Clinical Policy Title: Treatment for obstructive sleep apnea in adults

Transcription

1 Clinical Policy Title: Treatment for obstructive sleep apnea in adults Clinical Policy Number: CCP.1061 Effective Date: March 1, 2014 Initial Review Date: October 16, 2013 Most Recent Review Date: October 2, 2018 Next Review Date: October 2019 Policy contains: Positive airway pressure devices. Oral appliances. Surgery. Obstructive sleep apnea. Related policies: CCP.1090 CCP.1147 CCP.1172 CCP.1270 Bariatric surgery for adults Diagnosing obstructive sleep apnea in adults Uvulopalatopharyngoplasty Hypoglossal nerve stimulation ABOUT THIS POLICY: Select Health of South Carolina has developed clinical policies to assist with making coverage determinations. Select Health of South Carolina s clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of medically necessary, and the specific facts of the particular situation are considered by Select Health of South Carolina when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. Select Health of South Carolina s clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. Select Health of South Carolina s clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, Select Health of South Carolina will update its clinical policies as necessary. Select Health of South Carolina s clinical policies are not guarantees of payment. Coverage policy Select Health of South Carolina considers the use of treatments for obstructive sleep apnea in members (age 18 years) to be clinically proven and, therefore, medically necessary when the following diagnostic and treatment criteria are met: Diagnostic criteria (Qaseem, 2013; Balk, 2011): - Diagnosis of obstructive sleep apnea is based on a positive attended full-channel nocturnal polysomnography performed at a health care facility or on a positive home sleep test. - Severity of obstructive sleep apnea is defined as follows: Severe obstructive sleep apnea based on an apnea-hypopnea index or respiratory disturbance index 30 events per hour. Moderate obstructive sleep apnea based on an apnea-hypopnea index or respiratory disturbance index 15 events per hour but < 30 events per hour. 1

2 Mild obstructive sleep apnea based on an apnea-hypopnea index or respiratory disturbance index 5 events but < 15 events per hour. Treatment criteria: - Continuous positive airway pressure, auto-positive airway pressure, or bi-level positive airway pressure as the initial therapy (InterQual, 2018a; Qaseem, 2013; Randerath, 2011; Aurora, 2010). Coverage is limited initially to a 12-week trial period to identify members diagnosed with obstructive sleep apnea who benefit from positive airway pressure. Continuation of positive airway pressure therapy is medically necessary only for members diagnosed with obstructive sleep apnea who show symptomatic improvement during the 12-week trial period. - Mandibular advancement devices or removable oral appliances as an initial treatment for either (InterQual, 2018a; Balk, 2011; Randerath, 2011; Aurora, 2010): Members with documented mild to moderate obstructive sleep apnea. Members with documented severe obstructive sleep apnea for whom positive airway pressure is contraindicated, not tolerated, or refused. - The following surgical treatments may be offered after six-month failure or intolerance of non-invasive therapies (InterQual, 2018b; Aurora, 2010; Caples, 2010): Uvulopalatopharyngoplasty as a single surgery or in-phased surgery for members who meet the criteria for continuous positive airway pressure or auto-positive airway pressure but who are intolerant to positive airway pressure treatment (See CCP.1172 Uvulopalatopharyngoplasty). Maxillomandibular advancement with or without genioglossal advancement for members diagnosed with severe obstructive sleep apnea and who fail other treatment approaches. Tracheostomy for members with severe obstructive sleep apnea not manageable by other interventions. Surgery to correct discrete anatomic abnormalities of the upper airway that significantly contribute to obstructive sleep apnea (including, but not limited to, enlarged tonsils or an enlarged tongue) based on adequate documentation in the medical records. For Medicare members only Positive airway pressure (National Coverage Determination 240.4; Policy article A52467; Local Coverage Determination L33718): Single-level continuous positive airway pressure (E0601) covered when used in the treatment of obstructive sleep apnea, if all of the following criteria are met: - The beneficiary has a face-to-face clinical evaluation by the treating physician prior to the sleep test to assess the beneficiary for obstructive sleep apnea. - The beneficiary has a sleep test (as defined below) that meets either criteria: 2

3 Apnea-hypopnea index or respiratory disturbance index is 15 events per hour with a minimum of 30 events. Apnea-hypopnea index or respiratory disturbance index is 5 and 14 events per hour with a minimum of 10 events and documentation of excessive daytime sleepiness, impaired cognition, mood disorders or insomnia; or hypertension, ischemic heart disease or history of stroke. - The beneficiary or their caregiver have received instruction from the supplier of the device in the proper use and care of the equipment. Bi-level respiratory assist device without back-up rate (E0470) for those beneficiaries with obstructive sleep apnea who meet all criteria above and: - An E0601 has been tried and proven ineffective based on a therapeutic trial conducted in either a facility or a home setting. Adult beneficiaries who do not qualify for continuous positive airway pressure coverage based on criteria for obstructive sleep apnea diagnosis do qualify under Coverage with Evidence Determination when enrolled in a registered clinical research study that addresses one of the two questions below: - In Medicare-aged subjects with clinically identified risk factors for obstructive sleep apnea, how does the diagnostic accuracy of a clinical trial of continuous positive airway pressure compare with polysomnography and Types II, III and IV home sleep test in identifying subjects with obstructive sleep apnea who will respond to continuous positive airway pressure? - In Medicare-aged subjects with clinically identified risk factors for obstructive sleep apnea who have not undergone confirmatory testing with polysomnography or Types II, III and IV home sleep tests, does continuous positive airway pressure cause clinically meaningful harm? Oral appliances are considered medically necessary if the following criteria are met (A52512; A53497; L33611; L33468; L35047): The beneficiary has a face-to-face clinical evaluation by the treating physician prior to the sleep test to assess the beneficiary for obstructive sleep apnea. Beneficiary has a Medicare-covered sleep test that meets one of the following criteria: - Apnea-hypopnea index or respiratory disturbance index is 15 events per hour with a minimum of 30 events. - The apnea-hypopnea index or respiratory disturbance index is 5 and 14 events per hour with a minimum of 10 events and documentation of either: Excessive daytime sleepiness, impaired cognition, mood disorders or insomnia. Hypertension, ischemic heart disease or history of stroke. - If the apnea-hypopnea index > 30 or the respiratory disturbance index > 30 and meets either of the following: The beneficiary is not able to tolerate a positive airway pressure device. The treating physician determines that the use of a positive airway pressure device is contraindicated. 3

4 The device is ordered by the treating physician following review of the report of the sleep test. (The physician who provides the order for the oral appliance could be different from the one who performed the clinical evaluation.) The device is provided and billed for by a licensed dentist (DDS or DMD). Oral maxillofacial prostheses used in the treatment of obstructive sleep apnea will be covered when specifically fashioned to the needs and measurements of individual patients when used to treat essential sleep apnea (780.53) and obstructive sleep apnea (780.57). Medically necessary surgical treatments (L34526): Uvulopalatopharyngoplasty for patients who meet all of the following criteria: - Diagnosed obstructive sleep apnea (respiratory disturbance index 15). - Failure to respond to continuous positive airway pressure or intolerance for continuous positive airway pressure or other appropriate non-invasive treatment. - Documented counseling by a physician with recognized training in sleep disorders about the potential benefits and risks of the surgery. - Evidence of retropalatal or combination retropalatal/retrolingual obstruction as cause of obstructive sleep apnea. Mandibular maxillary osteotomy and advancement and/or genioglossus advancement with or without hyoid suspension is covered for those patients who meet all of the following criteria: - Diagnosed obstructive sleep apnea (respiratory disturbance index 15). - Failure to respond to continuous positive airway pressure or intolerance to continuous positive airway pressure or other appropriate non-invasive treatment. - Documented counseling by a physician with recognized training in sleep disorders about the potential benefits and risks of the surgery. - Evidence of retrolingual obstruction as the cause of obstructive sleep apnea, or previous failure of uvulopalatopharyngoplasty to correct the obstructive sleep apnea. Note regarding the mandibular maxillary osteotomy and advancement operation: - Separate repositioning of teeth would not be necessary except under unusual circumstances, but if necessary the dental work would be covered. - Application of an interdental fixation device is occasionally necessary and is a covered service. Tracheostomy is indicated either: - When patient is unresponsive to other means of treatment. - In cases where other means of treatment would be ineffective or not indicated. Surgery to correct discrete anatomic abnormalities of the upper airway that significantly contribute to obstructive sleep apnea (such as, but not limited to, enlarged tonsils or an enlarged tongue) based on adequate documentation in the medical records. Submucous radiofrequency reduction of hypertrophied turbinates for treatment of nasal obstruction due to turbinate hypertrophy that significantly contributes to obstructive sleep apnea or significantly compromises continuous positive airway pressure therapy. 4

5 Submucosal radiofrequency tissue volume reduction of the tongue base only when performed with other medically necessary surgical procedures for the treatment of obstructive sleep apnea that has not responded to appropriate medical management. Limitations: All other treatments for obstructive sleep apnea in adult members are not medically necessary. These include treatment for snoring alone without significant obstructive sleep apnea or interventions intended to improve adherence to obstructive sleep apnea treatment with positive airway pressure. A minimum of two months of active treatment is required between each intervention. Hypoglossal nerve stimulation (also known as the Inspire II Upper Airway Stimulator, Inspire Medical Systems, Maple Grove, Minnesota) is not medically necessary, as its effectiveness has not been established. See Clinical Policy CCP.1270 Hypoglossal nerve stimulation. Limitations to oral appliances include: Replacement of oral appliances at the end of their five-year reasonable useful lifetime or prior to the end of the five-year reasonable useful lifetime due to a change in the member s condition is medically necessary. Replacement needed due to misuse or abuse is not medically necessary. Follow-up care, including fitting, adjustments, modifications, professional services (not allinclusive) required during the first 90 days after provision of the oral appliance are considered to be included in the payment for device. Dental rehabilitation services (dentures, bridgework, etc.) as treatment for obstructive sleep apnea, even if medically necessary, are not available benefits. Members should review their dental benefits plan, if any. Alternative covered services: Evaluation by participating physicians and weight management according to plan benefits if appropriate. Background Sleep apnea is a type of sleep disorder characterized by pauses in breathing (apnea) or instances of shallow or infrequent breathing during sleep. Obstructive sleep apnea is the most common type of sleep apnea, caused by an obstruction of the upper airway during sleep, characterized by repetitive pauses in breathing during sleep, despite the effort to breathe, and is usually associated with a reduction in blood oxygen saturation (Balk, 2011). Untreated obstructive sleep apnea is associated with symptoms of sleep deprivation and excessive sleepiness, cognitive dysfunction, diminished quality of life and productivity, sexual dysfunction, mood changes, increased accident risk, hypertension, non-insulin-dependent diabetes 5

6 and other metabolic abnormalities, cardiac disease, and stroke. Obstructive sleep apnea affects persons in all age groups, especially middle-aged and elderly persons, and rates are increasing, likely due to escalating obesity rates. Polysomnography performed at a sleep lab is the standard diagnostic test for obstructive sleep apnea, but it can be performed at home. Results from polysomnography are reported as the apnea-hypopnea index and respiratory disturbance index, the former being a strong and independent predictor of all-cause mortality over several years of follow up, particularly among individuals with severe obstructive sleep apnea (Balk, 2011). According to the American Academy of Sleep Medicine, severity of obstructive sleep apnea according to apnea-hypopnea index is defined as mild (five to 14 events per hour), moderate (15 to 30 events per hour), and severe (> 30 events per hour) (Qaseem, 2013). There is no current established threshold level for the apnea-hypopnea index that would indicate the need for treatment, but generally, people with relatively few apnea or hypopnea events per hour (often < 5 or < 15, respectively) are not formally diagnosed with obstructive sleep apnea (Balk, 2011). The goal of treatment is to alleviate airway obstruction during sleep, normalize sleep quality, and improve apnea-hypopnea index and oxyhemoglobin saturation levels. It may improve comorbidities associated with untreated sleep apnea, primarily cardiovascular disease and non-insulin-dependent diabetes and associated mortality (Balk, 2011; Randerath, 2011). Treatment includes behavioral therapy (e.g., weight loss), drug therapy, continuous positive airway pressure, dental or mandibular advancement devices, palatal implants, and surgery (upper airway or bariatric). New minimally invasive surgical techniques are available to achieve better patient outcomes and reduce surgical morbidity. Surgical procedures include, but are not limited to, uvulopalatopharyngoplasty, maxillomandibular advancement, multilevel surgery, and tracheostomy. Other interventions include devices to alter sleep position, physical therapy to improve oropharyngeal muscle tone, atrial overdrive pacing for patients with nocturnal bradycardia, complementary and alternative therapies, and weight loss interventions (e.g., bariatric surgery). Searches Select Health of South Carolina searched PubMed and the databases of: UK National Health Services Centre for Reviews and Dissemination. Agency for Healthcare Research and Quality. The Centers for Medicare & Medicaid Services. We conducted searches on September August 21, Search terms were: "Sleep Apnea, Obstructive/surgery" (MeSH) and "Sleep Apnea, Obstructive/therapy" (MeSH). We included: Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies. Systematic reviews use 6

7 predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidence-grading hierarchies. Guidelines based on systematic reviews. Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost studies), reporting both costs and outcomes sometimes referred to as efficiency studies which also rank near the top of evidence hierarchies. Findings Assessment of effectiveness of obstructive sleep apnea treatments is based primarily on improvement of daytime sleepiness. The effect on other clinical outcomes, including hypertension, cardiovascular events and death, is uncertain. Long-term outcomes for all interventions were rarely reported. Evidence of adverse effects related to various management strategies for obstructive sleep apnea is sparse, especially from randomized controlled trials. The most serious adverse effects were reported for surgical interventions, particularly for oronasopharyngeal or bariatric surgery. An estimated 5 percent to 15 percent of patients treated with continuous positive airway pressure reported substantial adverse effects that could be alleviated with termination or treatment modification. Tooth loosening, dental crown damage, and temporomandibular joint pain were the most commonly reported adverse effects with mandibular advancement devices. No long-term adverse effects were reported for weight-loss interventions (Balk, 2011). Among other findings: There is moderate-quality evidence supporting the effectiveness of continuous positive airway pressure for treating obstructive sleep apnea. Data to determine the comparative efficacy of most continuous positive airway pressure modifications were insufficient; however, moderatequality evidence showed that fixed and auto- continuous positive airway pressure have overall similar efficacy and adherence despite small differences, and low-quality evidence showed that C-Flex and fixed continuous positive airway pressure were similarly efficacious. These modifications are used primarily as second-line measures for patients who are intolerant to continuous positive airway pressure. The American College of Physicians, the European Respiratory Society and the American Academy of Sleep Medicine recommend continuous positive airway pressure as the first-line therapy for severe obstructive sleep apnea (Qaseem, 2013; Randerath, 2011; Aurora, 2010). There is moderate-quality evidence supporting the effectiveness of mandibular advancement devices in patients with mild to moderate obstructive sleep apnea to lower apnea-hypopnea index scores and reduce sleepiness, but the evidence is insufficient to determine the comparative effectiveness of different mandibular advancement devices. There is moderate-quality evidence that continuous positive airway pressure is more effective than mandibular advancement devices. Mandibular advancement devices are available typically for patients with mild-to-moderate disease who are unable to tolerate or refuse continuous positive airway pressure (Balk, 2011; Randerath, 2011; Aurora, 2010). 7

8 There is insufficient evidence to determine which patients would benefit the most from either continuous positive airway pressure or mandibular advancement device treatment. One recent discrete choice experiment of 121 newly diagnosed patients in France found that, when offered either device, patients preferred continuous positive airway pressure to mandibular advancement devices (60.2 percent vs percent, respectively); negative impact on daily life and effectiveness of treatment constituted the most important factors of choice ahead of side effects, but these choices could be influenced heavily by out-of-pocket expenses (Krucien, 2013). There is insufficient evidence to evaluate the efficacy of interventions to improve obstructive sleep apnea treatment adherence (primarily continuous positive airway pressure). There is low-quality evidence to support the effectiveness of dietary weight loss programs in reducing the severity of obstructive sleep apnea, but not in relieving all respiratory events. There is insufficient evidence supporting the efficacy or comparative effectiveness of other non-continuous positive airway pressure or non-surgical obstructive sleep apnea treatments. There is insufficient evidence to support the effectiveness of surgical interventions for obstructive sleep apnea treatment, except for the following: - Low-quality evidence supports the effectiveness of maxillomandibular advancement for treating severe obstructive sleep apnea when used to correct hypopharyngeal and/or velo-orohypopharyngeal narrowing with or without skeletal hypoplasia. - Low-quality evidence supports the effectiveness of uvulopalatopharyngoplasty as a single procedure for treating moderate to severe obstructive sleep apnea. - Low-quality evidence supports the effectiveness of multilevel surgery (simultaneous or phased) for treating severe obstructive sleep apnea when maxillomandibular advancement is used as the phase 2 procedure. - Sufficient evidence supports the effectiveness of tracheostomy for treating obstructive sleep apnea, but it should be used as a salvage procedure. Policy updates: For the 2014 policy update, one new systematic review (Camacho, 2014) and no new guidelines were identified. The new information is consistent with the current policy. Therefore, no changes to the policy are warranted. For the 2015 policy update, two meta-analyses (Knudsen, 2015; Okuno, 2014), and one systematic review (Ward, 2014) were identified. These new studies would not change the previous conclusions. Therefore, no changes to the policy are warranted. In 2016, we added seven systematic reviews and meta-analyses, one evidence-based guideline and no economic analyses. Three analyses addressed the effect of surgical treatments of obstructive sleep apnea: maxillomandibular advancement (Zaghi, 2016); temperature-controlled radiofrequency ablation (Baba, 2015); and glossectomy (Murphey, 2015). Each procedure was studied in persons in whom other treatment options for obstructive sleep apnea had failed. Low quality evidence suggests that temperature-controlled 8

9 radiofrequency ablation directed at the base of the tongue and glossectomy procedures are effective treatments for obstructive sleep apnea in the short-term when performed as part of a multilevel procedure, but not as stand-alone procedures (Baba, 2015; Murphey, 2015). Maxillomandibular advancement is an effective treatment for patients with high residual apnea-hypopnea index and respiratory disturbance index after other unsuccessful surgical procedures for obstructive sleep apnea, and a preoperative apnea-hypopnea index of< 60 events per hour was most strongly associated with the highest incidence of surgical cure (Zaghi, 2016). Two meta-analyses compared the effectiveness of continuous positive airway pressure and mandibular advancement devices on blood pressure and sleepiness in persons with obstructive sleep apnea (Bratton, 2015a and 2015b). Both continuous positive airway pressure and mandibular advancement devices are effective at improving blood pressure and sleepiness outcomes, although continuous positive airway pressure has a significantly greater effect on sleepiness. For persons who cannot tolerate or refuse continuous positive airway pressure, mandibular advancement devices can be offered as an effective nonsurgical option. Two other systematic reviews provide inconclusive evidence demonstrating that continuous positive airway pressure reduces the risk of stroke or improves cognition (Kim, 2016; Pan, 2015). The use and published research of oral appliances/mandibular advancement devices for treating obstructive sleep apnea have increased considerably in recent years. Consequently, the American Academy of Sleep Medicine and American Academy of Dental Sleep Medicine updated their practice guideline from 2006 on oral appliances for treatment of obstructive sleep apnea and snoring (Ramar, 2015). The guideline encourages increased use of custom, titratable oral appliances, periodic follow-up by qualified dentists to assess dental side effects, and sleep testing to assess treatment efficacy. The new information does not change previous findings, and no policy changes are warranted. In 2017, the effectiveness of maxillomandibular advancements, modifications to uvulopalatopharyngoplasty surgery, and tonsillectomy for treating obstructive sleep apnea continue to be areas of active research; results of single-arm studies suggest each intervention can effectively treat obstructive sleep apnea, but comparative studies are lacking. An evidence report produced for the U.S. Preventive Services Task Force confirmed the benefit continuous positive airway pressure, weight loss surgery, and mandibular advancement devices in reducing apnea-hypopnea index, Epworth sleepiness scale scores, and blood pressure (Jonas, 2017). This information is consistent with previous finding, and no policy changes are warranted. In 2018, we added InterQual criteria for durable medical equipment that includes positive airway pressure devices and mandibular advancement devices and for surgical options for obstructive sleep apnea (InterQual, 2018a-b). These criteria are consistent with the current policy, and no changes are warranted. Policy ID changed from CP# to CCP Summary of clinical evidence: 9

10 Citation Jonas (2017) for the U.S. Preventive Services Task Force Screening for obstructive sleep apnea in adults Kim (2016) Effect of continuous positive airway pressure on stroke Zaghi (2016) Maxillomandibular advancement Baba (2015) Content, Methods, Recommendations Systematic review of 110 studies (46,188 total patients). Uncertainty about the accuracy or clinical utility of all potential screening tools. Continuous positive airway pressure v. sham (weighted mean difference [WMD], 95% confidence interval [CI]: - Apnea-hypopnea index (-33.8, to -25.6; 13 trials, 543 participants). - Epworth sleepiness scale (-2.0, -2.6 to -1.4; 22 trials, 2,721 participants). - Diurnal systolic blood pressure (-2.4 points, -3.9 to -0.9; 15 trials, 1,190 participants). - Diurnal diastolic blood pressure (-1.3 points, -2.2 to -0.4; 15 trials, 1,190 participants). - Sleep-related quality of life (Cohen d, 0.28 [95% CI, 0.14 to 0.42]; 13 trials, 2,325 participants). Mandibular advancement devices and weight loss programs reduced apneahypopnea index and excessive sleepiness. Effects of continuous positive airway pressure and other treatments on mortality or most other health outcomes are unclear. Systematic review and meta-analysis of one randomized controlled trial, two cohort studies, and two studies using administrative health data (60,186 total subjects). Overall quality: moderate. Low risk of bias in the randomized controlled trial, moderate or unclear risk of bias in other studies. Continuous positive airway pressure may reduce the risk of stroke, but results are conflicting. Pooled analysis of individual patient data from 45 studies with 518 unique patients/interventions; 197 patients had undergone prior surgery for obstructive sleep apnea. Significant improvements seen in the apnea-hypopnea index and respiratory disturbance index, oxygen saturation and sleepiness post operatively. Surgical cure rate: 175 of 455 patients (38.5%) based on apnea-hypopnea index data and 13 of 68 patients (19.1%) based on respiratory disturbance index data. Preoperative apnea-hypopnea index < 60 events/h was most strongly associated with the highest incidence of surgical cure. Patients with a preoperative apnea-hypopnea index > 60 events/h experienced large and substantial net improvements despite modest surgical cure rates. Temperature controlled radiofrequency tissue ablation Systematic review and meta-analysis of 20 studies. Overall quality: low. High risk of bias and significant heterogeneity. Temperature controlled radiofrequency tissue ablation is clinically effective in reducing respiratory disturbance index levels and symptoms of sleepiness in the short-term in patients with obstructive sleep apnea syndrome when directed at the 10

11 Citation Knudsen (2015) Maxillomandibular advancement with counterclockwise rotation Murphey (2015) Glossectomy Ramar (2015) for the American Academy of Sleep Medicine and American Academy of Dental Sleep Medicine Clinical practice guideline for the treatment of obstructive sleep apnea and snoring with oral appliance therapy in adults Canadian Agency for Drugs and Technologies in Health (2012) Adaptive servo ventilation, continuous positive airway pressure, bi-level positive airway pressure Content, Methods, Recommendations base of tongue as part of a multilevel procedure. Effect on apnea-hypopnea index was not consistently reported. Studies with longer-term outcomes are needed. Meta-analysis of four randomized controlled trials. Postoperative apnea-hypopnea index and lowest oxygen saturation showed vast improvement. Insufficient sample size to correlate pharyngeal volume changes and surgical method. Counterclockwise -maxillomandibular advancement or maxillomandibular advancement in patients with obstructive sleep apnea results in a statistically meaningful decrease in postoperative apnea-hypopnea index and a statistically meaningful increase in postoperative lowest oxygen saturation. Systematic review and meta-analysis of 18 single-arm studies (522 total patients treated with midline glossectomy, lingualplasty, and submucosal minimally invasive lingual excision). Baseline versus post-surgery as part of multilevel surgery: Significant improvement in apnea-hypopnea index, Epworth sleepiness scale, snoring visual analog scale, and lowest O2 saturation. Surgical success rate 59.6% (95% CI 53.0% to 65.9%), surgical cure rate 22.5% (95% CI 11.26% to 36.26%), acute complication rate 16.4%. Currently, there is promising but insufficient evidence to support glossectomy as a stand-alone procedure for obstructive sleep apnea. Key recommendations: Prescribe oral appliances, rather than no therapy, for adults who request treatment of primary snoring (without obstructive sleep apnea). Use a custom, titratable appliance over non-custom oral devices. Prescribe oral appliances, rather than no treatment, if intolerant of continuous positive airway pressure therapy or prefer alternate therapy. Provide dental oversight to survey for dental-related side effects or occlusal changes and reduce their incidence. Conduct follow-up sleep testing to improve or confirm treatment efficacy. Encourage periodic office visits, as opposed to no follow-up. Rapid review of one systematic review, one randomized controlled trial, one nonrandomized study and one guideline. Adaptive servo ventilation is effective in treating obstructive sleep apnea and congestive heart failure compared with continuous positive airway pressure or bi-level positive airway pressure. No evidence for the cost-effectiveness of adaptive servo ventilation vs. either positive airway pressure device for sleep apnea or congestive heart failure. Mostly industry-sponsored studies, uncertainty regarding the optimal settings for use. 11

12 Citation Agency for Healthcare Research and Quality (2011) Multiple interventions Randerath (2011) European Respiratory Society Task Force Non-continuous positive airway pressure interventions Caples (2010) Content, Methods, Recommendations Systematic review of 132 randomized controlled trials, six prospective nonrandomized comparative studies, five retrospective nonrandomized. Overall quality: Low to moderate. Few trials evaluated objective clinical outcomes and limited by short follow-ups, high dropout rates, and poor analyses and reporting. Continuous positive airway pressure: Effective in minimizing apnea-hypopnea index and improving sleepiness (moderate evidence); auto-titrating and fixed continuous positive airway pressure have similar effects (moderate evidence); comparisons to other continuous positive airway pressure devices (insufficient evidence). Mandibular advancement devices: overall effective (moderate evidence); continuous positive airway pressure is superior to mandibular advancement devices (moderate). Drug therapy: insufficient evidence. All other interventions, including surgery: insufficient evidence to compare outcomes between surgical procedures or between surgery and either continuous positive airway pressure or mandibular advancement device. Apnea-hypopnea index and Epworth Sleepiness Scale are independent predictors of continuous positive airway pressure compliance; low evidence that some treatments improve continuous positive airway pressure compliance. Evidence supports the use of mandibular advancement devices in mild to moderate obstructive sleep apnea. There is a trend toward improvement after weight loss. Positional therapy is clearly inferior to continuous positive airway pressure and longterm compliance is poor. Drugs, nasal dilators and apnea-triggered muscle stimulation: insufficient evidence. Maxillomandibular advancement is as efficient as continuous positive airway pressure in patients who refuse conservative treatment with some morbidity. Nasal surgery, radiofrequency tonsil reduction, tongue base surgery, uvulopalatal flap, laser midline glossectomy, tongue suspension and genioglossus advancement: insufficient evidence. Uvulopalatopharyngoplasty, pillar implants, and hyoid suspension: inconsistent results, most evidence available for uvulopalatopharyngoplasty. Multilevel surgery: inconsistent results regarding morbidity. Surgery Systematic review of 79 papers (three randomized controlled trials of single procedures, one randomized controlled trial of multilevel procedures, 44 case series of single procedures, 31 case series of multilevel procedures). Overall low quality; highly selected patients, varied preoperative and surgical approaches. Maxillomandibular advancement: Substantial and consistent reductions in apneahypopnea index for severe obstructive sleep apnea caused by hypopharyngeal and/or velo-orohypopharyngeal narrowing with or without skeletal hypoplasia; adverse events uncommonly reported. 12

13 Citation Content, Methods, Recommendations Uvulopalatopharyngoplasty: Used for moderate to severe obstructive sleep apnea as single procedure but inconsistent reduction in apnea-hypopnea index with some morbidity reported; often modified or combined with other surgical modifications. Other isolated pharyngeal/soft palatal interventions: for severe obstructive sleep apnea, inconsistent results often with significant residual obstructive sleep apnea post-surgery, poorly reported. Radiofrequency ablation: low-quality evidence for mild to moderate obstructive sleep apnea. Multilevel surgery (simultaneous or phased): low-quality evidence, likely that significant benefit of phased surgeries for patients failing phase one treatment were derived from maxillomandibular advancement used as phase two treatment. References Professional society guidelines/other: Aurora RN, Casey KR, Kristo D, et al. Practice parameters for the surgical modifications of the upper airway for obstructive sleep apnea in adults. Sleep Oct; 33(10): National Center for Biotechnology Information website. Accessed August 21, InterQual Durable Medical Equipment Criteria. Noninvasive Airway Assistive Devices. Change Healthcare LLC.(a) InterQual Medicare: Procedures Criteria. Surgical treatment of obstructive sleep apnea (OSA). Change Healthcare LLC.(b) Qaseem A, Holty JE, Owens DK, et al. Management of obstructive sleep apnea in adults: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2013; 159(7): DOI: / 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 J Clin Sleep Med. 2015; 11(7): DOI: /jcsm Randerath WJ, Verbraecken J, Andreas S, et al. Non-continuous positive airway pressure therapies in obstructive sleep apnoea. Eur Respir J May; 37(5): DOI: / Peer-reviewed references: Balk EM, Moorthy D, Obadan NO, et al. Diagnosis and Treatment of Obstructive Sleep Apnea in Adults [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2011 Jul. (Comparative 13

14 Effectiveness Reviews, No. 32.) National Center for Biotechnology Information website. Accessed August 21, Baba RY, Mohan A, Metta VV, Mador MJ. Temperature controlled radiofrequency ablation at different sites for treatment of obstructive sleep apnea syndrome: a systematic review and meta-analysis. Sleep Breath. 2015; 19(3): DOI: /s y. Bratton DJ, Gaisl T, Schlatzer C, Kohler M. Comparison of the effects of continuous positive airway pressure and mandibular advancement devices on sleepiness in patients with obstructive sleep apnoea: a network meta-analysis. Lancet Respir Med. 2015; 3(11): (a) DOI: /s (15) Bratton DJ, Gaisl T, Wons AM, Kohler M. CPAP vs mandibular advancement devices and blood pressure in patients with obstructive sleep apnea: a systematic review and meta-analysis. Jama. 2015; 314(21): (b) DOI: /jama Camacho M, Certal V, Brietzke SE, et al. Tracheostomy as treatment for adult obstructive sleep apnea: a systematic review and meta-analysis. Laryngoscope Mar; 124(3): DOI: /lary Canadian Agency for Drugs and Technologies in Health. Adaptive servo ventilation versus continuous or bilevel positive airway pressure: a review of the clinical effectiveness, cost-effectiveness and guidelines. Ottawa: Canadian Agency for Drugs and Technologies in Health; Caples SM, Rowley JA, Prinsell JR, et al. Surgical modifications of the upper airway for obstructive sleep apnea in adults: a systematic review and meta-analysis. Sleep Oct; 33(10): National Center for Biotechnology Information website. Accessed August 21, Iftikhar IH, Khan MF, Das A, Magalang UJ. Meta-analysis: continuous positive airway pressure improves insulin resistance in patients with sleep apnea without diabetes. Ann Am Thorac Soc Apr; 10(2): DOI: /jcsm Jonas DE, Amick HR, Feltner C, et al. Screening for obstructive sleep apnea in adults: evidence report and systematic review for the US Preventive Services Task Force. Jama. 2017; 317(4): DOI: /jama Kim Y, Koo YS, Lee HY, Lee SY. Can continuous positive airway pressure reduce the risk of stroke in obstructive sleep apnea patients? A systematic review and meta-analysis. PLoS One. 2016; 11(1): e DOI: /journal.pone Knudsen TB, Laulund AS, Ingerslev J, Homoe P, Pinholt EM. Improved apnea-hypopnea index and lowest oxygen saturation after maxillomandibular advancement with or without counterclockwise rotation in patients with obstructive sleep apnea: a meta-analysis. J Oral Maxillofac Surg. 2015; 73(4): DOI: /j.joms

15 Krucien N, Gafni A, Fleury B, Pelletier-Fleury N. Patients with obstructive sleep apnoea syndrome (OSAS) preferences and demand for treatment: a discrete choice experiment. Thorax May; 68(5): DOI: /thoraxjnl Murphey AW, Kandl JA, Nguyen SA, Weber AC, Gillespie MB. The effect of glossectomy for obstructive sleep apnea: a systematic review and meta-analysis. Otolaryngol Head Neck Surg. 2015; 153(3): DOI: / Okuno K, Sato K, Arisaka T, et al. The effect of oral appliances that advanced the mandible forward and limited mouth opening in patients with obstructive sleep apnea: a systematic review and meta-analysis of randomised controlled trials. J Oral Rehabil. 2014; 41(7): DOI: /joor Pan YY, Deng Y, Xu X, Liu YP, Liu HG. Effects of continuous positive airway pressure on cognitive deficits in middle-aged patients with obstructive sleep apnea syndrome: a meta-analysis of randomized controlled trials. Chin Med J (Engl). 2015; 128(17): DOI: / Ward K, Hoare KJ, Gott M. What is known about the experiences of using CPAP for OSA from the users' perspective? A systematic integrative literature review. Sleep medicine reviews. 2014; 18(4): DOI: /j.smrv Zaghi S, Holty JE, Certal V, et al. Maxillomandibular advancement for treatment of obstructive sleep apnea: a meta-analysis. JAMA Otolaryngol Head Neck Surg. 2016; 142(1): DOI: /jamaoto Centers for Medicare & Medicaid Services National Coverage Determinations: Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea (OSA) Sleep Testing for Obstructive Sleep Apnea (OSA). Local Coverage Determinations: A52512 Oral Appliances for Obstructive Sleep Apnea. A53497 Oral Maxillofacial Prosthesis. A52467 Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea. L33611 Oral Appliances for Obstructive Sleep Apnea. L35047 Oral Maxillofacial Prosthesis. 15

16 L33718 Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea. L34526 Surgical Treatment of Obstructive Sleep Apnea (OSA). Commonly submitted codes Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill accordingly. CPT Code Description Comment Impression and custom preparation; oral surgical splint Reconstruction of mandibular rami, horizontal, vertical, c, or l osteotomy; without bone graft Reconstruction of mandibular rami, horizontal, vertical, c, or l osteotomy; with bone graft (includes obtaining graft) Reconstruction of mandibular rami and/or body, sagittal split; without internal rigid fixation Reconstruction of mandibular rami and/or body, sagittal split; with internal rigid fixation Osteotomy, mandible, segmental Osteotomy, mandible, segmental; with genioglossus advancement Osteotomy, maxilla, segmental (e.g., wassmund or schuchard) Osteoplasty, facial bones; augmentation (autograft, allograft or prosthetic implant) Osteoplasty, facial bones; reduction Hyoid myotomy and suspension Tracheostomy, planned (separate procedure) Tongue base suspension, permanent suture technique Submucosal ablation of the tongue base, radiofrequency, 1 or more sites, per session Unlisted procedure, tongue, floor of mouth Uvulectomy, excision of uvula Palatopharyngoplasty (e.g., uvulopalatopharyngoplasty, uvulopharyngoplasty) Unlisted procedure, palate, uvula Tonsillectomy and adenoidectomy; age 12 or over Continuous positive airway pressure ventilation (continuous positive airway pressure), initiation and management. ICD-10 Code Description Comment G47.31 Obstructive sleep apnea (adult) (pediatric). 16

17 HCPCS Level II Code A4604 A7027 A7028 A7029 A7030 A7031 A7032 A7033 A7034 A7035 A7036 A7037 A7038 A7039 A7044 A7045 A7046 E0485 E0486 E0601 Description Tubing with integrated heating element for use with positive airway pressure device [4 per 12 months]. Combination oral/nasal mask, used with continuous positive airway pressure device, each [4 per 12 months]. Oral cushion for combination oral/nasal mask, replacement only, each [24 per 12 months]. Nasal pillows for combination oral/nasal mask, replacement only, pair [24 per 12 months]. Full face mask used with positive airway pressure device, each [4 per 12 months][replacement device is not covered due to misuse or abuse]. Face mask interface, replacement for full face mask, each [12 per 12 months] [replacement device is not covered due to misuse or abuse]. Cushion for use on nasal mask interface, replacement only, each [24 per 12 months] [replacement device is not covered due to misuse or abuse]. Pillow for use on nasal cannula type interface, replacement only, pair [24 per 12 months] [replacement device is not covered due to misuse or abuse]. Nasal interface (mask or cannula type) used with positive airway pressure device, with or without head strap [4 per 12 months][replacement device is not covered due to misuse or abuse]. Headgear used with positive airway pressure device [2 per 12 months] [replacement device is not covered due to misuse or abuse]. Chinstrap used with positive airway pressure device [2 per 12 months] [replacement device is not covered due to misuse or abuse]. Tubing used with positive airway pressure device [4 per 12 months] [replacement device is not covered due to misuse or abuse]. Filter, disposable, used with positive airway pressure device [24 per 12 months] [replacement device is not covered due to misuse or abuse]. Filter, non-disposable, used with positive airway pressure device [2 per 12 months] [replacement device is not covered due to misuse or abuse]. Oral interface used with positive airway pressure device, each. Exhalation port with or without swivel used with accessories for positive airway devices, replacement only. Water chamber for humidifier, used with positive airway pressure device, replacement, each [2 per 12 months]. Oral device/appliance used to reduce upper airway collapsibility, adjustable or non-adjustable, prefabricated, includes fitting and adjustment [covered only for obstructive sleep apnea in persons that meet criteria for continuous positive airway pressure but who are intolerant to positive airway pressure devices]. Oral device/appliance used to reduce upper airway collapsibility, adjustable or non-adjustable, custom fabricated, includes fitting and adjustment. Continuous airway pressure (continuous positive airway pressure) device [for obstructive sleep apnea with apnea-hypopnea index 15 or > = to 15 events per hour with minimum of 30 or apnea-hypopnea index > 5 and < 15 events per hour with minimum of 10 + one related diagnosis] [not covered for C-Flex]. Comment May be evaluated under medical or dental benefits for covered benefits. May be evaluated under medical or dental benefits for covered benefits. 17