This Clinical UM Guideline addresses the indications for continuous positive airway pressure (CPAP) and related devices for the treatment of obstructive sleep apnea (OSA) and upper airway resistance syndrome (UARS) in adults and indications for CPAP in children.  

Note: For the purposes of this document, the terms apnea hypopnea index (AHI) and respiratory disturbance index (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.

For information related to other technologies utilized in the treatment and management of sleep-related disorders, please see:

• MED.00002 Diagnosis of Sleep Disorders;
• MED.00054 Treatment for Obstructive Sleep Apnea in Adults;
• SURG.00074 Nasal Surgery for the Treatment of Obstructive Sleep Apnea (OSA) (including Radiofrequency Ablation of Nasal Turbinates for Nasal Obstruction with or without OSA);
• Clinical UM Guideline CG-MED-01 Polysomnography Studies in Adults and Children;
• Clinical UM Guideline CG-DME-27 Non-invasive Positive Pressure Respiratory Assist Devices (BiPAP^®).

FOR ADULTS:

Medically Necessary: 

Continuous positive airway pressure (CPAP) for the treatment of obstructive sleep apnea (OSA) is considered medically necessary for patients who meet either of the following criteria on polysomnography:

1. Apnea Hypopnea Index (AHI) or a Respiratory Disturbance Index (RDI) greater than or equal to 15 events per hour; OR
2. AHI (or RDI) greater than or equal to 5, and less than 15 events per hour with documentation demonstrating any of the following symptoms:
   • Excessive daytime sleepiness, as documented by either a score of greater than 10 on the Epworth Sleepiness scale or inappropriate daytime napping, (e.g., during driving, conversation or eating) or sleepiness that interferes with daily activities; or
   • Impaired cognition or mood disorders; or
   • Hypertension; or
   • Ischemic heart disease or history of stroke; or
   • Cardiac arrhythmias; or
   • Pulmonary hypertension.

Note:  The 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 polysomnography using actual recorded hours of sleep, (i.e., the AHI may not be extrapolated or projected).

 Continuous Positive Airway Pressure (CPAP) is considered medically necessary for the treatment of:

• obstructive sleep apnea meeting the above criteria; or
• upper airway resistance syndrome (UARS) as defined by AHI (or RDI) less than 5/hr but with more than 10 EEG arousals/hr associated with increased respiratory efforts (with or without concomitant observed snoring) and increased negative esophageal pressure (more negative than -10cms H2O).

Bilevel Positive Airway Pressure (BiPAP^®) is considered medically necessary when used by patients diagnosed with obstructive sleep apnea (OSA) or upper airway resistance syndrome (UARS) when CPAP has failed.

Note:  Please refer to CG-DME-27 Non-invasive Positive Pressure Respiratory Assist Devices (BiPAP^®) for the medical necessity criteria for BiPAP.

Failed CPAP is defined as any of the following criteria documented in the medical record:

• Claustrophobia; or
• Inability to breathe through the nose; or
• Pain or discomfort; or
• Patient intolerance; or
• Patients at high pressures of CPAP (>10 cm H20) complaining of pressure discomfort.

Auto-CPAP (APAP) is considered medically necessary when used as an alternative to technician-titrated CPAP to determine a fixed level of CPAP in patients with documented moderate to severe obstructive sleep apnea, (AHI greater than or equal to 15) without significant medical comorbidities (e.g., CHF, COPD, central sleep apnea, hypoventilation syndromes).

Auto-CPAP (APAP) is considered medically necessary as a second or third line alternative therapy for obstructive sleep apnea when documentation of the following is available:

1. The level of fixed CPAP required is at least 10cms H2O as evidenced by an in-laboratory, technician-attended CPAP titration during polysomnography; AND
2. The patient is intolerant of high fixed CPAP pressures (>10cms H2O) despite appropriate patient education and interventions to improve patient comfort and compliance. These interventions should include:
   • The use of a topical nasal corticosteroid spray or anticholinergic spray if nasal complaints are significant; and
   • Changes made by a nurse or technician, in consultation with the attending physician, to the CPAP circuit or mask, using different nose masks, face masks, nasal pillows or head harnesses as appropriate to achieve maximum patient comfort.

FOR ADULTS: 

Not Medically Necessary:

The use of CPAP is considered not medically necessary when the criteria listed above are not met.

The use of flexible positive airway pressure (PAP) devices, (such as C-Flex) is considered not medically necessary.

The use of Auto-CPAP as an alternative to technician-titrated CPAP to determine a fixed level of CPAP is considered not medically necessary if the patient does not snore (naturally or resulting from palate surgery) or when the conditions indicated above for the use of Auto-CPAP to determine a fixed level of CPAP are not met.

Auto-CPAP (APAP) is considered not medically necessary for the treatment of patients with the following conditions:

• Central apnea; or
• Congestive heart failure; or
• Lung disease (e.g., chronic obstructive pulmonary disease); or
• Nocturnal O2 desaturation due to conditions other than obstructive sleep apnea; or
• OSA in the absence of snoring (either natural or secondary to palatal surgery). [In these cases, APAP devices relying on vibration or sound in the device's algorithm should not be used.]

FOR CHILDREN: 

Medically Necessary: 

CPAP for the treatment of obstructive sleep apnea (OSA) is considered medically necessary when the following criteria are met:

• There is a documented diagnosis of obstructive sleep apnea (OSA) and polysomnography demonstrates an apnea index (AI) or apnea-hypopnea index (AHI) equal to or greater than one (1); AND
• Adenotonsillectomy has been unsuccessful in relieving OSA; OR
• Adenotonsillar tissue is minimal; OR
• Adenotonsillectomy is inappropriate based on OSA being attributable to another underlying cause (e.g., craniofacial anomaly) or adenotonsillectomy is contraindicated.                                                                                               

FOR CHILDREN: 

Not Medically Necessary: 

Pediatric uses of CPAP are considered not medically necessary when the criteria listed above are not met.

The following codes for treatments and procedures applicable to this guideline 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. 

Sleep disorders are some of the most common medical problems in the United States and have a significant impact on quality of life, productivity, and health.  There are many different types of sleep-related disorders including sleep apnea; upper airway resistance syndrome; 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).  Most, if not all, of these sleep-related disorders are treatable if diagnosed properly.  Sleep apnea is characterized by an interruption of breathing during sleep, due to extra or loose tissue in the upper airway that collapses into 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 can occur which is detected by the brain, causing the patient to wake just enough to tighten the airway muscles and allow breathing to then resume.  This may occur several hundred times in one night.  Obstructive sleep apnea can cause many symptoms, such as depression, irritability, sexual dysfunction, learning and memory difficulties, and falling asleep while at work or driving.  Sleep apnea treatment is intended to alleviate or eliminate the occurrence of sleep apnea.  This in turn should allow the patient to achieve healthy sleep patterns and mitigate or eliminate the symptoms of OSA.

Another type of sleep disturbance is simply known as "apnea" or "central apnea."  This condition, caused by problems in the central nervous system, is unrelated to obstructive sleep apnea and is not addressed in this Clinical UM Guideline, except for reference to central apnea as being considered a not medically necessary indication for APAP.

Continuous Positive Airway Pressure (CPAP) is the most common treatment for sleep apnea in adults.  During sleep, the patient 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 BiPAP^®, adjust the airflow to the needs of the patient.  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 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 obstructive sleep apnea and upper airway resistance syndrome (UARS) in adults. Standard CPAP, and the variants BiPAP and Auto-CPAP, have been found in randomized controlled trials to be highly effective in decreasing, and in some cases eliminating, obstructive sleep apnea events in patients with mild to moderate sleep apnea.  Additionally, there is clinical trial evidence that CPAP and its variants may provide significant benefit to patients suffering from restrictive lung disease and who demonstrate nocturnal oxygen desaturation.

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), 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 polysomnography study for CPAP titration, should a split night study not be feasible, or for determining a fixed level of CPAP in patients with OSA diagnosed by a portable home monitor.

2008 practice parameters for the use of auto-titrating CPAP devices were published as a report 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 patients with moderate to severe OSA without significant comorbidities, such as CHF, COPD, central sleep apnea or hypoventilation syndromes.

Among the literature supporting this position are two randomized controlled trials, comparing outcomes in patients with severe OSA and AHI>30 (Masa, 2004) or with a high pre-test probability of moderate to severe OSA, including oxygen desaturation events measured at >15/hr (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) and 3 months (Mulgrew), 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) concludes that there is sufficient evidence to justify determination of a fixed CPAP level by means of home APAP in patients 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 patient 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 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 polysomnography using actual recorded hours of sleep, (i.e., the AHI may not be extrapolated or projected). The prevalence of significant obstructive sleep apnea in adults, as defined by an AHI (or 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 polysomnography 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.

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). Supposedly, this increases CPAP compliance based on improved patient comfort. Aloia and colleagues conducted a small, non-randomized study demonstrating increased CPAP use (hrs per night) at 3 months using the C-flex system, compared to standard CPAP.  However, clinical outcomes were not significantly different.  Additionally, there were flaws, in terms of patient unblinding, (i.e., some knew they were using C-flex) and lack of use of C-flex technology to titrate that treatment group.

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 polysomnography 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 (Marcus, 2002; Hoban, 2007; Benninger, 2007; Darrow, 2007). 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 patients (Marcus, 2006), adherence to CPAP therapy may be suboptimal in the pediatric age group.

Peer Reviewed Publications:

1. Aloia MS, Stanchina M, Arnedt JT, et al.  Treatment adherence and outcomes in flexible vs. standard continuous positive airway pressure therapy.  Chest. 2005; 127(6):2085-2093.
2. Ayes NT.  Auto-titrating vs. standard continuous positive airway pressure for the treatment of obstructive sleep apnea:  Results of a meta-analysis.  Sleep.  2004; 27(2).
3. Benninger M, Walner D.  Obstructive sleep-disordered breathing in children. Clinical Cornerstones. 2007; 9, Issue Suppl 1.
4. Darrow DH. Surgery for pediatric sleep apnea. Otol Clin N Am. 2007; 40(4):855-875.
5. Findley L, Smith C, Hooper J, et al. Treatment with nasal CPAP decreases automobile accidents in patients with sleep apnea. Am J Respir Crit Care Med. 2000; 161(3 Pt 1):857-859.
6. Goroll AH, Mulley AG.  Approach to the patient with sleep apnea.  In:  Primary Care Medicine. 5^th ed.  Lippincott Williams & Wilkins. 2006.
7. Hoban TF, Chervin RD.  Sleep-related breathing disorders of childhood: description and clinical picture, diagnosis, and treatment approaches. Sleep Med Clin. 2007; 2(3):445-462.
8. Kessler R, et al. Evaluation of unattended automatic titration to determine therapeutic continuous positive airway pressure in patients with obstructive sleep apnea. Chest. 2003; 123(3).
9. Kingshott RN, Vennelle M, Hoy CJ, et al. Predictors of improvements in daytime function outcomes with CPAP therapy. Am J Respir Crit Care Med. 2000; 161(3 Pt 1):866-871.
10. Loube DI, et al. Indications for Positive Airway Pressure Treatment of Adult Obstructive Sleep Apnea Patients: A consensus statement. Chest. 1999; 115(3).
11. Marcus CL, et al. Adherence to and effectiveness of positive airway pressure therapy in children with obstructive sleep apnea.  Pediatrics.  2006; 117 (3): e442-451.
12. Masa JF, Jimenez A, Duran J, et al. Alternative methods of titrating continuous positive airway pressure. A large multicenter study. Am J Respir Crit Care Med. 2004; 170:1218-1224.
13. Montgomery-Downs HE, et al. Polysomnographic characteristics in normal preschool and early school-aged children.  Pediatrics. 2006; 117(3):741-753.
14. Massie C, McArdle N, Hart R, et al.  Comparison between automatic and fixed positive airway pressure therapy in the home. Am Respir Crit Care Med.  2003; 167:20-23.
15. Mulgrew AT, Fox N, Ayas NT, et al. Diagnosis and initial management of obstructive sleep apnea without polysomnography: a randomized validation study. Ann Int Med. 2007; 146(3):157-166.
16. Nussbaumer Y, Block KE, Genser T, Thurnheer R.  Equivalence of auto adjusted and constant continuous positive airway pressure in home treatment of sleep apnea.  Chest. 2006; 129(3):638-643.
17. Schulz R, Mahmoudi S, Hattar K, et al. Enhanced release of superoxide from polymorphonuclear neutrophils in obstructive sleep apnea. Impact of continuous positive airway pressure therapy. Am J Respir Crit Care Med. 2000; 162(2 Pt 1):566-570.
18. Senn S. Randomized Short-term Trial of Two AutoCPAP Devices versus Fixed Continuous Positive Airway Pressure for the Treatment of Sleep Apnea. Am J Respir Crit Care Med. 2003; 168:1506-1511.
19. Sin DD, Mayers I, man GC, Pawluk L. Clinical Investigations. Long-term compliance rates to continuous positive airway pressure in obstructive sleep apnea. A population-based study. Chest. 2002; 121(2):430-435.
20. Tauman R, Gulliver TE, Krishna J, et al.  Persistence of obstructive sleep apnea syndrome in children after adenotonsillectomy. J Ped. 2006; 149(6): 803-808.
21. Uliel S, Tauman R, Greenfeld M, Sivan Y. Normal polysomnographic respiratory values in children and adolescents. Chest. 2004; 125(3):872-878.
22. Yamashiro Y, et al.  CPAP titration for sleep apnea using a split night protocol.  Chest. 1995; 107(1):62-66.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Berry R, Parish J, Hartse M.  An American Academy of Sleep Medicine (AASM) Review.  The use of auto-titrating continuous positive airway pressure for treatment of adult obstructive sleep apnea.  Sleep. 2002; 25(2):148-173.
2. Centers for Medicare and Medicaid Services. National Coverage Determination for Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea (OSA). NCD #240.4. Effective April 4, 2005. Available at: http://www.cms.hhs.gov/mcd/index_list.asp?list_type=ncd#PP. Accessed on April 2, 2008.
3. Gay P, Weaver T, Loube D, Iber C.  American Academy of Sleep Medicine (AASM).  Positive Airway Pressure Task Force Standards of Practice Committee. Evaluation of positive airway pressure treatment for sleep-related breathing disorders in adults.  Sleep. 2006; 29(3):381-401.
4. Giles TL, Lasserson TJ, Smith BJ, et al.  Continuous positive airways pressure for obstructive sleep apnoea in adults.  Cochrane Database Syst Rev. 2006; (3):CD001106.
5. Haniffa M, Lasserson TJ, Smith I.  Interventions to improve compliance with continuous positive airway pressure for obstructive sleep apnoea.  Cochrane Database Syst Rev. 2004; (4):CD003531.
6. Hayes Inc. Hayes Medical Technology Directory.  Sleep Apnea Treatment, Devices.  Lansdale, PA: Hayes, Inc; September 16, 1999.  Search updated March 14, 2005.  Archived 2006.
7. Institute for Clinical Systems Improvement (ICSI).  Sleep Apnea, Diagnosis and Treatment of Obstructive Sleep Apnea.  Health Care Guideline.  Bloomington, MN: ISCI; released April, 2007.  Available at: http://www.icsi.org/sleep_apnea/sleep_apnea__diagnosis_and_treatment_of_obstructive_.html.  Accessed on April 2, 2008.
8. Kushida CA, Littner MR, Hirshkowitz M, et al.  Practice parameters for the use of continuous and bilevel positive airway pressure devices to treat adult patients with sleep-related breathing disorders.  Sleep.  2006; 29(3):375-380.
9. Littner M, Hirshkowitz M, Davila D, et al.  Practice parameters for the use of auto-titrating continuous positive airway pressure devices for titrating pressures and treating adult patients with obstructive sleep apnea syndrome.  An American Academy of Sleep Medicine Report.  Sleep. 2002; 25(2):143-147.
10. Marcus CL, et al. Clinical Practice Guideline: Diagnosis and Management of Childhood Obstructive Sleep Apnea Syndrome.  American Academy of Pediatrics (AAP).  Pediatrics. 2002; 109(4):704-712.
11. Morgenthaler TI, et al. Practice Parameters for the Use of Autotitrating Continuous Positive Airway Pressure Devices for Titrating Pressures and Treating Adult Patients with Obstructive Sleep Apnea Syndrome.  An American Academy of Sleep Medicine Report (AASM). Sleep; 2008; 31(1):141-147.
12. National Institutes of Health(NIH).  National Heart, Lung, and Blood Institute (NHLBI).  Sleep Apnea.  Available at:  http://www.nhlbi.nih.gov. Accessed on Jan. 8, 2008.
13. Sanders MH, Montserrat JM, Farre R, Givelber RJ. Proceedings of the American Thoracic Society Position Paper on Positive Pressure Therapy: A Perspective on Evidenced-based Outcomes and Methods of Application. Proc Am Thorac Soc. 2008; 5:161-172.
14. Schechter MS, et al. Technical Report: Diagnosis and Management of Childhood Obstructive Sleep Apnea Syndrome  American Academy of Pediatrics (AAP).  Pediatrics. 2002; 109(4).
15. Trikalinos TA, Lau J.  U.S. Department of Health and Human Services. Agency for Healthcare Research and Quality (AHRQ) Report: Obstructive Sleep Apnea Hypopnea Syndrome: Modeling different Diagnostic Strategies. Tufts New England Medical Center Evidence-based Practice Center.  Rockville, MD. Contract No. 290-02-0022. December 4, 2007. 
16. U.S. Department of Health and Human Services. National Institutes of Health (NIH). National Heart, Lung and Blood Institute (NHLBI).  Diseases and Conditions Index.  Available at: http://www.nhlbi.nih.gov/health/dci/Diseases/SleepApnea/SleepApnea_Summary.html.  Accessed on April 2, 2008.

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.