Medical Policy: 07.01.21
Original Effective Date: January 2001
Reviewed: March 2017
Revised: March 2017
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
Obstructive sleep apnea syndrome (OSA) is characterized by repetitive episodes of upper airway obstruction due to the collapse of the upper airway during sleep. The patient is usually unware of it and sometimes may awaken gasping for breath. In patients with OSA, the normal pharyngeal narrowing is accentuated by anatomic factors, such as a short, wide neck, elongated palate and uvula, or large tonsillar pillars with redundant lateral pharyngeal wall mucosa. The diagnosis of OSA involves measuring breathing during sleep, and is typically diagnosed by overnight monitoring with polysomnography (PSG) (sleep study).
The hallmark clinical symptom of OSA is excessive daytime sleepiness; the hallmark clinical sign is snoring. With 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 the repeated arousal during sleep can lead to impairment of daytime activity. Adult patients with OSA and associated daytime somnolence are thought to be a higher risk for accidents involving motorized vehicles or heavy equipment. 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, pulmonary hypertension and cor pulmonale. Systemic hypertension is common in patients with OSA. Severe OSA is also associated with decreased survival, presumably related to severe hypoxemia, hypertension, or an increase in automobile accidents related to daytime sleepiness.
In adults,OSA is often suspected on the basis of the clinical history and physical appearance. The presence or absence and severity of OSA must be determined before initiating treatment. The diagnostic criteria is 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 (polysomnography).
Excessive daytime sleepiness may be subjective and may be assessed by questionnaires (e.g. Epworth Sleepiness Scale, Berlin Questionnaire, STOP Questionnaire and STOP-BANG Questionnaire).
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 situations, in contrast to feeling just tired?”
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.
The STOP-BANG questionnaire is an OSA screening tool consisting of four yes/no questions and four clinical attributes that incorporates information on the signs and symptoms of OSA that includes snoring, tiredness, observed apneas, blood pressure, BMI, age, neck circumference and gender. The Berlin questionnaire consists of eleven questions divided into three categories to classify the patient as high or low risk for OSA. The STOP questionnaire consists of four yes/no questions to assess signs and symptoms of OSA.
The final diagnosis of OSA rests on a combination of clinical evaluation and objective criteria to identify those levels of obstruction that are considered to be clinically significant. The gold standard diagnostic test for sleep disorders is considered a polysomnogram (sleep study), which can be done in an accredited facility or sleep laboratory or in the home.
A facility based sleep study (polysomnography (PSG)) is conducted in an accredited facility or sleep laboratory site and requires an overnight stay. PSG is designed to capture multiple sensory channels including blood pressure, brain waves, breathing patterns and heartbeat as an individual sleeps. It can also record eye and leg movements and muscle tension which can be useful in diagnosing parasomnias. A PSG performed at a facility or sleep laboratory will record a minimum of 12 channels which involves at least 22 wire attachments to the individual. Sensors that send electrical signals to a computer are placed on the chest, face, head and legs. The test is attended by a technologist and the results are evaluated by a qualified sleep physician. A PSG may be performed in conjunction with positive airway pressure (PAP) machine to determine the titration of oxygen flow.
By definition, a polysomnogram always includes sleep staging. The three elements EEG, chin electromyogram and elctro-oculogram (EOG) are required for sleep staging. Sleep staging is performed to assess arousals from sleep, and determination of the frequency of apneas and hypopneas from channels measuring oxygen desaturation, respiratory airflow and respiratory effort. The actual components of the study will be dictated by the clinical situation.
Per the American Academy of Sleep Medicine (AASM) guidelines a facility based polysomnography (sleep study) is recommended rather than home sleep study for the diagnosis of OSA in patients with significant cardiorespiratory disease, potential respiratory muscle weakness due to neuromuscular condition, awake hypoventilation or suspicion of sleep related hypoventilation, chronic opioid medication use, history of stroke or severe insomnia. In this population of patients a facility based sleep study is considered the gold standard method for the diagnosis of OSA. Home based sleep studies have not been adequately validated or demonstrated to provide favorable clinical outcomes and efficient care in the above patient population, which may result in harm through inaccurate assessment of sleep disordered breathing. Facility based PSG are not appropriate for general screening of asymptomatic populations.
A facility or sleep laboratory-based PSG may also be indicated when a home sleep study (portable monitoring) is technically inadequate or fails to establish the diagnosis in an individual with a high pretest probability of OSA.
Unsupervised (unattended) home sleep study and PAP titration is an alternative to an accredited facility or sleep laboratory based sleep disorder testing to diagnose obstructive sleep apnea (OSA). There may be limited access to in-laboratory (facility based) testing in some areas. This may also be considered a more cost effective setting, which is often more comfortable and convenient for the individual and a more efficient way of testing a certain adult patient population. Based on the American Academy of Sleep Medicine guidelines regarding diagnostic testing for adult OSA, home sleep apnea testing with a technically adequate device may be used for the diagnosis of OSA in uncomplicated adult patients presenting with signs and symptoms that indicate an increased risk of moderate to severe OSA. An increased risk of moderate to severe OSA is indicated by the presence of excessive daytime sleepiness and at least two of the following: habitual loud snoring, witnessed apnea or gasping or choking, or diagnosed hypertension.
Based on clinical guidelines on the use of home sleep studies (unsupervised/unattended) for the diagnosis of obstructive sleep apnea (OSA) in adults by the American Academy of Sleep Medicine (AASM), the study should be performed only in conjunction with a comprehensive sleep evaluation and used for the diagnosis of OSA in uncomplicated adult patients presenting with signs and symptoms that indicate an increased risk of moderate to severe OSA. AASM defines an uncomplicated patient by the absence of the following: conditions that place the patient at increased risk of non-obstructive sleep disordered breathing (e.g. central sleep apnea, hypoventilation and sleep related hypoxemia): examples of these conditions include significant cardiopulmonary disease, potential respiratory muscle weakness due to neuromuscular conditions, history of stroke or chronic opiate medication use; concern for significant non-respiratory sleep disorder(s) that require evaluation (e.g. disorders of hypersomnolence, parasomnias, sleep related movement disorders) or interfere with accuracy of home sleep studies (e.g. severe insomnia); environmental or personal factors that preclude the adequate acquisition and interpretation of data. A technically adequate diagnostic test includes a minimum of 4 hours of technically adequate oximetry and flow data obtained during a recording attempt that encompasses the habitual sleep period. Also, home sleep studies are not appropriate for general screening of asymptomatic populations.
Home based sleep testing utilizes portable monitoring (PM) FDA approved devices that are designed to be used by an individual without supervision of a sleep technologist. Provision of the device, patient instruction, and support can be provided by sleep centers, professional providers, and/or independent diagnostic testing facilities that can demonstrate how to use FDA approved devices, inspect the devices and administer patient education. The patient applies the sensors as instructed to the body before sleep time and sleeps with the equipment. The equipment is returned to the diagnostic service provider/company where the data is downloaded and processed for interpretation by a sleep physician. Home based sleep testing portable monitoring devices measure fewer parameters than a laboratory based sleep study and per the American Academy of Sleep Medicine a technically adequate home sleep testing device incorporates a minimum of the following sensors: nasal pressure, chest and abdominal respiratory inductance plethysmography, and oximetry.
Traditionally sleep studies have been categorized as Type I, Type II, Type III or Type IV (see below sleep monitoring devices). Unattended/home based sleep studies fall into categories Type II through Type IV. Type II studies use the same monitoring sensors as full polysomnography (Type I). Type III studies use devices that measure limited cardiopulmonary parameters; two respiratory variables (e.g. effort to breathe, airflow), oxygen saturation and a cardiac variable (e.g. heart rate or electrocardiogram). Type IV studies utilize devices that measure only 1 or 2 parameters, typically oxygen saturation and heart rate, or in some cases just air flow. A home based study is conducted over at least one night.
|Type I||Comprehensive Standard Overnight polysomnography in a sleep center or laboratory with a sleep technician in constant attendance.||Minimum of 7 channels including EEG, EOG, chin EMG, ECG or heart rate, airflow, respiratory effort, oxygen saturation|
|Type II||Home sleep test (HST) type II portable monitor, unattended||
Minimum of 7 channels including EEG, EOG, EMG, ECG/heart rate, airflow, respiratory effort and oxygen saturation
Home sleep test (HST) type III portable monitor, unattended
Minimum of 4 channels: 2 respiratory movement/airflow, 1 ECG/heart rate and 1 oxygen saturation
|Type IV (A)||Home sleep test (HST) type IV portable monitor; three or more bioparameters||
Airflow and at least 2 other parameters (e.g. EOG, peripheral arterial tonometry (PAT), snoring or pulse oximetry)
|Type IV (B)||
Home sleep test (HST) type IV portable monitor; continuous single or dual bioparameter recording
Minimum of 1 parameter (e.g. overnight oximetry)
Note: Guidelines indicate that nocturnal pulse oximetry alone is not appropriately used as a case finding or screening method for OSA. Pulse oximetry, when used alone, has not been shown to have an adequate predictive value to rule out OSA. All patients with symptoms suggestive of OSA would require polysomnography regardless of whether the pulse oximetry was positive or negative.
When a diagnosis of OSA is established following a home study, home titration to determine a fixed PAP pressure can be effectively completed using auto-titrating positive airway pressure (APAP). Evidence from several well-designed trials demonstrates that home PAP titration using APAP compared to in-facility titration results in similar outcomes in terms of improvement in AHI, Epworth Sleepiness scores, and CPAP acceptance and adherence.
APAP devices deliver variable pressure according to the needs of the patient. When an obstructive event is detected, an APAP device will increase pressure until the event is eliminated. If no further events are detected during a set time period, the device will decrease pressure to a pre-set minimum. APAP devices may use combinations of physiologic signals to detect airflow obstruction, including snoring, flow or impedance. Because the minimum pressure required to keep the airway open is used, the mean pressure applied throughout the night is reduced. This reduction in mean pressure may improve tolerance in some patients, resulting in improved adherence with the use of PAP.
Per the American Academy of Sleep Medicine practice parameters for use of auto-titrating continuous positive airway pressure devices for titrating pressures and treating adult patients with obstructive sleep apnea syndrome: an update for 2007, the recommendations include that certain APAP devices may be used in an unattended way to determine fixed CPAP treatment pressure for patients with moderate to severe OSA without significant comorbidities (CHF, COPD, central sleep apnea syndrome, or hypoventilation syndromes).
There is adequate evidence to demonstrate that portable monitoring/home sleep apnea studies accurately predict AHI suggestive of OSA with high positive likelihood ratios and low negative likelihood ratios in patients with a high pretest probability of OSA. Comparative effectiveness studies that have evaluated clinical outcomes of patients managed with home testing vs. those managed with facility/sleep laboratory PSG and demonstrated similar outcomes in terms of functional improvement (e.g., sleepiness scores, activity level, vigilance, productivity), and CPAP adherence.
Apnea is defined as the cessation of airflow for at least 10 seconds.
Based on 2013 clarification by the American Academy of Sleep Medicine (AASM) the recommendation for hypopnea scoring criteria is the following:
The apnea-hypopnea index (AHI) is equal to the average number of episodes of apnea and hypopnea per hour of sleep without the use of positive airway pressure device. Sleep time can only be measured in a Type I (facility based polysomnogram) or Type II sleep study. The AHI is reported only in Type I or Type II sleep studies.
The respiratory disturbance index (RDI) is equal to the episodes of apnea and hypopnea per hour of recording without the use of a positive airway pressure device. The RDI is reported in Type III and Type IV sleep studies.
A full night polysomnography (PSG) is recommended for the diagnosis of sleep related breathing disorder, but a split-night study (initial diagnostic PSG followed by continuous positive airway pressure titration on the same night) is an alternative to one full night of diagnostic PSG. The split-night study may be performed if an apnea/ hypopnea index (AHI) > 40/hour is documented during a minimum of 2 hours of a diagnostic study but may be considered for an AHI of 20-40/hour based on clinical judgement. Also, there needs to be at least 3 hours available for PAP titration.
The diagnosis of OSA is confirmed if the number of obstructive events (apneas, hypopneas + respiratory event related arousals) on PSG is greater than 15 events/hour or greater than 5/hour in a patient who reports 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 patients sleep.
The medical professional who is interpreting a supervised sleep study 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.
Medical management of OSA includes:
The multiple sleep latency test (MLST) involves multiple trials (4 to 5 times) during a day to objectively assess sleep tendency by measuring the number of minutes it takes the patient to fall asleep.
The MSLT records whether the patient falls asleep during the test and what types and stages of sleep the patient is having. The MSLT is the better test for demonstration of sleep onset rapid of eye movement (REM) periods. The types and stages of sleep during the day can help establish the diagnosis of narcolepsy and idiopathic hypersomnia.
According to American Academy of Sleep Medicine (AASM), the MSLT is indicated as part of the evaluation of patients with suspected narcolepsy to confirm the diagnosis, and for patients with suspected idiopathic hypersomnia to help differentiate idiopathic hypersomnia from narcolepsy. The MSLT is not routinely indicated in the initial evaluation and diagnosis of obstructive sleep apnea or in assessment of change following treatment with nasal CPAP. The MSLT is not routinely indicated for evaluation of sleepiness in medical and neurological disorders (other than narcolepsy and idiopathic hypersomnia), insomnia, or circadian rhythm disorders.
Actigraphy refers to the assessment of activity patterns (body movement) using devices typically placed on the wrist or ankle that are interpreted by computer algorithms as periods of sleep (absence of activity) and wake (activity). Actigraphy devices are typically placed on the nondominate wrist with wristband and are worn continuously for at least 24 hours. Activity is usually recorded for a period of 3 days to 2 weeks but can be collected continuously over extended time periods with regular downloading of data onto a computer. The activity monitors may also be placed on the ankle for the assessment of restless leg syndrome.
The algorithms for detection of movement are variable among devices. Data on patient bed times (lights out) and rise times (lights on) are usually entered into the computer record from daily patient sleep logs or by patient activated event markers. Proprietary software is then used to calculate periods of sleep based on the absence of detectable movement, along with movement related to level of activity and periods of wake. In addition to providing graphic depiction of the activity pattern, device specific software may analyze and report a variety of sleep parameters including sleep onset, sleep offset, sleep latency, total sleep duration and wake after sleep onset. Actigraphy might also be used to measure the level of physical activity.
Actigraphy has been used for more than 2 decades as an outcome measure in sleep disorder research. For clinical applications, actigraphy is being evaluated as a measure of sleep-wake cycles in sleep disorders, including insomnia and circadian rhythm sleep disorders. In addition, actigraphy is being investigated as a measure of sleep-wake disturbances associated with numerous diseases and disorders.
Updated practice parameters in 2007 by American Academy of Sleep Medicine (AASM) on the use of actigraphy in the assessment of sleep and sleep disorders recommended actigraphy as a “standard” only as a method to estimate total sleep time in patients with obstructive sleep apnea syndrome when polysomnography (PSG) is not available. Other indications changed from “option” to “guideline” but failed to reach a recommendation of “standard” due primarily to the absence of high-quality trials. Few studies provided technical details related to the administration and scoring of actigraphy. In addition, most studies lacked descriptions of blinding, and there was “an inadequate description of whether visual inspection of data is performed, how missing data is handled, and other important decisions made in the analysis of actigraphy data.” AASM indicated the need for additional research in the following areas:
For individuals who have circadian sleep-wake rhythm disorders, central disorders of hypersomnolence, or insomnia who receive actigraphy, the evidence includes prospective and retrospective validation studies. The clinical validity of actigraphy depends, to a large extent, on the modality for which it is being compared. Comparisons with sleep diaries have shown reasonable correlations for measures of bedtime, sleep onset, and wake time in adults. The relative and unique contributions of actigraphy and sleep logs in the diagnosis of sleep disorders and measurement of treatment effects remain to be demonstrated. Comparisons with the more resource-intensive polysomnography or behavioral scoring have indicated that actigraphy has sufficient sensitivity to detect sleep but has poor specificity distinguishing between wake and sleep. The literature has also shown that the accuracy of actigraphy for differentiating between wake and sleep decreases as the level of sleep disturbance increases. Overall, progress has been made since 2007 American Academy of Sleep Medicine (AASM) research recommendations in comparing the reliability and the validity of different algorithms with the reference standard. Although actigraphy appears to provide reliable measures of sleep onset and wake time in some patient populations, its clinical utility over sleep diaries has not been demonstrated. Moreover, evidence has shown that actigraphy does not provide a reliable measure of sleep efficiency in clinical populations. The evidence to date does not indicate that this technology is as beneficial as the established alternatives and is insufficient to determine the effects on net health outcomes.
The SleepStrip is an OSA screening device that incorporates signal detection, acquisition and display in a disposable package. The self-adhesive device is placed on the upper lip at bedtime and adjusted until respiration is detected, as indicated by a flashing light. Two nasal thermistors and one oral thermistor produce flow signals that are processed within the SleepStrip’s microprocessor (CPU). The five possible results are as follows: zero (no apneas); one (mild sleep apnea, comparable to sleep lab AHI between 15 and 24); two (moderate sleep apnea, comparable to sleep lab AHI between 25 and 39); three (severe sleep apnea, comparable to sleep lab AHI of greater than 40); and E (error in measurement).
SleepStrip has a low correlation with the AHI as measured by PSG, and further studies are needed before this device can be recommended as a screening tool for the diagnosis of OSA. The evidence is insufficient to determine the effects on net health outcomes.
An abbreviated cardiorespiratory sleep study, referred to as a PAP-nap study, has been proposed as a method to acclimate patients to PAP and promote adherence to therapy. The PAP-nap study includes mask and pressure desensitization and therapy to overcome aversive emotional reactions, mental imagery, and physiologic exposure to PAP therapy during a nap period. There is insufficient evidence in the published medical literature to determine whether PAP-nap studies result in improved adherence to therapy and is insufficient to determine the effects on net health outcomes.
Topographic brain mapping has been briefly described in the evaluation and diagnosis of obstructive sleep apnea (OSA). The evidence is limited to small case series studies that do not allow full evaluation of this technology. Based on the peer review medical literature the evidence is insufficient to determine the effect on net health outcomes.
In 2017, the American Academy of Sleep Medicine (AASM) issued clinical practice guideline for diagnostic testing for adult obstructive sleep apnea which includes the following recommendations:
In 2005, the American Academy of Sleep Medicine (AASM) issued practice parameters for clinical use of the multiple sleep latency test and the maintenance of wakefulness test, which included the following recommendations:
|Home Sleep Study Testing (Unsupervised/Unattended)||
Home sleep study testing (unsupervised/unattended) may be considered medically necessary in adult patients who have symptoms suggestive of moderate to severe obstructive sleep apnea (OSA), when ALL of the following criteria are met:
*If no bed partner is available to report snoring or observed apneas, the patient must still meet the criteria as it relates to other signs and symptoms suggestive of OSA;
|Repeat Home Sleep Study Testing (Unsupervised/Unattended)||
Repeat home sleep study testing (unsupervised/unattended) may be considered medically necessary in adult patients for any of the following:
|Home sleep study (unsupervised/unattended) for asymptomatic individuals||
Home sleep study testing (unattended/unsupervised) for an asymptomatic individual is considered not medically necessary.
|Supervised sleep study performed in a facility or sleep laboratory for an adult patient who meets criteria for a home sleep study||A supervised sleep study performed in a facility or sleep laboratory is considered not medically necessary when an adult patient meets the criteria above for a home sleep study|
|Initial - supervised sleep study performed in a facility or sleep laboratory||
May be considered medically necessary in adult patients with symptoms suggestive of moderate to severe obstructive sleep apnea (OSA) when one of the following are met:
Note: Patients considered to have symptoms suggestive of moderate to severe OSA will include the following:
|Split night sleep study performed in a facility or sleep laboratory||
A split-night sleep study performed in a facility or sleep laboratory (initial diagnostic sleep study followed by PAP titration during sleep study on the same night) is an alternative to one full night diagnostic sleep study followed by a second night of titration and may be considered medically necessary when the following criteria are met:
|Repeat supervised sleep study performed in a facility or sleep laboratory||
Repeat supervised sleep study performed in a facility or sleep laboratory may be considered medically necessary in adult patients for one of the following reasons:
|Supervised sleep study performed in a facility or sleep laboratory for asymptomatic individuals||
Supervised sleep study performed in a facility or sleep laboratory for an asymptomatic individual is considered not medically necessary.
Supervised sleep study performed in a facility or sleep laboratory (95807, 95808, 95810, 95811) or a home sleep study (unsupervised/unattended) (95800, 95801, 95806, G0398, G0399, G0400), are considered not medically necessary including but not limited to the following indications:
Multiple Sleep Latency Test (MSLT) (95805)
|Initial multiple sleep latency testing (MSLT)||
Multiple sleep latency test (MSLT) would be considered medically necessary for the following indications:
Multiple sleep latency test (MSLT) is considered not medically necessary for any one of the following:
|Repeat multiple sleep latency testing (MSLT)||
Repeat multiple sleep latency test (MSLT) would be considered not medically necessary, unless one of the following occurs:
Actigraphy is considered investigational for the routine diagnosis, assessment of severity or management of any sleep disorders.
Overall, progress has been made since 2007 American Academy of Sleep Medicine (AASM) research recommendations in assessing the validity of different algorithms in comparison with the reference standard. Although actigraphy appears to provide reliable measures of sleep onset and wake time in some patient populations, the clinical utility of actigraphy over the less expensive sleep diary has not been demonstrated. Moreover, evidence indicates that actigraphy does not provide a reliable measure of sleep efficiency in clinical populations. Evidence to date does not indicate that this technology is as beneficial as the established alternatives or that the use of actigraphy would result in improved health outcomes for patients with sleep disorders. Therefore, actigraphy is considered investigational.
Based on peer reviewed literature topographic brain mapping has been briefly described in the evaluation and diagnosis of OSA. However, the evidence is limited to small case series studies that do not allow full evaluation of this technology. At this time, the level of evidence supporting topographic brain mapping is insufficient and therefore is considered investigational.
SleepStrip has a low correlation with the AHI as measured by PSG, and further studies are needed before this device can be recommended as a screening tool for the diagnosis of OSA. Therefore, the clinical effectiveness of this diagnostic testing has not been established and is considered investigational.
There is insufficient evidence in the published medical literature to determine whether PAP-nap studies result in improved adherence to therapy or improved patient outcomes. Therefore, the clinical effectiveness of this diagnostic testing has not been established and is considered investigational.
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