicians

The guidelines on the diagnosis of OSA in adults from the American College of Physicians (ACP; 2014) recommended that clinicians target their assessment of OSA to individuals with unexplained daytime sleepiness.^40,The ACP recommended PSG for diagnostic testing in patients suspected of OSA, and portable sleep monitors in patients without serious comorbidities as an alternative to PSG when PSG is not available for diagnostic testing (weak recommendation, moderate-quality evidence). Inconclusive areas of evidence included preoperative screening for OSA, phased testing for the diagnosis of OSA, and the utility of portable monitors for diagnosis OSA in patients with comorbid conditions.

The ACP (2013) guidelines on the management of OSA in adults recommended that all overweight and obese patients diagnosed with OSA be encouraged to lose weight (strong recommendation, low-quality evidence).^41,The ACP recommended CPAP as initial therapy for patients diagnosed with OSA (strong recommendation; moderate-quality evidence), and mandibular advancement devices as an alternative therapy to CPAP for patients diagnosed with OSA who prefer mandibular advancement devices or for those with adverse events associated with CPAP (weak recommendation, low-quality evidence).

American Academy of Craniofacial Pain

The American Academy of Craniofacial Pain (2013) published a position paper.^42, It indicated that oral appliance therapy was recognized as an effective therapy for many with primary snoring and mild-to-moderate OSA, as well as those with more severe OSA who cannot tolerate PAP therapies, but that oral appliance therapy has the potential to cause adverse events, including temporomandibular joint pain and dysfunction. The Academy recommended that dentists engaged in, or who want to engage in, the assessment and management of patients with snoring and OSA using mandibular advancement OA be properly trained and experienced in the assessment, diagnosis, and management of temporomandibular joint and craniofacial pain.

American Society of Metabolic and Bariatric Surgery

The American Society of Metabolic and Bariatric Surgery (2012) published guidelines on the perioperative management of OSA (reviewed in October 2015).^43, The guidelines noted that while some reports in the literature have recommended routine screening for OSA prior to bariatric surgery, other reports have suggested 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 PSG, but do not make this a routine preoperative test prior to bariatric surgery. The Society provided, based on the evidence in the literature to date, the following guidelines on OSA in the bariatric surgery patient and its perioperative management:

1. "OSA is highly prevalent in the bariatric patient population….

4. [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.

7. 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 [intensive care unit] setting.

8. No clear guidelines exist upon which to base recommendations for retesting for OSA following bariatric surgery…."

The American Academy of Otolaryngology-Head and Neck Surgery (2011) published guidelines on PSG for sleep-disordered breathing prior to tonsillectomy in children, which included the following^44,:

1. "Before determining the need for tonsillectomy, the clinician should refer children with SDB [sleep-disordered breathing] for PSG if they exhibit the following: obesity, Down syndrome, craniofacial abnormalities, neuromuscular disorders, sickle cell disease, or mucopolysaccharidoses.
2. The clinician should advocate for PSG prior to tonsillectomy for SDB in children without any of the comorbidities [listed above] for whom the need for surgery is uncertain or when there is discordance between tonsillar size of physical examination and the reported severity of SDB
3. Clinicians should communicate PSG results to the anesthesiologist prior to the induction of anesthesia for tonsillectomy in a child with SDB.
4. Clinicians should admit children with OSA documented on PSG for inpatient, overnight monitoring after tonsillectomy if they are younger than age 3 years or have severe OSA (apnea-hypopnea index of 10 or more obstructive events/hour, oxygen saturation nadir less than 80%, or both).
5. In children for whom PSG is indicated to assess SDB prior to tonsillectomy, clinicians should obtain laboratory-based PSG, when available."

The American Thoracic Society (2016) published a statement on the long-term effects and treatment of mild OSA in adults.^45, The Society's systematic review concluded:

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

The U.S. Preventive Services Task Force (2017) reported on the evidence for screening for OSA in adults and concluded that "the current evidence is insufficient to assess the balance and harms of screening for obstructive sleep apnea (OSA) in asymptomatic adults. Evidence on screening tools to accurately detect persons in asymptomatic populations who should receive further testing and treatment of subsequently diagnosed OSA to improve health outcomes is lacking, and the balance of benefits and harms cannot be determined."^46,47,

Ongoing and Unpublished Clinical Trials

A search of ClinicalTrials.gov in May 2020 identified over 300 studies on diagnosis and medical management of OSA.]
________________________________________________________________________________________

Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

___________________________________________________________________________________________________________________________

Index:
Diagnosis and Medical Management of Obstructive Sleep Apnea Syndrome
Diagnosis of Obstructive Sleep Apnea Syndrome
Home Sleep Testing
Obstructive Sleep Apnea, Diagnosis of
OSA, Diagnosis of
Polysomnography (PSG)
Portable Monitoring Devices for Home Sleep Testing
PSG (Polysomnography)
Sleep Studies
Sleep Testing Procedures
Medical Management of Obstructive Sleep Apnea Syndrome
Autoadjusting CPAP Device
Automatic CPAP Device
Autotitrating CPAP Device
AutoSet PAP Device
Bi-Level Positive Airway Pressure Device
Bi-PAP
BPAP
Continuous Positive Airway Pressure Device
CPAP
EPAP (Expiratory Positive Airway Pressure)
Expiratory Positive Airway Pressure (EPAP)
Home Positive Airway Pressure (PAP) Titration
Morphee Plus Alpha PAP Device
Nasal EPAP
Nasal Expiratory Positive Airway Pressure
Obstructive Sleep Apnea Syndrome, Medical Management
Oral Devices in the Treatment of OSAS
OSAS, Medical Management
PROVENT
Sleep Apnea Syndrome, Medical Management
Titration for Obstructive Sleep Apnea Syndrome
UARS, Medical Management
Unattended Home Positive Airway Pressure (PAP) Titration
Upper Airway Resistance Syndrome, Medical Management
Variable-Pressure PAP Device
Virtuoso PAP Device
Winx Sleep Therapy System
Attune Sleep Apnea System
ApniCure
PAP-NAP
BOAT (Biomimetic Oral Appliance Therapy)
Biomimetic Oral Appliance Therapy (BOAT)
Daytime-Nighttime Appliance® system (DNA applaince®)
mandibular Repositioning-Nighttime Appliance® (mRNA applaince®)
DNA applaince® (Daytime-Nighttime Appliance® system)
mRNA applaince® (mandibular Repositioning-Nighttime Appliance®)
Palate and Mandible Expansion Devices
Mandible and Palate Expansion Devices
Positional Therapy for Obstructive Sleep Apnea

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48. Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) for Continuous Positive Airway Pressure (CPAP) Therapy For Obstructive Sleep Apnea (OSA) (240.4). 2008; https://www.cms.gov/medicare-coverage-database/details/ncd- details.aspx?MCDId=16&ExpandComments=n&McdName=Thomson+Micromedex+DrugDex+%C2%AE+Compe ndium+Revision+Request+-+CAG- 00391&mcdtypename=Compendia&MCDIndexType=6&NCDId=226&ncdver=3&bc=BAAIAAAAAQAAAA%3D%3 D&. Accessed May 14, 2020.

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50. Centers for Medicare & Medicaid Services (CMS). CMS Manual System: Pub 100-03 Medicare National Coverage Determinations. Decision memo for sleep testing for obstructive sleep apnea (OSA) (CAG-00405N). 2009; https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=227&ver=11&NcaName=Sleep+Testing+for+Obstructive+Sleep+Apnea+(OSA)&CoverageSelection=National&KeyWord=sleep+testing&KeyWordLookUp=Title&KeyWordSearchType=And&bc=gAAAACAAEAAA& Accessed May 15, 2020.

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