DESCRIPTION
Obstructive sleep apnea is characterized by episodic airway obstruction due to the collapse of the upper airway during sleep. Oral appliance therapy uses an appliance that fits in the individual's mouth and mechanically increase the oropharyngeal space by advancing the mandible and/or tongue forward. These appliances can vary in design and are broadly categorized as mandibular advancing/positioning devices or tongue retaining devices, but all have the same purpose: to assist in maintaining an open airway for the individual while they sleep. Oral appliances are available “off the shelf” or custom made for the individual by a dental laboratory or similar provider.treatment of mild to moderate
Examples of different types of oral appliances for the treatment of obstructive sleep apnea (OSA) include: Klearway Oral Appliance™ and the Tongue Retaining Device™.
POLICY
An oral appliance used for the treatment of mild to moderate obstructive sleep apnea is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
See also: Palatal Implants for the Treatment of Obstructive Sleep Apnea or Snoring
MEDICAL APPROPRIATENESS
An oral appliance used for the treatment of mild to moderate obstructive sleep apnea is considered medically appropriate if ALL of the following criteria are met:
The treatment is ordered by a physician
The oral appliance is custom made
The individual has adequate dentition, particularly anterior teeth, to anchor the appliances
The individual has protrusive jaw movement from a position of maximum intercuspation of at least 7 mm
The individual has an unobstructed nasal airway
There is polysomnographic documentation of apneic episodes occurring five or more times per hour during sleep and it is determined that the episodes are not of central nervous system origin
ABSENCE of ALL of the following:
Temporomandibular dysfunction
Periodontal disease
Severe sleep apnea
Systemic disease, such as cardiac, respiratory, hypertension or neurological pathology
IMPORTANT REMINDER
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
The severity of OSA is determined by symptoms, frequency of obstructions and degree of desaturation.
and is determined by the most severe rating of three domains: sleepiness, respiratory disturbance (AHI), and gas exchange abnormalities (minimum and mean oxygen saturation).
Sleepiness
Mild: describes sleepiness present lonely when sedentary or when little attention is required, and may not be present every day. Such sleepiness produces only minor impairment of social or occupation function. As a guide, an Epworth Sleepiness Scale result might be less than 12.
Moderate: Describes daily sleepiness that occurs when minimally active and moderate degree of attention (e.g., driving attending meetings or movies). As a guide, an Epworth Sleepiness Scale result might be 13-17.
Severe: Describes daily sleepiness during active tasks or tasks that require significant attention. Examples might include driving, conversation, eating or walking, and usually sleepiness produces marked impairment of social or occupational function. As a guide, an Epworth Sleepiness Scale result might be 18-24.
Gas Exchange Abnormalities
Mild: Mean oxygen saturation remains greater than or equal to 90% and minimum remains greater than or equal to 85%.
Moderate: Mean oxygen saturation remains greater than or equal to 90% and minimum oxygen saturation remains greater than or equal to 70%.
Severe: Mean oxygen saturation remains less than 90% or minimum oxygen saturation remains less than 70%.
Respiratory Disturbance:
Mild: AHI (Apnea-hypopnea Index) 5-15
Moderate: AHI 16- 30
Severe: AHI greater than 30.
SOURCES
American Academy of Sleep Medicine. (2009). Clinical guideline for the evaluation, management, and long term care of obstructive sleep apnea. Retrieved April 25, 2011 from http://www.guideline.gov/content.aspx?id=15298&search=sleep+apnea.
BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2010). Diagnosis and medical management of obstructive sleep apnea syndrome (2.01.18). Retrieved April 18, 2011 from BlueWeb.
BlueCross BlueShield of Tennessee network physicians. October-November 2003.
ECRI Institute. Health Technology Assessment Information Service. Evidence Reports. (2002, February). Mandibular advancement devices for obstructive sleep apnea. Retrieved April 25, 2011 from ECRI Institute. (27 articles and/or guidelines reviewed)
Ferguson, K.A., Cartwright, R., Rogers, R., & Schmidt-Nowara, W. (2006). Oral appliances for snoring and obstructive sleep apnea: a review. Sleep, 29 (2), 244-262.(Level1 Evidence - Independent)
Krishnan, V., Collop, N.A., & Scherr, S.C. (2008). An evaluation of a titration strategy for prescription of oral appliances for obstructive sleep apnea. Chest, 133 (5), 1135-1141.(Level 3 Evidence - Independent)
Lee, C., Kim, J., Lee, H., Yun, P., Kim, D., Seo, B., et al. (2009). An investigation of upper airway changes associated with mandibular advancement device using sleep videofluoroscopy in patients with obstructive sleep apnea. Archives of Otolaryngology - Head Neck Surgery, 135(9), 910-914. (Level 3 Evidence - Independent)
U. S. Food and Drug Administration. (2005. September). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K0033822. Retrieved April 25, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf3/K033822.pdf.
U. S. Food and Drug Administration. (2005. September). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K060744. Retrieved April 25, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf6/K060744.pdf.
U. S. Food and Drug Administration. (2005. September). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K091035. Retrieved April 25, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf9/K091035.pdf.
Winifred B. Hayes, Inc. Medical Technology Directory. (2010, August). Mandibular advancement devices for sleep apnea. Retrieved April 25, 2011 from www.Hayesinc.com/subscribers. (77 articles and/or guidelines reviewed)
MOST RECENT REVIEW DATE: 6/9/2011
ID_BA
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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