Clinical Policy Title: Treatment for Obstructive Sleep Apnea in Adults

Clinical Policy Title: Treatment for Obstructive Sleep Apnea in Adults Clinical Policy Number: 07.01.01 Effective Date: March 1, 2015 Initial Review Date: Oct. 16, 2013 Most Recent Review Date: Nov. 15, 2014 Next Review Date: October 2015 Policy contains: Positive airway pressure devices. Oral appliances. Surgery. RELATED POLICIES: None ABOUT THIS POLICY: Keystone First has developed clinical policies to assist with making coverage determinations. Keystone First 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 Keystone First 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. Keystone First 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. Keystone First clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, Keystone First will update its clinical policies as necessary. Keystone First clinical policies are not guarantees of payment. Coverage Policy Keystone First considers the use of treatments for obstructive sleep apnea in adults age 18 years and older to be clinically proven and, therefore, medically necessary when the following diagnostic and treatment criteria are met: Diagnostic Criteria Diagnosis of OSA 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 OSA is defined as follows: 1. Severe OSA based on an apnea hypopnea index (AHI) or respiratory disturbance index (RDI) 30 events per hour. 2. Moderate OSA based on an AHI or RDI 15 events per hour but < 30 events per hour. 3. Mild OSA based on an AHI or RDI 5 events but < 15 events per hour. 1

AND Treatment Criteria Continuous positive airway pressure (CPAP) or autopap should be offered as the initial therapy. 1. Coverage is limited initially to a 12-week period to identify members diagnosed with OSA who benefit from CPAP or autopap. 2. CPAP or autopap is subsequently covered only for those beneficiaries diagnosed with OSA who benefitted from CPAP during this 12-week period. Mandibular advancement removable oral appliances may be offered as an initial treatment: 1. For members with documented mild to moderate OSA; or 2. For patients with documented severe OSA who cannot tolerate or refuse PAP treatment. The following surgical treatments may be offered after six-month failure of noninvasive therapies: 1. Uvulopalatopharyngoplasty (UPPP) as a single surgery or in phased surgery for members who meet the criteria for CPAP or autopap but who are intolerant to PAP treatment. 2. Maxillomandibular advancement (MMA) with or without genioglossal advancement for persons diagnosed with severe OSA and who fail other treatment approaches. 3. Tracheostomy for members with the most severe OSA not manageable by other interventions. 4. Surgery to correct discrete anatomic abnormalities of the upper airway that significantly contribute to OSA (including, but not limited to, enlarged tonsils or an enlarged tongue) based on adequate documentation in the medical records. FOR MEDICARE MEMBERS ONLY I. PAP (positive airway pressure) A. Single-level CPAP (E0601) covered when used in the treatment of OSA, if following criteria 1 3 are met: 1. 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. 2. The beneficiary has sleep test (as defined below) that meets either of the following criteria: a. AHI or RDI is 15 events per hour with a minimum of 30 events; or b. AHI or RDI 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. 3. The beneficiary and/or their caregiver has received instruction from the supplier of the device in the proper use and care of the equipment. B. Bi-level respiratory assist device without back-up rate (E0470) covered for those beneficiaries with OSA who meet criteria 1 3 above, in addition to criterion 4 below: 2

4. An E0601 has been tried and proven ineffective based on a therapeutic trial conducted in either a facility or in a home setting. C. Adult beneficiaries who do not qualify for CPAP coverage based on criteria for OSA diagnosi, do qualify under Coverage with Evidence Determination when enrolled in a registered clinical research study that addresses one of the two questions below: 1. In Medicare-aged subjects with clinically identified risk factors for OSA, how does the diagnostic accuracy of a clinical trial of CPAP compare with PSG and Types II, III and IV HST in identifying subjects with OSA who will respond to CPAP? 2. In Medicare-aged subjects with clinically identified risk factors for OSA who have not undergone confirmatory testing with PSG or Types II, III and IV HST, does CPAP cause clinically meaningful harm? II. Surgical treatment A. Medicare also covers submucous radiofrequency reduction of hypertrophied turbinates for treatment of nasal obstruction due to turbinate hypertrophy that significantly contributes to OSA or significantly compromises CPAP therapy. III. Oral appliances are considered medically necessary if following criteria A D are met: A. 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 testing. B. Beneficiary has a Medicare-covered sleep test that meets one of the following criteria (1 3): 1. AHI or RDI is 15 events per hour with a minimum of 30 events. 2. The AHI or RDI is 5 and 14 events per hour with a minimum of 10 events and documentation of: a. Excessive daytime sleepiness, impaired cognition, mood disorders or insomnia; or b. Hypertension, ischemic heart disease or history of stroke. 3. If the AHI > 30 or the RDI > 30 and meets either of the following: a. The beneficiary is not able to tolerate a positive airway pressure (PAP) device; or b. The treating physician determines that the use of a PAP device is contraindicated. C. 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 in criterion A.). D. The device is provided and billed for by a licensed dentist (DDS or DMD). E. Oral maxillofacial prostheses used in the treatment of obstructive sleep apnea (OSA) 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). IV. Covered surgical treatments A. UPPP for patients who meet all of the following criteria: 1. Diagnosed OSA (RDI 15). 2. Failure to respond to CPAP or intolerance for CPAP or other appropriate non-invasive treatment. 3. Documented counseling by a physician with recognized training in sleep disorders about the potential benefits and risks of the surgery. 4. Evidence of retropalatal or combination retropalatal/retrolingual obstruction as cause of OSA. B. 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: 1. Diagnosed OSA (RDI 15). 3

2. Failure to respond to CPAP or intolerance for CPAP or other appropriate non-invasive treatment. 3. Documented counseling by a physician with recognized training in sleep disorders about the potential benefits and risks of the surgery. 4. Evidence of retrolingual obstruction as the cause of OSA, or previous failure of UPPP to correct the obstructive sleep apnea. Note regarding the mandibular maxillary osteotomy and advancement operation: a. Separate repositioning of teeth would not be necessary except under unusual circumstances, but if necessary the dental work would be covered. b. Application of an interdental fixation device is occasionally necessary, and is a covered service. C. Tracheostomy is indicated: 1. When patient is unresponsive to other means of treatment; or 2. In cases where other means of treatment would be ineffective or not indicated. D. Surgery to correct discrete anatomic abnormalities of the upper airway that significantly contribute to OSA (such as, but not limited to, enlarged tonsils or an enlarged tongue) based on adequate documentation in the medical records. E. Submucous radiofrequency reduction of hypertrophied turbinates for treatment of nasal obstruction due to turbinate hypertrophy that significantly contributes to OSA or significantly compromises CPAP therapy. Limitations: All other treatments for OSA in adults are not medically necessary. These include treatment for snoring alone without significant OSA or interventions intended to improve adherence to OSA treatment with PAP. Limitations of oral appliances: o Replacement of oral appliances at the end of their five-year reasonable useful lifetime (RUL) or prior to the end of the five-year RUL due to a change in the member s condition. Replacement needed due to misuse or abuse is not covered. o 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. o Dental rehabilitation services (dentures, bridgework, etc.) as treatment for OSA, even if medically necessary, are not available benefits. Members should review their dental benefits plan, if any. A minimum of two months of active treatment is required between each intervention. 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 (OSA) is the most common type of sleep apnea, caused by an obstruction of the upper airway during sleep. Airflow obstruction arises when the muscles in the back of the throat fail to keep the airway open. OSA is characterized by repetitive pauses in breathing during sleep, despite the effort to breathe, and is usually associated with a reduction in blood oxygen saturation. Apneic episodes typically last 20 to 40 seconds. Apnea differs from hypopnea, which 4

involves episodes of overly shallow breathing or an abnormally low respiratory rate with some air flow (Hayes 2013). OSA is an important public health issue due to associated morbidity and mortality rates. Untreated OSA 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 and other metabolic abnormalities, cardiac disease, and stroke. OSA affects persons in all age groups, especially middle-aged and elderly persons. Evidence shows that OSA rates are increasing, likely due to escalating obesity rates (AHRQ 2011). Various diagnostic studies and treatment approaches are employed in managing this condition. Polysomnography performed at a sleep lab is the standard diagnostic test for OSA, and it can be performed at home. Results from polysomnography are reported as the apnea-hypopnea index (AHI) and the respiratory disturbance index (RDI). The AHI is an index used to assess the severity of sleep apnea based on the total number of complete cessations (apnea) and partial obstructions (hypopnea) of breathing occurring per hour of sleep. The AHI is a strong and independent predictor of all-cause mortality over several years of follow up, with the association being strongest among people with severe OSA(AHRQ 2011). The respiratory disturbance index (RDI) measures the number of respiratory-effort related arousals that disrupt sleep, as well as apnea and hypopnea events. There is no current established threshold level for the AHI that would indicate the need for treatment, but generally, people with relatively few apnea or hypopnea events per hour (often < 5 or < 15) are not formally diagnosed with OSA (AHRQ 2011). According to the American Academy of Sleep Medicine, severity of OSA classified according to AHI is defined as mild if 5 14 events per hour, moderate if 15 30 events per hour, and severe if > 30 events per hour (Qaseem 2013). The goal of OSA treatment is to alleviate airway obstruction during sleep. Outcomes of interest include resolution of the clinical signs and symptoms of OSA and the normalization of sleep quality and AHI and oxyhemoglobin saturation levels. Objective and relevant clinical outcomes include comorbidities associated with untreated sleep apnea, primarily cardiovascular disease and non-insulin-dependent diabetes. Other important adverse outcomes of OSA include mortality due to cardiovascular disease, diabetes, motor vehicle accidents and other causes (AHRQ 2011; Randerath 2011). Treatment of OSA includes behavioral therapy (e.g., weight loss), drug therapy, continuous positive airway pressure (CPAP), dental or mandibular advancement devices (MADs), palatal implants, and surgery (upper airway or bariatric). According to the American College of Physicians, the European Respiratory Society and the American Academy of Sleep Medicine, CPAP is the first-line therapy for severe OSA (Qaseem 2013; Randerath 2011; Aurora 2010). CPAP delivers compressed air into the airway to keep it open, serving as a "pneumatic splint" in order to prop open the airways during inspiration. However, many patients do not tolerate CPAP. To improve adherence, many technological modifications have been made to CPAP devices, primarily in altering when air pressure is delivered during the breathing cycle. These include, but are not limited to, BiPAP, DPAP, VPAP, AutoPAP, expiratory positive airway pressure (EPAP) nasal devices and adaptive servo-ventilation (ASV). These variations are used primarily as second-line measures for patients who are intolerant to CPAP. 5

A variety of oral appliances and prostheses, including tongue retainers and MADs, have been used to treat patients with OSA. MADs reposition the lower jaw forward and downward during sleep with the goal of widening the upper airways in order to improve upper airway patency and reduce snoring and OSA. MADs are available typically for patients with mild-to-moderate disease who are unable to tolerate CPAP or who refuse CPAP (AHRQ 2011; Randerath 2011; Aurora 2010). Surgical interventions are performed to remove obstructive tissue. New, minimally invasive surgical techniques are currently being developed to achieve better patient outcomes and reduce surgical morbidity. Surgical procedures include, but are not limited to, uvulopalatopharyngoplasty (UPPP), maxillomandibular advancement (MMA), multilevel surgery, radiofrequency ablation of the soft palate and/or tongue, laser-assisted uvulopalatoplasty (LAUP), palatal implants (e.g., Pillar implant), 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 medicine, and interventions to achieve weight loss, including bariatric surgery. Methods Searches Keystone First searched PubMed and the databases of: UK National Health Services Centre for Reviews and Dissemination. Agency for Healthcare Research and Quality s National Guideline Clearinghouse and other evidence-based practice centers. The Centers for Medicare & Medicaid Services. Initial searches were conducted on September 14, 2013 using the terms ("Sleep Apnea, Obstructive/surgery"[MeSH] or "Sleep Apnea, Obstructive/therapy"[MeSH].. Included were: 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 predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidencegrading 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 OSA 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 on adverse effects related to various management strategies for OSA is sparse, especially from RCTs. 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 CPAP reported adverse effects that they considered to be substantial but could be alleviated with termination or modification of the treatment. Tooth loosening, dental crown damage and temporomandibular joint pain were the most commonly reported adverse effects with MADs. No long-term adverse effects were reported for weight-loss interventions (AHRQ 2011). 6

Other findings include: There is moderate-quality evidence supporting the effectiveness of CPAP for treating OSA. Data to determine the comparative efficacy of most CPAP modifications were insufficient; however, moderatequality evidence showed that fixed and auto-cpap have overall similar efficacy and adherence despite small differences, and low-quality evidence showed that C-Flex and fixed CPAP were similarly efficacious. There is moderate-quality evidence supporting the effectiveness of MADs in patients with mild to moderate OSA to lower AHI scores and reduce sleepiness, but the evidence is insufficient to determine the comparative effectiveness of different MADs. There is moderate quality evidence that CPAP is more effective than MADs. There is insufficient evidence to determine which patients would benefit the most from either CPAP or MAD treatment. One recent discrete choice experiment of 121 newly diagnosed patients in France found that, when offered CPAP or MADs, patients preferred CPAP to MADs (60.2 percent vs. 36.2 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 OSA treatment adherence (primarily CPAP). There is low-quality evidence to support the effectiveness of dietary weight loss programs in reducing the severity of OSA, but not in relieving all respiratory events. There is insufficient evidence supporting the efficacy or comparative effectiveness of other non-cpap or non-surgical OSA treatments. There is insufficient evidence to support the effectiveness of surgical interventions for OSA treatment, with the following exceptions: o There is low-quality evidence supporting the effectiveness of MMA for treating severe OSA when used to correct hypopharyngeal and/or velo-orohypopharyngeal narrowing with or without skeletal hypoplasia. o There is low-quality evidence supporting the effectiveness of UPPP as a single procedure for treating moderate to severe OSA. o There is low-quality evidence supporting the effectiveness of multilevel surgery (simultaneous or phased) for treating severe OSA when MMA is used as the phase 2 procedure. o There is sufficient evidence supporting the effectiveness of tracheostomy for treating OSA, but should be used as a salvage procedure. Summary of Clinical Evidence Citation Caples 2010 Surgery Content, Methods, Recommendations Systematic review of 79 papers (three RCTs of single procedures, one RCT 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. MMA: Defined as hypopharyngeal and/or velo-orohypopharyngeal narrowing with or without skeletal hypoplasia. Substantial and consistent reductions in AHI across studies 7

Citation AHRQ 2011 PAP devices. Oral appliances and dental devices. Positional therapy. Weight loss interventions. Physical therapy, training, or strengthening of the airway. Surgery (airway or bariatric). Drug therapy. Miscellaneous interventions (including drugs, complementary and alternative medicine, and atrial overdrive pacing). Randerath 2011 European Respiratory Society Task Force Non-CPAP interventions CADTH 2012 Adaptive servo Content, Methods, Recommendations for severe OSA; adverse events uncommonly reported. UPPP: for moderate to severe OSA as single procedure but inconsistent reduction in AHI with some morbidity reported; often modified or combined with other surgical modifications. Other isolated pharyngeal/soft palatal interventions: for severe OSA, inconsistent results often with significant residual sleep apnea post-surgery, poorly reported. Radiofrequency ablation: low-quality evidence for mild to moderate OSA. Multilevel surgery (simultaneous or phased): low quality evidence, likely that significant benefit of phased surgeries for patients failing phase one treatment were derived from MMA used as phase two treatment. Systematic review of 132 RCTs, six prospective nonrandomized comparative studies, five retrospective nonrandomized. Few trials evaluated objective clinical outcomes. Studies were generally of moderate to poor quality, with short follow-ups, high dropout rates, and poor analyses and reporting. Continuous positive airway pressure (CPAP): effective in minimizing AHI and improving sleepiness (moderate evidence); autotitrating and fixed CPAP have similar effects (moderate); insufficient evidence regarding comparisons of other CPAP devices. Oral devices: overall effective (moderate evidence); CPAP is superior to oral devices (moderate). Drug therapy: insufficient evidence. All other interventions, including surgery: insufficient evidence to compare outcomes between surgical procedures or between surgery and either CPAP or MAD. AHI and Epworth Sleepiness Scale are independent predictors of CPAP compliance; low evidence that some treatments improve CPAP compliance. Evidence supports the use of mandibular advancement devices in mild to moderate OSA. There is a trend towards improvement after weight loss. Positional therapy is clearly inferior to CPAP and long-term compliance is poor. Drugs, nasal dilators and apnea-triggered muscle stimulation: insufficient evidence. MMA as efficient as CPAP in patients who refuse conservative treatment, some morbidity. Nasal surgery, radiofrequency tonsil reduction, tongue base surgery, uvulopalatal flap, laser midline glossectomy, tongue suspension and genioglossus advancement: insufficient evidence. UPPP, pillar implants and hyoid suspension: inconsistent results, most evidence available for UPPP. Multilevel surgery: inconsistent results with morbidity. One systematic review, one RCT, one non-randomized study and one guideline suggest that ASV is effective in treating sleep apnea and CHF compared with CPAP or 8

Citation ventilation (ASV) CPAP BiPAP Hayes 2012 Provent nasal device (Ventus Medical Inc.) Tomfohr 2012 CPAP on cortisol levels Anandam 2013 Dietary weight loss programs Baessler 2013 CPAP on inflammatory markers CRP, TNF-α, and IL-6 Choi 2013 Pillar implant Mason 2013 Cochrane review Drug therapy Iftikhar 2013 CPAP on insulin resistance in nondiabetic patients Content, Methods, Recommendations BiPAP. No evidence re: the cost-effectiveness of ASV vs. conventional CPAP or BiPAP for sleep apnea or CHF. Mostly industry-sponsored studies, uncertainty regarding the optimal settings for use. Low-quality evidence results inconclusive. No clear evidence that OSA is associated with alterations in cortisol levels or that treatment with CPAP changes cortisol levels. Meta-analysis of nine studies. Dietary weight-loss programs are effective in reducing the severity of OSA but not adequate in relieving all respiratory events. Weight loss programs are adjunctive, not curative. Meta-analysis of 23 case-control studies. Inconclusive evidence with high uncertainty. Systematic review of seven studies of patients with mild-to-moderate OSA. Inconclusive evidence. Systematic review of 30 trials of 25 drugs, n = 516. The overall quality of the available evidence was low. Inconclusive evidence. Systematic review of five RCTs. Evidence shows a favorable effect of CPAP on insulin resistance as measured by HOMA-IR. Effect size is modest, but not insignificant, vs. thiazolidinedione in nondiabetic patients with metabolic syndrome. POLICY UPDATE OCTOBER 2014 Methods Searches Keystone First searched PubMed and the databases of: UK National Health Services Centre for Reviews and Dissemination. Agency for Healthcare Research and Quality s National Guideline Clearinghouse and other evidence-based practice centers. The Centers for Medicare & Medicaid Services. 9

Searches were conducted on October 5, 2014 using the terms ("Sleep Apnea, Obstructive/surgery"[MeSH] or "Sleep Apnea, Obstructive/therapy"[MeSH]), limited to articles published from September 1, 2013 to October 5, 2014. Included were: 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 predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidencegrading 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 For this policy update, one new systematic review and no new guidelines were identified. The new information is consistent with the current policy. Therefore, no changes to the policy are warranted. Summary of Clinical Evidence Citation Camacho 2014 Content, Methods, Recommendations Systematic review of 18 primarily retrospective case series or historical cohorts. Overall quality: low. Tracheostomies significantly decrease apnea index, oxygen desaturation index, sleepiness and mortality in subjects with severe OSA. CMS coverage policy CMS NCD CMS Summary of LCDs CPAP coverage for: A. Adult patients diagnosed with OSA: 1. Coverage is initially limited to a 12-week period to identify beneficiaries diagnosed with OSA who benefit from CPAP. 2. CPAP is subsequently covered only for those beneficiaries diagnosed with OSA who benefit from CPAP during this 12-week period. OR B. Adult beneficiaries who do not qualify for CPAP coverage based on criteria for OSA diagnosis, under Coverage with Evidence Determination when enrolled in a registered clinical research study that addresses one of the two questions below. a. In Medicare-aged subjects with clinically identified risk factors for OSA, how does the diagnostic accuracy of a clinical trial of CPAP compare with PSG and Type II, III & IV HST in identifying subjects with OSA who will respond to CPAP? b. In Medicare-aged subjects with clinically identified risk factors for OSA who have not undergone confirmatory testing with PSG or Type II, III & IV HST, does CPAP cause clinically meaningful harm? Oral appliances considered medically necessary if criteria A-D are met: A. 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 testing. B. Beneficiary has a Medicare-covered sleep test that meets one of the following criteria (1-3): I. AHI or Respiratory Disturbance Index (RDI) is 15 events per hour with a minimum of 30 events; or, 10

II. III. The AHI or RDI is 5 and 14 events per hour with a minimum of 10 events and documentation of: a. Excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia; or, b. Hypertension, ischemic heart disease, or history of stroke; or, If the AHI > 30 or the RDI > 30 and meets either of the following(a or b): a. The beneficiary is not able to tolerate a positive airway pressure (PAP) device; or, b. The treating physician determines that the use of a PAP device is contraindicated. C. 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 in criterion A.) D. 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 (OSA) 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). PAP (positive airway pressure): I. Single-level CPAP (E0601) covered when used in the treatment of OSA if criteria A-C are met: A. 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. B. The beneficiary has sleep test (as defined below) that meets either of the following criteria (1 or 2): 1. AHI or RDI is 15 events per hour with a minimum of 30 events; or, 2. AHI or RDI is 5 and 14 events per hour with a minimum of 10 events and documentation of: a. Excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia; or, b. Hypertension, ischemic heart disease, or history of stroke. C. The beneficiary and/or their caregiver has received instruction from the supplier of the device in the proper use and care of the equipment. II. Bi-level respiratory assist device without back-up rate (E0470) is covered for those beneficiaries with OSA who meet criteria A-C above, in addition to criterion D: D. An E0601 has been tried and proven ineffective based on a therapeutic trial conducted in either a facility or in a home setting. Covered surgical treatments: I. UPPP for patients who meet the following criteria: A. Diagnosed OSA (RDI 15); and B. Failure to respond to CPAP or cannot tolerate CPAP or other appropriate noninvasive treatment; and C. Documented counseling by a physician, with recognized training in sleep disorders, about the potential benefits and risks of the surgery; and D. Evidence of retropalatal or combination retropalatal/retrolingual obstruction as cause of OSA. II. Mandibular Maxillary Osteotomy and Advancement and /or genioglossus advancement with or without hyoid suspension is covered for those patients who have all of the following: A. Diagnosed OSA (RDI 15); and B. Failure to respond to CPAP or cannot tolerate CPAP or other appropriate noninvasive treatment; and C. Documented counseling by a physician, with recognized training in sleep disorders, about the potential benefits and risks of the surgery; and D. Evidence of retrolingual obstruction as the cause of OSA, or previous failure of 11

UPPP to correct the obstructive sleep apnea. Note: Regarding the Mandibular Maxillary Osteotomy and Advancement operation: a. Separate repositioning of teeth would not be necessary except under unusual circumstances; but if necessary the dental work would be covered. b. b. Application of an interdental fixation device is occasionally necessary, and is a covered service (see Documentation Requirements). III. Tracheostomy is indicated: A. When patient is unresponsive to other means of treatment; or B. In cases where other means of treatment would be ineffective or not indicated. IV. Surgery to correct discrete anatomic abnormalities of the upper airway that significantly contribute to OSA (such as, but not limited to, enlarged tonsils or an enlarged tongue) based on adequate documentation in the medical records. IV. Submucous radiofrequency reduction of hypertrophied turbinates for treatment of nasal obstruction due to turbinate hypertrophy that significantly contributes to OSA or significantly compromises CPAP therapy. Not covered: Laser-assisted uvulopalatoplasty (LAUP). Palate reduction with the Somnoplasty System of Somnus Medical Systems. Palatal implants. Submucosal ablation of the tongue base, radiofrequency, one or more sites, per session. Glossary Apnea An absence of breathing (respirations). Apnea-hypopnea index (AHI) The number of apneic episodes (obstructive, central and mixed) plus hypopneas per hour of sleep. Bi-level positive airway pressure (BiPAP) A type of positive airway pressure (PAP) that delivers alternating levels of inspiratory pressure (IPAP) at higher pressure to keep the airway open as a patient breathes in, and expiratory pressure (EPAP) at lower pressure to reduce the work of exhaling. BiPAP can be set to drop the level at specific intervals or upon demand. Continuous positive airway pressure (CPAP) Device that delivers a steady, gentle flow of air through a soft, pliable face or nasal mask. Used to splint open a person s airway during sleep. Demand positive airway pressure (DPAP) A type of positive airway pressure (PAP) that uses a low base pressure and rapidly ramps up the pressure after an airway obstruction or flow limitation occurs. Genioglossus advancement (tongue advancement) A procedure that pulls the tongue forward in a manner that decreases the amount of tongue blockage during sleep. Hypersomnia Excessive deep or prolonged sleep period. Symptom is described as excess sleepiness. Hypopnea A partial reduction in breathing of at least 30 percent that lasts at least 10 seconds during sleep. This is measured by a nasal pressure transducer. 12

Laser assisted uvulopalatoplasty (LAUP) An outpatient procedure, in which a laser is used to remove parts or all of the uvula at the rear of the mouth. Medically Necessary- A service or benefit is Medically Necessary if it is compensable under the MA Program and if it meets any one of the following standards: The service or benefit will, or is reasonably expected to, prevent the onset of an illness, condition or disability. The service or benefit will, or is reasonably expected to, reduce or ameliorate the physical, mental or developmental effects of an illness, condition, injury or disability. The service or benefit will assist the Member to achieve or maintain maximum functional capacity in performing daily activities, taking into account both the functional capacity of the Member and those functional capacities that are appropriate for Members of the same age. Maxillomandibular advancement (MMA) A procedure that moves the upper jaw (maxilla) and the lower jaw (mandible) forward to widen the airway. Multi-level or stepwise surgery (MLS) This category includes a wide array of combined procedures to address narrowing of multiple sites in the upper airway. MLS frequently consists of phase I utilizing UPPP and/or genioglossus advancement and hyoid myotomy (GAHM). Phase II surgeries consist of utilizing maxillary and mandibular advancement osteotomy (MMO), offered to those failing phase I surgeries. Obstructive apnea Cessation of airflow into or out of the mouth or nose although efforts to breathe continue. Obstructive sleep apnea (OSA) A life-threatening and life-altering condition that causes a person to stop breathing repeatedly during sleep due to obstruction of the airway by excess tissue in the back of the throat, such as a semi-collapsed trachea, tongue relaxed to the back of the throat or a large amount of tissue in the uvula area Palatal implants Malleable plastic rods implanted into the soft palate under local anesthesia. Polysomnography (PSG) or overnight sleep study Standard method of detecting sleep disorders and evaluating treatments in children and adults while sleeping. PSG measures information such as airflow, brain activity (EEG), respiratory effort, eye movements (EOG), leg movements (EMG), blood oxygen saturation and unusual behavior. Positive airway pressure (PAP) Provides a stream of air through a mask worn during sleep. This airflow keeps the airway open, preventing pauses in breathing and restoring normal blood oxygen saturation. PAP can be continuous (CPAP), bilevel (BPAP) or autotitrating (APAP). Radiofrequency ablation (RFA) Placing a temperature-controlled radiofrequency probe typically in the tongue and/or soft palate in an effort at palatal stiffening. Respiratory disturbance index (RDI) The number of apneas (obstructive, central or mixed) plus hypopneas per hour of total sleep time as determined by all-night polysomnography. 13

Tracheostomy Creates an opening in the trachea for placement of a long-term indwelling tube or stoma for ventilation, thereby bypassing upper airway obstruction causing OSA. Uvula A fleshy extension at the back of the soft palate that hangs above the throat. Uvulopalatopharyngoplasty (UPPP) A procedure that enlarges the airway by removing excess tissue in the throat, which may include the uvula, soft palate, tonsils, adenoids and pharynx. Variable/bilevel positive airway pressure (VPAP) See BiPAP. References Professional society guidelines/others: 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. 2010 Oct;33(10):1408 13. 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 Sep 24. Randerath WJ, Verbraecken J, Andreas S, et al. Non-CPAP therapies in obstructive sleep apnoea. Eur Respir J. 2011 May;37(5):1000 28. Peer-reviewed references: Agency for Healthcare Research and Quality (AHRQ). Diagnosis and treatment of obstructive sleep apnea in adults. Comparative Effectiveness Review No. 32. (Prepared by Tufts Evidence-Based Practice Center under contract 290-2007-100551). Rockville, MD. Available at: http://www.effectivehealthcare.ahrq.gov/ehc/products/117/683/cer32_sleepapnea_finalreview_201 108.pdf. Accessed October 6, 2014. Anandam A, Akinnusi M, Kufel T, Porhomayon J, El-Solh AA. Effects of dietary weight loss on obstructive sleep apnea: a meta-analysis. Sleep Breath. 2013 Mar;17(1):227 34. Baessler A, Nadeem R, Harvey M, Madbouly E, Younus A, Sajid H, et al. Treatment for sleep apnea by continuous positive airway pressure improves levels of inflammatory markers - a meta-analysis. J Inflamm (Lond). 2013 Mar 22;10(1):13. CADTH. Adaptive servo ventilation versus continuous or bi-level positive airway pressure: a review of the clinical effectiveness, cost-effectiveness and guidelines. Ottawa: Canadian Agency for Drugs and Technologies in Health (CADTH); 2012. Camacho M, Certal V, Brietzke SE, Holty JE, Guilleminault C, Capasso R. Tracheostomy as treatment for adult obstructive sleep apnea: a systematic review and meta-analysis. Laryngoscope. 2014 Mar;124(3):803 11. 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. 2010 Oct;33(10):1396 407. 14

Choi JH, Kim SN, Cho JH. Efficacy of the Pillar implant in the treatment of snoring and mild-to-moderate obstructive sleep apnea: a meta-analysis. Laryngoscope. 2013 Jan;123(1):269 76. Hayes, Inc. Provent sleep apnea therapy (Ventus Medical Inc.). Lansdale, PA: Hayes Inc; 2012. 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. 2013 Apr;10(2):115 20. 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. 2013 May;68(5):487 8. Mason M, Welsh Emma J, Smith I. Drug therapy for obstructive sleep apnoea in adults. Cochrane Database of Systematic Reviews [serial on the Internet]. 2013; (5): CD003002. Available from: http://onlinelibrary.wiley.com/doi/10.1002/14651858.cd003002.pub3/abstract. Accessed October 5, 2014. Tomfohr LM, Edwards KM, Dimsdale JE. Is obstructive sleep apnea associated with cortisol levels? A systematic review of the research evidence. Sleep Med Rev. 2012 Jun;16(3):243 9. Clinical Trials: Searched Open Studies Exclude Unknown Interventional Studies "obstructive sleep apnea" NOT drug Adult, Senior on October 8, 2013. Results: 101 total studies, 72 studies relevant to topic. Searched Open Studies Exclude Unknown Interventional Studies "obstructive sleep apnea" NOT drug Adult, Senior on October 6, 2014. Six new relevant trials Centers for Medicare & Medicaid Services (CMS) national coverage determination 240.4 Continuous Positive Airway Pressure (CPAP) Therapy For Obstructive Sleep Apnea (OSA), http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?ncdid=226&ver=3. 240.4.1 Sleep Testing for Obstructive Sleep Apnea (OSA) http://www.cms.gov/medicare-coveragedatabase/details/ncd-details.aspx?ncdid=330&ver=1 Local coverage determinations L32975 Laparoscopic Sleeve Gastrectomy for Severe Obesity South Carolina (11201, 11202) http://www.cms.gov/medicare-coverage-database/details/lcddetails.aspx?lcdid=32975&ver=22&contrid=226&contrver=1 and http://www.cms.gov/medicarecoverage-database/details/lcd-details.aspx?lcdid=32975&ver=22&contrid=234&contrver=1 L28603 Oral Appliances for Obstructive Sleep Apnea Pennsylvania (16003) http://www.cms.gov/medicarecoverage-database/details/lcd-details.aspx?lcdid=28603&ver=16&contrid=137&contrver=1 15

L28620 Oral Appliances for Obstructive Sleep Apnea South Carolina, Louisiana (18003) http://www.cms.gov/medicare-coverage-database/details/lcddetails.aspx?lcdid=28620&ver=20&contrid=140&contrver=2 L31751 Oral Maxillofacial Prosthesis South Carolina (11202) http://www.cms.gov/medicare-coveragedatabase/details/lcd-details.aspx?lcdid=31751&ver=17&contrid=234&contrver=1 L33654 Oral Maxillofacial Prosthesis Pennsylvania (12501, A and B MAC, J - L) http://www.cms.gov/medicare-coverage-database/details/lcddetails.aspx?lcdid=33654&ver=10&contrid=318&contrver=1 L33654 Oral Maxillofacial Prosthesis Pennsylvania (12502, A and B MAC, J - L) http://www.cms.gov/medicare-coverage-database/details/lcddetails.aspx?lcdid=33654&ver=10&contrid=323&contrver=1 L33654 Oral Maxillofacial Prosthesis Pennsylvania (12901, A and B MAC, J - L) http://www.cms.gov/medicare-coverage-database/details/lcddetails.aspx?lcdid=33654&ver=10&contrid=324&contrver=1 L32643 Oral Maxillofacial Prosthesis Louisiana (07202, A and B MAC, J - H) http://www.cms.gov/medicarecoverage-database/details/lcd-details.aspx?lcdid=32643&ver=18&contrid=326&contrver=1 L32643 Oral Maxillofacial Prosthesis Louisiana (07201, A and B MAC, J - H) http://www.cms.gov/medicarecoverage-database/details/lcd-details.aspx?lcdid=32643&ver=18&contrid=328&contrver=1 L11518 Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea South Carolina, Louisiana (18003) http://www.cms.gov/medicare-coverage-database/details/lcddetails.aspx?lcdid=11518&ver=75&contrid=140&contrver=2 L11528 Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea Pennsylvania (16003) http://www.cms.gov/medicare-coverage-database/details/lcddetails.aspx?lcdid=11528&ver=75&contrid=137&contrver=1 L30731 Surgical Treatment of Obstructive Sleep Apnea (OSA) Louisiana, South Carolina (05901) http://www.cms.gov/medicare-coverage-database/details/lcddetails.aspx?lcdid=30731&ver=25&contrid=268&contrver=1 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. 16

CPT Code Description Comment 21085 Impression and custom preparation; oral surgical splint. 21193 21194 21195 21196 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. 21198 Osteotomy, mandible, segmental. 21199 Osteotomy, mandible, segmental; with genioglossus advancement. 21206 Osteotomy, maxilla, segmental (e.g., wassmund or schuchard). 21208 Osteoplasty, facial bones; augmentation (autograft, allograft or prosthetic implant). 21209 Osteoplasty, facial bones; reduction. 21685 Hyoid myotomy and suspension. 31600 Tracheostomy, planned (separate procedure). 41512 Tongue base suspension, permanent suture technique. 41530 Submucosal ablation of the tongue base, radiofrequency, 1 or more sites, per session. 41599 Unlisted procedure, tongue, floor of mouth. 42140 Uvulectomy, excision of uvula. 42145 Palatopharyngoplasty (e.g., uvulopalatopharyngoplasty, uvulopharyngoplasty). 42299 Unlisted procedure, palate, uvula. 42821 Tonsillectomy and adenoidectomy; age 12 or over. 94660 Continuous positive airway pressure ventilation (CPAP), initiation and management. ICD-9 Code Description Comment 327.23 Obstructive sleep apnea. ICD-10 Code Description Comment G47.31 Obstructive sleep apnea (adult) (pediatric). HCPCS Level II Description Comment 17

HCPCS Level II A4604 A7027 A7028 A7029 A7030 A7031 A7032 A7033 A7034 A7035 A7036 A7037 A7038 A7039 A7044 A7045 A7046 E0485 E0486 E0601 S8262 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 CPAP 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 (CPAP) device [for OSA with AHI 15 or > = to 15 events per hour with minimum of 30 or AHI > 5 and < 15 events per hour with minimum of 10 + one related diagnosis] [not covered for C-Flex]. Mandibular orthopedic repositioning device, each. Comment May be evaluated under medical or dental benefits for covered benefits. May be evaluated under medical or dental benefits for covered benefits. May be evaluated under medical or dental benefits for covered benefits. 18