Medical Affairs Policy

Medical Affairs Policy Service: Sleep Disorder Testing (Polysomnogram, Split Night Polysomnogram, Sleep Study, Multiple Sleep Latency Test (MSLT), Maintenance of Wakefulness Testing (MWT), Home Sleep Apnea Test (HSAT) Home sleep study testing (HST), Actigraphy, Pulse Oximetry, Apnea Link devices PUM 250-0030-1712 Medical Policy Committee Approval 09/21/18 Effective Date 01/01/19 Prior Authorization Needed Yes Disclaimer: This policy is for informational purposes only and does not constitute medical advice, plan authorization, an explanation of benefits, or a guarantee of payment. Benefit plans vary in coverage and some plans may not provide coverage for all services listed in this policy. Coverage decisions are subject to all terms and conditions of the applicable benefit plan, including specific exclusions and limitations, and to applicable state and federal law. Some benefit plans administered by the organization may not utilize Medical Affairs medical policy in all their coverage determinations. Contact customer services as listed on the member card for specific plan, benefit, and network status information. Medical policies are based on constantly changing medical science and are reviewed annually and subject to change. The organization uses tools developed by third parties, such as the evidence-based clinical guidelines developed by MCG to assist in administering health benefits. This medical policy and MCG guidelines are intended to be used in conjunction with the independent professional medical judgment of a qualified health care provider. To obtain additional information about MCG, email medical.policies@wpsic.com. Description: This policy addresses testing for sleep disorders that are diagnosed using polysomnography, multiple sleep latency test (MSLT), and other sleep tests and devices. Sleep disorders discussed in this policy include sleep disordered breathing, central sleep apnea, obstructive sleep apnea (OSA), sleep related hypoventilations, and narcolepsy. OSA is the most common form of sleep disordered breathing. The home or laboratory polysomnogram (PSG) is the most commonly performed diagnostic test. Significant Snoring (also referred to as heroic snoring): is defined, for the purpose of this policy, as snoring that occurs on a regular basis, loud enough to be heard 2 rooms away from the sleeper. Sleep Medicine Specialist: For purpose of this policy, a sleep medicine specialist is one of the following: o A Diplomate of the American Board of Sleep Medicine or o A certification in sleep medicine and one of the following Board-Certified Specialties: Pulmonologist, Otolaryngologist, Neurologist, Pediatrician, Internist, Family Medicine Physician, or Psychiatrist; or Nurse Practitioner or Physician Assistant working in collaboration with one of the listed specialists. Page 1 of 10

Monitoring Devices are classified by technologic capability: Classification is based on the number of sleep related parameters and channels of parameters the device can measure and record. Portable monitoring devices (PMD) vary widely in their technology and manufacturer description of channels. Type I devices are the most complex devices used primarily in laboratory technicianattended overnight PSG. Type II-IV PMD have fewer channels and are used for home PSG. For the purposes of this policy: Type II PMD must have a minimum of 7 channels which include EEG, EOG, EMG, ECG/heart rate, airflow, respiratory effort and O2 saturation Type III PMD must have capability to measure and record a minimum of 4 channels including two measures of respiratory movement/airflow, one measure of ECG/heart rate and one measure of O2 saturation. They typically lack the (EEG) ability to detect arousal from sleep or REM sleep Type IV devices have variable (1-3) parameters such as O2 saturation and airflow and are considered insufficient for home study and unproven to affect health outcomes The American Academy of Sleep Medicine recommends, when OSA is identified during a laboratory sleep study, that a split-night PSG study is considered the most effective evaluation and trial treatment. If CPAP titration cannot be completed on the same night, documentation of the reason for a separate night for CPAP titration should be submitted with the request for the titration study. See Section D of this policy. If an apnea hypopnea index (AHI) of 40 per hour or greater is obtained within the first two hours of sleep during an in-laboratory study on an adult, a split night study with titration should be performed that night. Indications of Coverage: For both in-lab and home sleep study requests: It is the policy of the health plan that services be administered in the least costly manner and location that are safe and appropriate for the patient. For an in-lab PSG, the request must document why a home sleep apnea test (HSAT) is not appropriate. If this is not documented, the request will be denied as not medically necessary. The medical record should include results of a health history, focused sleep history, and focused physical exam. Other causes of sleep disturbance (e.g. insomnia) have been ruled out and addressed prior to the request for the study. I. Polysomnogram (PSG): Page 2 of 10

I.A. Home Sleep Apnea Test for Obstructive Sleep Apnea (for an individual over age 18) is indicated when all of sections (1 through 3 below) are met: 1. Documentation of history and physical indicates that there are no medical conditions or comorbid sleep disorders that would make an in-lab study more appropriate, given patient safety or accuracy concerns. Note: If these conditions (listed below, a. through l.) are identified, proceed to the in-lab criteria in sections I.B, I.C, and I.D a. Body mass index (BMI) greater than 40 b. CHF, congested heart failure (includes New York Heart Association [NYHA] class III or IV, left ventricular ejection fraction [LVEF] under 45%) c. Chronic opioid use d. Chronic, moderate, or severe pulmonary disease including chronic obstructive pulmonary disease (COPD) e. Epilepsy f. Difficult to control high blood pressure (defined as hypertensive despite a maximum dose of 3 antihypertensive agents) while compliant with medical therapy g. Pulmonary hypertension h. Heart disease (arrhythmia-unstable or refractory to treatment) i. Significant neurologic or neuromuscular disease (Parkinson s disease, spina bifida, myotonic dystrophy, Amyotrophic Lateral Sclerosis (ALS), kyphoscoliosis, myasthenia gravis, polio, Guillain-Barre Syndrome j. Stroke with residual weakness k. Suspicion of or history of complex sleep apnea, central apnea, or complex sleep disorders including narcolepsy, parasomnias, periodic limb movement disorder, cataplexy, dementia with Lewy Bodies, or restless leg syndrome l. The member or care taker does not have the physical and cognitive ability to use portable monitoring equipment at home 2. Documentation of any of the following symptoms suggestive of OSA: a. Witnessed apnea b. Report of having fallen asleep while driving a motor vehicle c. Gasping/choking while sleeping d. Epworth sleep score of 10 or higher e. Significant snoring and any two of the following (aa. Through ee.): aa. Report of having fallen asleep while at the workplace bb. Neck circumference of greater than 17inches (if male) or greater than 16 inches (if female) cc. Body mass index (BMI) over 30 dd. Mallampati Score of III or higher or Friedman Tongue Position of FTP III or higher Page 3 of 10

ee. Marked retrognathia, crowding of the oropharynx, or other structural abnormality that constricts the upper airway 3. The device being used is a type II or III portable monitor device as defined in the policy description. Only one night (one unit) of home sleep study will be approved (regardless of how many nights are recorded) For repeat home study indications, see section I.D. I.B. In Laboratory PSG for the evaluation of apnea in adults must be ordered by a sleep medicine specialist (as defined in the policy description) and is considered medically necessary when documentation in the history and physical indicates both: 1. There are symptoms suggestive of OSA including any of the following (a. through e. below): a. Witnessed apnea b. Report of having fallen asleep while driving a motor vehicle c. Gasping/choking while sleeping d. Epworth sleep score of 10 or higher e. Significant snoring and any two of the following (aa. through ff.) : aa. Report of having fallen asleep while at the workplace bb. Neck circumference of greater than 17inches (if male) or greater than 16 inches (if female) cc. Body mass index (BMI) over 30 dd. Mallampati Score of III or higher or Friedman Tongue Position of FTP III or higher ee. Marked retrognathia, crowding of the oropharynx or other structural abnormality that constricts the upper airway ff. Difficult to control high blood pressure (defined as hypertensive despite a maximum dose of 3 antihypertensive agents) while compliant with medical therapy AND 2. The member has a condition that would make an in-lab study more appropriate, given patient safety or accuracy concerns. (See conditions listed above in section I. A. 1. of this policy) For PSG in the context of possible narcolepsy, see MSLT in section II. Page 4 of 10

I.C. For patients with co-morbid conditions who do not met the criteria in section I.B or ID., an in-laboratory PSG ordered by a sleep medicine specialist may also be considered medically necessary when there is documentation of at least one of the following conditions: a. Body mass index (BMI) over 40 b. Congestive heart failure-chf (includes NYHA class III or IV, LVEF under 45%) c. Chronic opioid use d. Chronic, moderate, or severe pulmonary disease including COPD e. Epilepsy f. Difficult to control high blood pressure/hypertension (defined as hypertensive despite a maximum dose of 3 antihypertensive agents) while compliant with medical therapy g. Pulmonary hypertension h. Heart disease (arrhythmia-unstable or refractory to treatment,) i. Significant neurologic or neuromuscular disease (Parkinson s disease, spina bifida, myotonic dystrophy, amyotrophic lateral sclerosis (ALS), kyphoscoliosis, myasthenia gravis, polio, Guillain-Barre Syndrome j. Stroke with residual weakness AND the member ALSO has any one of the following: a. Epworth score of 10 or higher b. Mallampati Score of III or higher or Friedman Tongue Position of FTP III or higher c. Marked retrognathia, crowding of the oropharynx or other structural abnormality that constricts the upper airway d. Neck circumference of greater than 17 inches (if male) or greater than 16 inches (if female) e. Report of having fallen asleep while at the workplace f. Significant snoring (as defined in the policy description above) I.D. PSG (in laboratory and ordered by a sleep medicine specialist) is considered medically necessary for the evaluation of any of the following conditions when these conditions are the only described conditions: 1. When a home sleep study identifies unanticipated central apnea, is inconclusive, or is negative; provided that a sleep medicine specialist assesses and recommends the in-lab study. 2. Narcolepsy (PSG is performed with MSLT). Narcolepsy is characterized by Excessive Daytime Sleepiness (EDS), sleep paralysis, hypnagogic hallucinations (hallucinations occurring immediately prior to sleep), recurrent Page 5 of 10

daytime naps or lapses into sleep for over 3-month period, and cataplexy (sudden bilateral loss of postural tone associated with intense emotion). 3. Cataplexy (sudden bilateral loss of postural tone associated with intense emotion), parasomnias, dementia with Lewy bodies, or periodic limb movement disorders. 4. Violent or injurious behavior to self or sleep partner during sleep: including seizures or rapid eye movement (REM) behavior disorder (violent dreams or vocalization during REM sleep). 5. History or clinical features associated with central sleep apnea (CSA) or complex sleep apnea (e.g. Cheyne-Stokes breathing, hyper or hypo-ventilation associated with respiratory disease, central nervous system disease or neuromuscular diseases). 6. Adult with obesity hypoventilation syndrome suspected as documented by all the following: a. Body mass index (BMI) greater than 30 b. Daytime hypercapnia with PaC02 of 45 mm Hg or greater c. Daytime hypoxemia with PaO2 of 70 mm Hg or less d. Normal TSH level e. No evidence of COPD by pulmonary function tests (e.g. normal FEV1/FVC ratio) 7. For postoperative evaluation of the effectiveness of palate or other surgery to correct obstruction if the surgery was covered (only one follow up/repeat polysomnogram is considered medically necessary). 8. To ensure therapeutic benefit of an oral appliance (OA) if the OA was approved/ covered. (Allow one home study with the appliance in place after the final fitting/adjustment of the device). All other follow up care including (but not limited to) adjustments, modifications, titration studies of a titratable device, and professional services are considered incidental to / included in the cost for oral appliance. 9. A two-month trial (with documented compliance of at least 4 hours of use per night for 70% of the nights of the 2-month trial) of a PAP/positive airway pressure device (for example, CPAP, BPAP, AutoPAP) has not resolved the sleep disorder symptoms, OR the symptoms returned after good initial response Page 6 of 10

to treatment despite appropriate follow up to address issues of PAP intolerance (such as claustrophobia, difficulty tolerating the pressure setting, appropriate mask fit, mucous membrane irritation, unintentional removal of mask during sleep). 10. For re-evaluation (polysomnogram or re-titration study) when an individual with diagnosed obstructive sleep apnea, consistently using a PAP device (device download that demonstrates a minimum of four hours of use per night is required), has a significant change in physical condition (for example, but not limited to: surgery of the neck, significant changes in weight defined as 10% change in of body weight). 11. To determine need for continued positive airway pressure (PAP) device use when PAP device was initiated during an inpatient hospital stay (home or laboratory PSG). 12. When a patient has been using Adaptive Servo Ventilation, VPAP Adapt with Adaptive Servo Ventilation (ASV) or BiPAP with auto Servo Ventilation (SV), and his left ventricular ejection fraction (LEVF) is less than or equal to 45%. I.E. Titration study for PAP devices: When a home sleep study result meets criterion for treatment (in Medical Policy, Sleep Disorder Treatment), a 4-week trial of home auto pap may be approved (separate prior authorization request is required for PAP device). A laboratory PSG to allow for PAP titration is indicated when any of the following occur: 1. An AHI of 40 was not documented in the first 2 hours of the initial laboratory PSG, but the entire PSG resulted in an AHI of 15/hour or higher. 2. An AHI of 40 was not documented in the first 2 hours of the initial laboratory PSG, but the entire PSG resulted in an AHI of between five and 15 per hour in an individual with the significant comorbidities listed in Section 1.C. 3. Titration during a split night study was not adequate to improve the AHI (e.g. inadequate amount of time left, unable to achieve adequate pressure, intolerance of mask or pressures). 4. Home Auto Pap titration has failed to resolve the AHI sufficiently after a fourweek trial I.F. Pediatric PSG: For criteria, refer to MCG: Polysomnography (PSG). Study is performed in a Sleep Center and ordered by a Sleep Medicine Specialist. Page 7 of 10

II. Multiple Sleep Latency Test (MSLT), performed in a sleep laboratory, is used to measure levels of daytime tendency to fall asleep. MSLT is considered medically necessary for the evaluation of suspected narcolepsy (characterized by EDS, sleep paralysis, hallucinations, and/or cataplexy) or idiopathic hypersomnia. A nighttime PSG, which has ruled out the presence of obstructive sleep apnea and documents appropriate sleep, should immediately precede the daytime MSLT. III. PSG with MSLT when PSG has already recently been performed: If a PSG has previously ruled out sleep apnea, the request for a repeat PSG immediately prior to the MSLT must include results of the first study and documentation explaining why a second sleep study is necessary to precede the MSLT. If the PSG prior to the MSLT was not at least 6 hours or if the MSLT was not requested with the first PSG because narcolepsy was not suspected, then the second PSG can be approved. IV. Maintenance of Wakefulness Testing, performed in a sleep lab to measure an individual s ability to stay alert is considered medically necessary for evaluation of narcolepsy and idiopathic hypersomnia. Limitations of Coverage: A. Review contract and endorsements for exclusions and prior authorization or benefit requirements. B. If requested/used for a condition/diagnosis other than listed in the Indications of Coverage, it will be denied as experimental, investigational, and unproven to affect health outcomes. C. If requested/used for a condition/diagnosis that is listed in the Indications of Coverage, but the criteria are not met, it will be denied as not medically necessary. D. The following services are considered not medically necessary: 1. A polysomnogram when these are the only conditions described: a. Snoring b. Acute or chronic insomnia c. Chronic obstructive pulmonary disease (COPD) d. Asthma e. Hypertension (high blood pressure) f. Headache Page 8 of 10

g. Frequent nighttime arousals h. Night terrors i. Sleep walking 2. A (second) laboratory polysomnogram for CPAP titration without documentation of the reason a split-night study was not done during the initial study. 3. An in-lab CPAP titration study after a positive home polysomnogram when there is no documentation of a contraindication to autopap titration (such as HST result suspicious for central sleep apnea or complex sleep apnea) 4. More than one follow-up sleep study for oral appliance effectiveness. 5. MSLTs that are unattended, performed at home, or repeated. 6. Pulse oximetry used alone for evaluation of sleep disorders, as this is considered a type IV portable device. E. The following tests are considered experimental, investigational, and unproven to affect health outcomes as there is insufficient peer-reviewed scientific literature documenting the effectiveness of these tests in the diagnosis of OSA: 1. Actigraphy. 2. SNAP test (or any home testing device) with less than 4 channels. 3. Sleep Strip (a sticker-type device adhered to the upper lip during sleep that can measure breathing irregularities). 4. Testing using Type IV portable monitor devices as described in policy description (e.g. Apnealink, ApneaLink with Oximetry WatchPAT Home Sleep Apnea Testing) 5. Maintenance of Wakefulness Testing is considered investigational for diagnosis of OSA, and for management or assessment of response to therapy for sleep disorders. Check member health plan for occupation related requests. Documentation Required: Office notes Page 9 of 10

Arise / WPS Review History: Implemented 04/01/15, 04/01/16, 01/01/17, 04/01/18, 01/01/19 Medical Policy 12/12/14, 12/11/15,12/09/16, 12/01/17, 09/21/18 Committee Approval Reviewed/Revised 12/12/14, 12/11/15, 12/09/16, formatting correction 02/07/2017, 12/01/17, 09/21/18 Note: For review/revision history prior to 2014 see previous Medical Policy or Coverage Policy Bulletin Approved by the Medical Director Page 10 of 10