Diagnosis and Medical Management of Obstructive Sleep Apnea in Adults

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Medical Policy: 07.01.21 
Original Effective Date: January 2001 
Reviewed: March 2015 
Revised: March 2015 


Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.


Description: 

Obstructive sleep apnea syndrome (OSA) is characterized by repetitive episodes of upper airway obstruction due to the collapse of the upper airway during sleep. The patient is usually unware of it and sometimes may awaken gasping for breath. In patients with OSA, the normal pharyngeal narrowing is accentuated by anatomic factors, such as a short, wide neck, elongated palate and uvula, or large tonsillar pillars with redundant lateral pharyngeal wall mucosa. OSA is typically diagnosed by overnight monitoring with polysomnography (PSG).

 

The hallmark clinical symptom of OSA is excessive daytime sleepiness; the hallmark clinical sign is snoring. With snoring, the snoring abruptly ceases during the apneic episodes and during the brief period of patient arousal and then resumes when the patient again falls asleep. Sleep fragmentation associated with the repeated arousal during sleep can lead to impairment of daytime activity. Adult patients with OSA associated daytime somnolence are thought to be a higher risk for accidents involving motorized vehicles or heavy equipment. In addition, OSA affects the cardiovascular and pulmonary systems. For example, apnea leads to periods of hypoxemia, alveolar hypoventilation, hypercapnia and acidosis. This in turn can cause systemic hypertension, cardiac arrhythmias, pulmonary hypertension and cor pulmonale. Systemic hypertension is common in patients with OSA. Severe OSA is also associated with decreased survival, presumably related to severe hypoxemia, hypertension, or an increase in automobile accidents related to daytime sleepiness. 

 

In adults,OSA is often suspected on the basis of the clinical history and physical appearance. The presence or absence and severity of OSA must be determined before initiating treatment. The diagnostic criteria is based on clinical signs and symptoms determined during a comprehensive sleep evaluation, which includes a sleep oriented history and physical examination and findings identified by sleep testing. 

 

Excessive daytime sleepiness may be subjective and may be assessed by questionnaires such as the Epworth Sleepiness Scale (ESS), a short self administered questionnaire that asks patients” How likely are you to doze off or fall asleep in the following situations, in contrast to feeling just tired?”

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

 

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

 

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. A standard polysomnogram, supervised by a trained sleep technician, typically requires the following physiologic signals:

• Electroencephlogram EEG (to stage sleep, detect arousal)
• Chin electromyogram
• Electro-oculogram (EOG) (to detect arousal, rapid eye movement [REM] sleep)
• Airflow
• Oxygen saturation
• Respiratory effort
• Electrocardiogram (ECG) or heart rate

 

Additional recommended parameters include body position and leg EMG derivations. Anterior tibialis EMG is useful to assist in detecting movement arousals and may have the added benefit of assessing periodic limb movements, which coexist with sleep related breathing disorders (SRBD) in many patients. 

 

By definition, a polysomnogram always includes sleep staging. The three elements EEG, chin electromyogram and elctro-oculogram (EOG) are required for sleep staging.   Sleep staging is performed to assess arousals from sleep, and determination of the frequency of apneas and hypopneas from channels measuring oxygen desaturation, respiratory airflow and respiratory effort. The actual components of the study will be dictated by the clinical situation.  

 

Home Sleep Test (HST)/Home Sleep Studies 
In light of the limited capacity of sleep laboratories, a variety of devices have been developed specifically to evaluate OSA at home. Clinical guidelines on the use of unattended home (portable) monitoring devices for the diagnosis of obstructive sleep apnea (OSA) in adults, from the American Academy of Sleep Medicine (AASM) state that for the diagnosis of OSA the study should be performed only in conjunction with a comprehensive sleep evaluation and that unattended sleep studies are not appropriate for the diagnosis of OSA in patients with significant co-morbid medical conditions that may degrade the accuracy of unattended sleep studies, including moderate to severe pulmonary disease, neuromuscular disease or congestive heart failure. The guidelines also note that unattended studies are not appropriate for the diagnostic evaluation of OSA in patients suspected of having other sleep disorders. Also, unattended sleep studies are not appropriate for general screening of asymptomatic populations.

 

Sleep Monitoring Devices

Type I

Comprehensive Standard Overnight polysomnography in a sleep center or laboratory with a sleep technician in constant attendance.

Minimum of 7 channels including EEG, EOG, chin EMG, ECG or heart rate, airflow, respiratory effort, oxygen saturation

Type II

Home sleep test (HST) type II portable monitor, unattended

Minimum of 7 channels including EEG, EOG, EMG, ECG/heart rate, airflow, respiratory effort and oxygen saturation

Type III

Home sleep test (HST) type III portable monitor, unattended

Minimum of 4 channels: 2 respiratory movement/airflow, 1 ECG/heart rate and 1 oxygen saturation

Type IV (A)

Home sleep test (HST) type IV portable monitor; three or more bioparameters

Airflow and at least 2 other parameters (e.g. EOG, peripheral arterial tonometry (PAT), snoring or pulse oximetry)

 

Type IV (B)

Home sleep test (HST) type IV portable monitor; continuous single or dual bioparameter recording

Minimum of 1 parameter (e.g. overnight oximetry)

 

Note: Guidelines indicate that nocturnal pulse oximetry alone is not appropriately used as a case finding or screening method for OSA. Pulse oximetry, when used alone, has not been shown to have an adequate predictive value to rule out OSA. All patients with symptoms suggestive of OSA would require polysomnography regardless of whether the pulse oximetry was positive or negative.

 

Diagnosis of Obstructive Sleep Apnea

Apnea is defined as the cessation of airflow for at least 10 seconds. 

 
Based on 2013 clarification by the American Academy of Sleep Medicine (AASM) the recommendation for hypopnea scoring criteria is the following:

  • The peak single excursions drop by >  30% of pre-event baseline using nasal pressure (diagnostic study), PAP device flow (titration study), or an alternative hypopnea sensor (diagnostic study).
  • The duration of the > 30%  drop in signal excursion is > 10 seconds.
  • There is a > 3%  oxygen desaturation from pre-event baseline and/or the event is associated with an arousal; OR There is a > 4%  oxygen saturation from pre-event baseline.   

The apnea-hypopnea index (AHI) is equal to the average number of episodes of apnea and hypopnea per hour of sleep without the use of positive airway pressure device. Sleep time can only be measured in a Type I (facility based polysomnogram) or Type II sleep study. The AHI is reported only in Type I or Type II sleep studies. 

 

The respiratory disturbance  index (RDI) is equal to the episodes of apnea and hypopnea per hour of recording without the use of a positive airway pressure device. The RDI is reported in Type III and Type IV sleep studies.

 

A full night polysomnography (PSG) is recommended for the diagnosis of sleep related breathing disorder, but a split-night study (initial diagnostic PSG followed by continuous positive airway pressure titration on the same night) is an alternative to one full night of diagnostic PSG. The split-night study may be performed if an apnea/ hypopnea index (AHI) > 40/hr is documented during 2 hours of a diagnostic study but may be considered for an AHI of 20-40/hr based on clinical judgement.    

 

The diagnosis of OSA is confirmed if the number of obstructive events (apneas, hypopneas + respiratory event related arousals) on PSG is greater than 15 events/hr or greater than 5/hr in a patient who reports any of the following: unintentional sleep episodes during wakefulness; daytime sleepiness; unrefreshing sleep; fatigue; insomnia; waking up breath holding, gasping or choking; or the bed partner describing loud snoring, breathing interruptions, or both during the patients sleep. 

 

OSA Severity:

• An AHI > 15 is typically considered moderate OSA
• An AHI greater than 30 is considered severe OSA
• An RDI > 5 and < 15 is considered mild OSA
• An RDI > 15 and < 30 is considered moderate OSA
• AN RDI > 30/hr is considered severe OSA  

 

It is estimated that about 7% of adults have moderate or severe OSA and 20% have at least mild OSA, and that the referral population of OSA patients represents a small proportion of patients who have clinically significant and treatable disease.

 

Medical Management
Medical management of OSA includes: 

• Weight loss;
• Avoiding consumption of alcohol and sedatives prior to bedtime;
• Oral appliances, and
•  Various types of CPAP (i.e., fixed CPAP, bi-level positive airway pressure [BPAP], or auto-adjusting CPAP [APAP]). 

 

 

Fixed CPAP
Fixed CPAP delivers positive airway pressure at a level that remains constant throughout the respiratory cycle. The positive airway pressure splints the upper airway open, preventing upper airway collapse or narrowing during sleep. No additional pressure above the level of CPAP is provided and patient must initiate every breath.

 

Fixed CPAP is the first-line therapy for most patients with obstructive sleep apnea (OSA) because its efficacy is well established and supported by extensive clinical experience. A trial of BPAP or auto-titrating CPAP may also be worthwhile for patients who do not tolerate fixed CPAP. 

 

Auto-Titrating CPAP  (APAP)
Auto-titrating CPAP delivers an amount of positive airway pressure that varies during the night. The variation is related to whether the device algorithm detects upper airway obstruction or confirms continued patency. In the presence of upper airway obstruction or increased airway resistance the delivered pressure gradually increases according to the algorithm until adequate patency is detected. After a period of sustained upper airway patency, the delivered level of pressure gradually decreases until the algorithm identifies recurrent upper airway obstruction, at which point the delivered pressure again increases. The result is that the delivered pressure varies throughout the night in an effort to provide the lowest pressure that is necessary to maintain upper airway patency.

 

Patients with certain comorbidities (e.g. congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), central sleep apnea syndromes and hypoventilation syndromes) should not receive treatment with auto-titrating devices since efficacy has not been demonstrated in these situations.

 

Bilevel Positive Airway Pressure (BPAP)
BPAP delivers positive airway pressure at different levels during inspiration and expiration. The level during inspiration is called the inspiratory positive airway pressure (IPAP) and the level during expiration is called the expiratory positive airway pressure (EPAP),

 

BPAP splints the upper airway open in a manner similar to CPAP. However, it provides additional ventilatory support because it augments tidal volume. The tidal volume produced is directly related to the difference between the IPAP and EPAP, which is equivalent to pressure support (PS).

 

With most BPAP devices, it is possible to set a backup respiratory rate, which is the number of breaths initiated by the BPAP device per minute. When no backup rate is set, the device is said to be in “spontaneous” (S) mode; when both patient-initiated and backup breaths are possible, the device is in “spontaneous-timed” (S-T) mode; and when only backup breaths are permitted, the device is in “timed” (T) mode. When BPAP is prescribed for obstructive sleep apnea (OSA) patients, the backup respiratory rate is generally not used or is set to initiate only a few breaths per minute, since most initiate a sufficient number of breaths without assistance.

 

BPAP should be reserved for those individuals who fail or complain of intolerance to fixed CPAP.

 

Determining the Amount of Postive Airway Pressure     
The optimal amount of positive airway pressure is determined by titration. The goal of titration is to identify a level of positive airway pressure that is acceptable to the patient, prevents recurrent upper airway obstruction during sleep, and maintains both sleep continuity and an acceptable oxyhemoglobin saturation during sleep.

 

Titration of fixed CPAP, auto-titration CPAP and BPAP should be performed during a sleep study, since a sleep study is the only way to confirm that the positive airway pressure has eliminated upper airway obstruction. The sleep study may be a full night in laboratory polysomnography,  a split-night in laboratory polysomnography or unattended home sleep study.  

 

• Titration during a full night, attended, in laboratory polysomnography is the preferred approach for the initiation of CPAP, auto-titrating CPAP or BPAP.
• Split night attended in laboratory polysomnography is appropriate for titrating CPAP. However, it is not recommended for auto-titrating CPAP or titration of BPAP because there is insufficient evidence that split night studies effectively guide the titration of these modes.   

 

Continuous Positive Airway Pressure Device Adherence
Adherence is defined as use of CPAP for at least 4 hours/night on 70% of nights during a consecutive 30 day period any time during the first 3 months of initial usage.

 

Multiple Sleep Latency Testing (MSLT)
The multiple sleep latency test (MLST) involves multiple trials (4 to 5 times) during a day to objectively assess sleep tendency by measuring the number of minutes it takes the patient to fall asleep.

 

The MSLT records whether the patient falls asleep during the test and what types and stages of sleep the patient is having. The MSLT is the better test for demonstration of sleep onset rapid of eye movement (REM) periods. The types and stages of sleep during the day can help establish the diagnosis of narcolepsy and idiopathic hypersomnia.

 

According to American Academy of Sleep Medicine (AASM), the MSLT is indicated as part of the evaluation of patients with suspected narcolepsy to confirm the diagnosis, and for patients with suspected idiopathic hypersomnia to help differentiate idiopathic hypersomnia from narcoplepsy. The MSLT is not routinely indicated in the initial evaluation and diagnosis of obstructive sleep apnea or in assessment of change following treatment with nasal CPAP. The MSLT is not routinely indicated for evaluation of sleepiness in medical and neurological disorders (other than narcolepsy), insomnia, or circadian rhythm disorders.

 

Actigraphy      
Actigraphy refers to the assessment of activity patterns by devices typically placed on the wrist or ankle that record body movement, which is interpreted by computer algorithms as periods of sleep (absence of activity) and wake (activity). Sleep/wake cycles may be altered in sleep disorders including insomnia and circadian rhythm sleep disorders.

 

Actigraphic devices are typically placed on the nondominate wrist with wristband and are worn continuously for at least 24 hours. Activity is usually recorded for a period of 3 days to 2 weeks but can be collected continuously over extended time periods with regular downloading of data onto a computer. The activity monitors may also be placed on the ankle for the assessment of restless leg syndrome. The algorithms for detection of movement are variable among devices. Data on patient bed times (lights out) and rise times (lights on) are usually entered into the computer record from daily patient sleep logs or by patient activated markers. Proprietary software is then used to calculate periods of sleep based on the absence of detectable movement, along with movement related to level of activity and periods of wake. In addition to providing graphic depiction of the activity pattern, device specific software may analyze and report a variety of sleep parameters including sleep onset, sleep offset, sleep latency, total sleep duration and wake after sleep onset.

 

Updated practice parameters in 2007 by American Academy of Sleep Medicine (AASM) on the use of actigraphy in the assessment of sleep and sleep disorders recommended actigraphy as a “standard” only as a method to estimate total sleep time in patients with obstructive sleep apnea syndrome when polysomnography (PSG) is not available. Also, recommends actigraphy as an “option”to characterize circadian rhythm patterns or sleep disturbances in individuals with insomnia, including insomnia associated depression.

 

The clinical validity of actigraphy, the assessment of activity patterns by devices typically placed on the write or ankle that record body movement, depends, to a large extent, on the modality with which it is being compared.

• Comparisons with sleep diaries show reasonable correlations for measures fo bedtime, sleep onset, and wake time in adults but not in adolescents. The relative and unique contributions of actigraphy and sleep logs in the diagnosis of sleep disorders and measurement of treatment effects remain to be demonstrated.
• Comparisons with the more resource-intensive polysomnography or behavioral scoring indicates that, with the appropriate sensitivity threshold, actigraphy has sufficient sensitivity to detect sleep but has poor specificity in distinguishing between wake and sleep. The literature also indicates  that the accuracy of actigraphy to differentiate between wake and sleep decreases s the level of sleep disturbance increases.

 

Overall, progress has been made since 2007 American Academy of Sleep Medicine (AASM) research recommendations in assessing the validity of different algorithms in comparison with the reference standard. Although actigraphy appears to provide reliable measures of sleep onset and wake time in some patient populations, the clinical utility of actigraphy over the less expensive sleep diary has not been demonstrated. Moreover, evidence indicates that actigraphy does not provide a reliable measure of sleep efficiency in clinical populations. Evidence to date does not indicate that this technology is as beneficial as the established alternatives. Therefore, actigraphy is considered investigational.


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Prior Approval: 

 

Not applicable


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Policy: 

This medical policy applies to patients 18 years and older

Related Policy: Diagnosis and Medical Management of Obstructive Sleep Apnea in Children 02.01.55 

 

Diagnostic  Studies
Note:
Interpretation of sleep study test results should be validated only by a board certified sleep specialist.

 

Home Sleep Test (HST)/Home Sleep Study (95800, 95801, 95806, G0398, G0399, G0400)

Unattended (unsupervised) home sleep studies may be considered medically necessary in adult patients who are at high pre-test probability for obstructive sleep apnea (OSA), when ALL of the following criteria are met:

 

Patients considered high probability must have at least two of the following symptoms:

  1. *Habitual snoring or gasping/choking episodes associated with awakenings
  2. *Observed apneas
  3. Excessive daytime sleepiness as evidenced by an Epworth Sleepiness Scale >10 (see information above under Description), inappropriate daytime napping (e.g. during driving, conversation or eating), or sleepiness that interferes with daily activities not explained by other conditions
  4. A body mass index > 30 kg/m2
  5. Increased neck circumference >17 inches for men or >16 inches in women
  6. Morning headaches
  7. Sleep fragmentation or frequent unexplained arousals from sleep
  8. Decreased concentration/memory loss
  9. Treatment resistant hypertension/unexplained hypertension; AND 

In addition, those patients eligible for an unattended home sleep study must have no evidence of a comorbid medical condition including but not limited to any of the following as they might alter ventilation or require alternative treatment:

  •  Moderate to Severe Pulmonary Disease
  • Congestive Heart Failure
  • Obesity hypoventilation syndrome
  • Neuromuscular disease; AND

Must not be suspected of having other sleep disorders including but not limited to the following:

  • Central sleep apnea
  • Periodic limb movement disorder
  •  Restless leg syndrome
  • Insomnia
  • Parasomnias
  • Circadian rhythm disorders
  • Narcolepsy; AND

Any one of the following sleep monitoring devices:

  • sleep monitoring using a Type II device; or
  • sleep monitoring using a Type III device; or
  • sleep monitoring using a Type IV(A) device, which must measure a minimum of three channels and must provide measurement of apnea-hypopnea index (AHI) 

Notes:

  • See above information under Description for full description of sleep monitoring devices.
  • Respiratory disturbance index (RDI) may be used in place of apnea/hypopnea index (AHI) in unattended sleep studies 
  • Sleep studies using devices that do not provide a measurement of apnea-hypopnea index (AHI) and oxygen saturation are considered not medically necessary because they do not provide sufficient information to prescribe treatment.
  • *If no bed partner is available to report snoring or observed apneas, the patient must still meet the criteria above as it related to other signs and symptoms suggiestive of obstructive sleep apnea (OSA).

Unattended (unsupervised) sleep studies are considered not medically necessary in adult patients who do not meet the criteria above as they would be considered low risk for OSA. Evidence to date shows that home sleep tests/studies have been predominately performed in high risk populations for moderate to severe obstructive sleep apnea (OSA) and should be limited to this group. 

 

Supervised In-Laboratory (95807, 95808, 95810, 95811)

Supervised polysomnography (Type I device) performed in a sleep laboratory may be considered medically necessary as a diagnostic test in patients with any of the following (1-3) who fail to meet requirements for an unattended home study:

 

1. *Observed apneas during sleep;
OR
2. A combination of at least two of the following (a - i):

a. 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. (See information above under description regarding Epworth Sleepiness Scale);

*b. Habitual snoring, or gasping/choking episodes associated with awakenings;
c. Unexplained hypertension/treatment resistant hypertension;
d. Obesity, defined as a body mass index greater than 30 kg/m2;

e. Increased neck circumference >17 inches for men or >16 inches for women; 
f. Neuromuscular disease (e.g. Parkinsons, spina bifida, myotonic dystrophy, amyotrophic lateral sclerosis);

g. Decreased concentration/memory loss;

h. Morning headaches;

i. Sleep fragmentation or frequent unexplained arousals from sleep; OR

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.

 

*If no bed partner is available to report snoring or observed apneas, the patient must still meet the criteria above as it relates to other signs and symptoms suggestive of obstructive sleep apnea (OSA).

 

Supervised polysomnography (PSG) or (unattended) home sleep test/studies are considered not medically necessary for the following indications (list is not all inclusive):

  • The diagnosis of chronic lung disease
  • The diagnosis or treatment of restless leg syndrome, except where uncertainty exists in the diagnosis
  • The diagnosis of circadian rhythm sleep disorders
  • Transient insomnia
  • Insomnia associated to psychiatric or neuropsychiatric disorders
  • The diagnosis of bruxism (grinding of teeth)
  • Establishment of a diagnosis or treatment of depression
  • Migraine headaches/headaches 

Based on peer reviewed literature supervised polysomnography (PSG) or (unattended) home sleep test/studies are not indicated in the routine evaluation for the above listed indications (list is not all inclusive) nor has this testing shown to improve patient health outcomes and therefore, is considered not medically necessary

 

 

Nocturnal Pulse Oximetry
Guidelines indicate that nocturnal pulse oximetry alone is not an appropriate diagnostic tool for diagnosing obstructive sleep apnea (OSA). Pulse oximetry when used alone, has not shown to have an adequate predictive value to rule out OSA and therefore, is considered not medically necessary. Also, all patients with symptoms suggestive of OSA would require polysomnography regardless of whether the pulse oximetry was positive or negative.  

 

 

Split-Night Study

 

A split-night in-laboratory polysomnography in which the initial diagnostic portion of the polysomnography is followed by positive airway pressure (PAP) titration may be considered medically necessary when EITHER of the following criteria is met:

  • Apnea/hypopnea index (AHI) of 40/hr or higher during the initial diagnostic portion of the split-night study
  • AHI of 20-40/hr with symptoms indicative of significant OSA (e.g., repetitive obstructions and significant oxygen desaturations) 

Repeat Testing

 

Supervised In-Laboratory (95807, 95808, 95810, 95811)

 

A repeat supervised polysomnography (Type I device)  may be considered medically necessary under the following circumstances due to a substantial change in symptoms:

 

1. To initiate and titrate continuous positive airway pressure (CPAP) in adult patients with clinically significant  OSA defined as those patients who have:

  • An apnea/hypopnea index (AHI) of at least 15 per hour; OR
  • An AHI of at least 5 per hour in a patient with excessive daytime sleepiness or unexplained hypertension.

 

Note: A split-night study, in which severe OSA is documented during the first half of the study using polysomnography, followed by CPAP during the second half of the study, can eliminate the need for a second study to titrate CPAP.  (See criteria for split-night study noted above.)

 

2. Failure of resolution of symptoms or recurrence of symptoms during treatment.
3. To assess efficacy of surgery (including adenotonsillectomy) or oral appliances/devices.
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.

 

 

Unsupervised Home Sleep Study (95800, 95801, 95806, G0398, G0399, G0400)


Repeat (unsupervised) home sleep studies may be considered medically necessary 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 re-titrated or possibly discontinued.

 

Multiple consecutive nights of supervised or unattended (unsupervised) sleep studies that do not meet the above criteria for repeat studies are not medically necessary.

 

Multiple Sleep Latency Test (MSLT) (95805)
Multiple sleep latency test (MSLT) would be considered medically necessary for the following indications:

  • For evaluation of symptoms of narcolepsy, to confirm the diagnosis; or
  • For evaluation of persons with suspected idiopathic hypersomnia to help differentiate idiopathic hypersomnia from narcolepsy; or
  • Individuals with previously identified sleep disorder such as obstructive sleep apnea syndrome or other sleep related breathing disorder who continue to experience excessive sleepiness despite optimal treatment may require evaluation for possible narcolepsy.

Repeat multiple sleep latency test (MSLT) for all other indications would be considered
not medically necessary, unless:

  • The initial test was invalid or uninterpretable; or
  • The initial test is affected by extraneous circumstances or when study conditions were present during initial testing; or
  • The patient is suspected to have narcolepsy but earlier MSLT evaluation did not provide polygraphic confirmation

Multiple sleep latency test (MSLT) is not medically necessary in any one of the following:

  • When performed in the initial evaluation and diagnosis of obstructive sleep apnea syndrome
  • For routine follow up after treatment of sleep related disorders
  • For evaluation of sleepiness in medical and neurological disorders (other than narcolepsy), insomnia or circadian rhythm disorders

Overnight polysomnography is the diagnostic procedure of choice for evaluation of individuals with possible sleep related breathing disorders and available evidence indicates that the routine use of the MSLT does not contribute significantly to diagnosis or assessment of response to treatment for sleep related breathing disorders and therefore is considered not medically necessary.

 

Multiple sleep latency test (MSLT) in the home (unattended/unsupervised) would be considered investigational as it has not been proven to be equivalent to a formal multiple sleep latency test (MSLT) peformed in a sleep laboratory.

 

Medical Management

 

PAP Devices

 

Continuous positive airway pressure (CPAP) and auto-titrating CPAP (APAP) may be considered medically necessary for the treatment of obstructive sleep apnea (OSA) when the following criteria are met:

  • The patient has a sleep study that meets either of the following:
    • The apnea-hypopnea index (AHI) or respiratory disturbance index (RDI) is > 15 events per hour; or
    •  The apnea-hypopnea index (AHI) or respiratory disturbance index (RDI) is > 5 and less than 15 events per hour and accompanied documentation supports the patient reports any of the following: unintentional sleep episodes during wakefulness; daytime sleepiness; unrefreshing sleep; fatigue; insomnia; waking up breath holding, gasping, or choking; or the bed partner describing loud snoring, breathing interruptions, or both during the patient’s sleep.   

A positive airway pressure device (CPAP,  APAP, BPAP) is considered not medically necessary if the above criteria is not met.

 
Bi-level positive airway pressure (BPAP) may be considered medically necessary for patients with obstructive sleep apnea who meet the criteria above for CPAP and a CPAP device has been tried and proven ineffective based on a therapeutic trial conducted during the sleep study.

 

Notes:

  • Ineffective is defined as documented failure to meet therapeutic goals using a CPAP device during the titration portion of the sleep study despite optimal therapy (i.e. proper mask selection and fitting and appropriate pressure settings).
  • If a CPAP device is tried and found ineffective during the initial facility-based titration or home trial, substitution of a BPAP device does not require a new initial face-to-face clinical evaluation or a new sleep study.  
  • Patients who fail the initial 3 month trial (12 weeks) are eligible to re-qualify for a PAP device but must have the following:
    • A face-to-face clinical re-evaluation by the treating physician to determine the etiology of the failure to respond to PAP therapy; and
    • Repeat sleep test to initiate and titrate PAP device in adult patient with OSA: and
    • Documentation to show proof of effectiveness and adherence (compliance) demonstrated when they re-try.
  • If a CPAP device is tried and found ineffective during the initial facility-based titration or home trial, substitution of BPAP does not change the length of the trial unless there is less than 30 days remaining in the trial period.
    • If more than 30 days remain in the trial period, the clinical re-evaluation would still occur between the 31st and 91st day following the initiation of CPAP and objective documentation of adherence (compliance) on the BPAP would need to occur prior to the 91st day following the initiation of the CPAP.
    • If less than 30 days remain in the trial period, the clinical re-evaluation and objective documentation of adherence (compliance) must occur before the 120th day following the initiation of the CPAP.
  • If a CPAP device is used for more than 3 months and the patient was then switched to BPAP, the clinical re-evaluation must occur between the 31st and 91st day following the initiation of the BPAP. There would also need to be documentation of adherence (compliance) to therapy during the 3 month trial of BPAP. 

Continued Use of PAP Devices Beyond the First Three Months of Therapy


Continued coverage beyond the first 3 months of therapy requires that no sooner than the 31st day but no later than the 91st day after initiating therapy, the treating provider must conduct a clinical re-evaluation and documentation should support the individual is benefiting from the therapy. Clinical benefit is demonstrated by both of the following:

  •  Face-to-face clinical re-evaluation by the treating provider with documentation that the symptoms of OSA have improved; and
  • Objective evidence of adherence (documentation should support adherence/compliance) to the use of the PAP device. Adherence to therapy is defined as the use of  PAP device for at least 4 hours/night on 70% of nights during a consecutive 30 day period any time during the first three months of initial use.

If the above criteria is not met, the continued coverage of the PAP device including related accessories are considered not medically necessary

 

Oral appliances:
Intraoral appliances may be considered medically necessary in patients with clinically significant obstructive sleep apnea, as defined above using AHI. Intraoral appliances include either tongue-retaining devices or mandibular advancing/positioning devices.

 

The following tests and treatments for OSA are considered investigational:

  • Topographic EEG
  • Actigraphy
  • Oral Pressure Therapy (OPT)

Overall, progress has been made since 2007 American Academy of Sleep Medicine (AASM) research recommendations in assessing the validity of different algorithms in comparison with the reference standard. Although actigraphy appears to provide reliable measures of sleep onset and wake time in some patient populations, the clinical utility of actigraphy over the less expensive sleep diary has not been demonstrated. Moreover, evidence indicates that actigraphy does not provide a reliable measure of sleep efficiency in clinical populations. Evidence to date does not indicate that this technology is as beneficial as the established alternatives or that the use of actigraphy would result in improved health outcomes for patients with sleep disorders. Therefore, actigraphy is considered investigational.

 

Based on peer reviewed literature topographic brain mapping has been briefly described in the evaluation and diagnosis of OSA.  However, the evidence is limited to small case series studies that do not allow full evaluation of this technology.  At this time, the level of evidence supporting topographic brain mapping is insufficient and therefore is considered investigational.

 

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





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Procedure Codes and Billing Guidelines: 

To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.

  • 94762 Noninvasive ear or pulse oximetry for oxygen saturation by continuous overnight monitoring
  • 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)
  • 95803 Actigraphy testing, recording, analysis, interpretation, and report (minimum of 72 hours to 14 consecutive days of recording)
  • 95805 Multiple sleep latency or maintenance of wakefulness testing, recording, analysis and interpretation of physiological measurements of sleep during multiple trials to assess sleepiness
  • 95806; Sleep study, unattended, simultaneous recording of, heart rate, oxygen saturation, respiratory airflow, and respiratory effort (e.g., thoracoabdominal movement)
  • 95807  Sleep study, simultaneous recording of ventilation, respiratory effort, ECG or heart rate, and oxygen saturation, attended by a technologist
  • 95808 Polysomnography; any age, sleep staging with 1-3 additional parameters of sleep, attended by a technologist
  • 95810 Age 6 years or older, sleep staging with 4 or more additional parameters of sleep, attended by a technologist
  • 95811 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 
  • E0470 Respiratory assist device, bi-level pressure capability with back up rate feature, used with noninvasive interface e.g., nasal or facial mask (intermittent assist device with continuous positive airway pressure)
  • E0471 Respiratory assist device, bi-level pressure capability, with backup rate feature, used with noninvasive interface e.g. nasal or facial mask (intermittent assist device with continuous positive airway pressure) 
  • E0601 Continuous airway pressure (CPAP) device (this code is also used for auto-titrating CPAP (APAP))
  • 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
  • S8040 Topographic brain mapping

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Selected References: 

  • The Medical Policy Reference Manual (MPRM) developed by the Blue Cross Blue Shield Association Health Management Systems, based on Technology Evaluation Center (TEC) criteria.
  • A review of the medical literature and recommendations from the Medical Policy Advisory Council (MPAC), which assists Wellmark's medical directors in the development of medical policies. MPAC is comprised of practicing physicians from Iowa and South Dakota.
  • Loube DI, Andrada T, Shanmagum N, Singer MT. Successful treatment of upper airway resistance syndrome with an oral appliance.  Case Report by Daniel I Louge MD, FCCP Sleep Disorder Center, Pulmonary/Critical Care Medicine Service, Walter Reed Army Medical Center, Washington DC. Revised Nov. 10th 1997.
  • Schoem SR. Review Article: Oral appliances for the treatment of snoring and obstructive sleep apnea. Otolaryngology Head and Neck Surgery 2000; 122:259-262.
  • Gagnadoux F, Pelletier-Fleury N, et al. Home unattended vs hospital telemonitored polysomnography in suspected obstructive sleep apnea syndrome: a randomized crossover trial.  Chest. 2002 Mar;121(3):753-8.
  • ECRI. Actigraphy for the Evaluation of Sleep Disorders. Plymouth Meeting (PA): ECRI Health Technology Information Service; 2005 March 9. 9 p.  (ECRI Hotline Response).
  • Hailey D, Tran K, et al.  A review of guidelines for referral of patients to sleep laboratories [Technology report no 55]. Ottawa: Canadian Coordinating Office for Health Technology Assessment; 2005.
  • Kushida CA, Littner MR, Morgenthaler T, Alessi CA, Bailey D, Coleman J, et al. Practice parameters for the indications for polysomnography and related procedures: an update for 2005. Accessed Nov 12, 2008.
  • Institute for Clinical Systems Improvement (ICSI). Diagnosis and treatment of obstructive sleep apnea in adults. Health Care Guideline. Bloomington (MN): Institute For Clinical Systems Improvement (ICSI); 2008 Jun. 55p. Accessed October 12, 2008.
  • Epstein LJ, Kristo D, trollo PJ Jr. Friedman N, Malhotra A, Patil SP, Ramar K, Rogers R, SchwabRJ, Weaver EM, Weinsteing MD; Adult Obstructive Sleep Apnea Task Force fo the American Academy of Sleep Medicine. Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults. J Clin Sleep Med. 2009 Jun 15:5(3)263-76.
  • ECRI Institute. Auto-titrating Continuous Positive Airway Pressure (Auto-CPAP) versus Fixed Continuous Positive Airway Pressure (CPAP) for Obstructive Sleep Apnea. Plymouth Meeting (PA): ECRI Institute; 2009 Nov 03. 9 p. [ECRI hotline response].
  • ECRI Institute. Oral Appliances in the Treatment of Obstructive Sleep Apnea (OSA) and Upper Airway Resistance Syndrome (UARS). Plymouth Meeting (PA): ECRI Institute; 2010 Jan 07. 13 p. [ECRI hotline response]. Also available: Skomro R, Gjevre J, Reid J, et al.  Outcomes of home-based diagnosis and treatment of obstructive sleep apnea. Chest. 2010 Aug; 138(2): 257-263
  • Mulgrew A, Fox N, Ayas N, et al.  Diagnosis and initial management of obstructive sleep apnea without polysomnography. Ann Intern Med. 2007; 146(3): 157-166.
  • Agency for Healthcare Research and Quality (AHRQ).  Effective Health Care Program: Diagnosis and Treatment of Obstructive Sleep Apnea in Adults. Comparative Effectiveness Review Number 32.
  • ECRI. Oral Appliances for Treating Obstructive Sleep Apnea and Upper Airway Resistance Syndrome. Plymouth Meeting (PA): ECRI Institute; 2011 November 14. [Hotline Service].
  • ECRI. Ambulatory/Portable Sleep Apnea Monitors for Diagnosis of Obstructive Sleep Apnea. Plymouth Meeting (PA): ECRI Institute; 2011 June 22. [Hotline Service].
  • ECRI. Autotitrating versus Fixed Continuous Positive Airway Pressure for Treating Obstructive Sleep Apnea. Plymouth Meeting (PA): ECRI Institute; 2011 November 1. [Hotline Service].
  • ECRI. Actigraphy for the Evaluation of Sleep Disorders. Plymouth Meeting (PA): ECRI Institute; 2011 July 18. [Hotline Service].
  • Crowley, K. E., et al. "Evaluation of a single-channel nasal pressure device to assess obstructive sleep apnea risk in laboratory and home environments." Journal of clinical sleep medicine: JCSM: official publication of the American Academy of Sleep Medicine 9.2 (2013): 109-116.
  • Chen H, Lowe AA. Updates in oral appliance therapy for snoring and obstructive sleep apnea. Sleep Breath. 2012 May 6. [Epub ahead of print]. Accessed 3/26/13.
  • A Multisite Randomized Trial of Portable Sleep Studies and Positive Airway Pressure Autotitration Versus Laboratory-Based Polysomnography for the Diagnosis and Treatment of Obstructive Sleep Apnea: The HomePAP Study. Rosen CL, Auckley D, Benca R, Foldvary-Schaefer N, ..., Kapur V, Rueschman M, Zee P, Redline S.  Sleep. 2012; 35(6):757-67
  • Centers for Medicare & Medicaid Services, National Coverage Determination (NCD) for Sleep Testing for Obstructive Sleep Apnea (OSA) (240.4.1).
  • Nancy A. Collop M.D. et al. Obstructive Sleep Apnea Devices for Out of Center (OOC) Testing: Technology Evalauation. Journal of Clinical Sleep Medicine, Vol.7, No. 5, 2011
  • American Academy of Sleep Medicine (AASM) Clarifies Hypopnea Scoring Criteria, September 23, 2013. AASM News Archives.
  • American Academy of Sleep Medicine(AASM),  Practice Parameters for Clinical Use of the Multiple Sleep Latency Test and the Maintenance of Wakefulness Test. Sleep, Vol. 28, No.1.2005.
  • American Academy of Sleep Medicine(AASM), Practice Parameters for the Use of Actigraphy in the Assessment of Sleep and Sleep Disorders: An Update for 2007. Sleep Vol. 30, No. 4, 2007.
  • Lawrence J. Epstein, M.D. et al., Adult Obstructive Sleep Apnea Task Force of the American Academy of Sleep Medicine,  Clinical Guidelines for the Evaluation, Management and Long Term Care of Obstructive Sleep Apnea in Adults. Journal of Clinical Sleep Medicine, Vol. 5, No.3, 2009.
  • Nancy A. Collop, M.D., et. al. Portable Monitoring Task Force of the American Academy of Sleep Medicine, Clinical Guidelines for the Use of Unattended Portable Monitors in the Diagnosis of Obstructive Apnea in Adult Patients, Journal of Clinical Sleep Medicine, Vol. 3, No. 7, 2007.
  • UpToDate. Clinical Presentation and Diagnosis of Obstructive Sleep Apnea in Adults. Lewis R. Kline, M.D.. Topic last updated December 9, 2013.
  • UpToDate. Sleep Related Breating Disorders in Adults. Definitions. Kingman P. Strohl M.D., Topic last updated January 29, 2013.
  • UpToDate. Portable Monitoring in Obstructive Sleep Apnea in Adults. Nancy Collop, M.D., Topic last updated February 19, 2014.
  • UpToDate. Polysomnography in Obstructive Sleep Apnea in Adults. Richard P. Milliman, M.D., Naomi R. Kramer, M.D., Topic last updated September 20, 2013.
  • Richard J. Schwab, et al. An American Thoracic Society Statement: Continuous Positive Airway Pressure Adherence Tracking Systems. The Optimal Monitoring Strategies and Outcome Measures in Adults.  Am J Respir Crit Care Med, Vol 188, Iss. 5, pp 613-620, Sep 1, 2013
  • Clete A. Kushida, M.D., PhD, RPSGT (Chair). et al, Clinical Guidelines for the Manual Titration of Positive Airway Pressure in Patients with Obstructive Sleep Apnea, Positive Airway Pressure Titration Task Force of the American Academy of Sleep Medicine. Journal of Clinical Sleep Medicine, Vol 4, No. 2, 2008.
  • Clete A. Kushida, M.D., PhD, RPSGT, et al., Practice Parameters for the Use of Continuous and Bilevel Positive Airway Pressure Devices to Treat Adult Patients with Sleep Related Breathing Disorders, An American Academy of Sleep Medicine Report. Sleep, Vol. 29, No. 3, 2006.
  • Timothy Morgenthaler, M.D., et al., Practice Parameters for the Use of Autotitrating Continuous Positive Airway Pressure Devices for Titrating Pressures and Treating Adult Patients with Obstructive Sleep Apnea Syndrome: An Update for 2007, An American Academy of Sleep medicine Report. Sleep, Vol, 31, No.1, 2008
  • UpToDate. Initiation of Positive Airway Pressure Therapy for Obstructive Sleep Apnea in Adults. Nilesh B. Dave, M.D., MPH, Lee K. Brown, M.D.. Topic last updated July 2, 2013
  • UpToDate. Adherence with Continuous Positive Airway Pressure (CPAP). Terri Weaver, PhD, R.N., FAAN, Nancy Collop, M.D., Topic last updated November 25, 2013
  • Clete A. Kushida M.D., PhD, et. al. Practice Parameters for the Polysomnography and Related Procedures: An Update for 2005, The American Academy of Sleep Medicine, Sleep, Vol. 28, No. 4, 2005.
  • ECRI. Hotline Response. Continuous Positive Airway Pressure for Treating Obstructive Sleep Apnea July 2014. Also available at www.ecri.org
  • ECRI. Hotline Response. Ambulatory Sleep Apnea Monitors for Diagnosing Obstructive Sleep Apnea. June 2014. Also available at www.ecri.org

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Policy History: 

 

Date                                        Reason                              Action

July 2011                               Annual review                   Policy revised

May 2012                             Annual review                   Policy renewed

May 2013                             Annual review                   Policy revised

April 2014                             Annual review                   Policy revised

June 2014                             Interim review                   Policy revised

July 2014                              Interim review                   Policy revised

October 2014          New policy created for children        Policy revised

March 2015                          Annual review                   Policy revised


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Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.

Contact Information
New information or technology that would be relevant for Wellmark to consider when this policy is next reviewed may be submitted to:
  Wellmark Blue Cross and Blue Shield
  Medical Policy Analyst
  P.O. Box 9232
  Des Moines, IA 50306-9232
© Wellmark, Inc. All Rights Reserved.
Wellmark Blue Cross and Blue Shield is an Independent Licensee of the Blue Cross and Blue Shield Association doing business in Iowa and South Dakota.
 
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