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Diagnosis of Obstructive Sleep Apnea Syndrome

Number 2.01.503

Effective Date March 10, 2014

Revision Date(s) 03/10/14; 11/11/13; 10/14/13; 08/12/13; 11/27/12; 11/13/12; 10/09/12; 04/10/12; 01/10/12; 10/11/11; 09/01/11; 01/11/11; 05/11/10; 03/09/10; 02/09/10; 05/12/09; 10/14/08; 03/11/08; 04/10/07; 12/12/06; 05/09/06; 05/10/05; 12/14/04; 07/13/04; 06/08/04; 06/17/03; 02/11/03; 05/14/02; 02/12/02; 09/11/01; 05/08/01; 11/02/99; 06/01/99; 04/14/98

Replaces 2.01.18

Policy

Diagnostic Testing

Home/Unattended Sleep Study

Unattended (unsupervised) home sleep studies may be considered medically necessary for adult patients who have symptoms suggestive of obstructive sleep apnea (OSA), when ALL of the following criteria are met:

  • Absence of health conditions that decrease accuracy of the study including, but not limited to:
  • Congestive heart failure
  • Hypo-ventilation syndrome
  • Moderate to severe pulmonary disease
  • Neuromuscular disease
  • Absence of suspicion of other sleep disorders, including, but not limited to:
  • Central sleep apnea
  • Narcolepsy
  • Parasomnias
  • Use of a home sleep study device with a minimum of 4 recording channels (including oxygen saturation, respiratory movement, airflow, and EKG or heart rate) is limited to 1 night per testing episode, if testing is successful. A second night of testing is allowed if technical difficulties occurred.

Unattended or facility based testing of the asymptomatic general population is considered not medically necessary.

Unattended home sleep studies are considered investigational in children (younger than 18 years of age).

Note: Interpretation of test results of unattended home sleep studies should be validated only by sleep specialists (suggested board certification in sleep medicine or board eligible).

Facility/Laboratory Sleep Study

Facility/laboratory polysomnogram (PSG) may be considered medically necessary for patients with symptoms suggestive of OSA when:

  • A previous home study was technically inadequate; or
  • A previous home study failed to establish the diagnosis of OSA in a patient with a high pretest probability of OSA; or
  • A home study is contraindicated due to co-morbid health conditions which decrease the accuracy of the study, including, but not limited to, moderate to severe pulmonary disease, neuromuscular disease, congestive heart failure, or hypo-ventilation syndrome.

Facility/laboratory PSG may be considered medically necessary when testing is being done for patients to rule out other sleep disorders such as central sleep apnea, parasomnias, or narcolepsy. When there is a concern that the primary diagnosis is PLMD (periodic limb disorder movement), facility based testing may be considered if obstructive sleep apnea has been ruled out. ( PLMD is a very rare diagnosis, and has not been shown to impact morbidity and mortality)

A split-night facility/laboratory PSG study may be considered medically necessary when patients do not meet criteria for unattended home sleep studies as described above.

Facility/laboratory PSG is considered not medically necessary when adult patients meet criteria for unattended home sleep studies.

PAP-NAP

The daytime PAP-NAP desensitization procedure is considered investigational to help patients with insomnia/panic attacks/claustrophobia overcome anxiety about the mask and pressure sensations of the PAP device.

Actigraphy

Actigraphy is addressed in a separate policy. (See Related Policies)

Titration

Home/Unattended

Unattended home positive airway pressure (PAP) titration may be considered medically necessary for adult patients with moderate to severe OSA without serious co morbidities (moderate to severe pulmonary disease, neuromuscular disease, congestive heart failure, or hypo-ventilation syndrome) or other sleep disorders (including central sleep apnea, parasomnias, or narcolepsy).

Facility/Laboratory

Facility/laboratory based PAP titration may be considered medically necessary for adult patients when home/unattended PAP titration fails or is contraindicated due to serious co morbid conditions or other sleep disorders.

Facility/laboratory based PAP titration is considered not medically necessary when adult patients meet criteria for home/unattended PAP titration.

Repeat Testing

Repeat testing in the above appropriate settings may be considered medically necessary for any of the following reasons:

  • To assess efficacy of surgery or oral appliances/devices.
  • A non-diagnostic home study within the past 3 months (e.g., technical complications or negative test with a high pretest probability of OSA).
  • Failure of resolution of symptoms or recurrence of symptoms during treatment.
  • To re-evaluate the diagnosis of obstructive sleep apnea and need for continued CPAP, (e.g. if there is a significant change in weight or change in symptoms suggesting that CPAP should be re-titrated or possibly discontinued).

Intraoral Appliances

Intraoral appliances (tongue-retaining devices or mandibular advancing/positioning devices) may be considered medically necessary in adult patients with clinically significant OSA defined by an apnea/hypopnea index (AHI) of at least 15 per hour or an AHI of at least 5 events per hour in a patient with excessive daytime sleepiness or unexplained hypertension.

  • For intra oral appliances such as oral airway dilators, oral orthotics, oral airway devices or mandibular advancement devices –- the following criteria must be met:
  • A physician with additional training in sleep disorders must evaluate the patient and order this appliance; AND
  • The patient has failed continuous positive airway pressure (CPAP); OR
  • The patient prefers to use the oral appliance.

Nasal Expiratory Positive Airway Pressure (EPAP) Device

EPAP devices are considered investigational to treat OSA. An example of this is The Provent® Professional Sleep Apnea Therapy Device.

Oral Pressure Therapy (OPT) Device

OPT devices are considered investigational to treat OSA. An example of this is The Winx™ Sleep Therapy System.

Related Policies

1.01.524

Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea

2.01.73

Actigraphy

5.01.605

Medical Necessity Criteria for Pharmacy Edits

7.01.101

Surgical Treatment of Snoring and Obstructive Sleep Apnea Syndrome

Policy Guidelines

Risk Assessment for Suspected Obstructive Sleep Apnea (OSA)

Diagnostic criteria for obstructive sleep apnea (OSA) are based on clinical signs and symptoms determined during a comprehensive sleep evaluation, which includes a sleep oriented history and physical examination, and findings identified by sleep testing.

Patients with a high pretest probability for OSA include those with the following conditions:

  • Atrial fibrillation
  • Congestive heart failure
  • Nocturnal dysrhythmias
  • Obesity (BMI greater than 35)
  • Patients being evaluated for bariatric surgery
  • Pulmonary hypertension
  • Resistant hypertension (refractory to treatment)
  • Stroke
  • Type 2 diabetes

A routine OSA screen should include:

  • A history of snoring and daytime sleepiness
  • An evaluation for the presence of obesity
  • Hypertension
  • Retrognathia

Positive findings from the OSA health evaluation screen should lead to a more comprehensive sleep history and physical examination which includes:

  • Decreased concentration and memory
  • Evaluation for snoring
  • Excessive sleepiness not explained by other factors, including assessment of sleepiness severity by the Epworth Sleepiness Scale
  • Gasping/choking episodes
  • Morning headaches
  • Nocturia
  • Sleep fragmentation/sleep maintenance insomnia
  • Total sleep amount
  • Witnessed apnea events

Technology for Home Studies

Technology used in Portable Monitoring (Unattended sleep study) may include:

  • Cardiac monitoring, including but not limited to:
  • Arterial tonometry
  • Heart rate or heart rate variability
  • Measures of sleep wake activity, including but not limited to:
  • Actigraphy
  • Body position
  • Electroencephalography (EEG)
  • Oximetry
  • Respiratory monitoring, including but not limited to:
  • Airflow
  • Effort
  • End-tidal carbon dioxide
  • Esophageal pressure
  • Snoring

Diagnostic Criteria for OSA

Diagnostic criteria for OSA are based on clinical signs and symptoms determined during a comprehensive sleep evaluation, which includes a sleep oriented history and physical examination, and findings identified by sleep testing.

Adults

The diagnosis of OSA in adults is confirmed by a sleep study result showing:

  • The presence of at least 5 obstructive respiratory events (apneas, hypopneas + respiratory event related arousals) per hour of sleep, and
  • Sleep related symptoms which includes any of the following: unintentional sleep episodes during wakefulness; daytime sleepiness; unrefreshing sleep; fatigue, insomnia; waking up breath holding, gasping, or choking; or the bed partner describing loud snoring, breathing interruptions, or both during the patient’s sleep, or
  • The presence of 15 or more obstructive respiratory events (apneas, hypopneas + respiratory event related arousals) per hour of sleep in the absence of sleep related symptoms.

OSA severity is defined as:

  • Mild for respiratory disturbance index (RDI) greater than 5/hr. and less than 15/hr.
  • Moderate for RDI of 15/hr. or greater and 30/hr. or less
  • Severe for RDI of greater than 30/hr.

Children

The diagnosis of obstructive sleep apnea in children is established by a sleep study result showing an apneic/hypopneic index (AHI) greater than 1.5. (An AHI of 15 is considered severe in children.)

Diagnostic Criteria for Other Sleep Disorders:

Concern for the presence of other sleep disorders may be an indication for a facility based test. The physician assessment must document history and exam that supports these diagnoses, and also indicate that a diagnosis of obstructive sleep apnea is unlikely. When there is concern that symptoms may be due to several underlying disorders including sleep apnea, it is important to remember that sleep apnea is common, has known health sequellae, and can be diagnosed with a home based study. The following are indications and criteria where inpatient testing may be an appropriate first step:

  • Central Sleep Apnea: symptoms are similar to those found in obstructive sleep apnea, however snoring may not be reported. Other patient characteristics suggestive of this as primary disorder include age over 65 years, male gender, and other comorbid conditions such as heart failure, stroke, long –term opioid treatment (methadone therapy), acromegaly or renal failure.
  • Narcolepsy: daytime sleepiness, with cataplexy, hypnagogic hallucinations and sleep paralysis – however only one third of patients have all three components. Many individuals with narcolepsy will also have other sleep disorders, therefore an attended sleep study as well as MSLT will be needed
  • Parasomnias: Parasomnias are undesirable physical events (movements, behaviors) or experiences (emotions, perceptions, dreams) that occur during entry into sleep, within sleep, or during arousals from sleep. The behaviors can be complex and appear purposeful; however, the patient has no conscious awareness of the behavior. The most common ones are confusional arousals, sleep walking and night terrors.
  • Periodic Limb Movement Disorder (PLMD): When this diagnosis is the primary reason for a facility test the plan requires that sleep apnea testing using a home test be conducted initially. Periodic limb movement symptoms are very common in the general population, and should only be treated if they disrupt sleep. Periodic limb movement disorder (PLMD) is a rare sleep disorder characterized by rhythmic movements of the limbs during sleep. The movements typically involve the legs, but upper extremity movements may also occur. Movements occur periodically throughout the night and can fluctuate in severity from one night to the next. Is often associated with Parkinson’s disease, the use of certain medications including antidepressants.

Hypoventilation:

  • An increase in arterial CO2 to a value of >55 mmHg for at least 10 minutes, OR
  • A >10mmHg rise in PaCO2 during sleep to a value >50 mmHg for at least 10 minutes.

Coding

There is not full correspondence between the CPT codes and the most current categorization scheme for the different types of studies. In the current practice parameters of the American Academy of Sleep Medicine (2), there are 4 types of monitoring procedures:

  • Type 1, standard attended in-lab comprehensive polysomnography;
  • Type 2, comprehensive portable polysomnography;
  • Type 3, modified portable sleep apnea testing (also referred to as cardiorespiratory sleep studies), consisting of 4 or more channels of monitoring (e.g., Edentrace, Vitalog, SNAP and NovaSom QSG)
  • Type 4, continuous single or dual bioparameters, consisting of 1 or 2 channels, typically oxygen saturation, or airflow.

CPT

Attended Sleep Studies

95782

Polysomnography; younger than 6 years, sleep staging with 4 or more additional parameters of sleep, attended by a technologist

95783

Polysomnography; younger than 6 years, sleep staging with 4 or more additional parameters of sleep, with initiation of continuous positive airway pressure therapy or bi-level ventilation, attended by a technologist

95807

Sleep study, simultaneous recording of ventilation, respiratory effort, electrocardiogram (ECG) or heart rate, and oxygen saturation, attended by a technologist

95808

Polysomnography; any age, sleep staging with 1-3 additional parameters of sleep, attended by a technologist

95810

Polysomnography; sleep staging with 4 or more additional parameters of sleep, attended by a technologist

95811

Polysomnography; age 6 years or older, sleep staging with 4 or more additional parameters of sleep, with initiation of continuous positive airway pressure therapy or bilevel ventilation, attended by a technologist

Unattended Sleep Studies

95800

Sleep study, unattended, simultaneous recording; heart rate, oxygen saturation, respiratory analysis (e.g., by airflow or peripheral arterial tone), and sleep time

95801

Sleep study, unattended, simultaneous recording; minimum of heart rate, oxygen saturation, and respiratory analysis (e.g., by airflow or peripheral arterial tone)

95806

Sleep study, simultaneous recording of ventilation, respiratory effort, ECG or heart rate, and oxygen saturation, unattended by a technologist

HCPCS

G0398

Home sleep study test (HST) with type II portable monitor, unattended; minimum of 7 channels EEG, EMG, ECG/heart rate, airflow, respiratory effort and oxygen saturation

G0399

Home sleep test (HST) with type III portable monitor, unattended; minimum of 4 channels; 2 respiratory movement/airflow, 1 ECG/heart rate and 1 oxygen saturation

G0400

Home sleep test (HST) with type IV portable monitor, unattended; minimum of 3 channels

Home or portable monitoring implies unattended sleep studies that are typically conducted in the patient’s home.

There is no CPT code for “unattended” polysomnography.

Cardiorespiratory sleep studies without EEG may be called polygraphs, and can either be attended or unattended by a technologist. The 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.

Description

Obstructive sleep apnea syndrome (OSA) is characterized by repetitive episodes of upper airway obstruction due to the collapse and obstruction of the upper airway during sleep. OSA is typically diagnosed by overnight monitoring with polysomnography (PSG). Medical management of OSA may include weight loss, avoidance of stimulants, body position adjustment, oral appliances, and use of continuous positive airway pressure (CPAP) during sleep.

Background

In patients with OSA, the normal pharyngeal narrowing is accentuated by anatomic factors such as a short, wide “bull” neck, elongated palate and uvula, and large tonsillar pillars with redundant lateral pharyngeal wall mucosa. Furthermore, OSA may be associated with a wide variety of craniofacial abnormalities, including micrognathia, retrognathia, or maxillary hypoplasia. In addition, OSA is associated with obesity. Obstruction anywhere along the upper airway can result in apnea. Therefore, OSA is associated with a heterogeneous group of anatomic variants producing obstruction.

The hallmark symptom of OSA is excessive daytime sleepiness; the hallmark clinical symptom 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. Sleep fragmentation associated with repeated arousal during sleep can lead to impairment of daytime activity. For example, adult patients with OSA-associated daytime somnolence are thought to be at higher risk for accidents involving motorized vehicles, i.e., cars, trucks, or heavy equipment. OSA in children may result in neurocognitive impairment and behavioral problems. In addition, OSA affects the cardiovascular and pulmonary systems. For example, apnea leads to periods of hypoxemia, alveolar hypoventilation, hypercapnia, and acidosis. This in turn can cause systemic hypertension, cardiac arrhythmias, 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 accidents related to daytime sleepiness.

In adults, OSA is often suspected on the basis of the clinical history and physical appearance: i.e., an overweight individual with a wide neck. The most common symptoms are snoring, excessive daytime sleepiness, and hypertension. Excessive daytime sleepiness may be subjective and may be assessed by questionnaires such as the Epworth Sleepiness Scale (ESS), a short self-administered questionnaire that asks patients, “How likely are you to doze off or fall asleep in the following 8 situations, in contrast to feeling just tired?” (See appendix for ESS)

  1. Sitting and reading
  2. Watching TV
  3. Sitting inactive in a public place (i.e., theater)
  4. As a passenger in a car for one hour without a break
  5. Laying down to rest in the afternoon when circumstances permit
  6. Sitting and talking to someone
  7. Sitting quietly after a lunch without alcohol
  8. In a car, while stopped for a few minutes in traffic

The patient rates his or her likelihood of falling asleep in these 8 different situations as: 0 (would never doze), 1 (slight chance of dozing), 2 (moderate chance of dozing), or 3 (high chance of dozing). The maximum score is 24 and a score of 10 or below is considered normal.

Daytime sleepiness may also be measured objectively with tests such as the multiple sleep latency test or the maintenance of wakefulness test. The multiple sleep latency test measures how quickly the patient falls asleep when instructed to relax in a quiet and dimly lit room, and the maintenance of wakefulness test measures sleep latency when the patient is instructed to attempt to remain awake in an unstimulating environment. These tests are not considered necessary to evaluate sleep apnea, but the multiple sleep latency test (MSLT) may be used when symptoms, including excessive daytime sleepiness, suggest narcolepsy.

Daytime sleepiness is uncommon in young children with OSA. Symptoms in children may include habitual snoring (often with intermittent pauses, snorts, or gasps), disturbed sleep, and daytime neurobehavioral problems. OSA can occur in children of all ages, from neonates to adolescents. Risk factors include adenotonsillar hypertrophy, obesity, craniofacial anomalies, and neuromuscular disorders.

In otherwise healthy children, OSA is usually associated with adenotonsillar hypertrophy and/or obesity. The first-line treatment for pediatric OSA is adenotonsillectomy.

The final diagnosis of OSA rests on a combination of clinical evaluation and objective criteria to identify those levels of obstruction that are clinically significant. The gold standard diagnostic test for sleep disorders is considered to be a polysomnogram performed in a sleep laboratory. (1) A standard polysomnogram, supervised by a sleep lab technician, typically includes:

  • EEG [electroencephalography] (to stage sleep, detect arousal)
  • Electro-oculogram (to detect arousal, REM sleep)
  • Submental electromyogram

Additional parameters of sleep that may be measured during a polysomnogram include:

  • Continuous blood pressure monitoring
  • Electrocardiography
  • Gastroesophageal reflux (GERD)
  • Oxygen desaturation
  • Penile tumescence
  • Respiratory airflow and effort (to detect apnea)
  • Sleep position
  • Snoring

The first three elements for a standard polysomnogram listed above, EEG, submental electromyogram, and electro-oculogram are required for sleep staging. By definition, a polysomnogram always includes sleep staging, while a cardiorespiratory "sleep study" does not. The actual components of the study will be dictated by the clinical situation. Supervision of the test may be considered important to ensure that the monitors are attached appropriately to the patient and do not become dislodged during the night. In addition, an attendant can identify severe OSA so that continuous airway pressure can be instituted in the second part of the night, and the most effective level of continuous positive airway pressure (continuous PAP or CPAP) therapy can be determined. These studies are known as "split-night" studies, in which the diagnosis of OSA is established during the first portion of the night and CPAP titration is conducted during the second portion of the night. If successful, this strategy can eliminate the need for an additional polysomnogram for CPAP titration.

Typically, the evaluation of OSA includes sleep staging to assess arousals from sleep and determination of the frequency of apneas and hypopneas from channels measuring oxygen desaturation, respiratory airflow, and respiratory effort. In adults, apnea is defined as a drop in the peak signal excursion (airflow) by 90% or more of pre-event baseline using an oronasal thermal sensor (diagnostic study), PAP device flow (titration study), or an alternative apnea sensor, for at least 10 seconds. (2) Hypopnea in adults is scored when the peak signal excursions drop by at least 30% of pre-event baseline for at least 10 seconds in association with either at least 3% arterial oxygen desaturation or an arousal. The apnea/hypopnea index (AHI) may also be referred to as the respiratory disturbance index (RDI). The AHI is defined as the total number of events per hour of sleep. RDI may be defined as the number of apneas, hypopneas, and RERAs per hour of sleep. When sleep onset and offset are unknown (e.g., in home sleep studies), the RDI may be calculated based on the number of apneas and hypopneas per hour of recording time. A diagnosis of OSA syndrome is accepted when an adult patient has an AHI greater than 5 and symptoms of excessive daytime sleepiness or unexplained hypertension. An AHI equal to or greater than 15 is typically considered moderate OSA, while an AHI greater than 30 is considered severe OSA.

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. An apnea is scored when peak signal excursions (airflow) drop by at least 90% of pre-event baseline using an oronasal thermal sensor (diagnostic study), PAP device flow (titration study), or an alternative sensor; and the event meets duration and respiratory effort criteria for an obstructive, mixed, or central apnea. (2) A hypopnea is scored in children when the peak signal excursions drop is at least 30% of pre-event baseline using nasal pressure (diagnostic study) PAP device flow (titration study), or an alternative sensor, for at least the duration of 2 breaths in association with either a 3% or greater oxygen desaturation or an arousal. In pediatric patients, an AHI greater than 1.5 is considered abnormal, and an AHI of 15 or greater is considered severe. Although there is poor correlation between AHI and OSA symptoms, an increase in mortality is associated with an AHI of greater than 15 in adults. Mortality has not been shown to be increased in adult patients with an AHI between 5 (considered normal) and 15. Sources of measurement error with polysomnography include data loss, artifact, event recognition errors, measurement errors, use of different types of leads, and night-to-night variability.

It is estimated that about 7% of adults have moderate or severe OSA, and 20% have at least mild OSA and that the referral population of OSA patients represents a small proportion of patients who have clinically significant and treatable disease. (3) In light of the limited capacity of sleep laboratories, a variety of devices have been developed specifically to evaluate OSA at home. These 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 the majority of portable monitors do not record EEG. It has been proposed that unattended studies with portable monitoring devices may improve the diagnosis and treatment of patients with OSA, although the limited number of channels in comparison with full polysomnographic recording may decrease the capability for differential diagnosis or detection of comorbid conditions.

Medical management of OSA includes weight loss, oral appliances, and various types of positive airway pressure (PAP) therapy (i.e., fixed/continuous positive airway pressure [CPAP], bilevel positive airway pressure [BiPAP], or auto-adjusting CPAP [APAP]). 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. BiPAP is similar to CPAP, but these devices are capable of generating 2 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 BiPAP and APAP are more comfortable for the patient, and thus might improve patient compliance or acceptance. Medical Management of OSA using DME (CPAP, BiPAP, APAP) is covered in a separate policy. (See Related Policies)

Nasal Expiratory Positive Airway Pressure (EPAP) Device

In 2010, a nasal expiratory resistance valve (PROVENT®, Ventus Medical, Inc.) received marketing clearance through the FDA‘s 510(k) process, for the treatment of OSA. PROVENT® is a single use device containing valves that are inserted into the nostrils and secured with adhesive. The insert’s action increases the expiratory pressure by creating resistance, which results in airway positive back pressure during expiration. The increased air pressure helps to keep the airway open.

Oral Pressure Therapy (OPT) Device

The Winx™ Sleep Therapy System, (Apnicure, Inc) which uses oral pressure therapy (OPT) for the treatment of OSA, received marketing clearance in 2012. OPT provides light negative pressure to the oral cavity by using a flexible mouthpiece connected to a bedside console that delivers negative pressure. This device is proposed to increase the size of the retropalatal airway by pulling the soft palate forward and stabilizing the base of the tongue.

Intraoral Appliances

Oral appliances can be broadly categorized as mandibular advancing/positioning devices or tongue retaining devices. Oral appliances can either be “off the shelf” or custom made for the patient by a dental laboratory or similar provider. A number of oral appliances have received marketing clearance through the 510(k) pathway (product code LQZ) for the treatment of snoring and mild to moderate sleep apnea, including the Narval CC™ Lamberg SleepWell-Smarttrusion, 1st Snoring Appliance, Full Breath Sleep Appliance, PM Positioner, Snorenti, Snorex, Osap, Desra, Elastomeric Sleep Appliance, Snoremaster Snore Remedy, Snore-no-More, Napa, Snoar™ Open Airway Appliance, and The Equalizer Airway Device.

Surgical Intervention

Surgical management of OSA (i.e., adenotonsillectomy, uvulopalatopharyngoplasty, orthognathic surgery) is discussed in a separate policy. (See Related Policies)

Polysomnography (PSG) may also be performed in patients with symptoms suggestive of narcolepsy (excessive sleepiness, cataplexy, sleep paralysis, and sleep-related hallucinations), unrefreshing sleep with daytime fatigue/sleepiness but without snoring or witnessed apneas, obesity hypoventilation syndrome (obesity with poor breathing, leading to hypoxia and hypercarbia), parasomnias, periodic limb movements during sleep, sleep-related seizure disorder, and neuromuscular disorders with sleep-related symptoms. The American Academy for Sleep Medicine (AASM) has published guidelines for polysomnography and related procedures for these indications. (1)

Scope

Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to the limits and conditions of the member benefit plan. Members and their providers should consult the member benefit booklet or contact a customer service representative to determine whether there are any benefit limitations. This policy does not apply to Medicare Advantage.

Benefit Application

An unattended home sleep study may be billed with payment limited to 1 night (CPT 95806).

Rationale

This policy was originally created in 1998. Since that time the policy has been reviewed and updated using PUBMed literature searches. The most recent update with literature review covered the period of November 2012 through June 2013. Following is a summary of the key literature.

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 (MWT) is an objective measure of the ability to stay awake under soporific conditions (used to assess occupational safety). (4) The MSLT and MWT are not routinely indicated in the evaluation and diagnosis of OSA or in assessment of change following treatment with CPAP. The MSLT may be indicated as part of 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. (4, 5) Since it is not possible to differentiate the excessive sleepiness caused by OSA and narcolepsy, the OSA should be treated before confirming a diagnosis of narcolepsy with the MSLT.

The presentation of obstructive sleep apnea (OSA) in children may differ from that of adults. Children frequently exhibit behavioral problems or hyperactivity rather than daytime sleepiness, and an apnea/hypopnea index (AHI) greater than 1.5 is considered abnormal (an AHI of 15 is 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.

As described in Cochrane reviews from 2006, treatment of obstructive sleep apnea (OSA) with continuous positive airway pressure (CPAP) or oral appliances has been shown to improve objective and subjective symptoms in patients with obstructive sleep apnea. (6, 7) This policy focuses, therefore, on patient selection criteria for polysomnography (PSG), or sleep study, and the use of home sleep studies as an alternative to a supervised laboratory study. In addition, the use of expiratory positive airway pressure (EPAP), oral pressure therapy (OPT), auto-adjusting positive airway pressure (APAP) or bilevel positive airway pressure (BiPAP) in patients with OSA is reviewed.

Diagnosis and Treatment

The original rationale for the diagnosis and treatment of OSA was based on epidemiologic studies that suggested increased mortality in patients with an apneic index greater than 20. However, considering that an apneic/hypopnea index (AHI) of 5 is considered normal, there is obviously a great range of severity of OSA, ranging from those with only snoring as a complication to those with associated severe excessive daytime sleepiness, hypertension, or cardiac arrhythmias. If OSA is considered mild to moderate and snoring is the only manifestation, an intervention would be considered not medically necessary. For example, pronounced snoring may be considered predominantly a social annoyance to the patient's bed partner with no impact on the patient him/herself.

In 2011, the Agency for Healthcare Research and Quality (AHRQ) conducted a comparative effectiveness review (CER) on the diagnosis and treatment of OSA in adults. (8) The CER found strong evidence that an AHI greater than 30 events/hour is an independent predictor of all-cause mortality, with low or insufficient evidence for an association between AHI and other clinical outcomes. The CER found moderate evidence that type 3 and type 4 monitors may have the ability to accurately predict AHI suggestive of OSA and that type 3 monitors perform better than type 4 monitors at AHI cutoffs of 5, 10, and 15 events per hour. Despite no or weak evidence for an effect of CPAP on clinical outcomes, given the large magnitude of effect on the intermediate outcomes of AHI, Epworth Sleepiness Scale (ESS), and arousal index, the strength of evidence that CPAP is an effective treatment to alleviate sleep apnea signs and symptoms was rated moderate. The strength of the evidence that mandibular advancement devices improve sleep apnea signs and symptoms was rated moderate, and there was moderate evidence that CPAP is superior to mandibular advancement devices in improving sleep study measures.

Portable Home Monitors

Attended PSG has been considered to be the gold standard in the diagnosis and treatment of OSA. In 2007, AHRQ conducted a technology assessment on portable monitoring for the Medicare Evidence Development and Coverage Committee (MedCAC). (9)

The report concluded:

  • Baseline AHI (or other indices obtained from sleep studies) is only modestly associated with response to CPAP or CPAP use among people with high (pre-test) probability for obstructive sleep apnea-hypopnea syndrome. None of the eligible studies assessed hard clinical outcomes (i.e., mortality, myocardial infarctions, strokes, and similar outcomes).
  • Based on limited data, type 2 monitors may identify AHI suggestive of obstructive sleep apnea-hypopnea syndrome with high positive likelihood ratios (>10) and low negative likelihood ratios (<0.1) both when the portable monitors were studied in the sleep laboratory and at home.
  • Type 3 monitors may have the ability to predict AHI suggestive of obstructive sleep apnea-hypopnea syndrome with high positive likelihood ratios and low negative likelihood ratios compared to laboratory-based PSG, especially when manual scoring is used. The ability of type 3 monitors to predict AHI suggestive of obstructive sleep apnea-hypopnea syndrome appears to be better in studies conducted in the specialized sleep unit compared to studies in the home setting.
  • Studies of type 4 monitors that record at least three bioparameters showed high positive likelihood ratios and low negative likelihood ratios. Studies of type 4 monitors that record one or two bioparameters also had high positive likelihood ratios and low negative likelihood ratios, at least for selected sensitivity and specificity pairs from receiver operating characteristic (ROC) curve analyses. Similarly to type 3 monitors, the ability of type 4 monitors to predict AHI suggestive of obstructive sleep apnea-hypopnea syndrome appears to be better in studies conducted in specialized sleep units.
  • Patients older than the studied subjects (the median average age was approximately 50 years in the analyzed studies) may have more comorbidities that affect sleep (i.e., non-obstructive sleep apnea-hypopnea syndrome conditions such as cardiac insufficiency; chronic obstructive pulmonary disease; obesity hypoventilation syndrome; or periodic limb movements in sleep and restless leg syndrome). These conditions may be misdiagnosed if the sleep monitors do not record channels necessary for differential diagnosis from obstructive sleep apnea-hypopnea syndrome.
  • For studies in the home setting, there are no direct data on whether and to what extent technologist support and patient education affect the comparison of portable monitors with facility-based PSG.
  • Overall, manual scoring or manual editing of automated scoring seems to have better agreement with facility-based PSG. The automated scoring algorithms may vary across different monitors, or even with the specific software version or settings. Thus, their ability to recognize respiratory events may differ.
  • Signal loss was more often observed in home studies, and 1 study associated discrepancies in the AHI measurement with poor quality airflow signals in the unattended home-based recordings.

In 2008, the Centers for Medicare and Medicaid Services (CMS) implemented a national coverage decision allowing an initial 12-week period of CPAP based on a clinical evaluation and a positive sleep test performed with either an attended PSG performed in a sleep laboratory or an unattended home sleep test with a device that measures at least three channels. (10) Previously, coverage for CPAP required determination of AHI from attended PSG in a sleep laboratory, effectively establishing PSG-defined AHI as the only acceptable measure of OSA. As indicated in the AHRQ report, there is a poor correlation between AHI and daytime sleepiness, as well as between improvement in AHI and improvement of symptoms with CPAP usage. In addition, effectiveness of CPAP is affected by tolerance to the device (mask and airway pressure) and ultimately by compliance with treatment. These issues raise the question of whether PSG-defined AHI and manual titration of CPAP should remain the only means for diagnosis and treatment of OSA. Therefore, this policy evaluates the literature on the clinical utility of portable monitoring devices to identify patients with a high likelihood of benefit from treatment, without increasing potential harm from misdiagnosis.

Ambulatory Diagnosis and Management by a Sleep Specialist

In 2012 Rosen et al. published results from the HomePAP study, reporting that a home-based strategy for diagnosis and treatment of OSA was non-inferior to in-laboratory PSG. (11) HomePAP was an independently-funded multi-center trial of 373 patients with a high pre-test probability of moderate to severe OSA. All of the study sites were accredited by a professional sleep medicine society and staffed by sleep medicine specialists. The clinical algorithm used to determine a high pretest probability of OSA was an Epworth Sleepiness Scale (ESS) of 12 or greater and an “adjusted neck circumference” of at least 43 cm, calculated as the measured neck circumference plus an additional 3 cm if habitual snoring was present; 4 cm if hypertension was present; and 3 cm if apnea, gasping, or choking was present on most nights. Patients were randomized to diagnosis with limited channel portable sleep studies (airflow, respiratory effort, oxygen saturation, electrocardiogram, and body position) and titration with APAP, or to laboratory-based PSG with CPAP titration. Patients in the home arm were asked to undergo in-lab PSG if the recording was technically unacceptable or if the AHI was less than 15. Repeat in-lab PSG was required in 11.1% of patients while the technical failure rate in the home arm was 21.4%. About half the patients in each study arm were diagnosed with an AHI of 15 or more and were eligible to continue to titration. At 3 months, patients in the home arm were using CPAP 1 hour more per night (4.7 vs. 3.7 hr) and had higher adherence (62.8% of nights had >4 hr use vs. 49.4%). The 2 strategies were similar for acceptance of CPAP therapy, titration pressures, effective titrations, time to treatment, and improvement in ESS scores.

Several other randomized studies have found outcomes to be similar between home diagnosis and treatment in comparison with hospital-based diagnosis (PSG) and treatment (titration) when both strategies are supervised by a sleep medicine specialist. Kuna et al. conducted a noninferiority trial that compared home testing with a type 3 portable monitor followed by at least 3 nights of APAP versus in-laboratory titration and testing in 296 patients. (12) Patients with an AHI of 15 or more on home monitoring were scheduled for 4- to 5-day APAP titration, while patients with an AHI of less than 15 per hour on home monitoring underwent in-laboratory PSG. Improvement in ESS, Center for Epidemiologic Studies Depression Scale (CES-D), mental component of the Short Form (SF)-12, and Functional Outcomes of Sleep Questionnaire (FOSQ) was similar for home-based and hospital-based treatment, meeting noninferiority parameters. In another study, 66 patients with a high level of clinical suspicion of OSA (ESS >12 and a Sleep Apnea Clinical Score >15) were randomized to home respiratory polygraphy and home follow-up, hospital PSG and hospital follow-up, or home respiratory polygraphy and hospital follow-up. CPAP pressure was calculated mathematically. At 6-month follow-up, significantly more patients in the home group were compliant (73%) compared to the hospital-based groups (68% and 57%). Other outcomes (e.g., ESS, functional outcomes of sleep) did not differ between the groups. (13)

Skomro et al. conducted a randomized controlled trial (102 patients) of home-based testing followed by 1 week of auto-CPAP (APAP), compared with in-laboratory PSG followed by CPAP titration. (14) The study included adult patients with suspected OSA who had been referred to participating sleep medicine physicians at a tertiary sleep disorders clinic. Patients were included in the study if they had at least 2 symptoms of OSA (ESS >10, witnessed apneas, or snoring). The average ESS at baseline was 12.5. Exclusion criteria were respiratory or heart failure, clinical features of another sleep disorder, use of hypnotics, upper airway surgery, CPAP or oxygen therapy, pregnancy, or a safety-sensitive occupation. For home testing, a type 3 monitor was used that measured airflow, respiratory effort, oxygen saturation, heart rate, and body position, and home studies with technical failures or less than 4 hours of recording were repeated (17% of patients). After completion of testing and before application of APAP/CPAP, the subjects also underwent the other sleep test (home or laboratory). All studies were scored manually by a technician and reviewed by a sleep medicine physician, and subjects and investigators were blinded to the results of the second test. After sleep testing, 89 subjects received a diagnosis of OSA and were prescribed CPAP; 10 of those patients rejected CPAP treatment. After 4 weeks of therapy, there were no significant differences between laboratory and home monitoring groups on any of the outcome measures; daytime sleepiness measured by the ESS (6.4 vs. 6.5), sleep quality measured by the Pittsburgh Sleep Quality Index (5.4 vs. 6.2), quality of life (4.5 vs. 4.6), Short-Form 36 (SF-36) Health Survey (62.2 vs. 64.1), blood pressure (129/84 vs. 125/81), or CPAP adherence (5.6 h/night vs. 5.4 h/night – all respectively).

Garcia-Diaz and colleagues assessed the sensitivity and specificity of home respiratory polygraphy and actigraphy to diagnose OSA in relation to laboratory PSG. (15) The cohort consisted of 65 consecutive patients referred to the sleep laboratory for PSG because of suspected OSA. Using an AHI cutoff of 15 or more, 2 independent evaluators were found to identify PSG-defined OSA in 90% to 92% of the patients (sensitivity of 84–88% and specificity of 97%). Analysis of data from the Swiss respiratory polygraphy registry found that in patients selected for portable monitoring (based on high clinical suspicion of OSA by licensed pulmonary physicians by a combination of hypersomnia, snoring, or observed apneas), confirmation or exclusion of sleep disordered breathing was possible in 96% of the 8,865 diagnostic sleep studies. (16) From these type 3 studies (four channels including airflow and respiratory movement, heart rate or electrocardiogram [ECG], and oxygen saturation), 3.5% were not conclusive and required additional PSG.

Interpretation of Sleep Studies

The medical professional who is interpreting a polysomnogram or home sleep study should have training in sleep medicine and should review the raw data from PSG and home sleep studies in order to detect artifacts and data loss. In addition, the treatment of patients diagnosed with OSA should be initiated and monitored by a professional with training in sleep medicine. It is important to monitor symptoms and adherence to positive airway pressure (PAP) treatment, e.g., reviews of symptoms and device utilization between 30 and 90 days.

Section Summary

A number of studies, including randomized controlled trials, indicate that for patients with a high probability of moderate to severe sleep apnea and no contraindications, a home-based strategy with a multiple channel device that is overseen by a sleep specialist results in outcomes that are roughly equivalent to in-hospital diagnosis and management, and some studies report that compliance with treatment is better following a home-based strategy.

Use of APAP for Diagnosis and Treatment with Supervision by a Sleep Specialist

Mulgrew et al. published a randomized validation study of the diagnosis and management of OSA with a single channel monitor followed by APAP. (17) They developed a diagnostic algorithm (ESS score greater than 10, Sleep Apnea Clinical Score of 15 or greater, and a respiratory disturbance index [RDI] of 15 or greater on overnight oximetry) that was found to have a 94% positive predictive value for moderate to severe OSA assessed by PSG. Patients who passed the screening (n=68) were randomized to either attended in-laboratory PSG with CPAP titration or to home monitoring with a portable APAP unit. Home monitoring consisted of autotitration for 1 week, followed by download and assessment of efficacy data for the week (i.e., CPAP, mask leak, residual respiratory events, and use) and determination of the pressure for CPAP by the study physician. A second assessment of efficacy data was conducted for a week of CPAP use, and the pressure setting was adjusted by the CPAP coordinator in conjunction with the study physician. After 3 months of CPAP use, the subjects returned to the laboratory for PSG (with CPAP); no difference was observed between lab-PSG and home-managed patients in any of the outcome measures (median AHI of 3.2 vs. 2.5, median ESS of 5.0 vs. 5.0, and Sleep Apnea Quality-of-Life Index of 5.5 vs. 5.8, all respectively). Another study assessed the clinical utility of home oximetry in comparison with PSG by measuring the accuracy with which sleep physicians could predict which patients would benefit from treatment of OSA. (18) The primary outcome measure was the change in sleep apnea-specific quality of life after treatment. Subjects were randomly selected from a pool of referred patients; 307 were randomized, and 288 began a trial of CPAP. An additional 51 patients (18%) quit before the end of the 4-week CPAP trial; 31 indicated that they had trouble sleeping with CPAP, 3 removed the mask in their sleep, and 2 had nasal or sinus congestion. Overall, physicians predicted success in 50% of patients and 42% met the criterion for improvement. Outcomes of treatment were similar in the 2 groups, with improvements in ESS scores of 3.4 for home monitoring and 4.0 for PSG. The ability of physicians to predict the outcome of treatment was similar for the 2 methods. Five cases (2%) required PSG for diagnosis of other nonrespiratory sleep disorders (narcolepsy, periodic leg movements, and idiopathic hypersomnolence).

Senn and colleagues assessed whether an empiric approach, using only a 2-week trial of APAP, could be effective for the diagnosis of OSA. (19) 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 of 13.6). Exclusion criteria were contraindications to CPAP or APAP (heart failure, lung disease, obesity, hypoventilation syndrome), previous diagnosis or treatments of a sleep disorder, or a diagnosis of an internal medical, neurologic, or psychiatric disorder explaining the symptoms. At the end of the 2-week trial, patients were asked to rate the perceived effect of treatment and to indicate whether they had used CPAP for more than 2 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 sensitivity of 80%, specificity of 97%, and positive and negative predictive values of 97% and 78%, respectively.

Monitoring of APAP use by daily transmission to a web-based database and review by a research coordinator was shown to improve compliance to PAP therapy (191 vs. 105 min/day). (20) For the telemedicine arm of this randomized trial, 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 greater than 30% of the night, less than 4 hours of use for 2 consecutive nights, machine measured AHI more than 10 events/hr, and 90th percentile of pressure greater than 16 cm H2O. Evaluation by their physician sleep specialist after 3 months of therapy showed a similar decrease in AHI for the 2 groups (1.6 for telemedicine and 0.7 for controls).

Primary Care vs. Specialist Care

A 2013 randomized noninferiority trial by Chai-Coetzer et al. compared primary care vs. specialist sleep center management of OSA. (21) Prospective participants were screened for eligibility by 34 primary care physicians using a screening questionnaire (n=402) followed by overnight oximetry (n=301). Inclusion criteria were a score of 5 or more on the questionnaire, at least 16 events per hour of oxygen desaturation (3% or more), and an ESS of 8 or higher or persistent hypertension. An ambulatory sleep study with the recommended number of channels was not performed. Enrolled subjects were then randomly allocated to management by a primary care physician and community-based nurse, both of whom received brief training in sleep medicine (n=81), or to a sleep medicine specialist (n=74). CPAP pressure was determined through either 3 days of APAP or PSG titration. At the 6-month follow-up, 63% of patients in the primary care group and 61% of patients in the specialist groups were using CPAP. ESS scores improved to a similar extent in both groups, from a mean score of 12.8 to 7.0 in the primary care group and from 12.5 to 7.0 in the specialist group. There were similar improvements in secondary outcomes (FOSQ, Sleep Apnea Symptoms Questionnaire, and Short Form-36 Health Survey) for the 2 groups.

Peripheral Arterial Tone

In 2009, CMS issued a coverage decision to accept use of a sleep testing device that included actigraphy, oximetry, and peripheral arterial tone to aid the diagnosis of OSA in beneficiaries who have signs and symptoms indicative of OSA. (22) (See Medicare National Coverage, below, along with the Policy Guidelines section regarding new category III codes for devices with this configuration of sensors.) A literature review of this technology in September 2009 identified a review of use of peripheral arterial tone for detecting sleep disordered breathing. (23) This review includes the critical evaluation of a number of studies comparing the Watch-PAT™ with laboratory-based PSG. Relevant studies that included appropriate study populations (patients referred for evaluation of OSA or following CPAP treatment) are described.

Berry and colleagues randomized 106 patients who had been referred for a sleep study for suspected OSA at a local Veterans Administration center to portable monitoring followed by APAP (PM-APAP) or to PSG for diagnosis and treatment. (24) Patients were screened with a detailed sleep and medical history questionnaire including an ESS. To be included in the study, patients had to have an ESS score of 12 or greater and the presence of at least 2 of the following: loud habitual snoring, witnessed apnea/gasping, or treatment for hypertension. Patients on alpha-blockers or not in sinus rhythm were excluded due to the type of portable monitoring device used (Watch-PAT™ 100), which records sympathetic changes in peripheral arterial tone, heart rate, pulse oximetry, and actigraphy. Also excluded were patients with moderate to severe heart failure, use of nocturnal oxygen, chronic obstructive pulmonary disease, awake hypercapnia, neuromuscular disease, cataplexy, restless leg syndrome, use of narcotics, psychiatric disorder, shift work, or a prior diagnostic study or treatment. Of the 53 patients randomized to PSG, 6 (11%) did not have PSG-defined OSA; 43 of 49 patients (88%) with CPAP titrations started on CPAP. In the portable monitoring arm, 4 of 53 patients (8%) were found not to have OSA. A physician affiliated with the sleep research laboratory reviewed the tracings for technical quality to determine if the events were correctly identified by the analysis program. Four studies (8%) were repeated due to technical failure or insufficient sleep. Patients with negative studies were then crossed over, which identified an additional 2 patients from the PSG arm as having OSA and 1 patient from the PM-APAP arm as having OSA. These patients (total of 50) had at least 1 APAP titration, 45 of the 50 (90%) had an adequate APAP titration and accepted treatment. Adherence was similar in the two groups, with 91% of patients in the PSG arm and 89% of patients in the PM-APAP arm continuing treatment at 6 weeks. Treatment outcomes were similar in the two groups, with a 7-point improvement in ESS score, 3-point improvement in the Functional Outcomes of Sleep Questionnaire, and a machine estimate of residual AHI of 3.5 in the PM-APAP group and 5.3 in the PSG group.

Pittman et al. evaluated residual OSA in 70 patients who had self-reported adherence to CPAP for at least 3 months. (25) Exclusion criteria for the study were diagnosis of periodic leg movement disorder, RDI less than 20 on diagnostic PSG, history of peripheral vascular disease, peripheral neuropathy, nonsinus cardiac rhythm, permanent pacemaker, severe lung disease, bilateral cervical or thoracic sympathectomy, finger deformity precluding sensor application, and use of alpha-adrenergic blockers. Compared to concurrently recorded PSG, the area under the curve (AUC) from receiver-operator characteristic (ROC) analysis for RDI greater than 15 was 0.95 (85% sensitivity and 90% specificity). Specificity decreased dramatically at lower cutoffs (67% for RDI >10 and 47% for an RDI >5). Another small study of 37 consecutive patients referred to a sleep center for OSA reported a high correlation between PSG and concurrently recorded Watch-PAT RDI (r=0.93). (26) (Correlation coefficients are not considered to be as meaningful as estimates of sensitivity and specificity.) Sensitivities for AHIs greater than 5, 15, and 35 in this study were 94%, 96%, and 83%, respectively. Specificity was reported at 80%, 79%, and 72%, respectively, for these thresholds. Penzel and colleagues raised concern about the specificity of this device in an independently conducted small study of 21 patients with suspected sleep apnea. (27) The study found that for 16 of the 17 subjects with adequate recordings, the number of Watch-PAT events was greater than the number of respiratory events. The device was found to have reasonable reliability and to be very sensitive to arousal, although since arousals are not unique to apnea events, the authors concluded that the specificity of the Watch-PAT is limited. The long list of exclusion criteria in company-sponsored trials also raises questions about the clinical utility of the indirect measure of peripheral arterial tone in place of directly measuring airflow and respiratory effort. In a 2004 report, Pittman and colleagues noted other potential disadvantages of the Watch-PAT, including the inability to differentiate between the type of respiratory event (e.g., obstructive, central, mixed, or hypopnea) or to identify body position, and susceptibility to artifact from arrhythmias. (28) In this study, 28% of the cases did not achieve concordance (defined as both Watch-PAT and PSG RDI of >40 per hour, or within 10 events per hour in patients with an RDI <40 per hour). It is noteworthy that the American Academy of Sleep Medicine (AASM) has not changed their 2007 guidelines, recommending that portable monitors should minimally record airflow, respiratory effort, and blood oxygenation, using biosensors conventionally used for in-laboratory PSG. (29) At this time, evidence is insufficient to support a change in the sensors required for portable monitoring.

Treatment

BiPAP and APAP

A 1995 study by Reeves-Hoche et al. randomized patients with OSA to receive either CPAP or BiPAP. (30) The authors found that patient complaints and effective use were similar in both groups but that the dropout rate was significantly higher in the CPAP group. This study suggests that BiPAP should be limited to those patients who have failed a prior trial of CPAP. The 2011 AHRQ CER found moderate evidence that APAP and fixed pressure CPAP result in similar levels of compliance (hours used per night) and treatment effects for patients with OSA. (8)

Evidence-based guidelines from the AASM concluded that CPAP and APAP devices have similar outcomes in terms of AHI, oxygen saturation, and arousals. (31-34) As indicated in the 2011 AHRQ CER, increased compliance with APAP devices has not been well-documented in clinical trials. (31-37) Thus, the issues associated with APAP are similar to BiPAP; i.e., APAP may be considered medically necessary in patients who have failed a prior trial of CPAP. In addition to the studies (described above) that used unattended APAP devices to titrate CPAP pressure, 2007 AASM practice parameters on autotitration identified 5 randomized trials supporting the use of unattended APAP to determine a fixed CPAP treatment pressure for patients with moderate to severe OSA without significant comorbidities affecting respiration. (34) This new practice parameter was considered an option (uncertain clinical use), with automatic titration or treatment requiring close clinical follow-up (standard). The practice parameters for the use of APAP issued by the AASM point out that results may vary with different APAP devices based on different underlying technologies, and thus caution must be exercised in selecting a particular device for use. (31-34)

PAP-NAP

In 2008, Krakow et al. reported use of a daytime abbreviated sleep study to acclimate patients with complex insomnia to PAP. (38) 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 of these patients had anxiety, fear, and/or resistance regarding PAP therapy or the diagnosis of OSA. Thirty-nine patients who could not be persuaded to 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 consisted of 5 components: pretest instructions to maximize chances for daytime napping; introduction of PAP therapy addressing barriers to use; type 3 monitoring hookup (10 channels without EEG leads); PAP therapy during 1 to 2 hours in bed in which the patient has the possibility of falling 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 to historical controls (n=38) with 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 compared with 23% of controls. Adherence, defined as at least 5 days per week with an average of at least 4 hours per day, was 56% in the PAP-NAP group and 17% in controls.

Oral Appliance Therapy

A 2013 randomized cross-over trial by Phillips et al. found similar health outcomes after 1 month of CPAP or oral appliance therapy (OAT) in 126 patients (82% with moderate to severe OSA, AHI >15). (39) CPAP was more effective than mandibular advancement therapy in reducing AHI (CPAP AHI=4.5, OAT AHI=11.1), but patient-reported compliance was higher with OAT (6.5 vs. 5.2 hours/night). Neither treatment improved the primary outcome of 24-hour ambulatory blood pressure, except in a subgroup of patients who were initially hypertensive. The 2 treatments resulted in similar improvements in sleepiness (improvement of 1.6 to 1.9), FOSQ (improvement of 1.0), some measures on driving simulator performance, and disease-specific quality of life (QOL). OAT was superior to CPAP in 4 domains on the SF-36.

Nasal Expiratory Positive Airway Pressure (EPAP)

One randomized controlled trial and several prospective case series have been published with the PROVENT device.

In 2011, Berry et al. reported an industry-sponsored multicenter double-blind randomized sham-controlled trial of nasal EPAP. (40) Two-hundred and fifty patients with OSA and an AHI of 10 or more per hour were randomized to nasal EPAP (n=127) or a sham device (n=123) for 3 months. PSG was performed on 2 nights (device-on, device off, in a random order) at week 1 (92% follow-up) and after 3 months of treatment (78% follow-up). EPAP reduced the AHI from a median of 13.8 to 5.0 (-52.7%) at week 1 and from 14.4 to 5.6 (-42.7%) at 3 months. This was a significantly greater reduction in AHI than the sham group (-7.3% at week 1 and -10.1% at 3 months). Over 3 months, the decrease in ESS was statistically greater in the EPAP group (from 9.9 to 7.2) than in the sham group (from 9.6 to 8.3), although the clinical significance of a 1 point difference in the ESS is unclear. Treatment success and oxygenation data were presented only for the 58% of per-protocol patients who had an AHI of 5 or more per hour on the device-off PSG night. The oxygenation results (oxygenation desaturation index and % of total sleep time with SpO2 <90%) showed small but statistically significant decreases at 1 week and 3 months. Treatment success, defined as a 50% or greater reduction in the AHI or an AHI reduced to less than 10 (if device-off AHI was 10 or more), was greater in the EPAP group at 1 week (62% vs. 27.2%) and 3 months (50.7% vs. 22.4%). Device-related adverse events were reported by 45% of patients in the EPAP group and 34% of patients in the sham group, with 7% of patients in the EPAP group discontinuing the study due to adverse events. Overall, the validity of these results is limited by the high dropout rate, and the clinical significance of the results is uncertain.

An open-label extension of the 2011 randomized study by Berry et al. evaluated 12-month safety and durability of the treatment response in patients who had an initial favorable response to EPAP. (41) Included were 41 patients (32% of 127) in the EPAP arm of the study who used the device for an average of at least 4 hours per night on at least 5 nights per week during months 1 and 2 and had at least a 50% reduction in AHI, or reduction to less than 10 events per hour, compared to the device-off PSG. Of the 51 patients (40% of 127) eligible, 41 enrolled in the extension study, and 34 (27% of 127) were still using the EPAP device at the end of 12 months. Median AHI was reduced from 15.7 to 4.7 events per hour; the percentage of patients who met criteria for success was not reported. The arousal index was modestly decreased (from 23.9 to 19.0). Over 12 months of treatment, the ESS decreased from 11.1 to 6.0. The median percentage of reported nights used (entire night) was 89.3%. Device-related adverse events were reported by 42% of patients, and the most frequently reported adverse events were difficulty exhaling, nasal discomfort, dry mouth, headache, and insomnia. This open-label extension study is limited by the inclusion of responders only and by the potential for a placebo effect on the ESS. However, the data suggest that some patients may respond to this device, and the patient compliance data might indicate a positive effect on daytime sleepiness that leads to continued use of the device in about 1 in 4 patients. Additional controlled studies are needed to distinguish between these alternatives.

Oral Pressure Therapy (OPT)

No full-length, peer-reviewed studies on oral pressure therapy have been identified in the published literature. Therefore, it is not possible to evaluate the efficacy of this treatment based on scientific evidence.

Summary

Current literature indicates that evaluation of obstructive sleep apnea (OSA) should be by clinical evaluation and overnight monitoring, either by attended polysomnography (PSG) or by portable unattended home monitoring under qualified supervision and that this may be followed by a trial of auto-adjusting positive airway pressure (APAP) to evaluate efficacy and adjust pressure.

  • Portable monitoring should only be conducted in adult patients with a high pretest probability of OSA and absence of comorbid conditions as determined by clinical evaluation.
  • A positive portable monitoring study with at least four channels of recording, including 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 [continuous positive airway pressure] trial to determine 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.
  • Due to the probability of artifacts or loss of data, raw data from the portable monitoring device should be interpreted by a sleep specialist. Follow-up and review of the APAP trial is also needed.

Based on the current evidence, use of portable monitoring may be considered medically necessary in adult patients considered to be at high risk for OSA, with clinical evaluation and follow-up conducted by a medical professional experienced in the diagnosis and treatment of sleep disorders.

Use of the novel EPAP device has been reported in several prospective case series and one industry-sponsored randomized controlled trial. The main finding of this study was a decrease in apnea/hypopnea index (AHI) with minor impact on oxygenation and the Epworth Sleepiness Scale (ESS). No evidence was identified on the oral therapy device. Evidence at this time is insufficient to permit conclusions regarding the effect of these technologies on health outcomes. One comparative trial with historical controls was identified on use of a PAP-NAP study for patients with complex insomnia who are resistant to CPAP titration or use. Additional study is needed to evaluate the efficacy of this intervention with greater certainty.

Practice Guidelines and Position Statements

The patient selection criteria for a PSG or sleep study require an estimate of the pretest probability of OSA, based on the signs and symptoms of OSA. Ideally, one would like to know the necessity of a PSG (i.e., with electroencephalography [EEG]) versus a sleep study (without EEG). A detailed analysis of these issues is beyond the scope of this policy. However, in 1997 the American Sleep Disorders Association (now the AASM) published practice parameters for PSG and related procedures; these were updated in 2005. (1, 42)

American Sleep Disorders Association (AASM) published practice parameters for PSG and related procedures in 1997 and 2005. The guidelines suggested that patients had a 70% likelihood of having an AHI index of at least 10 if all of the following were present: habitual snoring, excessive daytime sleepiness, a body mass index greater than 35, and observed apneas. In 2005, full-night PSG was recommended for the diagnosis of sleep-related breathing disorders and for PAP titration in patients with an RDI of at least 15 per hour, or with an RDI of at least 5 per hour in a patient with excessive daytime sleepiness. (1) For patients in the high-pretest-probability stratification group, an attended cardiorespiratory sleep study (type 3 with respiratory effort, airflow, arterial oxygen saturation, and electrocardiogram [ECG] or heart rate) was considered an acceptable alternative to full-night PSG, provided that repeat testing with full-night PSG was permitted for symptomatic patients who had a negative cardiorespiratory sleep study finding. In their 2005 Guidelines, AASM stated that data were insufficient to support unattended portable sleep studies, but they might be considered acceptable when the patient has severe symptoms requiring immediate treatment and PSG is not available, the patient cannot be studied in a sleep laboratory (i.e., non-ambulatory), or for follow-up studies to evaluate response to therapy. (1) The document further stated that, in these patients, a sleep study may be an acceptable alternative to PSG. However, a sleep study may only “rule in” disease, and PSG should be available for patients with false-negative sleep study results.

An additional recommendation of note is that sleep studies were not recommended in patients with comorbid conditions or secondary sleep complaints. Most of the literature reviewed specifically excluded patients with comorbid conditions. A cardiorespiratory sleep study without EEG recording was not recommended for CPAP titration, as sleep staging was considered necessary. Finally, practice parameters stated that a multiple sleep latency test is not routinely indicated for most patients with sleep-related breathing disorders.

American Academy for Sleep Medicine (AASM) Practice Parameters indicate that a split-night study (initial diagnostic polysomnography [PSG] followed by CPAP titration during PSG on the same night) is an alternative to one full night of diagnostic PSG followed by a second night of titration if the following four criteria are met (1):

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

Portable monitoring (PM) devices were addressed by a joint project of the AASM, the American Thoracic Society, and the American College of Chest Physicians in 2003. (43, 44) In 2007 the AASM issued revised guidelines for the use of unattended portable monitors, recommending that portable monitors should minimally record airflow, respiratory effort, and blood oxygenation, with biosensors conventionally used for in-laboratory PSG, and that testing be performed by an experienced sleep technologist and scored by a board-certified sleep medicine specialist under the auspices of an AASM-accredited comprehensive sleep medicine program. (29)

Evidence-based guidelines on BiPAP, APAP, and dental appliances have been published by the AASM. (31-34) The Practice Parameters provided a recommendation of “guideline” (moderate clinical certainty) that although not as efficacious as CPAP, oral appliances are indicated for use in patients with mild to moderate OSA who prefer oral appliances to CPAP, or who do not respond to CPAP, are not appropriate candidates for CPAP, or who fail treatment attempts with CPAP or treatment with behavioral measures such as weight loss or sleep-position change. Patients with severe OSA should have an initial trial of nasal CPAP because greater effectiveness has been shown with this intervention than with the use of oral appliances. Oral appliances should be fitted by qualified dental personnel who are trained and experienced in the overall care of oral health, the temporomandibular joint, dental occlusion and associated oral structures. There was moderate clinical certainty that BiPAP was appropriate as an optional therapy in some cases in which high pressure is needed and the patient experiences difficulty exhaling against a fixed pressure or coexisting central hypoventilation present. (45) APAP was not recommended to diagnose OSA, for split-night studies or for patients with heart failure, significant lung disease such as chronic obstructive pulmonary disease, patients expected to have nocturnal arterial oxyhemoglobin desaturation due to conditions other than OSA (e.g., obesity hypoventilation syndrome), patients who do not snore, and patients who have central sleep apnea syndromes. (34) Unattended APAP in patients without significant comorbidities was considered an option (uncertain clinical use). The guidelines indicated that patients being treated on the basis of APAP titration must have close clinical follow-up to determine treatment effectiveness and safety, especially during the first few weeks of PAP use, and a re-evaluation and, if necessary, a standard CPAP titration should be performed if symptoms do not resolve or if the APAP treatment otherwise appears to lack efficacy.

The AASM published evidence-based guidelines for respiratory indications for polysomnography in children in 2011. (46) “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 suggests 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 is 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 is indicated for positive airway pressure titration in children with OSA.

AASM Clinical Guideline for the Evaluation and Management of Chronic Insomnia in Adults was published in 2003 and updated in 2008. One of the practice standards states in part that polysomnography and daytime multiple sleep latency testing (MSLT) are not indicated in the routine evaluation of transient or chronic insomnia, including insomnia due to psychiatric or neuropsychiatric disorders. Polysomnography may be indicated when there is reasonable clinical suspicion of breathing (sleep apnea) or movement disorders, when initial diagnosis is uncertain, treatment fails (behavioral or pharmacologic), or precipitous arousals occur with violent or injurious behavior (53).

The American Academy of Pediatrics (AAP) published a 2012 guideline 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 updates the AAP’s 2002 guidelines. (47, 48) The AAP recommends that all children/adolescents should be screened for snoring, and PSG should be performed in children/adolescents with snoring and symptoms/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/adolescents range from 1.2% to 5.7%. Adenotonsillectomy is recommended as the first line of treatment for patients with adenotonsillar hypertrophy, and patients should be reassessed clinically post-operatively to determine whether additional treatment is required. High-risk patients should be re-evaluated with an objective test or referred to a sleep specialist. CPAP is recommended if adenotonsillectomy is not performed or if OSA persists postoperatively. Weight loss is 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.

The American Academy of Craniofacial Pain (AACP) Task Force on Mandibular Advancement Oral Appliance Therapy for Snoring and Obstructive Sleep Apnea published a position paper in 2013. (49) The position paper states that oral appliance therapy is 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 effects including temporomandibular joint (TMJ) pain and dysfunction. The authors recommend that dentists engaged in, or who wish to engage in, the assessment and management of patients with snoring and OSA using mandibular advancement oral appliances should be properly trained and experienced in the assessment, diagnosis and management of TMJ and craniofacial pain.

The American Academy of Otolaryngology – Head and Neck Surgery published clinical practice guidelines on PSG for sleep-disordered breathing prior to tonsillectomy in children in 2011. (50) The committee made the following recommendations: before determining the need for tonsillectomy, the clinician should refer children with sleep-disordered breathing for PSG if they exhibit certain complex medical conditions such as obesity, Down syndrome, craniofacial abnormalities, neuromuscular disorders, sickle cell disease, or mucopolysaccharidoses; the clinician should advocate for PSG prior to tonsillectomy for sleep-disordered breathing 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 sleep-disordered breathing; clinicians should communicate PSG results to the anesthesiologist prior to the induction of anesthesia for tonsillectomy; 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 (AHI of 10 or more, oxygen saturation nadir less than 80%, or both); in children for whom PSG is indicated to assess sleep-disordered breathing prior to tonsillectomy, clinicians should obtain laboratory-based PSG, when available.

National Institute for Health and Clinical Excellence (NICE) in 2008, issued guidance on CPAP treatment of OSA, based on a review of the literature and expert opinion. (51) The recommendations included:

  • Moderate to severe OSA/hypopnea syndrome (OSAHS) can be diagnosed from patient history and a sleep study using oximetry or other monitoring devices carried out in the person’s home. In some cases, further studies that monitor additional physiological variables in a sleep laboratory or at home may be required, especially when alternative diagnoses are being considered. The severity of OSAHS is usually assessed on the basis of both severity of symptoms (particularly the degree of sleepiness) and the sleep study, by using either the AHI or the oxygen desaturation index. OSAHS is considered mild when the AHI is 5–14 in a sleep study, moderate when the AHI is 15–30, and severe when the AHI is over 30. In addition to the AHI, the severity of symptoms is also important.
  • CPAP is recommended as a treatment option for adults with moderate or severe symptomatic OSAHS. CPAP is only recommended as a treatment option for adults with mild OSAHS if: they have symptoms that affect their quality of life and ability to go about their daily activities, and lifestyle advice and any other relevant treatment options have been unsuccessful or are considered inappropriate.
  • Treatments aim to reduce daytime sleepiness by reducing the number of episodes of apnea/hypopnea experienced during sleep. The alternatives to CPAP are lifestyle management, dental devices, and surgery. Lifestyle management involves helping people to lose weight, stop smoking and/or decrease alcohol consumption. Dental devices are designed to keep the upper airway open during sleep. The efficacy of dental devices has been established in clinical trials, but these devices are traditionally viewed as a treatment option only for mild and moderate OSAHS. Surgery involves resection of the uvula and redundant retrolingual soft tissue. However, there is a lack of evidence of clinical effectiveness, and surgery is not routinely used in clinical practice.
  • The diagnosis and treatment of OSAHS, and the monitoring of the response, should be carried out by a specialist service with appropriately trained medical and support staff.
  • The Committee discussed the use of CPAP therapy for children and adolescents with OSAHS. The Committee heard that OSAHS is less common among children than in adults and that the clinical issues and etiology in children are different from those encountered in adults. The Committee concluded that the recommendations for CPAP should apply only to adults with OSAHS.

Medicare National Coverage

The use of CPAP devices are covered under Medicare when ordered and prescribed by the licensed treating physician to be used in adults with OSA if either of the following criteria using the AHI or RDI are met:

  • AHI or RDI equal to or greater than 15 events per hour, or
  • AHI or RDI between 5 and 14 events per hour with documented symptoms of excessive daytime sleepiness, impaired cognition, mood disorders or insomnia, or documented hypertension, ischemic heart disease, or history of stroke.

The AHI or RDI is equal to the average number of episodes of apnea and hypopnea per hour and must be based on a minimum of 2 hours of sleep using actual recorded number of hours of sleep (i.e., the AHI or RDI may not be extrapolated or projected). Apnea is defined as a cessation of airflow for at least 10 seconds. Hypopnea is defined as an abnormal respiratory event lasting at least 10 seconds with at least a 30% reduction in thoracoabdominal movement or airflow as compared to baseline, and with at least a 4% oxygen desaturation.

In 2001, the CMS (formerly Health Care Financing Administration), published a decision memorandum for CPAP that addressed the issue of how to define moderate to severe OSA as a guide to a coverage policy for CPAP. This review of the literature suggested that there is a risk of hypertension with an AHI greater than 15, and thus treatment is warranted for these patients without any additional signs and symptoms. For patients with an AHI between 5 and 15 and associated symptoms, the CMS document concluded that the data from 3 randomized controlled trials demonstrated improved daytime somnolence and functioning in those treated with CPAP.

In 2008, CMS expanded coverage of CPAP to include those beneficiaries with a diagnosis of OSA made with a combination of a clinical evaluation and unattended home sleep monitoring using a device with at least three channels. (10, 52) The coverage of CPAP would initially be limited to a 12-week period to identify beneficiaries diagnosed with OSA who benefit from CPAP. This is a change from prior coverage, which specified that PSG must be performed in a facility-based sleep study laboratory and not in a home or a mobile facility. CMS defines AHI as the average number of episodes of apnea and hypopnea per hour of sleep, while the RDI is equal to the average number of respiratory disturbances per hour of continuous monitoring. There is variability in the published medical literature about the definition of the events that constitute a respiratory disturbance, and for the purposes of this national coverage decision, a respiratory disturbance is defined in the context of the sleep test technology of interest and, for portable monitoring devices that do not measure AHI or RDI directly, does not require direct measurement of airflow.

Effective for claims with dates of service on and after March 13, 2008, CMS determines that CPAP therapy when used in adult patients with OSA is considered reasonable and necessary under the following situations:

  1. The use of CPAP is covered under Medicare when used in adult patients with OSA. Coverage of CPAP is initially limited to a 12-week period to identify beneficiaries diagnosed with OSA as subsequently described who benefit from CPAP. CPAP is subsequently covered only for those beneficiaries diagnosed with OSA who benefit from CPAP during this 12-week period.
  2. The provider of CPAP must conduct education of the beneficiary prior to the use of the CPAP device to ensure that the beneficiary has been educated in the proper use of the device. A caregiver, for example a family member, may be compensatory, if consistently available in the beneficiary's home and willing and able to safely operate the CPAP device.
  3. A positive diagnosis of OSA for the coverage of CPAP must include a clinical evaluation and a positive:
  1. attended PSG performed in a sleep laboratory; or
  2. unattended home sleep test with a type II home sleep monitoring device; or
  3. unattended home sleep test with a type III home sleep monitoring device; or
  4. unattended home sleep test with a type IV home sleep monitoring device that measures at least 3 channels.
  1. The sleep test must have been previously ordered by the beneficiary’s treating physician and furnished under appropriate physician supervision.
  2. An initial 12-week period of CPAP is covered in adult patients with OSA if either of the following criteria using the AHI or RDI are met:
  1. AHI or RDI greater than or equal to 15 events per hour, or
  2. AHI or RDI greater than or equal to 5 events and less than or equal to 14 events per hour with documented symptoms of excessive daytime sleepiness, impaired cognition, mood disorders or insomnia, or documented hypertension, ischemic heart disease, or history of stroke.
  1. The AHI or RDI is calculated on the average number of events of per hour. If the AHI or RDI is calculated based on less than 2 hours of continuous recorded sleep, the total number of recorded events to calculate the AHI or RDI during sleep testing must be at minimum the number of events that would have been required in a 2-hour period.
  2. Apnea is defined as a cessation of airflow for at least 10 seconds. Hypopnea is defined as an abnormal respiratory event lasting at least 10 seconds with at least a 30% reduction in thoracoabdominal movement or airflow as compared to baseline, and with at least a 4% oxygen desaturation.
  3. Coverage with Evidence Development: Medicare provides the following limited coverage for CPAP in adult beneficiaries who do not qualify for CPAP coverage based on criteria 1–7 cited here. A clinical study seeking Medicare payment for CPAP provided to a beneficiary who is an enrolled subject in that study must address one or more of the following questions
  1. In Medicare-aged subjects with clinically identified risk factors for OSA, how does the diagnostic accuracy of a clinical trial of CPAP compare with PSG and types II, III, and IV home sleep test in identifying subjects with OSA who will respond to CPAP?
  2. In Medicare-aged subjects with clinically identified risk factors for OSA who have not undergone confirmatory testing with PSG or types II, III, and IV home sleep test, does CPAP cause clinically meaningful harm?

In March 2009, CMS issued the following national coverage decision (CAG-00405N) for the types of sleep testing devices that would be approved for coverage. (22)

CMS finds that the evidence is sufficient to determine that the results of the sleep tests identified below can be used by a beneficiary’s treating physician to diagnose OSA:

  1. Type I PSG is covered when used to aid the diagnosis of OSA in beneficiaries who have clinical signs and symptoms indicative of OSA if performed attended in a sleep lab facility.
  2. A type II or type III sleep testing device is covered when used to aid the diagnosis of OSA in beneficiaries who have clinical signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility, or attended in a sleep lab facility.
  3. A type IV sleep testing device measuring three or more channels, one of which is airflow, is covered when used to aid the diagnosis of OSA in beneficiaries who have signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility, or attended in a sleep lab facility.
  4. A sleep testing device measuring three or more channels that include actigraphy, oximetry, and peripheral arterial tone is covered when used to aid the diagnosis of OSA in beneficiaries who have signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility, or attended in a sleep lab facility.

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Coding

Codes

Number

Description

CPT

94762

Noninvasive ear or pulse oximetry for oxygen saturation; by continuous overnight monitoring (separate procedure)

 

95800

Sleep study, unattended, simultaneous recording; heart rate, oxygen saturation, respiratory analysis (e.g., by airflow or peripheral arterial tone), and sleep time

 

95801

Sleep study, unattended, simultaneous recording; minimum of heart rate, oxygen saturation, and respiratory analysis (e.g., by airflow or peripheral arterial tone)

 

95806

Sleep study, unattended, simultaneous recording of heart rate, oxygen saturation, respiratory airflow, and respiratory effort (e.g., thoracoabdominal movement)

 

95807

Sleep study, simultaneous recording of ventilation, respiratory effort, ECG or heart rate, and oxygen saturation, attended by a technologist

 

95808

Polysomnography; sleep staging with 1-3 additional parameters of sleep, attended by a technologist

 

95810

sleep staging with 4 or more additional parameters of sleep, attended by a technologist

 

95811

sleep staging with 4 or more additional parameters of sleep, with initiation of continuous positive airway pressure therapy or bilevel ventilation, attended by technologist

ICD-9 Procedure

89.17

Polysomnogram

 

89.18

Other sleep disorder function tests (includes multiple sleep latency test (MLST)

 

93.90

Respiratory Therapy; non-invasive mechanical ventilation

ICD-9 Diagnosis

780.09

Other alteration of consciousness (somnolence)

 

780.51

Insomnia with sleep apnea, unspecified

 

780.52

Insomnia, unspecified

 

780.53

Hypersomnia with sleep apnea, unspecified

 

780.57

Unspecified sleep apnea

 

780.57

Unspecified sleep apnea

HCPCS

A7027

Combination oral/nasal mask, used with continuous positive airway pressure device, each

 

A7028

Oral cushion for combination oral/nasal mask, replacement only, each

 

A7029

Nasal pillow for combination oral/nasal mask, replacement only, pair

 

A7034

Nasal interface (mask or cannula type) used with positive airway pressure device, with or without head strap

 

A7035

Headgear used with positive airway pressure device

 

A7036

Chin strap used with positive airway pressure device

 

A7037

Tubing used with positive airway pressure device

 

A7038

Filter, disposable, used with positive airway pressure device

 

A7039

Filter, nondisposable, used with positive airway pressure device

 

A9279

Monitoring feature/device, stand-alone or integrated, any type, includes all accessories, components and electronics, not otherwise classified

 

E0470

Respiratory assist device, bi-level pressure capability, without backup rate feature, used with noninvasive interface, e.g., nasal or facial mask (intermittent assist device with continuous positive airway pressure device)

 

E0485

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

 

E0486

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

 

E0561

Humidifier, non-heated, used with positive airway pressure device

 

E0562

Humidifier, heated, used with positive airway pressure device

 

E0565

Compressor, air power source for equipment which is not self-contained or cylinder driven

 

E0572

Aerosol compressor, adjustable pressure, light duty for intermittent use

 

G0398

Home sleep study test (HST) with type II portable monitor, unattended; minimum of 7 channels: EEG, EOG, EMG, ECG/heart rate, airflow, respiratory effort and oxygen saturation

 

G0399

Home sleep test (HST) with type III portable monitor, unattended; minimum of 4 channels: 2 respiratory movement/airflow, 1 ECG/heart rate and 1 oxygen saturation

 

G0400

Home sleep test (HST) with type IV portable monitor, unattended; minimum of 3 channels

ICD-10-CM
(effective 10/01/14)

G47.33

Obstructive sleep apnea (adult) (pediatric)

 

R06.81

Apnea, not elsewhere classified elsewhere

 

R40.0

Somnolence

 

G47.30

Sleep apnea, unspecified

 

G47.8

Other sleep disorders

 

G47.9

Sleep disorder unspecified

ICD-10-PCS
(effective 10/01/14)

4A1ZXQZ

Measurement and monitoring, physiological systems, monitoring, external, sleep, polysomnogram

 

5A09357

Extracorporeal assistance and performance, physiological systems, assistance, respiratory, less than 24 consecutive hours, ventilation, continuous positive airway pressure

 

5A09358

Extracorporeal assistance and performance, physiological systems, assistance, respiratory, less than 24 consecutive hours, ventilation, intermittent positive airway pressure

 

5A0935Z

Extracorporeal assistance and performance, physiological systems, assistance, respiratory, less than 24 consecutive hours, ventilation

 

5A09457

Extracorporeal assistance and performance, physiological systems, assistance, respiratory, 24-96 consecutive hours, ventilation, continuous positive airway pressure

 

5A09458

Extracorporeal assistance and performance, physiological systems, assistance, respiratory, 24-96 consecutive hours, ventilation, intermittent positive airway pressure

 

5A0955Z

Extracorporeal assistance and performance, physiological systems, assistance, respiratory, 24-96 consecutive hours, ventilation

 

5A09557

Extracorporeal assistance and performance, physiological systems, assistance, respiratory, greater than 96 consecutive hours, ventilation, continuous positive airway pressure

 

5A09558

Extracorporeal assistance and performance, physiological systems, assistance, respiratory, greater than 96 consecutive hours, ventilation, intermittent positive airway pressure

 

5A0955Z

Extracorporeal assistance and performance, physiological systems, assistance, respiratory, greater than 96 consecutive hours, ventilation

Type of Service

Medical

 

Place of Service

Facility/
Home

 

Appendix

EPWORTH SLEEPINESS SCALE

Name: ___________________________________________________ Date: _______________________________

How likely are you to doze off or fall asleep in the following situations, in contrast to feeling just tired? This refers to your usual way of life in recent times. Even if you have not done some of these things recently, try to work out how they would have affected you. Use the following scale to choose the most appropriate number for each situation:

0 = would never doze

1 = slight chance of dozing

2 = moderate chance of dozing

3 = high chance of dozing

Situation Chance for Dozing

Sitting and reading _______________

Watching TV _______________

Sitting inactive in a public place (e.g., a theater or a meeting) _______________

As a passenger in a car for an hour without a break _______________

Lying down to rest in the afternoon when circumstances permit _______________

Sitting and talking to someone _______________

Sitting quietly after a lunch without alcohol _______________

In a car, while stopped for a few minutes in the traffic _______________

Thank you for your cooperation.

History

Date

Reason

04/14/98

Add to Medicine Section - New Policy

06/01/99

Replace policy - Added information on Upper Airway Resistance Syndrome.

11/02/99

Replace policy - Policy Guidelines changed.

05/08/01

Replace policy - Policy reviewed and updated; description expanded.

09/11/01

Replace policy - Policy revised to include information received from Dr. Elmer on humidifiers.

02/12/02

Replace policy - Policy reviewed; UARS description updated.

05/14/02

Replace policy - Policy updated to delete the requirement for a trial of CPAP prior to purchase.

02/11/03

Replace policy - Policy updated to local medical practice.

06/17/03

Replace policy - Policy reviewed and updated, regarding surgical treatments for OSA.

06/08/04

Replace policy - Policy revised with code updates; no criteria changes.

07/13/04

Replace policy - Policy revised; no change in policy statement.

09/01/04

Replace policy - Policy renumbered from PR.2.01.103. No date changes.

12/14/04

Replace policy - Redundant information removed from the Rationale section.

05/10/05

Replace policy - Policy reviewed and updated regarding minimally invasive surgery for snoring, obstructive sleep apnea syndrome/upper airway resistance syndrome.

02/06/06

Codes updated - No other changes.

05/09/06

Replace policy - Policy reviewed with literature search; references updated; no change in policy statement.

12/12/06/06

Replace policy - Policy updated with literature review; policy statement updated to indicate portable home sleep studies as medically necessary when criteria are met. References added.

04/10/07

Replace policy - Policy updated with literature review; references added and codes updated. No change in policy statement.

03/11/08

Replace policy - Policy updated with literature search; no change in policy statement. References and code added.

07/08/08

Codes Updated - Added HCPCS codes: G0398, G0399, G0400 – retroactive to 3/13/08.

10/14/08

Replace policy - Policy updated with literature search, no change to the policy statement. References added.

05/12/09

Replace policy - Policy updated with literature search, no change to the policy statement. Policy guidelines extensively updated. Reference added.

09/15/09

Codes updated - Added 0203T & 0204T. No other changes.

02/09/10

Replace policy - Policy updated with literature search; Additional policy statements re: CPAP, auto-adjusting CPAP, Bilevel positive airway pressure added as medically necessary. Additional information regarding children added.

03/09/10

Replace policy - Policy updated with literature search; no change to the policy statement. Minor update to policy guidelines section, regarding unsupervised home sleep studies limited to 1 night.

05/11/10

Replace policy - Policy updated with literature. Provent Device added to policy statement as investigational. Statements revised re: diagnosis of OSA. Additional high risk conditions added (Hypertension despite optimal medical management, preoperative evaluation for bariatric surgery, type 2 diabetes, nocturnal dysrhythmias, high risk driving populations, pulmonary hypertension, male gender or postmenopausal females. Unsupervised sleep studies high risk conditions revised to add insomnia, parasomnias). Finally, interpretation of test results of unattended sleep studies should be validated only by sleep specialists (suggested board certification in sleep medicine or board eligible).

01/11/11

Replace policy - Policy updated with literature review and extensive updates and reorganization. The word “treatment” within the title has been changed to “medical management”. References have been updated, added, removed and reordered. The policy statements have been updated and organized by category: risk assessment, diagnostic testing, diagnosis criteria, titration, repeat testing, and durable medical equipment. The Policy Guidelines have been updated with CPT codes for PAP-NAP. The policy will be effective September 1, 2011, following 90-day hold for provider notification.

09/1/11

Policy changes of 1/1/11 are now effective.

10/11/11

Replace policy – Policy updated for clarification purposes: criteria for medically necessary policy statement on unattended home sleep studies modified with the inclusion of “suspicion of” as it relates to the absence of other sleep disorders, with listed examples unchanged; the criteria listed for the medically necessary policy statement on facility/laboratory sleep studies was altered to clarify the inclusion of patients with a contraindication for home sleep study due to suspicion of other sleep disorders.

01/10/12

Replace policy – Policy statement on multiple sleep latency test as not medically necessary removed. This test will no longer require clinical review.

04/10/12

Replace policy - Clarification was made within the medical necessity criteria for facility/laboratory PSG in patients with suspected OSA for whom testing is being done to rule out other sleep disorders; these patients may qualify.

10/09/12

Replace policy. Policy statements and rationale pertaining to DME removed and placed in new policy 1.01.524, Added references 24, 25, 26. Removed insomnia and circadian rhythm disorders from policy statements. Code 94660 removed from policy; this applies to CPAP which is now covered in a separate medical policy.

11/27/12

Replace policy. Policy Guidelines section updated to clearly indicate an AHI of 15 is considered severe in children; reference to American Academy of Chest Surgeons and American Academy of Sleep Medicine suggested diagnosis guidelines removed. Policy statements remain unchanged.

04/15/13

HCPCS code E0471 removed from policy; this code is for bipap with assistance (ventilator support) which does not apply to this policy.

08/12/13

Replace policy. Policy section updated with statement that actigraphy test is addressed in a separate policy and oral pressure therapy (OPT)-Winx system, is considered investigational. Policy guidelines – conditions alphabetized. Rationale section updated based on literature review through June 2013. Reference 38 added; others renumbered/removed. Policy statement changed as noted.

10/14/13

Replace policy. Added hypoventilation definition to guidelines section. Removed Medical Management and Upper Airway Respiratory Syndrome from the policy title.

12/04/13

Replace policy. Diagnostic criteria and definitions for other sleep disorders (central sleep apnea, narcolepsy, and PMLD) added to the Policy Guidelines section. Add ICD-10 codes.

03/10/14

Replace policy. Policy section updated to indicate that facility sleep testing may be considered medically necessary when there is a concern that the primary diagnosis is PLMD (periodic limb disorder movement), if obstructive sleep apnea has been ruled out.


Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA).
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