Medical Policy: 02.01.55
Original Effective Date: October 2014
Reviewed: June 2017
Revised: June 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.
Child is defined as 1 through 17 years of age.
Obstructive sleep apnea (OSA) is characterized by episodes of complete or partial upper airway obstruction during sleep, often resulting in gas exchange abnormalities and disrupted sleep. Untreated OSA is associated with learning and behavioral problems, cardiovascular complications and impaired growth (including failure to thrive). OSA occurs in 1 to 5 percent of children. It can occur at any age and may be most common in those between two and six years of age.
Adenotonsillar hypertrophy and obesity (BMI > 97th percentile for age and gender) are the major risk factors for obstructive sleep apnea (OSA) in otherwise healthy children. The contribution of each of these risk factors varies among individuals and also tends to vary with age.
Other risk factors for medical, neurological, skeletal or dental conditions that reduce upper airway size, affect the neural control of the upper airway, or impact the collapsibility of the upper airway are also risk factors. Examples include the following:
Clinicians should incorporate questions about sleep into routine health assessment for children of all ages because parents may not volunteer information about their child’s sleep, or may not appreciate the potential relationship between sleep problems and daytime behavior. Children with sleep disorders may present with different symptoms than adults. Most children with obstructive sleep apnea may present with daytime attentional or behavioral problems rather than overt sleepiness. Even within the pediatric age group, the clinical manifestations of sleep problems may vary by age and developmental level. A school aged child with excessive sleepiness may exhibit motor overactivity, inattentiveness, irritability or maintaining sleep (insomnia) may coexist with anxiety or depression in adolescents, and may worsen certain medical or psychiatric problems.
A thorough sleep and medical history provides the foundation for diagnosis and management of sleep problems. A variety of checklists and questionnaires are available to supplement the history. BEARS is a screening acronym that prompts a clinician to inquire about five sleep areas (B= Bedtime issues; E= Excessive daytime sleepiness; A= Night awakenings; R= Regularity and duration of sleep; S= Sleep disordered breathing (or snoring)). This type of screen can help identify patients who should be evaluated with a more detailed sleep history. Once the chief sleep complaint is identified, the history can focus on details that distinguish among disorders in that category. The history should include details about the duration and frequency of the problem, temporal profile of onset (abrupt, gradual, intermittent), and degree of variability from night to night. Most chief complaints can be placed into one (or more) of four categories:
Parents are generally asleep during the night, they may struggle to provide a full history, as they may witness only portions of nighttime events. Some parents may generate diaries or logs of sleep problems, and the widespread availability of home video cameras and smartphones have increased the opportunity for physicians to observe episodes of abnormal movement or behavior.
The physical examination is directed towards identification of causes of sleep disorders or conditions associated with sleep pathology. The examination includes a general physical examination, oropharynx/airway examination and neurological examination.
Thorough assessment and treatment of children and adolescents with sleep disorders can require a multidisciplinary approach. For suspected obstructive sleep apnea (OSA) if polysomnography is indicated, this can be arranged by the sleep physician.
Overnight supervised polysomnography (PSG) in a sleep laboratory remains the gold standard diagnostic test to diagnose, exclude or assess obstructive sleep apnea (OSA) severity in children and adolescents. A single overnight study is usually adequate if a sufficient duration of sleep occurs, including at least one period of rapid eye movement (REM) sleep. It should be noted that polysomnography (PSG) values in children with obstructive sleep apnea (OSA) is not unanimously agreed upon in the literature. The final interpretation of sleep study findings by a qualified sleep medicine physician must be considered in the context of the child’s health, symptoms, and daytime functional impairment to most accurately assess OSA significance, severity and impact. The diagnosis of OSA in a child generally is made when relevant symptoms are present, and a facility/laboratory based sleep study shows a respiratory disturbance (RDI) or apnea-hypopnea index (AHI) >1 per hour of sleep.
Polysomnography sleep test involves the continuous, simultaneous recording of physiological parameters for a period of at least 6 hours. The parameters measured are a frontal, central and occipital lead EEG (3 leads), submental EMG lead and left and right EOG, (from which sleep is staged), plus four or more additional parameters. The additional parameters typically required in polysomnography are listed below:
The following are the current diagnostic criteria for pediatric obstructive sleep apnea (OSA) as defined by the American Academy of Sleep Medicine (AASM). Each of the five criteria should be present for a child to be diagnosed with OSA:
Polysomnography in children should be performed and interpreted in accordance with the recommendations of the AASM Manual for the Scoring of Sleep Associated Events.
Polysomnography is also used in evaluation for non-respiratory issues in children, such as sleep related movements or behaviors. The polysomnography may also be used in conjunction with a multiple sleep latency test (MSLT).
Based on recommendations from American Academy of Sleep Medicine (AASM) a supervised facility/laboratory polysomnography would be indicated in the following non-respiratory indications:
Based on the American Academy of Sleep Medicine (AASM) guidelines for the Manual Titration of Positive Airway Pressure in Patients with Obstructive Sleep Apnea they consider an adult ( ≥ 12 years ) and a pediatric patient (< 12 years).
A full-night, attended/supervised polysomnography performed in the laboratory is the preferred approach for titration to determine optimal positive airway pressure; however, split-night, diagnostic titration studies are usually adequate for a patient ≥ 12 years of age. The titration algorithm for a split-night CPAP or BPAP titration study should be identical to that of a full-night CPAP or BPAP titration study.
There is insufficient data per AASM guidelines to make any recommendations for split-night CPAP or BPAP titration studies in children <12 years.
Home sleep studies/unattended (unsupervised) sleep studies/ambulatory sleep studies in children have been used predominately in the research setting. There has been a small amount of research comparing unattended (unsupervised) sleep studies to traditional in laboratory attended (supervised) sleep studies, and there is insufficient data upon which to base reliable clinical recommendations for children at this time. Further studies are needed and therefore, this testing is considered investigational for children and adolescents.
Alternative diagnostic testing/screening techniques such as nocturnal video recording, nocturnal oximetry, daytime nap polysomnography or ambulatory polysomnography are being investigated in the diagnosis of obstructive sleep apnea (OSA) in children. Based on the available peer reviewed literature the safety and/or effectiveness of these alternative diagnostic testing/screening techniques in the diagnosis of obstructive sleep apnea cannot be established and is considered investigational.
Airway radiography, cephalometry (a lateral radiograph of the head and neck), and computed tomography of the upper airway are not indicated in the routine diagnostic evaluation of children with suspected obstructive sleep apnea (OSA).
The multiple sleep latency testing (MSLT) is an objective, in-laboratory assessment for excessive daytime sleepiness. This test is based on the concept that the speed in which one falls asleep is an indication of the severity of sleepiness. The MSLT is also used more specifically to assess for narcolepsy when the clinical history suggest this diagnosis.
The MSLT is performed following a nocturnal facility based supervised polysomnography (PSG) and consists of five nap opportunities at two-hour intervals across the day. A maximum of 20 minutes is permitted for the nap attempt. If no sleep occurs, the sleep latency for that nap is considered to be 20 minutes when the mean sleep latency is calculated. Normative values in children are less well defined than in adults, but normal school-aged children typically remain awake throughout each 20 minute nap opportunity, or demonstrate mean sleep latency in the 15 to 20 minute range.
According to American Academy of Sleep Medicine (AASM), the MSLT is not routinely indicated in the initial evaluation and diagnosis of obstructive sleep apnea or in assessment of change following treatment with CPAP. The MSLT is not routinely indicated for evaluation of sleepiness in medical and neurological disorders (other than narcolepsy) and idiopathic insomnia.
Actigraphy refers to the assessment of activity patterns (body movements) 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 non-dominate 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.
Note: Interpretation of sleep study test results should be validated by a board certified sleep specialist.
Home sleep studies/unattended sleep studies/ambulatory sleep studies are considered investigational in children and adolescents.
Home sleep studies/unattended sleep studies/ambulatory sleep studies outside the sleep laboratory in children have been used predominately in the research setting. There have been a small amount of research comparing home/unattended sleep studies to traditional in laboratory attended sleep studies, and there is insufficient data upon which to base reliable clinical recommendations for children at this time and therefore this testing is considered investigational.
Facility/laboratory (supervised) sleep studies in children and adolescents may be considered medically necessary when any one of the following are met:
Frequent snoring ≥ 3 nights per week and any of the following complaints or associated features of obstructive sleep apnea (OSA):
The use of supervised sleep studies performed in a sleep facility/laboratory is considered investigational for all other indications due to lack of evidence demonstrating improved net health outcomes.
A split-night sleep study in the facility/laboratory (supervised), in which the initial diagnostic portion of the sleep study is followed by positive airway pressure (PAP) titration (titration alogorithm should be identical to that of a full night CPAP or BPAP titration study) may be considered medically necessary in children ≥ 12 years of age.
Based on peer reviewed literature there is insufficient data to make any recommendations for a split-night sleep study in children < 12 years of age and would be considered investigational.
Repeat supervised facility/laboratory sleep study in children and adolescents may be considered medically necessary when any one of the following are met:
Six to eight weeks post adenotonsillectomy or other pharyngeal surgery for obstructive sleep apnea (OSA) and obstructive sleep apnea (OSA) was present on pre-operative sleep study or other symptoms related to pre-operative sleep disordered breathing persist or recur.
Alternative diagnostic testing/screening techniques for the diagnosis of obstructive sleep apnea (OSA) in children and adolescents, including but not limited to the following are considered investigational:
Based on the available peer reviewed literature the safety and/or effectiveness of these alternative diagnostic testing/screening techniques in the diagnosis of obstructive sleep apnea cannot be established and therefore is considered investigational.
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.
After obstructive sleep apnea (OSA) has been ruled out by polysomnography, multiple sleep latency testing (MLST) may be considered medically necessary in children and adolescents for any one of the following:
Multiple sleep latency testing (MSLT) is considered not medically necessary in children and adolescents for any one of the following:
Multiple sleep latency testing (MSLT) in the home (unattended/unsupervised) would be considered investigational as it has not been proven to be equivalent to a formal multiple sleep latency test (MSLT) performed in a sleep laboratory/facility.
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