: Positive Airway Pressure, Oral Appliances, and Surgical Interventions Policy: Obstructive sleep apnea (OSA) is characterized by an interruption of breathing during sleep most commonly due to extra or loose tissue in the upper airway that collapses into the air passage with the effort of inhalation. Individuals with untreated OSA exhibit symptoms of hypersomnolence, fatigue, and cognitive impairment. Untreated OSA is considered a significant health risk factor for several conditions. The presence of untreated severe OSA increases the odds of fatal cardiovascular event by 2.87 and the odds of nonfatal cardiovascular events by 3.17. OSA is also linked to an increased risk of stroke, epilepsy, insulin resistance and the development of diabetes. When OSA is suspected, a polysomnogram (PSG) study is often required for definitive diagnosis. The apnea hypopnea index (AHI) and/or respiratory disturbance index (RDI) are measured by the PSG. For purposes of this policy, the following definitions are provided: 1. The AHI is equal to the average number of episodes of apnea and hypopnea per hour 2. The RDI is equal to the average number of respiratory disturbances per hour 3. Apnea is defined as a cessation of airflow for at least 10 seconds 4. Hypopnea is defined as an abnormal respiratory event lasting at least 10 seconds with at least a 30% reduction in thoracoabdominal movement or airflow as compared to baseline, and with at least a 4% oxygen desaturation IEHP considers the treatment of obstructive sleep apnea (OSA) medically necessary according to the criteria outlined below: PAP (positive airway pressure): Positive airway pressure (PAP) therapy is considered the standard treatment of choice for mild, moderate, or severe OSA. Determination of medically necessary PAP therapy is as follows: CPAP (continuous positive airway pressure) 16 : 1. Presence of OSA and a complete PSG has been performed within the previous year in which the RDI or AHI: a. Must be equal to or greater than 15; and, i. The obstructive sleep apnea improves with the application of CPAP; or 10801 Sixth St, Suite 120, Rancho Cucamonga, CA 91730 Tel (909) 890-2000 Fax (909) 890-2003 Visit our web site at: www.iehp.org A Public Entity
Page 2 of 8 2. RDI or AHI is equal to or greater than 5 and less than 15 with at least one of the following associated symptoms: a. Excessive daytime sleepiness; b. Impaired cognition; c. Mood disorders; d. Insomnia; e. Hypertension; f. Ischemic Heart Disease; g. History of stroke BiPAP (Bi-level positive airway pressure devices) 11 : BiPAP devices are considered medically necessary DME for Members who are intolerant to CPAP or for whom CPAP is ineffective. BiPAP may also be considered medically necessary for OSA Members with concomitant breathing disorders, which include restrictive thoracic disorders, COPD, and nocturnal hypoventilation. Oral Appliances 6,7,8 : Oral appliances are custom fitted devices that are prescribed for individuals who cannot tolerate or decline PAP therapy. The two general types of oral devices are ones that reposition the patient s jaw and ones that hold the tongue forward. Jaw repositioning devices can also be classified as titratable or non-titratable. Over-the-counter devices are available, but only a custom fitted device can assure the most effective intervention. Oral appliances are indicated for Members with mild to moderate OSA. Oral appliances are accepted therapy for patients with severe OSA who do not respond to or are unable or unwilling to tolerate PAP therapies. Oral appliances can also serve as an adjunct to PAP therapy and/or other treatment modalities for the management of OSA. Surgical Interventions: 1. Uvulopalatopharyngoplasty (UPPP) 9,10,11 : Uvulopalatopharyngoplasty is used to treat OSA by enlarging the oropharynx. It is considered medically necessary for OSA members who meet the criteria for CPAP, but who are intolerant to CPAP. The medical records must document that the member has attempted CPAP before considering surgery. Uvulopalatopharyngoplasty (UPPP) is considered medically necessary if ALL of the following (1-4) are present: 1. Documented obstructive sleep apnea with apnea-hypopnea index (AHI) meeting the following parameters: a. UPPP as sole procedure: with AHI greater than15 and less than 40, or b. UPPP as sole procedure with AHI between 10-15 with one or more of the conditions listed below: i. Hypertension; or
Page 3 of 8 OR ii. Cardiac arrhythmias predominately during sleep; or iii. Pulmonary hypertension; or iv. Documented ischemic heart disease; or v. Impaired cognition or mood disorders; or vi. History of stroke; or vii. Excessive daytime sleepiness, as documented by either a score of greater than 10 on the Epworth Sleepiness Scale or inappropriate daytime napping, (e.g., during driving, conversation or eating) or sleepiness that interferes with daily activities. c. UPPP as part of a planned staged or combined surgery aimed at also relieving retrolingual obstruction, (e.g. genioglossal advancement, hyoid myotomy and suspension) with AHI greater than15, or d. UPPP as part of a planned staged or combined surgery aimed at also relieving retrolingual obstruction, (e.g. genioglossal advancement, hyoid myotomy and suspension) with AHI between 10-15 with one or more of the conditions listed below: i. Hypertension; or ii. Cardiac arrhythmias predominately during sleep; or iii. Pulmonary hypertension; or iv. Documented ischemic heart disease; or v. Impaired cognition or mood disorders; or vi. History of stroke; or vii. Excessive daytime sleepiness, as documented by either a score of greater than 10 on the Epworth Sleepiness Scale or inappropriate daytime napping, (e.g., during driving, conversation or eating) or sleepiness that interferes with daily activities. 2. CPAP (continuous positive airway pressure) has been tried with well-supported follow-up and clearly failed or is not tolerated, and 3. Fiberoptic endoscopy suggests retro-palatal narrowing is the primary source of airway obstruction if UPPP is the sole procedure or a contributing source of airway obstruction if part of a planned staged or combined surgery aimed at also relieving retrolingual obstruction. 4. The individual is 18 years of age or older 2. Soft Tissue Reconstruction 9 : Hyoid myotomy and suspension, with or without mandibular osteotomy with genioglossus (tongue) advancement, for the treatment of OSA is considered medically necessary when ALL of the following criteria (1-4) are met:
Page 4 of 8 AND 1. The treatment of OSA in the individual is medically necessary based on either a or b below: a. AHI greater than or equal to 15, or b. AHI greater than or equal to 5, and less than 15 with documentation demonstrating any of the following symptoms: i. Hypertension; or ii. Cardiac arrhythmias; or iii. Pulmonary hypertension; or iv. Documented ischemic heart disease; or v. Impaired cognition or mood disorders; or vi. History of stroke; or vii. Excessive daytime sleepiness, as documented by either a score of greater than 10 on the Epworth Sleepiness Scale or inappropriate daytime napping, (e.g., during driving, conversation or eating) or sleepiness that interferes with daily activities. 2. CPAP (continuous positive airway pressure) has been tried with wellsupported follow-up and clearly failed or is not tolerated, and 3. There is significant soft tissue and/or tongue base abnormalities with airway collapse (objective evidence of hypopharyngeal obstruction may be documented by either fiberoptic endoscopy or cephalometric radiographs.), and 4. The individual is 18 years of age or older 3. Jaw Realignment Surgery 9,10,11 : Jaw realignment surgery (that is, maxillomandibular advancement) is considered medically necessary when ALL of the following criteria (1-4) are met: 1. The treatment of OSA in the individual is medically necessary based on either a or b below: a. AHI greater than or equal to 15, or b. AHI greater than or equal to 5, and less than 15 with documentation demonstrating any of the following symptoms: i. Hypertension; or ii. Cardiac arrhythmias; or iii. Pulmonary hypertension; or iv. Documented ischemic heart disease; or v. Impaired cognition or mood disorders; or vi. History of stroke; or vii. Excessive daytime sleepiness, as documented by either a score of greater than 10 on the Epworth Sleepiness Scale or inappropriate daytime napping, (e.g., during driving, conversation or eating) or sleepiness that interferes with daily activities.
Page 5 of 8 AND 2. CPAP (continuous positive airway pressure) has been tried with well-supported follow-up and clearly failed or is not tolerated, and 3. The individual has failed surgical intervention with either UPPP or genioglossus advancement and/or hyoid myotomy with suspension or both of these surgical procedures, and 4. The individual is 18 years of age or older Jaw realignment surgery is also considered medically necessary for individuals with a documented severe jaw/facial bony abnormality that contributes to OSA, including, but not limited to, craniofacial abnormalities, micrognathia, retrognathia, or small retro-positioned jaw with associated overbite and small mouth. 4. Tracheostomy 10,11 : Tracheostomy is considered medically necessary for those Members with the most severe OSA when other medical and surgical options do not exist, have failed or are refused, or when deemed necessary by clinical urgency. 5. Uvelectomy and Laser Assisted Uvuloplasty (LAUP) 11 : Cold knife uvulectomy and laser assisted uvuloplasty (LAUP, laser uvulectomy) are considered experimental and investigational for OSA because they have not been shown to be as effective as UPPP for this indication. However, IEHP may consider these procedures medically necessary, upon individual case review, for members with severe OSA who have other medical conditions that make them unable to undergo UPPP and have failed a trial of CPAP or the use of an oral appliance or device. Uvulectomy is considered experimental and investigational as a treatment for recurrent throat infections and for all other indications. 6. Pediatric OSA: Tonsillectomy with or without Adenoidectomy 12 : Tonsillectomy with or without adenoidectomy is medically necessary for the treatment of obstructive sleep apnea in children since the available medical literature suggests that the majority of cases are amenable to and will benefit from these surgeries. The criteria is as follows: 1. Diagnosis of OSA with documentation of ALL of the following: a. Tonsillar hypertrophy; and b. PSG with an AHI greater than 1.0 CPAP and oral appliances may be considered medically necessary for the treatment of clinically significant OSA in children.
Page 6 of 8 Surgical Interventions deemed not medically necessary, experimental or investigational: 1. UPPP as a sole procedure with AHI under 10 2. Treatment of primary snoring disorder without OSA which is a benign condition 3. Use of palatal implants (e.g. injection snoreplasy, the Pillar TM system) 4. UPPP for UARS (upper airway resistance syndrome) 5. Cautery-assisted Palatal Stiffening Operation (CAPSO) 6. Radiofrequency Volumetric Tissue Reduction (RFVTR) of the soft palate and/or the base of the tongue including Somnoplasty and Coblation 7. Nasal Surgery 8. Transpalatal advancement pharyngoplasty 9. Bone-anchored tongue base suspension systems by permanent suture techniques (which include the AIRvance TM System [formerly the Repose System] and the ENCORE TM Tongue Suspension System) 10. Hypoglossal nerve stimulation Background: Obstructive sleep apnea (OSA) occurs when the patency of the nasopharyngeal airway becomes insufficient during sleep. Anatomic risk factors include nuchal obesity, deviated septum, nasal polyps, enlarged uvula and soft palate, small chin with deep overbite, enlarged tonsils, and hypertrophy of the lateral pharyngeal musculature. Patients with OSA also appear to be unable to maintain oropharyngeal muscle dilator activity during sleep sufficient to prevent airway collapse during the negative pressure of inspiration. Apneas and hypopneas are common during REM sleep, when muscles completely relax resulting in occlusion of the airway. The apneic event is terminated by a brief arousal to wakefulness or a lighter stage of sleep, which is accompanied by activation of the upper airway dilator and abductor muscles and restoration of airway patency. Snoring is highly prevalent in adults and children, and it is also the most common symptom of OSA. Snoring that is not accompanied by an AHI greater than or equal to 5 in adults and not associated with reports of excessive daytime sleepiness is referred to as primary snoring and is considered a benign condition. Snoring that is associated with OSA, however, is generally loud and intermittent, and is accompanied by awakening with gasping or choking, sleep fragmentation, restlessness, impaired concentration, and daytime sleepiness. Daytime sleepiness is thought to be related to sleep disruption and may also be related to recurrent hypoxemia. It is not unusual for patients subsequently diagnosed with OSA to initially present with hypertension, arrhythmias, or heart failure. There is mounting evidence that the presence and severity of OSA is associated with increased risk of cardiovascular disease. OSA is thought to play a role in the pathogenesis of systemic hypertension and heart failure and may also be associated with acute coronary syndromes, pulmonary hypertension, arrhythmias, and stroke. The American Academy of Sleep Medicine (2014) provides the following diagnostic criteria for obstructive sleep apnea in adults: (A and B) or C: A. The presence of one or more of the following:
Page 7 of 8 a. Patient complains of sleepiness, nonrestorative sleep, fatigue, or insomnia symptoms b. Patient wakes with breath holding, gasping, or choking c. Bed partner or other observer reports habitual snoring, breathing interruptions, or both during patient s sleep d. Patient has been diagnosed with hypertension, a mood disorder, cognitive dysfunction, coronary artery disease, stroke, congestive heart failure, atrial fibrillation, or type 2 diabetes mellitus B. PSG demonstrates: a. AHI greater than or equal to 5 C. PSG demonstrates: a. AHI equal to or greater than 15 All patients with OSA should receive education on lifestyle and behavior modification such as weight loss and alcohol intake reduction. Positive airway pressure therapy, with the CPAP being the most common, is the standard treatment of choice for mild, moderate, and severe OSA. Oral appliances may be used in mild and moderate OSA, or in patients who cannot tolerate positive airway pressure therapy. Surgical interventions may also be performed in appropriate OSA patients who have failed or cannot tolerate positive airway pressure therapy. Effective Date: November 29, 2007 Reviewed Annually: November 9, 2016 Revised: November 9, 2016 Bibliography: 1. "Adenotonsillectomy and Obstructive Sleep Apnea in Children", The Journal of Otolaryngology, Head and Neck Surgery, 2007, volume 136, pages 169-175. 2. "A Prospective Study of Surgical Outcomes of Children with Sleep Disordered Breathing," Journal of sleep, 2004, volume 27, pages 95-100. 3. "Sleep apnea, part one," Nonsurgical and Surgical Management of Infants and Children with Obstructive Sleep Apnea Syndrome," The Otolaryngology Clinics of North America, December 1998, page 969. 4. Blue Cross of California Medical Policy Bulletin: Treatment for Obstructive Sleep Apnea in Adults, Med. 00054 (rev. date 02/05/07) 5. Aetna Clinical Policy Bulletin: Uvulopalatopharyngoplasty, Surgery, Number:0004 (rev. 10/05/07). 6. Anthem Medical Policy: Prefabricated Oral Appliances for the Treatment of Obstructive Sleep Apnea, Number DME.00039, 10/04/2016, 7. Ramar, et al, Clinical Practice Guideline for the Treatment of Obstructive Sleep Apnea and Snoring with Oral Appliance Therapy: An Update for 2015, Journal of Clinical Sleep Medicine, Vol. 11, No. 7, pg. 773-827, 2015. 8. Sherr, et al, Definition of an Effective Oral Appliance for the Treatment of Obstructive Sleep Apnea and Snoring, Journal of Dental Sleep Medicine, Vol. 1, No. 1, pg. 51, 2014. 9. Anthem Medical Policy: Oral, Pharyngeal and Maxillofacial Surgical Treatment for Obstructive Sleep Apnea, Number SURG.00129, 01/05/2016. 10. Cigna Medical Coverage Policy: Obstructive Sleep Apnea Diagnosis and Treatment Services, Number 0158, 11/15/2015.
Page 8 of 8 11. Aetna: Obstructive Sleep Apnea in Adults, Number 0004, 03/29/2016. 12. Anthem Clinical UM Guideline: Tonsillectomy for Children with or without Adenoidectomy, Number CG- SURG-30, 05/19/2016. 13. Aetna: Obstructive Sleep Apnea in Children, Number 0752, 11/20/2015. 14. Aurora, et al, Practice Parameters for the Respiratory Indications for Polysomnography in Children, Sleep, Vol. 34, No. 3, 2011. 15. Centers for Medicare & Medicaid Services: National Coverage Determination (NCD) for Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea (240.4), Effective 3/13/2008. 16. Medi-Cal Provider Manual, Continuous Positive Airwary Pressure (CPAP) Equipment, Durable Medical Equipment (CME): Bill for Oxygen and Respiratory Equipment, pg. 22, May 2014. Disclaimer IEHP Clinical Authorization Guidelines (CAG) are developed to assist in administering plan benefits, they do not constitute a description of plan benefits. The Clinical Authorization Guidelines (CAG) express IEHP s determination of whether certain services or supplies are medically necessary, experimental and investigational, or cosmetic. IEHP has reached these conclusions based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). IEHP makes no representations and accepts no liability with respect to the content of any external information cited or relied upon in the Clinical Authorization Guidelines (CAG). IEHP expressly and solely reserves the right to revise the Clinical Authorization Guidelines (CAG), as clinical information changes.