![]() | Clinical UM Guideline |
| Subject: | Continuous Positive Airway Pressure (CPAP) and Auto-titrating Positive Airway Pressure (APAP) Devices | ||
| Guideline #: | CG-DME-32 | Current Effective Date: | 01/11/2012 |
| Status: | Revised | Last Review Date: | 11/17/2011 |
| Description |
This document addresses continuous positive airway pressure (CPAP) and auto-titrating positive airway pressure (APAP) devices for the treatment of obstructive sleep apnea (OSA) and upper airway resistance syndrome (UARS) in adults and CPAP for OSA in children.
For information related to other technologies utilized in the treatment and management of sleep-related disorders, please see:
| Clinical Indications |
A. FOR ADULTS:
Medically Necessary:
CPAP or APAP is considered medically necessary for the treatment of an individual with OSA who meets either of the following criteria:
CPAP is considered medically necessary for the treatment of an individual with UARS as defined by AHI (or RDI) less than 5 per hour but with more than 10 EEG arousals per hour associated with increased respiratory efforts (with or without concomitant observed snoring) and increased negative esophageal pressure (more negative than -10cms H2O).
Auto-CPAP (APAP) is considered medically necessary to determine a fixed level of CPAP (instead of lab or facility based titration).
Not Medically Necessary:
CPAP is considered not medically necessary when the criteria listed above for the use of CPAP are not met.
APAP is considered not medically necessary when the criteria listed above for the use of APAP are not met.
APAP is considered not medically necessary for the treatment of individuals with the following conditions:
The use of flexible positive airway pressure (PAP) devices, (such as C-Flex) is considered not medically necessary.
B. FOR CHILDREN
Medically Necessary:
CPAP for the treatment of OSA is considered medically necessary when the following criteria are met:
Not Medically Necessary:
CPAP is considered not medically necessary in children when the criteria listed above are not met.
APAP is considered not medically necessary for use in children.
C. COMPLIANCE MONITORING AND CONTINUED COVERAGE CRITERIA FOR POSITIVE AIRWAY PRESSURE DEVICES:
Medically Necessary:
Ongoing use of positive airway pressure devices is considered medically necessary when either of the following criteria are met:
Not Medically Necessary:
Ongoing use of positive airway pressure devices is considered not medically necessary when neither of the criteria in this section are met.
| Coding |
The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.
| HCPCS | |
| E0561 | Humidifier, non-heated, used with positive airway pressure device |
| E0562 | Humidifier, heated, used with positive airway pressure device |
| E0601 | Continuous airway pressure (CPAP) device [may be used for either CPAP or APAP] |
| E1399 | Durable medical equipment, miscellaneous [when specified as flexible devices (C-Flex)] |
| ICD-9 Diagnosis | |
| All diagnoses | |
| Discussion/General Information |
Sleep disorders are common and have a significant impact on quality of life, productivity, and health. There are many different types of sleep disorders including obstructive sleep apnea (OSA); upper airway resistance syndrome (UARS); insomnia; narcolepsy; nocturnal movement disorders, such as Restless Leg Syndrome (RLS) and Periodic Limb Movement Disorder (PLMD); unexplained excessive daytime sleepiness; and arousal disorders (parasomnias).
OSA is characterized by an interruption of breathing (known by the medical term, apnea) during sleep. It is thought that the apneas may occur due to extra or lax tissue in the upper airway that collapses into and obstructs the air passage with the effort of inhalation. This is often linked to obesity and decreased muscle tone due to aging. When the airway becomes blocked, a drop in blood oxygen content and a rise in the blood carbod dioxide content can occur. When this is detected by the brain, the individual may awaken just enough to tighten the airway muscles and allow breathing to then resume. This may occur several hundred times in one night. OSA can cause many symptoms, such as depression, irritability, sexual dysfunction, learning and memory difficulties, and falling asleep while at work or driving. OSA treatment is intended to alleviate or eliminate the occurrence of apnea during sleep. This, in turn, should allow the individual to achieve healthy sleep patterns and mitigate or eliminate the symptoms of OSA.
Upper airway resistance syndrome (UARS) is a very similar but less severe sleep disorder than OSA and is also characterized by airway resistance to breathing during sleep. However, the parameters used to determine severity in OSA (Apnea-Hypopnea Index [AHI] or Respiratory Disturbance Index [RDI] and oxygen saturation levels) are less severely affected in UARS than in OSA. The primary symptoms of UARS include daytime sleepiness and excessive fatigue. Untreated UARS can progress to the diagnosis of OSA.
Another type of sleep disturbance is simply known as apnea or central sleep apnea (CSA). This condition, caused by problems in the Central Nervous System, is unrelated to OSA and is not addressed in this document, except for reference to CSA as being considered a not medically necessary indication for APAP.
CPAP is the most common treatment for OSA in adults. During sleep, the individual wears a mask over the nose attached to an air compressor that forces air through the nasal passages, opening the back of the throat. In OSA, tissues in the upper airway, including the tongue, soft palate and nasal passages, sag and block the airway. The pressurized air in CPAP forces the tissues in the upper airway out of the way, allowing normal breathing to occur during sleep. Variations of the CPAP device, including auto-CPAP and BPAP (also frequently referred to as the branded device, BiPAP®), adjust the airflow to the needs of the individual. Some side effects that may occur include discomfort, nasal irritation and drying facial skin irritation, abdominal bloating, mask leaks, sore eyes, and headaches. CPAP prevents airway closure while in use, but apneic episodes (i.e., brief cessation of breathing) return when CPAP is stopped or if it is used improperly.
Currently, peer-reviewed medical literature supports the use of CPAP for the treatment of OSA and UARS in adults. Standard CPAP, and the variants (BPAP and Auto-CPAP) have been found in randomized controlled trials to be highly effective in decreasing, and in some cases eliminating, OSA events in individuals with mild to moderate OSA. Additionally, there is clinical trial evidence that CPAP and its variants may provide significant benefit to individuals suffering from restrictive lung disease and who demonstrate nocturnal oxygen desaturation (i.e., a drop in serum oxygen levels during sleep).
Auto-titrating continuous positive airway pressure (auto-CPAP or APAP) utilizes a device that continually adjusts the level of pressure, as needed, to maintain airway patency. It has been investigated, both as a means to establish the required level of therapeutic "fixed" CPAP for long-term use, (as an alternative to sleep laboratory, technician- titrated CPAP during a Type I polysomnography [PSG]), and as a long-term therapeutic alternative to fixed CPAP in adults. Auto-titration typically takes place unattended in the home over 1-7 days and has been promoted as obviating the need for a second PSG study for CPAP titration, should a split night study not be feasible, or for determining a fixed level of CPAP in individuals with OSA diagnosed by a portable home monitor.
The 2008 practice parameters for The Use of Auto-titrating CPAP Devices were published by the American Academy of Sleep Medicine (AASM), (Morgenthaler, 2008). Based on a literature review, the report recommends as an "option" that certain APAP devices may be used in an unattended way to determine a fixed CPAP treatment pressure for individuals with moderate to severe OSA without significant comorbidities, such as congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), CSA or hypoventilation syndromes.
Among the literature supporting this position are two randomized controlled trials, comparing outcomes in individuals with severe OSA and AHI greater than 30 (Masa, 2004) or with a high pre-test probability of moderate to severe OSA, including oxygen desaturation events measured at greater than 15 per hour (Mulgrew, 2007) where CPAP therapy was based on either standard CPAP titration or 1-7 days of APAP titration to determine a fixed CPAP level for ongoing treatment. At one year (Masa, 2004) and three months (Mulgrew, 2007), there were no significant differences between the two groups regarding AHI, Epworth sleepiness scale scores, quality of life measurements or CPAP levels. Additionally, a review on "Positive Pressure Therapy" in the Proceedings of the American Thoracic Society (Sanders, 2008) concluded that there is sufficient evidence to justify determination of a fixed CPAP level by means of home APAP in individuals with unequivocal symptomatic OSA without serious medical or psychiatric comorbidities, and who are educated as to the nature of OSA and its treatment.
As an ongoing therapeutic alternative to fixed CPAP, there is a theoretical advantage to APAP, based on the use of lower mean airway pressures and improved compliance. However, as reflected in the 2008 AASM document, most studies have not demonstrated improved compliance using auto-CPAP, nor have functional outcomes, (e.g., daytime sleepiness) been superior to those seen with fixed CPAP.
The Apnea Hypopnea Index (AHI) is equal to the average number of episodes of apnea and hypopnea per hour and must be based on a minimum of two hours of sleep recorded by PSG or Type II or III home portable monitors ([HPM] see CG-MED-01 for details about HPM devices) using actual recorded hours of sleep, (i.e., the AHI may not be extrapolated or projected). The prevalence of significant OSA in adults, as defined by an AHI (or Respiratory Disturbance Index [RDI]) of at least 5 associated with excessive daytime somnolence, has been demonstrated to be 4% in males and 2% in females in the 30 – 60 year old age group. However, the presence of snoring, hypertension or obesity in isolation does not carry sufficient predictive value to warrant a PSG in all individuals with these single complaints or conditions. Snoring alone is said to occur in up to 40% of the population, and this increases over the age of 50 years. For the purposes of this document, the terms AHI and RDI are interchangeable, although they may differ slightly in clinical use. In some cases, respiratory effort-related arousals (or RERAS) are included in the RDI value. RERA episodes represent EEG arousals associated with increased respiratory efforts but do not qualify as apneic or hypopneic episodes because of the absence of their defining air flow changes and/or levels of oxygen desaturation.
C-flex is a variation on CPAP that adjusts airway pressure during exhalation, keeping it low initially but increasing it towards end exhalation up to therapeutic CPAP levels, thereby preventing airway collapse, (which tends to occur towards end exhalation). It is speculated that this increases CPAP compliance based on improved comfort. Aloia conducted a small, non-randomized study demonstrating increased CPAP use (hours per night) at three months using the C-flex system, compared to standard CPAP. However, clinical outcomes were not significantly different. Additionally, there were flaws, in terms of user unblinding, (i.e., some knew they were using C-flex) and lack of use of C-flex technology to titrate that treatment group.
Compliance with treatment is both crucial for clinical improvement and sometimes difficult due to discomfort with positive airway pressure treatments. There are limited studies which assess the minimum duration of treatment which would be expected to produce meaningful clinical improvement. Weaver published the results of a multicenter study of individuals with severe OSA treated with CPAP (total cohort n = 149; the numbers of included participants ranged from 85 – 120, depending on outcome analyzed) which investigated outcomes prior to CPAP use and at three months after initiation of CPAP use. Significant differences in mean nightly CPAP duration of use between treatment responders and nonresponders was noted across outcomes. Thresholds above which further improvements were less likely relative to nightly duration of CPAP use were identified for Epworth Sleepiness Scale score (4 hours), Multiple Sleep Latency Test (6 hours), and Functional Outcomes associated with Sleepiness Questionnaire (7.5 hours). A linear dose-response relationship (P < 0.01) between increased use and normal levels achieved was shown for objective and subjective daytime sleepiness, but only up to 7 hours use for functional status. It was also noted that even among those subjects using CPAP for more than 7 hours per night, there was a significant proportion that remained excessively sleepy despite what appears to be optimal therapy, i.e., that had residual sleepiness. Individuals who used CPAP for less than 4 hours were less likely to demonstrate clinical improvement, however, 41% demonstrated improvement in ESS with as little as 2 hours of use per night. The basis for such incongruities between CPAP use and achieving normal levels of sleepiness and function at both ends of the spectrum of adherence remain to be explained. The authors concluded that a greater percentage of subjects will achieve normal functioning with longer nightly CPAP duration of use, however, what constitutes adequate use varies between individuals and outcomes (Weaver, 2007).
In children, both the clinical presentation and criteria for the diagnosis of OSA differ from those in adults, hence adult criteria for diagnosis and treatment cannot be applied to the pediatric population. Although PSG is required for the diagnosis of OSA in children, it has not been well standardized in its performance or interpretation. The International Classification of Sleep Disorders, Second Edition Guidelines for the Diagnosis of Pediatric OSA require an AHI of at least one (1) scorable respiratory event lasting at least two (2) respiratory cycles (Hoban, 2007). However, Schechter (2002), reporting for the American Academy of Pediatrics and others, notes that, while this value of one (1) is of statistical significance based on normative data, it is unclear what level of AHI is of clinical significance or is associated with the development of adverse health outcomes.
OSA occurs most commonly in preschool aged children when the tonsils and adenoids are the largest, in relation to the airway size. For this reason, adenotonsillectomy (AT) is generally recognized as the most appropriate first-line treatment of choice for childhood OSA (Benninger, 2007; Darrow, 2007; Hoban, 2007; Marcus, 2002). Success rates for AT in relieving OSA have been reported to be in the 75%-85% range, although lower rates have been reported in other studies, and Tauman (2006) reported a reduction in AHI to one (1) or less (i.e., complete resolution of OSA) in only 25% of 110 children, with obesity being associated with the lesser rates of success. For children whose OSA has failed to resolve following AT, or who have a condition not amenable to AT (e.g., craniofacial anomaly as the primary underlying cause of OSA), or where AT is contraindicated, CPAP has been shown to be effective therapy with success rates in the 74%-97% range (Hoban, 2007). However, as reported in a small study of 29 individuals (Marcus, 2006), adherence to CPAP therapy may be suboptimal in the pediatric age group.
| References |
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
| Web Sites for Additional Information |
| Index |
Apnea/Hypopnea Index (AHI)
APAP
C-flex
Obstructive Sleep Apnea (OSA)
OSA
Upper Airway Resistance Syndrome
UARS
The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.
| History |
| Status | Date | Action |
| Revised | 11/17/2011 | Medical Policy & Technology Assessment Committee (MPTAC) review. The criteria for use of BPAP were removed and added to CG-DME-27. The medically necessary criteria for APAP were revised to consider medically necessary as a first line treatment of OSA when criteria are met. Criteria for compliance monitoring were added. The not medically necessary statement and criteria for APAP regarding need for presence of snoring in OSA were removed. A not medically necessary statement was added for APAP use in children. The Background and References were updated. |
| Reviewed | 05/19/2011 | MPTAC review. No change to criteria. The References were updated. |
| 10/01/2010 | Updated Coding section with 10/01/2010 ICD-9 changes. | |
| Reviewed | 05/13/2010 | MPTAC review. No change to criteria. References were updated. |
| Reviewed | 05/21/2009 | MPTAC review. No change to criteria. References were updated. |
| Revised | 05/15/2008 | MPTAC review. Added medically necessary criteria for the use of auto-CPAP (APAP) as an alternative to technician-titrated CPAP for individuals with obstructive sleep apnea. Discussion and Reference sections were also updated. |
| Revised | 02/21/2008 | MPTAC review. Clinical UM guideline has been revised to add medical necessity criteria for pediatric applications for CPAP. The title was changed from Continuous Positive Airway Pressure (CPAP) and Related Devices for the Treatment of Obstructive Sleep Apnea in Adults to: Continuous Positive Airway Pressure (CPAP) for the Treatment of Obstructive Sleep Apnea in Adults and Children and Related Devices for the Treatment of Obstructive Sleep Apnea in Adults. References were also updated. |
| New | 08/23/2007 | MPTAC review. Initial Clinical UM Guideline development. (The medical necessity criteria for use of CPAP and related devices was split off MED.00054 [Treatment for Obstructive Sleep Apnea in Adults] and placed in this new Clinical UM Guideline.) |
| Pre-Merger Organizations: | Last Review Date | Document Number | Title |
| Anthem, Inc. | 11/07/2000 | MED.00002 | Diagnosis of Sleep Disorders and Treatment of Obstructive Sleep Apnea |
| WellPoint Health Networks, Inc. | 09/23/2004 | Clinical Guideline | Clinical Guidelines: CPAP, BiPAP, AUTO-PAP, and Oral Appliances for Treatment of OSA in Adults |