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 increases 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. The purpose of these devices is assist in maintaining an open airway for the individual while they sleep. Oral appliances are customized for the individual by a dental laboratory or a similar provider for the treatment of mild to moderate obstructive sleep apnea.
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:
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:
Apnea-hypopnea index (AHI) or Respiratory Disturbance Index (RDI) meets ANY ONE of the following:
Greater than or equal to 15 events per hour with a minimum of 30 events
Greater than or equal to 5 and less than or equal to 14 events per hour with a minimum of 10 events and ANY ONE of the following:
Excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia
Hypertension, ischemic heart disease, or history of stroke
Greater than 30 and ANY ONE of the following:
Unable to tolerate a positive airway pressure (PAP) device
Physician determines that use of PAP device is contraindicated
Treatment is ordered by a physician following review of a medically appropriate sleep study
Oral appliance is customized by a qualified dentist
Individual has adequate dentition, particularly anterior teeth, to anchor the appliance
Individual has protrusive jaw movement from a position of maximum intercuspation of at least 7 mm
Individual has unobstructed nasal airway
ABSENCE of ALL of the following:
Temporomandibular dysfunction
Periodontal disease
Severe sleep apnea that is treatable by CPAP
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
Institute for Clinical Systems Improvement has developed a Determination of Severity for obstructive sleep apnea. The severity of OSA is determined by symptoms, frequency of obstructions and degree of desaturation.
The severity of the OSA 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 only 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.
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.aasmnet.org/Resources/ClinicalGuidelines/OSA_Adults.pdf.
BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2012). Diagnosis and medical management of obstructive sleep apnea syndrome (2.01.18). Retrieved February 21, 2013 from BlueWeb. (42 articles and/or guidelines reviewed)
CGS Administrators, LLC. (2012, July). Local Coverage Determination (LCD): Oral appliances for obstructive sleep apnea (L28620). Retrieved February 21, 2013 from http://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=28620&ContrId=140&ver=18&ContrVer=2&CoverageSelection=Both&ArticleType=All&PolicyType=Final&s=Tennessee&KeyWord=oral+appliances+obstructive+sleep&KeyWordLookUp=Title&KeyWordSearchType=And&from2=search.asp&bc=gAAAABAAAAAAAA%3d%3d&.
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.
U. S. Food and Drug Administration. (2012. March). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K103704. Retrieved February 22, 2013 from http://www.accessdata.fda.gov/cdrh_docs/pdf10/K103704.pdf.
Winifred B. Hayes, Inc. Medical Technology Directory. (2010, August; last update search August 2011). Mandibular advancement devices for sleep apnea. Retrieved April 25, 2011 from www.Hayesinc.com/subscribers. (77 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 4/1/2002
MOST RECENT REVIEW DATE: 3/14/2013
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.
This document has been classified as public information.