National Medical Policy

Transcription

1 National Medical Policy Subject: Obstructive Sleep Apnea, Diagnosis and Medical Treatments (ADULT) Policy Number: NMP28 Effective Date*: September 2003 Updated: October 2015 This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document For Medicaid Plans: Please refer to the appropriate State s Medicaid Manual(s), publication(s), citation(s), and documented guidance for coverage criteria and benefit guidelines prior to applying Health Net Medical Policies The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use Source Reference/Website Link X National Coverage Determination (NCD) Continuous Positive Airway Pressure (CPAP) Therapy For Obstructive Sleep Apnea (OSA) (240.4): X National Coverage Manual Citation Local Coverage Determination (LCD)* Sleep Testing for Obstructive Sleep Apnea (OSA) ( ): Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea; Respiratory Assist Devices; Polysomnography and Other Sleep Studies; Sleep Disorders Testing; Polysomnography and Sleep Studies for Testing Sleep and Respiratory Disorders; Oral Appliances for Obstructive Sleep Apnea; Respiratory Assists Device: Obstructive Sleep Apnea Diagnosis and Medical Treatment Sep 15 1

2 X Article (Local)* Polysomnography and Sleep Studies Supplemental Instructions Article; CPAP and Respiratory Assist Devices APNEA/Hypopnea Index; X Other Technology Assessments: Effectiveness of Portable Monitoring Devices for Diagnosing Obstructive Sleep Apnea; Update of a Systematic Review; Home diagnosis of Obstructive Sleep Apnea-Hypopnea Syndrome; Obstructive Sleep Apnea-Hypopnea Syndrome: modeling different diagnostic strategies: CMS.gov. Continuous Positive Airway Pressure (CPAP) Therapy For Obstructive Sleep Apnea (OSA) (240.4): ge-with-evidence-development/continuous- Positive-Airway-Pressure-CPAP-Therapy-For- Obstructive-Sleep-Apnea-OSA-2404.html CMS, Decision memo for sleep testing for obstructive sleep apnea (OSA) (CAG-00405N) July 10, 2009: ep+testing+for+obstructive+sleep+apnea+(o SA)&CoverageSelection=National&KeyWord=sle ep+testing&keywordlookup=title&keywordsea rchtype=and&bc=gaaaacaaeaaa& None Use Health Net Policy Instructions Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions. Medicare LCDs and Articles apply to members in specific regions. To access your specific region, select the link provided under Reference/Website and follow the search instructions. Enter the topic and your specific state to find the coverage determinations for your region. *Note: Health Net must follow local coverage determinations (LCDs) of Medicare Administration Contractors (MACs) located outside their service area when those MACs have exclusive coverage of an item or service. (CMS Manual Chapter 4 Section 90.2) If more than one source is checked, you need to access all sources as, on occasion, an LCD or article contains additional coverage information than contained in the NCD or National Coverage Manual. Obstructive Sleep Apnea Diagnosis and Medical Treatment Sep 15 2

3 If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance. Definitions AASM AHI AOSATF of ASSM APAP BMI CPAP IDTF JCAHO MSLT MWT OSA PM PSG RDI Screening tools for OSA American Academy of Sleep Medicine Apnea-Hypopnea Index (AHI) by PM is the number of apneas + hypopneas / total recording time rather than total sleep time. (normal <5; mild 5-15; high >30) Adult Obstructive Sleep Apnea Task Force of the American Academy of Sleep Medicine Autotitrating positive airway pressure Body mass index (body weight divided by the square of the height) continuous positive airway pressure Independent Diagnostic Testing Facilities Joint Commission on Accreditation of Healthcare Organizations Multiple Sleep Latency Test (also called Maintenance of Wakefullness Test Maintenance of Wakefulness Test used as a treatment outcomes measure and may be used to determine ability to remain alert for driving or work related tasks obstructive sleep apnea portable monitoring (in home sleep studies) polysomnography respiratory disturbance index (normal <5 respiratory events per hour Cleveland Questionnaire, Epworth Sleepiness Scale, Berlin Questionnaire (for sleep apnea) Note: Health Net has a separate policy for the pediatric population. Please refer to the OSA in Children Medical Policy General Remarks Obstructive Sleep Apnea (OSA) is a disorder of the upper airway with collapse and obstruction caused by relaxation of the muscles of the posterior pharynx. This leads to spells of apnea during sleep and pathologic daytime somnolence. Periods of apnea lead to hypoxia, hypercapnia, and respiratory acidosis that can acutely lead to cardiac arrhythmias and sudden death. Chronic hypoxia and other chemical abnormalities lead to refractory hypertension, pulmonary hypertension, and congestive heart failure. OSA has an adverse effect on mortality and morbidity. Obstructive Sleep Apnea (OSA) is currently seen in 2% of middle-aged women Obstructive Sleep Apnea Diagnosis and Medical Treatment Sep 15 3

4 and 4% of middle-aged men. The incidence is increasing due to the relationship to obesity and an increased public awareness resulting in more patients and family members bringing symptoms to the attention of health care providers. Diagnosing Sleep Apnea Risk Factors Risk factors (from American Academy of Sleep Medicine) that increase the likelihood and/or risk of having obstructive sleep apnea include: Obesity Congestive heart failure Atrial fibrillation Treatment refractory hypertension Type 2 diabetes Nocturnal dysrhythmias Stroke Pulmonary hypertension High-risk driving populations Preoperative for bariatric surgery Patients undergoing upper airway surgery for snoring History and Physical Examination A careful history and physical examination with questions focusing on sleep habits should be performed initially. Since many symptoms of obstructive sleep apnea occur during fragmented sleep, house partners/spouses are often a better source of history than the patient. Co-workers, friends, and/or the patient may report that the patient falls asleep during business meetings, conversations, while stopped at traffic lights, or while driving. This may lead to a history of motor vehicle accidents. The history may include fitful sleep and always being tired during the day and excessive caffeine or stimulant use (to combat daytime somnolence). Signs/Symptoms of obstructive sleep apnea (OSA): Apnea spells o Unable to breathe due to airway closure/obstruction o Usually last greater than 10 seconds and end with a loud gasp or grunt as the airway is forced open. Partners can be asked to evaluate the patient in the evening by observing, counting, and timing the apnea spells Snoring that can be excessively loud, erratic, variable, and so disruptive that bed partners have to sleep in another room Gasping and choking for breath Frequent awakening during the night Sleep walking; sleep talking Displaying wildly erratic behavior during sleep Daytime somnolence or fatigue due to sleep fragmentation Morning Headaches Limited attention Memory loss Physical Examination Obstructive Sleep Apnea Diagnosis and Medical Treatment Sep 15 4

5 The physical exam is usually normal but may show signs of airway obstruction such as macroglossia, tonsillar hypertrophy, nasal polyps, septal deviation, turbinate hypertrophy, elongated/enlarged uvula, narrow/high arched hard palate, or retrognathia (e.g. jutting lower jaw). Patients are often obese (BMI > 30) with increased neck circumference (men 17 inches, women > 16 inches). Sleep Questionnaires (See Sleep Questionnaires in Evidence Based Clinical Support Section for more information) The following sleep questionnaires (all self-answered by the patient) attempt to quantify the probability of having OSA: Epworth Sleepiness Scale Berlin Questionnaire STOP Bang Eight questions Maximum score 24 Score >10 indicates moderate to high probability of OSA Ten questions Two or more categories where the score is positive indicates high probability of OSA Eight questions A yes answer on three or more questions indicates high probability of OSA Sleep Studies Indications Following the history, physical examination, and score on one or more of the above sleep questionnaires, patients should be stratified according to the probability of having OSA Sleep study is not indicated as a screening study in asymptomatic patients. Patients with moderate to high pre-test probability of OSA should have the diagnosis confirmed with a home or in-facility sleep study. Note: See inlaboratory polysomnography (PSG) and Home Portable Monitoring (PM) for guidelines on whether facility or home sleep study is indicated). In appropriately screened patients, home portable monitoring is the preferred method for the diagnosis of OSA. Sleep study is indicated for re-assessment of treatment results (PAP) for a patient with known OSA when any of the following has occurred: Substantial weight gain (10% of body weight) with return of symptoms BMI falls below 30 and there is either intolerance of PAP pressure or a desire to discontinue PAP therapy. Clinical response is insufficient Symptoms return despite a good initial response to CPAP Tests for Sleep Apnea In-laboratory polysomnography (PSG) (Facility Sleep Study) PSG is called Type I monitoring. It consists of minimum of 6 hours of constant monitoring in a controlled facility environment that involves 7 measurement parameters (1 or 2 channel EEG, 2 channel electrooculography, 2 muscle EMG, ECG or heart rate, oxygen saturation, airflow monitoring, and measures of breathing/respiratory effort). Some facilities also record body position (with video) Obstructive Sleep Apnea Diagnosis and Medical Treatment Sep 15 5

6 and snoring (via microphone). Results are reported and calculations of the Apnea- Hypoxia Index (AHI) or Respiratory Disturbance Index (RDI) are performed. PSG scoring: OSA is confirmed if > 15 obstructive events per hour or >5 obstructive events per hour plus clinical symptoms. Obstructive events include apneas, hypopneas, or respiratory eventrelated arousals Clinical symptoms include unintentional sleep episodes during wakefulness; daytime sleepiness; unrefreshing sleep; fatigue; insomnia; waking up breath holding, gasping, or choking; or the bed partner describes loud snoring, breathing interruptions, or both during the patient s sleep. Indications for Polysomnography (PSG) rather than home Portable Monitoring (home sleep study) CPT is used for full-night studies while CPT is used with a split-night study where both the study and the subsequent positive airway pressure or bi-level ventilation are initiated during the same visit. The following indications are for either study: 1. Patient has any of the following pre-morbid sleep related or medical conditions: Narcolepsy Parasomnias Periodic limb movement disorder (PLMD) Central sleep apnea Complex sleep apnea Morbid obesity (BMI>45, or pulmonary function studies show Obesity Hypoventilation Syndrome, or BMI>35 plus arterial blood gas with PCO2>45, or BMI>35 plus inability to lie flat in bed) Moderate to severe pulmonary disease (for example: COPD, asthma) with nocturnal oxygen use or documented arterial blood gases showing PO2 <60 or PCO2 >45 Neuromuscular disease (for example: Parkinson s, documented stroke or stroke with residua, active epilepsy, spina bifida, myotonic dystrophy, ALS) Moderate to severe congestive heart failure with documented pulmonary congestion or known left ventricular fraction <45%* Other critical illness that would prevent them from using the equipment 2. Portable Monitoring (home sleep study) is not feasible due to any of the following (PSG requests in this category which have high pretest probability of OSA and fit the below split night criteria, should undergo rather than 95810): Patient lacks the mobility or dexterity to use the equipment safely at home Technician is not available (for those conditions that require an attendant) Portable Monitoring (home sleep study) has been attempted and is inadequate or uninterpretable. Obstructive Sleep Apnea Diagnosis and Medical Treatment Sep 15 6

7 Patient has high probability of OSA and had a negative Portable Monitoring study (home sleep study) Split Night Sleep Study A benefit of using attended polysomnography for diagnosis is the ability to perform a "split study," wherein the first portion of testing is for purposes of establishing the diagnosis, and the remaining portion of testing is used to ascertain an effective CPAP (continuous positive airway pressure) treatment pressure. This can be achieved in the majority of cases in one night and is the current standard approach. This is the approach required for CPAP authorization by the Centers for Medicare and Medicaid Services. Split night study (CPT95811) can be performed if: Apnea Hypopnea Index (AHI) is greater than 15/hr for no less than 2 hours of testing, and there is at least 3 hours of sleep time remaining for PAP titration. Split night studies may also be considered for patients with an AHI of >15, based on clinical observations such as the occurrence of obstructive respiratory events in association with severe oxygen desaturation, triggered cardiac arrhythmia, or other clinical events that puts the patient at immediate risk. Split night studies require the recording and analysis of the same parameters as a standard diagnostic PSG. A minimum of 3 hours sleep is preferred to adequately titrate CPAP after this treatment is initiated during a split night study Home Portable Monitoring (PM) (Home Sleep Study) PMs may be used to diagnose OSA when utilized as part of a comprehensive sleep evaluation in patients with a high pretest likelihood of moderate to severe OSA. Recent data supports clinical pathways utilizing portable monitoring and PAP autotitration. These pathways yield similar results compared with PSG and facilitybased CPAP titration when evaluating treatment acceptance, adherence, and clinical outcomes. Patient education and training on device use are necessary pathway components. The parameters, settings, filters, technical specifications, sleep stage scoring and event scoring should be done in accordance with the AASM Manual for the Scoring of Sleep and Associated Events. A PM should, at a minimum, record airflow, respiratory effort, and blood oxygenation. The type of biosensors used to monitor these parameters for in- laboratory PSG are recommended for use in PMs and include the following: o Oronasal thermal sensor and nasal pressure transducer for airflow, apnea and hypopnea, and o Oximetry with a high sampling rate and fast averaging time for blood oxygenation, and o Ideally, a calibrated or uncalibrated respiratory inductance plethysmography for respiratory effort Due to the known rate of false negative PM, in-laboratory PSG should be performed in cases where PM is technically inadequate or fails to establish the diagnosis of OSA in patients with a high pretest probability. PM s are likely to underestimate the severity of events compared to the Apnea- Hypopnea Index (AHI) by PSG. Obstructive Sleep Apnea Diagnosis and Medical Treatment Sep 15 7

8 A follow-up visit to review test results should be performed for all patients undergoing PM. Levels of Home Portable Monitoring (PM): There are currently 3 levels of home PM s, with varying number of monitored parameters. Each can be used with or without an attendant. HCPCS Codes Type Features G0398 Type II PM At least 7 monitored channels and can calculate AHI. Home sleep 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 Type III PM At least 4 monitored channels (airflow/ventilation, heart rate, oxygen saturation, respiratory movement. 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 Type IV PM Measures 1-3 parameters. Home sleep test (HST) with type IV portable monitor, unattended; with 3 channels. Note : Decision Memorandum from the memo for sleep testing for obstructive sleep apnea (OSA) (CAG-00405N) July 10, 2009 from Centers for Medicare & Medicaid Services Decision concluded in 2009 that there is sufficient evidence to support the use of devices that measure three or more channels that include actigraphy, oximetry, and peripheral arterial tone to aid the diagnosis of OSA in patients with signs and symptoms of OSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility. Indications for Home Portable Monitoring (Home Sleep Study): High pretest probability of moderate to severe OSA and NONE of the following premorbid sleep related or medical conditions are present: Narcolepsy Parasomnias Periodic limb movement disorder (PLMD) Central sleep apnea Complex sleep apnea Morbid obesity (BMI>45, or pulmonary function studies show Obesity Hypoventilation Syndrome, or BMI>35 plus arterial blood gas with PCO2>45, or BMI>35 plus inability to lie flat in bed) Moderate to severe pulmonary disease (for example: COPD, asthma) with nocturnal oxygen use or documented arterial blood gases showing PO2 <60 or PCO2 >45. Neuromuscular disease (for example: Parkinson s, documented stroke or stroke with residua, active epilepsy, spina bifida, myotonic dystrophy, ALS) Moderate to severe congestive heart failure with documented pulmonary congestion or known left ventricular ejection fraction <45%* Other critical illness that would prevent patient from using the equipment. Patient does not have an impairment of the mobility and dexterity to use the equipment safely at home and the ability to follow instructions. Home portable monitoring may also be used to: Obstructive Sleep Apnea Diagnosis and Medical Treatment Sep 15 8

9 Assess treatment results after surgical treatment for moderate to severe OSA, Assess treatment results after therapeutic trial with an oral appliance, As a follow-up study if a technician has demonstrated to the patient how to use CPAP and symptoms are not completely resolved by CPAP. Note: PM is not appropriate in patients treated with CPAP whose symptoms are resolved by CPAP treatment. Treatment of Obstructive Sleep Apnea Positive Airway Pressure (PAP) Indications Positive airway pressure is the treatment of choice for mild, moderate, and severe OSA and should be offered as an option to all patients. PAP for OSA may be applied through the following interfaces: Nasal, Oral or Oranasal Continuous Positive Airway Pressure (CPAP) CPAP s proposed mechanism of action is as a pneumatic splint that maintains the patency of the upper airway in a dose-dependent fashion. Autotitrating Positive Airway Pressure (APAP) (APAP) is the first recommended treatment of individuals who are recently diagnosed with Obstructive Sleep Apnea (OSA). APAP devices are designed to analyze upper airway patency and increase the pressure to open the airway as needed, and then decrease the pressure if no events are detected. Unlike CPAP, APAP s automatic titrating feature allows for use without the assistance of a sleep technician. In the initial management of patients with moderate to severe obstructive sleep apnea, PAP therapy is the treatment of choice. PSG for PAP titration and treatment in high pre-test probability patients confers no advantage over the use of autotitrating PAP (APAP). Not Medically Necessary Health Net, Inc. does not consider any of the following diagnostic and/or medical management methods medically necessary in patients with symptoms suggestive of OSA: Topographic electroencephalogram (EEG) mapping in the diagnosis and/or medical management of OSA syndrome; or Multiple sleep latency testing (MSLT) in the diagnosis of OSA syndrome except to exclude or confirm narcolepsy in the diagnostic work-up; or Limited-channel NPSG for distinguishing sleep from wake or determining sleep stage; or The static charge sensitive bed; or Actigraphy alone; or Electrosleep therapy, which uses the passage of weak electric currents to the brain to induce sleep. PAP-NAP sleep study Obstructive Sleep Apnea Diagnosis and Medical Treatment Sep 15 9

10 Health Net, Inc. does not consider intraoral appliances medically necessary for the treatment of snoring without the presence of OSA or appliances that are available over-the- counter. Dental rehabilitation (dentures, bridgework, etc.) as treatment for OSA is not a covered benefit under our medical plans. Note: Health Net, Inc. considers dual therapy of mandibular appliance and CPAP for the treatment of obstructive sleep apnea, not medically necessary, since there is no evidence based information that supports this. Investigational Health Net, Inc. considers any of the following diagnostic and/or medical management methods in patients with symptoms suggestive of OSA investigational. Although studies are still being done, the clinical validity in scientifically controlled studies has not been proven at this time: Nocturnal pulse oximetry alone as a case finding or screening method to rule out OSA (e.g. ApneaLink); or Acoustic pharyngometry Codes Related To This Policy NOTE: The codes listed in this policy are for reference purposes only. Listing of a code in this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and medical necessity criteria. This list of codes may not be all inclusive. On October 1, 2014, the ICD-9 code sets used to report medical diagnoses and inpatient procedures will be replaced by ICD-10 code sets. Health Net National Medical Policies will now include the preliminary ICD-10 codes in preparation for this transition. Please note that these may not be the final versions of the codes and that will not be accepted for billing or payment purposes until the October 1, 2014 implementation date. ICD-9 Codes Morbid obesity with sleep apnea Pickwickian Syndrome Alterations of consciousness; drowsiness, somnolence Sleep disturbances Insomnia with sleep apnea Hypersomnia with sleep apnea Other hypersomnia Disturbance of 24-hour sleep-wake cycle Dysfunctions associated with sleep stages or arousal from sleep Other and unspecified sleep apnea Other sleep disturbance ICD-10 Codes E66.01 Morbid (severe) obesity due to excess calories E66.2 Morbid (severe) obesity with alveolar hypoventilation G G47.9 Sleep Disorders Obstructive Sleep Apnea Diagnosis and Medical Treatment Sep 15 10

11 R40.0 Somnolence CPT Codes Palatal lift prosthesis Oral surgical splints Unlisted maxillofacial prosthetic procedure Unlisted craniofacial or maxillofacial procedure Unlisted musculoskeletal procedure, head CPAP initiation and management Sleep study, unattended, simultaneous recording; heart rate, oxygen saturation, and respiratory analysis (eg, by airflow or peripheral arterial tone), and sleep time. Do not report in conjunction with , 93228, 93229, , 95801, 95803, For unattended sleep study that measures a minimum of heart rate, oxygen saturation, and respiratory analysis, report Sleep study, unattended, measures a minimum of heart rate, oxygen saturation, and respiratory analysis (eg, by airflow or peripheral arterial tone) Do not report in conjunction with , 93228, 93229, , 95800, For unattended sleep study that measures heart rate, oxygen saturation, respiratory analysis and sleep time, use Multiple sleep latency or maintenance of wakefulness testing, recording, analysis and interpretation of physiological measurements of sleep during multiple trials to assess sleepiness The multiple sleep latency test (MSLT) is not routinely indicated in the initial evaluation and diagnosis of OSA or in an assessment of change following treatment with nasal CPAP. However, if excessive sleepiness continues despite optimal treatment, the patient may require an evaluation for possible narcolepsy, including the MSLT (95805) Sleep study, unattended, simultaneous recording of heart rate, oxygen saturation, respiratory airflow and respiratory effort (e.g. thoracoabdominal movement) Do not report in conjunction with 93012, 93014, , 93228, 93229, , 0203T, 0204T) For unattended sleep study that measures heart rate, oxygen saturation, respiratory analysis, and sleep time, use 0203T. For unattended sleep study that measures heart rate, oxygen saturation, and respiratory analysis, report 0204T Sleep study, simultaneous recording of ventilation, respiratory effort, ECG or heart rate, and oxygen saturation, attended by a technologist Polysomnography; sleep staging with 1-3 additional parameters of sleep, attended by a technologist Polysomnography; sleep staging with 4 or more additional parameters of sleep, attended by a technologist Polysomnography; 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 Obstructive Sleep Apnea Diagnosis and Medical Treatment Sep 15 11

12 HCPCS Codes Code Description A7030 Full face mask used with positive airway pressure device, each A7031 Face mask interface, replacement for full face mask, each A7032 Replacement cushion for nasal application device, each A7033 Replacement pillows for nasal application device, pair A7034 Nasal interface (mask or cannula type) used with positive airway pressure device, with or without head strap A7035 Headgear used with positive airway pressure device A7036 Chinstrap used with positive airway pressure device A7037 Tubing used with positive airway pressure device A7038 Filter, disposable, used with positive airway pressure device A7039 Filter, non disposable, used with positive airway pressure device A7044 Oral interface used with positive airway pressure device, each Respiratory assist device, bi-level pressure capability, without back-up rate E0470 feature, used with noninvasive interface, e.g., nasal or facial mask (intermittent assist device with continuous positive airway pressure device) Respiratory assist device, bi-level pressure capability, with back-up rate E0471 feature, used with noninvasive interface, e.g., nasal or facial mask (intermittent assist device with continuous positive airway pressure device) E0485 Oral device/appliance used to reduce upper airway collapsibility, adjustable or non adjustable, prefabricated, includes fitting and adjustment E0561 Humidifier, nonheated, used with positive airway pressure device E0562 Humidifier, heated, used with positive airway pressure device E0601 Continuous airway pressure (CPAP) device (rental or purchase) Home sleep study test (HST) with type II portable monitor, unattended; G0398 minimum of 7 channels: EEG, EOG, EMG, ECG/heart rate, airflow, respiratory effort and oxygen saturation Home sleep test (HST) with type III portable monitor, unattended; G0399 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 Sleep Questionnaires Epworth Sleepiness Scale The Epworth Sleepiness Scale is used to determine the level of daytime sleepiness. A score of 10 or more is considered sleepy. A score of 18 or more is very sleepy. If you score 10 or more on this test, you should consider whether you are obtaining adequate sleep, need to improve your sleep hygiene and/or need to see a sleep specialist. These issues should be discussed with your personal physician. Use the following scale to choose the most appropriate number for each situation: 0 = would never doze or sleep. 1 = slight chance of dozing or sleeping 2 = moderate chance of dozing or sleeping 3 = high chance of dozing or sleeping Situation Sitting and reading Watching TV Chance of Dozing or Sleeping Obstructive Sleep Apnea Diagnosis and Medical Treatment Sep 15 12

13 Sitting inactive in a public place Being a passenger in a motor vehicle for an hour or more Lying down in the afternoon Sitting and talking to someone Sitting quietly after lunch (no alcohol) Stopped for a few minutes in traffic Total score (add up the scores and this is the Epworth score) Berlin Questionnaire Patient BMI - 1. Do you snore? (Yes/No/Not sure) If you snore: 2. Your snoring is: a. Slightly louder than breathing b. As loud as talking c. Louder than talking d. Very loud-can be heard in adjacent rooms 3. How often do you snore? a. Almost every day b. 3-4 times a week c. 1-2 times a week d. 1-2 times a month e. Never or almost never 4. Does your snoring bother other people? (Yes/No/Don t know) 5. Has anyone noticed that you quit breathing during your sleep? a. Almost every day b. 3-4 times a week c. 1-2 times a week d. 1-2 times a month e. Never or almost never 6. Are you tired after sleeping? a. Almost every day b. 3-4 times a week c. 1-2 times a week d. 1-2 times a month e. Never or almost never 7. Are you tired during waketime? a. Almost every day b. 3-4 times a week c. 1-2 times a week d. 1-2 times a month e. Never or almost never 8. Have you ever nodded off or fallen asleep while driving? (Yes/No) 9. If yes, how often does this occur? a. Almost every day b. 3-4 times a week c. 1-2 times a week Obstructive Sleep Apnea Diagnosis and Medical Treatment Sep 15 13

14 d. 1-2 times a month e. Never or almost never 10. Do you have high blood pressure? (Yes/No/Not sure) Categories and scoring Category 1: Items 1-5 Category 2: Items 6, 7, 8 (item 9 should be noted separately) Category 3: RESULTS Item 1: if Yes, assign 1 point Item 2: if c or d is the response, assign 1 point Item 3: if a or b is the response, assign 1 point Item 4: if a is the response, assign 1 point Item 5: if a or b is the response, assign 2 points Add Points. Category 1 is positive if the total score is 2 or more points Item 6: if a or b is the response, assign 1 point Item 7: if a or b is the response, assign 1 point Item 8: if a is the response, assign 1 point Add Points. Category 2 is positive if the total score is 2 or more points Category 3 is positive if the answer to Item 10 is Yes OR if the BMI of the patient is greater than 30kg/m2. (BMI must be calculated. BMI is defined as weight (kg) divided by height (m) squared, i.e., kg/m2). High Risk: if there are 2 or more Categories where the score is positive Low Risk: if there is only 1 or no Categories where the score is positive STOP Bang Questionnaire 1. Snoring Do you snore loudly (louder than talking or loud enough to be heard though closed doors)? 2. Tired Do you often feel tired, fatigued, or sleepy during daytime? 3. Observed Has anyone observed you stop breathing during your sleep? 4. Blood Pressure You have or are you being treated for high blood pressure? 5. BMI BMI higher than 35 kg/m2? 6. Age Age over 50 years old 7. Neck Circumference Neck circumference greater than 40 cm 8. Gender Gender Male? Yes or No Results: High Risk of OSA: answering yes to three or more items Low Risk of OSA: answering yes to less than three items Scientific Rationale for Pap Nap - September 2014 Abbreviated Cardio-Respiratory Sleep Study, also known as the PAP-NAP is an attended sleep study that combines psychological and physiological treatments into one procedure, to enhance PAP therapy adherence, including insomnia patients, during a 100- minute daytime nap period and a post-test discussion and plan. PAP- NAP is not intended to as a substitute for APAP or in lab titration. It is a daytime study for purposes of formal desensitization to PAP in selected intolerant individuals. It is proposed that patients are more likely to correctly use and stick with their PAP therapy if they receive individual or group education, sleep technologist coaching, and close follow-up. Obstructive Sleep Apnea Diagnosis and Medical Treatment Sep 15 14

15 The procedure itself is a short, in-lab cardiorespiratory recording that is attended by a sleep technologist and ranges from 60 to 180 minutes in length. It is expected that the patient will become comfortable enough with the PAP therapy to fall asleep. During the PAP Nap, patients have individual coaching and counseling by a sleep technologist to overcome any fears or discomforts they have about PAP therapy and to make them more comfortable with the mask and pressure sensations. Minimal bioelectrodes are used during these studies. Patients are given the opportunity to sleep with PAP therapy after going through this counseling session. Compliance with CPAP is the goal. There is a paucity of data evaluating Pap-Nap. Krakow et al (2008) assessed the impact of a daytime sleep medical procedure--the PAP-NAP--on adherence to positive airway pressure (PAP) therapy among insomnia patients with sleep disordered breathing (SDB). The authors reported the PAP-NAP is based on Current Procedural Terminology (CPT) codes and combines psychological and physiological treatments into one procedure, which increases contact time between SDB patients and polysomnography technologists to enhance PAP therapy adherence. Using a Sleep Dynamic Therapy framework, explicating SDB as a mindbody disorder, the PAP-NAP includes mask and pressure desensitization, emotionfocused therapy to overcome aversive emotional reactions, mental imagery to divert patient attention from mask or pressure sensations, and physiological exposure to PAP therapy during a 100-minute nap period. Patients treated with the PAP-NAP test (n = 39) were compared to an historical control group (n = 60) of insomnia patients with SDB who did not receive the test. All 99 insomnia patients were diagnosed with SDB (mean AHI /- 26.3, mean RDI /- 24.9), and all reported a history of psychiatric disorders or symptoms as well as resistance to PAP therapy. Among 39 patients completing the PAP-NAP, 90% completed overnight titrations, compared with 63% in the historical control group; 85% of the nap-tested group filled PAP therapy prescriptions for home use compared with 35% of controls; and 67% of the nap-tested group maintained regular use of PAP therapy compared with 23% of the control group. Using standards from the field of sleep medicine, the nap-tested group demonstrated objective adherence of 49% to 56% compared to 12% to 17% among controls. The authors concluded in this pilot study, the PAP-NAP functioned as a brief, useful, reimbursable procedure to encourage adherence in insomnia patients with SDB in comparison to an historical control group that did not undergo the procedure. At this time, there is a lack of evidence in the peer review literature to demonstrate that Pap-Nap improves patient compliance with C-PAP. Review History November 2013 March 2014 September 2014 October 2015 Update. Added MedSolution Criteria for Sleep Apnea Guidelines. Codes reviewed. Update. No revisions. Codes reviewed. Update Added Pap Nap sleep study to the not medically necessary section of the policy. Update no revisions References Update September Krakow B, Ulibarri V, Melendrez D, et al. A daytime, abbreviated cardiorespiratory sleep study (CPT ) to acclimate insomnia patients with sleep disordered breathing to positive airway pressure (PAP-NAP). J Clin Sleep Med Jun 15;4(3): References - Update March 2014 Obstructive Sleep Apnea Diagnosis and Medical Treatment Sep 15 15

16 1. Adult Obstructive Sleep Apnea Task Force of the American Academy of Sleep Medicine. Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults. 2. American Academy of Sleep Medicine. AASM Manual for the Scoring of Sleep and Associated Events: Rules, Terminology and Technical Specifications Journal of Clinical Sleep Medicine, 2009:5(3): Berry, RB. Uses and Limitations of Portable Monitoring for Diagnosis and Management of Obstructive Sleep Apnea. Sleep Med Clin. (2011). 4. Javaheri S, Smith J, Chung E. The prevalence and natural history of complex sleep apnea. J Clin Sleep Med 2009;5(3): Krakow B, Ulibarri V, Melendrez D, et al. A daytime, abbreviated cardiorespiratory sleep study (cpt ) to acclimate insomnia patients with sleep disordered breathing to positive airway pressure (pap-nap). J Clin Sleep Med 2008;4(3): 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 sleep apnea in adult patients. J Clin Sleep Med 2007;3(7): Rosen CL, Auckley D, Benca R, et al. 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. SLEEP 2012;35(6): References - Update November Benbadis, Selim et al. Association between the Epworth Sleepiness Scale and the Multiple Sleep Latency Test in a Clinical Population. Annals of Internal Medicine. V 130 No. 4, February Berry et. al. Portable Monitoring and Autotitration versus Polysomnography for the Diagnosis and Treatment of Sleep Apnea. SLEEP 2008;31(10): Boyer, S and Kapur V. Role of portable sleep studies for diagnosis of obstructive sleep apnea. Curr Opin Pulm Med 2003 Nov;9(6): Chesson Jr., Andrew et al. American Sleep Disorders Association, Standards of Practice Committee, Polysomnography Task Force. Practice parameters for the indications for polysomnography and related procedures. Sleep 1997;20(6): Chung, Frances et al. STOP Questionnaire. Anesthesiology, V 107 No 5, May CMS Decision Memo for Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea (OSA), (CAG-00093R2). March 13, Collop NA, Anderson WM, Boehlecke B, et al. 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): Collop, Nancy A. Home Sleep Testing: It Is Not About the Test. CHEST 2010;138: Epstein LJ, Kristo D, Strollo PJ, et al. Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults. J Clin Sleep Med 2009;5(3): Fletcher EC, Stich J, Yang KL. Unattended home diagnosis and treatment of obstructive sleep apnea without polysomnography. Arch Fam Med 2000;9: Johns, Murray W., A New Method for Measuring Daytime Sleepiness: The Epworth Scale. Sleep 1991; 14(6): Kimoff, John R. To Treat or Not to Treat: Can a Portable Monitor Reliably Guide Decidion-Making in Sleep Apnea? Am J Respir Crit Care Med 2011;184: Kushida CA, Chediak A, Berry RB, et al. Clinical Guidelines for the manual titration of positive airway pressure in patients with obstructive sleep apnea. J Clin Sleep Obstructive Sleep Apnea Diagnosis and Medical Treatment Sep 15 16

17 Med 2008;4(2): Mulgrew, Alan et al. Diagnosis and Initial Management of Obstructive Sleep Apnea without Polysomnography. Annals of Internal Medicine. 2007;146: Netzer NC, Stoohs RA, Netzer CM, et al. Using the Berlin Questionnaire to identify patients at risk for the sleep apnea syndrome. Ann Intern Med 1999 Oct;131(7): Patel, et al. Split-Night Polysomnography. CHEST 2007; 131: Practice Parameters for the Indications for Polysomnography and Related Procedures: An Update for 2005 Clete A. Kushida, MD, PhD1; Michael R. Littner, MD2; Timothy Morgenthaler, MD3; Cathy A. Alessi, MD4; Dennis Bailey, DDS5; Jack Coleman, Jr., MD6; Leah Friedman, PhD7; Max Hirshkowitz, PhD8; Sheldon Kapen, MD9; Milton Kramer, MD10; Teofilo Lee-Chiong, MD11; Daniel L. Loube, MD12; Judith Owens, MD13; Jeffrey P. Pancer,DDS14; Merrill Wise, MD15. SLEEP, Vol. 28, No. 4, Skomro RP, Gjevre J, Reid J, et al. Outcomes of Home-Based Diagnosis and Treatment of Obstructive Sleep Apnea. CHEST 2010;138(2): Whitelaw WA, Brand RF, Flemons WW et al. Clinical Usefulness of Home Oximetry Compared with Polysomnography for Assessment of Sleep Apnea. Am J Respir Crit Care Med 2005;171(2): Important Notice General Purpose. Health Net's National Medical Policies (the "Policies") are developed to assist Health Net in administering plan benefits and determining whether a particular procedure, drug, service or supply is medically necessary. The Policies are based upon a review of the available clinical information including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the drug or device, evidence-based guidelines of governmental bodies, and evidence-based guidelines and positions of select national health professional organizations. Coverage determinations are made on a case-by-case basis and are subject to all of the terms, conditions, limitations, and exclusions of the member's contract, including medical necessity requirements. Health Net may use the Policies to determine whether under the facts and circumstances of a particular case, the proposed procedure, drug, service or supply is medically necessary. The conclusion that a procedure, drug, service or supply is medically necessary does not constitute coverage. The member's contract defines which procedure, drug, service or supply is covered, excluded, limited, or subject to dollar caps. The policy provides for clearly written, reasonable and current criteria that have been approved by Health Net s National Medical Advisory Council (MAC). The clinical criteria and medical policies provide guidelines for determining the medical necessity criteria for specific procedures, equipment, and services. In order to be eligible, all services must be medically necessary and otherwise defined in the member's benefits contract as described this "Important Notice" disclaimer. In all cases, final benefit determinations are based on the applicable contract language. To the extent there are any conflicts between medical policy guidelines and applicable contract language, the contract language prevails. Medical policy is not intended to override the policy that defines the member s benefits, nor is it intended to dictate to providers how to practice medicine. Policy Effective Date and Defined Terms. The date of posting is not the effective date of the Policy. The Policy is effective as of the date determined by Health Net. All policies are subject to applicable legal and regulatory mandates and requirements for prior notification. If there is a discrepancy between the policy effective date and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. * In some states, new or revised policies require prior notice or posting on the website before a policy is deemed effective. For information regarding the effective dates of Policies, contact your provider representative. The Policies do not include definitions. All terms are defined by Health Net. For information regarding the definitions of terms used in the Policies, contact your provider representative. Policy Amendment without Notice. Health Net reserves the right to amend the Policies without notice to providers or Members. In some states, new or revised policies require prior notice or website posting before an amendment is deemed effective. Obstructive Sleep Apnea Diagnosis and Medical Treatment Sep 15 17

18 No Medical Advice. The Policies do not constitute medical advice. Health Net does not provide or recommend treatment to members. Members should consult with their treating physician in connection with diagnosis and treatment decisions. No Authorization or Guarantee of Coverage. The Policies do not constitute authorization or guarantee of coverage of particular procedure, drug, service or supply. Members and providers should refer to the Member contract to determine if exclusions, limitations, and dollar caps apply to a particular procedure, drug, service or supply. Policy Limitation: Member s Contract Controls Coverage Determinations. The determination of coverage for a particular procedure, drug, service or supply is not based upon the Policies, but rather is subject to the facts of the individual clinical case, terms and conditions of the member s contract, and requirements of applicable laws and regulations. The contract language contains specific terms and conditions, including pre-existing conditions, limitations, exclusions, benefit maximums, eligibility, and other relevant terms and conditions of coverage. In the event the Member s contract (also known as the benefit contract, coverage document, or evidence of coverage) conflicts with the Policies, the Member s contract shall govern. Coverage decisions are the result of the terms and conditions of the Member s benefit contract. The Policies do not replace or amend the Member s contract. If there is a discrepancy between the Policies and the Member s contract, the Member s contract shall govern. Policy Limitation: Legal and Regulatory Mandates and Requirements. The determinations of coverage for a particular procedure, drug, service or supply is subject to applicable legal and regulatory mandates and requirements. If there is a discrepancy between the Policies and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. Policy Limitations: Medicare and Medicaid. Policies specifically developed to assist Health Net in administering Medicare or Medicaid plan benefits and determining coverage for a particular procedure, drug, service or supply for Medicare or Medicaid members shall not be construed to apply to any other Health Net plans and members. The Policies shall not be interpreted to limit the benefits afforded Medicare and Medicaid members by law and regulation. Obstructive Sleep Apnea Diagnosis and Medical Treatment Sep 15 18