Clinical Policy Title: Diagnosing Obstructive Sleep Apnea in Adults

Transcription

1 Clinical Policy Title: Diagnosing Obstructive Sleep Apnea in Adults Clinical Policy Number: Effective Date: July 1, 2015 Initial Review Date: November 19, 2014 Most Recent Review Date: February 18, 2015 Next Review Date: November 2015 Policy contains: Polysomnography. Cardiorespiratory study. Portable monitoring. Obstructive sleep apnea. RELATED POLICIES: CP# Obstructive sleep apnea in adults ABOUT THIS POLICY: Keystone First has developed clinical policies to assist with making coverage determinations. Keystone First clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of medically necessary, and the specific facts of the particular situation are considered by Keystone First when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. Keystone First clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. Keystone First clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, Keystone First will update its clinical policies as necessary. Keystone First clinical policies are not guarantees of payment. Coverage policy Keystone First considers the use of polysomnography or portable sleep monitoring to be clinically proven and, therefore, medically necessary when ordered by qualified specialists in pulmonary, neurological or sleep medicine as part of a comprehensive sleep evaluation to diagnose obstructive sleep apnea (OSA) in adults (age 18 years or older) when the following criteria from both A and B are met: A. One of the following devices is used to determine the apnea-hypopnea index (AHI) or respiratory disturbance index (RDI): Sleep testing device Level I: Full attended polysomnography ( 7 channels) in a laboratory setting. At a minimum, polysomnography should record electroencephalography (EEG), electrooculography (EOG), chin electromyography (EMG), airflow, arterial, arterial oxygen saturation, respiratory effort, and electrocardiography (ECG) or heart rate. Identifies sleep and awake states. Measures the AHI. Level II: Portable unattended polysomnography ( 7 channels). Records the 1

2 same information as Type I; may use fewer channels, but records signals that allow for the reliable identification of arousals from sleep (EEG, EOG, EMG, ECG) and has at least two airflow channels or one airflow and one effort channel. Identifies sleep and awake states. Measures the AHI. Level III (cardiorespiratory): Portable study that requires a minimum of the following four channels: respiratory effort, airflow, arterial oxygen saturation, and ECG or heart rate. Does not measure asleep or awake states, but has at least two respiratory channels (two airflow channels or one airflow and one effort channel) and estimates episodes of apnea and hypopnea over time as the respiratory disturbance index (RDI). B. The following medical necessity criteria for polysomnography or portable monitoring are met. Device Unattended fullchannel (Level II), or limited channel portable monitoring (Level III) Criteria for medical necessity 1. Patient has moderate to high suspicion of OSA defined as unexplained daytime sleepiness and at least one of the following: a. Body mass index (BMI) greater than 30kg/m 2. b. Abnormal airway (Mallampati score greater than 2). c. Snoring. d. Neck circumference greater than 17 inches in men and greater than 16 inches in women. -AND- 2. Patient has no contraindications to limited channel monitoring/home sleep testing, including any of the following: a. Physical or cognitive inability to use sleep testing device at home. b. Co-morbid sleep disorder (e.g., narcolepsy parasomnia with disruptive, violent or potentially injurious sleep behavior suspicious of rapid eye movement (REM) behavior disorder [RBD]; history of central sleep apnea; periodic limb movement disorder). c. Co-morbidity that could impact the accuracy of the study, including but not limited to: i. Moderate to severe pulmonary disease (e.g., chronic obstructive pulmonary disorder [COPD] or asthma) defined as forced expiratory volume in 1 second/forced vital capacity (forced expiratory volume in one second [FEV1]/forced volume capacity [FVC]) less than or equal to 0.7 and FEV1 less than 80 percent of predicted; or ii. Neuromuscular disease (e.g., Parkinson s disease, spina bifida, amyotrophic lateral sclerosis); or iii. Stroke within the previous 30 days; or iv. Epilepsy; or v. Significant cardiac disease (e.g., congestive heart failure [NYHA class III or IV], uncontrolled significant persistent 2

3 Device Criteria for medical necessity cardiac arrhythmia); or vi. Obesity defined as 35kg/m 2 ; or vii. Established obesity hypoventilation syndrome. NOTE: Unattended sleep studies may be medically necessary for patients in whom a full attended Level 1 polysomnography cannot be performed due to immobility or critical illness, or when a full attended Level 1 polysomnography is unavailable. Attended fullchannel nocturnal polysomnography (Level 1 device) 1. For initial diagnosis of OSA when one or more of the following occurs: a. Home sleep monitoring is contraindicated.; b. Home sleep monitoring results are negative or technically inadequate.; c. There is a low probability of OSA defined as normal BMI (less than 30), normal airway (Mallampati score 1 or 2), no snoring, or normal neck circumference (less than 17 inches in men, less than 16 inches in women).; d. To confirm diagnosis of OSA prior to surgical modifications of the upper airway. -OR- 2. To perform a split-night study (diagnosis and continuous positive airway pressure [CPAP] titration performed in one night) for patients with severe OSA as an alternative to one full night of diagnostic phase followed by a second night of titration as long as: a. The decision to proceed to CPAP titration in the same night is based on either: i. An AHI greater than or equal to 15 events per hour recorded for at least two hours during the diagnostic phase of the test period.; ii. An AHI greater than or equal to five events per hour and less than 15 events per hour recorded for at least two hours during the diagnostic phase with clinical judgment. b. CPAP titration is carried out for more than three hours. c. Polysomnography documents that CPAP eliminates or nearly eliminates the respiratory events during REM and NREM sleep for at least two hours. -OR- 3. To titrate CPAP in persons with clinically significant OSA for whom attended full channel nocturnal polysomnography (Level I device) was medically necessary but who were unable to undergo a splitnight study because of: a. An insufficient AHI (less than 15 events per hour) during the first two hours of testing; or 3

4 Device Repeat testing Criteria for medical necessity b. Inadequate CPAP titration (i.e., less than three hours of titration or failure to eliminate the vast majority of obstructive respiratory events). Repeat attended or unattended polysomnography/portable monitoring may be medically necessary: 1. If the first study is technically inadequate due to equipment failure. or 2. If the subject could not sleep or slept for an insufficient amount of time to allow a clinical diagnosis. 3. If the results of the first study were inconclusive or ambiguous.; 4. If initiation of therapy or confirmation of the efficacy of prescribed therapy is needed. Repeat sleep testing for diagnosing sleep apnea requires documentation justifying the medical necessity for the repeated test. Follow-up testing Follow-up polysomnography/portable monitoring (up to two tests per year) is medically necessary for any of the following indications: 1. To assess the effectiveness of upper airway surgery or oral appliances for treatment of OSA. 2. After substantial weight loss has occurred in patients on PAP treatment of sleep-related breathing disorders to determine whether continued treatment with PAP is still needed at the previously titrated pressure. 3. When clinical response is insufficient or when symptoms return despite a good initial response to treatment with CPAP. Limitations: All other uses of full or limited channel polysomnography or cardiorespiratory sleep testing in patients with OSA are not medically necessary, including: o Unattended sleep studies for the diagnosis of any other sleep disorder, including but not limited to narcolepsy, central sleep apnea or insomnia. o Screening asymptomatic persons. o Routine follow-up for patients treated with positive airway pressure (PAP) whose symptoms continue to be resolved with PAP treatment. The use of unattended sleep studies in patients with chronic opiate narcotic use limits validity of interpretation. Diagnostic sleep testing for patients using opiate narcotics for acute self-limited conditions should ideally be deferred until the medications have been stopped. A Level IV portable study that typically uses one to three channels but fails to fulfill criteria for Level III monitors is not medically necessary for diagnosing OSA. This includes sleep testing devices measuring three or more channels that involve actigraphy, oximetry and peripheral arterial tone. 4

5 Other tests performed either alone or in combination are not medically necessary to diagnose OSA but may be medically necessary to assess risk of OSA or select patients for more definitive testing. Other tests include but are not limited to: o Actigraphy testing when used alone. o Radiographic studies. o Daytime nap polysomnography; o Diagnostic audio recording, with or without pulse oximetry. o Laryngeal function studies. o Maintenance of wakefulness test. o Multiple sleep latency test. o Peripheral arterial tonometry. o Phased testing (simple tests followed by more intensive tests in selected patients). o Serum inflammatory markers. Clinical prediction models are not medically necessary for the diagnosis of OSA. The use of auto-cpap devices during attended titration in patients with congestive heart failure is not medically necessary due to an absence of evidence in this population. Alternative covered services: Clinical evaluation and sleep history. Background OSA is a sleep and breathing disorder characterized by recurrent episodes of partial or complete upper airway obstruction during sleep. It may manifest as a reduction in airflow (hypopnea) or complete cessation of airflow (apnea), which impairs sleep continuity, autonomic functionand gas exchange. OSA associated with excessive daytime sleepiness is commonly called obstructive sleep apnea syndrome (OSAS) also referred to as obstructive sleep apnea-hypopnea syndrome (OSAHS) (Downey 2014). In the U.S., the prevalence of OSA associated with accompanying daytime sleepiness is approximately 3 percent for adult men and 2 percent for adult women in the general population according to the Wisconsin Sleep Cohort Study (Punjabi 2008). Disease prevalence is higher in different population subsets, including overweight or obese people, those of a minority race, older individuals and patients referred for sleep evaluation. The true burden of disease is likely underestimated, as estimates are based on risk factors that are increasing in the general population. Advancing age, excess body weight and male gender are associated with increased risk of OSA. Race may play a role, as well as craniofacial anatomy, familial and genetic predisposition, smoking and alcohol consumption, and medical comorbidity. Other conditions that may be implicated in the increased prevalence of OSA include polycystic ovary syndrome, hypothyroidism and pregnancy (Punjabi 2008). Lack of awareness of signs and symptoms among health-care providers and patients and hesitancy of patients to follow through on diagnosis and eventual therapy contribute to underdiagnosis (Punjabi 2008). 5

6 Untreated OSA can have numerous negative health consequences. Adults may suffer fatigue, somnolence, headaches, cardiovascular disease and decreased quality of life (QOL), as well as face an increased risk of motor vehicle accidents (Punjabi 2008). Therefore, knowledge of risk factors for OSA is crucial to properly directing diagnostic attention toward those with the highest risk. Diagnosis The diagnosis of OSA begins with a sleep history and physical examination to stratify patients according to their risk of OSA. Those patients deemed high risk should have the diagnosis confirmed and severity determined with objective testing. Improvements in diagnosis and treatment are at the forefront of efforts to reduce the harmful consequences of this disease. However, considerable clinical uncertainty exists regarding OSA with respect to the type and level of respiratory abnormality used to define the disorder, as well as uncertainty with available diagnostic methods for its detection. Patients may present with clinical symptoms that suggest underlying sleep-disordered breathing such as excessive snoring, episodes of apnea, and daytime hypersomnolence. Attended overnight Level I polysomnography (PSG) is a definitive diagnostic tool to confirm the presence and severity of upper airway obstruction (Epstein 2009). The Level 1 PSG is facility-based overnight monitoring of many body functions during sleep, including brain activity(eeg), eye movement (EOG), muscle activity or skeletal muscle activation (EMG), heart rhythm (ECG), respiratory airflow, respiratory effort, and peripheral pulse oximetry. A Level 1 PSG is typically performed over two nights consisting of diagnosis of sleep apnea during the first night CPAP titration during the second. Alternatively, a split-night sleep study may be performed during which diagnosis is determined and followed by CPAP titration in one night. The U.S. Food and Drug Administration regulates polysomnographs as Class II devices (product code OLV standard polysomnograph with electroencephalograph ) (21CFR ). Several devices with this code have 510(k) marketing clearances; however, not all of these clearances are for devices for split-night sleep studies. The frequency of airflow obstructive events is generally reported as the AHI, which, in adults, is a measure of the number of apneas (events of breathing cessation greater than 10 seconds) and hypopneas (greater than 30 percent decline in breathing effort coupled with greater than 4 percent oxygen saturation (SaO 2 ) desaturation and/or arousal) per hour during sleep. However, there is no empirically validated threshold level for the AHI that would indicate clinically significant disease (Balk 2011). By consensus, the American Academy of Sleep Medicine (AASM) sets a threshold of 15 events per hour with or without symptoms or five events per hour with symptoms for OSA diagnosis in adults, but other definitions of OSA employing thresholds of AHI greater than or equal to 15 events per hour have been reported (Epstein 2009). The primary treatment for OSA in adults is CPAP. Facility-based Level 1 PSG with CPAP titration is the most cost-effective approach to evaluation of sleep disorders in adults when required, but its main drawbacks are limited numbers of recording beds, high cost, long waiting lists, labor requirements, and inconvenience to the patient (Pagel 2007). Surgical outcomes continue to depend heavily on the AHI to validate OSA surgical effectiveness. However, AHI is known to correlate poorly with both patient perception of their OSA as well as many other measures of disease burden (Tam 2014). 6

7 Less resource-intensive and more convenient alternatives to PSG have been sought as a means of assessing disease burden and severity and measuring treatment response. These include, but are not limited to, the use of self-administered sleep questionnaires, biomarkers, clinical prediction models, overnight pulse oximetry, testing for daytime somnolence, craniofacial morphology, phased testing and portable monitoring performed in-laboratory or at home. The ideal device should be inexpensive, readily accessible, easily used with minimal instructions, have no risk or side effects to the patient, and be both sufficiently sensitive and specific to potentially obviate the need for Level 1 PSG. Methods Searches: Keystone First searched PubMed and the databases of: UK National Health Services Centre for Reviews and Dissemination. Agency for Healthcare Research and Quality s National Guideline Clearinghouse and other evidencebased practice centers. The Centers for Medicare & Medicaid Services. Searches were conducted on October 9-10, 2014 using the term "sleep apnea, obstructive/diagnosis"[mesh] and the free text term sleep testing. Included were: Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies. Systematic reviews use predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidence-grading hierarchies. Guidelines based on systematic reviews. Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost studies), reporting both costs and outcomes sometimes referred to as efficiency studies which also rank near the top of evidence hierarchies. Findings: Keystone First identified eight systematic reviews/meta-analyses and four evidence-based guidelines for this policy. Studies generally included adult patients who were either referred to specialized sleep centers or hospitals for evaluation of suspected OSA or studied at home. It is unclear if the results of the studies are applicable to a more general population of patients with comorbidities or other sleep-related breathing disorders (SBD). The overall quality of the evidence comparing testing alternatives to Level 1 PSG is low to moderate due to selection bias, varying study designs, use of varying cutoff values of AHI for defining OSA, patient attrition, and a lack of rigorous evaluation of the impact on outcomes for treatment directed by results of alternative testing. These limitations contribute to the wide ranges of diagnostic test accuracy determined by metaanalysis and the subsequent uncertainty in finding suitable replacements for Level 1 PSG. The evidence is sufficient to support the use of dual-night Level 1 PSG with CPAP titration for diagnosing OSA. The body of evidence supporting Level 1 PSG is of moderate quality, and evidencebased guidance supports its use as the standard of care (Qaseem 2014, Epstein 2009). 7

8 The evidence is sufficient to support the use of split-night sleep studies as an alternative to dualnight Level 1 sleep studies for diagnosing OSA in adults who are suspected of having moderateto-severe OSA. Results of randomized controlled trials suggest that attended split-night studies perform comparably to portable home monitoring with auto CPAP titration in this population (Hayes 2012). The American Association of Sleep Medicine (AASM) recommends split-night PSG when an AHI greater than or equal to 40 events per hour is recorded for at least two hours during the diagnostic phase of the test period, or for an AHI of per hour based on clinical judgment (Epstein 2009). There is a role for split-night testing when carried out by a trained and experienced sleep technologist and when there is recognition that further testing may be required to rule in or out a diagnosis of OSA (Hayes 2012, Epstein 2009). There is an absence of evidence supporting the use of auto-cpap devices during attended titration in patients with congestive heart failure (Hayes 2012). The evidence is sufficient to support the use of Level III portable monitors as an alternative to dual-night Level 1 sleep studies for diagnosing OSA in adults who have a high clinical suspicion of OSA and no major comorbidities. A portable monitor must be able to report the number of respiratory events during sleep as either the AHI or RDI. However, substantial differences in the measurement of AHI/RDI between portable monitors and Level 1 PSG may exist, leading to judgments on the trade-off between poorer diagnostic performance than Level 1 PSG and appropriate use of limited resources. Studies to date have been performed predominantly in populations at high risk for moderate to severe OSA. Insufficient research has been conducted to directly compare the relative diagnostic performance of different portable monitors, to determine the discriminatory capacity of various portable monitors to detect low levels of OSA versus high levels of OSA, or in pediatric or older (greater than age 65) populations (El Shayeeb 2014, Balk 2011, Collup 2011). According to the AASM, a portable monitor should, at a minimum record airflow, respiratory effort and blood oxygenation values sufficient to estimate the number of respiratory events during sleep (Epstein 2009, Collup 2007). Low- to moderate-quality evidence suggests unattended Level III portable devices that record at least airflow, respiratory effort and blood oxygenation are sufficiently accurate to predict an AHI suggestive of OSA with high positive likelihood ratios and low negative likelihood ratios (high false negative rate) for various AHI cutoffs in PSG (Balk 2011, El Shayeb 2014, Qaseem 2014). With the high false negative rates associated with Level III devices, unattended home sleep tests are not appropriate for patients with major medical or sleep comorbidities that may degrade test accuracy or with other sleep disorders, or for screening asymptomatic individuals. A Level 1 sleep study should be performed in cases where portable monitoring is technically inadequate or fails to establish the diagnosis of OSA in patients with a high suspicion of disease (Epstein 2009). The AASM supports using portable monitoring for patients in whom a full attended Level 1 study cannot be performed due to immobility or critical illness (Epstein 2009, Collup 2007). The American College of Physicians (ACP) also recommends portable monitoring in patients without serious comorbidities as an alternative to PSG when PSG is unavailable for diagnostic testing (Qaseem 2014). 8

9 The evidence is insufficient to support the use of Level IV portable monitors as an alternative to dual-night Level 1 sleep studies for diagnosing OSA in adults. Level IV devices cannot differentiate between obstructive and central apneas. Because CPAP may be contraindicated in patients with central sleep apnea, an accurate differential diagnosis using Level I, II or III testing is indicated for appropriate treatment management (Qaseem 2014). The evidence is insufficient to support using other testing either alone or in combination, or clinical prediction models as surrogates for PSG to diagnose OSA. However, if these tests are found to be sufficiently predictive of the results of full sleep testing, they may have value as a screening tool to identify patients who should be worked up further, treated for OSA or considered not to have OSA. Studies comparing questionnaires to PSG for screening OSA were of low quality and limited by high likelihood of selection bias, or they were supported by only single studies. Whether the various questionnaires can accurately predict the clinical severity of sleep apnea and the likelihood of clinically important sequelae is unknown. Questionnaires may help rule out OSA but generally are not helpful in identifying patients affected by sleep apnea (Abrishami 2010, Balk 2011, Myers 2013). Other tests such as peripheral arterial tonometry, tests for excessive daytime sleepiness, and serum biomarkers may aid in identifying high risk patients for OSA, but are not routinely recommended (Yalamanchali 2013, Nadeem 2013, Balk 2011, Littner 2005). There is insufficient evidence to support using phased testing (simple tests followed by more intensive tests in selected patients) as predictors of OSA (Balk 2011). The American College of Physicians suggests targeting the assessment of OSA to individuals with unexplained daytime sleepiness (Qaseem 2014). This assessment should include evaluation of the risk factors and common presenting symptoms for OSA. The best documented risk factor for OSA is obesity. Clinical symptoms for OSA include unintentional sleep episodes during wakefulness, daytime sleepiness, unrefreshing sleep, fatigue, insomnia and snoring. Sleepiness questionnaires, such as the Eppworth Sleepiness Scale, may help in assessing the symptom severity of OSA but cannot assess the AHI and lack sufficient sensitivity and specificity to replace a sleep study in diagnosing OSA. The ACP makes no recommendation for or against the use of other questionnaires in assessing risk of OSA (Qaseem 2014). Many of the large referral-based studies that developed clinical prediction rules for sleep apnea are heterogeneous and impractical for use in primary care. All models in the included meta-analyses had been internally validated, but not externally validated in independent populations (Balk 2011, Myers 2013). Some clinical prediction models have been developed or tested specifically for the prediction of severe OSA (defined as AHI greater than or equal to 20 or 30 events per hour) to prioritize patients for a split-night protocol. Their clinical value as defined by their impact on clinical outcomes, beyond simple studies of diagnostic test accuracy, has not been determined. The AASM does not recommend using clinical predictions models to assess severity of OSA (Epstein 2009). There is insufficient evidence to support routine preoperative testing using PSG for OSA. The rationale for using PSG for routine preoperative assessment is to identify surgical candidates with 9

10 undiagnosed sleep apnea, who would be at an increased risk of perioperative pulmonary and cardiovascular complications. Routinely screening all (or selected) patients undergoing anesthesia or surgery may allow for improved perioperative care to minimize problems with intubation, extubation and other respiratory events. At present, the value of screening all or selected surgical patients and the most effective and efficient method of screening has not been determined (Balk 2011). There is insufficient evidence to support the routine use of full PSG or attended cardiorespiratory (Level III) devices to monitor treatment effectiveness. AASM consensus-based recommendations suggest unattended Level III portable devices may be indicated to monitor patients after a good response to oral appliance treatment, surgical or dental treatment, substantial weight loss (e.g., 10 percent of body weight), substantial weight gain with return of symptoms, when clinical response is insufficient, or when symptoms return despite a good initial response to CPAP (Epstein 2009). Follow-up PSG or PM is not routinely indicated in patients treated with CPAP whose symptoms continue to be resolved with CPAP treatment. The type of surgery and clinical judgment will dictate the frequency of post-surgical follow-up and OSA-related evaluation (Epstein 2009). The U.S. Preventive Services Task Force posted a final research plan on screening for obstructive sleep apnea in asymptomatic adults and persons with unrecognized symptoms of OSA. The goal is to identify persons at high risk of OSA and determine if screening improves health outcomes in this population. The research plan will help guide a comprehensive systematic review to support evidence-based recommendations for the use of screening in persons at high risk of OSA (USPSTF 2014). Summary of clinical evidence: Citation Content, Methods, Recommendations Adult populations El Shayeb (2014) Level III portable vs. Level I PSG Key Points: Meta-analysis of 19 studies of diagnostic accuracy and treatment impact in a referral population with stable comorbidities or without comorbidities. The estimated area under the receiver operating characteristics curve (AROC) ranged between 0.85 and 0.99 across different levels of disease severity. Summary sensitivity = 0.79 to 0.97, summary specificity = 0.60 to 0.93 across different AHI cut-offs. No significant difference in the clinical management parameters between patients who underwent either test. Level III portable devices showed good diagnostic performance compared with level 1 sleep tests in adult patients with a high pretest probability of moderate to severe OSA and no unstable comorbidities. For patients suspected of having other types of sleepdisordered breathing or sleep disorders not related to breathing, level 1 testing remains the reference standard. Hayes (2014) Split-Night PSG Key Points: Systematic review of eight studies including three randomized controlled trials (RCTs) (n = 102 to 373; OSA defined as AHI 10 to 15 events/hour; follow-up one to three months); three retrospective comparative studies (n = 200 to 608; OSA defined as AHI 30 to 40 events/hour; follow up four to six weeks); and two retrospective cohort studies (n = 198 to 418; OSA defined as AHI 15 to > 40 events/hour. Overall quality: low. Variable methods, OSA definitions, high drop-out rates, short 10

11 Citation Myers (2013) Clinical exam Nadeem (2013) Serum inflammatory markers Yalamanchali (2013) Peripheral arterial tonometry (PAT), primarily Watch- PAT 100 (Itamar Medical; Franklin, MA) Content, Methods, Recommendations follow-up. Split-night PSG with CPAP titration is a safe and reasonable alternative to dual-night PSG and CPAP titration when limited to patients with a high clinical suspicion of having moderate-to-severe OSA. Split-night PSG is not as efficacious for patients with milder OSA since there is insufficient time to capture meaningful AHI data and other sleep disturbances. Split-night PSG has outcomes similar to those of portable monitoring at home, which is an increasingly popular alternative to in-laboratory testing whether by the split-night or dual-night protocols. There is a clinical role for split-night PSG when carried out by a trained and experienced sleep technologist, and when there is recognition that further testing is required to rule in or out a diagnosis of OSA. Key Points: Systematic review of 42 studies. The most useful observation for identifying patients with OSA was nocturnal choking or gasping (summary likelihood ratio [LR], 3.3; 95%CI, ) when the diagnosis was established by AHI 10/h). Snoring is not useful for establishing the diagnosis (summary LR, 1.1; 95%CI, ). Patients with mild snoring and BMI < 26 are unlikely to have moderate or severe OSA (LR, 0.07; 95%CI, at threshold of AHI 15/h). Oropharyngeal examinations and craniofacial structure provided limited information for the diagnosis of OSA at thresholds from 5/h or higher to 15/h or higher. Several recently published multi-itemed questionnaires may help rule out OSA, but are not helpful in identifying patients affected by sleep apnea. Many of the large referral-based studies that developed prediction rules for sleep apnea are heterogeneous and impractical for use in primary care. The new Sleep Apnea Clinical Score (SACS) shows promise but requires validation in more general populations by primary care clinicians. The clinical examination of patients with suspected OSA is useful for selecting patients for more definitive testing. Key Points: Systematic review and meta-analysis of 51 studies. Overall quality: not reported. OSA = AHI of >/= 5/h. (30 studies for CRP, 19 studies for TNF-alpha, eight studies for ICAM, 18 studies for IL-6, six studies for VCAM and five studies for Selectins). The levels of inflammatory markers were higher in patients with OSA compared to control group. Standardized pooled mean differences were: 1.77 for CRP, 1.03 for TNFalpha, 2.16 for IL-6, 4.22 for IL-8, 2.93 for ICAM, 1.45 for Selectins and 2.08 for VCAM. All levels were positively correlated with severity of OSA. Future studies needed to validate the role of these markers re: progression or prognosis of disease, disease severity or treatment effectiveness. Key Points: Systematic review and meta-analysis of 14 trials (n = 909 patients). Overall quality: low to moderate. High risk of selection bias, low risk of publication bias. Correlation between the respiratory disturbance index (RDI) and AHI (r = [95% CI, to 0.911]; P <.001) in one nonblinded study. Correlation between PAT and PSG with respect to: o RDI (95% CI, ; P <.001). o AHI, ( ; P <.001. o Oxygen desaturation index (ODI), ( ; P <.001). Respiratory indices calculated using PAT-based portable devices positively correlated with those calculated from the scoring of PSG either in lab or at home. 11

12 Citation Balk (2011) AHRQ update of 2007 review Various diagnostic methods Abrishami (2010) Questionnaires for screening OSA Hayes (2008) Actigraphy, primarily Watch- PAT100 device (Itamar Medical; Content, Methods, Recommendations Results confounded by inclusion of patients with hypertension. PAT is less sensitive than PSG; patients with a negative result require formal laboratorybased PSG. Specific selection criteria must be determined to evaluate its appropriate diagnostic use for patients with suspected OSA. Key Points: Systematic review of 46 studies of diagnostic tests. Overall quality: low to moderate. High risk of bias. Low-quality evidence that Level II monitors used at home are accurate to diagnose OSA (as defined by PSG), but substantial differences in the [measurement of] AHI may be encountered between them and Level 1 PSG. Moderate evidence that Level III and Level IV monitors can accurately predict an elevated AHI (as determined by PSG). Level III monitors perform better than Level IV monitors at AHI cutoffs of five, 10 and 15 events/hr. Insufficient evidence to adequately compare specific monitors to each other. No studies evaluated the predictive ability of portable monitors for clinical outcomes, response to treatment, or impact of patient triage via screening tests and/or portable monitors. Low-quality evidence that the Berlin questionnaire is able to prescreen patients with OSA with moderate accuracy. Insufficient evidence to evaluate other questionnaires: STOP (Snoring, Tiredness during daytime, Observed apnea, and high blood Pressure), the STOP-Bang (STOP with BMI, age, neck circumference, and sex variables), the American Society of Anesthesiologists (ASA) screening checklist for OSA in surgical patients, Hawaii Sleep Questionnaire and the Epworth Sleepiness Scale. Insufficient evidence to evaluate clinical prediction rules. All included models were internally validated, but not externally validated in independent populations. Their application to clinical practice has not been studied. No study adequately addressed phased testing for OSA. Insufficient evidence to evaluate routine preoperative testing for OSA. Key Points: Systematic review of 10 studies (n = 1,484 patients). Overall quality: Low or unclear. Unclear risk of bias, poor reporting, heterogeneous design (population, questionnaire type, validity). Berlin questionnaire most commonly studied (four studies) followed by the Wisconsin sleep questionnaire (two studies). Highest methodological quality = studies on snoring, tiredness, observed apnea and high blood pressure (STOP) and STOP including body mass index, age, neck circumference, gender (Bang) questionnaires. For persons with sleep disorders (four studies), pooled Se = 72.0% (95% CI %; I 2 = 23.0%), pooled Sp = 61.0% (95% CI %; I 2 = 43.8%). For patients without history of sleep disorders (six studies), pooled Se = 77.0% (95% CI %; I 2 =78.1%), pooled Sp = 53.0% (95% CI 50 57%, I 2 = 88.8%). Authors conclusion: Promising but inconsistent results. Suggest STOP and STOP-Bang questionnaires for screening of OSA in the surgical population due to their higher methodological quality and easy-to-use features. Key Points: Systematic review of 11 simple cohort studies. Overall quality: Low. There is insufficient evidence to support the routine use of actigraphy alone for the inlaboratory or home-based diagnosis of OSAS or for monitoring the use of CPAP treatment for OSAS. 12

13 Citation Content, Methods, Recommendations Franklin, MA) Actigraphy combined with cardiorespiratory variables using the Watch-PAT 100 device, provides a moderately accurate (sensitivity and specificity > 80%) alternative to PSG in persons with moderate to severe OSA used for initial in-laboratory and home assessment and follow-up assessment for patients receiving CPAP therapy. Other organizations Organization CMS National Coverage Determination (NCD) for Sleep Testing for Obstructive Sleep Apnea (OSA) ( ) CMS Summary of LCD requirements Policy Nationally Covered Indications Effective for claims with dates of service on and after March 3, 2009, the Centers for Medicare & Medicaid Services finds that the evidence is sufficient to determine that the results of the sleep tests identified below can be used by a beneficiary s treating physician to diagnose OSA, that the use of such sleep testing technologies demonstrates improved health outcomes in Medicare beneficiaries who have OSA and receive the appropriate treatment, and that these tests are thus reasonable and necessary under section 1862(a)(1)(A) of the Social Security Act. 1. Type I PSG is covered when used to aid the diagnosis of OSA in beneficiaries who have clinical signs and symptoms indicative of OSA if performed attended in a sleep lab facility. 2. Type II or Type III sleep testing devices are covered when used to aid the diagnosis of OSA in beneficiaries who have clinical signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility. 3. Type IV sleep testing devices measuring three or more channels, one of which is airflow, are covered when used to aid the diagnosis of OSA in beneficiaries who have signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility. 4. Sleep testing devices measuring three or more channels that include actigraphy, oximetry, and peripheral arterial tone, are covered when used to aid the diagnosis of OSA in beneficiaries who have signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility. Nationally Non-Covered Indications Effective for claims with dates of services on and after March 3, 2009, other diagnostic sleep tests for the diagnosis of OSA, other than those noted above for prescribing CPAP, are not sufficient for the coverage of CPAP and are not covered. Diagnosis of obstructive sleep apnea requires documentation of: AHI /RDI** greater than or equal to 15 events per hour, or AHI greater than or equal to 5 and less than or equal to 14 events per hour with documented symptoms of excessive daytime sleepiness, impaired cognition, mood disorders or insomnia, or documented hypertension, ischemic heart disease, or history of stroke. *The AHI is equal to the average number of episodes of apnea and hypopnea per hour and must be based on a minimum of 30 episodes recorded by polysomnography using actual recorded hours of sleep without symptoms and 10 episodes with symptoms above. (CMS Publication 100-3, Medicare National Coverage Determinations Manual, Chapter 1, Section [Rev.35, ]). **The =RDI is defined as the number of apneas and hypopneas per hour of recording time. 13

14 The use of CPAP devices is covered under Medicare when ordered and prescribed by the licensed treating physician to be used in adult patients with OSA if either of the AHI/RDI criteria mentioned above is met. The polysomnography, Type II, III or Type IV devices must be performed in a facility-based sleep study laboratory or by portable monitoring (including in other parts of a facility, out of facility, or at home testing) under the restrictions listed below and with the credentialing requirements being met. Initial claims must be supported by medical documentation (separate documentation where electronic billing is used) with documentation of medical necessity. Type II monitors have a minimum of seven channels (e.g., EEG, EOG, EMG, ECG-heart rate, airflow, breathing/respiratory effort, SaO 2 )-this type of device monitors sleep staging, so AHI can be calculated). Type III monitors have a minimum of four monitored channels including ventilation or airflow (at least two channels of respiratory movement or respiratory movement and airflow), heart rate or ECG, and oxygen saturation. Type IV devices may measure one, two, three or more parameters but do not meet all the criteria of a higher category device. Sleep testing devices measuring three or more channels that include actigraphy, oximetry, and peripheral arterial tone, are covered when used to aid the diagnosis of OSA in beneficiaries who have signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility. "Split-night" study (initial diagnostic polysomnogram followed by CPAP titration during polysomnography on the same night). Indicated for patients with severe and unambiguous OSA This approach may be an alternative to one full night of diagnostic polysomnography followed by a second night of titration as long as: CPAP titration is carried out for more than three hours; and Polysomnography documents that CPAP eliminates or nearly eliminates the respiratory events during REM and NREM sleep. Repeat polysomnography or sleep testing for diagnosing sleep apnea requires documentation justifying the medical necessity for the repeated test. Repeat polysomnography/sleep testing may be indicated: if the first study is technically inadequate due to equipment failure. if the subject could not sleep or slept for an insufficient amount of time to allow a clinical diagnosis. if the results were inconclusive or ambiguous. if initiation of therapy or confirmation of the efficacy of prescribed therapy is needed. Follow-up polysomnography or sleep studies are not routinely indicated for patients treated with CPAP whose symptoms continue to be resolved with CPAP treatment. Follow-up polysomnography studies may be indicated, however, for the following conditions: After substantial weight loss has occurred in patients on CPAP for treatment of sleep-related breathing disorders to ascertain whether CPAP is still needed at the previously titrated 14

15 pressure. After substantial weight gain has occurred in patients previously treated with CPAP successfully, who are again symptomatic despite the continued use of CPAP, to ascertain whether pressure adjustments are needed. When clinical response is insufficient or when symptoms return despite a good initial response to treatment with CPAP. Home Sleep Testing The physician services related to home sleep testing (G0398, G0399 and G0400) are covered for the purpose of testing a patient for the diagnosis of obstructive sleep apnea if the home sleep testing is reasonable and necessary for the diagnosis of the patient s condition, meets all other Medicare requirements, and the physician who performs the service has sufficient training and experience to reliably perform the service. A home sleep test is covered only when it is performed in conjunction with a comprehensive sleep evaluation and in patients with a high pretest probability of moderate to severe obstructive sleep apnea. Home sleep testing is not covered for persons with comorbidities (moderate to severe pulmonary disease, neuromuscular disease or congestive heart failure). Home sleep studies are only covered for the diagnosis of OSA. They are not covered for any other sleep disorders (central sleep apnea, periodic limb movement disorder, insomnia, parasomnias, circadian rhythm disorders or narcolepsy) or for screening asymptomatic persons. Glossary Actigraphy A method of monitoring activity with a portable device or actimeter that can be used while patients are sleeping. Actigraph devices include a small accelerometer that is typically fixed to a patient's wrist to record movement (AASM, 2007). Apnea An absence of breathing (respiration). Apnea-hypopnea index (AHI) The number of apneic episodes (obstructive, central and mixed), plus hypopneas per hour of sleep. Only full polysomnography and portable monitors that measure airflow directly measure AHI. Attended A technologist or qualified health care professional is physically present (i.e., sufficient proximity such that the qualified health care professional can physically respond to emergencies, to other appropriate patient needs or to technical problems at the bedside) throughout the recording session. Hypopnea A partial reduction in breathing of at least 30 percent that lasts at least 10 seconds during sleep. This is measured by a nasal pressure transducer. 15

16 Medically Necessary- A service or benefit is Medically Necessary if it is compensable under the MA Program and if it meets any one of the following standards: The service or benefit will, or is reasonably expected to, prevent the onset of an illness, condition or disability. The service or benefit will, or is reasonably expected to, reduce or ameliorate the physical, mental or developmental effects of an illness, condition, injury or disability. The service or benefit will assist the Member to achieve or maintain maximum functional capacity in performing daily activities, taking into account both the functional capacity of the Member and those functional capacities that are appropriate for Members of the same age. Obstructive sleep apnea (OSA) A life-threatening and life-altering condition that causes a person to stop breathing repeatedly during sleep due to obstruction of the airway by excess tissue in the back of the throat. Cessation of breathing during sleep, due to a mechanical obstruction, such as a semi-collapsed trachea, tongue relaxed to the back of the throat or a large amount of tissue in the uvula area. Phased testing Process of diagnosing OSA using simple tests followed by more intensive tests in selected patients. Polysomnogram The continuous and simultaneous recording of multiple physiologic variables during sleep, i.e., electroencephalogram, electrooculogram, electromyogram (these are the three basic stagescoring parameters), electrocardiogram, respiratory air flow, respiratory movements, leg movements and other electrophysiologic variables. Polysomnography (PSG) or overnight sleep study Standard method of detecting sleep disorders and evaluating treatments in children and adults while sleeping. PSG measures information such as airflow, brain activity (EEG), respiratory effort, eye movements (EOG), leg movements (EMG), blood oxygen saturation and unusual behavior. May be facility-based or portable. The American Sleep Disorders Association classifies sleep study devices as follows: (Kushida 2005) Level I: Full attended polysomnography ( 7 channels) in a laboratory setting. At a minimum polysomnography should record EEG, EOG, EMG, airflow, arterial, arterial oxygen saturation, respiratory effort, and ECG or heart rate. It identifies sleep and awake statesand measures the AHI. Level II (G0398): Portable full unattended polysomnography ( seven channels). Records the same information as Type I; may use fewer channels, but records signals that allow for the reliable identification of arousals from sleep (EEG, EOG, EMG, ECG). It has at least two airflow channels or one airflow and one effort channel. It also identifies sleep and awake states and measures the AHI. Level III (G0399, cardiorespiratory): Portable study that requires a minimum of the following four channels: respiratory effort, airflow, arterial oxygen saturation, and ECG or heart rate. It does not measure asleep or awake states, but has at least two respiratory channels (two airflow channels or 16

17 one airflow and one effort channel) and estimates episodes of apnea and hypopnea over time as the RDI. Level IV (G0400): Portable study that uses one to three channels, usually using oximetry as one of the parameters, but fails to fulfill criteria for Type III monitors. It does not measure asleep or awake states and may or may not have two airflow channels. It also estimates episodes of apnea and hypopnea over time as the RDI. Respiratory disturbance index (RDI) Also known as respiratory distress index A formula used in reporting the frequency of respiratory events during sleep. It is calculated as the number of events (including apneas and hypopneas) per hour of recording. Unattended A technologist or qualified health care professional is not physically present with the patient during the recording session. Related policies Keystone First Utilization Management program description. References Professional society guidelines/others: 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. Portable Monitoring Task Force of the American Academy of Sleep Medicine. Journal of Clinical Sleep Medicine: JCSM: official publication of the American Academy of Sleep Medicine. Dec ;3(7): Collop NA, Tracy SL, Kapur V, et al. Obstructive sleep apnea devices for out-of-center (OOC) testing: technology evaluation. Journal of Clinical Sleep Medicine: JCSM: official publication of the American Academy of Sleep Medicine. Oct ;7(5): Epstein LJ, Kristo D, Strollo PJ, Jr., et al. Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults. Journal of Clinical Sleep Medicine: JCSM: official publication of the American Academy of Sleep Medicine. Jun ;5(3): Qaseem A, Dallas P, Owens DK, Starkey M, Holty JE, Shekelle P. Diagnosis of obstructive sleep apnea in adults: a clinical practice guideline from the American College of Physicians. Ann Intern Med. Aug ;161(3): Peer-reviewed references: 21CFR Standard Polysomnograph with Electroencephalograph. Abrishami A, Khajehdehi A, Chung F. A systematic review of screening questionnaires for obstructive sleep apnea. Can J Anaesth. 2010;57(5):