Medical Policy



Subject: Prefabricated Oral Appliances for the Treatment of Obstructive Sleep Apnea
Document #: DME.00039 Current Effective Date:    09/27/2017
Status: Reviewed Last Review Date:    08/03/2017

Description/Scope

This document addresses the use of prefabricated oral appliances for the treatment of obstructive sleep apnea (OSA). Oral appliances have been used as an alternative to positive airway pressure (PAP) therapy. These devices can be custom made or prefabricated. Prefabricated devices are pre-made or "off the shelf" devices which are trimmed, bent, relined or otherwise modified to an individual's oral structures. This document does not address the use of custom oral appliances.

Note: For information regarding surgical management of OSA, please see:

Position Statement

Investigational and Not Medically Necessary:

The use of prefabricated oral appliances to treat obstructive sleep apnea is considered investigational and not medically necessary in all cases.

Rationale

PAP therapy is considered the standard treatment of choice for mild, moderate or severe OSA (Epstein, 2009). Oral appliances (OAs) can be prescribed for individuals who cannot tolerate or decline PAP therapy. There are two general types of oral devices used to treat OSA, mandibular repositioning devices (MRDs) and tongue retaining devices (TRDs), which hold the tongue forward. The major societies (AADSM, 2014; AASM/AADSM, 2015) consider only MRDs, not TRDs to be oral appliances. MRD OAs can also be classified as titratable or non-titratable. Titratable devices are designed to allow for adjusting the level of mandibular protrusion, while non-titratable devices remain stationary (Ramar, 2015).

The American Academy of Dental Sleep Medicine (AADSM) describes oral appliances as follows:

The purpose of an oral appliance is to treat obstructive sleep apnea (OSA), primary snoring, and associated symptoms. Oral appliances are intended to decrease the frequency and/or duration of apneas, hypopneas, respiratory effort related arousals (RERAs) and/or snoring events. Oral appliances have been demonstrated to improve nocturnal oxygenation as well as the adverse health and social consequences of OSA and snoring. Oral appliances are indicated for patients with mild to moderate OSA and primary snoring. Oral appliances are accepted therapy for patients with severe OSA who do not respond to or are unable or unwilling to tolerate positive airway pressure (PAP) therapies. Although oral appliances are typically used as a stand-alone therapy, they can serve as an adjunct to PAP therapy and/or other treatment modalities for the management of OSA.

The authors also note that an oral appliance is a custom fabricated device based upon impressions and models of an individual's oral structures and is not primarily a prefabricated device (2014).

The American Academy of Sleep Medicine (AASM) and the AADSM 2015 Clinical Practice Guidelines on the treatment of OSA and snoring have several recommendations regarding the use of oral appliances (OAs) including the following:

When oral appliance therapy is prescribed by a sleep physician for an adult patient with obstructive sleep apnea, we suggest that a qualified dentist use a custom, titratable appliance over non-custom oral devices.

We recommend that sleep physicians consider prescription of oral appliances, rather than no treatment, for adult patients with obstructive sleep apnea who are intolerant of CPAP therapy or prefer alternate therapy.

The authors note that a systematic review of the evidence supports that custom OAs reduce several sleep quality indexes, including apnea hypopnea index (AHI), arousal index, and oxygen desaturation index, and increase the oxygen saturation to a greater extent than non-custom OAs.

The American Association of Oral and Maxillofacial Surgeons (AAOMS) position paper on the evaluation and management of OSA (2013) notes that custom made oral appliances which are fitted by qualified dental personnel can be an effective therapy for individuals with mild to moderate OSA. The position paper does not reference prefabricated devices.

Several medical societies do address and recommend the use of OAs to treat OSA in a specific population when fabricated by qualified providers. However, these recommendations are limited to custom OAs and societies do not recommend prefabricated devices.  

Vanderveken and colleagues (2008) compared the efficacy of custom-made and prefabricated mandibular advancement devices (MAD) in the treatment of sleep disordered breathing in a randomized controlled cross-over trial. A total of 35 individuals with a diagnosis of snoring or mild to moderate obstructive sleep apnea–hypopnea syndrome (OSAHS) who had failed or refused CPAP treatment were included in the study. Individuals were randomized to receive either 4 months of treatment with a custom MAD or prefabricated MAD. Following the initial 4-month treatment and a 1-month washout, individuals were treated with the alternate device. The custom MAD resulted in a partial or complete response in 60% (21/35) of the cases versus 31% of cases treated with prefabricated MAD (p=0.02). Compliance failure due to insufficient overnight retention was documented in one-third of the prefabricated devices. Sixty-three percent (15/24) of those cases deemed to be treatment failures with prefabricated devices were successfully treated with custom MADs.

In a systematic review of MADs, Serra-Torres and associates (2016) evaluated the effectiveness of different types of MADs in the treatment of mild or moderate OSA/hypopnea syndrome. Outcomes were assessed using AHI, oxygen saturation, changes in the upper airway and reported improvements in symptoms such as snoring and somnolence. One small (n=14) prospective study reported a significant improvement in AHI and oxygen saturation with prefabricated devices. This study had significant limitations including a drop-out rate of 21% (n=3), with only 10 participants who completed the entire protocol. The authors of the systematic review noted that individual discomfort and treatment noncompliance influenced the treatment effectiveness of prefabricated oral appliances to a greater degree than the treatment effectiveness of custom oral appliances. In addition, custom devices provide an improved degree of control of mandibular advancement.

While there are multiple other studies which evaluate the use of OAs in the treatment of OSA, these studies focus on custom OAs. There are a few small, nonrandomized, lower quality studies which suggest prefabricated devices might provide some benefit in OSA (Banhiran, 2014; Poon, 2008). The authors of these studies note that further studies are needed. Currently, there is a lack of evidence that supports the efficacy of prefabricated OAs in the treatment of OSA.

Background/Overview

OSA affects approximately 10-17% of men and 3-9% of women in the United States (Peppard, 2013). An estimated 7 to 18 million individuals are affected with minimal sleep-disordered breathing and an additional 2 to 4 million people are affected with moderate to severe disease (Buchanan, 2016). However, this condition remains largely undiagnosed. Park (2011) estimates that up to 82% of men and 93% of women with moderate to severe OSA have not been diagnosed and are not being treated. 

Individuals with untreated OSA exhibit symptoms of hypersomnolence, fatigue and cognitive impairment. In addition to a decreased quality of life, untreated OSA is considered a significant health risk factor for several conditions. The presence of untreated severe OSA increased the odds of fatal cardiovascular events by 2.87 and the odds of nonfatal cardiovascular events by 3.17. OSA has also been linked to an increased risk of stroke, epilepsy, insulin resistance and the development of diabetes (Park, 2011).

The joint clinical practice guideline by AASM and AADSM (2015) defines a custom OA as:

Fabricated using digital or physical impressions and models of an individual patient's oral structures. As such, it is not a primarily prefabricated item that is trimmed, bent, relined, or otherwise modified. It is made of biocompatible materials and engages both the maxillary and mandibular arches.

The authors define a non-custom OA, also known as boil and bite devices, as "primarily prefabricated and usually partially modified to an individual patient's oral structures."

Definitions

Apnea: A transient period where breathing ceases.

Obstructive sleep apnea (OSA): This is a form of sleep disturbance, which occurs as the result of a physical occlusion of the upper airway during sleep, which interferes with normal breathing. The occlusion is usually in the back of the tongue and/or flabby tissue in the upper airway. This condition is associated with frequent awakening and often with daytime sleepiness.

According to the American Academy of Sleep Medicine (AASM), updated definitions of OSA severity are provided as follows:

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.

When services are Investigational and Not Medically Necessary:
When the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

HCPCS  
E0485 Oral device/appliance used to reduce upper airway collapsibility, adjustable or non-adjustable, prefabricated, includes fitting and adjustment
ICD-10 Diagnosis  
  All diagnoses
   
References

Peer Reviewed Publications:

  1. Banhiran W, Kittiphumwong P, Assanasen P, et al. Adjustable thermoplastic mandibular advancement device for obstructive sleep apnea: outcomes and practicability. Laryngoscope. 2014; 124(10):2427-2432.
  2. Buchanan A, Cohen R, Looney S, Kalathingal S, De Rossi S. Cone-beam CT analysis of patients with obstructive sleep apnea compared to normal controls. Imaging Sci Dent. 2016; 46(1):9-16.
  3. Park JG, Ramar K, Olson EJ. Updates on definition, consequences, and management of obstructive sleep apnea. Mayo Clin Proc. 2011; 86(6):549-554.
  4. Peppard PE, Young T, Barnet JH, et al. Increased prevalence of sleep-disordered breathing in adults. Am J Epidemiol. 2013; 177(9):1006-1014.
  5. Poon KH, Chay SH, Chiong KF. Airway and craniofacial changes with mandibular advancement device in Chinese with obstructive sleep apnoea. Ann Acad Med Singapore. 2008; 37(8):637-644.
  6. Serra-Torres S, Bellot-Arcís C, Montiel-Company JM, et al. Effectiveness of mandibular advancement appliances in treating obstructive sleep apnea syndrome: a systematic review. Laryngoscope. 2016; 126(2):507-514.
  7. Vanderveken OM, Devolder A, Marklund M, et al. Comparison of a custom-made and a thermoplastic oral appliance for the treatment of m

Government Agency, Medical Society, and Other Authoritative Publications:

  1. American Academy of Dental Sleep Medicine (AADSM).
  2. American Association of Oral and Maxillofacial Surgeons (AAOMS). Position Paper: Evaluation and Management of Obstructive Sleep Apnea – Overview. 2013. Available at: http://www.aaoms.org/docs/govt_affairs/advocacy_white_papers/osa_position_paper.pdf. Accessed on June 27, 2017.
  3. Epstein LJ, Kristo D, Strollo PJ Jr, et al.; Adult Obstructive Sleep Apnea Task Force of the American Academy of Sleep Medicine. Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults. J Clin Sleep Med. 2009; 5(3):263-276.
  4. Qaseem A, Holty JE, Owens DK, et al.; Clinical Guidelines Committee of the American College of Physicians. Management of obstructive sleep apnea in adults: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2013; 159(7):471-483.
  5. Ramar K, Dort LC, Katz SG, et al. Clinical practice guideline for the treatment of obstructive sleep apnea and snoring with oral appliance therapy: an update for 2015. J Clin Sleep Med. 2015; 11(7):773-827.
  6. Scherr SC, Dort LC, Almeida FR, et al. Definition of an effective oral appliance for the treatment of obstructive sleep apnea and snoring: a report of the American Academy of Dental Sleep Medicine. J Dent Sleep Med. 2014; 1(1):39-50. Available at: http://aadsm.org/resources/pdf/definitionoforalappliance.pdf. Accessed on June 27, 2017.
  7. Spencer J, Patel M, Mehta N, et al.; American Academy of Craniofacial Pain Task Force on Mandibular Advancement Oral Appliance Therapy for Snoring and Obstructive Sleep Apnea. Special consideration regarding the assessment and management of patients being treated with mandibular advancement oral appliance therapy for snoring and obstructive sleep apnea. Cranio. 2013; 31(1):10-13.
Websites for Additional Information
  1. U.S. National Library of Medicine. MedlinePlus. Obstructive sleep apnea-adults. Reviewed January 27, 2016. Available at: https://www.nlm.nih.gov/medlineplus/ency/article/000811.htm . Accessed on June 27, 2017.
  2. U.S. National Library of Medicine. PubMed Health. Obstructive Sleep Apnea (OSA). Available at: http://www.ncbi.nlm.nih.gov/pubmedhealth/PMHT0024431/. Accessed on June 27, 2017.
Index

Mandibular Advancement Appliance (MAA)
Mandibular Advancement Device (MAD)
Mandibular Advancement Splint (MAS)
Mandibular Repositioning Device (MRD)
Oral Appliance Therapy (OAT)

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.

Document History
Status Date Action
Reviewed 08/03/2017 Medical Policy & Technology Assessment Committee (MPTAC) review. Updated Description, Rationale and References sections.
New 08/04/2016 MPTAC review. Initial document development.