Medical Affairs Policy & Procedure

Medical Affairs Policy & Procedure Service: Sleep Disorder Testing (Polysomnogram, Split Night Polysomnogram, Sleep Study, Multiple Sleep Latency Test (MSLT), Maintenance of Wakefulness Testing (MWT), Home sleep study testing (HST), Actigraphy, Pulse Oximetry, Apnea Link devices Revised (changes made) Reviewed (no changes) Developed Policy Committee Approval 11/16/12, 12/13/13, 12/12/14, 06/22/01, 09/28/01, 04/26/02, 10/25/02, 01/24/03, 02/24/06, 11/16/07, 11/21/08, 12/28/09, 10/22/10, 11/18/11 11/16/12, 12/13/13, 12/12/14 Disclaimer: Benefit plans vary in coverage and some plans may not provide coverage for certain 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/or federal law. Medical policy does not constitute plan authorization, an explanation of benefits, or a guarantee of payment. Description: Sleep disorders include conditions such as obstructive sleep apnea (OSA) (blockage of the upper airway causes breathing irregularities during sleep), narcolepsy (recurring sudden periods of deep daytime sleep which may be associated with disrupted nocturnal sleep), and insomnia (inability to sleep). Various tests are used to evaluate the presence and degree of a particular sleep disorder. The most commonly performed test is the polysomnogram (PSG) to diagnose Obstructive Sleep Apnea. The polysomnogram (PSG) sleep laboratory study, and Home Sleep study Test (HST) involve the measurement of multiple hemodynamic parameters to evaluate episodes of sleep disorders. A split night sleep study is a polysomnogram performed in a sleep laboratory followed that same night by polysomnography with continuous positive airway pressure devices (e.g. CPAP). 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 F 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. Page 1 of 11

Actigraphy is an evaluation of sleep quality, usually performed with a portable device worn on the wrist-used for diagnosis of conditions such as circadian rhythm disorders. Maintenance of Sleep Wakefulness (MWT) involves the measurement of multiple hemodynamic parameters to evaluate an individual s ability to remain awake. Multiple Sleep Latency Test (MSLT) or nap test involves the measurement of multiple hemodynamic parameters to evaluate daytime levels of sleepiness through a series of nap trials Pulse oximetry is an evaluation of the heart rate and blood oxygen content. Apnea Hypopnea Index (AHI) is defined as the number of obstructive apneas and hypopneas per hour of recorded sleep. This is typically reported as the average number of apneas and hypopneas per hour during a (two hour minimum) polysomnogram. AHI = (Hypopneas + Apneas) X 60 / Total Sleep Time (TST) in minutes. Respiratory Disturbance Index (RDI) is defined as the total number of breathing disturbances per hour of monitoring time (ie, the number of apneas, hypopneas, and respiratory event-related arousals (RERA s). RDI = (RERAs + Hypopneas + apneas) X 60 /Total Sleep Time-TST (in minutes). Respiratory event-related arousals (RERA s) are respiratory event related arousals from sleep that may be seen during a sleep study with EEG. The degree of hypoxia is not low enough to fulfill the criteria for apnea or hypopnea, but does result in brief arousal. Indications of Coverage: There are many risk factors, conditions, symptoms, and physical findings that have been identified and studied in an effort to predict whether an individual has sleep apnea or other sleep disorders. For all indications, the medical record should include results of a health history, focused sleep history, and focused physical exam that supports the suspicion of sleep apnea or other sleep disorder. Physical night time symptoms, daytime sleepiness symptoms, and pertinent physical findings should be included as these findings in combination may be linked to an increased risk of sleep apnea. Other causes of sleep disturbance, such as an unmanageable thyroid condition, side effects of medications, sleep schedule, difficulties in initiating or maintaining sleep, should be ruled out and addressed prior to the request for the study. Snoring alone is not an indication for a sleep study. It is the policy of WPS that services be administered in the least costly manner and location that are safe and appropriate for the patient. If an in-lab PSG study is requested, the request must document why a home study is not appropriate Page 2 of 11

A. Home Sleep Study PSG (HST) (unattended for individuals over age 18) with a type II ( minimum of 7 channels ) or III (minimum of 4 channels) portable monitoring device, ordered by a sleep specialist provider, is indicated when all of the following are met: 1. Criteria for a PSG (see criteria in sections B and C) is met and 2. There is documentation that there are no co-morbid conditions that could affect the accuracy of a home study, including: a) significant heart disease b) CHF ( includes NYHA class III or IV, LVEF under 45% c) chronic, moderate, or severe pulmonary disease d) neuromuscular or neuro degenerative disorder e) BMI over 45 f) suspicion or history of complex sleep apnea, central apnea, or complex sleep disorders including narcolepsy, parasomnias, or periodic limb movement disorder, and 3. The member or care taker has the physical and cognitive ability to use portable monitoring equipment at home, and 4. The device being used is a type I, II or III portable monitor: has capability to measure and record a minimum of: two measures of respiratory effort (e.g. ventilation/airflow); cardiac rate or EKG; and blood oxygenation using biosensors typically used for in laboratory testing (such as: ApneaLink Plus with oximetry Four channel Type III home sleep test) Note: Only one night (one unit) of home sleep study will be approved (regardless of how many nights are recorded) B. PSG for the evaluation of apnea is considered medically necessary when any ONE of the following sets of conditions are met: The criteria below are based upon the research for evaluation of sleep disorders in adults. However, many older children exhibit similar symptoms and findings. Sleep study may be approved for adults and children who meet these criteria. If criteria are not met, send for physician review. 1) Physical Sleep Symptoms with: daytime sleep related symptoms and/or physical findings when ALL of the following are met: a. One or more of the following physical sleep symptoms: 1. Witnessed apnea during sleep: Apneas are defined as periods of temporary cessation of breathing (typically 10 seconds or more) 2. Gasping/choking that awakens the individual or sleep partner Page 3 of 11

3. Significant or Heroic snoring on a regular basis: typically defined as snoring loud enough to be heard 2 rooms away from the sleeper and b. Epworth sleep score of 10 or higher OR any two or more of the following: 1. Report of having fallen asleep while operating a motor vehicle. (if this is documented and criteria for sleep study is not met, send for physician review) 2. Berlin Score: Positive in of 2 (of 3) categories 3. Report of having fallen asleep while at the workplace 4. Neck size of > 17inches( males) >16 (females) 5. BMI over 35 6. Mallampati Score of 3 or higher ( scale of 1-4) 7. Marked retronagthia, crowding of the oropharynx or other structural abnormality that constricts the upper airway ) 2) If No Physical Sleep Symptoms are identified (e.g. sleep is not witnessed and there is no self-report of gasping /choking): send for physician review. C. PSG for apnea in a patient with co-morbid conditions is considered medically necessary when all of the following are met: 1) One or more of the following significant co-morbid conditions is documented: a) Unexplained right heart failure b) Presence of cardiac arrhythmias c) Unexplained pulmonary hypertension d) Hypertension e) Body mass index (BMI) greater than 40 f) Cerebrovascular disease g) Congestive Heart Failure (CHF) 2) Any one of the following symptoms or findings is documented: a) Physical sleep symptoms. Witnessed apnea during sleep, gasping/choking associated with awakenings OR Significant or Heroic snoring on a regular basis (typically defined as snoring loud enough to be heard 2 rooms away from the sleeper) OR b) Physical findings: Mallampati Score of 3 or higher OR Neck size of >17 inches( males) >16 (females) OR Marked retronagthia, OR crowding of Page 4 of 11

the oropharynx OR other structural abnormality that constricts the upper airway OR c) Daytime Sleepiness Symptoms: Epworth score of 10 or higher, Report of having fallen asleep while operating a motor vehicle. (if this is documented, but criteria for sleep study is not met, send for physician review), BERLIN Score: Positive in of 2 (of 3) categories, or Report of having fallen asleep while at the workplace D. PSG is considered medically necessary for the evaluation of any of the following conditions when these conditions are the only described conditions: 1) Narcolepsy, which is characterized by Excessive Daytime Sleepiness (EDS), sleep paralysis, hypnagogic hallucinations (hallucinations occurring immediately prior to sleep), cataplexy. 2) To evaluate 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) 3) History of or clinical features associated with central sleep apnea (CSA) (e.g. Cheyne-Stokes breathing, hyper or hypo-ventilation associated with respiratory disease, central nervous system disease or neuromuscular diseases) 4) 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). 5) To insure therapeutic benefit of an oral appliance if the OA was covered. (Home or in lab study with the appliance in place after final fitting/adjustment of the device) All other follow up care including (but not limited to) adjustments, modifications, titration studies of a titratable device, professional services are considered to be incidental to / included in the oral appliance. 6) A two-month trial of a positive airway pressure device (for example, CPAP, BiPAP (BPAP), AutoPAP) has not resolved the sleep disorder symptoms, OR the symptoms returned after good initial response 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 7) For re-evaluation (polysomnogram or re-titration study) when an individual with diagnosed obstructive sleep apnea, consistently using a PAP device, has a significant change in physical condition (for example but not limited to: surgery of the neck, significant changes in weight) Page 5 of 11

8) When CPAP was initiated during an inpatient hospital stay (e.g. to determine need for continued home PAP use or for titration) E. Titration study for PAP devices: A second laboratory PSG to allow for PAP titration or home Auto PAP titration (in lieu of laboratory 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 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 PSG, but the entire PSG resulted in an AHI of between five and 15 per hour in an individual with significant comorbidities ( see Section B 1) 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 F. MSLT test, 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 polysomnogram, which has ruled out the presence of obstructive sleep apnea, should immediately precede the daytime MSLT. 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 as to why a second sleep study should precede the MSLT. G. Maintenance of Wakefulness Testing, performed in a sleep lab in an attempt to measure an individual s ability to stay alert is considered medically necessary for evaluation of narcolepsy and idiopathic hypersomnia. Limitations of Polysomnogram Coverage: A. Review contract and endorsements for exclusions and prior authorization or benefit requirements. B. If used for a condition/diagnosis other than is listed in the Indications of Coverage, deny as experimental or investigative. C. If used for a condition/diagnosis that is listed in the Indications of Coverage, but the criteria are not met, deny 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 Page 6 of 11

b) Acute or chronic insomnia c) Chronic obstructive pulmonary disease d) Asthma e) Hypertension f) Headache g) Frequent nighttime arousals h) Night terrors i) Sleep walking 2) A (second) laboratory polysomnogram for CPAP titration when there is no documentation of the reason a split-night study was not done during the initial study 3) An in-lab CPAP titration study after home polysomnogram when there is no documentation of a contraindication to autopap titration. 4) More than one follow up study for oral appliance effectiveness. 5) MSLT s that are unattended, performed at home, or repeated. 6) Pulse oximetry used alone for evaluation of sleep disorders. E. The following tests are considered experimental or investigational 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. ( Older models ) 3) Sleep Strip (a sticker-type device adhered to the upper lip during sleep that can measure breathing irregularities). 4) Apnealink, ApneaLink with Oximetry and other type IV devices 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 certificate for occupation related requests. Page 7 of 11

Documentation Required: Office notes Rationale: Obstructive sleep apnea (OSA) is a common type of sleep disorder involving obstruction of the upper airway, that results in breathing difficulties during sleep that usually cause arousal from sleep. Several anatomic conditions, such as obesity, anatomic abnormalities in the oropharynx (such as nasal septal deviation or polyps, enlarged tonsils, uvula or soft palate) may lead to this condition. Sleep studies are indicated for the evaluation of OSA to determine the treatment option that best suits the individual based on the severity of the findings. PSG s and MSLT s can record a range of bodily functions during sleep, such as: measurement of breathing, respiratory effort, oxygen saturation levels, heart monitoring, eye movement, and heart, brain and muscle activity. The American Academy of Sleep Medicine (AASM) recommends a thorough sleep history and physical examination that includes the respiratory, cardiovascular, and neurologic systems, to determine whether OSA symptoms are present and whether further evaluation is necessary. There are a variety of questionnaires and scoring tools available to aid in determining the need for a sleep study. Few have been validated in the general population. The Epworth score has been validated and is endorsed by the AASM. The Berlin scoring tool has been validated. AASM recommends that an laboratory split night study to initiate CPAP treatment of OSA may be considered if an AHI equal to or greater than 40 per hour in the first two hours or for an AHI of 20-39 per hour based on clinical judgment. Split night studies are not typically performed in children. Several methods of OSA testing have been proposed, but in-laboratory polysomnogram testing has been shown to be the most reliable and effective. However, the American Academy of Sleep Medicine (AASM) guidelines for sleep studies state that home studies may be recommended for certain individuals where OSA is strongly suspected. The AASM recommends that a thorough evaluation by a sleep medicine physician be completed prior to a home study. Four types of monitoring devices have been defined for sleep studies. Type I devices are used for in laboratory technician attended overnight PSG. Although attempts have been made to classify the numerous devices proposed for home use for the diagnosis of OSA, classification of Type I, II, and IV devices is unclear. Identifying whether a device meets the minimum requirements of a Type III device is frequently questionable. Depending upon the capability of the device, AHI calculated may not correlate with AHI obtained using a Type I device, and respiratory effort related arousals may not be detected. The AASM recommends only type II or III devices for home studies. In general, a device that measures only the heart rate (electrocardiogram) and oxygen saturation (for example, a pulse oximeter) is not adequate for the evaluation of OSA. Page 8 of 11

The Multiple Sleep Latency Test is indicated for the evaluation of narcolepsy, but is not routinely used for the diagnosis of OSA, evaluating the effectiveness of CPAP, insomnia, or circadian rhythm disorders. References: 1. Centers for Medicare and Medicaid Services (CMS). National Coverage Determination (NCD): NCD for sleep testing for obstructive sleep apnea (OSA). NCD 240.4.1. Effective date: 08/10/09. Available at: www.cms.hhs.gov/mcd/index_list.asp?list_type=ncd. Accessed: 7 Oct 10. 2. Centers for Medicare and Medicaid Services (CMS). Local Coverage Determination, Sleep Disorders Testing. Article for Sleep Disorders Testing (A50380) Novitas solutions, Inc updated 4/18/2013. Accessed 12 Nov 13 3. Chung F, Yegneswaren B, Liao. Validation of the Berlin Questionnaire and American Sovciety of Anesthesiologists Checklist as Screening Tools for Obstructive Sleep Apnea in Surgical Patients. Anesthesiology May 2008 - Volume 108 - Issue 5 - pp 822-830. Available at http://www.ncbi.nlm.nih.gov/pubmed/18431117. Accessed 30 Oct 13 4. Chung F, Subramanyam R, Liao P et.al. High STOP-Bang score indicates a high probability of sleep apnoea. BrJ Anaesth 2012 May;108 (5):768-775. Available at Available at http://www.ncbi.nlm.nih.gov/pmc/articles/pmc3325050/ Accessed 28 Oct 13. 5. Collop NA; Anderson WM; Boehlecke B; Claman D; Goldberg R; Gottlieb DJ; Hudgel D; Sateia M; Schwab R. Clinical guidelines for the use of unattended portable monitors in the diagnosis of obstructive sleep apnea in adult patients. J Clin Sleep Med 2007;3(7):737-747. Available at: http://www.aasmnet.org/practiceparameters.aspx?cid=120 Accessed 1 Nov 2012 6. Collop NA; Tracy SL; Kapur V; Mehra R; Kuhlmann D; Fleishman SA; Ojile JM. Obstructive sleep apnea devices for out-of-center (OOC) testing: technology evaluation. J Clin Sleep Med 2011;7(5):531-548. Available at: http://www.aasmnet.org/practiceparameters.aspx?cid=120 Accessed 1 Nov 12. 7. Dempsey JA, Veasey SC,Morgan BJ, O Donnell CP. Pathophysiology of Sleep Apnea. Physiol Rev 90:47-112, 2010;doi:10.1152/physrev.00043.2008 8. Epstein L, Kristo D, Strollo P, et.al.clinical Guideline for the Evaluation, Management and Long-term Care of Obstructive Sleep Apnea in Adults. Journal of Clinical Sleep Medicine, Vol.5, No. 3, 2009 9. Kushida C, Littner M, Morgenthaler T, Alessi C, Bailey D, Coleman J, Friedman L, Hirshkowitz M, Kapen S, Kramer M, Lee-Chiong T, Loube D, Owens J, Pancer J, Wise M. Practice parameters for the indications for polysomnography and related procedures: an update for 2005. Available at: Page 9 of 11

www.aasmnet.org/resources/practiceparameters/pp_polysomnography.pdf. Accessed: 7 Oct 10. 10. Lee E, Harris J. Sleep Disorders. American Academy of Neurology. Available at: www.aan.com/familypractice/pdf/final%20sleep%2012.pdf. Accessed: 7 Oct 10. 11. Littner MR, Kushida C, Wise M, Davila DG, Morgenthaler T, Lee-Chiong T. Practice parameters for clinical use of the multiple sleep latency test and the maintenance of wakefulness test. 2005. Available at: www.aasmnet.org/resources/practiceparameters/pp_msltmwt.pdf. Accessed: 1 Nov 12 12. Trikalinos TA, Ip S, Raman G, Cepeda MS, Balk E, DAmbrosio C, Lau J. Home diagnosis of obstructive sleep apnea-hypopnea syndrome. Technology Assessment. Prepared for AHRQ by the Tufts-New England Medical Center Evidence-based Practice Center. Rockville, MD: Agency for Healthcare Research and Quality (AHRQ); August 8, 2007. Available at: www.cms.hhs.gov/determinationprocess/downloads/id48ta.pdf. Accessed: 7 Oct 10. 13. Aurora RN, et al. Practice parameters for the respiratory indications for polysomnography in children. Sleep 2011;34(3):379-88. (Reaffirmed 2013 Nov) Update 2014: 1. MCG Inpatient and Surgical Care 18 th Edition. Apnea, Apparent Life Threatening Event ORG: P-12 (ISC) 2. MCG Ambulatory Care 18 th Edition. ACG:A-0144 Polysomnography (PSG), Portable or Home Sleep Study 3. MCG Ambulatory Care 18 th Edition. ACG:A-0145 Polysomnography (PSG, Sleep Center 4. Hayes Medical Technology Directory. Actigraphy for Diagnosis of Circadian Rhythm Sleep Disorders. Annual Review Oct 14, 2014 5. Hayes Search and Summary. Split-Night Sleep Study for CPAP Titration in Children with Obstructive Sleep Apnea. Dec 13, 2013 6. Hayes Medical Technology Directory. Home Sleep Studies for Diagnosis of Obstructive Sleep Apnea Syndrome in Patients Younger than 18 years of Age. Annual Review Oct 15, 2014 7. Hayes Health Technology Brief. Split-Night Polysomnography for Continuous Positive Airway Pressure (CPAP) Titration in Adults with Obstructive Sleep Apnea. Publication Date March 19, 2014 Page 10 of 11

8. Sutherland K, Vanderveken OM, Tsuda H et al: on behalf of the ORANGE registry. Oral Appliance treatment for obstructive sleep apnea: an update. J Clin Sleep Med 2014; 10(2) 215-227. Accessed 11/21/14. Available at: http://www.aasmnet.org/jcsm/viewabstract.aspx?pid=29343 Approved by the Medical Director Page 11 of 11