Disclaimer

Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract.  Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage.  Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.

Description

Policy

Policy Guidelines

Benefit Application

Rationale

As described in Cochrane reviews from 2006, treatment of obstructive sleep apnea (OSA) with continuous positive airway pressure (CPAP) or oral appliances has been shown to improve objective and subjective symptoms in patients with obstructive sleep apnea. (3, 4) This revised policy focuses, therefore, on patient selection criteria for polysomnography or sleep study, and the use of home sleep studies as an alternative to a supervised laboratory study. In addition, the use of auto-adjusting CPAP (APAP) or bilevel positive airway pressure (BPAP) in patients with OSA is reviewed.

Definition of Clinically Significant OSA

The original rationale for the diagnosis and treatment of OSA was based on epidemiologic studies that suggested increased mortality in patients with an apneic index greater than 20. However, considering that an apneic/hypopnea index (AHI) of 5 is considered normal, there is obviously a great range of severity of OSA, ranging from those with only snoring as a complication to those with associated severe excessive daytime sleepiness, hypertension, or cardiac arrhythmias. If OSA is considered mild to moderate and snoring is the only manifestation, an intervention would be considered not medically necessary. For example, pronounced snoring may be considered predominantly a social annoyance to the patient's bed partner with no impact on the patient him/herself.

Attended polysomnography (PSG) has been considered to be the gold standard in the diagnosis and treatment of OSA. In 2007, the Agency for Healthcare Research and Quality (AHRQ) conducted a technology assessment on portable monitoring for the Medicare Evidence Development and Coverage Committee (MedCAC). (5)

The report concluded:

• Baseline AHI (or other indices obtained from sleep studies) is only modestly associated with response to CPAP or CPAP use among people with high (pre-test) probability for obstructive sleep apnea-hypopnea syndrome. None of the eligible studies assessed hard clinical outcomes (i.e., mortality, myocardial infarctions, strokes, and similar outcomes).
• Based on limited data, type 2 monitors may identify AHI suggestive of obstructive sleep apnea-hypopnea syndrome with high positive likelihood ratios (> 10) and low negative likelihood ratios (< 0.1) both when the portable monitors were studied in the sleep laboratory and at home.
• Type 3 monitors may have the ability to predict AHI suggestive of obstructive sleep apnea-hypopnea syndrome with high positive likelihood ratios and low negative likelihood ratios compared to laboratory-based PSG, especially when manual scoring is used. The ability of type 3 monitors to predict AHI suggestive of obstructive sleep apnea-hypopnea syndrome appears to be better in studies conducted in the specialized sleep unit compared to studies in the home setting.
• Studies of type 4 monitors that record at least 3 bioparameters showed high positive likelihood ratios and low negative likelihood ratios. Studies of type 4 monitors that record 1 or 2 bioparameters also had high positive likelihood ratios and low negative likelihood ratios, at least for selected sensitivity and specificity pairs from ROC curve analyses. Similarly to type 3 monitors, the ability of type 4 monitors to predict AHI suggestive of obstructive sleep apnea-hypopnea syndrome appears to be better in studies conducted in specialized sleep units.
• Patients older than the studied subjects (the median average age was approximately 50 years in the analyzed studies) may have more comorbidities that affect sleep (i.e., non- obstructive sleep apnea-hypopnea syndrome conditions such as cardiac insufficiency; chronic obstructive pulmonary disease; obesity hypoventilation syndrome; or periodic limb movements in sleep and restless leg syndrome). These conditions may be misdiagnosed if the sleep monitors do not record channels necessary for differential diagnosis from obstructive sleep apnea-hypopnea syndrome.
• For studies in the home setting, there are no direct data on whether and to what extent technologist support and patient education affect the comparison of portable monitors with facility-based PSG.
• Overall, manual scoring or manual editing of automated scoring seems to have better agreement with facility-based PSG. The automated scoring algorithms may vary across different monitors, or even with the specific software version or settings. Thus, their ability to recognize respiratory events may differ.
• Signal loss was more often observed in home studies, and 1 study associated discrepancies in the AHI measurement with poor quality airflow signals in the unattended home-based recordings.
  

The AHRQ report addressed the available literature through February 2007, and a supplemental search of the MEDLINE database was performed for the period of March 2007 through December 2007.

Evidence at this time suggested that portable monitoring could potentially provide an effective alternative to PSG for evaluating patients suspected of having OSA. There were, however, a number of limitations with available devices and procedures. First, there was no standardization of recording and scoring parameters for the monitoring devices that are available. A variety of scoring algorithms had been used, and the appropriate screening and cutoff values for each device had not been established. For example, in a study by Bridevaux and coworkers, 88 ambulatory sleep recordings were independently scored by 8 physicians. (6) Intraclass correlation coefficients were 0.73 for AHI, 0.71 for hypopnea index, and 0.98 for desaturation index. Automated analysis was found to underestimate AHI by an average of 5.1 events. The authors concluded that in a clinical setting, agreement on AHI was limited, and that efforts should be directed toward standardization of visual analysis and improvement and quality control of ambulatory sleep studies. Questions also remained about the reliability of unattended automated recordings and about the expertise of the medical personnel who might request, assist, and interpret the home sleep studies. Therefore, use of type 3 and type 4 portable monitoring devices for the diagnosis of OSA was considered investigational; the policy statements were unchanged.

In 2008, the Centers for Medicare and Medicaid services (CMS) implemented a national coverage decision allowing an initial 12-week period of CPAP based on a clinical evaluation and a positive sleep test performed with either an attended PSG performed in a sleep laboratory or an unattended home sleep test with a device that measures at least 3 channels. (7) Previously, coverage for CPAP required determination of AHI from attended PSG in a sleep laboratory, effectively establishing PSG-defined AHI as the only acceptable measure of OSA. As indicated in the AHRQ report, there is a poor correlation between AHI and daytime sleepiness, as well as between improvement in AHI and improvement of symptoms with CPAP usage. In addition, effectiveness of CPAP is affected by tolerance to the device (mask and airway pressure) and ultimately by compliance with treatment. These issues raise the question of whether PSG-defined AHI and manual titration of CPAP should remain the only means for diagnosis and treatment of OSA. Therefore, this update evaluates the literature on the clinical utility of portable monitoring devices to identify patients with a high likelihood of benefit from treatment, without increasing potential harm from misdiagnosis.

Mulgrew et al published a randomized validation study of the diagnosis and management of OSA with a single channel monitor followed by APAP. (8) They developed a diagnostic algorithm (Epworth Sleepiness Scale score greater than 10, Sleep Apnea Clinical Score of 15 or greater, and a respiratory disturbance index [RDI] of 15 or over on overnight oximetry) that was found to have a 94% positive predictive value for moderate to severe OSA assessed by PSG. Patients who passed the screening (n = 68) were randomized to either attended in-laboratory PSG with CPAP titration or to home monitoring with a portable APAP unit. Home monitoring consisted of autotitration for 1 week, followed by download and assessment of efficacy data for the week (i.e., CPAP, mask leak, residual respiratory events, and use) and determination of the pressure for CPAP by the study physician. A second assessment of efficacy data was conducted for a week of CPAP use, and the pressure setting was adjusted by the CPAP coordinator in conjunction with the study physician. After 3 months of CPAP use the subjects returned to the laboratory for PSG (with CPAP); no difference was observed between lab-PSG and home-managed patients in any of the outcome measures (median AHI of 3.2 vs. 2.5, median Epworth Sleepiness Scale of 5.0 vs. 5.0 and Sleep Apnea Quality of Life Index of 5.5 vs. 5.8). Another study assessed the clinical utility of home oximetry in comparison with PSG by measuring the accuracy with which sleep physicians could predict which patients would benefit from treatment of OSA. (9) The primary outcome measure was the change in sleep apnea-specific quality of life after treatment. Subjects were randomly selected from a pool of referred patients; 307 were randomized, and 288 began a trial of CPAP. An additional 51 patients (18%) quit before the end of the 4 week CPAP trial; 31 indicated that they had trouble sleeping with CPAP, 3 removed the mask in their sleep, and 2 had nasal or sinus congestion. Overall, physicians predicted success in 50% of patients and 42% met the criterion for improvement. Outcomes of treatment were similar in the two groups, with improvements in Epworth Sleepiness Scale scores of 3.4 for home monitoring and 4.0 for PSG. The ability of physicians to predict the outcome of treatment was similar for the two methods. Five cases (2%) required PSG for diagnosis of other nonrespiratory sleep disorders (narcolepsy, periodic leg movements, and idiopathic hypersomnolence).

Senn and colleagues assessed whether an empiric approach, using only a 2-week trial of APAP, could be effective for the diagnosis of OSA. (10) Patients (n =76) were included in the study if they had been referred by primary care physicians for evaluation of suspected OSA, were habitual snorers, complained of daytime sleepiness, and had an Epworth Sleepiness Scale score of 8 or greater (mean of 13.6). Exclusion criteria were contraindications to CPAP or APAP (congestive heart failure, lung disease, obesity, hypoventilation syndrome), previous diagnosis or treatments of a sleep disorder, or a diagnosis of an internal medical, neurologic, or psychiatric disorder explaining the symptoms. At the end of the 2-week trial patients were asked to rate the perceived effect of treatment and to indicate whether they had used CPAP for more than 2 hours per night and were willing to continue treatment. Patients without a clear benefit of CPAP received further evaluation including clinical assessment and PSG. Compared with PSG, patient responses showed sensitivity of 80%, specificity of 97%, and positive and negative predictive values of 97% and 78%, respectively.

In a company sponsored study, Berry and colleagues randomized 106 patients who had been referred for a sleep study for suspected OSA at a local Veterans Administration center to portable monitoring followed by APAP (PM-APAP) or to PSG for diagnosis and treatment. (11) Patients were screened with a detailed sleep and medical history questionnaire including an Epworth Sleepiness Scale. To be included in the study patients had to have an Epworth Sleepiness Scale score of 12 or greater and the presence of at least 2 of the following: loud habitual snoring, witnessed apnea/gasping, or treatment for hypertension. Patients on alpha-blockers or not in sinus rhythm were excluded due to the type of portable monitoring device used (Watch PAT 100), which records sympathetic changes in peripheral arterial tone, heart rate, pulse oximetry, and actigraphy. Also excluded were patients with moderate-to-severe congestive heart failure, use of nocturnal oxygen, chronic obstructive pulmonary disease, awake hypercapnia, neuromuscular disease, cataplexy, restless leg syndrome, use of narcotics, psychiatric disorder, shift work, or a prior diagnostic study or treatment. Of the 53 patients randomized to PSG, 6 (11%) did not have PSG-defined OSA; 43 of 49 patients (88%) with CPAP titrations started on CPAP. In the portable monitoring arm, 4 of 53 patients (8%) were found not to have OSA. A physician affiliated with the sleep research laboratory reviewed the tracings for technical quality to determine if the events were correctly identified by the analysis program. Four studies (8%) were repeated due to technical failure or insufficient sleep. Patients with negative studies were then crossed over, which identified an additional 2 patients from the PSG arm as having OSA and 1 patient from the PM arm as having OSA. These patients (total of 50) had at least 1 APAP titration, 45 of the 50 (90%) had an adequate APAP titration and accepted treatment. Adherence was similar in the two groups, with 91% of patients in the PSG arm and 89% of patients in the PM-APAP arm continuing treatment at 6 weeks. Treatment outcomes were similar in the two groups, with a 7-point improvement in Epworth Sleepiness Scale score, 3-point improvement in the Functional Outcomes of Sleep Questionnaire, and a machine estimate of residual AHI of 3.5 in the PM-APAP group and 5.3 in the PSG group.

Garcia-Diaz and colleagues assessed the sensitivity and specificity of home respiratory polygraphy and actigraphy to diagnose OSA in relation to laboratory PSG. (12) The cohort consisted of 65 consecutive patients referred to the sleep laboratory for PSG because of suspected OSA. Using an AHI cutoff of 15 or more, 2 independent evaluators were found to identify PSG-defined OSA in 90% to 92% of the patients (sensitivity of 84%–88% and specificity of 97%). Analysis of data from the Swiss respiratory polygraphy registry found that in patients selected for portable monitoring (based on high clinical suspicion of OSA by licensed pulmonary physicians by a combination of hypersomnia, snoring, or observed apneas), confirmation or exclusion of sleep disordered breathing was possible in 96% of the 8,865 diagnostic sleep studies. (13) From these type 3 studies (4 channels including airflow and respiratory movement, heart rate or ECG, and oxygen saturation), 3.5% were not conclusive and required additional PSG.

BiPAP and APAP

A 1995 study by Reeves-Hoche et al randomized patients with OSA to receive either CPAP or BiPAP. (14) The authors found that patient complaints and effective use were similar in both groups but that the dropout rate was significantly higher in the CPAP group. This study suggests that BiPAP should be limited to those patients who have failed a prior trial of CPAP. Evidence-based guidelines from the American Academy of Sleep Medicine concluded that CPAP and APAP devices have similar outcomes in terms of AHI, oxygen saturation, and arousals. (15-18) However, increased compliance with APAP devices has not been well documented in clinical trials (19-21). Thus the issues associated with APAP are similar to BiPAP; i.e., APAP may be considered medically necessary in patients who have failed a prior trial of CPAP. In addition to the studies (described previously) that used unattended APAP devices to titrate CPAP pressure, 2007 American Academy of Sleep Medicine (AASM) practice parameters on autotitration identified 5 randomized trials supporting the use of unattended APAP to determine a fixed CPAP treatment pressure for patients with moderate to severe OSA without significant comorbidities affecting respiration. (18) This new practice parameter was considered an option (uncertain clinical use), with automatic titration or treatment requiring close clinical follow-up (standard). The practice parameters for the use of APAP issued by the American Academy of Sleep Medicine point out that results may vary with different APAP devices based on different underlying technologies, and thus caution must be exercised in selecting a particular device for use. (15-18)

Atrial Pacing

Because of the bradycardia that is noted during episodes of apnea, atrial pacing has been studied as a treatment for sleep apnea. A study by Simantirakis (22) compared pacing to CPAP and a study by Krahn (23) compared pacing to no treatment. In neither study was an effect seen on the AHI for those treated with pacing. Thus, this is considered investigational.

Physician Specialty Society and Academic Medical Center Input

In response to requests, input was received from 5 physician specialty societies (6 reviewers) and 3 academic medical centers while this policy was under review. While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted. Professional society guidelines and position statements were also reviewed. In general, the input supported the use of polysomnography, portable sleep monitoring tests, multiple sleep latency test, and CPAP for adults as described in the policy. The 2009 update includes reviewer’s recommendations for clarifications and modifications to the policy statements.

Summary

Current literature indicates that evaluation of OSA should be by clinical evaluation and overnight monitoring, either by attended PSG or by portable unattended home monitoring under qualified supervision, and that this may be followed by a trial of APAP to evaluate efficacy and adjust pressure.

• Portable monitoring should only be conducted in patients with a high pretest probability of OSA and absence of comorbid conditions as determined by clinical evaluation.
• A positive study with at least 3 channels of recording (e.g., arterial oxygen saturation, airflow, respiratory effort, or heart rate) has a high positive predictive value for OSA and can be used as the basis for a CPAP trial to determine efficacy of treatment.
• A negative study cannot be used to rule out OSA. Patients who have a negative result from portable monitoring or who do not respond to CPAP should undergo further evaluation.
• Due to the probability of artifacts or loss of data, raw data from the portable monitoring device should be reviewed by a sleep specialist. Follow-up and review of the APAP trial is also needed.
  

Although evidence indicates that portable monitoring can be a safe and effective method to evaluate OSA, the variety of portable monitoring devices available and the lack of standardization remains problematic. Additional study is needed to determine the most reliable types of devices and combinations of sensors. Questions also remain about the specific training of the medical personnel required to diagnose OSA without increasing risk of misdiagnosis. Based on the current evidence, use of portable monitoring may be considered medically necessary in patients considered to be at high risk for OSA, with clinical evaluation and follow-up conducted by a medical professional experienced in the diagnosis and treatment of sleep disorders.

Professional Society Guidelines and Position Statements

The patient selection criteria for a polysomnogram or sleep study require an estimate of the pretest probability of OSA, based on the signs and symptoms of OSA. Ideally, one would like to know the necessity of a polysomnogram (i.e., with EEG) versus a sleep study (without EEG). A detailed analysis of these issues is beyond the scope of this policy. However, in 1997 the American Sleep Disorders Association (now the American Academy of Sleep Medicine, or AASM) published practice parameters for polysomnography and related procedures; these were most recently updated in 2005. (2, 24) The guidelines suggested that patients had a 70% likelihood of having an AHI index of at least 10 if all of the following were present: habitual snoring, excessive daytime sleepiness, a body mass index greater than 35, and observed apneas. In 2005, full-night PSG was recommended for the diagnosis of sleep-related breathing disorders and for PAP titration in patients with an RDI of at least 15 per hour, or with an RDI of at least 5 per hour in a patient with excessive daytime sleepiness. (1) For patients in the high-pretest-probability stratification group, an attended cardiorespiratory sleep study (type 3 with respiratory effort, airflow, arterial oxygen saturation, and ECG or heart rate) was considered an acceptable alternative to full-night PSG, provided that repeat testing with full-night PSG was permitted for symptomatic patients who had a negative cardiorespiratory sleep study finding. Guidelines from the American Academy of Sleep Medicine stated that data were insufficient to support unattended portable sleep studies, but they might be considered acceptable when the patient has severe symptoms requiring immediate treatment and polysomnography is not available, the patient cannot be studied in a sleep laboratory (i.e., nonambulatory), or for follow-up studies to evaluate response to therapy. (2, 25) The document further stated that, in these patients, a sleep study may be an acceptable alternative to polysomnography. However, a sleep study may only “rule in” disease, and polysomnography should be available for patients with false negative sleep study results. An additional recommendation of note is that sleep studies were not recommended in patients with comorbid conditions or secondary sleep complaints. Most of the literature reviewed specifically excluded patients with comorbid conditions. A cardiorespiratory sleep study without EEG recording was not recommended for CPAP titration, as sleep staging was considered necessary. Finally, practice parameters stated that a multiple sleep latency test is not routinely indicated for most patients with sleep-related breathing disorders.

Evidence-based guidelines on BiPAP, APAP, and dental appliances have been published by the AASM. (15-18, 26) There was moderate clinical certainty that BiPAP was appropriate as an optional therapy in some cases where high pressure is needed and the patient experiences difficulty exhaling against a fixed pressure or coexisting central hypoventilation present. (17) APAP was not recommended to diagnose OSA, for split-night studies, or for patients with congestive heart failure, significant lung disease such as chronic obstructive pulmonary disease, patients expected to have nocturnal arterial oxyhemoglobin desaturation due to conditions other than OSA (e.g., obesity hypoventilation syndrome), patients who do not snore, and patients who have central sleep apnea syndromes. (18) Unattended APAP in patients without significant comorbidities was considered an option (uncertain clinical use). The guidelines indicated that patients being treated on the basis of APAP titration must have close clinical follow-up to determine treatment effectiveness and safety, especially during the first few weeks of PAP use, and a re-evaluation and, if necessary, a standard CPAP titration should be performed if symptoms do not resolve or if the APAP treatment otherwise appears to lack efficacy.

Portable monitoring (PM) devices were addressed by a joint project of the American Academy of Sleep Medicine, the American Thoracic Society, and the American College of Chest Physicians in 2003. (27, 28) In 2007 the AASM issued revised guidelines for the use of unattended portable monitors, recommending that portable monitors should minimally record airflow, respiratory effort, and blood oxygenation, with biosensors conventionally used for in-laboratory PSG, and that testing be performed by an experienced sleep technologist and scored by a board certified sleep medicine specialist under the auspices of an AASM-accredited comprehensive sleep medicine program. (29)

The American Academy of Pediatrics (AAP) published a 2002 guideline on the diagnosis and management of uncomplicated childhood OSA associated with adenotonsillar hypertrophy and/or obesity in an otherwise healthy child treated in the primary care setting; complex high-risk patients should be referred to a specialist. (30) The AAP guidelines stated that diagnostic evaluation is useful in discriminating between primary snoring and OSA; although the gold standard is PSG, other diagnostic tests may be useful if results are positive; adenotonsillectomy is the first line of treatment for most children, and continuous positive airway pressure is an option for those who are not candidates for surgery or do not respond to surgery; patients should be reevaluated post-operatively to determine whether additional treatment is required.

In 2008 the United Kingdom’s National Institute for Health and Clinical Excellence (NICE) issued guidance on CPAP treatment of OSA, based on a review of the literature and expert opinion. (30) The recommendations included:

• Moderate to severe OSAHS can be diagnosed from patient history and a sleep study using oximetry or other monitoring devices carried out in the person’s home. In some cases, further studies that monitor additional physiological variables in a sleep laboratory or at home may be required, especially when alternative diagnoses are being considered. The severity of OSAHS is usually assessed on the basis of both severity of symptoms (particularly the degree of sleepiness) and the sleep study, by using either the apnea/hypopnea index (AHI) or the oxygen desaturation index. OSAHS is considered mild when the AHI is 5–14 in a sleep study, moderate when the AHI is 15–30, and severe when the AHI is over 30. In addition to the AHI, the severity of symptoms is also important.
• Continuous positive airway pressure (CPAP) is recommended as a treatment option for adults with moderate or severe symptomatic obstructive sleep apnea/hypopnea syndrome (OSAHS). CPAP is only recommended as a treatment option for adults with mild OSAHS if: they have symptoms that affect their quality of life and ability to go about their daily activities, and lifestyle advice and any other relevant treatment options have been unsuccessful or are considered inappropriate.
• Treatments aim to reduce daytime sleepiness by reducing the number of episodes of apnea/hypopnea experienced during sleep. The alternatives to CPAP are lifestyle management, dental devices and surgery. Lifestyle management involves helping people to lose weight, stop smoking and/or decrease alcohol consumption. Dental devices are designed to keep the upper airway open during sleep. The efficacy of dental devices has been established in clinical trials, but these devices are traditionally viewed as a treatment option only for mild and moderate OSAHS. Surgery involves resection of the uvula and redundant retrolingual soft tissue. However, there is a lack of evidence of clinical effectiveness, and surgery is not routinely used in clinical practice.
• The diagnosis and treatment of OSAHS, and the monitoring of the response, should be carried out by a specialist service with appropriately trained medical and support staff.
• The Committee discussed the use of CPAP therapy for children and adolescents with OSAHS. The Committee heard that OSAHS is less common among children than in adults and that the clinical issues and etiology in children are different from those encountered in adults. The Committee concluded that the recommendations for CPAP should apply only to adults with OSAHS.
  

Medicare National Coverage

The use of CPAP devices are covered under Medicare when ordered and prescribed by the licensed treating physician to be used in adults with OSA (obstructive sleep apnea) if either of the following criteria using the Apnea-Hypopnea Index (AHI) or Respiratory Distress Index (RDI) are met:

• AHI or RDI >/= 15 events per hour, or
• AHI or RDI between 5 and 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 or RDI is equal to the average number of episodes of apnea and hypopnea per hour and must be based on a minimum of 2 hours of sleep using actual recorded number of hours of sleep (i.e., the AHI or RDI may not be extrapolated or projected). Apnea is defined as a cessation of airflow for at least 10 seconds. Hypopnea is defined as an abnormal respiratory event lasting at least 10 seconds with at least a 30% reduction in thoracoabdominal movement or airflow as compared to baseline, and with at least a 4% oxygen desaturation.

In 2001, the Centers for Medicare and Medicaid Services (CMS, formerly HCFA), published a decision memorandum for CPAP that addressed the issue of how to define moderate to severe OSA as a guide to a coverage policy for CPAP. This review of the literature suggested that there is a risk of hypertension with an AHI greater than 15, and thus treatment is warranted for these patients without any additional signs and symptoms. For patients with an AHI between 5 and 15 and associated symptoms, the CMS document concluded that the data from 3 randomized controlled trials demonstrated improved daytime somnolence and functioning in those treated with CPAP.

In 2008, CMS expanded coverage of CPAP to include those beneficiaries with a diagnosis of OSA made with a combination of a clinical evaluation and unattended home sleep monitoring using a device with at least 3 channels. (7) The coverage of CPAP would initially be limited to a 12-week period to identify beneficiaries diagnosed with OSA who benefit from CPAP. This is a change from prior coverage, which specified that polysomnography must be performed in a facility-based sleep study laboratory, and not in a home or a mobile facility. CMS defines AHI as the average number of episodes of apnea and hypopnea per hour of sleep, while the RDI is equal to the average number of respiratory disturbances per hour of continuous monitoring. There is variability in the published medical literature about the definition of the events that constitute a respiratory disturbance, and for the purposes of this national coverage decision, a respiratory disturbance is defined in the context of the sleep test technology of interest and, for portable monitoring devices that do not measure AHI or RDI directly, does not require direct measurement of airflow. (31)

Effective for claims with dates of service on and after March 13, 2008, CMS determines that CPAP therapy when used in adult patients with OSA is considered reasonable and necessary under the following situations:

• The use of CPAP is covered under Medicare when used in adult patients with OSA. Coverage of CPAP is initially limited to a 12-week period to identify beneficiaries diagnosed with OSA as subsequently described who benefit from CPAP. CPAP is subsequently covered only for those beneficiaries diagnosed with OSA who benefit from CPAP during this 12-week period.
• The provider of CPAP must conduct education of the beneficiary prior to the use of the CPAP device to ensure that the beneficiary has been educated in the proper use of the device. A caregiver, for example a family member, may be compensatory, if consistently available in the beneficiary's home and willing and able to safely operate the CPAP device.
• A positive diagnosis of OSA for the coverage of CPAP must include a clinical evaluation and a positive:
  • attended PSG performed in a sleep laboratory; or
  • unattended home sleep test with a type II home sleep monitoring device; or
  • unattended home sleep test with a type III home sleep monitoring device; or
  • unattended home sleep test with a type IV home sleep monitoring device that measures at least 3 channels.
• The sleep test must have been previously ordered by the beneficiary’s treating physician and furnished under appropriate physician supervision.
• An initial 12-week period of CPAP is covered in adult patients with OSA if either of the following criteria using the AHI are met:
  • AHI greater than or equal to 15 events per hour, or
  • AHI greater than or equal to 5 events 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 calculated on the average number of events of per hour. If the AHI is calculated based on less than 2 hours of continuous recorded sleep, the total number of recorded events to calculate the AHI during sleep testing must be at minimum the number of events that would have been required in a 2-hour period.
• Apnea is defined as a cessation of airflow for at least 10 seconds. Hypopnea is defined as an abnormal respiratory event lasting at least 10 seconds with at least a 30% reduction in thoracoabdominal movement or airflow as compared to baseline, and with at least a 4% oxygen desaturation.
• Coverage with Evidence Development: Medicare provides the following limited coverage for CPAP in adult beneficiaries who do not qualify for CPAP coverage based on criteria 1–7 cited here. A clinical study seeking Medicare payment for CPAP provided to a beneficiary who is an enrolled subject in that study must address one or more of the following questions
  • In Medicare-aged subjects with clinically identified risk factors for OSA, how does the diagnostic accuracy of a clinical trial of CPAP compare with PSG and types II, III, and IV home sleep test in identifying subjects with OSA who will respond to CPAP?
  • In Medicare-aged subjects with clinically identified risk factors for OSA who have not undergone confirmatory testing with PSG or types II, III, and IV home sleep test, does CPAP cause clinically meaningful harm?
    

In March 2009, CMS issued the following national coverage decision (CAG-00405N) for the types of sleep testing devices that would be approved for coverage. (32)

CMS 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:

• 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.
• A type II or type III sleep testing device is 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.
• A type IV sleep testing device measuring three or more channels, one of which is airflow, is 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.
• A sleep testing device measuring three or more channels that include actigraphy, oximetry, and peripheral arterial tone is 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.

References:

Index

Policy History