Established:
61885, 61886, 64553, 64568, 64569, 64570, 95970, 95974, 95975, L8680,
L8681, L8682, L8683, L8684, L8685,
L8686, L8687, L8688, L8689
Non-established:
E0770 |
Basic benefit and medical policy
Vagus nerve stimulation
Vagus nerve stimulation has been established. It may be considered a useful therapeutic or diagnostic option when indicated.
Non-implanted and transcutaneous vagal nerve stimulators are experimental. Their positive affect on clinical outcomes hasn’t been definitively demonstrated.
This policy is effective July 1, 2018.
Inclusions:
Seizures that are refractory to medical treatment.
Exclusions:
Other conditions not listed in the inclusions include, but aren’t limited to:
- Depression
- Heart failure
- Upper-limb impairment due to stroke
- Essential tremor
- Headaches (cluster headaches, migraines, etc.)
- Fibromyalgia
- Tinnitus
- Traumatic brain injury
- Autism
- Schizophrenia
Transcutaneous (nonimplantable) vagus nerve stimulation devices are considered experimental for all indications. |
Established:
95782, 95783, 95800, 95805, 95806,
95807, 95808, 95810, 95811, E0486,
G0398, G0399
Non-established:
95801, A7047, E0485, E1399, G0400 |
Basic benefit and medical policy
Sleep disorders: Diagnosis and medical management
Diagnosis
Polysomnography, or PSG, is an attended (supervised) sleep study performed in a hospital or freestanding sleep laboratory. The safety and effectiveness of PSG, including a split-night PSG, have been established. It may be considered a useful diagnostic option when indicated.
The safety and effectiveness of an unattended sleep study with a minimum of four recording channels (including oxygen saturation, respiratory movements, airflow and ECG or heart rate) in a home setting (home sleep study/test) have been established. It may be considered a useful diagnostic option when indicated.
The safety and effectiveness of multiple sleep latency testing, or MSLT, have been established. It may be a useful tool in diagnosing narcolepsy.
Medical management
The safety and effectiveness of oral appliances to reduce upper airway collapsibility in the treatment of OSA have been established. Oral appliances may be considered a useful therapeutic option when indicated.
Palate and mandible expansion devices are considered experimental for the treatment of OSA. There is insufficient evidence in the current medical literature to support their efficacy and use in clinical practice.
Nasal expiratory positive airway pressure, or nasal EPAP, for the treatment of OSA is considered experimental. There is insufficient evidence in the current medical literature to support its efficacy and use in clinical practice.
Oral pressure therapy for the treatment of OSA is considered experimental. There is insufficient medical literature found to support its efficacy.
Inclusionary and exclusionary guidelines
Diagnosis
Unattended (unsupervised) home sleep study (with minimum of four recording channels, including oxygen saturation, respiratory movements, airflow and ECG or heart rate)
Inclusions:
- Adult patients 18 years of age or older with high pretest probability for moderate to severe OSA
- Observed apneas during sleep, or
- A combination of at least two of the following:
- Excessive daytime sleepiness evidenced by an Epworth sleepiness > 10, inappropriate daytime napping (e.g., during driving, conversation or eating) or sleepiness that interferes with daily activities that isn’t explained by other conditions
- Habitual snoring or gasping/choking episodes associated with awakenings
- Treatment-resistant hypertension (persistent hypertension in a patient taking three or more antihypertensive medications)
- Obesity, defined as a body mass index (BMI) > 35 kg/m2 or neck circumference defined as > 17 inches in men or >16 inches in women
- Craniofacial or upper airway soft tissue abnormalities
- No exclusions or contraindications to a home sleep study
Exclusions:
- Younger than 18 years of age
- Morbid obesity, defined as a body mass index (BMI) > 40 kg/m2 or the patient is 100 pounds over the ideal body weight for their height
- Obesity hypoventilation syndrome
- Narcolepsy
- Periodic limb disorder during sleep
- Central sleep disorder
- Parasomnias
- REM behavior disorder
- Moderate to severe congested heart failure – New York Heart Association class III or IV
- Moderate to severe pulmonary disease (e.g., pulmonary function test results with an arterial blood gas showing PO2 < 60 or PCO2 > 45, pulmonary congestion or left ventricular ejection fraction < 45 percent)
- Documented neuromuscular disease (e.g., Parkinson’s, myotonic dystrophy, ALS)
- Critical illness that would prevent the patient from using the equipment
Repeat unattended (unsupervised) home sleep study (with a minimum of four recording channels, including oxygen saturation, respiratory movements, airflow and ECG or heart rate)
Inclusions:
- To assess efficacy of surgery or oral appliances/devices, or
- To re-evaluate the diagnosis of OSA and need for continued continuous positive airway pressure, e.g., if there’s a significant change in weight or change in symptoms suggesting that CPAP should be retitrated or possibly discontinued.
- Attended (supervised) sleep study performed in a sleep lab
Inclusions for adults (18 years of age or older):
- Adult patients age 18 or older with a moderate to high pretest probability for OSA
- Observed apneas during sleep, or
- A combination of at least two of the following:
- Excessive daytime sleepiness evidenced by an Epworth sleepiness > 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
- Habitual snoring or gasping/choking episodes associated with awakenings
- Treatment-resistant hypertension (persistent hypertension in a patient taking three or more antihypertensive medications)
- Obesity, defined as a body mass index (BMI) > 30 kg/m2 or neck circumference > 17 inches in men or >16 inches in women
- Craniofacial or upper airway soft tissue abnormalities
- When unattended (unsupervised) home sleep study is contraindicated (see exclusions to unattended home sleep study above)
Inclusions for children younger than age 18:
- Pediatric patients younger than age 18 with a moderate to high probability of OSA
- Habitual snoring in association with one or more of criteria below:
- Restless or disturbed sleep
- Behavioral disturbance or learning disorders including deterioration in academic performance, attention deficit disorder, hyperactivity
- Frequent awakenings
- Enuresis (bedwetting)
- Growth retardation or failure to thrive
- Excessive daytime somnolence or altered mental status not explained by other conditions, or
- Polycythemia not explained by other conditions, or
- Cor pulmonale not explained by other conditions, or
- Witnessed apnea with duration greater than two respiratory cycles, or
- Labored breathing during sleep, or
- Hypertrophy of the tonsils or adenoids in patients at significant surgical risk such that the exclusion of OSA would allow avoidance of surgery, or
- Suspected congenital central alveolar hypoventilation syndrome or sleep-related hypoventilation due to neuromuscular disease or chest wall deformities, or
- Clinical evidence of a sleep-related breathing disorder in infants who have experienced an apparent life-threatening event, or
- For exclusion of OSA in a patient who has undergone adenotonsillectomy for suspected OSA more than eight weeks previously, or
- The initial study was inadequate, equivocal or non-diagnostic and the child’s parents or caregiver report that the breathing patterns observed at home were different from those during testing
Repeated (attended) sleep study performed in a sleep lab
Inclusions:
- Equipment failure or less than six hours or recording
- To initiate and titrate CPAP in adult patients who have:
- An 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.
- Respiratory disturbance index may be used in place of AHI in unattended sleep studies.
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.
- To initiate and titrate CPAP in children:
- In pediatric patients, an AHI greater than 1.5 is considered abnormal, and an AHI of 10 or more may be considered severe.
- To re-evaluate the diagnosis of OSA and need for continued CPAP (e.g., if there is a significant change in weight or change in symptoms suggesting that CPAP should be retitrated or possibly discontinued.)
Note: This statement doesn’t imply that supervised studies are needed routinely following unattended studies. This statement means a re-evaluation based on a substantial change in symptoms or in the clinical situation.
- To assess efficacy of surgery (including adenotonsillectomy) or oral appliances/devices.
Multiple sleep latency testing
MSLT is considered experimental to diagnose obstructive sleep apnea except to exclude or confirm narcolepsy in the diagnostic workup of OSA syndrome.
Medical management
PAP therapies, i.e. continuous positive airway pressure, automatic positive airway pressure, bilevel positive airway pressure and variable positive airway pressure, may be considered medically necessary for the management of OSA, central sleep apnea or mixed apnea. These devices for treatment are addressed in our policy titled “Positive Pressure Airway Devices.”
Intraoral appliances (tongue-retaining devices or mandibular advancing/positioning devices) may be considered established in adult patients with clinically significant OSA. (Verify coverage of intraoral appliances under the DME benefit.)
Inclusions (all of the following):
- A trial of CPAP has failed or is contraindicated.
- The device is prescribed by a treating physician.
- The device is custom-fitted by qualified dental personnel.
- There is absence of temporomandibular dysfunction or periodontal disease.
Exclusions:
- Prefabricated (not custom-fit) devices.
- Palate and mandible expansion devices are considered experimental.
- Nasal expiratory positive airway pressure is considered experimental.
- Oral pressure therapy is considered experimental.
Policy guidelines
Risk factors for OSA
Although not an exclusive list, patients with all four of the following symptoms are considered to be at high risk for obstructive sleep apnea:
- Habitual snoring
- Observed apneas
- Excessive daytime sleepiness
- A body mass index greater than 35 kg/m2
If no bed partner is available to report snoring or observed apneas, other signs and symptoms suggestive of OSA (e.g., age of the patient, male gender, thick neck, craniofacial or upper airway soft tissue abnormalities, or unexplained hypertension) may be considered. Objective clinical prediction rules are being developed; however, at the present time, risk assessment is based primarily on clinical judgment.
The STOP-BANG questionnaire is a method developed for non-sleep specialists to assess the signs and symptoms of OSA (snore, tired, observed apnea, blood pressure, BMI, age, neck, gender) and has been shown to have 97 percent sensitivity and a negative predictive value of 96 percent (specificity of 33 percent) for the identification of patients with severe OSA (Apnea/Hypopnea Index [AHI] score >30 events per hour). Overnight oximetry has been used by some sleep specialists as a component of the risk assessment but isn’t adequate for the diagnosis of OSA. Therefore, a follow-up polysomnography or home sleep study would still be required to confirm or exclude a diagnosis of OSA.
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 body mass index greater than the 90th percentile for the weight/height ratio. Although the definition of severe OSA in children isn’t well established, an AHI greater than 1.5 events per hour is considered abnormal (an AHI score of >10 events per hour may be considered severe). In addition, the first-line treatment in children is usually adenotonsillectomy. Continuous positive airway pressure is an option for children who aren’t 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 isn’t 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.
Multiple sleep latency test
The multiple sleep latency test, or MSLT, is an objective measure of the tendency to fall asleep in the absence of alerting factors, while the maintenance of wakefulness test, or MWT, is an objective measure of the ability to stay awake under soporific conditions (used to assess occupational safety). The MSLT and MWT aren’t routinely indicated in the evaluation and diagnosis of OSA or in assessment of change following treatment with CPAP. The MSLT may be indicated as part of the evaluation of patients with suspected narcolepsy to confirm the diagnosis (often characterized by cataplexy, sleep paralysis and hypnagogic/hypnopompic hallucinations) or to differentiate between suspected idiopathic hypersomnia and narcolepsy. Narcolepsy and OSA can co-occur. Because it isn’t possible to differentiate the excessive sleepiness caused by OSA and narcolepsy, OSA should be treated before confirming a diagnosis of narcolepsy with the MSLT.
Specialist training
In order to perform and get reimbursed for in-center and out-of-center sleep testing, a doctor must be board-certified in sleep medicine by the American Board of Medical Specialties or the American Board of Sleep Medicine. Any M.D. or D.O. may order a sleep test if it’s performed and interpreted by a doctor who is board-certified in sleep medicine. Follow our preauthorization program for in-lab sleep testing.
Split-night studies
American Academy of Sleep Medicine practice parameters indicate that a split-night study (initial diagnostic 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 two hours of diagnostic PSG. Split-night studies may sometimes be considered at an AHI of 20 to 40 events per hour, 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-level requirements, based on split-night studies, may be less accurate than in full-night calibrations.
- CPAP titration is carried out for more than three 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 and non-REM 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 is confirmed, but criteria b and c aren’t met.
|