Clinical Policy: Facility-based Sleep Studies for Obstructive Sleep Apnea Form

# Clinical Policy: Facility-based Sleep Studies for Obstructive Sleep Apnea
Reference Number: CP.MP.248  
Date of Last Revision: 10/25  

[Coding Implications](Coding Implications)  
[Revision Log](Revision Log)  

See [Important Reminder](Important Reminder) at the end of this policy for important regulatory and legal information.  

## Description  
Polysomnography (PSG) is the continuous and concurrent monitoring and recording of various physiological and pathophysiological parameters of sleep that includes physician evaluation, interpretation and dissemination. PSG is performed to diagnose various sleep disorders and evaluate the response to treatments such as continuous positive airway pressure (CPAP).⁶ This policy establishes the medical necessity requirements for facility-based PSG, split-night studies, bi-level and continuous positive airway pressure (CPAP/BiPAP) titration for suspected obstructive sleep apnea (OSA), and titration PSG for hypoglossal nerve stimulation.  

The policy criteria are derived from a combination of the American Academy of Sleep Medicine (AASM) guidelines¹⁴,²³, CMS local coverage determinations⁶, and systematic reviews 4,5,7,9,10,19,23,25,26,27,28,29,30,31,32 which state that while PSG is currently considered the gold standard diagnostic test for OSA, home sleep apnea testing (HSAT) is an alternative method used and may be less costly and more efficient in some adult populations.²³ Indications not sourced from one of the reference types above are offered as supplemental options for meeting criteria in addition to those noted by AASM guidelines, local coverage determinations and systematic reviews.  

Many HSAT devices have been validated against standard PSG, typically by testing the same patient with both modalities in the sleep laboratory. The sensitivity and specificity appear to be high in populations considered by sleep specialists to be at high risk of uncomplicated, moderate to severe OSA on the basis of clinical symptoms, assuming there are no comorbid medical disorders or other suspected sleep disorders.¹⁰  

In addition to increased member/enrollee convenience, the main clinical advantage for HSAT is that sleep data can be obtained over several nights of sleep in the comfort of the member/enrollee’s home rather than one night in a laboratory setting where the member/enrollee may not sleep for prolonged periods.  

Given the performance of home sleep testing versus facility-based testing and the potential for medically appropriate members/enrollees to more closely replicate a typical night of sleep during home testing, as well as the criteria’s consistency with AASM guidelines, this policy represents a favorable balance of benefits versus risks.  

*Note: For criteria applicable to Medicare plans, please see MC.CP.MP.248 Facility-based Sleep Studies for Obstructive Sleep Apnea.*  

*Note: For suspected central sleep apnea, please refer to nationally recognized clinical decision support tools.*  

# CLINICAL POLICY  
FACILITY-BASED PSG FOR OSA  

## Policy/Criteria  
  
            iii. History of ventricular fibrillation or sustained ventricular tachycardia in the absence of an implanted defibrillator;  
            iv. Neurologic or neuromuscular disease (e.g., stroke with significant residual effects, epilepsy, Parkinson’s disease, spina bifida, myotonic dystrophy, amyotrophic lateral sclerosis)⁶,²³;  
              
            i. Daytime sleepiness⁹;  
            ii. Two or more of the following²³:  
                a) Habitual loud snoring;  
                b) Observed apnea or awakening with gasping or choking;  
                c) Diagnosis of hypertension.  

II. It is the policy of non-Medicare health plans affiliated with Centene Corporation that repeat facility-based polysomnography (PSG) or split-night study (after an initial PSG or split-night study) for evaluation of OSA for members/enrollees ≥ 18 years of age is **medically necessary** when meeting all of the following:  
A. All of the criteria in section I.B are met;  
  
    9. Signs, symptoms and strong clinical suspicion of OSA in member/enrollee with a negative study at least six months previous.²³  

  

IV.It is the policy of non-Medicare health plans affiliated with Centene Corporation that facility-based titration PSG for hypoglossal nerve stimulation is **medically necessary** when conducted three to six months after device implantation.³⁶  

V. It is the policy of non-Medicare health plans affiliated with Centene Corporation that there is insufficient evidence to support the use of actigraphy testing alone for diagnosis of obstructive sleep apnea as its effectiveness has not been established.⁶  

# CLINICAL POLICY  
FACILITY-BASED PSG FOR OSA  

| Classification | Characteristics |
|----------------|-----------------|
| Class I        | Patients with cardiac disease but without the resulting limitations in physical activity. Ordinary activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain |
| Class II       | Patients with heart disease resulting in slight limitations of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea or anginal pain |
| Class III      | Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain |
| Class IV       | Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. The symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort increases. |

## Background  
Sleep-disordered breathing consists of several distinct disorders including obstructive sleep apnea (OSA), central sleep apnea (CSA), both with and without Cheyne-Stokes respiration, and sleep-related hypoventilation and hypoxemia.²,³ Sleep apnea, a serious and potentially dangerous sleep disorder in which breathing repeatedly stops and starts, is divided into two main types, OSA and CSA. ⁴,⁵,⁶,⁷ The most common form of sleep apnea, OSA, is characterized by the partial or complete collapse of the upper airway during sleep, which causes symptoms such as excessive daytime sleepiness, gasping, snorting, loud snoring, and interrupted breathing.⁴,⁵  

The International Classification of Sleep Disorders defines OSA as five or more predominantly obstructive respiratory events per hour in the presence of symptoms or certain comorbidities; or by 15 or more predominantly obstructive respiratory events per hour in asymptomatic patients.⁴ Global estimates suggest that 936 million people between the ages of 30 and 69 years old have been diagnosed with mild to severe OSA and 425 million people with moderate to severe OSA.⁴  

A detailed sleep history and examination accompanied by validated screening tools such as the Epworth Sleepiness Scale or STOP-Bang questionnaire, assist with the identification of patients with sleep-disordered breathing.³ However, sleep testing is necessary for diagnostic confirmation.³  

OSA should be suspected when a patient presents with excessive daytime sleepiness, snoring and choking, or gasping during sleep, especially in the presence of high-risk factors like advanced age and obesity, and in those with a male reproductive system. Additional complications related to OSA include refractory hypertension, atrial fibrillation, nocturnal angina, dysrhythmias, congestive heart failure, stroke, and transient ischemic attacks.⁴,⁸,⁹  

Polysomnography (PSG) is a comprehensive sleep study that monitors several physiologic components relevant to the assessment of sleep-disordered breathing, such as sleep stage,  

# CLINICAL POLICY  
FACILITY-BASED PSG FOR OSA  

respiratory flow, respiratory effort, pulse oximetry and ventilation.²,¹² PSG results are interpreted by the reviewing clinician, and treatment recommendations are made based on the recorded signals, results of scoring, and clinical history.¹² PSG tests can be used as a part of the diagnosis of a variety of additional sleep disorders, including sleep-related movement disorders, narcolepsy, and certain parasomnias.¹² PSG tests are also used for titration of positive airway pressure and to assess the adequacy of ongoing therapy.¹¹,¹³  

PSG is conducted as a full-night study or split night study. A full night study involves monitoring the patient overnight, and if OSA is diagnosed, a return to the facility for PAP titration is sometimes necessary. A split-study involves monitoring of the patient’s sleep pattern for the first part of the night, and if OSA is diagnosed, PAP titration is initiated the second part of the night.⁴  

Home sleep apnea testing (HSAT) may be an appropriate, less stressful option for select patients with a high pretest probability of moderate to severe uncomplicated OSA, provided there is no suspicion of non-respiratory sleep disorders (e.g., narcolepsy, severe insomnia, parasomnias, movement disorders); no significant cardiorespiratory disease (e.g., COPD, asthma, CHF); they are not a mission-critical worker (e.g., airline pilot, bus driver, truck driver, astronaut); and a sleep expert is available to interpret the results.⁴,⁵,¹¹,¹⁴,¹⁵  

The most common HSAT devices currently used are classified as sleep monitoring devices of type 3 and type 4. Type 3 is preferred to type 4 because of the additional number of variables measured- four to seven versus one to three variables. The AASM considers home monitoring devices adequate when a minimum of the following sensors are included: nasal pressure, chest and abdominal respiratory inductance plethysmography, oximetry, or peripheral artery tone (PAT), actigraphy, oximetry.⁴,¹⁰,¹⁶  

Studies have demonstrated the validity of HSAT results when compared to facility-based PSG. They note high sensitivity and specificity in populations at high risk of moderate to severe OSA based on clinical symptoms and in the absence of significant comorbidities that affect sleep or non-respiratory sleep disorders.⁴,¹⁰,¹⁶  

Advantages of HSAT include the convenience of testing at home and cost effectiveness.¹⁰ The primary disadvantage of HSAT is that fewer physiologic variables are measured when compared with facility-based PSG, which can increase the likelihood for false-negative results. For most patients with suspected mild OSA, facility-based PSG is preferred since HSAT may lead to the under detection of sleep-related events in this population.⁴,¹⁰  

The standard of care for hypoglossal nerve stimulation (HNS) titration is a facility-based titration PSG, which is completed approximately three to six months after device activation and patient acclimation to the device. Titration PSG is essential to objectively assess device settings in order to calibrate stimulation strength to achieve both treatment efficacy and patient comfort.³⁶  

## Coding Implications  
  

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