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Description:
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Obstructive sleep apnea (OSA) syndrome is characterized by repetitive episodes of upper airway obstruction due to the collapse of the upper airway during sleep. This causes a drop in blood oxygenation and a brief arousal, and can occur as frequently as every minute throughout the night. The most common signs and symptoms in adults are snoring, excessive daytime sleepiness, and hypertension. Excessive daytime sleepiness may be subjective, and is assessed by questionnaires such as the Epworth Sleepiness Scale, a short self-administered questionnaire that asks patients how likely they are to fall asleep in different scenarios such as watching TV, sitting quietly in a car, or sitting and talking to someone. Daytime sleepiness is uncommon in young children with OSA. Symptoms in children may include disturbed sleep and daytime neurobehavioral problems. In otherwise healthy children, OSA is usually associated with adenotonsillar hypertrophy and/or obesity.
A hallmark sign of OSA is snoring. The snoring abruptly ceases during the apneic episodes and during the brief period of patient arousal and then resumes when the patient again falls asleep. Upper airway resistance syndrome (is a variant of OSA 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” [RERAs]). The sleep fragmentation associated with repeated sleep disruption can lead to impairment of daytime activity. Adults with OSA-associated daytime somnolence are thought to be at higher risk for accidents involving motorized vehicles (i.e., cars, trucks, heavy equipment), while OSA in children may result in neurocognitive impairment and behavioral problems.
OSA can also affect the cardiovascular and pulmonary systems. 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. It is estimated that about 7% of adults have moderate or severe OSA, 20% have mild OSA, and the referral population of OSA patients represents a small proportion of patients who have clinically significant and treatable disease (Somers, 2008).
OSA in Children
The presentation of OSA in children may differ from that of adults. Children frequently exhibit behavioral problems or hyperactivity rather than daytime sleepiness. Obesity is defined as a BMI greater than the 90th percentile for the weight/height ratio. Although the definition of severe OSA in children is not well established, an AHI or RDI greater than 1.5 events per hour is considered abnormal (an AHI or RDI =10 events per hour may be considered severe). In addition, the first-line treatment in children is usually adenotonsillectomy. Continuous positive airway pressure (CPAP) is an option for children who are not candidates for surgery or who have an inadequate response to surgery.
Bariatric Surgery Patients
Screening for OSA should be performed routinely in patients scheduled for bariatric surgery, due to the high prevalence of OSA in this population. The optimal screening approach is not certain. An in-laboratory PSG or home sleep study is the most accurate screening method. Some experts recommend a symptom-based screening instrument, followed by PSG in patients who exceed a certain threshold, as an alternative to performing PSG in all patients. It should be noted that there is a high prevalence of obesity hypoventilation syndrome in patients who are candidates for bariatric surgery. Therefore, obesity hypoventilation syndrome should be ruled out prior to home sleep testing in this population.
Significant Weight Change
There is no established threshold for significant change in weight. Studies have reported improvements in OSA with an average weight loss of 20 kg or 20% of body weight.
Multiple Sleep Latency Test (MSLT)
The multiple sleep latency test (MSLT) is an objective measure of the tendency to fall asleep in the absence of alerting factors, while the maintenance of wakefulness test is an objective measure of the ability to stay awake under soporific conditions (used to assess occupational safety). The MSLT and maintenance of wakefulness test are not routinely indicated in the evaluation and diagnosis of OSA or in the assessment of change following treatment with CPAP.
Specialist Training
The medical professional who is interpreting a polysomnogram or home sleep study should have training in sleep medicine and should review the raw data from PSG and home sleep studies in order to detect artifacts and data loss. In addition, the treatment of patients diagnosed with OSA should be initiated and monitored by a professional with training in sleep medicine. It is important to monitor symptoms and adherence to positive airway pressure (PAP) treatment, eg, review of symptoms and device utilization between 30 and 90 days.
Split Night Studies
A split-night study is a supervised PSG in which moderate-to-severe OSA is documented during the first portion of the study using PSG, followed by CPAP during the second portion of the study. American Academy for Sleep Medicine (AASM) Practice Parameters indicate that a split-night study (initial diagnostic polysomnography [PSG] followed by CPAP titration during PSG on the same night) is an alternative to one full night of diagnostic PSG followed by a second night of titration if the following four criteria are met (Kushida on behalf of AASM, 2005):
- An AHI of at least 40 is documented during a minimum of 2 hours of diagnostic PSG. Split-night studies may sometimes be considered at an AHI of 20 to 40, based on clinical judgment (e.g., if there are also repetitive long obstructions and major desaturations). However, at AHI values below 40, determination of CPAP pressure requirements, based on split-night studies, may be less accurate than in full-night calibrations.
- CPAP titration is carried out for more than 3 hours (because respiratory events can worsen as the night progresses).
- PSG documents that CPAP eliminates or nearly eliminates the respiratory events during rapid eye movement (REM) and non-REM (NREM) sleep, including REM sleep with the patient in the supine position.
- A second full night of PSG for CPAP titration is performed if the diagnosis of a sleep-related breathing disorder (SRBD) is confirmed, but criteria #2 and #3 are not met.
Categorization of Polysomnography and Portable Monitoring
There is not full correspondence between the CPT codes and the most current categorization scheme for the different types of studies. In the 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 bioparameters, consisting of 1 or 2 channels, typically oxygen saturation, or airflow. Types 1 and 2 would be considered polysomnographic studies, and types 3 and 4 would be considered polygraphic sleep studies. The terms sleep studies and 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 are no specific codes for remotely monitored home sleep studies. They would likely be reported with the CPT code for the sleep study with the GT modifier (“via interactive audio and video telecommunications systems”) appended. There is no CPT code for “unattended” 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.
DIAGNOSIS
The criterion standard diagnostic test for sleep disorders is a polysomnogram performed in a sleep laboratory Kushida, 2005). A standard polysomnogram includes EEG, submental electromyogram (EMG), and electrooculogram (to detect rapid eye movement [REM] sleep) for sleep staging. Polysomnography (PSG) also typically includes electrocardiography and monitoring of respiratory airflow, effort, snoring, oxygen desaturation, and sleep position. An attended study ensures that the electrodes and sensors are functioning adequately and do not dislodge during the night. In addition, an attendant is able to identify severe OSA in the first part of the night and titrate continuous positive airway pressure (CPAP) in the second part of the night, commonly known as a "split-night" study. If successful, this strategy eliminates the need for an additional PSG for CPAP titration. Auto-adjusting positive airway pressure (APAP) may also be used to determine the most effective pressure.
Typically, the evaluation of OSA includes sleep staging to assess arousals from sleep and determination of the frequency of apneas and hypopneas. In adults, apnea is defined as a drop in the peak signal excursion (airflow) by 90% or more of pre-event baseline for at least 10 seconds.3 Hypopnea in adults is scored when the peak signal excursions drop by at least 30% of pre-event baseline for at least 10 seconds in association with either at least 3% arterial oxygen desaturation or an arousal. The Apnea/Hypopnea Index (AHI) and the Respiratory Disturbance Index (RDI) are 2 instruments that report on respiratory events during sleep. 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 is accepted when an adult has an AHI greater than 5 events per hour and symptoms of excessive daytime sleepiness or unexplained hypertension. An AHI of 15 or more events per hour is typically considered moderate OSA, while an AHI greater than 30 is considered severe OSA.
Due to faster respiratory rates in children, pediatric scoring criteria define an apnea as 2 or more missed breaths, regardless of its duration in seconds. An apnea is scored when peak signal excursions (airflow) drop by at least 90% of pre-event baseline and the event meets duration and respiratory effort criteria for an obstructive, mixed, or central apnea.3 A hypopnea is scored in children when the peak signal excursions drop is at least 30% of pre-event baseline for at least the duration of 2 breaths in association with either a 3% or greater oxygen desaturation or an arousal. In pediatric patients, an AHI greater than 1.5 events per hour is considered abnormal, and an AHI of 10 or more may be considered severe. Although there is poor correlation between AHI and OSA symptoms, an increase in mortality is associated with an AHI of 15 or more events per hour in adults. Mortality has not been shown to be increased in adult patients with an AHI between 5 (considered normal) and 15 events per hour.
A variety of devices have been developed specifically to evaluate OSA at home. They range from portable full PSG 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 activity.
CODING
Attended Studies
CPT Code 95807: Sleep study, simultaneous recording of ventilation, respiratory effort, electrocardiogram
(ECG) or heart rate, and oxygen saturation, attended by a technologist.
CPT Code 95808: Polysomnography; any age, sleep staging with 1-3 additional parameters of sleep, attended by a technologist.
CPT Code 95810: Polysomnography; age 6 years or older, sleep staging with 4 or more additional parameters of sleep, attended by a technologist.
CPT Code 95811: Polysomnography; age 6 years or older, sleep staging with 4 or more additional parameters of sleep, with initiation of continuous positive airway pressure therapy or bilevel ventilation, attended by a technologist.
CPT Code 95782: Polysomnography; younger than 6 years, sleep staging with 4 or more additional parameters of sleep, attended by a technologist.
CPT Code 95783: Polysomnography; younger than 6 years, sleep staging with 4 or more additional parameters of sleep, with initiation of continuous positive airway pressure therapy or bilevel ventilation, attended by a technologist.
Unattended Study
CPT Code 95806: Sleep study, unattended, simultaneous recording of heart rate, oxygen saturation, respiratory airflow, and respiratory effort (eg, thoracoabdominal movement). (Note that this CPT code is identical to 95807 except that the study is not monitored.)
CPT Code 95800: Sleep study, unattended, simultaneous recording; heart rate, oxygen saturation, respiratory analysis (eg, by airflow or peripheral arterial tone), and sleep time
CPT Code 95801: Sleep study, unattended, simultaneous recording; minimum of heart rate, oxygen saturation, and respiratory analysis (eg, 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).
In 2008, Medicare created some G codes to facilitate their national coverage decision:
G0398: Home sleep study test (HST) with type II portable monitor, unattended; minimum of 7 channels:
EEG, EOG, EMG, ECG/heart rate, airflow, respiratory effort and oxygen saturation
G0399: Home sleep test (HST) with type III portable monitor, unattended; minimum of 4 channels: 2
respiratory movement/airflow, 1 ECG/heart rate and 1 oxygen saturation
G0400: Home sleep test (HST) with type IV portable monitor, unattended; minimum of 3 channels
Related Policies:
217 – Home Apnea Monitors
687 - Actigraphy
716 – Minimally Invasive Surgery for Snoring and Obstructive Sleep Apnea Syndrome
1234 - Medical Management of Obstructive Sleep Apnea Syndrome
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Policy/
Coverage:
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Effective November 01, 2023
DIAGNOSIS of OSA
Unattended Home Sleep Studies
A single unattended (unsupervised) home sleep study with a minimum of 3 recording channels with the following sensors: nasal pressure, chest and abdominal respiratory inductance plethysmography, and oximetry; OR alternatively peripheral arterial tone (PAT), oximetry and actigraphy may be considered medically necessary in adults who are at high risk for obstructive sleep apnea (OSA):
With the following symptoms:
- Observed apneas during sleep; OR
- Unexplained pulmonary hypertension; OR
- A combination of at least two of the following:
- Excessive daytime sleepiness evidenced by an Epworth Sleepiness Scale greater than 10, inappropriate daytime napping (e.g., during driving, conversation, or eating), or sleepiness that interferes with daily activities and is not explained by other conditions, (this may be expressed as learning difficulties or other daytime neurobehavioral problems in young children);
- Habitual snoring or gasping/choking episodes associated with awakenings;
- Unexplained hypertension;
- Obesity, defined as a body mass index greater than 35 kg/m2 in adults;
- Craniofacial or upper airway soft tissue abnormalities, including adenotonsillar hypertrophy, or neuromuscular disease
AND
Have no evidence based on history and physical examination of a health condition that might alter ventilation or require alternative treatment, including:
- central sleep apnea,
- documented Class III or Class IV Congestive heart failure,
- documented moderate/severe Chronic pulmonary disease,
- obesity hypoventilation syndrome,
- neuromuscular disorders with sleep-related symptoms,
- injurious or potentially injurious parasomnias,
- or narcolepsy.
A single unattended (unsupervised) home sleep study with a minimum of 3 recording channels as described above, may be considered medically necessary as a screening tool in patients who are scheduled for bariatric surgery and have no evidence of a health condition that might alter ventilation or require alternative treatment that is listed above.
Repeated unattended (unsupervised) home sleep studies with a minimum of 3 recording channels as described above, may be considered medically necessary in adults under the following circumstances:
- To assess efficacy of surgery or oral appliances or devices;
Note: For titration post-surgery, repeat unattended home sleep study is limited to once
OR
2. To reevaluate the diagnosis of OSA and need for CPAP, eg, if there is a significant change in weight or change in symptoms suggesting that CPAP should be retitrated or possibly discontinued.
Unattended home sleep studies that do not meet the above criteria are considered not medically necessary.
Unattended home sleep studies are considered investigational in children (<18 years of age).
Investigational and not medically necessary services are Plan exclusions.
Supervised Polysomnography
Supervised polysomnography (PSG) performed in a sleep laboratory may be considered medically necessary in patients with a moderate or high pretest probability of OSA in the following situations:
- Pediatric patients (<18 years of age); OR
- When patients do not meet criteria for an unattended home sleep study as described above; OR
- A previous home study failed to establish the diagnosis of OSA in a patient with a high pretest probability of OSA; OR
- A previous home study was technically inadequate; OR
- Failure of resolution of symptoms or recurrence of symptoms during treatment; OR
- When testing is done to rule out other sleep disorders such as central sleep apnea, injurious or potentially injurious parasomnias, or narcolepsy; OR
- Presence of a comorbidity that might alter ventilation or decrease the accuracy of a home sleep study, including, but not limited to Class III or Class IV congestive heart failure, moderate/severe chronic pulmonary disease, obesity hypoventilation syndrome, or neuromuscular disease.
A repeated, supervised PSG performed in a sleep laboratory may be considered medically necessary in patients who meet the criteria above for an in-laboratory PSG under the following circumstances:
- To initiate and titrate CPAP in adults who have:
- An AHI or RDI of at least events 15 per hour, OR
- An AHI or RDI of at least events 5 per hour in a patient with excessive daytime sleepiness or unexplained hypertension.
Note: A split-night study, in which moderate-to-severe OSA is documented during the first portion of the study using PSG, followed by CPAP during the second portion of the study, can eliminate the need for a second study to titrate CPAP (see below criteria to perform a split-night study).
2. To initiate and titrate CPAP in children:
- In pediatric patients, an AHI or RDI of at least 5; OR
- An AHI or RDI at least 1.5 in a patient with excessive daytime sleepiness, behavioral problems or hyperactivity.
3. To assess efficacy of surgery (including adenotonsillectomy) or oral appliances/devices.
Note: For titration post-surgery, repeat supervised PSG is limited to once
Split-night study (initial diagnostic polysomnography [PSG] followed by CPAP titration during PSG on the same night) is an alternative to one full night of diagnostic PSG followed by a second night of titration if the following four criteria are met:
- An AHI of at least 40 is documented during a minimum of 2 hours of diagnostic PSG. Split-night studies may sometimes be considered at an AHI of 20 to 40, based on clinical judgment (e.g., if there are also repetitive long obstructions and major desaturations). However, at AHI values below 40, determination of CPAP pressure requirements, based on split-night studies, may be less accurate than in full-night calibrations.
- CPAP titration is carried out for more than 3 hours (because respiratory events can worsen as the night progresses).
- PSG documents that CPAP eliminates or nearly eliminates the respiratory events during rapid eye movement (REM) and non-REM (NREM) sleep, including REM sleep with the patient in the supine position.
- A second full night of PSG for CPAP titration is performed if the diagnosis of a sleep-related breathing disorder (SRBD) is confirmed, but criteria #2 and #3 are not met.
Supervised sleep studies that do not meet the above criteria are considered not medically necessary.
Not medically necessary services are Plan exclusions.
Other Sleep Studies
The use of an abbreviated daytime sleep study (PAP-NAP) as a supplement to standard sleep studies is considered investigational.
Multiple sleep latency testing is considered not medically necessary in the diagnosis of OSA except to exclude or confirm narcolepsy in the diagnostic workup of OSA syndrome.
Investigational and not medically necessary services are Plan exclusions.
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Rationale:
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This policy has been updated periodically using the MEDLINE database. The most recent update was performed through April 16, 2025.
DIAGNOSIS SUSPECTED OBSTRUCTIVE SLEEP APNEA
Multichannel Home Sleep Testing
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 (Balk, 2011). 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.
Home sleep testing with 3 recording channels that include respiratory effort, airflow, and oxygen saturation, but not heart rate, are considered by some, including the Centers for Medicare & Medicaid, to be sufficient for home sleep studies. Corral et al (2017) reported a multicenter noninferiority trial of home sleep testing using a 3-channel monitor compared with in-laboratory PSG in 430 patients. Included in the study were patients referred to tertiary hospitals in Spain for suspected OSA, who had snoring or sleep apneas observed by a partner, ESS score of 10 or greater, and absence of clinical suspicion of any other sleep pathology. Both groups of patients who were diagnosed with OSA received CPAP titration with a single APAP session at home. The median baseline ESS score was 13 in both groups. CPAP was indicated in 68% of patients in the PSG arm compared with 53% in the home sleep testing group, with the difference attributed to the underestimation of AHI in home sleep studies. All patients, including those treated with CPAP and those who were not, were assessed at 6-month follow-up. ESS score improved by -4.2 (95% confidence interval [CI], -4.8 to -3.6) in the home sleep testing group and by -4.9 (95% CI, -5.4 to -4.3) in the PSG group. With a noninferiority margin of 2 points on the ESS, home sleep testing was noninferior to in-laboratory PSG.
Limited Channel Home Sleep Testing
Use of Auto-Adjusting Positive Airway Pressure for Diagnosis and Treatment Supervised by a Sleep Specialist
Mulgrew et al. (2007) published a randomized validation study of the diagnosis and management of OSA with a single channel monitor followed by APAP. They developed a diagnostic algorithm (ESS score greater than 10, Sleep Apnea Clinical Score of 15 or greater, and a respiratory disturbance index [RDI] of 15 or greater on overnight oximetry) that was found to have a 94% positive predictive value for moderate to severe OSA assessed by PSG. Patients who passed the screening (n=68) were randomized to either attended in-laboratory PSG with CPAP titration or to home monitoring with a portable APAP unit. Home monitoring consisted of auto-titration for 1 week, followed by download and assessment of efficacy data for the week (i.e., CPAP, mask leak, residual respiratory events, and use) and determination of the pressure for CPAP by the study physician. A second assessment of efficacy data was conducted for a week of CPAP use, and the pressure setting was adjusted by the CPAP coordinator in conjunction with the study physician. After 3 months of CPAP use, the subjects returned to the laboratory for PSG (with CPAP); no difference was observed between lab-PSG and home-managed patients in any of the outcome measures (median AHI of 3.2 vs. 2.5, median ESS of 5.0 vs. 5.0, and Sleep Apnea Quality-of-Life Index of 5.5 vs. 5.8, all respectively). Another study assessed the clinical utility of home oximetry in comparison with PSG by measuring the accuracy with which sleep physicians could predict which patients would benefit from treatment of OSA (Whitelaw, 2005). The primary outcome measure was the change in sleep apnea-specific quality of life after treatment. Subjects were randomly selected from a pool of referred patients; 307 were randomized, and 288 began a trial of CPAP. An additional 51 patients (18%) quit before the end of the 4-week CPAP trial; 31 indicated that they had trouble sleeping with CPAP, 3 removed the mask in their sleep, and 2 had nasal or sinus congestion. Overall, physicians predicted success in 50% of patients and 42% met the criterion for improvement. Outcomes of treatment were similar in the 2 groups, with improvements in ESS scores of 3.4 for home monitoring and 4.0 for PSG. The ability of physicians to predict the outcome of treatment was similar for the 2 methods. Five cases (2%) required PSG for diagnosis of other nonrespiratory sleep disorders (narcolepsy, periodic leg movements, and idiopathic hypersomnolence).
Berry and colleagues (2008) 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, and patients on a-blockers or not in sinus rhythm were excluded due to the type of portable monitoring device used (Watch-PAT 100). Of the 53 patients randomized to PSG, 6 (11%) did not have PSG-defined OSA; in the portable monitoring arm, 4 (8%) of 53 patients were found not to have OSA. Treatment outcomes were similar in both groups, with a 7-point improvement in ESS score, 3-point improvement in the Functional Outcomes of Sleep Questionnaire score, and a machine estimate of residual AHI of 3.5 events per hour in the portable monitoring APAP group and 5.3 in the PSG group.
Peripheral Arterial Tone
In 2009, CMS issued a coverage decision to accept use of a sleep testing device that included actigraphy, oximetry, and peripheral arterial tone to aid the diagnosis of OSA in beneficiaries who have signs and symptoms indicative of OSA. A literature review of this technology in September 2009 identified a review of use of peripheral arterial tone for detecting sleep disordered breathing (Pepin, 2009) This review includes the critical evaluation of a number of studies comparing the Watch-PAT™ with laboratory-based PSG. Relevant studies that included appropriate study populations (patients referred for evaluation of OSA or following CPAP treatment) are described.
Pittman et al. (2006) evaluated residual OSA in 70 patients who had self-reported adherence to CPAP for at least 3 months. Exclusion criteria for the study were diagnosis of periodic leg movement disorder, RDI less than 20 on diagnostic PSG, history of peripheral vascular disease, peripheral neuropathy, nonsinus cardiac rhythm, permanent pacemaker, severe lung disease, bilateral cervical or thoracic sympathectomy, finger deformity precluding sensor application, and use of alpha-adrenergic blockers. Compared to concurrently recorded PSG, the area under the curve (AUC) from receiver-operator characteristic (ROC) analysis for RDI greater than 15 was 0.95 (85% sensitivity and 90% specificity). Specificity decreased dramatically at lower cutoffs (67% for RDI >10 and 47% for an RDI >5). Another small study of 37 consecutive patients referred to a sleep center for OSA reported a high correlation between PSG and concurrently recorded Watch-PAT RDI (r=0.93) (Pang, 2007). (Correlation coefficients are not considered to be as meaningful as estimates of sensitivity and specificity.) Sensitivities for AHIs greater than 5, 15, and 35 in this study were 94%, 96%, and 83%, respectively. Specificity was reported at 80%, 79%, and 72%, respectively, for these thresholds.
Penzel and colleagues (2004) raised concern about the specificity of this device in an independently conducted small study of 21 patients with suspected sleep apnea. The study found that for 16 of the 17 subjects with adequate recordings, the number of Watch-PAT events was greater than the number of respiratory events. The device was found to have reasonable reliability and to be very sensitive to arousal, although since arousals are not unique to apnea events, the authors concluded that the specificity of the Watch-PAT is limited.
There is also uncertainty about the clinical utility of the indirect measure of peripheral arterial tone compared to measuring airflow and respiratory effort directly. In 2004, Pittman et al noted other potential disadvantages of the Watch-PAT, including its inability to differentiate between the type of respiratory event (eg, obstructive, central, mixed, or hypopnea) or to identify body position, and its susceptibility to artifact from arrhythmias (Pittman et al, 2004). It is noteworthy that the American Academy of Sleep Medicine (AASM) has not changed its 2007 guidelines, recommending that portable monitors should minimally record airflow, respiratory effort, and blood oxygenation, using biosensors conventionally used for in-laboratory PSG (Collop et al, 2007). At this time, evidence does not support a change in the sensors required for portable monitoring.
Apnea Risk Evaluation System (ARES™)
In 2008, Ayappa et al reported a validation study of a small apnea monitor that is self-applied to the forehead. The device measures blood oxygen saturation and pulse rate, airflow, snoring levels, head movement, and head position. The study enrolled 80 individuals with a high likelihood of OSA and 22 with a low risk of OSA; results of simultaneous ARES™ recording and PSG were available for 92 individuals. When healthy subjects were excluded from analysis, sensitivity (0.91) and specificity (0.92) were relatively high, for an AHI of 15 or greater, but dropped considerably with an AHI between 5 and 15 (sensitivity, 0.97; specificity, 0.78). Five percent of the subjects could not tolerate the device and were not included in the analysis.
Monitoring of APAP use by daily transmission to a web-based database and review by a research coordinator has been shown to improve compliance to positive airway pressure therapy (191 min/d vs 105 min/d) (Fox et al, 2012). For the telemedicine arm of this randomized trial, the research coordinator reviewed the transmitted data daily and contacted the patient if any of the following were present: mask leak greater than 40 L/min for more than 30% of the night, less than 4 hours of use for 2 consecutive nights, machine-measured AHI of more than 10 events per hour, and 90th percentile of pressure greater than 16 cm H2O. Evaluation by their physician sleep specialist after 3 months of therapy showed a similar modest decrease in AHI for the 2 groups (1.6 for telemedicine, 0.7 for controls).
SleepImage System
The SleepImage System is cloud-based software a medical device that generates AHI from data recorded with a single photoplethysmogram sensor. The SleepImage algorithms calculate heart rate variability, respiration, and oxygen saturation with cardiopulmonary coupling analysis. Hilmisson et al (2020) compared results calculated by the SleepImage System with manually scored PSG in 805 children ages 5 to 9.9 yrs of age who participated in the Childhood Adenotonsillectomy Trial (CHAT).9, The CHAT study included 1244 habitually snoring children who were referred for PSG. A total of 805 children had successfully collected data from the sensor.
SUMMARY OF EVIDENCE
Diagnosis
For individuals who have suspected OSA who receive home sleep testing with at least 4 recording channels, the evidence includes RCTs. Relevant outcomes are test accuracy, symptoms, functional outcomes, and resource utilization. RCTs have reported that home sleep testing with type 3 monitors (those with =4 recording channels) is noninferior to testing in the sleep lab for adults with a high pretest probability of OSA and absence of comorbid conditions as determined by clinical evaluation. A positive portable monitoring study with channels that include arterial oxygen saturation, airflow, and respiratory effort has a high positive predictive value for OSA and can be used as the basis for a CPAP trial to determine the efficacy of treatment. A negative portable monitoring study cannot be used to rule out OSA. Patients who have a negative result from portable monitoring or have a positive study but do not respond to CPAP should undergo further evaluation. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.
For individuals who have suspected OSA who receive limited channel home sleep testing, the evidence includes studies on diagnostic accuracy. Relevant outcomes are test accuracy, symptoms, functional outcomes, and resource utilization. The ability to detect clinically significant OSA without sensors for heart rate, respiratory effort, airflow, and oxygen saturation lacks support in the literature. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
Ongoing and Unpublished Clinical Trials
A search of ClinicalTrials.gov identified over several ongoing studies on the diagnosis of OSA.
Clinical Input Received Through Physician Specialty Societies and Academic Medical Centers
While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted.
2009
In response to requests, input was received from 5 physician specialty societies (6 reviewers) and 3 academic medical centers while this policy was under review in 2009. Professional society guidelines and position statements were also reviewed. In general, the input supported the use of PSG, portable sleep monitoring tests, multiple sleep latency test, and CPAP for adults as described in the policy. The March 2009 update includes the reviewer’s recommendations for clarifications and modifications to the policy statements.
2010
In response to requests, input was received from 1 physician specialty society and 6 academic medical centers (8 reviewers) for the 2010 policy update. The input focused on the sensors required for unattended home sleep studies and on diagnosis and treatment of OSA in children. In general, the reviewers supported the requirement that home monitors measure four parameters, including respiratory effort, airflow, and oxygen saturation, and that their use be restricted to adults. Some exceptions were noted for specific situations. The January 2010 policy update includes recommendations from reviewers regarding indications that are specific to pediatric patients.
2014 Input
In response to requests, input was received from 7 physician specialty societies (8 reviewers) and 4 academic medical centers (6 reviewers) while this policy was under review in 2014. Input focused on routine screening of patients scheduled to undergo bariatric surgery. There was consensus that routine screening is considered medically necessary in this population due to the high prevalence of obstructive sleep apnea (OSA) in patients with a body mass index greater than 40 kg/m2, combined with the increased rate of perioperative complications in patients with OSA. Input was mixed on whether the use of portable home sleep testing was appropriate for patients scheduled for bariatric surgery. Concerns were raised about the high prevalence of obesity hypoventilation syndrome in this population, which is a contraindication to home sleep testing. Other reviewers considered home sleep testing to be appropriate in patients scheduled for bariatric surgery, with the caveat that obesity hypoventilation syndrome should be ruled out prior to home sleep testing
PRACTICE GUIDELINES AND POSITION STATEMENTS
American Academy of Sleep Medicine
In 2017, AASM published clinical practice guidelines on diagnostic testing for adult obstructive sleep apnea (OSA). AASM provided the following recommendations:
- -We recommend that clinical tools, questionnaires, and prediction algorithms not be used to diagnose OSA in adults, in the absence of PSG or HSAT. SOR: Strong. QOE: Moderate
- -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. SOR: Strong. QOE: Moderate
- -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. SOR: Strong. QOE: Moderate
- -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. SOR: Strong. QOE: Very low
- -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. SOR: Weak. QOE: Low
- -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. SOR: Weak. QOE: Very low
(HSAT: home sleep apnea testing; OSA: obstructive sleep apnea; PSG: polysomnography; QOE: quality of evidence; SOR: strength of recommendation).
The AASM considers a technically adequate home sleep apnea test (HSAT) device to incorporate "a minimum of the following sensors: nasal pressure, chest and abdominal respiratory inductance plethysmography, and oximetry; or else PAT [peripheral arterial tone] with oximetry and actigraphy." The guidelines refer to the AASM Manual for the Scoring of Sleep and Associated Events for additional information regarding HSAT sensor requirements.
In 2021, the AASM (Caples et al on behalf of 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.
The following clinical guidance statements were provided:
- "Follow-up PSG or HSAT is not recommended for routine reassessment of asymptomatic patients with obstructive sleep apnea on PAP therapy, however, follow-up PSG or HSAT can be used to reassess patients with recurrent or persistent symptoms, despite good PAP adherence.
- Follow-up PSG or HSAT is recommended to assess response to treatment with non-PAP interventions.
- Follow-up PSG or HSAT may be used if clinically significant weight gain or loss has occurred since diagnosis of OSA or initiation of its treatment.
- Follow-up PSG may be used for reassessment of sleep-related hypoxemia and/or sleep-related hypoventilation following initiation of treatment for OSA
- Follow-up PSG or HSAT may be used in patients being treated for OSA who develop or have a change in cardiovascular disease.
- Follow-up PSG may be used in patients with unexplained PAP device-generated data."
AASM also issued guidelines in 2009 on the evaluation, management, and long-term care of adults with OSA. 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 recommended that patients who are obese, retrognathic, hypertensive, or who complain of snoring or daytime sleepiness should be assessed for presence or absence as well as severity of OSA using the following methods (standard):
- Sleep history assessment includes “witnessed apneas, gasping/choking at night, excessive sleepiness … total sleep amount, nocturia, morning headaches … and decreased concentration and memory.”
- Physical assessment includes evaluation of “respiratory, cardiovascular, and neurologic systems…. signs of upper respiratory narrowing….”
- Objective testing, under an AASM-accredited program, and attended by trained technical personnel. The diagnosis of OSA is confirmed if the number of obstructive events (apneas, hypopneas plus respiratory event related to arousals) is greater than 15 events/hour or greater than 5 events/hour in a patient reporting any of the following: unintentional sleep episodes during wakefulness; daytime sleepiness, unrefreshing sleep; fatigue; insomnia; waking up breath holding, gasping, or choking; or a bed partner describing loud snoring, breathing interruptions, or both.
- In laboratory polysomnography (standard) records “electroencephalogram … electrooculogram … chin electromyogram, airflow, oxygen saturation, respiratory effort, … and heart rate.”
- Home testing with portable monitors should “at minimum, record air flow, respiratory effort, and blood oxygenation.”
American Academy of Pediatrics
The American Academy of Pediatrics (AAP) published a 2012 guideline on the diagnosis and management of uncomplicated childhood OSA associated with adenotonsillar hypertrophy and/or obesity in an otherwise healthy child treated in the primary care setting, which updates the AAP’s 2002 guidelines (AAP, 2002; Marcus, 2012). The AAP recommends that all children/adolescents should be screened for snoring, and PSG should be performed in children/adolescents with snoring and symptoms/signs of OSA as listed in the guideline. If PSG is not available, an alternative diagnostic test or referral to a specialist may be considered (Option). The estimated prevalence rates of OSA in children/adolescents range from 1.2% to 5.7%. Adenotonsillectomy is recommended as the first line of treatment for patients with adenotonsillar hypertrophy, and patients should be reassessed clinically post-operatively to determine whether additional treatment is required. High-risk patients should be re-evaluated with an objective test or referred to a sleep specialist. CPAP is recommended if adenotonsillectomy is not performed or if OSA persists postoperatively. Weight loss is recommended in addition to other therapy in patients who are overweight or obese, and intranasal corticosteroids are an option for children with mild OSA in whom adenotonsillectomy is contraindicated or for mild postoperative OSA.
American Society of Metabolic and Bariatric Surgery
The American Society of Metabolic and Bariatric Surgery (ASMBS, 2012) Clinical Issues Committee published guidelines on the perioperative management of obstructive sleep apnea in 2012. The guidelines note that while some reports in the literature recommend routine screening for obstructive sleep apnea (OSA) prior to bariatric surgery, other reports suggest clinical screening only does not result in any increase in postoperative pulmonary complications after laparoscopic Roux-en-Y gastric bypass (RYGB), and that most current surgical practices refer patients with clinical symptoms of OSA for polysomnography, but do not make this a routine preoperative test prior to bariatric surgery. The ASMBS provided, based on the evidence in the literature to date, the following guidelines regarding OSA in the bariatric surgery patient and its perioperative management:
- OSA is highly prevalent in the bariatric patient population. The high prevalence demonstrated in some studies suggests that consideration be given to testing all patients, and especially those with any preoperative symptoms suggesting obstructive sleep apnea.
- Patients with moderate to severe OSA should bring their CPAP machines, or at least their masks, with them at the time of surgery and use them following bariatric surgery at the discretion of the surgeon.
- Routine pulse oximetry or capnography for postoperative monitoring of patients with OSA after bariatric surgery should be utilized, but the majority of these patients do not routinely require an ICU setting.
- No clear guidelines exist upon which to base recommendations for retesting for OSA following bariatric surgery. Strong consideration should be given to retesting patients who present years after bariatric surgery with regain of weight, a history of previous OSA, and who are being reevaluated for appropriate medical and potential reoperative surgical therapy.
U.S. Preventive Services Task Force Recommendations
In 2022, 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.” (Mangione et al, 2022).
Regulatory Status
Novel devices for OSA diagnosis are described below (listed by Device, Manufacturer, Description, FDA Marketing Clearance Number, FDA Product Code, Year of FDA Approval).
Diagnosis
- SleepImage System. MyCardio. Software as a medical device that provides automated analysis of sleep data from a single photoplethysmogram sensor to aid in the evaluation of sleep disorders. K163696. MNR. 2017
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CPT/HCPCS:
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| 94762 | Noninvasive ear or pulse oximetry for oxygen saturation; by continuous overnight monitoring (separate procedure) |
| 95782 | Polysomnography; younger than 6 years, sleep staging with 4 or more additional parameters of sleep, attended by a technologist |
| 95783 | Polysomnography; younger than 6 years, sleep staging with 4 or more additional parameters of sleep, with initiation of continuous positive airway pressure therapy or bi level ventilation, attended by a technologist |
| 95800 | Sleep study, unattended, simultaneous recording; heart rate, oxygen saturation, respiratory analysis (eg, by airflow or peripheral arterial tone), and sleep time |
| 95801 | Sleep study, unattended, simultaneous recording; minimum of heart rate, oxygen saturation, and respiratory analysis (eg, by airflow or peripheral arterial tone) |
| 95806 | Sleep study, unattended, simultaneous recording of, heart rate, oxygen saturation, respiratory airflow, and respiratory effort (eg, thoracoabdominal movement) |
| 95807 | Sleep study, simultaneous recording of ventilation, respiratory effort, ECG or heart rate, and oxygen saturation, attended by a technologist |
| 95808 | Polysomnography; any age, sleep staging with 1 3 additional parameters of sleep, attended by a technologist |
| 95810 | Polysomnography; age 6 years or older, sleep staging with 4 or more additional parameters of sleep, attended by a technologist |
| 95811 | Polysomnography; age 6 years or older, sleep staging with 4 or more additional parameters of sleep, with initiation of continuous positive airway pressure therapy or bilevel ventilation, attended by a technologist |
| G0398 | Home sleep study test (hst) with type ii portable monitor, unattended; minimum of 7 channels: eeg, eog, emg, ecg/heart rate, airflow, respiratory effort and oxygen saturation |
| G0399 | Home sleep test (hst) with type iii portable monitor, unattended; minimum of 4 channels: 2 respiratory movement/airflow, 1 ecg/heart rate and 1 oxygen saturation |
| G0400 | Home sleep test (hst) with type iv portable monitor, unattended; minimum of 3 channels |
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| ICD9: |
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| ICD10: |
| G47.30 | Sleep apnea, unspecified |
| G47.33 | Obstructive sleep apnea (adult) (pediatric) |
| G47.8 | Other sleep disorders |
| G47.9 | Sleep disorder, unspecified |
| R06.81 | Apnea, not elsewhere classified |
| R40.0 | Somnolence |
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American Medical Association.
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