BlueCross BlueShield of Tennessee Medical Policy Manual

Sleep Disorder Diagnosis and Treatment

DESCRIPTION

Sleep Apnea Syndrome (SAS)

Sleep apnea syndrome is a breathing disorder characterized by the cessation of breathing for at least ten seconds, which occurs repetitively throughout the night and is accompanied by hypoxia and hypercapnia. Apnea may occur as a result of failure of respiratory drive (central apnea), obstruction of the upper airway (obstructive apnea), or a mixed pattern (mixed apnea) during sleep. The initial evaluation of individuals suspected of having sleep apnea syndrome should include a thorough medical and sleep history (including family or bed partner observations), and a physical examination including laboratory serologic testing, and possibly a detailed sleep log and/or psychological testing. If there is a high suspicion of sleep apnea syndrome after evaluating an individual, a sleep study is indicated to establish a diagnosis.

Polysomnography

Currently, polysomnography (PSG), which requires an overnight stay in a sleep laboratory, is the optimum test for diagnosing sleep apnea. It includes evaluation of sleep staging, airflow and ventilatory effort, arterial oxygen saturation, electrocardiogram (single lead), body position, and periodic limb movements (i.e., anterior tibialis EMG to assess sleep-associated leg movements). Determined from the collective data are total sleep time, sleep latency, arousals after sleep onset, time spent in nREM and REM sleep, central and obstructive sleep apneas, and the severity of SAS in terms of the apneas and/or hypopneas per hour. Only one polysomnogram is needed to confirm a diagnosis of SAS. A second polysomnogram may be required to adjust the nasal CPAP device. It is imperative that a sleep study be interpreted by someone with expertise in sleep disorders since an accurate diagnosis is crucial to avoid undertreatment or overtreatment of individuals. Treatment may consist of modification of behavioral factors (e.g., weight loss, avoidance of alcohol and sedatives before sleep, avoidance of supine sleep position); nasal CPAP; oral/dental devices; or surgical procedures (e.g., uvulopalatopharyngoplasty [UPPP], nasal surgery, tonsillectomy, maxillofacial surgery, tracheostomy).

Sleep staging requires a 1-4 lead electroencephalogram (EEG) to monitor stages of sleep, electrooculogram (EOG) to monitor eye movements and REM sleep, and a submental electromyogram (EMG).

Multiple Sleep Latency Testing (MSLT)

A multiple sleep latency test involves repeated measurement of sleep latency, which is the time to the onset of sleep. The test is performed in the daytime under standardized and controlled conditions following quantified nocturnal sleep. Usually two to six tests are performed, one testing every two hours, to measure daytime sleep tendency. A mean latency of five minutes or less indicates severe excessive sleepiness.

Expiratory Positive Airway Pressure (EPAP) Nasal Device

The expiratory positive airway pressure (EPAP) nasal device has been developed to provide a new therapeutic op¬tion for obstructive sleep apnea.  (Provent Therapy, Ventus Medical Inc., Belmont, CA). The single use EPAP device contains a mechanical valve with very low inspiratory resistance but high expiratory resistance and is applied to each nostril with adhesive to provide a seal. The high expiratory resistance results in positive pressure throughout exhalation, which splints open the upper airway, making it more resistant to collapse on subsequent inspiration.

POLICY

• A supervised polysomnography (PSG) is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)

• A repeat supervised polysomnography (PSG) is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)

• Multiple sleep latency testing (MSLT) to exclude or confirm narcolepsy is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)

• Multiple sleep latency testing (MSLT) in the diagnosis any other sleep related condition is considered not medically necessary.

• The use of non-invasive positive pressure ventilators (e.g. Trilogy™, Newport®, Vela®, IVent, Puritan™,  and LTV®) for the treatment of obstructive sleep apnea is considered not medically necessary. The clinical outcomes with this treatment have not been shown to be superior to other approaches (e.g., CPAP, BiPAP) and non-invasive positive pressure ventilators are generally more costly than these alternatives.

• Unattended (e.g., unsupervised, portable polysomnography, or “in-home") sleep studies are considered investigational.

• A nasal expiratory positive airway pressure (EPAP) device is considered investigational.

• Polysomnography as a diagnostic test for other conditions/diseases, including, but not limited to, the following is considered investigational:

• • Insomnia
  • Depression
  • Restless leg syndrome (to diagnosis or treat)
  • Circadian rhythm disorders

See also:  Actigraphy

MEDICAL APPROPRIATENESS

• Sleep disorder studies are considered medically appropriate for ANY ONE of the following criteria:

• • Polysomnography for adults if ALL of the following criteria are met:
  • • An evaluation must be performed prior to the polysomnography that includes a thorough sleep history and a physical examination, which includes the respiratory, cardiovascular and neurologic systems
    • Diagnosis cannot be made through clinical evaluation of the signs and symptoms, or through use of less comprehensive diagnostic tests
    • The polysomnography results are used as a diagnostic test in adult individuals who present with ANY ONE of the following:
    • • Witnessed apneas, hypopneas, or respiratory effort related events while sleeping
      • Snoring associated with observed apneas and/or excessive daytime sleepiness
      • Unexplained hypertension or arrhythmia when sleep related complaints are present
      • Suspected narcolepsy
      • Sleep related behaviors that are violent or otherwise injurious (e.g., atypical or unusual parasomnias)
      • Periodic limb movements during sleep in individuals who present with complaints of excessive daytime sleepiness associated with fragmented sleep
      • Suspected sleep related epilepsy, when there are strong clinical reasons for suspecting the disorder and routine EEG has not detected the epileptic phenomena
  • Polysomnography for pediatric individuals for ANY ONE of the following criteria:
  • • Loud snoring with irregular respirations or apnea and comorbid conditions associated with apnea (e.g., tonsil hypertrophy, obesity, neuromuscular disease, genetic syndromes, cranial facial abnormalities)
    • Sleepwalking and night terrors associated with comorbid conditions associated with sleep apnea
    • “Seizure” like events in sleep when a routine EEG has not detected the epileptic phenomena
    • Decreasing scholastic performance, sudden personality changes, enuresis (bedwetting) without other obvious cause, associated with hypersomnolence and comorbid conditions associated with sleep apnea
    • Presence of systemic hypertension
    • Pulmonary hypertension
    • Marked sinus arrhythmia and bradycardia
  • Repeat supervised polysomnography is considered medically appropriate to evaluate treatment efficacy during nasal continuous positive airway pressure titration for individuals that meet ANY ONE of the following criteria:
  • • Substantial weight gain or loss (to ascertain whether pressure adjustments are needed)
    • Clinical response is insufficient or symptoms have returned
    • When symptoms return following surgical or dental treatments for obstructive sleep apnea
  • Multiple sleep latency testing (MSLT) to exclude or confirm narcolepsy if ALL of the following conditions are met:
  • • The MSLT is performed following a supervised polysomnography (PSG) performed on the preceding night
    • A full MSLT or a four-nap test with at least two onset REM periods is required for an accurate diagnosis; single nap studies are not sufficient for the diagnosis of narcolepsy

IMPORTANT REMINDERS

• Any specific products referenced in this policy are just examples and are intended for illustrative purposes 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. These examples are contained in the parenthetical e.g. statement.

• We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.

ADDITIONAL INFORMATION

Only one polysomnogram is needed to confirm a diagnosis of obstructive sleep apnea syndrome (OSAS). A second polysomnogram may be required to adjust the CPAP device. Additional polysomnograms may be necessary for evaluating treatment response and making subsequent treatment management decisions. More than three polysomnograms in a 12-month period should undergo utilization review.

A polysomnogram that is diagnostic for sleep apnea syndrome in adults is one with a RDI greater than five. This number represents the number of apneas and hypopneas per hour of sleep. For example, 60 apneic periods during an eight-hour study results in an RDI of 7.5.

Sleep studies must be performed in a place of service certified as required by applicable state and federal regulations and accredited by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and/or accredited by the American Osteopathic Association (AOA) and/or accredited by the American Academy of Sleep Medicine. The evaluating physician and staff are required to have specialized training that meets the standards set forth by the American Academy of Sleep Medicine.

No controlled studies were found in the published literature that validates the use of polysomnography as a diagnostic test for insomnia, depression, restless leg syndrome or to diagnosis circadian rhythm disorders.

There is insufficient evidence to permit conclusions regarding the effect of nasal expiratory positive airway pressure (EPAP) on health outcomes.

SOURCES

Agency for Healthcare Research and Quality. (2007, August). Home diagnosis of obstructive sleep apnea-hypopnea syndrome. Retrieved July 11, 2008 from http://www.ahrq.gov.

Agency for Healthcare Research and Quality. (2011, July). Diagnosis and treatment of obstructive sleep apnea in adults. Retrieved November 9, 2011 from http://www.effectivehealthcare.ahrq.gov/ehc/products/117/685/sleep-apnea_clinician.pdf.

American Academy of Sleep Medicine. (2007, December). Standards for accreditation of laboratories for sleep related breathing disorders. Retrieved July 11, 2008 from. http://www.aasmnet.org/Resources/PDF/LaboratoryStandards.pdf.

American Academy of Sleep Medicine. (2010). Practice parameters for the respiratory indications for polysomnography in children. SLEEP, 34 (3), 379-388.

American Academy of Sleep Medicine. (2011, August). Standards for accreditation of sleep disorders centers. Retrieved November 9, 2011 from. http://www.aasmnet.org/Resources/PDF/AASMcenteraccredstandards.pdf.

Berry, R. B, Kryger, M. H., & Massie, C. A. (2012). A novel nasal expiratory positive airway pressure (EPAP) device for the treatment of obstructive sleep apnea: A randomized controlled trial. SLEEP, 34 (4), 479-485.

BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2012). Diagnosis and medical management of obstructive sleep apnea syndrome (2.01.18). Retrieved June 15, 2012 from BlueWeb. (42 articles and/or guidelines reviewed)

Collop, N. A., Anderson, W. M., Boehlecke, B., Claman, D., Goldberg, R., Gottlieb, D. J., et al. (2007). 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, 3 (7), 737-747.

Complete Guide to Medicare Issues. [Computer software]. (2011, August). Sleep disorder clinics. (70, 4-226). Ingenix.

Complete Guide to Medicare Issues. [Computer software]. (2011, November). Sleep testing for obstructive sleep apnea (OSA). (NCD 240.4.1, 2-205). Ingenix.

De Backer, W., & Javaheri, S. (2007). Treatment of sleep apnea in heart failure. Sleep Medicine Clinics, 2 (4), 631-638.

Kushida, C. A., Littner, M. R., Morgenthaler, T., Alessi, C. A., Bailey, D., Coleman, J., Jr., et al. (2005). Practice parameters for the indications for polysomnography and related procedures: An update for 2005. Sleep, 28 (4), 499-521.

Littner, M. R., Kushida, C., Wise, M., Davila, D. G., Morgenthaler, T., Lee-Chiong, T., et al. (2005). Practice parameters for clinical use of the multiple sleep latency test and the maintenance of wakefulness test. An American Academy of Sleep Medicine report. Standards of Practice Committee of the American Academy of Sleep Medicine. Sleep, 28 (1), 113-121.

Morgenthaler, T. I., Aurora, R. N., Brown, T., Zak, R., Alessi, C., Boehlecke, B., et.al, (2008). 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 update for 2007. An American Academy of Sleep Medicine report. Sleep, 31 (1), 141-147.

Mulgrew, A. T., Fox, N., Ayas, N. T., & Ryan, C. F. (2007). Diagnosis and initial management of obstructive sleep apnea without polysomnography. A randomized validation study. Annals of Internal Medicine, 146 (3), 157-166. (Level 2 Evidence - Industry sponsored)

Owens, J. (2007). Classification and epidemiology of childhood sleep disorders. Sleep Medicine Clinics, 2 (3); 353-361.

U. S. Food and Drug Administration. (2006, September). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K061764. Retrieved August 5, 2008 from http://www.fda.gov/cdrh/pdf6/K061764.pdf.

U. S. Food and Drug Administration. (2007, July). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K071556. Retrieved August 5, 2008 from http://www.fda.gov/cdrh/pdf7/K071556.pdf.

U. S. Food and Drug Administration. (2009, April). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K090398. Retrieved June 18, 2012 from http://www.accessdata.fda.gov/cdrh_docs/pdf9/K090398.pdf.

Winifred S. Hayes, Inc. Medical Technology Directory. (2008, April). Actigraphy for diagnosis of obstructive sleep apnea syndrome in adults. Retrieved September 21, 2011 from www.Hayesinc.com/subscribers. ( articles and/or guidelines)

Winifred S. Hayes, Inc. Medical Technology Directory. (2008, May). Home sleep studies for diagnosis of obstructive sleep apnea syndrome in adults. Retrieved July 10, 2008 from www.Hayesinc.com/subscribers. (55 articles and/or guidelines)

Winifred S. Hayes, Inc. Medical Technology Directory. (2010, November). Actigraphy for diagnosis of circadian rhythm sleep disorders. Retrieved September 21, 2011 from www.Hayesinc.com/subscribers. (58 articles and/or guidelines)

ORIGINAL EFFECTIVE DATE:  7/1982

MOST RECENT REVIEW DATE: 4/26/2013

ID_BT

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

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