| Coverage Policy Manual | |
| Policy #: | 2009019 |
| Category: | Medicine |
| Initiated: | August 2009 |
| Last Review: | July 2023 |
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| Diagnosis of Obstructive Sleep Apnea Syndrome (e.g., polysomnography, sleep study) | |
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| Description: |
Obstructive sleep apnea (OSA) syndrome is characterized by repetitive episodes of upper airway obstruction due to the collapse 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.
In individuals with obstructive sleep apnea (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. 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 sign 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 individuals 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, pulmonary hypertension, and cor pulmonale. Systemic hypertension is common in individuals 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.
Upper airway resistance syndrome (UARS) is a variant of OSA that is characterized by a partial collapse of the airway, resulting in increased resistance to airflow. The increased respiratory effort is associated with multiple sleep fragmentations, as measured by very short alpha electroencephalographic (EEG) arousals (“Respiratory Event Related Arousals,” or “RERAs”). The resistance to airflow is typically subtle and does not result in scoreable apneic or hypopneic events. RERAs are scored if there is a sequence of breaths lasting at least 10 seconds characterized by increasing respiratory effort or flattening of the nasal pressure waveform leading to an arousal from sleep when the sequence of breaths does not meet criteria for an apnea or hypopnea. Snoring may not be a feature of UARS. However, it does result in increasingly negative intrathoracic pressure during inspiration, which can be measured using an esophageal manometer as an adjunct to a polysomnogram. Therefore, this diagnosis rests on polysomnographic documentation of greater than 10 EEG arousals per hour of sleep correlated with episodes of greater than normal negative intrathoracic pressures. RERAs can also be detected absent manometry during polysomnography. It has been proposed that UARS is a distinct syndrome from OSA that may be considered a disease of arousal. In the absence of intrathoracic pressure monitoring, a positive response to continuous positive airway pressure (CPAP) has also been used to support the diagnosis.
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 individuals, “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.
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 considered to be clinically significant. The gold standard diagnostic test for sleep disorders is considered a polysomnogram, performed in a sleep laboratory. (1) A standard polysomnogram, supervised by a sleep lab technician, typically includes:
Additional parameters of sleep that are typically measured during in-lab polysomnography include:
The first three elements listed here (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 (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, an obstructive apnea is defined as at least a 10-second cessation of respiration associated with ongoing ventilatory effort. Obstructive hypopnea is an equal to or greater than 30% reduction in airflow, with an associated fall in oxygen saturation (at least 4%) or arousal. (An accepted alternative definition of hypopnea is an equal to or greater than 50% reduction in airflow with equal to or greater than 3% desaturation). 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. Hypopneas are scored by a 50% or greater drop in nasal airflow and either an equal to or greater than 3% decrease in oxygen saturation or an associated arousal. In pediatric individuals, 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 individuals 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.
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. Hypopneas are scored by a 50% or greater drop in nasal airflow and either an equal to or greater than 3% decrease in oxygen saturation or an associated arousal. In pediatric individuals, an AHI greater than 1.5 is considered abnormal, and an AHI of 15 or greater is considered severe.
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 individuals represents a small proportion of individuals who have clinically significant and treatable disease (Somers, 2008). 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 individuals 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.
PSG may also be performed in individuals 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 (Kushida, 2005).
The operational rules used to classify monitors in sleep studies are defined as levels 1-4. Level 1 is facility based, with 14-16 channels with indicative signals for EEG, EOG, EMG, ECG/HR, airflow, effort, and SaO2, at least two airflow/effort channels, identifies awake/sleep and records the AHI (Apnea-Hypopnea Indes). Level 2 is portable with 7 or more channels with indicative channels for (may have EEG) Heart Rate, EOG, Chin EMG, ECG/HR, airflow, effort and SaO2, with at least two airflow/effort channels, identifies awake/asleep and records the AHI. Level 3 is portable with 4 or more channels, indicative signals for airflow and/or effort, ECG/HR and SaO2, with at least two airflow/effort channels. Level 4 is portable with 1 to 3 indicative signals and includes all monitors that do not qualify as level 3.
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 may be used when symptoms, including excessive daytime sleepiness, suggest narcolepsy.
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 (2005) practice parameters of the American Academy of Sleep Medicine, (Kushida, 2005) there are four 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; and type 4, continuous single or dual bio parameters, consisting of 1 or 2 channels, typically oxygen saturation, or airflow. Types 1 and 2 would be considered polysomnographic studies, and types 3 and 4 would be considered polygraphic sleep studies. The terms sleep studies and polysomnography are often used interchangeably. CPT coding makes a distinction between sleep studies that do not include electroencephalographic (EEG) monitoring, and polysomnography, which includes EEG monitoring. Polysomnography is usually conducted in a sleep laboratory and attended by a technologist but may also be conducted with type 2 portable monitoring. The type of study is further characterized as attended (supervised) or unattended by a technologist. Home or portable monitoring implies unattended sleep studies, typically conducted in the patient’s home. There is no CPT code for “unattended” polysomnography.
Cardiorespiratory sleep studies without EEG may be called polygraphic studies 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. Current recommendations are that the portable monitoring device have four channels (oxygen saturation, respiratory effort, respiratory airflow, and heart rate) and allow review of the raw data. Type IV monitors with fewer than three channels are not recommended due to reduced diagnostic accuracy and higher failure rates. As with attended PSG, it is important that the raw data from home sleep studies be reviewed by a professional with training in sleep medicine in order to detect artifacts and data loss.
Attended Studies
Unattended Study
CPT Code 95806: Sleep study, simultaneous recording of ventilation, respiratory effort, ECG or heart rate, and oxygen saturation, unattended by a technologist. (Note that this CPT code is identical to 95807 except that the study is not monitored.)
Effective January 1, 2011, there are additional CPT codes for 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)
These differ from 95806 in the description of a single respiratory sensor (either air flow or peripheral arterial tone) instead of the standard configuration of both respiratory effort and respiratory airflow (ventilation).
Use of overnight oximetry alone would be indicated by CPT code 94762: Noninvasive ear or pulse oximetry for oxygen saturation; by continuous overnight monitoring (separate procedure).
HCPCS Codes:
G0398: Home sleep study test 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 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 with type IV portable monitor, unattended; minimum of 3 channels
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Policy/ Coverage: |
Effective October 2023
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
For adults, supervised polysomnography performed in a sleep laboratory meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness as a diagnostic test in individuals with any of the following (1-5):
For children, supervised polysomnography performed in a sleep laboratory meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness as a diagnostic test in a child or adolescent with:
Level 2 Unattended (unsupervised) home sleep studies with a minimum of 7 recording channels meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in adult individuals who are at high risk for obstructive sleep apnea (OSA) and have no evidence by history or physical examination of a health condition that might alter ventilation or require alternative treatment, including any of the following:
A repeated supervised polysomnography performed in a sleep laboratory meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes under the following circumstances:
Repeated unattended (unsupervised) home sleep studies with a minimum of 7 recording channels (including oxygen saturation, respiratory movement, airflow, and EKG/heart rate) meets member benefit certificate primary coverage criteria in adult individuals under the following circumstances:
A split-night study, in which severe OSA is documented during the first portion of the study using polysomnography, followed by CPAP during the second portion of the study, can eliminate the need for a second study to titrate CPAP when:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Supervised polysomnography performed in a sleep laboratory not meeting the criteria listed above does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, supervised polysomnography performed in a sleep laboratory not meeting the criteria listed above is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Unattended (unsupervised) home sleep studies not meeting the coverage criteria listed above, do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes, including but not limited to the situations or circumstances below:
For members with contracts without primary coverage criteria, unattended (unsupervised) sleep studies not meeting the coverage criteria listed above, including but not limited to the situations or circumstances below, are considered not medically necessary:
Services that are not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
Multiple sleep latency testing does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in the diagnosis of OSA except to exclude or confirm narcolepsy in the diagnostic workup of OSA syndrome.
For members with contracts without primary coverage criteria, multiple sleep latency testing in the diagnosis of OSA is investigational except to exclude or confirm narcolepsy in the diagnostic workup of OSA syndrome. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective March 2022 through September 2023
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
For adults, supervised polysomnography performed in a sleep laboratory meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness as a diagnostic test in patients with any of the following (1-4):
For children, supervised polysomnography performed in a sleep laboratory meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness as a diagnostic test in a child or adolescent with:
Level 2 Unattended (unsupervised) home sleep studies with a minimum of 7 recording channels meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in adult patients who are at high risk for obstructive sleep apnea (OSA) and have no evidence by history or physical examination of a health condition that might alter ventilation or require alternative treatment, including the following:
A repeated supervised polysomnography performed in a sleep laboratory meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes under the following circumstances:
Note: This statement does not imply that supervised studies are needed routinely following unattended studies. This statement means a re-evaluation based on a substantial change in symptoms or in the clinical situation.
Repeated unattended (unsupervised) home sleep studies with a minimum of 7 recording channels (including oxygen saturation, respiratory movement, airflow, and EKG/heart rate) meets member benefit certificate primary coverage criteria in adult patients under the following circumstances:
A split-night study, in which severe OSA is documented during the first portion of the study using polysomnography, followed by CPAP during the second portion of the study, can eliminate the need for a second study to titrate CPAP when:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Multiple sleep latency testing does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in the diagnosis of OSA except to exclude or confirm narcolepsy in the diagnostic workup of OSA syndrome.
For members without primary coverage criteria, multiple sleep latency testing in the diagnosis of OSA is investigational except to exclude or confirm narcolepsy in the diagnostic workup of OSA syndrome. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Unattended (unsupervised) sleep studies do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in:
For members with contracts without primary coverage criteria, unattended (unsupervised) sleep studies in adult patients who are considered at low to moderate risk for OSA and in pediatric patients younger than 18 years of age are considered not medically necessary. Services that are not medically necessary are specific contract excludions in most member benefit certificates of coverage.
Level 3 and Level 4 unattended sleep studies do not meet member benefit certificate primary coverage criteria of effectiveness.
For members with contracts without primary coverage criteria, Level 3 and Level 4 unattended sleep studies are considered not medically necessary. Services that are not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
EFFECTIVE PRIOR TO March 2022
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
For adults, supervised polysomnography performed in a sleep laboratory meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness as a diagnostic test in patients with any of the following (1-4):
For children, supervised polysomnography performed in a sleep laboratory meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness as a diagnostic test in a child or adolescent with:
Level 2 Unattended (unsupervised) home sleep studies with a minimum of 7 recording channels meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in adult patients who are at high risk for obstructive sleep apnea (OSA) and have no evidence by history or physical examination of a health condition that might alter ventilation or require alternative treatment, including the following:
A repeated supervised polysomnography performed in a sleep laboratory meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes under the following circumstances:
Note: This statement does not imply that supervised studies are needed routinely following unattended studies. This statement means a re-evaluation based on a substantial change in symptoms or in the clinical situation.
Repeated unattended (unsupervised) home sleep studies with a minimum of 7 recording channels (including oxygen saturation, respiratory movement, airflow, and EKG/heart rate) meets member benefit certificate primary coverage criteria in adult patients under the following circumstances:
A split-night study, in which severe OSA is documented during the first portion of the study using polysomnography, followed by CPAP during the second portion of the study, can eliminate the need for a second study to titrate CPAP when:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Multiple sleep latency testing does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in the diagnosis of OSA except to exclude or confirm narcolepsy in the diagnostic workup of OSA syndrome.
For members without primary coverage criteria, multiple sleep latency testing in the diagnosis of OSA is investigational except to exclude or confirm narcolepsy in the diagnostic workup of OSA syndrome. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Unattended (unsupervised) sleep studies do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in:
For members with contracts without primary coverage criteria, unattended (unsupervised) sleep studies in adult patients who are considered at low to moderate risk for OSA and in pediatric patients younger than 18 years of age is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Level 3 and Level 4 unattended sleep studies do not meet member benefit certificate primary coverage criteria of effectiveness.
For members with contracts without primary coverage criteria, Level 3 and Level 4 unattended sleep studies are considered not medically necessary. Services that are not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
EFFECTIVE PRIOR TO JULY 2018
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
For adults, supervised polysomnography performed in a sleep laboratory meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness as a diagnostic test in patients with any of the following (1-3):
1. Observed apneas during sleep; OR
2. A combination of at least two of the following (a-e):
3. Moderate or severe congestive heart failure, stroke/transient ischemic attack, coronary artery disease, or significant tachycardia or bradycardic arrhythmias in patients who have nocturnal symptoms suggestive of a sleep-related breathing disorder or otherwise are suspected of having sleep apnea.
For children, supervised polysomnography performed in a sleep laboratory meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness as a diagnostic test in a child or adolescent with:
Level 2 Unattended (unsupervised) home sleep studies with a minimum of 7 recording channels meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in adult patients who are at high risk for obstructive sleep apnea (OSA) and have no evidence by history or physical examination of a health condition that might alter ventilation or require alternative treatment, including the following:
· central sleep apnea
· congestive heart failure
· chronic pulmonary disease
· obesity hypoventilation syndrome
· narcolepsy
· periodic limb movements in sleep
· restless leg syndrome
A repeated supervised polysomnography performed in a sleep laboratory meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes under the following circumstances:
1. To initiate and titrate continuous positive airway pressure (CPAP) in adult patients with clinically significant OSA defined as those patients who have:
2. Failure of resolution of symptoms or recurrence of symptoms during treatment; OR
3. To assess efficacy of surgery (including adenotonsillectomy) or oral appliances/devices; OR
4. To re-evaluate the diagnosis of OSA and need for continued CPAP, e.g., if there is a significant change in weight or change in symptoms suggesting that CPAP should be retitrated or possibly discontinued.
Note: This statement does not imply that supervised studies are needed routinely following unattended studies. This statement means a re-evaluation based on a substantial change in symptoms or in the clinical situation.
Repeated unattended (unsupervised) home sleep studies with a minimum of 7 recording channels (including oxygen saturation, respiratory movement, airflow, and EKG/heart rate) meets member benefit certificate primary coverage criteria in adult patients under the following circumstances:
1. To assess efficacy of surgery or oral appliances/devices; OR
2. To re-evaluate the diagnosis of OSA and need for continued CPAP, e.g., if there is a significant change in weight or change in symptoms suggesting that CPAP should be retitrated or possibly discontinued. (Statement amended 7/20/2015).
A split-night study, in which severe OSA is documented during the first portion of the study using polysomnography, followed by CPAP during the second portion of the study, can eliminate the need for a second study to titrate CPAP when:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Multiple sleep latency testing does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in the diagnosis of OSA except to exclude or confirm narcolepsy in the diagnostic workup of OSA syndrome.
For members without primary coverage criteria, multiple sleep latency testing in the diagnosis of OSA is investigational except to exclude or confirm narcolepsy in the diagnostic workup of OSA syndrome. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Unattended (unsupervised) sleep studies do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in:
For members with contracts without primary coverage criteria, unattended (unsupervised) sleep studies in adult patients who are considered at low to moderate risk for OSA and in pediatric patients younger than 18 years of age is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Level 3 and Level 4 unattended sleep studies do not meet member benefit certificate primary coverage criteria of effectiveness.
For members with contracts without primary coverage criteria, Level 3 and Level 4 unattended sleep studies are considered not medically necessary. Services that are not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
EFFECTIVE prior to October 2012
Supervised polysomnography performed in a sleep laboratory may meet primary coverage criteria as a diagnostic test in patients with any of the following (1-3):
Level 2 unattended (unsupervised) home sleep studies are covered. Level 3 and level 4 unattended studies do not meet primary coverage criteria for effectiveness and are not covered.
For contracts without primary coverage criteria, level 3 and level 4 studies are considered investigational and are not covered.
Multiple sleep latency testing does not meet primary coverage criteria in the diagnosis of obstructive sleep apnea syndrome except to exclude or confirm narcolepsy in the diagnostic workup of OSA syndrome. For members without primary coverage criteria language in their contracts multiple sleep latency testing is considered not medically necessary in the diagnosis of obstructive sleep apnea syndrome except to exclude or confirm narcolepsy in the diagnostic workup of OSA syndrome.
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| Rationale: |
Definition of Clinically Significant OSA
The original rationale for the diagnosis and treatment of OSA was based on epidemiologic studies that suggested increased mortality in patients with an apneic index greater than 20. However, considering that an apneic/hypopnea index (AHI) of 5 is considered normal, there is obviously a great range of severity of OSA, ranging from those with only snoring as a complication to those with associated severe excessive daytime sleepiness, hypertension, or cardiac arrhythmias. If OSA is considered mild to moderate and snoring is the only manifestation, an intervention would be considered not medically necessary. For example, pronounced snoring may be considered predominantly a social annoyance to the patient's bed partner with no impact on the patient him/herself.
Attended polysomnography (PSG) has been considered to be the gold standard in the diagnosis and treatment of OSA. In 2007, the Agency for Healthcare Research and Quality (AHRQ) conducted a technology assessment on portable monitoring for the Medicare Evidence Development and Coverage Committee (MedCAC).
The report concluded:
The AHRQ report addressed the available literature through February 2007, and a supplemental search of the MEDLINE database was performed for the period of March 2007 through December 2007.
Evidence at this time suggested that portable monitoring could potentially provide an effective alternative to PSG for evaluating patients suspected of having OSA. There were, however, a number of limitations with available devices and procedures. First, there was no standardization of recording and scoring parameters for the monitoring devices that are available. A variety of scoring algorithms had been used, and the appropriate screening and cutoff values for each device had not been established. For example, in a study by Bridevaux and coworkers, 88 ambulatory sleep recordings were independently scored by 8 physicians. Intraclass correlation coefficients were 0.73 for AHI, 0.71 for hypopnea index, and 0.98 for desaturation index. Automated analysis was found to underestimate AHI by an average of 5.1 events. The authors concluded that in a clinical setting, agreement on AHI was limited, and that efforts should be directed toward standardization of visual analysis and improvement and quality control of ambulatory sleep studies. Questions also remained about the reliability of unattended automated recordings and about the expertise of the medical personnel who might request, assist, and interpret the home sleep studies. Therefore, use of type 3 and type 4 portable monitoring devices for the diagnosis of OSA was considered investigational; All unattended monitoring is a contract exclusion in most member benefit certificates.
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 3 channels. 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 update 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.
Mulgrew et al published a randomized validation study of the diagnosis and management of OSA with a single channel monitor followed by APAP. They developed a diagnostic algorithm (Epworth Sleepiness Scale score greater than 10, Sleep Apnea Clinical Score of 15 or greater, and a respiratory disturbance index [RDI] of 15 or over 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 Epworth Sleepiness Scale of 5.0 vs. 5.0 and Sleep Apnea Quality of Life Index of 5.5 vs. 5.8). 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. 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 two groups, with improvements in Epworth Sleepiness Scale 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 two 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. 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 Epworth Sleepiness Scale score of 8 or greater (mean of 13.6). Exclusion criteria were contraindications to CPAP or APAP (congestive 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.
In a company sponsored study, 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. Patients were screened with a detailed sleep and medical history questionnaire including an Epworth Sleepiness Scale. To be included in the study patients had to have an Epworth Sleepiness Scale 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 congestive 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 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 Epworth Sleepiness Scale 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.
Garcia-Diaz and colleagues assessed the sensitivity and specificity of home respiratory polygraphy and actigraphy to diagnose OSA in relation to laboratory PSG. 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. From these type 3 studies (4 channels including airflow and respiratory movement, heart rate or ECG, and oxygen saturation), 3.5% were not conclusive and required additional PSG.
Summary
Current literature indicates that evaluation of OSA should be by clinical evaluation and overnight monitoring, either by attended PSG or by portable unattended home monitoring under qualified supervision, and that this may be followed by a trial of APAP to evaluate efficacy and adjust pressure.
Although evidence indicates that portable monitoring can be a safe and effective method to evaluate OSA, the variety of portable monitoring devices available and the lack of standardization remains problematic. Additional study is needed to determine the most reliable types of devices and combinations of sensors. Questions also remain about the specific training of the medical personnel required to diagnose OSA without increasing risk of misdiagnosis. Based on the current evidence, use of portable monitoring may be considered medically necessary in 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.
Professional Society Guidelines and Position Statements
The patient selection criteria for a polysomnogram 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 polysomnogram (i.e., with 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 American Academy of Sleep Medicine, or AASM) published practice parameters for polysomnography and related procedures; these were most recently updated in 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. For patients in the high-pretest-probability stratification group, an attended cardiorespiratory sleep study (type 3 with respiratory effort, airflow, arterial oxygen saturation, and 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. Guidelines from the American Academy of Sleep Medicine 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 polysomnography is not available, the patient cannot be studied in a sleep laboratory (i.e., nonambulatory), or for follow-up studies to evaluate response to therapy. The document further stated that, in these patients, a sleep study may be an acceptable alternative to polysomnography. However, a sleep study may only “rule in” disease, and polysomnography 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.
Portable monitoring (PM) devices were addressed by a joint project of the American Academy of Sleep Medicine, the American Thoracic Society, and the American College of Chest Physicians in 2003. 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.
The American Academy of Pediatrics (AAP) published a 2002 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; complex high-risk patients should be referred to a specialist. The AAP guidelines stated that diagnostic evaluation is useful in discriminating between primary snoring and OSA; although the gold standard is PSG, other diagnostic tests may be useful if results are positive; adenotonsillectomy is the first line of treatment for most children, and continuous positive airway pressure is an option for those who are not candidates for surgery or do not respond to surgery; patients should be reevaluated post-operatively to determine whether additional treatment is required.
2012 Update
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. 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.
Skomro et al., 2010, conducted a randomized trial (102 patients) of home testing followed by 1 week of APAP, compared with in-laboratory PSG followed by CPAP titration. 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. In the home monitoring group, the proportion of subjects with an AHI greater than 30 was significantly lower, and the APAP-derived CPAP pressure was significantly higher than the manually-titrated CPAP pressure from the laboratory study. 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).
The AASM published evidence-based guidelines for respiratory indications for polysomnography in children in 2011 (Aurora, 2011). “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.
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 (Roland, 2011). 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.
In 2008 the United Kingdom’s National Institute for Health and Clinical Excellence (NICE, 2008) issued guidance on CPAP treatment of OSA, based on a review of the literature and expert opinion. The recommendations included:
2015 Update
A literature search conducted through January 2015 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
Louter et al reported a study of actigraphy as a diagnostic aid for REM sleep behavior disorder (RBD) in 45 consecutive patients with Parkinson disease (Louter, 2014). The study population included patients referred for a variety of reasons, including insomnia, restless legs syndrome, and sleep apnea. Following video PSG, 23 patients were diagnosed with RBD. There was no significant difference between the 2 groups for the presence of other sleep disorders. Using a cutoff of 95 wake bouts per night, actigraphy had a sensitivity of 26.1% and specificity of 95.5%, with a positive predictive value of 85.7%.
A systematic review of leg actigraphy to quantify periodic limb movements of sleep (PLMS) found significant heterogeneity for the sensitivity and specificity of different devices (Plante, 2014). Factors contributing to the heterogeneity were variability in devices tested, placement of the devices (eg, foot or ankle), thresholds to define clinically significant PLMS (eg, 5, 10, or 15/hour), and algorithms used to calculate the periodic limb movements. The inability to combine actigraphy data from both legs also presents a limitation for clinical use at this time.
Actigraphy Compared With Video-electroencephalography (vEEG)
A prospective validation study of actigraphy for determining sleep-wake patterns in children with epilepsy was reported in 2014 (Sadaka, 2014). In this study, 27 children with medically refractory epilepsy wore activity monitors while being evaluated with at least 24-hour vEEG (mean of 70.5 hours) in an inpatient epilepsy monitoring unit. vEEG and actigraphy data were evaluated by 2 independent and blinded reviewers. Although sensitivity and specificity were not reported, correlation coefficients between the 2 measures were very high (r=0.93 to 0.99) for night sleep period, night sleep time, duration of night wake time, and percent time of sleep during the day. Consistent with lower specificity to detect awakenings during sleep, the correlation for the number of awakenings after sleep onset was less robust.
2016 Update
A literature search conducted through October 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
The 2016 SAVE RCT found no benefit of randomization to CPAP on the primary composite outcome of death or hospitalization for cardiovascular events in 2717 adults with moderate-to-severe OSA and cardiovascular disease (McEvoy, 2016). With a mean duration of adherence to CPAP therapy of 3.3 hours per night, CPAP significantly reduced daytime sleepiness (adjusted difference in ESS, -2.5; 95% CI, -2.8 to -2.2; p<0.001) and improved health-related quality of life (HR-QOL) and mood.
A 2015 systematic review identified 18 studies (total N=920 patients) that had data on pre- and postnasal EPAP (Riaz, 2015). Study designs included 10 conference papers and 8 publications (case series, cohort studies, RCTs). Of the patients included in the meta-analysis (n=345 patients) AHI decreased from 27.32 to 12.78 events per hour (p<0.001). For 359 patients, ESS patient was modestly improved from 9.9 to 7.4 (p<0.001). Data from the Berry RCT (described above) were not included in the meta-analysis as mean data were not reported. Response to nasal EPAP was variable and inconsistent, and there were no clear characteristics (demographic factors, medical history, and/or physical exam finding) that predicted a favorable response.
AASM has also issued clinical guidelines on the evaluation, management, and long-term care of adults with obstructive sleep apnea (OSA) (Epstein, 2016). The levels of recommendation are “standard” (generally accepted patient-care strategy, with high degree of certainty; Level 1 to 2 evidence), “guideline” (moderate degree of clinical certainty; Level 2 to 3 evidence), or “option” (uncertain clinical use; insufficient or inconclusive evidence).
Diagnosis
AASM recommends that patients who are obese, retrognathic, hypertensive, or who complain of snoring or daytime sleepiness should be assessed for presence or absence as well as severity of OSA using the following methods (standard):
Treatment with Positive Airway Pressure (PAP)
Treatment with Oral Appliances (OA): for patients with mild to moderate OSA, who prefer OAs to CPAP, or who do not respond to CPAP, or are not appropriate candidates for CPAP, or have failed CPAP (guideline).
In 2016, ATS published a research statement on the long-term effects and treatment of mild OSA in adults (Chowhuri, 2016). One research question in the statement was to determine if treatment of mild OSA improved daytime sleepiness, quality of life, and reduced neurocognitive consequences. ATS’s systematic review concluded:
Neurocognition: treatment effects inconsistent.
2017 Update
A literature search conducted using the MEDLINE database through October 2017 did not reveal any new information that would prompt a change in the coverage statement.
In 2017, AASM published clinical practice guidelines on diagnostic testing for adult obstructive sleep
apnea (OSA) (Kapur, 2017). AASM provided the following recommendations:
Summary of Recommendations
Recommendation Statement SOR QOE Benefits vs Harms
We recommend that clinical tools, questionnaires, and prediction algorithms not be used to diagnose OSA in adults, in the absence of PSG or HSAT
Strength of Evidence: Strong
Quality of Evidence: Moderate
Benefits vs Harms: High certainty that harms outweigh benefits
We recommend that PSG, or HSAT with a technically adequate device, be used for the diagnosis of OSA in uncomplicated adult patients presenting with signs and symptoms that indicate an increased risk of moderate to severe OSA.
Strength of Evidence: Strong
Quality of Evidence: Moderate
Benefits vs Harms: High certainty that harms outweigh benefits
We recommend that if a single HSAT is negative, inconclusive, or technically inadequate, PSG be performed for the diagnosis of OSA.
Strength of Evidence: Strong
Quality of Evidence: Low
Benefits vs Harms: High certainty that benefits outweigh harms
We recommend that PSG, rather than home sleep testing, be used for patients with significant cardiorespiratory disorder, potential respiratory muscle weakness, awake or suspected sleep hypoventilation, chronic opioid medication use, history of stoke or severe insomnia.
Strength of Evidence: Strong
Quality of Evidence: Very Low
Benefits vs Harms: High certainty that benefits outweigh harms
We suggest that, if clinically appropriate, a split-night diagnostic protocol, rather than a full-night diagnostic protocol for PSG be used for the diagnosis of OSA
Strength of Evidence: Weak
Quality of Evidence: Low
Benefits vs Harms: Low certainty that benefits outweigh harms
We suggest that when the initial PSG is negative, and there is still clinical suspicion for OSA, a second PSG be considered for the diagnosis of OSA.
Strength of Evidence: Weak
Quality of Evidence: Very Low
Benefits vs Harms: Low certainty that benefits outweigh harms
U.S. PREVENTIVE SERVICES TASK FORCE RECOMMENDATIONS
In 2017, the U.S. Preventive Services Task Force (USPSTF) reviewed the evidence on screening for OSA in adults and concluded that “the current evidence is insufficient to assess the balance and harms of screening for obstructive sleep apnea (OSA) in asymptomatic adults. Evidence on screening tools to accurately detect persons in asymptomatic populations who should receive further testing and treatment of subsequently diagnosed OSA to improve health outcomes is lacking, and the balance of benefits and harms cannot be determined” (USPSTF, 2017; Jonas, 2017).
2018 Update
Annual policy review completed with a literature search using the MEDLINE database through June 2018. The key identified literature is summarized below.
PRACTICE GUIDELINES AND POSITION STATEMENTS
AASM (2017) published a position statement on the clinical use of a home sleep apnea test (Rosen, 2017). AASM indicated that a home sleep apnea test should be ordered by a physician after “a face-to-face examination” to diagnose OSA or evaluate treatment efficacy and should not be used for general screening of asymptomatic populations. AASM supported the review of “raw data” and interpretation by a “physician board-certified in sleep medicine”, stating that automatically scored data “could lead to sub-optimal care that jeopardizes patient health and safety”.
2019 Update
A literature search was conducted through June 2019. There was no new information identified that would prompt a change in the coverage statement.
2020 Update
A literature search was conducted through June 2020. There was no new information identified that would prompt a change in the coverage statement.
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through June 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
The Epworth Sleepiness Scale (ESS) is a short self-administered questionnaire that asks patients how likely they are to fall asleep in 8 different situations (eg, watching TV, sitting quietly in a car, or sitting and talking to someone). An ESS of ≥10 is considered excessively sleepy. A decrease of 2 points is considered the minimal important difference (MID) (Crook, 2019).
Ulibarri et al conducted a retrospective chart review of 139 patients who were diagnosed with OSA or upper airway resistance syndrome between 2011 and 2016 and had initially refused titration of PAP but accepted a trial of PAP with a PAP-NAP (Ulibarri, 2020). The most common risk factors for initial PAP rejection were depression, insomnia, claustrophobia, and trauma exposure, while the most common indications for PAP-NAP were general reluctance, anxiety, and claustrophobia. The procedure averaged about 3 hours, which included 83 + 30 min of coaching and 107 + 57 min napping; 99% of patients experienced expiratory pressure intolerance and a majority preferred an alternative PAP mode for the nap period. Use at follow-up was determined by renewal request for PAP supplies, retitration, clinic appointment or other contact with staff. The duration of use is unclear from the report, but at the time of follow-up 71% of patients who had initially refused PAP were considered users and 29% were non-users.
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through June 2022. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
In 2021, the AASM published a guidance statement that focuses on indications for follow-up sleep apnea testing with PSG or home sleep apnea tests in patients with OSA (Caples, 2021). The following clinical guidance statements were provided:
In 2021, the American Heart Association (AHA) published a scientific statement on OSA and cardiovascular disease (Yeghiazarians, 2021). The treatment options for OSA and eligibility for their use are described in the statement.
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through June 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
The U.S. Preventive Services Task Force (2022) reported on the evidence for screening for OSA in adults and concluded that "the current evidence is insufficient to assess the balance of benefits and harms of screening for obstructive sleep apnea in the general adult population. Evidence on screening tools to accurately detect persons in the general adult population at increased risk of OSA who should receive further testing and treatment is lacking" (Mangione, 2022).
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