Appeal type: Medical necessity
Decision: Overturned

Diagnosis Sleep Apnea
Treatment Oral Appliance
The insurer denied the oral appliance.
The determination is overturned.

This patient is requesting E486 oral appliance prescribed by his general dentist There is a failure in the documentation of examination of dental, oral-pharyngeal and maxillofacial  anatomy; trial of using continuous positive airway pressure (CPAP) in conjunction with an oral appliance; and no differentiation documented between peripheral or central etiology of sleep apnea due to lack of an ear, nose, and throat (ENT) evaluation.  A Portable Type 3 Device Sleep Study was conducted moderate obstructive sleep apnea (OSA) was reported. This patient is not compliant with a recommendation for a CPAP machine due to intolerance to the face mask presence on his face. At issue is the medical necessity of an oral appliance.

The oral appliance to be worn during sleep is medically necessary for this patient This patient is documented as having moderate OSA, with an AHI score of 18.4. Traditionally, oral appliance therapy is well supported in the literature for effective and favorable results treating snoring and mild sleep apnea. Per the MCG 23rd edition, Oral Appliances (Mandibular Advancement Devices) ACG: A-0341: Oral appliance (Mandibular advancement device) may be indicated for 1 or more of the following:
Mild OSA (AHI >5 and <15) and ALL of the following: 

1) CPAP not able to be used as long term treatment due to intolerance or refuses CPAP 2) Sufficient dentition to allow for retention of appliance 3) No active periodontal disease or dental decay 4) No active temporomandibular Joint disorder 5) No restriction in mandibular opening or protrusion

However, there is also documentation that has studied the successful quantification and measurement of moderate and severe obstructive sleep apnea patients, such as this patient, using oral appliances without a continuous positive airway pressure (CPAP) machine.
According to the article by Gjerde, Lehmann, Berge, Johansson and Johansson (2), "The aim of this retrospective study was to evaluate the effect of individually adjusted custom-made mandibular advancement device/oral appliance (OA) in treatment of patients with moderate and severe obstructive sleep apnoea (OSA), who were non-adherent to continuous positive airway pressure (CPAP) therapy. During 2007-2013, 116 patients with moderate (number [n] = 82) and severe (n = 34) OSA non-adherent to CPAP treatment were referred for dental management with an individually adjusted OA at a specialist sleep clinic. Ten of the participants (86%) were lost to follow-up, leaving the data set to consist of 106 patients (71 men/35 women, mean age 57 year, range 28-90). Nocturnal respiratory polygraphic recordings were performed at baseline and follow-up. Average time between baseline polygraphy and follow-up was 12 months. A successful OA treatment outcome was based on polygraphy at the follow-up and divided into three groups: 1 = apnea hypopnea [AHI] less than (<) 5; 2 = 5 less than or equal to (<=) AHI <10 and greater than (>) 50% reduction in baseline AHI; and 3. >50% reduction in baseline AHI. If there was a <= 50% reduction in baseline AHI at the follow-up, the treatment was considered as a failure. The overall treatment success rate was 75%. There was no significant difference in success rates between patients in the moderate and severe categories (69% and 77%, respectively). Low oxygen saturation (SpO2   nadir had a high predictive value for OA treatment failure. OA treatment of patients non-adherent to CPAP is efficient and especially promising for the severe OSA group who are at greatest risks for developing serious comorbidities, if left untreated." Moderate OSA patients had documented improvement of their apnea hypopnea index (AHI) to permit a patient without the ability to use a CPAP machine by utilizing an oral appliance alone.
According to the article by Haviv, Bachar, Aframian, Almoznino, Michaeli, and Benoliel (3), "In a retrospective study, 52 OSA patients with an apnea-hypopnea index (AHI) >=40, who did not tolerate CPAP treatment, were enrolled and fitted with a modified Herbst oral appliance. A 2-year mean follow-up including a second somnography was conducted in 36 of the patients....A significant reduction (probability [P] < 0.0001) in the AHI was demonstrated between the initial somnography (55.25  10.79,) and the followed one (17.74  11.0, number [n] = 36). Overall, 57.7% of total study subjects (n = 52) and 63.9% (n = 36) that had sequential somnography continued using the device. The reduction in AHI in the user group was 42.4  3.1 (n = 23), which was significantly higher (probability [P] = 0.013) than in the non-user group (28.9  17.2; n = 13). Moreover, 53% (n = 19) reached AHI of <15....Oral appliances were found to be successful for treating for severe OSA after first-line treatment had failed." This again supports moderate to severe OSA patients utilizing an oral appliance that advances mandibular position in lieu of a CPAP machine.
Finally, according to Chan, Lee, and Cistulli (4), "Oral appliances for the treatment of obstructive sleep apnea (OSA) are worn during sleep to maintain the patency of the upper airway by increasing its dimensions and reducing its collapsibility. Oral appliances are a simpler alternative to continuous positive airway pressure (CPAP). Over the last decade, there has been a significant expansion of the evidence base to support the use of oral appliances, with robust studies demonstrating their efficacy. This work has been underpinned by the recognition of the importance of upper airway anatomy in the pathophysiology of OSA. The updated practice parameters of the American Academy of Sleep Medicine now recommend their use for mild-to-moderate OSA, or for patients with severe OSA who are unable to tolerate CPAP or refuse treatment with CPAP. Oral appliances have been shown to have a beneficial impact on a number of important clinical end points, including the polysomnographic indexes of OSA, subjective and objective measures of sleepiness, blood pressure (BP), aspects of neuropsychological functioning, and quality of life. Elucidation of the mechanism of action of oral appliances has provided insight into the factors that predict treatment response and may improve the selection of patients for this treatment modality. Longitudinal studies to characterize the long-term adverse effects of oral appliance use are now beginning to emerge. Although less efficacious than CPAP for improving the polysomnographic indexes of OSA, oral appliances are generally preferred by patients. This has the potential to translate to better patient adherence and may provide an equivalent health outcome."  There is evidence that in lieu with incompatibility with CPAP utilization, oral appliances are of benefit with strong evidence of improvement of AHI.
Oral appliances have strong applications for the mild-moderate and sometimes severe OSA patients that require assistance to improve hypopnea and their AHI scores and overall health.